双波长HPLC法测定穿心莲片的溶出度

Determination of in Vitro Dissolution Rate of Chuanxinlian Tablets by HPLC with Dual-wavelength Detection

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 develop a method for determining dissolution rate in vitro of Chuanxinlian tablets. Method： A dualwavelength HPLC system was employed, with detection wavelengths of 225nm and 254nm, anodrographolide and dehydroanodrographolide were simultaneously determined from dissolved tablets. The dissolution rate in vitro of different batches of Chuanxinlian tablets were tested, using stirring basket assemblies, with stirring rate of 100 r. min^-1 and medium of 0.2% SDS. Then dissolving parameters of T50 ,Td and m of these two compounds were calculated, and analyzed with variance test separately. Result： The dissolution rates of different batches of Chuanxinlian tablets at 45 minutes were all over 90%. Significant differences were not found in parameters of T50, Td and m （P 〉 0.05 ）. Conclusion： The method is simple and accurate. It can be used for the quality control of Chuanxinlian tablets.