人参地黄桑葚片制备工艺、质量标准及功效学研究

发布时间：2018-04-25 22:32

本文选题：人参地黄桑葚片 + 制备工艺、质量标准　；参考：《吉林大学》2017年硕士论文

【摘要】：目的:探究人参地黄桑葚片的制备工艺、质量标准及其对小鼠免疫功能的影响。实验方案:1、人参地黄桑葚片的工艺研究1)对微粉人参的制备工艺进行考察,以堆密度、休止角及产出比为指标,探究风力因素、粉碎时间、单次进料量对人参微分化的影响2)对熟地、桑椹、覆盆子的提取工艺进行考察,通过正交试验以出膏率为评价指标,探究加水量、提取时间、提取次数对提取工艺的影响。3)考察干燥方式、干燥温度及干燥压力对干燥效果的影响。4)对制粒工艺进行考察,采用固定漏斗法对浸膏粉的流动性进行测定、采用量筒法对堆密度进行测定、采用漏斗法对休止角进行测定。2、人参地黄桑葚片的质量标准研究1)根据《中国药典》2015版对原料药材进行质量标准研究2)对微粉人参进行质量标准的研究,采用薄层色谱法对微粉人参进行鉴别;参照《中国药典》2015版附录ⅨH水分测定法进行水分检查;用全自动激光粒度测定仪检测平均粒径和粒度分布,同时采用固定漏斗法测定休止角;利用人参皂苷对照品Rg1、Re、Rb1,采用高效液相色谱法对其中的人参皂苷含量进行测定。3)对人参地黄桑葚片进行质量标准研究,参照药典方法分别对人参微粉、熟地、桑葚、覆盆子进行鉴别;照药典通则0101对重量差异及微生物限度进行检查;分别以毛蕊花糖苷及鞣花酸为对照品进行熟地及覆盆子的含量测定实验,根据药典选择流动相及检测波长,考察系统适用性、溶液稳定性、制备标准曲线、进行精密度实验、重现性实验后测定原料药材及供试品溶液,计算回收率,确定含量限度。3、人参地黄桑葚片的功效学研究1)按人群推荐日摄入量0.0533g/kg BW扩大5、10、30倍设置低、中、高三个剂量组,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五个大组,每大组56只小鼠,均分4组:对照组、受试物低、中、高三个剂量组,每个剂量组15只。其中i组小鼠进行cona诱导的小鼠脾淋巴细胞转化、nk细胞活性实验;ii组小鼠进行迟发型变态反应实验(dth);Ⅲ组小鼠进行抗体生成细胞检测和血清溶血素的测定;Ⅳ组小鼠进行小鼠碳廓清实验;Ⅴ组小鼠进行小鼠腹腔巨噬细胞吞噬鸡红细胞实验经口每日1次给予小鼠相应剂量的受试物,小鼠灌胃量为20ml/kgbw。连续灌胃30天后,测定各项增强免疫力功能指标。2)评价人参地黄桑葚片的对小鼠免疫功能的影响,采用mtt法探究对cona诱导小鼠脾淋巴细胞转化实验的影响;采用足趾增厚法探究对绵羊红细胞(srbc)诱导小鼠迟发型变态反应的影响;采用jerne改良玻片法探究对抗体生成细胞的影响;采用血凝法探究对血清溶血素的影响;探究对碳廓清实验的影响;采用半体内法探究对小鼠腹腔巨噬细胞吞噬鸡红细胞实验的影响;采用乳酸脱氢酶ldh测定法探究对nk细胞活性的影响。实验结果:1、人参地黄桑葚片的工艺研究结果1)人参微粉的最佳生产工艺为:风袋长度20cm,粉碎时间40min/次,单次进料量为500g。2)熟地、桑椹、覆盆子的最佳提取工艺的研究:加水10倍量,回流提取3次,每次1.5小时,出膏率最高。3)最佳干燥工艺:采用减压干燥,温度为60-70℃,压力为0.08mpa时干燥效果好。4)最佳制剂工艺:采用95%乙醇制粒成型。2、人参地黄桑葚片的质量标准制定人参地黄桑葚片的质量标准草案3、人参地黄桑葚片药效学研究结果1)各剂量组对小鼠体重无影响;2)各剂量组能显著提高小鼠的胸腺指数及脾脏指数;3)高剂量组能显著性增强cona诱导的小鼠脾淋巴细胞增殖能力;4)中剂量组、高剂量组能显著提高绵羊红细胞诱导的小鼠迟发型变态反应;5)各剂量组对抗体生成细胞能力无明显影响;6)各剂量组对小鼠血清溶血素含量无明显影响;7)中剂量组、高剂量组能显著性增强小鼠碳廓清能力;8)高剂量组能显著提高小鼠腹腔巨噬细胞吞噬鸡红细胞功能;9)中剂量组、高剂量组能够显著提高小鼠NK细胞活性;实验结论:1、人参地黄桑葚片的最佳工艺:人参经风袋长度20cm,粉碎时间40min/次,单次进料量为500g粉碎为人参微粉,熟地、桑椹、覆盆子经料水比1:10,回流提取3次,每次1.5小时后,经60-70℃、0.08mpa减压干燥成干膏,粉碎过100目筛,将混合粉末与人参微粉混合,制粒、干燥、压片后得成品人参地黄桑葚片。并完成如正文所示的质量标准草案。2、在本实验条件下该受试样品具有增强免疫力功能的作用。
[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.

【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;R285.5

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