摘要
目的探讨舒洛地特原料药的安全性。方法按2015年版《中国药典(四部)》通则方法及要求,对舒洛地特原料药过敏反应、降压物质和异常毒性检查法进行研究。结果舒洛地特原料药的过敏反应检查限值为500LSU/kg,降压物质检查限值为50LSU/kg,异常毒性检查限值为2000LSU/kg。结论该研究为制订舒洛地特质量标准提供了依据。
Objective To investigate the safety of active pharmaceutical ingredients(API)of sulodexide.Methods According to the requirements and methods of the general rule in the Chinese Pharmacopoeia(2015 edition,volumeⅣ),allergic response test,depressor substances test,and the abnormal toxicity test of API of sulodexide were studied.Results The limit value of allergic response test was 500 LSU/kg and the limit value of depressor substances test was 50 LSU/kg,the limit value of abnormal toxicity test was 2 000 LSU/kg.Conclusion This study can provide a basis for the formulation of the quality standard of sulodexide.
作者
张娟
魏霞
李水仙
祝清芬
ZHANG Juan;WEI Xia;LI Shuixian;ZHU Qingfen(Shandong Institute for Food and Drug Control,Jinan,Shandong,China 250101)
出处
《中国药业》
CAS
2019年第14期22-25,共4页
China Pharmaceuticals
关键词
舒洛地特
原料药
过敏反应
降压物质
异常毒性
安全性检查
sulodexide
active pharmaceutical ingredients
allergic response
depressor substances
abnormal toxicity
safety test
