CN105963390A - Preparation method of Shuganning preparation - Google Patents
Preparation method of Shuganning preparation Download PDFInfo
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- CN105963390A CN105963390A CN201610338255.8A CN201610338255A CN105963390A CN 105963390 A CN105963390 A CN 105963390A CN 201610338255 A CN201610338255 A CN 201610338255A CN 105963390 A CN105963390 A CN 105963390A
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- ganoderma
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/074—Ganoderma
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/19—Acanthaceae (Acanthus family)
- A61K36/195—Strobilanthes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/282—Artemisia, e.g. wormwood or sagebrush
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- A—HUMAN NECESSITIES
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
- A61K36/315—Isatis, e.g. Dyer's woad
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/74—Rubiaceae (Madder family)
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation 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
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction 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 or decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation 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
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
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- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Mycology (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Molecular Biology (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention discloses a preparation method of a Shuganning 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 extraction method of the lucid ganoderma extract is improved, and particularly the specific technology and parameters are improved so that total triterpenes in the lucid ganoderma are measured more easily, and the content of the measured total triterpenes is high. The efficacy of the Shuganning preparation can be effectively improved.
Description
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to the preparation method of a kind of easypro treating hepatopathy.
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 extract active ingredient of Chinese herbs effective to human body from complicated mixture.To improve drug effect.
Soothing liver-QI injection for curing is liver-protecting medicine, is mainly made up of Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin, Radix Isatidis extract and Ganoderma extract.There is heat-clearing and toxic substances removing, dampness removing jaundice eliminating, QI invigorating righting, effect of hepatoprotective.For jaundice due to damp-heat, disease meeting mesh is the most yellow, costa sternales distension, nausea and vomiting, and yellowish or reddish urine is 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, Ganoderma extract and extraction process thereof have carried out substantial amounts of research, inventor finds in research process, using existing Ganoderma extract, in the soothing liver-QI injection for curing made, the total triterpene in Ganoderma is difficult to measure, and the total triterpene in Ganoderma is the principle active component of Ganoderma, but Ganoderma extract prepared by prior art, total triterpene contents is the highest, have impact on the curative effect of medicine.
Summary of the invention
It is an object of the invention to, it is provided that the preparation method of a kind of easypro treating hepatopathy, the wherein extracting method of Ganoderma extract, its concrete technology and parameter are improved, make the total triterpene in Ganoderma be easier to measure, and the total triterpene contents measured is high.Can effectively improve the drug effect of easypro treating hepatopathy.
To achieve these goals, the present invention provides following technical scheme: the preparation method of a kind of easypro treating hepatopathy, described easypro treating hepatopathy calculates by weight, mainly it is made up as follows of 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: in baicalin, add water for injection, make it suspended, then add 10% sodium hydroxide solution and make dissolving；Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract are separately added into water for injection, dissolve, 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 1000 parts by volume, filter, embedding, sterilizing, to obtain final product；The extracting method of described Ganoderma extract is: take Ganoderma, after adding soak immersion, filters, adds water decoction, filters, after filtrate is condensed into concentrated solution, obtain Aqueous extracts, standby；Filtering residue adds ethanol solution, reflux, extract, filters, and filtering residue discards, and obtains alcohol extract, reclaims ethanol, and alcohol extract merges with above-mentioned Aqueous extracts, concentrates as extractum, dry, pulverize, to obtain final product.
In the preparation method of aforesaid easypro treating hepatopathy, described easypro treating hepatopathy calculates by weight, main by Herba Artemisiae Scopariae extract 4 parts, Fructus Gardeniae extract 3 parts, baicalin 22 parts, Radix Isatidis 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；It is dissolved in water for injection respectively in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, mixing, adds 0.2% activated carbon, stirs evenly, boil 15 minutes, filter, with 10% sodium hydroxide solution regulation pH value to 7.5～8.0, inject water to 1000 parts by volume, filter, embedding, sterilizing, to obtain final product.
