滴阴炎妇科洗液制备工艺优选及质量标准研究  

Research On The Preparation Technology Optimization And The Quality Standard Of Diyinyan Gynecological Lotion

作　　者：刘军 李文静 柳茜 刘本臣 董亚楠 张丽媛 LIU Jun;LI Wenjing;LIU Qian;LIU Benchen;DONG Yanan;ZHANG Liyuan(Yinchuan Hospital of Traditional Chinese Medicine,Yinchuan 750001,China)

机构地区：[1]宁夏回族自治区银川市中医医院,宁夏银川750001

出　　处：《中国民族民间医药》2020年第17期22-26,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：2018年宁夏回族自治区重点研发一般项目(2018BEG03079):滴阴炎妇科洗液的研发。

摘　　要：目的:优选滴阴炎妇科洗液制备工艺并建立质量标准。方法:采用单因素考察法,以溶液澄清度及3种增溶剂[Tween-80、泊洛沙姆188、泊洛沙姆407]对CHG溶解度影响程度为评价指标,优选最佳增溶剂;采用高效液相色谱法对滴阴炎妇科洗液中CHG的含量进行测定并采用滤纸片法进行抑菌效果评估。结果:增溶效果:吐温-80>泊洛沙姆407>泊洛沙姆188;葡萄糖酸氯己定在0.0172~0.1548mg/mL与峰面积分值呈良好的线性关系(r=0.9999);滴阴炎妇科洗液对金黄色葡萄球菌、大肠埃希菌、白色念球菌的抑菌环直径均值分别为14.56mm、11.10mm、7.72mm。结论:滴阴炎妇科洗液制备工艺简单,建立的CHG含量测定法专属性良好,抑菌效果良好,可用于质量控制。Objective To screen the preparation technology optimizationand to establish the quality standard of Diyinyan Gynecological Lotion.Methods Using the single factor investigation to select the best solvent based on clarifing degree of solution and three kinds of solubilizer[Tween-80,Poloxamer 188,Poloxamer407]to CHG solubility influence degree as evaluation index;To determinate the content of Chlorhexidine Gluconate in Diyinyan antibacterial agent by HPLC method,and asses the inhibitory effect through bacteriostatic test based on the disinfection technical specifications.Results Solubilization effect:Tween-80>Poloxamer 407>Poloxamer 188.the line range of Chlorhexidine Gluconate was 0.0109~0.0872 mg/mL,respectively,with good linear relationship with the peak area integral value(r=0.9999);The diameter of Bacteriostatic ring for Staphylococcus aureus,e.coli,white read aureus was 14.56mm,11.10mm,7.72mm.Conclusion the preparation technology of Diyinyan gynecological lotion with a good bacteriostatic action is simple and reasonable,The established HPLC method has good selectivity and stability for the determination of Chlorhexidine Gluconate.It can be used for the quality control of Diyinyan gynecological lotion.

关 键 词：滴阴炎妇科洗液 增溶剂 葡萄糖酸氯己定 高效液相 抑菌试验 

分 类 号：R944.1[医药卫生—药剂学]