CN102743712A - Medicine composition for hepatitis - Google Patents
Medicine composition for hepatitis Download PDFInfo
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- CN102743712A CN102743712A CN2012102785712A CN201210278571A CN102743712A CN 102743712 A CN102743712 A CN 102743712A CN 2012102785712 A CN2012102785712 A CN 2012102785712A CN 201210278571 A CN201210278571 A CN 201210278571A CN 102743712 A CN102743712 A CN 102743712A
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- 208000006454 hepatitis Diseases 0.000 title claims abstract description 23
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- 229940079593 drug Drugs 0.000 title claims description 12
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Abstract
The invention relates to a medicine composition for hepatitis and a preparation method thereof. The technical scheme is that each pellet or each slice end product contains rheum emodin chrysophanol with the integral dose no less than 70 mug, no less than 100 mug schizandrin and no less than 240 mug curcumin. The medicine composition for the hepatitis and the preparation method can effectively protect active principles such as the schizandrin and schisandra chinensis and improve curative effects.
Description
Technical field
The present invention relates to a kind of medicine for curing hepatitis composition and method of making the same.
Background technology
Nine flavor liver Thailands are the medicines that are used to treat hepatitis B that adopt nine flavor natural Chinese medicines to process, and it is resolving blood stasis and dredging collateral that its function cures mainly, soothing liver and strengthening spleen.Be used for qi depression to blood stasis hold concurrently side of body costalgia or twinge due to the stagnation of liver-QI with deficiency of the spleen, depressed unhappy, inappetence, abdominal distention after meal gastral cavity painful abdominal mass, it is uncomfortable defecate, or the side of body descends hepatitis B symptoms such as mass in the abdomen.This product is a kind of Chinese patent medicine preparation of pure natural treatment hepatitis B, in the many prescriptions of treatment hepatitis B, takes the course of its own, and market prospect is wide.
And the production technology of stipulating in the existing quality standard of these article is not produced best product; Main effective ingredient curcumin as in Rhizoma Curcumae Longae, the Radix Curcumae is water insoluble; And its process using decocting boils; Find by no curcumin content in the sample of this explained hereafter through detecting, and curcumin has anti-inflammatory analgetic, antioxidation, has to treat the hepatitis effect preferably; Active substance is the thermal sensitivity composition in the medical material such as Rhizoma Curcumae Longae, Fructus Schisandrae Chinensis for another example, and conventional baking causes effective ingredient to destroy, and content seriously reduces, the curative effect variation.
Summary of the invention
For overcome exist in the prior art to the destructive defective of effective ingredient such as curcumin, Fructus Schisandrae Chinensis; The present invention provides a kind of new medicine for curing hepatitis composition and method of making the same; Adopt medicine for curing hepatitis composition and method of making the same of the present invention; Can protect effective ingredient such as curcumin, Fructus Schisandrae Chinensis effectively, improve curative effect.
The present invention adopts following technical scheme to realize:
A kind of medicine for curing hepatitis compositions wherein contains emodin chrysophanol total amount in every or the every finished product and is not less than 70 μ g, contains schisandrin and is not less than 100 μ g, contains curcumin and is not less than 240 μ g.
Above-mentioned medicine for curing hepatitis compositions wherein comprises 80 parts of Radix Notoginseng, 240 parts of Radix Curcumaes, 240 parts of Fructus Tribulis, 80 parts in Rhizoma Curcumae Longae, 128 parts of Radix Et Rhizoma Rhei (processed with wine), 160 parts of Radix Scutellariaes, 224 parts of Scolopendras, 720 parts of Rhizoma Dioscoreaes, 64 parts of Fructus Schisandrae Chinensis, and above-mentioned part is unit of weight.
