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Composition of naloxone hydrochloride and polyvinylpyrrolidone and preparation method thereof

A technology of polyvinylpyrrolidone and naloxone hydrochloride, which is applied in the field of medicine, can solve problems such as instability to light and heat, achieve stable and significant curative effect, avoid degradation, and have good resolubility

Inactive Publication Date: 2010-06-16
BEIJING SIHUAN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to provide a pharmaceutical composition of naloxone hydrochloride and polyvinylpyrrolidone with stable quality and a preparation method thereof, so as to solve the problems of light, heat instability and easy degradation in aqueous solution in existing naloxone preparations. question

Method used

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  • Composition of naloxone hydrochloride and polyvinylpyrrolidone and preparation method thereof
  • Composition of naloxone hydrochloride and polyvinylpyrrolidone and preparation method thereof
  • Composition of naloxone hydrochloride and polyvinylpyrrolidone and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] prescription:

[0058] Naloxone hydrochloride 0.4g

[0059] (In C 19 H 21 NO 4 ·HCl meter)

[0060] Polyvinylpyrrolidone (K-60) 2g

[0061] Mannitol 48g

[0062] Add water for injection to 1000ml

[0063]

[0064] 1000 bottles

[0065] The preparation process is as follows: Take 0.4g of naloxone hydrochloride and 2g of polyvinylpyrrolidone, place them in a mixing container, add 900mL water for injection, add 48g of mannitol, and stir to dissolve; add 0.02% (w / v) activated carbon to the solution After stirring for 15 minutes, the drug solution was decarburized through a 0.8μm microporous membrane. Dilute hydrochloric acid was added to the filtrate to adjust the pH to 3.5±0.2, and water for injection was added to 1000mL; the filtrate was finely filtered through a 0.22μm membrane and the filtrate was tested; In a high-grade environment, the qualified filtrate is divided into 5mL cleaned, dried and sterilized control bottles, the divided volume is...

Embodiment 2

[0067] prescription:

[0068] Naloxone hydrochloride 1.0g

[0069] (In C 19 H 21 NO 4 ·HCl meter)

[0070] Polyvinylpyrrolidone (K-60) 5g

[0071] Mannitol 45g

[0072] Add water for injection to 1000ml

[0073]

[0074] 1000 bottles

[0075] The preparation process is: take 1.0 g of naloxone hydrochloride and 5 g of polyvinylpyrrolidone, place them in a mixing container, add 900 mL of water for injection, add 45 g of mannitol, and stir to dissolve; add 0.02% (w / v) activated carbon to the solution After stirring for 15 minutes, the drug solution was decarburized through a 0.8μm microporous membrane. Dilute hydrochloric acid was added to the filtrate to adjust the pH to 3.5±0.2, and water for injection was added to 1000mL; the filtrate was finely filtered through a 0.22μm membrane and the filtrate was tested; In a high-grade environment, the qualified filtrate is divided into 5mL cleaned, dried and sterilized control bottles, the divided volume is 1m...

Embodiment 3

[0077] prescription:

[0078] Naloxone hydrochloride 2.0g

[0079] (In C 19 H 21 NO 4 ·HCL meter)

[0080] Polyvinylpyrrolidone (K-60) 10g

[0081] Mannitol 40g

[0082] Add water for injection to 1000ml

[0083]

[0084] 1000 bottles

[0085] The preparation process is as follows: Take 2.0 g of naloxone hydrochloride and 10 g of polyvinylpyrrolidone, place them in a mixing container, add 900 mL of water for injection, add 40 g of mannitol, and stir to dissolve; add 0.02% (w / v) activated carbon to the solution After stirring for 15 minutes, the drug solution was decarburized through a 0.8μm microporous membrane. Dilute hydrochloric acid was added to the filtrate to adjust the pH to 3.5±0.2, and water for injection was added to 1000mL; the filtrate was finely filtered through a 0.22μm membrane and the filtrate was tested; In a high-grade environment, the qualified filtrate is divided into 5mL cleaned, dried and sterilized control bottles, the divided...

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PUM

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Abstract

The invention belongs to the technical field of medicines, in particular a composition of naloxone hydrochloride and polyvinylpyrrolidone and a preparation method thereof. The weight ratio of the naloxone hydrochloride to the polyvinylpyrrolidone in the composition is 1:1-1:10, and the composition can contain auxiliary materials. The composition of the invention solves the problem of instability of the naloxone hydrochloride under the condition of high temperature and illumination intensity, so that the naloxone hydrochloride becomes more stable with easy storage.

Description

1. Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a composition of naloxone hydrochloride and polyvinylpyrrolidone and a preparation method. 2. Background technology [0002] Naloxone hydrochloride (chemical name 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride) is the monohydrochloride of naloxone, naloxone Ketone is a derivative of hydroxydihydromorphone. Its chemical structure is similar to morphine. Only the N-methyl group of morphine is replaced by an allyl group, and the 6-position hydroxyl group is changed to a ketone group. Its pharmacological effect is completely the same as that of morphine. On the contrary, it is a specific antagonist of opioid receptors. Its affinity with opioid receptors is greater than that of morphine and β-endorphin. It can competitively prevent and replace morphine-like substances from binding to receptors, thereby blocking morphine-like substances To achieve its medici...

Claims

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Application Information

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IPC IPC(8): A61K31/485A61K47/32A61K9/19A61P25/32A61P39/02A61P9/00A61P43/00
Inventor 车冯升郭维城贾中新霍彩霞孟宪慧
Owner BEIJING SIHUAN PHARMA
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