| 摘要: |
| 目的:研制环孢素眼用透明乳剂,筛选最佳处方组成及用量,并对其进行药学质量评价。方法:对增溶剂、乳化剂、渗透
压调节剂、缓冲剂进行筛选与用量考察,确定处方后进行处方变量考察,用简单混合搅拌制备处方,并进行稳定性实验考察。结
果:处方组成为环孢素0. 1%、乙醇0. 1%、聚氧乙烯(35)蓖麻油3. 0%、甘油2. 2%、磷酸二氢钠一水合物0. 14%、氢氧化钠0. 031%、
注射用水;配液步骤为油相制备、水相制备、乳化、稀释定容,粒径约为45 nm,包封率约为90%;稳定性实验期间产品质量稳定,含
量、失水变化<5%,其他检验项符合限度要求。结论:本实验开发的处方用量合理,生产工艺简单,产品质量可控,稳定性好。 |
| 关键词: 环孢素 眼用乳剂 春季角结膜炎 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2025.07.005 |
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| 基金项目: |
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| Development and Quality Evaluation of Transparent Cyclosporine Ophthalmic Emulsion |
| Fan Weiping1, Zhang Da,1 Dai Gaoyue2, Zhu Na1, Nie Liya1 |
| ((1. Beijing Huonland Pharmaceutical Co. , Ltd. , Beijing
101106, China; 2. College of Veterinary Medicine, Beijing University of Agriculture, Beijing 102206, China)) |
| Abstract: |
| Objective: To develop the transparent cyclosporine ophthalmic emulsion, screen the optimal prescription composition and
dosage, and evaluate the pharmacological quality. Methods: Solubilizers, emulsifiers, osmotic pressure regulators, and buffers were
screened and the dosages were investigated. After determining the prescription, prescription variables were examined. The prescription
was prepared by simple mixing and stirring, and its stability was investigated. Results: The prescription was made of 0. 1%
cyclosporine, 0. 1% ethanol, 3. 0% polyoxyethylene ( 35 ) castor oil, 2. 2% glycerol, 0. 14% sodium dihydrogen phosphate
monohydrate, 0. 031% sodium hydroxide, and water for injection. The preparation steps included oil phase preparation, water phase
preparation, emulsification, and dilution to achieve the desired concentration. The particle size was about 45 nm, and the encapsulation
rate was about 90%. The product quality remained stable during the stability period, with changes in content and loss on drying not
exceeding 5%, while other test items met the acceptance criteria. Conclusion: The prescription developed in this experiment has
reasonable dosage, simple production process, controllable product quality, and good stability. |
| Key words: cyclosporine ophthalmic emulsion vernal keratoconjunctivitis |
