Traditional Chinese medicine composition for preventing and treating chikungunya fever as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating chikungunya fever as well as a preparation method and application of the traditional Chinese medicine composition. The composition is prepared from sweet wormwood herb, honeysuckle flower, giant knotweed rhizome, coix seed, red paeony root and liquorice root according to a specific ratio, and has the effects of clearing away heat and toxic materials, eliminating dampness and promoting superficies, and promoting blood circulation to remove meridian obstruction on the basis of the theory of'warm pathology '. Experiments show that the composition can significantly inhibit chikungunya virus replication (EC = 47.2 [mu] g / mL), has better effects than ribavirin and isatis root, and can effectively relieve fever and arthralgia. The invention also provides a plurality of dosage forms such as decoction, granules and spray, is suitable for large-scale prevention and clinical treatment of epidemic areas, and has the advantages of multi-link effectiveness, low cost and small side effect.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition with antiviral, antipyretic and analgesic and immunoregulatory effects for the prevention and treatment of chikungunya fever (CHIKV infection). BACKGROUND

[0002] Chikungunya fever is an acute infectious disease caused by chikungunya virus and transmitted by mosquitoes. Its clinical features include sudden high fever, severe joint pain, swelling, muscle pain, headache, nausea, fatigue and rash. Some patients may develop chronic arthritis, leading to long-term mobility impairment and loss of labor. Currently, there is no specific antiviral drug or registered vaccine for this virus worldwide, and the clinical treatment is mainly symptomatic support with limited efficacy.

[0003] In recent years, chikungunya fever has shown an accelerating spread globally. According to the latest epidemiological report released by the Pan American Health Organization (PAHO) in 2024, Brazil is experiencing one of the most severe epidemics on record, with over 500,000 suspected cases in the first half of 2024, putting a huge pressure on the local healthcare system.

[0004] Currently, in clinical practice, doctors and patients often turn to some classic broad-spectrum antiviral traditional Chinese medicines, such as Banlangen preparations and Shuanghuanglian preparations, when facing viral infectious diseases. However, these drugs are not designed for specific viral pathogenesis, and they often have limited effect on the "damp-heat epidemic toxin" pathogenesis of chikungunya virus (CHIKV) infection, as well as its unique severe joint pain and persistent inflammatory damage, which have the defects of lack of specificity and insufficient efficacy. Therefore, developing a specific traditional Chinese medicine composition that can target both CHIKV and its associated immune pathological damage has become an urgent and unmet technical need in the field. SUMMARY

[0005] Objectives of the present application To provide a traditional Chinese medicine composition for chikungunya virus, with definite efficacy, multi-link effect, and suitable for different application scenarios, and a preparation method thereof. Technical solutions

[0006] A traditional Chinese medicine composition for preventing and treating chikungunya fever, consisting of the following raw materials by weight: · Artemisia annua 30-50 parts · Honeysuckle 20-30 parts · Polygonum multiflorum 15-25 parts · Coix seed 30-40 parts · Red peony root 10-15 parts · Licorice 5-10 parts (2.) According to 1, the traditional Chinese medicine composition is characterized in that it further comprises 5-10 parts of Notopterygium incisum and / or 5-10 parts of Gentiana macrophylla and 30-50 parts of gypsum.

[0007] (3). The traditional Chinese medicine composition according to any one of (1)-(2), characterized in that the dosage form of the composition is a decoction, granules, capsules or spray.

[0008] (4). A method for preparing any one of the traditional Chinese medicine compositions described in (1)-(2), characterized in that it includes the following steps: weighing each raw material according to the ratio; soaking in water for 30-60 minutes; boiling over high heat and then simmering over low heat for 20-40 minutes; filtering and collecting the filtrate; concentrating the filtrate to contain 0.8-1.2g of raw medicine per milliliter to obtain the decoction.

[0009] (5). The method according to (4) is characterized in that, when preparing granules, it further includes: spray drying the concentrate to obtain extract powder; adding dextrin and flavoring agent, granulating, drying, and packaging.

[0010] (6). A method for preparing the spray of (3), characterized in that it comprises: taking the concentrated decoction obtained in claim 4, adding glycerin, preservative and penetration enhancer, adding water to make up to a certain volume, aseptically filtering and filling it into a spraying device.

[0011] (7). The use of any one of the traditional Chinese medicine compositions described in (1)-(3) in the preparation of a medicine for the prevention or treatment of chikungunya virus infection.

[0012] (8). The application according to (7) is characterized in that the drug is used to relieve fever, joint pain or rash symptoms caused by chikungunya fever. (9) (3) The application of the spray in the preparation of skin protection products for repelling mosquitoes and preventing chikungunya virus infection.

[0013] Advantages and Technological Advancements of the Invention 1. Highly innovative formulation: For the first time, Artemisia annua, Polygonum cuspidatum, and Coix lacryma-jobi are combined as the core ingredients to exert a synergistic effect on the pathogenesis of CHIKV "damp-heat epidemic toxin".

[0014] 2. Comprehensive mechanism of action: It has three effects: directly inhibiting viral replication, regulating cytokine storm, and repairing joint damage.

[0015] 3. Wide range of dosage forms: New dosage forms suitable for large-scale prevention (granules) and convenient local protection (sprays) have been developed.

[0016] 4. Solid data support: In vitro experiments confirm its anti-CHIKV activity (ECG). 50= 47.2 μg / mL) significantly better than the positive control drug ribavirin and the classic traditional Chinese medicine Banlangen.

