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Establishment of dissolution method and similarity evaluation of dissolution curves of omega-3-acid ethyl ester 90 soft capsules*
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Qian SHEN1, Hai-li DONG2, Xi ZHANG1, Xiao-jia LIU1, 3, Yuan-yang WU1, Hao RUAN1, **
Chinese Journal of Pharmaceutical Analysis | 2024, 44(12) : 2180 - 2188
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(12): 2180-2188
• Standard Deliberation •
Establishment of dissolution method and similarity evaluation of dissolution curves of omega-3-acid ethyl ester 90 soft capsules*
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Qian SHEN1, Hai-li DONG2, Xi ZHANG1, Xiao-jia LIU1, 3, Yuan-yang WU1, Hao RUAN1, **
Affiliations
  • 1.Zhejiang Institute for Food and Drug Control, NMPA Key Laboratory for Core Technology of Generic Drug Evaluation, Hangzhou 310052, China
  • 2.Hangzhou Institute for Food and Drug Control, Hangzhou 310022, China
  • 3.Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 211198, China
Published: 2024-12-31 doi: 10.16155/j.0254-1793.2024-2180
Outline
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Objective:

To develop a flow-through cell method for the dissolution test of omega-3-acid ethyl ester 90 soft capsules and compare the dissolution behaviors from different manufacturers.

Methods:

The medium (surfactant and its concentration, pH, dosage of pepsin), flow rate and system mode (closed versus open) were investigated. The samples were collected at the specified time and determined by HPLC. The similarity of the dissolution curves between generic drugs and reference listed drug was evaluated by similarity factor (f2).

Results:

A closed-loop mode of flow-through cell apparatus was employed, with 0.01 mol·L-1 hydrochloric acid solution containing 4.0% Triton X-100 as the dissolution medium, and the flow rate was 2.0 mL·min-1. The dissolution curves of the samples that have passed consistency evaluation are similar to those of the reference and the samples produced by enterprise in the declaration stage are partly similar. The method has effective distinguish ability for product quality and different prescriptions.

Conclusion:

The newly established method can be used for the quality control of omega-3-acid ethyl ester 90 soft capsules, and can provide references for further consistency evaluation and the dissolution method development of lipid-filled soft gelatin capsule (SGC).

omega-3-acid ethyl ester 90 soft capsules  /  flow-through cell method  /  dissolution curves  /  distinguishing ability  /  consistency evaluation  /  ethyl eicosapentaenoate  /  ethyl docosahexaenoate
Qian SHEN, Hai-li DONG, Xi ZHANG, Xiao-jia LIU, Yuan-yang WU, Hao RUAN. Establishment of dissolution method and similarity evaluation of dissolution curves of omega-3-acid ethyl ester 90 soft capsules*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (12) : 2180 -2188 . DOI: 10.16155/j.0254-1793.2024-2180
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Year 2024 volume 44 Issue 12
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Article Info
doi: 10.16155/j.0254-1793.2024-2180
  • Receive Date：2024-04-21
  • Online Date：2026-03-13
  • Published：2024-12-31
Article Data
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History
  • Received：2024-04-21
Funding
Affiliations
    1.Zhejiang Institute for Food and Drug Control, NMPA Key Laboratory for Core Technology of Generic Drug Evaluation, Hangzhou 310052, China
    2.Hangzhou Institute for Food and Drug Control, Hangzhou 310022, China
    3.Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 211198, 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
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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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