Study On Determination Of Multiple Components In Fill In Buzhong Yiqi Pills By A Quantitative Assay Of Multi-components By Single-marker

Objective:Existing "Chinese Pharmacopoeia" 2015 edition defines the quality standards Buzhong Yiqi Pills,Mainly through the use of microscopic identification,the angelica,licorice and dried tangerine peel use TLC qualitative identification,and content determination of Astragaloside ? by Evaporative Light Scattering Detector.In order to provide a reference for the improvement of the requirements of the Buzhong Yiqi Pills.Based on the "Chinese Pharmacopoeia" 2015 edition,this paper studies TLC identification and content determination of Buzhong Yiqi Pill,and establishes a method for simultaneous determination of various components of Buzhong Yiqi Pills and establishes the inspection mode of its methodology.At the same time,the fingerprints of Buzhong Yiqi Pill were studied,and the characteristic mode of High performance liquid chromatography fingerprint pattern was established.Methods:1.In this study,the eight herbs in Buzhong yiqi pill prescription were identified by thin layer chromatography,which have added Cimicifuga foetida,Astragalus,radix bupleuri,Atractylodes,Codonopsis thin layer identification.2.A Quantitative Assay of Multi-components by Single-marker(QAMS)for the determination of relative correction factor between six main components of hesperidin,Calycosin-7-glucoside,isoferulic acid,liquiritin,ferulic acid and ammonium glycyrrhizinate,and examines its methodology.At the same time,the content of the above six components in 12 batches of medicinal herbswas determined by external standard method.3.The fingerprints of Bu zhong Yi qi Pill were studied by high performance liquid chromatography(HPLC),and the common model of the Fingerprint of Bu Zhong yi qi was established by using the similarity evaluation system software of Chinese herbal medicine,and the similarity was evaluated.Result:1.The results of thin layer identification showed that the thin layer identification of dried tangerine peel,licorice and angelica was in accordance with the provisions of the Chinese Pharmacopoeia 2015 edition;The addition of Astragalus,Cimicifuga foetida,Bupleurum for the test sample chromatography,with the corresponding reference substance or control drug chromatography corresponding to the location of the same color or fluorescent spots,with the strongly specificity and good reproducibility;While Atractylodes and Codonopsis identification method to be further optimized.2.Completed a component of Bu zhong Yi qi pill in a variety of components of the multi-component determination.The established method has a good linear relationship,precision,stability and repeatability,laying a foundation for establishing a fast,effective and convenient method for the quality standard of Bu zhong Yi qi Pill.The six components of 12 batches of products were measured by a multi-evaluation method.The significant difference between the measured and calculated values was(0.181,0.497,0.216,0.402,0.586),which were all greater than 0.01,and there was no significant difference.3.The common model of the Fingerprint of Bu Zhong yi qi pills was established,and the method had the advantages of simple,accurate and reproducible.The resulting chromatogram baseline stable,good peak shape,number of peaks more evenly distributed peaks,most peaks had reached baseline separation.The similarity of the different batches of water droplets and the control fingerprints of the same enterprises was 0.968,all above0.95,which accorded with the national technical requirements for fingerprints of medicinal materials.Conclusion:In this paper,the new method of identification of Astragalus membranaceus,Cimicifuga foetida and Bupleurum can provide reference for improving the quality standard of Bu zhong Yi qi Pill.The establishment of a multi-evaluation method is simple,fast and reproducible,which provides a scientific basis forthe establishment of the standard for improving the quality of the pills,in order to ensure the safety and effectiveness of clinical medicine and can be used as a new method for the quantitative analysis of multi-component analysis of Bu zhong Yi qi Pills.The Fingerprint of Bu zhong yi qi Pills can effectively control the authenticity and merits of different batches of Bu zhong Yi qi Pills,which is of great significance to the quality control and standard improvement of the preparation.