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目的利用改良干酪素法对丹参注射液实现鞣质含量控制,以保证注射液的质量。方法通过对中国药典中鞣质含量测定方法(干酪素法)进行改良,设定了适宜的样品稀释比例,建立了丹参注射液的鞣质含量测定方法。结果测定方法的改良取得了良好的效果,所测市售样品鞣质含量在0.83~2.06 mg.mL 1之间。结论鞣质限度检查两法的限度要求不一致,鞣质含量测定在生产控制及质量考察中具有实际意义。
Objective To improve the quality of injection by using modified casein method to control the content of tannin in Salvia miltiorrhiza injection. Methods The method of determination of tannin content in Chinese Pharmacopoeia (casein method) was modified, and the appropriate sample dilution ratio was set up to establish a method for the determination of tannin content in Salvia miltiorrhiza injection. The results of the determination of improved methods have achieved good results, the measured commercial samples tannin content of 0.83 ~ 2.06 mg.mL 1 between. Conclusions There are inconsistent limits for the two methods of tannin testing. The determination of tannin content is of practical significance in the production control and quality inspection.