CN106248859A - 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
CN106248859A
CN106248859A CN201610779032.5A CN201610779032A CN106248859A CN 106248859 A CN106248859 A CN 106248859A CN 201610779032 A CN201610779032 A CN 201610779032A CN 106248859 A CN106248859 A CN 106248859A
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CN
China
Prior art keywords
lung
solution
removing heat
medicine
radix scutellariae
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CN201610779032.5A
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Chinese (zh)
Inventor
闫晓楠
潘勤
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ZHONGXIN INNOVA LABORATORIES
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ZHONGXIN INNOVA LABORATORIES
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Priority to CN201610779032.5A priority Critical patent/CN106248859A/en
Publication of CN106248859A publication Critical patent/CN106248859A/en
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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
    • 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
    • G01N30/02Column chromatography
    • G01N30/04Preparation or injection of sample to be analysed
    • G01N30/06Preparation
    • 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
    • G01N30/02Column chromatography
    • G01N30/04Preparation or injection of sample to be analysed
    • G01N30/06Preparation
    • G01N2030/062Preparation extracting sample from raw material

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 Scutellariae, 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, adds methanol 30mL, supersound process 30 minutes, filters, and filtrate is evaporated, and residue adds 15mL water dissolution, adjusts ph value to 2~3 with hydrochloric acid, with ethyl acetate extraction 2 times, each 30mL, merging ethyl acetate liquid, is evaporated, Residue adds methanol 1mL makes dissolving, as need testing solution.
Prepared by control medicinal material solution: separately take Radix Scutellariae control medicinal material 0.5g, be made in the same way of control medicinal material solution.
Prepared by reference substance solution: baicalin reference substance, adds methanol and makes every 1mL solution containing 1mg, molten as reference substance Liquid.
Thin layer chromatography condition: according to thin layer chromatography (four annex general rules 0502 of " Chinese Pharmacopoeia " version in 2015) test, inhale Take above-mentioned each 2 L of three kinds of solution, put respectively on same polyamide board, with acetic acid-water (10:0.9) as developing solvent, launch, take Going out, dry, spray, with 2% ferric chloride ethanol solution, is inspected under daylight.
Result judges: in test sample chromatograph, with on reference substance and the corresponding position of control medicinal material chromatograph, aobvious identical dark Green speckle person is qualified.
(3) advantages of the present invention and good effect are:
The present invention at lung clearing cough suppressing phlegm transforming medicinal ball, establishes the thin-layer identification method of Radix Scutellariae, filters out reproduction on the basis of primary standard Revised quality standard in the method inclusive criteria that property is good, specificity is strong, spot development is clear, result easily judges, improves The quality control of medicine, the qualitative detection making medicine is more accurate, and quality is more prone to control.
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 Scutellariae of the present invention, the most from left to right: baicalin reference substance solution, Radix Scutellariae pair According to medical material solution, first need testing solution, second batch need testing solution, the 3rd batch of need testing solution, negative sample solution.
Detailed description of the invention
Embodiment 1
One, material
Test sample: clearing heat in the lung relieving cough and resolving phlegm ball, Lerentang Pharmaceutical Factory, Zhongxin Pharmaceutical Group Co., Ltd., Tianj, lot number: 160801、160802、160803。
Reference substance: baicalin reference substance, National Institute for Food and Drugs Control, lot number 110715-201117.
Control medicinal material: Radix Scutellariae control medicinal material, National Institute for Food and Drugs Control, lot number 120955-200607.
Negative sample: the technique announced according to pharmacopeia and the prescription preparation sample without Radix Scutellariae.
Two, detection
The preparation of need testing solution: take this product 5g, finely ground, add methanol 30mL, supersound process 30 minutes, filter, filtrate is evaporated, residual Slag adds 15mL water dissolution, adjusts pH value to be 2-3 with hydrochloric acid, with ethyl acetate extraction 2 times, each 30mL, merges ethyl acetate liquid, steams Dry, residue adds methanol 1mL makes dissolving, as need testing solution.
