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。
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.
出处
《广东药学院学报》
CAS
2005年第1期32-33,共2页
Academic Journal of Guangdong College of Pharmacy
