本文選題：拉諾康唑 + 原料藥�。� 參考：《蘇州大學(xué)》2014年碩士論文

【摘要】：淺部真菌感染為一種傳染性強的常見病和多發(fā)病。近年來，隨著致病真菌對抗真菌藥物的耐藥性日趨嚴重，研發(fā)新的抗真菌藥物，可緩解目前市售抗真菌藥的抗藥性。 在中國，拉諾康唑原料藥及其乳膏均未上市。本課題旨在研究開發(fā)一種療效更好、抗藥性低、不良反應(yīng)少、使用更方便的抗真菌乳膏制劑。 本課題主要進行了以下研究工作： 開發(fā)拉諾康唑原料合成路線，并進行結(jié)構(gòu)確證。 采用自制的拉諾康唑原料藥，選擇較常用的油相及水相基質(zhì)，對乳膏的性狀、手感、含量、酸度、耐冷及耐熱性等指標進行考察，確定合理的處方，開發(fā)出具有粒度小、分布均勻、細膩、涂布性好、穩(wěn)定性好、不易發(fā)生油水分離以及適合工業(yè)化生產(chǎn)等優(yōu)點的拉諾康唑乳膏制備工藝。 結(jié)合拉諾康唑的藥物特性和乳膏的質(zhì)量要求，建立了拉諾康唑乳膏的質(zhì)量標準，，包括性狀、鑒別、裝量、粒度、微生物限度、有關(guān)物質(zhì)及含量測定等全面的質(zhì)控項目。 根據(jù)建立的質(zhì)量標準，對拉諾康唑乳膏分別進行了光照、高溫和高濕等影響因素和加速試驗、長期留樣試驗的考察，在此基礎(chǔ)上為拉諾康唑乳膏選擇包裝材料、貯存條件提供依據(jù)并預(yù)測有效期。 采用自制的拉諾康唑乳膏進行了皮膚刺激性和過敏性試驗，結(jié)果表明拉諾康唑軟膏對家兔皮膚無明顯刺激性，對豚鼠皮膚未見明顯過敏反應(yīng)。 綜上，本文對拉諾康唑原料合成路線、乳膏的制備工藝、質(zhì)量標準、制劑的穩(wěn)定性及其皮膚刺激性和過敏性等進行了研究，其制備工藝科學(xué)、質(zhì)控項目全面，為以后生產(chǎn)出售奠定了堅實的基礎(chǔ)。
[Abstract]:Superficial fungal infection is a common and frequent infectious disease. In recent years, with the drug resistance of pathogenic fungi becoming more and more serious, the development of new antifungal drugs can alleviate the current market antifungal drug resistance. In China, ranokonazole raw materials and cream are not on the market. The purpose of this study was to develop a more effective, less resistant, less adverse reaction and more convenient antifungal cream. The main work of this thesis is as follows: The synthetic route of raw materials of ranokonazole was developed and the structure was confirmed. The properties, feel, content, acidity, cold resistance and heat resistance of the cream were investigated by using the self-made ranokonazole raw material and the common oil and water phase matrix. The reasonable prescription was determined and the particle size was small. The preparation process of ranokonazole cream was characterized by uniform distribution, fine distribution, good coating property, good stability, easy oil and water separation and suitable for industrial production. Combined with the drug characteristics of ranokonazole and the quality requirements of cream, the quality standard of ranokonazole cream was established, including the quality control items such as character, identification, loading quantity, particle size, microbial limit, related substances and content determination. According to the established quality standard, the effects of light, high temperature and high humidity on the ranokonazole cream and the accelerated test were investigated, and the long-term sample retention test was carried out. On this basis, the packing materials were selected for the ranokonazole cream. The storage conditions provide the basis and predict the validity period. The skin irritation and anaphylaxis test were carried out with the self-made ranokonazole cream. The results showed that there was no obvious irritation to rabbit skin and no obvious allergic reaction to guinea pig skin. In this paper, the synthetic route of ranokonazole raw material, preparation technology, quality standard, stability, skin irritability and allergenicity of the preparation were studied. The preparation process was scientific and the quality control items were comprehensive. For the future production and sales laid a solid foundation.
【學(xué)位授予單位】：蘇州大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R943

【參考文獻】

相關(guān)期刊論文 前1條

1 劉敬娟;;抗真菌藥物的研究現(xiàn)狀[J];黑龍江醫(yī)藥;2008年03期

本文編號：1819198