The preparation of reference substance solution: take baicalin reference substance, adds methanol and makes every 1mL solution containing 1mg, as reference substance Solution.
The preparation of control medicinal material solution: take Radix Scutellariae control medicinal material 0.5g, make comparison according to need testing solution preparation method Medical material solution.
Prepared by negative controls: prepare the sample without Radix Scutellariae according to technique and prescription, take this sample molten according to test sample Prepared by liquid and preparation method thereof.
Chromatographic condition:
Adsorbent polyamide
Point sample amount 2 μ L
Developing solvent acetic acid-water (10:0.9)
Colour developing spray, with 2% ferric chloride ethanol solution, is inspected under daylight
Result judges: test sample differentiates as stated above.In test sample chromatograph, with baicalin reference substance chromatograph and Radix Scutellariae pair According on the position that medical material chromatograph is corresponding, aobvious identical dirty-green speckle person is qualified.
Three, result
Test sample differentiates as stated above.In test sample chromatograph, with baicalin reference substance chromatograph and Radix Scutellariae control medicinal material color Compose on corresponding position, aobvious identical dirty-green speckle, 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 Scutellariae 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 Scutellariae is:
1. the preparation of need testing solution: take this product 5g, finely ground, add methanol 30mL, supersound process 30 minutes, filter, filtrate is evaporated, Residue adds 15mL water dissolution, with hydrochloric acid adjust ph value to 2~3, with ethyl acetate extraction 2 times, each 30mL, merging ethyl acetate Liquid, is evaporated, and residue adds methanol 1mL makes dissolving, as need testing solution;
2. the preparation of control medicinal material solution: take Radix Scutellariae control medicinal material 0.5g, makes control medicinal material solution with 1. method;
3. the preparation of reference substance solution: take baicalin reference substance, adds methanol and makes every 1mL solution containing 1mg, molten as reference substance Liquid;
4. thin layer condition: draw above-mentioned each 2 L of three kinds of solution, put respectively on same polyamide board, with acetic acid-water (10: 0.9) being developing solvent, launch, taking out, dry, spray, with 2% ferric chloride ethanol solution, is inspected under daylight.
CN201610779032.5A 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 CN106248859A (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100998654A (en) * 2007-01-15 2007-07-18 北京汉典中西药研究开发中心 Method for preparing Shuanghuanglian dispersion tablet containing honeysuckle and other herb medicines, and its quality control method
CN101095900A (en) * 2007-07-10 2008-01-02 黑龙江省中医研究院 Sichuan chrysanthemum pain-relieving capsule and method for preparing the same
CN101732552A (en) * 2010-01-27 2010-06-16 昆明中药厂有限公司 Method for detecting quality of lung clearing and phlegm eliminating pill
CN102049012A (en) * 2011-01-11 2011-05-11 上海市儿童医院 Traditional Chinese medicine composition for treating sexual precocity of children and preparation and quality detection method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100998654A (en) * 2007-01-15 2007-07-18 北京汉典中西药研究开发中心 Method for preparing Shuanghuanglian dispersion tablet containing honeysuckle and other herb medicines, and its quality control method
CN101095900A (en) * 2007-07-10 2008-01-02 黑龙江省中医研究院 Sichuan chrysanthemum pain-relieving capsule and method for preparing the same
CN101732552A (en) * 2010-01-27 2010-06-16 昆明中药厂有限公司 Method for detecting quality of lung clearing and phlegm eliminating pill
CN102049012A (en) * 2011-01-11 2011-05-11 上海市儿童医院 Traditional Chinese medicine composition for treating sexual precocity of children and preparation and quality detection method thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
余晓琴 等: "利胆片中药材的鉴别及大黄的含量测定", 《现代医药卫生》 *
陈岚: "咳喘宁口服液质量标准的研究", 《海峡药学》 *

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