32种静脉用粉针剂药物的不溶性微粒考察

Studies on the Insoluble Particles of 32 Different Powdered Drugs forⅣInjection

本文通过对３２种静脉用粉针剂的考察表明，每种药均含有不同粒径及数量的不溶性微粒。其中青霉素钠等６种常用药物含≥１０μｍ的微粒已超标。提示生产厂家还应按ＧＭＰ要求改善生产环境，严格生产条件和管理措施，提高产品质量，确保用药安全。

The size and number of insoluble particles of 32 different powdered drugs for Ⅳ injection were determined. The results showed that the insoluble particles(≥6μm) in 6 drugs did not meet the requirement of Pharmacopeia of the People's Republic of China.It indicates that the pharmaceutical factories should further improve the technic and management of production and quality of products,so as to ensure the safety of drug use.