【摘要】：曲安奈德益康唑乳膏既有抗菌的作用,也有抗炎的作用,臨床主要用于濕疹患者的治療,也用于治療皮炎患者。曲安奈德益康唑乳膏曲安奈德含量為0.1%,硝酸益康唑含量為1%,是由二者組成的復(fù)合制劑。曲安奈德屬中強(qiáng)效的糖皮質(zhì)激素,既有抗炎癥的功效,同時具有抗過敏和抗毒活性,做為外用制劑應(yīng)用時具有系統(tǒng)吸收少的特點,臨床用于治療各種非感染性炎癥性皮膚病。 在處方工藝研究的前期研究中,首先建立了有關(guān)物質(zhì)高效液相色譜法分析方法。方法學(xué)研究證明,確定的有關(guān)物質(zhì)測定方法可以有效的分離各雜質(zhì),且專屬性良好。 在處方工藝研究的前期研究中,建立了含量測定高效液相色譜法分析方法。線性關(guān)系研究結(jié)果表明,曲安奈德在30.24～70.56μg/mL濃度范圍內(nèi)濃度與色譜峰面積呈現(xiàn)良好的線性關(guān)系,益康唑在0.3012～0.7028mg/mL濃度范圍內(nèi)濃度與色譜峰面積呈現(xiàn)良好的線性關(guān)系。同時,方法學(xué)研究結(jié)果表明精密度、回收率試驗均符合要求。 另外,在處方研究中,以產(chǎn)品性狀、含量、有關(guān)物質(zhì)等參數(shù)為考察指標(biāo),進(jìn)行了處方單因素考察,并對主要工藝參數(shù)進(jìn)行研究,最后通過正交優(yōu)化試驗進(jìn)行了優(yōu)化,并確定最優(yōu)處方。 同時,本論文對制得的曲安奈德益康唑乳膏進(jìn)行了質(zhì)量研究,擬定初步質(zhì)量標(biāo)準(zhǔn)。樣品穩(wěn)定性考察結(jié)果表明：加速試驗(溫度40℃±2℃、濕度RH75%±5%)考察6個月,分別于1、2、3、6月取樣檢測,與零月數(shù)據(jù)比較,各檢測項目無明顯變化。試驗結(jié)果表明本品在加速條件下放置6個月質(zhì)量穩(wěn)定；長期試驗(溫度25℃±2℃、濕度RH60%±10%)考察12個月,分別于3、6、9、12月取樣檢測,各檢測項目與零月數(shù)據(jù)比較,無明顯變化,說明本品基本穩(wěn)定,質(zhì)量穩(wěn)定可靠。 最后,對曲安奈德益康唑乳膏的體外透皮性及安全性進(jìn)行了研究。透皮研究發(fā)現(xiàn)本品在24小時內(nèi)透過皮膚進(jìn)入接受液中的藥物量都極少,但均測到了皮膚中的滯留量,說明本品可有效產(chǎn)生局部效應(yīng)而避免全身作用。而安全性評價研究表明本品與市售品曲安奈德益康唑乳膏及市售派瑞松對家兔完整皮膚及破損皮膚有輕度的刺激性,末次給藥后第八天紅斑消退,兩者比較未見明顯差別：兩者均無過敏性。
[Abstract]:Triamcinolone acetonide econazole cream has both antibacterial and anti-inflammatory effects. It is mainly used in the treatment of eczema and dermatitis. The contents of triamcinolone acetonide and econazole nitrate were 0.1 and 1, respectively. Triamcinolone acetonide is a kind of medium effective glucocorticoid, which has not only anti-inflammatory effect, but also anti-allergic and antitoxic activity. In the previous study of prescription technology, a HPLC method was established for the analysis of related substances. Methodological studies show that the determined method can effectively separate impurities, and the specificity is good. In the previous study of prescription technology, a HPLC method for content determination was established. The results showed that the concentration of triamcinolone acetonide in the range of 30.24 渭 g/mL and 70.56 渭 g/mL showed a good linear relationship with the chromatographic peak area. There was a good linear relationship between the concentration of econazole and the chromatographic peak area in the range of 0.3012~0.7028mg/mL concentration. At the same time, the methodological research results show that the precision and recovery test are in line with the requirements. In addition, in the study of prescription, the parameters such as product character, content and related substances were used as the index, the single factor of prescription was investigated, and the main technological parameters were studied. Finally, the optimization was carried out by orthogonal optimization test. The optimal prescription was determined. At the same time, the quality of triamcinolone acetonide econazole cream was studied. The results of the stability test showed that the accelerated test (temperature 40 鈩，

本文編號：2356557