Traditional Chinese medicine for relieving itching and diminishing swelling

Abstract

The invention provides a traditional Chinese medicine for relieving itching and diminishing swelling, and relates to the technical field of biological medicine, the traditional Chinese medicine comprises the following components by mass percentage: self-made vinegar accounting for 50%-75% of the total mass of the traditional Chinese medicine, the self-made vinegar is prepared by cooking and saccharifying glutinous rice and polished round-grained rice according to a mass ratio of 1: 1, and fermenting at 6-8 DEG C for 1-2 months; the Chinese herbal medicine semen accounts for 20-45% of the total mass of the traditional Chinese medicines, and the Chinese herbal medicine semen is obtained by mixing a Chinese herbal medicine extracting solution extracted from lysimachia christinae hance and phyllanthus urinaria according to the mass ratio of 1: 1 with honey according to the mass ratio of 4: 1; the skin penetration enhancer accounts for 0.1%-0.3% of the total mass of the traditional Chinese medicine, and the penetration enhancer is a saponin extract; and the acid-base buffer system accounts for 0.1-0.5% of the total mass of the traditional Chinese medicines. The traditional Chinese medicine for relieving itching and diminishing swelling is based on self-made fermented vinegar, Chinese herbal medicine extracts, honey enzymatic hydrolysate and skin permeation enhancing components, a composite, mild and efficient natural external preparation is constructed, and the traditional Chinese medicine can effectively relieve pruritus, inhibit skin inflammation response and promote skin barrier repair.

Description

Technical Field

[0001] The present invention relates to the field of biological medicine technology, and particularly relates to an antipruritic and detumescent traditional Chinese medicine for relieving skin itching and eliminating swelling reaction, and a preparation method thereof, which is applicable to the external treatment of symptoms such as mosquito bites, mild allergies, skin itching and inflammation. Background Art

[0002] In traditional Chinese medicine external treatment methods, it has a long history of using natural herbs or fermentation products to treat skin itching and redness reactions. However, although existing antipruritic external traditional Chinese patent medicines or chemical drugs (such as calamine lotion, antihistamine preparations) can relieve symptoms, they have deficiencies such as skin dryness, strong irritation, single component or strong dependence after use. In addition, the curative effects of some natural medicine preparations are unstable, the component extraction methods are traditional and extensive, and the active pharmaceutical ingredients are not fully released, resulting in slow action or limited effects. Therefore, it is of great clinical significance and industrial value to develop a natural antipruritic and detumescent traditional Chinese medicine with multi-component synergy, full release of component activity, and adaptation to the skin acid-base environment. Summary of the Invention

[0003] The purpose of the present invention is to provide an antipruritic and detumescent traditional Chinese medicine, which constructs a compound and mild and highly efficient natural external preparation based on self-made fermented vinegar, Chinese herbal medicine extract, honey enzymatic hydrolysate and skin penetration enhancer components, and can effectively relieve itching, inhibit skin inflammatory reactions and promote skin barrier repair.

[0004] The above technical purpose of the present invention is achieved through the following technical solutions: An antipruritic and detumescent traditional Chinese medicine, comprising the following components in mass percentage: Self-made vinegar, accounting for 50% - 75% of the total mass of the traditional Chinese medicine, and the self-made vinegar is obtained by steaming and saccharifying glutinous rice and japonica rice in a mass ratio of 1:1, and fermenting at 6°C - 8°C for 1 - 2 months; Chinese herbal medicine semen, accounting for 20% - 45% of the total mass of the traditional Chinese medicine, and the Chinese herbal medicine semen is obtained by mixing a Chinese herbal medicine extract obtained by extracting Lysimachia christinae Hance and Phyllanthus niruri Linn in a mass ratio of 1:1 with honey in a mass ratio of 4:1; Skin penetration enhancer, accounting for 0.1% - 0.3% of the total mass of the traditional Chinese medicine, and the penetration enhancer is a saponin extract; Acid-base buffer system, accounting for 0.1% - 0.5% of the total mass of the traditional Chinese medicine, and the acid-base buffer system is composed of sodium citrate and sodium lactate in a mass ratio of 1:1, and is used to adjust the pH value of the traditional Chinese medicine to 4.5 - 5.5.

