注射用门冬酰胺酶中可见异物检查方法改进的可行性探索  

Exploration on improvement of test method of visible particles in Asparaginase for Injection

作　　者：楼永军 王宇 左丽丽 何璐璐 艾婕 陈平平 谢升谷 倪维芳 LOU Yongjun;WANG Yu;ZUO Lili;HE Lulu;AI Jie;CHEN Pingping;XIE Shenggu;NI Weifang(NMPA Key Laboratory for Core Technology of Generic Drug Evaluation,Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China;Zhejiang university of technology,Hangzhou 310014,China)

机构地区：[1]浙江省食品药品检验研究院,国家药品监督管理局仿制药评价关键技术重点实验室,杭州310052 [2]浙江工业大学,杭州310014

出　　处：《中国药品标准》2020年第2期119-123,共5页Drug Standards of China

基　　金：国家药典委员会项目(国药典综发[2014]12号)——动植物来源等特殊品种注射剂中可见异物成因与控制示范性研究。

摘　　要：目的:了解目前注射用门冬酰胺酶中可见异物的基本情况,分析其产生的原因,并对其检查方法进行探索性研究。方法:对收集的不同来源注射用门冬酰胺酶,采用灯检法进行可见异物检查,对检测结果进行汇总分析;对存在乳光的样品,采用浊度仪测定其浊度值;同时重点考察各种影响因素(如光照、高温、高湿、复溶溶剂种类等)对可见异物形成的影响。结果:部分样品中检出有纤维状不溶物;部分样品复溶后呈现有乳光,其浊度值范围为2~20 NTU。影响因素分析发现高温对注射用门冬酰胺酶可见异物生成有较明显影响。结论:可以采用灯检法来检测注射用门冬酰胺酶中的“纤维状不溶物”,采用测定浊度值来解决注射用门冬酰胺酶中“乳光”判定问题。Objective:To investigate the origins of visible particles in Asparaginase for Injection and to establish the test method of visible particles.Methods:The visible particles in multiple batches of Asparaginase for Injection from different manufacturers were tested by lamp test method,and the test results were analyzed.The turbidity was tested with turbidimeter for the samples presenting opalescence.The effects of exogenous factors(such as light,temperature,humidity,types and volumes of different reconstitution solvents,etc.)on visible particles in Asparaginase for Injection were also investigated.Results:The fibrous insoluble substances were found in some samples,the opalescence appeared in some samples after reconstitution with the turbidity values of 2 to 20 NTU.The test results of exogenous factors showed that high temperature had a significant effect on formation of visible particles in the Asparaginase for Injection.Conclusion:The lamp test method can be used to detect the fibrous insoluble substances in Asparaginase for Injection.The turbidity value can be used to judge the opalescence in Asparaginase for Injection.

关 键 词：注射用门冬酰胺酶 可见异物 纤维状不溶物 乳光 外源性影响因素 

分 类 号：R921.2[医药卫生—药学]