Preparation method of abelmoschus manihot composition external medicinal liquor for treating psoriasis

Abstract

The invention discloses a preparation method of abelmoschus manihot composition external medicinal liquor for treating psoriasis, and relates to the technical field of traditional Chinese medicine external preparations. Comprising the following steps: (1) raw material compatibility and pretreatment: taking 10-30 parts by mass of abelmoschus manihot, 5-15 parts by mass of processed pinellia ternate, 5-15 parts by mass of processed paris polyphylla, 5-15 parts by mass of rheum officinale, 5-15 parts by mass of tobacco stems, 5-15 parts by mass of senecio scandens, 3-10 parts by mass of nidus vespae, 5-15 parts by mass of cortex dictamni, 5-15 parts by mass of szechwan chinaberry fruit, 5-15 parts by mass of cocklebur fruit, 5-15 parts by mass of cortex lycii radicis, 5-15 parts by mass of fructus kochiae and 5-15 parts by mass of coptis chinensis. The ministerial drug processed rhizoma paridis relieves swelling and pain, the adjuvant processed rhizoma pinelliae eliminates dampness and phlegm, and the conductant drug borneol is transdermal and guides channels; the eighteen medicinal materials have a synergistic effect and have a treatment effect on multiple links such as inflammation, hyperplasia, pruritus and infection of the psoriasis; extracting effective components with different polarities by stages by adopting a gradient soaking extraction process; the clarity and the stability of the medicinal liquor are ensured by a multi-stage precise filtering system; the low-temperature treatment protects the activity of volatile components.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine external preparations, specifically a method for preparing a topical medicinal wine for treating psoriasis using a golden sunflower composition. Background Technology

[0002] Psoriasis is a common chronic relapsing inflammatory skin disease, typically characterized by erythema, scaling, and itching, severely impacting patients' quality of life. Currently, topical medications for psoriasis mainly include corticosteroids, vitamin D3 derivatives, and calcineurin inhibitors. While these medications have some efficacy, they suffer from the following problems: long-term use can easily lead to side effects such as skin atrophy and telangiectasia; relapse is common after discontinuation, and some patients develop drug resistance; efficacy is limited for certain types of psoriasis (such as pustular psoriasis); and they are expensive, placing a heavy financial burden on patients. Traditional Chinese medicine (TCM) has a long history of topical treatment for psoriasis, with medicated wine formulations offering advantages such as good transdermal absorption, direct action, and ease of use. However, existing TCM medicated wine formulations have the following shortcomings: simple formulas with limited therapeutic effects; crude preparation processes resulting in insufficient extraction of active ingredients; unstable quality with significant batch-to-batch variations; lack of systematic pharmacological research and clinical validation; and strong irritation leading to poor patient tolerance. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this invention provides a method for preparing a topical medicinal wine for treating psoriasis using a golden sunflower composition. This method solves the following problems with existing traditional Chinese medicine wines: single formula, limited therapeutic effect; crude preparation process, insufficient extraction of effective components; unstable quality, large batch-to-batch differences; lack of systematic pharmacological research and clinical validation; strong irritation, and poor patient tolerance.

