Content detection method of Chinese medicine preparation for treating gastropathy

The technology of a traditional Chinese medicine preparation and a detection method is applied to the content detection of traditional Chinese medicine preparations and the field of traditional Chinese medicine preparations for the treatment of gastric diseases, and can solve the problems of poor reproducibility, unstable quality, and unfavorable quality control of Jinlianweishu tablets.

Inactive Publication Date: 2013-02-27
广西万寿堂药业有限公司
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  • Abstract
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  • Application Information

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Problems solved by technology

The existing Jinlian Weishu Tablet preparation quality inspection method uses TLC scanning method for content determination items, th

Method used

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  • Content detection method of Chinese medicine preparation for treating gastropathy
  • Content detection method of Chinese medicine preparation for treating gastropathy
  • Content detection method of Chinese medicine preparation for treating gastropathy

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] The research of the content assay method of embodiment 1 tetrahydropalmatine

[0017] (1) Instruments and reagents

[0018] High-performance liquid chromatography: Agilent 1100, G1311A (quaternary pump), G1314A (VWD detector), BP211D electronic balance of 1 / 100,000.

[0019] Corydalin reference substance is provided by China National Institute of Pharmaceutical and Biological Products for content determination, the purity is (above 98%), methanol is chromatographically pure, water is double distilled water, and other reagents are analytically pure. The Jinlian Weishu tablet to be tested was provided by Guangxi Wanshoutang Pharmaceutical Co., Ltd.

[0020] (2) Chromatographic conditions Chromatographic column

[0021] The mobile phase volume ratio is methanol-water-triethylamine (65:35:0.5), the flow rate is 1ml / min; the detection wavelength: 280nm.

[0022] (3) Selection of extraction time

[0023] Take about 0.5g of Jinlian Weishu Tablets (batch number: 120601, spe...

Embodiment 2

[0056] The determination of the content of tetrahydropalmatine in embodiment 2 Jinlian Weishu Tablets

[0057] The contents of 10 batches of Jinlian Weishu Tablets were determined respectively according to the above-mentioned content determination method, and the determination results are shown in Table 7.

[0058] Table 7 Containment test results of 10 batches of samples

[0059]

[0060] The test results of 10 batches of Jinlian Weishu Tablets (specification: small tablets (film-coated tablets)) show that the minimum content of tetrahydropalmatine in 10 batches of samples is 1.140mg / tablet. The gold contained in the preparation shall not be less than 0.6 mg in terms of tetrahydropalmatine.

Embodiment 3

[0061] Embodiment 3 compares the content detection method of two kinds of tetrahydropalmatine

[0062]The original standard method: take 20 pieces of Jinlian Weishu Tablets (batch number: 120601), remove the coating, accurately weigh, grind finely, take 3g, accurately weigh, put in a stoppered Erlenmeyer flask, add 5ml of concentrated ammonia test solution to make After wetting, add 20ml of chloroform precisely, seal it tightly, weigh it, soak it for 2 hours, treat it with ultrasonic for 30 minutes, let it cool, weigh it again, make up the lost weight with chloroform, shake well, filter it, and take it precisely Filtrate 5ml, evaporate to dryness, add appropriate amount of methanol to the residue to dissolve, transfer to a 2ml measuring bottle, dilute to the mark with methanol, shake well, and use it as the test solution. Another appropriate amount of tetrahydropalmatine reference substance was accurately weighed, and methanol was added to make a solution containing 0.5 mg per...

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Abstract

The invention discloses a content detection method of a Chinese medicine preparation for treating gastropathy. The method disclosed herein improves the content detection method of tetrahydropalmatine in stephania sinica diels total alkali in existing detection technology, selects optimal chromatographic conditions, and provides reliable guarantees for guaranteeing the stable and controllable quality and stable and accurate curative effect of Jinlian Weishu Pian or capsule related products.

Description

technical field [0001] The invention belongs to the field of quality detection of traditional Chinese medicine preparations, in particular to a method for detecting the content of traditional Chinese medicine preparations for treating stomach diseases, and relates to Chinese medicine preparations for treating stomach diseases made of Jinbuhuan extracts, dried alum and old snake lotus, such as Jinlianweishu Determination method for the content of tetrahydropalmatine in Jinbuhuan total alkaloids in preparations such as tablets or capsules. Background technique [0002] Jinbuhuan total alkaloids are the dried block and processed extract of Jinbuhuan, a plant of Fangjiaceae. The relevant preparations currently on the market include Jinlian Weishu Tablets, which are recorded in the "National Compilation of Chinese Patent Medicine Standards" where the local standards of Chinese patent medicines have risen and the national standards are part of the Internal Medicine Spleen and Stom...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 蒋冰清凌中华农常东
Owner 广西万寿堂药业有限公司
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