CN105902651A - Production method of shuganning injection preparation - Google Patents
Production method of shuganning injection preparation Download PDFInfo
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Abstract
The invention discloses a production method of a shuganning injection preparation. The shuganning preparation is mainly prepared from oriental wormwood extracts, gardenia jasminoides ellis extract, baicalin, isatis root extract and ganoderma lucidum extract. According to the method disclosed by the invention, specific processes and parameters are improved, so that the effective ingredient indirubin in isatis root can be easily measured, and the measured indirubin content is high. The drug effect of the shuganning injection preparation can be effectively increased.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to the manufacture method 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, Radix Isatidis extract and extraction process thereof
Having carried out substantial amounts of research, inventor finds in research process, existing Radix Isatidis extract, and that makes relaxes
In proheparin injection, in Radix Isatidis, indirubin is difficult to measure.And the indirubin in Radix Isatidis is the master of Radix Isatidis
Want effective ingredient, but Radix Isatidis extract prepared by prior art, Content Determination of Indirubin is the highest, have impact on medicine
Curative effect.
Summary of the invention
The invention provides the manufacture method of the peaceful ejection preparation of a kind of soothing liver-QI, wherein Radix Isatidis takes thing
Extracting method, is improved its concrete technology and parameter, makes the effective ingredient indirubin in Radix Isatidis hold
Easily measure, and the Content Determination of Indirubin 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 method, 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 0.2% activated carbon, stir evenly, boil, filter, with 10% sodium hydroxide solution regulation
PH value, to 7.5～8.0, injects water to ormal weight, filters, embedding, sterilizing, to obtain final product；Described Baphicacanthus cusia
The extracting method of root extract is: take Radix Isatidis, after adding soak immersion, filters, heats back with ethanol
Stream extract, filter, medicinal residues are standby, extracting solution decompression recycling ethanol, concentrated solution add water to volume every milliliter with
The ratio of medical material amount every gram is 1-3:3-1, upper macroporous adsorbent resin, adds water elution, then with ethanol elution, collects
Eluent, reclaims ethanol, obtains alcohol extract, standby；Medicinal residues add water extraction, filter, filtrate, dense
After shortening concentrated solution into, merging with above-mentioned alcohol extract, at being concentrated into 50-60 DEG C, relative density is the leaching of 1.1-1.2
Cream, to obtain final product.
In the manufacture method 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 manufacture method of the peaceful ejection preparation of aforesaid soothing liver-QI, the extracting method of described Radix Isatidis extract is:
Taking Radix Isatidis, the soak adding 5-7 times amount soaks 8-12h, filters, then adds 8-12 times amount 70-85% second
Alcohol heating and refluxing extraction 1-5 time, each 0.5-3 hour, filters, and medicinal residues are standby, extracting solution recovered under reduced pressure
Ethanol, it is 1-3:3-1 that concentrated solution adds water to the ratio of volume every milliliter and medical material amount every gram, upper macroporous absorption tree
Fat, adds 4-10 times of column volume of water elution, then with 4-10 times of column volume eluting of 30-70% ethanol, collects eluting
Liquid, reclaims ethanol, obtains alcohol extract, standby；Medicinal residues add 8-12 times amount water extraction 2-3 time, every time
1-3 hour, filter, merging filtrate, after being condensed into concentrated solution, merge with above-mentioned alcohol extract, be concentrated into
At 50-60 DEG C, relative density is the extractum of 1.1-1.2, to obtain final product.
In the manufacture method of the peaceful ejection preparation of aforesaid soothing liver-QI, the extracting method of described Radix Isatidis extract is:
Taking Radix Isatidis, the soak adding 6 times amount soaks 10h, filters, then adds 10 times amount 80% ethanol and heat back
Stream extracts 3 times, each 2 hours, filters, and medicinal residues are standby, extracting solution decompression recycling ethanol, and concentrated solution adds
Water is 1.5:1.5 to the ratio of volume every milliliter with medical material amount every gram, and upper macroporous adsorbent resin adds water elution 7
Times column volume, then with 7 times of column volume eluting of 50% ethanol, collect eluent, reclaim ethanol, obtain alcohol extract,
Standby；Medicinal residues add 10 times amount water extraction 3 times, each 2 hours, filter, merging filtrate, are condensed into
After concentrated solution, merging with above-mentioned alcohol extract, at being concentrated into 50-60 DEG C, relative density is the extractum of 1.1-1.2,
Obtain.
In the manufacture method 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 manufacture method 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.
