Objective:To establish the quality standard of compound Baixianpi eczema cream according to the quality standard of compound preparation in Pharmacopoeia of the People's Republic of China(2020 edition).Methods:TLC was used to identify Baixianpi(Dictamni cortex),Shechuangzi(Cnidii fructus),Huangbo(Phello-dendri chinensis cortex)and Machixian(Portulacae herba)in the cream qualitatively,HPLC was applied to detect the contents of the index components chlorogenic acid,berberine hydrochloride and brucine in the cream.Results:The methods for qualitative identification of Baixianpi,Shechuangzi,Huangbo and Machixian,are specific and the negative control has no interference;chlorogenic acid,berberine hydrochloride and brucine presented good linear relation in the rang between 0.011 04 and 0.176 64 mg/mL(R=0.9998),0.003 204 and 0.051 264 mg/mL(R=0.9996),0.003 018 and 0.048 288 mg/mL(R=0.9992);and their average recovery rates were 99.09%,98.30%and 97.35%,RSD were 1.77%,1.48%and 1.04%respectively.Conclusion:The quality standard,which is easy to operate,accurate,stable and without interference,could be used for quality control of the preparation.
compound Baixianpi eczema creamTLCHPLCquality standard
NETL
NSTL
万方数据
