CN106324176A - Quality control method of medicine for clearing lung, eliminating phlegm and relieving coughs - Google Patents
Quality control method of medicine for clearing lung, eliminating phlegm and relieving coughs Download PDFInfo
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- CN106324176A CN106324176A CN201610787630.7A CN201610787630A CN106324176A CN 106324176 A CN106324176 A CN 106324176A CN 201610787630 A CN201610787630 A CN 201610787630A CN 106324176 A CN106324176 A CN 106324176A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
- G01N30/91—Application of the sample
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
- G01N30/94—Development
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
- G01N30/95—Detectors specially adapted therefor; Signal analysis
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Abstract
The invention relates to a quality control method of a medicine for clearing lung, eliminating phlegm and relieving coughs. On the basis of an original standard of Qingjin cough-relieving and phlegm-eliminating pills, a thin-layer chromatography method of bitter oranges and pummel peels is established, a method with good reproducibility, high specificity, clear spot color development and easy-to-judge results is screened out and incorporated into an amended quality standard, the quality control on the medicine is improved, so that qualitative detection of the medicine is more accurate, and the quality is easier to control.
Description
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 need testing solution: take this product 5g, finely ground, adds methanol 20ml, supersound process 20 minutes, filters, and filtrate is concentrated into
1ml, as need testing solution.
Prepared by reference substance solution: take naringin reference substance 1g, adds methanol and makes every 1ml solution containing 0.4 mg, as right
According to product solution.
The preparation of medical material solution: take pummelo pee medicinal material 1g, Fructus Aurantii medical material 1g, prepare by the preparation method of need testing 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 4 μ l of above two solution, put respectively on same silica gel g thin-layer plate, with chloroform-acetone-methanol-ammonia (3 3
3 1) being developing solvent, launch, taking out, dry, spray, with aluminum chloride test solution, is put and is inspected under ultra-violet lamp (365nm).
Result judge: contrast test sample, reference substance, control medicinal material chromatogram, wherein in test sample chromatograph, with compare
On product, control medicinal material chromatograph relevant position, the speckle person of aobvious same color is qualified.
(3) advantages of the present invention and good effect are:
The present invention on the basis of primary standard, establishes the thin-layer identification method of Fructus Aurantii and Exocarpium Citri Grandis at lung clearing cough suppressing phlegm transforming medicinal ball, sieve
Select favorable reproducibility, revised quality mark in specificity is strong, spot development is clear, result easily judges method inclusive criteria
Standard, improves the quality control of medicine, and 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 Fructus Aurantii of the present invention and Exocarpium Citri Grandis, the most from left to right: naringin contrast solution,
Pummelo pee medicinal material solution, Fructus Aurantii medical material solution, first need testing solution, second batch need testing solution, the 3rd batch of test sample are molten
Liquid, negative sample solution.
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。
Reference substance: naringin reference substance, National Institute for Food and Drugs Control, lot number 110722-201111.
Control medicinal material: Exocarpium Citri Grandis control medicinal material, National Institute for Food and Drugs Control, lot number 121165-200001;
Fructus Aurantii control medicinal material, National Institute for Food and Drugs Control, lot number 120981-200403.
Prepared by negative control: the technique announced according to pharmacopeia and prescription preparation are without Fructus Aurantii, the drug sample of Exocarpium Citri Grandis.
Two, detection
The preparation of need testing solution: take this product 5g, finely ground, add methanol 20ml, supersound process 20 minutes, filter,.
The preparation of reference substance solution: take naringin reference substance, adds methanol and makes every 1ml solution containing 0.4 mg,.
The preparation of medical material solution: take pummelo pee medicinal material 1g, Fructus Aurantii medical material 1g, prepare by the preparation method of need testing solution.
Prepared by negative controls: prepare without Fructus Aurantii, the sample of Exocarpium Citri Grandis according to prescription and technique, takes this sample by for examination
Prepared by product solution preparation.
