CN105412294A - Production method of Shuganning Preparation - Google Patents

Production method of Shuganning Preparation Download PDF

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CN105412294A
CN105412294A CN201510967169.9A CN201510967169A CN105412294A CN 105412294 A CN105412294 A CN 105412294A CN 201510967169 A CN201510967169 A CN 201510967169A CN 105412294 A CN105412294 A CN 105412294A
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extract
ethanol
product
add
ganoderma
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CN105412294B (en
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何峰
张昀
潘金成
彭相印
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Guizhou Ruihe Pharmaceutical Co ltd
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LONGLI PHARMACEUTICAL FACTORY OF GUIZHOU RUIHE PHARMACEUTICAL Co
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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Abstract

The invention discloses a production method of a Shuganning preparation. The Shuganning preparation is mainly prepared from a capillary artemisia extract, a gardenia extract, baicalin, a radix isatidis extract and a lucid ganoderma extract. According to the production method disclosed by the invention, a method for extracting the lucid ganoderma extract is improved, and especially the concrete process and parameters of the method are improved, such that polysaccharose in lucid ganoderma is easily detected and the content of the detected polysaccharose in the lucid ganoderma is high. The drug effect of the Shuganning preparation can be effectively improved.

Description

A kind of manufacture method of easypro treating hepatopathy
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of manufacture method 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 complicated, need extract the effective active ingredient of Chinese herbs of human body from the mixture of complexity.To improve drug effect.
Soothing liver-QI injection for curing is liver-protecting medicine, makes primarily 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 order is all yellow, costa sternales distension, nausea and vomiting, and yellowish or reddish urine is weak, poor appetite, loose stool; Acute chronic viral hepatitis sees above states symptom.
In prior art, in soothing liver-QI injection for curing raw material, Ganoderma extract many employings water extraction process extracts, and namely extracts twice, decocts, concentrated, to obtain final product.But inventor finds in research process, existing extraction process is adopted to make Ganoderma extract, in the soothing liver-QI injection for curing made, ganoderan in Ganoderma is not easily measured, and the polysaccharide in Ganoderma is the principle active component of Ganoderma, but Ganoderma extract prepared by prior art, polyoses content is not high, have impact on the curative effect of medicine.
Summary of the invention
The invention provides a kind of manufacture method of easypro treating hepatopathy, especially wherein the extracting method of Ganoderma extract, its concrete technology and parameter are improved, the polysaccharide in Ganoderma is more easily measured, and the ganoderma polyoses content measured is high.Effectively can improve the drug effect of easypro treating hepatopathy.
To achieve these goals, the invention provides following technical scheme: a kind of manufacture method of easypro treating hepatopathy, described easypro treating hepatopathy calculates by weight, make as follows primarily 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: add water for injection to baicalin, make it be suspended, then add 10% sodium hydroxide solution and make dissolving; In Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, add water for injection respectively, make dissolving, mixing, add active carbon, stir evenly, boil, filter, with 10% sodium hydroxide solution adjust ph to 7.5 ~ 8.0, inject water to ormal weight, filter, embedding, sterilizing, to obtain final product; The extracting method of described Ganoderma extract is: get Ganoderma, cleans, after adding soak with ethanol, breaks into serosity, after adding citric acid solution and the mixing of HCL solution, adds ethanol, extracts, filter, collect filtrate, reclaim ethanol, for subsequent use; Medicinal residues extracting in water, extracting solution concentrates, filter with inorganic ceramic film, add water during filtration washing effective ingredient several times, medicinal liquid after filtration is directly adsorbed by processed good resin column, effluent is discarded, with the speed of 0.5-1.5ml per second, be that post washed by the 1-3 times of column volume deionized water of 2-6 or 5-15% ethanol with pH value, then be the 75-85% ethanol elution of 4-6 with pH value, collect the darker elution fractions of color, reclaim ethanol, concentrate with vacuum evaporator, dry, obtain crude extract; Crude extract is added 15-25% ethanol, stirring and dissolving, then carry out ultrafiltration, filtrate recycling ethanol with rolling ultrafiltration membrane, concentrate with vacuum evaporator, dry, pulverize, to obtain final product.