Above-mentioned medicine for curing hepatitis compositions, wherein adopt following method preparation:
(1) get 80 parts of superfine pulverizing of Radix Notoginseng, cross the 120-200 mesh sieve, subsequent use;
(2) get 64 parts of Fructus Schisandrae Chinensis pulverizing backs and cross the 10-60 mesh sieve, with 50～95% ethanol, heating and refluxing extraction 2～3 times, each 0.5～2 hour; Merge extractive liquid, filters, and decompression filtrate recycling ethanol is concentrated into the clear paste of relative density 1.10～1.25; Drying is ground into fine powder, and is subsequent use;
(3) get 80 parts of curcuma powders and be broken into coarse powder, 50～95% alcohol heating reflux extract 1～3 time, 3～7 times of each solubilizers, and each 0.5～2 hour, merge extractive liquid, filtered, and decompression filtrate recycling ethanol is concentrated into the clear paste of relative density 1.05～1.25, and is subsequent use; Medicinal residues are put in addition;
(4) get 240 portions of Fructus Tribulis, 160 parts of Radix Scutellariaes, 224 parts of Scolopendras, 720 portions of Rhizoma Dioscoreaes, 240 portions of Radix Curcumaes and above-mentioned medicinal residues and merge, add 4～8 times of water gagings, decoct 1～2 time, decocted 0.5～2 hour at every turn, filter filtrate for later use; Medicinal residues add Radix Et Rhizoma Rhei (processed with wine) 128 parts and decoct 1～2 time again, and each 4～8 times of water gagings decocted 0.5～2 hour at every turn; Collecting decoction filters, and filtrating merges with above-mentioned filtrating; Being concentrated into relative density is the clear paste of 1.15～1.25 (60 ℃), merges mixing with aforementioned Rhizoma Curcumae Longae clear paste; Spray drying (inlet temperature 160-220 ℃, outlet temperature 80-120 ℃), dried cream powder is subsequent use;
(5) dried cream powder adds Fructus Schisandrae Chinensis dried cream powder, Notoginseng Root, adds suitable adjuvant, and mixing is granulated, and drying is processed suitable pharmaceutical formulation;
Above-mentioned part is unit of weight.
Above-mentioned medicine for curing hepatitis compositions, superfine crushing technology or superfine communication technique are adopted in the described superfine pulverizing of the step of wherein said method for preparing (1).
Above-mentioned medicine for curing hepatitis compositions, wherein adopt following method preparation:
(1) get 80 parts of superfine pulverizing of Radix Notoginseng, cross 150 mesh sieves, subsequent use;
(2) get 64 parts of Fructus Schisandrae Chinensis and pulverize the back and cross 20 mesh sieves, use 90% ethanol, heating and refluxing extraction 3 times, each 1 hour, merge extractive liquid,, filtration, decompression filtrate recycling ethanol is concentrated into the clear paste of relative density 1.2, and drying is ground into fine powder, and is subsequent use;
(3) get 80 parts of curcuma powders and be broken into coarse powder and cross 10 mesh sieves, 65% alcohol heating reflux extracts 2 times, 5 times of each solubilizers, and each 1 hour, merge extractive liquid, filtered, and decompression filtrate recycling ethanol is concentrated into the clear paste of relative density 1.15, and is subsequent use; Medicinal residues are put in addition;
(4) get 240 portions of Fructus Tribulis, 160 parts of Radix Scutellariaes, 224 parts of Scolopendras, 720 portions of Rhizoma Dioscoreaes, 240 portions of Radix Curcumaes and above-mentioned medicinal residues and merge, add 6 times of water gagings, decocted 1 hour, filter filtrate for later use; Medicinal residues add Radix Et Rhizoma Rhei (processed with wine) 128 parts and decoct 2 times again, and each 6 times of water gagings decocted 1 hour; Collecting decoction filters, and filtrating merges with above-mentioned filtrating; Being concentrated into relative density is the clear paste of 1.15～1.20 (60 ℃), merges mixing with aforementioned Rhizoma Curcumae Longae clear paste; Spray drying (inlet temperature 190-200 ℃, outlet temperature 100-120 ℃), dried cream powder is subsequent use;
(5) dried cream powder adds Fructus Schisandrae Chinensis dried cream powder, Notoginseng Root, adds suitable adjuvant, and mixing is granulated, and drying is processed suitable pharmaceutical formulation;
Above-mentioned part is unit of weight.
The present invention has following characteristics:
1, Radix Notoginseng is adopted micronizing or superfine pulverizing, makes the stripping fully rapidly of our monarch drug composition, and the performance drug effect is rapid.
