CN1476855A - Chinese medicine composition and its preparation method - Google Patents
Chinese medicine composition and its preparation method Download PDFInfo
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- CN1476855A CN1476855A CNA021291926A CN02129192A CN1476855A CN 1476855 A CN1476855 A CN 1476855A CN A021291926 A CNA021291926 A CN A021291926A CN 02129192 A CN02129192 A CN 02129192A CN 1476855 A CN1476855 A CN 1476855A
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Abstract
The present invention discloses a Chinese medicine composition and its preparation method, and also discloses a quality control method of Chinese medicine composition. The Chinese medicine composition is made up by using 8 Chinese medicinal materials of antelope horn, bulb of ussuri fritillary, rhubarb, scutellaria root, chlorite, crude gypsum, artificial bovine bezoar and licorice.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and preparation method thereof, particularly relate to and treat flu and anxious, slow property tracheitis Chinese medicine composition and preparation method thereof.
Background technology
Infantile bronchitis, bronchopneumonia belong to lung pattern disease category in motherland's medical science, and phlegm-heat cough is one of main pattern of syndrome in the lung pattern disease.How because of wind and cold or wind-heat invading the lung, give birth in expectorant is turbid, strongly fragrant and heat-transformation is due to the impairment of dispersing and descending function of the lung.Lung-heat excess syndromes such as clinical manifestation is cough, thick, thirsty, the pharyngalgia of expectorant, and very then out of breath, flaring of nares, yellow fur are thick.
Infantile bronchitis, bronchopneumonia are one of usual diseases of childhood, frequently-occurring disease.Its pathogen mostly is viral infection, because antibiotic medicine treatment viral infection is invalid, and toxic and side effects is in various degree arranged, and therefore chases a kind of safe, effective, medicine of having no side effect, is the urgent problem that the department of pediatrics worker faces.
Technology contents
The object of the invention is to provide a kind of Chinese medicine composition and preparation method thereof; The object of the invention also is to provide a kind of method of quality control of Chinese medicine composition.
The present invention seeks to be achieved through the following technical solutions:
Cornu Saigae Tataricae 8-12 weight portion Bulbus Fritillariae Ussuriensis 12-20 weight portion
Radix Et Rhizoma Rhei 20-35 weight portion Radix Scutellariae 10-18 weight portion
Lapis Chloriti 10-18 weight portion Gypsum Fibrosum 15-25 weight portion
Artificial Calculus Bovis 8-12 weight portion Radix Glycyrrhizae 20-35 weight portion
More than eight flavors, Cornu Saigae Tataricae powder is broken into fine powder, adds 8-12 times of water gaging and sodium hydroxide 2-6 weight portion, back hydrolysis filters, medicinal residues add 3-6 times of water gaging and sodium hydroxide 1-2 weight portion, back hydrolysis to almost molten entirely, filters merging filtrate; Being concentrated into relative density is 1.020-1.030; Lapis Chloriti, gypsum powder are broken into coarse powder, decoct 2 hours with 8-12 times of water gaging heating, filter, and medicinal residues add 6-10 times of water gaging and decocted 1-2 hour, filter, and merge filtrate twice, and being concentrated into relative density is 1.015-1.019; Artificial Calculus Bovis 3-6 doubly measured the 50-90% ethanol extraction 2-4 hour, and medicinal residues were doubly measured the 50-90% alcohol reflux 1-2 hour with 3-6, filtered, and merge and express liquid, decompression recycling ethanol, being concentrated into relative density is 1.020～1.030; Four flavors such as all the other Bulbus Fritillariae Ussuriensiss add 8-12 times of water gaging and decocted 1-3 hour, filter, medicinal residues add 3-6 times of water gaging heating and decocted 1-2 hour, filter merging filtrate, be concentrated into relative density 1.10, centrifugal, supernatant adds 2-5 and doubly measures 50-90% ethanol, stir evenly, leave standstill, get supernatant, filter, reclaim ethanol, be concentrated into relative density and be about 1.08; Get above-mentioned concentrated solution, add conventional adjuvant and make clinical acceptable forms, as oral liquid, capsule, granule, tablet, injection.
