CN102028784A

CN102028784A - Traditional Chinese medicine composite with effects of reducing heat, relieving ache and resisting virus and preparation method thereof

Info

Publication number: CN102028784A
Application number: CN2009101792632A
Authority: CN
Inventors: 萧伟; 王振中; 刘涛; 郑伟然; 韩兆忠; 章晨峰; 陈凤龙
Original assignee: Jiangsu Kanion Pharmaceutical Co Ltd
Current assignee: Jiangsu Kanion Pharmaceutical Co Ltd
Priority date: 2009-09-30
Filing date: 2009-09-30
Publication date: 2011-04-27
Anticipated expiration: 2029-09-30
Also published as: CN102028784B

Abstract

The invention relates to a traditional Chinese medicine composite, in particular to a traditional Chinese medicine composite with the effects of reducing heat, relieving ache and resisting virus and the preparation method thereof. The composite is prepared from 3 to 9 weight parts of lightyellow sophora root, 6 to 9 weight parts of gardenia and 3 to 9 weight parts of Chinese gentian. The traditional Chinese medicine composite can be prepared into tablets, capsules, pills, grains, soft capsules, injection or oral liquid by adopting the conventional medicine preparation method in pharmacy. The experiment research indicates that the traditional Chinese medicine composite has the advantages of obvious treatment effect, high safety and wide application prospect.

Description

A kind of Chinese medicine composition and method for making thereof with analgesic, analgesia, antivirus action

Technical field

The present invention relates to a kind of Chinese medicine composition, be specifically related to a kind of Chinese medicine composition and preparation method thereof with analgesic, analgesia, antivirus action.

Technical background

Virus is minimum biopathogen body, and numerous disease is caused by viral infection.A kind of virus can cause multiple disease, and a kind of disease can be caused that also virus can different diseases cause measles as Measles virus generally speaking with infecting different the causing of body condition, can cause giant cell pneumonia on one's body the immunocompromised by multiple virus; After the nervous system persistent infection, can cause the full brain class of subacute sclerosis.Flu can be caused for another influenza virus on one's body common people, and myocarditis can be caused and life-threatening simultaneously on one's body the immunocompromised.The research and development of antiviral drugs have become the emphasis of drug research work.

Because the development of antiviral drugs is started late, the medicine that can treat viral disease clinically effectively is very deficient, only is 1%～2% at medicine selling market, world proportion.Over nearly 10 years, along with diseases such as AIDS and viral hepatitis at global rapid spread, the demand of medicine is sharply increased, promoted the development of new drug and developing rapidly of selling market.

In recent years, though antiviral drug research has obtained certain progress, but it is still limited to have definite curative effect and safe and reliable antiviral drugs, for example, though the broad-spectrum antiviral preparation virazole can shorten the course of disease of first, influenza B, but big and the probability of teratogenesis is arranged because of its toxicity, be not approved for control virus always.Therefore, develop that the influenza new drug is still very urgent safely and effectively.

Summary of the invention

The purpose of this invention is to provide a kind of Chinese medicine composition with antivirus action;

Another object of the present invention provides the preparation method of this Chinese medicine composition;

The present invention also aims to provide that this Chinese medicine composition is analgesic in preparation, the purposes in the analgesic.

Of the present invention being achieved through the following technical solutions:

A kind of Chinese medicine composition is made by following bulk drugs: Radix Sophorae Flavescentis 3～9, Fructus Gardeniae 6～9, Radix Gentianae 3～6.

The preferred raw material weight proportioning of above-mentioned Chinese medicine composition is: Radix Sophorae Flavescentis 6, Fructus Gardeniae 8, Radix Gentianae 5.

The preferred raw material weight proportioning of above-mentioned Chinese medicine composition can also be: Radix Sophorae Flavescentis 9, Fructus Gardeniae 9, Radix Gentianae 6.

The preferred raw material weight proportioning of above-mentioned Chinese medicine composition can also be: Radix Sophorae Flavescentis 9, Fructus Gardeniae 9, Radix Gentianae 9.

The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and this preparation method is: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add in the sour water and decoct, filter, filtrate is concentrated into extractum, adds ethanol and leaves standstill, filter, filtrate recycling ethanol also is concentrated into extractum, extracts with n-butyl alcohol, collect extract, extract is recycled to no n-butyl alcohol, and drying is pulverized, add adjuvant, make required Chinese medicine preparation.

Above-mentioned Chinese medicine composition preparation method preferably be: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.1～0.5% aqueous hydrochloric acid solution that adds 8～20 times of amounts, decoct 1～3 time, each 1～3 hour, filter, filtrate decompression is concentrated into extractum, adds ethanol to containing alcohol amount 60～80%, left standstill 12～48 hours, filter, decompression filtrate recycling ethanol also is concentrated into extractum, extracts with n-butyl alcohol, collect extract, extract reclaim under reduced pressure n-butyl alcohol is not to there being n-butyl alcohol, and drying is pulverized, add adjuvant, make required Chinese medicine preparation.

Above-mentioned Chinese medicine composition preparation method more optimized technical scheme is: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.3% aqueous hydrochloric acid solution that adds 15 times of amounts, decoct 2 times, each 2 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, adds ethanol to containing alcohol amount 60～80%, left standstill 36 hours, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.05～1.10 extractum extracts with n-butyl alcohol, collect extract, extract reclaim under reduced pressure n-butyl alcohol is not to there being n-butyl alcohol, and drying is pulverized, add adjuvant, make required Chinese medicine preparation.

To Chinese medicine composition of the present invention, the present invention also provides another preparation method, and is specific as follows:

(1) hydrochloric acid reflux of getting Radix Sophorae Flavescentis adding 0.05%～0.15% extracts, and filters, and filtering residue adds 0.05%～0.15% hydrochloric acid reflux extraction again, filter merging filtrate, concentrating under reduced pressure, get sour extracted extract, cooling transfers to neutrality with sodium hydroxide, adds ethanol again and reaches 60%～80% to containing the alcohol amount, leave standstill, filter, filtrate recycling ethanol concentrates, get the preceding extractum of Radix Sophorae Flavescentis upper prop, last macroporous adsorptive resins, water, 5%～30% ethanol elution discard eluent successively, reuse 40%～70% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Sophorae Flavescentis highly finished product;

(2) get Fructus Gardeniae and add the water reflux, extract,, filter, filtering residue adds the water reflux, extract, again, filters, merging filtrate, concentrating under reduced pressure gets the Fructus Gardeniae the water extracted immersing paste, cooling, add ethanol and reach 60%～80%, leave standstill, filter to containing the alcohol amount, filtrate recycling ethanol gets the preceding extractum of Fructus Gardeniae upper prop, last macroporous adsorptive resins, the water eluting discards eluent, reuse 10%～30% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Fructus Gardeniae highly finished product;

(3) get Radix Gentianae and add the water reflux, extract,, filter, filtering residue adds the water reflux, extract, again, filters, merging filtrate, concentrating under reduced pressure gets the Radix Gentianae the water extracted immersing paste, cooling, add ethanol and reach 60%～80%, leave standstill, filter to containing the alcohol amount, filtrate recycling ethanol gets the preceding extractum of Radix Gentianae upper prop, last macroporous adsorptive resins, the water eluting discards eluent, reuse 8%～30% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Gentianae highly finished product;

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, the mixing of Radix Gentianae highly finished product, add adjuvant, make required Chinese medicine preparation.

