摘要：目的:筛选优化白首乌中C21甾体酯苷类成分的提取工艺及大孔树脂纯化工艺。方法:采用正交试验设计,以C21甾苷得率为指标,优化乙醇回流提取工艺;比较AB-8及HP-20型大孔树脂的吸附效果,并以纯化后C21甾苷收率及浸膏中甾苷的质量分数为指标,优选纯化工艺。结果:C21甾苷的最佳提取工艺为:6倍量90%乙醇提取3次,每次1h。AB-8型大孔树脂对C21甾苷有较好的吸附分离性能,优选的纯化工艺为:上样液质量浓度***-1,以6倍量80%乙醇洗脱,纯化后总甾苷含量可达46.91%。结论:优选工艺简单稳定,对C21甾苷提取精制效果好,可为其工业制备提供参考依据。

摘要：To compare the pharmacokinetics properties of enalapril-felodipine sustained-release tablet with enalapril and felodipine in the two reference formulations in Chinese healthy volunteers, the study was designed to a randomized, open label, crossover and two treatment pharmacokinetic study using enalapril-felodipine sustatined-release tablet as the test formulation. A total of 12 individuals were randomly assigned to 2 gorups （6 individuals in each group）. The wash-out period was 14 d. Compared with the reference formulations, felodipine in the sustained-release tablet showed significantly sustained-release characteristics, while the pharmacokinetics processes of enalapril and its active metabolite enalaprilat were basically similar in Chinese healthy volunteers.