[0005] In some embodiments, the Chinese herbal medicine extract is obtained by a two-stage temperature difference extraction method, and the method includes the following steps: a) Decoct the mixture of Lysimachia christinae Hance and Phyllanthus niruri Linn at 95°C for 30 minutes to extract fat-soluble components; b) Cool the obtained decoction to 70 °C and continue extraction for 60 minutes to extract water-soluble polysaccharides and flavonoid components; c) Subject the extract to chromatography separation and retain the middle fraction for mixing with honey.

[0006] In some embodiments, the honey is honey gum treated with a composite enzyme, the composite enzyme is dextranase and fructase, their mass ratio is 1:1, the treatment conditions are treatment at 40 °C ± 2 °C for 15 ± 2 minutes, and the enzyme dosage is 5% - 10% of the mass of the honey.

[0007] In some embodiments, the saponin extract is derived from Bupleurum chinense, Glycyrrhiza uralensis or Gleditsia sinensis fruits.

[0008] In some embodiments, in the acid-base buffer system, the mass fractions of sodium citrate and sodium lactate are both 0.15%.

[0009] In some embodiments, this antipruritic and detumescent traditional Chinese medicine can be further prepared into any of the following dosage forms: a) Freeze-dried powder dosage form: Quick-freeze the traditional Chinese medicine below -40 °C and perform vacuum drying for more than 12 hours; b) Soluble patch-type plaster: Mix the traditional Chinese medicine with edible gelatin and glycerol according to a mass ratio of 10:3:2, and stir evenly to form a patch.

[0010] In some embodiments, the gelatin is medicinal gelatin with a viscosity ≥ 200 Bloom, the glycerol is pharmaceutical grade, the patch is formed by a film-forming device at 25 °C - 35 °C, and the thickness is 0.3 - 0.6 mm.

[0011] Compared with the prior art, the beneficial effects of the present invention are: The components of the traditional Chinese medicine formula of the present invention are derived from nature and have high safety. It combines the active vinegar fermentation broth, plant extracts and honey enzymatic hydrolysis products, which can act synergistically to provide good anti-inflammatory, anti-allergic and antipruritic effects. The saponin components are used to enhance skin permeability, and the buffer system adjusts the pH value to adapt to the skin barrier function. The patch or freeze-dried dosage form is convenient for storage and use. It can significantly relieve swelling, itching and local inflammatory reactions through pre-clinical observations, and has good application prospects. Brief Description of the Drawings

[0012] Figure 1 It is the preparation flow chart of the traditional Chinese medicine of the present invention. Detailed Description of the Embodiments

[0013] The present invention aims to prepare a traditional Chinese medicine with good antipruritic and detumescent effects, which is achieved through the synergistic effect of self-made vinegar, Chinese herbal medicine semen (containing extracts of Lysimachia christinae and Phyllanthus niruri) and honey gum treated with a composite enzyme. The following describes in detail its ingredient ratios, preparation processes through specific examples, and sets up a control group and experimental data to highlight the advantages of this combination.

[0014] This embodiment aims to verify the anti-itching and swelling-reducing effects of self-made vinegar, Chinese herbal medicine semen (containing extracts of Lysimachia christinae and Phyllanthus niruri, using a two-stage temperature difference extraction method), and honey glue treated with composite enzymes, and to deeply explore the promoting effects of skin penetration enhancers (saponin extracts) and acid-base buffer systems (sodium citrate and sodium lactate) on anti-itching and swelling reduction. By setting up multiple control groups, the specific contributions of each technical feature in the process of anti-itching and swelling reduction are clarified.

[0015] (I) Experimental Materials and Methods 1) Experimental Materials Self-made vinegar: Prepared through a low-temperature anaerobic fermentation process, with the pH precisely adjusted to 3.1 - 3.3 to maintain the stability of its antibacterial and anti-inflammatory active ingredients. Components such as acetic acid in self-made vinegar can effectively inhibit the reproduction of bacteria on the skin surface, reducing the risk of infection. It can also regulate the skin pH value, inhibit the release of inflammatory mediators, and relieve redness and itching.

