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为比较国产盐酸丁咯地尔片剂和进口盐酸丁咯地尔（活脑灵）片剂的药代动力学参数，求出国产制剂的生物利用度，将１２ 名健康志愿者随机分为２ 组，分别单次口服国产盐酸丁咯地尔片及进口活脑灵片３００ｍ ｇ，用ＨＰＬＣ法测定血药浓度，采用３Ｐ９７ 程序处理实验数据，进行药代动力学和相对生物利用度研究。结果表明，口服国产和进口两种制剂的药时曲线均符合一室模型，血药峰浓度Ｃｍ ａｘ 分别为（１．９５±０．４２）ｍ ｇ／Ｌ和（２．００±０．５７）ｍ ｇ／Ｌ，达峰时间Ｔｐｅａｋ 分别为（２．４２±０．６３）ｈ 和（２．４８±０．４６）ｈ，药时曲线下面积ＡＵＣ分别为（１６．１６±３．４６）ｍ ｇ／Ｌ·ｈ 和（１６．２１±２．８２）ｍ ｇ／Ｌ·ｈ。两组参数差别均无统计学意义（Ｐ＞０．０５）。国产盐酸丁咯地尔片剂与进口活脑灵片剂相比，相对生物利用度为（１００．７±１９．１）％ ，两种片剂为生物等效制剂
In order to compare the pharmacokinetic parameters of buflomedil hydrochloride tablets and buflomedil hydrochloride (live brain spirit tablets) in China, the bioavailability of domestic preparations was calculated and 12 healthy volunteers were randomly divided into 2 groups Group were treated with Buflomedil Hydrochloride tablets and imported Huaxiling tablet 300mg once daily. The plasma concentration was determined by HPLC method. The pharmacokinetics and relative bioavailability were studied by 3P97 program. The results showed that the pharmacokinetic profiles of both domestic and imported preparations were in accordance with the one-compartment model. The peak plasma concentrations of Cm ax were (1.95 ± 0.42) m g / L and (2.00 ± 0.57 ) M g / L and peak time Tpeak were (2.42 ± 0.63) h and (2.48 ± 0.46) h, respectively. The area under the curve of medicine time was AUC of (16.16 ± 3.46 ) M g / L · h and (16.21 ± 2.82) m g / L · h. There was no significant difference between the two groups (P> 0.05). The relative bioavailability of domestic buprenorphine tablet compared with that of imported Naoning tablet was (100.7 ± 19.1)%, and the two tablets were bioequivalent