PHarmaceutical Research Of Diterpene Lactones Of Ginkgo Injection

Diterpene Lactones of Ginkgo Injection is made by changing the dosage form of ginkgo diterpene lactone meglumine injection which has been listed on the production by Jiangsu kanion pharmaceutical co.,LTD.Its main composition is ginkgo lactone A,B.,K,with the pharmacological effects of anti platelet aggregation,the protection of ischemic injury,resistance ofatherosclerosis and so on.Clinical is mainly used for the treatment of cerebral infarction.Diterpene Lactones of Ginkgo Injection adopts freeze drying process which is carried out under the condition of low temperature and vacuum to avoid heating make drugs produce change.Product has the characteristics ofstable skeleton,good solubility,water content is low,good stability and convenient for storage and transportation.??The research ofprescription screening and freeze drying technology of Ginkgo diterpene lactone for injection1.The prescription screening of Diterpene Lactones of Ginkgo InjectionWith the appearance,after soluable,clarity as evaluation index to screenthe kind and dosage of the support agent of Diterpene Lactones of Ginkgo Injection,finally to determine 25 mg gingko diterpene lactone and 125 mg mannitol in per bottle as the best prescription.At the same time examines the effects which pH value has on the the stability of the aqueous solution of ginkgo biloba diterpene lactone,the results showed that:the clarityis better when pH 8.0 to 9.0.2.Diterpene Lactones of Ginkgo Injection sterilization process researchWith the changes of ginkgo lactone A,B,C,K as an index and using activated carbon process and microfiltration process to proceed the antibacterial research for the Diterpene Lactones of Ginkgo Injection.Using orthogonal test to investigate the dosage of activated carbon,adsorption time,stirring speed and solution temperature,the experimental results show that the activated carbon dosage and adsorption time have important effects on ginkgo lactone content,0.2%activated carbon dosage,stiring for 20 minutes at 25?.According to the above determined best prescription to dispense solution,using the aseptic technique of combination of activated carbon and 0.22 um microporous membrane filter,with ginkgo lactone content,heat source,bacterial endotoxin as evaluation index,three groups ofparallel experiment was carried out.The results show that the aseptic process of combination of the activated carbon and 0.22 um microporous membrane filter can achieve the requirements of controling the pyrogen and the bacterial endotoxin of the Diterpene Lactones of Ginkgo Injection,and the transfer rate of ginkgo total diterpene lactone content can reach 94%3.Research on freeze drying of Diterpene Lactones of Ginkgo InjectionThe key parameters of the freeze drying process:the lowest melting point,precool temperature,precool time,precool rate,sublimation drying temperature,sublimation drying time,drying temperatureof analyticalinvestigation,drying time of analyticalinvestigation have been made a tatol inspection.Eventually determine the freeze drying process is:the pre-frozen temperature 40?,precool time4 hours;Sublimation drying temperature 10?,the sublimation drying time 16 hours.Drying temperature 20?,parse the drying time of 8 hours.4.Research on Compatibility and try to enlarge of Diterpene Lactones of Ginkgo Injection solutionCompatibility studies of Diterpene Lactones of Ginkgo Injectionsolutionwas carried out,the results showed that:combined with 0.9%sodium chloride injection,5%dextrose injection,Diterpene Lactones of Ginkgo Injection is stable within 12 hours.Having three batch of pilot magnification for Diterpene Lactones of Ginkgo Injection,the results showed that:the prescription and freeze-drying technology parameterof Diterpene Lactones of Ginkgo Injectionis stable,product qualification rate and the quality can meet the requirements.??Research on quality standards of Diterpene Lactones of Ginkgo InjectionIn accordance with(Chinese Pharmacopoeia 2010 edition an appendix I U injection),from the aspects of visible foreign matter,insoluble particles,related substances,sterile,pyrogen,bacterial endotoxinContent determination and fingerprintto develop quality standards for Diterpene Lactones of Ginkgo Injection,thereby to provide a scientific basis for the safety and quality of products.??Preliminary study on stability of Diterpene Lactones of Ginkgo Injection1.Factors affecting testDiterpene Lactones of Ginkgo Injection were at high temperature 60?,humidity(RH=92.5±5%),the light intensity of 4500±500Lx conditions for 10 days,respectively,in 0 days,5 days,10 days sampling,inspection Appearance traits,visible foreign matter,insoluble particles,related substances,pyrogen content,fingerprint,the results showed that:the indicators did not change significantly.2.Accelerated stability testDiterpene Lactones of Ginkgo Injection were at 40?(RH=92.5±5%)is placed under six months,respectively,in 0,1,2,3,6 sampling,inspection Appearance,visible foreign body,insoluble particles,related substances,pyrogen content,fingerprint,the results showed that:the indicators did not change significantly.3.Long-term stability testDiterpene Lactones of Ginkgo Injection were at 25?(RH?60±10%)is placed under Twelve months,respectively,in 0,3,6,9,12 sampling,inspection Appearance,visible foreign body,insoluble particles,related substances,pyrogen content,fingerprint,the results showed that:the indicators did not change significantly.??Preliminary study on safety of Diterpene Lactones of Ginkgo InjectionThe Diterpene Lactones of Ginkgo Injection were hemolytic test,muscle stimulation test,vascular stimulation test,active systemic anapHylaxis test,passive cutaneous anapHylaxis test and safety test.The results show that:the injection of Ginkgo Terpene Lactones two no haemolytic effect on rabbit red blood cell;no significant stimulation to the auricular vein,no obviousstimulation effect on rat stock four myo,no allergic reactions in guinea pigs,and rabbits pyrogen test results also show that,without increasing the temperature.??Preliminary study on crystal type of Diterpene Lactones of Ginkgo InjectionDiterpene Lactones of Ginkgo Injection by different freeze-drying process and a different prescription ingredients lyopHilized powder diffraction X-sample test results showed that:the process of freeze-drying the grain pre-freezing temperatures for the second injection of terpene lactones in Ginkgo plays a major role in the formation of type injection Ginkgo diterpene lactone type mainly crystalline polymorpH of mannitol during freeze-drying form.