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Process for preparing naloxone hydrochloride injection

A technology for preparation of injection and naloxone hydrochloride, applied in the field of medicine, can solve problems such as inability to prevent oxidative deterioration of products, and achieve the effects of preventing oxidative deterioration, reducing related substances and ensuring product quality

Inactive Publication Date: 2009-12-02
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But none of them can prevent the oxidative deterioration of the product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] The specification is 10ml: 4mg. By strictly controlling the pH range of 3.0-4.0 in the production, the pH can be kept unchanged during the placement process. At the same time, the method of inert gas protection is used in the production to reduce the oxygen content in the liquid medicine and the ampoule. To the minimum, prevent the oxidative deterioration of naloxone hydrochloride injection, and reduce related substances. Through the above two technologies, the product quality is greatly guaranteed.

Embodiment 2

[0013] The specification is 1ml: 1mg. By strictly controlling the pH range of 3.0-4.0 in the production, the pH can be kept unchanged during the placement process. At the same time, the method of inert gas protection is used in the production to reduce the oxygen content in the liquid medicine and the ampoule. To the minimum, prevent the oxidative deterioration of naloxone hydrochloride injection, and reduce related substances. Through the above two technologies, the product quality is greatly guaranteed.

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PUM

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Abstract

The invention provides a process for preparing naloxone hydrochloride injection. The pH of the naloxone hydrochloride injection can be unchangeable during placing by strictly controlling the pH range in production; and simultaneously, a method for inert gas protection adopted in the production reduces the oxygen content in liquid medicine and an ampoule to the minimum so as to prevent oxidative deterioration of the naloxone hydrochloride injection to reduce related substances. The technology greatly ensures the product quality.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a preparation process of naloxone hydrochloride injection. Background technique [0002] 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 still has anti-shock effect. Morphine-like dependence, withdrawal symptoms and respiratory depression are not produced. [0003] Naloxone hydrochloride is currently the most wide...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/485A61P39/02A61P25/00
Inventor 李印秋
Owner SHANDONG XINHUA PHARMA CO LTD
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