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Pharmaceutical composition and preparation method of naloxone hydrochloride injection

A kind of technology of naloxone hydrochloride and composition, applied in the field of medicine, can solve the problems of accumulation, subcutaneous granuloma and the like

Active Publication Date: 2017-01-25
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, adding polyvinylpyrrolidone to the injection can easily form subcutaneous granulomas at the injection site, and may accumulate in body organs

Method used

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  • Pharmaceutical composition and preparation method of naloxone hydrochloride injection
  • Pharmaceutical composition and preparation method of naloxone hydrochloride injection
  • Pharmaceutical composition and preparation method of naloxone hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] Embodiment 1: Preparation of naloxone hydrochloride pharmaceutical composition

[0084] formula:

[0085] Naloxone Hydrochloride 1mg,

[0086] Maltose 30mg,

[0087] Citric acid 0.3mg,

[0088] Water for injection, add appropriate amount to 1ml,

[0089] Injection target pH value = 4.0;

[0090] Preparation method:

[0091] (a) Take by weighing the prescribed amount of naloxone hydrochloride, carbohydrates and organic acids, add an appropriate amount (about 70%) of water for injection to dissolve, then add activated carbon, stir, and decarbonize by filtration;

[0092] (b) add water for injection to the full amount, stir evenly, measure the pH value of the solution and optionally determine the active ingredient content, and adjust to the specified pH value with an acid-base regulator if necessary;

[0093] (c) The obtained solution is carefully filtered, filled into an ampoule bottle, and sterilized by autoclaving at 115° C. for 30 minutes to obtain a pharmaceuti...

Embodiment 2

[0094] Embodiment 2: Preparation of naloxone hydrochloride pharmaceutical composition

[0095] formula:

[0096] Naloxone Hydrochloride 1mg,

[0097] Maltose 20mg,

[0098] Citric acid 0.5 mg,

[0099] Water for injection, add appropriate amount to 0.5ml,

[0100] Injection target pH value = 3.0;

[0101] Preparation method:

[0102] (a) Take by weighing the prescribed amount of naloxone hydrochloride, carbohydrates and organic acids, add an appropriate amount (about 70%) of water for injection to dissolve, then add activated carbon, stir, and decarbonize by filtration;

[0103] (b) add water for injection to the full amount, stir evenly, measure the pH value of the solution and optionally determine the active ingredient content, and adjust to the specified pH value with an acid-base regulator if necessary;

[0104] (c) The obtained solution is carefully filtered, filled into an ampoule bottle, and sterilized by autoclaving at 115° C. for 30 minutes to obtain a pharmac...

Embodiment 3

[0105] Embodiment 3: Preparation of naloxone hydrochloride pharmaceutical composition

[0106] formula:

[0107] Naloxone Hydrochloride 1mg,

[0108] Maltose 30mg,

[0109] Citric acid 0.2mg,

[0110] Water for injection, add appropriate amount to 4ml,

[0111] Injection target pH value = 6.5;

[0112] Preparation method:

[0113] (a) Take by weighing the prescribed amount of naloxone hydrochloride, carbohydrates and organic acids, add an appropriate amount (about 70%) of water for injection to dissolve, then add activated carbon, stir, and decarbonize by filtration;

[0114] (b) add water for injection to the full amount, stir evenly, measure the pH value of the solution and optionally determine the active ingredient content, and adjust to the specified pH value with an acid-base regulator if necessary;

[0115] (c) The obtained solution is carefully filtered, filled into an ampoule bottle, and sterilized by autoclaving at 115° C. for 30 minutes to obtain a pharmaceut...

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Abstract

The invention belongs to the technical field of medicines, relates to a pharmaceutical composition of a naloxone hydrochloride injection and a preparation method of pharmaceutical composition, and particularly relates to a pharmaceutical composition of a naloxone hydrochloride injection. The pharmaceutical composition comprises naloxone hydrochloride, and particularly comprises naloxone hydrochloride, saccharides, organic acid and injection water. The naloxone hydrochloride in the pharmaceutical composition is added to the composition in a form of 17-allyl-4,5alpha-epoxy-3,14-dihydroxy-pyran-6-methadone hydrochloride dehydrate; the saccharides are selected from one or more of the following components: mannitol, sorbitol, lactose, maltose, glycine, mycose, glucose and the like. The pharmaceutical composition disclosed by the invention can be used after opioid compound anaesthesia to resist respiratory depression caused by the medicine and prompt patients to revive, is used for respiratory depression caused by excessive opioids and complete or partial reversion of the opioids, is used for saving acute alcohol poisoning, and is used for diagnosing excessive acute opioids.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a pharmaceutical composition of naloxone hydrochloride, in particular to the pharmaceutical composition of injection of naloxone hydrochloride, and to a preparation method of the pharmaceutical composition. Background technique [0002] Naloxone Hydrochloride, whose English name is Naloxone Hydrochloride, is the hydrochloride dihydrate of naloxone base, chemical name: 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan -6-one hydrochloride dihydrate, its chemical structure is: [0003] [0004] Naloxone hydrochloride is white crystal or crystalline powder, easily soluble in water, soluble in methanol, almost insoluble in chloroform or ether. [0005] Naloxone is a pure opioid receptor antagonist with no intrinsic activity itself. However, it can competitively antagonize various opioid receptors and has a strong affinity for μ receptors. Naloxone takes effect quickly and has a stro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/485A61K47/26A61K47/36A61K47/18A61K47/10A61K47/12A61P25/00
Inventor 吴国庆伍隆霞左伟苟治君肖流婷赵东明
Owner CHENGDU TIANTAISHAN PHARMA
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