CN105878469A - Preparation technology of Shuganning injection preparation - Google Patents

Preparation technology of Shuganning injection preparation Download PDF

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Publication number
CN105878469A
CN105878469A CN201610338252.4A CN201610338252A CN105878469A CN 105878469 A CN105878469 A CN 105878469A CN 201610338252 A CN201610338252 A CN 201610338252A CN 105878469 A CN105878469 A CN 105878469A
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extract
water
herba artemisiae
artemisiae scopariae
filter
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姚光哲
张昀
熊毅刚
张丽
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LONGLI PHARMACEUTICAL FACTORY OF GUIZHOU RUIHE PHARMACEUTICAL Co
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LONGLI PHARMACEUTICAL FACTORY OF GUIZHOU RUIHE PHARMACEUTICAL Co
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • AHUMAN NECESSITIES
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
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    • A61K36/74Rubiaceae (Madder family)
    • A61K36/744Gardenia
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    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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    • A61K2236/30Extraction of the material
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    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The invention discloses a preparation technology of a Shuganning injection preparation. The Shuganning preparation is mainly prepared from a herba artemisiae scopariae extract, a fructus gardeniae extract, baicalin, a radix isatidis extract and a lucid ganoderma extract. In the method disclosed by the invention, the specific technology and parameters are improved, so that the active ingredient chlorogenic acid in the herba artemisiae scopariae is easily measured, and the measured content of chlorogenic acid is high. The efficacy of the Shuganning injection preparation can be effectively enhanced.

Description

A kind of processing technology of the peaceful ejection preparation of soothing liver-QI
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to the processing technology of the peaceful ejection preparation of a kind of soothing liver-QI.
Background technology
Chinese medicine extraction is a kind of method conventional in herbal pharmaceutical, and chemical composition of Chinese materia medica is extremely complex, need to be from multiple Miscellaneous mixture extracts active ingredient of Chinese herbs effective to human body.To improve drug effect.
Soothing liver-QI injection for curing is liver-protecting medicine, mainly by Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin, plate Blue root extract and Ganoderma extract are made.There is heat-clearing and toxic substances removing, dampness removing jaundice eliminating, QI invigorating righting, protect the liver and protect Effect of liver.For jaundice due to damp-heat, disease meeting mesh is the most yellow, costa sternales distension, nausea and vomiting, yellowish or reddish urine, Weak, poor appetite, loose stool;Acute chronic viral hepatitis is shown in foregoing conditions person.
One of inventor's raw material to making used by soothing liver-QI injection for curing, Herba Artemisiae Scopariae extract and extraction process thereof are entered Having gone substantial amounts of research, inventor finds in research process, uses existing Herba Artemisiae Scopariae extract, and that makes relaxes In proheparin injection, Herba Artemisiae Scopariae Content of Chlorogenic Acid is difficult to measure.And the chlorogenic acid in Herba Artemisiae Scopariae is the main effective of Herba Artemisiae Scopariae Composition, but Herba Artemisiae Scopariae extract prepared by prior art, chlorogenic acid content is the highest, have impact on the curative effect of medicine.
Summary of the invention
The invention provides the processing technology of the peaceful ejection preparation of a kind of soothing liver-QI, wherein Herba Artemisiae Scopariae takes carrying of thing Access method, is improved its concrete technology and parameter, makes the active ingredient chlorogenic acid in Herba Artemisiae Scopariae easily survey Go out, and the chlorogenic acid content measured is high.Can effectively improve the drug effect of the peaceful ejection preparation of soothing liver-QI.