In the manufacture method of aforesaid easypro treating hepatopathy, described easypro treating hepatopathy calculates by weight, primarily of 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 be suspended, then add 10% sodium hydroxide solution and make dissolving; Be dissolved in water for injection respectively in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, mixing, adds 0.2% active carbon, stirs evenly, boil 15 minutes, filter, with 10% sodium hydroxide solution adjust ph to 7.5 ~ 8.0, inject water to ormal weight, filter, embedding, sterilizing, to obtain final product.
In the manufacture method of aforesaid easypro treating hepatopathy, the extracting method of described Ganoderma extract is:
1, get Ganoderma, clean, adding 2-4 times amount concentration is that the ethanol of 80-90% soaks 2-4 hour at 75-85 DEG C, obtains A product;
2, A product are broken into serosity, in serosity, add the citric acid solution of 0.1-0.3 times amount 0.01-0.03mol/l and the HCL solution mixing of 0.05-0.15 times amount 1-2mol/l, obtain B product;
3, in B product, add the ethanol of medical material amount 4-6 times amount 80-90% again, carry out reflux, extract, 2-4 hour, filter, collect filtrate, reclaim ethanol, obtain C product; Medicinal residues add 5-7 times amount water extraction 2-4 time again, each 0.5-1.5 hour, and merge extractive liquid, mixes with C product, is condensed into concentrated solution, obtains D product;
4, D product inorganic ceramic film is filtered, the rate of filtration is 5-20L/h, the water washing effective ingredient of 1-4 times of medicine liquid volume amount is added several times during filtration, medicinal liquid after filtration is directly adsorbed by processed good resin column, effluent is discarded, with the speed of 0.5-1.5ml per second, be that post washed by the 1-3 times of column volume deionized water of 2-6 or 5-15% ethanol with pH value, be the 75-85% ethanol elution of 4-6 again with pH value, collect the darker elution fractions of color, reclaim ethanol, concentrate with vacuum evaporator, drying, obtains crude extract; Crude extract is added 15-25% ethanol, stirring and dissolving, then carry out ultrafiltration, filtrate recycling ethanol with rolling ultrafiltration membrane, concentrate with vacuum evaporator, dry, pulverize, to obtain final product.
In the manufacture method of aforesaid easypro treating hepatopathy, the extracting method of described Ganoderma extract is:
1, get Ganoderma, clean, add 3 times amount concentration be 85% ethanol soak 3 hours at 80 DEG C, obtain A product;
2, A product are broken into serosity, in serosity, add the citric acid solution of 0.2 times amount 0.02mol/l and the HCL solution mixing of 0.1 times amount 1-2mol/l, obtain B product;
3, in B product, add the ethanol of medical material amount 5 times amount 85% again, carry out reflux, extract, 3 hours, filter, collect filtrate, reclaim ethanol, obtain C product; Medicinal residues add 6 times amount water extraction 3 times again, each 1 hour, and merge extractive liquid, mixes with C product, be condensed into concentrated solution, obtains D product;
4, D product inorganic ceramic film is filtered, the rate of filtration is 10-15L/h, the water washing effective ingredient of 2-3 times of medicine liquid volume amount is added several times during filtration, medicinal liquid after filtration is directly adsorbed by processed good resin column, effluent is discarded, with the speed of 1ml per second, be that post washed by 2 times of column volume deionized waters of 2-6 or 10% ethanol with pH value, be 80% ethanol elution of 4-6 again with pH value, collect the darker elution fractions of color, reclaim ethanol, concentrate with vacuum evaporator, drying, obtains crude extract; Crude extract is added 20% ethanol, stirring and dissolving, then carry out ultrafiltration, filtrate recycling ethanol with rolling ultrafiltration membrane, concentrate with vacuum evaporator, dry, pulverize, to obtain final product.
In the manufacture method of aforesaid easypro treating hepatopathy, described preparation is injection.
