本文選題：人參地黃桑葚片 + 制備工藝、質(zhì)量標(biāo)準(zhǔn)��； 參考：《吉林大學(xué)》2017年碩士論文

【摘要】：目的:探究人參地黃桑葚片的制備工藝、質(zhì)量標(biāo)準(zhǔn)及其對(duì)小鼠免疫功能的影響。實(shí)驗(yàn)方案:1、人參地黃桑葚片的工藝研究1)對(duì)微粉人參的制備工藝進(jìn)行考察,以堆密度、休止角及產(chǎn)出比為指標(biāo),探究風(fēng)力因素、粉碎時(shí)間、單次進(jìn)料量對(duì)人參微分化的影響2)對(duì)熟地、桑椹、覆盆子的提取工藝進(jìn)行考察,通過(guò)正交試驗(yàn)以出膏率為評(píng)價(jià)指標(biāo),探究加水量、提取時(shí)間、提取次數(shù)對(duì)提取工藝的影響。3)考察干燥方式、干燥溫度及干燥壓力對(duì)干燥效果的影響。4)對(duì)制粒工藝進(jìn)行考察,采用固定漏斗法對(duì)浸膏粉的流動(dòng)性進(jìn)行測(cè)定、采用量筒法對(duì)堆密度進(jìn)行測(cè)定、采用漏斗法對(duì)休止角進(jìn)行測(cè)定。2、人參地黃桑葚片的質(zhì)量標(biāo)準(zhǔn)研究1)根據(jù)《中國(guó)藥典》2015版對(duì)原料藥材進(jìn)行質(zhì)量標(biāo)準(zhǔn)研究2)對(duì)微粉人參進(jìn)行質(zhì)量標(biāo)準(zhǔn)的研究,采用薄層色譜法對(duì)微粉人參進(jìn)行鑒別;參照《中國(guó)藥典》2015版附錄ⅨH水分測(cè)定法進(jìn)行水分檢查;用全自動(dòng)激光粒度測(cè)定儀檢測(cè)平均粒徑和粒度分布,同時(shí)采用固定漏斗法測(cè)定休止角;利用人參皂苷對(duì)照品Rg1、Re、Rb1,采用高效液相色譜法對(duì)其中的人參皂苷含量進(jìn)行測(cè)定。3)對(duì)人參地黃桑葚片進(jìn)行質(zhì)量標(biāo)準(zhǔn)研究,參照藥典方法分別對(duì)人參微粉、熟地、桑葚、覆盆子進(jìn)行鑒別;照藥典通則0101對(duì)重量差異及微生物限度進(jìn)行檢查;分別以毛蕊花糖苷及鞣花酸為對(duì)照品進(jìn)行熟地及覆盆子的含量測(cè)定實(shí)驗(yàn),根據(jù)藥典選擇流動(dòng)相及檢測(cè)波長(zhǎng),考察系統(tǒng)適用性、溶液穩(wěn)定性、制備標(biāo)準(zhǔn)曲線、進(jìn)行精密度實(shí)驗(yàn)、重現(xiàn)性實(shí)驗(yàn)后測(cè)定原料藥材及供試品溶液,計(jì)算回收率,確定含量限度。3、人參地黃桑葚片的功效學(xué)研究1)按人群推薦日攝入量0.0533g/kg BW擴(kuò)大5、10、30倍設(shè)置低、中、高三個(gè)劑量組,即0.325g/kg BW、0.75 g/kg BW、2.250g/kg BW。小鼠按批次分i、ii、Ⅲ、Ⅳ、Ⅴ五個(gè)大組,每大組56只小鼠,均分4組:對(duì)照組、受試物低、中、高三個(gè)劑量組,每個(gè)劑量組15只。其中i組小鼠進(jìn)行cona誘導(dǎo)的小鼠脾淋巴細(xì)胞轉(zhuǎn)化、nk細(xì)胞活性實(shí)驗(yàn);ii組小鼠進(jìn)行遲發(fā)型變態(tài)反應(yīng)實(shí)驗(yàn)(dth);Ⅲ組小鼠進(jìn)行抗體生成細(xì)胞檢測(cè)和血清溶血素的測(cè)定;Ⅳ組小鼠進(jìn)行小鼠碳廓清實(shí)驗(yàn);Ⅴ組小鼠進(jìn)行小鼠腹腔巨噬細(xì)胞吞噬雞紅細(xì)胞實(shí)驗(yàn)經(jīng)口每日1次給予小鼠相應(yīng)劑量的受試物,小鼠灌胃量為20ml/kgbw。連續(xù)灌胃30天后,測(cè)定各項(xiàng)增強(qiáng)免疫力功能指標(biāo)。2)評(píng)價(jià)人參地黃桑葚片的對(duì)小鼠免疫功能的影響,采用mtt法探究對(duì)cona誘導(dǎo)小鼠脾淋巴細(xì)胞轉(zhuǎn)化實(shí)驗(yàn)的影響;采用足趾增厚法探究對(duì)綿羊紅細(xì)胞(srbc)誘導(dǎo)小鼠遲發(fā)型變態(tài)反應(yīng)的影響;采用jerne改良玻片法探究對(duì)抗體生成細(xì)胞的影響;采用血凝法探究對(duì)血清溶血素的影響;探究對(duì)碳廓清實(shí)驗(yàn)的影響;采用半體內(nèi)法探究對(duì)小鼠腹腔巨噬細(xì)胞吞噬雞紅細(xì)胞實(shí)驗(yàn)的影響;采用乳酸脫氫酶ldh測(cè)定法探究對(duì)nk細(xì)胞活性的影響。實(shí)驗(yàn)結(jié)果:1、人參地黃桑葚片的工藝研究結(jié)果1)人參微粉的最佳生產(chǎn)工藝為:風(fēng)袋長(zhǎng)度20cm,粉碎時(shí)間40min/次,單次進(jìn)料量為500g。2)熟地、桑椹、覆盆子的最佳提取工藝的研究:加水10倍量,回流提取3次,每次1.5小時(shí),出膏率最高。3)最佳干燥工藝:采用減壓干燥,溫度為60-70℃,壓力為0.08mpa時(shí)干燥效果好。4)最佳制劑工藝:采用95%乙醇制粒成型。2、人參地黃桑葚片的質(zhì)量標(biāo)準(zhǔn)制定人參地黃桑葚片的質(zhì)量標(biāo)準(zhǔn)草案3、人參地黃桑葚片藥效學(xué)研究結(jié)果1)各劑量組對(duì)小鼠體重?zé)o影響;2)各劑量組能顯著提高小鼠的胸腺指數(shù)及脾臟指數(shù);3)高劑量組能顯著性增強(qiáng)cona誘導(dǎo)的小鼠脾淋巴細(xì)胞增殖能力;4)中劑量組、高劑量組能顯著提高綿羊紅細(xì)胞誘導(dǎo)的小鼠遲發(fā)型變態(tài)反應(yīng);5)各劑量組對(duì)抗體生成細(xì)胞能力無(wú)明顯影響;6)各劑量組對(duì)小鼠血清溶血素含量無(wú)明顯影響;7)中劑量組、高劑量組能顯著性增強(qiáng)小鼠碳廓清能力;8)高劑量組能顯著提高小鼠腹腔巨噬細(xì)胞吞噬雞紅細(xì)胞功能;9)中劑量組、高劑量組能夠顯著提高小鼠NK細(xì)胞活性;實(shí)驗(yàn)結(jié)論:1、人參地黃桑葚片的最佳工藝:人參經(jīng)風(fēng)袋長(zhǎng)度20cm,粉碎時(shí)間40min/次,單次進(jìn)料量為500g粉碎為人參微粉,熟地、桑椹、覆盆子經(jīng)料水比1:10,回流提取3次,每次1.5小時(shí)后,經(jīng)60-70℃、0.08mpa減壓干燥成干膏,粉碎過(guò)100目篩,將混合粉末與人參微粉混合,制粒、干燥、壓片后得成品人參地黃桑葚片。并完成如正文所示的質(zhì)量標(biāo)準(zhǔn)草案。2、在本實(shí)驗(yàn)條件下該受試樣品具有增強(qiáng)免疫力功能的作用。
