注射用硫喷妥钠质量标准的探讨

目的:对注射用硫喷妥钠的质量标准进行探讨。方法:通过对注射用硫喷妥钠现有质量标准的分析,结合国外药典中本品种的质量标准及相关参考文献,对我国现行标准中"鉴别"、"检查"和"含量测定"项下等有待商榷和提高之处进行探讨。结果与结论:建议在"鉴别"项下增加红外光谱鉴别项、删减部分理化鉴别项,在"检查"项中用高效液相色谱法代替薄层色谱法对有关物质进行检查,在"含量测定"项中根据中国食品药品检验研究院提供的对照品情况进行相应修订。所提出的建议可为全面评价注射用硫喷妥钠的质量和完善其质量标准提供借鉴和参考。

Discussion on Quality Standard of Thiopental Sodium for Injection

OBJECTIVE：To discuss the quality standard of Thiopental sodium for injection（TSI）.METHODS：Through analyzing the current quality standard of TSI,combined with the quality standard of the variety stated in foreign pharmacopeia and related literatures.Some aspects of ＂identification＂,＂detection＂ and ＂content determination＂ need to be improved and were open to question.RESULTS CONCLUSIONS：It is suggested to add IR spectrometry and cancel physiochemical identification in term of ＂identification＂;HPLC instead of TLC for the detection of related substance in term of ＂detection＂;quality standard should be revised in accordance with substance control supplied by National Institute for Food and Drug Control.The suggestions provide useful reference for complete evaluation and the improvement of the quality standard of TSI.