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研制复方盐酸萘替芬纳米乳(NTF-CIN-NE),并对其质量和安全性进行考察。筛选合适的油相、表面活性剂、助表面活性剂,利用伪三元相图法确定纳米乳的最佳配方。利用透射电子显微镜、激光粒度分析仪等评价其性质,通过紫外分光光度计考察纳米乳中盐酸萘替芬(NTF)和肉桂醛(CIN)的含量,通过皮肤刺激性试验评价纳米乳的安全性。结果表明,NTF-CIN-NE中各组分的质量分数为:w(盐酸萘替芬NTF)=0.72%,w(肉桂醛CIN)=3.62%,w(EL-40)=16.27%,w(1,2-丙二醇)=5.42%,w(蒸馏水)=73.97%。在透射电子显微镜下,NTF-CIN-NE乳滴为圆球状,平均粒径为13.35 nm,分别采用双波长差法(λ1=253.2 nm,λ2=323.2 nm)和三波长法(λ1=322.6 nm,λ2=285.6 nm,λ3=254.2 nm)测定NTF-CIN-NE中NTF和CIN的含量,检测方法的专属性好。皮肤刺激性试验表明,该纳米乳对皮肤无刺激性,安全性良好。成功制备出了NTF-CIN-NE,该纳米乳是一种安全稳定的制剂。
Development of compound naftifine hydrochloride nanoemulsion (NTF-CIN-NE), and its quality and safety were investigated. Screening the appropriate oil phase, surfactant, co-surfactant, the use of pseudo-ternary phase diagram method to determine the best nanoemulsion formula. The properties of the nanoemulsion, such as naftifine (NTF) and cinnamaldehyde (CIN), were evaluated by transmission electron microscopy and laser particle size analyzer. The safety of nanoemulsion was evaluated by skin irritation test . The results showed that the mass fraction of each component in NTF-CIN-NE was: w (naftifine hydrochloride 0.72%, w (cinnamaldehyde CIN) = 3.62%, w (EL-40) = 16.27% (1,2-propanediol) = 5.42%, w (distilled water) = 73.97%. Under the transmission electron microscope, NTF-CIN-NE emulsion droplets were spherical with an average particle size of 13.35 nm. The difference of the two wavelengths (λ1 = 253.2 nm, λ2 = 323.2 nm) and the three- , λ2 = 285.6 nm, λ3 = 254.2 nm) for the determination of NTF and CIN in NTF-CIN-NE. Skin irritation test showed that the nanoemulsion non-irritating to the skin, good safety. Successfully prepared NTF-CIN-NE, the nanoemulsion is a safe and stable preparation.