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A kind of cyclobenzaprine hydrochloride sublingual spray and preparation method thereof

A technology of cyclobenzaprine hydrochloride and spray, which is applied in the direction of aerosol delivery, anti-inflammatory agent, pharmaceutical formula, etc., to achieve the effect of rapid action, convenient administration and remarkable effect

Active Publication Date: 2021-04-30
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Cyclobenzaprine hydrochloride was first developed by Merk Company. In 1978, cyclobenzaprine hydrochloride tablets were launched in the United States, with specifications of 5mg and 10mg. They are used to relieve muscle spasms accompanied by acute painful musculoskeletal diseases. It is still the most popular drug in the United States. One of the commonly used muscle relaxants, which has not been marketed in China

Method used

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  • A kind of cyclobenzaprine hydrochloride sublingual spray and preparation method thereof
  • A kind of cyclobenzaprine hydrochloride sublingual spray and preparation method thereof
  • A kind of cyclobenzaprine hydrochloride sublingual spray and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1 Preparation of cyclobenzaprine hydrochloride-DM-β-cyclodextrin inclusion compound 1

[0023] Weigh an appropriate amount of DM-β-cyclodextrin and add an appropriate amount of distilled water to dissolve it completely, add acetone to dissolve cyclobenzaprine hydrochloride with a mass ratio of 1:2 to DM-β-cyclodextrin under the condition of heating and stirring at 30°C , stirring for an appropriate time until it dissolves completely, the solvent is evaporated to dryness by rotary evaporation, and the obtained solid is vacuum-dried under reduced pressure to obtain that.

Embodiment 2

[0024] Example 2 Preparation of cyclobenzaprine hydrochloride-DM-β-cyclodextrin inclusion compound 2

[0025] Weigh an appropriate amount of DM-β-cyclodextrin and add an appropriate amount of distilled water to dissolve it completely, add acetone-dissolved cyclobenzaprine hydrochloride with a mass ratio of 1:3 to DM-β-cyclodextrin under the condition of heating and stirring at 35°C, Stir for an appropriate time until it dissolves completely, dry the solvent by rotary evaporation, and vacuum-dry the obtained solid under reduced pressure to obtain the obtained product.

Embodiment 3

[0026] Example 3 Preparation of cyclobenzaprine hydrochloride-DM-β-cyclodextrin inclusion compound 3

[0027] Weigh an appropriate amount of DM-β-cyclodextrin and add an appropriate amount of distilled water to dissolve it completely, add acetone-dissolved cyclobenzaprine hydrochloride with a mass ratio of 1:4 to DM-β-cyclodextrin under the condition of heating and stirring at 40°C, Stir for an appropriate time until it dissolves completely, dry the solvent by rotary evaporation, and vacuum-dry the obtained solid under reduced pressure to obtain the obtained product.

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PUM

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Abstract

The invention relates to a cyclobenzaprine hydrochloride sublingual spray and a preparation method thereof, belonging to the field of pharmaceutical preparations. The cyclobenzaprine hydrochloride sublingual spray of the present invention preferably comprises 15 parts of cyclobenzaprine hydrochloride-DM-β-cyclodextrin inclusion compound, 7 parts of vitamins, 3 parts of aspartame, 4 parts of peppermint essence, 0.3 part of acid, appropriate amount of pH regulator, 105 parts of distilled water, the present invention adopts DM-β-cyclodextrin as clathrate material to clathrate cyclobenzaprine hydrochloride to prepare sublingual spray, which is convenient for administration and rapid in action, and The dosage is small, the applicability to patients is strong, the quality is stable, and the effect is remarkable.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a cyclobenzaprine hydrochloride sublingual spray and a preparation method thereof. Background technique [0002] In a modern society where the pace of life is getting faster and faster, back pain is one of the common diseases. People generally treat it with rest. However, rest cannot solve the fundamental problem. Not being able to work will not only cost a lot of medical expenses, but also long-term and a large number of missed work will affect the gross social product. [0003] Acute pain refers to back and lower back pain that lasts less than 3 months. The initial feeling is muscle spasm, muscle soreness, and limited local activities. The symptoms generally last for several weeks and affect the quality of daily life and work efficiency. If not treated properly , will gradually transform into chronic pain, and further worsen, the situation will become more serious. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/12A61K31/135A61K47/69A61P29/00A61P21/02A61P19/08
CPCA61K9/006A61K31/135
Inventor 王明刚陈阳生刘晓霞孙桂玉臧云龙
Owner CP PHARMA QINGDAO CO LTD
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