[0016] Chinese herbal medicine raw materials: Lysimachia christinae and Phyllanthus niruri are carefully selected and mixed in a mass ratio of 1:1 to ensure the balanced efficacy components of the raw materials. Lysimachia christinae has the effect of clearing heat and detoxifying, and can relieve skin itching and redness symptoms caused by heat toxin. It has a certain anti-inflammatory and anti-itching effect on some skin inflammations caused by bacterial infections, such as eczema and dermatitis. Lysimachia christinae contains various active ingredients and has a certain antibacterial and anti-inflammatory effect, which can inhibit the growth and reproduction of bacteria and reduce the risk of skin infection. Phyllanthus niruri contains certain volatile oils and alkaloids, which can repel mosquitoes and relieve skin itching. Therefore, Phyllanthus niruri may have a more direct effect on anti-itching, especially for discomfort caused by mosquito bites or skin allergies.

[0017] Honey: High-quality natural honey is selected as a natural moisturizer and binder to enhance the adhesiveness and moisturizing property of the preparation.

[0018] Composite enzyme: Composed of dextranase and fructase mixed in a mass ratio of 1:1, used to optimize the enzymatic hydrolysis process of honey and enhance its biological activity.

[0019] Saponin extract: As a skin penetration enhancer, saponin extract can significantly increase the skin penetration of drug components and improve the drug efficacy. And saponin itself has a certain anti-inflammatory effect, which acts synergistically with other components in the drug to enhance the overall anti-inflammatory effect.

[0020] Acid-base buffer system: Composed of sodium citrate and sodium lactate mixed in a mass ratio of 1:1, used to adjust the pH value of the preparation, reduce skin irritation, and enhance drug stability. The acid-base buffer system can maintain the pH value of the preparation within an appropriate range, reduce skin irritation, and improve patient comfort. It can also prevent the inactivation or degradation of drug components due to pH value changes, ensuring the long-term stability of the preparation.

[0021] Experimental animals: 120 SPF-grade Kunming mice, with an equal number of males and females, to ensure the reliability of experimental results.

[0022] Inducer: A mixture of 0.5% dichlorobenzene and 0.1% formalin, used to induce an acute contact dermatitis model in mice.

[0023] 2) Detailed description of the preparation process of the spray a. Preparation of self-made vinegar Using low-temperature anaerobic fermentation technology, precisely controlling the fermentation temperature and time to ensure the generation and accumulation of active ingredients (such as acetic acid, amino acids, etc.) in the vinegar. After fermentation, through precision filtration and pH adjustment, the pH value of the vinegar is stabilized at 3.1 - 3.3 to maintain its best antibacterial and anti-inflammatory activities.

[0024] b. Preparation of Chinese herbal medicine extract (including two-stage temperature difference extraction method) The first stage (high-temperature extraction): Place the Chinese herbal medicine raw materials in a 95°C water bath and heat-extract for 30 minutes to mainly extract fat-soluble components and some water-soluble components with good thermal stability.

[0025] The second stage (low-temperature extraction): Cool the extract to 70°C and continue to extract for 60 minutes to fully extract water-soluble components and avoid the destruction of heat-sensitive components by high temperature.

[0026] Combine the extracts: Combine the extracts from the two stages and remove impurities through fine filtration to obtain the Chinese herbal medicine extract.

[0027] In the above method, fat-soluble components are extracted at high temperature and water-soluble components are extracted at low temperature, which can ensure the full extraction of various active ingredients in Chinese herbal medicine. And it can also avoid the destruction of heat-sensitive components by continuous high-temperature extraction and retain their biological activities.

[0028] c. Honey treatment (complex enzyme treatment) Mix honey with a complex enzyme at a mass ratio of 8% and place it in a 40°C water bath for enzymatic hydrolysis for 15 minutes to decompose macromolecular substances in honey into small molecules, improving its biological activity and solubility. After enzymatic hydrolysis, inactivate the enzyme activity by heating to obtain enzymatically hydrolyzed honey glue. Enzymatic hydrolysis decomposes macromolecular substances in honey into small molecules, improving its biological activity and solubility. And after mixing enzymatically hydrolyzed honey glue with the Chinese herbal medicine extract, a more stable system is formed, enhancing the adhesion and moisturizing properties of the preparation.

[0029] d. Preparation of the spray Experimental group: Composition: 68.0% self-made vinegar, 30.5% Chinese herbal medicine extract (a mixture of Chinese herbal medicine extract prepared by the two-stage temperature difference extraction method and enzymatically hydrolyzed honey glue), 0.2% saponin extract, 0.3% acid-base buffer system; Preparation: Mix in proportion, degas by ultrasound, filter, and fill.