To achieve these goals, the present invention provides following technical scheme: the system of the peaceful ejection preparation of a kind of soothing liver-QI Making technique, described easypro treating hepatopathy calculates by weight, mainly by Herba Artemisiae Scopariae extract 1-8 part, Fructus Gardeniae extract 1-5 part, baicalin 15-25 part, Radix Isatidis extract 1-10 part, Ganoderma extract 1-7 part are as follows Make: add water for injection to baicalin so that it is suspended, then add 10% sodium hydroxide solution and make dissolving;To Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract are separately added into water for injection, Make dissolving, mixing, add activated carbon, stir evenly, boil, filter, with 10% sodium hydroxide solution regulation pH value To 7.5~8.0, inject water to ormal weight, filter, embedding, sterilizing, to obtain final product;Described Herba Artemisiae Scopariae extract Extracting method be: taking Herba Artemisiae Scopariae, after soak soaks, filter, add water decoction, filter, filtrate decompression is dense Shortening extractum into, add ethanol, be stirred continuously, stand, filter, decompression filtrate recycling ethanol is also concentrated into 50 DEG C Time relative density be the extractum of 1.05-1.10, adjust PH with hydrochloric acid, insulation, tipping supernatant, filter, precipitation Wash with water, concentrate, vacuum drying, it is ground into fine powder, to obtain final product.
In the processing technology of the peaceful ejection preparation of aforesaid soothing liver-QI, described easypro treating hepatopathy calculates by weight, main Will be by Herba Artemisiae Scopariae extract 4 parts, Fructus Gardeniae extract 3 parts, baicalin 22 parts, Radix Isatidis extract 5 parts, spirit Sesame extract 3.5 parts is made as follows: adds water for injection to baicalin so that it is suspended, then adds 10% Sodium hydroxide solution makes dissolving;Extract to Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma Thing is dissolved in water for injection respectively, mixing, adds 0.2% activated carbon, stir evenly, boil 15 minutes, filter, With 10% sodium hydroxide solution regulation pH value to 7.5~8.0, inject water to ormal weight, filter, embedding, Sterilizing, to obtain final product.
In the processing technology of the peaceful ejection preparation of aforesaid soothing liver-QI, the extracting method of described Herba Artemisiae Scopariae extract is: take Herba Artemisiae Scopariae, the soak adding 5-7 times amount soaks 8-12h, filters, then add 7-12 times of soak by water 2-4 time, often Secondary 1-3 hour, filtering, merging filtrate, being evaporated to relative density when 50 DEG C is the extractum of 1.05-1.10, Adding ethanol makes alcohol content reach 50%-75%, is stirred continuously, and stands 12-48 hour, filters, and filtrate decompression is returned Receive ethanol and when being concentrated into 50 DEG C relative density be the extractum of 1.05-1.10, adjust PH to 2 with hydrochloric acid, 40-60 DEG C It is incubated 3-8 hour, tipping supernatant, filter, it is 3-4 that precipitation washes with water to PH, concentrates, vacuum drying, It is ground into fine powder, to obtain final product.
In the processing technology of the peaceful ejection preparation of aforesaid soothing liver-QI, the extracting method of described Herba Artemisiae Scopariae extract is: take Herba Artemisiae Scopariae, the soak adding 6 times amount soaks 10h, filters, add 9 times of soak by water 3 times, each 2 hours, Filtering, merging filtrate, being evaporated to relative density when 50-60 DEG C is the extractum of 1.05-1.10, adds ethanol and makes Alcohol content 50%-75%, is stirred continuously, and stands 28 hours, filters, and decompression filtrate recycling ethanol is also concentrated into When 50 DEG C, relative density is the extractum of 1.05-1.10, adjusts PH to 2 with hydrochloric acid, and 40-60 DEG C is incubated 5 hours, Tipping supernatant, filters, and it is 3-4 that precipitation washes with water to PH, concentrates, vacuum drying, is ground into fine powder, Obtain.
In the processing technology of the peaceful ejection preparation of aforesaid soothing liver-QI, described soak is prepared: take 2-8 parts by volume White vinegar, add 90-110 parts by volume boiling water in, add the green tea of 5-15 weight portion, stir a little, Stand 20-40 minute, filter, to obtain final product.
In the processing technology of the peaceful ejection preparation of aforesaid soothing liver-QI, described soak is prepared: take 5 parts by volume White vinegar, add in the boiling water of 100 parts by volume, add the green tea of 10 weight portions, stir a little, stand 30 minutes, filter, to obtain final product.
