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Quality control method of Lanhuayao

A quality control method and blue flower technology, which are applied in pharmaceutical formulations, medical preparations containing active ingredients, measuring devices, etc., can solve problems such as difficult operation and easy volatility, and achieve simple methods, accurate results and good reproducibility. Effect

Inactive Publication Date: 2009-03-25
大连美罗中药厂有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Diethyl ether is a low boiling point solvent, which is extremely volatile during ultrasonic extraction and difficult to operate in practical applications

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] According to the standard preparation method, blue anther (provided by Dalian Meiluo Traditional Chinese Medicine Factory Co., Ltd., batch number: 20070502) was made.

[0028] The reference substances and reference medicinal materials were provided by China National Institute for the Control of Pharmaceutical and Biological Products.

[0029] According to Chinese Pharmacopoeia 2005 edition an appendix VID high-performance liquid chromatography method to measure Qingdai content, operation steps are as follows:

[0030] Chromatographic conditions: Octadecylsilane bonded silica gel as filler;

[0031] Use methanol-water with a volume ratio of 73:27 as the mobile phase;

[0032] The detection wavelength is 289nm;

[0033] The number of theoretical plates should not be less than 7000 based on the indirubin peak;

[0034] Preparation of reference substance solution: Accurately weigh 5 mg of indirubin reference substance, put it in a 25ml measu...

Embodiment 2

[0038] On the basis of embodiment 1, according to the Chinese Pharmacopoeia edition in 2005 an appendix VIE gas chromatography, the borneol content is measured, and the operation steps are as follows:

[0039] Chromatographic conditions: polyethylene glycol (PEG)-20M capillary column (column length 30m, inner diameter 0.32mm, film thickness 0.5μm), column temperature 140°C; the number of theoretical plates should not be less than 30,000 based on the borneol peak;

[0040] Determination of correction factor: Accurately weigh methyl salicylate reference substance plus absolute ethanol to make a solution containing 2mg per 1ml as an internal standard solution; accurately weigh borneol reference substance and add internal standard solution to make a solution containing 2mg per 1ml , as the reference substance solution; draw 0.5 μl of the reference substance solution, inject it into the gas chromatograph, and calculate the correction factor;

[0041] Preparation of the test solutio...

Embodiment 3

[0044]On the basis of embodiment 1 or embodiment 2, according to Chinese Pharmacopoeia 2005 edition an appendix VIB middle thin-layer chromatography carries out qualitative identification to Borneolum, operation steps are as follows:

[0045] Take 1.5g of blue anther, grind finely, add 15ml of chloroform, shake well, soak for 2 hours, filter, and the filtrate is used as the test solution; take borneol reference substance, add chloroform to make a solution containing 2mg per 1ml, as a control sample solution; draw 4 μl of each of the above two solutions, spot them on the same silica gel G thin-layer plate, develop with benzene-acetone with a volume ratio of 9:1, take it out, dry it, and spray it with 5% vanillin sulfuric acid Solution, heated at 105°C until the spot color is clear; in the chromatogram of the test product, the main spot of the same color appears on the position corresponding to the chromatogram of the reference product.

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Abstract

The invention discloses a quality control method for a Lanhuayao which is composed of 10 kinds of Chinese herbs of borax, borneol, natural indigo, weathered sodium sulfate, talcum powder, amber, calcined alum, gesso, catechu and figwortflower picrorhiza rhizome; the invention is the quality control method for the Lanhuayao, which measures the natural indigo content by utilizing the high-effective liquid chromatography method, measures the borneol content by gas phase chromatography method and performs qualitative identification for the borneol and catechu by thin-layer chromatography method; the quality control method can make up shortcomings in prior art; the perfect quality control standard can ensure the reliability and uniformity of medicine quality, and is simple and practicable with operability.

Description

Technical field: [0001] The invention relates to a quality control method of blue anther made from 10 traditional Chinese medicinal materials such as borax, borneol, Qingdai, xuanming powder, talcum powder, amber, dried alum, gypsum, catechu, and Coptis chinensis. Quality control methods for the determination of the content of Indigo Naturalis by liquid chromatography, the content of borneol by gas chromatography, and the qualitative identification of borneol and catechu by thin-layer chromatography. Background technique: [0002] Blue flower medicine is a Chinese patent medicine used to treat acute and chronic tonsillitis, red and swollen gums, sore throat and infantile malnutrition. 3 -B-0647-91), made of borax, borneol, Qingdai, Xuanming powder, talcum powder, amber, dry alum, gypsum, catechu and Huhuanglian ten herbs. In its quality standards, the prescription, preparation method, properties and identification methods of indigo anther are specified, but there are only c...

Claims

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Application Information

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IPC IPC(8): A61K36/80A61P1/02A61P11/04G01N30/02G01N30/36G01N30/90A61K31/045A61K33/04A61K33/06A61K33/12A61K33/22A61K35/10
Inventor 张成海周文波刘志昆陈心石桂芳李延成姜伟
Owner 大连美罗中药厂有限公司
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