复方川脊片溶出度的测定

摘 要 目的:测定自制复方川脊片中原儿茶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。

Dissolution Determination of Compound Chuanji Tablets

Objective： To study the dissolution determination of protocatechuie acid and paeoniflorin in compound Chuanji tablets. Method： According to the Chp 2010 edition appendix XC （the second method）, buffer solution with pH of 6.8 was used as the dissolu- tion medium with rotation speed of 50 r . Min ^-1. Drug concentration was determined by HPLC. Result： Protocatechuic acid and paeoniflorin showed good linearity within the range of 5.27-105.50 （r = 0.999 9 ）and 86.04-1 721.00 μg ml^-1 （r = 0.999 9 ） , respectively. The average recoveries of the investigated compounds were within the range of 98.76%-99.85% with RSDs below 1.68% （n = 6）. The dissolution of 3 batches of samples was above 95% in 90 rain. Conclusion： The tablets have satisfactory dissolution characteristics. The method can be used for the quality control of compound Chuanji tablets.