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

作　　者：余辉 徐楚 陈林 刁义平 龚春燕 陈旭 YU Hui;XU Chu;CHEN Lin;DIAO Yiping;GONG Chunyan;CHEN Xu(Centre of Medicinal Preparations,Institute of Dermatology,Chinese Academy of Medical Sciences&Peking Union Medical College,Nanjing 210042,China;Department of Pharmacy,Institute of Dermatology,Chinese Academy of Medical Sciences&Peking Union Medical College,Nanjing 210042,China;Jiangsu Key Laboratory of Molecular Biology for Skin Diseases and STIs,Institute of Dermatology,Chinese Academy of Medical Sciences&Peking Union Medical College,Nanjing 210042,China)

机构地区：[1]中国医学科学院皮肤病医院制剂中心,南京210042 [2]中国医学科学院皮肤病医院药剂科,南京210042 [3]中国医学科学院皮肤病医院江苏省皮肤病与性病分子生物学重点实验室,南京210042

出　　处：《药学与临床研究》2024年第5期416-420,共5页Pharmaceutical and Clinical Research

摘　　要：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.

关 键 词：盐酸二甲双胍 凝胶 处方筛选 紫外可见分光光度法 

分 类 号：R943[医药卫生—药剂学]