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Naloxone hydrochloride injection and preparation method thereof

A technology for naloxone hydrochloride and injection, applied in the field of medicine, can solve the problems of poor heat resistance of naloxone hydrochloride injection, combined excessive use, illegal molecule utilization, etc., and achieves easy control of the preparation process, low cost, and prescription. The effect of few ingredients

Active Publication Date: 2020-04-10
GUANGDONG QIFANG MEDICINES CO LTD +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] Following the disclosure of a method for preparing naloxone and the obtained naloxone product in Chinese patent CN103695497B, the inventor is not limited by the development trend of the prior art, and does not give up paying attention to naloxone hydrochloride injection , studies have found that solid preparations such as naloxone hydrochloride powder injections are easily combined and used in excess, and will be used by criminals, so there is still a need to develop new naloxone hydrochloride injections; moreover, the inventor is not afraid of existing Existing technology has always been unable to solve the problem of poor heat resistance of naloxone hydrochloride injection, and faced up to the difficulties. After arduous research, a new prescription of naloxone hydrochloride injection was unexpectedly developed, which enhanced its heat resistance Resistant, making it suitable for high temperature sterilization and long-term storage, can be sterilized by overkill method with F0 value up to 15

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  • Naloxone hydrochloride injection and preparation method thereof
  • Naloxone hydrochloride injection and preparation method thereof
  • Naloxone hydrochloride injection and preparation method thereof

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Embodiment Construction

[0035] The content of the present invention is further illustrated below by way of examples. Unless otherwise specified, the technical means used in the examples are conventional means well known to those skilled in the art and commercially available common instruments and reagents. For reference, please refer to the pharmaceutical test manual and the manufacturer’s instructions of corresponding instruments and reagents.

[0036] 1. Prescription (specification: 0.4mg / ml)

[0037]

[0038]

[0039] 2. Preparation method

[0040] Step 1: take by weighing naloxone hydrochloride (in terms of naloxone hydrochloride anhydrous), sodium chloride and edetate disodium of above-mentioned prescription quantity (the exemplary edetate disodium in prescription Concentration can be respectively 0.001, 0.01 or 0.1mg / ml), add water for injection, mix and stir to make it all dissolve, obtain the first intermediate solution of naloxone hydrochloride injection;

[0041] Step 2: Add water f...

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Abstract

Disclosed is a naloxone hydrochloride injection and a preparation method therefor. The injection consists of naloxone hydrochloride, sodium chloride, ethylenediamine tetraacetate, hydrochloric acid, a related substance and water, wherein the amount of the related substance is at most 0.5% after sterilizing the injection at 121℃ for 15 min. The preparation method comprises dissolving the naloxone hydrochloride, ethylenediamine tetraacetate and sodium chloride, adjusting the pH with hydrochloric acid to 3.0-6.5, filtering, filling with an inert gas, potting and sterilizing at 121℃ for 15 min.

Description

technical field [0001] The invention belongs to the technical field of medicine, specifically, the invention relates to naloxone hydrochloride injection, its prescription makes it have strong heat resistance, and the amount of related substances is kept at an extremely low level under conditions of high temperature sterilization and long-term storage, Thereby the high quality of the liquid formulation can be maintained. In addition, the present invention also relates to a preparation method of the naloxone hydrochloride injection. Background technique [0002] Naloxone, chemically known as 17-allyl-4,5a-epoxy-3,14-dihydroxymorphinan-6-one, usually available as the hydrochloride salt, is an opioid receptor antagonist , mainly used to reverse narcotic analgesia and respiratory depression caused by morphine substances (drugs), and can be used to rescue poisoning caused by substances such as ethanol. [0003] The prescription and preparation process of naloxone hydrochloride i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/18A61K47/02A61K31/485A61P25/00A61P25/04A61P25/18A61P39/02
CPCA61K9/0019A61K9/08A61K31/485A61K47/02A61K47/183A61P25/00A61P25/04A61P25/18A61P39/02
Inventor 刘军黄梅李南汐黄进袁仕云高先庆杨春玮
Owner GUANGDONG QIFANG MEDICINES CO LTD
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