关于含有杂质的中药饮片假劣药定性的辨析

目的：探讨对含有杂质的中药饮片依法认定假劣药的标准，讨论如何结合具体案情、质量风险等对处罚措施进行综合裁量，确保患者用药安全。方法：汇总国家药品监管部门颁布的相关法规及标准、有关省份的炮制规范及相关规定，查阅相关文献，并结合笔者参与某个假劣药认定的专家会议切身体会，针对相关问题展开讨论，提出建议。结果：中药饮片的杂质超标原因比较复杂，导致的结果不尽相同，有的可能不影响安全性、有效性，有的则可能危害人体。我国关于中药饮片含有杂质案件的假药/劣药认定和处罚存在一定的模糊地带，各省的执行情况也不统一。结论：在严格查处生产、销售假药/劣药定性的基础上，规范适用条款的认定，严重的情形应当视为生产销售假药；对从轻处罚的情形实施涉案中药饮片召回；对生产销售的中药材实行分级管理；亟需确立杂质占比超过标准多少被认定为假劣药的处罚标准；并尽快制定全国统一中药饮片的炮制规范。

Discrimination on the Identification of Counterfeit and Inferior Drugs inChinese Herbal Pieces Containing Impurities

Objective: To explore the criteria for identifying counterfeit and substandard drugs in accordancewith the law for Chinese herbal pieces containing impurities, and to discuss how to implement comprehensivediscretionary penalties based on specifi c cases, quality risks, and other factors to ensure the safety of patients''medication. Methods: Summarize the relevant regulations and standards issued by the national drug regulatoryauthorities, as well as the processing norms and relevant regulations of the relevant provinces, consult theliterature, and combine the author''s participation in the expert meeting of a counterfeit and substandard drugidentifi cation, discuss the relevant issues and make recommendations. Results: The phenomenon of impuritiesexceeding the standard in Chinese herbal pieces is common. The reasons are complicated, and it leads to different results. Some of the excessive impurities may not affect the safety and effectiveness, and some may endangerthe human body. For all that there is a certain vague zone in the identification and punishment of counterfeit/substandard drugs in the case of Chinese herbal pieces containing impurities in China, and the implementation ofthe provinces is not uniform. Conclusion: On the basis of strict investigation and punishment of the productionand sale of counterfeit drugs/substandard drugs, the identifi cation of applicable provisions should be standardized.And serious cases should be regarded as production and sale of counterfeit drugs. In the case of light punishment,the recall of Chinese herbal pieces involved can be implemented. Hierarchical management can be used in theproduction and sales of Chinese medicinal materials. It is urgent to establish a penalty standard for determiningthe proportion of impurities exceeding the standard as counterfeit or inferior drugs. And the national processingstandards of Chinese herbal pieces should be established as soon as possible.