Above-mentioned Chinese medicine composition preparation method preferably be:

(1) gets Radix Sophorae Flavescentis and add 10～20 times of amount 0.1% hydrochloric acid, reflux, extract, 1～3 hour filters, and filtering residue adds 10～20 times of amount 0.1% hydrochloric acid again, reflux, extract, 1～3 hour, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, get sour extracted extract, be cooled to room temperature, transfer to neutrality, add ethanol again and reach 70% to containing the alcohol amount with 10%～30% sodium hydroxide, left standstill 6～24 hours, filter, filtrate recycling ethanol is not distinguished the flavor of to there being alcohol, and relative density is 1.05～1.10, get the preceding extractum of Radix Sophorae Flavescentis upper prop, last macroporous adsorptive resins, water successively, 5%～30% ethanol elution discards eluent, reuse 45%～55% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Sophorae Flavescentis highly finished product to dry;

(2) get Fructus Gardeniae and add 10～20 times of water gagings, reflux, extract, 1～3 hour filters, filtering residue adds 10～20 times of water gagings again, and reflux, extract, 1～3 hour filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 70%, left standstill 6～24 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Fructus Gardeniae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 10%～20% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Fructus Gardeniae highly finished product to dry;

(3) get Radix Gentianae and add 10～20 times of water gagings, reflux, extract, 1～3 hour filters, filtering residue adds 10～20 times of water gagings again, and reflux, extract, 1～3 hour filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 70%, left standstill 6～24 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Radix Gentianae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 8%～15% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Radix Gentianae highly finished product to dry;

Above-mentioned Chinese medicine composition preparation method more optimized technical scheme is:

(1) gets Radix Sophorae Flavescentis and add 15 times of amount 0.1% hydrochloric acid, reflux, extract, 2 hours filters, and filtering residue adds 15 times of amount 0.1% hydrochloric acid again, reflux, extract, 2 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, get sour extracted extract, be cooled to room temperature, and transfer to neutrality, add ethanol again and reach 70% to containing the alcohol amount with 20% sodium hydroxide, left standstill 12 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, and to be concentrated into relative density be 1.05～1.10, get the preceding extractum of Radix Sophorae Flavescentis upper prop, last macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution discards eluent, reuse 50% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Sophorae Flavescentis highly finished product to dry;

(2) get Fructus Gardeniae and add 15 times of water gagings, reflux, extract, 2 hours filters, filtering residue adds 15 times of water gagings again, and reflux, extract, 2 hours filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 70%, left standstill 12 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Fructus Gardeniae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 15% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Fructus Gardeniae highly finished product to dry;

(3) get Radix Gentianae and add 15 times of water gagings, reflux, extract, 2 hours filters, filtering residue adds 15 times of water gagings again, and reflux, extract, 2 hours filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 70%, left standstill 12 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Radix Gentianae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 10% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Radix Gentianae highly finished product to dry;

Chinese medicine composition provided by the invention and preparation method thereof can adopt pharmaceutical methods conventional in the pharmaceutics to be prepared into tablet, capsule, pill, granule, soft capsule, injection, oral liquid.

Chinese medicine composition provided by the invention and preparation thereof can be applied to prepare the antipyretic medicine.

Chinese medicine composition provided by the invention and preparation thereof can also be applied to prepare the analgesic medicine.

Chinese medicine composition provided by the invention and preparation thereof can also be applied to prepare antiviral drug.

Effects such as that Chinese medicine composition of the present invention has is analgesic, analgesia, antiviral, the inventor has carried out experimentation to this content, in order to the therapeutical effect of proof Chinese medicine composition of the present invention.

Following experiment is used to further specify effect of the present invention, but does not limit the present invention.

Experiment one: the experimentation that yeast is caused heating rat model refrigeration function

1. experiment purpose

Cause the rat fever model by duplicating yeast, observe the refrigeration function of Chinese medicine composition of the present invention (being designated hereinafter simply as " compound light-yellow sophora root compositions ").

2. experiment material

2.1 medicine and reagent

2.1.1 test sample: compound light-yellow sophora root compositions: be brown ceramic powder, every gram is equivalent to crude drug in whole 4.55g.

2.1.2 contrast medicine: analgin tablet: 0.5g * 2 slice/bag, the sharp monarch in Xi'an pharmaceutical Co. Ltd.

2.1.3 reagent: yeast (eating): the 20g/ bag, Hubei Angel Yeast Co.,Ltd provides, lot number: 20080305.

2.2 laboratory animal: 60 of SD rats, male, body weight 200～220g, cleaning level, Zhejiang Province's Experimental Animal Center provides, the quality certification number: (Zhejiang) 2008-0004.

2.3 key instrument: electronic clinical thermometer.

3. experimental technique

3.1 modeling method

Get 60 of male SD rats, every day, adaptability was surveyed the anus temperature 1 time, continuous 2d, and get 2 days average body temperature and make basal body temperature, in the 3rd day subcutaneous injection 20% yeast suspension 1.5ml/ only, the person is modeling success rat more than 0.8 ℃ to select body temperature to raise than basal body temperature after 6 hours.

3.2 animal is handled

All rats are modeling as stated above all, will become the mould rat to change by body temperature and is divided into 5 groups at random, be i.e. dosage group, compound light-yellow sophora root compositions low dose group in model group, dipyrone group, compound light-yellow sophora root compositions high dose group, the compound light-yellow sophora root compositions, 9 every group.Gastric infusion immediately after the grouping, model group gives isometric distilled water, the dipyrone group is given dipyrone suspension 0.09g/kg, compound light-yellow sophora root compositions high dose group is given compound light-yellow sophora root compositions 1.18g/kg, the dosage group is given compound light-yellow sophora root compositions 0.59g/kg in the compound light-yellow sophora root compositions, and compound light-yellow sophora root compositions low dose group is given compound light-yellow sophora root compositions 0.29g/kg.Each organizes the administration volume is 10ml/kg.1h measures body temperature for the first time after the administration, administration for the second time immediately, and method dosage is the same.

3.3 observation index: 1h, 2h, 3h, 4h, 5h survey and respectively organize rat temperature and record after administration.

3.4 statistical method: all measurement datas adopt x ± s to represent, adopt t check comparable group differences.

4. experimental result and conclusion

Experimental result sees Table 1, heat up relatively with model group, three dosage groups of compound light-yellow sophora root compositions all have extremely significant difference (P＜0.001) at 5 period body temperature, and compound light-yellow sophora root combination object height, middle dosage group and dipyrone group be there was no significant difference (P＞0.05) relatively.Show that the compound light-yellow sophora root compositions causes the heating rat model to yeast all the better antipyretic effect.

Table 1 compound light-yellow sophora root compositions causes the influence of heating rat model body temperature to yeast

Compare #P＜0.001 with model group

Experiment two: experiment of analgesic research

1. test objective

By comparing the inhibitory action that compound light-yellow sophora root compositions Dichlorodiphenyl Acetate causes mice pain, observe its analgesic activity.

2. test material

2.1 experimental animal

50 male ICR mouses, body weight 18～22g, available from the Nanjing Military Command hospital general, the quality certification: SCXK (Soviet Union) 2007-012.

