銀翹藍芩口服液的質(zhì)量標準及靶動物安全性研究
發(fā)布時間：2018-12-21 09:56
【摘要】：銀翹藍芩口服液是中國農(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、板藍根等多味中藥制成。對禽呼吸道感染性疾病有較好的防治效果,尤其是對雞傳染性支氣管炎效果顯著。本研究對銀翹藍芩口服液的質(zhì)量標準進行研究,同時考察其對靶動物雞的安全性,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。對金銀花、連翹、黃芩及苦參薄層鑒別時所用的點樣量、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,建立的方法斑點清晰、分離度高、簡便易行、重復(fù)性好,陰性無干擾,可用于銀翹藍芩口服液的定性質(zhì)量控制。2.根據(jù)《中國獸藥典》2010年版要求,對銀翹藍芩口服液中綠原酸、黃芩苷及連翹苷三種主要成分進行含量測定,對其含量測定的方法學(xué)進行考察,結(jié)果顯示建立的含量測定的方法系統(tǒng)適應(yīng)性好,陰性對照無干擾,線性關(guān)系試驗、精密度試驗、加樣回收率試驗都符合方法學(xué)考察要求,且該方法操作簡單,靈敏度高,結(jié)果準確,可用于銀翹藍芩口服液中主要有效成分的含量測定,為該口服的質(zhì)量控制提供依據(jù)。3.按照《中國獸藥典》2010年版一部要求,需對口服液的微生物污染程度進行評價。建立了微生物限度檢查方法,并對方法進行驗證。檢查方法分別考察了菌液配置、培養(yǎng)基適應(yīng)性和計數(shù)方法驗證。控制菌(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)性和計數(shù)方法驗證。驗證結(jié)果顯示,可以采用上述驗證過的常規(guī)法對該口服液進行微生物限度檢查和控制菌檢查。檢查結(jié)果表明,銀翹藍芩口服液的微生物限度符合《中國獸藥典》2010年版要求。4.對銀翹藍芩口服液中試產(chǎn)品進行穩(wěn)定性考察,為其儲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、高溫試驗和高濕試驗。在試驗過程中檢測綠原酸和黃芩苷的含量,并考察其性狀、澄清度、相對密度、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,其它各項檢測指標均無明顯變化,穩(wěn)定性較好,符合質(zhì)量標準草案。5.依據(jù)獸藥研究技術(shù)指導(dǎo)原則,開展銀翹藍芩口服液對靶動物雞的安全性研究,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,進行血常規(guī)、血液生化指標、臟器指數(shù)和組織病理學(xué)檢查,并與對照組比較。試驗結(jié)果顯示,與對照組相比,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)果表明銀翹藍芩口服液飲水給藥對靶動物雞是安全的。
[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)位級別】：碩士
【學(xué)位授予年份】：2016
【分類號】：S853.7
本文編號：2388753
[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)位級別】：碩士
【學(xué)位授予年份】：2016
【分類號】：S853.7
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