处方药味均一化处理是减少不同批次中药制剂质量差异的有效方法。为推动均一化处理在中药制剂生产中的应用，通过对均一化研究的现状及相关要求进行回顾，进而对均一化的研究对象、前期准备、质量要求、计算方法、风险管理等进行讨论。此外，提出了中药制剂中药用物质的概念，认为保证药用物质的稳定是保证药品安全、有效的关键，就药用物质的均一化研究设想进行探讨，并提出以下建议：（1）以饮片为对象进行均一化投料，需关注待检饮片的同质性，设法保证检验抽样的代表性，必要时应增加取样包件数、包件内取样量，以减少抽样误差。（2）如中药新药处方中的饮片单独提取与混合提取对药品的安全性及有效性影响不大，可将饮片制成的提取物作为处方药味列入处方，并将饮片制成提取物的工艺列入提取物质量标准。（3）应根据制剂的质量目标、质量传递情况合理确定均一化需达到的质量要求，并结合品种特点（如给药途径、安全风险、成分特点及含量高低等）进行调整。（4）建议以制剂中的药用物质为均一化对象，开展探索性研究。如将其作为均一化对象，将比饮片更有利于减少不同批次中药制剂的质量波动；建议加强以多个处方药味合并提取得到的药用物质为均一化对象的研究，并就相关质量指标、质量要求、质量管理、风险控制等进行探索，积累经验，为今后以药用物质为对象进行均一化处理提供科学基础和管理基础。

It is an effective method to reduce the quality difference of different batches of traditional Chinese medicine (TCM) compound products by homogenizing the materials in the prescription. To facilitate the homogenization of TCM compound products, this paper reviews the researches about current situation and relevant requirements on homogenization of TCM compound products, it also discusses the homogenization in terms of prophase preparation, research object, quality requirements, calculation methods, risk management, etc. The concept of medicinal substances in TCM compound products is put forward in this paper, considering that the stability of medicinal substances is critical to ensure safety and effectiveness of drugs, and the idea of homogenization of medicinal substances is also discussed. Some suggestions are put forward as follows: (1) When decoction pieces are used as the object of homogenization, the homogeneity within the batches of decoction pieces intended for blending should be noticed. The representativeness of samples should be ensured. If necessary, the number of sampling packages and the amount of sampling within packages should be increased to reduce sampling errors. (2) If it shows little difference on the safety and effectiveness between new compound product made from multi-decoction pieces in individual extraction and that in together extraction, then each decoction piece could be extracted individually and their extracts could be separately listed in the prescription as ingredients in replacement of decoction pieces, meanwhile the quality standard including extracting process for each extract should be made as specifications. (3) Based on the objectives of quality and the transfer of quantity-value, the requirements on homogenization should be reasonably set and adjusted in consideration of characteristics and variety of specific product such as administration route, safety risk, the profile and contents of medicinal substances in products. (4) It is suggested to explore homogenization of TCM compound products based on medicinal substances, because controlling medicinal substances is more applicable than controlling decoction pieces for homogenization of a compound product. It is proposed to strengthen the research on the homogenization of medicinal substances extracted from combination of several decoction pieces, explore the relevant quality indicators, quality requirements, quality management, risk control, and accumulate experience, so as to provide a scientific foundation and regulatory foundation for the homogenization of medicinal substances in the TCM product in the future.

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