利用改良干酪素法对丹参注射液实现鞣质含量控制

Use of Modified Casein Method for Radix Salvia Miltiorrhiza Injection to Achieve Tannin Content Control

摘要: 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。

Abstract: OBJECTIVE Use of Modified Casein Method for Radix Salvia miltiorrhiza injection to achieve tannin content control, to ensure the quality of injection. METHODS Determination method of tannin in Chinese Pharmacopoeia (casein method) was improved by setting the suitable sample dilution ratio, establishing determination method of tannin in Danshen injection. RESULTS Modified determination method has achieved good results, tannin content is 0.83-2.06 mg·mL^-1 in commercial samples. CONCLUSION The requirements of Tannin limit is inconsistent in two limit tests in Chinese pharmacopoeia, tannin content determination in production control and quality inspection is of practical significance.