2.2 medicine and reagent

The compound light-yellow sophora root compositions: be brown ceramic powder, every g is equivalent to crude drug in whole 4.55g.

Aspirin, Nanjing Pharmaceutical Plant provides, lot number: 070614, specification: 0.3g/ sheet;

Acetic acid (AR) is learned the production of reagent company limited, lot number: 20070410 by triumphant Tonghua, Tianjin.

3. test method

50 mices are divided into 5 groups at random, every group 10: the normal control group, the aspirin group is given aspirin suspension 0.25g/kg, compound light-yellow sophora root compositions high dose group is given compound light-yellow sophora root compositions 1.62g/kg, the dosage group is given compound light-yellow sophora root compositions 0.81g/kg in the compound light-yellow sophora root compositions, and compound light-yellow sophora root compositions low dose group is given compound light-yellow sophora root compositions 0.40g/kg.Each group is by corresponding dosage gastric infusion, administration volume 0.1ml/10g.After the administration 30 minutes lumbar injection 0.6% acetic acid 0.2ml/ only, that writes down each Mus in 30 minutes turns round the body number of times.

4. result of the test and conclusion

Experimental result sees Table 2, compares with the normal control group, can significantly reduce the mouse writhing reaction (p＜0.05 or p＜0.01) that acetic acid causes after aspirin group, the administration of three dosage groups of compound light-yellow sophora root compositions.Show that the compound light-yellow sophora root compositions has the effect that remarkable inhibition acetic acid causes mice pain.

The analgesic activity of table 2 compound light-yellow sophora root compositions (x ± s, n=10)

Compare with the normal control group: * p＜0.05, * * p＜0.01

Experiment three: extracorporeal antivirus effect effect

1. test objective

Observe the outer antivirus action of compound light-yellow sophora root composition of the present invention, to judge its curative effect, for clinical practice provides the pharmacodynamics foundation.

2. test material

2.1 medicine:

2.2 seed culture of viruses:

Coxsackie virus CVB ₃Type and 7 types and syncytial virus (RSV) provide by pestilence teaching and research room of Nanjing University of Traditional Chinese Medicine.Go down to posterity 4 times in chick embryo allantoic cavity.And measure its TCID50.

2.3 experimental instrument and equipment

Tissue Culture Plate (U.S. Corning company); CO ₂Incubator (U.S. Shel-lab company)

2.4 culture medium IMDM (U.S. GIBC product)

3. test method

3.1 the preparation of medicinal liquid

Use Hank ' s liquid that the kuh-seng soup extract of two kinds of different process is diluted in 1: 10,1: 20,1: 40,1: 80,1: 160,1: 320 and 1: 640 ratio, liquor strength is respectively 300.00g/ml, 150.00g/ml, 75.00g/ml, 37.50g/ml, 18.75g/ml, 9.38g/ml, the 4.69g/ml of crude drug in whole.

3.2 medicine is to the maximal non-toxic concentration (TD of HeLa cell ₀) measure

In the HeLa cell monolayer of 96 porocyte culture plates, add the kuh-seng soup extract of different quality concentration respectively, put 37 ℃, 5%CO ₂Cultivate 96h in the incubator, the observation of cell pathological changes.

3.3 virus virulence is measured: 96 orifice plates are cultivated the HeLa cell monolayer, the different dilution factors (10 with RSV of inoculation CVB3 ^-1～10 ^-10/ mL) viral liquid, each dilution factor is inoculated 6 holes, puts 37 ℃ and cultivates 96h, and the observation of cell pathological changes is determined its TCID ₅₀

3.4 the inhibition test of compound light-yellow sophora root compositions pair cell pathological changes

Experiment records the compound light-yellow sophora root compositions maximal non-toxic concentration of HeLa cell is 300g/ml.In the HeLa of two 96 well culture plates cell monolayer, CVB is infected in every hole ₃And RSV100TCID ₅₀, the 2h hypsokinesis venom of preventing or cure a disease adds the kuh-seng soup extract of different quality concentration respectively, cultivates observation of cell pathological changes behind the 96h.("-" represents acellular pathological changes; "+" expression has 25% cell generation pathological changes; " ++ " expression has 50% cell generation pathological changes; " +++" expression has 75% cell generation pathological changes; " ++ ++ " expression has 100% cell generation pathological changes).

4. result of the test and conclusion

Each organizes cytopathy shown in table 3, table 4, and the result shows when compound light-yellow sophora root composition concentration of the present invention is 300g/ml the HeLa cell is had protective effect, can significantly suppress the activity of CVB3 and RSV, demonstrates stronger antivirus action.

Table 3 compound light-yellow sophora root compositions is to the therapeutical effect of the HeLa cell of CVB3 infection

Table 4 compound light-yellow sophora root compositions is to the therapeutical effect of the HeLa cell of rsv infection

Experiment four: to the influence of mice influenza virus property pneumonia

1. test objective

Observe the influence of compound light-yellow sophora root compositions of the present invention, understand the antivirus action of this product, provide theoretical foundation for further developing we to infective virus pneumonia mice.

2. test material

2.1 experimental animal

120 of healthy adult kunming mices, male, the cleaning level, body weight 18～22g is provided the quality certification by the Nanjing Military Command hospital general: SCXK (Soviet Union) 2003-0004;

2.2 be subjected to the reagent thing

Compound light-yellow sophora root compositions of the present invention;

SHUANGHUANGLIAN FENZHENJI is provided by No. 2 TCM Factory.

2.3 seed culture of viruses

Influenza A virus FM1 Mus lung adapted strain is provided by pestilence teaching and research room of Nanjing University of Traditional Chinese Medicine, after mice strengthens virulence, goes down to posterity 4 times in chick embryo allantoic cavity, and measures its half and extremely measure (LD ₅₀).

3. test method

3.1 virus dilution

Before the test, get seed culture of viruses and dash with flowing water and soak thawing, be diluted to per 0.05 milliliter with Sterile Saline and contain 20 LD ₅₀, put in the frozen water and preserve.

3.2 infecting mouse

Divide positive drug group (SHUANGHUANLIAN), virus control and trial drug group mice at random, 20 every group.Under the slight anesthesia of ether, with titration influenza virus drop nose infection, 4 of every Mus, about 0.05 milliliter (20 LD ₅₀).Establish the normal mouse matched group simultaneously.

3.3 administration

Mice is pressed 0.5 times, 1 times, 2 times administrations of clinical equivalent dose, and positive drug (SHUANGHUANLIAN) matched group dosage is 0.10g/kg, aseptic filtration.Above medicine all begins the tail vein injection administration in virus attack the previous day, and once a day, administration is five days altogether.

3.4 measure lung fat number

Infected back four days, and cutd open mice extremely, fasting was prohibited water more than 4 hours before cuing open extremely.Claim the mice body weight, put to death the back and take out the Mus lung, write down lesion degree, lung is placed in the plate that fills 0.9% normal saline washs secondary, blot surface moisture with absorbent paper, it is heavy to weigh up lung.Calculate lung fat number and suppression ratio as follows:

4. result of the test and conclusion

Experimental result sees Table 5, compares with model group, and compound light-yellow sophora root combination object height, middle dosage group lung index all significantly reduce.The result shows that compound light-yellow sophora root compositions of the present invention has significant protective effect to the mouse lung of influenza virus infection, demonstrates antivirus action preferably.

