Traditional Chinese medicine composition for preventing and treating African swine fever, pharmaceutical composition and preparation method

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating African swine fever, a pharmaceutical composition and a preparation method, and belongs to the technical field of veterinary use. The invention discloses a traditional Chinese medicine composition for preventing and treating African swine fever. The traditional Chinese medicine composition is prepared from the following raw materials: gypsum rubrum, meadowrue root and rhizome, Chinese mahonia stem, eleusine indica, sculellaria barbata, radix paeoniae rubra, cortex moutan, humifuse euphorbia herb, indigo naturalis, henon bamboo leaf and honeysuckle stem. A pharmaceutical composition for preventing and treating African swine fever is prepared into a veterinary preparation by taking the traditional Chinese medicine composition as a raw material and matching with auxiliary materials. The traditional Chinese medicine composition has good prevention and treatment effects on various viral infections such as African swine fever virus; moreover, the feed additive is low in cost, free of antibiotics and drug residues, capable of being widely applied and capable of solving major problems of the pig raising industry.

Description

Technical Field

[0001] This invention relates to the field of veterinary technology, and in particular to a traditional Chinese medicine composition, a pharmaceutical composition, and a preparation method for preventing and treating African swine fever. Background Technology

[0002] African swine fever (ASF), a double-stranded DNA enveloped virus originating in Africa, is an acute, highly contagious, and fatal disease of domestic and wild pigs caused by the African swine fever virus (ASFV) species. Domestic and wild pigs are the only natural hosts of the disease. It has no seasonality and is transmitted through contact and vector-borne transmission. Because there is currently no effective vaccine for ASF worldwide, prevention and control measures are limited to passive measures such as keeping pigs in enclosed environments and strictly controlling the entry of personnel, vehicles, and susceptible animals into farms.

[0003] Existing technologies include traditional Chinese medicine (TCM) compositions for the prevention and treatment of chronic swine fever, such as patent CN104258139A, "A Pharmaceutical Composition for the Prevention and Treatment of Chronic Swine Fever," which discloses a pharmaceutical composition composed of gypsum, gardenia, rehmannia root, arborvitae leaf, peony bark, reed rhizome, trichosanthes root, lophatherum leaf, dayflower, fern root, knotweed, dandelion, lotus leaf, lotus seed heart, ophiopogon root, forsythia, scrophularia root, licorice root, piglet's ear, dog's liver vegetable, purslane, shepherd's purse, white peony root, ground quince, trichosanthes fruit, monkey egg, giant clam meat, and smilax, and its application in the prevention and treatment of chronic swine fever. However, this pharmaceutical composition is complex, and there is no evidence to prove its ability to prevent and / or treat acute African swine fever.

[0004] Therefore, there is an urgent need for a drug that can effectively prevent and treat African swine fever in order to solve the major difficulties encountered in pig farming. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition, a pharmaceutical composition, and a preparation method for the prevention and treatment of African swine fever.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: A traditional Chinese medicine composition for the prevention and treatment of African swine fever, comprising the following raw materials: Cold water stone, horse tail, magnolia wood, goosegrass, scutellaria barbata, red peony, peony bark, euphorbia humifusa, indigo naturalis, bamboo leaf heart, honeysuckle vine.

[0007] In some embodiments, the raw materials consist of the following parts by weight: 500-1500 parts of gypsum, 50-200 parts of horsetail, 50-200 parts of magnolia, 50-200 parts of goosegrass, 50-200 parts of scutellaria barbata, 30-120 parts of red peony, 30-120 parts of peony bark, 25-100 parts of euphorbia humifusa, 25-100 parts of indigo naturalis, 25-100 parts of bamboo leaf heart, and 25-100 parts of honeysuckle vine.

[0008] In some embodiments, the raw materials consist of the following parts by weight: 700-1300 parts of gypsum, 80-120 parts of horsetail, 80-120 parts of magnolia, 80-120 parts of goosegrass, 80-120 parts of scutellaria barbata, 40-80 parts of red peony, 40-80 parts of peony bark, 30-70 parts of euphorbia humifusa, 30-70 parts of indigo naturalis, 30-70 parts of bamboo leaf heart, and 30-70 parts of honeysuckle vine.

[0009] In some embodiments, the raw materials consist of the following parts by weight: 800 parts of gypsum, 100 parts of horsetail, 100 parts of magnolia, 100 parts of goosegrass, 100 parts of scutellaria barbata, 60 parts of red peony, 60 parts of peony bark, 50 parts of euphorbia humifusa, 50 parts of indigo naturalis, 50 parts of bamboo leaf heart, and 50 parts of honeysuckle vine.

[0010] A pharmaceutical composition for the prevention and treatment of African swine fever, using a traditional Chinese medicine composition as raw material and excipients, is prepared into a veterinary preparation; The veterinary preparations include: liquid preparations and solid preparations.

[0011] A method for preparing a pharmaceutical composition for the prevention and treatment of African swine fever, used in the pharmaceutical composition; A1. The preparation of liquid formulations includes the following steps: Extract the various Chinese medicinal herbs to obtain the extract; concentrate or not concentrate, add or not add excipients; mix evenly to prepare a liquid preparation; A2. The preparation of solid dosage forms includes the following steps: Extracts are obtained from various Chinese medicinal herbs to obtain extracts; the extracts are concentrated or not, and excipients are added; the mixtures are then homogeneous to prepare solid dosage forms. Alternatively, each Chinese herbal medicine can be pulverized, with or without excipients added; mixed evenly, and prepared into a solid preparation.

