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Naloxone hydrochloride freeze-dried powder injection and preparation method thereof

A technology of naloxone hydrochloride and freeze-dried powder injection, which is applied in the field of naloxone hydrochloride freeze-dried powder for injection and its preparation, can solve problems such as poor stability of water injection, and achieve the effect of improving product quality

Active Publication Date: 2011-12-14
ZHEJIANG JINHUA CONBA BIO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] In order to solve the technical defect of poor stability of existing aqueous injections, an object of the present invention is to provide a freeze-dried powder injection of naloxone hydrochloride, which has the characteristics of simple formula, easy large-scale production, and good stability

Method used

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  • Naloxone hydrochloride freeze-dried powder injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] 1. Raw materials:

[0059] Naloxone hydrochloride 0.4 g

[0060] Mannitol 48 g

[0061] Edetate disodium 0.1 g.

[0062] Two, the preparation process is as follows:

[0063] 1.1 Weighing: Weighing strictly according to the prescription and ingredient instruction list (conventional ingredients 22,000 pieces / box), using a double-check system, weighing prescription quantities of naloxone hydrochloride, mannitol, edetate disodium, activated carbon, , placed in an appropriate container, weighed a small amount of water for injection, dissolved edetate disodium and naloxone hydrochloride respectively for later use, weighed activated carbon according to 0.1% of the total amount prepared, and adjusted the humidity with water for later use;

[0064] 1.2 Preparation:

[0065] 1.2.1 The dilute dispensing tank and feed liquid pipe are sterilized by pure steam and circulated for 30 minutes;

[0066] 1.2.2 Add an appropriate amount of water for injection that has been cooled to r...

Embodiment 2

[0088] 1. Raw materials:

[0089] Naloxone hydrochloride 1 g

[0090] Mannitol 48 g

[0091] Edetate disodium 0.1 g.

[0092] Two, the preparation process is as follows: prepare following 5 kinds of solutions by the method shown in embodiment 1:

[0093] Solution 1: pH value 5.0;

[0094] Solution 2: PH value 4.5;

[0095] Solution three: pH value 4.0;

[0096] Solution 4: pH value 3.5;

[0097] Solution five: pH value 3.0;

[0098] Solution six: pH value 2.5.

Embodiment 3

[0100] 1. Raw materials:

[0101] Naloxone hydrochloride 2 g

[0102] Mannitol 48 g

[0103] Edetate disodium 0.1 g.

[0104] Two, the preparation process is as follows: prepare following 5 kinds of solutions by the method shown in embodiment 1:

[0105] Solution 1: pH value 5.0;

[0106] Solution 2: PH value 4.5;

[0107] Solution three: pH value 4.0;

[0108] Solution 4: pH value 3.5;

[0109] Solution five: pH value 3.0;

[0110] Solution six: pH value 2.5.

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Abstract

The invention relates to a naloxone hydrochloride freeze-dried powder injection and a preparation method thereof. The naloxone hydrochloride freeze-dried powder injection in every 1000 bottles is obtained by adding water for injection to dissolve the following ingredients and then freeze-drying: 0.1-5g of naloxone hydrochloride, 30-60g of mannitol and 0.01-0.5g of edetate disodium; before the freeze-drying, the pH value of the solution is 2.0 to 5.0. According to the invention, through controlling different pH value regulation ranges during the preparation process of different specifications of the naloxone hydrochloride for injection, the finished products can meet the prescribed standards after the freeze-drying, so that the quality and the stability of the product are improved.

Description

technical field [0001] The invention relates to naloxone hydrochloride freeze-dried powder injection and a preparation method thereof. Background technique [0002] Naloxone hydrochloride, English name: NALOXONE HYDROCHLORIDE, chemical name: 17-allyl-4,5a-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride. The structural formula is as follows: [0003] [0004] Naloxone hydrochloride 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 strong antagonistic effect. Naloxone also reverses all effects of opioid agonists, including analgesia. In addition, it also has resuscitating effects that are not related to antagonizing opioid receptors. It can quickly reverse the respiratory depression caused by opioid analgesics, can cause high excitement, and make cardiovascular hyperfunction. Naloxone hydrochloride...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/485A61K47/18A61P25/00A61P25/36
Inventor 倪建中吴国华王国华蔡月明李刚金琪谈国军黄伟强高伟杨燕
Owner ZHEJIANG JINHUA CONBA BIO PHARM CO LTD
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