Table 5 compound light-yellow sophora root compositions is to the influence of mouse infection influenza virus property pneumonia (x ± s)

Compare with model group: * P＜0.05, * * P＜0.01.

Experiment five: to the protective effect of influenza virus infecting mouse

1. test objective

Observe antivirus action in the compound light-yellow sophora root composition of the present invention,, provide the pharmacodynamics foundation for further developing we to judge its curative effect.

2. test material

2.1 medicine

Compound light-yellow sophora root compositions of the present invention;

SHUANGHUANGLIAN FENZHENJI is provided by No. 2 TCM Factory.

2.2 animal

100 of healthy adult kunming mices, male, the cleaning level, body weight 18～22g is provided by Nanjing General Hospital, Nanjing Military Area Command, PLA.

2.3 seed culture of viruses

3. test method

3.1 virus dilution

Before the test, get seed culture of viruses and be diluted to per 0.05 milliliter with physiological saline solution and contain 20 LD50, put in the frozen water and preserve.

3.2 infecting mouse

100 mices are divided 5 groups at random, 20 every group, are respectively positive drug group (SHUANGHUANLIAN), normal control group, compound light-yellow sophora root compositions high dose group, middle dosage group, low dose group.Under the slight anesthesia of ether, with titration influenza virus drop nose infection, 4 of every Mus, about 0.05 milliliter (is equivalent to 20 LD ₅₀).

3.3 dosage design and administration

Mice is pressed 0.5 times, 1 times, 2 times administrations of clinical equivalent dosage, and positive drug (SHUANGHUANLIAN) matched group dosage is 0.10g/kg.The all beginning administrations in 6 hours after virus attack of above medicine, administration is 12 days altogether, once a day, intravenous administration.

3.4 observe

Day by day observe animal morbidity and death toll, observed altogether 15 days, if the still not dead person that exceedes 15 days is in 15 days, dead person disregards within two days.

4. result of the test and conclusion

Experimental result sees Table 6, and compound light-yellow sophora root combination object height, middle dosage group are compared with the normal control group, significant difference (p＜0.05 or p＜0.01) is all arranged on mean survival time, survival rate, and have the doses dependency.The result shows, the protective effect that the compound light-yellow sophora root compositions has influenza A virus FM1 strain infecting mouse.

Table 6 kuh-seng soup extract to the protective effect of influenza virus infecting mouse (x+s, n=20)

Compare with model group: * P＜0.05; * P＜0.01

Beneficial effect of the present invention:

1. the prescription of the present composition is made up of Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae three flavor medical materials, Fructus Gardeniae bitter cold in the side, and energy pathogenic fire purging relieving restlessness, heat-clearing and toxic substances removing can remove the three warmers pathogenic heat, as monarch drug; The Radix Sophorae Flavescentis bitter in the mouth is cold in nature, and the energy heat clearing and damp drying is except that last, middle Jiao's heat; Radix Gentianae is cold in nature, can heat-clearing and toxic substances removing, it is descending to draw heat, is longer than damp-heat in lower-JIAO clearly, with Radix Sophorae Flavescentis be ministerial drug altogether, with the power of reinforcement Fructus Gardeniae clearing away heat-fire; Three medicines share, and are collaborative mutually, play heat-clearing and toxic substances removing altogether, lead to and rush down damp and hot merit.Studies show that by experiment, evident in efficacy, and safe, the application prospect that tool is wide.

2. the physicochemical property of Chinese medicine composition prescription flavour of a drug middle finger mark property composition, effectiveness composition according to the present invention by research, at the character of the active ingredient in the present composition medical material, the invention provides 2 kinds of preparation methoies:

First kind of preparation method advantage is: adopt acid extraction, can extract the active ingredient in the medical material fully, thereby guarantee the effect of finished product performance good curing; Adopt process for refining such as ethanol precipitation and counter-current extraction techniques, have simple to operate, active ingredient accumulation rate height, the working condition gentleness, operating cost is low and can adapt to advantage such as industrialized great production requirement.

Second kind of preparation method advantage is: this preparation method adopts through macroporous adsorption resin technology and handles, and absorption and eluting selectivity are good, can make the active ingredient highly dense, keep more effective ingredient, and impurity is few, dosage dwindles, improve inherent quality, also be convenient to quality control; And, after macroporous adsorption resin technology is handled, can remove moisture absorption compositions such as a large amount of saccharides, inorganic salt, lymphatic temperament effectively, reduce the moisture absorption of product, strengthen the stability of medicine; In addition, adopt macroporous adsorption resin technology easy and simple to handle, equipment needed thereby is simple, and resin regeneration is easy, but repetitive operation can also be shortened the production cycle.

3. the invention provides the preparation method of multiple pharmaceutical dosage form, the present composition is prepared into certain pharmaceutical dosage form, can use more easily, improve therapeutic effect simultaneously.

The specific embodiment

Embodiment 1: capsule

Prescription: Radix Sophorae Flavescentis 900g, Fructus Gardeniae 900g, Radix Gentianae 900g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.3% aqueous hydrochloric acid solution of 15 times of amounts, decoct 2 times, each 2 hours, to filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 70%, left standstill 36 hours, and filtered, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extract with n-butyl alcohol, collect extract, extract is recycled to no n-butyl alcohol, drying, pulverize, mixing adds appropriate amount of starch or dextrin, drying, pulverize, sieve, incapsulate, make 1000.

Function cures mainly: heat-clearing and toxic substances removing, logical rush down damp and hot.Be used for the treatment of diseases such as hyperpyrexia, micro evil wind that influenza causes are cold, a general pain, cough, expectorant Huang.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 2: capsule

Prescription: Radix Sophorae Flavescentis 500g, Fructus Gardeniae 700g, Radix Gentianae 400g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.3% aqueous hydrochloric acid solution that adds 12 times of amounts, decoct 2 times, each 3 hours, to filter, filtrate decompression is concentrated into extractum, add ethanol to containing alcohol amount 70%, left standstill 24 hours, and filtered, filtrate decompression is concentrated into extractum, extract with n-butyl alcohol, collect extract, extract is recycled to no n-butyl alcohol, drying, pulverize, add an amount of adjuvant in the dry powder (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, in dilution such as the mannitol adjuvant one or more), drying is pulverized, sieve, incapsulate, make 1000, promptly.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 3: capsule

Prescription: Radix Sophorae Flavescentis 900g, Fructus Gardeniae 900g, Radix Gentianae 600g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.2% aqueous hydrochloric acid solution that adds 20 times of amounts, decoct 1 time, 3 hours, to filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 75%, left standstill 36 hours, and filtered, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extract with n-butyl alcohol, collect extract, extract is recycled to no n-butyl alcohol, drying, pulverize, add an amount of adjuvant in the dry powder (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, in dilution such as the mannitol adjuvant one or more), drying is pulverized, sieve, incapsulate, make 1000, promptly.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 4: granule

Prescription: Radix Sophorae Flavescentis 300g, Fructus Gardeniae 600g, Radix Gentianae 300g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.2% aqueous hydrochloric acid solution that adds 20 times of amounts, decoct 1 time, 3 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 75%, left standstill 24 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extract with n-butyl alcohol, collect extract, extract is recycled to no n-butyl alcohol, dry, pulverize, add an amount of adjuvant in the dry powder (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, in dilution such as the mannitol adjuvant one or more), dry, pulverize, add suitable bonding (binding agent such as PEG200, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, microcrystalline Cellulose etc. or liquid adhesive such as ethanol, gelatine size, starch slurry, syrup etc. one or more), granulate, granulate is made granule 1000g, promptly.

