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Powder and injection preparation of hydrochloric naloxone and preparation method

A technology of naloxone hydrochloride powder injection and naloxone hydrochloride, which is applied in the fields of anti-toxic agent, powder delivery, and pharmaceutical formula, and can solve the problems of inconvenient large-scale production and cumbersome operation.

Inactive Publication Date: 2005-06-15
FUDAN UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the prescription of naloxone hydrochloride aqueous injection often needs to add a large number of auxiliary materials such as antioxidants, metal ion chelating agents, pH regulators, osmotic pressure regulators, and antibacterial agents. During the production process, nitrogen filling and other measures must be taken, which is cumbersome to operate. , which brings great inconvenience to mass production

Method used

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Embodiment Construction

[0015] Preparation process: Weigh the above-mentioned prescribed amount of medicine and excipients in an appropriate amount of sterile water for injection in an aseptic operation room. After dissolving, the volume is adjusted to 100ml. After sterile filtration, the filtrate is divided into sterile vials for freeze-drying , and then put on the rubber stopper and roll the aluminum cover, that is to say.

[0016] The product obtained in prescription 1 is a white loose block or white loose powder, which can be quickly dissolved by adding an appropriate amount of water for injection or normal saline and shaking to obtain a colorless and clear solution. The dosage of mannitol in the prescription can account for 0.5%-20% of the total amount of the preparation, preferably 1%-10%. If the dosage is less than 1%, the appearance of the product will not be plump; if it exceeds 10%, the internal structure of the product will be dense, the redispersibility is poor, and the solution wi...

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Abstract

A powder injection of naloxone hydrochloride is prepared from the naloxone hydrochloride and water-soluble medical auxiliary for injection. Its advantages aer high stability and high quality.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and relates to a naloxone hydrochloride injection preparation and a preparation method thereof. Specifically relates to a stable naloxone hydrochloride freeze-dried powder injection and a preparation process thereof. Background technique [0002] Naloxone hydrochloride is an opioid receptor antagonist. It is clinically used for acute poisoning of narcotic analgesics and acute alcohol poisoning. It is firstly used for respiratory depression and coma caused by known or suspected opioid overdose. Differential diagnosis in opioid addicts. The route of injection includes subcutaneous, intramuscular or intravenous injection, etc., with quick onset, high bioavailability and easy dose adjustment and control, so it is the preferred route of administration. The commercially available naloxone hydrochloride preparation for injection is its water injection. [0003] Naloxone hydrochloride is 17-allyl-4,5α...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/19A61K31/485A61P25/32A61P25/36A61P39/02
Inventor 蒋新国高小玲仇缀百陈平
Owner FUDAN UNIV
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