Preparation and Quality Control of Diphenhydramine Hydrochloride Gel / 中国药房

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.RE?SULTSThe diphenhydramine hydrochloride gel was even,fine and which has a good dispersivity;In the concentration range of100～400?g/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.