The peaceful ejection preparation of soothing liver-QI of the present invention is mainly by Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Radix Isatidis Extract is made.Wherein, Herba Artemisiae Scopariae, ArtemisiacapillarisThunb, meridian distribution of property and flavor: bitter, pungent, it is slightly cold. Return spleen, stomach, liver, gallbladder meridian.There is Herba Artemisiae Scopariae clearing away heat-damp and promoting diuresis, effect of jaundice eliminating.Can be used for treating jaundice, little The most unfavorable, eczema pruritus, infectious jaundice type liver.Fructus Gardeniae (formal name used at school: Gardeniajasminoides Ellis), Belong to the l that Ministry of Public Health promulgates and criticize medicine-food two-purpose resource, there is hepatoprotective, function of gallbladder promoting, blood pressure lowering, calmness, stop blooding, disappear Swollen grade acts on.It is usually used in treating the diseases such as icterohepatitis, bruise, hypertension, diabetes at tcm clinical practice. Baicalin (Baicalin) is to extract a kind of flavone compound separated from scutellariae,radix, has significantly Biological activity, has antibacterial, diuresis, antiinflammatory, resistance state and a spasmolysis, and has stronger anticancer The physiological potencies such as reaction.Critical role has been occupied at clinical medicine.Baicalin can also absorb ultraviolet, removes Oxygen-derived free radicals, can suppress again melanic generation, therefore can be not only used for medicine it can also be used to cosmetics, be A kind of good functional cosmetics raw material.There is removing the relative excess fire, dehumidifying heat, hemostasis, antiabortive effect. Can be used for high fever excessive thirst, cough due to lung-heat, damp-heat dysentery, jaundice, pyretic stranguria, tell, be defeated in battle, collapse, leak, conjunctival congestion Swell and ache, frequent fetal movement, carbuncle furuncle.Radix Isatidis, Isatis tinctoria, doing for cruciferae isatis Dry, cold in nature, taste is the most micro-sweet rear pained, has effect of heat-clearing and toxic substances removing, preventing cold, sore-throat relieving.Mainly For treating the disease such as maculae caused by violent heat pathogen, purple dark, the scarlet fever of crimson tongue.
Applicant has carried out long-term substantial amounts of research to the manufacture method of soothing liver-QI injection for curing, it has been found that With existing Herba Artemisiae Scopariae extract as raw material, in the peaceful ejection preparation of soothing liver-QI made, effective one-tenth of Herba Artemisiae Scopariae extract Chlorogenic acid is divided to be difficult to measure.Inventor finds in technical study, uses the mattress that the method for the invention is made Old extract is as raw material, in the peaceful ejection preparation of soothing liver-QI made, containing of the active ingredient chlorogenic acid in Herba Artemisiae Scopariae Amount adds a lot unexpectedly, and therefore this technique promotes the dissolution rate of active ingredient chlorogenic acid in Herba Artemisiae Scopariae.Green former Acid is one of main chemical compositions in Herba Artemisiae Scopariae, it is seen that this technique promotes the dissolution of Herba Artemisiae Scopariae Content of Chlorogenic Acid.Permissible It is effectively improved the drug effect of the peaceful ejection preparation of soothing liver-QI.
Compared with prior art, in the peaceful ejection preparation of soothing liver-QI that the method for the invention makes, Herba Artemisiae Scopariae extract In active ingredient chlorogenic acid easily measure, and it is high to measure chlorogenic acid content.Can effectively improve soothing liver-QI peaceful The drug effect of ejection preparation.
The present invention has carried out substantial amounts of experimentation, is below the result of experimentation of the present invention:
Experimental example 1 chlorogenic acid content is investigated
1 raw material
1.1 injections of the present invention, make as described in Example 1.
1.2 existing injections: make by following technique:
Prescription: Herba Artemisiae Scopariae extract 4g, Fructus Gardeniae extract 3g, baicalin 22g, Radix Isatidis extract 5g, spirit Sesame extract 3.5g and adjuvant.
Technique: add the water for injection of 1.5 times amount to baicalin so that it is suspended, then it is molten to add 10% sodium hydroxide Liquid makes dissolving;Difference 1.5 in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract Being dissolved in water for injection of times amount, mixing, add activated carbon, stir evenly, boil, filter, use 10% hydroxide Sodium solution regulation pH value, to 7.5~8.0, injects water to ormal weight, filters, embedding, sterilizing, to obtain final product.
Wherein, described Herba Artemisiae Scopariae extract is commercially available.
