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目的初步探讨仿制制剂厄贝沙坦氢氯噻嗪片与参比制剂CoAprovel中厄贝沙坦的体外溶出曲线和体内生物利用度的关系。方法测定仿制制剂和参比制剂中厄贝沙坦在多个介质的溶出曲线,采用f2评价其匹配情况。测定44名健康志愿者口服仿制制剂与参比制剂后厄贝沙坦的血药浓度,评价其生物等效性。结果仿制制剂与参比制剂CoAprovel的厄贝沙坦在pH 1.0和pH 4.5介质中溶出匹配,在pH 4.5+0.4%SDS,pH 6.8,pH 6.8+0.5%聚山梨酯20介质中溶出不匹配。体内生物利用度等效。结论本试验中的厄贝沙坦在体外溶出与体内吸收不完全相关。
Objective To investigate the relationship between irbesartan hydrochloride hydrochlorothiazide tablets and reference drug CoAprovel in vitro dissolution curve and in vivo bioavailability of irbesartan. Methods The dissolution profiles of irbesartan in multiple media were determined in imitation and reference preparations, and the matching was evaluated by f2. The plasma concentrations of irbesartan in 44 healthy volunteers after oral formulation and reference preparation were determined and their bioequivalence was evaluated. Results Imidacusan dissolution profile of the generic formulation versus the reference formulation CoAprovel at pH 1.0 and pH 4.5 media did not match with pH 4.5 + 0.4% SDS, pH 6.8, pH 6.8 + 0.5% polysorbate 20 media . In vivo bioavailability is equivalent. Conclusion In this study, irbesartan dissolution in vitro and in vivo absorption are not completely related.