中药固体制剂溶出度研究与展望

溶出度试验是固体药物制剂的“灵魂”，在制药发达国家已得到高度重视，而中药制剂“重提取、重纯化、重分离、轻成型”。本文阐述中药固体制剂溶出度意义，抓住了这一点，就可“撬动”整个固体制剂行业和相关产业的发展；通过分析现行中药固体制剂溶出度评价的局限性，提出其质量控制评价的新模式。从化学和生物双重角度共同把关中药固体制剂溶出度，建立标准溶出谱，体现中医药的整体观，弥补现行“惟成分论”的中药质量控制和评价方法的不足。

Innovation and Development of Dissolution Testing for Chinese Medicine Solid Preparations

The dissolution testing is considered the soul of solid drug evaluation and used as an important tool for drug quality control in the developed countries. Chinese medicine solid preparations (CMSP) think highly of extraction, depuration and separation, but usually neglect the forming process. This study emphasizes the significance of the dissolution testing for CMSP, which serves as the foundation for the development of the pharmaceutical industry. Due to the complexity of the dissolution testing of CMSP, we develop a new evaluation method for controlling the quality of CMSP. That is to establish standard dissolution curves using the bioassay method combined with chemical analysis in vitro. This may provide a new approach for the holistic quality control of multiple constituents.