烏錦顆粒劑的制備與藥效毒理學研究
發(fā)布時間:2018-05-27 18:20
本文選題:中藥顆粒劑 + 制備工藝。 參考:《中國農(nóng)業(yè)科學院》2015年碩士論文
【摘要】:羔羊痢疾主要是由產(chǎn)氣莢膜桿菌等致病菌引起的一種新生羔羊毒血癥,以羔羊腹脹,持續(xù)性排粥樣或水樣稀糞,脫水等為基本特征,發(fā)病率為10~40%。本研究以羔羊痢疾中獸藥治療為研究對象,以傳統(tǒng)獸醫(yī)理論和現(xiàn)代中藥制劑制備工藝為指導,進行中獸藥防治羔羊痢疾的研究,旨在研制有效治療羔羊痢疾的中獸藥復方顆粒劑。根據(jù)中藥制劑的穩(wěn)定性和獸醫(yī)臨床用藥便捷性的需求,確立治療羔羊痢疾的中獸藥劑型為顆粒劑。以“澀腸止瀉、健脾和胃”為治則,擬定候選中藥方,以臨床療效為導向開展臨床試驗,篩選出有效治療羔羊痢疾的烏錦顆粒劑,及其最佳用藥劑量,即1.2g/kg·bw,2次/d。治愈率達89.3%,總用效率為96.4%。采用L9(34)正交試驗法優(yōu)選提取工藝,并以制粒的難易和顆粒成型率優(yōu)化顆粒制備工藝,優(yōu)選了烏錦顆粒劑的制備工藝為:厚樸用12倍70%乙醇回流提取2次,每次1 h,合并乙醇液,減壓回收至無醇味,得厚樸提取液,備用。黃連、地錦草、茯苓等6味中藥加10倍水,煎煮3次,每次1 h濾過,合并濾液,濃縮至相對密度為0.9~1.1,得水煎濃縮液。濃縮液與厚樸提取液合并,濃縮至相對密度為1.31~1.35(50~55℃)的稠膏,加0.8倍藥材量的可溶性淀粉和蔗糖粉(17:3),制成顆粒,干燥,即得“烏錦顆粒劑”。確定了烏錦顆粒劑中黃連、地錦草、厚樸和茯苓4味藥的薄層鑒別條件和鹽酸小檗堿、厚樸酚和和厚樸酚的HPLC測定方法。采用急性毒性與亞慢性毒性試驗方法,對烏錦顆粒劑進行安全評價。小鼠急性毒性試驗得出,烏錦顆粒劑的LD5040g/kg·bw,最大耐受劑量為160g/kg·bw,是臨床用藥量的80倍,在用藥劑量合理的情況下,臨床用藥安全無毒。Wistar大鼠亞慢性毒性試驗表明,除高劑量外,烏錦顆粒劑對Wistar大鼠的體重增長、血液常規(guī)指標、血清學指標、主要臟器指數(shù)等均無顯著(P0.05)影響。急性與亞慢性毒性試驗表明,烏錦顆粒劑屬無毒產(chǎn)品。通過小腸墨汁推進運動試驗、羔羊離體回腸蠕動試驗、止瀉試驗、耳廓腫脹抑制試驗和扭體法鎮(zhèn)痛試驗表明烏錦顆粒劑具有澀腸止瀉、抗炎、鎮(zhèn)痛作用。本研究證實,烏錦顆粒劑組方合理,制備工藝穩(wěn)定、可行,具有止瀉、抗炎、鎮(zhèn)痛作用,安全有效,是防治羔羊痢疾的有效中藥制劑。
[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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