Tigecycline composition and preparation method thereof
A technology of tigecycline and composition, applied in the field of tigecycline composition, tigecycline composition and its preparation, capable of solving problems such as tigecycline instability and increasing tigecycline, Achieve the effects of reducing the formation of epimers, enhancing resistance, and inhibiting oxidative degradation
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Embodiment 1
[0025] (A) Place 50 mg of tigecycline in a 10 mL sample bottle, add 2 mL of water to dissolve; (B) Place 50 mg of tigecycline in a 10 mL sample bottle, add 2 mL of water to dissolve, and adjust the pH to 4.5; (C) 50mg of vitamin C was dissolved in 2mL of water, added with NaOH aqueous solution to adjust the pH to 3.5, added 50mg of tigecycline, stirred to dissolve, and adjusted to pH 3.5; (D) 50mg of vitamin C was dissolved in 2mL of water , Add NaOH aqueous solution to adjust the pH to 4.5, add 50mg tigecycline, stir to dissolve, adjust the pH to 4.5; (E) 50mg vitamin C dissolved in 2mL of water, adjust the pH to 6.0, add 50mg tigecycline, stir Dissolve, adjust the pH to 6.0; (F) Dissolve 100mg of threonine in 2mL of water, add hydrochloric acid to adjust the pH to 3.5, add 50mg of tigecycline, stir to dissolve, adjust the pH to 3.5; (G) 100mg of threonine The acid was dissolved in 2mL of water, hydrochloric acid was added to adjust the pH to 4.5, 50mg of tigecycline was added...
Embodiment 2
[0037] (A') 25mg of vitamin C was dissolved in 2mL of water, added NaOH aqueous solution to adjust the pH to 4.5, added 50mg of tigecycline, stirred to dissolve, adjusted to pH 4.5; (B') 50mg of vitamin C was dissolved in 2mL of In water, add NaOH aqueous solution to adjust the pH to 4.5, add 50mg of tigecycline, stir to dissolve, adjust the pH to 4.5; (C') 100mg of vitamin C is dissolved in 2mL of water, NaOH to adjust the pH to 4.5, add 50mg of substitute Gecycline, stir to dissolve, adjust the pH to 4.5; (D') 250mg of vitamin C dissolved in 2mL of water, NaOH to adjust the pH to 4.5, add 50mg of tigecycline, stir to dissolve, adjust the pH to 4.5; (E ') 25mg of threonine was dissolved in 2mL of water, adjusted to pH 4.5 with hydrochloric acid, 50mg of tigecycline was added, stirred to dissolve, and adjusted to pH 4.5; (F') 50mg of threonine was dissolved in 2mL of water, Adjust the pH to 4.5 with hydrochloric acid, add 50mg of tigecycline, stir to dissolve, adjust the pH to ...
Embodiment 3
[0043] (A") 50 mg of vitamin C was dissolved in 2 mL of water, added with NaOH aqueous solution to adjust the pH to 4.5, then 50 mg of tigecycline was added, stirred to dissolve, and adjusted to pH 4.5; (B") 100 mg of threonine was dissolved in Add hydrochloric acid aqueous solution to adjust the pH to 4.5 in 2 mL of water, add 50 mg of tigecycline, stir to dissolve, and adjust the pH to 4.5. The solutions prepared above were respectively filled through a 0.22 μm filter membrane, freeze-dried, and filled with nitrogen to press the plug.
[0044] The freeze-dried sample was placed under the condition of 40° C. / 75% RH for 90 days, and the sample was analyzed by HPLC. The detection method was the same as that in Example 1. The results are shown in Table 3. It can be seen that the addition of vitamin C or its pharmaceutically acceptable salt or amino acid can significantly increase the stability of tigecycline during storage.
[0045] table 3
[0046]
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