Preparation and Quality Control of Xiaodouning Cream / 中国药房

ABSTRACT

OBJECTIVE:To prepare Xiaodouning cream and establish a method for its quality control. METHODS: The cream was prepared using glycerol monstearate as matrix with clindamycin hydrochloride and metronidazole as principle agents. The contents of the principal agents were determined by HPLC. The stability of the cream within 6 months was investigated. RESULTS: The cream was well-distributed and delicate with suitable viscidity,and it met the criteria of Chinese Pharmacopeia(2005 edition) in test and identification. The linear ranges of clindamycin hydrochloride and metronidazole were 2.342～11.71 ?g (r=0.999 8) and 0.97～4.85 ?g (r=0.999 8),respectively,with average recoveries at 98.3% (RSD=0.7%) and 100.3% (RSD=1.6%),respectively. In the stability test,no obvious change was noted for all indexes. CONCLUSION: The preparation technology of this cream is simple and feasible and its quality is stable and controllable.