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目的:测定自制复方川脊片中原儿荼酸和芍药苷两种成分的溶出度。方法:采用《中国药典》2010年版二部附录XC第二法,以pH 6.8缓冲液为溶出介质,转速为50 r·min~(-1),HPLC法测定其溶出度。结果:复方川脊片中原儿茶酸和芍药苷分别在5.27～105.50(r=0.999 9),86.04～1 721.00μg·ml~(-1)(r=0.999 9)范围内线性关系良好,各组分平均回收率均在98.76%～99.85%之间,RSD均小于1.68%(n=6);3批样品在90 min溶出度均大于95%。结论:自制复方川脊片有较好的溶出度,本文建立的溶出度检测方法可作为该制剂的质控方法。
OBJECTIVE: To determine the dissolution of prochotrimic acid and paeoniflorin in homemade compound Chuangji tablets. Methods: The Chinese Pharmacopoeia (2010) edition, the second edition of Annex XC, the second method, the pH 6.8 buffer as the dissolution medium, the rotational speed of 50 r · min -1, HPLC determination of dissolution. Results: The concentrations of protocatechuic acid and paeoniflorin in Fufang Chuanji tablets were good in the range of 5.27-105.50 (r = 0.999 9) and 86.04-1,721.00 μg · ml -1 (r = 0.999 9) The average recoveries of the components ranged from 98.76% to 99.85%, and the RSDs were all less than 1.68% (n = 6). The dissolution rates of three batches of samples were all above 95% at 90 min. Conclusion: The self-made compound Chuanji tablets have good dissolution rate. The dissolution testing method established in this paper can be used as the quality control method of this preparation.