CN101912594A - Traditional Chinese medicine preparation for treating gastrointestinal diseases - Google Patents
Traditional Chinese medicine preparation for treating gastrointestinal diseases Download PDFInfo
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- CN101912594A CN101912594A CN2010102509249A CN201010250924A CN101912594A CN 101912594 A CN101912594 A CN 101912594A CN 2010102509249 A CN2010102509249 A CN 2010102509249A CN 201010250924 A CN201010250924 A CN 201010250924A CN 101912594 A CN101912594 A CN 101912594A
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Abstract
The invention discloses a traditional Chinese medicine preparation for treating gastrointestinal diseases. The traditional Chinese medicine comprises costustoot, berberine hydrochloridum, immature bitter orange, white paeony root, officinal magnolia bark, areca seed, dried ginger or ginger and the like, or is improved to be additionally added with a liquid extract of rhubarb, and is rationally formulated according to the formulation principle of the traditional Chinese medicine theory. The traditional Chinese medicine preparation can be prepared into hard capsules, soft capsules, granules, powder, tablets, pills, mixtures or syrups. The traditional Chinese medicine preparation for treating the gastrointestinal diseases has the advantages that: the traditional Chinese medicine preparation has the effects of eliminating summer heat and dispersing cold, and relieving dyspepsia and stopping diarrhea or promoting the circulation of Qi and relaxing the bowels, and is applied to treating gastrointestinal dyspepsia, red and white scour, abdominal pain and bulge, difficult urination or defecation, tenesmus and the like. The function and application of the traditional Chinese medicine preparation for treating the gastrointestinal diseases have been proved by pharmacodynamics experiments and the clinical research of treating damp-heat dysentery. The toxicologic study proves that the traditional Chinese medicine preparation has high safety and no untoward effect. Various oral preparations prepared by the formula have the advantages of high medicine content, accurate administration dosage, high bioavailability, quick response, stable curative effect and convenient administration, storage and carrying. The medicine stability research proves that the products of the traditional Chinese medicine preparation prepared by the formula have high quality stability.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, especially a kind of Chinese medicine preparation for the treatment of gastroenteropathy.
Background technology
Motherland's medical science to dysentery understanding very early, successive dynasties doctor work is executed to control to dysentery dialectical and is explored; Xianglian Wan, Muxiang Binlang Wan and zhishi daozhi pills are traditional patent medicine preparations, and the representative prescription of certain curative effect is arranged for the treatment bacillary dysentery.We are the new sides that add and subtract reorganization by above-mentioned tripartite prescription theory, and being used in combination the modern Chinese medicine compound recipe prescription of the effective components of Chinese medicinal reorganization that the modern science and technology technological means extracts, it is made up of Chinese medicines such as the Radix Aucklandiae, berberine hydrochloride, Fructus Aurantii Immaturus, the Radix Paeoniae Alba, Cortex Magnoliae Officinalis, Semen Arecae, Rhizoma Zingiberis or Rhizoma Zingiberis Recenss.This Chinese medicine preparation side separates: our berberine hydrochloride is a principal agent, heat clearing and damp drying, and anti-inflammation is used for infecting bacillary dysentery and diarrhoea; Be aided with Radix Aucklandiae promoting qi circulation, resolving food retention, strengthening the spleen to promote digestion; Fructus Aurantii Immaturus dispelling the stagnated QI removing food stagnancy; Assistant is with the pain relieving of Radix Paeoniae Alba suppressing the hyperactive liver; Cortex Magnoliae Officinalis dampness intestinal stasis relieving; Make with Semen Arecae circulation of qi promoting intestinal stasis relieving, Rhizoma Zingiberis or Rhizoma Zingiberis Recens can relax the pungent high strong property of medicine of Cortex Magnoliae Officinalis, strengthen the alleviating distention in middle-JIAO effect of regulating the flow of vital energy.Each medicine is changed the function of stagnation dysentery with having dispelling summer-heat and expelling cold pathogen; Be applied to the intestines and stomach dyspepsia, red Hakuri disease, abdominal pain with tenesmus, the treatment of diseases such as dysuria; Add the Radix Et Rhizoma Rhei fluid extract up on the basis and can help, can be used for disease and have disease treatments such as stool is not smooth, tenesmus concurrently with the circulation of qi promoting relieving constipation.This square preparation is on probation through clinical research, thinks that curative effect is remarkable definite, has no adverse reaction, and dose is few, and produce effects is fast, short treating period, the consistent similar Chinese patent medicine that is better than treating at present bacillary dysentery, enteritis that reflects.
Summary of the invention
The object of the present invention is to provide a kind of curative effect brilliance definitely to have no adverse reaction and treat the new Chinese medicine preparation of gastroenteropathy safely and effectively.This Chinese medicine preparation concentrates by extracting purification, discards the dross and select the essential selection process, improved bioavailability, the medicament contg height has reduced dose, and produce effects is fast, short treating period, have no adverse reaction, make bitterness and discomfort that various preparations have been covered medicine, user's compliance is good, dispersing and dissolving is fast in gastrointestinal, easily absorbs.