1.3 U.S. Agilent 1100 type high performance liquid chromatographs, 7725i proportional valve, variable wavelength ultraviolet is examined Survey device;UV-265FW type spectrophotometer (Japan's Shimadzu);AUW220D type double-range analytical balance (Japan Shimadzu).SCQ-250 type ultrasonic extraction instrument (Shen, the Shanghai ultrasonic company of ripple).Chlorogenic acid reference substance is (purchased from China Pharmaceutical biological product examines and determine institute, lot number: 110753-200212), acetonitrile is chromatographically pure, and phosphoric acid is analytical pure, Water is brand-new purified water.
2 experimental techniques and result
2.1 chromatographic condition
Chromatographic column: Kromasil C18(4.6mm × 250mm, 5um);Flowing phase: acetonitrile-0.1% phosphoric acid (9: 91);Flow velocity: 0.9mL/min;Detection wavelength: 327nm;Column temperature: 40 DEG C;Sample size: 10uL.Green former Acid and other component baseline separation, R > 1.5.Calculating post effect with chlorogenic acid peak, its number of theoretical plate answers >=3000.
The preparation of 2.2 reference substance solution
Take chlorogenic acid reference substance appropriate, accurately weighed, add 50% methanol and make every 1mL solution containing 20ug, Obtain.
The preparation of 2.3 need testing solutions
The preparation of need testing solution 1: precision measures injection 2ml of the present invention, puts in 25ml brown measuring bottle, Add methanol to scale, shake up, to obtain final product.
The preparation of need testing solution 2: precision measures existing injection 2ml, puts in 25ml brown measuring bottle, adds Methanol, to scale, shakes up, and to obtain final product.
The investigation of 2.4 linear relationships
Take chlorogenic acid reference substance and prepare reference substance solution by method below " 2.2 " item;Precision draws above-mentioned liquid respectively 0.5,1.0,2.0,4.0,8.0mL, it is placed in lO mL volumetric flask, adds 50% methanol solution and be diluted to carve Degree, shakes up.Precision draws each 10ul of above-mentioned solution respectively, injects high performance liquid chromatograph, records chromatogram. With peak area (A), chlorogenic acid concentration (C) is drawn standard curve, calculates regression equation and obtain: A=31.832C-20.208, r=0.9997.Result show chlorogenic acid 4.9~78.4ug/mL concentration model Enclose internal linear relation good.
2.5 precision test
Take reference substance solution, repeat sample introduction 6 times, each 10l, the RSD=0.87% of chlorogenic acid peak area, Show that precision is good.
2.6 stability test
Essence takes need testing solution 1, presses sample determination method in 10h, measures once every 2h.Chlorogenic acid peak Area RSD=0.92%, shows that need testing solution 1 is stable in 10h.
Essence takes need testing solution 2, presses sample determination method in 10h, measures once every 2h.Chlorogenic acid peak Area RSD=0.95%, shows that need testing solution 2 is stable in 10h.
2.7 replica test
Take with batch of injection of the present invention 6 parts, every part of about 2ml, accurately weighed, by need testing solution 1 side of preparation Prepared by method, measure in accordance with the law, result shows, RSD is 1.01%, and the method repeatability is good.
Take with batch of existing injection 6 parts, every part of about 2ml, accurately weighed, by need testing solution 2 preparation method Preparation, measures in accordance with the law, and result shows, RSD is 1.32%, and the method repeatability is good.
2.8 sample-adding recovery tests
Take the injection of the present invention of known content and existing injection 2ml respectively, accurately weighed, parallel 9 parts, point The inaccurate reference substance solution that adds is appropriate, prepares need testing solution 1 by test sample preparation method, according to sample determination Method measures, and calculates the response rate.End product is that average recovery rate is respectively 99.87% and 98.78%, RSD=0.62% and RSD=0.85%.Therefore this method reliability is good.
The mensuration of 2.9 samples
Measure injection of the present invention and existing injection 2ml respectively, accurately weighed, by need testing solution 1 with for examination Prepared by product solution 2 preparation method, parallel measure 6 parts, and precision draws each 10ul of above-mentioned solution respectively, injects liquid Chromatography, the assay of sample Content of Chlorogenic Acid the results are shown in Table l.
