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目的研究2种西酞普兰在健康受试者体内的生物等效性。方法 18例健康男性受试者随机分组,自身对照,单次口服西酞普兰片20 mg,测定西酞普兰的血浆浓度,用DAS 2.1软件计算药代动力学参数,并进行方差分析和生物等效性评价。结果试验药与对照药的t_(max)分别为(4.14±3.10),(3.53±2.05)h;C_(max)分别为(32.46±8.29),(34.55±7.05)ng·mL~(-1);t_(1/2)分别为(46.99±10.72),(42.91±8.23)h;AUC_(0-t)分别为(1379.83±301.72),(1455.61±349.93)ng·h·mL~(-1);试验药相对于对照药的生物利用度为(96.00±13.10)%。结论建立的分析方法灵敏、快速、准确,试验药与对照药有生物等效性。
Objective To study the bioequivalence of two citalopram in healthy volunteers. Methods Eighteen healthy male subjects were randomly assigned to self-control, single oral citalopram 20 mg, plasma concentrations of citalopram, pharmacokinetic parameters calculated using the DAS 2.1 software, and analysis of variance and biology Validity evaluation. Results The t max of experimental and control drugs were (4.14 ± 3.10) and (3.53 ± 2.05) h, respectively. The maximal values of Cmax were (32.46 ± 8.29) and (34.55 ± 7.05) ng · mL -1 ); t 1/2 was respectively (46.99 ± 10.72) and (42.91 ± 8.23) h; AUC 0 t was 1379.83 ± 301.72 and 1455.61 ± 349.93 ng · h · mL ~ (- 1). The bioavailability of the test drug relative to the control drug was (96.00 ± 13.10)%. Conclusion The established analytical method is sensitive, rapid and accurate, and the bioequivalence of test drug and reference drug is good.