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Preparation method of temperature-sensitive dyclonine hydrochloride gel

A temperature-sensitive gel matrix and temperature-sensitive technology, which can be applied to non-active ingredient medical preparations, active ingredient-containing medical preparations, and pharmaceutical formulations. To achieve reliable diagnosis results, improve compliance, and relieve irritation and discomfort

Inactive Publication Date: 2017-05-24
TIANJIN PHARMA GROUP XINZHENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to its own physical properties, the glue stays in the esophagus and intestinal tract for a short time after oral administration or enema, and its fluidity is too high, making it difficult to cover the entire inner surface of the cavity, resulting in reduced anesthesia effect
If you want to achieve better results without changing the dosage form, you need to increase the dosage, which increases the cost of medication. At the same time, because dyclonine hydrochloride itself has a bitter taste, the patient will still have a certain sense of discomfort when taking it after the concentration is increased.

Method used

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  • Preparation method of temperature-sensitive dyclonine hydrochloride gel
  • Preparation method of temperature-sensitive dyclonine hydrochloride gel
  • Preparation method of temperature-sensitive dyclonine hydrochloride gel

Examples

Experimental program
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Effect test

Embodiment 1

[0023] A temperature-sensitive dyclonine hydrochloride gel, which is composed of the following ingredients in weight percentage: dyclonine hydrochloride 1%, poloxamer 407 2.5%, poloxamer 188 0.5%, polyvinyl alcohol 5 %, citric acid 0.3%, sodium citrate 0.1%, ethylparaben 0.03%, glycerin 2.5%, stevia 0.08%, menthol 0.05%, sweet orange flavored water-soluble essence 0.5%, polyoxyethylene polyoxygen Propylene pentaerythritol ether 3%, the balance is purified water.

[0024] The preparation method of above-mentioned thermosensitive type dyclonine hydrochloride gel specifically comprises the following steps:

[0025] 1) Dissolve the weighed temperature-sensitive gel matrix (poloxamer 407 and poloxamer 188) in an appropriate amount of purified water at 4°C, stir evenly, and put it into a preparation tank for later use;

[0026] 2) Dissolve the viscosity modifier (polyvinyl alcohol) with an appropriate amount of hot (40-60°C) purified water and add it to the preparation tank;

[00...

Embodiment 2

[0030] A temperature-sensitive dyclonine hydrochloride gel, which is composed of the following components by weight percentage: 1% dyclonine hydrochloride, 2% poloxamer 407, 0.3% poloxamer 188, polyvinyl alcohol 6 %, citric acid 0.2%, sodium citrate 0.2%, ethylparaben 0.05%, stevia 0.05%, glycerin 2%, sweet orange flavor water-soluble essence 0.3%, polyoxyethylene polyoxypropylene pentaerythritol ether 5 %, and the balance is purified water.

[0031] Refer to Example 1 for the preparation method of the above temperature-sensitive dyclonine hydrochloride gel.

Embodiment 3

[0033] A temperature-sensitive dyclonine hydrochloride gel, which is composed of the following ingredients in weight percentage: dyclonine hydrochloride 1%, poloxamer 407 1.8%, poloxamer 188 0.1%, polyvinyl alcohol 5 %, citric acid 0.3%, sodium citrate 0.2%, ethylparaben 0.01%, glycerin 2%, sucralose 0.05%, menthol 0.05%, sweet orange flavored water-soluble essence 0.5%, polyoxyethylene poly Oxypropylene pentaerythritol ether 4%, the balance is purified water.

[0034] Refer to Example 1 for the preparation method of the above temperature-sensitive dyclonine hydrochloride gel.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a preparation method of a temperature-sensitive dyclonine hydrochloride gel. The method comprises the following steps: 1) under the condition of 2-6 DEG C, dissolving a temperature-sensitive gel substrate in a right amount of purified water, and stirring uniformly for later use; 2) dissolving a viscosity modifier in a right amount of purified water, and adding into the solution obtained in the step 1); 3) dissolving dyclonine hydrochloride in a right amount of purified water, simultaneously adding the dyclonine hydrochloride solution and a pH regulator into the solution obtained in the step 2), and dissolving by stirring; and 4) adding a preservative, a flavoring agent, a medical defoaming agent and the balance of purified water into the solution obtained in the step 3), and uniformly mixing. The gel prepared by the method is used for larynx anesthetization and lubrication during digestive tract endoscopy, greatly increases the retention time and coverage area under the condition of the same administration volume, has the characteristics of strong anesthetization, quick drug effect taking, favorable defoaming effect, proper mouthfeel and the like, enhances the compliance of the patient, and is worthy of clinical application and popularization.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a temperature-sensitive dyclonine hydrochloride gel preparation and a preparation method thereof. Background technique [0002] Thermosensitive gel is a new dosage form studied in recent years. At room temperature, the preparation is in a liquid state with good fluidity. When the temperature rises to body temperature, the fluidity and adhesion increase, and it can form a gel in the cavity or affected area. Gel-like, so that under the same dosage volume conditions, the residence time and coverage area ratio are greatly increased. Therefore, both the dosage and drug concentration of the preparation can be significantly reduced, which can not only improve the adaptability of patients, but also reduce the cost of the preparation. [0003] Dyclonine hydrochloride is a local anesthetic that has been reported to significantly reduce discomfort in patient...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/4453A61K47/10A61K47/32A61P23/02
CPCA61K9/06A61K9/0053A61K31/4453A61K47/10A61K47/32
Inventor 李俊霞白艳鹤王瑞玲周遂成张继业田广林
Owner TIANJIN PHARMA GROUP XINZHENG