医疗机构中药制剂质量标准处方中用药名称存在的问题探析

Analysis on the problems with names of TCM materials used in specifications of traditional Chinese medicine formulations in medical institutions

目的:为保证医疗机构中药制剂的质量、疗效和使用安全,探析医疗机构中药制剂处方中用药名称存在的问题、产生的原因、提出规范修订的建议及对策,旨在科学、规范医疗机构中药制剂质量标准处方中欠妥的用药名称。方法:考证分析云南中医集团调剂使用的中药制剂品种的质量标准处方中不科学、不规范的中药饮片名称和实际所指的中药饮片的品种和制品。结果:具有时代印迹的医疗机构中药制剂质量标准处方虽经过多次再注册和修订,但处方中的用药名称并未随着《中国药典》及地方标准的改版而及时修订,存在药物名称与实际用药和现行国家和地方标准不相符的情况。结论:因处方中药名称的问题,使得制剂生产面临着为保质量、疗效和使用安全而违规生产,或者放弃制剂的质量、疗效和使用安全的困境。本研究为确保中药制剂持续发挥疾病预防控制、中医特色服务的作用和优势,并为上级主管部门制定统一的标准提供依据和参考。

OBJECTIVE In order to ensure the quality,efficacy and safety of traditional Chinese medicine formulations in medical institutions,to explore the problems with names of TCM materials used in traditional Chinese medicine formulations in medical institutions and their causes,and to put forward suggestions and countermeasures for revision of their specifications,aiming at scientific standardization of inappropriate names of TCM materials used in specifications of traditional Chinese medicine formulations in medical institutions.METHODS The unscientific and informal names of decoction pieces of TCM materials used in the specifications of traditional Chinese medicine formulations for dispensing in Yunnan Traditional Chinese Medicine Group,and their varieties and products actually referring to,were examined and analyzed.RESULTS It was found that,although prescriptions in those specifications of traditional Chinese medicine formulations in medical institutions with the impression of the times had been re-registered and revised many times,the names of TCM materials used in the prescriptions were not revised in time with the revisions of the Chinese Pharmacopoeia and local standards,and noncompliance of TCM material names with actually used materials and current national and local specifications existed.CONCLUSION Because of the problem with names of TCM materials in prescriptions,the production of the formulations is faced with the dilemma of illegal production in order to ensure quality,efficacy and safety of use,or in order to ensure legitimate production by abandoning the quality,efficacy and safety of the formulations.This study provides reference and evidence for guarantee of sustainability of the role and advantages of traditional Chinese formulations within medical institutions for disease prevention and control and TCM-featured service,and development of standardized specifications by any upper level competent authority.