[0004] To achieve the above objectives, the present invention provides the following technical solution: a method for preparing a topical medicinal wine for treating psoriasis using a golden hibiscus composition, comprising the following steps: (1) Raw material compatibility and pretreatment: Take 10-30 parts of golden hibiscus, 5-15 parts of processed pinellia, 5-15 parts of processed Paris polyphylla, 5-15 parts of rhubarb, 5-15 parts of tobacco stems, 5-15 parts of Senecio scandens, 3-10 parts of bee honeycomb, 5-15 parts of dictamnus dasycarpus, 5-15 parts of Melia toosendan fruit, 5-15 parts of Xanthium sibiricum, 5-15 parts of Lycium chinense root bark, 5-15 parts of Kochia scoparia fruit, 5-15 parts of Coptis chinensis, 5-15 parts of Phellodendron chinense, 5-15 parts of Scutellaria baicalensis, 5-15 parts of Spirodela polyrhiza, 1-5 parts of borneol, and 1-5 parts of camphor crystals according to the following mass proportions: After washing the medicinal materials, dry them at a low temperature of 40-50℃ until the moisture content is less than 8%; (2) Precision grinding: Mix the dried medicinal materials and grind them to a particle size of 50-80 mesh using ultra-micro grinding technology to obtain uniform medicinal material particles; (3) Raw material mixing: Mix the medicinal material granules with borneol and camphor crystals according to the ratio and put them into a ceramic container; (4) Gradient soaking extraction: Add sorghum liquor with an alcohol content of 60-65 degrees to the container. The mass ratio of medicinal materials to liquor is 1:3-1:4. After sealing, soak at 15-25℃ for 90-110 days. Stir once a day for the first 30 days, and let it stand for soaking for the next 60-80 days. (5) Multi-stage precision filtration: The soaked medicinal wine raw liquor is first coarsely filtered through a 100-200 mesh sieve, then finely filtered through a plate and frame filter press, and finally sterilized through a 0.45μm microporous filter membrane. (6) Scientific blending: Blend the filtered medicinal wine base with purified water at a volume ratio of 1:1 to 1:2, and adjust the alcohol content to 30-40 degrees. (7) Aseptic filling: The blended medicinal wine is filled into pre-sterilized brown glass bottles in a Class 100,000 clean environment and sealed with nitrogen. (8) Obtain the finished product of the Golden Sunflower Composition for external use in treating psoriasis.

[0005] Preferably, the mass fractions of the raw materials mentioned in step (1) are: 15-25 parts of golden sunflower, 8-12 parts of processed pinellia, 8-12 parts of processed Paris polyphylla, 8-12 parts of rhubarb, 8-12 parts of tobacco stems, 8-12 parts of Senecio scandens, 5-8 parts of bee honeycomb, 8-12 parts of dictamnus dasycarpus root bark, 8-12 parts of Sichuan chinaberry fruit, 8-12 parts of cocklebur, 8-12 parts of lycium chinense root bark, 8-12 parts of Kochia scoparia fruit, 8-12 parts of coptis chinensis, 8-12 parts of phellodendron chinense, 8-12 parts of scutellaria baicalensis, 8-12 parts of duckweed, 2-4 parts of borneol, and 2-4 parts of camphor crystals.

[0006] Preferably, the pulverization in step (2) adopts a segmented pulverization process: first coarsely pulverize to 20-30 mesh, and then finely pulverize to 50-80 mesh.

[0007] Preferably, the soaking in step (4) is carried out with gradient temperature control: soaking at 20-25℃ for the first 15 days, soaking at 15-20℃ for the middle 45 days, and standing at a low temperature of 10-15℃ for the last 30 days.

[0008] Preferably, in step (4), a plant extract synergist accounting for 0.1%-0.5% of the total mass of the medicinal materials is added, wherein the synergist is tea polyphenol or grape seed extract.

[0009] Preferably, the fine filtration in step (5) is carried out at a low temperature of 10-15°C to prevent the loss of volatile components.

[0010] Preferably, the mixing in step (6) adopts a step-by-step dilution method: first, mix the original pulp with a small amount of purified water, stir evenly, and then add the remaining purified water.

[0011] Preferably, the glass bottle described in step (7) is sterilized by high-pressure steam at 121°C for 20-30 minutes, and immediately sealed with high-purity nitrogen after filling.

[0012] Beneficial effects This invention provides a method for preparing a topical medicinal wine for treating psoriasis using a combination of *Hippophae rhamnoides* (golden hibiscus) and overcomes the following shortcomings of existing traditional Chinese medicine wines: single formula, limited therapeutic effect; crude preparation process, insufficient extraction of effective components; unstable quality, large batch-to-batch variations; lack of systematic pharmacological research and clinical validation; strong irritation, and poor patient tolerance. In this invention, *Hippophae rhamnoides* is the principal ingredient for clearing heat and detoxifying; *Paris polyphylla* is the assistant ingredient for reducing swelling and relieving pain; *Pinellia ternata* is the adjuvant ingredient for drying dampness and resolving phlegm; and borneol is the guiding ingredient for transdermal absorption. The synergistic effect of these eighteen medicinal herbs targets the inflammation, hyperplasia, itching, and infection associated with psoriasis. This product exhibits therapeutic effects through multiple stages; it employs a gradient soaking extraction process to extract effective components of different polarities in stages; a multi-stage precision filtration system ensures the clarity and stability of the medicinal wine; low-temperature treatment protects the activity of volatile components; the wine has excellent transdermal absorption, allowing the medication to act directly on the affected area; it is used as a spray, ensuring even distribution and making it suitable for treating large areas of skin lesions; all raw materials are natural medicinal herbs, and their toxicity has been reduced through scientific formulation; as a topical preparation, it avoids the systemic side effects of oral medications; it also possesses multiple functions including anti-inflammatory, antipruritic, antibacterial, and skin repair promotion. Detailed Implementation