The present invention's treating hepatopathy that relaxes is made primarily 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, 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 treatment jaundice, dysuria, eczema pruritus, infectious jaundice type liver.Fructus Gardeniae (formal name used at school: GardeniajasminoidesEllis), the l belonging to Ministry of Public Health promulgation criticizes medicine-food two-purpose resource, has the effects such as hepatoprotective, function of gallbladder promoting, blood pressure lowering, calmness, hemostasis, detumescence.The diseases such as treatment icterohepatitis, bruise, hypertension, diabetes are usually used at tcm clinical practice.Baicalin (Baicalin) is extraction and isolation a kind of flavone compound out from scutellariae,radix, there is significant biological activity, there is antibacterial, diuresis, antiinflammatory, resistance state and spasmolysis, and there is the physiological potencies such as stronger antitumor response.Critical role is occupied at clinical medicine.Baicalin can also absorb ultraviolet, scavenging activated oxygen, again can the generation of check melanin, and therefore both can be used for medicine, also can be used for cosmetics, is a kind of good functional cosmetics raw material.There is removing the relative excess fire, except damp and hot, 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, Isatistinctoria is the dry root of cruciferae isatis, cold in nature, and taste is micro-sweet rear bitterness first, has effect of heat-clearing and toxic substances removing, preventing cold, sore-throat relieving.Be mainly used in the diseases such as treatment maculae caused by violent heat pathogen, crimson tongue are purple dark, scarlet fever.
In prior art, Ganoderma extract often adopts following method to extract, that is: get after Ganoderma dry, pulverize, add the water of 6-10 times amount, decoct 2 times, each 2-3h, then merges decoction liquor, is condensed into extractum, extract dry.But adopt the Ganoderma extract that said extracted technique is made, in the easypro treating hepatopathy made, the ganoderan in Ganoderma extract is not easily measured.Inventor finds in technical study, and the Ganoderma extract that employing the method for the invention is made is as raw material, and in the easypro treating hepatopathy made, the content of ganoderan adds much unexpectedly, and this technique facilitates the stripping of ganoderan as seen.
Compared with prior art, in the easypro treating hepatopathy that the method for the invention makes, the easy stripping of ganoderan, the ganoderma polyoses content measured is high, effectively can also improve the drug effect of easypro treating hepatopathy.
Invention has been a large amount of experimentatioies, is below the result of experimentation of the present invention:
Experimental example 1: ganoderma polyoses content 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: the water for injection adding 1.5 times amount to baicalin, makes it be suspended, then adds 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 active carbon, stirs evenly, boil, filter, with 10% sodium hydroxide solution adjust ph to 7.5 ~ 8.0, inject water to ormal weight, filter, embedding, sterilizing, to obtain final product.
Wherein, the extracting method of described Ganoderma extract is: get after Ganoderma dry, pulverize, add the water of 6-10 times amount, decoct 2 times, each 2-3h, then merges decoction liquor, filters, when filtrate is condensed into 60-70 DEG C, relative density is the extractum of 1.0-1.1, and extractum, extract dry, obtains Ganoderma extract.
1.3 Shimadzu UV-2450 type ultraviolet-uisible spectrophotometers (Japanese Shimadzu Corporation); TDL ultrasonic cleaner (Kunshan Instrument Ltd.); Desk centrifuge TDL-40B (Anting Scientific Instrument Factory, Shanghai), purchased from Fluka, concentrated sulphuric acid, sodium hydroxide, ethanol, copper sulfate, sodium citrate, phenol are analytical pure to glucosan reference substance (molecular weight is 500000).
2 experimental techniques and result
The preparation of 2.1 cupferron solution takes 0.75gCuSO respectively 45H 2o and 7.5g sodium citrate, is dissolved in water and is diluted to 250mL, for subsequent use as the mixing of cupferron storing solution.Get cupferron storing solution 50mL, add water 50mL, adds solid anhydrous sodium sulfate 12.5g and make it dissolve after mixing.Face used time preparation.
The preparation of 2.2 reference substance solution
Precision takes through drying under reduced pressure appropriate to the glucosan reference substance of constant weight, is dissolved in water and is mixed with the solution product solution in contrast that 1mL contains 1mg glucosan.
