70批29种超过3年无效期注射剂质量的研究  

Studies on the Qualities of 70 Batches of Injections Without Expiry Date and Exceeding Three Years From Production Date

作　　者：谢智勇[1] 谢冰玲[1] 董仲[1] 

机构地区：[1]湖南医科大学附属第三医院药剂科,长沙市410013

出　　处：《中国药房》1999年第6期276-277,共2页China Pharmacy

摘　　要：目的 :研究从临床抽出的70批29种已超过3年无效期注射剂的质量。方法 :检查70批注射剂的澄明度、性状 ,测定其中55批注射剂的pH值、35批注射剂的含量。结果 :澄明度、性状有14批不符合规定 ,pH值有2批不符合规定 ,检测的35批注射剂的含量都符合规定 ;总计抽检70批 ,16批不符合规定 ,不合格率为22 9 %。结论OBJECTIVE:To study the qualities of the 70 batches of injections without expiry date and exceeding three years from produced date.METHODS:To test the clarity and the property of the 70 batches of injections,the pH of 55 batches of injections,the contents of 35 batches of injections.RESULTS:The clarity and property of 14 batches,the pH of 2 batches did not meet standards,however,the content of the 35 batches tested was fit to standards.So,16 batches of the 70 batches tested did not meet standards.The unqualified rate was 22.9%.CONCLUSION:The supervision and management of the injection without expiry date should be tightened up.

关 键 词：注射剂 效期 质量 

分 类 号：R943[医药卫生—药剂学]