三黄片的体外溶出度考察

A Study on in vitro Dissolution of Sanhuang Tablets

目的测定5个不同厂家(分别以代码A,B,C,D和E表示)三黄片的体外溶出度,为评价和控制药品质量提供依据和参考。方法以水为释放介质,用高效液相色谱法对不同厂家的三黄片的溶出度进行测定和比较。使用SPSS中的一般线性模型(general linear model)对不同厂家三黄片的体外溶出度进行多重比较。结果5个不同厂家相互之间的溶出度有显著差异(Sig.<0.01),只有厂家A和厂家B之间无显著差异(Sig.=0.945),厂家C和厂家E之间无显著差异(Sig.=0.238)。结论有必要对各个厂家的三黄片剂进行溶出度检查,以保证临床用药疗效。

Objective To determine the in vitro dissolution of Sanhuang Tablets from five different manufactures （ coded as A, B, C, D and E, respectively）. Methods The dissolution rates of Sanhuang Tablets were determined by HPLC, using distilled water as dissolution medium. The multiple comparisons were performed on the in vitro dissolution of Sanhuang tablets using SPSS General Linear Model. Results Five manufactures （ A,B ,C, D and E） differed significantly from one another in their dissolution（ Sig. 〈 0.01 ）, except between A and B（ Sig. = 0. 945 ）, between C and E（ Sig. = 0.238）. Conclusion It is suggested that the dissolubility of tablets from different manufactures should be tested to control the quality and ensure clinical efficacy.