Study On The Quality Standard Of Maxing Zhike Series Preparations

There are four dosage forms of Maxing Zhike: syrup,tablet,capsule and granule.All the prescriptions are derived from the prescription of the classic chinese medicine of Maxing Shigan Tang.Because of its effect of relieve exterior by pungent-cold drugs and clearing lung and asthma,It is regarded as a classical prescriptions to date.However,its quality control standard is relatively simple,it is necessary to refine and upgrade its quality standards to ensure the safety of drug use.The main content of study is as follow:1)Identification item of pseudoephedrine hydrochloride was added.The exploration included selection of thin layer plates,species and ratio of developing solvent,temperature and humidity.The experimental results showed that the method was good in specificity,durability and reproducibility.In addtion,TLC method has improved the original method of the Pharmacopoeia of licorice was modified.It is more effective to identify licorice in the sample.2)The content determination item had been upgraded and revised.established an HPLC method for simultaneously determination of five components,such as ephedrine hydrochloride,pseudoephedrine hydrochloride,amygdalin,glycyrrhizin,glycyrrhizic acid in series pharmaceutics of Maxing cough.The analysis was performed on Thermo C18 column(250 mm×4.6 mm,5 ?m),using acetonitrile(A)-0.02 mol/L of potassium dihydrogen phosphate solution containing 0.1% triethylamine and 0.1% phosphoric acid(B)as mobile phase under gradient elution and the flow rate was 1.0 mL/min.The column temperature was 25 and the detective wavelength was 210 nm?(ephedrine hydrochloride,pseudoephedrine hydrochloride,amygdalin)and 237 nm(glycyrrhizin,glycyrrhizic acid);The experimental results showed that this new method was simple,efficient,good repeatability and strong specificity.It applied to the quality control of Series preparations.3)Specific chromatogram of kinds of dosage forms was studied coupled with UPLC-MS/MS.Except for five components in the determination of content and adjacent chromatographic peaks of amygdalin(It was concluded that the isomers of amygdalin may be the isomers of amygdalin by mass spectrometry),Other characteristic chromatographic peaks did not exist.Because it did not truly reflect the advantage of the feature map,the method was not established.In this study,we studied separately the four dosage forms.such as Maxing Zhike Syrup,Maxing Zhike tablets,Maxing Zhike capsule,Maxing Zhike particles.The consistency of four kinds of dosage form quality control methods was basically maintained after condition screening and comprehensive investigation.This method of the topic is not only effective for improving the level of quality control Maxing Zhike series preparations also provides a basis for further amendments of the quality standard.