肠溶植物滴丸囊皮配方优化OA

Optimization of the capsule shell formulation of enteric plant dropping pills

中文摘要英文摘要

为优化肠溶植物滴丸的制备工艺,提升其机械性能,促进其在食品和生物医药领域的应用,通过单因素实验和响应面分析确定肠溶植物滴丸的最优配方为:普鲁兰多糖质量分数2.875%、海藻酸钠质量分数0.702%、mκ-卡拉胶∶m结冷胶=3∶1、甘油质量分数2.5%、KCl质量分数0.20%.验证实验结果表明,所制得囊皮薄膜的抗拉强度为10.98±0.42 MPa,断裂伸长率为55.31%±0.65%,与理论预测值相近,表明囊皮薄膜具有良好的机械性能.由该配方制得的肠溶植物滴丸先后在模拟胃液中检查2 h和模拟小肠液中检查3 h未出现崩解或软化现象,而在模拟结肠液中11±3 min内完全崩解,满足《中华人民共和国药典》(2020年版)要求.同时,滴丸在胃液和肠液中的溶胀率分别为38.32%±4.63%和294.92%±7.33%,且外形未出现侵蚀和变形,溶胀性能良好.研究结果可为机械性能优良的肠溶植物滴丸制备提供理论基础和技术支撑,有助于其在食品和医药领域的应用拓展.

The aim of this study is to optimize the preparation process of enteric plant dropping pills and to enhance their comprehensive properties in order to promote their application in food and biomedical fields.Single factor experiments and response surface methodology were employed to optimize the optimal formula:pullulan 2.875%,sodium alginate 0.702%,mκ-carrageenan∶mgellan gum=3∶1,glycerol 2.5%,KCl 0.20%.The results of the verification experiments showed that the tensile strength of the resulting film was 10.98±0.42 MPa and the elongation at break was 55.31%±0.65%,which were similar to the theoretical predictions and showed good mechanical properties.Moreover,the enteric plant dropping pills made from this formula were tested in simulated gastric fluid and simulated intestinal fluid for 2 h and 3 h,respectively,and showed no signs of disintegration or softening.Whereas the dropping pills completely disintegrated in simulated colonic fluid within 11±3 min,meeting the requirements of the Pharmacopoeia of the People's Republic of China(2020 edition).Meanwhile,the dissolution rates of the dropping pills in gastric and intestinal fluids were 38.32%±4.63%and 294.92%±7.33%,respectively,and there was no erosion or deformation,showing good dissolution properties.This study provides a theoretical basis and technical support for the preparation of enteric plant dropping pills with excellent mechanical properties,and strongly promotes their application expansion in the fields of food and medicine.

喻喜华;黄宛璐;陈琳方;李刘若兰;苏志伟;杨林英;肖美添

国药控股星鲨制药(厦门)有限公司,福建厦门 361026||厦门市母婴健康营养产品重点实验室,福建厦门 361026华侨大学化工学院,福建厦门 361021华侨大学化工学院,福建厦门 361021国药控股星鲨制药(厦门)有限公司,福建厦门 361026||厦门市母婴健康营养产品重点实验室,福建厦门 361026国药控股星鲨制药(厦门)有限公司,福建厦门 361026||厦门市母婴健康营养产品重点实验室,福建厦门 361026国药控股星鲨制药(厦门)有限公司,福建厦门 361026||厦门市母婴健康营养产品重点实验室,福建厦门 361026华侨大学化工学院,福建厦门 361021||厦门市海洋生物资源综合利用工程技术研究中心,福建厦门 361021

轻工纺织

肠溶植物滴丸响应面分析法普鲁兰多糖κ-卡拉胶结冷胶

enteric plant dropping pillsresponse surface methodologypullulanκ-carrageenangellan gum

《陕西师范大学学报(自然科学版)》 2026 (1)

64-75,12

福建省高校产学合作项目(2024Y4007)福建省科技计划项目(2023Y0027,2023Y3007)厦门市重大科技计划项目(3502Z20251001)

10.15983/j.cnki.jsnu.2026007

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