Research On The Quality Control Method Of Pingfei Oral Liquid

Objective:Perfecting and improving the quality control method of Pingfei oral liquid for to control the quality of the preparation and to ensure clinical efficacy.Method:(1)By optimizing the extraction method and the Thin Layer Chromatography(TLC)conditions,this method can be used for qualitative identification of Fritillariae Thunbergii Bulbus,Akebiae Fructus,Schisandrae Chinensis Fructus,Raphani Semen,Atractylodis Macrocephalae Rhizoma,Houttuyniae Herba.(2)HPLC-DAD is used for the chromatographic fingerprint analysis of Pingfei oral liquid.Qualitative identification of characteristic chemical components in the preparation by relative retention time and spectrum of chromatographic peaks.By contrast with the single herb medicine atlas to determine the ownership of the relevant peaks.(3)The HPLC-DAD method is used for determination of sinapine,chlorogenic acid,schisandrin.The mobile phase was acetonitrile(A)-0.1%phosphoric acid solution(B)with gradient elution,the flow-rate was 1.0 mL·min-1,the detection wavelength was 327nm(0-40min),216 nm(40-80min).The HPLC-ELSD method is used for determination of peimine and peiminine.The mobile phase consisted of acetonitrile-0.1%diethylamine solution(60:40),the flow-rate was 1.0 mL·min-1,the temperature for the detector drift tube was 85?,the gas flow-rate was 2.0L·min-1.MCX mixed cation exchange column was used to SPE.Result:(1)The spots are clearly identifiable,the negative control was without interference and the method has a specificity and optimizing the extraction method and and system expansion condition.(2)Analysis of 10 batches of samples by HPLC-DAD,21 common peaks were generated and 18 peaks was identified.The similarity between the spectra of each batch of samples and the control spectra is from 0.989 to 0.997.(3)The methods achieved good linearity in the ranges of 0.02792?g-0.3350?g(r=0.9999)for sinapine,0.04044?g-0.4853?g(r=0.9999)for chlorogenic acid,0.01290?g-0.1548?g(r=0.9999)for schisandrin,0.3081?g-3.0810?g(r=0.9999)for peimine,0.3174?g-3.1740?g(r=0.9999)for peiminine,respectively.The average recovery rate were 101.0%(RSD=1.22%),103.1%(RSD=0.46%),103.8%(RSD=0.83%),93.8%(RSD=2.07%),94.4%(RSD=1.79%)(n=9),respectively.Conclusion:The methods in this study are simple,accurate and specific by TLC qualitative methods,the chromatographic fingerprint analysis and the determination method of the five target components.It can be used for the quality control of Pingfei oral liquid.