胆宁分散片中盐酸小檗碱溶出度测定方法的研究

Study on the determination method of dissolution rate of berberine hydrochloride in Danning Dispersible Tablets

目的建立胆宁分散片中盐酸小檗碱溶出度测定方法。方法照2005年版《中国药典》(二部)溶出度测定第二法,以脱气处理的人工胃液750mL为溶出介质,转速为75r.min-1,分别于5,10,25,45和60min取样。以高效液相色谱法进行含量测定,检测波长345nm。结果盐酸小檗碱在0.015 6～0.234μg范围内线性关系良好,线性方程为Y=5 533.2 X-15.543(r=0.999 8),平均回收率为98.40%,RSD为0.83%(n=6)。结论该方法简便、准确,可作为胆宁分散片溶出度检查方法,用于其质量控制。

Objective To establish a method for the determination of dissolution rate of berberine hydrochloride in Danning dispers-ible Tablets. Methods According to Appendix X C Ⅱ of Chinese Pharmacopoeia 2005 edition Vol. Ⅱ , the dissolution medium was 750 mL artificial gastric juice and the rotating speed was 75 r · min^-1. At 5,10,25,45,and 60 min,the dissolution samples were taken and analyzed by HPLC at 345 nm. Results Berberine hydrochloride was linear in the range of 0. 015 6-0. 234 μg,the regres-sion equation was Y=5 533.2X-15. 543 （ r=0. 999 8 ）, the average recovery was 98. 40%, and RSD was 0. 83 % （ n= 6 ）. Conclusion This method is simple and aeeurate,it could be used to determine the dissolution rate of berberine hydrochloride in Danning Disper-sible Tablets.