蛋白类药物口服吸收研究方法及鹿茸有效物质的示范研究

It is a thorny issue for medical researchers whether proteins from animal drugs used in Traditional Chinese Medicine could be absorbed into bloodstream after oral administration. Due to the limitations of detection methods, up to now, there has no clear active ingredient was discovered and No clear mechanism of activity was elucidated in all animal medicines, which greatly influenced the development and application of modern animal medicine. To solve this problem, we have set up a protein tracing method with protein mixture extracted from pilose antler when oral administrated to rat. The result showed that protein from the mixture could be detected in rat blood. On the basis of the work above, in this project, we will fully scan whole protein from Pilose Antler, to determine which components could be detected in the rat blood after oral administered. With the information provided on the the antler protein library, clinical information and comprehensive analysis of the modern Pharmacology, the absorbed protein from Pilose Antler were selected for the further research of the activity to clarify the following issues: 1. Is it reasonable for oral administration mode for Pilose Antler? 2. Is the effect of extracted protein in consistent with the theory of traditional medicine? This method can be extended to other animal drugs with a great innovative significance and application value.

传统中药的用药方式多为口服给药，口服后，中药中的大分子蛋白质成份经过体内的生物降解与修饰，发生一系列的变化，由于结构变化复杂、同源背景噪音高、检测手段有限等原因，至今尚没有合适的方法检测口服蛋白类药物吸收入血的过程及其药效作用机制。本研究用鹿茸蛋白作为方法学研究对像，用胃肠道稳定的荧光分子标记N末端，利用偏振光成像、荧光关联谱等生物光子学技术进行探测，结合蛋白质组学相关手段，确定口服鹿茸蛋白能否被吸收入血及可吸收入血的蛋白种类，并进一步证明吸收入血的蛋白为药理活性成份，阐明鹿茸蛋白的作用机制，建立完整的蛋白类药物口服吸收研究方法。该方法避免了复杂的分离提取过程，可在极低浓度下追踪大分子中药活性成份，锁定活性物质，可用于中药大分子吸收过程、体内代谢过程、脏器分布等方面的研究，为阐明中药复方作用机理及相关制剂的开发和质量控制提供新的实验技术，并可推广到其他蛋白类药物，具有普遍应用价值。

传统中药的用药方式多为口服给药，口服后，中药中的大分子蛋白质成份经过体内的生物降解与修饰，发生一系列的变化，由于结构变化复杂、同源背景噪音高、检测手段有限等原因，至今尚没有合适的方法检测口服蛋白类药物吸收入血的过程及其药效作用机制。本研究用鹿茸蛋白作为方法学研究对像，用胃肠道稳定的荧光分子标记N末端，利用偏振光成像、荧光关联谱等生物光子学技术进行探测，结合蛋白质组学相关手段，确定口服鹿茸蛋白能否被吸收入血及可吸收入血的蛋白种类，并进一步证明吸收入血的蛋白为药理活性成份，阐明鹿茸蛋白的作用机制，建立完整的蛋白类药物口服吸收研究方法。该方法避免了复杂的分离提取过程，可在极低浓度下追踪大分子中药活性成份，锁定活性物质，可用于中药大分子吸收过程、体内代谢过程、脏器分布等方面的研究，为阐明中药复方作用机理及相关制剂的开发和质量控制提供新的实验技术，并可推广到其他蛋白类药物，具有普遍应用价值。