基于直接压片的多孔核壳粒子优化和应用  

Optimization and application of porous core-shell particles for direct compaction

作　　者：李哲[1] 肖燕琳 朱琳[2] 刘文君 杨凌宇 金正吉 Abid Naeem 朱卫丰[1] 冯怡[1,4] 明良山[1] Zhe Li;Yanlin Xiao;Lin Zhu;Wenjun Liu;Lingyu Yang;Zhengji Jin;Abid Naeem;Weifeng Zhu;Yi Feng;Liangshan Ming(Key Laboratory of Modern Preparation of TCM,Ministry of Education,Institute for Advanced Study,Jiangxi University of Chinese Medicine,Nanchang 330004,Jiangxi,China;Macao Centre for Research and Development in Chinese Medicine,State Key Laboratory of Quality Research in Chinese Medicine,Institute of Chinese Medical Sciences,University of Macao,Macao,China;Jiangzhong Pharmaceutical Co.Ltd.,Nanchang 330049,Jiangxi,China;Engineering Research Center of Modern Preparation Technology of TCM of Ministry of Education,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]江西中医药大学高等研究院现代中药制备教育部重点实验室,江西南昌330004 [2]澳门大学中医药研究所,澳门中医药研究发展中心,中药品质研究国家重点实验室,中国澳门 [3]江中药业股份有限公司,江西南昌330049 [4]上海中医药大学中药现代制备技术教育部工程研究中心,上海201203

出　　处：《Journal of Chinese Pharmaceutical Sciences》2024年第5期412-429,共18页中国药学（英文版）

基　　金：National Natural Science Foundation of China(Grant No.82003953,82360777);China Postdoctoral Science Foundation(Grant No.2019M662278);National Natural Science Foundation of Jiangxi Province(Grant No.20202BAB216039,20232ACB216015,20212BAB216009 and 20232BAB206166);2020-2022 Young Talents Support Project of Chinese Society of Chinese Medicine(Grant No.2020-QNRC2-07);Jiangxi University of Chinese Medicine Science and Technology Innovation Team Development Program(Grant No.CXTD-22004);Doctoral Research start-up Fund Project of Jiangxi University of Chinese Medicine(Grant No.2021BSZR015,2022BSZR003)。

摘　　要：采用中心复合设计优化了影响多孔型核壳复合颗粒(PCPs)直接压片(DC)性能的配方参数。分别以PVP和NH4HCO3作为壳层材料和制孔剂,选择共喷雾干燥为制备工艺。以PCPs的产率、流动性、压缩性和崩解时间作为响应值。结果表明,NH4HCO3和PVPK30的最佳配比分别为4.76%和9.42%。产率、流动性、压缩性和崩解时间的测定值分别为62.00%、38.50°、4.02 MPa和14.33 min。预测误差分别为2.99%、1.09%、5.70%和2.28%。在本研究中,最优的PCPs与四种DC辅料混合用于连续DC。结果表明,优化后的PCPs具有优良的直压性能和适用性,为其他中药制备PCPs及实现DC提供思路和理论支持。Xiao Er Xi Shi formulation powder(XEXS)is often used to treat indigestion for children and its extract powders have poor functional properties.In order to prepare XEXS-PCPs(porous core-shell composite particles)with optimal properties,the central composite design was used to optimize the formulation parameters that affect the direct compaction(DC)properties of PCPs based on XEXS.The proportions of shell material and pore-forming agent were taken as independent variables,and the yield,flowability,compactibility and disintegration time of PCPs were used as the response values.It was found that the best proportions of NH4HCO3 and PVP K30 were 4.76%and 9.42%,respectively.Furthermore,the measured values of yield,flowability,compactibility and disintegration time were 62.00%,38.50°,4.02 MPa and 14.33 min,respectively.The prediction errors were 2.99%,1.09%,5.70%and 2.28%,respectively.In the present study,the optimal PCPs were mixed with four DC-grade excipients for continuous DC.The results showed that the optimal PCPs had excellent DC properties and applicability.It provides ideas and theoretical support for preparing PCPs and realizing DC for other traditional Chinese medicine.

关 键 词：多孔型核壳复合粒子 优化 喷雾干燥 直接压片 应用 

分 类 号：R943[医药卫生—药剂学]