The assay result of table 1 chlorogenic acid
As known from Table 1, the average content of injection Content of Chlorogenic Acid of the present invention is 0.365mg/g, existing injection The average content of Content of Chlorogenic Acid is 0.128mg/g.
Conclusion: compared with existing injection, in injection of the present invention, the content of Herba Artemisiae Scopariae active ingredient chlorogenic acid is more High.In like manner, according to the preparation of other dosage forms that extracting method of the present invention is made, the effective ingredient of Herba Artemisiae Scopariae is green former Acid content also should increase.
Experimental example 2. effect experiment
1 materials and methods
1.1 trial drug
Injection the most of the present invention, with embodiment 1.
The most existing injection: with experimental example 1.
1.2 animal Kunming mouses, male, body weight 18-22g, Sichuan Academy of Medical Sciences's laboratory animal is ground Study carefully and provided.
1.3 reagent A LT (GTT), AST (GOT) test kit, Mei Sheng Industrial Co., Ltd. produces.Carbon tetrachloride (analytical pure), Tianjin Bo Di Chemical Co., Ltd. produces.Thioacetamide, Beijing chemical reagent three factory is raw Produce,.56 degree of Red Star strong, colourless liquor distilled from sorghum, Hongxing Co., Ltd. Beijing produces.
1.4 instrument TMS-1024i type automatic clinical chemistry analyzers, Tokyo trade Co., Ltd.. Multiskan MK3 type microplate reader, Thermo Labsystems company.
2 experimental techniques
40 mices are randomly divided into 4 groups, i.e. Normal group, model group, of the present invention group and existing preparation group, Often group 10, each group tail vein injection is administered.Injecting injection of the present invention for of the present invention group, concentration is 0.1ml/10g, is configured to the medicinal liquid of 40%, 20%, 10% before use with Dextrose and Sodium Chloride Inj. dilution, Injection.Existing preparation group injects existing injection, and dosage is 0.1ml/10g, uses glucose sodium chloride before use Injection dilution is configured to the medicinal liquid of 40%, 20%, 10%, injection.Normal group and model group injection Normal saline, is given daily 1 time, continuous 8 days.From being administered the 4th day, after every day is administered 0.5h, little 56 degree of Red Stars strong, colourless liquor distilled from sorghum Chinese liquor 8mL/kg (normal group is to equal volume distilled water) of Mus gavage, 2 times/day, Two minor tick 3-4h, mice is administered and fills all fasting before wine.Continuous 5 days, 1h after last gavage Chinese liquor, Extract eyeball of mouse and take blood, separate serum, measure serum alt and AST level, anatomical isolation liver, Weighing, calculate liver index, separately take same area hepatic tissue, 10% formaldehyde is fixed, section, after HE dyeing Observation liver pathomorphology changes.The results are shown in Table 2, table 3.
Table 2 is on acute alcohol liver injury model mouse liver index and Serum ALT, the impact of AST level
Compare with Normal group,#P < 0.01,##P<0.01;
Compare with model group,*P < 0.05,**P<0.01;
Compare with existing ejection preparation group,+P<0.05;
The table 3 impact on acute alcohol liver injury model mouse liver Histopathologic changes
Note: pathological changes classification standard: " one ", normally, without pathological changes such as hepatocyte puffing, balloon sample changes; "+", lobules of liver is less than 1/3 region slight hepatic cell swelling, endochylema puffing.But hepatic cords is basic Clear, sinus hepaticus is the most visible." ++ ", moderate endochylema puffing, between slight hepatic cell swelling and balloon sample Between, the slightly aobvious disorder of liver rope, sinus hepaticus starts to occur narrow.
As seen from table, the peaceful ejection preparation of soothing liver-QI of the present invention and the peaceful ejection preparation of existing soothing liver-QI all have reduction Mouse Blood The effect of ALT and AST level, and soothing liver-QI of the present invention peaceful ejection preparation effect clearly is better than existing soothing liver-QI and rather injects Preparation.Histopathologic examination shows, model group mouse liver cell occur endochylema puffing in various degree, Cellular edema, balloon sample become, lytic necrosis, and the pathological changes such as liver rope is disorderly, sinus hepaticus is narrow, soothing liver-QI is peaceful Injection successive administration 8 days, the peaceful ejection preparation of soothing liver-QI of the present invention and the peaceful ejection preparation of existing soothing liver-QI all present not Improvement result with degree.Wherein, soothing liver-QI of the present invention peaceful ejection preparation effect is better than existing soothing liver-QI and rather injects system Agent.
