论文部分内容阅读
目的:制备盐酸倍他洛尔离子/温度敏感型眼用原位凝胶,建立药物的含量测定方法并进行体外评价。方法:以脱乙酰结冷胶和泊洛沙姆407作为基质制备凝胶;采用高效液相色谱法测定药物含量;采用无膜溶出模型和离体角膜渗透实验研究药物的体外释放行为。结果:原位凝胶处方组成为主药0.28%,载体为0.5%的脱乙酰结冷胶和9%的泊洛沙姆407,等渗调节剂为5%的甘露醇,抑菌剂为0.03%的羟苯乙酯。与盐酸倍他洛尔溶液剂相比,该制剂的药物透过速度慢。结论:该制剂制备工艺简便,具有缓释特性。
OBJECTIVE: To prepare the betaxolol hydrochloride / temperature-sensitive ophthalmic in situ gel and to establish a method for the determination of the content of the drug and to evaluate it in vitro. Methods: Gel was prepared with deacetylated gellan gum and Poloxamer 407 as matrix. The drug content was determined by HPLC. The release behavior of the drug in vitro was evaluated by membraneless dissolution model and in vitro corneal permeation test. RESULTS: The in situ gel formulation consisted of 0.28% primary drug, 0.5% deacetylated gellan gum and 9% poloxamer 407, 5% mannitol as an isotonicity regulator and 0.03 % Of phenethyl ester. The drug permeates slowly as compared to the solution of betaxolol hydrochloride. Conclusion: The preparation process is simple, with sustained release characteristics.