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研制了一种缓释的磷酸丙吡胺包衣片剂。包衣材料主要是乙基纤维素。用转篮法测定包衣片中药物的溶出速度表明,第1h 溶出约17%,可连续释药8h 以上。8名健康志愿者口服缓释包衣片200mg 后,测定了血药浓度及动力学参数,并与两种临床有效的控释磷酸丙吡胺片和胶囊剂作对照。结果表明,从起效速度,体内作用持续时间及生物利用度诸方面考察,皆可与两种或一种控释制剂相比拟。
A sustained-release phosphate-coated tablet was developed. The coating material is mainly ethyl cellulose. The determination of the dissolution rate of the drug in the coated tablets by the basket spinning method showed that the dissolution rate was about 17% in the first hour, and the drug release rate could be continuously released for more than 8 hours. Eight healthy volunteers oral sustained-release coated tablets 200mg, the determination of plasma concentration and kinetic parameters, and with two clinically effective controlled release of propylene phosphate and capsules tablets as a control. The results show that, from the onset rate, the duration of in vivo effects and bioavailability of various aspects, can be compared with two or a controlled release formulations.