盐酸达克罗宁凝胶的制备与质量控制

Preparation and quality control of Dyclonine Hydrochloride Gel

目的 :研制盐酸达克罗宁凝胶剂 ,并制定合适的质量控制。方法 :以卡波姆 94 0为凝胶基质制备盐酸达克较宁凝胶剂 ,用一阶导数光度法进行含量测定。结果 :盐酸达克罗宁溶液在 2～ 16 μg·ml-1范围内 ,浓度C与振幅D有良好的线性关系 ,其回归方程为C =- 0 .0 2 6 1+1.0 70 1D(r =0 .9997) ,平均回收率为 99.8% ,RSD为 0 .5 % (n =6 )。结论 :盐酸达克罗宁凝胶制备工艺简单 ,用一阶导数光度法测定含量快捷、简便、准确。

Objective: To prepare a dyclonnine hydrochloride gel and establish a quality control standard. Method: The dyclonnine hydrochloride gel was prepared with carbopol 940 as base material. The content was measured by first order derivative spetrophotometry. Result: A linearity of concentration( C ) and amplitude( D ) of dyclonnine hydrochloride solution was found in range of 2～16 μg·ml -1 with a regression equation of C=-0.0261+1.0701 C ( r=0.999 7 ). The average recovery was 99.8%, RSD was 0.5%( n=6 ). Conclusion: The preparing technique of dyclonnine hydrochloride gel is simple. The first order derivative spetrophotoetry is a rapid, simple and accurate method for content determination.