苯麻鼻用温敏凝胶的制备及质量控制  

Preparation and Quality Control of Thermosensitive Nasal Gel of Ephedrine Hydrochloride and Diphenhydramine Hydrochloride

作　　者：周俊[1] 唐蕾[1] 刘锐锋[1] 李卓亚[1] 

机构地区：[1]中山市人民医院,广东中山528403

出　　处：《中国药师》2016年第3期596-598,共3页China Pharmacist

摘　　要：目的:制备苯麻鼻用温敏凝胶,并建立其质量控制方法。方法:以胶凝温度为指标,通过正交试验考察泊洛沙姆407(P407)、泊洛沙姆188(P188)及聚乙二醇6000(PEG 6000)的用量;采用高效液相色谱法测定制剂中盐酸苯海拉明和盐酸麻黄碱的含量。结果:P407、P188及PEG 6000的最佳处方量分别为19%、2%和1%;盐酸麻黄碱在1.600 0~2.400 0 mg·ml^(-1)浓度范围内线性关系良好(r=0.999 6),平均加样回收率为99.76%,RSD为1.02%(n=9);盐酸苯海拉明在0.160 0~0.240 0mg·ml^(-1)浓度范围内线性关系良好(r=0.999 7),平均加样回收率为101.27%,RSD为1.10%(n=9)。结论:该制剂处方设计和工艺方法可行,建立的高效液相色谱法可用于该制剂的质量控制。Objective： To prepare the thermosensitive nasal gel of ephedrine hydrochloride and diphenhydramine hydrochloride and establish its quality control method. Methods： The amounts of P407,P188 and PEG 6000 were optimized by an orthogonal test with the gelling temperature as the index. An HPLC method was established to determine the contents of ephedrine hydrochloride and diphenhydramine hydrochloride. Results： The optimum amount of P407,P188 and PEG 6 000 was 19%,2% and 1%,respectively.The linear range of ephedrine hydrochloride was 1. 600 0-2. 400 0 mg·ml（-1）（r = 0. 999 6）,and the average recovery was 99. 76%with RSD of 1. 02%（ n = 9）. The linear range of diphenhydramine hydrochloride was 0. 160 0-0. 240 0 mg·ml（-1）（r = 0. 999 7）,and the average recovery was 101. 27% with RSD of 1. 10%（ n = 9）. Conclusion： The formula design and preparation technology of the gel are feasible. The HPLC method is suitable for the quality control of the preparation.

关 键 词：盐酸麻黄碱 盐酸苯海拉明 鼻用温敏凝胶 高效液相色谱法 

分 类 号：R944.9[医药卫生—药剂学]