响应面法优化柴黄片包衣工艺及其稳定性研究
投稿时间:2021-07-14     点此下载全文
引用本文: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.响应面法优化柴黄片包衣工艺及其稳定性研究[J].中国现代中药,2022,24(5):876-881
DOI:10.13313/j.issn.1673-4890.20210714006
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作者中文名作者英文名单位中文名单位英文名E-Mail
郭田甜 GUO Tian-tian 鲁南厚普制药有限公司,山东 临沂 276006
中药制药共性技术国家重点实验室,山东 临沂 276006
Lunan Houpu Pharmaceutical Co., Ltd., Linyi 276006, China
State Key Laboratory of Generic Manufacture Technology of Traditional Chinese Medicine, Linyi 276006, China
 
房兆营 FANG Zhao-ying 鲁南贝特制药有限公司,山东 临沂 276006 Lunan Beite Pharmaceutical Co., Ltd., Linyi 276006, China  
窦希波 DOU Xi-bo 鲁南厚普制药有限公司,山东 临沂 276006 Lunan Houpu Pharmaceutical Co., Ltd., Linyi 276006, China  
邵明杰 SHAO Ming-jie 鲁南厚普制药有限公司,山东 临沂 276006 Lunan Houpu Pharmaceutical Co., Ltd., Linyi 276006, China  
张微 ZHANG Wei 鲁南厚普制药有限公司,山东 临沂 276006
中药制药共性技术国家重点实验室,山东 临沂 276006
Lunan Houpu Pharmaceutical Co., Ltd., Linyi 276006, China
State Key Laboratory of Generic Manufacture Technology of Traditional Chinese Medicine, Linyi 276006, China
 
郝豪奇 HAO Hao-qi 鲁南厚普制药有限公司,山东 临沂 276006
中药制药共性技术国家重点实验室,山东 临沂 276006
Lunan Houpu Pharmaceutical Co., Ltd., Linyi 276006, China
State Key Laboratory of Generic Manufacture Technology of Traditional Chinese Medicine, Linyi 276006, China
 
王立友 WANG Li-you 鲁南厚普制药有限公司,山东 临沂 276006
中药制药共性技术国家重点实验室,山东 临沂 276006
Lunan Houpu Pharmaceutical Co., Ltd., Linyi 276006, China
State Key Laboratory of Generic Manufacture Technology of Traditional Chinese Medicine, Linyi 276006, China
 
刘震远* LIU Zhen-yuan 鲁南厚普制药有限公司,山东 临沂 276006
中药制药共性技术国家重点实验室,山东 临沂 276006
Lunan Houpu Pharmaceutical Co., Ltd., Linyi 276006, China
State Key Laboratory of Generic Manufacture Technology of Traditional Chinese Medicine, Linyi 276006, China
 
关永霞 GUAN Yong-xia 鲁南厚普制药有限公司,山东 临沂 276006
中药制药共性技术国家重点实验室,山东 临沂 276006
Lunan Houpu Pharmaceutical Co., Ltd., Linyi 276006, China
State Key Laboratory of Generic Manufacture Technology of Traditional Chinese Medicine, Linyi 276006, China
 
基金项目:山东省重点研发计划项目(2020CXGC010505)
中文摘要: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。
中文关键词:柴黄片  薄膜包衣  响应面法  黄芩苷  稳定性
 
Optimization of Coating Process by Response Surface Methodology Improves Stability of Chaihuang Tablets
Abstract: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.
keywords:Chaihuang Tablets  film coating  response surface methodology  baicalin  stability
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