盐酸二甲双胍外用凝胶处方的筛选和质量标准的建立

Study on Prescription Screening and Quality Control of Metformin Hydrochloride Topical Gels

目的:以盐酸二甲双胍为主药,凝胶材料等为辅料,筛选外用凝胶制剂的处方,进行制备工艺和质量控制研究。方法:采用单因素筛选法,以盐酸二甲双胍为主药,优选出其凝胶剂的处方组成及配制工艺,采用紫外可见分光光度法测定盐酸二甲双胍的含量。结果:筛选出盐酸二甲双胍外用凝胶处方组成为:主药为2.0%盐酸二甲双胍,辅料组成为2.50%甲基纤维素,5.00%丙二醇,1.00%苯氧乙醇,NaOH溶液适量(0.1 mol·L^(-1))。制备工艺为:取丙二醇、苯氧乙醇溶于适量水中,加入盐酸二甲双胍溶于上述溶液中,再加入甲基纤维素,用NaOH溶液(0.1 mol·L^(-1))调节pH值至4.0~6.0,加水至足量,充分溶胀,搅拌均匀即得。结论:该制剂的处方及制备工艺稳定可靠,质量可控。

Objective:Using metformin hydrochloride as main drug and gel factors as excipient,the formulation screening,preparation process and quality control of gel preparations for external use were studied.Methods:A single factor screening method was used to optimize the formulation and preparation process of metformin hydrochloride gels,and the contents of metformin hydrochloride were determined by ultraviolet spectrophotometry.Results:The topical gel formulation of metformin hydrochloride was selected as follows:the main drug was 2.0%metformin hydrochloride,the excipients included 2.50%methyl cellulose,5.00%propylene glycol,1.00%phenoxyethanol and NaOH solution(0.1 mol·L^(-1)).The preparation process was as follows:dissolve propylene glycol and phenoxyethanol in appropriate amount of water,add metformin hydrochloride to be dissolved in the above solution,then add methyl cellulose,adjust pH value to 4.0-6.0 with NaOH solution(0.1 mol·L^(-1))and add water to sufficient amount,stir evenly when fully swelled.Conclusion:The formulation and preparation process of this preparation are stable and reliable,and its quality is controllable.