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目的对冻干乙型脑炎减毒活疫苗和冻干麻疹减毒活疫苗的外观结晶粗糙的原因进行分析，以改 善疫苗冻干质量。方法从制品入柜时的不同板层温度、制冷速度、冻结过程等，分析其对制品外观结晶性状的影 响。结果冻干机制冷系统的性能好坏、冻结过程的改变和制品入柜时冻干机板层温度的变化，是决定制品是否 产生粗结晶的主要因素。结论冻干机板层温度从常温降至－４０℃以下的时间控制在２ｈ左右，制品在冻结过程 中，尽量避免在－２０℃左右的区域停留，制品入柜时，板层温度控制在５～１５℃范围，能使制品冻干后的物理外观质 量得到明显改善。
Objective To analyze the reason of rough appearance of freeze-dried live attenuated JE vaccine and live attenuated freeze-dried measles vaccine in order to improve the quality of freeze-dried vaccine. Methods The effects of various factors, such as plate temperature, cooling rate and freezing process, on the appearance and crystallization of products were analyzed. Results The performance of the refrigeration system of the freeze dryer is good or bad. The change of the freezing process and the change of the temperature of the lyophilizer plate when entering the cabinet is the main factor that determines whether the product has a crude crystallization. Conclusion The temperature of the layer of freeze-dried machine is controlled from about room temperature to below -40 ℃ in about 2h. During the freezing process, the product should be kept in the area of -20 ℃ as far as possible. When the product enters the cabinet, the temperature of the floor is controlled at 5 ~ 15 ℃ range, can make the product after the appearance of the physical appearance of the quality of freeze-dried has been significantly improved.