药用辅料二甲基亚砜质量标准研究

Comparative Study on Quality Standards of Medicinal Excipients Dimethyl Sulfoxide

目的提高和完善我国药用辅料二甲基亚砜质量标准。方法参考现行各国标准要求,从凝点、氢氧化钾变深物和有关物质等方面进行研究。结果各国凝点标准规定难以协调,建议对凝点项目不进行控制,或者参考二甲基亚砜国内化学试剂(优级品)标准(GB/T21395-2008),修订为"不低于18.10℃"。氢氧化钾变深物检查项检测的目标物质不明确,建议删除该项目。改进有关物质的测定方法,在该色谱条件下,二甲基亚砜中各杂质能完全分离。结论拟定的药用辅料二甲基亚砜质量标准能更好的控制二甲基亚砜质量。

OBJECTIVE To improve the quality standards of China′s pharmaceutical excipients dimethyl sulfoxide.METHODS Refer to the current Chinese Pharmacopoeia 2015 edition of the four editions,the United States Pharmacopoeia 40 edition and the European Pharmacopoeia 9.0 edition and other quality standards,from the point of condensation,potassium hydroxide deepening and related substances.RESULTS It is difficult to coordinate the national standards for freezing points.It is recommended that the freezing point project be not controlled,or refer to the dimethyl sulfoxide domestic chemical reagent(excellent grade) standard(GB/T21395-2008),and revised to"not less than 18.10℃".The target substance detected by the potassium hydroxide deepening inspection item is not clear,and it is recommended to delete the item.The method for determining the substance is improved,and under the chromatographic conditions,each impurity in dimethyl sulfoxide can be completely separated.CONCLUSION The proposed pharmaceutical excipient dimethyl sulfoxide quality standard can better control the quality of dimethyl sulfoxide.