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盐酸苯海拉明凝胶的制备及质量控制
引用本文:张广求,张美祥,郑锦秀. 盐酸苯海拉明凝胶的制备及质量控制[J]. 中国药房, 2005, 16(14): 1065-1067
作者姓名:张广求  张美祥  郑锦秀
作者单位:1. 湖北省黄冈市第一人民医院药剂科,黄冈市,438000
2. 湖北省黄冈市卫尔康医药有限公司,黄冈市,438000
摘    要:目的:制备盐酸苯海拉明凝胶并建立其质量控制方法。方法:以羧甲基纤维素钠等作为凝胶基质,以正交试验筛选基质最佳配方,并采用紫外分光光度法在258nm波长处测定盐酸苯海拉明的含量。结果:制备的凝胶均匀细腻,分散性好;盐酸苯海拉明检测浓度在100~400μg/ml范围内线性关系良好(r=0.9999,n=6),平均回收率为99.95%,RSD=0.95%(n=9)。结论:该制剂质量稳定,质控方法可靠。

关 键 词:盐酸苯海拉明  凝胶  制备  质量控制
文章编号:1001-0408(2005)14-1065-03
修稿时间:2004-12-01

Preparation and Quality Control of Diphenhydramine Hydrochloride Gel
ZHANG Guangqiu,Zhang Meixiang,Zheng Jinxiu. Preparation and Quality Control of Diphenhydramine Hydrochloride Gel[J]. China Pharmacy, 2005, 16(14): 1065-1067
Authors:ZHANG Guangqiu  Zhang Meixiang  Zheng Jinxiu
Abstract:OBJECTIVE:To prepare diphenhydramine hydrochloride gel and establish its quality control.METHODS:The best formula was optimized by orthogonal design with sodium carboxymethyl cellulose and so on as the base materials,the content of diphenhydramine hydrochloride was determined by UV-spectrophotometry at the wavelength of258nm.REˉSULTS:The diphenhydramine hydrochloride gel was even,fine and which has a good dispersivity;In the concentration range of100~400μg/ml,the diphenhydramine hydrochloride had a linear relationship(r=0.9999,n=6),the average recovery was99.95%,RSD=0.95%(n=9).CONCLUSION:The preparation was stable in quality and reliable in quality control method.
Keywords:Diphenhydramine hydrochloride  Gel  Preparation  Quality control
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