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。
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.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第14期1065-1067,共3页
China Pharmacy
关键词
盐酸苯海拉明
凝胶
制备
质量控制
Diphenhydramine hydrochloride
Gel
Preparation
Quality control
