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目的:建立穿心莲片的溶出度测定方法。方法:以0.2%十二烷基硫酸钠溶液(SDS)为溶出介质,转速为100 r·min~(-1),双波长HPLC法同时检测穿心莲内酯和脱水穿心莲内酯,测定波长为225 nm、254nm。采用转篮法测定不同批号穿心莲片的体外溶出度,计算溶出参数T_(50)、T_d和m。结果:穿心莲片在45min时的溶出度均大于90%;对不同批号的样品溶出参数值进行方差分析,结果无显著性差异(P>0.05)。结论:该方法操作简便、准确可靠,可用于穿心莲片的质量控制。
Objective: To establish a method for the determination of the dissolution rate of Andrographis Tablet. Methods: A 0.2% sodium dodecyl sulfate (SDS) solution was used as the dissolution medium at a rotational speed of 100 r · min -1. Dual wavelength HPLC was used to simultaneously determine andrographolide and dehydroandrographolide at a wavelength of 225 nm, 254 nm. In vitro dissolution of different lots of Andrographis paniculata was determined by spin basket method. The dissolution parameters T_ (50), T_d and m were calculated. Results: The dissolution rates of Andrographis paniculata at 45 min were all over 90%. Analysis of variance of sample dissolution parameters with different lot numbers showed no significant difference (P> 0.05). Conclusion: The method is simple, accurate and reliable, and can be used for the quality control of Andrographis.