他克莫司眼用乳液的质量控制

Quality Control of Tacrolimus Ophthalmic Emulsion

关键词:  他克莫司  眼用乳液  质量控制

Key words:  tacrolimus  ophthalmic emulsion  quality control

摘要:

目的建立他克莫司眼用乳液的质量控制方法。方法根据中国药典2005年版眼用制剂项下规定建立他克莫司眼用乳液的质量控制方法，用高效液相色谱法测定他克莫司的含量，观察家兔眼部刺激性，并对制剂的稳定性进行考察。结果他克莫司在6.25～200 mg·mL-1浓度内线性关系良好(r=0.999 9)，平均回收率为99.83％，RSD为0.59％，方法重现性的RSD为1.04％(n=6)。滴眼后无刺激性，而且稳定性相对较好。结论本方法专属性强、操作简便、结果准确，可用于他克莫司眼用乳液的质量控制。

Abstract:

OBJECTIVE To establish the quality standard of tacrolimus ophthalmic emulsion. METHODS Quality standard of tacrolimus ophthalmic emulsion was established according to ChP, and its content was determined by HPLC. Stimulus of tacrolimus on rabbits' eyes and stability of tacrolimus ophthalmic emulsion were observed. RESULTS The calibration curve of tacrolimus was linear within the concentration range of 6.25-200 mg·mL-1，r＝0.999 9. The average recovery rate of tacrolimus was 99.83% (RSD=0.59%), and the RSD of the repeatability test was 1.04% (n=6). Tacrolimus had no stimulus on rabbits' eyes and its stability was relatively good. CONCLUSION The method is simple, quick and specific. It can be used to contorl the quality of tacrolimus ophthalmic emulsion.