Study On Preparation And Quality Standard Of Ginkgo Biloba Injection

OBJECTIVE:This subject study on preparation of raw medicine containing ginkgolide A andginkgolide B.Prepare ginkgolides injection from this basis.And establish a standard forquality control of raw medicine and ginkgolides injection. Provide theoretical guidanc forenlarged production.METHODS:1. Study on drying method of fresh ginkgo leavesBy investigating fresh ginkgo leaves drying methods commonly, to determine theoptimum drying method; further investigating different drying temperatures to determine theoptimum drying temperature; On this basis, study on ginkgo terpene lactone content variationwith drying time, to determine the best drying time. Finally obtain optimal conditions fordrying method of fresh ginkg leaves.2. Preparation of raw medicine containing ginkgolide A and ginkgolide BUsing static adsorption test、column chromatography test to compare effectiveness from differentchromatographic filler by separation of ginkgo terpene lactones, to abtain ginkgolide A,ginkgolide Bextract; then compare purification effectiveness from acidic alumina、MCI gel to abtain raw medicinecontaining ginkgolide A and ginkgolide B. Finally to obtain more than98%purity raw medicine.3. Establish a standard for quality control of raw medicineTo study on the quality of raw medicine, develop the determination method of raw medicine, thenverify the method of determination; while drafting standard quality of raw medicine.4. The preparation of ginkgolides injectionThe ginkgolides in the raw medicine almost insoluble in water, in order to increase their’s solubilityand avoid ginkgolides injection patent restrictions, try to use the HS15excipient to solubilize.5. Establish a standard for quality control of ginkgolides injectionTo study on the quality of ginkgolides injection, develop the determination method of the main drug ininjection, then verify the method of determination; while drafting standard quality of g ginkgolidesinjection. Conclusion: Successfully prepared ginkgolides injection,and establish a standard quality of rawmedicine and ginkgolides injection;the preparation of raw medicine was optimal and theinjection was stable,which was able to enlarge producing.