本文選題：曲安奈德　切入點：硝酸益康唑　出處：《重慶醫(yī)科大學》2014年碩士論文

【摘要】：曲安奈德益康唑乳膏是由楊森-Cilag制藥公司開發(fā)的一種復方皮膚外用制劑，國內生產廠家為西安楊森制藥有限公司。主要用于治療皮膚真菌性疾病，如皮炎、濕疹、體癬、手足癬等。該復方制劑上市劑型目前只有乳膏，而沒有以卡波姆為凝膠基質的乳劑型凝膠。為使劑型多樣化，本文對原劑型乳膏進行了劑型改進，改變?yōu)槿閯┬湍z，在外觀性狀、油膩感、涂抹后美觀等方面有了較大改善，提高了患者用藥的依從性。 本文的主要內容包括：（1）對曲安奈德益康唑乳劑型凝膠進行了處方篩選及制備工藝研究；（2）進行了曲安奈德益康唑乳劑型凝膠的質量研究；（3）考察了曲安奈德益康唑乳劑型凝膠的穩(wěn)定性；（4）開展了曲安奈德益康唑乳劑型凝膠的體外經(jīng)皮滲透性和刺激性研究。 參照市售乳膏，，本文首先進行了處方設計，確定了原輔料種類，并考察和篩選了輔料的用量。由單因素實驗結果，確定了影響乳劑型凝膠外觀性狀和穩(wěn)定性的主要因素有丙二醇、乙醇、液體石蠟、辛酸癸酸聚乙二醇甘油酯和司盤-80，以外觀性狀、離心試驗、藥物晶體析出情況為指標，進行正交試驗，優(yōu)選處方。對工藝參數(shù)乳化轉速、溫度和時間進行考察，確定了最佳制備工藝。 采用HPLC法，建立了含量測定方法，曲安奈德和硝酸益康唑分別在4.78～86.04μg/ml和49.86～897.48μg/ml濃度范圍內呈良好線性關系，回收率、精密度和溶液穩(wěn)定性均符合要求�？疾炝饲材蔚乱婵颠蛉閯┬湍z的質量，外觀為微白色乳劑型凝膠，pH計測定其平均pH值為5.63，25℃的平均動力黏度為40.5Pa·S，含量、粒度、裝量差異、耐寒和耐熱試驗均符合要求。 對曲安奈德益康唑乳劑型凝膠進行了影響因素、加速和長期穩(wěn)定性試驗考察，發(fā)現(xiàn)本品在高溫60℃和光照下不穩(wěn)定，應避光、陰涼保存。30℃±2℃、相對濕度（65±5）%條件下進行加速試驗，含量和有關物質的變化在規(guī)定范圍內。以市售包裝，密封、陰涼處放置6個月，樣品各指標均無明顯變化。說明該處方和工藝對于生產研究有一定的參考價值。 對曲安奈德益康唑乳劑型凝膠進行了體外經(jīng)皮滲透性研究，與市售品乳膏相比，各取樣點和平均累積滲透量無顯著差異，初步判定兩者的有效性無明顯差別。同時還考察了曲安奈德益康唑乳劑型凝膠的皮膚刺激性，結果表明，對家兔皮膚無刺激，有較好的安全性。
[Abstract]:Triamcinolone acetonide econazole cream is a compound skin preparation developed by Yang Sen -Cilag Pharmaceutical Company. The domestic manufacturer is Xi'an Yang Sen Pharmaceutical Co., Ltd. It is mainly used to treat skin fungal diseases, such as dermatitis, eczema, tinea corporis, etc. Tinea of hand and foot etc. At present, there is only cream, but no gel with carbomer as gel matrix. In order to diversify the dosage form, this article has improved the dosage form of the original dosage form cream, changed it into emulsion gel, The appearance, greasy feeling and beauty after smear were improved greatly, and the compliance of the patients was improved. The main contents of this paper include: (1) screening of the formulation and preparation process of triamcinolone acetonide econazole emulsion gel; (2) study on the quality of triamcinolone acetonide econazole emulsion gel; (3) investigation of triamcinolone acetonide econazole gel. The in vitro transdermal permeability and irritation of triamcinolone acetonide econazole emulsion gel were studied. With reference to the market cream, the prescription was designed to determine the type of raw and auxiliary materials, and the dosage of excipients was investigated and screened. The main factors affecting the appearance and stability of emulsion gel are propylene glycol, ethanol, liquid paraffin, caprylic acid polyethylene glycol glyceride and Span-80. The main factors affecting the appearance and stability of emulsion gel are propylene glycol, ethanol, liquid paraffin, sebacic acid polyethylene glycol glyceride and Span-80. Orthogonal test was carried out to optimize the formulation. The optimum preparation process was determined by investigating the emulsification speed, temperature and time of the process parameters. A method for the determination of triamcinolone acetonide and econazole nitrate was established by HPLC. The linear range of triamcinolone acetonide and econazole nitrate was 4.78 渭 g/ml and 49.86 渭 g/ml, respectively. The quality of traamcinolone acetonide econazole emulsion gel was investigated. The average dynamic viscosity of triamcinolone acetonide econazole emulsion gel pH meter with average pH value of 5.63 鈩

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