浅论中药材、中药饮片制订有效期的必要性

目的:敦促国家相关管理部门尽快制订、出台关于中药材、中药饮片有效期的相关规定。方法:分析药品、药品有效期、劣药的定义,药品在流通和使用中管理难、药监人员执法难、患者维权难的原因所在以及社会对食品、药品保质期的重视情况。结果与结论:制订中药材、中药饮片的有效期是中药质量标准化的重要内容。可借鉴西药和国外对植物药有效期的评定方法,结合中药特性及传统的保管、贮存经验,制订符合中药本身特点的安全有效期。

Necessity of Establishing Effective Drug Duration for Chinese Medicinal Materials and Chinese Medicinal Decoction Pieces

OBJECTIVE:To urge the concerned governmental management department to work out and issue the related regulation on the effective drug duration(EDD)of Chinese medicinal materials and Chinese medicinal decoction pieces. METHODS:We analyzed the definitions of drugs,EDD,and inferior drugs,the difficulty in the management of medicines in the process of circulation and use,the difficulties for drug supervisors to enforce the law and for patients to safeguard their legal interest,and the attention of society paid to the EDD of food and medicines.RESULTS & CONCLUSION:Establishing EDD Chinese medicinal materials and Chinese medicinal decoction pieces is a key for the quality standardization of traditional Chinese medicines.It is advisable to establish safe EDD tailored to the characteristics of Chinese medicinal materials by drawing expe- riences from abroad regarding the EDD evaluation method of the western medicines and plant amedica and combining the characteristics of Chinese medicinal materials together with the experiences in the storage and stockpile.