[Abstract]:Objective: To explore the preparation technology of Ginseng Radix Rehmanniae mulberry tablets, the quality standard and the effect on the immune function of mice. Experimental scheme: 1, study on the technology of Ginseng Radix Rehmanniae mulberry tablets 1) investigation on the preparation technology of Panax ginseng, with the index of pile density, repose angle and output ratio, to explore the factors of wind, crushing time and single feed amount to ginseng micro The influence of differentiation 2) the extraction process of Radix rehmanniae, mulberry and raspberry was investigated. Through orthogonal test, the effect of addition of water, extraction time, and extraction times on the extraction process was investigated by orthogonal test. The effect of drying method, drying temperature and drying pressure on dry effect was investigated by.4) and the process of granulating was investigated and fixed by fixing the process. The funnel method was used to determine the fluidity of the extract powder, measuring the density of the heap by the measure method, using the funnel method to measure the repose angle.2, the quality standard of the radix rehmanniae mulberry tablets of ginseng 1) study on the quality standard of the micropowder ginseng according to the quality standard study 2 of the raw material medicinal materials by the Chinese Pharmacopoeia >2015 edition, and adopt the thin layer color. The spectrum method was used to identify the micropowder ginseng; the water test was carried out according to the water determination method of appendix IX H of >2015 edition of Chinese Pharmacopoeia; the average particle size and the distribution of grain size were detected by the automatic laser particle size analyzer, and the rest angle was determined by the fixed funnel method. The ginseng saponin control products, Rg1, Re, Rb1, were used in the high performance liquid chromatography The content of saponins was determined by.3). The quality standard of Radix Rehmanniae mulberry tablets was studied. According to the Pharmacopoeia method, ginseng micropowder, cooked ground, mulberry and raspberry were identified respectively. The weight difference and microbial limit of 0101 were examined according to the Pharmacopoeia general rule. The content of raspberry and raspberry was carried out with tannin acid and tannin acid as the control products respectively. Test the experiment, select the mobile phase and the detection wavelength according to the Pharmacopoeia, investigate the applicability of the system, the stability of the solution, the preparation of the standard curve, the precision experiment, the determination of the material and the solution, the recovery rate, the determination of the recovery rate, the determination of the content limit.3, the efficacy of ginseng ground yellow mulberry tablets 1) recommended daily intake of 0.05 by the crowd. 33g/kg BW expanded 5,10,30 times to set low, middle and high dose groups, that is, 0.325g/kg BW, 0.75 g/kg BW, 2.250g/kg BW. mice by batch I, II, III, IV, V, 56 mice in each group, equally divided into 4 groups: the control group, the subjects were low, middle and high dosage groups, and each dose group 15. Cell transformation, NK cell activity test, group II mice carried out delayed allergy test (DTH), group III mice to detect antibody producing cells and serum hemolysin test, group IV mice to carry out carbon clearance experiment in mice; group V mice peritoneal macrophages phagocytic red blood cell experiment in mice 1 times a day to give the corresponding dose of mice. The effects of Radix Rehmanniae mulberry tablets on the immune function of mice were evaluated by 20ml/kgbw. after 30 days after gastric perfusion, and the effect of Radix Rehmanniae mulberry tablets on the immune function of mice was evaluated. The effect of MTT method on the transformation of spleen lymphocyte in mice