中文摘要：

目的：制备20（S）-原人参二醇[20（S）-PPD]片,建立其含量测定及溶出度考察方法。方法：采用高效液相色谱法,C18色谱柱,乙腈-水（88∶12）为流动相,检测波长203 nm,流速1.0 mL.min-1,对样品中的20（S）-原人参二醇含量进行测定;并参照《中国药典》2010年版二部溶出度测定法第二法,以0.5%十二烷基硫酸钠水溶液为溶出介质,转速为100 r.min-1,对其进行体外溶出度考察,采用SAS软件非线性回归NLIN程序包中的Levenberg-Marquardt法进行迭代计算药物溶出度Weibull分布参数和特征溶出参数。结果：20（S）-原人参二醇的含量测定线性范围为20.4～1 020.0 mg.L-1（r=0.999 9）,平均回收率为97.0%,RSD为1.99%;溶出度方法学考察,含量测定线性范围为10.0～80.0 mg.L-1（r=0.999 9）,平均回收率为99.9%,RSD为2.13%,20 min即溶出完全;Weibull分布参数α位置参数为0.5 266,m形状参数为0.602 1,β尺度参数为2.387 2;特征参数Td为4.766 8 min,T50为2.834 7 min。结论：所建立的20（S）-原人参二醇片剂的含量测定和体外溶出度测定方法简便、准确、可靠,采用SAS系统可以简单快速的求解药物溶出度Weibull分布参数和特征参数。

英文摘要：

Objective：To prep 20（S）-PPD（protopanaxdiol） tablets,and establish the determination and in-vitro evaluation methods.Method：The determination method was established by HPLC,using C18 liquid chromatography column at a detecting wavelength of 203 nm,and acetonitrile-water（88： 12） as the mobile phase with flowing rate of 1.0 mL.min-1.The dissolution behavior of 20（S）-PPD tablets was investigated by paddle method（second method listed in Volume II of Chinese Pharmacopeia）,in the 0.5% SDS solution at the rotating rate of 100 r.min-1.The parameters of drug dissolution rate were treated with nonlinear regression by SAS software and iterated by Levenberg-Marquardt algorithm（LMA） to calculate Weibull ’s distribution parameters and characteristic dissolution parameters.Result：The linear range of HPLC determination was 20.4-1 020.0 mg.L-1（r= 0.999 9）,with the average recovery rate 97.0%（RSD 1.99%）.In the methodology study of dissolution,the tablets were completely dissolved in 20 min,with the linear range of 10.0-80.0 mg.L-1（r=0.999 9） and the average recovery rate 99.9%（RSD 2.13%）.In Weibull’s distribution analysis,the location parameter（α） was 0.526 6,the shape parameter（m） 0.602 1 and the scale parameter（β） 2.387 2.In characteristic dissolution profile,Td was 4.766 8 min and T502.834 7 min.Conclusion：The determination and in vitro evaluation methods is simple,exactly and reliable.SAS system is a convenient and rapid instrument to calculate Weibull’s distribution parameters and characteristic dissolution parameters.