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目的:制备温度敏感型清开灵眼用即型凝胶并对其质量进行评价。方法:采用单因素试验优选清开灵眼用即型凝胶基质,通过考察该制剂的渗透压、眼部滞留能力、黏度和体外释放度以评价其质量。结果:采用16%泊洛沙姆407与0.1%透明质酸钠的混合液作为凝胶基质时较好,清开灵注射液在9.9 min即流失完毕,而眼用即型凝胶剂的滞留时间可达30.6 min,眼部滞留能力明显延长。结论:制备的清开灵眼用即型凝胶具有良好成型性,符合即型凝胶的要求。与清开灵注射液相比,本品在用药部位停留时间较长,黏度显著增加,具有较好的缓释特性。
OBJECTIVE: To prepare a temperature-sensitive, clear-eyelid gel and evaluate its quality. Methods: The single factor test was used to optimize the gel-like matrix of Qingkailing ophthalmic gel. The osmotic pressure, ocular retention capacity, viscosity and in vitro release of the preparation were evaluated to evaluate the quality. Results: When using 16% Poloxamer 407 and 0.1% sodium hyaluronate as gel matrix, Qingkailing injection disappeared at 9.9 min, while retention of ophthalmic gel Time up to 30.6 min, eye retention capacity was significantly prolonged. Conclusion: The preparation of Qingkailing ophthalmic gels with good formability, in line with the type of gel requirements. Compared with Qingkailing injection, the product stay longer in the drug site, viscosity increased significantly, with good sustained-release properties.