摘要
目的制备盐酸丁卡因眼用凝胶,对其质量进行考察。方法以卡波姆-940为凝胶基质,用酸-碱法制备盐酸丁卡因眼用凝胶,建立酸碱度、鉴别、黏度、渗透压、含量测定等质量控制方法,测定其体外释放度及凝胶溶蚀量,观察对兔眼的刺激性。结果盐酸丁卡因眼用凝胶的pH值为6.8～7.8,黏度3.6～5.6 Pa.s,渗透压摩尔浓度225～275 mOsmol.kg-1,紫外分光光度法测得丁卡因平均回收率99.47%,RSD=0.21%(n=9);丁卡因累积释放量和凝胶累积溶蚀量均显示为零级动力学特征,二者线性关系良好;对兔眼无刺激作用。结论该眼用凝胶的制备方法简单,质量可靠,可用于临床。
Objective To prepare the ophthalmic gel of tetracaine hydrochloric, and study its quahty. Methods Tetraeaine hydrochloric ophthalmic gel was prepared in an acid-alkaline way by using Carbopol-940 as matrix and then evaluated such as pH, identification, viscosity, osmotic pressure and contents. The release rate in vitro and eye irritation was measured as well. Results The pH value of tetraeaine hydrochloric ophthalmic gel was 6.8 - 7.8, viscosity was 3.6 - 5.6 Pa · s, and osmotic pressure was 225 -275 mOsmol · kg^-1. The average recovery of tetracaine hydrochloric was 99.47 % , RSD = 0. 21% （n = 9） ; Both cumulative emissions and amount of gel solution of tetracaine shown zero-level dynamic characteristics, and had a good linear relationship. None of the eye stimulus on rabbit was found. Conclusion The preparing technique is simple and reliable and could be used in clinical practice.
出处
《医药导报》
CAS
2009年第12期1604-1606,共3页
Herald of Medicine
关键词
丁卡因
盐酸
眼用凝胶
制备
质量控制
Tetracaine hydrochloric
Ophthalmic gel
Preparation
Quality control