[0030] Control Group 1 (lacking self-made vinegar): Composition: 30.5% Chinese herbal medicine semen, honey glue treated with compound enzyme, 0.2% saponin extract, 0.3% acid-base buffer system, and the balance is made up with distilled water; Preparation: The same as the experimental group.

[0031] Control Group 2 (the two-stage temperature difference extraction method is not used for Chinese herbal medicine semen): Composition: 68.0% self-made vinegar, 30.5% Chinese herbal medicine semen (prepared by conventional extraction method), honey glue treated with compound enzyme, 0.2% saponin extract, 0.3% acid-base buffer system; Preparation: The same as the experimental group.

[0032] Control Group 3 (honey glue is not treated with compound enzyme): Composition: 68.0% self-made vinegar, 30.5% Chinese herbal medicine semen (a mixture of Chinese herbal medicine extract prepared by the two-stage temperature difference extraction method and honey glue without enzymatic hydrolysis), 0.2% saponin extract, 0.3% acid-base buffer system; Preparation: The same as the experimental group.

[0033] Control Group 4 (saponin extract is not added): Composition: 68.0% self-made vinegar, 30.5% Chinese herbal medicine semen (a mixture of Chinese herbal medicine extract prepared by the two-stage temperature difference extraction method and enzymatically hydrolyzed honey glue), 0.3% acid-base buffer system; Preparation: The same as the experimental group.

[0034] Control Group 5 (acid-base buffer system is not added): Composition: 68.0% self-made vinegar, 30.5% Chinese herbal medicine semen (a mixture of Chinese herbal medicine extract prepared by the two-stage temperature difference extraction method and enzymatically hydrolyzed honey glue), 0.2% saponin extract; Preparation: The same as the experimental group.

[0035] 3) Modeling: After shaving the back of the mice, apply a mixture of 0.5% dichlorobenzene and 0.1% formalin to induce an acute contact dermatitis model.

[0036] Grouping and treatment: Randomly divide the mice into 6 groups (n = 20), and spray the corresponding traditional Chinese medicine spray 2 times a day, about 0.2 mL each time, to ensure that the drug evenly covers the affected area.

[0037] Observation indicators: Record the swelling area, itching behavior (scratching frequency within 30 minutes), epidermal temperature, and healing time (the time when the erythema subsides and the scab falls off).

[0038] (II) Experimental results and analysis 1) Changes in the area of redness and swelling 2) Changes in itching behavior 3) Changes in epidermal temperature 4) Healing time Through systematic experimental studies on the traditional Chinese medicine for relieving itching and reducing swelling of the present invention, and setting up multiple control groups for comparative analysis, the following experimental conclusions were obtained: a. The core role of self-made vinegar in the itching and swelling relieving spray: Experimental data showed that the redness and swelling subsidence rate of the experimental group (including self-made vinegar) reached 83.3%, significantly higher than 66.1% of the control group 1 (lacking self-made vinegar).

[0039] The scratching frequency reduction rate of the experimental group was 88.9%, also higher than 77.3% of the control group 1.

[0040] The epidermal temperature reduction rate of the experimental group was 6.7%, also higher than 5.1% of the control group 1.

[0041] The average healing time of the experimental group was 4.2 ± 0.5 days, significantly shorter than 5.5 ± 0.6 days of the control group 1.

[0042] These data fully demonstrated that self-made vinegar played a crucial role in the itching and swelling relieving spray. Components such as acetic acid contained in it could effectively inhibit the reproduction of bacteria on the skin surface, regulate the skin pH value, inhibit the release of inflammatory mediators, thus significantly reducing the symptoms of redness and itching.

[0043] b. The promoting effect of the two-stage temperature difference extraction method on the extraction of effective components of Chinese herbal medicines and the itching and swelling relieving effect: The effect of the experimental group was better than that of the control group 2 (the semen of Chinese herbal medicines was not extracted by the two-stage temperature difference extraction method). Indicators such as the redness and swelling subsidence rate, scratching frequency reduction rate, epidermal temperature reduction rate, and healing time all showed that the two-stage temperature difference extraction method could extract the effective components in Chinese herbal medicines more fully and improve the itching and swelling relieving effect of the preparation.

