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Stable favipiravir injection and preparation method thereof

A technology for favipiravir and injection, which is applied to the field of favipiravir injection and its preparation, can solve the problems of difficulty in redissolving sodium salts, poor reconstitution of freeze-dried preparations, and affecting the convenience of clinical use, and achieves good Effects of Feature Properties

Active Publication Date: 2020-06-09
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, patent TW201934539A reports a method for preparing a lyophilized preparation of Favipiravir sodium salt for injection. After the inventor used sodium hydroxide and Favipiravir to form a salt, he prepared a Favipiravir sodium lyophilized preparation by a conventional method , but the reconstitution of the lyophilized preparation is extremely poor, which affects the convenience of clinical use
Patent CN103209967A discloses a freeze-dried preparation of pilavir meglumine salt for injection, the formed compound has excellent resolubility, and overcomes the problem that sodium salt freeze-drying is difficult to redissolve

Method used

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  • Stable favipiravir injection and preparation method thereof
  • Stable favipiravir injection and preparation method thereof
  • Stable favipiravir injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] 100 prescriptions

[0030]

[0031] Preparation

[0032] (1) Take 60% of the prescription amount of water for injection, heat it until the temperature is between 60-70°C, add sulfobutyl ether-β-cyclodextrin sodium, stir to dissolve. Add 1M sodium hydroxide solution to alkalinize the sodium sulfobutyl ether-β-cyclodextrin solution, and measure the pH between 8.5 and 9.5;

[0033] (2) Add Favipiravir, stir for 0.25 to 0.5 hours to obtain a clear solution, adjust the pH of the solution to between 6.8 and 7.6 with 1M hydrochloric acid or 1M sodium hydroxide solution, preferably pH 7.2, replenish water to full amount, and filter through 0.22 μm membrane filtration;

[0034] (3) The filtrate is filled in ampoules, each with a volume of 10 mL, sealed, terminally sterilized by moist heat (121°C, sterilized for 12 minutes), packaged, and stored.

Embodiment 2

[0036] 100 prescriptions

[0037]

[0038] Preparation

[0039] (1) Take water for injection with 70% of the prescribed amount, heat it until the temperature is between 60-70°C, add sulfobutyl ether-β-cyclodextrin sodium, stir to dissolve. Add 10% ammonia solution to alkalinize the sodium sulfobutyl ether-β-cyclodextrin solution, and measure the pH between 8.5 and 9.5;

[0040] (2) Add Favipiravir, stir for 0.25-0.5h to obtain a clear solution, adjust the pH of the solution to between 6.8 and 7.6 with 1M hydrochloric acid or 10% ammonia solution, preferably pH 7.2, replenish water to full amount, and use a 0.22 μm filter membrane filter;

[0041] (3) Fill the filtrate into 15 or 20mL vials, each with a volume of 10mL, seal it, perform terminal moist heat sterilization (121°C, sterilize for 12min), pack and store.

Embodiment 3

[0043] 100 prescriptions

[0044]

[0045] Preparation

[0046] (1) Take 70% of the prescription amount of water for injection, heat it until the temperature is between 60-70°C, add sulfobutyl ether-β-cyclodextrin sodium, stir to dissolve. Add 1M potassium hydroxide solution to alkalinize the sodium sulfobutyl ether-β-cyclodextrin solution, and measure the pH between 8.5 and 9.5;

[0047] (2) Add Favipiravir, stir for 0.25-0.5h to obtain a clear solution, adjust the pH of the solution to between 6.8 and 7.6 with 1M potassium hydroxide solution or 6M phosphoric acid solution, preferably pH 7.2, replenish water to full amount, 0.22μm Membrane filtration;

[0048](3) Fill the filtrate into 15 or 20mL vials, each with a volume of 10mL, seal it, perform terminal moist heat sterilization (121°C, sterilize for 12min), pack and store.

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Abstract

The invention relates to a stable favipiravir injection and a preparation method thereof. The stable favipiravir injection comprises favipiravir, a solubilizer sulfobutyl ether-beta-cyclodextrin sodium and an acid-base regulator. The stable favipiravir injection can endure terminal sterilization and has good safety and stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a stable favipiravir injection and a preparation method thereof. Background technique [0002] Favipiravir (favipiravir), the chemical name is 6-fluoro-3-hydroxypyrazine-2-carboxamide, a kind of RNA-dependent RNA polymerase inhibitor broad-spectrum antiviral developed by Toyama Chemical Industry Co., Ltd. The drug was launched in Japan in July 2014. The dosage form is a tablet with a specification of 200mg / tablet, and it is used for the treatment of new or recurrent influenza virus infection. [0003] Favipiravir is shown in the following structural formula: [0004] [0005] Favipiravir is metabolized into ribose triphosphate (Favipiravir RTP) in cells, and Favipiravir RTP selectively inhibits the replication-associated RNA polymerase of influenza virus, and its inhibitory effect on human RNA polymerase IC 50 The value is 905 μml / L. In view of this, in order to achieve a h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/40A61K31/4965A61P31/16
CPCA61K9/08A61K9/0019A61K47/40A61K31/4965A61P31/16Y02A50/30
Inventor 严轶东刘露刘东铎廉康夫阚玉庚谭永刚陆宁邢昊楠姚佳欢
Owner FUKANGREN BIO PHARMA
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