复方红素软胶囊的研制-药剂学专业论文.docx

PAGE PAGE 1 摘 要 复方红素软胶囊的研制 研究生：云琦 导师：高晓黎 教授 摘 要 目的：以番茄红素与大豆异黄酮组方，通过制剂研究、质量研究及药理毒理研 究，制备用于中老年抗氧化的产品。 方法：①通过原辅料相容性试验，选择适宜辅料，采用正交试验优选辅料用量， 确定内容物及胶皮处方。②对产品生产使用的胶体磨和干燥设备参数进行考察，确 定生产工艺条件。③按照 20 倍处方量进行三批产品中试放大，验证和完善有关参数。 ④建立活性成分及各测定项目的分析方法，并与上市同类产品进行对比分析，考察 产品质量。⑤小鼠灌胃给予低中高剂量供试品，测定血清 MDA 含量、GSH-Px 活力 和 SOD 活力，观察产品抗氧化作用。⑥取三批中试产品，照药典规定方法进行稳定 性试验，进一步考察产品质量及确定产品有效期。 结果：①内容物采用红花籽油作为溶剂，添加 1.5%蜂蜡作为增稠剂，10.0%辛 癸酸甘油酯和 3.0%大豆磷脂作为分散剂，1.2%VitE 和 0.015%TBHQ 作为抗氧化剂。 胶皮中使用 1.0%二氧化钛作为遮蔽剂，加入 0.0015%玫瑰红色素以增加产品美观性。 ②内容物乳化时间为 7min，软胶囊干燥时间为 4h。③制定产品生产工艺参数符合要 求，三批产品成品率在 96%以上。④所建立方法符合方法学有关要求，本品质量优 于上市参照品质量。⑤本品可提高小鼠血清 GSH-Px 活力和降低血中 MDA 含量，具 有抗氧化功能。⑥各观察项目与试验前比较均无明显变化，产品在 24 个月内质量稳 定可控。 结论：本产品处方工艺稳定可行，能够工业化生产，产品质量稳定可控，产品 质量不低于参照品，动物试验表明本品具有抗氧化功能，未出现毒副作用。 关键词：番茄红素；大豆异黄酮；自由基；抗氧化；软胶囊 新疆医科大学医学硕士学位论文 Preparation of Compound Lycopene and Soybean Isoflavone Soft Capsule Postgraduate：Yun Qi Supervisor：Prof. Gao xiaoli Abstract Objective :TO develope a anti-oxidation product of lycopene and soy isoflavone for the middle-aged through preparation research,quality research,pharmacology and toxicology research. Methods: ①Excipientes were selected by testing the compatibility with APIs,and its amount were optimized by orthogonal test,and obtained the better formulation.②To establish the critical process parameters about Colloid mill and Drying equipment.③For the validation of manufacturing process three batch samples were yieled in scale up 20 times amount of the prescribed.④Established anlytical methodes to study the production quality,and Compared with the reference preparation.⑤The rats were orally administered the sample in low dose,middle dose and high dose. The content of MDA and the activities of GSH-Px and SOD in serum were measured respectively.⑥Observed the quality of three batch preparations through the stability test according to Chinese Pharmacopoeia,and Confirmed the storage time. Results: ①We choose Safflower Seed Oil as diluents. The preparation containes 1.5% beeswax as suspending agent,10.0%