induced by ConA was investigated. The induction of sheep red blood cells (SRBC) by the method of toe thickening was studied. The effect of delayed allergy in rats; the effect of Jerne modified slide method on the antibody producing cells; the effect of blood coagulation on the serum hemolysin; the influence on the carbon clearance experiment; the effect of the semi body method on the mouse peritoneal macrophage phagocytosis experiment of the chicken red cell; the lactate dehydrogenase assay method was used. Study the effect on the activity of NK cell. Experimental results: 1, the result of the study on the technology of Radix Rehmanniae mulberry 1) the optimum production process of ginseng powder is: the length of the wind bag is 20cm, the crushing time is 40min/, the single feed is 500g.2), the best extraction process of the mulberry, mulberry and raspberry is studied: 10 times the amount of water, 3 times the reflux extraction, 1.5 hours each time. The best drying process is.3) the best drying process: the best preparation process is to use the vacuum drying, the temperature is 60-70 C, the pressure is 0.08mpa, and the drying effect is good.4). The quality standard of the radix rehmanniae mulberry is 3, the result 1 of the ginseng mulberry tablet 1) each dose group. No effect on the weight of mice; 2) each dose group could significantly increase the thymus index and spleen index of mice; 3) high dose group could significantly enhance the proliferation ability of spleen lymphocyte induced by ConA in mice; 4) middle dose group, high dose group could significantly increase the delayed allergic reaction induced by sheep red cells, and 5) the antibody producing cells were used in each dose group. 6) the dose group had no obvious effect on the serum hemolysin content of mice; 7) middle dose group, high dose group could significantly enhance the carbon clearance ability of mice; 8) high dose group could significantly increase the function of phagocytic red cell macrophages in mice peritoneal macrophages; 9) medium dose group, the high dose group can significantly improve the activity of NK cells in mice; Conclusion: 1, the best process of Ginseng Radix Rehmanniae mulberry tablet: Ginseng through the wind bag length 20cm, crushing time 40min/ times, single feed amount of 500g pulverized ginseng powder, cooked ground, mulberry, raspberry water ratio at 1:10, reflux extraction 3 times, 1.5 hours each time, 60-70 degrees, 0.08mpa vacuum drying to dry paste, crushed over 100 mesh sieves, mixed powder and ginseng powder After mixing, granulating, drying and pressing, the finished ginseng Rehmannia mulberry slices were prepared, and the draft quality standard.2, as shown in the text, was completed. Under this experimental condition, the sample had the function of enhancing immunity function.

【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)】：R283.6;R285.5

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4 本報(bào)記者 趙彥華;媒介影響力的質(zhì)量標(biāo)準(zhǔn)[N];中華新聞報(bào);2003年

5 楊德廣;提高高校質(zhì)量的幾點(diǎn)建議[N];光明日?qǐng)?bào);2003年

6 本報(bào)記者 于麗珊;應(yīng)加快中藥質(zhì)量標(biāo)準(zhǔn)研究[N];中國(guó)中醫(yī)藥報(bào);2002年

7 白云;進(jìn)口煤“質(zhì)量標(biāo)準(zhǔn)”助推煤市轉(zhuǎn)好[N];中國(guó)能源報(bào);2014年

8 ;完善質(zhì)量標(biāo)準(zhǔn) 推動(dòng)中藥國(guó)際化[N];中國(guó)中醫(yī)藥報(bào);2001年

9 耿爽;工程承包合同如何約定質(zhì)量標(biāo)準(zhǔn)[N];廣東建設(shè)報(bào);2006年

10 國(guó)家食品藥品監(jiān)督管理局藥品審評(píng)中心 馬秀t，

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