In the preparation method of aforesaid easypro treating hepatopathy, the extracting method of described Ganoderma extract is: take Ganoderma, and the soak adding 5-7 times amount soaks 8-12h, filters, add 6-10 times amount soak by water 2-4 time, each 1.5-2.5h, to filter, filtrate merges, after being condensed into concentrated solution, obtain Aqueous extracts, standby；Filtering residue adds the ethanol solution of 6-10 times amount 75-85%, reflux, extract, 2-4 time, each 1-3h, filters, merging filtrate, reclaims ethanol, obtains alcohol extract, and alcohol extract merges with above-mentioned Aqueous extracts, when being concentrated into 50-60 DEG C, relative density is the extractum of 1.10-1.20, dry, pulverize, and to obtain final product.
In the preparation method of aforesaid easypro treating hepatopathy, the extracting method of described Ganoderma extract is: take Ganoderma, and the soak adding 6 times amount soaks 10h, filters, add 8 times amount soak by water 3 times, each 2h, to filter, filtrate merges, after being condensed into concentrated solution, obtain Aqueous extracts, standby；Filtering residue adds the ethanol solution of 8 times amount 80%, reflux, extract, 3 times, each 2h, filters, merging filtrate, reclaims ethanol, obtains alcohol extract, and alcohol extract merges with above-mentioned Aqueous extracts, when being concentrated into 50-60 DEG C, relative density is the extractum of 1.10-1.20, dry, pulverize, and to obtain final product.
In the preparation method of aforesaid easypro treating hepatopathy, 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, stir a little, stand 20-40 minute, filters, to obtain final product.
In the preparation method of aforesaid easypro treating hepatopathy, described soak is prepared: take the white vinegar of 5 parts by volume, adds in the boiling water of 100 parts by volume, adds the green tea of 10 weight portions, stirs a little, stands 30 minutes, filters, to obtain final product.
The preparation method of a kind of easypro treating hepatopathy, described preparation is injection.
The present invention treating hepatopathy that relaxes mainly is made up of Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, baicalin and Radix Isatidis extract.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, dysuria, eczema pruritus, infectious jaundice type liver.Fructus Gardeniae (formal name used at school: Gardeniajasminoides Ellis), belongs to the l that Ministry of Public Health promulgates and criticizes medicine-food two-purpose resource, have hepatoprotective, function of gallbladder promoting, blood pressure lowering, calmness, stop blooding, the effect such as detumescence.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 significant biological activity, has antibacterial, diuresis, antiinflammatory, resistance state and spasmolysis, and has the physiological potencies such as stronger antitumor response.Critical role has been occupied at clinical medicine.Baicalin can also absorb ultraviolet, scavenging activated oxygen, can suppress again melanic generation, therefore can be not only used for medicine it can also be used to cosmetics, is 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 and swelling pain, frequent fetal movement, carbuncle furuncle.Radix Isatidis, Isatis tinctoria, for the dry root of cruciferae isatis, 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.It is mainly used in 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, Ganoderma extract and extraction process thereof have carried out substantial amounts of research, inventor finds in research process, use existing Ganoderma extract, in the soothing liver-QI injection for curing made, total triterpene in Ganoderma is difficult to measure, and the total triterpene in Ganoderma is the principle active component of Ganoderma, but Ganoderma extract prepared by prior art, total triterpene contents is the highest, and research in recent years finds, total triterpene be in Ganoderma in addition to polysaccharide the another kind of main compound having obvious pharmacologically active, there is calmness, pain relieving, removing toxic substances, protect the liver, the effects such as poisoning tumor, make the to relax drug effect for the treatment of hepatopathy that total triterpene contents is the highest is the best.Applicant finds through long-term lot of experiments research, use the Ganoderma extract that the method for the invention is made as raw material, in the easypro treating hepatopathy made, the content of the total triterpene in Ganoderma adds a lot unexpectedly, this technique visible promotes the dissolution of total triterpene in Ganoderma, can be effectively improved the drug effect of easypro treating hepatopathy.