Radix Notoginseng is to be ground into fine powder to be used as medicine in the safe original production process of nine flavor livers, this is carried out the crushing technology innovation, adopts superfine communication technique or is ground into impalpable powder.The broken technology of Chinese medicine ultra-fine powder, the main broken technology of phalangeal cell level wall-broken micro powder.The main pharmacodynamics composition of Chinese medicine is distributed in usually in the cell and asks in the crack with cell, and being main in the cell.Effective ingredient comes out in its cell after the cell wall breaking, and the rate of release of medicine and burst size can increase substantially, and therefore drug effect increases substantially, and onset speed is fast.Its technical characterstic has following 6 points: the bioavailability of pharmaceutically active ingredient in 1, can improving greatly.2, can significantly improve the industrial extraction ratio of middle pharmaceutically active ingredient.3, can improve quality, hygienic quality and the interpolation scope of Chinese medicine for animals.4, Chinese medicine is after micronizing, and it has unique physicochemical property, and good absorbability, dissolubility, chemism, biological activity are arranged, and these attributes have fabulous value to producing and using.As: herbal medicine efficacy is accelerated, is strengthened, and can match in excellence or beauty with Western medicine, for the development prospect of Chinese medicine has been created good condition.5, make Chinese medicine produce, treatment, brand-new, use revolutionary variation taken place, with the production technology of rewriting Chinese Chinese medicine again, the method for inspection and working specification.6, protected natural resources of Chinese medicinal materials.Radix Notoginseng is after micronizing, and microscopically is observed does not have the intact cell existence basically, and just directly stripping of effective ingredient like this discharges rapidly, makes the finished product drug effect rapid-action.
These article former [method for making] Radix Notoginseng technology is: be ground into fine powder and be used as medicine.Common crushing fine powder yield is lower, and vibrating pulverizer is a kind of novel disintegrating apparatus, and its comminution ratio is high; The pulverizing time is short, and its flour extraction, main constituent stripping quantity are examined or check, and is dry straight; Can improve flour extraction; Practice thrift cost, the main constituent stripping quantity is increased, will obviously improve the product curative effect.
Get pseudo-ginseng 1000g, in about 70 ℃, be dried to moisture below 7%, 150 mesh sieves are crossed in vibrant pulverization, get impalpable powder, weigh, and calculate flour extraction, and average powder delivery reaches 94.6%, far above the flour extraction 90% of common pulverizing.
Get Radix Notoginseng with batch medical material, pulverize separately becomes fine powder and impalpable powder (being not less than 150 orders), adopts ultraviolet spectrophotometry, and fine powder, impalpable powder and 60 minutes total saponins stripping quantities thereof are measured.Radix Notoginseng fine powder and impalpable powder total saponin content are more or less the same, but 60 minutes extractum and total saponins stripping quantity impalpable powder have improved 10%, 15% respectively than fine powder, are that the impalpable powder specific surface area increases, and stripping makes the rapid onset of product due to accelerating like this.
2, Rhizoma Curcumae Longae increases the alcohol extraction operation, and the main pharmacodynamics composition of these article is extracted fully, brings into play important drug action.
Rhizoma Curcumae Longae can promoting blood circulation to remove blood stasis, promoting the circulation of QI to relieve pain, is used for the card of qi depression to blood stasis, is the ministerial drug of these article, is crucial raw material, mainly contains curcumin, and curcumin is dissolved into ethanol easily, is insoluble in water.The former technology of these article is considered from the cost aspect, adopt water to carry, and alcohol extraction could fully be extracted curcumin, considers from the product curative effect, should adopt alcohol extraction.
Simultaneously, through test relatively the water of Rhizoma Curcumae Longae carry with alcohol extraction relatively, measure the content of curcumin, promptly the Rhizoma Curcumae Longae medicinal material coarse powder adds 65% ethanol extraction twice, 5 times of amounts for the first time, reflux, extract, 1 hour adds 5 times of amounts, reflux, extract, 1 hour for the second time; The Rhizoma Curcumae Longae medicinal material coarse powder extracting in water twice of equivalent, 5 times of amounts for the first time, reflux, extract, 1 hour adds 5 times of amounts, reflux, extract, 1 hour for the second time; With Rhizoma Curcumae Longae medicinal material coarse powder 65% soak with ethanol of equivalent 12 hours, extracting in water twice, 5 times of amounts for the first time, reflux, extract, 1 hour adds 5 times of amounts, reflux, extract, 1 hour for the second time.Liquid after the extraction filters respectively, is concentrated to equal volume, detect water carry with alcohol extraction after curcumin content; The result shows; Curcumin content after the Rhizoma Curcumae Longae alcohol extraction is 9 times that water is carried content, after Radix Curcumae, the Rhizoma Curcumae Longae soak with ethanol again the curcumin content carried of water be 6 times that water is carried content, explain that alcohol extraction has obvious effects; Curcumin content is obviously increased, will obviously improve the product curative effect.
