《中国药典》中药固体制剂水分控制标准提升及关键问题探析

中药固体制剂是临床广泛运用的剂型,由于其制剂原料的特殊性而具有易吸潮的问题,导致制剂性状改变,甚或霉变和有效成分损失,进而影响产品质量和疗效,水分超标是制约中药现代化的关键因素之一,水分控制对于中药固体制剂的安全有效至关重要。对历版《中国药典》收录的不同类型中药固体制剂水分控制的标准变迁进行分析,基于质量源于设计的制剂理论,围绕水分控制策略、分析检测技术、制剂工艺环节等影响中药固体制剂含水量的关键问题,研究及探析中药固体制剂现代化进程中水分控制的现状及存在问题,以期为中药固体制剂的开发和应用提供参考。

Discussion on promotion and key issues of water control criteria for solid preparation of traditional Chinese medicine in Chinese Pharmacopoeia

Solid preparation of traditional Chinese medicine (TCM) is a widely used dosage form in clinical practice. However, due to the particularity of its raw material, it is easy to absorb moisture, leading to the change of preparation properties, or even mildew and loss of active ingredients, which in turn to affect the quality and efficacy of products. Therefore, excessive water content is one of the key factors restricting the modernization of TCM, and water content control is very important for the development of solid preparation of TCM. In this paper, the variation of water control standards for solid preparation of TCM in different versions of Chinese Pharmacopoeia was focused and analyzed. Based on the preparation theory of quality by design (QbD), the present situation and problems of water control in the modernization process of solid preparation of TCM are systematically researched and discussed in three key points including water control strategy, analysis techniques, and preparation process, which can provide the basis for development and application of solid preparation of TCM.