Quality Standard Study Of Te Zhi Jiegu Pills

Objective:One of the traditional medicine of Pingle Zhenggu is the Tezhi Jiegu Pills,it is an internal preparation of the hospital in Luoyang,Henan Province.It has been applied in clinical for decades and has received the good clinical curative effect.So it is incorporated into the development and research project of the traditional medicine in Pingle Zhenggu,Henan Province.The experiment is mainly to establish the quality standard system of the Tezhi Jiegu Pills for the medicinal preparation of the bonesetting hospital in Luoyang,Henan Province.Methods:we use the method of microscopic identification to identify e-xclusive organizational structure characteristics of various herbs in Te zhi Jiegu Pills,the purpose is to lay a foundation for the qualitative i-dentification of the preparation.we use the method of thin layer chromatography?TLC?to identify 10flavour of traditional Chinese medicine in the prescription,including A-stragalus membranaceus,Rhizoma drynariae,Red ginseng,Pseudoginseng,Teasel root and so on.We mainly investigate some influence factors,suc-h as sample pretreatment method,a system and sample volume,the pur-pose is to lay a foundation for improving the quality standards of the preparation.HPLC-UV was used the analysis was carried on Wonda Sil?ODS column?4.6mm*250mm,5um?;The mobile phase was the methanolwater?40:60?;The column temperature was 30?;The flow rate was 1.0m L*min^-1 and the detection wavelength was 283nm.We establish a method f-or content determination of naringin in Tezhi Jiegu Pills,the purpose is to provide reference for the quality control of the preparation.In the process of the experiment of the part,First of all,we use a single factor experiment,we focus on extraction method,the kind and amount of solvent,extraction time and the proportion of mobile phase.Secondly,we mainly investingate the specificity of the method,repeatabi-lityy,precision,stability and recovery from several aspects,so as to est-ablish a stable and feasible method of the aringin content determinatio-n method.HPLC-ELSD was used the analysis was carried on Wonda Sil?OD-S column?4.6mm*250mm,5um?;The mobile phase was the acetonitrile water?34:66?;The column temperature was 25?;The flow rate was 1.0m L*min^-1,the drift tube temperature was 105?,the gas flow was 2.8L*min^-1.The sample quantity was 20u L.We establish a method for conten-t determination of astragalus armour glycosides in Tezhi Jiegu Pills,the purpose is to provide reference for the quality control of the prepara-tion.In the process of the experiment of the part,First of all,we use a single factor experiment,we focus on extraction method,the kind and amount of solvent,extraction time and the proportion of mobile phase.And we optimize the parameters of the ELSD.Secondly,we mainly investigate the specificity of the method,repeatability,precision,stability and recovery from several aspects,so as to establish a stable and feasible method of the astragalus armourglycosides content determination method.To establish a quantitative analysis of multicomponent with a sin-gle markermethod for the determination of panax notoginseng saponin-s R₁,ginseng saponin Rg₁ and Re,and astragalus glycosides in Tezhi Jie gu Pills.The ginseng saponins Rg₁ was used as the internal reference substance.HPLC method was adopted to determination the content of g-inseng saponins Rg₁ and obtain relative correction factor of it to oth-er three components for calculation.At the same time the external sta-ndard method was adopted for the content determination of four comp-onentts and compared with multicomponent quantitation by one mark.In the process of the experiment of the part,First of all,we use a single factor experiment,we focus on extraction method,the kind and amount of solvent,extraction time and the proportion of mobile phase.And we optimize the parameters of the ELSD.Secondly,we mainly inv-estingate the specificity of the method,repeatability,precision,stability a-nd recovery from several aspects.In this experiment,we use the relativ e-e retention time value to peak position for measuring component chr-omatographic,and the durability of the relative retention time and relat-ive correction factor was investigated from different instruments,differ-ent chromatographic column,column temperature,and so as to establish a stable and feasible method of four components content determinatio-n method.Results:Microscopic identification features was obvious,its intuitive and specificity is strong.especially structure characteristics of the animal m-edicine,including ground beetle,deer antler.The characteristic of 8 TCM in the thin layer chromatogram which is established in this paper is strong,the spots were clear.The determination method of the content determination of naringin in this paper was carried out.The range of content is that this product contains the bone fragments and it is not less than that 1.0903mg/g.The determination method of the content determination of naringin in this paper was carried out.The range of content is that this product contains the astragalus,which is not less than that 0.0311mg/g.Notoginsenoside R₁,ginsenosides Rg₁,ginsenosides Re and astragaloside respectively in 0.515¹.030,2.500⁵.000,1.510³.020,2.810⁵.620ug go od linearity in the range.The results showed that thef value of notogi-nsenoside R₁,ginsenosides Re and astragaloside to ginsenosides Rg₁ we re 0.8494,0.9302,0.9581.Conclusion:The method of the microscopic and TLC qualitative identi-fication which is established is simple feasible,specificity is strong an-d repeatability is good.This method is accurate,reproducible and conven-ient for quality control over Tezhi Jiegu Pills.Multicomponents quanti-tation by one mark is feasible for the content determination of four saponins in Tezhi Jiegu Pills.