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目的:本实验以氯霉素为模型药物,泊洛沙姆407为凝胶基质,制备氯霉素眼用温度敏感原位凝胶给药系统,并进行体外释放度研究。最终通过控制药物释放速率,达到维持眼内局部有效抗菌药物浓度、缓释长效和提高患者顺应性的目的。方法:研究制剂的制备工艺,采用双波长紫外分光光度法测定制剂中氯霉素的含量,进行药物体外释放特性的初步研究。结果:氯霉素在5～30mg.L-1的范围内与吸收差值呈良好的线性关系,氯霉素的平均回收率为99.67%,RSD为0.67%。氯霉素眼用温敏凝胶在人工泪液中6h释放约76%～83%,12h释放完全。结论:该凝胶的制备工艺简单,性质稳定,药物质量可控,用药方便,缓释、长效,可满足临床要求。
OBJECTIVE: In this study, chloramphenicol was used as a model drug and poloxamer 407 as a gel matrix to prepare chloramphenicol ophthalmic temperature-sensitive in situ gel delivery system and to study its in vitro release. Finally, by controlling the rate of drug release, to achieve the purpose of maintaining the local effective concentration of antibacterial drugs in the eye, long-term sustained release and improve patient compliance. Methods: The preparation process of the preparation was studied. The content of chloramphenicol in the preparation was determined by dual-wavelength ultraviolet spectrophotometry and the in vitro release characteristics of the drug were studied. RESULTS: Chloramphenicol had a good linear relationship with the difference of absorption in the range of 5 ~ 30 mg.L-1. The average recoveries of chloramphenicol was 99.67% and the RSD was 0.67%. Chloramphenicol ophthalmic temperature-sensitive gel in human tear 6h release of about 76% to 83%, 12h completely released. Conclusion: The gel preparation process is simple, stable, drug quality controllable, convenient medication, sustained release, long-term, to meet the clinical requirements.