CN1709371A - Chinese medicine formulation for treating respiratory tract disease, and its preparation method and quality control method - Google Patents
Chinese medicine formulation for treating respiratory tract disease, and its preparation method and quality control method Download PDFInfo
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Abstract
The present invention discloses a Chinese medicine Qingre Jiedu preparation for curing the diseases of respiratory tract, its preparation method and quality control method. Said Chinese medicine preparation can be made into Qingre Jiedu dispersing tablet or dripping pills, and is made up by using 12 Chinese medicinal materials of crude gypsum, lonicern flower, scrophularia root, rehmannia root, forsythia seed, gardenia fruit and others as main components. Said invention also provides the concrete steps of its preparation method, its bioavailability is high, and its quality controllability and stability are good, so that its therapeutic effect also is raised.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation and preparation method thereof and method of quality control, relate in particular to a kind of Chinese medicine preparation for the treatment of respiratory tract disease and preparation method thereof and method of quality control.
Background technology:
Dispersible tablet in the Chinese medicine preparation or drop pill, change dosage form and manage as new drug research according to the relevant laws and regulations of China's drug control as a kind of pharmaceutical dosage form.The existing dosage form of this product is a tablet, has listed the national drug ministry standard in.
The technology features of the Chinese medicine preparation heat-clearing and toxic substances removing sheet of existing treatment respiratory tract disease be get Fructus Forsythiae, Radix Scutellariae powder is broken into fine powder, ten flavors such as all the other Gypsum Fibrosum decoct with water three times, filter respectively, merging filtrate concentrates, and adds above-mentioned fine powder, mixing, drying is ground into fine powder, granulates, adding 1% magnesium stearate mixes thoroughly, compacting is in blocks, sugar coating, promptly.The Chinese medicine preparation heat-clearing and toxic substances removing sheet of existing treatment respiratory tract disease exist disintegration long, carry and take shortcomings such as inconvenience, bioavailability is low.
Summary of the invention:
The purpose of this invention is to provide a kind of Chinese medicine preparation for the treatment of respiratory tract disease and preparation method thereof, overcome the above-mentioned drawback of prior art, improve the quality and the curative effect of product, satisfy the needs of medical treatment better.
The objective of the invention is to be achieved through the following technical solutions.
The Chinese medicine preparation of treatment respiratory tract disease, it is that main component is heat-clearing and toxic substances removing dispersible tablet or the drop pill of Gypsum Fibrosum, Flos Lonicerae, Radix Scrophulariae, Radix Rehmanniae, Fructus Forsythiae, Fructus Gardeniae, Herba Gueldenstaedtiae, Radix Scutellariae, Radix Gentianae, Radix Isatidis, the Rhizoma Anemarrhenae, Radix Ophiopogonis.
Its preparation method is:
(1) medicine constituent and percentage by weight consumption thereof are as follows:
Gypsum Fibrosum 22.3-66.9%, Flos Lonicerae 4.4-13.2%, Radix Scrophulariae 3.5-10.6%, Radix Rehmanniae 2.7-8.0%, Fructus Forsythiae, Fructus Gardeniae, Herba Gueldenstaedtiae, Radix Scutellariae, Radix Gentianae, each 2.3-6.8% of Radix Isatidis, the Rhizoma Anemarrhenae, Radix Ophiopogonis each 1.8-5.4%;
Medicine constituent optimum weight percentage ratio is:
Gypsum Fibrosum 44.6%, Flos Lonicerae 8.8%, Radix Scrophulariae 7.1%, Radix Rehmanniae 5.3%, Fructus Forsythiae, Fructus Gardeniae, Herba Gueldenstaedtiae, Radix Scutellariae, Radix Gentianae, Radix Isatidis each 4.5%, the Rhizoma Anemarrhenae, Radix Ophiopogonis each 3.6%;
(2) get Fructus Forsythiae, Radix Scutellariae powder is broken into fine powder, and is standby;
(3) ten flavor medicines such as all the other Gypsum Fibrosum decoct with water three times, and warm macerating decocted 1-2 hour after 2 hours at every turn; Filter respectively, merging filtrate is concentrated into relative density and is 1.1-1.50 (80 ℃) extractum, and is standby;
(4) get the extractum mix homogeneously of (2) gained fine powder and (3) gained, drying is ground into fine powder, and it is standby to get mixed powder;
(5) get the mixed powder of (4) gained, add an amount of adjuvant, mix homogeneously is granulated, drying, and granulate is pressed into dispersible tablet;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, use with by arbitrary proportion: low-substituted hydroxypropyl cellulose, dimension splash form sediment 5000, polyvinylpolypyrrolidone 1NF-10, Polyethylene Glycol, polyvidon class, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, cellulose acetate-phthalate, hydroxypropyl methylcellulose phthalate, hydroxymethyl ethyl cellulose, microcrystalline Cellulose, citric acid, cholic acid, fumaric acid, succinic acid, tartaric acid, colloidality silicon dioxide, magnesium stearate, Pulvis Talci.
