44个不同厂家复方丹参片的体外溶出度比较

目的: 比较44个厂家复方丹参片的溶出度,考察其质量。 方法: 采用浆法进行体外溶出度试验,转速50 r·min^-1,溶出介质600 mL。以高效液相色谱进行丹酚酸B的含量测定,计算其累计溶出百分率,并以MATLAB统计软件求解威布尔分布模型参数,用SPSS统计软件对各厂家T₅₀、T_d与崩解时限进行相关分析。 结果: 44个厂家复方丹参片的体外溶出差异大,各厂家T₅₀、T_d与崩解时限无显著相关性。 结论: 各厂应严格控制产品内在质量。

Objective: To compare the in vitro dissolution rates of Fufang Danshen tablets from 44 companies. Methods: The dissolution test was carried out with paddle method in dissolution medium at a volume of 600 mL.The rotating speed was 50 r·min^-1 and the content of salvianolic acid B was determined by HPLC.The accumulative dissolution percent was calculated and the distribution parameters of Weibull were solved by MATLAB curve fit toolbox.The interrelations among the T₅₀,T_d and disintegration time were discussed based on the correlation analysis by SPSS. Results: There were significant differences in the dissolution parameters of the Fufang Danshen tablets from 44 companies,and there was no correlation between T₅₀ and disintegration time or T_d and disintegration time. Conclusions: It is necessary to control the intrinsic quality of Fufang Danshen tablets.

1 ChP(中国药典).2010.Vol Ⅰ(一部):904
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