乌锦颗粒剂的制备与药效毒理学研究

发布时间：2018-05-27 18:20

  本文选题：中药颗粒剂 + 制备工艺　； 参考：《中国农业科学院》2015年硕士论文

【摘要】：羔羊痢疾主要是由产气荚膜杆菌等致病菌引起的一种新生羔羊毒血症,以羔羊腹胀,持续性排粥样或水样稀粪,脱水等为基本特征,发病率为10~40%。本研究以羔羊痢疾中兽药治疗为研究对象,以传统兽医理论和现代中药制剂制备工艺为指导,进行中兽药防治羔羊痢疾的研究,旨在研制有效治疗羔羊痢疾的中兽药复方颗粒剂。根据中药制剂的稳定性和兽医临床用药便捷性的需求,确立治疗羔羊痢疾的中兽药剂型为颗粒剂。以“涩肠止泻、健脾和胃”为治则,拟定候选中药方,以临床疗效为导向开展临床试验,筛选出有效治疗羔羊痢疾的乌锦颗粒剂,及其最佳用药剂量,即1.2g/kg·bw,2次/d。治愈率达89.3%,总用效率为96.4%。采用L9(34)正交试验法优选提取工艺,并以制粒的难易和颗粒成型率优化颗粒制备工艺,优选了乌锦颗粒剂的制备工艺为:厚朴用12倍70%乙醇回流提取2次,每次1 h,合并乙醇液,减压回收至无醇味,得厚朴提取液,备用。黄连、地锦草、茯苓等6味中药加10倍水,煎煮3次,每次1 h滤过,合并滤液,浓缩至相对密度为0.9~1.1,得水煎浓缩液。浓缩液与厚朴提取液合并,浓缩至相对密度为1.31~1.35(50~55℃)的稠膏,加0.8倍药材量的可溶性淀粉和蔗糖粉(17:3),制成颗粒,干燥,即得“乌锦颗粒剂”。确定了乌锦颗粒剂中黄连、地锦草、厚朴和茯苓4味药的薄层鉴别条件和盐酸小檗碱、厚朴酚和和厚朴酚的HPLC测定方法。采用急性毒性与亚慢性毒性试验方法,对乌锦颗粒剂进行安全评价。小鼠急性毒性试验得出,乌锦颗粒剂的LD5040g/kg·bw,最大耐受剂量为160g/kg·bw,是临床用药量的80倍,在用药剂量合理的情况下,临床用药安全无毒。Wistar大鼠亚慢性毒性试验表明,除高剂量外,乌锦颗粒剂对Wistar大鼠的体重增长、血液常规指标、血清学指标、主要脏器指数等均无显著(P0.05)影响。急性与亚慢性毒性试验表明,乌锦颗粒剂属无毒产品。通过小肠墨汁推进运动试验、羔羊离体回肠蠕动试验、止泻试验、耳廓肿胀抑制试验和扭体法镇痛试验表明乌锦颗粒剂具有涩肠止泻、抗炎、镇痛作用。本研究证实,乌锦颗粒剂组方合理,制备工艺稳定、可行,具有止泻、抗炎、镇痛作用,安全有效,是防治羔羊痢疾的有效中药制剂。
[Abstract]:Lamb dysentery is a kind of newborn lamb toxemia caused mainly by bacteria such as Clostridium perfringens. It is characterized by lambs abdominal distension, persistent discharge of atherosclerotic or watery feces, dehydration and so on. The incidence rate of lambs is 100.40%. In this study, the treatment of lamb dysentery with veterinary medicine was studied, and the traditional veterinary theory and modern Chinese medicine preparation technology were used to study the prevention and treatment of lamb dysentery. To develop an effective Chinese veterinary medicine granules for the treatment of dysentery in lambs. According to the requirement of the stability of traditional Chinese medicine and the convenience of veterinary medicine, the form of Chinese veterinary medicine for the treatment of lamb dysentery was established as granule. Taking "astringent intestines to stop diarrhea, invigorate spleen and stomach" as the treatment principle, a candidate prescription of traditional Chinese medicine was formulated, clinical trials were carried out under the guidance of clinical efficacy, and the Wujin granules, which were effective in the treatment of dysentery in lambs, were screened out, and their best dosage, that is, 1.2g/kg BWN 2 times / d. The cure rate was 89. 3% and the total efficiency was 96. 4%. The extraction process was optimized by L9 / 34) orthogonal test method, and the preparation process was optimized by the difficult and easy granulation and particle forming rate. The preparation process of Wujin granules was as follows: Magnolia officinalis was refluxed with 12 times 70% ethanol for 2 times each time for 1 hour, and the ethanol solution was combined. Decompression recovery to no alcohol flavor, Magnolia officinalis extract, set aside. Rhizoma Coptidis, Dijingcao, Poria cocos and other 6 kinds of traditional Chinese medicine were added 10 times of water, boiled for 3 times, filtered for 1 hour each time, combined with filtrate, concentrated to the relative density of 0.9g 1.1.1.The concentrated solution was obtained. The concentrated solution was combined with the extract of Magnolia officinalis and concentrated to a thick paste with a relative density of 1.31 ~ 1.35 ~ 5055 鈩，

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