小儿腹泻外敷凝胶膏剂的制备及质量控制

Preparation and Quality Control of Xiaoer Fuxie Topical Gel Ointments

目的:制备小儿腹泻外敷凝胶膏剂,并建立其质量控制方法。方法:以吴茱萸、胡椒、丁香、肉桂提取物为主药,聚丙烯酸钠和卡波姆为凝胶骨架成分制备凝胶膏剂;采用TLC鉴别方中胡椒、丁香、肉桂,HPLC测定吴茱萸碱含量。结果:制备的凝胶膏剂成型性好,具有适宜的机械强度和黏附性。TLC中检出胡椒、丁香、肉桂,分离度好、专属性强,阴性对照无干扰。HPLC吴茱萸碱在0.05～0.4μg与峰面积呈良好线性关系,平均回收率99.3%(RSD 1.01%)。结论:该制备工艺稳定合理,建立的质量控制方法准确、可靠、专属性强,可用于该制剂的质量评价。

Objective： To prepare Xiaoer Fuxie topical gel ointments,and establish its quality control standards.Method： Gel ointments was prepared with extract of Fructus Evodiae,Fructus Piperis,Flos Caryophylli and Cortex Cinnamomi as materials,sodium polyacrylate and carbomer as gel skeleton matrix.Fructus Piperis,Flos Caryophylli and Cortex Cinnamomi were identified by TLC.The content of evodiamine was determined by HPLC.Result： Moldability of prepared gel ointments was good with a suitable mechanical strength and adhesion.Fructus Piperis,Flos Caryophylli and Cortex Cinnamomi were detected by TLC,characteristic identification was distinct and highly specific.Evodiamine showed a good linear relationship in the range of 0.05 ～ 0.4 μg（r = 0.999 9） with an average recovery of 99.3%（RSD 1.01%）.Conclusion： This preparation technology was stable and reasonable.This established quality control method was reliable,accurate and specific,which could be used for quality evaluation of Xiaoer Fuxie topical gel ointments.