Technical scheme of the present invention is:
Option A: a kind of Chinese medicine preparation for the treatment of gastroenteropathy, this Chinese medicine preparation formulation weight component: 400-600 part Radix Aucklandiae, 30-50 part berberine hydrochloride, 400-600 part Fructus Aurantii Immaturus, 400-600 part Radix Paeoniae Alba, 400-600 part Cortex Magnoliae Officinalis, 400-600 part Semen Arecae, 12-18 part Rhizoma Zingiberis or 40-60 part Rhizoma Zingiberis Recens.The preparation method step of this prescription oral liquid: a, get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction filters, and gets filtrate or squeezing extracting juice; Get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as b, outer all the other Radix Aucklandiae of demineralizing acid berberine become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; C, add 2 times of volumes of 95% ethanol and stir evenly; D, left standstill 24 hours, get supernatant, reclaim ethanol; E, get medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; F, thick paste add the long-pending amount of diploid purified water and stir evenly dilution, cold preservation is more than 24 hours, get supernatant, with filter paper filtering, filtrate adds the berberine hydrochloride dissolving, adds sucrose 800-1200 or 2000-3000 part heating for dissolving and becomes concentrated wiring liquid, Fructus Aurantii Immaturus volatile oil dilutes with ethanol 80-120 part, under agitation slowly add in the concentrated wiring liquid, stir evenly filtration, add purified water and make oral liquid mixture or syrup.Said preparation also can be made into oral solid formulation, preparation process changes into or thick paste is dry below 80 ℃ at above-mentioned steps f, be ground into fine powder, add berberine hydrochloride, Fructus Aurantii Immaturus volatile oil adds the about 30-50 part of starch and absorbs, with above-mentioned fine powder mixing, make oral solid formulation hard capsule, soft capsule, granule, powder, tablet or drop pill.This Chinese medicine preparation formula optimization composition by weight: 500 parts of Radix Aucklandiae, 40 parts of berberine hydrochlorides, 500 parts of Fructus Aurantii Immaturuss, 500 portions of Radix Paeoniae Albas, 500 parts of Cortex Magnoliae Officinalis, 500 portions of Semen Arecaes, 15 portions of Rhizoma Zingiberiss or 50 portions of Rhizoma Zingiberis Recenss.This Chinese medicine preparation has dispelling summer-heat and expelling cold pathogen, changes stagnation dysentery function; Be applied to the intestines and stomach dyspepsia, red-white dysentery, abdominal pain with tenesmus, treatment for diseases such as dysuria.
Option b: or a kind of Chinese medicine preparation for the treatment of gastroenteropathy, this Chinese medicine preparation formulation optimization improvement composition by weight: 400-600 part Radix Aucklandiae, 30-50 part berberine hydrochloride, 400-600 part Fructus Aurantii Immaturus, 400-600 part Radix Paeoniae Alba, 400-600 part Cortex Magnoliae Officinalis, 400-600 part Semen Arecae, 12-18 part Rhizoma Zingiberis or 40-60 part Rhizoma Zingiberis Recens, 400-600 part Extractum Rhei Liquidum.The preparation method step of this prescription oral liquid: a, get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction filters, and gets filtrate or squeezing extracting juice; Get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as b, demineralizing acid berberine, outer all the other Radix Aucklandiae of Extractum Rhei Liquidum become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; C, add 2 times of volumes of 95% ethanol and stir evenly; D, left standstill 24 hours, get supernatant, reclaim ethanol; E, get medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; F, thick paste add the long-pending amount of diploid purified water and stir evenly dilution, cold preservation is more than 24 hours, get supernatant, with filter paper filtering, filtrate adds the berberine hydrochloride dissolving, add Extractum Rhei Liquidum, add sucrose 800-1200 or 2000-3000 part heating for dissolving and become concentrated wiring liquid, Fructus Aurantii Immaturus volatile oil under agitation slowly adds in the concentrated wiring liquid with the dilution of ethanol 80-120 part, stir evenly filtration, add purified water and make oral liquid mixture or syrup.Said preparation also can be made into oral solid formulation, preparation process changes into or thick paste is added Extractum Rhei Liquidum at above-mentioned steps f, concentrating under reduced pressure, dry below 80 ℃, be ground into fine powder, add berberine hydrochloride, Fructus Aurantii Immaturus volatile oil adds the about 30-50 part of starch and absorbs, with above-mentioned fine powder mixing, make oral solid formulation hard capsule, soft capsule, granule, powder, tablet or drop pill.This Chinese medicine preparation formula optimization composition by weight: 500 parts of Radix Aucklandiae, 40 parts of berberine hydrochlorides, 500 parts of Fructus Aurantii Immaturuss, 500 portions of Radix Paeoniae Albas, 500 parts of Cortex Magnoliae Officinalis, 500 portions of Semen Arecaes, 15 portions of Rhizoma Zingiberiss or 50 portions of Rhizoma Zingiberis Recenss, 500 parts of Extractum Rhei Liquidums.This Chinese medicine preparation has dispelling summer-heat and expelling cold pathogen, changes stagnation dysentery, circulation of qi promoting bowel relaxing functions; Be applied to the intestines and stomach dyspepsia, red-white dysentery, abdominal pain with tenesmus, treatment for diseases such as dysuria, stool are not smooth, tenesmus.
The invention has the advantages that: the function that this Chinese medicine preparation has cures mainly:
The option A advantage: dispelling summer-heat and expelling cold pathogen, change stagnation dysentery.Be applied to the intestines and stomach dyspepsia, red Hakuri disease, abdominal pain with tenesmus, treatment of conditions such as dysuria.
