Atropa belladonna liquid extract and method for detecting atropine in sample containing atropa belladonna liquid extract

A belladonna liquid extract and detection method technology, which is applied in the detection field of atropine in samples, can solve the problems of unscientific calculation of atropine sulfate content, inability to effectively distinguish (-) scopolamine and atropine, and achieve the effect of ensuring safety

Active Publication Date: 2020-12-18
江西省药品检验检测研究院
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Problems solved by technology

It has been reported in the literature that the hyoscyamine present in belladonna is mainly (-) hyoscyamine (that is, hyoscyamine), and only a small amount of (+) hyoscyamine is contained. The current "Chinese Pharmacopoeia" 2015 edition is a belladonna liquid extract [identification 】(1) Using atropine sulfate as a control for TLC identification, the chromogenic agent used is dilute bismuth iodide potassium test solution, a universal chromogenic agent for alkaloids, hyoscyamine and its racemate atropine showed the same color at the same position. The spots of color cannot effectively distinguish (-) scopolamine and atropine; at the same time, the content of its alkaloids was determined by HPLC method, and the lower limit of quantification was stipulated in terms of atropine sulfate
In fact, the belladonna liquid extract should mainly contain hyoscyamine and a small amount of (+) hyoscyamine, but not atropine. Atropine sulfate is used as a control in the identification of the current quality standard of belladonna liquid extract, and the alkaloid content It is unscientific to calculate the content with atropine sulfate in the determination

Method used

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  • Atropa belladonna liquid extract and method for detecting atropine in sample containing atropa belladonna liquid extract
  • Atropa belladonna liquid extract and method for detecting atropine in sample containing atropa belladonna liquid extract
  • Atropa belladonna liquid extract and method for detecting atropine in sample containing atropa belladonna liquid extract

Examples

Experimental program
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Embodiment 1

[0053] The present embodiment provides a kind of detection method of atropine in anti-inflammatory analgesic ointment, comprising:

[0054] Preparation of reference solution: take hyoscyamine sulfate reference substance (provided by China Institute for Food and Drug Control, batch number: 111982-201401), atropine sulfate reference substance (provided by China Institute for Food and Drug Control, batch number: 100040-201011), precision Weigh it, add absolute ethanol (analytical grade) to prepare solutions containing 0.25 mg of hyoscyamine sulfate and 0.5 mg of atropine sulfate per 1 ml, respectively, to obtain final product.

[0055] Preparation of the test solution: cancel inflammation analgesic ointment (manufacturer: Jiangxi Ji'an Sanli Pharmaceutical Co., Ltd. 190212, the batch number provided by Jiangsu Baiyi Pharmaceutical Co., Ltd. is 180402) 700cm 2 , remove the lid liner, cut into strips, put in a 250ml flask, add 200ml of ethanol, heat and reflux for 1.5 hours, take t...

Embodiment 2

[0063] A total of 286 batches of anti-inflammatory analgesic ointment samples from 18 companies were tested using the detection method provided in Example 1 and the thin-layer chromatography specified in the Pharmacopoeia. The detection results are as follows:

[0064] manufacturer batch number (+) scopolamine peak area / (-) scopolamine peak area ratio Anhui Golden Horse Pharmaceutical Co., Ltd. 20180117 0.188 Anhui Golden Horse Pharmaceutical Co., Ltd. 20190106 0.069 Anhui Golden Horse Pharmaceutical Co., Ltd. 20181209 0.101 Anhui Golden Horse Pharmaceutical Co., Ltd. 20180804 0.192 Anhui Golden Horse Pharmaceutical Co., Ltd. 20190101 0.173 Anhui Golden Horse Pharmaceutical Co., Ltd. 20181207 0.159 Anhui Golden Horse Pharmaceutical Co., Ltd. 20180815 0.122 Anhui Golden Horse Pharmaceutical Co., Ltd. 20181208 0.069 Anhui Golden Horse Pharmaceutical Co., Ltd. 20180508 0.166 Anhui Golden Horse Pharmace...

Embodiment 3

[0068] The present embodiment provides a kind of detection method of atropine in belladonna liquid extract, comprising:

[0069] The preparation of the reference solution, the chromatographic conditions and the assay method are all consistent with those in the detection method provided in Example 1. The difference is that the negative control solution is a blank solution, and the preparation of the test solution is as follows:

[0070] Preparation of the test solution: Take 0.2ml of belladonna liquid extract (manufacturer: Shandong Mingren Freda Sanitary Materials Co., Ltd.), add 15ml of water, 1ml of concentrated ammonia test solution, shake well, shake and extract with chloroform, Chloroform was evaporated to dryness overnight, and the residue was dissolved in 1ml of absolute ethanol as the test solution.

[0071] For test results, see Figure 6 , Figure 6 The high liquid test result chart of belladonna fluid extract provided for Shandong Mingren Freda Sanitary Materials...

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Abstract

The invention relates to the technical field of drug analysis and detection, in particular to an atropa belladonna liquid extract and a method for detecting atropine in a sample containing the atropabelladonna liquid extract. The atropa belladonna liquid extract or the sample containing the atropa belladonna liquid extract is detected by using high performance liquid chromatography, wherein the chromatographic column is a Chiral CD-Ph chiral chromatographic column, and the mobile phase is a mixed solution of acetonitrile and a phosphate buffer solution. The method can effectively detect the content of hyoscylamine in the atropa belladonna liquid extract or the sample containing the atropa belladonna liquid extract, can judge whether atropine is additionally added or not, and ensures the safety of raw material medicines and finished medicines.

Description

technical field [0001] The invention relates to the technical field of drug analysis and detection, in particular to a detection method for atropine in belladonna liquid extract and samples containing belladonna liquid extract. Background technique [0002] The belladonna liquid extract in the prior art is a liquid extract processed from the dried whole herb of the plant Atropa belladonna L. of the family Solanaceae. It has been reported in the literature that the hyoscyamine present in belladonna is mainly (-) hyoscyamine (that is, hyoscyamine), and only a small amount of (+) hyoscyamine is contained. The current "Chinese Pharmacopoeia" 2015 edition is a belladonna liquid extract [identification 】(1) Using atropine sulfate as a control for TLC identification, the chromogenic agent used is dilute bismuth iodide potassium test solution, a universal chromogenic agent for alkaloids, hyoscyamine and its racemate atropine showed the same color at the same position. The spot of c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/86
CPCG01N30/02G01N30/8634
Inventor 许妍袁铭铭任琦施锦芳丁银平付辉政郑盈莹周志强刘艳梅沈敏
Owner 江西省药品检验检测研究院
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