复方莫匹罗星成膜凝胶的制备及质量控制  

Preparation and Quality Control of Compound Mupirocin Film Forming Gel

作　　者：刘丽娜[1,2] 陈鹰[1] 袁萍[1,2] Liu Li＇ na Chen Ying Yuan Ping(Department of Pharmacy, Wuhan General Hospital of PLA, Wuhan 430070, China College of Pharmacy,Hubei University of Chinese Medicine)

机构地区：[1]中国人民解放军武汉总医院药剂科,武汉430070 [2]湖北中医药大学药学院

出　　处：《中国药师》2017年第2期357-359,共3页China Pharmacist

摘　　要：目的:制备复方莫匹罗星成膜凝胶并建立其质量控制方法。方法:采用单宁酸和水杨酸为酯化剂,与羟丙基纤维素发生酯化反应,再与酒石酸和山梨醇交联形成新型成膜材料,加入抗菌药莫匹罗星和局麻药达克罗宁,制备得复方成膜凝胶。用高效液相法测定主药莫匹罗星和达克罗宁的含量,色谱柱:Hypersil ODS_2(250 mm×4.6 mm,5μm),流动相:甲醇-醋酸铵缓冲液(醋酸铵1.15 g,加水300 ml溶解,加冰醋酸1 ml)(75∶25),流速:1.0 ml·min^(-1),检测波长:230 nm,柱温:30℃,进样量:20μl。结果:所制得的成膜凝胶室温下为淡黄棕色澄明液体,涂布于皮肤后会形成一层透明的药膜。莫匹罗星和达克罗宁的线性范围分别为20~400μg·ml-1(r=0.999 9)和10~200μg·ml^(-1)(r=0.999 6),平均回收率分别为99.9%(RSD=0.54%,n=9)和99.6%(RSD=1.45%,n=9)。结论:该制剂处方合理,制备工艺简单,质量可控,适用于制备较为理想的成膜凝胶。Objective： To prepare compound mupirocin fiRm forming gel and establish the quality control methods. Methods： The compound film forming gel was prepared using tannic acid and salicylic acid as the esterifying agents interacting with hydroxypropyl cel- lulose followed by cross-linking with tartaric acid and sorbitol to form a new film forming material, and then antimicrobial mupirocin and anesthetic dyelonine were added to prepare compound mupiroein film forming gel. The contents of mupirocin and dyelonine were deter- mined by HPLC. The column was Hypersil ODS2 （ 250 mm ×4.6 mm, 5 μm） and the mobile phase consisted of methanol-ammonium acetate buffer （1.15 g ammonium acetate, 300 ml water, 1 ml glacial acetic acid） （75：25 ）. The flow rate was 1.0 ml min-1 and the detection wavelength was 230 nm. The column temperature was 30 ℃ and the injection volume was 20μl. Results： The film form- ing gel was yellow, brown and gelatinous at the normal temperature, and formed transparent film after coating on the skin. The linear range of mupirocin and dyclonine was 20-400 p,g . ml -1 （ r = 0.9999） and 10-200 μg . ml -1 （ r = 0.999 6）, respectively. The aver- age recovery was 99.9% （RSD =0.54%, n = 9） and 99.6% （RSD = 1.45%, n = 9）, respectively. Conclusion： The preparation process is reasonable, simple and controllable in the preparation of ideal film forming gel.

关 键 词：莫匹罗星 达克罗宁 成膜凝胶 制备 质量控制 

分 类 号：R944.9[医药卫生—药剂学]