自制恩替卡韦片与上市对照制剂体外溶出度对比研究

目的: 比较自制恩替卡韦片与对照制剂体外溶出行为。 方法: 参照日本《医疗用药品品质情报集》中的溶出度试验条件,分别考察自制制剂与对照制剂在pH1.2的人工胃液、pH4.0的醋酸盐缓冲液、pH6.8的磷酸盐缓冲液及水中的体外溶出行为,溶出方法为桨法,转速为50 r·min^-1。 结果: 自制制剂与对照制剂在4种不同的溶出介质中溶出曲线均相似。 结论: 自制制剂与对照制剂体外溶出度基本一致。

Objective: To compare the in vitro dissolution behavior of Self-made entecavir tablets and the control agents. Methods: According to the dissolution test conditions of carbamazepine tablets in Japan's "quality of medical drugs information set", different carbamazepine products were inspected in pH1.2 solution, pH 4.0 acetate buffer, pH 6.8 phosphate buffer and water ( paddle, 50 r·min^-1). Results: The in vitro dissolution of self-made preparations and control preparations in 4 different dissolution media were similar. Conclusion: Self-made preparations and control preparations consistent dissolution.