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 the brown measuring bottle of 25ml, adds methanol to scale, shake up, to obtain final product.
The preparation of need testing solution 2: precision measures existing injection 2ml, puts in the brown measuring bottle of 25ml, adds methanol to scale, shake up, to obtain final product.
The selection of 2.4 mensuration wavelength
Reference ultraviolet visible spectrophotometry (" Chinese Pharmacopoeia 2005 version annex VA), in 340-550nm wave-length coverage, respectively spectral scan is carried out to reference substance solution and need testing solution, result shows, both all have an absworption peak at about 490nm, therefore, using 490nm as mensuration wavelength.
The investigation of 2.5 linear relationships
Precision measure reference substance solution 0.2,0.4,0.6,0.8,1.0,1.2ml, put respectively in 25ml measuring bottle, add 70% ethanol dilution to scale, shake up.With 70% ethanol for blank, according to ultraviolet visible spectrophotometry (" Chinese Pharmacopoeia 2005 version annex VA), absorbance is measured at the wavelength place of 490nm, with glucosan concentration for abscissa, absorbance is vertical coordinate, and obtaining equation of linear regression is y=0.00514x+0.00571, correlation coefficient r=0.9996, result shows, glucose is good linear relationship with absorbance in 21.76 μ g/ml ~ 217.6 μ g/ml concentration ranges.
2.6 precision test
Get reference substance solution (C:0.0241mg/ml), measure absorbance at 490nm place, METHOD FOR CONTINUOUS DETERMINATION 6 times, result shows that the RSD measured for 6 times is 0.90%, and instrument precision is good.
2.7 stability test
Get reference substance solution (C:0.0241mg/ml), need testing solution 1 and need testing solution 2, respectively at 0,15,20,60,90,120min, polyoses content is measured at 490nm place, result shows, reference substance solution, need testing solution 1 and need testing solution 2 are stable in 120min, its RSD is respectively 0.63%, 0.61% and 0.71%, has good stability.
2.8 replica test
Get with a collection of injection of the present invention 6 parts, every part of about 2ml, accurately weighed, by the preparation of need testing solution 1 preparation method, measure, the content of polysaccharide in calculation sample, result shows in accordance with the law, and RSD is 1.15%, and the method repeatability is good.
Get with a collection of existing injection 6 parts, every part of about 2ml, accurately weighed, by the preparation of need testing solution 2 preparation method, measure, the content of polysaccharide in calculation sample, result shows in accordance with the law, and RSD is 1.52%, and the method repeatability is good.
2.9 application of sample recovery tests
Get the injection of the present invention of known content and existing injection 2ml respectively, accurately weighed, parallel 9 parts, precision adds reference substance solution in right amount respectively, prepares need testing solution 1, measure in accordance with the law by test sample preparation method, calculates the response rate.End product is that average recovery rate is respectively 99.87% and 99.58%, RSD=0.65% and RSD=0.89%.Therefore this method reliability is good.
2.9 sample tests
Measure injection of the present invention and existing injection 2ml respectively, accurately weighed, by need testing solution 1 and the preparation of need testing solution 2 preparation method, parallelly measure 6 parts, measure in accordance with the law and calculate the content of polysaccharide.The results are shown in Table 1.
The assay result of table 1 total coumarins
As known from Table 1, in injection of the present invention, the average content of polysaccharide is 2.55%, and in existing injection, the average content of polysaccharide is 1.87%.
Conclusion: compared with existing injection, in injection of the present invention, the content of ganoderan polysaccharide is higher.Ganoderan (PolysaccharideofGanodermLucidum) has multiple drug effect. except antitumor exception. and ganoderan can also improve immunity of organisms and hypoxia-bearing capability, eliminate interior free yl, anti-radiation, improve liver detoxification function, function of gallbladder promoting heat clearing away, blood circulation promoting and blood stasis dispelling etc.Therefore, in Ganoderma extract, polyoses content improves, and contributes to the drug effect increasing easypro treating hepatopathy.In like manner, the preparation of other dosage forms made according to extracting method of the present invention, ganoderma polyoses content also should increase.Thus drug effect is increased.
