【摘要】：目的:篩選寵物藥浴香波——復方鹽酸特比萘芬納米乳配方,制備復方鹽酸特比萘芬納米乳,并對其質(zhì)量進行評價,為臨床治療寵物真菌與螨蟲混合感染提供一種寵物藥浴香波。方法:(1)篩選復方鹽酸特比萘芬納米乳配方:首先依據(jù)鹽酸特比萘芬和百里香酚在不同油相中溶解度的不同而選擇合適的油相,再結(jié)合偽三元相圖篩選表面活性劑與Km值,最后確定出最佳配方。(2)復方鹽酸特比萘芬納米乳的制備:室溫下,按照配方量先將鹽酸特比萘芬、百里香酚溶于茶樹油中,使其全部溶解,再加入RH-40和BS-12與之混合均勻,將VB5與K12-Na溶于蒸餾水中,最后向該體系中緩慢滴加水相并快速攪拌,直至形成澄清透明液體,即得復方鹽酸特比萘芬納米乳。(3)復方鹽酸特比萘芬納米乳的質(zhì)量評價:用染色法鑒定其結(jié)構(gòu)類型,通過激光粒度分析儀測定其粒徑大小、粒度分布、多分散系數(shù),用透射電子顯微鏡觀察其形態(tài),用紫外分光光度法測定藥物含量,經(jīng)過離心加速試驗、長期試驗以及光照穩(wěn)定試驗考察納米乳的穩(wěn)定性。結(jié)果:(1)復方鹽酸特比萘芬納米乳的配方:w(鹽酸特比萘芬)=1.2%,w(百里香酚)=1.0%,w(VB5)=0.9%,w(茶樹油)=2%,w(RH-40)=18%,w(BS-12)=6%,w(K12-Na)=2%,w(蒸餾水)=68.9%。(2)所制備的納米乳外觀表現(xiàn)為澄清透明的液體,經(jīng)染色法鑒定為水包油結(jié)構(gòu);透射電鏡觀察表明其乳滴呈均勻的圓球形,大小均一;激光粒度儀分析結(jié)果表明,其粒徑范圍為7.80~40.72nm,平均粒徑為15.74 nm,多分散系數(shù)0.225;穩(wěn)定性實驗結(jié)果表明,該納米乳經(jīng)離心、光照、長期試驗均無分層、破乳以及絮凝等現(xiàn)象,且其中藥物含量基本無變化。(3)經(jīng)紫外分光光度法檢測,復方鹽酸特比萘芬納米乳中鹽酸特比萘芬最佳檢測波長為282nm,在0.78125~25μg/mL的濃度范圍內(nèi)與吸光度的線性關(guān)系良好,百里香酚最佳檢測波長為277 nm,在0.78125~25μg/mL的濃度范圍內(nèi)與吸光度的線性關(guān)系良好。結(jié)論:制備的寵物藥浴香波——復方鹽酸特比萘芬納米乳具有良好的穩(wěn)定性,符合納米乳的質(zhì)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.
【學位授予單位】：西北農(nóng)林科技大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：S859.5

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