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Nalmefene hydro chloride lyophilized powder formulation for injection

A technology of freeze-dried powder injection and nalmefene, which is applied in the direction of freeze-dried transportation, medical preparations containing active ingredients, anti-toxins, etc., can solve the problems of unfavorable long-term storage and poor stability, and achieve simplified process and good stability , Reasonable effect of the composition

Inactive Publication Date: 2006-08-09
王颖
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there is no nalmefene hydrochloride injection on the market in China, and the nalmefene hydrochloride injection that has been marketed abroad is a small water injection, which has poor stability and is not conducive to long-term storage

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] prescription:

[0020] Nalmefene hydrochloride 0.1108g

[0021] Mannitol 20g

[0022] Process: ①Take 1000ml of water for injection into the mixing tank, add the full amount of mannitol in the prescription, and stir until it dissolves; ②Add the prescription amount of Nalmefene hydrochloride and stir until it dissolves; then use a 0.22μm microporous membrane to filter to Clear; ③filled in a vial (filled with 1ml of liquid in a 2ml vial); ④freeze-dried (pre-freeze, reduce the temperature to -40℃, after two hours at a rate of 0.15℃ per minute Raise the temperature to -5°C, sublimate and dry at this temperature for 10 hours, then raise the temperature to 40°C at a temperature increase rate of 0.4°C per minute, and dry at this temperature for 7-10 hours); ⑤Capping, labeling, and packaging , The finished product will be obtained after passing the inspection.

[0023] PH value: Take 10 bottles of this product, add 1ml of water to each bottle and dissolve them together, and determin...

Embodiment 2

[0025] prescription:

[0026] Nalmefene hydrochloride 0.1108g

[0027] Mannitol 20g

[0028] Process: ①Take 1000ml of water for injection into the mixing tank, add the full amount of mannitol in the prescription, and stir until it dissolves; ②Add the prescription amount of Nalmefene hydrochloride and stir until it dissolves; then use a 0.22μm microporous membrane to filter to Clear and bright; ③Filled in a vial (same as Example 1); ④Freeze-drying (pre-freeze, reduce the temperature to -40℃, after two hours, increase the temperature to -5℃ at a rate of 0.15℃ per minute, Sublimate and dry at this temperature for 10 hours, then increase the temperature to 40°C at a temperature increase rate of 0.4°C per minute, and dry at this temperature for 7-10 hours); ⑤Capping, labeling, packaging, and inspection to obtain the finished product .

[0029] PH value: The measurement method is the same as in Example 1, and the pH value is 6.06.

Embodiment 3

[0031] prescription:

[0032] Nalmefene hydrochloride 0.2216g

[0033] Mannitol 20g

[0034] Process: ①Take 1000ml of water for injection into the mixing tank, add the full amount of mannitol in the prescription, and stir until it dissolves; ②Add the prescription amount of Nalmefene hydrochloride and stir until it dissolves; then use a 0.22μm microporous membrane to filter to Clear and bright; ③Filled in a vial (same as Example 1); ④Freeze-drying (pre-freeze, reduce the temperature to -40℃, after two hours, increase the temperature to -5℃ at a rate of 0.15℃ per minute, Sublimate and dry at this temperature for 10 hours, then increase the temperature to 40°C at a temperature increase rate of 0.4°C per minute, and dry at this temperature for 7-10 hours); ⑤Capping, labeling, packaging, and inspection to obtain the finished product .

[0035] PH value: The measurement method is the same as in Example 1, and the pH value is 5.85.

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PUM

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Abstract

The present invention relates to a nalmefene hydrochloride freeze-dried powder injection preparation for injection. Said preparation is formed from effective component malmefene hydrochloride and proper medicinal carrier, in which the content range of nalmefene hydrochloride in the preparation is 0.1-4.5 mg generally, the medicinal carrier can be one or several kinds selected from mannitol, glucose, sodium chloride, beta-cyclodextrin, glucosan, fructose and sorbitol. The content range of said medicinal carrier can be 10-100 mg. the pH value of said preparation is 5.0-7.0.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation, particularly a nalmefene hydrochloride freeze-dried powder injection preparation for injection, which contains a therapeutically effective amount of nalmefene hydrochloride and an appropriate amount of drug carrier. Background technique: [0002] Nalmefene hydrochloride (chemical name 17-cyclopropylmethyl-4,5-epoxy-6-methylenemorphinan-3,14-diol hydrochloride) is a long-acting injectable Opioid antagonist, this product has the advantages of high strength, long duration, high bioavailability, and few side effects. It is often used abroad to reverse the effects of opioids and rescue patients with opioid overdose. Nalmefene hydrochloride was approved by the US FDA in 1995 to reverse the effects of opioids, including respiratory depression, lethargy, and hypotension. It can also be used in the emergency room for the treatment of known or suspected opioid overdose. Existing animal experiments and clinical t...

Claims

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Application Information

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IPC IPC(8): A61K31/485A61K9/19A61P25/32A61P39/02A61P11/00
Inventor 王颖
Owner 王颖
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