Menthol complex gel patch

Abstract

A menthol complex gel patch, comprising a backing layer, a drug reservoir and a protective layer, characterized in that the drug reservoir comprises an aqueous phase, an oil phase and active ingredients, the aqueous phase is a hydrogel, and the oil phase is emulsified and dispersed in the aqueous phase; the active ingredients comprise menthol and oil-soluble ingredients, the menthol is dissolved in the aqueous phase, and the oil-soluble ingredients are dissolved in the oil phase.

Description

Technical Field

[0001] This invention relates to a topical formulation comprising menthol, and more particularly to a gel patch. Background Technology

[0002] Menthol, also known as peppermint, is a terpenoid organic compound. It is a white crystalline substance extracted from the leaves and stems of peppermint and is the main component of peppermint and spearmint essential oils. Externally, it is used for local analgesia, itch relief, headache, dizziness, and insect bites. Nasal drops are used for nasal congestion caused by colds. Due to its cooling effect, it can be used in soothing cold compresses to lower body temperature, constrict blood vessels, and reduce internal bleeding and swelling.

[0003] However, a cooling effect alone is insufficient to address the progression of sports injuries. After a certain period of application, as bleeding stops, further anti-inflammatory, analgesic, and blood circulation-promoting effects are needed. Therefore, a menthol-based compound topical formulation is required that can simultaneously provide the immediate cooling effect of the patch and sustained anti-inflammatory, analgesic, and blood-circulation-promoting effects.

[0004] Gel patches, also known as poultices, have a higher drug loading capacity and stronger ability to carry water-soluble and low-ionic-strength components compared to other topical patches. They also have a higher water content and no allergic reactions or irritation. They are widely used in the treatment of sports injuries. Because of their high drug loading capacity and high water content, they can be applied for a longer period of time. In light of the aforementioned issues, a menthol-based composite gel patch that can provide both immediate cooling and sustained anti-inflammatory, analgesic, and blood-activating effects has become a pressing problem to be solved in the existing technology. Summary of the Invention

[0005] To solve the above-mentioned technical problems, the technical solution provided by the present invention is as follows:

[0006] The menthol composite gel patch consists of a backing layer, a drug reservoir, and a protective layer. The drug reservoir includes an aqueous phase, an oil phase, and active ingredients. The aqueous phase is a hydrogel, and the oil phase is emulsified and dispersed in the aqueous phase. The active ingredients include menthol and an oil-soluble component. The menthol is soluble in the aqueous phase, and the oil-soluble component is soluble in the oil phase.

[0007] The menthol accounts for 0.1% to 1% of the weight of the drug storage, preferably 0.2% to 0.5%.

[0008] The oil-soluble component is selected from at least one of the following: Panax notoginseng extract, Carthamus tinctorius extract, Panax notoginseng extract, Angelica sinensis extract, Spatholobus suberectus extract, Boswellia carterii, and Commiphora myrrha. The oil-soluble component accounts for 1% to 3% of the total weight of the drug.

[0009] The oil phase component accounts for 15-25% of the weight of the drug reservoir. The oil phase component is a vegetable oil selected from soybean oil, castor oil, sesame oil, rapeseed oil, flaxseed oil, and perilla seed oil. The oil-soluble components are dispersed in the oil phase.

[0010] The aqueous phase consists of 5-10% sodium polyacrylate, 20-40% humectant, 0.5%-1% carbomer 943, 0.5%-2% hydroxypropyl methylcellulose (HPMC), 0.2%-0.4% aluminum hydroxypropyl methylcellulose, accounting for 1-3% of the drug's weight, and the remainder water. The aqueous phase forms a hydrogel, the filler is dispersed and filled in the hydrogel, and the oil phase is emulsified and dispersed in the hydrogel to form a drug reservoir.

[0011] The sodium polyvinyl chloride used for partial neutralization is preferably NP700; the humectant is glycerol; and the filler is preferably kaolin.

