复方醋酸氯己定凝胶的制备和质量控制

Preparation and Quality Control of Compound Chlorhexidine Acetate Gels

目的:制备复方醋酸氯己定凝胶,并建立其质量控制方法。方法:以醋酸氯己定、盐酸达克罗宁、薄荷脑、曲安奈德为主药,以甲基纤维素4500为基质制备凝胶;采用高效液相色谱法测定醋酸氯己定、盐酸达克罗宁的含量。结果:制备的凝胶均匀细腻,分散性好;醋酸氯己定浓度在0.08152～0.40760μg范围内呈良好的线性关系(r=0.9999,n=5),平均回收率为98.82%,RSD为1.19(n=9);盐酸达克罗宁在0.1636～0.8180μg范围内呈良好的线性关系(r=0.9999,n=5),平均回收率为98.85%,RSD为1.13(n=9)。结论:本制剂组方合理,制备工艺简便可行,质量稳定可控。

Objective： To prepare a compound chlorhexidine acetate gels and establish the quality control meth- ods. Methods： The compound gels were prepared with chlorhexidine acetate, dyclonine hydrochloride, menthol and triamcinolone acetonide as the main components using methylcellulose 4500 as the stroma. HPLC method was used to determine the contents of chlorhexidine acetate dyclonine hydrochloride. Results： The gel preparation was even and fine and a good dispersivity. In the concentration range of 0.081 52 - 0.407 60 μg, chlorhexidine acetate had a lin- ear relationship （r = 0.999 9, n = 5）, the average recovery was 98.82%, RSD = 1.19%（n = 9） ; In the concentration range of 0.163 6 - 0.818 0 μg,the dyclonine hydrochloride had a linear relationship （r = 0.999 9,n = 5）, the average recovery was 98.85%, RSD = 1.13% （n = 9）. Conclusion： The formulation of the gelata is reasonable and the production technology is simple and feasible, and the quality of preparation is stable and controllable.