丹七片薄膜包衣工艺及稳定性研究

Film-Coating Technology of Danqi Tablets and their Stability

目的:探讨丹七片薄膜包衣的最佳工艺参数,提高丹七片的稳定性。方法:采用正交试验,以片床温度、包衣液浓度、包衣增重率、蠕动泵频率为考察因素,以吸湿性、崩解时限和包衣合格率为考察指标,优选包衣工艺。结果:改进后的工艺参数为片床温度50℃、包衣增重率4%、包衣液浓度10%、蠕动泵频率14Hz。在此条件下,薄膜包衣片在稳定性试验中的性状、吸湿性、崩解时限、丹参酮ⅡA含量等指标无明显变化。结论:该方法简便、易行,工艺稳定,可用于丹七片的包衣生产。

Objective:To improve the parameters of film coating technology for Danqi Tablets in order to improve their stability.Methods:Orthogonal test was adopted to review the influence on moisture absorption rate,the disintegration time limit and qualified rate of coating woked by the factors such as bed temperature,coating solution concentration,coating weight gain and peristaltic pump frequency to improve the coating technology.Results:The improved technology parameters were as follows:bed temperature 50℃,coating weight gain 4%,coating solution concentration 10%and peristaltic pump frequency 14Hz.Under the given conditions,the indexes such as properties,moisture absorption rate,disintegration time,tanshinone II A content of film coated tablets did not significantly change while their stability was studied.Conclusion:The method is stable,fast and can be used to manufacture the Danqi Tablets.