Detailed description of the invention:
Embodiment 1:
Formula: Herba Artemisiae Scopariae extract 4g, Fructus Gardeniae extract 3g, baicalin 22g, Radix Isatidis extract 5g and spirit Sesame extract 3.5g.
The processing technology of the peaceful injection of soothing liver-QI: add water for injection to baicalin so that it is suspended, then add 10% Sodium hydroxide solution makes dissolving;Extract to Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma Thing is dissolved in water for injection respectively, mixing, adds 0.2% activated carbon, stir evenly, boil 15 minutes, filter, With 10% sodium hydroxide solution regulation pH value to 7.5~8.0, inject water to 1000ml, filter, embedding, Sterilizing, obtains injection.
The extraction process of Herba Artemisiae Scopariae extract: take Herba Artemisiae Scopariae, the soak adding 6 times amount soaks 10h, filters, then Add 9 times of soak by water 3 times, each 2 hours, filter, merging filtrate, be evaporated to when 50-60 DEG C relative Density is the extractum of 1.05-1.10, adds ethanol and makes alcohol content 50%-75%, is stirred continuously, and stands 28 hours, Filter, decompression filtrate recycling ethanol and when being concentrated into 50 DEG C relative density be the extractum of 1.05-1.10, use hydrochloric acid Adjust PH to 2,40-60 DEG C be incubated 5 hours, tipping supernatant, filter, precipitation wash with water to PH be 3-4, Concentrate, vacuum drying, be ground into fine powder, to obtain final product.
Described soak is prepared: take the white vinegar of 50ml, adds in the boiling water of 1000ml, adds 100g Green tea, stir a little, stand 30 minutes, filter, to obtain final product.
Usage and dosage: intravenous drip, one time 10~20ml, with 10% glucose injection 250~500ml Dilution posterior vein instils, 1 time on the one;Intramuscular injection can be used instead after remission, one day 2~4ml, one day 1 time.
Points for attention: 1, anemia of pregnant woman and allergic constitution person are cautious use of;
2, close observation medicinal liquid character before injection, forbids to make when having muddiness, precipitation, floccule With.
Specification: every dress 2ml, 10ml or 20ml.
Embodiment 2:
Formula: Herba Artemisiae Scopariae extract 4g, Fructus Gardeniae extract 3g, baicalin 22g, Radix Isatidis extract 5g and spirit Sesame extract 3.5g.
The processing technology of the peaceful injection of soothing liver-QI: add water for injection to baicalin so that it is suspended, then add 10% Sodium hydroxide solution makes dissolving;Extract to Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma Thing is dissolved in water for injection respectively, mixing, adds 0.2% activated carbon, stir evenly, boil 15 minutes, filter, With 10% sodium hydroxide solution regulation pH value to 7.5~8.0, inject water to 1000ml, filter, embedding, Sterilizing, obtains injection.
The extraction process of Herba Artemisiae Scopariae extract: take Herba Artemisiae Scopariae, the soak adding 7 times amount soaks 12h, filters, then Add 12 times of soak by water 4 times, each 3 hours, filter, merging filtrate, be evaporated to when 50 DEG C the closeest Degree is the extractum of 1.05-1.10, and adding ethanol makes alcohol content reach 75%, is stirred continuously, and stands 48 hours, filters, Decompression filtrate recycling ethanol and when being concentrated into 50 DEG C relative density be the extractum of 1.05-1.10, adjust PH with hydrochloric acid To 2,40-60 DEG C is incubated 8 hours, and tipping supernatant filters, and it is 4 that precipitation washes with water to PH, concentrates, Vacuum drying, is ground into fine powder, to obtain final product.
Described soak is prepared: take the white vinegar of 80ml, adds in the boiling water of 1100ml, adds 150g Green tea, stir a little, stand 40 minutes, filter, to obtain final product.