(6) with one or more of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188 or other suitable adjuvant, use with by arbitrary proportion, add in (4) prepared mixed powder after being heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70-100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, with the drop pill drop of molding to the greatest extent and remove coolant, dry coationg promptly.
The method of quality control of heat-clearing and toxic substances removing dispersible tablet or drop pill: get this product, porphyrize, precision takes by weighing 1-3g, add methanol 30ml, reflux 20-40 minute, put cold, filter, get filtrate 4-6ml, evaporate to dryness, residue adds water 15ml stirring makes dissolving, filters, and filtrate is regulated pH value 1～2 with hydrochloric acid, with ethyl acetate extraction 2-3 time, each 10ml, merge extractive liquid,, put evaporate to dryness in the water-bath, residue adds methanol 1ml makes dissolving, as need testing solution.Other gets the baicalin reference substance, adds methanol and makes the solution that contains 0.5-2mg among every 1ml, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with with ethyl acetate-butanone-formic acid-water (4-6: 2-4: 0.5-1.5: 0.5-1.5) be developing solvent, launch, take out, dry, spray is with 1-3% ferric chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Specific embodiments:
The present invention further specifies as follows in conjunction with specific embodiments:
A kind of Chinese medicine preparation for the treatment of respiratory tract disease, it is that main component is heat-clearing and toxic substances removing dispersible tablet or the drop pill of Gypsum Fibrosum, Flos Lonicerae, Radix Scrophulariae, Radix Rehmanniae, Fructus Forsythiae, Fructus Gardeniae, Herba Gueldenstaedtiae, Radix Scutellariae, Radix Gentianae, Radix Isatidis, the Rhizoma Anemarrhenae, Radix Ophiopogonis.
Chinese medicine preparation of the present invention is mainly used in the treatment influenza, upper respiratory tract infection and various febrile disease.
The preparation method of Chinese medicine preparation of the present invention is:
(1) medicine constituent and weight consumption are as follows:
Gypsum Fibrosum 670g, Flos Lonicerae 134g, Radix Scrophulariae 107g, Radix Rehmanniae 80g, Fructus Forsythiae 67g, Fructus Gardeniae 67g, Herba Gueldenstaedtiae 67g, Radix Scutellariae 67g, Radix Gentianae 67g, Radix Isatidis 67g, Rhizoma Anemarrhenae 54g, Radix Ophiopogonis 54g;
(2) get Fructus Forsythiae, Radix Scutellariae powder is broken into fine powder, and is standby;
(3) ten flavor medicines such as all the other Gypsum Fibrosum decoct with water three times, and warm macerating decocted 1.5 hours after 2 hours for the first time, and decocted 1.5 hours the second time, decocted for the third time 1 hour.Filter respectively, merging filtrate is concentrated into relative density and is 1.30 (80 ℃) extractum, and is standby;
(4) get the extractum mix homogeneously of (2) gained fine powder and (3) gained, drying is ground into fine powder, and it is standby to get mixed powder;
(5) the Chinese medicine preparation heat-clearing and toxic substances removing dispersible tablet of treatment respiratory tract disease, its preparation method is a mixed powder of getting (4) gained, add cross-linking polyethylene pyrrolidone 24g, low-substituted hydroxypropyl cellulose 36g, microcrystalline cellulose 86g, micropowder silica gel 2g cross 100 mesh sieves, mix homogeneously, cross 80 mesh sieve secondaries, tabletting promptly.
(6) the Chinese medicine preparation heat-clearing and toxic substances removing drop pill of treatment respiratory tract disease, its preparation method is a mixed powder of getting (4) gained, Polyethylene Glycol PEG6000 300g, stearic acid 60g, Poloxamer188 30g, treat to add in the mixed powder of (4) gained after Polyethylene Glycol PEG6000, stearic acid, Poloxamer188 are heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 80 ℃, at heat-retaining condition by splashing in the liquid paraffin, be condensed into ball, with the drop pill drop of molding to the greatest extent and the erasing liquor paraffin body, cold drying promptly.
