药物药剂学评价因素研究

Pharmaceutical Evaluation Factors of Clinical Drugs

目的:为构建药剂学评价的理论和方法奠定基础。方法:综合文献及经验,归纳并阐释包含制剂的合理性、质量的可控性及传输的有效性等方面的药剂学评价因素。结果:制剂的合理性包括剂型、规格及包装量的选择;质量的可控性包括活性成分、杂质、包装及稳定性;传输的有效性包括溶出度或释放度、装置包装。结论:该评价因素系统具有系统性、动态性及实用性。

OBJECTIVE： To lay a basis on constructing theory and method of the pharmaceutical evaluation. METHODS： By synthesizing the literature and experience, the authors summarized and explained the pharmaceutical evaluation factors which included rationality of preparations, quality controllability, and delivery efficacy etc. RESULTS： The factors of rationality of preparations included the choice of dosage form, specification and package amount; the factors of quality controllability included active constituent, foreign matter, package and stability, and the factors of delivery efficacy included dissolution or releasing degree and device packaging, CONCLUSION： This system of evaluation factors is systematic, dynamic and practical.