种顺铂注射制剂的稳定性研究
无菌分装粉末,,顺铂；注射剂；冻干粉针；无菌分装粉末；稳定性,1仪器与试药,2实验方法及结果,3讨论,参考文献
摘 要 目的 考察顺铂冻干粉针、顺铂无菌分装粉末及顺铂注射液的稳定性，为临床应用提供指导。方法 采用热、湿及光加速试验，以外观、主药含量、降解产物及pH值为重点考察指标，进行稳定性研究。结果 两种注射用顺铂粉针(冻干型及粉末型)的热、湿及光稳定性无明显差别(P>0.05)，但均明显优于顺铂注射液(P<0.05)。光对顺铂稳定性影响较热、湿更显著。结论 两种注射用顺铂粉针稳定性较好，顺铂注射液稳定性较差，临床应用应以注射用顺铂粉针为佳。关键词 顺铂；注射剂；冻干粉针；无菌分装粉末；稳定性
Stability study of three preparations of cisplatin injections
XIAO Hongjun,LUO Yun,LI Rongling
(Pharmacy Department, Remin Hospital of Wuhan University, Wuhan 430060,China)
Abstract Objective To investigate the stabilities of lyophilized powder of cisplatin for injection, sterile powder of cisplatin for injection, and cisplatin injections. Methods Heat, moisture and light acceleration tests were conducted in the stability tests with appearance, drug content, degradation products, and pH values as the major parameters. Results There were no significant differences among the heat, moisture, and light stabilities of lyophilized powder of cisplatin for injection and sterile powder of cisplatin for injection (P>0.05); and the stabilities of lyophilized powder of cisplatin for injection and sterile powder of cisplatin for injection is markedly better than that of cisplatin injections. The impact of light on the stability of cisplatin is larger than that of heat and moisture. Conclusion The stabilities of lyophilized powder of cisplatin for injection and sterile powder of cisplatin for injection is better than that of cisplatin injection, and lyophilized powder of cisplatin for injection and sterile powder of cisplatin for injection should be the preferential choices in clinical use. ......
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