金龙胶囊中金钱白花蛇的分子质量控制  

Molecular quantification for quality control of Jinqian Baihuashe in Jinlong Capsule

作　　者：林慧[1] 李婵[1] 晁志[1] LIN Hui;LI Chan;CHAO Zhi(School of Traditional Chinese Medicine,Southern Medical University,Guangzhou 510515,China)

机构地区：[1]南方医科大学中医药学院,广东广州510515

出　　处：《药学学报》2023年第9期2771-2776,共6页Acta Pharmaceutica Sinica

基　　金：国家自然科学基金(81573540);广州市重点研发计划(202206010111);建生鲜药创研基金(JSJC-2019-01-03-045,JSJC-20200102-054,JSJC-20210102-065)。

摘　　要：中成药中动物类药材的质量控制相对比较困难,因为大多数动物药的有效成分仍不清晰。即使有相关的方法,通常也是定性的,而定量的指标或缺少,或特异性比较差。因此,本文提出运用分子定量技术对中成药中动物类药材进行质量控制。本研究以金龙胶囊为例,建立了其中金钱白花蛇基于荧光定量PCR的分子定量法。该方法特异性好、灵敏度高、重复性好,DNA片段含量与CT(cycle threshold)值呈良好线性关系;金龙胶囊中金钱白花蛇特异片段含量在24.1~46.6 IU·mg^(-1),建议将金钱白花蛇特异片段含量不低于19.3 IU·mg^(-1)作为金龙胶囊质控标准之一。研究可以为含动物类药材的中成药的质量控制提供参考。The quality control of Chinese patent medicines containing animal-derived crude drugs is relatively difficult,because the effective constituents of most animal-derived crude drugs remain unknown.Even if there are relevant methods,they are usually qualitative,and quantitative indicators are either lacking or have poor specificity.This paper has proposed to use molecular quantitative technology to control the quality of Chinese patent medicines containing animal-derived crude drugs.In this study,a molecular quantitative method based on fluorescence quantitative PCR was established for the determination of Jinqian Baihua She in Jinlong Capsule.The method has good specificity,sensitivity,and repeatability.There is a good linear relationship between the content of DNA fragments and the CT(cycle threshold)value.The content of the Bungarus multicinctus-specific fragment in Jinlong Capsule is 24.1-46.6 IU·mg^(-1).It is suggested that the content of the specific fragment of Jinqian Baihua She should not be less than 19.3 IU·mg^(-1)as one of the quality control criteria of Jinlong Capsule.The study can provide a reference for the quality control of Chinese patent medicines containing animal-derived crude drugs.

关 键 词：金钱白花蛇 银环蛇 金龙胶囊 分子定量 质量控制 实时荧光定量PCR 

分 类 号：R917[医药卫生—药物分析学]