生脉饮塑料包装工艺与稳定性研究

Study on Plastic Packing Craft and Stability of Shengmai Oral Liquid

目的改进生脉饮(党参方)塑料包装的灌装(灭菌)工艺,使生产操作简单可控,质量指标符合内控标准,并保持稳定。方法采用正交实验法对煮沸灭菌及保温灌装工艺进行优选,确定最佳工艺后连续生产3批进行工艺验证、稳定性实验,重点考察pH、密度、含量等指标。结果工艺条件确定为:保温温度控制为60℃,药液pH控制在4.0,保温灌装时限控制在8 h内,检测结果符合内控标准,并且质量稳定。结论实验结果为确定正式的生产工艺提供了实验依据。

Objective To improve the plastic packing （antiseptic） craft of shengmai oral liquid to make the production operation simply controllable. Methods Orthogonal testing method was used to optimize the boiling antisepsis and the heat preservation packing craft . Results The technological conditions were determined as follows ：the preservation temperature was controled to 60 ℃, the solution pH to 4.0, the time limit of heat preservation to with in 8 hours, with detection result conforming internal control standard. Conclusion The test results provide the experimental basis for determinaing the formal production craft.