Preparation Of Ginkgo Biloba Extract Lyophilized Powder

Ginkgo biloba extract is one of the nature plant extracts in the world,that is often used as raw material in the fields of medicine,health food,beverages,cosmetics and so on.Now the annual sales of Ginkgo Preparations in China reached 6.0 billion RMB.There are Ginkgo Dipyridolum injections,ShuXueNing injections,Xingxiong injections etc in China.The annual sales of ginkgo injections already reached 4.2 billion RMB.But all the species are water injection.Because of bad stability in water solvent lead to the water injection prone to oxidation and content decreased,the color becomes darker,thus increase the incidence of adverse reactions.Ginkgo biloba extract lyophilized powder preparation of the application despite the production approval,but no products in market,and had not been reported in literature.Therefore,the purpose of this paper is to prepare Ginkgo biloba extract lyophilized powder,to establish a quality standard to control it and to study the stability of it.In order to effectively control the quality of products and ensure the safety of clinical medication,mainly includes the following content.1.Above all,we have researched the quality of Ginkgo biloba leaves by test the content of active ingredients in different parts of Ginkgo.The results showed that the content of flavonol glycosides and terpene lactones in ginkgo leaves are the highest in different parts of Ginkgo.Then we established the grade of the ginkgo leaves by test the content from different ginkgo leaves.2.Secondly,we extracted the active constituents from crushed Ginkgo leaf with 60% ethanol-water,in 70? water bath,extraction 2 times.After the ethanol solution were evaporated to alcohol less under reduced pressure,the extracted solution was separated by DM130 and HPD417 mixed resins column,and removed the Ginkgolic acid from the extract ginkgo leaves with the LX-60 resin column chromatography.We got the crude extracts by concentrating and evaporate to dryness the elution solution which quality can reached the standard of the 2015 edition pharmacopoeia.The content of flavonoids should not be less than 24%,terpene lactones should not be less than 6% and ginkgo acid should not exceed 10mg·kg-1 in the ginkgo biloba extract.At last,we improved the water-solubility and clarity of the crude extract to obtain the Pharmaceutical intermediates which have 3% water soluble and no milky or turbidity after 2 times of high temperature sterilization.3.Thirdly,we studied the preparation process of Ginkgo biloba extract lyophilized powder on screen the type and dosage of excipient and the pH of solution.The results showed it should not less than 4.2mg flavonoids and 0.7mg terpene lactones in one bottle.Mannitol was used as filler about 5%.At the same time,it should be adjusted the pH to 5.The eutectic point of the solution was-7 ? determined by the falling temperature method.The preparation process is identified as follows.Preparation of Ginkgo biloba extract lyophilized powder liquid,add activated charcoal and heat for 30 min helped to eliminate pyrogen,and sterilization with 121 ?,microfiltration before packing.Then pre-frozen in-80 ? for 6 hrs,take them into the lyophilizing machine to lyophilization for 12 hrs,and we can get Ginkgo biloba extract lyophilized powder.4.Fourthly,we studied the quality standard of Ginkgo biloba extract lyophilized powder.Product quality evaluation system was established,including traits,chemical identification,re-solubility time,pH,peak area ratio of flavonoids,moisture level,protein,tannin,resins,residue of ignition,gross deviation.Then we have established the quality standard of Ginkgo biloba extract freeze-dried powder.5.Finally,the stability of Ginkgo biloba extract lyophilized powder was researched on the influencing factors,accelerated and long-term test.The results showed the storage condition of the product is in shading and the storage time is 12 months.