Usage and dosage: oral, every day 2～3 times, each 5～10g.

Embodiment 5: tablet

Prescription: Radix Sophorae Flavescentis 800g, Fructus Gardeniae 600g, Radix Gentianae 300g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.4% aqueous hydrochloric acid solution that adds 18 times of amounts, decoct 2 times, 1 hour, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 80%, left standstill 36 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extract with n-butyl alcohol, collect extract, extract is recycled to no n-butyl alcohol, dry, pulverize, add an amount of adjuvant in the dry powder (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, the dilution adjuvant that mannitol and other pharmaceuticss are commonly used etc. one or more), mix, dry, pulverize, add an amount of binding agent (binding agent such as PEG200, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, the macromolecular material polyvinylpyrrolidone, sodium carboxymethyl cellulose, methylcellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl emthylcellulose, sodium alginate etc. or liquid adhesive such as ethanol, gelatine size, starch slurry etc. one or more), the system granule, add lubricant (as magnesium stearate, Pulvis Talci, sodium stearyl fumarate etc. one or more), granulate, total mixing, be pressed into 1000, promptly.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 6: soft capsule

Prescription: Radix Sophorae Flavescentis 700g, Fructus Gardeniae 700g, Radix Gentianae 400g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.3% aqueous hydrochloric acid solution that adds 18 times of amounts, decoct 2 times, 2 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 65%, left standstill 48 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extracts with n-butyl alcohol, collects extract, extract is recycled to no n-butyl alcohol, drying is pulverized, and adds an amount of adjuvant in the dry powder (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, in dilution such as the mannitol adjuvant one or more), dry, pulverize, with proper supplementary material (as PEG200, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500 and vegetable oil series etc., antiseptic such as sorbic acid or potassium salt, benzoic acid and propanoic acid etc.; Solubilizing agent such as tween series wait one or more, antioxidant such as sodium sulfite, sodium thiosulfate etc. one or more), behind the mixing, in incapsulating, make 1000 soft capsules, promptly by any way.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 7: oral liquid

Prescription: Radix Sophorae Flavescentis 700g, Fructus Gardeniae 800g, Radix Gentianae 500g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.3% aqueous hydrochloric acid solution that adds 18 times of amounts decocts 2 hours 2 times, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, adds ethanol to containing alcohol amount 70%, leaves standstill 36 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extracts with n-butyl alcohol, collects extract, extract is recycled to no n-butyl alcohol, drying is pulverized, and joins in the boiling water, the heat treatment appropriate time, cold preservation filters, add the adjuvant correctives as sucrose, Mel, xylitol, stevioside, maltose alcohol etc. one or more; Antiseptic such as sorbic acid or potassium salt, benzoic acid and propanoic acid etc. one or more; Solubilizing agent such as tween series etc., antioxidant such as sodium sulfite, sodium thiosulfate or the like one or more), filter, 1000mL is made in embedding, sterilization, promptly.

Usage and dosage: oral, every day 2～3 times, each 5～10mL.

Embodiment 8: concentrated pill

Prescription: Radix Sophorae Flavescentis 600g, Fructus Gardeniae 800g, Radix Gentianae 400g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.3% aqueous hydrochloric acid solution that adds 18 times of amounts decocts 2 hours 2 times, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, adds ethanol to containing alcohol amount 70%, leaves standstill 36 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extracts with n-butyl alcohol, collects extract, extract is recycled to no n-butyl alcohol, drying is pulverized, and adds suitable quantity of water, the general ball of making, cold drying is made 5000 of concentrated pills, promptly.

Usage and dosage: oral, every day 2～3 times, each 5～10.

Embodiment 9: chewable tablet

Prescription: Radix Sophorae Flavescentis 600g, Fructus Gardeniae 900g, Radix Gentianae 500g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.4% aqueous hydrochloric acid solution that adds 16 times of amounts, decoct 3 times, 2 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 75%, left standstill 36 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extract with n-butyl alcohol, collect extract, extract is recycled to no n-butyl alcohol, dry, pulverize, add appropriate amount of auxiliary materials (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, in dilution such as lactose or the mannitol adjuvant one or more) mix, dry, pulverize, obtain fine powder and an amount of binding agent (binding agent such as PEG200, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, the macromolecular material polyvinylpyrrolidone, sodium carboxymethyl cellulose, methylcellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl emthylcellulose, sodium alginate or the like or liquid adhesive such as ethanol, starch slurry, the dextrin slurry waits one or more) mixed granule, add an amount of correctives (as mannitol, sucrose, xylitol, stevioside, maltose alcohol, Mentholum, erythrol, orange peel oil, Oleum Cinnamomi, various essence etc. one or more), lubricant is (as magnesium stearate, Pulvis Talci, sodium stearyl fumarate, magnesium laurylsulfate etc. one or more), disintegrating agent is (as carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, pregelatinized Starch, microcrystalline Cellulose, soybean polysaccharide, alginic acid, handle agar etc. one or more) granulate, total mixing, be pressed into 1000, promptly.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 10: drop pill

Prescription: Radix Sophorae Flavescentis 600g, Fructus Gardeniae 600g, Radix Gentianae 500g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.2% aqueous hydrochloric acid solution that adds 15 times of amounts, decoct 3 times, 1.5 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 80%, left standstill 24 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, extract with n-butyl alcohol, collect extract, extract is recycled to no n-butyl alcohol, dry, pulverize, with Polyethylene Glycol-4000 and dry powder with 1～6: 1～5 ratio melting mixing, methyl-silicone oil is made coolant, drip and make 1000 of drop pill, promptly.

Usage and dosage: oral, every day 2～3 times, each 5～10 balls.

Embodiment 11: injection

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.3% aqueous hydrochloric acid solution of 15 times of amounts, decoct 2 times, each 2 hours, to filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 60～80%, left standstill 36 hours, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.05～1.10 extractum extracts with n-butyl alcohol, collects extract, extract reclaim under reduced pressure n-butyl alcohol is to there not being n-butyl alcohol, drying is pulverized, and gets dry powder; Get water for injection 1000ml, boil, add dry powder, boiled 15 minutes, cold preservation was not less than 48 hours, filtered, get filtrate, transfer pH, add 0.5% active carbon after boiling and boil, after the absorption, filter, get filtrate, be chilled to room temperature, 100 of injection are sterilized, made to ultrafiltration,, promptly at embedding.

Usage and dosage: intravenous drip, every day 1 time, each 10ml～20ml (1～2) instils with 5% glucose injection or 0.9% normal saline solution 250ml dilution posterior vein.

