摘要
目的通过胶塞相容性研究,分析影响注射用盐酸头孢替安溶液澄清度的因素,以便采取针对性措施提高药品质量。方法通过测定样品的浊度值及胶塞迁移出的指征性成分——抗氧剂2,6-二叔丁基对甲酚(BHT)的量,探讨胶塞成分迁移与药物澄清度的关系;通过胶塞相容性加速试验,讨论影响胶塞成分迁移的因素。结果浊度值与BHT迁移量、贮存时间显著正相关(P<0.01);头孢替安规格越小,胶塞对其澄清度影响越大(P<0.01)。影响胶塞成分迁移的因素为胶塞的质量、储存温度及放置状态。结论应通过提高胶塞质量或包装设计、降低贮藏温度、保持正置等措施以降低胶塞成分迁移,解决小规格产品澄清度不合格的问题。
Objective Through the compatibility study on rubber plug, to analyze the influences on clarity of Cefotiam Hydrochloride for Injection solution, in order to take corresponding measures to improve the quality of drugs. Methods By measuring the turbidity of the sample and the content of antioxidant 2, 6-butylated hydroxytoluene （BHT） that migrated out of rubber plug, the correlation between the rubber plug component migration and clarity of solution was explored. Results The turbidity value was positively related to BHT migration and storage time （P 〈 0.01）; Rubber plug effect on the clarification was larger when cefotiam specification is smaller （P 〈 0.01）. Factors affecting the component migration were quality of rubber plug, temperature, and drug placement status. Conclusion Through the improvement of the quality of rubber plug or packaging design, reducing the storage temperature, and keeping the drug placement status, the rubber plug component migration could be reduced, so as to solve the clarity unqualified problem of the small specification product.
出处
《药物评价研究》
CAS
2014年第5期420-423,共4页
Drug Evaluation Research
关键词
注射用盐酸头孢替安
胶塞相容性
浊度
2
6-二叔丁基对甲酚
Cefotiam Hydrochloride for Injection
compatibility between rubber closures and drug
turbidity
2, 6-butylated hydroxytoluene （BHT）
