浅谈中药冻干粉成型的影响因素

Influential Factors on Lyophilizing Procedure of Chinese Medicinal Powder Injection

目的论述影响中药冻干粉成型的主要工艺参数,以便对其成品的外观和质量进行控制。方法对影响中药冻干粉成型过程的几个主要工艺参数如赋形剂用量、种类及吸湿性、共晶点或塌陷温度、玻璃化温度、退火等进行了综合论述。结果指出中药冻干粉成品外观中常见问题的形成原因,并针对问题提出解决办法。结论该文对中药冻干粉的成型及质量控制具有一定的指导意义。

Objective This article discusses technological parameters of Lyophilizing procedure of Chinese medicinal powder injection that the appearance and quality of finished product are controled. Methods Predominant technological parameters on Lyophilizing procedure of Chinese medicinal powder injection are discussed, for instance, the dosis, sort and hygroscopicity of filler, eutectic or collapse temperature, the temperature of glass transition, renaturation, renaturation ect.. Results The common problems of finished product are pointed out and the solutions are given. Conclusion This article has directive significance in the formation and quality control of Chinese medicinal powder injection.