关键词: font-size:medium, ">复方乙酰水杨酸片；溶出度；溶出曲线；高效液相色谱

Abstract: Objective： To establish a method for dissolution determination of compound acetylsalicylic acid tablets. Methods：The HPLC method was used to investigate the dissolution rate of compound acetylsalicylic acid tablets， using the hydrochloric acid solution(24 mL of dilute hydrochloric acid was diluted with water to a final volume of 1 000 mL) as the dissolution medium at the speed of 75 r·min-1. Results：R-values of the three linear equation for acetylsalicylic acid， caffeine and phenacetin were all 1.000. Relative standard deviation (RSD) values for reproducibility， stability (24 h) and durability tests were all lower than 2.0%. The average recovery of these three tests was 99.5%， 100.2% and 100.2%(RSD<1.0%， n=6)， respectively. The stripping system， sampling system and filter membrane didn′t have interference on the test. Among products from 9 manufactures， only one batch from one manufacture didn′t meet the regulation. Conclusion：The newly established method for dissolution determination of compound acetylsalicylic acid tablets can detect the difference between manufactures， thus supports the optimization of the product.

Key words: font-size:medium, ">Compound aspirin tablets； Dissolution； Dissolution curve； High performance liquid chromatography (HPLC)