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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。
Objective: To prepare 20 (S) - protopanaxadiol [20 (S) -PPD] tablets and to establish a method for the determination of its content and dissolution. Methods: High performance liquid chromatography (HPLC) with C18 column and acetonitrile-water (88:12) as the mobile phase was used. The detection wavelength was set at 203 nm and the flow rate was 1.0 mL.min-1. Alcohol content determination; and reference to “Chinese Pharmacopoeia” 2010 edition two dissolution assay second method, 0.5% sodium dodecyl sulfate aqueous solution as the dissolution medium, speed of 100 r.min-1, its in vitro Dissolution was investigated using the Levenberg-Marquardt method in NLIN package of SAS software for iterative calculation of drug dissolution Weibull distribution parameters and characteristic dissolution parameters. Results: The linear range of 20 (S) - protopanaxadiol was 20.4-1 020.0 mg.L-1 (r = 0.999 9) with an average recovery of 97.0% and a RSD of 1.99% , The linear range was 10.0-80.0 mg.L-1 (r = 0.999 9), the average recovery was 99.9% and the RSD was 2.13%, which was completely eluted in 20 min. The Weibull distribution parameter α possessed a position parameter of 0.5 266 m The shape parameter is 0.602 1, the β-scale parameter is 2.387 2, the characteristic parameter Td is 4.766 8 min and the T50 is 2.834 7 min. Conclusion: The established 20 (S) - protopanaxadiol tablet has a simple, accurate and reliable method for the determination of dissolution and dissolution in vitro. SAS system can be used to solve the Weibull distribution parameters and characteristic parameters of drug dissolution easily and quickly.