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目的:研究昂丹司琼微乳及其鼻用微乳凝胶剂制备工艺的优化,并考察其体外释放度。方法:通过溶解度和“伪三元相”图筛选微乳处方的乳化剂、Km值和油相,以胶凝温度及凝胶强度筛选凝胶基质的组成和比例;并从体外释放度、凝胶稳定性和纤毛毒性实验考察凝胶性质。结果:乳化剂为Tween-80,Km值为1∶1,油相为Labrafil M-1944;鼻用凝胶基质为泊洛沙姆和卡波姆,比例分别为19%和1%,胶凝温度为(32.6±0.4)℃,凝胶强度为(37.5±1.2)s,8 h体外累积释放度为88.7%;其纤毛毒性与0.9%氯化钠溶液比较其差异无统计学意义(P>0.05),符合用药要求。结论:所制备的昂丹司琼微乳凝胶剂具有性质稳定、纤毛毒性低、具生物黏附的特点,较片剂释放完全,符合鼻用制剂标准。
Objective: To study the preparation of Ondansetron microemulsion and its nasal microemulsion gel, and to investigate its in vitro release. Methods: The emulsifier, Km value and oil phase of microemulsion prescription were screened by solubility and pseudo-ternary phase diagram, and the composition and proportion of gel matrix were screened by gelling temperature and gel strength. , Gel Stability and Ciliary Toxicity Experiments examine gel properties. RESULTS: The emulsifier was Tween-80 with a Km value of 1: 1 and the oil phase was Labrafil M-1944. The nasal gel matrix was poloxamer and carbomer with 19% and 1%, respectively, gelling The temperature was (32.6 ± 0.4) ℃, the gel strength was (37.5 ± 1.2) s, and the cumulative release in vitro was 88.7% in 8 h. There was no significant difference in cilium toxicity between the cilium and 0.9% sodium chloride solution (P> 0.05), in line with medication requirements. CONCLUSION: Ondansetron microemulsion gel has stable properties, low ciliary toxicity and bioadhesion. It is more stable than tablet and conforms to the standard of nasal preparation.