The option b advantage: or dispelling summer-heat and expelling cold pathogen, change stagnation dysentery, circulation of qi promoting relieving constipation.Be applied to the intestines and stomach dyspepsia, red Hakuri disease, abdominal pain with tenesmus, treatment for diseases such as dysuria, stool are not smooth, tenesmus.
Adopt option A or option b, use safety is not all observed any untoward reaction.The trier thinks that this square preparation taste is suitable, and compliance is good.The function of this Chinese medicine preparation cures mainly and uses from the clinical research of pharmacodynamics test and treatment dysentery due to damp-heat and was confirmed already, and toxicologic study confirms that safety is very big.The clinical research result shows: this product is a kind of effective medicine of treatment dysentery due to damp-heat, and especially dose is little, and is rapid-action, and onset person reaches 82.7% in one day.Quicken to studies show that with long-time stability, this Chinese medicine preparation reserved sample observing room temperature preservation 2 years, preparation is not rotten, and drug quality is stable.
One, this Chinese medicine preparation preparation technology
The thin layer chromatography that with the main pharmacodynamics is index and main constituent is followed the tracks of, preferred technology.
The preferred component of this Chinese medicine preparation:
The preferred component of option A: 500 parts of Radix Aucklandiae, 40 parts of berberine hydrochlorides, 500 parts of Fructus Aurantii Immaturuss, 500 portions of Radix Paeoniae Albas, 500 parts of Cortex Magnoliae Officinalis, 500 portions of Semen Arecaes, 15 portions of Rhizoma Zingiberiss or 50 portions of Rhizoma Zingiberis Recenss.
The preferred component of option b: or 500 parts of Radix Aucklandiae, 40 parts of berberine hydrochlorides, 500 parts of Fructus Aurantii Immaturuss, 500 portions of Radix Paeoniae Albas, 500 parts of Cortex Magnoliae Officinalis, 500 portions of Semen Arecaes, 15 portions of Rhizoma Zingiberiss or 50 portions of Rhizoma Zingiberis Recenss, 500 parts of Extractum Rhei Liquidums.
This Chinese medicine preparation active ingredient or position extraction and purification process:
Option A technology: a, get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as b, outer all the other Radix Aucklandiae of demineralizing acid berberine become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; C, add 2 times of volumes of 95% ethanol and stir evenly; D, left standstill 24 hours, get supernatant, reclaim ethanol; E, get medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; F (1) thick paste adds the long-pending amount of diploid purified water and stirs evenly dilution, cold preservation is more than 24 hours, get supernatant, with filter paper filtering, filtrate adds the berberine hydrochloride dissolving, adds sucrose 1000 or 2500 parts of heating for dissolving and is made into concentrated wiring liquid, Fructus Aurantii Immaturus volatile oil is with 100 parts of dilutions of ethanol, under agitation slowly add in the concentrated wiring liquid, stir evenly filtration, add purified water and make { mixture (oral liquid) or syrup }; F (2) or thick paste are dry below 80 ℃, are ground into fine powder, add berberine hydrochloride, and Fructus Aurantii Immaturus volatile oil adds the about 40 parts of absorptions of starch, with above-mentioned fine powder mixing, makes oral solid formulation (hard capsule, soft capsule, granule, powder, tablet, drop pill).
Option b technology: or a, get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as b, demineralizing acid berberine, outer all the other Radix Aucklandiae of Extractum Rhei Liquidum become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; C, add 2 times of volumes of 95% ethanol and stir evenly; D, left standstill 24 hours, get supernatant, reclaim ethanol; E, get medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; F (1) thick paste adds the long-pending amount of diploid purified water and stirs evenly dilution, cold preservation is more than 24 hours, get supernatant, with filter paper filtering, filtrate adds the berberine hydrochloride dissolving, add Extractum Rhei Liquidum, add sucrose 1000 or 2500 parts of heating for dissolving and be made into concentrated wiring liquid, Fructus Aurantii Immaturus volatile oil under agitation slowly adds in the concentrated wiring liquid with 100 parts of dilutions of ethanol, stir evenly filtration, add purified water and make { mixture (oral liquid) or syrup }; F (2) or thick paste added Extractum Rhei Liquidum, concentrating under reduced pressure, dry below 80 ℃, be ground into fine powder, add berberine hydrochloride, Fructus Aurantii Immaturus volatile oil adds the about 40 parts of absorptions of starch, with above-mentioned fine powder mixing, makes oral solid formulation (hard capsule, soft capsule, granule, powder, tablet, drop pill).
Two, this Chinese medicine preparation drug standard
[character] this product oral liquid be yellowish-brown to brown liquid, the sweet little hardship of distinguishing the flavor of.The oral solid formulation content is the powder of yellowish-brown; Gas delicate fragrance, flavor extremely bitter (granule is the sweet little hardship of flavor).