One of inventor's raw material to making used by soothing liver-QI injection for curing, Radix Isatidis extract and extraction process are carried out
Substantial amounts of research, inventor finds in research process, existing Radix Isatidis extract, the soothing liver-QI made is peaceful
In preparation, the effective ingredient indirubin of Radix Isatidis is difficult to measure.Inventor finds in technical study, uses
The Radix Isatidis extract that the method for the invention is made is as raw material, in the peaceful ejection preparation of soothing liver-QI made, plate
The content of the effective ingredient indirubin of Lan Genzhong adds much unexpectedly, and therefore this technique promotes in Radix Isatidis
The dissolution rate of effective ingredient indirubin.Indirubin (indirubin) is main active ingredient antibacterial in Radix Isatidis,
It it is one of active ingredient treating chronic myelocytic leukemia in Radix Isatidis.This technique visible promotes Radix Isatidis
The dissolution of middle indirubin, can be 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, Radix Isatidis extracts
Effective ingredient indirubin in thing is easily measured, and it is high to measure Content Determination of Indirubin.Can effectively improve soothing liver-QI
The drug effect of peaceful 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 Content Determination of Indirubin 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 Radix Isatidis extract is commercially available.
1.3SPD-LC10A type high performance liquid chromatograph (Japan's Shimadzu)；BP210S electronic balance (moral
Sartorius company of state).Indirubin reference substance (Nat'l Pharmaceutical & Biological Products Control Institute)；Ethanol is medicinal
Specification, other reagent are analytical pure and chromatographically pure.
2 experimental techniques and result
2.1 chromatographic condition
Dikma DiamonsilTMC18Chromatographic column (5um, 200mm*4.6mm), flowing is methanol-0.1 mutually
Mol/L ammonium acetate-acetic acid (70:30:1), flow velocity 1ml/min, detects wavelength 280nm, column temperature 40 DEG C.
The preparation of 2.2 reference substance solution
Accurate weighing is dried the indirubin reference substance about 2mg to constant weight respectively, is placed in 50ml measuring bottle, adds
Chloroform dissolves and constant volume, to obtain final product.
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
Under above-mentioned chromatographic condition, accurate draw indirubin reference substance solution 1,2.5,5,10,15,20ul
Injecting high performance liquid chromatograph, measure peak area, with indirubin peak area as vertical coordinate (Y), indirubin contains
Amount is abscissa (X), calculates regression equation: Y=1.900*107X-64860 (r=0.9995, n=5).
Result shows that indirubin sample size has good linear relationship in the range of 0.0166～0.3312ug.
2.5 precision test
Take reference substance solution, repeat sample introduction 6 times, each 5ul, the RSD=1.58% of indirubin peak area,
Show that instrument precision is good.
2.6 stability test
Essence takes need testing solution 1, presses sample determination method in 10h, measures once every 2h.Indirubin contains
The RSD=0.82% of amount, shows that need testing solution is stable in 10h.
Essence takes need testing solution 2, presses sample determination method in 10h, measures once every 2h.Indirubin contains
The RSD=0.83% of amount, shows that need testing solution 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, calculate 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.
2.9 the mensuration of sample
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, by above-mentioned chromatographic condition, sample size 10ul, surveys
Fixed, external standard method calculates content, the results are shown in Table 1..
The assay result of table 1 indirubin
As known from Table 1, in injection of the present invention, the average content of indirubin is 0.20%, indigo in existing injection
The average content of rubine is 0.15.
Conclusion: compared with existing injection, the content of effective ingredient of isatis root indirubin in injection of the present invention
Higher.In like manner, according to the preparation of other dosage forms that extracting method of the present invention is made, the effective ingredient of Radix Isatidis
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 manufacture method 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 Radix Isatidis extract: take Radix Isatidis, the soak adding 6 times amount soaks 10h, filters,
Adding 10 times amount 80% alcohol heating reflux again to extract 3 times, each 2 hours, filter, medicinal residues are standby, extract
Liquid decompression recycling ethanol, it is 1.5:1.5 that concentrated solution adds water to the ratio of volume every milliliter and medical material amount every gram, on
Macroporous adsorbent resin, adds 7 times of column volumes of water elution, then with 7 times of column volume eluting of 50% ethanol, collects eluting
Liquid, reclaims ethanol, obtains alcohol extract, standby；Medicinal residues add 10 times amount water extraction 3 times, each 2 little
Time, filter, merging filtrate, after being condensed into concentrated solution, merge with above-mentioned alcohol extract, be concentrated into 50-60 DEG C
Lower relative density is the extractum of 1.1-1.2, 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 manufacture method 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 Radix Isatidis extract: take Radix Isatidis, the soak adding 7 times amount soaks 12h, filters,
Adding 12 times amount 85% alcohol heating reflux again to extract 5 times, each 3 hours, filter, medicinal residues are standby, extract
Liquid decompression recycling ethanol, it is 3:1 that concentrated solution adds water to the ratio of volume every milliliter and medical material amount every gram, upper macropore