Experimental example 2. effect experiment
1 materials and methods
1.1 trial drug
1.1.1 injection of the present invention, with embodiment 1.
1.1.2 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..MultiskanMK3 type microplate reader, ThermoLabsystems company.
2 experimental techniques
40 mices are divided into 4 groups at random, i.e. Normal group, model group, of the present invention group and existing preparation group, often organize 10, the administration of each group tail vein injection.Inject injection of the present invention for of the present invention group, concentration is 0.1ml/10g, is mixed with the medicinal liquid of 40%, 20%, 10% before use, injection with Dextrose and Sodium Chloride Inj. dilution.Existing preparation group injects existing injection, and dosage is 0.1ml/10g, is mixed with the medicinal liquid of 40%, 20%, 10% before use, injection with Dextrose and Sodium Chloride Inj. dilution.Normal group and model group injecting normal saline, daily 1 time, continuous 8 days.From administration the 4th day, after administration every day 0.5h, mouse stomach 56 degree of Red Star strong, colourless liquor distilled from sorghum Chinese liquor 8mL/kg (normal group is to equal volume distilled water), 2 times/day, two minor tick 3-4h, mice administration with fill with all fasting before wine.Continuous 5 days, 1h after last gavage Chinese liquor, extractd eyeball of mouse and gets blood, separation of serum, measure serum alt and AST level, anatomical isolation liver, weighs, and calculates liver index, separately get 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 the impact of acute alcohol liver injury model mouse liver index and Serum ALT, 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;
Table 3 is on the impact of acute alcohol liver injury model mouse liver Histopathologic changes
Note: pathological changes classification standard: " one ", normally, without pathological changes such as hepatocyte puffing, the changes of balloon sample; "+", lobules of liver less than 1/3 region slight hepatic cell swelling, endochylema puffing.But hepatic cords is substantially clear, sinus hepaticus is still visible." ++ ", moderate endochylema puffing, between slight hepatic cell swelling and balloon sample, liver rope is slightly aobvious disorderly, and sinus hepaticus starts to occur narrow.
As seen from table, relax treating hepatopathy and existing easypro treating hepatopathy of the present invention all has the effect reducing mice serum ALT and AST level, and the present invention is relaxed, treating hepatopathy effect is better than existing easypro treating hepatopathy.Histopathologic examination shows, model group mouse liver cell appearance endochylema puffing in various degree, cellular edema, the change of balloon sample, lytic necrosis, the pathological changes such as liver rope is disorderly, sinus hepaticus is narrow, soothing liver-QI injection for curing successive administration 8 days, relax treating hepatopathy and existing easypro treating hepatopathy of the present invention all presents improvement result in various degree.Wherein, the present invention's 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, makes it be suspended, then adds 10% sodium hydroxide solution and make dissolving; Be dissolved in water for injection respectively in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, mixing, adds 0.2% active carbon, stirs evenly, boil 15 minutes, filter, with 10% sodium hydroxide solution adjust ph to 7.5 ~ 8.0, inject water to 1000ml, filter, embedding, sterilizing, obtains injection.
The extraction process of Ganoderma extract:
1, get Ganoderma, clean, add 3 times amount concentration be 85% ethanol soak 3 hours at 80 DEG C, obtain A product;
2, A product are broken into serosity, in serosity, add the citric acid solution of 0.2 times amount 0.02mol/l and the HCL solution mixing of 0.1 times amount 1-2mol/l, obtain B product;
3, in B product, add the ethanol of medical material amount 5 times amount 85% again, carry out reflux, extract, 3 hours, filter, collect filtrate, reclaim ethanol, obtain C product; Medicinal residues add 6 times amount water extraction 3 times again, each 1 hour, and merge extractive liquid, mixes with C product, be condensed into concentrated solution, obtains D product;
4, filtered by D product inorganic ceramic film, the rate of filtration is 12L/h, adds the water washing effective ingredient of 1.5 times of medicine liquid volume amounts during filtration several times, medicinal liquid after filtration is directly adsorbed by processed good resin column, effluent is discarded, and with the speed of 1ml per second, washes post with 2 times of column volume 10% ethanol that pH value is 4, be 80% ethanol elution of 5 again with pH value, collect the darker elution fractions of color, reclaim ethanol, concentrate with vacuum evaporator, drying, obtains crude extract; Crude extract is added 20% ethanol, stirring and dissolving, then carry out ultrafiltration, filtrate recycling ethanol with rolling ultrafiltration membrane, concentrate with vacuum evaporator, dry, pulverize, obtain Ganoderma extract.