This product content 0.1g (oral solid formulation) or 2ml (evaporate to dryness) (oral liquid) are got in [discriminating] (1), add 3 of strong aqua ammonia and methanol 10ml, and jolting filters for a moment, and filtrate is as need testing solution.Other gets the Hesperidin reference substance, adds methanol and makes saturated solution product solution in contrast; Get naringin, berberine hydrochloride reference substance again, add methanol and make the solution that every 1ml contains 0.5mg and 0.2mg respectively, in contrast product solution.Test according to thin layer chromatography (appendix of Chinese Pharmacopoeia version in 2005), draw above-mentioned need testing solution and three kinds of each 1 μ l of reference substance solution, put respectively on same polyamide film, with third western ketone-water (1: 1) is developing solvent, launches, and takes out, dry, spray is dried with the alchlor test solution, puts under the ultra-violet lamp (365nm) and inspects.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
(2) get this product content 0.3g (oral solid formulation) or 5ml (evaporate to dryness) (oral liquid), add chloroform 10ml, flooded 6 hours, filter, filtrate is concentrated into 1ml, as need testing solution.Other gets Radix Aucklandiae control medicinal material 0.5g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix of Chinese Pharmacopoeia version in 2005), draw each 5 μ l of above-mentioned two kinds of solution, putting in same sodium carboxymethyl cellulose respectively is on the silica gel g thin-layer plate of adhesive, with the chloroform is developing solvent, put in 0.5 hour the expansion cylinder of developing solvent steam presaturation, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution.In the offerings chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
[inspection] should meet relevant every regulation (appendix of Chinese Pharmacopoeia version in 2005) under relevant each preparation item.
[assay] berberine hydrochloride is got 2 (balls of this product, sheet, bottle, bag) (oral solid formulation) or 10ml (oral liquid), the accurate title, decide or measure, put in the apparatus,Soxhlet's, (oral liquid go ahead of the rest evaporate to dryness), the mixed solution that adds hydrochloric acid-methanol (1: 100) is an amount of, reflux is to extracting liquid colourless, extracting solution (concentrating in case of necessity) is moved in the 50ml measuring bottle, and the mixed solution that adds hydrochloric acid-methanol (1: 100) is diluted to scale, shakes up, test according to column chromatography (appendix of Chinese Pharmacopoeia version in 2005), precision is measured 5ml, puts neutral alumina post (10g, internal diameter 0.9cm, wet method dress post, with ethanol 30ml prewashing) on, with ethanol 25ml eluting, collect eluent, put in the 50ml measuring bottle,, shake up to scale with ethanol dilution, precision is measured 2ml, put in the 50ml measuring bottle, be diluted to scale with the 0.05mol/L sulfuric acid solution, shake up, according to spectrophotography (appendix of Chinese Pharmacopoeia version in 2005), measure the absorption degree at 345nm wavelength place, press berberine hydrochloride (C
20H
18ClNO
4) absorptance be 728 to calculate, promptly.
This product every (ball, sheet, bottle, bag) (oral solid formulation) or the not hydrochloric berberine (C of the every ml score of oral liquid
20H
18ClNO
4) should be 36.0mg～44.0mg or 7.2mg～8.8mg.
Cortex Magnoliae Officinalis is got 1 of this product (ball, sheet, bottle, bag) (oral solid formulation) or 5ml (oral liquid), and accurate the title quantitatively gets, and puts in the tool plug conical flask, (oral liquid go ahead of the rest evaporate to dryness) adds methanol 10ml, supersound process 20 minutes, filter, divide washing residue and container 5 times with small amount of methanol, washing liquid merges with filtrate, is concentrated in right amount, be transferred in the 5ml measuring bottle, add methanol and be diluted to scale, shake up, as need testing solution.Other gets magnolol and the magnolol reference substance is an amount of, and accurate the title decides, and adds methanol and makes the mixed solution that every 1ml contains 0.52mg and 0.46mg, in contrast product solution.According to thin layer chromatography (appendix of Chinese Pharmacopoeia version in 2005) test, draw above-mentioned need testing solution 4 μ l, reference substance solution 3 μ l and 5 μ l, respectively the cross point in same be the silica gel G F of adhesive with the sodium carboxymethyl cellulose
254On the lamellae, be developing solvent with benzene-methanol (9: 1), presaturation launched after 30 minutes, took out, and dried, and put location under the ultra-violet lamp (254nm).Scan wavelength according to thin layer chromatography (appendix thin layer chromatography scanning of Chinese Pharmacopoeia version in 2005): λ s=290nm, λ
R=350nm measures test sample trap integrated value and reference substance trap and crosses integrated value, calculates, promptly.
The every ml score of this product every (ball, sheet, bottle, bag) (oral solid formulation) or oral liquid does not contain Cortex Magnoliae Officinalis with magnolol (C
18H
18O
2) and honokiol (C
18H
18O
2) the total amount meter, must not be less than 3.0mg and maybe must not be less than 0.6mg
This product quality of the pharmaceutical preparations is controlled, and the medicament contg height is taken accurate measurement.
Three, this Chinese medicine preparation stability study
It is the stability that index is investigated this Chinese medicine preparation with the berberine hydrochloride that this Chinese medicine preparation adopts the constant temperature accelerated test, and this Chinese medicine preparation adds the kinetics of thermal decomposition experimental result, and the Return Law and graphing method get K
25 ℃(hr
-1), t
25 ℃ 0.9(year) is respectively 1.2340 * 10
-6, 1.2589 * 10
-69.7 and 9.5.38 ℃ ± 1 ℃ of temperature, relative humidity are that 75% above high temperature is investigated and reserved sample observing room temperature preservation 2 years, preparation is not rotten, detect the drug standard requirement that all meets by the every index of this Chinese medicine preparation drug standard, presentation of results this product preparation stabilization is convenient to transportation and is carried storage.
