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Berberine hydrochloride bulk drug analysis and detection method

A technology of berberine hydrochloride and detection method, which is applied in the field of analysis and detection of berberine hydrochloride raw materials, achieving remarkable economic and social benefits

Active Publication Date: 2021-03-30
SHENYANG INSTITUTE OF CHEMICAL TECHNOLOGY
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  • Abstract
  • Description
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  • Application Information

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Problems solved by technology

[0011] It can be seen that the analysis and detection of related substances in berberine hydrochloride raw materials traces from the source, traces back to the source, theoretically and experimentally confirms the related substances in the synthesis of berberine hydrochloride, and the type, structure and content of related substances in berberine hydrochloride The analysis and detection is very necessary, and the research on this technical method has not been reported

Method used

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  • Berberine hydrochloride bulk drug analysis and detection method
  • Berberine hydrochloride bulk drug analysis and detection method
  • Berberine hydrochloride bulk drug analysis and detection method

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Embodiment approach

[0056] 3.1 Analysis of impurities in industrial ortho-vanillin

[0057] 3.1.1 HPLC analysis

[0058] (1) Preparation of standard stock solution

[0059] Accurately weigh 25 mg each of ortho-vanillin, methyl vanillin, ethyl vanillin and vanillin standard substances, place them in 25ml volumetric flasks, dissolve and dilute to the mark with chromatographically pure acetonitrile, and shake well to obtain The corresponding standard stock solution has a concentration of 1mg / ml and is stored in a refrigerator at 4°C.

[0060] (2) Preparation of mixed standard intermediate solution

[0061] ① Precisely measure an appropriate amount of standard stock solutions of methyl vanillin, ethyl vanillin and vanillin, place them in a 10ml volumetric flask, dilute to the mark with acetonitrile, and shake well to obtain a mixed standard intermediate solution with a concentration of 100, 10, 1, 0.1, 0.01, 0.001, 0.0001 μg / ml, stored in a 4°C refrigerator.

[0062] ② Precisely measure an appropri...

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Abstract

The invention discloses a berberine hydrochloride bulk drug analysis and detection method, and relates to a drug analysis and detection method, which comprises the following steps that an analysis anddetection scheme of impurities in industrial ortho vanillin is established by taking ortho vanillin, methyl vanillin, ethyl vanillin and vanillin which are analytically pure (Aladdin) as standard samples; gas-phase and liquid-phase chromatographic analysis is carried out on single and mixed samples; ethyl vanillin is used as a raw material, dimethyl carbonate is used as a methylation reagent, andp-methoxy-m-ethoxy benzaldehyde is prepared and used as a fifth substance. According to the analysis and detection method disclosed by the invention, five related substances are prepared for the first time from the source by tracing the source, and the related substances in berberine hydrochloride are detected and analyzed, so that an analysis and detection technical scheme is established, and the source, the structure and the species of the related substances are confirmed; detection and analysis show that the structures and contents of five related substances in the berberine hydrochloridebulk drug are shown. The technology fills the blank of analysis and detection of berberine hydrochloride related substances in Chinese pharmacopoeia.

Description

technical field [0001] The invention relates to a drug analysis and detection method, in particular to a berberine hydrochloride crude drug analysis and detection method. Background technique [0002] On September 28, 2018, the U.S. FDA issued a massive recall of heart and blood pressure center drugs, blocking all drugs made from Chinese plants until "it is fully determined how the impurity was introduced into its API, or active pharmaceutical ingredient, and repaired its Quality System". Because at least two potentially carcinogenic impurities were found in a drug (Valsartan) related to blood pressure and heart failure (imported by China Huahai Pharmaceutical). In addition to receiving the FDA's import ban, the European Union's EMA also determined that Huahai Pharmaceutical Company's GMP was not up to standard and prohibited its related products from being exported to Europe. [0003] The State Administration of Food and Drug Administration announced the "Catalogue of Gen...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/54G01N30/74
CPCG01N30/02G01N30/06G01N30/54G01N30/74G01N2030/025G01N2030/062
Inventor 王国胜陈小妮张子阳王一雯汲畅秦卓荣丁鉴煦崔浩然
Owner SHENYANG INSTITUTE OF CHEMICAL TECHNOLOGY
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