注射用炎琥宁质量标准可行性探讨

目的:探讨注射用炎琥宁质量标准的可行性。方法:选取13家厂家生产的注射用炎琥宁,采用高效液相色谱(HPLC)法和紫外分光光度法测定制剂中脱水穿心莲内酯琥珀酸半酯含量;采用HPLC和薄层色谱(TLC)法对制剂进行有关物质检查。比较各检测方法的可行性。结果:HPLC法测定含量能将主成分与降解产物分开;制剂的有关物质按不同检验方法测定的结果差异较大,TLC法在检测限及准确性上均不及HPLC法。结论:个别企业产品质量有待进一步提高,注射用炎琥宁质量标准有待进一步完善。

Feasibility of the Quality Standard of Potassium Sodium Pehydroandroandrographolide Succinate for Injection

OBJECTIVE： To study the feasibility of the quality standard of Potassium sodium pehydroandroandro- grapholide succinate for injection. METHODS： The contents of dehydroandyograpolide succinate in Potassium sodium dehydroandrograpolide succinate for injection from 13 manufacturers were determined by HPLC and UV spectometry.The related substances of all the samples were determined by HPLC and TLC, respectively. The feasibility of different assaying methods was compared. RESULTS： Determined by HPLC assay, the principal constituent and the degradation products could be separated. There were significant differences between different assaying methods in the determination results of the related substances of samples; TLC assay was inferior to HPLC in respect of the limit of quantitation and accuracy. CONCLUSION： The quality in a few enterprises remains to be improved and the quality standard of Potassium sodium pehydroandroandrographolide succinate for injection remains to be further improved.