Four, the pharmacology of this Chinese medicine preparation and toxicological study
1 pharmacological research
The MIC of this Chinese medicine preparation vitro inhibition shigella flexneri growth is 31mg/ml; 0.95g/ml rabbit intestinal ligation section topical is 98.0% to the shigella flexneri growth inhibition ratio of intestinal segment local infection, can obviously alleviate the inflammatory reaction of infected intestinal segment.2.6g/kg the mice enterokinesia that dosage causes pilocarpine is hyperfunction the obvious suppression effect is arranged; Normal rat is exsomatized add the myenteron shrinkage amplitude and weaken, the stripped ileum flesh shrinkage amplitude that pilocarpine is caused increases and also is inhibitory action.1.3g/kg the reaction of the mouse writhing due to dosage Dichlorodiphenyl Acetate suppression ratio is 60.9%; Suppression ratio was 40% when the burn method was caused mice whipping 120min.
2 toxicological studies
This Chinese medicine preparation 102.42g (crude drug amount)/kg gives mouse stomach, and all are normal in 7 days, and this dosage is 504 times of 50kg Coming-of-Age Day consumption (10.16g); 705 times of 70kg Coming-of-Age Day consumption, safety is very big.
Five, the clinical research of this Chinese medicine preparation treatment dysentery due to damp-heat
The clinical research result of this Chinese medicine preparation treatment dysentery due to damp-heat shows: this Chinese medicine preparation is to recent cure rate (84%) and total obvious effective rate (95%) of dysentery due to damp-heat.This Chinese medicine preparation is to the clinical various recent cure rate all very high (84.1% and 83.9%) of dysentery due to damp-heat.Patient's feces dysentery bacterium is cultivated negative conversion rate up to 91.7%.Treatment back numeration of leukocyte all obviously descends.In clinical research,, there is no other untoward reaction except that finding that a few patients has the slight constipation.Can think that this Chinese medicine preparation is a kind of effective medicine of treatment dysentery due to damp-heat, especially dose is little, the bioavailability height, and the medicament contg height, release fast, rapid-action (onset person reaches 82.7% in one day), drug safety has no adverse reaction.
Concrete preparation embodiment
Example 1 hard capsule (one) method for making:
The 400 gram Radix Aucklandiae, 30 gram part berberine hydrochlorides, 400 gram Fructus Aurantii Immaturuss, the 400 gram Radix Paeoniae Albas, 400 gram Cortex Magnoliae Officinalis, 400 gram Semen Arecaes, 12 gram Rhizoma Zingiberiss or 40 gram Rhizoma Zingiberis Recenss.Get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as outer all the other Radix Aucklandiae of demineralizing acid berberine become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; Adding 2 times of volumes of 95% ethanol stirs evenly; Left standstill 24 hours, and got supernatant, reclaim ethanol; Get the medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; Dry below 80 ℃, be ground into fine powder, add berberine hydrochloride, Fructus Aurantii Immaturus volatile oil adds starch 30g and absorbs, and with above-mentioned fine powder mixing, incapsulates, and makes 1000, promptly.
Example 2 soft capsule method for makings:
The 500 gram Radix Aucklandiae, 40 gram part berberine hydrochlorides, 500 gram Fructus Aurantii Immaturuss, the 500 gram Radix Paeoniae Albas, 500 gram Cortex Magnoliae Officinalis, 500 gram Semen Arecaes, 15 gram Rhizoma Zingiberiss or 50 gram Rhizoma Zingiberis Recenss.Get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as outer all the other Radix Aucklandiae of demineralizing acid berberine become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; Adding 2 times of volumes of 95% ethanol stirs evenly; Left standstill 24 hours, and got supernatant, reclaim ethanol; Get the medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; Dry below 80 ℃, be ground into fine powder, add berberine hydrochloride powder, Fructus Aurantii Immaturus volatile oil adds vegetable oil 40g and makes suspendible fluid through colloid mill, makes soft capsule with system of dripping or pressing, makes 1000 balls, promptly.
Example 3 powder method for makings:
The 600 gram Radix Aucklandiae, 50 gram part berberine hydrochlorides, 600 gram Fructus Aurantii Immaturuss, the 600 gram Radix Paeoniae Albas, 600 gram Cortex Magnoliae Officinalis, 600 gram Semen Arecaes, 18 gram Rhizoma Zingiberiss or 60 gram Rhizoma Zingiberis Recenss.Get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as outer all the other Radix Aucklandiae of demineralizing acid berberine become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; Adding 2 times of volumes of 95% ethanol stirs evenly; Left standstill 24 hours, and got supernatant, reclaim ethanol; Get the medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; Dry below 80 ℃, be ground into fine powder, add berberine hydrochloride, Fructus Aurantii Immaturus volatile oil adds starch 50g and absorbs, and with above-mentioned fine powder mixing, in the bottle of packing into, makes 1000 bottles, promptly.
Example 4 granule method for makings:
The 500 gram Radix Aucklandiae, 40 gram part berberine hydrochlorides, 500 gram Fructus Aurantii Immaturuss, the 500 gram Radix Paeoniae Albas, 500 gram Cortex Magnoliae Officinalis, 500 gram Semen Arecaes, 15 gram Rhizoma Zingiberiss or 50 gram Rhizoma Zingiberis Recenss.Get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as outer all the other Radix Aucklandiae of demineralizing acid berberine become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; Adding 2 times of volumes of 95% ethanol stirs evenly; Left standstill 24 hours, and got supernatant, reclaim ethanol; Get the medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; Dry below 80 ℃, be ground into fine powder, add berberine hydrochloride powder; with Icing Sugar 1500g, pregelatinized Starch 500g, mixing; with 40-70% ethanol system soft material, granulation, drying, granule granulate; Fructus Aurantii Immaturus volatile oil absorbs with 40g starch; with above-mentioned granule mixing, packing, every bag of 5g; make 1000 bags, promptly.
