心可宁胶囊质量标准研究

Quality Standard for Xinkening Capsule

目的建立心可宁胶囊的质量标准,以提高其质量标准。方法采用薄层色谱法对方中主要药味丹参、牛黄、蟾酥、红花、三七、人参须进行定性鉴别研究,采用高效液相色谱法测定方中丹参酚酸B含量。结果薄层色谱图谱清晰,专属性强,重现性好;HPLC法测定丹酚酸B含量在0.144μg^1.44μg范围内线性关系良好[0](r=0.9997,n=6),平均回收率为101.2%(RSD=2.1%,n=6)。结论该方法快速简便,专属性强,重现性好,能有效地控制药品质量。为完善心可宁胶囊的质量标准提供了依据。

Objective To establish the quality standard for Xinkening capsule.Method Medicines in this description were identified by TLC.The content of salvianolic acid B which is the effective substance in the preparation was determined as the index by HPLC.Results Medicines could be detected by TLC from three batches of samples.The linear correlation of the salvianolic acid B is good in extent of 0.144μg～1.44μg and the average recovery rate is 101.2%（RSD=2.1%,n=6）.Conclusion The quality control is feasible and can be applied to control the products from mass production.It can ensure the stability of the pharmaceutical quality.