Embodiment 12: powder ampoule agent for injection

Prescription: Radix Sophorae Flavescentis 600g, Fructus Gardeniae 600g, Radix Gentianae 900g

Preparation method: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add 0.3% aqueous hydrochloric acid solution of 15 times of amounts, decoct 2 times, each 2 hours, to filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 60～80%, left standstill 36 hours, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.05～1.10 extractum extracts with n-butyl alcohol, collects extract, extract reclaim under reduced pressure n-butyl alcohol is to there not being n-butyl alcohol, drying is pulverized, and gets dry powder; Get water for injection 1000ml, boil, add dry powder, boiled 15 minutes, cold preservation was not less than 48 hours, filtered, and got filtrate, transfer pH, add 0.5% active carbon after boiling and boil, after the absorption, filter, get filtrate, be chilled to room temperature, microfiltration, ultrafiltration, lyophilizing, packing is made 100 of powder ampoule agent for injection, promptly.

Usage and dosage: intravenous drip.Each 1～2,1 time on the one; Before facing usefulness, instil with sodium chloride injection or 5% glucose injection 500ml dilution posterior vein.

Embodiment 13: capsule

Prescription: Radix Sophorae Flavescentis 300g, Fructus Gardeniae 800g, Radix Gentianae 700g

Preparation method: (1) is got Radix Sophorae Flavescentis and is added 15 times of amount 0.1% hydrochloric acid, reflux, extract, 2 hours filters, and filtering residue adds 15 times of amount 0.1% hydrochloric acid again, reflux, extract, 2 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, get sour extracted extract, be cooled to room temperature, and transfer to neutrality, add ethanol again and reach 70% to containing the alcohol amount with 20% sodium hydroxide, left standstill 12 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, and to be concentrated into relative density be 1.05～1.10, get the preceding extractum of Radix Sophorae Flavescentis upper prop, last macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution discards eluent, reuse 50% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Sophorae Flavescentis highly finished product to dry;

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, the mixing of Radix Gentianae highly finished product, add an amount of adjuvant (as in dilution such as dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, the mannitol adjuvant one or more), dry, pulverize, sieve, incapsulate, make 1000, promptly.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 14: tablet

Prescription: Radix Sophorae Flavescentis 300g, Fructus Gardeniae 900g, Radix Gentianae 600g

Preparation method: (1) is got Radix Sophorae Flavescentis and is added 20 times of amount 0.1% hydrochloric acid, reflux, extract, 3 hours filters, and filtering residue adds 10 times of amount 0.1% hydrochloric acid again, reflux, extract, 1 hour, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, get sour extracted extract, be cooled to room temperature, and transfer to neutrality, add ethanol again and reach 75% to containing the alcohol amount with 20% sodium hydroxide, left standstill 24 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, and to be concentrated into relative density be 1.05～1.10, get the preceding extractum of Radix Sophorae Flavescentis upper prop, last macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution discards eluent, reuse 50% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Sophorae Flavescentis highly finished product to dry;

(2) get Fructus Gardeniae and add 20 times of water gagings, reflux, extract, 3 hours filters, filtering residue adds 10 times of water gagings again, and reflux, extract, 1 hour filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 65%, left standstill 12 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Fructus Gardeniae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 15% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Fructus Gardeniae highly finished product to dry;

(3) get Radix Gentianae and add 20 times of water gagings, reflux, extract, 3 hours filters, filtering residue adds 10 times of water gagings again, and reflux, extract, 1 hour filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 65%, left standstill 24 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Radix Gentianae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 10% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Radix Gentianae highly finished product to dry;

(4) get the Radix Sophorae Flavescentis highly finished product, the Fructus Gardeniae highly finished product, the Radix Gentianae highly finished product mix, add an amount of adjuvant (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, the dilution adjuvant that mannitol and other pharmaceuticss are commonly used etc. one or more), mix, dry, pulverize, add an amount of binding agent (binding agent such as PEG200, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, the macromolecular material polyvinylpyrrolidone, sodium carboxymethyl cellulose, methylcellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl emthylcellulose, sodium alginate etc. or liquid adhesive such as ethanol, gelatine size, starch slurry etc. one or more), the system granule, add lubricant (as magnesium stearate, Pulvis Talci, sodium stearyl fumarate etc. one or more), granulate, total mixing, be pressed into 1000, promptly.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 15: concentrated pill

Prescription: Radix Sophorae Flavescentis 500g, Fructus Gardeniae 900g, Radix Gentianae 600g

Preparation method: (1) is got Radix Sophorae Flavescentis and is added 15 times of amount 0.1% hydrochloric acid, reflux, extract, 3 hours filters, and filtering residue adds 15 times of amount 0.1% hydrochloric acid again, reflux, extract, 3 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, get sour extracted extract, be cooled to room temperature, and transfer to neutrality, add ethanol again and reach 80% to containing the alcohol amount with 20% sodium hydroxide, left standstill 12 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, and to be concentrated into relative density be 1.05～1.10, get the preceding extractum of Radix Sophorae Flavescentis upper prop, last macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution discards eluent, reuse 50% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Sophorae Flavescentis highly finished product to dry;

(2) get Fructus Gardeniae and add 20 times of water gagings, reflux, extract, 3 hours filters, filtering residue adds 20 times of water gagings again, and reflux, extract, 3 hours filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 70%, left standstill 18 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Fructus Gardeniae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 15% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Fructus Gardeniae highly finished product to dry;

(3) get Radix Gentianae and add 10 times of water gagings, reflux, extract, 2 hours filters, filtering residue adds 10 times of water gagings again, and reflux, extract, 2 hours filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 80%, left standstill 18 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Radix Gentianae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 10% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Radix Gentianae highly finished product to dry;

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, the mixing of Radix Gentianae highly finished product, drying is pulverized, and adds suitable quantity of water, the general ball of making, and cold drying is made 5000 of concentrated pills, promptly.

Usage and dosage: oral, every day 2～3 times, each 5～10.

Embodiment 16: granule

Prescription: Radix Sophorae Flavescentis 800g, Fructus Gardeniae 800g, Radix Gentianae 800g

Preparation method: the hydrochloric acid reflux that (1) gets Radix Sophorae Flavescentis adding 0.05% extracts, and filters, and filtering residue adds 0.05% hydrochloric acid reflux extraction again, filter merging filtrate, concentrating under reduced pressure, get sour extracted extract, cool off, and transfer to neutrality, add ethanol again and reach 60% to containing the alcohol amount with sodium hydroxide, leave standstill, filter, filtrate recycling ethanol, and concentrate, get the preceding extractum of Radix Sophorae Flavescentis upper prop, last macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution discards eluent, reuse 50% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Sophorae Flavescentis highly finished product;

(2) get Fructus Gardeniae and add the water reflux, extract,, filter, filtering residue adds the water reflux, extract, again, filters, merging filtrate, concentrating under reduced pressure gets the Fructus Gardeniae the water extracted immersing paste, cooling, add ethanol and reach 60%, leave standstill, filter to containing the alcohol amount, filtrate recycling ethanol gets the preceding extractum of Fructus Gardeniae upper prop, last macroporous adsorptive resins, the water eluting discards eluent, reuse 15% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Fructus Gardeniae highly finished product;

(3) get Radix Gentianae and add the water reflux, extract,, filter, filtering residue adds the water reflux, extract, again, filters, merging filtrate, concentrating under reduced pressure gets the Radix Gentianae the water extracted immersing paste, cooling, add ethanol and reach 60%, leave standstill, filter to containing the alcohol amount, filtrate recycling ethanol gets the preceding extractum of Radix Gentianae upper prop, last macroporous adsorptive resins, the water eluting discards eluent, reuse 10% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Gentianae highly finished product;

(4) get the Radix Sophorae Flavescentis highly finished product, the Fructus Gardeniae highly finished product, the Radix Gentianae highly finished product mix, add an amount of adjuvant (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, in dilution such as the mannitol adjuvant one or more), dry, pulverize, add suitable bonding (binding agent such as PEG200, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, microcrystalline Cellulose etc. or liquid adhesive such as ethanol, gelatine size, starch slurry, syrup etc. one or more), granulate, granulate is made granule 1000g, promptly.