[0013] The present invention will be further described in detail below through specific embodiments. These embodiments are for illustrative purposes only and are not intended to limit the scope of the invention.

[0014] Example 1: A method for preparing a topical medicinal wine for treating psoriasis using a golden hibiscus composition, comprising the following steps: (1) Raw material compatibility and pretreatment: Take 20 parts of golden hibiscus, 10 parts of processed pinellia, 10 parts of processed Paris polyphylla, 10 parts of rhubarb, 10 parts of tobacco stems, 10 parts of Senecio scandens, 6 parts of bee honeycomb, 10 parts of dictamnus dasycarpus, 10 parts of Melia toosendan fruit, 10 parts of Xanthium sibiricum, 10 parts of Lycium chinense root bark, 10 parts of Kochia scoparia fruit, 10 parts of Coptis chinensis, 10 parts of Phellodendron chinense, 10 parts of Scutellaria baicalensis, 10 parts of duckweed, 3 parts of borneol, and 3 parts of camphor crystals according to the following mass proportions: After washing the medicinal plants, dry them at a low temperature of 45℃ until the moisture content is less than 7%; (2) Precision grinding: Mix the dried medicinal materials and use ultra-micro grinding technology to grind them in stages, first coarsely grinding them to 25 mesh, and then finely grinding them to 60 mesh; (3) Raw material mixing: Mix the medicinal material granules with borneol and camphor crystals according to the ratio and put them into a ceramic container; (4) Gradient soaking extraction: Add sorghum liquor with an alcohol content of 63 degrees to the container. The mass ratio of medicinal materials to liquor is 1:3. After sealing, soak at 23℃ for the first 15 days, soak at 18℃ for the middle 45 days, and let stand at 12℃ for the last 30 days. Stir once a day for the first 30 days. (5) Multi-stage precision filtration: The soaked medicinal wine raw liquor is first coarsely filtered through a 150-mesh sieve, then finely filtered through a plate and frame filter press at 12°C, and finally sterilized by a 0.45μm microporous filter membrane. (6) Scientific blending: Blend the filtered medicinal wine base with purified water at a volume ratio of 1:1.5 and adjust the alcohol content to 35 degrees. (7) Aseptic filling: The blended medicinal wine is filled into pre-sterilized brown glass bottles in a Class 100,000 clean environment. The glass bottles are sterilized at 121°C for 25 minutes and then sealed with nitrogen. (8) Obtain the finished product of the Golden Sunflower Composition for external use in treating psoriasis.