Usage and dosage: intravenous drip, a 10 ~ 20ml, dilutes posterior vein with 10% glucose injection 250 ~ 500ml and instils, 1 time on the one; Intramuscular injection can be used instead, 2 ~ 4ml on the one, 1 time on the one after remission.
Points for attention: 1, anemia of pregnant woman and allergic constitution person are cautious use of;
2, close observation medicinal liquid character before injection, has when muddiness, precipitation, floccule and forbids to use.
Specification: often prop up 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, makes it be suspended, then adds 10% sodium hydroxide solution and make dissolving; Be dissolved in water for injection respectively in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, mixing, adds 0.2% active carbon, stirs evenly, boil 15 minutes, filter, with 10% sodium hydroxide solution adjust ph to 7.5 ~ 8.0, inject water to 1000ml, filter, embedding, sterilizing, obtains injection.
The extraction process of Ganoderma extract:
1, get Ganoderma, clean, add 4 times amount concentration be 90% ethanol soak 4 hours at 75-85 DEG C, obtain A product;
2, A product are broken into serosity, in serosity, add the citric acid solution of 0.3 times amount 00.03mol/l and the HCL solution mixing of 0.15 times amount 2mol/l, obtain B product;
3, in B product, add the ethanol of medical material amount 6 times amount 80-90% again, carry out reflux, extract, 4 hours, filter, collect filtrate, reclaim ethanol, obtain C product; Medicinal residues add 7 times amount water extraction 4 times again, each 01.5 hour, and merge extractive liquid, mixes with C product, be condensed into concentrated solution, obtains D product;
4, filtered by D product inorganic ceramic film, the rate of filtration is 20L/h, adds the water washing effective ingredient of 4 times of medicine liquid volume amounts during filtration several times, medicinal liquid after filtration is directly adsorbed by processed good resin column, effluent is discarded, and with the speed of 1.5ml per second, is 3 times of column volume deionization washing posts of 6 with pH value, be 85% ethanol elution of 6 again with pH value, collect the darker elution fractions of color, reclaim ethanol, concentrate with vacuum evaporator, drying, obtains crude extract; Crude extract is added 25% ethanol, stirring and dissolving, then carry out ultrafiltration, filtrate recycling ethanol with rolling ultrafiltration membrane, concentrate with vacuum evaporator, dry, pulverize, to obtain final product.
Usage and dosage: intravenous drip, a 10 ~ 20ml, dilutes posterior vein with 10% glucose injection 250 ~ 500ml and instils, 1 time on the one; Intramuscular injection can be used instead, 2 ~ 4ml on the one, 1 time on the one after remission.
Points for attention: 1, anemia of pregnant woman and allergic constitution person are cautious use of;
2, close observation medicinal liquid character before injection, has when muddiness, precipitation, floccule and forbids to use.
Specification: often prop up dress 2ml, 10ml or 20ml.
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, makes it be suspended, then adds 10% sodium hydroxide solution and make dissolving; Be dissolved in water for injection respectively in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, mixing, adds 0.2% active carbon, stirs evenly, boil 15 minutes, filter, with 10% sodium hydroxide solution adjust ph to 7.5 ~ 8.0, inject water to 1000ml, filter, embedding, sterilizing, obtains injection.
