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Isavuconazonium sulfate freeze-dried powder injection and preparation method

A technology of isavuconazole and freeze-dried powder injection, which is applied in the field of isavuconazolium sulfate freeze-dried powder injection and preparation, can solve the problems of low bioavailability, poor stability of isavuconazole, etc., and achieve improvement Curative effect, plump appearance, loose texture effect

Inactive Publication Date: 2017-05-10
NANJING NORMAL UNIVERSITY
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Problems solved by technology

[0020] Another object of the present invention is to provide a preparation method of isavuconazole sulfate freeze-dried powder injection, which solves the problems of poor stability and low bioavailability of isavuconazole caused by insolubility

Method used

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  • Isavuconazonium sulfate freeze-dried powder injection and preparation method
  • Isavuconazonium sulfate freeze-dried powder injection and preparation method
  • Isavuconazonium sulfate freeze-dried powder injection and preparation method

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Embodiment 1-7

[0045] Table 1. Excipient dosage and filling volume screening

[0046] project Example 1 Example 2 Example 3 Example 4 Example 5 Example 6 Example 7 Isavuconazole / g 4 4 4 4 4 4 4 Mannitol / g / 1 2 1 4 / / Lactose / g / / / / 2 / / NaCl / g / / / / / 3 / Sorbitol / g / / / 2 / / 3 Water for injection / ml 40 40 40 40 40 40 30 Preparation volume / bottle 10 10 10 10 10 10 10

[0047] Preparation method: Take 70-80% of the water for injection to dissolve the excipient (here there is no strict requirement on the amount of water for injection, as long as the final constant volume is not exceeded, the excipient can be completely dissolved), and after all the water is dissolved , lower the temperature to 0-15°C (the temperature can be controlled within this range), add isavuconazolium sulfate, stir to dissolve into a clear solution, adjust the pH to 1.2-1.8 with dilute sulfuric acid, a...

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Abstract

The invention discloses isavuconazonium sulfate freeze-dried powder injection and a preparation method and belongs to the technical field of antifungal freeze-dried powder injections. The powder injection contains an effective treating ingredient isavuconazonium sulfate, an excipient mannitol and a pH regulator dilute sulfuric acid. In the preparation process, the mannitol is dissolved with 70-80% water for injection firstly, heat preservation is performed to 0-15 DEG C after all the mannitol is dissolved, the isavuconazonium sulfate is added, pH is regulated to be 1.2-1.8 with the dilute sulfuric acid after stirring and dissolution, the volume is fixed with the water for injection to make the concentration of the isavuconazonium sulfate be 90-130 mg / mL, and then pyrogen removal, aseptic filtration, split charging (the volume is 3-4 mL) and freeze drying are performed to obtain the injection. The prepared isavuconazonium sulfate freeze-dried powder injection is quick to redissolve, complete, good in stability and convenient to store and transport, and the application of the isavuconazonium sulfate in the field of preparations is enriched.

Description

technical field [0001] The invention belongs to the technical field of antifungal freeze-dried powder injections, and more specifically relates to isavuconazolium sulfate freeze-dried powder injections and a preparation method. Background technique [0002] The Chinese chemical name of isavuconazolium sulfate: [0003] Glycine, N-methyl-, [2-[[[1-[1-[(2R,3R)-3-[4-(4-cyanophenyl)-2-thiazolyl]-2-(2 ,5-difluorophenyl)-2-hydroxybutyl]-4H-1,2,4-triazolium-4-yl]ethoxy]carbonyl]methylamino]-3-pyridyl]methyl ester , sulfate; [0004] English chemical name: [0005] Glycine,N-methyl-,[2-[[[1-[1-[(2R,3R)-3-[4-(4-cyanophenyl)-2-thiazolyl]-2-(2,5-difluorophenyl) -2-hydroxybutyl]-4H-1,2,4-triazolium-4-yl]ethoxy]carbonyl]methylamino]-3-pyridinyl]methylester,sulfate; [0006] Molecular weight: 814.853; [0007] CAS registration number: 946075-13-4; [0008] Molecular formula: C 35 h 36 f 2 N 8 o 5 S·SO 4 ; [0009] Its structural formula is (attached figure 1 shown): [001...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4439A61P31/10
CPCA61K9/0019A61K9/19A61K31/4439
Inventor 李海玲赵波朱永强唐云
Owner NANJING NORMAL UNIVERSITY
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