Usage and dosage: intravenous drip, one time 10~20ml, with 10% glucose injection 250~500ml Dilution posterior vein instils, 1 time on the one;Intramuscular injection can be used instead after remission, one day 2~4ml, one day 1 time.
Points for attention: 1, anemia of pregnant woman and allergic constitution person are cautious use of;
2, close observation medicinal liquid character before injection, forbids to make when having muddiness, precipitation, floccule With.
Specification: every dress 2ml, 10ml or 20ml.
Embodiment 3:
Formula: Herba Artemisiae Scopariae extract 4g, Fructus Gardeniae extract 3g, baicalin 22g, Radix Isatidis extract 5g and spirit Sesame extract 3.5g.
The processing technology of the peaceful injection of soothing liver-QI: add water for injection to baicalin so that it is suspended, then add 10% Sodium hydroxide solution makes dissolving;Extract to Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma Thing is dissolved in water for injection respectively, mixing, adds 0.2% activated carbon, stir evenly, boil 15 minutes, filter, With 10% sodium hydroxide solution regulation pH value to 7.5~8.0, inject water to 1000ml, filter, embedding, Sterilizing, obtains injection.
The extraction process of Herba Artemisiae Scopariae extract: take Herba Artemisiae Scopariae, the soak adding 5 times amount soaks 8h, filters, then Add 7 times of soak by water 2 times, each 1 hour, filter, merging filtrate, be evaporated to when 50 DEG C the closeest Degree is the extractum of 1.05-1.10, and adding ethanol makes alcohol content reach 50%%, is stirred continuously, and stands 12 hours, mistake Filter, decompression filtrate recycling ethanol and when being concentrated into 50 DEG C relative density be the extractum of 1.05-1.10, adjust with hydrochloric acid PH to 2,40-60 DEG C be incubated 3 hours, tipping supernatant, filter, precipitation wash with water to PH be 3-4, Concentrate, vacuum drying, be ground into fine powder, to obtain final product.
Described soak is prepared: take the white vinegar of 20ml, adds in the boiling water of 900ml, adds 50g Green tea, stir a little, stand 20 minutes, filter, to obtain final product.
Usage and dosage: intravenous drip, one time 10~20ml, with 10% glucose injection 250~500ml Dilution posterior vein instils, 1 time on the one;Intramuscular injection can be used instead after remission, one day 2~4ml, one day 1 time.
Points for attention: 1, anemia of pregnant woman and allergic constitution person are cautious use of;
2, close observation medicinal liquid character before injection, forbids to make when having muddiness, precipitation, floccule With.
Specification: every dress 2ml, 10ml or 20ml.

Claims (6)

1. the processing technology of the peaceful ejection preparation of soothing liver-QI, it is characterised in that: described easypro treating hepatopathy calculates by weight, Main by Herba Artemisiae Scopariae extract 1-8 part, Fructus Gardeniae extract 1-5 part, baicalin 15-25 part, Radix Isatidis extract 1-10 part, Ganoderma extract 1-7 part are made as follows: add water for injection to baicalin so that it is suspended, Add 10% sodium hydroxide solution again and make dissolving;To Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract is separately added into water for injection, makes dissolving, mixing, add activated carbon, stir evenly, boil, filter Cross, with 10% sodium hydroxide solution regulation pH value to 7.5~8.0, inject water to ormal weight, filter, Embedding, sterilizing, to obtain final product;The extracting method of described Herba Artemisiae Scopariae extract is: take Herba Artemisiae Scopariae, after soak soaks, and mistake Filter, adds water decoction, filters, and filtrate reduced in volume becomes extractum, adds ethanol, is stirred continuously, and stands, mistake Filter, decompression filtrate recycling ethanol and when being concentrated into 50 DEG C relative density be the extractum of 1.05-1.10, adjust with hydrochloric acid PH, insulation, tipping supernatant, filter, precipitation washes with water, concentrates, and vacuum drying is ground into fine powder, Obtain.
