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CN-121971497-A - Triamcinolone acetonide econazole cream for promoting barrier repair and preparation method thereof

CN121971497ACN 121971497 ACN121971497 ACN 121971497ACN-121971497-A

Abstract

The invention relates to triamcinolone acetonide econazole cream for promoting barrier repair and a preparation method thereof. The invention creatively introduces the brown algae extract rich in fucan, so that the triamcinolone acetonide econazole cream can effectively relieve local adverse reaction risks such as skin atrophy and telangiectasia caused by triamcinolone acetonide while maintaining the original anti-inflammatory and antifungal effects, inhibit the generation of fungal drug resistance and obviously enhance the barrier repair and moisturizing capability of the skin. In addition, the red algae extract is introduced into the cream formula to play a synergistic effect with the brown algae extract, so that the local adverse reaction is further relieved, the fungal drug resistance is inhibited, and the barrier repair and moisturizing capability of the skin are enhanced.

Inventors

  • CAI BEILEI
  • PAN YI
  • AUM sambaji shelk

Assignees

  • 江苏知原药业股份有限公司

Dates

Publication Date
20260505
Application Date
20260228

Claims (10)

  1. 1. The triamcinolone acetonide and econazole cream for promoting barrier repair is characterized by comprising, by weight, 0.9-1.1 parts of triamcinolone acetonide, 9-11 parts of econazole nitrate, 3-6 parts of brown algae extract, 129-151 parts of oil phase matrix, 55-65 parts of emulsifying agent, 140-150 parts of humectant, 1-2 parts of preservative, 0.4-0.6 part of chelating agent, 0.4-0.6 part of antioxidant and 600-650 parts of purified water.
  2. 2. The triamcinolone acetonide econazole cream according to claim 1, wherein the brown algae extract comprises one of a Ascophyllum nodosum extract, a Fucus vesiculosus extract and a kelp extract, wherein the mass percentage content of fucans is not less than 20%.
  3. 3. The triamcinolone acetonide econazole cream according to claim 1, wherein the oil phase base comprises the following components, by weight, 9-11 parts of white vaseline, 65-75 parts of cetostearyl alcohol, and 55-65 parts of light liquid paraffin.
  4. 4. The triamcinolone acetonide econazole cream of claim 1, wherein the emulsifier comprises polyoxyl stearate and the humectant comprises glycerin.
  5. 5. The triamcinolone acetonide econazole cream according to claim 1, wherein the preservative comprises one of ethyl hydroxybenzoate and benzoic acid, the chelating agent comprises disodium edetate, and the antioxidant comprises dibutyl hydroxytoluene.
  6. 6. The triamcinolone acetonide econazole cream according to claim 1, further comprising red algae extract, the red algae extract comprises one of Eucheuma Gelatinosum extract, carrageenan extract and herba Gei Alopecuroidis extract.
  7. 7. The triamcinolone acetonide and econazole cream according to claim 6, wherein the triamcinolone acetonide and econazole cream comprises, by weight, 0.9-1.1 parts of triamcinolone acetonide, 9-11 parts of econazole nitrate, 3-6 parts of brown algae extract, 1-4 parts of red algae extract, 129-151 parts of oil phase matrix, 55-65 parts of emulsifier, 140-150 parts of humectant, 1-2 parts of preservative, 0.4-0.6 parts of chelating agent, 0.4-0.6 parts of antioxidant, and 600-650 parts of purified water.
  8. 8. The triamcinolone acetonide econazole cream according to claim 7, wherein the triamcinolone acetonide econazole cream comprises, by weight, 1 part of triamcinolone acetonide, 10 parts of econazole nitrate, 3 parts of brown algae extract, 2 parts of red algae extract, 10 parts of white vaseline, 70 parts of cetostearyl alcohol, 60 parts of light liquid paraffin, 59 parts of polyoxyl stearate, 145 parts of glycerin, 2 parts of benzoic acid, 0.5 part of disodium edetate, 0.5 part of dibutylhydroxytoluene, and 630 parts of purified water.
  9. 9. A process for preparing a triamcinolone acetonide econazole cream according to any one of claims 1 to 8, comprising the steps of: s1, preparing an oil phase, namely mixing an oil phase matrix, an emulsifier and an antioxidant, heating and melting, uniformly stirring, and preserving heat for later use; S2, preparing an aqueous phase, namely mixing purified water, a humectant, an brown algae extract, a red algae extract, a preservative and a chelating agent, heating for dissolving, uniformly stirring, and preserving heat for later use; s3, emulsifying, namely slowly adding the oil phase in the step S1 into the water phase in the step S2 under stirring, and shearing and emulsifying to form colostrum; s4, adding triamcinolone acetonide and econazole nitrate after the colostrum is cooled, and continuously stirring until uniformity is achieved.
  10. 10. The preparation method according to claim 9, wherein in the step S1, the temperature of the heating and melting is 75-85 ℃; And/or in the step S2, the temperature of heating and dissolving is 70-80 ℃; and/or in the step S3, the temperature of the shearing emulsification is 70-80 ℃.

