首页|白簕多糖颗粒剂的制备工艺研究

白簕多糖颗粒剂的制备工艺研究

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目的 研究白簕多糖颗粒的制备工艺.方法 采用湿法制粒工艺制备颗粒,以成型率、休止角、溶化性作为颗粒剂制备工艺的考察指标.应用单因素法考察多糖与稀释剂配比、润湿剂浓度与用量、干燥温度、干燥时间对颗粒剂质量的影响;在此基础上,以多糖与稀释剂配比、润湿剂浓度、润湿剂用量为考察因素,采用星点设计-响应面法优化处方,并进行工艺验证,计算综合评分评估制备工艺的可行性.结果 最优制备工艺为:赤藓糖醇与白簕多糖配比为3.22∶1、润湿剂乙醇浓度为73.68%、乙醇用量为17.51%,在该条件下制备的白簕多糖颗粒剂的成型率达93.60%,休止角为28.20°,溶化率达98.12%,平均综合评分为97.24.制得的白簕多糖颗粒剂在外观、粒度、水分、总糖含量等方面均符合2020年版《中国药典》颗粒剂项下要求.结论 该制备工艺稳定可行,质量可靠.
Study on preparation process of Acanthopanax trifoliatus(L.)Merr polysaccharides granules
Objective To investigate the preparation process of Acanthopanax trifoliatus(L.)Merr polysaccharides granules.Methods:The granules were prepared using a wet granulation technique.Shaping rate,angle of repose,and solubility were used as indicative parameters to optimize the preparation process.The single factor method was used to investigate the effects of the ratio of A.trifoliatus(L.)Merr polysaccharides to diluents,the concentration of wetting agents,the volume of wetting agent,drying temperature and drying duration on the quality of granules.The central composite design-response surface methodology was employed to optimize the formula by the ratio of A.trifoliatus(L.)Merr polysaccharides to diluents,the concentration of wetting agents and the volume of wetting agent as factors,followed by three batches of process validation.A comprehensive score was calculated to evaluate the feasibility of the preparation process.Results The optimal formula consisted of a 3.22:1 ratio of erythritol to A.trifoliatus(L.)Merr polysaccharides,a wetting agent with an ethanol concentration of 73.68%,and ethanol volume usage of 17.51%.Under these conditions,the A.trifoliatus(L.)Merr polysaccharides granules achieved a 93.60%shaping rate,a 28.20° angle of repose,and a 98.12%dissolution rate,with an average comprehensive score of 97.24.The prepared Acanthopanax trifoliatus(L.)Merr polysaccharides granules meet the requirements of the 2020 edition of the Chinese Pharmacopoeia in terms of appearance,particle size,moisture content,and total sugar content.Conclusion The preparation process is stable and feasible with reliable quality.

Acanthopanax trifoliatus(L.)Merr polysaccharidesgranulepharmaceutical formulation processcentral composite design-response surface methodologyquality evaluation

伍国羽、林榆子、潘育方

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广东药科大学药学院,广东 广州 510006

广东药科大学新药研发中心,广东 广州 510006

广东省局部精准药物递药制剂工程技术研究中心,广东 广州 510006

白簕多糖 颗粒 制剂工艺 星点设计-响应面法 质量评价

广东省自然科学基金项目广州市科学技术局基础与应用基础研究专题

2017A0303136232023A04J1140

2024

10.16809/j.cnki.2096-3653.2023111007

广东药科大学学报
广东药学院

广东药科大学学报

CSTPCD
影响因子：0.698
ISSN：1006-8783
年,卷(期)：2024.40(1)
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