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本文采用膜控法制备盐酸强力霉素缓释微丸。实验表明,本品的体外溶出符合零级动力学过程(K_r~0=20.5 mg/h);贮存期为两年,胃刺激性明显低于普通片剂(p<0.001),体内动力学过程符合表观零级吸收与一级消除的单室模型。体内数据经NONLIN计算机程序处理,求得各项参数如下:K_a=58.08 mg/h,K=0.032 h-1,V_d=82.211,t_(max)=3.94 h,c_(max)=2.30μg/ml。按强力霉素的常规用药方案给药,本品与市售普通片生物等效。本品的体内外数据具有显著的相关性(p<0.001)。
In this paper, membrane-controlled preparation of doxycycline hydrochloride sustained-release pellets. Experiments show that the in vitro dissolution meets the zero-order kinetics (K_r ~ 0 = 20.5 mg / h); the storage period is two years and the gastric irritation is obviously lower than that of the ordinary tablet (p <0.001) A single-compartment model that corresponds to apparent zero-order absorption and first-order elimination. In vivo data were processed by NONLIN computer program to obtain the following parameters: K_a = 58.08 mg / h, K = 0.032 h-1, V_d = 82.211, t_max = 3.94 h, c_max = 2.30 μg / ml . Doxorubicin by conventional drug administration program, this product is commercially available and ordinary bio-bio-equivalent. This product in vivo data have significant correlation (p <0.001).