Compared with prior art, in the easypro treating hepatopathy that the method for the invention makes, the easy dissolution of total triterpene in Ganoderma, the total triterpene contents measured is high, is effectively improved the drug effect of easypro treating hepatopathy.
The present invention has carried out substantial amounts of experimentation, is below the result of experimentation of the present invention:
Experimental example 1: total triterpene contents is investigated
1 raw material
1.1 injections of the present invention: with embodiment 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 and Ganoderma extract 3.5g and adjuvant.
Technique: add the water for injection of 1.5 times amount to baicalin so that it is suspended, then add 10% sodium hydroxide solution and make dissolving；Being dissolved in water for injection of 1.5 times amount respectively in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, mixing, adds activated carbon, stirs 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.
Wherein, described Ganoderma extract is commercially available.
1.3 main agents ursolic acid standard substance, are purchased from Nat'l Pharmaceutical & Biological Products Control Institute；Perchloric acid, glacial acetic acid, vanillin, dehydrated alcohol is analytical pure.
1.4 key instrument 752C visible ultraviolet spectrophotometers；Rotary Evaporators.
2 experimental techniques
The preparation precision of 2.1 standard solutions weighs ursolic acid standard substance 8.0mg, with dehydrated alcohol constant volume in 100mL volumetric flask, obtains 80ug/mL ursolic acid standard solution.
The preparation of 2.2 sample solutions 1
Precision measures injection 2ml of the present invention, puts in 25ml brown measuring bottle, adds methanol to scale, shakes up, to obtain final product.
The preparation of 2.3 sample solutions 2
The preparation of need testing solution 2: precision measures existing injection 2ml, puts in 25ml brown measuring bottle, adds methanol to scale, shakes up, to obtain final product.
2.4 selections measuring wavelength
Under 548nm wavelength, all there is an absorption maximum to carrying out UV-Vis scans, result ursolic acid and Ganoderma sample liquid after the anhydrous alcohol solution of ursolic acid and sample solution colour developing, and blank is noiseless.Therefore, selecting 548nm is this measuring wavelength.
2.5 developers use condition to select
(1) 5% vanillin-glacial acetic acid consumption is investigated.Accurate absorption standard solution 0.5mL6 part, respectively adds 5% vanillin-glacial acetic acid 0.1,0.2,0.3 after water bath method, 0.4,0.5,0.6mL, respectively add perchloric acid 0.6mL, in 60 DEG C, heat 15min, take out and put cooling in frozen water, add glacial acetic acid 5mL, at 548nm, after shaking up, measure absorbance.Result is that absorbance is respectively 0.240,0.253,0.261,0.267,0.273,0.272.
(2) perchloric acid consumption is investigated.Take ursolic acid reference substance liquid 0.5mL 6 parts, water bath method, respectively add 5% vanillin-glacial acetic acid 0.5mL, then add perchloric acid 0.5,0.6 respectively, 0.7,0.8,0.9,1.0mL, in 60 DEG C of water-baths, heat 15min, take out and put cooling in frozen water, add glacial acetic acid 5mL, at 548nm, after shaking up, measure absorbance.Result is respectively as follows: 0.244,0.258,0.269,0.275,0.275,0.274.
(3) investigation of bath temperature.Drawing standard solution 0.5mL 1 part, ibid method is respectively 40,50,60,70,80,90 DEG C, observes, measures absorbance at 548nm under the conditions of 15min.Result is respectively as follows: 0.261,0.270,0.279,0.288,0.290,0.295.
