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IVRT study on cyclosporine ophthalmic emulsion*
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Shuang-tao DONG1, Bao-xia LI1, Zheng MA2, *
Chinese Journal of Pharmaceutical Analysis | 2024, 44(6) : 1082 - 1088
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(6): 1082-1088
• Standard Deliberation •
IVRT study on cyclosporine ophthalmic emulsion*
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Shuang-tao DONG1, Bao-xia LI1, Zheng MA2, *
Affiliations
  • 1.Shanxi Pharmaceutical Vocational College, Taiyuan 030030, China
  • 2.Zhejiang Arthur Pharmaceutical Co., Ltd., Jiaxing 314001, China
Published: 2024-06-30 doi: 10.16155/j.0254-1793.2024.06.20
Outline
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Objective:

To develop a method for characterizing in vitro release of cyclosporine ophthalmic emulsion.

Methods:

The Franz diffusion cell and the polyvinylidene fluoride membrane were adopted with buffer-ethanol (40∶60) as receiving media. The sampling time was set at 60, 125, 190, 255, 320, 385 min, respectively.

Results:

The in vitro release method showed that the inertia of membrane, specificity, sensitivity and selectivity met the requirements. The validation of HPLC showed that the quantitative limit of the method was 0.07 μg·mL-1 and a good linear relationship between the concentration range of 0.07-44.62 μg·mL-1. The average recovery was 98.9%. Compared with the original preparation by FDA guideline, the in vitro release of the self-developed preparation was the same as the reference preparation.

Conclusions:

This method is suitable for the in vitro release evaluation of cyclosporine eye drops.

cyclosporine ophthalmic emulsion  /  in vitro release (IVRT)  /  reference preparation  /  self-developed preparation  /  method validation
Shuang-tao DONG, Bao-xia LI, Zheng MA. IVRT study on cyclosporine ophthalmic emulsion*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (6) : 1082 -1088 . DOI: 10.16155/j.0254-1793.2024.06.20
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Year 2024 volume 44 Issue 6
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Article Info
doi: 10.16155/j.0254-1793.2024.06.20
  • Receive Date：2023-09-12
  • Online Date：2026-03-13
  • Published：2024-06-30
Article Data
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History
  • Received：2023-09-12
Affiliations
    1.Shanxi Pharmaceutical Vocational College, Taiyuan 030030, China
    2.Zhejiang Arthur Pharmaceutical Co., Ltd., Jiaxing 314001, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
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Genus		 种数
Number of
species		 占总种数比例
Percentage of total
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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