The heat-clearing and toxic substances removing dispersible tablet that it makes or the quality control of drop pill are: get this product, and porphyrize, precision takes by weighing 2g, add methanol 30ml, reflux 30 minutes is put cold, filter, get filtrate 5ml, evaporate to dryness, residue adds water 15ml stirring makes dissolving, filters, and filtrate is regulated pH value 1～2 with hydrochloric acid, with ethyl acetate extraction 2 times, each 10ml, merge extractive liquid,, put evaporate to dryness in the water-bath, residue adds methanol 1ml makes dissolving, as need testing solution.Other gets the baicalin reference substance, adds methanol and makes the solution that contains 1mg among every 1ml, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with with ethyl acetate-butanone-formic acid-water (5: 3: 1: 1) be developing solvent, launch, take out, dry, spray is with 2% ferric chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Advantage of the present invention is:
Carry, taking convenience, the bioavilability height, controllability and good stability are conducive to improve curative effect.
Claims (4)
1, a kind of Chinese medicine preparation for the treatment of respiratory tract disease is characterized in that it is that main component is heat-clearing and toxic substances removing dispersible tablet or the drop pill of Gypsum Fibrosum, Flos Lonicerae, Radix Scrophulariae, Radix Rehmanniae, Fructus Forsythiae, Fructus Gardeniae, Herba Gueldenstaedtiae, Radix Scutellariae, Radix Gentianae, Radix Isatidis, the Rhizoma Anemarrhenae, Radix Ophiopogonis.
2, a kind of preparation method for the treatment of the Chinese medicine preparation of respiratory tract disease, it is the preparation method of heat-clearing and toxic substances removing dispersible tablet or drop pill, it is characterized in that:
(1) medicine constituent and percentage by weight consumption thereof are as follows:
Gypsum Fibrosum 22.3-66.9%, Flos Lonicerae 4.4-13.2%, Radix Scrophulariae 3.5-10.6%, Radix Rehmanniae 2.7-8.0%, Fructus Forsythiae, Fructus Gardeniae, Herba Gueldenstaedtiae, Radix Scutellariae, Radix Gentianae, each 2.3-6.8% of Radix Isatidis, the Rhizoma Anemarrhenae, Radix Ophiopogonis each 1.8-5.4%;
(2) get Fructus Forsythiae, Radix Scutellariae powder is broken into fine powder, and is standby;
(3) ten flavor medicines such as all the other Gypsum Fibrosum decoct with water three times, and warm macerating decocted 1-2 hour after 2 hours at every turn; Filter respectively, merging filtrate is concentrated into relative density and is 1.1-1.50 (80 ℃) extractum, and is standby;
(4) get the extractum mix homogeneously of (2) gained fine powder and (3) gained, drying is ground into fine powder, and it is standby to get mixed powder;
(5) get (4) prepared mixed powder, add suitable adjuvant after, mixing is made dispersible tablet or drop pill;
The preparation method of its dispersible tablet: get the mixing fine powders of (4) gained, add an amount of adjuvant, mix homogeneously is granulated, drying, and granulate is pressed into dispersible tablet;
Adjuvant is one or more mixture or other suitable adjuvant in the following material, use with by arbitrary proportion: low-substituted hydroxypropyl cellulose, dimension splash form sediment 5000, polyvinylpolypyrrolidone 1NF-10, Polyethylene Glycol, polyvidon class, methylcellulose, ethyl cellulose, hydroxypropyl emthylcellulose, cellulose acetate-phthalate, hydroxypropyl methylcellulose phthalate, hydroxymethyl ethyl cellulose, microcrystalline Cellulose, citric acid, cholic acid, fumaric acid, succinic acid, tartaric acid, colloidality silicon dioxide, magnesium stearate, Pulvis Talci;
The preparation method of its drop pill is: with one or more of stearic acid or glyceryl monostearate or insect wax or Cera Flava or Polyethylene Glycol (PEG4000 or PEG6000) or sodium stearate or glycerin gelatine or polyoxyethylene monostearate (S-40) or Poloxamer188 or other suitable adjuvant, use with by arbitrary proportion, add in (4) prepared mixing fine powders after being heated to whole fusions, be transferred in the liquid containing bottle rapidly after stirring, airtight and the insulation at 70-100 ℃, under heat-retaining condition, go in the liquid coolant (liquid paraffin or methyl-silicone oil or vegetable oil or water or ethanol) by dropping-pill machine, condensation cured becomes ball, with the drop pill drop of molding to the greatest extent and remove coolant, dry coationg promptly.
