CN106124686A - A kind of method of quality control of removing heat from the lung and dissipating phlegm antitussive medicine - Google Patents

A kind of method of quality control of removing heat from the lung and dissipating phlegm antitussive medicine Download PDF

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Publication number
CN106124686A
CN106124686A CN201610778920.5A CN201610778920A CN106124686A CN 106124686 A CN106124686 A CN 106124686A CN 201610778920 A CN201610778920 A CN 201610778920A CN 106124686 A CN106124686 A CN 106124686A
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lung
removing heat
medicine
quality control
dissipating phlegm
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闫晓楠
潘勤
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ZHONGXIN INNOVA LABORATORIES
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ZHONGXIN INNOVA LABORATORIES
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/90Plate chromatography, e.g. thin layer or paper chromatography

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  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The present invention relates to the method for quality control of a kind of removing heat from the lung and dissipating phlegm antitussive medicine, at lung clearing cough suppressing phlegm transforming medicinal ball on the basis of primary standard, establish the thin-layer identification method of Radix Peucedani, filter out favorable reproducibility, revised quality standard in specificity is strong, spot development is clear, result easily judges method inclusive criteria, improve the quality control of medicine, the qualitative detection making medicine is more accurate, and quality is more prone to control.

Description

A kind of method of quality control of removing heat from the lung and dissipating phlegm antitussive medicine
Technical field
The invention belongs to technical field of Chinese medicines, relate to the detection method of Chinese medicine, the especially quality of lung clearing cough suppressing phlegm transforming medicinal ball Control method.
Background technology
Lung clearing cough suppressing phlegm transforming medicinal ball prescription: Radix Scutellariae 96g, Radix Trichosanthis 48g, Bulbus Fritillariae Thunbergii 24g, Fructus Aurantii (removing flesh parched with bran) 24g, Radix Platycodonis 24g, Cortex Mori (processed with honey) 24g, Radix Et Rhizoma Rhei 12g, Rhizoma Anemarrhenae 12g, 12g Radix Ophiopogonis, Exocarpium Citri Grandis 12g, Semen Armeniacae Amarum (peeling fry) 12g, front 12g, Radix Stemonae 12g, Radix Glycyrrhizae 3g recklessly.
Preparation method: by above 14 tastes, be ground into fine powder, sieve, mixing, with water pill, it is dried, to obtain final product.
Function cures mainly: lung heat clearing, reduces phlegm, antitussive.The cough yellow sputum caused for lung-heat expectorant, chest and diaphragm is not smooth, hoarseness of having sore throat, greatly Dry stool is dry.
Clearing heat in the lung this prescription of relieving cough and resolving phlegm ball with Radix Scutellariae, Radix Trichosanthis as principal agent, the clear eliminating the pathogens from the lung scorching phlegm syndrome of intestines and internal organs of the body internal organs;With Radix Peucedani, Radix Platycodonis, Bulbus Fritillariae Thunbergii are that auxiliary abundant expectoration due to lung-heat of controlling is coughed;Relievining asthma with Semen Armeniacae Amarum, Cortex Mori, stemona root cough relieving, Radix Ophiopogonis, the Rhizoma Anemarrhenae nourish lung yin, Radix Et Rhizoma Rhei is equipped with Radix Trichosanthis and rushes down large intestine internal organs heat, with Exocarpium Citri Grandis, Fructus Aurantii activating QI to eliminate phlegm, and prevents Radix Et Rhizoma Rhei, Radix Scutellariae from rushing down clearly too, for assistant Medicine;Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription.Full side ten four Chinese medicines work in coordination with onset, are exclusively used in the cough yellow sputum that treatment abundant expectoration due to lung-heat causes, and chest and diaphragm is not Freely, hoarseness of having sore throat, it is hard and dry.For bronchitis, the pneumonia person that occurs above-mentioned symptom.
Existing standard is recorded in the 7th (Chinese medicine one-tenth of " Drug Standard of Ministry of Public Health of the Peoples Republic of China " in 1993 version Square preparation) page 172 (WS3-B-1433-93).Its quality standard only defines appearance character, microscopical identification and Elsholtzia The thin-layer identification method of material, it is impossible to the fundamentally control product inherent quality of qualitative, quantitative.Through retrieval, find no pass clearing heat in the lung The patent documentation of Zhisou-Huatan tablet detection method.
