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将两种规格的卡波姆与不溶性材料乙基纤维素合用作为骨架材料制备盐酸二甲双胍缓释片。以体外释放度为指标,考察了卡波姆规格及用量、填充剂种类及用量和润滑剂用量对释放度的影响,并通过正交试验筛选得最佳处方。对比了自制缓释片和参比制剂(Glucophage XR)的体外释放行为和兔体内药动学特征。结果表明,本品与参比制剂在pH 6.8磷酸盐缓冲液中的释放曲线相似。兔体内试验表明,本品的相对生物利用度为99%。体内外相关性考察表明,本品的体外释放与体内吸收具有良好的相关性。
Prepare metformin hydrochloride sustained release tablets by combining two kinds of carbomers with insoluble ethylcellulose as the skeleton material. Taking the release rate in vitro as an index, the effects of carbomer specifications and dosage, filler type and dosage, and lubricant dosage on the release rate were investigated. The best prescription was screened by orthogonal test. The in vitro release behavior of Glucophage XR and the reference formulation (Glucophage XR) were compared with the pharmacokinetics in rabbits. The results showed that the product and reference formulations in pH 6.8 phosphate buffer release curve similar. Rabbit in vivo tests showed that the relative bioavailability of this product was 99%. In vitro and in vivo studies have shown that this product in vitro release and absorption in vivo has a good correlation.