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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，也为药品的国际接轨提供依据
OBJECTIVE: Domestic digoxin tablets have long had the problem of poor bioavailability. To this end, Hangzhou Minsheng Pharmaceutical Factory has made technological improvements. Methods: The British Lanoxin tablets as a control, fluorescence polarization immunoassay was used to measure the oral dose of a single dose of 0.5mg digoxin tablets of eight healthy male subjects, by PKBP N1 program fitting to calculate the drug Dynamic parameters. Results: Domestic and imported Cmax were 3.0 ± 0.6ng · ml-1 and 2.5 ± 0.5ng · ml-1 respectively; Tmax was 1.1 ± 0.6h and 1.1 ± 0 respectively. 4h; AUC was 37.9 ± 4.2ng · h · ml-1 and 37.2 ± 6.1ng · h · ml-1, respectively; the relative bioavailability of the modified tablets in Hangzhou Minsheng Pharmaceutical Factory was 103. 8% ± 17.0%. Conclusion: Domestic tablets are completely equivalent to imported tablets of digoxin. This provides a reference for clinical application, but also provide the basis for the international standards of pharmaceuticals