發(fā)布時(shí)間：2018-12-21 09:56

【摘要】：銀翹藍(lán)芩口服液是中國(guó)農(nóng)業(yè)科學(xué)院蘭州畜牧與獸藥研究所根據(jù)中獸醫(yī)理論研制的預(yù)防和治療禽呼吸道感染性疾病的復(fù)方中藥口服液制劑,由金銀花、連翹、黃芩、板藍(lán)根等多味中藥制成。對(duì)禽呼吸道感染性疾病有較好的防治效果,尤其是對(duì)雞傳染性支氣管炎效果顯著。本研究對(duì)銀翹藍(lán)芩口服液的質(zhì)量標(biāo)準(zhǔn)進(jìn)行研究,同時(shí)考察其對(duì)靶動(dòng)物雞的安全性,為其在臨床安全科學(xué)的應(yīng)用提供數(shù)據(jù)支持。1.根據(jù)《中國(guó)獸藥典》2010年版要求,開展了制劑中主要中藥材的薄層鑒別研究。對(duì)金銀花、連翹、黃芩及苦參薄層鑒別時(shí)所用的點(diǎn)樣量、展開劑、樣品前處理方法、薄層板類型、顯色方法等條件進(jìn)行了優(yōu)化,建立了上述4味中藥材的薄層鑒別方法。研究結(jié)果顯示,建立的方法斑點(diǎn)清晰、分離度高、簡(jiǎn)便易行、重復(fù)性好,陰性無(wú)干擾,可用于銀翹藍(lán)芩口服液的定性質(zhì)量控制。2.根據(jù)《中國(guó)獸藥典》2010年版要求,對(duì)銀翹藍(lán)芩口服液中綠原酸、黃芩苷及連翹苷三種主要成分進(jìn)行含量測(cè)定,對(duì)其含量測(cè)定的方法學(xué)進(jìn)行考察,結(jié)果顯示建立的含量測(cè)定的方法系統(tǒng)適應(yīng)性好,陰性對(duì)照無(wú)干擾,線性關(guān)系試驗(yàn)、精密度試驗(yàn)、加樣回收率試驗(yàn)都符合方法學(xué)考察要求,且該方法操作簡(jiǎn)單,靈敏度高,結(jié)果準(zhǔn)確,可用于銀翹藍(lán)芩口服液中主要有效成分的含量測(cè)定,為該口服的質(zhì)量控制提供依據(jù)。3.按照《中國(guó)獸藥典》2010年版一部要求,需對(duì)口服液的微生物污染程度進(jìn)行評(píng)價(jià)。建立了微生物限度檢查方法,并對(duì)方法進(jìn)行驗(yàn)證。檢查方法分別考察了菌液配置、培養(yǎng)基適應(yīng)性和計(jì)數(shù)方法驗(yàn)證�？刂凭�(大腸埃希菌)檢查方法同樣考察了菌液配置、培養(yǎng)基適應(yīng)性和計(jì)數(shù)方法驗(yàn)證。驗(yàn)證結(jié)果顯示,可以采用上述驗(yàn)證過的常規(guī)法對(duì)該口服液進(jìn)行微生物限度檢查和控制菌檢查。檢查結(jié)果表明,銀翹藍(lán)芩口服液的微生物限度符合《中國(guó)獸藥典》2010年版要求。4.對(duì)銀翹藍(lán)芩口服液中試產(chǎn)品進(jìn)行穩(wěn)定性考察,為其儲(chǔ)藏條件和有效期的制定提供依據(jù)。穩(wěn)定性考察包括影響因素試驗(yàn)、高溫試驗(yàn)和高濕試驗(yàn)。在試驗(yàn)過程中檢測(cè)綠原酸和黃芩苷的含量,并考察其性狀、澄清度、相對(duì)密度、p H等變化。結(jié)果發(fā)現(xiàn)兩種主要成分的含量沒有明顯變化,其它各項(xiàng)檢測(cè)指標(biāo)均無(wú)明顯變化,穩(wěn)定性較好,符合質(zhì)量標(biāo)準(zhǔn)草案。5.依據(jù)獸藥研究技術(shù)指導(dǎo)原則,開展銀翹藍(lán)芩口服液對(duì)靶動(dòng)物雞的安全性研究,為其臨床應(yīng)用的安全性提供數(shù)據(jù)資料。按銀翹藍(lán)芩口服液臨床推薦劑量的1、3、5倍連續(xù)飲水給藥7 d,給藥后,采集血液和臟器,進(jìn)行血常規(guī)、血液生化指標(biāo)、臟器指數(shù)和組織病理學(xué)檢查,并與對(duì)照組比較。試驗(yàn)結(jié)果顯示,與對(duì)照組相比,各給藥組雞的血常規(guī)、血液生化、增重和臟器系數(shù)等指標(biāo)差異均不顯著(P0.05),各臟器組織未見明顯的病理學(xué)變化。結(jié)果表明銀翹藍(lán)芩口服液飲水給藥對(duì)靶動(dòng)物雞是安全的。
[Abstract]:Yinqiao Lanqin Oral liquid, developed by Lanzhou Institute of Animal Husbandry and Veterinary Medicine, Chinese Academy of Agricultural Sciences, is a compound Chinese medicine oral liquid for the prevention and treatment of infectious diseases in the respiratory tract of poultry. It consists of Lonicera Lonicerae, Forsythia, Scutellaria baicalensis, Radix Isatidis and other multi-flavor Chinese medicine made. It has good control effect on avian respiratory infectious diseases, especially on chicken infectious bronchitis. In this study, the quality standard of Yinqiao Lanqin oral liquid was studied, and the safety of Yinqiao Lanqin oral liquid was investigated to provide data support for its application in clinical safety science. 1. According to the requirements of the Chinese Veterinary Pharmacopoeia in 2010, TLC identification of the main Chinese medicinal materials in the preparation was carried out. The TLC identification methods of the four herbs were established, such as the sample quantity, the development agent, the sample pretreatment method, the thin-layer plate type, the color development method and so on, used in the TLC identification of Flos Lonicerae, Forsythia suspensa, Radix Scutellariae and Sophora flavescens. The results showed that the established method was characterized by clear spots, high separation, simplicity, good reproducibility and no interference, and could be used for qualitative quality control of Yinqiao Lanqin oral liquid. 