和辉胶囊的质量标准研究

Study on Quality Standard for Hehui Capsule

关键词:  和辉胶囊  质量标准  理化鉴别  薄层色谱  高效液相色谱

Key words:  Hehui capsule  quality standard  physical and chemical identification  TLC  HPLC

摘要:

目的 建立和完善和辉胶囊的质量标准。方法 利用盐酸-镁粉反应鉴定沙棘中的总黄酮；采用薄层色谱法对丹参中的丹参酮Ⅱ_A、荜茇中的胡椒碱以及制大黄中的大黄素分别进行鉴别；使用HPLC测定制剂中丹酚酸B的含量。结果 盐酸-镁粉反应呈阳性；薄层色谱斑点清晰，阴性对照无干扰；丹酚酸B在0.2029~1.622 9 μg内呈现良好的线性关系，r=0.999 8，平均加样回收率为98.83%，RSD为1.73%。结论 建立和完善的质量标准具有简便、可行、重复性好的特点，可用于该制剂的质量控制。

Abstract:

OBJECTIVE To establish and improve the quality standard for Hehui capsule. METHODS The total flavonoids in Hippophae rhamnoides were identified by hydrochloric acid-Mg reaction. The tanshinoneⅡ_A in Salvia miltiorrhiza Bge, the piperine in Piper longum, and the emodin in Rhubarb were identified by TLC, and the content of salvianolic acid B in the preparation was determined by HPLC. RESULTS The hydrochloric acid-Mg reaction was positive; the TLC spots were clear and the negative control had no interference. The salvianolic acid B showed a good linear relationship in the linear range of 0.202 9~1.622 9 μg, r=0.999 8, the average recovery rate was 98.83%, and RSD was 1.73%. CONCLUSION The established and improved quality standard is simple, feasible and reproducible, and can be used for the quality control of the preparation.