Summary of the invention
(1) it is an object of the invention to provide a kind of can the quality control of qualitative detection a kind of removing heat from the lung and dissipating phlegm antitussive medicine Method, this method has that detection means is simple, testing result feature more accurately.
(2) technical scheme that the present invention is concrete:
Prepared by test sample: take this product 5g, finely ground, and add diethyl ether 20ml, supersound process 15 minutes, filters, and filtrate is evaporated, and residue adds three Chloromethanes 1ml makes dissolving, as need testing solution.
Prepared by control medicinal material solution: separately take Radix Peucedani control medicinal material 1 g, be made in the same way of control medicinal material solution.
Thin layer chromatography condition: according to thin layer chromatography (four annex general rules 0502 of " Chinese Pharmacopoeia " version in 2015) test, inhale Take each 2 μ l of above two solution, put respectively on same silica gel g thin-layer plate, with petroleum ether (60 ~ 90 DEG C)-ethyl acetate-first Acid (7 3 0.1) is developing solvent, launches, and takes out, dries, put and inspect under ultra-violet lamp (365nm).
Result judge: contrast test sample, control medicinal material, the chromatogram of negative control sample, wherein test sample with compare medicine On wood color spectrum relevant position, the speckle of aobvious same color this, person be qualified.
(3) advantages of the present invention and good effect are: the present invention, sets up at lung clearing cough suppressing phlegm transforming medicinal ball on the basis of primary standard The thin-layer identification method of Radix Peucedani, filters out favorable reproducibility, specificity is strong, spot development is clear, result easily judges method is received Entering revised quality standard in standard, improve the quality control of medicine, the qualitative detection making medicine is more accurate, and quality is more Add and be easily controlled.
With detailed description of the invention, the present invention is elaborated below in conjunction with the accompanying drawings, not the restriction to invention.All according to This area equivalent that the disclosure of invention is carried out, belongs to protection scope of the present invention.
Accompanying drawing explanation
Fig. 1 is the thin layer identification color spectrogram of Radix Peucedani of the present invention, the most from left to right: Radix Peucedani control medicinal material, Radix Peucedani comparison medicine Material, 20060605 batches of test samples, 20060610 batches of test samples, 20060615 batches of test samples, negative samples.
Detailed description of the invention
Embodiment 1
One, material
Test sample: lung clearing cough suppressing phlegm transforming medicinal ball, Lerentang Pharmaceutical Factory, Zhongxin Pharmaceutical Group Co., Ltd., Tianj, lot number: 160801、160802、160803。
Control medicinal material: Radix Peucedani control medicinal material, National Institute for Food and Drugs Control, lot number 120951-200704.
Prepared by negative control: the technique announced according to pharmacopeia and the prescription preparation drug sample without Radix Peucedani.
Two, detection
The preparation of need testing solution: take this product 5g, finely ground, add diethyl ether 20ml, supersound process 15 minutes, filters, and filtrate is evaporated, residual Slag adds chloroform 1ml makes dissolving,.
The preparation of control medicinal material solution: take Radix Peucedani control medicinal material 1g, prepare by the preparation method of need testing solution.
The preparation of medical material solution: take Radix Peucedani medical material 1g, prepare by the preparation method of need testing solution.
Prepared by negative controls: prepare the sample without Radix Peucedani according to prescription and technique, take this sample by need testing solution Prepared by preparation method.
Chromatographic condition: adsorbent: silica gel G
Developing solvent: petroleum ether (60~90 DEG C)-ethyl acetate-formic acid (7 3 0.1)
Colour developing: put and inspect under ultra-violet lamp (365nm).
Result judge: contrast test sample, control medicinal material, the chromatogram of negative control sample, wherein test sample with compare medicine On wood color spectrum relevant position, the speckle of aobvious same color this, person be qualified.
Three, result
Three batches of test samples (20060605,20060610,20060615) differentiate as stated above.In test sample chromatograph, with front Control medicinal material chromatograph relevant position is identical fluorescence mottle recklessly, and negative noiseless.

