中药固体制剂均匀性问题分析

Analysis on Uniformity Problem of Chinese Materia Medica Solid Preparation

揭示中药固体制剂均匀性方面存在的问题,讨论问题产生的原因及问题带来的影响,为保证药物生产一致性提供参考。检索近10年来国内中药固体制剂均匀性相关文献报道,探讨中药固体制剂物理、化学、生物效应方面存在的均匀性问题,包括导致固体制剂均匀性差的原因,分析固体制剂不均匀对固体制剂有效性、安全性和可控性的影响。中药固体制剂在物理、化学、生物效应方面存在较大差异,这主要是由生产工艺引起的。固体制剂均匀性的问题主要由2个方面因素造成的:1不像液体制剂能通过简单的搅拌实现混匀,固体制剂混合、制粒、干燥、成型等过程中都可能导致制剂不均匀,且中药厂家制备工艺各异,流程及用量、设备、工艺参数各自为政,这导致不同厂家生产的药物存在化学和物理上的差异。2《中国药典》2015年版至今未对中药制剂的化学均匀性进行具体的规定,这导致了中药厂家很少关注均匀性的问题,也是市售中药固体制剂含量差异如此大的原因之一。固体制剂均匀性问题会影响药物有效性、安全性,必须引起重视。

This paper aims to reveal the existing problems of uniformity of Chinese materia medica solid preparation,discuss the causes and impact of problems,and provide the reference for consistency of the drug production. Through searching the literature reports about uniformity of solid preparations of Chinese medicine in the recent ten years,the problem of uniformity of Chinese materia medica solid preparation from the three aspects in physics,chemistry and biological effects were discussed,the causes of poor uniformity of solid preparation were discussed,the effect of effectiveness,safety and controllability of solid preparation that caused by ununiformity of solid were analysed. There were difference among solid preparations in physics,chemistry and biological effects,which mainly caused by the difference of production technics. Drug efficacy and safety were affeced by uniformity problems of solid preparation,and insiders should pay more attention to this problem.