丹酚酸胶囊的制备与临床应用

Preparation and Therapeutic Effect of Salvianolic Acid Capsule

目的:制备丹酚酸胶囊并观察该制剂治疗冠心病的临床疗效。方法:采用水提醇沉、大孔树脂吸附等方法提取丹参中的总丹酚酸,采用HPLC法测定该制剂中丹酚酸B的含量,对56例患冠心病患者进行疗效观察。结果:该制剂丹酚酸B含量测定的回收率为98．5％-102．0％,RSD为1．44％。治疗心绞痛的总有效率为85．7％。结论:该制剂制备工艺合理,质量稳定,疗效确切。

Objective： To study the preparation technology and quality control method of salvianolic acid capsule. To observe the clinical effect on treating coronary artery disease. Method： Salvianolic acid was extracted from Salvia miltiorrhiza Bunge by means of aqueous extraction-alcohol precipitation and absorption of macroporous resin. The content of salvianolic acid B in the capsule was determined by HPLC. 56 patients with coronary artery disease were enrolled and the therapeutic effect of the capsule was observed. Result： The recovery rate for salvianolic acid B was 98.5%-102.0% and RSD was 1.44%, the RSD of the reproducibility was 1.44%. The total effective rate of coronary artery disease therapy was 85.7%. Conclusion： The preparation technology is easy. The preparation quality is stable and the curative effect is reliable.