我国已上市中药注射剂说明书溶媒选择推荐

摘要

目的：探讨中药注射剂临床静脉配制溶媒选择合理性与安全性问题。方法通过检索国家食品药品监督管理总局网站数据库，对中国已上市中药注射剂品种及溶媒选择进行分析汇总。结果截至2013年12月31日，中国已上市中药注射剂品种有134个，其中静脉滴注品种有62个，说明书中溶媒选择推荐0．9％氯化钠溶液（生理盐水）品种有6个，推荐5％葡萄糖溶液（5％GS）品种有13个，推荐10％葡萄糖溶液（10％GS）品种有6个，推荐生理盐水或5％GS品种有12个，推荐生理盐水或10％GS品种有2个，推荐5％GS或10％GS品种有7个，推荐生理盐水或5％GS或10％GS品种有4个，推荐直接静脉滴注品种有6个，推荐不规范品种有6个。结论中国已上市中药注射剂说明书规范性有待提高，临床静脉配制应注意溶媒选择问题，对于特殊要求品种应特殊对待。%Objective To investigate the rationality and safety of the traditional Chinese medicine injections ( TCMIs) solvent choice in clinical practice.Methods Information about TCMIs from the website database of China Food and Drug Administration were classified and summarized.Results To December 31, 2013, there was a total of 134 varieties of TCMIs in the Chinese market, and of which 62 varieties were administered by intravenous drip, including 6 varieties dissolved in normal saline ( NS) , 13 varieties in a 5%glucose solution ( 5%GS ) , 6 varieties in a 10% glucose solution ( 10%GS ) , 12 varieties in either NS or 5%GS, 2 varieties in either NS or 10%GS, 7 varieties in either 5%GS or 10%GS, 4 varieties in either NS, 5%GS or 10%GS, and 6 varieties without dilution solvent, 6 varieties with incomplete description about solvent types and doses.Conclusions Most of the TCMIs instructions are under confusing condition, and attention should be put to the solvent choice in clinical venous configuration, especially individual varieties.