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Sublingual pellicles containing naloxone hydrochloride and preparing method thereof

A technology of naloxone hydrochloride and film, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, organic active ingredients, etc., can solve the problems of unsatisfactory use effect and slow drug absorption, and achieve low manufacturing cost and high dissolution rate. The effect of fast speed and large melting area

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

AI Technical Summary

Problems solved by technology

In order to solve the difficulty of medication, domestic enterprises currently have developed and produced sublingual tablets, which have been marketed. This preparation is convenient to use, but its drug absorption is slower than that of injection preparations, and the use effect is not ideal.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Sublingual film formulation containing naloxone hydrochloride:

[0018] Naloxone hydrochloride 2%

[0019] Sodium Carboxymethyl Cellulose 2%

[0020] Propylene Glycol 0.5%

[0021] amount of sweetener

[0022] Citric acid appropriate amount

[0023] Peppermint oil

[0024] Amount of ethanol

[0025] Appropriate amount of purified water

[0026] The preparation method is as follows: dissolving an appropriate amount of menthol oil in ethanol to prepare liquid A, taking an appropriate amount of purified water, dissolving naloxone hydrochloride, sweetener and citric acid in sequence with purified water, then adding liquid A, stirring evenly, and then adding membrane Dissolving the material, adding a plasticizer and stirring, then defoaming, coating, drying, stripping, testing, dividing into doses, and packaging to obtain the naloxone hydrochloride-containing sublingual film of the present invention.

Embodiment 2

[0028] Sublingual film formulation containing naloxone hydrochloride:

[0029] Naloxone hydrochloride 2%

[0030] Hypromellose 18%

[0031] Glycerol 6%

[0032] amount of sweetener

[0033] Citric acid appropriate amount

[0034] Peppermint oil

[0035] Amount of ethanol

[0036] Appropriate amount of purified water

[0037] The preparation method is the same as in Example 1.

Embodiment 3

[0039] Sublingual film formulation containing naloxone hydrochloride:

[0040] Naloxone hydrochloride 4%

[0041] Polyvinyl alcohol 20%

[0042] Macrogol 200 7%

[0043] amount of sweetener

[0044] Citric acid appropriate amount

[0045] Peppermint oil

[0046] Amount of ethanol

[0047] Appropriate amount of purified water

[0048] The preparation method is the same as in Example 1.

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Abstract

The present invention relates to a sublingual membrane preparation containing naloxone hydrochloride. Said preparation composition includes medicinal effective component naloxone hydrochloride, ethylene homopolymer or water-soluble cellulose derivative membrane material and water-soluble plasticizer. Besides, said invention also provides its preparation method and concrete stops.

Description

technical field [0001] The invention relates to a naloxone hydrochloride pharmaceutical preparation and a preparation method thereof, in particular to a sublingual film containing naloxone hydrochloride and a preparation method thereof. Background technique [0002] Naloxone hydrochloride is an opioid-specific antagonist, which can resist respiratory depression, blood pressure drop, coma, convulsions, etc. caused by analgesic anesthetics such as morphine. For the first aid and treatment of infarction, respiratory failure, neonatal asphyxia, craniocerebral injury, etc., although the drug can be absorbed orally, it is only 1 / 50 of the same dose by injection due to its strong first-pass effect. It is administered by injection, but all injection preparations need to be injected by medical staff, which is not very convenient to use. In order to solve the difficulty of drug use, domestic companies have developed and produced sublingual tablets, which hav...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/485A61K9/70A61P25/32A61P25/36A61P9/10
Inventor 徐进滑千里赵学刚王英利徐强岳玉敏
Owner 岳振江
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