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A kind of flumazenil injection and preparation method thereof

A technology of flumazenil and injection, which is applied in the field of flumazenil injection and its preparation, can solve problems such as increasing manufacturing costs, and achieve the effects of improving quality, reducing toxic and side effects, and low cost

Active Publication Date: 2017-05-10
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

A large amount of liposome raw materials need to be added, which increases the manufacturing cost

Method used

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  • A kind of flumazenil injection and preparation method thereof
  • A kind of flumazenil injection and preparation method thereof
  • A kind of flumazenil injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A Yanhuning freeze-dried powder injection, the formula is as follows:

[0023]

[0024] Under the protection of inert gas, take flumazenil, sodium chloride, disodium edetate, trehalose, and lysine, dissolve them in 1000ml of water for injection, filter them coarsely, add 10g of activated carbon for needles, stir for 30min, and filter to remove carbon ; Then add 9000ml of water for injection, sterilize and filter with a 0.22 μm microporous membrane, potting, and sterilizing, to obtain. The specification of flumazenil injection can be 2ml: 0.2mg, 5ml: 0.5mg or 10ml: 1mg (injection volume: weight of flumazenil).

Embodiment 2

[0026] The difference between the present embodiment and embodiment 1 is that the formula is different, specifically as follows:

[0027]

[0028]

Embodiment 3

[0030] The difference between the present embodiment and embodiment 1 is that the formula is different, specifically as follows:

[0031]

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PUM

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Abstract

The invention provides a flumazenil injection. The flumazenil injection is prepared from the following drugs and excipient by weight: 1 part of flumazenil, 70 to 110 parts of sodium chloride, 0.5 to 2 parts of disodium edetate, 20 to 100 parts of mycose and 10 to 50 parts of lysine. The preparation method for the flumazenil injection comprises the following steps: weighting flumazenil, sodium chloride, disodium edetate, mycose and lysine; dissolving the above-mentioned components with a part of injection water and carrying out rough filtration; then adding the rest injection water and carrying out fine filtration; and carrying out filling, sealing and disinfection. Compared with the prior art, the invention has the following advantages: since mycose and lysine are added into the injection and cooperatively used with disodium edetate, stability of flumazenil is effectively improved, the quality of a preparation product is enhanced, and toxic and side effects are reduced; and the preparation method is simple, has low cost and is applicable to industrial large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a flumazenil injection and a preparation method thereof. Background technique [0002] The chemical name of flumazenil is 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo-[1,5-a][1,4]benzodiazepine -Ethyl 3-formate, molecular formula C 15 h 14 FN 3 o 3 , the molecular weight is 303.29, and the structural formula is as follows: [0003] [0004] Flumazenil is a white or off-white crystalline powder, almost insoluble in water. [0005] Flumazenil is a 1,4-imidazole benzodiazepine derivative, a benzodiazepine (BZD) receptor antagonist, which can act on the brain BDZ receptor, reverse the central sedative effect of BDZ, and block the BDZ receptor. body without producing the effects of BDZ drugs. Flumazenil can reverse the effects of BDZ and non-BDZ drugs (such as Upiclone and triazolopyridazines) that have affinity for BDZ receptors in the central nervous system,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/5517A61K9/08A61K47/36A61K47/16A61P25/20
Inventor 王志涛张丽华曹俊王海树
Owner HAINAN GENERAL & KANGLI PHARMA
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