The above results shows: when other conditions constant, and along with the increase of 5% vanillin-glacial acetic acid liquid consumption, absorbance increases accordingly, to 0.5mL and above consumption, being basically unchanged of absorbance.Therefore, 0.5mL is 5% vanillin-glacial acetic acid liquid optimum amount.When other conditions constant, along with the increase of perchloric acid consumption, absorbance increases accordingly, to 0.8mL and above consumption, being basically unchanged of absorbance.Therefore, 0.8mL is perchloric acid optimum amount.When other conditions constant, along with temperature raises, absorbance increases accordingly；But when bath temperature is more than 60 DEG C, blank solution starts variable color.Therefore, selecting 60 DEG C is bath temperature.
The drafting of 2.6 standard curves
Accurate drawing standard solution 0.1,0.2,0.3,0.4,0.5,0.6mL, measure absorbance by above-mentioned optimum condition and step at 548nm, with the micrograms of ursolic acid as abscissa, absorbance is vertical coordinate, Criterion curve.Regression equation Y=0.0066X+0.007, r=0.9981, represent absorbance and ursolic acid content in the range of 12～53ug in good linear relationship.
2.7 study on the stability take 0.3mL sample liquid, by standard curve method, are measured respectively in 0～120min.Result shows: absorbance is unstable in 0～4min, and RSD is 19.91%；Between 4～45min more stable, RSD is 1.26%；45～120min stability begin to decline, and RSD is 25.81%.Therefore, nitrite ion is suitable in 4～45min measuring absorbance.
2.8 recovery test precisions weigh the sample 200mg of known content, and process sample as stated above；Accurately add quantitative ursolic acid standard substance afterwards, be measured by under sample size item.Average recovery rate is 96.59%, and RSD is 1.55%.
2.9 take injection of the present invention and existing injection respectively, make sample solution 1 and sample solution 2, parallel measure 6 parts, measure according to the method under standard curve, the results are shown in Table 1.
The assay result of table 1 total triterpene
As known from Table 1, in injection of the present invention, the average content of total triterpene is 0.20%, and in existing injection, the average content of total triterpene is 0.14%.
Conclusion: compared with existing injection, in injection of the present invention, the content of total triterpene is higher.Total triterpenoids be in Ganoderma in addition to polysaccharide the another kind of main compound having obvious pharmacologically active, there is calmness, pain relieving, detoxify, protect the liver, kill the effects such as tumor, therefore, in Ganoderma extract, total triterpene contents improves, and contributes to increasing the drug effect of easypro treating hepatopathy.In like manner, according to the preparation of other dosage forms that extracting method of the present invention is made, total triterpene contents also should increase.So that drug effect increases.
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, institute of lab animals of Sichuan Academy of Medical Sciences provides.
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 produces,.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, and 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%, injection before use with Dextrose and Sodium Chloride Inj. dilution.Existing preparation group injects existing injection, and dosage is 0.1ml/10g, is configured to the medicinal liquid of 40%, 20%, 10%, injection before use with Dextrose and Sodium Chloride Inj. dilution.Normal group and model group injecting normal saline, be given daily 1 time, continuous 8 days.From being administered the 4th day, after every day is administered 0.5h, 56 degree of Red Stars strong, colourless liquor distilled from sorghum Chinese liquor 8mL/kg (normal group is to equal volume distilled water) of mouse stomach, 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, extracts eyeball of mouse and takes blood, separate serum, measure serum alt and AST level, anatomical isolation liver, weigh, calculate liver index, separately taking same area hepatic tissue, 10% formaldehyde is fixed, section, observes liver pathomorphology and change after HE dyeing.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 < 0.05,##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 the clearest, sinus hepaticus is the most visible." ++ ", moderate endochylema puffing, between slight hepatic cell swelling and balloon sample, the slightly aobvious disorder of liver rope, sinus hepaticus starts to occur narrow.
