Improvement of Quality Standard and Safety Evaluation of Paishi Mixture
Objective To improve the quality standard of Paishi Mixture and evaluate its safety.Methods Thin layer chromatography(TLC)was used for the qualitative identification of Moutan Cortex,Glycyrrhizae Radix et Rhizoma and Persicae Semen in Paishi Mixture.The content of paeonol in the preparation was determined by high-performance liquid chromatography(HPLC).Waters Xbridge R C18(250 mm×4.6 mm,5 µm)column was adopted,using methanol-water(45:55,V/V)at the flow rate of 1.0 ml/min as mobile phase.The detection wavelength was 274 nm,the column temperature was 35℃,and the injection volume was 10 μl.The samples were treated by microwave digestion,then the contents of Pb,As,Cd,Hg and Cu in the samples were determined by ICP-MS.Results The TLC method used had strong specificity.The TLC chromatograms of Moutan Cortex,Glycyrrhizae Radix et Rhizoma and Persicae Semen showed clear spots and good separation,and the chromatogram of negative control showed that there was no interference.The concentration of paeonol showed a good linear relationship with the peak area in the range of 10.5-104.9 µg/ml(r=0.9999).The recovery of paeonol was 100.1%,with RSD of 0.51%(n=6).The RSDs of precision,stability and repeatability tests were less than 1.00%.The average content of paeonol in 12 batches of samples was 1203.04 μg/ml.The contents of Pb,As,Cd,Hg and Cu were within the specified limits.Conclusion The quality standard established in this experiment can be used for the quality control of Paishi Mixture.The mehod is easy to operate,and the results ate accurate and reliable.The contents of Pb,As,Cd,Hg and Cu in Paishi Mixture meet the national standard and can be safely used for patients.
Paishi Mixturequality standardHPLCTLCMoutan CortexGlycyrrhizae Radix et RhizomaPersicae Semenheavy metal
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