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目的 以羟丙甲纤维素 (HPMC)为骨架材料制备持续释药 12h的磷酸川芎嗪缓释片。方法 分别采用中国药典 1995年版溶出度测定法第 2法及高效液相色谱法测定缓释片的体外释放度及兔体内生物利用度。结果 缓释片体外 1h释药 2 0 %左右 ,12h释药 85 %以上 ,12h内释药平稳 ,释药曲线符合Higuchi方程 ,体外释药受HPMC类型、黏度、用量影响较大。缓释片与市售常释片相比 ,兔体内峰浓度降低 ,达峰时间延迟 ,平均滞留时间延长 ,吸收程度生物等效。结论 缓释片体内外缓释效果良好 ,并具有良好的体内外相关性。
OBJECTIVE To prepare tetramethylpyrazine phosphate sustained release tablets sustained release for 12 hours by using hypromellose (HPMC) as the matrix material. Methods The Chinese Pharmacopoeia 1995 edition dissolution assay method 2 and high performance liquid chromatography determination of sustained release tablets in vitro release and rabbit bioavailability. Results The sustained-release tablets showed a sustained release of about 20% in vitro for 1 hour and over 85% in 12 hours. The drug release was stable within 12 hours. The drug release curves were in accordance with the Higuchi equation. The in vitro drug release was greatly influenced by the type, viscosity and dosage of HPMC. Sustained-release tablets and commercially available tablets compared to the rabbit peak concentration decreased peak time delay, the average residence time extended absorption of bioequivalence. Conclusion Sustained release sustained release tablets in vivo and in good effect, and has good correlation in vitro and in vivo.