增加骨密度片剂的研究

发布时间：2018-03-28 21:30

本文选题：增加骨密度　切入点：片剂　出处：《吉林大学》2017年硕士论文

【摘要】：骨质疏松(osteoporosis,OP)是一种以低骨量和骨组织微结构破坏为特征,以全身骨量减少,导致骨质脆性增加和易于骨折的全身性骨代谢性疾病。其发生多由于体内破骨细胞与成骨细胞对骨代谢影响的失衡引起的。骨质疏松属于老年人的常见病及多发病之一,由于我国人口基数庞大,并且随着老龄化的加剧,骨质疏松人群将会逐年增加。由于其高发病率,复发率,以及带来的较大的社会经济负担,使得骨质疏松的预防变得尤为的重要,本文研发了一种制剂,处方以大豆,淫羊藿,骨碎补为原料,经醇提取,干燥,制片包衣而成。主要有增加骨密度的功效。本文主要研究了增加骨密度片剂的生产提取工艺,制剂制备工艺,以总大豆异黄酮的含量以及淫羊藿苷的含量为指标建立质量标准,并对其进行了稳定性以及功能性评价研究。主要内容如下:1.提取工艺的研究大豆的主要有效成分为大豆异黄酮,具有植物源性雌激素样作用。淫羊藿苷为淫羊藿代表性有效成分,具有益肾壮阳、强筋壮骨的作用。骨碎补主要成分之一为柚皮苷。采用醇提法可以有效的对其进行提取,操作简单,成本低,有利于大批量生产。我们拟采用正交试验对大豆,淫羊藿,骨碎补的醇提工艺进行正交筛选L9(34)从而确定最佳提取工艺是:乙醇的浓度为70%,提取的次数为3次,加醇的倍数为6倍量,提取的时间为3小时。2.制剂工艺研究通过大量预实验对制剂工艺与处方进行筛选,最终确定片剂的处方为:大豆、淫羊藿、骨碎补提取物,分别与辅料淀粉、甘露醇、微晶纤维素、PEG6000、PEG4000、糊精、羧甲基淀粉钠混合,经制粒,干燥,压片,包衣所得。3.质量标准参照2015年中国药典,中华人民共和国国家标准GB/T23788-2009,以及食药监食监三便函[2013]143号保健食品检验的具体要求操作,使用高效液相色谱法(HPLC)对总大豆异黄酮的含量以及淫羊藿苷的含量进行测定,实验结果显示该方法对于增加骨密度片剂的含量测定具有专属性强,重现性好,灵敏度高等优点。使用(TLC)薄层鉴别法对柚皮苷进行鉴别。最终建立该制剂的质量标准。4.稳定性的考察通过长期以及加速等考察实验对性状、崩解时限、片重差异,含量、微生物限度等方面进行考察,结果显示指标均无明显变化,表明本制剂的稳定性良好。5.功能性评价研究经过保健食品技术评价规范中增加骨密度功能性实验,该样品具有增加动物骨密度的作用。
[Abstract]:Osteoporosis osteoporosis is characterized by low bone mass and microstructural destruction of bone tissue, and decreases in bone mass throughout the body. A systemic metabolic disease that increases the fragility of bone and is prone to fracture. It is caused by the imbalance between osteoclasts and osteoblasts on bone metabolism in the body. Osteoporosis is one of the common diseases and frequent diseases in the elderly. Because of the large population base in our country, and with the aggravation of aging, the population of osteoporosis will increase year by year. The prevention of osteoporosis has become particularly important. In this paper, a preparation was developed, which was formulated from soybean, Epimedium and Fructus osseum, extracted and dried by alcohol. This paper mainly studied the production and extraction process of BMD tablets and the preparation process, and established the quality standard based on the contents of total soybean isoflavones and icariin. The stability and functional evaluation were studied. The main contents are as follows: 1. The main effective component of soybean isoflavones is soybean isoflavones. Icariin is the representative effective component of Epimedium, it has the function of tonifying the kidney and strengthening the bone, and one of the main components of Herba Branchiae is naringin, which can be effectively extracted by alcohol extraction. The operation is simple, the cost is low, it is advantageous to mass production. We plan to use orthogonal test to soybean, Epimedium, The optimum extraction process was determined as follows: the concentration of ethanol was 70 times, the times of extraction was 3 times, and the multiple of adding alcohol was 6 times. The extraction time was 3 hours. 2. The preparation process was screened by a large number of pre-experiments, and the prescription of the tablets was determined as soybean, Epimedium, Fructus, starch and mannitol, respectively. Microcrystalline cellulose PEG6000, PEG4000, dextrin, carboxymethyl starch sodium mixed, granulated, dried, pressed tablets, coated with .3.The quality standard of reference 2015 Chinese Pharmacopoeia, The contents of total soybean isoflavones and icariin were determined by high performance liquid chromatography (HPLC). The experimental results show that this method has strong specificity and good reproducibility for increasing the content of BMD tablets. TLC TLC method was used to identify naringin. Finally, the quality standard of naringin was established. The results showed that there was no obvious change in the indexes, which indicated that the stability of the preparation was good .5.The functional evaluation study increased the BMD functional experiment in the technical evaluation criterion of health food. The sample has the effect of increasing animal bone density.
【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】：R943

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