3, adopt spray drying technology, drying time is short, makes the product active ingredient not be damaged better efficacy.
Spray drying method is under pressure or action of centrifugal force; Through nebulizer egg liquid is sprayed into the vaporific microgranule of high degree of dispersion, mean particle dia is about 10～50 microns, thereby has increased the surface area of egg liquid greatly; Improved water evaporates speed; The fine mist wink-dry becomes spherical powder, falls within the hothouse bottom, thereby obtains dry powdered egg.All dry run only needed to accomplish in 15～30 seconds.Can make Chinese medicine medicated powder after Chinese medicine put forward thing concentrated solution spray drying, stable in the time of can guaranteeing the medicine refabrication makes it to be easy to take and dissolve, the yield that has improved medicine with keep drug effect.Fast because of its rate of drying, the active ingredient heated time is short, is difficult for making protein generation degeneration, and other compositions also influence atomic, and color is just distinguished the flavor of; Spray drying is carried out in confined conditions, and powder is little, needn't pulverize, and can guarantee the hygienic quality of product; Spray drying method is prone to mechanization, automatic continuous production.
Spray-dired relative density of medicine liquid, import and export pathogenic wind-warm are examined or check.The result carries out spray drying with the clear paste that medicinal liquid is concentrated into relative density about 1.15 (60 ℃), and inlet temperature 190-200 ℃, outlet temperature 100-120 ℃.Content with emodin and curcumin is the examination index, and assay shows that the emodin content after the spray drying is common exsiccant 1.2 times, and curcumin is 1.4 times, explains that spray drying is little to the active ingredient influence.
4, our compatibility is exquisite, after above 3 big innovations, the product curative effect is obviously improved
Nine flavor liver Thailands under instruction of Chinese Medicine theory, with eliminating evil be main, with disperse blood stasis and dredge collateral, the damp and hot residual poison of removing summer-heat, and can blood stasis dispersing and fresh blood promoting, and reach the stasis of blood not impairment of YIN of loosing, heresy is gone the purpose of positive runback.Is main and much treated the hepatitis B product in the past with the method for tonification, and the method for abusing tonification is mended and do not rushed down, and often makes the rising of patient's liver-fire, increases the weight of the state of an illness more.Chronic hepatitis are Chinese, "hypochondriac", "dampness" and other areas, from the clinical manifestations can be divided into stagnation and spleen deficiency, blood stasis, damp and other syndromes.If course of disease delay is with the passing of time, wherein with the stagnation of liver-QI stasis, the clear person of residual poison real in seeing more, and clinical normal performance deficient vital QI leading to lingering of pathogen various see disease, like distending pain over the hypochondrium or twinge, inappetence, abdominal distention after meal gastral cavity painful abdominal mass, it is uncomfortable defecate, tongue with ecchymosis or coerce under symptom such as mass in the abdomen.So plan is with blood stasis dispelling ability network, the damp and hot residual poison of removing summer-heat is a method, selects for use Radix Notoginseng, Radix Curcumae, Fructus Tribuli, Rhizoma Curcumae Longae, Radix Et Rhizoma Rhei, Radix Scutellariae, Scolopendra, Rhizoma Dioscoreae, Fructus Schisandrae Chinensis nine flavors to form nine flavor livers Thailands and writes out a prescription.
