胃舒散质控方法中含铋量标准的校正及秩和检验  

Correction and Rank Sun Test for Standard of Bismuth Subcarbonate Content in Quality Control of Weishusan

作　　者：郑奕辉[1] 张寓云[1] 周泽清[1] 郑宗茂[1] 

机构地区：[1]汕头大学医学院附属第二医院,汕头市515041

出　　处：《中国药房》2003年第6期360-361,共2页China Pharmacy

基　　金：广东省汕头市重点科技计划项目 (2001-55)

摘　　要：目的 :校正胃舒散含铋量标准。方法 :采用络合滴定法测定胃舒散以及3个对照品中有效铋的含量 ,并对胃舒散调整剂量后进行临床秩和检验。结果 :通过比较 ,胃舒散原来的含铋量较高。胃舒散中碱式碳酸铋投料量在处方工艺条件下减半为7 0kg。结论 :质量标准修订为每1 0g胃舒散含碱式碳酸铋0 10g(±10% )。OBJECTIVE:To correct the standard of bismuth content in Weishusan.METHODS:The contents of effective bismuth in Weishusan and other three reference substances were detected by compleximetry.After adjusting the dosage of Weishusan,clinical rank sum test was carried out.RESULTS:The content of bismuth in original formula of Weishusan was rather high,therefore the inventory of bismuth subcarbonate in preparation technic of Weishusan should be reduced to7.0kg.CONCLUSION:The quality standard should be reformulated as bismuth subcarbonate0.1g(±10%)in per gram of Weishusan.

关 键 词：胃舒散 铋 校正 秩和检验 质量标准 质量控制 中西药复方散剂 

分 类 号：R975[医药卫生—药品]