响应面法优化柴黄片包衣工艺及其稳定性研究  

Optimization of Coating Process by Response Surface Methodology Improves Stability of Chaihuang Tablets

作　　者：郭田甜 房兆营 窦希波 邵明杰 张微 郝豪奇 王立友 刘震远 关永霞 GUO Tian-tian;FANG Zhao-ying;DOU Xi-bo;SHAO Ming-jie;ZHANG Wei;HAO Hao-qi;WANG Li-you;LIU Zhen-yuan;GUAN Yong-xia(Lunan Houpu Pharmaceutical Co.,Ltd.,Linyi 276006,China;State Key Laboratory of Generic Manufacture Technology of Traditional Chinese Medicine,Linyi 276006,China;Lunan Beite Pharmaceutical Co.,Ltd.,Linyi 276006,China)

机构地区：[1]鲁南厚普制药有限公司,山东临沂276006 [2]中药制药共性技术国家重点实验室,山东临沂276006 [3]鲁南贝特制药有限公司,山东临沂276006

出　　处：《中国现代中药》2022年第5期876-881,共6页Modern Chinese Medicine

基　　金：山东省重点研发计划项目(2020CXGC010505)。

摘　　要：目的:针对柴黄片糖衣包裹易吸潮、霉变,药物有效期短等问题,以柴黄素片为试材,探究了薄膜包衣对柴黄片成品性状及稳定性的影响。方法:采取响应面分析法,以进风温度、包衣液体积分数、雾化压力、滚筒转速为考察因素,以包衣合格率和崩解时限为考察指标,优选薄膜包衣工艺条件。将该条件生产的薄膜包衣片与糖衣片进行加速及长期稳定性对比实验。结果:薄膜包衣最佳工艺参数为进风温度65℃、包衣液体积分数12%、雾化压力0.3 MPa、滚筒转速12 r·min^(–1),此条件下薄膜包衣片在稳定性试验中性状、吸湿性、崩解时限、黄芩苷含量均优于糖衣片。结论:柴黄片薄膜包衣可以有效延长药物有效期,该方法简便、易行、工艺稳定,可用于柴黄片的包衣生产。Objective:Sugar-coated Chaihuang Tablets are easy to absorb moisture and become moldy and have a short validity period.In this study,we explored the effects of film coating on the properties and stability of the finished Chaihuang Tablets.Methods:Response surface methodology was employed to optimize the conditions(air inlet temperature,coating solution concentration,atomization pressure,and roller rotation speed)of film coating,with the qualified rate of coating and disintegration time as the indicators.Accelerated and long-term stability comparative tests were conducted for film-coated Tablets produced under the optimized conditions and sugar-coated tablets.Results:The optimum conditions for film coating were the inlet air temperature of 65℃,the coating liquid concentration of 12%,the atomization pressure of 0.3 MPa,and the drum speed of 12 r·min^(-1).Under these conditions,the film-coated tablets had better performance than the sugar-coated tablets in terms of properties,hygroscopicity,disintegration time,and baicalin content.Conclusion:The film coating of Chaihuang tablets can prolong the validity period of the medicine.This method is simple and stable and can be used for the coating of Chaihuang Tablets in production.

关 键 词：柴黄片 薄膜包衣 响应面法 黄芩苷 稳定性 

分 类 号：R286[医药卫生—中药学]