2. According to the requirements of the Chinese Veterinary Pharmacopoeia in 2010, the contents of Lv Yuan, baicalin and suspensin in Yinqiao Lanqin Oral liquid were determined, and the methods of determination were investigated. The results showed that the established method had good adaptability, negative control had no interference, linear relation test, precision test and sample recovery test all met the requirements of methodological investigation, and the method was simple and sensitive. The results are accurate and can be applied to the determination of the main active components in Yinqiao Lanqin Oral liquid. According to the requirements of the Chinese Veterinary Pharmacopoeia in 2010, the degree of microbial contamination of oral liquid should be evaluated. The method of microbial limit examination was established and verified. The bacterial solution configuration, the adaptability of culture medium and the verification of counting method were investigated. Control bacteria (Escherichia coli) methods were also investigated in liquid configuration, medium adaptability and counting method. The results showed that the microbiological limit test and bacteria control test could be used in the oral liquid. The results showed that the microbial limit of Yinqiao Lanqin Oral liquid was in accordance with the requirements of the Chinese Veterinary Pharmacopoeia 2010 edition. 4. The stability of the pilot-scale product of Yinqiao Lanqin oral liquid was investigated to provide the basis for the formulation of storage conditions and validity period. The stability test includes influence factor test, high temperature test and high humidity test. The contents of Lv Yuan acid and baicalin were detected during the experiment, and the changes of their properties, clarity and relative density, p H were investigated. The results showed that the content of the two main components did not change obviously, and the other indexes were not changed obviously, the stability was good, and the content of the two main components was in accordance with the draft quality standard. 5. According to the technical guiding principle of veterinary drug research, the safety of Yinqiao Lanqin oral liquid to the target animal chicken was studied, which provided data for the safety of its clinical application. According to the clinical recommended dose of Yinqiao Lanqin Oral liquid, the patients were given drinking water for 7 days. Blood routine examination, blood biochemical index, visceral index and histopathology were collected and compared with those in the control group. The results showed that compared with the control group, the blood routine, blood biochemistry, weight gain and organ coefficient were not significantly different (P0.05), and no obvious pathological changes were found in the tissues of each viscera. The results showed that Yinqiao Lanqin oral solution was safe for target chickens.
【學(xué)位授予單位】：甘肅農(nóng)業(yè)大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：S853.7

