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目的:研制TJ0711盐酸盐混合骨架缓释片,并评价其体外释放特性。方法:研究了HPMC的黏度和用量,十八醇、CMC-Na的用量对药物释放的影响,并通过正交试验设计对片剂的处方进行优化。结果:正交设计所得最优处方为十八醇、HPMC K4M、CMC-Na的用量分别为片重的20%,40%,10%。药物体外释放良好,符合Higuchi模型(Q=33.909t1/2-20.263,r=0.996 2),持续释药达12 h。结论:经正交优化的TJ0711盐酸盐缓释片处方可行。
Objective: To develop TJ0711 hydrochloride mixed matrix sustained-release tablets and to evaluate its in vitro release characteristics. Methods: The effects of the amount and viscosity of HPMC on the drug release were studied. The prescriptions of the tablets were optimized by orthogonal design. Results: The optimum prescription of orthogonal design was octadecanol, HPMC K4M and CMC-Na were 20%, 40% and 10% of the tablet weight, respectively. Good in vitro release of the drug, in line with the Higuchi model (Q = 33.909t1 / 2-20.263, r = 0.996 2), sustained release of up to 12 h. Conclusion: Orthogonal optimization of TJ0711 hydrochloride sustained release tablets prescription feasible.