Chromatographic condition: adsorbent: silica gel G
Developing solvent: chloroform-acetone-methanol-ammonia (3 33 1)
Colour developing: spray, with aluminum chloride test solution, is put and inspected under ultra-violet lamp (365nm).
Result judge: contrast test sample, reference substance, control medicinal material chromatogram, wherein in test sample chromatograph, with compare
On product, control medicinal material chromatograph relevant position, the speckle person of aobvious same color is qualified.
Three, testing result
Three batches of test samples differentiate as stated above.In test sample chromatograph, corresponding to naringin reference substance and control medicinal material chromatograph
Position is identical fluorescence mottle, 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
Fructus Aurantii in antitussive drug prescription and Exocarpium Citri Grandis.
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 Fructus Aurantii and Exocarpium Citri Grandis is:
1. the preparation of need testing solution: take this product 5g, finely ground, add methanol 20ml, supersound process 20 minutes, filter, filtrate concentrates
To 1ml, as need testing solution;
2. the preparation of reference substance solution: take naringin reference substance 1g, adds methanol and makes every 1ml solution containing 0.4 mg, as right
According to product solution;
3. thin layer condition: draw each 4 μ l of above two solution, put respectively on same silica gel g thin-layer plate, with chloroform-the third
Ketone-methanol-ammonia (3 33 1) is developing solvent, launches, and takes out, dries, and spray, with aluminum chloride test solution, puts ultra-violet lamp
(365nm) inspect under, in test sample chromatograph, on position corresponding with reference substance chromatograph, the fluorescence speckle of aobvious same color.
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CN201610787630.7A CN106324176A (en) | 2016-08-31 | 2016-08-31 | Quality control method of medicine for clearing lung, eliminating phlegm and relieving coughs |
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CN201610787630.7A CN106324176A (en) | 2016-08-31 | 2016-08-31 | Quality control method of medicine for clearing lung, eliminating phlegm and relieving coughs |
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Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1939461A (en) * | 2005-09-30 | 2007-04-04 | 北京奇源益德药物研究所 | Quality control of Chinese medicinal compound preparation |
CN101396460A (en) * | 2008-10-29 | 2009-04-01 | 深圳海创医药科技发展有限公司 | Preparation method of anti-hemorrhoid extract containing rutin and naringin |
CN102048941A (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-welfare tablets serving as Chinese medicinal preparation |
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 |
CN104459005A (en) * | 2014-11-21 | 2015-03-25 | 四川中方制药有限公司 | Quality control method of brain-clearing tranquilization liquid |
CN105334286A (en) * | 2015-11-25 | 2016-02-17 | 吉林修正药业新药开发有限公司 | Quality control method for medicine for treating common cold due to wind-cold |
-
2016
- 2016-08-31 CN CN201610787630.7A patent/CN106324176A/en active Pending
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1939461A (en) * | 2005-09-30 | 2007-04-04 | 北京奇源益德药物研究所 | Quality control of Chinese medicinal compound preparation |
CN101396460A (en) * | 2008-10-29 | 2009-04-01 | 深圳海创医药科技发展有限公司 | Preparation method of anti-hemorrhoid extract containing rutin and naringin |
CN102048941A (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-welfare tablets serving as Chinese medicinal preparation |
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 |
CN104459005A (en) * | 2014-11-21 | 2015-03-25 | 四川中方制药有限公司 | Quality control method of brain-clearing tranquilization liquid |
CN105334286A (en) * | 2015-11-25 | 2016-02-17 | 吉林修正药业新药开发有限公司 | Quality control method for medicine for treating common cold due to wind-cold |
Non-Patent Citations (3)
Title |
---|
姜华 等: "妇欣胶囊质量标准的研究", 《湖南中医药大学学报》 * |
曹君 等: "中药枳壳的质量标准研究概况", 《时珍国医国药》 * |
黄海欣 等: "舒肝丸(浓缩丸)的薄层色谱鉴别", 《中国药师》 * |
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