Example 5 tablets (one) method for making:
The 500 gram Radix Aucklandiae, 40 gram part berberine hydrochlorides, 500 gram Fructus Aurantii Immaturuss, the 500 gram Radix Paeoniae Albas, 500 gram Cortex Magnoliae Officinalis, 500 gram Semen Arecaes, 15 gram Rhizoma Zingiberiss or 50 gram Rhizoma Zingiberis Recenss.Get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as outer all the other Radix Aucklandiae of demineralizing acid berberine become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; Adding 2 times of volumes of 95% ethanol stirs evenly; Left standstill 24 hours, and got supernatant, reclaim ethanol; Get the medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; Dry below 80 ℃, be ground into fine powder, add berberine hydrochloride powder, add starch slurry, granulation, drying, Fructus Aurantii Immaturus volatile oil absorbs with 40g starch, and with above-mentioned granule mixing, tabletting, the bag film-coat is made 1000, promptly.
Example 6 drop pill method for makings:
The 500 gram Radix Aucklandiae, 40 gram part berberine hydrochlorides, 500 gram Fructus Aurantii Immaturuss, the 500 gram Radix Paeoniae Albas, 500 gram Cortex Magnoliae Officinalis, 500 gram Semen Arecaes, 15 gram Rhizoma Zingiberiss or 50 gram Rhizoma Zingiberis Recenss.Get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as outer all the other Radix Aucklandiae of demineralizing acid berberine become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; Adding 2 times of volumes of 95% ethanol stirs evenly; Left standstill 24 hours, and got supernatant, reclaim ethanol; Get the medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; Dry below 80 ℃, be ground into fine powder, add berberine hydrochloride powder, Fructus Aurantii Immaturus volatile oil adds medical polyethylene glycol 6000 or medical polyethylene glycol 400040g heating and melting mixing, and airtight and insulation is at 80 ℃～90 ℃, splashes in 10 ℃～15 ℃ the liquid Paraffin, liquid Paraffin is use up and wiped to the drop pill drop that is shaped, drying is made 1000 balls, promptly altogether.
Example 7 mixture (oral liquid) method for making:
The 500 gram Radix Aucklandiae, 40 gram part berberine hydrochlorides, 500 gram Fructus Aurantii Immaturuss, the 500 gram Radix Paeoniae Albas, 500 gram Cortex Magnoliae Officinalis, 500 gram Semen Arecaes, 15 gram Rhizoma Zingiberiss or 50 gram Rhizoma Zingiberis Recenss.Get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as outer all the other Radix Aucklandiae of demineralizing acid berberine become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; Adding 2 times of volumes of 95% ethanol stirs evenly; Left standstill 24 hours, and got supernatant, reclaim ethanol; Get the medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; Thick paste adds the long-pending amount of diploid purified water and stirs evenly dilution, cold preservation is more than 24 hours, get supernatant, with filter paper filtering, filtrate adds the berberine hydrochloride dissolving, add sucrose 1000g heating for dissolving and become concentrated wiring liquid, Fructus Aurantii Immaturus volatile oil under agitation slowly adds in the concentrated wiring liquid with ethanol 100ml dilution, stirs evenly filtration, add purified water and make 5000ml, promptly.
Example 8 syrups (one) method for making:
The 500 gram Radix Aucklandiae, 40 gram part berberine hydrochlorides, 500 gram Fructus Aurantii Immaturuss, the 500 gram Radix Paeoniae Albas, 500 gram Cortex Magnoliae Officinalis, 500 gram Semen Arecaes, 15 gram Rhizoma Zingiberiss or 50 gram Rhizoma Zingiberis Recenss.Get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as outer all the other Radix Aucklandiae of demineralizing acid berberine become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; Adding 2 times of volumes of 95% ethanol stirs evenly; Left standstill 24 hours, and got supernatant, reclaim ethanol; Get the medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; Thick paste adds the long-pending amount of diploid purified water and stirs evenly dilution, cold preservation is more than 24 hours, get supernatant, with filter paper filtering, filtrate adds the berberine hydrochloride dissolving, add sucrose 2500g heating for dissolving and become concentrated wiring liquid, Fructus Aurantii Immaturus volatile oil under agitation slowly adds in the concentrated wiring liquid with ethanol 100ml dilution, stirs evenly filtration, add purified water and make 5000ml, promptly.
Example 9 hard capsules (two) method for making:
The 400 gram Radix Aucklandiae, 30 gram part berberine hydrochlorides, 400 gram Fructus Aurantii Immaturuss, the 400 gram Radix Paeoniae Albas, 400 gram Cortex Magnoliae Officinalis, 400 gram Semen Arecaes, 12 gram Rhizoma Zingiberiss or 40 gram Rhizoma Zingiberis Recenss, 400ml Extractum Rhei Liquidum.Get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as demineralizing acid berberine, outer all the other Radix Aucklandiae of Extractum Rhei Liquidum become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; Adding 2 times of volumes of 95% ethanol stirs evenly; Left standstill 24 hours, and got supernatant, reclaim ethanol; Get the medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, add Extractum Rhei Liquidum, concentrating under reduced pressure, dry below 80 ℃, be ground into fine powder, add berberine hydrochloride, Fructus Aurantii Immaturus volatile oil adds starch 30g and absorbs, with above-mentioned fine powder mixing, incapsulate, make 1000, promptly.
