妇科调经片成型工艺的优化及其稳定性研究  

Study on the Optimization and Stability of the Forming Process of Gynecological Menstruation Tablets

作　　者：郭田甜 关永霞 张微 刘震远 张兰 韩培 毕艳艳 陈意菲 房兆营 崔海霞 GUO Tian-tian;GUAN Yong-xia;ZHANG Wei;LIU Zhen-yuan;ZHANG Lan;HAN Pei;BI Yan-yan;CHEN Yi-fei;FANG Zhao-ying;CUI Hai-xia(Lunan Houpu Pharmaceutical Co.,Ltd.,Linyi 276000,China;State Key Laboratory of Generic Manufacture Technology of Traditional Chinese Medicine,Linyi 276000,China;Lunan Beite Pharmaceutical Co.,Ltd.,Linyi 276000,China;Administration for Market Regulation of Linyi,Lanshan,Linyi 276000,China)

机构地区：[1]鲁南厚普制药有限公司,山东临沂276000 [2]中药制药共性技术国家重点实验室,山东临沂276000 [3]鲁南贝特制药有限公司,山东临沂276000 [4]临沂市兰山区市场监督管理局,山东临沂276000

出　　处：《现代中药研究与实践》2022年第4期66-72,共7页Research and Practice on Chinese Medicines

基　　金：山东省重点研发计划(重大科技创新工程:2021CXGC010508);兰山区科技创新发展计划项目(1942)。

摘　　要：目的优化妇科调经片成型工艺,考察其成品稳定性。方法以妇科调经片的浸膏相对密度、润湿剂浓度、物料液固比、助流剂用量作为考察因素,将崩解时限、脆碎度、装量差异三者综合评分作为考察指标,利用响应面法对妇科调经片成型工艺进行优化并探究保质期内稳定性。结果响应面优化出的工艺参数为浸膏相对密度1.20 g/mL、润湿剂浓度80%、物料液固比30%、助流剂用量0.6%,此条件下生产的妇科调经片品质最佳,在稳定性考察过程中加速试验和长期试验均符合规定。结论优化后的妇科调经片成型工艺试验参数精确,生产工艺稳定、可行,有效成分含量高,为药品上市及后续研究提供了理论指导依据。Objective To optimize the molding process of gynecological menstrual adjustment tablets and investigate the stability of the finished product.Methods The relative density of the extract,wetting agent concentration,material liquid-solid ratio,and amount of glidant of gynecological menstruation tablets were used as the factors to be investigated.Taking the disintegration time limit,friability and loading difference as the evaluation indicators,the response surface method was used to optimize the molding process of gynecological menstrual adjustment tablets and explore the stability during the shelf life.Results The process parameters optimized by the response surface were as follows:the relative density of the extract was 1.20 g/mL,the concentration of the wetting agent was 80%,the liquid-solid ratio of the material was 30%,and the amount of the glidant was 0.6%.During the stability investigation,the accelerated test and the long-term test were in compliance with the regulations.Conclusion The optimized gynecological menstruation-adjusting tablet molding process test parameters are accurate,the production process is stable and feasible,the active ingredient content is high,which provides a scientific theoretical basis for drug marketing and subsequent research.

关 键 词：妇科调经片 响应面法 成型工艺优化 稳定性 

分 类 号：R283.3[医药卫生—中药学]