摘要
目的:探索影响玉竹多糖吸湿的因素,研制玉竹多糖防潮中间体片剂。方法:以玉竹多糖粉末中多糖、蛋白质、果糖的含量,以及表征玉竹多糖粉体性质的指标中位径D50、分布跨度Span、比表面积、休止角、松密度、振实密度为研究对象,采用逐步回归分析法探索影响玉竹多糖吸湿的主要因素。根据逐步回归分析结果,通过制片的方法降低比表面积;采用单因素实验考察片剂直径、稀释剂、润滑剂对休止角、吸湿率、硬度、脆碎度的影响;在此基础上,采用Box-Behnken设计-响应面法优化片剂处方,制备玉竹多糖防潮中间体片剂,同时测定其平衡吸湿率、临界相对湿度,并与玉竹多糖粉末比较。结果:逐步回归结果表明,玉竹多糖粉末的比表面积、松密度,以及蛋白质、果糖等杂质的含量对玉竹多糖吸湿均有显著影响,其中比表面积的因子系数最大;玉竹防潮中间体片剂的处方为:乳糖17.00%、微晶纤维素(MCC)17.00%、硬脂酸镁0.80%;与玉竹多糖粉末比较,平衡吸湿率由22.25%降低至11.03%,临界相对湿度由48.40%提高到75.00%。结论:比表面积是玉竹多糖吸湿的主要因素。将玉竹多糖制备成防潮中间体片剂可减小玉竹多糖粉末的比表面积,进而降低其吸湿性。
Objective:To investigate the factors affecting the hygroscopicity of Polygonatum odoratum polysaccharide and to develop moisture-resistant intermediate tablets.Methods:The contents of polysaccharide,protein and fructose in Polygonatum odoratum polysaccharide powder and the indicators characterizing the properties of Polygonatum odoratum polysaccharide powder,such as median diameter D50,distribution span,specific surface area,angle of repose,bulk density and tap density were used as the research objects to determine the most critical factors affecting the hygroscopicity of Polygonatum odoratum polysaccharide by stepwise regression method.The prepare tablet method was used to reduce the specific surface area based on the results of the stepwise regression method.In addition,the effects of tablet diameter,diluent and lubricant on the angle of repose,moisture absorption rate,hardness and fragility were investigated through single-factor experiments.On this basis,moisture-resistant intermediate tablets of Polygonatum odoratum polysaccharide were formulated using the Box-Behnken design-response surface method.The tablet's equilibrium moisture absorption rate and critical relative humidity were simultaneously determined and compared to Polygonatum odoratum polysaccharide powder.Results:The results of stepwise regression indicated that the specific surface area,bulk density,and content of protein,fructose,and other impurities in Polygonatum odoratum polysaccharide powder had significant effects on the powder's moisture absorption,with the specific surface area factor coefficient being the largest.The composition of the moisture-resistant intermediate tablets of Polygonatum odoratum was as follows:Lactose 17.00%,microcrystalline cellulose(MCC)17.00%and magnesium stearate 0.80%.Compared to Polygonatum odoratum polysaccharide powder,the equilibrium moisture absorption rate decreased from 22.25%to 11.03%,and the critical relative humidity increased from 48.40%to 75.00%.Conclusion:Specific surface area was the main factor of moisture absorption of Polygonatum odoratum polysaccharide.Preparing Polygonatum odoratum polysaccharide powder into a moisture-resistant intermediate tablet could decrease its specific surface area,thereby reduce its hygroscopicity.
作者
邓碧莲
吴璐
李婷
柳婷
欧阳征海
杨华生
DENG Bilian;WU Lu;LI Ting;LIU Ting;OUYANG Zhenghai;YANG Huasheng(College of Pharmacy,Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China)
出处
《食品工业科技》
CAS
北大核心
2023年第17期212-221,共10页
Science and Technology of Food Industry
基金
国家自然科学基金地区基金项目(81960724)。
关键词
玉竹多糖
吸湿性
逐步回归分析
防潮中间体
片剂
Polygonatum odoratum polysaccharide
hygroscopicity
stepwise regression method
moisture-resistant intermediate
tablet
作者简介
邓碧莲(1998-),女,硕士研究生,研究方向:药物新剂型和新技术,E-mail:15807909327@163.com;通信作者:杨华生(1974-),男,博士,教授,研究方向:传统中医药理论及制剂,E-mail:yanghuasheng456@126.com。
