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 the problems of complex manufacturing process, limited actual value, high manufacturing cost, etc., and achieve low production cost, good stability, and stable formula Ease of process effect

Active Publication Date: 2015-10-07
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, among the auxiliary materials described in this patent, auxiliary materials such as trehalose and polyvinylpyrrolidone should not be used as auxiliary materials for inj

Method used

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  • Flumazenil injection and preparation method thereof
  • Flumazenil injection and preparation method thereof
  • Flumazenil injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] A flumazenil injection is prepared from 0.5 parts by weight of flumazenil, 45 parts by weight of sodium chloride, 0.5 parts by weight of disodium edetate, an appropriate amount of glacial acetic acid and 5000 parts by weight of water for injection.

[0038] The appropriate amount of glacial acetic acid is used to adjust the pH of the flumazenil injection at 3.8-3.9.

[0039] A kind of preparation method of the flumazenil injection of above-mentioned raw material formula, its steps are as follows:

[0040] (1) Disodium ethylenediaminetetraacetic acid and sodium chloride of formula quantity are put into batching tank, then add 30% water for injection of formula quantity, fill nitrogen gas while stirring, fully stir to make it all dissolve;

[0041] (2) Add medicinal charcoal of 0.1% (w / v, g / mL) of the solution obtained in step (1), then fully stir for 15 minutes, then let stand for 15 minutes, turn on the sanitary pump, and let the solution pass through a 0.45 μm filter ...

Embodiment 2

[0049] A flumazenil injection is prepared from 0.5 parts by weight of flumazenil, 45 parts by weight of sodium chloride, 0.5 parts by weight of disodium edetate, an appropriate amount of glacial acetic acid and 5000 parts by weight of water for injection.

[0050]The appropriate amount of glacial acetic acid is used to adjust the pH of the flumazenil injection at 3.0-3.2.

[0051] A kind of preparation method of the flumazenil injection of above-mentioned raw material formula, its steps are as follows:

[0052] (1) Disodium ethylenediaminetetraacetic acid and sodium chloride of formula quantity are put into batching tank, then add 30% water for injection of formula quantity, fill nitrogen gas while stirring, fully stir to make it all dissolve;

[0053] (2) Add medicinal charcoal of 0.1% (w / v, g / mL) of the solution obtained in step (1), then fully stir for 15 minutes, then let stand for 15 minutes, turn on the sanitary pump, and let the solution pass through a 0.45 μm filter C...

Embodiment 3

[0061] A flumazenil injection is prepared from 0.5 parts by weight of flumazenil, 45 parts by weight of sodium chloride, 0.5 parts by weight of disodium edetate, an appropriate amount of glacial acetic acid and 5000 parts by weight of water for injection.

[0062] The appropriate amount of glacial acetic acid is used to adjust the pH of the flumazenil injection at 4.5-5.0.

[0063] A kind of preparation method of the flumazenil injection of above-mentioned raw material formula, its steps are as follows:

[0064] (1) Disodium ethylenediaminetetraacetic acid and sodium chloride of formula quantity are put into batching tank, then add 30% water for injection of formula quantity, fill nitrogen gas while stirring, fully stir to make it all dissolve;

[0065] (2) Add medicinal charcoal of 0.1% (w / v, g / mL) of the solution obtained in step (1), then fully stir for 15 minutes, then let stand for 15 minutes, turn on the sanitary pump, and let the solution pass through a 0.45 μm filter ...

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Abstract

The invention relates to the technical field of medicament preparations, and in particular discloses a flumazenil injection and a preparation method thereof. The flumazenil injection contains flumazenil, osmotic pressure regulator, stabilizer, pH regulator and the like, wherein the osmotic pressure regulator is sodium chloride, the stabilizer is ethylene diamine tetraacetic acid disodium, and the pH regulator is acetic acid. By improving the formula and the preparation process, the stability of the physical and chemical properties of the flumazenil injection is improved, and the flumazenil injection has very high application value.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a flumazenil injection and a preparation method thereof. Background technique [0002] 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, and can also partially antagonize the action of sodium valproate. Anticonvulsant effect. Clinically, flumazenil is used to reverse the central sedative effect of BDZ: (1) after anesthesia: after induction and maintenance of general anesthesia with BDZ in hospitalized patients, this product can terminate its effect; (2) for emergency: As a diagnos...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/5517A61K47/12A61K47/18A61P25/00
Inventor 舒志元余修祥金涛王志涛李旻李瑛王钢莲
Owner HAINAN GENERAL & KANGLI PHARMA
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