Pharmacokinetic Study on Lovastatin Sustained-release Tablet and Sustained-release Capsule in Begal Dogs

This study pharmacokinetically examined the lovastatin sustained-release tablet and sustained-release capsule in Beagle dogs. An reversed-phase HPLC method was established for the determination of lovastatin in Beagle dog plasma. Pharmacokinetic findings were compared among three preparation(lovastatin sustained-release tablet,T p; sustained-release capsule,T J and conventional capsule). Our results showed that the pharmacokinetic parameters in 6 dogs after single-dose oral administration of three perparations were calculated. T max, C max and MRT revealed significant difference (P<0.05). Relative bioavailability was 111.5±16.9 % (T P) and 110.4%±9.6 % (T J). The pharmacokinetic parameters in the 6 dogs after multiple-dose oral administration of three perparations, T max, C max MRT and DF had significant difference (P<0.05); C av , C min and AUC 0-24 h displayed no significant difference (P>0.05). It is concluded that the lovastatin sustained-release tablet and sustained-release capsule are able to maintain a sustained-release for 24 h.

固骨缓释胶囊有效部位的提取纯化

目的:优选固骨缓释胶囊中淫羊藿、骨碎补有效部位提取和分离纯化工艺的最佳条件。方法:以淫羊藿苷、柚皮苷、干膏收率(%)为指标,采用正交试验法考察最佳提取和分离纯化工艺,用HPLC法测定目标成分含量。结果:最佳渗漉工艺为过3号筛的粗粉以80%乙醇浸泡12h,流速为5mL·min^(-1)(以1kg药材计),渗漉量为6倍量;最佳精制工艺为加入1.5%活性炭,调pH值为1～2,加入8%食盐。结论:该最佳纯化工艺条件得到的结果稳定,活性成分含量高,可以用于工业生产。