[0012] The menthol composite gel patch provided by this invention dissolves menthol in the aqueous phase to form a hydrogel, and dissolves the oil-soluble components of traditional Chinese medicine or its extracts, which have the effects of promoting blood circulation, warming, and reducing inflammation, in the oil phase. The oil phase components are then emulsified and dispersed in the hydrogel to form a drug reservoir. Thus, the cooling and analgesic effects of menthol can be exerted during application, and the blood-activating, anti-inflammatory, and analgesic effects of the oil phase components can be exerted during long-term continuous application. Detailed Implementation

[0013] The menthol composite plaster in this embodiment of the invention is prepared according to the following method:

[0014] 1) Oil phase components: Heat vegetable oil to 50-70℃, add oil-soluble components, and stir to disperse to obtain oil phase liquid (1);

[0015] 2) Preparation of drug storage: Neutralized sodium polyacrylate, glycerol, carbomer 943 hydroxypropyl methylcellulose and aluminum hydroxide are dispersed in water to obtain hydrogel. The hydrogel is heated to 50-70°C and then an oil phase liquid (1) at 50-70°C is added while stirring with a homogenizer. After the oil phase is added, the filler is added and stirred evenly. After standing and vacuum degassing, a paste-like drug storage is obtained.

[0016] 3) Apply the drug reservoir to the backing layer and attach a protective layer to the upper surface. This yields a menthol composite gel patch.

[0017] The weight percentage prescriptions (drug reservoirs) for Examples 1 to 6 are as follows:

[0018] In all embodiments, the neutralizing sodium polyacrylate was NP700 (manufactured by Showa Denko kk), the humectant was glycerol, the filler was 2% kaolin, and the vegetable oil was soybean oil.

[0019]

[0020] The gel patches obtained in Examples 1-6 were examined and found to have a smooth and uniform appearance, and a smooth drug storage paste. The formability, paste content, initial tack, adhesion and film residue all met the requirements.

Claims

1. A menthol complex gel patch consisting of a backing layer, a drug reservoir and a protective layer, characterized in that The drug reservoir comprises an aqueous phase, an oil phase, and active ingredients. The aqueous phase is a hydrogel, and the oil phase is emulsified and dispersed in the aqueous phase. The active ingredients include menthol and oil-soluble components. Menthol is soluble in the aqueous phase, and the oil-soluble components are soluble in the oil phase.

2. The menthol composite gel patch as described in claim 1, characterized in that: The menthol constitutes 0.1% to 1% of the weight of the drug storage container; The oil-soluble component is selected from at least one of the following: Panax notoginseng extract, Carthamus tinctorius extract, Panax notoginseng extract, Angelica sinensis extract, Spatholobus suberectus extract, Boswellia carterii, and Commiphora myrrha. The oil-soluble component accounts for 1% to 3% of the total weight of the drug. The oil phase component accounts for 15-25% of the weight of the drug reservoir. The oil phase component is a vegetable oil selected from soybean oil, castor oil, sesame oil, rapeseed oil, flaxseed oil, and perilla seed oil. The oil-soluble components are dispersed in the oil phase. The aqueous phase consists of 5-10% sodium polyacrylate, 20-40% humectant, 0.5%-1% carbomer 943, 0.5%-2% hydroxypropyl methylcellulose (HPMC), 0.2%-0.4% aluminum hydroxypropyl methylcellulose, accounting for 1-3% of the drug's weight, and the remainder water. The aqueous phase forms a hydrogel, the filler is dispersed and filled in the hydrogel, and the oil phase is emulsified and dispersed in the hydrogel to form a drug reservoir.

3. The menthol composite gel patch as described in claim 3, characterized in that: The menthol accounts for 0.2% to 0.5% of the weight of the drug storage.

4. The menthol composite gel patch as described in claim 2 or 3, characterized in that... The neutralized sodium polyvinyl acetate is NP700; the humectant is glycerol; and the filler is kaolin.

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