Study and discussion on the quality standard of Jubei mixture
Objective:To study the quality standard of Jubei mixture(桔贝合剂)and new test items and methods are added.Methods:The TLC methods for identification of Platycodon grandiflorum and Eriobotrya japonica in Jubei mixture were established.A HPLC specific chromatogram of the Jubei mixture was established.The HPLC test was performed in Agilent ZORBAX-C18(250 mm×4.6 mm,5 μm).Gradient elution was conducted with acetonitrile(A)and 0.1%acetic acid aqueous solution(B)as the mobile phase,and the column temperature was 30℃,the flow rate was 1.0 mL/min,the detection wavelength was 250 nm.HPLC-ELSD was adopted to determine the contents of Peimine and Peiminine in Jubei mixture.The HPLC test was performed in Waters T3 C18(250 mm×4.6 mm,5 μm)under the gradient elution of acetonitrile and 0.1%diethylamine aqueous solution(70:30),the column temperature was 30℃,and the flow rate was 1.0 mL/min.Results:The TLC chromatograms showed the characteristic spots were clear for the Platycodon grandiflorum and Eriobotrya japonica,and there were good separation resolutions.The characteristic fingerprints of the HPLC with Baicalin as the reference peak was established,and eight common peaks were defined,separated from bitter almond,licorice,scutellaria baicalensis and sodium benzoate,the similarities between 12 batches of samples characteristic fingerprints and the reference characteristic fingerprints were more than 0.95.The linear ranges of Peimine and Peiminine fell into 52-520 μg/mL and 58-580 μg/mL respectively.The mean recoveries of Peimine and Peiminine were 101.0%and 96.3%,the contents of Peimine and Peiminine in 12 batches of samples were 12.4-55.4 μg/mL and 6.2-48.3 μg/mL respectively,and the sum of two components was 19.2-85.3 μg/mL.Conclusion:The TLC and HPLC used in this study and established methods can be used for qualitative identification and quantitative determination of Jubei mixture,and they can effectively evaluate and control the quality of Jubei mixture.
Jubei mixtureTLCHPLC Specific chromatogramPeiminePeiminineContentResearch of specification
万方数据
维普
