本文關(guān)鍵詞：黑米花青素片劑的制備工藝及質(zhì)量標(biāo)準(zhǔn)研究　出處：《吉林大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 黑米花青素 穩(wěn)定性 片劑 制備工藝 質(zhì)量標(biāo)準(zhǔn) 抗氧化

【摘要】：隨著社會(huì)的進(jìn)步和經(jīng)濟(jì)的發(fā)展,人們對(duì)自身健康日益關(guān)注,用食品調(diào)節(jié)人體機(jī)能已成為民眾的健身手段�；ㄇ嗨厥亲匀唤缰袕V泛存在于植物中的水溶性天然色素,其抗氧化保健功能已被廣泛研究,但目前攝入花青素的方式仍為食補(bǔ),關(guān)于其制劑的研究非常少,限制了其應(yīng)用,因此,研究花青素制劑具有廣闊的市場(chǎng)前景。黑米中含有以矢車菊素-3-O-葡萄糖苷為主成分的花青素。本文以黑米花青素為原料,開發(fā)黑米花青素片劑,對(duì)其制備工藝及質(zhì)量標(biāo)準(zhǔn)進(jìn)行研究。本文通過研究得出結(jié)果如下:(一)原料性質(zhì):高濕條件及強(qiáng)光照射條件對(duì)黑米花青素穩(wěn)定性影響較大,高溫條件對(duì)其穩(wěn)定性影響較小,黑米花青素在室溫下分解10%所需的時(shí)間為210天。Fe~(2+)、Fe~(3+)、Cu~(2+)均使其含量明顯下降,其中Fe~(3+)影響最大,Mg~(2+)有增加穩(wěn)定性的作用。酸性條件有利于黑米花青素的穩(wěn)定,且溶液pH值越低,黑米花青素越穩(wěn)定。原料本身流動(dòng)性很差(休止角α=61.07°,松密度ρ松=0.235,振實(shí)密度ρ實(shí)=0.407,壓縮度=42.26%),屬于“有引濕性”。(二)制劑工藝:黑米花青素與稀釋劑的最佳配比為1:1,稀釋劑中淀粉與糊精的最佳配比為1:1.5,崩解劑交聯(lián)聚乙烯比咯烷酮(PVPP)的最佳用量為2%,潤(rùn)濕劑中乙醇的最佳濃度為75%。黑米花青素成型制備工藝如下:黑米花青素與各輔料分別過100目尼龍藥篩,按處方量稱重,將黑米花青素與稀釋劑及1/2崩解劑混合均勻,將酒石酸分散于適量潤(rùn)濕劑中,制軟材,過20目尼龍藥篩制粒,顆粒在45℃條件下干燥,干燥后過20目篩整粒,細(xì)粉與硬脂酸鎂及另外1/2崩解劑混合均勻后再與顆�；靹�,壓片。按成型處方及工藝制備的黑米花青素片劑,經(jīng)質(zhì)量檢查符合藥典要求,處方及制備工藝合理。(三)質(zhì)量標(biāo)準(zhǔn)研究:本品為深紫色凸面圓形片劑,大小均勻、色澤一致,表面完整光潔。以矢車菊素-3-O-葡萄糖苷為對(duì)照品進(jìn)行鑒別,鑒別方法為高效液相法。3批黑米花青素片劑各項(xiàng)質(zhì)量檢查均合格。采用高效液相法測(cè)定制劑中矢車菊素-3-O-葡萄糖苷的含量,經(jīng)考察,該方法理論塔板數(shù)N=3947,重復(fù)性好(RSD=1.32%),靈敏度高(檢出限為0.2μg/mL,定量限為1μg/mL。),峰無前延或拖尾現(xiàn)象(拖尾因子T=0.97),分離度R=2.411.5,完全分離,方法專屬性強(qiáng),精密度高(日內(nèi)精密度RSD=0.37%,日間精密度RSD=0.63%),準(zhǔn)確度可滿足復(fù)雜成分的檢測(cè)要求(加樣回收率=78.89%),且12小時(shí)內(nèi)穩(wěn)定(RSD=0.76%),方法可靠,適用于本制劑中矢車菊素-3-O-葡萄糖苷的含量測(cè)定。除此之外,采用色價(jià)法測(cè)定制劑中總黑米花青素的含量,方法精密度高(日內(nèi)精密度RSD=0.87%,日間精密度RSD=1.19%),準(zhǔn)確度可滿足檢測(cè)要求(加樣回收率=81.71%),且12小時(shí)內(nèi)穩(wěn)定(RSD=1.29%),方法可靠,適用于本制劑中總花青素含量的測(cè)定。(四)體外抗氧化活性測(cè)定:黑米花青素原料及其制劑均表現(xiàn)出較強(qiáng)的體外自由基清除能力及抗氧化還原能力。制劑過程對(duì)黑米花青素的抗氧化活性未有大的影響。(五)片劑初步穩(wěn)定性:影響因素試驗(yàn)中,溫度對(duì)黑米花青素片劑穩(wěn)定性影響最小,室溫下分解10%所需的時(shí)間為427天。高濕條件及強(qiáng)光照射條件下,黑米花青素片劑穩(wěn)定性相對(duì)較低,在加速試驗(yàn)條件下,3個(gè)批次黑米花青素片劑的穩(wěn)定性隨時(shí)間的增加略有降低。綜上所述,黑米花青素片劑的制備工藝切實(shí)可行,質(zhì)量控制方法科學(xué)合理,準(zhǔn)確可行。
[Abstract]:With the progress of the society and the development of the economy, people are increasingly concerned about their own health. The use of food to regulate human functions has become a means of fitness for the people. Anthocyanins are widely present in nature in plants in the water soluble natural pigment, antioxidant health function has been extensively studied, but there is still intake from Sibu, research on its preparation is very few, therefore, limit the application of anthocyanin preparation has broad market prospects. Black rice contains anthocyanins, which are mainly composed of -3-O- glucoside. In this paper, black rice anthocyanins are used as raw materials to develop black rice anthocyanin tablets. The preparation technology and quality standard of black rice are studied. In this paper, the following research results are as follows: (1) raw material properties: high humidity condition and strong light irradiation condition have great influence on the stability of anthocyanin in black rice. The influence of high temperature on its stability is relatively small. The time needed to decompose 10% of anthocyanins in black rice at room temperature is 210 days. The content of Fe~ (2+), Fe~ (3+) and Cu~ (2+) all decreased obviously, of which Fe~ (3+) had the greatest influence, and Mg~ (2+) had the effect of increasing stability. The acid condition is beneficial to the stability of black rice anthocyanin, and the lower the pH value of the solution, the more stable the black rice anthocyanin. The raw material itself illiquid (repose angle alpha =61.07 degrees, the density of pine pine =0.235, tap density is =0.407, compression degree =42.26%), is a "moisture". (two) preparation process: the best ratio of black rice anthocyanin and diluent is 1:1, the best ratio of starch to dextrin in diluent is 1:1.5, the best dosage of disintegrating agent crosslinked polyethylene, PVPP is 2%, and the best concentration of ethanol in wetting agent is 75%. The black rice anthocyanins forming preparation process are as follows: the black rice anthocyanins and other auxiliary material are 100 mesh nylon sieve, weighing according to the prescription, and will be the black rice anthocyanins diluent and disintegrating agent 1/2 mixed evenly, the tartaric acid dispersed in the amount of wetting agent, made of soft material, 20 mesh nylon sieve granulation, granule at 45 DEG C under the conditions of drying, drying after 20 mesh fine powder with whole grain, magnesium stearate and 1/2 disintegrating agent are mixed evenly and then with the particle mixing and tabletting. The black rice anthocyanin tablets prepared by the molding prescription and process are in accordance with the requirements of the Pharmacopoeia, and the formulation and preparation process are reasonable. (three) quality standard study: This product is a deep purple convex surface circular tablet with uniform size, uniform color and smooth surface. -3-O- glucoside was identified as a control product, and the identification method was high performance liquid phase method. The quality of the 3 batch of black rice anthocyanins were all qualified. The content of the -3-O- N=3947 glucoside in the preparation was determined by HPLC. The theoretical plate number is N=3947, repeatability is good (RSD=1.32%), and the sensitivity is high (the detection limit is 0.2 g/mL, and the limit of quantification is 1 g/mL. No delay before the peak), or smearing (trailing factor T=0.97), the degree of separation of R=2.411.5, completely separated. The method has high specificity and high precision (the precision of RSD=0.37%, the intra and inter day precision RSD=0.63%), accuracy can meet the detection requirements of complex components (recovery rate = 78.89%), and 12 hours stable (RSD=0.76%), the method is reliable and suitable for the determination of the preparation of cyanidin glucoside -3-O-. In addition, determination of total anthocyanins in black rice preparation by color value method, method of high precision (the precision of RSD=0.87%, the intra and inter day precision RSD=1.19%), accuracy can meet the requirements of detection (recovery =81.71%), and within 12 hours of stable (RSD=1.29%), the method is reliable and suitable for determination of the total anthocyanin content of the preparation. (four) determination of antioxidant activity in vitro: black rice anthocyanin material and its preparation all showed strong free radical scavenging ability in vitro and antioxidant reduction ability. The preparation process has no significant effect on the antioxidant activity of black rice anthocyanins. (five) the initial stability of the tablets: the influence of temperature on the stability of black rice anthocyanin tablets was the least, and the time required for decomposition of 10% at room temperature was 427 days. Under the condition of high humidity and strong light, the stability of black rice anthocyanin tablets was relatively low. Under accelerated test conditions, the stability of 3 batches of black rice anthocyanin tablets decreased slightly with time. To sum up, the preparation technology of black rice anthocyanin tablets is practical, the quality control method is scientific and reasonable, and it is accurate and feasible.
【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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