OBJECTIVE:To prepare Oxymetazoline hydrochloride in situ forming eye gel and to control the quality of it.METHODS:The gel was prepared with poloxamer 407 as base,and the content of oxymetazoline hydrochloride was determined by HPLC.RESULTS:The linear range of oxymetazoline hydrochloride was 50~500 mg·L-1(r=0.999 9) with recovery rate of 100.48%(RSD=1.4%).CONCLUSION:The preparation method is reasonable,simple and controllable,and it is an ideal ophthalmic preparation.
目的:探讨盐酸羟甲唑啉眼用即型凝胶的制备及其药物含量的测定方法.方法:采用冷溶法,以泊洛沙姆407(F127)为主要眼用即型凝胶截体材料,0.6%的泊洛沙姆188(F68)为促渗剂,制备盐酸羟甲唑啉眼用即型凝胶溶液;采用高效液相色谱(HPLC)法测定眼用即型凝胶中盐酸羟甲唑啉的含量.结果:盐酸羟甲唑啉眼用即型凝胶最佳处方组成为21% F127,胶凝温度为27.6℃;盐酸羟甲唑啉在线性范围为50~500 mg·L-1浓度范围内与峰面积呈良好的线性关系(r=0.9999),日内和日间精密度良好,平均回收率为100.48%.结论:本滴眼剂处方工艺简单,质量容易控制,热可逆性好.