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 許春燕;劉希望;楊亞軍;郭沂濤;李劍勇;;銀翹藍(lán)芩口服液薄層色譜鑒別方法研究[J];動(dòng)物醫(yī)學(xué)進(jìn)展;2015年11期

2 劉愛明;;消炎止咳片微生物限度檢查法研究[J];遼寧中醫(yī)藥大學(xué)學(xué)報(bào);2015年02期

3 辛任升;劉宇;張超;梁劍平;;復(fù)方苦豆子灌注液總生物堿含量測(cè)定方法的建立[J];動(dòng)物醫(yī)學(xué)進(jìn)展;2014年12期

4 王武;;家禽呼吸道疾病的癥狀與防治[J];鄉(xiāng)村科技;2014年19期

5 王永彬;周緒正;張繼瑜;;板黃口服液在靶動(dòng)物雞中的安全性研究[J];中國(guó)畜牧獸醫(yī);2014年09期

6 任麗花;辛蕊華;程龍;羅永江;王貴波;羅超應(yīng);謝家聲;李錦宇;鄭繼方;;金根芩連散的質(zhì)量標(biāo)準(zhǔn)研究[J];中國(guó)畜牧獸醫(yī);2014年08期

7 張翅;馬悅;高慧敏;張啟偉;王智民;;苦參化學(xué)成分研究進(jìn)展[J];中國(guó)實(shí)驗(yàn)方劑學(xué)雜志;2014年04期

8 宗昕如;張曉輝;辛凌翔;楊迪;劉彩;沈向榮;王文超;鮑恩東;;磷酸替米考星可溶性粉在靶動(dòng)物雞的安全性試驗(yàn)[J];畜牧與獸醫(yī);2014年02期

9 賴建彬;劉娟;朱兆榮;顧員印;;術(shù)苦芩顆粒對(duì)靶動(dòng)物仔豬的安全性試驗(yàn)[J];中獸醫(yī)醫(yī)藥雜志;2014年01期

10 金國(guó)泰;李博;代龍;;改善中藥口服液澄清度工藝研究進(jìn)展[J];遼寧中醫(yī)藥大學(xué)學(xué)報(bào);2013年12期

相關(guān)會(huì)議論文 前1條

1 王貴波;王東升;謝家聲;鄭繼方;羅超應(yīng);李錦宇;羅永江;辛蕊華;;射干地龍顆粒對(duì)靶動(dòng)物的安全性試驗(yàn)研究[A];中國(guó)畜牧獸醫(yī)學(xué)會(huì)中獸醫(yī)學(xué)分會(huì)2013年學(xué)術(shù)年會(huì)論文集[C];2013年

相關(guān)博士學(xué)位論文 前1條

1 葛冰;復(fù)方白頭翁顆粒的研制及其藥效學(xué)研究[D];中國(guó)農(nóng)業(yè)大學(xué);2015年

相關(guān)碩士學(xué)位論文 前3條

1 陳佳娟;中獸藥“炎毒熱清”注射液的篩選與毒理藥效學(xué)研究[D];甘肅農(nóng)業(yè)大學(xué);2010年

2 曲歡歡;連翹化學(xué)成分和生物活性研究[D];西北大學(xué);2008年

3 張杲;連翹（Forsythia suspensa）葉藥用價(jià)值及其藥用活性組分的初步研究[D];陜西師范大學(xué);2006年

，

本文編號(hào)：2388753