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软胶囊产品的质量考察指标——明胶交联程度的评价方法研究 被引量:6

Investigation on the soft capsules retained and evaluation the method of estimating the degree of gelatin crosslinking
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摘要 目的:对评价明胶交联程度的指标及不同留样时间的软胶囊产品进行考察,以检验各指标在反映交联程度中的变化规律以及软胶囊产品随时间延长产品质量的变化趋势,探讨可能的原因和机理。方法:用甲醛处理明胶胶片模拟交联反应,对明胶交联程度的评价指标如氨基酸残基含量(Y)、平衡溶胀量(Seq)、囊皮溶解速率(K)、崩解时间(D)进行测定并进行相关性考察;对番茄红素软胶囊、AD软胶囊、前列卫士软胶囊、共轭亚油酸软胶囊、茶多酚软胶囊、多维软胶囊产品的3种指标Y、Seq、D进行测定。结果:随甲醛浓度的增加,明胶的Y、Seq、K均下降,D延长;明胶发生交联反应后Y、Seq、K、D之间存在良好的线性关系;番茄红素软胶囊、AD软胶囊、前列卫士软胶囊、共轭亚油酸软胶囊、茶多酚软胶囊、多维软胶囊6种产品均随贮存时间的延长Y、Seq减小,D延长。结论:软胶囊产品在贮存期内有随时间延长交联程度增大的趋势,而明胶的自氧化交联和低分子醛类物质交联是导致这个问题的主要原因。 Objective: To evaluate the index of reflecting the degree of gelatin crosslinking and investigate the soft capsules retained under different storing time, to reveal the rule of varity on reflecting the degree of gelatin crosslinking and deduce the variational tendency of quality with prolong of time. To discuss the cause and mechanism of retarded dissolution. Methods: Gelatin flakes were dipped in different concentration of formaldehyde, which simulated gelatin crosslinking. To investigate the correlation between amino group content (Y), swelling equilibrium quantity (Seq), dissolution rate(K), disintegration time(D). The Lycopene soft capsule, Vitamin AD soft capsule, Qianlieweishi soft capsule, Conjugated linoleic acid soft capsule, Tea Polyphe^ols soft capsule and Multi vitamin soft capsule were tested with these indexes. Results: With the increase of formaldehyde concentration, Y, Seq, K decrease, D increase. After gelatin crosslinked, a good lineal relativity was found between Y, Seq, K and D (r =0. 9917-0. 9983). With prolong of time, six kinds of soft capsules show Y and Seq decrease, D increase. Conclusion: Crosslinking increased after storage in a longer time. Soft capsule retarded dissolution was mainly caused by gelatin's selfoxidation crosslinking and the aldehyde's crosslinking.
出处 《新疆医科大学学报》 CAS 2007年第8期794-797,共4页 Journal of Xinjiang Medical University
基金 "十一五"自治区工程技术研究中心组建项目(新科计字[2007])
关键词 软胶囊 氨基酸残基含量 平衡溶胀量 囊皮溶解速率 崩解迟缓 soft capsules amino group content swelling equilibrium quantity dissolution rate retarded dissolution
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