大容量注射液长期稳定性考察及分析  

Inspection and analysis on long-term stability of large volume injection

作　　者：林伊梅[1] 马亮英[1] 郑立明[1] 王震峰[1] 

机构地区：[1]新疆医科大学第二附属医院药剂科,新疆乌鲁木齐830028

出　　处：《新疆医科大学学报》2004年第5期441-442,共2页Journal of Xinjiang Medical University

摘　　要：目的 :探讨大容量注射液含量、pH值及有关质量重点考察项目随时间变化的规律 ,为其有效期的确定提供科学的依据。 方法 :测定大容量注射液在 6个时间段的重点考察项目 ,并进行统计学分析。 结果 :含糖大容量注射液的 5 羟甲基糠醛 (5 HMF)量在 6个时间段的差异有统计学意义 (P <0 .0 1) ;含 0 .9%氯化钠的大容量注射液的pH值在 6个时间段的差异也具有统计学意义 (P <0 .0 1) ;其它项目在 6个时间段内的差异均无统计学意义 (P >0 .0 5 )。 结论 :含糖大容量注射液的 5 HMF量和含 0 .9%氯化钠的大容量注射液的 pH值随着贮存时间的延长而发生改变 ,在确定大输液有效期时要考虑此变化。Objectives: In order to provide scientific basis of confirming expiry of large volume injection, to discuss the variation rule of content, pH, and other key inspection item with time. Methods: To determine the key inspection item related to quality and to statistic analysis the results. Results: There is a significant difference on 5-HMF in large volume injection glucose contained within 6 months (P<0.01). There is a significant difference on pH of large volume injection sodium chloride contained within 6 months (P<0.01). There is no significant difference on other inspection items (P>0.05). Conclusion: The 5-HMF of large volume injection glucose contained and the pH of large volume injection sodium chloride contained varied with storage time. The results indicate that the variation of 5-HMF and pH will be considered while confirming expiry of large volume injection.

关 键 词：大容量注射液 稳定性 葡萄糖 氯化钠 

分 类 号：R944.1[医药卫生—药剂学] R927.11[医药卫生—药学]