As seen from table, relax treating hepatopathy and existing easypro treating hepatopathy of the present invention all has reduction mice serum ALT and an effect of AST level, and present invention treating hepatopathy effect of relaxing is better than existing easypro treating hepatopathy.Histopathologic examination shows, there is endochylema puffing in various degree, cellular edema, the change of balloon sample, lytic necrosis in model group mouse liver cell, the pathological changes such as liver rope is disorderly, sinus hepaticus is narrow, soothing liver-QI injection for curing successive administration 8 days, the present invention relaxes treating hepatopathy and existing easypro treating hepatopathy all presents improvement result in various degree.Wherein, present invention treating hepatopathy effect of relaxing is better than existing easypro treating hepatopathy.
Detailed description of the invention:
Embodiment 1:
Formula: Herba Artemisiae Scopariae extract 4g, Fructus Gardeniae extract 3g, baicalin 22g, Radix Isatidis extract 5g and Ganoderma 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 and make dissolving；It is dissolved in water for injection respectively in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, mixing, adds 0.2% activated carbon, stirs 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, obtain injection.
The extraction process of Ganoderma extract:
Taking Ganoderma, the soak adding 6 times amount soaks 10h, filters, adds 8 times amount soak by water 3 times, and each 2h filters, and filtrate merges, and after being condensed into concentrated solution, obtains Aqueous extracts, standby；Filtering residue adds the ethanol solution of 8 times amount 80%, reflux, extract, 3 times, each 2h, filters, merging filtrate, reclaims ethanol, obtains alcohol extract, and alcohol extract merges with above-mentioned Aqueous extracts, when being concentrated into 50-60 DEG C, relative density is the extractum of 1.10-1.20, dry, pulverize, and to obtain final product.
Described soak is prepared: take the white vinegar of 50ml, adds in the boiling water of 1000ml, adds the green tea of 100g, stir a little, stand 30 minutes, filters, to obtain final product.
Usage and dosage: intravenous drip, one time 10～20ml, instil with 10% glucose injection 250～500ml dilution posterior vein, 1 time on the one；Intramuscular injection can be used instead after remission, one day 2～4ml, 1 time on the one.
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 when having muddiness, precipitation, floccule to use.
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 Ganoderma 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 and make dissolving；It is dissolved in water for injection respectively in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, mixing, adds 0.2% activated carbon, stirs 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, obtain injection.
The extraction process of Ganoderma extract:
Taking Ganoderma, the soak adding 7 times amount soaks 12h, filters, adds 10 times amount soak by water 4 times, and each 2.5h filters, and filtrate merges, and after being condensed into concentrated solution, obtains Aqueous extracts, standby；Filtering residue adds the ethanol solution of 10 times amount 85%, reflux, extract, 4 times, each 3h, filters, merging filtrate, reclaims ethanol, obtains alcohol extract, and alcohol extract merges with above-mentioned Aqueous extracts, when being concentrated into 50-60 DEG C, relative density is the extractum of 1.10-1.20, dry, pulverize, and to obtain final product.
Described soak is prepared: take the white vinegar of 80ml, adds in the boiling water of 1100ml, adds the green tea of 150g, stir a little, stand 40 minutes, filters, to obtain final product.
Usage and dosage and specification are with embodiment 1.
Embodiment 3:
Formula: Herba Artemisiae Scopariae extract 4g, Fructus Gardeniae extract 3g, baicalin 22g, Radix Isatidis extract 5g and Ganoderma 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 and make dissolving；It is dissolved in water for injection respectively in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, mixing, adds 0.2% activated carbon, stirs 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, obtain injection.
The extraction process of Ganoderma extract:
Taking Ganoderma, the soak adding 5 times amount soaks 8h, filters, adds 6 times amount soak by water 2 times, and each 1.5h filters, and filtrate merges, and after being condensed into concentrated solution, obtains Aqueous extracts, standby；Filtering residue adds the ethanol solution of 6 times amount 75%, reflux, extract, 2 times, each 1h, filters, merging filtrate, reclaims ethanol, obtains alcohol extract, and alcohol extract merges with above-mentioned Aqueous extracts, when being concentrated into 50-60 DEG C, relative density is the extractum of 1.10-1.20, dry, pulverize, and to obtain final product.
