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Cyclobenzaprine hydrochloride sublingual spray and preparation method thereof

A cyclobenzaprine hydrochloride and spray technology, which is applied in aerosol delivery, anti-inflammatory agents, and pharmaceutical formulations, to achieve the effects of less dosage, strong applicability, and rapid action

Active Publication Date: 2017-12-22
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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  • Cyclobenzaprine hydrochloride sublingual spray and preparation method thereof
  • Cyclobenzaprine hydrochloride sublingual spray and preparation method thereof
  • 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 cyclobenzaprine hydrochloride with a mass ratio of 1:2 dissolved in acetone to DM-β-cyclodextrin under heating and stirring at 30°C After stirring for an appropriate time, the dissolution is complete, the solvent is evaporated by rotary evaporation, and the obtained solid is vacuum-dried under reduced pressure to obtain.

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 cyclobenzaprine hydrochloride with a mass ratio of 1:3 dissolved in acetone to DM-β-cyclodextrin under heating and stirring at 35°C. Stir for an appropriate time until the dissolution is complete, and the solvent is evaporated by rotary evaporation, and the obtained solid is dried under reduced pressure and vacuum to obtain.

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 cyclobenzaprine hydrochloride with a mass ratio of 1:4 dissolved in acetone to DM-β-cyclodextrin under heating and stirring at 40°C. Stir for an appropriate time until the dissolution is complete, and the solvent is evaporated by rotary evaporation, and the obtained solid is dried under reduced pressure and vacuum to obtain.

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PUM

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Abstract

The invention relates to a cyclobenzaprine hydrochloride sublingual spray and a preparation method thereof, and belongs to the field of pharmaceutical preparations. Preferably, the cyclobenzaprine hydrochloride sublingual spray consists of 15 parts of a cyclobenzaprine hydrochloride-DM-[beta]-cyclodextrin inclusion compound, 7 parts of vitamins, 3 parts of aspartame, 4 parts of peppermint essence, 0.3 part of sorbic acid, a proper amount of a pH regulator and 105 parts of distilled water. The sublingual spray provided by the invention is prepared by including the cyclobenzaprine hydrochloride with DM-[beta]-cyclodextrin as an inclusion material; and the sublingual spray is convenient for administration and rapid in actions, and the sublingual spray is low in administration dose, strong in applicability to patients, stable in quality and obvious in effect.

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 the 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 does not solve the fundamental problem. The pain symptoms will increase day by day, until the pain makes you fundamental Inability to work, not only costs a lot more than medical expenses, but also long-term and a large number of mis-union 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 cramps, muscle aches, and local activity limitation. The symptoms usually last for several weeks, which affects the quality of daily life and work efficiency. If the treatment is improper , It will gradually transform i...

Claims

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Application Information

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Patent Type & Authority Applications(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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