[0017] 5. Clear application scenarios: It provides a comprehensive solution that combines prevention and treatment, filling a gap in existing technologies. Attached Figure Description

[0018] · Figure 1 : Block diagram of the formulation and compatibility principle of this invention.

[0019] · Figure 2 : Flowchart of the preparation process of the decoction, granules and spray of the present invention.

[0020] · Figure 3 Comparison of the in vitro anti-CHIKV activity of the composition of the present invention with that of ribavirin and isatis root.

[0021] · Figure 4 : Data graph of skin retention and mosquito repellent effect of the spray of this invention. Detailed Implementation

[0023] The present invention will be further described below with reference to embodiments, but the scope of protection of the present invention is not limited thereto.

[0024] Example 1: Preparation of the basic formula decoction Clean the medicinal materials according to the following standards: • Dried aerial parts of Artemisia annua L. • Dried flower buds of honeysuckle (Lonicera japonica Thunb.) • Dried rhizomes and roots of Polygonum cuspidatum Sieb. et Zucc. • Job's tears (dried mature seeds of Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf) • Dried root of Paeonia veitchii Lynch (red peony) • Dried root and rhizome of licorice (Glycyrrhiza uralensis Fisch.) Weigh the following ingredients by weight: 40g Artemisia annua, 25g Lonicera japonica, 20g Polygonum cuspidatum, 35g Coix lacryma-jobi, 12g Paeonia lactiflora, and 8g Glycyrrhiza uralensis. Soak in water (10 times the volume of water) for 40 minutes. Bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter and concentrate the filtrate to 100ml to obtain the decoction.

[0025] Example 2: Preparation of modified formulation granules Based on the formulation of Example 1, 8g of Notopterygium root and 40g of gypsum were added. After decoction, filtration, and concentration according to the method of Example 1, the concentrate was spray-dried to obtain extract powder. An equal amount of dextrin and an appropriate amount of flavoring agent were added, granulated, dried, and packaged into 5g granules per bag.

[0026] Example 3: Preparation of the spray Take the concentrated decoction obtained in Example 1 (equivalent to 500g of crude drug), add 50g of glycerol and 0.5g of benzalkonium chloride, add water for injection to approximately 1000mL, and stir to dissolve. Add 1g of menthol pre-dissolved in a small amount of ethanol, and bring the volume to 1000mL. Filter aseptically through a 0.22μm microporous membrane and fill into a sterile spray device to obtain the final product.

[0027] Experiment Example 4: Efficacy and Comparative Verification 1. In vitro antiviral experiment: The plaque reduction assay was used, and the results are shown in Table 1.

[0028] Table 1 Comparison of in vitro anti-CHIKV activities (ECG) 50 (μg / mL) Sample EC 50 Selectivity Index (SI) The composition of the present invention is 47.2 10.6 Ribavirin 78.9 3.6 Isatis root granules 285.4 ~ 1.75 2. Specialized experiment on spray: • Skin retention: (12.5 ± 1.8 μg / cm²), indicating that an effective protective layer can be formed on the skin surface.

[0029] • Mosquito repellent effect: Reduces the number of times mosquitoes land by 75.4%.

[0030] • Mucosal irritation: HET-CAM test score of 0.5, indicating non-irritation.

[0031] 3. Animal model experiment: In the rhesus monkey infection model, the fever reduction time in the treatment group (28±3.2 hours) was significantly shorter than that in the control group (47±4.1 hours) (p<0.01).

[0032] Although the present invention has been described in detail above with general descriptions, specific embodiments and experiments, the present invention is not limited to the above embodiments. Those skilled in the art will understand that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention, all of which fall within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition for preventing and treating chikungunya fever, characterized in that, The composition is prepared from the following raw materials: Artemisia annua 30-50 parts, Lonicera japonica 20-30 parts, Polygonum cuspidatum 15-25 parts, Coix seed 30-40 parts, Red peony root 10-15 parts, and Licorice 5-10 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It also contains Notopterygium 5-10 parts and / or Gentiana 5-10 parts, and Gypsum fibrosum 30-50 parts.

3. The traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, The dosage form of the composition is water decoction, granules, capsules or spray.

4. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, The method comprises the following steps: weighing the raw materials according to the proportion; soaking in water for 30-60 minutes; boiling with strong fire and then simmering with medium fire for 20-40 minutes; Filtering and collecting the filtrate; concentrating the filtrate to 0.8-1.2g of raw medicine per milliliter to obtain the water decoction.

5. The method of claim 4, wherein, When preparing granules, the method further comprises: spray drying the concentrated solution to obtain extract powder; adding dextrin and flavoring agent, granulating, drying and packaging.

6. A process for the preparation of a spray as claimed in claim 3, characterised in that, The method comprises the following steps: The concentrated solution of the water decoction obtained in claim 4 is added with glycerol, preservative and penetration enhancer, water is added to constant volume, sterile filtration and filling in a spray device.

7. Use of the traditional Chinese medicine composition of any one of claims 1-3 in the preparation of a medicine for preventing or treating Chikungunya virus infection.

8. Use according to claim 7, characterized in that, The medicine is used for relieving fever, joint pain or rash symptoms caused by Chikungunya fever.

9. Use of the spray of claim 3 in the preparation of a skin protection product for repelling mosquitoes and preventing Chikungunya virus infection.

Images