Preparation and Quality Control of Biyanling Nasal Drops / 中国药房

ABSTRACT

OBJECTIVE: To prepare Biyanling nasal drops and establish a method for its quality control.METHODS: Biyanling nasal drops was prepared with ephedrine hydrochloride and chlorpheniramine maleate etc,and an HPLC method was established for the determination of chlorpheniramine maleate and ephedrine hydrochloride in Biyanling nasal drops.RESULTS: The Biyanling nasal drops were yellow emulsion and in line with the related standard specified in Chinese Pharmacopeia(2005 Edition) in identification and tests.The linear ranges of ephedrine hydrochloride and chlorpheniramine maleate were 0.210～2.096(r=0.999 8)?g?mL-1 and 79.6～796.0(r=0.999 9)?g?mL-1,respectively,and the average recoveries of ephedrine hydrochloride and chlorpheniramine maleate were 98.83%(RSD=1.45%) and 99.19%(RSD=1.37%),respectively.CONCLUSION: The preparation of nasal drops is feasible in technique,stable and controllable in quality.