3, a kind of method of quality control for the treatment of the Chinese medicine preparation of respiratory tract disease, it is the method for quality control of heat-clearing and toxic substances removing dispersible tablet or drop pill, it is characterized in that: get this product, porphyrize, precision takes by weighing 1-3g, add methanol 30ml, reflux 20-40 minute, put cold, filter, get filtrate 4-6ml, evaporate to dryness, residue add water 15ml stirring makes dissolving, filter, filtrate is regulated pH value 1～2 with hydrochloric acid, uses ethyl acetate extraction 2-3 time, each 10ml, merge extractive liquid,, put evaporate to dryness in the water-bath, residue adds methanol 1ml makes dissolving, as need testing solution; Other gets the baicalin reference substance, adds methanol and makes the solution that contains 0.5-2mg among every 1ml, in contrast product solution; Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with with ethyl acetate-butanone-formic acid-water (4-6: 2-4: 0.5-1.5: 0.5-1.5) be developing solvent, launch, take out, dry, spray is with 1-3% ferric chloride alcoholic solution; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
4, a kind of preparation method for the treatment of the Chinese medicine preparation of respiratory tract disease according to claim 2 is characterized in that the optimum weight percentage ratio of its main constituent is:
Gypsum Fibrosum 44.6%, Flos Lonicerae 8.8%, Radix Scrophulariae 7.1%, Radix Rehmanniae 5.3%, Fructus Forsythiae, Fructus Gardeniae, Herba Gueldenstaedtiae, Radix Scutellariae, Radix Gentianae, Radix Isatidis each 4.5%, the Rhizoma Anemarrhenae, Radix Ophiopogonis each 3.6%.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102416098A (en) * | 2011-12-07 | 2012-04-18 | 郑丽霞 | Medicine preparation used for treating upper respiratory tract infection |
| CN105301169A (en) * | 2015-12-09 | 2016-02-03 | 河南省奥林特药业有限公司 | Method for identifying authenticity of gueldenstaedtia multiflora bunge by using thin-layer chromatography |
| CN106668485A (en) * | 2017-02-14 | 2017-05-17 | 佛山市腾瑞医药科技有限公司 | Traditional Chinese medicine composition capable of clearing away heat and removing toxins and preparation method of traditional Chinese medicine composition |
| CN109470782A (en) * | 2018-10-22 | 2019-03-15 | 中国药科大学 | Betulic acid, which is used as, distinguishes cape jasmine-Fructus Forsythiae medicine to the purposes of the marker of single pan-fried mixed liquor and mixed decocting liquid |
| CN116870094A (en) * | 2023-06-26 | 2023-10-13 | 江西和盈药业有限公司 | Preparation method of oral liquid for clearing heat and detoxicating |
-
2005
- 2005-07-06 CN CN 200510031822 patent/CN1709371A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102416098A (en) * | 2011-12-07 | 2012-04-18 | 郑丽霞 | Medicine preparation used for treating upper respiratory tract infection |
| CN102416098B (en) * | 2011-12-07 | 2014-03-26 | 郑丽霞 | Medicine preparation used for treating upper respiratory tract infection |
| CN105301169A (en) * | 2015-12-09 | 2016-02-03 | 河南省奥林特药业有限公司 | Method for identifying authenticity of gueldenstaedtia multiflora bunge by using thin-layer chromatography |
| CN106668485A (en) * | 2017-02-14 | 2017-05-17 | 佛山市腾瑞医药科技有限公司 | Traditional Chinese medicine composition capable of clearing away heat and removing toxins and preparation method of traditional Chinese medicine composition |
| CN109470782A (en) * | 2018-10-22 | 2019-03-15 | 中国药科大学 | Betulic acid, which is used as, distinguishes cape jasmine-Fructus Forsythiae medicine to the purposes of the marker of single pan-fried mixed liquor and mixed decocting liquid |
| CN116870094A (en) * | 2023-06-26 | 2023-10-13 | 江西和盈药业有限公司 | Preparation method of oral liquid for clearing heat and detoxicating |
| CN116870094B (en) * | 2023-06-26 | 2024-05-14 | 江西和盈药业有限公司 | Preparation method of oral liquid for clearing heat and detoxicating |
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