發(fā)布時(shí)間：2018-03-28 21:30

  本文選題：增加骨密度　切入點(diǎn)：片劑　出處：《吉林大學(xué)》2017年碩士論文

【摘要】：骨質(zhì)疏松(osteoporosis,OP)是一種以低骨量和骨組織微結(jié)構(gòu)破壞為特征,以全身骨量減少,導(dǎo)致骨質(zhì)脆性增加和易于骨折的全身性骨代謝性疾病。其發(fā)生多由于體內(nèi)破骨細(xì)胞與成骨細(xì)胞對(duì)骨代謝影響的失衡引起的。骨質(zhì)疏松屬于老年人的常見病及多發(fā)病之一,由于我國(guó)人口基數(shù)龐大,并且隨著老齡化的加劇,骨質(zhì)疏松人群將會(huì)逐年增加。由于其高發(fā)病率,復(fù)發(fā)率,以及帶來的較大的社會(huì)經(jīng)濟(jì)負(fù)擔(dān),使得骨質(zhì)疏松的預(yù)防變得尤為的重要,本文研發(fā)了一種制劑,處方以大豆,淫羊藿,骨碎補(bǔ)為原料,經(jīng)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劑的生產(chǎn)提取工藝,制劑制備工藝,以總大豆異黃酮的含量以及淫羊藿苷的含量為指標(biāo)建立質(zhì)量標(biāo)準(zhǔn),并對(duì)其進(jìn)行了穩(wěn)定性以及功能性評(píng)價(jià)研究。主要內(nèi)容如下:1.提取工藝的研究大豆的主要有效成分為大豆異黃酮,具有植物源性雌激素樣作用。淫羊藿苷為淫羊藿代表性有效成分,具有益腎壯陽、強(qiáng)筋壯骨的作用。骨碎補(bǔ)主要成分之一為柚皮苷。采用醇提法可以有效的對(duì)其進(jìn)行提取,操作簡(jiǎn)單,成本低,有利于大批量生產(chǎn)。我們擬采用正交試驗(yàn)對(duì)大豆,淫羊藿,骨碎補(bǔ)的醇提工藝進(jìn)行正交篩選L9(34)從而確定最佳提取工藝是:乙醇的濃度為70%,提取的次數(shù)為3次,加醇的倍數(shù)為6倍量,提取的時(shí)間為3小時(shí)。2.制劑工藝研究通過大量預(yù)實(shí)驗(yàn)對(duì)制劑工藝與處方進(jìn)行篩選,最終確定片劑的處方為:大豆、淫羊藿、骨碎補(bǔ)提取物,分別與輔料淀粉、甘露醇、微晶纖維素、PEG6000、PEG4000、糊精、羧甲基淀粉鈉混合,經(jīng)制粒,干燥,壓片,包衣所得。3.質(zhì)量標(biāo)準(zhǔn)參照2015年中國(guó)藥典,中華人民共和國(guó)國(guó)家標(biāo)準(zhǔn)GB/T23788-2009,以及食藥監(jiān)食監(jiān)三便函[2013]143號(hào)保健食品檢驗(yàn)的具體要求操作,使用高效液相色譜法(HPLC)對(duì)總大豆異黃酮的含量以及淫羊藿苷的含量進(jìn)行測(cè)定,實(shí)驗(yàn)結(jié)果顯示該方法對(duì)于增加骨密度片劑的含量測(cè)定具有專屬性強(qiáng),重現(xiàn)性好,靈敏度高等優(yōu)點(diǎn)。使用(TLC)薄層鑒別法對(duì)柚皮苷進(jìn)行鑒別。最終建立該制劑的質(zhì)量標(biāo)準(zhǔn)。4.穩(wěn)定性的考察通過長(zhǎng)期以及加速等考察實(shí)驗(yàn)對(duì)性狀、崩解時(shí)限、片重差異,含量、微生物限度等方面進(jìn)行考察,結(jié)果顯示指標(biāo)均無明顯變化,表明本制劑的穩(wěn)定性良好。5.功能性評(píng)價(jià)研究經(jīng)過保健食品技術(shù)評(píng)價(jià)規(guī)范中增加骨密度功能性實(shí)驗(yàn),該樣品具有增加動(dòng)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.
【學(xué)位授予單位】：吉林大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R943

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