Objective: To compare the consistency in vitro release of test preparation and reference preparation. Methods: Franz diffusion cell method and 0.45 μm polyethersulfone membrane were used. 7 mL of degassed Transcutol P-water (50∶50) was used as the receiving liquid, the speed was 500 r·min-1, the temperature was 32 ℃, the sampling volume was 2 mL. Samples were taken at 0.5, 1, 2, 4 and 6 hours, and the release amount of the drug in the artificial membrane was determined with time by HPLC method. The consistency in vitro release of test preparation and reference preparation was evaluated. Results: The cumulative release percentages of test preparation and reference preparation in the receiving solution were 93.7% and 89.1%, respectively, and the cumulative release per unit area was 2 622.0 and 2 479.0 μg·cm-2, respectively. The 90% confidence interval of the ratio of the in vitro release rate of the two was within 75%-133.33% according to FDA guidelines. Conclusion: In vitro release behavior of the test preparation is consistent with that of the reference preparation.
SHI Ling-ling, CHEN Yi-jia, ZHU Yun-long
. Study on in vitro release test conditions of the topical product of ozenoxacin[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(11)
: 1989
-1996
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DOI: 10.16155/j.0254-1793.2023.11.23
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