[0044] Lipid-soluble components were extracted at high temperature, and water-soluble components were extracted at low temperature. This extraction method ensured the full extraction of various effective components in Chinese herbal medicines, and at the same time avoided the destruction of thermosensitive components by continuous high-temperature extraction and retained their biological activities.

[0045] c. The enhancement of the synergistic effect between honey glue and the extract of Chinese herbal medicines by composite enzyme treatment: The experimental group had better effects than the control group 3 (honey glue without complex enzyme treatment), indicating that complex enzyme treatment can enhance the synergistic effect between honey glue and Chinese herbal medicine extract.

[0046] Complex enzyme treatment decomposes macromolecular substances in honey into small molecules, improving its biological activity and solubility. After mixing with Chinese herbal medicine extract, it forms a more stable system, enhancing the adhesion and moisturizing properties of the preparation, thus improving the antipruritic and detumescence effects.

[0047] d. Promoting effect of saponin extract as a skin penetration enhancer on antipruritic and detumescence effects: The experimental group had better effects than the control group 4 (without adding saponin extract), verifying the importance of saponin extract as a skin penetration enhancer.

[0048] Saponin extract can significantly increase the skin penetration of drug components, improve drug efficacy, and saponin itself has certain anti-inflammatory effects. Acting synergistically with other components in the drug, it enhances the overall anti-inflammatory effect.

[0049] e. Important role of the acid-base buffer system in regulating the pH value of the spray, reducing skin irritation, and maintaining drug stability: The experimental group had better effects than the control group 5 (without adding the acid-base buffer system), indicating that the acid-base buffer system plays an important role in regulating the pH value of the spray, reducing skin irritation, and maintaining drug stability.

[0050] The acid-base buffer system can maintain the pH value of the preparation within an appropriate range, reduce skin irritation, improve patient comfort, and prevent the inactivation or degradation of drug components due to pH value changes, ensuring the long-term stability of the preparation.

[0051] In summary, the antipruritic and detumescent traditional Chinese medicine of the present invention achieves good antipruritic and detumescence effects through the synergistic effects of self-made vinegar, Chinese herbal medicine semen (including the mixture of Chinese herbal medicine extract prepared by the two-stage temperature difference extraction method and enzymolyzed honey glue), saponin extract, and acid-base buffer system. The experimental data fully prove the important roles of each component in the preparation and their synergistic effects with each other.

[0052] (III) To further verify the anti-tinea effect of the traditional Chinese medicine of the present invention on the basis of antipruritic and detumescence, this example conducted an extended experiment on the spray for skin tinea diseases (such as tinea corporis, tinea cruris, etc.) caused by fungal infections: 1) Establishment of the experimental model Sixty SPF-grade Kunming mice were selected. After shaving the hair on their backs, Trichophyton rubrum was used for inoculation to induce skin surface fungal infections and form a tinea model.

[0053] 2) Treatment method The model mice were divided into an experimental group and a control group (n = 30). The experimental group was administered the spray of the present invention 2 times a day, and the control group was administered normal saline. The observation period was 7 days.

[0054] 3) Observation indicators Change in the area of infection plaques Epidermal desquamation and scale thickness Fungal positive rate (by microscopic examination of dandruff) 4) Experimental results On the 5th day, the average area of the skin lesion area in the experimental group decreased by 72.6%. On the 7th day, the fungal positive rate detected by microscopic examination decreased to 13.3%, while the positive rate in the control group was still as high as 73.3%. The epidermis of the experimental group recovered to be smooth, and the scales were significantly reduced, indicating that the spray of the present invention has significant anti - psoriasis ability.

[0055] 5) Analysis of the mechanism of action The combined extract of Lysimachia christinae and Phyllanthus niruri contains flavonoids, phenols and alkaloid components, which have antibacterial and antifungal effects; the organic acids in the self - made vinegar can regulate the acid - base environment of the affected area and inhibit the reproduction of fungi; the saponin penetrant helps the active ingredients to penetrate deep into the stratum corneum of the skin, thus effectively inhibiting skin fungal infections and psoriasis symptoms.