The oral liquid content assaying method of making by the inventive method is: precision is measured oral liquid 25ml, puts in the 250ml flask, adds 5mol/L sulfuric acid solution 25ml, add chloroform 80ml again, water-bath refluxed 4 hours, divided and got chloroform solution, surplus liquid adds chloroform 60ml again, continues to reflux 3 hours, divides and gets chloroform layer; Residual liquid adds chloroform gradation vibration and is washed till colourlessly, divides and gets and merge above-mentioned chloroform solution, adds moisture time vibration and is washed till neutrality, divides and gets chloroform solution, is recycled to dried; Residue adds dissolve with methanol and is settled to 5ml, as need testing solution; Other gets the emodin reference substance, adds methanol and makes the solution that every 1ml contains 0.1mg, and product solution according to the thin layer chromatography test, is drawn need testing solution 10-15 μ l, reference substance solution 2 μ l and 8 μ l in contrast, and the cross point is on same silica gel g thin-layer plate respectively; With 2-4: 1-2: 0.1-0.3: 0.03-0.06: the upper solution of 0.2-0.5 benzene-ethyl acetate-methanol-formic acid-water is developing solvent, takes out, and dries; Scan wavelength according to thin layer chromatography: λ
S=450nm, λ
R=600nm measures test sample trap integrated value and reference substance trap integrated value, calculates, promptly; Every 10ml contains Radix Et Rhizoma Rhei with emodin (C
15H
10O
5) meter, must not be less than 0.4% (mg/ml).
Medicine checking treatment children's phlegm-heat cough 400 examples of the present invention are wherein treated A and are organized 100 examples, and effective percentage (recovery from illness adds produce effects) is 92%; The open group of bronchitis 143 examples, effective percentage is 86.7%; The open group of bronchopneumonia 57 examples, people's efficient is 86.0%.Oral liquid is totally 300 examples, and total effective rate is 88.3%.
Table 1 is respectively organized patient's comprehensive therapeutic effect and is judged
| Medical diagnosis on disease medication grouping | Comprehensive therapeutic effect is judged | Cure rate effective percentage Ridit value (%) (%) |
| The recovery from illness produce effects invalid meter that takes a turn for the better | ||
| A bronchitis B | 64????28??????2???????6???????100 65????22??????6???????7???????100 | ??64.0????92.0????0.073 ??65.0????87.0 |
| The open group of bronchitis | 95????29??????14??????5???????143 | ??66.4????86.7 |
| The open group of bronchitis | 26????23??????4???????4???????57 | ??45.6????86.0 |
| The oral liquid treatment group | 185???80??????20??????15??????300 | ??61.7????88.3 |
Embodiment:
Cornu Saigae Tataricae 9.45g Bulbus Fritillariae Ussuriensis 17.25g Radix Et Rhizoma Rhei 31.50g
Radix Scutellariae 15.75g Lapis Chloriti 15.75g Gypsum Fibrosum 23.62g
Artificial Calculus Bovis 9.45g Radix Glycyrrhizae 31.50g
More than eight the flavor, Cornu Saigae Tataricae powder is broken into fine powder, adds 10 times of water gagings and sodium hydroxide 4g, back hydrolysis 24 hours, filter, medicinal residues add 5 times of amounts: water and sodium hydroxide 2g, back hydrolysis, to almost molten entirely, filter, merge filtrate twice: being concentrated into relative density is 20 ℃ of 1.020-1.030; Lapis Chloriti, gypsum powder are broken into coarse powder, decoct 2 hours with 10 times of water gaging heating, filter, and medicinal residues add 8 times of water gagings and decocted 1.5 hours, filter, and merge filtrate twice, and being concentrated into relative density is 1.015-1.019 (85 ℃); The artificial Calculus Bovis flows backwards with 5 times of amount 70% ethanol and extracted 3 hours, and medicinal residues were measured 70% alcohol reflux 1.5 hours with 5 times, filtered, and merge twice and express liquid, decompression recycling ethanol, being concentrated into relative density is 1.020～1.030 (85 ℃); Four flavors such as all the other Bulbus Fritillariae Ussuriensiss add 10 times of water gagings and decocted 2 hours, filter, medicinal residues add 5 times of water gaging heating and decocted 1.5 hours, filter, and merge filtrate twice, be concentrated into relative density and be about 1.10 (85 ℃), centrifugal, supernatant adds 4 times of amount ethanol, stir evenly, left standstill 48 hours, and got supernatant, filter, decompression recycling ethanol is concentrated into relative density and is about 1.08 (85 ℃); The stevioside who gets above-mentioned concentrated solution and 0.2% mixes, and after stirring evenly, adds water to 1000ml, stir evenly, and heated and boiled 20 minutes, cold preservation 48 hours filters, and filtrate adds the water adjustment.
