Study On Quality Control Of Kechuanning Granule

With the rapid development of modern drug analysis technology,the quality control of traditional Chinese medicine and its preparation have developped from the traditional character identification to use spectroscopy and chromatography as the main means to control the overall quality of medicines,which play an important role in the guarantee the safety and effectiveness of drugs,theirby,to improve the quality standards of traditional Chinese medicine,and promote the sustainable development of Chinese medicine.According to the prescription of ingredients and component characteristics,this study selected Kechuanning Granule as the research object,and started from the effectiveness,stability and security respectively to carry out its quality standards,in order to Establish a scientific,effective and comprehensive quality control methods to ensure that Kechuanning Granule safe and effective.Objective:1.To establish the method of TLC of Radix stemonae,Ephedra,Bitter almond,Glycyrrhiza and Aster in Kechuanning Granule,and to promote the quality standard of Kechuanning Granule.2.To establish multi-component content determination method ofKechuanning Granule by HPLC and make further efforts to improve thequality control of Kechuanning Granule.3.The HPLC characteristic spectrun of Kechuanning particles was established,which provided scientific and comprehensive reference for the quality evaluation of Kechuanning granule.4.The content of aflatoxin in Kechuanning Granule was determined,and its safety was discussed preliminarily.Methods:1.The TLC method was used to study the five herbs in Kechuanning Granule,and the specificity and durability of the proposed method were investigated.2.The HPLC method was used to determine the content of ephedrine hydrochloride,pseudoephedrine hydrochloride and amygdalin in Kechuanning Granule.The separation of targeted compounds were performed on a Tech Mate C18-ST column(5μm,4.6mm×250mm).The mobile phase consisted of methanol(A)and 0.1% phosphoric acid(B)with gradient elution at flow rate of1.0ml/min.The detection wavelength was 207 nm and the column temperature was 35℃.3.To establish specific chromatograms analysis of Kechuanning Granul and provide experimental basis for more scientific and comprehensive quality evaluation.Multi-Wavelength switching technique is obtained by Tech Mate C18-ST column(5μm,4.6×250mm)with the gradient elution solvent system composed of acetonitrile-0.1% phosphoric acid.The detective wavelength was set at 207nm(0 ~ 40min)and 237nm(40 ~ 55min).The flow rate was 0.9ml/min and the column temperature was maintained at 30℃.4.The contents of aflatoxin in Kechuanning Granule were determined,according to the Principles 2351 of the Four pairs in Chinese Pharmacopoeia2015 edition.1.The method of TLC identification of each drug substance was verified by method.The results showed that the spots were clear,specific and showed no interference.2.In the method,that the content of the multi-component of Kechuanning Granule was simultaneous determined.The linear relation of ephedrine hydrochloride,pseudoephedrine hydrochloride and amygdalin were 1.8260~182.60 μg/mL(r=0.9997),1.8482~184.815 μg/mL(r=0.9997)and 2.9807~298.0692 μg/mL(r=0.9996),respectively.The average recovery rate was97.00 %,97.40 % and 98.30 %,respectively.3.The relative retention time of the main characteristic peaks was calculated by DAD scanning method combined with the control herbs and reference substance.The ephedrine hydrochloride peak was the reference peak1,the glycyrrhizin peak was the reference peak 2.The results showed that there were 9 common peaks,which belong to Radix stemonae,Ephedra,Bitter almond and Glycyrrhiza,and identified ephedrine hydrochloride,pseudoephedrine hydrochloride,amygdalin,glycyrrhizin and glycyrrhizic acid ammoniumtotal of 5 characteristic peaks.4.The content of aflatoxin in the test samples did not exceed the limit and met the relevant requirements.Conclusion:1.The TLC method can be used as an effective method for the identification of Kechuanning granules.2.The simultaneous determination of the content of the multi-component of Kechuanning Granule can control the ingredients of ephedra and almond,which can provide a more effective means for the quality control of the preparation.Results:3.The HPLC characteristic chromatogram of Kechuanning particles can be evaluated comprehensively and scientifically,which provides a useful foundation for the quality control of Kechuanning Granule.4.The content of aflatoxin in the tested Kechuanning Granule was lower than the limit value of the relevant regulations,which indicated that Kechuanning Granule had higher medicinal safety.This study provided useful reference for the future study of the safety of Kechuanning Granule.