对两个制剂品种钠盐鉴别试验的建议

Suggestion on sodium identification test of two drug products

目的:对丹参酮ⅡA磺酸钠注射液和碳酸氢钠滴耳液钠盐鉴别(2)试验结果进行分析,并对质量标准的修订提出建议。方法:分别对上述两个品种按照现行质量标准进行钠盐鉴别(2)试验,观察试验现象并分析原因。结果:丹参酮ⅡA磺酸钠注射液钠盐鉴别(2)试验最终生成棕红色沉淀,非焦锑酸钠白色致密沉淀。碳酸氢钠滴耳液处方中的甘油可溶解焦锑酸钠,因此钠盐鉴别(2)试验最终无法得到白色致密沉淀。上述两个品种的钠盐鉴别(2)均不呈正反应。结论:《中国药典》2015年版四部通则钠盐鉴别(2)不适用于上述两个品种,建议在质量标准中删去此鉴别项。

Objective:To analysis the results of sodium identification test(2)of sulfotanshinone sodium injection and sodium bicarbonate ear drop,and to propose a suggestion on the revision of specifications.Methods:Sodium identification test(2)of the above two drug products was performed based on their corresponding current specifications.The test phenomena were observed and the reasons were analyzed.Results:Sodium identification test(2)of sulfotanshinoneⅡA sodium injection yielded brownish red precipitate,but not white dense sodium pyroantimonate precipitate.Glycerol in sodium bicarbonate ear drop could dissolve sodium pyroantimonate and lead to a failure to form white dense precipitate.The sodium identification tests of the above two products did not yield the positive reaction.Conclusion:Sodium identification test(2)in general chapter of Chinese Pharmacopoeia 2015 is not applicable to sulfotanshinone sodium injection and sodium bicarbonate ear drop.It is recommended that the sodium identification test(2)is deleted from their corresponding specifications.