明胶胶囊中醛基的测定研究与应用  

Determination of aldehyde groups in gelatin capsules:research and application

作　　者：徐雅婷 金孔语恬 沈晨栋 凌宗涛 崔迎 董华平[1] 寿建昕[1] 朱帅辉 骆翔 XU Yating;JIN Kongyutian;SHEN Chendong;LING Zongtao;CUI Ying;DONG Huaping;SHOU Jianxin;ZHU Shuaihui;LUO Xiang(Shaoxing University,Shaoxing 312000,China;Zhejiang Huaguang Capsule Co.,Ltd.,Shaoxing 312500,China)

机构地区：[1]绍兴文理学院,浙江绍兴312000 [2]浙江华光胶囊股份有限公司,浙江绍兴312500

出　　处：《中国药剂学杂志（网络版）》2023年第5期241-249,共9页Chinese Journal of Pharmaceutics：Online Edition

基　　金：2020年新昌县科技攻关计划(20200008);2020年浙江省大学生科技创新活动计划暨新苗人才计划(2020R444007);绍兴文理学院校级重点科研项目(2020LG1002)。

摘　　要：目的明胶胶囊是用途广泛的一种药用辅料,但其氧化交联反应严重影响胶囊产品性能和胶囊产品有效期,导致胶囊剂的药物溶出度和生物利用度下降。方法为了减缓明胶胶囊的交联反应,本研究以不同抗氧剂制备的抗交联明胶胶囊;采用品红—亚硫酸法和2,4-二硝基苯肼法测定醛基,并筛选消除胶囊中醛基最有效的抗氧剂。结果加速实验显示茶多酚和甘氨酸能够显著消除明胶胶囊中的醛基,具有较好的抗氧化能力。结论利用抗氧剂保护明胶胶囊,消除其中的醛基,减缓明胶的交联反应,可改善明胶胶囊的溶出性能和明胶胶囊剂的有效期,为开发抗交联明胶胶囊提供理论基础和技术指导。Purpose Gelatin capsules are widely used as a kind of pharmaceutical excipients,but the oxidative cross-linking reaction seriously affects the physicochemical properties and the validity period of capsules,resulting in the decrease of drug dissolution and bioav ailability for capsule preparations.Methods In order to slow down the cross-linking rate of gelatin capsules,the cross-linking resistant gelatin capsules were fabricated with different antioxidants;Then,the fuchsin-sulfurous acid reagent and 2,4-dinitrophenylhydrazine reagent were used to determine the aldehyde groups,and the most effective antioxidants were optimal for eliminating the aldehyde groups in the capsules.Results Accelerated experiments showed that tea polyphenols and glycine could eliminate the aldehyde groups significantly in gelatin capsules and exhibited better antioxidant capacity.Conclusion Antioxidants are used to protect gelatin capsules,eliminate aldehyde groups,slow down the cross-linking rate of gelatin,and improve the dissolution performance and the validity period of gelatin capsules.This study provide s the theoretical basis and technical guidance for the development of cross-linking resistant gelatin capsules.

关 键 词：明胶交联 醛基 品红—亚硫酸法 2 4-二硝基苯肼法 抗氧剂 

分 类 号：R94[医药卫生—药剂学]