Usage and dosage: oral, every day 2～3 times, each 5～10g.

Embodiment 17: soft capsule

Prescription: Radix Sophorae Flavescentis 800g, Fructus Gardeniae 700g, Radix Gentianae 500g

Preparation method: the hydrochloric acid reflux that (1) gets Radix Sophorae Flavescentis adding 0.15% extracts, and filters, and filtering residue adds 0.15% hydrochloric acid reflux extraction again, filter merging filtrate, concentrating under reduced pressure, get sour extracted extract, cool off, and transfer to neutrality, add ethanol again and reach 80% to containing the alcohol amount with sodium hydroxide, leave standstill, filter, filtrate recycling ethanol, and concentrate, get the preceding extractum of Radix Sophorae Flavescentis upper prop, last macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution discards eluent, reuse 50% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Sophorae Flavescentis highly finished product;

(2) get Fructus Gardeniae and add the water reflux, extract,, filter, filtering residue adds the water reflux, extract, again, filters, merging filtrate, concentrating under reduced pressure gets the Fructus Gardeniae the water extracted immersing paste, cooling, add ethanol and reach 80%, leave standstill, filter to containing the alcohol amount, filtrate recycling ethanol gets the preceding extractum of Fructus Gardeniae upper prop, last macroporous adsorptive resins, the water eluting discards eluent, reuse 15% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Fructus Gardeniae highly finished product;

(3) get Radix Gentianae and add the water reflux, extract,, filter, filtering residue adds the water reflux, extract, again, filters, merging filtrate, concentrating under reduced pressure gets the Radix Gentianae the water extracted immersing paste, cooling, add ethanol and reach 80%, leave standstill, filter to containing the alcohol amount, filtrate recycling ethanol gets the preceding extractum of Radix Gentianae upper prop, last macroporous adsorptive resins, the water eluting discards eluent, reuse 10% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Gentianae highly finished product;

(4) get the Radix Sophorae Flavescentis highly finished product, the Fructus Gardeniae highly finished product, the Radix Gentianae highly finished product mix, add an amount of adjuvant (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, in dilution such as the mannitol adjuvant one or more), dry, pulverize, with proper supplementary material (as PEG200, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500 and vegetable oil series etc., antiseptic such as sorbic acid or potassium salt, benzoic acid and propanoic acid etc.; Solubilizing agent such as tween series wait one or more, antioxidant such as sodium sulfite, sodium thiosulfate etc. one or more), behind the mixing, in incapsulating, make 1000 soft capsules, promptly by any way.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 18: drop pill

Preparation method: (1) is got Radix Sophorae Flavescentis and is added 10 times of amount 0.1% hydrochloric acid, reflux, extract, 1 hour filters, and filtering residue adds 10 times of amount 0.1% hydrochloric acid again, reflux, extract, 3 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, get sour extracted extract, be cooled to room temperature, and transfer to neutrality, add ethanol again and reach 70% to containing the alcohol amount with 30% sodium hydroxide, left standstill 24 hours, filter, filtrate recycling ethanol is not distinguished the flavor of to there being alcohol, and relative density is 1.05～1.10, get the preceding extractum of Radix Sophorae Flavescentis upper prop, last macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution discards eluent, reuse 50% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Sophorae Flavescentis highly finished product to dry;

(2) get Fructus Gardeniae and add 20 times of water gagings, reflux, extract, 3 hours filters, filtering residue adds 20 times of water gagings again, and reflux, extract, 3 hours filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 70%, left standstill 24 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Fructus Gardeniae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 15% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Fructus Gardeniae highly finished product to dry;

(3) get Radix Gentianae and add 20 times of water gagings, reflux, extract, 3 hours filters, filtering residue adds 20 times of water gagings again, and reflux, extract, 3 hours filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 70%, left standstill 24 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Radix Gentianae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 10% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Radix Gentianae highly finished product to dry;

(4) get Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product and mix, drying, dry powder, with Polyethylene Glycol-4000 and dry powder with 1～6: 1～5 ratio melting mixing, methyl-silicone oil is made coolant, drips to make 1000 of drop pill, promptly.

Usage and dosage: oral, every day 2～3 times, each 5～10 balls.

Embodiment 19: chewable tablet

Prescription: Radix Sophorae Flavescentis 300g, Fructus Gardeniae 900g, Radix Gentianae 300g

Preparation method: (1) is got Radix Sophorae Flavescentis and is added 18 times of amount 0.1% hydrochloric acid, reflux, extract, 1.5 hours filters, and filtering residue adds 16 times of amount 0.1% hydrochloric acid again, reflux, extract, 2.5 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, get sour extracted extract, be cooled to room temperature, and transfer to neutrality, add ethanol again and reach 70% to containing the alcohol amount with 15% sodium hydroxide, left standstill 20 hours, filter, filtrate recycling ethanol is not distinguished the flavor of to there being alcohol, and relative density is 1.05～1.10, get the preceding extractum of Radix Sophorae Flavescentis upper prop, last macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution discards eluent, reuse 50% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Sophorae Flavescentis highly finished product to dry;

(2) get Fructus Gardeniae and add 17 times of water gagings, reflux, extract, 2.5 hours filters, filtering residue adds 14 times of water gagings again, and reflux, extract, 1.5 hours filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Fructus Gardeniae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 70%, left standstill 15 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Fructus Gardeniae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 15% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Fructus Gardeniae highly finished product to dry;

(3) get Radix Gentianae and add 11 times of water gagings, reflux, extract, 2 hours filters, filtering residue adds 17 times of water gagings again, and reflux, extract, 3 hours filters, merging filtrate, being evaporated to relative density is 1.05～1.10, gets the Radix Gentianae the water extracted immersing paste, be cooled to room temperature, add ethanol and reach 70%, left standstill 16 hours, filter to containing the alcohol amount, filtrate recycling ethanol is to there not being the alcohol flavor, and relative density is 1.05～1.10, gets the preceding extractum of Radix Gentianae upper prop, last macroporous adsorptive resins, the water eluting, discard eluent, reuse 10% ethanol elution is collected eluent, decompression recycling ethanol promptly gets the Radix Gentianae highly finished product to dry;

(4) get the Radix Sophorae Flavescentis highly finished product, the Fructus Gardeniae highly finished product, the Radix Gentianae highly finished product mix, add appropriate amount of auxiliary materials (as silicon dioxide, dextrin, starch, phosphate, carbonate, mannitol, sorbitol, sorbic acid or potassium salt, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, in dilution such as lactose or the mannitol adjuvant one or more) mix, dry, pulverize, obtain fine powder and an amount of binding agent (binding agent such as PEG200, PEG300, PEG400, PEG600, PEG800, PEG1000, PEG1500, the macromolecular material polyvinylpyrrolidone, sodium carboxymethyl cellulose, methylcellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl emthylcellulose, sodium alginate or the like or liquid adhesive such as ethanol, starch slurry, the dextrin slurry waits one or more) mixed granule, add an amount of correctives (as mannitol, sucrose, xylitol, stevioside, maltose alcohol, Mentholum, erythrol, orange peel oil, Oleum Cinnamomi, various essence etc. one or more), lubricant is (as magnesium stearate, Pulvis Talci, sodium stearyl fumarate, magnesium laurylsulfate etc. one or more), disintegrating agent is (as carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, pregelatinized Starch, microcrystalline Cellulose, soybean polysaccharide, alginic acid, handle agar etc. one or more) granulate, total mixing, be pressed into 1000, promptly.