The extraction process of Ganoderma extract:
1, get Ganoderma, clean, adding 2-4 times amount concentration is that the ethanol of 80-90% soaks 2-4 hour at 75-85 DEG C, obtains A product;
2, A product are broken into serosity, in serosity, add the citric acid solution of 0.1 times amount 0.01mol/l and the HCL solution mixing of 0.05 times amount 1mol/l, obtain B product;
3, in B product, add the ethanol of medical material amount 4 times amount 80% again, carry out reflux, extract, 2 hours, filter, collect filtrate, reclaim ethanol, obtain C product; Medicinal residues add 5 times amount water extraction 2 times again, each 0.5 hour, and merge extractive liquid, mixes with C product, be condensed into concentrated solution, obtains D product;
4, filtered by D product inorganic ceramic film, the rate of filtration is 5L/h, adds the water washing effective ingredient of 1 times of medicine liquid volume amount during filtration several times, medicinal liquid after filtration is directly adsorbed by processed good resin column, effluent is discarded, and with the speed of 0.5ml per second, washes post with 1 times of column volume 5% ethanol that pH value is 2, be 75% ethanol elution of 4 again with pH value, collect the darker elution fractions of color, reclaim ethanol, concentrate with vacuum evaporator, drying, obtains crude extract; Crude extract is added 15% ethanol, stirring and dissolving, then carry out ultrafiltration with rolling ultrafiltration membrane, filtrate filtrate recycling ethanol, concentrate with vacuum evaporator, dry, pulverize, to obtain final product.
Usage and dosage: intravenous drip, a 10 ~ 20ml, dilutes posterior vein with 10% glucose injection 250 ~ 500ml and instils, 1 time on the one; Intramuscular injection can be used instead, 2 ~ 4ml on the one, 1 time on the one after remission.
Points for attention: 1, anemia of pregnant woman and allergic constitution person are cautious use of;
2, close observation medicinal liquid character before injection, has when muddiness, precipitation, floccule and forbids to use.
Specification: often prop up dress 2ml, 10ml or 20ml.

Claims (5)

1. the manufacture method of an easypro treating hepatopathy, it is characterized in that: described easypro treating hepatopathy calculates by weight, make as follows primarily 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: add water for injection to baicalin, make it be suspended, then add 10% sodium hydroxide solution and make dissolving; In Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, add water for injection respectively, make dissolving, mixing, add active carbon, stir evenly, boil, filter, with 10% sodium hydroxide solution adjust ph to 7.5 ~ 8.0, inject water to ormal weight, filter, embedding, sterilizing, to obtain final product; The extracting method of described Ganoderma extract is: get Ganoderma, cleans, after adding soak with ethanol, breaks into serosity, after adding citric acid solution and the mixing of HCL solution, adds ethanol, extracts, filter, collect filtrate, reclaim ethanol, for subsequent use; Medicinal residues extracting in water, extracting solution concentrates, filter with inorganic ceramic film, add water during filtration washing effective ingredient several times, medicinal liquid after filtration is directly adsorbed by processed good resin column, effluent is discarded, with the speed of 0.5-1.5ml per second, be that post washed by the 1-3 times of column volume deionized water of 2-6 or 5-15% ethanol with pH value, then be the 75-85% ethanol elution of 4-6 with pH value, collect the darker elution fractions of color, reclaim ethanol, concentrate with vacuum evaporator, dry, obtain crude extract; Crude extract is added 15-25% ethanol, stirring and dissolving, then carry out ultrafiltration, filtrate recycling ethanol with rolling ultrafiltration membrane, concentrate with vacuum evaporator, dry, pulverize, to obtain final product.
2. the manufacture method of the treating hepatopathy that relaxes as claimed in claim 1, it is characterized in that: described easypro treating hepatopathy calculates by weight, primarily of 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 be suspended, then add 10% sodium hydroxide solution and make dissolving; Be dissolved in water for injection respectively in Herba Artemisiae Scopariae extract, Fructus Gardeniae extract, Radix Isatidis extract and Ganoderma extract, mixing, adds 0.2% active carbon, stirs evenly, boil 15 minutes, filter, with 10% sodium hydroxide solution adjust ph to 7.5 ~ 8.0, inject water to ormal weight, filter, embedding, sterilizing, to obtain final product.