[0015] Example 2: A method for preparing a topical medicinal wine for treating psoriasis using a golden hibiscus composition includes the following steps: (1) Raw material compatibility and pretreatment: Take 25 parts of golden hibiscus, 8 parts of processed pinellia, 12 parts of processed Paris polyphylla, 8 parts of rhubarb, 12 parts of tobacco stems, 8 parts of Senecio scandens, 8 parts of bee honeycomb, 8 parts of dictamnus dasycarpus, 12 parts of Melia toosendan fruit, 8 parts of Xanthium sibiricum, 12 parts of Lycium chinense root bark, 8 parts of Kochia scoparia fruit, 12 parts of Coptis chinensis, 8 parts of Phellodendron chinense, 12 parts of Scutellaria baicalensis, 8 parts of duckweed, 2 parts of borneol, and 4 parts of camphor crystals according to the following mass proportions: After washing the medicinal materials, dry them at a low temperature of 50℃ until the moisture content is less than 8%; (2) Precision grinding: Mix the dried medicinal materials and use ultra-micro grinding technology to grind them in stages, first coarsely grinding them to 25 mesh, and then finely grinding them to 70 mesh; (3) Raw material mixing: Mix the medicinal material granules with borneol and camphor crystals according to the ratio and put them into a ceramic container; (4) Gradient soaking extraction: Add sorghum liquor with an alcohol content of 63 degrees to the container. The mass ratio of medicinal materials to liquor is 1:4. After sealing, soak at 25℃ for the first 15 days, soak at 20℃ for the middle 45 days, and let stand at 15℃ for the last 30 days. Stir once a day for the first 30 days. (5) Multi-stage precision filtration: The soaked medicinal wine raw liquor is first coarsely filtered through a 200-mesh sieve, then finely filtered through a plate and frame filter press at 15°C, and finally sterilized by a 0.45μm microporous filter membrane. (6) Scientific blending: Blend the filtered medicinal wine raw liquor with purified water at a volume ratio of 1:2 and adjust the alcohol content to 38 degrees. (7) Aseptic filling: The blended medicinal wine is filled into pre-sterilized brown glass bottles in a Class 100,000 clean environment. The glass bottles are sterilized at 121°C for 25 minutes and then sealed with nitrogen. (8) Obtain the finished product of the Golden Sunflower Composition for external use in treating psoriasis.

[0016] Comparative Example 1 Traditional preparation method: According to the formula in Example 1, the medicinal materials are pulverized to 20 mesh, soaked at room temperature for 30 days, and then used after simple filtration.

[0017] Comparative Example 2 Commercially available psoriasis ointment: 0.1% mometasone furoate cream.

[0018] Physicochemical index testing Transdermal absorption test In vitro transdermal assays were performed using a Franz diffusion cell: The cumulative penetration of the medicinal wine in Example 1 over 24 hours was (92.3±4.8) μg / cm². Comparative Example 1 was (38.6±3.9) μg / cm²; The transdermal rate of Example 1 was significantly better than that of Comparative Example 1.

[0019] Clinical efficacy observation 180 patients with various types of psoriasis were selected and randomly divided into three groups: Example 1 group: External application of the medicinal wine of this invention, twice daily; Comparative Group 1: External application of traditionally prepared medicinal wine, twice daily; Comparative Example 2: Topical application of 0.1% mometasone furoate cream once daily; Observe the efficacy after 12 weeks of treatment: Safety assessment The incidence of adverse reactions in Group 1 of Example 1 was 5.0%, mainly manifested as mild local irritation; The incidence of adverse reactions in the comparative group 1 was 15.0%, including obvious irritation and itching; The incidence of adverse reactions in the comparative group 2 was 18.3%, including skin atrophy and telangiectasia.

[0020] Analysis of treatment efficacy for different types of psoriasis Patient satisfaction survey The survey covered aspects such as ease of use, speed of onset of action, and comfort. Example 1 group satisfaction rate was 94%; Comparative group 1 had a satisfaction rate of 70%; The satisfaction rate of the two control groups was 82%.

[0021] This invention, through scientific raw material formulation and advanced preparation technology, has successfully developed a topical medicinal wine for treating psoriasis using a Golden Sunflower composition that is both effective and safe to use. Compared with traditional methods, this invention's product has significant advantages in terms of active ingredient content, transdermal absorption, clinical efficacy, and patient satisfaction. It is particularly effective in treating specific types of psoriasis (such as pustular psoriasis), providing psoriasis patients with a new treatment option.

[0022] It should be noted that in this paper, relational terms such as first and second are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations.

Claims

1. A method for preparing a topical medicinal wine for treating psoriasis using a golden sunflower composition, characterized in that, Includes the following steps: (1) Raw material compatibility and pretreatment: Take 10-30 parts of golden hibiscus, 5-15 parts of processed pinellia, 5-15 parts of processed Paris polyphylla, 5-15 parts of rhubarb, 5-15 parts of tobacco stems, 5-15 parts of Senecio scandens, 3-10 parts of bee honeycomb, 5-15 parts of dictamnus dasycarpus, 5-15 parts of Melia toosendan fruit, 5-15 parts of Xanthium sibiricum, 5-15 parts of Lycium chinense root bark, 5-15 parts of Kochia scoparia fruit, 5-15 parts of Coptis chinensis, 5-15 parts of Phellodendron chinense bark, 5-15 parts of Scutellaria baicalensis, 5-15 parts of duckweed, 1-5 parts of borneol, and 1-5 parts of camphor crystals according to the following mass proportions: After washing the medicinal plants, dry them at a low temperature of 40-50℃ until the moisture content is less than 8%; (2) Precision grinding: Mix the dried medicinal materials and grind them to a particle size of 50-80 mesh using ultra-micro grinding technology to obtain uniform medicinal material particles; (3) Raw material mixing: Mix the medicinal material granules with borneol and camphor crystals according to the ratio and put them into a ceramic container; (4) Gradient soaking extraction: Add sorghum liquor with an alcohol content of 60-65 degrees to the container. The mass ratio of medicinal materials to liquor is 1:3-1:

4. After sealing, soak at 15-25℃ for 90-110 days. Stir once a day for the first 30 days, and let it stand for soaking for the next 60-80 days. (5) Multi-stage precision filtration: The soaked medicinal wine raw liquor is first coarsely filtered through a 100-200 mesh sieve, then finely filtered through a plate and frame filter press, and finally sterilized through a 0.45μm microporous filter membrane. (6) Scientific blending: Blend the filtered medicinal wine raw liquor with pure water at a volume ratio of 1:1-1:2, and adjust the alcohol content to 30-40 degrees. (7) Aseptic filling: The blended medicinal wine is filled into pre-sterilized brown glass bottles in a Class 100,000 clean environment and sealed with nitrogen. (8) Obtain the finished product of the Golden Sunflower Composition for external use in treating psoriasis.

2. The method for preparing a topical medicinal wine for treating psoriasis using a golden hibiscus composition according to claim 1, characterized in that, The mass fractions of the raw materials mentioned in step (1) are as follows: 15-25 parts of golden sunflower, 8-12 parts of processed pinellia, 8-12 parts of processed Paris polyphylla, 8-12 parts of rhubarb, 8-12 parts of tobacco stems, 8-12 parts of Senecio scandens, 5-8 parts of bee honeycomb, 8-12 parts of dictamnus dasycarpus root bark, 8-12 parts of Sichuan chinaberry fruit, 8-12 parts of Xanthium sibiricum, 8-12 parts of Lycium chinense root bark, 8-12 parts of Kochia scoparia fruit, 8-12 parts of Coptis chinensis, 8-12 parts of Phellodendron chinense bark, 8-12 parts of Scutellaria baicalensis, 8-12 parts of duckweed, 2-4 parts of borneol, and 2-4 parts of camphor crystals.

3. The method for preparing a topical medicinal wine for treating psoriasis using a golden hibiscus composition according to claim 1, characterized in that, The crushing process described in step (2) is a segmented crushing process: first coarse crushing to 20-30 mesh, and then fine crushing to 50-80 mesh.

4. The method for preparing a topical medicinal wine for treating psoriasis using a golden hibiscus composition according to claim 1, characterized in that, The soaking in step (4) is carried out with gradient temperature control: soaking at 20-25℃ for the first 15 days, soaking at 15-20℃ for the middle 45 days, and standing at a low temperature of 10-15℃ for the last 30 days.

5. The method for preparing a topical medicinal wine for treating psoriasis using a golden hibiscus composition according to claim 1, characterized in that, In step (4), a plant extract synergist, comprising 0.1%-0.5% of the total mass of the medicinal materials, is added. The synergist is tea polyphenols or grape seed extract.

6. The method for preparing a topical medicinal wine for treating psoriasis using a golden hibiscus composition according to claim 1, characterized in that, The fine filtration described in step (5) is carried out at a low temperature of 10-15℃ to prevent the loss of volatile components.

7. The method for preparing a topical medicinal wine for treating psoriasis using a golden hibiscus composition according to claim 1, characterized in that, The mixing process described in step (6) is a step-by-step dilution method: first, mix the raw pulp with a small amount of purified water, stir evenly, and then add the remaining purified water.

8. The method for preparing a topical medicinal wine for treating psoriasis using a golden hibiscus composition according to claim 1, characterized in that, The glass bottles described in step (7) are sterilized by high-pressure steam at 121°C for 20-30 minutes, and then immediately filled with high-purity nitrogen and sealed.

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