Pseudo-ginseng blood-circulation-invigovating dissipating blood stasis in the safe prescription of nine flavor livers has obvious inhibitory action to the experiment granuloma, has been used to treat hepatitis gravis, chronic hepatitis, is monarch drug in the side; Radix Curcumae has the effect of alleviating to the acute and chronic infectious hepatitis; Fructus Tribuli has the effect of diuresis toxin expelling; The Rhizoma Curcumae Longae function of gallbladder promoting increases biliary generation and secretion, and experimental swelling is had tangible antiinflammatory action, can prolong mice viral hepatitis model life span, and the substantive damaging action of the liver of improvement is arranged; Ministerial drug in Radix Curcumae, Rhizoma Curcumae Longae, the Fructus Tribuli side of being; Radix Et Rhizoma Rhei, the dissipating blood stasis detoxifcation has the reduction serum bilirubin to hepatitis gravis, improves liver function; Radix Scutellariae, heat clearing and damp drying, eliminating fire and detoxication promote serum bilirubin to drain, and reduce capillary permeability, alleviate the viral hepatitis symptom, and hepatitis b surface antigen positive is turned out cloudy; Scolopendra has obvious jaundice eliminating subcutaneous ulcer to viral hepatitis, improves stomach and receives, eliminates the effect of exerting one's utmost effort, and take for a long time and have no side effect; Rhizoma Dioscoreae, tonifying the spleen and stomach, lung benefiting kidney, treatment weakness of the spleen and stomach, effects such as lack of appetite diarrhoea; Fructus Schisandrae Chinensis, the protection hepatic injury, transaminase lowering promotes hepatocyte internal protein anabolism, promotes mitochondrial recovery and regeneration, and acute, the chronic silent hepatitis of delay property are all had obvious effect of reducing enzyme levels; More than nine flavors play disperse blood stasis and dredge collateral, the effect of soothing liver and strengthening spleen altogether.
More than three innovative points, have tangible technological innovation, monarch drug in the Radix Notoginseng side of being, most important raw material simply carries out micronizing or superfine pulverizing to it, makes the fully rapidly stripping of its composition, the performance drug effect is rapid; To two flavor ministerial drugs, also be two more important flavor raw medicinal materials of we simultaneously, carry out alcohol extraction, former technology only considers to practice thrift cost; And do not consider that this two flavors medical material Main Ingredients and Appearance is dissolved in ethanol easily, and be insoluble in the water, therefore adopt alcohol extraction; Make the medicine basis that great change take place, fully extract pure dissolubility curcumin, on pharmaceutical technology; The change of solvent is great process reform, definitely has novelty, the more important thing is the curative effect that has improved product; Adopt spray drying technology simultaneously, make the extractum after the extraction be dried to granule (about 10 seconds) rapidly, microorganism is qualified; Need not sterilize, with respect to former common drying, the time long (2 to 5 days); Power consumption is big; Common dry heavy damage and lost active ingredient adopts spray drying technology to make the product active ingredient fully obtain keeping, and has tangible novelty.
Through an above combined innovation, carry out middle trial production, make the production cycle shortening of product, more convenient big production; Operation easily; Particularly, through preliminary clinical trial, curative effect obviously improves; Clinical total obvious effective rate and total effective rate are increased to 68.0% and 96.0% respectively, and the HBsAg negative conversion rate is increased to 40.0%, the HBeAg negative conversion rate is increased to 52.0%, anti--HBc sun rate of rotation is increased to 44.0%, anti--HBe sun rate of rotation is increased to 40.0%.Explain through above combined innovation, the product curative effect is obviously improved.
The safe clinical efficacy comparison sheet of nine flavor livers of table 1 the old and new explained hereafter
Through zoopery; Also can prove that new technology is superior to former technology; Situation is summed up as follows: the safe capsule of nine flavor livers with former explained hereafter is contrast; Adopt D-GalN to cause the acute liver damage model of rat, observe the variation of transaminase and glutathion (GSH-PX), superoxide dismutase (SOD) and malonaldehyde (MDA), hepatic glycogen.The result: the safe capsule of nine flavor livers can obviously reduce AST activity, MDA and GSH-PX content in the serum, the content of SOD activity improving, hepatic glycogen.The safe capsule of nine flavor livers that the safe capsule reduction of the nine flavor livers glutamate pyruvate transaminase (ALT) that new technology is produced, the active effect of serum glutamic oxalacetic transaminase (AST) significantly are superior to former explained hereafter, other indexs are not seen notable difference.Conclusion: the safe capsule of nine flavor livers has the certain protection effect to the rats'liver damage model due to the D-GalN, and its mechanism of action maybe be relevant with antioxidation.Nine of nine safe capsules of flavor liver that new technology is produced and former explained hereafter distinguished the flavor of the safe capsules of livers relatively, and liver-protective effect detail is superior to former technology.Relevant test data is relatively like table 2, table 3:
Nine flavor liver Thailands of table 2 the old and new explained hereafter cause the influence of acute liver damage model liver function index to aminogalactose
Remarks: the positive matched group of bifendate group, the safe 2# of nine flavor livers is former explained hereafter sample, the safe 1# of nine flavor livers is the new technology production sample.
