摘要
目的：国产地高辛片长期以来存在着生物利用度差的问题，为此杭州民生药厂进行了工艺改进。方法：以英国Ｌａｎｏｘｉｎ片为对照，采用荧光偏振免疫分析法测定了８名健康男性受试者口服单剂量０．５ｍｇ地高辛片的药时数值，经ＰＫＢＰＮ１程序拟合，计算其药动学参数。结果：国产和进口的Ｃｍａｘ分别为３．０±０．６ｎｇ·ｍｌ－１和２．５±０．５ｎｇ·ｍｌ－１；Ｔｍａｘ分别为１．１±０．６ｈ和１．１±０．４ｈ；ＡＵＣ分别为３７．９±４．２ｎｇ·ｈ·ｍｌ－１和３７．２±６．１ｎｇ·ｈ·ｍｌ－１；杭州民生药厂工艺改进后的片剂相对生物利用度为１０３．８％±１７．０％。结论：国产片与进口片地高辛完全等效。这为临床应用提供参考。
OBJECTIVE:To compare the bioavailability of two digoxin tablets.METHODS:Digoxin concentration in human serum was determined by FPIA.A single 0.5 mg oral administration of domestic digoxin tablet and lanoxin tablet was given to 8 healthy male volunteers.The pharmacokinetic parameters of digoxin was simulated by PKBP N1.RESULTS:The pharmacokinetic parameters of digoxin of the two products were: C max 3.0 ± 0.6 ng·ml -1 and 2.5 ± 0.5 ng·ml -1 , T max 1.1 ± 0.6 h and 1.1 ± 0.4 h respectively.Relative bioavailability of domestic digoxin tablet was 103.8% ± 17.0% .CONCLUSIONS:The bioavailability of domestic digoxin tablet was bioequivalent to lanoxin tablet.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
1999年第1期3-5,共3页
Chinese Journal of Hospital Pharmacy