[0056] Thus, it can be seen that the antipruritic and detumescent traditional Chinese medicine of the present invention also shows significant curative effects in the treatment of psoriasis. Compared with the control group, the skin lesion area in the experimental group significantly decreased on the 5th day, the fungal positive rate significantly decreased on the 7th day, and at the same time, epidermal desquamation decreased and the skin texture recovered well, showing good antifungal and skin repair effects. Combining the broad - spectrum antibacterial characteristics of Lysimachia christinae and Phyllanthus niruri, the acidic antibacterial environment of the self - made vinegar and the penetration synergistic effect of the saponin component, this traditional Chinese medicine preparation can not only relieve itching and reduce swelling, but also be effectively used to treat psoriasis - like diseases caused by fungal infections.

[0057] This specific embodiment is only an explanation of the present invention, and it is not a limitation of the present invention. After reading this specification, those skilled in the art can make modifications to this embodiment without creative contributions as needed, but as long as it is within the scope of the claims of the present invention, it is protected by the patent law.

Claims

1. A traditional Chinese medicine for relieving itching and reducing swelling, characterized in that, Comprising components with the following mass percentages: Self-made vinegar, accounting for 50% - 75% of the total mass of traditional Chinese medicine. The self-made vinegar is obtained by steaming and saccharifying glutinous rice and polished rice in a mass ratio of 1:1, and then fermenting at 6°C - 8°C for 1 - 2 months. Chinese herbal medicine semen, accounting for 20% - 45% of the total mass of traditional Chinese medicine. The Chinese herbal medicine semen is obtained by mixing the Chinese herbal medicine extract extracted from Lysimachia christinae Hance and Phyllanthus urinaria L. in a mass ratio of 1:1 with honey in a mass ratio of 4:

1. Skin penetration enhancer, accounting for 0.1% - 0.3% of the total mass of traditional Chinese medicine. The penetration enhancer is a saponin extract. Acid-base buffer system, accounting for 0.1% - 0.5% of the total mass of traditional Chinese medicine. The acid-base buffer system is composed of sodium citrate and sodium lactate in a mass ratio of 1:1, and is used to adjust the pH value of the traditional Chinese medicine to 4.5 - 5.

5.

2. The anti-itching and swelling-reducing traditional Chinese medicine according to claim 1, characterized in that, The Chinese herbal medicine extract is prepared by a two-stage temperature difference extraction method, and the method includes the following steps: a) Decoct the mixture of Lysimachia christinae Hance and Phyllanthus urinaria L. at 95°C for 30 minutes to extract fat-soluble components. b) Cool the obtained decoction to 70°C and continue to extract for 60 minutes to extract water-soluble polysaccharides and flavonoid components. c) Separate the extract by chromatography and retain the middle fraction for mixing with honey.

3. The anti-itching and swelling-reducing traditional Chinese medicine according to claim 1, wherein, The honey is honey gum treated with a composite enzyme. The composite enzyme is dextranase and fructase, and their mass ratio is 1:

1. The treatment conditions are to treat at 40°C ± 2°C for 15 ± 2 minutes, and the enzyme dosage is 5% - 10% of the mass of honey.

4. The anti-itching and swelling-reducing traditional Chinese medicine according to claim 1, characterized in that, The saponin extract is derived from Bupleurum chinense DC., Glycyrrhiza uralensis Fisch. or Gleditsia sinensis Lam. fruit.

5. A traditional Chinese medicine for relieving itching and reducing swelling according to claim 1, characterized in that, In the acid-base buffer system, the mass fraction of each of sodium citrate and sodium lactate is 0.15%.

6. The anti-itching and swelling-reducing traditional Chinese medicine according to claim 1, wherein This antipruritic and detumescent traditional Chinese medicine can be further made into any of the following dosage forms: a) Freeze-dried powder dosage form: Quick-freeze the traditional Chinese medicine below -40°C and conduct vacuum drying for more than 12 hours. b) Soluble patch-type plaster: Mix the traditional Chinese medicine with edible gelatin and glycerin in a mass ratio of 10:3:2, and stir evenly to form a patch.

7. The anti-itching and swelling-reducing traditional Chinese medicine according to claim 6, characterized in that, The gelatin is pharmaceutical gelatin with a viscosity ≥ 200 Bloom, and the glycerin is medical grade. The patch is formed by a film-forming device at 25°C - 35°C, and the thickness is 0.3 - 0.6 mm.

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