Nine flavor liver Thailands of table 3 the old and new explained hereafter cause the influence of acute liver damage model hepatic glycogen to aminogalactose
Remarks: the positive matched group of bifendate group, the safe 2# of nine flavor livers is former explained hereafter sample, the safe 1# of nine flavor livers is the new technology production sample.
The specific embodiment
Embodiment 1
1, preparation:
(1) get the superfine pulverizing of 80 gram Radix Notoginseng, cross 150 mesh sieves, subsequent use;
(2) get 64 gram Fructus Schisandrae Chinensis and pulverize the back and cross 20 mesh sieves, use 90% ethanol, heating and refluxing extraction 3 times, each 1 hour, merge extractive liquid,, filtration, decompression filtrate recycling ethanol is concentrated into the clear paste of relative density 1.2, and drying is ground into fine powder, and is subsequent use;
(3) get 80 gram curcuma powders and be broken into coarse powder and cross 10 mesh sieves, 65% alcohol heating reflux extracts 2 times, 5 times of each solubilizers, and each 1 hour, merge extractive liquid, filtered, and decompression filtrate recycling ethanol is concentrated into the clear paste of relative density 1.15, and is subsequent use; Medicinal residues are put in addition.
(4) get 240 gram Fructus Tribulis, 160 gram Radix Scutellariaes, 224 gram Scolopendras, 720 Keshan medicines, 240 gram Radix Curcumaes and above-mentioned medicinal residues and merge, add 6 times of water gagings, decocted 1 hour, filter filtrate for later use; Medicinal residues add Radix Et Rhizoma Rhei (processed with wine) 128 grams and decoct 2 times again, and each 6 times of water gagings decocted 1 hour; Collecting decoction filters, and filtrating merges with above-mentioned filtrating; Being concentrated into relative density is the clear paste of 1.15～1.20 (60 ℃), merges mixing with aforementioned Rhizoma Curcumae Longae clear paste; Spray drying (inlet temperature 190-200 ℃, outlet temperature 100-120 ℃), dried cream powder is subsequent use.
(5) dried cream powder adds Fructus Schisandrae Chinensis dried cream powder, Notoginseng Root, adds suitable adjuvant, and mixing is granulated, and drying is processed suitable pharmaceutical formulation.
2, detect
Detection to Fructus Schisandrae Chinensis: the powder of getting above-mentioned preparation is an amount of, adds chloroform 20ml, and reflux 30 minutes filters, the filtrating evaporate to dryness, and residue adds chloroform 1ml makes dissolving, as need testing solution.Other gets Fructus Schisandrae Chinensis control medicinal material 1g, shines medical material solution in pairs with legal system.Get the deoxyschizandrin reference substance again, add chloroform and process the solution that every 1ml contains 1mg, as reference substance solution.According to the thin layer chromatography test, draw each 10 μ l of above-mentioned four kinds of solution, put respectively on same silica GF254 lamellae; Upper solution with petroleum ether (30～60 ℃)-Ethyl formate-formic acid (15:5:1) is developing solvent, launches, and takes out; Dry, put under the ultra-violet lamp and inspect.In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the speckle of same color.
Ponticin is checked: take by weighing these article powder 1g, add the 20ml ethyl acetate and carry out, reflux 30min filters evaporate to dryness, and residue adds 5ml methanol and dissolves.The rheochrysin reference substance that fetches earth adds methanol and processes the solution that every 1ml contains 0.2mg.According to the thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with chloroform-methanol-formic acid-water (10:3.5:0.2:0.3), launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, be to show the speckle of same color on the reference substance chromatograph relevant position.
Rhizoma Curcumae Longae is differentiated: get these article powder 0.5g, add methanol 50ml, filter reflux half an hour, get filtrating 10ml, volatilize, add dehydrated alcohol 2ml dissolving, as need testing solution.Other gets the curcumin reference substance and adds dehydrated alcohol and process the solution that every 1ml contains 0.5mg, as reference substance solution, according to the thin layer chromatography test; Drawing above-mentioned two kinds of each 4ul of solution, on same silica gel G plate, is developing solvent with chloroform-methanol-formic acid (96:4:0.7); Launch, dry, place respectively under daylight and the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle or the fluorescence speckle of same color.
