宠物药浴香波—复方盐酸特比萘芬纳米乳的制备和质量评价

发布时间：2018-10-31 20:18

【摘要】：目的:筛选宠物药浴香波——复方盐酸特比萘芬纳米乳配方,制备复方盐酸特比萘芬纳米乳,并对其质量进行评价,为临床治疗宠物真菌与螨虫混合感染提供一种宠物药浴香波。方法:(1)筛选复方盐酸特比萘芬纳米乳配方:首先依据盐酸特比萘芬和百里香酚在不同油相中溶解度的不同而选择合适的油相,再结合伪三元相图筛选表面活性剂与Km值,最后确定出最佳配方。(2)复方盐酸特比萘芬纳米乳的制备:室温下,按照配方量先将盐酸特比萘芬、百里香酚溶于茶树油中,使其全部溶解,再加入RH-40和BS-12与之混合均匀,将VB5与K12-Na溶于蒸馏水中,最后向该体系中缓慢滴加水相并快速搅拌,直至形成澄清透明液体,即得复方盐酸特比萘芬纳米乳。(3)复方盐酸特比萘芬纳米乳的质量评价:用染色法鉴定其结构类型,通过激光粒度分析仪测定其粒径大小、粒度分布、多分散系数,用透射电子显微镜观察其形态,用紫外分光光度法测定药物含量,经过离心加速试验、长期试验以及光照稳定试验考察纳米乳的稳定性。结果:(1)复方盐酸特比萘芬纳米乳的配方:w(盐酸特比萘芬)=1.2%,w(百里香酚)=1.0%,w(VB5)=0.9%,w(茶树油)=2%,w(RH-40)=18%,w(BS-12)=6%,w(K12-Na)=2%,w(蒸馏水)=68.9%。(2)所制备的纳米乳外观表现为澄清透明的液体,经染色法鉴定为水包油结构;透射电镜观察表明其乳滴呈均匀的圆球形,大小均一;激光粒度仪分析结果表明,其粒径范围为7.80~40.72nm,平均粒径为15.74 nm,多分散系数0.225;稳定性实验结果表明,该纳米乳经离心、光照、长期试验均无分层、破乳以及絮凝等现象,且其中药物含量基本无变化。(3)经紫外分光光度法检测,复方盐酸特比萘芬纳米乳中盐酸特比萘芬最佳检测波长为282nm,在0.78125~25μg/mL的浓度范围内与吸光度的线性关系良好,百里香酚最佳检测波长为277 nm,在0.78125~25μg/mL的浓度范围内与吸光度的线性关系良好。结论:制备的宠物药浴香波——复方盐酸特比萘芬纳米乳具有良好的稳定性,符合纳米乳的质量要求。
[Abstract]:Objective: to select the formula of compound terbinafine hydrochloride nano-emulsion and to prepare compound terbinafine hydrochloride nano-emulsion and evaluate its quality. To provide a pet medicine bath shampoo for clinical treatment of mixed infection of pet fungi and mites. Methods: (1) screening the formula of compound terbinafine hydrochloride nanoemulsion: firstly, according to the different solubility of terbinafine hydrochloride and thymol in different oil phase, the suitable oil phase was selected, then the surfactant and Km value were screened by pseudo-ternary phase diagram. Finally, the optimum formula was determined. (2) preparation of compound terbinafine hydrochloride nanoemulsion: terbinafine hydrochloride and thymol were dissolved in tea tree oil at room temperature, Then add RH-40 and BS-12 to mix them evenly, dissolve VB5 and K12-Na in distilled water, add water phase slowly to the system and stir quickly until clear and transparent liquid is formed. The compound terbinafine hydrochloride nanoemulsion was obtained. (3) the quality evaluation of compound terbinafine hydrochloride nanoemulsion. The structure type of compound terbinafine hydrochloride nanoemulsion was identified by staining method. The particle size, particle size distribution and polydispersity coefficient of terbinafine hydrochloride nanoemulsion were measured by laser particle size analyzer. The morphology was observed by transmission electron microscope (TEM), the drug content was determined by ultraviolet spectrophotometry, the stability of nano-emulsion was investigated by centrifugation accelerated test, long-term test and illumination stability test. Results: (1) the formula of compound terbinafine hydrochloride nanoemulsion: w (hydrochloride terbinafine) = 1.2% Thymol = 1.0cm w (VB5) = 0.9g w (tea tree oil) = 2cw (RH-40) = 18. W (BS-12) = 6w (K12-Na) = 2g / w (distilled water) = 68.9%. (2) the appearance of the prepared nanoemulsion was clear and transparent liquid, which was identified as the oil-in-water structure by staining method. Transmission electron microscopy (TEM) showed that the emulsion droplets were spherical and uniform in size, and the laser particle size analysis showed that the particle size ranged from 7.80 to 40.72 nm, the average particle size was 15.74 nm, and the polydispersity coefficient was 0.225; The results of stability test showed that the nano-emulsion was not stratified, demulsified and flocculated by centrifugation, illumination and long-term test, and the content of the drug was basically unchanged. (3) the content of the drug was detected by UV spectrophotometry. The optimum detection wavelength of terbinafine hydrochloride in compound terbinafine hydrochloride nanoemulsion is 282 nm. The linear relationship between terbinafine hydrochloride and absorbance in the concentration range of 0.78125 渭 g/mL is good. The best detection wavelength of thymol is 277 nm,. The linear relationship between the absorbance and absorbance is good in the concentration range of 0.78125 渭 g/mL. Conclusion: the prepared pet medicine bath shampoo compound terbinafine hydrochloride nanoemulsion has good stability and meets the quality requirements of nanometer emulsion.
【学位授予单位】：西北农林科技大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：S859.5

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