提高缺氧耐受力咀嚼片的研究

发布时间：2017-12-27 19:00

本文关键词：提高缺氧耐受力咀嚼片的研究　出处：《吉林大学》2017年硕士论文　论文类型：学位论文

【摘要】：缺氧是一种病理现象,通常由机体组织氧供应不足或者无法有效利用氧所导致。轻度缺氧时,中枢神经系统受到的损害较轻,其能对化学感受器传来的缺氧冲动做出正确应答,进而出现一定的代偿反应,但如果缺氧程度超过一定界限,机体将进入失代偿的阶段,继而产生一定的痛苦和明显的损伤,如头晕、心律失常、哮喘、昏厥甚至死亡。如今,随着社会生活节奏越来越快,城市拥挤、环境恶化等问题也越发严重,缺氧已不仅是生活在高原低氧地区人们所面临的问题,也是生活在繁忙都市的人们不可忽视的病症。鉴于此现象,本文研发了一种能够提高机体缺氧耐受力的咀嚼片,该咀嚼片由红景天和蜂胶两味中药组成,具有提高缺氧耐受力的功效。本论文主要对该咀嚼片的提取工艺、制剂工艺、质量标准、稳定性及功能学进行了研究,结果如下:利用正交实验,分别以干膏得率、红景天苷含量为考察指标对红景天、蜂胶药材的提取工艺进行了筛选,确定最佳提取工艺为:乙醇浓度70%,溶剂量7倍,提取时间2h,提取次数3次。经三批实验验证,该提取工艺稳定。通过对咀嚼片处方进行筛选,确定了以玉米淀粉、甘露醇为稀释剂,甜蜜素、糖精钠、柠檬酸、食用盐为矫味剂,羧甲基淀粉钠为崩解剂,70%乙醇为粘合剂,硬脂酸镁为润滑剂的处方组成,具体用量为每100g片剂处方中含有提取物50g,玉米淀粉19.5g、甘露醇12g,甜蜜素0.7g,糖精钠0.35g,柠檬酸6.45g,食用盐0.5g,羧甲基淀粉钠10g,再用适量70%乙醇制粒,最后外加硬脂酸镁0.5g。该处方经三批制剂验证,片剂性质均稳定,表明该制剂工艺重现性好。对咀嚼片的质量标准进行了研究,规定了与片剂质量有关的常规指标检测方法及范围,并利用薄层色谱法对片中蜂胶的主要成分进行了鉴别,同时采用高效液相色谱法测定了片中红景天苷的含量,结果显示在0.5mg/ml~3.0mg/ml范围内红景天苷浓度与峰面积有较好的线性关系,并且测定方法的精密度、重现性、稳定性、回收率良好,最终确定本制剂每100g含红景天苷不得少于250mg。经初步稳定性考察显示三批样品在加速及长期试验条件下均稳定。对该咀嚼片进行功能性研究,结果显示高剂量组可以有效延长常压缺氧小鼠及亚硝酸钠中毒缺氧小鼠的存活时间,表明该咀嚼片在一定剂量范围内具有提高小鼠缺氧耐受力的功能。
[Abstract]:Hypoxia is a pathological phenomenon, usually caused by insufficient oxygen supply in the body tissue or the inability to use oxygen effectively. Mild hypoxia, by central nervous system damage is light, it can feel the impulse of chemical hypoxia is to make the correct response, and compensatory response to certain, but if the degree of hypoxia exceeds a certain limit, the body will enter the decompensation stage, and then have a constant pain and obvious damage, such as dizziness, arrhythmia, asthma, coma and death. Nowadays, with the increasing pace of social life, the problems of urban crowding and environmental deterioration are more and more serious. Anoxia is not only a problem faced by people living in plateau hypoxia area, but also a disease that people can't ignore in busy cities. In view of this phenomenon, we developed a chewing tablet which can improve the hypoxia tolerance of the body. The chewing tablet is made up of two Chinese herbs, Rhodiola rosea and propolis, and it has the effect of increasing hypoxia tolerance. This paper focuses on the chewable tablets extraction, preparation process, quality standard, stability and function were studied. The results are as follows: using orthogonal experiment, respectively, the yield of dry extract as indexes, the content of salidroside extraction process of Rhodiola, propolis medicinal herbs were screened for the optimal extraction process was: the ethanol concentration was 70%, 7 times the amount of solvent, extraction time 2h, extraction times of 3 times. The three batch experiments proved that the extraction process was stable. The chewable tablets prescription screening, identified with corn starch and mannitol as diluents, sodium cyclamate, saccharin sodium, citric acid, edible salt for flavoring agent, sodium carboxymethyl starch as disintegrant, 70% ethanol as adhesive, magnesium stearate as lubricant formulation, the specific amount for each of the 100 to prescription contains extracts of 50g, corn starch 19.5g, mannitol 12g, 0.7G sodium cyclamate, saccharin sodium 0.35g, citric acid 6.45g, salt 0.5g, sodium carboxymethyl starch 10g, and the amount of 70% ethanol granulation, finally with magnesium stearate 0.5g. The formulation was verified by three batches of preparations, and the properties of the tablets were all stable, which showed that the reproducibility of the preparation was good. The quality standard of chewable tablets was studied. The provisions of the conventional indicators related to tablet quality detection method and range, and by TLC method of main components of Propolis tablets were identified at the same time, the content of salidroside tablets by high performance liquid chromatography in the determination, the results are displayed in the 0.5mg/ml~3.0mg/ml range of salidroside the concentration and peak area had a good linear relationship, and the determination method of the precision, reproducibility, stability, good recovery rate, to determine the final preparations containing 100g per rhodioside shall not be less than 250mg. The preliminary stability investigation showed that the three batches of samples were stable under the conditions of accelerated and long-term test. Functional studies on the chewable tablet showed that the high dose group could effectively prolong the survival time of anoxic mice under normal atmospheric hypoxia and sodium nitrite poisoning, indicating that the chewable tablet had a function of increasing hypoxia tolerance in a certain dose range.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R283.6

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