Adsorbent resin, adds 10 times of column volumes of water elution, then with 10 times of column volume eluting of 70% ethanol, collects eluent,
Reclaim ethanol, obtain alcohol extract, standby；Medicinal residues add 12 times amount water extraction 3 times, each 3 hours,
Filter, merging filtrate, after being condensed into concentrated solution, merge with above-mentioned alcohol extract, phase at being concentrated into 50-60 DEG C
It is the extractum of 1.1-1.2 to density, 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 manufacture method 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 Radix Isatidis extract: take Radix Isatidis, the soak adding 5 times amount soaks 8h, filters,
Adding 8 times amount 70% alcohol heating reflux again to extract 0.5 hour, filter, medicinal residues are standby, and extracting solution reduces pressure back
Receiving ethanol, it is 1:3 that concentrated solution adds water to the ratio of volume every milliliter and medical material amount every gram, upper macroporous adsorbent resin,
Add 4 times of column volumes of water elution, then with 4 times of column volume eluting of 30% ethanol, collect eluent, reclaim ethanol,
Obtain alcohol extract, standby；Medicinal residues add 8 times amount water extraction 2 times, each 1 hour, filter, and merge
Filtrate, after being condensed into concentrated solution, merges with above-mentioned alcohol extract, and at being concentrated into 50-60 DEG C, relative density is
1.1-1.2 extractum, 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 manufacture method 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 0.2% 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；The extracting method of described Radix Isatidis extract is: take Radix Isatidis, adds soak
After immersion, filtering, extract with alcohol heating reflux, filter, medicinal residues are standby, extracting solution decompression recycling ethanol,
It is 1-3:3-1 that concentrated solution adds water to the ratio of volume every milliliter and medical material amount every gram, and upper macroporous adsorbent resin adds water
Eluting, then with ethanol elution, collect eluent, reclaim ethanol, obtain alcohol extract, standby；Medicinal residues add again
Enter water extraction, filter, filtrate, after being condensed into concentrated solution, merge with above-mentioned alcohol extract, be concentrated into 50-60 DEG C
Lower relative density is the extractum of 1.1-1.2, to obtain final product.
2. the manufacture method 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 manufacture method of the peaceful ejection preparation of soothing liver-QI as claimed in claim 1, it is characterised in that: described Radix Isatidis carries
The extracting method taking thing is: take Radix Isatidis, and the soak adding 5-7 times amount soaks 8-12h, filters, then adds
8-12 times amount 70-85% alcohol heating reflux extracts 1-5 time, each 0.5-3 hour, filters, and medicinal residues are standby
With, extracting solution decompression recycling ethanol, it is 1-3 that concentrated solution adds water to the ratio of volume every milliliter and medical material amount every gram:
3-1, upper macroporous adsorbent resin, add 4-10 times of column volume of water elution, then with 4-10 times of cylinder of 30-70% ethanol
Long-pending eluting, collects eluent, reclaims ethanol, obtains alcohol extract, standby；Medicinal residues add 8-12 times amount water
Extracting 2-3 time, each 1-3 hour, filter, merging filtrate, after being condensed into concentrated solution, with above-mentioned alcohol extraction
Taking liquid to merge, at being concentrated into 50-60 DEG C, relative density is the extractum of 1.1-1.2, to obtain final product.
4. the manufacture method of the peaceful ejection preparation of soothing liver-QI as claimed in claim 3, it is characterised in that: described Radix Isatidis
The extracting method of extract is: take Radix Isatidis, and the soak adding 6 times amount soaks 10h, filters, then adds
10 times amount 80% alcohol heating reflux extract 3 times, each 2 hours, filter, and medicinal residues are standby, and extracting solution subtracts
Pushing back receipts ethanol, it is 1.5:1.5 that concentrated solution adds water to the ratio of volume every milliliter and medical material amount every gram, upper macropore
Adsorbent resin, adds 7 times of column volumes of water elution, then with 7 times of column volume eluting of 50% ethanol, collects eluent,
Reclaim ethanol, obtain alcohol extract, standby；Medicinal residues add 10 times amount water extraction 3 times, each 2 hours,
Filter, merging filtrate, after being condensed into concentrated solution, merge with above-mentioned alcohol extract, phase at being concentrated into 50-60 DEG C
It is the extractum of 1.1-1.2 to density, to obtain final product.
5. the manufacture method 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 manufacture method 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610338253.9A CN105902651A (en) | 2016-05-20 | 2016-05-20 | Production method of shuganning injection preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610338253.9A CN105902651A (en) | 2016-05-20 | 2016-05-20 | Production method of shuganning injection preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105902651A true CN105902651A (en) | 2016-08-31 |
Family
ID=56748318
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610338253.9A Withdrawn CN105902651A (en) | 2016-05-20 | 2016-05-20 | Production method of shuganning injection preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105902651A (en) |
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2016
- 2016-05-20 CN CN201610338253.9A patent/CN105902651A/en not_active Withdrawn
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Application publication date: 20160831 |