Study On Excipient Of Freeze-drying Varicella Vaccine(Live)and Optimizing The Freeze-drying Curve

Objection:Research the freeze-dry produce technics of varicella attenuated live vaccine.Optimize the existed freeze-dry cycle curve , inspect and evaluate the influence of different curve against the varicella products.Methods:It is always make the disqualificational products in exterior quality,even for the virus titre and moisture content index when the varicella attenuated live vaccine in the process of freeze-dry.It mainly displayed as color anormaly,crude crystals,exist obvious bar shape flashed crstal block-we usually called it "mecrocrystalline"and few products happened to drop off the base and shrink which is lead to low produce rate after freeze.Afer the above-mentioned problem happened,products usually difficult to solute but the normal freeze-dried product should be microcrystaled,well-distributed,loosen and fast solute.In order ot solve this problem,we filter out a set of relative optimized protective solute component,compare the relation between freeze process and mecrocrystalline,design the refined freeze-dried curve,make the experiment many times and gain a lot of test data on the premise of that make sure the three kinds freeze-dried protective solute.To use the method of theory combined with practice,we can designed the experiment process to the point against the exterior quality,restult of moisture content,virus titre index of the freeze-dried varicella attenuated live vaccine.Research the influence of different freeze-dried technics against varicella attenuated live vaccine freeze-dry dose and optimize the freeze-dry technic parameter.To analysis and evaluate every steps of experiment result.Afer the step result is obtained,wen can take advantage of the experiment result and combined with the new theory instruction to make a further adjustment of the next experiment step and redesign the experiment program up until the time of the optimalizing technic curve is obtained.Conclusions:obtain the better freeze-dry procedures than the intrinsicfreeze-dry cycle curve by serious design and carry out of the experiment...