3, measure content
The content of measuring schisandrin adopts high effective liquid chromatography for measuring, and concrete steps are:
(1) chromatographic condition and system suitability test.Use octadecylsilane chemically bonded silica to be filler; Methanol-water (55:45) is a mobile phase; Detect wavelength 250nm.Number of theoretical plate calculates by schisandrin should be not less than 2000.
(2) preparation of reference substance solution.It is an amount of to get the schisandrin reference substance, and accurate the title decides, and puts in the same measuring bottle, adds methanol and processes the solution that every 1ml contains schisandrin 0.04mg, promptly gets.
(3) preparation of need testing solution.Get the content under the content uniformity item, porphyrize is got 3.5g approximately, accurate claims surely, puts in the 250mL conical flask, and precision adds 50ml methanol, weighs, and ultrasonic 30 minutes, put coldly, claim again decide weight, supply the weight that subtracts mistake with methanol, filter, getting continues filtrates and is need testing solution.
(4) algoscopy.Accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing inject chromatograph of liquid, measure.Containing schisandrin content in every or every is 0.27mg.
The content of measuring curcumin adopts high effective liquid chromatography for measuring, and concrete steps are:
(1) chromatographic condition and system suitability test.Use octadecylsilane chemically bonded silica to be filler; Acetonitrile-4% glacial acetic acid solution (55:45) is a mobile phase; Detect wavelength 430nm.Number of theoretical plate calculates by curcumin should be not less than 4000.
(2) preparation of reference substance solution.It is an amount of to get the curcumin reference substance, and accurate the title decides, and puts in the same measuring bottle, adds methanol and processes the solution that every 1ml contains schisandrin 10ug, promptly gets.
(3) preparation of need testing solution.Get the content under the content uniformity item, porphyrize is got 0.5g approximately, and accurate the title decides, and puts in the 250mL conical flask; Precision adds 50ml methanol, weighs, and reflux 30 minutes is put coldly, claims to decide weight again; Supply the weight that subtracts mistake with methanol, shake up, filter, get the filtrating of continuing and be need testing solution.
(4) algoscopy.Accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing inject chromatograph of liquid, measure.Containing curcumin content in every or every is 0.45mg.
Embodiment 2
Preparation, detection and mensuration content method such as embodiment 1
The content of measuring schisandrin in every or every is 0.21mg.
The content of measuring curcumin in every or every is 0.47mg.
Embodiment 3
Preparation, detection and mensuration content method such as embodiment 1
Measure the content 0.19mg of schisandrin in every or every.
The content of measuring curcumin in every or every is 0.45mg.
Claims (5)
1. medicine for curing hepatitis compositions is characterized in that containing emodin chrysophanol total amount in every or the every finished product is not less than 70 μ g, contains schisandrin and is not less than 100 μ g, contains curcumin and is not less than 240 μ g.
2. gastroenteropathy as claimed in claim 1 is used drug composition; It is characterized in that comprising 80 parts of Radix Notoginseng, 240 parts of Radix Curcumaes, 240 parts of Fructus Tribulis, 80 parts in Rhizoma Curcumae Longae, 128 parts of Radix Et Rhizoma Rhei (processed with wine), 160 parts of Radix Scutellariaes, 224 parts of Scolopendras, 720 parts of Rhizoma Dioscoreaes, 64 parts of Fructus Schisandrae Chinensis, above-mentioned part is unit of weight.