Example 10 tablets (two) method for making:
The 500 gram Radix Aucklandiae, 40 gram part berberine hydrochlorides, 500 gram Fructus Aurantii Immaturuss, the 500 gram Radix Paeoniae Albas, 500 gram Cortex Magnoliae Officinalis, 500 gram Semen Arecaes, 15 gram Rhizoma Zingiberiss or 50 gram Rhizoma Zingiberis Recenss, 500ml Extractum Rhei Liquidum.Get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as demineralizing acid berberine, outer all the other Radix Aucklandiae of Extractum Rhei Liquidum become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; Adding 2 times of volumes of 95% ethanol stirs evenly; Left standstill 24 hours, and got supernatant, reclaim ethanol; Get the medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time; 1 hour for the second time; filter, merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge; be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes; add Extractum Rhei Liquidum, concentrating under reduced pressure, dry below 80 ℃; be ground into fine powder; add berberine hydrochloride powder, add starch slurry, granulation, drying; Fructus Aurantii Immaturus volatile oil adds starch 40g and absorbs; with above-mentioned granule mixing, tabletting, the bag film-coat; make 1000, promptly.
Example 11 syrups (two) method for making:
The 600 gram Radix Aucklandiae, 50 gram part berberine hydrochlorides, 600 gram Fructus Aurantii Immaturuss, the 600 gram Radix Paeoniae Albas, 600 gram Cortex Magnoliae Officinalis, 600 gram Semen Arecaes, 18 gram Rhizoma Zingiberiss or 60 gram Rhizoma Zingiberis Recenss, 600ml Extractum Rhei Liquidum.Get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction, filter, get filtrate or squeezing extracting juice, get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decoct with water secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as demineralizing acid berberine, outer all the other Radix Aucklandiae of Extractum Rhei Liquidum become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; Adding 2 times of volumes of 95% ethanol stirs evenly; Left standstill 24 hours, and got supernatant, reclaim ethanol; Get the medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; Thick paste adds the long-pending amount of diploid purified water and stirs evenly dilution, cold preservation was got supernatant more than 24 hours, with filter paper filtering, filtrate adds the berberine hydrochloride dissolving, add Extractum Rhei Liquidum, add sucrose 3000g heating for dissolving and become concentrated wiring liquid, Fructus Aurantii Immaturus volatile oil dilutes with ethanol 120ml, under agitation slowly add in the concentrated wiring liquid, stir evenly filtration, add purified water and make 5000ml, promptly.
Claims (10)
1. Chinese medicine preparation for the treatment of gastroenteropathy is characterized in that: this Chinese medicine preparation formulation weight component:
Radix Aucklandiae 400-600 berberine hydrochloride 30-50 Fructus Aurantii Immaturus 400-600
Radix Paeoniae Alba 400-600 Cortex Magnoliae Officinalis 400-600 Semen Arecae 400-600
Rhizoma Zingiberis 12-18 or Rhizoma Zingiberis Recens 40-60.
2. according to the described a kind of Chinese medicine preparation for the treatment of gastroenteropathy of claim 1, it is characterized in that: this Chinese medicine preparation formulation optimization improvement composition by weight
Radix Aucklandiae 400-600 berberine hydrochloride 30-50 Fructus Aurantii Immaturus 400-600
Radix Paeoniae Alba 400-600 Cortex Magnoliae Officinalis 400-600 Semen Arecae 400-600
Rhizoma Zingiberis 12-18 or Rhizoma Zingiberis Recens 40-60 Extractum Rhei Liquidum 400-600.
3. according to the described a kind of Chinese medicine preparation for the treatment of gastroenteropathy of claim 1, it is characterized in that: the preparation method step of this prescription oral liquid:
A, get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction filters, and gets filtrate or squeezing extracting juice; Get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as b, outer all the other Radix Aucklandiae of demineralizing acid berberine become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; C, add 2 times of volumes of 95% ethanol and stir evenly; D, left standstill 24 hours, get supernatant, reclaim ethanol; E, get medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; F, thick paste add the long-pending amount of diploid purified water and stir evenly dilution, cold preservation is more than 24 hours, get supernatant, with filter paper filtering, filtrate adds the berberine hydrochloride dissolving, adds sucrose 800-1200 or 2000-3000 part heating for dissolving and becomes concentrated wiring liquid, Fructus Aurantii Immaturus volatile oil dilutes with ethanol 80-120 part, under agitation slowly add in the concentrated wiring liquid, stir evenly filtration, add purified water and make oral liquid mixture or syrup.
4. according to claim 1 or 3 described a kind of Chinese medicine preparation for the treatment of gastroenteropathy, it is characterized in that: this prescription also can be made into oral solid formulation, preparation process changes into or thick paste is dry below 80 ℃ at above-mentioned steps f, be ground into fine powder, add berberine hydrochloride, Fructus Aurantii Immaturus volatile oil adds the about 30-50 part of starch and absorbs, and with above-mentioned fine powder mixing, makes oral solid formulation hard capsule, soft capsule, granule, powder, tablet or drop pill.
