三维亚铁咀嚼片全水性薄膜包衣工艺研究  

Study on the Coating Process of Three-dimensional Ferrous Chewable Tablets with Fully Water-based Film

作　　者：朱雅红 Zhu Yahong(Sinopharm Xingsha Pharmaceuticals(xiamen)Co.,Ltd.,Xiamen,Fujian 316026,China)

机构地区：[1]国药控股星鲨制药(厦门)有限公司,福建厦门361026

出　　处：《化工与医药工程》2023年第5期52-56,共5页Chemical and Pharmaceutical Engineering

摘　　要：通过正交试验,以包衣锅转速(A)、进风温度(B)、喷液量(C)为考察因素,对三维亚铁咀嚼片全水性薄膜包衣工艺进行研究,并对新工艺生产的产品进行加速稳定性和长期稳定性考察,同时与以有机溶媒为分散剂的薄膜包衣产品相比较。通过正交因素考察,得出最佳包衣工艺方案A2B2C3,即转速6 r/min、温度65℃、喷液量95 g/min;加速稳定性实验和长期稳定性实验结果表明,产品的外观性能和含量指标均在合格范围内,符合该药品质量标准的各项规定。说明采用水溶性包衣生产工艺所制备的三维亚铁咀嚼片试样均符合产品标准,表明水溶性包衣可行。Through orthogonal experiments,the full water-based film coating process of three-dimensional ferrous chewable tablets was studied using the coating pot speed(A),inlet air temperature(B),and spray volume(C)as the factors to investigate.The accelerated stability and long-term stability of the products produced by the new process were also investigated,and compared with the film coating products using organic solvents as dispersants.Through orthogonal factor analysis,the optimal coating process plan A2B2C3 was obtained,which includes a rotational speed of 6R r/min,a temperature of 65℃,and a spray volume of 95 g/min;The results of the accelerated stability experiment and long-term stability experiment indicate that the appearance performance and content indicators of the product are within the qualified range,meeting the various provisions of the drug quality standard.The three-dimensional ferrous chewable tablet samples prepared using the water-soluble coating production process meet the product standards,indicating that water-soluble coating is feasible.

关 键 词：正交试验 水性 薄膜包衣 三维亚铁咀嚼片 

分 类 号：R943[医药卫生—药剂学]