中药丹参及其制剂心宁片丹参素质量控制研究

Investigation on the quality control of tanshinone in Chinese materia medica salvia miltiorrhiza and its preparation of Xinning tablets

目的 通过对中药丹参及其制剂心宁片中丹参素质量控制研究,有效指导中药制剂心宁片生产,保障其质量。方法 采用高效液相色谱法。色谱柱为迪马C_(18)(150 mm×4.6 mm,5μm),流动相为甲醇-0.6%的醋酸溶液(5∶95),流速为1.0 ml/min,检测波长为280 nm,柱温25℃。结果 丹参素钠在0.020 77~0.207 73 mg/ml线性范围内呈良好线性关系,R^(2)=0.999 95,丹参药材及其制剂心宁片丹参素钠平均回收率分别为95.2%、93.4%,相对标准偏差(RSD)分别为1.30%、1.93%。结论 该方法操作简便、准确、可靠,可用于丹参药材及其制剂心宁片中丹参素含量检测,有效控制心宁片中丹参素质量,并指导生产。

Objective To effectively guide the production of Chinese materia medica preparation of Xinning tablets and ensure its quality through the investigation on the quality control of tanshinone in Chinese materia medica salvia miltiorrhiza and its preparation of Xinning tablets.Methods High performance liquid chromatography was adopted.The chromatographic column was Diamonsil C 18(150 mm×4.6 mm,5μm).The mobile phase was methanol-0.6%acetic acid solution(5∶95),the flow rate was 1.0 ml/min,the detection wavelength was 280 nm,and the column temperature was 25℃.Results The sodium tanshinone has a good linear relationship within the linear range of 0.02077-0.20773 mg/ml,with R^(2)=0.99995.The average recoveries of sodium tanshinone in Chinese materia medica salvia miltiorrhiza and its preparation of Xinning tablets were 95.2%and 93.4%respectively,with their RSD of 1.30%and 1.93%respectively.Conclusion The method is simple,accurate and reliable,and can be used to detect the content of tanshinone in Chinese materia medica salvia miltiorrhiza and its preparation of Xinning tablets.It can effectively control the quality of tanshinone in Xinning tablets and guide the production.