5. according to the described a kind of Chinese medicine preparation for the treatment of gastroenteropathy of claim 2, it is characterized in that: the preparation method step of this prescription oral liquid:
A, get Rhizoma Zingiberis or Rhizoma Zingiberis Recens, decoct with water secondary after smashing to pieces, collecting decoction filters, and gets filtrate or squeezing extracting juice; Get the Cortex Magnoliae Officinalis shredding, decoct filtrate with ginger ale or Sucus Zingberis is mixed thoroughly, put in the pot, fry to ginger ale with slow fire and decoct filtrate or Sucus Zingberis is exhausted, take out, oven drying at low temperature is ground into coarse powder, decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, collecting decoction; Four flavor pulverize separately such as b, demineralizing acid berberine, outer all the other Radix Aucklandiae of Extractum Rhei Liquidum become coarse powder, and Fructus Aurantii Immaturus extracts volatile oil, and the aqueous solution after distillation device is in addition collected; The Radix Paeoniae Alba decocts with water secondary, and 1.5 hours for the first time, 1 hour for the second time, merge the aqueous solution after Cortex Magnoliae Officinalis and Radix Paeoniae Alba decocting liquid and Fructus Aurantii Immaturus distill, filter, filtrate is concentrated into the clear paste that 60 ℃ of heat are surveyed relative density 1.20; C, add 2 times of volumes of 95% ethanol and stir evenly; D, left standstill 24 hours, get supernatant, reclaim ethanol; E, get medicinal residues behind the Cortex Magnoliae Officinalis decocting and the Radix Aucklandiae, Semen Arecae, add the alcohol reflux secondary, 1.5 hours for the first time, 1 hour for the second time, filter merging filtrate, reclaim behind the ethanol with above-mentioned precipitate with ethanol after decocting liquid merge, be condensed into 60 ℃ of heat and survey relative density 1.3 thick pastes, standby; F, thick paste add the long-pending amount of diploid purified water and stir evenly dilution, cold preservation is more than 24 hours, get supernatant, with filter paper filtering, filtrate adds the berberine hydrochloride dissolving, add Extractum Rhei Liquidum, add sucrose 800-1200 or 2000-3000 part heating for dissolving and become concentrated wiring liquid, Fructus Aurantii Immaturus volatile oil under agitation slowly adds in the concentrated wiring liquid with the dilution of ethanol 80-120 part, stir evenly filtration, add purified water and make oral liquid mixture or syrup.
6. according to claim 2 or 5 described a kind of Chinese medicine preparation for the treatment of gastroenteropathy, it is characterized in that: this prescription also can be made into oral solid formulation, preparation process changes into or thick paste is added Extractum Rhei Liquidum at above-mentioned steps f, concentrating under reduced pressure, dry below 80 ℃, be ground into fine powder, add berberine hydrochloride, Fructus Aurantii Immaturus volatile oil adds the about 30-50 part of starch and absorbs, and with above-mentioned fine powder mixing, makes oral solid formulation hard capsule, soft capsule, granule, powder, tablet or drop pill.
7. according to the described a kind of Chinese medicine preparation for the treatment of gastroenteropathy of claim 1, it is characterized in that: this Chinese medicine preparation formula optimization composition by weight
The Radix Aucklandiae 500 berberine hydrochlorides 40 Fructus Aurantii Immaturuss 500
The Radix Paeoniae Alba 500 Cortex Magnoliae Officinalis 500 Semen Arecaes 500
Rhizoma Zingiberis 15 or Rhizoma Zingiberis Recens 50.
8. according to the described a kind of Chinese medicine preparation for the treatment of gastroenteropathy of claim 2, it is characterized in that: this Chinese medicine preparation formula optimization composition by weight
The Radix Aucklandiae 500 berberine hydrochlorides 40 Fructus Aurantii Immaturuss 500
The Radix Paeoniae Alba 500 Cortex Magnoliae Officinalis 500 Semen Arecaes 500
Rhizoma Zingiberis 15 or Rhizoma Zingiberis Recens 50 Extractum Rhei Liquidums 500.
9. according to the described a kind of Chinese medicine preparation for the treatment of gastroenteropathy of claim 1, it is characterized in that: this Chinese medicine preparation has dispelling summer-heat and expelling cold pathogen, changes stagnation dysentery function; Be applied to the intestines and stomach dyspepsia, red-white dysentery, abdominal pain with tenesmus, the treatment of diseases such as dysuria.
10. according to the described a kind of Chinese medicine preparation for the treatment of gastroenteropathy of claim 2, it is characterized in that: this Chinese medicine preparation has dispelling summer-heat and expelling cold pathogen, changes stagnation dysentery, the circulation of qi promoting bowel relaxing functions; Be applied to the intestines and stomach dyspepsia, red-white dysentery, abdominal pain with tenesmus, disease treatments such as dysuria, stool are not smooth, tenesmus.
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| CN102614481A (en) * | 2011-10-18 | 2012-08-01 | 宋协勘 | Chinese medicine for treating chronic gastritis |
| CN104352755A (en) * | 2014-11-15 | 2015-02-18 | 天农大（天津）生物科技有限公司 | Traditional Chinese medicine composition for treating cattle constipation and preparation method thereof |
| CN108721587A (en) * | 2018-08-09 | 2018-11-02 | 河南润弘本草制药有限公司 | The Chinese medicine of middle benefit gas qi-regulating promoting digestion |
| CN113499364A (en) * | 2021-08-24 | 2021-10-15 | 北京杏林药业有限责任公司 | Preparation process of cortex magnoliae officinalis with ginger |
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