江苏省传统中药制剂备案现状及向中药新药转化的探讨

目的：为促进我省医疗机构应用传统工艺配制中药制剂（以下简称传统中药制剂）备案及传统中药制剂向中药新药转化提供参考。方法：统计分析江苏省传统中药制剂备案系统中医疗机构中药制剂备案数量、剂型分布、主要问题等。结果：传统中药制剂备案实施以来，备案申请每年多在35～40件之间；合剂、颗粒剂、胶囊剂占总申请的81.1%；委托配制占31.4%；从申报资料看，备案研究和资料准备均有较多问题。结论：我省传统中药制剂备案积极性不高；认识不足、能力薄弱和临床医生和药学人员之间缺乏相互沟通和支持影响备案；修订备案程序、完善技术指导原则，逐步推动中医药理论、人用经验和临床试验相结合证据体系在传统中药制剂备案中的运用，为传统中药制剂向中药新药转化打下基础。

Discussion on the Filing Status of Traditional Chinese Medicine Preparations in Jiangsu Province and the Transformation of Traditional Chinese Medicine Preparations to New Chinese Medicine Drugs

Objective: To provide reference for promoting the application of traditional technology in the preparation of traditional Chinese medicine preparations (hereinafter referred to as traditional Chinese medicine preparations) in medical institutions in our province, and for the transformation of traditional Chinese medicine preparations into new Chinese medicine drugs. Methods: The number, dosage form distribution and main problems of traditional Chinese medicine preparations in medical institutions in the Jiangsu Traditional Chinese Medicine Preparations Recording System were statistically analyzed. Results: Since the implementation of the filing of traditional Chinese medicine preparations, the number of filing applications has been between 35 and 40 per year. Mixture, granules and capsules accounted for 81.1% of the total applications. Entrusted preparation accounted for 31.4%. From the declaration data, there are many problems in research and data preparation. Conclusion: The enthusiasm of filing traditional Chinese medicine preparations in our province is not high. Lack of awareness, weak ability and lack of mutual communication and support between doctors and pharmacists are factors affecting the filing. Revising the filing procedure, improving the technical guiding principles, and gradually promoting the application of the evidence system combining traditional Chinese medicine theory, human experience and clinical trials in the filing of traditional Chinese medicine preparations, will all lay the foundation for the transformation of traditional Chinese medicine preparations into new Chinese medicine drugs.