CAJ | 학술논문

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。
목적：탐토중약주사제림상정맥배제용매선택합이성여안전성문제。방법통과검색국가식품약품감독관리총국망참수거고，대중국이상시중약주사제품충급용매선택진행분석회총。결과절지2013년12월31일，중국이상시중약주사제품충유134개，기중정맥적주품충유62개，설명서중용매선택추천0．9％록화납용액（생리염수）품충유6개，추천5％포도당용액（5％GS）품충유13개，추천10％포도당용액（10％GS）품충유6개，추천생리염수혹5％GS품충유12개，추천생리염수혹10％GS품충유2개，추천5％GS혹10％GS품충유7개，추천생리염수혹5％GS혹10％GS품충유4개，추천직접정맥적주품충유6개，추천불규범품충유6개。결론중국이상시중약주사제설명서규범성유대제고，림상정맥배제응주의용매선택문제，대우특수요구품충응특수대대。
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.