复方风湿宁注射液质量稳定性研究  

Study on the Stability of Compound Fengshining Injection

作　　者：黄炜忠 邓敏 张清民 

机构地区：[1]广东罗浮山国药股份有限公司质量部,广东惠州516133

出　　处：《广东化工》2016年第9期90-92,30,共4页Guangdong Chemical Industry

摘　　要：目的研究复方风湿宁注射液的质量稳定性。方法本研究通过在特殊条件(-35℃;25±2℃,相对湿度60±5%;40℃±2℃,相对湿度75%±5%;60℃±2℃,相对湿度75%±5%)及常温条件下放置三批复方风湿宁注射液,按计划取样进行全检,项目包括:性状、p H、含量测定等。结果在上述四种贮存条件下,各项考察内容均符合规定。结论结果表明复方风湿宁注射液在高温、高湿或低温等条件下贮存,质量稳定。OBJECIVE Study on the Stability of the Compound Fengshining Injection. METHODS In the study, stored three batches of Compound Fengshining Injection in special conditions（-35 ℃; 25±2 ℃, RH 60±5 %, 40 ℃±2 ℃, RH 75 %±5 %; 60 ℃±2 ℃, RH 75 %±5 %）and ambient temperature, and tested the samples on plan, with the characters, the p H, the content and so on. RESULTS On these four storge conditions, various index accorded with the regulation. CONCLUSION The results show that Compound Fengshining Injection is stable by stored at high temperatures, high humidity or low temperature and other conditions.

关 键 词：复方风湿宁注射液 稳定性 

分 类 号：TS262.5[轻工技术与工程—发酵工程]