Description

Triamcinolone acetonide econazole cream for promoting barrier repair and preparation method thereof Technical Field The invention belongs to the technical field of biological medicines, and relates to triamcinolone acetonide econazole cream for promoting barrier repair and a preparation method thereof. Background The triamcinolone acetonide and econazole nitrate cream is a compound external preparation consisting of the glucocorticoid triamcinolone acetonide and the imidazole antifungal drug econazole nitrate, and is widely used for treating dermatitis and eczema accompanied with fungal infection or having a tendency to fungal infection and inflammatory dermatomycosis caused by dermatophytes, saccharomycetes and moulds clinically. The compound combines the anti-inflammatory and antipruritic effects of triamcinolone acetonide and the broad-spectrum antifungal activity of econazole nitrate, and has synergistic treatment effect. However, the existing triamcinolone acetonide and econazole cream products have obvious clinical disadvantages in that the first, long-term or improper use of the glucocorticoid triamcinolone acetonide may cause local adverse reactions including skin atrophy, telangiectasia, pigmentation, secondary infections, etc. Second, the long-term use of econazole nitrate as a single antifungal ingredient risks inducing increased fungal resistance, especially limited effectiveness against certain fungal biofilms, affecting long-term efficacy. Third, existing formulations focus on anti-inflammatory and antifungal agents, and lack active repair capability for skin barrier damage that may be caused by disease or by the drug itself, leading to dry, fragile skin, affecting post-healing quality. The prior related studies have focused on improving the physical stability of the formulation, preventing discoloration, or increasing the transdermal rate of the drug. For example, patent CN113018252B discloses a triamcinolone acetonide econazole cream and a preparation method thereof, which improves the stability of the preparation and prevents discoloration by adding sodium dodecyl sulfate as an emulsifier, and patent CN105534993a discloses a triamcinolone acetonide econazole cream and a preparation method thereof, which solves the problem of product stability to a certain extent by adjusting the proportion of benzyl propionate, mannitol and sucrose stearate, and does not cause discoloration during the effective period. None of these solutions systematically improve the three core clinical drawbacks of local adverse reactions such as skin atrophy, risk of fungal resistance, and insufficient barrier repair capability. In the field of skin care product research, seaweed extracts, particularly seaweed extracts rich in sulfated polysaccharides such as fucan (Fucoidan), are widely reported to have excellent antioxidant, anti-aging and other multiple effects （Ji Hye Kim,Jae-Eun Lee,Kyoung Heon Kim,et.al.Beneficial Effects of Marine Algae-Derived Carbohydrates for Skin Health.2018 Nov 21;16(11):459. doi: 10.3390/md16110459）., however, how to use such natural active ingredients to solve the three above-mentioned drawbacks specific to triamcinolone acetonide econazole cream, namely how to synergistically reduce hormone side effects, delay fungal resistance and enhance barrier repair through formulation integration, has not been reported. Disclosure of Invention The invention provides triamcinolone acetonide econazole cream for promoting barrier repair and a preparation method thereof, and aims to overcome the defects of the existing triamcinolone acetonide econazole cream. The invention creatively introduces specific functional auxiliary materials (namely brown algae extract rich in sulfated polysaccharide such as fucan and the like), effectively relieves local adverse reaction risks such as skin atrophy and telangiectasis caused by triamcinolone acetonide, inhibits the generation of fungal drug resistance, and obviously enhances the barrier repair and moisturizing capability of the skin while maintaining the original anti-inflammatory and antifungal effects. In addition, the red algae extract is introduced into the cream formula to play a synergistic effect with the brown algae extract, so that the local adverse reaction is further relieved, the fungal drug resistance is inhibited, and the barrier repair and moisturizing capability of the skin are enhanced. The aim of the invention can be achieved by the following scheme: In a first aspect, the invention provides triamcinolone acetonide and econazole cream for promoting barrier repair, which comprises, by weight, 0.9-1.1 parts of triamcinolone acetonide, 9-11 parts of econazole nitrate, 3-6 parts of brown algae extract, 129-151 parts of oil phase matrix, 55-65 parts of emulsifying agent, 140-150 parts of humectant, 1-2 parts of preservative, 0.4-0.6 part of chelating agent, 0.4-0.6 part of antioxidant and 600-650 parts of purified water. As one embodiment of the inv