优化连参通淋片的薄膜包衣工艺-《西部中医药》

文章信息/Info

Author(s):: GAO Huiqin, LU Xiaofeng, QU Yunping△,WANG Jiao, LI Fei; China Shineway Pharmaceutical Group Ltd., Shijiazhuang 051430, China

Keywords:: LianShen TongLin tablets; film coating process; orthogonal design test

摘要:: 目的：优化连参通淋片的薄膜包衣工艺。方法：以薄膜包衣预混剂的用量、出风温度、雾化压力、包衣液浓度为考察因素，以崩解、外观合格率为评价指标，采用正交试验设计优化连参通淋片的薄膜包衣工艺。结果：薄膜包衣预混剂的用量、出风温度对包衣工艺具有显著影响，其次为雾化压力，而包衣液浓度对包衣工艺无显著影响，综合确定其最佳工艺为薄膜包衣预混剂用量为4%，出风温度40℃，雾化压力为0.35 MPa，包衣液浓度为7%。结论：优化后所得包衣工艺参数有效可行，结果稳定，可用于连参通淋片的薄膜包衣工艺。

Abstract:: Objective: To optimize film coating process of LianShen TongLin tablets. Methods: The dose of film coating premix, outlet temperature, atomization pressure and the concentrations of coating solution were chosen as the investigation factors, qualification rates of disintegration and appearance as the evaluation indexes, film coating process of LianShen TongLin tablets was optimized using orthogonal design test. Results: The dose of film coating premix, outlet temperature showed significant effects on coating process, atomization pressure the next, while the concentrations of coating solution had no significant effects on coating process, the optimal process was the dose of film coating premix 4%, outlet temperature 40℃, atomization pressure 0.35MPa and the concentrations of coating solution 7% by comprehensive determination. Conclusion: The parameters of film coating process are valid and feasible after the optimization, the results are stable, and the process could be use for film coating of LianShen TongLin tablets.