2. the processing technology of the peaceful ejection preparation of soothing liver-QI as claimed in claim 1, it is characterised in that: described soothing liver-QI is rather made Agent calculates by weight, mainly by Herba Artemisiae Scopariae extract 4 parts, and Fructus Gardeniae extract 3 parts, baicalin 22 parts, plate Blue root extract 5 parts, Ganoderma extract 3.5 parts are made as follows: add water for injection to baicalin, Make it suspended, then add 10% sodium hydroxide solution and make dissolving;To Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Baphicacanthus cusia Root extract and Ganoderma extract are dissolved in water for injection respectively, mixing, add 0.2% activated carbon, stir evenly, Boil 15 minutes, filter, with 10% sodium hydroxide solution regulation pH value to 7.5~8.0, inject and use water To ormal weight, filter, embedding, sterilizing, to obtain final product.
3. the processing technology of the peaceful ejection preparation of soothing liver-QI as claimed in claim 1, it is characterised in that: described Herba Artemisiae Scopariae is extracted The extracting method of thing is: take Herba Artemisiae Scopariae, and the soak adding 5-7 times amount soaks 8-12h, filters, then adds 7-12 Times soak by water 2-4 time, each 1-3 hour, filters, merging filtrate, is evaporated to relative density when 50 DEG C For the extractum of 1.05-1.10, add ethanol and make alcohol content reach 50%-75%, be stirred continuously, stand 12-48 hour, Filter, decompression filtrate recycling ethanol and when being concentrated into 50 DEG C relative density be the extractum of 1.05-1.10, use hydrochloric acid Adjust PH to 2,40-60 DEG C be incubated 3-8 hour, tipping supernatant, filter, precipitation wash with water to PH be 3-4, Concentrate, vacuum drying, be ground into fine powder, to obtain final product.
4. the processing technology of the peaceful ejection preparation of soothing liver-QI as claimed in claim 3, it is characterised in that: described Herba Artemisiae Scopariae carries The extracting method taking thing is: take Herba Artemisiae Scopariae, and the soak adding 6 times amount soaks 10h, filters, then adds 9 times of water Decocting 3 times, each 2 hours, filter, merging filtrate, being evaporated to relative density when 50-60 DEG C is
The extractum of 1.05-1.10, adds ethanol and makes alcohol content 50%-75%, be stirred continuously, and stands 28 hours, filters, Decompression filtrate recycling ethanol and when being concentrated into 50 DEG C relative density be the extractum of 1.05-1.10, adjust PH with hydrochloric acid To 2,40-60 DEG C is incubated 5 hours, and tipping supernatant filters, and it is 3-4 that precipitation washes with water to PH, concentrates, Vacuum drying, is ground into fine powder, to obtain final product.
5. the processing technology of the peaceful ejection preparation of soothing liver-QI as described in claim 1,3 or 4, it is characterised in that: described Soak is prepared: take the white vinegar of 2-8 parts by volume, adds in the boiling water of 90-110 parts by volume, adds The green tea of 5-15 weight portion, stirs a little, stands 20-40 minute, filters, to obtain final product.
6. the processing technology of the peaceful ejection preparation of soothing liver-QI as claimed in claim 5, it is characterised in that: described soak this Prepared by sample: take the white vinegar of 5 parts by volume, adds in the boiling water of 100 parts by volume, adds the green of 10 weight portions Tea, stirs a little, stands 30 minutes, filters, to obtain final product.
CN201610338252.4A 2016-05-20 2016-05-20 Preparation technology of Shuganning injection preparation Withdrawn CN105878469A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1486743A (en) * 2002-11-01 2004-04-07 贵州瑞和制药有限公司 Chinese medicine injection and its production process
CN105412294A (en) * 2015-12-21 2016-03-23 贵州瑞和制药有限公司龙里药厂 Production method of Shuganning Preparation
CN105434342A (en) * 2015-12-21 2016-03-30 贵州瑞和制药有限公司龙里药厂 Preparation method for Shuganning injection preparation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1486743A (en) * 2002-11-01 2004-04-07 贵州瑞和制药有限公司 Chinese medicine injection and its production process
CN105412294A (en) * 2015-12-21 2016-03-23 贵州瑞和制药有限公司龙里药厂 Production method of Shuganning Preparation
CN105434342A (en) * 2015-12-21 2016-03-30 贵州瑞和制药有限公司龙里药厂 Preparation method for Shuganning injection preparation

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