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本文通过对30种静脉用针剂不溶性微粒考察表明:每种静脉用针剂均含有不同粒径及数量的微粒。其中头孢唑林、头孢拉定、黄芪注射液、双黄连粉针等12种药物的微粒数量超过《中国药典》1995年二部静脉滴注用输液规定。提示生产厂家严格按GMP要求改善生产环境,提高产品质量。药典应增设对100ml以下静脉用针剂不溶性微粒的限量规定,同时还要求高精度的输液滤器用于临床,以确保用药安全。
In this paper, 30 intravenous injection of insoluble particles examination showed that: each intravenous injection contains different particle size and number of particles. Cefazolin, cefradine, Astragalus injection, Shuanghuanglian powder and other 12 kinds of drugs in the number of particles more than the “Chinese Pharmacopoeia” in 1995 two intravenous infusion regulations. Prompt manufacturers to strictly follow the GMP requirements to improve the production environment, improve product quality. Pharmacopoeia should be added to 100ml intravenous injection of insoluble particles limited provisions, but also requires high-precision infusion filter for clinical use, to ensure drug safety.