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本文用尿排药法,将三种核黄素(R)制剂给9个志愿者顿服15mg后,研究其生物利用度,并作药物动力学分析。三种制剂为普通片(IA)、包有软明胶皮的六合维生素丸(IB)以及一种长效缓释片剂(IC)。另外,口服R片剂(IIA),5mg,日服三次,作为生物利用度的参比标准。尿中R的回收率以IIA为最高,达67.52％,IA、IB、IC分别为62.09、51.7和47.12％。从以上结果可见:①IIA与IA为生物等效性,这表明普遍使用的给药方案(5mg,日服三次)从生物利用度观点来看,可以简化为15mg日服一次,②释药迅速的制剂较缓释制剂(明胶包衣的丸剂、缓释片剂)为优。六合维生素丸中的核黄素,生物利用度较差。对IA、IB、IC的药物动力学分析,结果显示消除速度常数β无显著差异,但吸收速度常数K。及达峰时t_m均有显著差异。
In this paper, urinary discharge method, the three riboflavin (R) preparations to nine volunteers Dayton served 15mg, the study of its bioavailability, and for pharmacokinetic analysis. The three formulations were general tablet (IA), soft gelatin bark (IB) and a long-acting sustained-release tablet (IC). In addition, oral R tablets (IIA), 5mg, served three times daily as a reference standard for bioavailability. The recovery rate of R in urine was highest with IIA reaching 67.52%, and IA, IB and IC were 62.09, 51.7 and 47.12% respectively. From the above results, it can be seen that: (1) IBA and IA are bioequivalent, indicating that the commonly used dosing regimen (5mg, three times a day) can be simplified to 15mg once a day from the viewpoint of bioavailability; Formulations The more sustained release formulations (gelatin coated pills, extended release tablets) are preferred. Liuhe vitamin pills in the riboflavin, bioavailability is poor. Pharmacokinetic analysis of IA, IB and IC showed that there was no significant difference in the elimination rate constant β, but the absorption rate constant K. And reached a peak t_m significant difference.