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目的:制备环孢素眼用微乳原位凝胶并对其质量进行考察。方法:制备环孢素微乳原位凝胶制剂,通过考察其理化特性,粒径及分布,含量,流变学性质,并通过影响因素试验及稳定性试验来评价该制剂的质量。结果:制备的环孢素微乳原位凝胶制剂为澄清透明的溶液,理化特性研究显示各指标均在眼部制剂的要求范围内,粒径小于50 nm,且分布均匀,高效液相法测定其含量简单准确,流变学考察显示该制剂为假塑型流体,影响因素试验研究显示该制剂不受温度和高温的影响,且高温保存6个月稳定。结论:本研究制备的环孢素微乳原位凝胶制剂符合眼用制剂的要求。
Objective: To prepare cyclosporin in situ microemulsion in situ gel and investigate its quality. Methods: Cyclosporin microemulsion in situ gel preparation was prepared. The physicochemical properties, particle size and distribution, content and rheological properties of cyclosporin microemulsion were evaluated. The quality of the preparation was evaluated by influencing factor test and stability test. Results: The prepared cyclosporin microemulsion in situ gel preparation was a clear and transparent solution. Physical and chemical properties showed that all the indexes were within the scope of the eye preparation, the particle size was less than 50 nm, and the distribution was homogeneous. High performance liquid chromatography Determination of its content is simple and accurate, the rheological study showed that the preparation of pseudoplastic fluid, the impact of experimental studies have shown that the preparation from the temperature and high temperature, and high temperature storage stability of 6 months. Conclusion: The cyclosporin microemulsion in situ gel preparation prepared in this study meets the requirements of ophthalmic preparations.