Claims (2)

1. the method for quality control of a removing heat from the lung and dissipating phlegm antitussive medicine, it is characterised in that use thin layer chromatography to differentiate removing heat from the lung and dissipating phlegm Radix Peucedani in antitussive drug prescription.
The method of quality control of a kind of removing heat from the lung and dissipating phlegm antitussive medicine the most according to claim 1, it is characterised in that: described thin Layer chromatography differentiates that in prescription, the method for Radix Peucedani is:
1. the preparation of need testing solution: take this product 5g, finely ground, add diethyl ether 20ml, supersound process 15 minutes, filters, and filtrate is evaporated, Residue adds chloroform 1ml makes dissolving, as need testing solution;
2. the preparation of reference substance solution: take Radix Peucedani control medicinal material 1 g, makes control medicinal material solution with 1. method;
3. thin layer condition: draw each 2 μ l of above two solution, put respectively on same silica gel g thin-layer plate, with petroleum ether (60 ~ 90 DEG C)-ethyl acetate-formic acid (7 3 0.1) is developing solvent, launches, take out, dry, put and inspect under ultra-violet lamp (365nm); In test sample chromatograph, on position corresponding with control medicinal material chromatograph, the fluorescence speckle of aobvious same color.
CN201610778920.5A 2016-08-31 2016-08-31 A kind of method of quality control of removing heat from the lung and dissipating phlegm antitussive medicine Pending CN106124686A (en)

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CN101190282A (en) * 2006-11-22 2008-06-04 天津中新药业集团股份有限公司乐仁堂制药厂 Sugar-free compound traditional Chinese medicinal preparation for treating upper respiratory tract infection and quality control method thereof
CN102048864A (en) * 2009-11-03 2011-05-11 天津中新药业集团股份有限公司达仁堂制药厂 Quality control method of children lung clearing pills serving as Chinese medicinal preparation
CN102297926A (en) * 2011-07-12 2011-12-28 刘金伶 Rapid TLC identification and three-component simultaneous quantitative determination method for antitussive tablets
JP4998151B2 (en) * 2007-08-29 2012-08-15 株式会社ツムラ Purification method of pesticide residues in crude drug samples
CN103869041A (en) * 2012-12-08 2014-06-18 迪沙药业集团有限公司 Quality control method for cough-relieving oral pharmaceutical composition

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6383525B1 (en) * 2000-12-14 2002-05-07 Globoasia L.L.C. Herbal compositions for treating immunological disorders
CN1515272A (en) * 2003-01-08 2004-07-28 江苏康缘药业股份有限公司 Chinese medicine composition for curing cough, its preparation method and quality control method
CN101190282A (en) * 2006-11-22 2008-06-04 天津中新药业集团股份有限公司乐仁堂制药厂 Sugar-free compound traditional Chinese medicinal preparation for treating upper respiratory tract infection and quality control method thereof
JP4998151B2 (en) * 2007-08-29 2012-08-15 株式会社ツムラ Purification method of pesticide residues in crude drug samples
CN102048864A (en) * 2009-11-03 2011-05-11 天津中新药业集团股份有限公司达仁堂制药厂 Quality control method of children lung clearing pills serving as Chinese medicinal preparation
CN102297926A (en) * 2011-07-12 2011-12-28 刘金伶 Rapid TLC identification and three-component simultaneous quantitative determination method for antitussive tablets
CN103869041A (en) * 2012-12-08 2014-06-18 迪沙药业集团有限公司 Quality control method for cough-relieving oral pharmaceutical composition

Non-Patent Citations (4)

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Title
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国家药典委员会编: "《国家药品标准 新药转正标准 第88册》", 31 August 2011, 北京:中国医药科技出版社 *
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