發(fā)布時(shí)間：2018-04-27 12:09

  本文選題：雙氯芬酸鈉 + 注射液�。� 參考：《山東農(nóng)業(yè)大學(xué)》2017年碩士論文

【摘要】：獸用雙氯芬酸鈉注射液有效成分為雙氯芬酸鈉,適用靶動(dòng)物為豬,可緩解手術(shù)、外傷、關(guān)節(jié)炎等原因引起的疼痛,降低細(xì)菌感染及其它病因引起的高燒發(fā)熱;可緩解豬發(fā)熱,關(guān)節(jié)、肌肉疼痛,跛行等病癥。本文主要對(duì)其處方及工藝、質(zhì)量、穩(wěn)定性、臨床有效性等進(jìn)行研究總結(jié)及評(píng)價(jià)。以雙氯芬酸鈉為原料,依據(jù)藥劑學(xué)等資料,結(jié)合藥物的溶解性、穩(wěn)定性對(duì)制備工藝進(jìn)行一系列的相關(guān)試驗(yàn),進(jìn)行處方篩選,制備工藝驗(yàn)證,確定有效成分的含量、溶媒的處方量,成功制備了雙氯芬酸鈉注射液,并進(jìn)行了工業(yè)化生產(chǎn)放大。在高溫(60℃)、強(qiáng)光(4500±500LX)條件下對(duì)主藥與溶劑之間進(jìn)行了10天的影響因素考察,分別于第5天、第10天對(duì)性狀、鑒別、檢查、含量測(cè)定與第0天進(jìn)行對(duì)比,結(jié)果顯示選用的溶劑適宜,化學(xué)性質(zhì)穩(wěn)定,與主藥不發(fā)生反應(yīng),對(duì)主藥的含量測(cè)定沒(méi)有干擾,配制的雙氯芬酸鈉注射液性質(zhì)穩(wěn)定(中華人民共和國(guó)獸藥典,2015年版第一部)。建立了雙氯芬酸鈉注射液中雙氯芬酸鈉的含量測(cè)定方法,雙氯芬酸鈉線性方程為y=21.052x-30.792(R~2=0.9999,n=5),雙氯芬酸鈉在23.4~376.0μg/mL的濃度范圍內(nèi)線性良好;雙氯芬酸雜質(zhì)A線性方程為:y=36.324x-0.057(R~2=0.9998,n=5),雙氯芬酸雜質(zhì)A在0.4~4.8μg/mL的濃度范圍內(nèi)線性良好。雙氯芬酸鈉與雙氯芬酸雜質(zhì)A的最低定量檢測(cè)濃度分別為105.8ng/mL、81.4ng/m L,最低檢測(cè)濃度分別為52.9ng/mL、40.7ng/m L;在不同的C18色譜柱、柱溫、流動(dòng)相比例及流速條件下,其耐用性良好,主峰及雜質(zhì)峰能達(dá)到基線分離,RSD為1.3%,含量測(cè)定結(jié)果準(zhǔn)確。為驗(yàn)證雙氯芬酸鈉注射液對(duì)靶動(dòng)物豬的抗炎解熱鎮(zhèn)痛效果及合理劑量,對(duì)靶動(dòng)物豬進(jìn)行了雙氯芬酸鈉注射液對(duì)內(nèi)毒素誘導(dǎo)豬發(fā)熱的臨床解熱試驗(yàn)、雙氯芬酸鈉注射液對(duì)仔豬去勢(shì)疼痛的臨床鎮(zhèn)痛試驗(yàn)。確定5%雙氯芬酸鈉注射液用量為:一次量,每1kg體重,豬注射0.05mL,具有抗炎及解熱鎮(zhèn)痛作用,適用于手術(shù)、外傷、關(guān)節(jié)炎等炎性疼痛,細(xì)菌感染及其它疾病繼發(fā)感染引起的高燒發(fā)熱;可緩解發(fā)熱,關(guān)節(jié)、肌肉疼痛,跛行等病癥。雙氯芬酸鈉注射液制備工藝合理、質(zhì)量可控、對(duì)靶動(dòng)物豬的解熱鎮(zhèn)痛效果較好,具有良好的開(kāi)發(fā)應(yīng)用價(jià)值。
[Abstract]:The effective ingredient of diclofenac sodium injection is diclofenac sodium, which is suitable for target animals in pigs. It can relieve the pain caused by surgery, trauma, arthritis and other causes, reduce fever caused by bacterial infection and other causes, and relieve pig fever. Joint, muscle pain, lameness, etc. In this paper, the prescription and technology, quality, stability, clinical effectiveness and so on were summarized and evaluated. Using diclofenac sodium as raw material, according to the data of pharmacology, combining with the solubility and stability of the drug, a series of related experiments were carried out on the preparation process, and the prescription was screened, the preparation process was verified, and the content of the active components was determined. Diclofenac sodium injection was successfully prepared by the formulation of solvent and amplified in industrial production. The influencing factors between the main drug and the solvent were investigated at 60 鈩，

本文編號(hào)：1810676