Assesment of Adulterated Traditional Chinese Medicines in China: 2003-2017
Assesment of Adulterated Traditional Chinese Medicines in China: 2003-2017
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DOI：
10.3389/fphar.2019.01446
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发表时间：
2019-11-29
影响因子：
5.6
通讯作者：
Shi, Luwen
中科院分区：
文献类型：
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作者：
Xu, Mingzhe;Huang, Baobin;Shi, Luwen
传统中医（tcm）是补充和替代医学的一种形式。生产的普及性和复杂性使它们具有吸引力，并且在从种植到生产的各个阶段容易掺假。掺假是指添加了不应该存在于中药中的外来的、不适当的或劣质的成分。为了检测和打击掺假中药，补充检测方法（STMs）扩大了常规检测标准的能力，自2003年以来一直在中国应用。从2003年到2017年，中国国家药品监督管理部门共批准了184个中药制剂。通过评估这些中药材，本研究旨在确定易掺假的中药材，列出常见的掺假成分，并对分析技术进行表征。结果表明，中药掺假主要分为三大类：添加未申报的药品/化学物质、以非药物成分替代、添加外来非药物原料。中药材易掺假的前五大治疗领域分别是糖尿病、镇静睡眠、性功能障碍、止痛和风湿病。本研究共检出掺假中药制剂和中药制品166种，其中中药制剂158种，中药制品43种，共有35种。每个STM由不同的药物分析技术组成，包括物理化学性质、色谱、光谱技术和质谱测试。STMs的分析方法依赖于这些技术的组合，其中HPLC技术的比例最高（76.1%），物理化学技术的比例最低（11.4%）。这项研究表明，中药材在打击掺假中药中发挥了至关重要的作用。然而，stm仅仅代表了一种以产品测试为中心的监管策略。还应加强对种植和生产过程的检查。更重要的是，应提高中药生产企业在实施良好生产规范和规范原料种植栽培方面的意识和自律。
Traditional Chinese medicines (TCMs) represent one form of complementary and alternative medicine. The popularity and complexity in production make them attractive and vulnerable to adulteration in stages ranging from planting to production. Adulteration refers to the addition of extraneous, improper, or inferior ingredients that should not be present in TCMs. To detect and combat adulterated TCMs, supplementary testing methods (STMs), which expand the capability of routine testing standards, have been applied in China since 2003. From 2003 to 2017, a total of 184 STMs for TCMs were approved by the Chinese national drug regulatory authority. By assessing these STMs, this research intends to identify those TCMs vulnerable to adulteration, to list common adulterants, and to characterize the techniques of analysis. The results show that adulteration of TCMs can be classified into three main categories: the addition of undeclared drugs/chemical substances, substitution with non-drug components, and the addition of foreign non-drug materials. The top five therapeutic areas of TCMs vulnerable to adulteration are diabetes, calm and sleep, sexual dysfunction, pain relief, and rheumatism. A total of 166 adulterants were detected in the adulterated TCM preparations and herbal products studied here, with 158 adulterants in TCM preparations and 43 in herbal products, with 35 adulterants in common. Each STM consists of different pharmaceutical analysis techniques, including tests for physical-chemical properties, chromatography, spectroscopic techniques, and mass spectrometry. The analytical methodology of STMs relies on the combination of these techniques, with HPLC ranking the highest percentage (76.1%) and physical-chemical techniques the lowest percentage (11.4%). This research shows that STMs have played a crucial role in combating adulterated TCMs. However, STMs represent merely a product testing-centered regulatory strategy. The inspection of cultivation and manufacturing processes should also be strengthened. More importantly, the awareness and self-discipline of TCM manufacturers in implementing good manufacturing practices and regulating the planting and cultivation of raw materials should be improved.