3. medicine for curing hepatitis compositions as claimed in claim 1 is characterized in that adopting following method preparation:
(1) get 80 parts of superfine pulverizing of Radix Notoginseng, cross the 120-200 mesh sieve, subsequent use;
(2) get 64 parts of Fructus Schisandrae Chinensis pulverizing backs and cross the 10-60 mesh sieve, with 50～95% ethanol, heating and refluxing extraction 2～3 times, each 0.5～2 hour; Merge extractive liquid, filters, and decompression filtrate recycling ethanol is concentrated into the clear paste of relative density 1.10～1.25; Drying is ground into fine powder, and is subsequent use;
(3) get 80 parts of curcuma powders and be broken into coarse powder, 50～95% alcohol heating reflux extract 1～3 time, 3～7 times of each solubilizers, and each 0.5～2 hour, merge extractive liquid, filtered, and decompression filtrate recycling ethanol is concentrated into the clear paste of relative density 1.05～1.25, and is subsequent use; Medicinal residues are put in addition;
(4) get 240 portions of Fructus Tribulis, 160 parts of Radix Scutellariaes, 224 parts of Scolopendras, 720 portions of Rhizoma Dioscoreaes, 240 portions of Radix Curcumaes and above-mentioned medicinal residues and merge, add 4～8 times of water gagings, decoct 1～2 time, decocted 0.5～2 hour at every turn, filter filtrate for later use; Medicinal residues add Radix Et Rhizoma Rhei (processed with wine) 128 parts and decoct 1～2 time again, and each 4～8 times of water gagings decocted 0.5～2 hour at every turn; Collecting decoction filters, and filtrating merges with above-mentioned filtrating; Being concentrated into relative density is the clear paste of 1.15～1.25 (60 ℃), merges mixing with aforementioned Rhizoma Curcumae Longae clear paste; Spray drying (inlet temperature 160-220 ℃, outlet temperature 80-120 ℃), dried cream powder is subsequent use;
(5) dried cream powder adds Fructus Schisandrae Chinensis dried cream powder, Notoginseng Root, adds suitable adjuvant, and mixing is granulated, and drying is processed suitable pharmaceutical formulation;
Above-mentioned part is unit of weight.
4. medicine for curing hepatitis compositions as claimed in claim 3 is characterized in that superfine crushing technology or superfine communication technique are adopted in the described superfine pulverizing of step (1) of described method for preparing.
5. medicine for curing hepatitis compositions as claimed in claim 3 is characterized in that adopting following method preparation:
(1) get 80 parts of superfine pulverizing of Radix Notoginseng, cross 150 mesh sieves, subsequent use;
(2) get 64 parts of Fructus Schisandrae Chinensis and pulverize the back and cross 20 mesh sieves, use 90% ethanol, heating and refluxing extraction 3 times, each 1 hour, merge extractive liquid,, filtration, decompression filtrate recycling ethanol is concentrated into the clear paste of relative density 1.2, and drying is ground into fine powder, and is subsequent use;
(3) get 80 parts of curcuma powders and be broken into coarse powder and cross 10 mesh sieves, 65% alcohol heating reflux extracts 2 times, 5 times of each solubilizers, and each 1 hour, merge extractive liquid, filtered, and decompression filtrate recycling ethanol is concentrated into the clear paste of relative density 1.15, and is subsequent use; Medicinal residues are put in addition;
(4) get 240 portions of Fructus Tribulis, 160 parts of Radix Scutellariaes, 224 parts of Scolopendras, 720 portions of Rhizoma Dioscoreaes, 240 portions of Radix Curcumaes and above-mentioned medicinal residues and merge, add 6 times of water gagings, decocted 1 hour, filter filtrate for later use; Medicinal residues add Radix Et Rhizoma Rhei (processed with wine) 128 parts and decoct 2 times again, and each 6 times of water gagings decocted 1 hour; Collecting decoction filters, and filtrating merges with above-mentioned filtrating; Being concentrated into relative density is the clear paste of 1.15～1.20 (60 ℃), merges mixing with aforementioned Rhizoma Curcumae Longae clear paste; Spray drying (inlet temperature 190-200 ℃, outlet temperature 100-120 ℃), dried cream powder is subsequent use;
(5) dried cream powder adds Fructus Schisandrae Chinensis dried cream powder, Notoginseng Root, adds suitable adjuvant, and mixing is granulated, and drying is processed suitable pharmaceutical formulation;
Above-mentioned part is unit of weight.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103063767A (en) * | 2012-12-21 | 2013-04-24 | 邯郸摩罗丹药业股份有限公司 | Quality standard of sanhuang dispersible tablets and detection method thereof |
| CN106215101A (en) * | 2016-08-22 | 2016-12-14 | 湖南康尔佳制药股份有限公司 | A kind of medicine of soothing liver and strengthening spleen and preparation method thereof |
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| CN102743712B (en) | 2014-12-17 |
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