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Pharmaceutical composition and preparation method of naloxone hydrochloride powder for injection

A technology of naloxone hydrochloride powder injection and naloxone hydrochloride, which is applied in the field of medicine and can solve problems such as accumulation and subcutaneous granuloma

Active Publication Date: 2017-01-18
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 powder for injection
  • Pharmaceutical composition and preparation method of naloxone hydrochloride powder for injection
  • Pharmaceutical composition and preparation method of naloxone hydrochloride powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099] Embodiment 1: Preparation of naloxone hydrochloride pharmaceutical composition

[0100] formula:

[0101] Naloxone Hydrochloride 1mg,

[0102]Maltose 30mg,

[0103] Citric acid 0.3mg;

[0104] Preparation method:

[0105] (a) Weighing naloxone hydrochloride, freeze-dried excipients and pharmaceutical auxiliaries of the prescribed amount, adding water for injection to dissolve, then adding activated carbon, stirring, and decarbonizing by filtration;

[0106] (b) Add water for injection to 1ml, stir evenly, measure the pH value of the solution and optionally determine the content of active ingredients, and adjust to pH 3.3-3.7 with an acid-base regulator if necessary;

[0107] (c) sterilize and filter the medicinal liquid, fill it in vials, and divide 1ml into each bottle;

[0108] (d) Freeze-drying to remove moisture, and stoppering, to obtain.

Embodiment 2

[0109] Embodiment 2: Preparation of naloxone hydrochloride pharmaceutical composition

[0110] formula:

[0111] Naloxone Hydrochloride 1mg,

[0112] Maltose 20mg,

[0113] Citric acid 0.5mg;

[0114] Preparation method:

[0115] (a) Weighing naloxone hydrochloride, freeze-dried excipients and pharmaceutical auxiliaries of the prescribed amount, adding water for injection to dissolve, then adding activated carbon, stirring, and decarbonizing by filtration;

[0116] (b) Add water for injection to 1ml, stir evenly, measure the pH value of the solution and optionally determine the content of active ingredients, and adjust to pH 3.3-3.7 with an acid-base regulator if necessary;

[0117] (c) sterilize and filter the medicinal liquid, fill it in vials, and divide 1ml into each bottle;

[0118] (d) Freeze-drying (using freeze-drying curve B) to remove moisture, and stoppering to obtain the product.

Embodiment 3

[0119] Embodiment 3: Preparation of naloxone hydrochloride pharmaceutical composition

[0120] formula:

[0121] Naloxone Hydrochloride 1mg,

[0122] Maltose 75mg,

[0123] Citric acid 0.2mg;

[0124] Preparation method:

[0125] (a) Weighing naloxone hydrochloride, freeze-dried excipients and pharmaceutical auxiliaries of the prescribed amount, adding water for injection to dissolve, then adding activated carbon, stirring, and decarbonizing by filtration;

[0126] (b) Add water for injection to 1ml, stir evenly, measure the pH value of the solution and optionally determine the content of active ingredients, and adjust to pH 3.3-3.7 with an acid-base regulator if necessary;

[0127] (c) sterilize and filter the medicinal liquid, fill it in vials, and divide 1ml into each bottle;

[0128] (d) Freeze-drying to remove moisture, and stoppering, to obtain.

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Abstract

The invention belongs to the technical field of medicines, relates to an injection-use naloxone hydrochloride powder injection medicine composition and a preparation method thereof and particularly relates to the injection-use naloxone hydrochloride powder injection medicine composition which includes naloxone hydrochloride and especially includes the naloxone hydrochloride, a freeze-drying excipient and medicinal additives. The naloxone hydrochloride is added to the composition in the form of 17-allyl-4,5[alpha]-epoxy-3,14-dihydroxylmorphinan-6-one hydrochloride dihydrate. The freeze-drying excipient is selected from one or more of mannitol, sorbitol, lactose, maltose, glycine, trehalose, glucose and the like. The medicine composition can be used of post-operation of compound anesthesia with opioid medicines and has an antagonism effect of respiratory depression caused by the opioid medicines for promoting analepsia of a patient. The medicine composition is used in overdose of the opioid medicines, is used for reversing the respiratory depression caused by the opioid medicines completely or partially, is used for rescuing acute alcoholism and is used for diagnosis of acute opioid medicines overdose.

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 a pharmaceutical composition of freeze-dried powder 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 quic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/485A61P11/16A61P39/02A61P25/36
Inventor 吴国庆左伟伍隆霞苟治君肖流婷赵东明
Owner CHENGDU TIANTAISHAN PHARMA
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