Described soak is prepared: take the white vinegar of 20ml, adds in the boiling water of 900ml, adds the green tea of 50g, stir a little, stand 20 minutes, filters, to obtain final product.
Usage and dosage and specification are with embodiment 1.
Claims (7)
1. the preparation method of an easypro treating hepatopathy, it is characterized in that: described easypro treating hepatopathy calculates by weight, mainly it is made up as follows of 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: in baicalin, add water for injection, make it suspended, then add 10% sodium hydroxide solution and make dissolving；Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract are separately added into water for injection, dissolve, 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 1000 parts by volume, filter, embedding, sterilizing, to obtain final product；The extracting method of described Ganoderma extract is: take Ganoderma, after soak soaks, filters, adds water decoction, filters, after filtrate is condensed into concentrated solution, obtain Aqueous extracts, standby；Filtering residue adds ethanol solution, reflux, extract, filters, and filtering residue discards, and obtains alcohol extract, reclaims ethanol, and alcohol extract merges with above-mentioned Aqueous extracts, concentrates as extractum, dry, pulverize, to obtain final product.
2. the preparation method of the treating hepatopathy that relaxes as claimed in claim 1, it is characterized in that: described easypro treating hepatopathy calculates by weight, main by Herba Artemisiae Scopariae extract 4 parts, Fructus Gardeniae extract 3 parts, baicalin 22 parts, Radix Isatidis 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；It is dissolved in water for injection respectively in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, mixing, adds 0.2% activated carbon, stirs evenly, boil 15 minutes, filter, with 10% sodium hydroxide solution regulation pH value to 7.5～8.0, inject water to 1000 parts by volume, filter, embedding, sterilizing, to obtain final product.
3. the preparation method of the treating hepatopathy that relaxes as claimed in claim 1, it is characterized in that: the extracting method of described Ganoderma extract is: take Ganoderma, the soak adding 5-7 times amount soaks 8-12h, filters, adds 6-10 times amount soak by water 2-4 time, 1.5-2.5h every time, filtering, filtrate merges, after being condensed into concentrated solution, obtain Aqueous extracts, standby；Filtering residue adds the ethanol solution of 6-10 times amount 75-85%, reflux, extract, 2-4 time, each 1-3h, filters, merging filtrate, reclaims ethanol, obtains alcohol extract, and alcohol extract merges with above-mentioned Aqueous extracts, when being concentrated into 50-60 DEG C, relative density is the extractum of 1.10-1.20, dry, pulverize, and to obtain final product.
4. the preparation method of the treating hepatopathy that relaxes as claimed in claim 3, it is characterized in that: the extracting method of described Ganoderma extract is: take Ganoderma, the soak adding 6 times amount soaks 10h, filters, adds 8 times amount soak by water 3 times, 2h every time, filtering, filtrate merges, after being condensed into concentrated solution, obtain Aqueous extracts, standby；Filtering residue adds the ethanol solution of 8 times amount 80%, reflux, extract, 3 times, each 2h, filters, merging filtrate, reclaims ethanol, obtains alcohol extract, and alcohol extract merges with above-mentioned Aqueous extracts, when being concentrated into 50-60 DEG C, relative density is the extractum of 1.10-1.20, dry, pulverize, and to obtain final product.
5. the preparation method of the easypro treating hepatopathy 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, add the green tea of 5-15 weight portion, stir a little, stand 20-40 minute, filter, to obtain final product.
6. the preparation method of the treating hepatopathy that relaxes as claimed in claim 5, it is characterised in that: described soak is prepared: take the white vinegar of 5 parts by volume, adds 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.
7. the preparation method of the treating hepatopathy that relaxes as claimed in claim 1, it is characterised in that: described preparation is injection.
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