Assay: precision is measured above-mentioned oral liquid 25ml, puts in the 250ml flask, adds 5mol/L sulfuric acid solution 25ml, adds chloroform 80ml again, and water-bath refluxed 4 hours, divides and gets chloroform solution, and surplus liquid adds chloroform 60ml again, continues to reflux 3 hours, divides and gets chloroform layer; Residual liquid adds chloroform gradation vibration and is washed till colourlessly, divides and gets and merge above-mentioned chloroform solution, adds moisture time vibration and is washed till neutrality, divides and gets chloroform solution, is recycled to dried.Residue adds dissolve with methanol and is settled to 5m0l, as need testing solution; Other gets the emodin reference substance, adds methanol and makes the solution that every 1ml contains 0.1mg, and product solution according to the thin layer chromatography test, is drawn need testing solution 10-15 μ l, reference substance solution 2 μ l and 8 μ l in contrast, and the cross point is on same silica gel g thin-layer plate respectively; With 3: 1: 0.2: the upper solution of 0.05: 0.5 benzene-ethyl acetate-methanol-formic acid-water was developing solvent, and exhibition is taken out apart from 11.5cm, dries; Scan wavelength according to thin layer chromatography: λ
S=450nm, λ
R=600nm measures test sample trap integrated value and reference substance trap integrated value, calculates, promptly.
This product 10ml contains Radix Et Rhizoma Rhei with emodin (C
15H
10O
5) meter, must not be less than 0.4% (mg/ml).
Claims (6)
1, a kind of Chinese medicine composition is characterized in that this Chinese medicine composition made by following crude drug:
Cornu Saigae Tataricae 8-12 weight portion Bulbus Fritillariae Ussuriensis 12-20 weight portion
Radix Et Rhizoma Rhei 20-35 weight portion Radix Scutellariae 10-18 weight portion
Lapis Chloriti 10-18 weight portion Gypsum Fibrosum 15-25 weight portion
Artificial Calculus Bovis 8-12 weight portion Radix Glycyrrhizae 20-35 weight portion
2, Chinese medicine composition as claimed in claim 1 is characterized in that this Chinese medicine composition made by following crude drug:
Cornu Saigae Tataricae 9.45 weight portion Bulbus Fritillariae Ussuriensiss 17.25 weight portions
Radix Et Rhizoma Rhei 31.50 weight portion Radix Scutellariaes 15.75 weight portions
Lapis Chloriti 15.75 weight portion Gypsum Fibrosum 23.62 weight portions
Artificial Calculus Bovis 9.45 weight portion Radix Glycyrrhizaes 31.50 weight portions
3, a kind of preparation method of Chinese medicine composition is characterized in that this method is:
Cornu Saigae Tataricae 8-12 weight portion Bulbus Fritillariae Ussuriensis 12-20 weight portion
Radix Et Rhizoma Rhei 20-35 weight portion Radix Scutellariae 10-18 weight portion
Lapis Chloriti 10-18 weight portion Gypsum Fibrosum 15-25 weight portion
Artificial Calculus Bovis 8-12 weight portion Radix Glycyrrhizae 20-35 weight portion
More than eight flavors, Cornu Saigae Tataricae powder is broken into fine powder, adds 8-12 times of water gaging and sodium hydroxide 2-6 weight portion, back hydrolysis filters, medicinal residues add 3-6 times of water gaging and sodium hydroxide 1-2 weight portion, back hydrolysis to almost molten entirely, filters merging filtrate; Being concentrated into relative density is 1.020-1.030; Lapis Chloriti, gypsum powder are broken into coarse powder, decoct 2 hours with 8-12 times of water gaging heating, filter, and medicinal residues add 6-10 times of water gaging and decocted 1-2 hour, filter, and merge filtrate twice, and being concentrated into relative density is 1.015-1.019; Artificial Calculus Bovis 3-6 doubly measured the 50-90% ethanol extraction 2-4 hour, and medicinal residues were doubly measured the 50-90% alcohol reflux 1-2 hour with 3-6, filtered, and merge and express liquid, decompression recycling ethanol, being concentrated into relative density is 1.020～1.030; Four flavors such as all the other Bulbus Fritillariae Ussuriensiss add 8-12 times of water gaging and decocted 1-3 hour, filter, medicinal residues add 3-6 times of water gaging heating and decocted 1-2 hour, filter merging filtrate, be concentrated into relative density 1.10, centrifugal, supernatant adds 2-5 and doubly measures 50-90% ethanol, stir evenly, leave standstill, get supernatant, filter, reclaim ethanol, be concentrated into relative density and be about 1.08; Get above-mentioned concentrated solution, add conventional adjuvant and make clinical acceptable forms.
