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Lidocaine hydrochloride gel and preparation method thereof

A technology of lidocaine hydrochloride and gel, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, and medical preparations containing active ingredients. Weakness and other problems, to achieve the effect of blocking heat conduction, good transdermal effect, and reducing pain

Active Publication Date: 2021-08-13
HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the problems of low skin penetration rate, high skin irritation, weak analgesic effect and short analgesic time of existing gels, the invention provides a lidocaine hydrochloride gel

Method used

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  • Lidocaine hydrochloride gel and preparation method thereof
  • Lidocaine hydrochloride gel and preparation method thereof
  • Lidocaine hydrochloride gel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] This embodiment provides a lidocaine hydrochloride gel, which comprises the following components in terms of mass percent: Poloxamer 407: 12%, Poloxamer 188: 0.3% and nanoemulsion: 87.7%, wherein, The above-mentioned nanoemulsion includes the following components based on the total amount of each component as 100%: ethyl oleate: 3%, Tween 80: 20%, absolute ethanol: 7%, deionized water: 68% and lidocaine hydrochloride Caine: 2%.

[0040] The preparation method of above-mentioned lidocaine hydrochloride gel comprises the following steps:

[0041] Step 1, taking each component according to the above-mentioned raw material ratio;

[0042] Step 2, adding the above-mentioned lidocaine hydrochloride to ethyl oleate, Tween 80 and dehydrated ethanol to dissolve to obtain an emulsion; Add dropwise to the emulsion at 25°C;

[0043] Step 3: Mix the above-mentioned poloxamer 407 and poloxamer 188 to obtain a gel matrix, add the above-mentioned gel matrix to the above-mentioned na...

Embodiment 2

[0045] This embodiment provides a lidocaine hydrochloride gel, which comprises the following components in terms of mass percent: Poloxamer 407: 13%, Poloxamer 188: 0.1% and nanoemulsion: 86.9%, wherein, The above-mentioned nanoemulsion includes the following components based on the total amount of each component as 100%: oleic acid: 2%, Tween 20: 21%, absolute ethanol: 5%, deionized water: 70% and lidocaine hydrochloride :2%.

[0046] The preparation method of above-mentioned lidocaine hydrochloride gel comprises the following steps:

[0047]Step 1, taking each component according to the above-mentioned raw material ratio;

[0048] Step 2, adding the above-mentioned lidocaine hydrochloride to oleic acid, Tween 20 and absolute ethanol to dissolve to obtain an emulsion; the deionized water is dripped at a rate of 4mL / min under the condition that the stirring speed is 13r / s Add it to the emulsion at 30°C to obtain nanoemulsion;

[0049] Step 3: Mix the above-mentioned poloxam...

Embodiment 3

[0051] This embodiment provides a lidocaine hydrochloride gel, which comprises the following components in terms of mass percent: Poloxamer 407: 11%, Poloxamer 188: 0.5% and nanoemulsion: 88.5%, wherein, The above-mentioned nanoemulsion includes the following components based on the total amount of each component as 100%: isopropyl myristate: 5%, laurate: 23%, glycerin cocoate: 10%, deionized water: 60% % and lidocaine hydrochloride: 2%.

[0052] The preparation method of above-mentioned lidocaine hydrochloride gel comprises the following steps:

[0053] Step 1, taking each component according to the above-mentioned raw material ratio;

[0054] Step 2, adding the above-mentioned lidocaine hydrochloride to isopropyl myristate, laurate and glyceryl cocoate to dissolve to obtain an emulsion; Add dropwise to the emulsion at 28°C at a rate of mL / min;

[0055] Step 3: Mix the above-mentioned poloxamer 407 and poloxamer 188 to obtain a gel matrix, add the above-mentioned gel matri...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses lidocaine hydrochloride gel and a preparation method thereof. The gel is prepared from the following components in percentage by mass of 11 percent to 13 percent of poloxamer 407, 0.1 percent to 0.5 percent of poloxamer 188 and 86.5 percent to 88.5 percent of nanoemulsion, wherein the nanoemulsion is prepared from the following components in percentage by mass of 2 percent to 5 percent of an oil phase, 15 percent to 23 percent of a surfactant, 5 percent to 10 percent of a cosurfactant, 60 percent to 70 percent of deionized water and 2 percent of lidocaine hydrochloride on the basis that the total amount of the components is 100 percent. According to the gel, lidocaine hydrochloride is dispersed in the nanoemulsion, a gel matrix with a temperature-sensitive characteristic is formed by poloxamer 407 and poloxamer 188 according to a specific ratio, and the nanoemulsion is loaded on the gel matrix to form the nano-emulsion-in-situ gel which has a long-acting analgesic effect.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a lidocaine hydrochloride gel and a preparation method thereof. Background technique [0002] Lidocaine or its pharmaceutically acceptable salts is an amide local anesthetic that stabilizes neuronal membranes by inhibiting the ionic flux generated by impulse initiation and conduction. After transdermal administration, lidocaine or its pharmaceutically acceptable salts penetrate into intact skin in an amount sufficient to produce analgesic effects. [0003] The gel is a transdermal preparation, currently mainly using transdermal accelerators such as azone, propylene glycol, urea, menthol, etc., but the skin penetration rate of the above-mentioned transdermal accelerators to the drug lidocaine hydrochloride is low, and after long-term preservation Or after accelerated investigation, the skin penetration rate drops rapidly. At the same time, the analgesic effect...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/167A61K47/26A61P23/02A61K9/107
CPCA61K31/167A61K9/06A61K47/26A61K9/0014A61P23/02A61K9/1075
Inventor 张丹参景永帅金姗
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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