[他克莫司0.06%滴眼液的盖伦制剂研发与分析]
[Galenic and analytic development of tacrolimus 0.06% eye drops].
作者信息
Gauthier A-S, Rival B, Sahler J, Fagnoni-Legat C, Limat S, Guillaume Y, Delbosc B
机构信息
Service d'ophtalmologie, CHU Jean-Minjoz, 2, boulevard Fleming, 25030 Besançon, France.
出版信息
J Fr Ophtalmol. 2013 May;36(5):408-13. doi: 10.1016/j.jfo.2012.03.019. Epub 2012 Dec 5.
PURPOSE
The administration of topical tacrolimus (FK506) eye drops or ointment is effective in treating certain immunologic corneal diseases and in the prevention of rejection of high-risk corneal grafts. The purpose of this study is to determine the optimal formulation of tacrolimus 0.06% eye drops. A procedure for preparation is presented and discussed.
METHODS
Tacrolimus monohydrate powder and virgin castor oil are used in this new formulation. The manufacturing process guarantees consistency of product sterility. Measurement by high-performance liquid chromatography allows precise control of the concentration of tacrolimus.
RESULTS
The manufacture and packaging of tacrolimus 0.06% eye drops involve numerous controls allowing for guaranteed sterility and stability. The drops remained sterile and stabile for 28 days after opening regardless of storage conditions and can be stored for 3 months after manufacture. Tolerability studies are currently being performed.
目的
局部应用他克莫司（FK506）滴眼液或眼膏可有效治疗某些免疫性角膜疾病，并预防高危角膜移植排斥反应。本研究旨在确定0.06%他克莫司滴眼液的最佳配方。本文介绍并讨论了其制备方法。
方法
该新配方使用一水合他克莫司粉末和初榨蓖麻油。生产工艺确保产品无菌的一致性。通过高效液相色谱法进行测量可精确控制他克莫司的浓度。
结果
0.06%他克莫司滴眼液的生产和包装涉及多项控制措施，以确保无菌和稳定性。无论储存条件如何，滴眼液在开封后28天内保持无菌和稳定，生产后可储存3个月。目前正在进行耐受性研究。
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