Study On The Determination Of Multi-component Of Ginkgo Biloba Extract And The Stability Of Finished Product Infusion

Ginkgo Biloba Extract(GBE)is a kind of product which is rich in active ingredients by using the dry leaves of Ginkgo biloba L.as raw material and using appropriate solvent.Ginkgo deciduous trees can be as high as forty meters.The trunk is straight and has a gray bark.The branches are long,short two,and the leaves are shaped like a fan.In many provinces in China can see its distribution,with many medicinal value,in the earliest existing pharmacology monograph "Shen Nong's Materia Medica" in the relevant description,wrote: "There are wet lungs,asthma,cough,etc." In Li Shizhen's "Compendium of Materia Medica" also have "Dingchuan cough","only with turbidity","shrink" and "Tongling effect" and other related records.Pharmacopoeia from the drug data can be found,ginkgo preparations market share in the first cardiovascular medicine,far ahead of the rest of the species.Such agents have a significant effect on cardiovascular and cerebrovascular diseases.At present,the pharmacological effects of Ginkgo biloba have been from all over the world,many experts have to pay attention to,they carried out a large number of studies,study,found that flavonoids and terpene lactones is its main active substances.Ginkgo biloba extract can improve the recovery of human arterial blood vessels,increase red blood cells to carry oxygen capacity,so as to achieve the effect of improving myocardial resuscitation.Observation of our hospital clinical patients medication records,found that the relevant adverse reactions occur.Analysis of the reasons for the various manufacturers of Ginkgo biloba raw materials,origin,origin,picking and processing more chaotic extraction,production conditions and production processes are not uniform standards.Part one Contents of active ingredients in nine kinds of Ginkgo biloba extract were determined by UPLC-MS / MSObjective:(Narcotic glycosides),Rutin(Rutin),Rutin(Rutin),Rutin(Rutin),Rutin(Rutin)Kaempferol,Quercetin,Isorhamnetin,Ginkgolide A,Ginkgolide B,Ginkgolide C,Ginkgolide B,Ginkgolide B,Ginkgolide B,Ginkgolide B,Ginkgolide B,Ginkgolide The content of nine major active ingredients.Methods: Using ultra performance liquid chromatography-tandem mass spectrometry.The column was Phenomenex Kenetix C18 column(50 mm × 3mm,5 ?m)and the temperature of the column was room temperature.The mobile phase consisted of methanol-water containing 0.1% formic acid and gradient eluted with a flow rate of 0.3m L/min.Source MRM mode,quantitative analysis,the source injection voltage of-4500 V,ion source temperature is 600 ?.(407.1/351.1),ginkgolide B(423.1/367.3),ginkgolide C(439.1/383.3),ginkgolide(325/163),quercetin(301.1/150.9),Isorhamnetin(315/300),kaempferol(285.3/117),rutin(609.1/300),andnarcissus(623.1/315.1).Results: 9 species of the correlation coefficient(r? 0.9973).The RSD of the precision was 1.1% ~ 1.9%(n = 6),the stability was good within 12 h,the reproducibility of the experiment was good,and the correlation coefficient of the nine substances was completely separated.The recoveries were 95.44% ~103.47%.Conclusion: The method of study has good reproducibility,precision and good recovery.Simple and fast,can be good for Ginkgo biloba extract injection for quality control.Statistical analysis showed that there were no statistically significant differences in quercetin among the nine components of Ginkgo biloba extract,and the other eight components were statistically different(P <0.05).Part Two Study on the Stability of Ginkgo Biloba Extract InjectionObjective: The Ginkgo biloba extract of three different manufacturers(Yuekang Pharmaceutical,Shenwei Pharmaceutical and Taiwan Jisheng Pharmaceutical)were tested with different solvents(sodium chloride solution and glucose solution)at different times and different conditions(Roomtemperature,high temperature and light).Methods: Ginkgo biloba extract and two kinds of solvents compatibility,divided into normal temperature group,high temperature group and light group,to observe the appearance of the finished product infusion,insoluble particles,p H and flavonoid content changes,which appearance,insoluble particles by 2015 Edition "Chinese Pharmacopoeia" fourth general rule under the characteristics of the inspection method for testing,flavonoid compounds were determined by HPLC-UV methodResults: Finished product 24 h clarification,no significant turbidity and precipitation,no significant change in color,yellow clarity,p H value and particle value was no significant change;5% glucose injection as a solvent p H value than 0.9% sodium chloride injection Low,but all meet the requirements of the finished product infusion p H;the finished product infusion of quercetin,isorhamnetin content in the 24 h remained essentially unchanged,Shenwei Pharmaceutical kaempferol content higher than the other two manufacturers,but Are within the standard range.Conclusion: Three different manufacturers of finished product infusion under different conditions are more stable.