Usage and dosage: oral, every day 2～3 times, each 2～4.

Embodiment 20: injection

(4) get water for injection 1000ml, boil, add Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product, boiled 15 minutes, cold preservation 72 hours filters, get filtrate, transfer pH, add 0.5% active carbon after boiling and boil, after the absorption, filter, get filtrate, be chilled to room temperature, 100 of injection are sterilized, made to ultrafiltration,, promptly at embedding.

Usage and dosage: intravenous drip, every day 1 time, each 10ml～20ml (1～2)

Instil with 5% glucose injection or 0.9% normal saline solution 250ml dilution posterior vein.

Embodiment 21: injection

Prescription: Radix Sophorae Flavescentis 900g, Fructus Gardeniae 600g, Radix Gentianae 300g

(4) get water for injection 1000ml, boil, add Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product, boiled 15 minutes, cold preservation was not less than 48 hours, filtered, get filtrate, transfer pH, add 0.5% active carbon after boiling and boil, after the absorption, filter, get filtrate, be chilled to room temperature, 100 of injection are sterilized, made to ultrafiltration,, promptly at embedding.

Usage and dosage: intravenous drip, every day 1 time, each 10ml～20ml (1～2)

Embodiment 22: powder ampoule agent for injection

Prescription: Radix Sophorae Flavescentis 900g, Fructus Gardeniae 600g, Radix Gentianae 600g

(4) get water for injection 1000ml, boil, add Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product, boiled 15 minutes, cold preservation 60 hours filters, and gets filtrate, transfer pH, add 0.5% active carbon after boiling and boil, after the absorption, filter, get filtrate, be chilled to room temperature, microfiltration, ultrafiltration, lyophilizing, packing is made 100 of powder ampoule agent for injection, promptly.

Embodiment 23: powder ampoule agent for injection

(4) get water for injection 1000ml, boil, add Radix Sophorae Flavescentis highly finished product, Fructus Gardeniae highly finished product, Radix Gentianae highly finished product, boiled 25 minutes, cold preservation 72 hours filters, and gets filtrate, transfer pH, add 0.5% active carbon after boiling and boil, after the absorption, filter, get filtrate, be chilled to room temperature, microfiltration, ultrafiltration, lyophilizing, packing is made 100 of powder ampoule agent for injection, promptly.

Claims

1. Chinese medicine composition with antivirus action is characterized in that said composition made by following bulk drugs: Radix Sophorae Flavescentis 3～9, Fructus Gardeniae 6～9, Radix Gentianae 3～9.

2. 1 Chinese medicine composition as claimed in claim is characterized in that the weight proportion of said composition crude drug is as follows: Radix Sophorae Flavescentis 6, Fructus Gardeniae 8, Radix Gentianae 5.

3. 1 Chinese medicine composition as claimed in claim is characterized in that the weight proportion of said composition crude drug is as follows: Radix Sophorae Flavescentis 9, Fructus Gardeniae 9, Radix Gentianae 6.

4. 1 Chinese medicine composition as claimed in claim is characterized in that the weight proportion of said composition crude drug is as follows: Radix Sophorae Flavescentis 9, Fructus Gardeniae 9, Radix Gentianae 9.

5. as Chinese medicine composition as described in the claim 1～4, it is characterized in that preparation method is as follows: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, add in the sour water and decoct, filter, filtrate is concentrated into extractum, adds ethanol and leaves standstill, filter, filtrate recycling ethanol also is concentrated into extractum, extracts with n-butyl alcohol, collect extract, extract is recycled to no n-butyl alcohol, and drying is pulverized, add adjuvant, make required Chinese medicine preparation.

6. preparation method as claimed in claim 5, it is characterized in that: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.1～0.5% aqueous hydrochloric acid solution that adds 8～20 times of amounts, decoct 1～3 time, each 1～3 hour, filter, filtrate decompression is concentrated into extractum, add ethanol to containing alcohol amount 60～80%, left standstill 12～48 hours, filter, decompression filtrate recycling ethanol also is concentrated into extractum, extract with n-butyl alcohol, collect extract, extract reclaim under reduced pressure n-butyl alcohol is to there not being n-butyl alcohol, dry, pulverize, add adjuvant, make required Chinese medicine preparation.

7. preparation method as claimed in claim 6, it is characterized in that: get Radix Sophorae Flavescentis, Fructus Gardeniae, Radix Gentianae, 0.3% aqueous hydrochloric acid solution that adds 15 times of amounts, decoct 2 times, each 2 hours, filter, it is 1.05～1.10 extractum that filtrate decompression is concentrated into relative density, add ethanol to containing alcohol amount 60～80%, left standstill 36 hours, filter, decompression filtrate recycling ethanol and to be concentrated into relative density be 1.05～1.10 extractum, extract with n-butyl alcohol, collect extract, extract reclaim under reduced pressure n-butyl alcohol is to there not being n-butyl alcohol, dry, pulverize, add adjuvant, make required Chinese medicine preparation.

8. as Chinese medicine composition as described in the claim 1～4, it is characterized in that preparation method is as follows:

9. preparation method as claimed in claim 8 is characterized in that:

10. preparation method as claimed in claim 9 is characterized in that:

(1) gets Radix Sophorae Flavescentis and add 15 times of amount 0.1% hydrochloric acid, reflux, extract, 2 hours filters, and filtering residue adds 15 times of amount 0.1% hydrochloric acid again, reflux, extract, 2 hours, filter, merging filtrate, being evaporated to relative density is 1.05～1.10, get sour extracted extract, be cooled to room temperature, transfer to neutrality, add ethanol again and reach 70% to containing the alcohol amount with 20% sodium hydroxide, left standstill 12 hours, filter, filtrate recycling ethanol is not to there being the alcohol flavor, and being concentrated into relative density is 1.05～1.10, get the preceding extractum of Radix Sophorae Flavescentis upper prop, last macroporous adsorptive resins, water successively, 5% ethanol, 10% ethanol, 20% ethanol, 30% ethanol elution discards eluent, reuse 50% ethanol elution, collect eluent, decompression recycling ethanol promptly gets the Radix Sophorae Flavescentis highly finished product to dry;

11., it is characterized in that adopting pharmaceutical methods conventional in the pharmaceutics to be prepared into tablet, capsule, pill, granule, soft capsule, injection, oral liquid as the described preparation method of claim 5～7.

12., it is characterized in that the application of said composition in analgesic, the analgesic of preparation as the described Chinese medicine composition of claim 1～4.

13., it is characterized in that the application of said composition in the preparation antiviral drugs as the described Chinese medicine composition of claim 1～4.