4, method as claimed in claim 3 is characterized in that this method is:
Cornu Saigae Tataricae 9.45 weight portion Bulbus Fritillariae Ussuriensiss 17.25 weight portions
Radix Et Rhizoma Rhei 31.50 weight portion Radix Scutellariaes 15.75 weight portions
Lapis Chloriti 15.75 weight portion Gypsum Fibrosum 23.62 weight portions
Artificial Calculus Bovis 9.45 weight portion Radix Glycyrrhizaes 31.50 weight portions
More than eight the flavor, Cornu Saigae Tataricae powder is broken into fine powder, adds 10 times of water gagings and sodium hydroxide 4 weight portions, back hydrolysis 24 hours, filter, medicinal residues add 5 times of amounts: water and sodium hydroxide 2 weight portions, back hydrolysis, to almost molten entirely, filter, merge filtrate twice: being concentrated into relative density is 20 ℃ of 1.020-1.030; Lapis Chloriti, gypsum powder are broken into coarse powder, decoct 2 hours with 10 times of water gaging heating, filter, and medicinal residues add 8 times of water gagings and decocted 1.5 hours, filter, and merge filtrate twice, and being concentrated into relative density is 1.015-1.019 (85 ℃); The artificial Calculus Bovis flows backwards with 5 times of amount 70% ethanol and extracted 3 hours, and medicinal residues were measured 70% alcohol reflux 1.5 hours with 5 times, filtered, and merge twice and express liquid, decompression recycling ethanol, being concentrated into relative density is 85 ℃ 1.020～1.030; Four flavors such as all the other Bulbus Fritillariae Ussuriensiss add 10 times of water gagings and decocted 2 hours, filter, medicinal residues add 5 times of water gaging heating and decocted 1.5 hours, filter, and merge filtrate twice, be concentrated into relative density and be about 1.10 (85 ℃), centrifugal, supernatant adds 4 times of amount ethanol, stir evenly, left standstill 48 hours, and got supernatant, filter, decompression recycling ethanol is concentrated into relative density and is about 1.08 (85 ℃); The stevioside who gets above-mentioned concentrated solution and 0.2% mixes, after stirring evenly, stirs evenly, and heated and boiled 20 minutes, cold preservation 48 hours filters, and filtrate adds the water adjustment, makes oral liquid.
5, the oral liquid assay method of pharmaceutical composition as claimed in claim 1 or 2, it is characterized in that this method is: precision is measured oral liquid 25ml, put in the 250ml flask, add 5mol/L sulfuric acid solution 25ml, add chloroform 80ml again, water-bath refluxed 4 hours, divide and get chloroform solution, surplus liquid adds chloroform 60ml again, continues to reflux 3 hours, divides and gets chloroform layer; Residual liquid adds chloroform gradation vibration and is washed till colourlessly, divides and gets and merge above-mentioned chloroform solution, adds moisture time vibration and is washed till neutrality, divides and gets chloroform solution, is recycled to dried; Residue adds dissolve with methanol and is settled to 5ml, as need testing solution; Other gets the emodin reference substance, adds methanol and makes the solution that every 1ml contains 0.1mg, and product solution according to the thin layer chromatography test, is drawn need testing solution 10-15ul, reference substance solution 2ul and 8ul in contrast, and the cross point is on same silica gel g thin-layer plate respectively; With 2-4: 1-2: 0.1-0.3: 0.03-0.06: the upper solution of 0.2-0.5 benzene-ethyl acetate-methanol-formic acid-water is developing solvent, takes out, and dries; Scan wavelength according to thin layer chromatography: λ
S=450nm, λ
R=600nm measures test sample trap integrated value and reference substance trap integrated value, calculates, promptly; Every 10ml contains Radix Et Rhizoma Rhei in emodin, must not be less than 0.4% (mg/ml).