3. the manufacture method of the treating hepatopathy that relaxes as claimed in claim 1, is characterized in that: the extracting method of described Ganoderma extract is:
(1) get Ganoderma, clean, adding 2-4 times amount concentration is that the ethanol of 80-90% soaks 2-4 hour at 75-85 DEG C, obtains A product;
(2) A product are broken into serosity, in serosity, add the citric acid solution of 0.1-0.3 times amount 0.01-0.03mol/l and the HCL solution mixing of 0.05-0.15 times amount 1-2mol/l, obtain B product;
(3) in B product, add the ethanol of medical material amount 4-6 times amount 80-90% again, carry out reflux, extract, 2-4 hour, filter, collect filtrate, reclaim ethanol, obtain C product; Medicinal residues add 5-7 times amount water extraction 2-4 time again, each 0.5-1.5 hour, and merge extractive liquid, mixes with C product, is condensed into concentrated solution, obtains D product;
(4) D product inorganic ceramic film is filtered, the rate of filtration is 5-20L/h, the water washing effective ingredient of 1-4 times of medicine liquid volume amount is added several times during filtration, medicinal liquid after filtration is directly adsorbed by processed good resin column, effluent is discarded, with the speed of 0.5-1.5ml per second, be that post washed by the 1-3 times of column volume deionized water of 2-6 or 5-15% ethanol with pH value, be the 75-85% ethanol elution of 4-6 again with pH value, collect the darker elution fractions of color, reclaim ethanol, concentrate with vacuum evaporator, drying, obtains crude extract; Crude extract is added 15-25% ethanol, stirring and dissolving, then carry out ultrafiltration, filtrate recycling ethanol with rolling ultrafiltration membrane, concentrate with vacuum evaporator, dry, pulverize, to obtain final product.
4. the manufacture method of the treating hepatopathy that relaxes as claimed in claim 3, is characterized in that: the extracting method of described Ganoderma extract is:
(1) get Ganoderma, clean, add 3 times amount concentration be 85% ethanol soak 3 hours at 80 DEG C, obtain A product;
(2) A product are broken into serosity, in serosity, add the citric acid solution of 0.2 times amount 0.02mol/l and the HCL solution mixing of 0.1 times amount 1-2mol/l, obtain B product;
(3) in B product, add the ethanol of medical material amount 5 times amount 85% again, carry out reflux, extract, 3 hours, filter, collect filtrate, reclaim ethanol, obtain C product; Medicinal residues add 6 times amount water extraction 3 times again, each 1 hour, and merge extractive liquid, mixes with C product, be condensed into concentrated solution, obtains D product;
(4) D product inorganic ceramic film is filtered, the rate of filtration is 10-15L/h, the water washing effective ingredient of 2-3 times of medicine liquid volume amount is added several times during filtration, medicinal liquid after filtration is directly adsorbed by processed good resin column, effluent is discarded, with the speed of 1ml per second, be that post washed by 2 times of column volume deionized waters of 2-6 or 10% ethanol with pH value, be 80% ethanol elution of 4-6 again with pH value, collect the darker elution fractions of color, reclaim ethanol, concentrate with vacuum evaporator, drying, obtains crude extract; Crude extract is added 20% ethanol, stirring and dissolving, then carry out ultrafiltration, filtrate recycling ethanol with rolling ultrafiltration membrane, concentrate with vacuum evaporator, dry, pulverize, to obtain final product.
5. the manufacture method of the treating hepatopathy that relaxes as claimed in claim 1 or 2, is characterized in that: described preparation is injection.
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CN105878469A (en) * 2016-05-20 2016-08-24 贵州瑞和制药有限公司龙里药厂 Preparation technology of Shuganning injection preparation
CN107137431A (en) * 2017-04-26 2017-09-08 独山县军鹏农产品有限责任公司 A kind of processing method of ganoderma lucidum
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105878469A (en) * 2016-05-20 2016-08-24 贵州瑞和制药有限公司龙里药厂 Preparation technology of Shuganning injection preparation
CN107137431A (en) * 2017-04-26 2017-09-08 独山县军鹏农产品有限责任公司 A kind of processing method of ganoderma lucidum
CN109932441A (en) * 2019-03-01 2019-06-25 贵州瑞和制药有限公司 A kind of method for building up of easypro liver injection for curing HPLC finger-print
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