6, oral liquid assay method as claimed in claim 5 is characterized in that this method is:
Precision is measured oral liquid 25ml, puts in the 250ml flask, adds 5mol/L sulfuric acid solution 25ml, adds chloroform 80ml again, and water-bath refluxed 4 hours, divides and gets chloroform solution, and surplus liquid adds chloroform 60ml again, continues to reflux 3 hours, divides and gets chloroform layer; Residual liquid adds chloroform gradation vibration and is washed till colourlessly, divides and gets and merge above-mentioned chloroform solution, adds moisture time vibration and is washed till neutrality, divides and gets chloroform solution, is recycled to dried.Residue adds dissolve with methanol and is settled to 5ml, as need testing solution; Other gets the emodin reference substance, adds methanol and makes the solution that every 1ml contains 0.1mg, and product solution according to the thin layer chromatography test, is drawn need testing solution 10-15 μ l, reference substance solution 2 μ l and 8 μ l in contrast, and the cross point is on same silica gel g thin-layer plate respectively; With 3: 1: 0.2: the upper solution of 0.05: 0.5 benzene-ethyl acetate-methanol-formic acid-water was developing solvent, and exhibition is taken out apart from 11.5cm, dries; Scan wavelength according to thin layer chromatography: λ
S=450nm, λ
R=600nm measures test sample trap integrated value and reference substance trap integrated value, calculates, that is, the 10ml oral liquid contains Radix Et Rhizoma Rhei in emodin, must not be less than 0.4% (mg/ml).
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| CNB021291926A CN1251740C (en) | 2002-08-20 | 2002-08-20 | Chinese medicine composition and its preparation method |
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| CNB021291926A CN1251740C (en) | 2002-08-20 | 2002-08-20 | Chinese medicine composition and its preparation method |
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| CN1251740C CN1251740C (en) | 2006-04-19 |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101991763B (en) * | 2009-08-20 | 2012-05-23 | 江苏康缘药业股份有限公司 | Application of traditional Chinese medicinal composition to preparing medicaments for resisting influenza virus |
| CN101721604B (en) * | 2008-10-28 | 2012-11-28 | 江苏康缘药业股份有限公司 | Application of traditional Chinese medicine composition in preparing medicine for treating hand, mouth and foot diseases |
| CN105548375A (en) * | 2014-10-29 | 2016-05-04 | 江苏康缘药业股份有限公司 | Traditional Chinese medicine composition and fingerprint detection method of raw material herb of traditional Chinese medicine composition |
| CN108562684A (en) * | 2018-04-20 | 2018-09-21 | 国药集团德众（佛山）药业有限公司 | The identification method of cornu caprae hircus |
| CN108619372A (en) * | 2018-06-27 | 2018-10-09 | 江苏康缘药业股份有限公司 | A kind of Chinese medicine composition is preparing the application in treating cor pulmonale drug |
| CN108704058A (en) * | 2018-08-21 | 2018-10-26 | 江苏康缘药业股份有限公司 | A kind of composition and its preparation method and application with treatment pharyngitis |
| CN109820947A (en) * | 2019-02-26 | 2019-05-31 | 江苏康缘药业股份有限公司 | A kind of application of Chinese medicine composition in preparation treatment epithelium healing cough syndrome drug |
Families Citing this family (1)
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| CN101327294B (en) * | 2007-06-22 | 2010-12-15 | 江苏康缘药业股份有限公司 | Chinese medicinal composition for treating common cold, acute and chronic tracheitis and preparation method thereof |
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2002
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101721604B (en) * | 2008-10-28 | 2012-11-28 | 江苏康缘药业股份有限公司 | Application of traditional Chinese medicine composition in preparing medicine for treating hand, mouth and foot diseases |
| CN101991763B (en) * | 2009-08-20 | 2012-05-23 | 江苏康缘药业股份有限公司 | Application of traditional Chinese medicinal composition to preparing medicaments for resisting influenza virus |
| CN105548375A (en) * | 2014-10-29 | 2016-05-04 | 江苏康缘药业股份有限公司 | Traditional Chinese medicine composition and fingerprint detection method of raw material herb of traditional Chinese medicine composition |
| CN108562684A (en) * | 2018-04-20 | 2018-09-21 | 国药集团德众（佛山）药业有限公司 | The identification method of cornu caprae hircus |
| CN108619372A (en) * | 2018-06-27 | 2018-10-09 | 江苏康缘药业股份有限公司 | A kind of Chinese medicine composition is preparing the application in treating cor pulmonale drug |
| CN108619372B (en) * | 2018-06-27 | 2021-03-30 | 江苏康缘药业股份有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for treating pulmonary heart disease |
| CN108704058A (en) * | 2018-08-21 | 2018-10-26 | 江苏康缘药业股份有限公司 | A kind of composition and its preparation method and application with treatment pharyngitis |
| CN109820947A (en) * | 2019-02-26 | 2019-05-31 | 江苏康缘药业股份有限公司 | A kind of application of Chinese medicine composition in preparation treatment epithelium healing cough syndrome drug |
| CN109820947B (en) * | 2019-02-26 | 2021-07-13 | 江苏康缘药业股份有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for treating upper airway cough syndrome |
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| CN1251740C (en) | 2006-04-19 |
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