[0012] A method for preparing a pharmaceutical composition for the prevention and treatment of African swine fever, for use in a liquid formulation; comprising the following steps: S1. Prepare the dosage of each Chinese herbal medicine according to the required volume of the liquid preparation. Each 1ml of liquid preparation contains 1.0~2.0g of crude drug. S2, water extraction; Take the calcite and crush it, then mix it with horsetail, goosegrass, bamboo leaf heart, and ground euphorbia. Submerge the medicinal materials in water and soak at 40-50℃ for 0.5-1.0 hours; Then, simmer twice; the first time for 1.5 to 2.0 hours, and the second time for 1.0 to 1.5 hours. Filter while hot and combine the filtrates; The filtrate was concentrated under reduced pressure to a relative density of 1.15~1.20 (60℃); solution A was obtained and refrigerated for later use. S3, alcohol extraction; Take the remaining 6 Chinese herbs and extract them twice by hot reflux with 70-80% ethanol; each time for 1.0-2.0 hours, at a temperature of 35-50℃. Combine the alcohol extracts and recover the ethanol; Concentrate under reduced pressure until the relative density is not less than 0.95; obtain drug solution B, refrigerate for later use; S4. Combine solutions A and B and concentrate under reduced pressure until the relative density is 1.10~1.15; Add ethanol to achieve an alcohol content of 60-70%; refrigerate and let stand for 24 hours. Filter the solution, recover the ethanol from the filtrate, concentrate under reduced pressure until no alcohol odor remains; filter again to obtain the herbal filtrate. S5. Add water for injection to 90% of the volume of the Chinese herbal medicine filtrate; Add 0.5-1.0% activated carbon to the total mass of the Chinese herbal medicine filtrate, stir at 55-65℃ for 30 minutes, and then filter. Refrigerate the filtrate for 24 hours, then filter it again. Add 1%~2% by volume of Tween-80 and 0.1%~0.3% by volume of sodium benzoate, and stir well; Add water for injection to the final volume. Stir well, filter; fill and sterilize to obtain the corresponding volume of liquid preparation.

[0013] In some embodiments, in steps S2 to S4, the reduced pressure concentration environment is: 0.08 to 0.1 MPa, and the temperature is 60 to 70°C.

[0014] In some embodiments, the refrigeration temperature in steps S2 to S5 is 2 to 8°C; The filter media is a 0.45μm microporous membrane; the filtrate concentration standard is mass (g) / volume (ml).

[0015] Application of a pharmaceutical composition for the prevention and treatment of African swine fever.

[0016] Compared with the prior art, the present invention provides a traditional Chinese medicine composition, a pharmaceutical composition and a preparation method for the prevention and treatment of African swine fever, which has the following beneficial effects.

[0017] 1. This invention has good preventive and therapeutic effects on various viral infections such as African swine fever virus; moreover, it is low in cost, antibiotic-free and drug residue-free, and can be widely used, solving major problems in the pig farming industry.

[0018] Other advantages, objectives and features of the invention will be set forth in part in the description which follows; and in part will be apparent to those skilled in the art upon examination of the following description; or may be learned from practice of the invention. Attached Figure Description

[0019] Figure 1 This is a flowchart of the present invention. Detailed Implementation

[0020] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0021] A traditional Chinese medicine composition for the prevention and treatment of African swine fever, comprising the following raw materials: Cold water stone, horse tail, magnolia wood, goosegrass, scutellaria barbata, red peony, peony bark, euphorbia humifusa, indigo naturalis, bamboo leaf heart, honeysuckle vine.

[0022] The effects of each of the Chinese medicinal herbs are as follows.

[0023] ①Gypsum fibrosum: It has a pungent and salty taste, is cold in nature, and enters the heart and stomach meridians; it clears heat and drains fire, relieves irritability and quenches thirst; This product enters the Heart Meridian and is good at clearing away heart fire. It is often used for fever and mania caused by heat invading the pericardium. This product enters the Stomach Meridian and is good at clearing away stomach fire. It is often used for persistent high fever caused by excessive stomach heat.

[0024] ② Coptis chinensis: bitter in taste, cold in nature, enters the heart, lung, liver, gallbladder and large intestine meridians; clears heat and drains fire, dries dampness and detoxifies; This product enters the Heart Meridian and is good at clearing heart fire, often used for fever and irritability; this product enters the Lung Meridian and is good at clearing lung fire, often used for cough and asthma due to lung heat; this product enters the Liver and Gallbladder Meridians and is good at clearing damp heat in the liver and gallbladder, often used for damp-heat jaundice; this product enters the Large Intestine Meridian and is good at clearing damp heat in the large intestine, often used for damp-heat diarrhea.

[0025] ③ Mahonia: It tastes bitter and is cold in nature. It enters the liver, stomach, and large intestine meridians. It clears heat and dries dampness, drains fire and detoxifies. This product enters the liver meridian and is good at clearing damp-heat in the liver and gallbladder. It is often used for scanty dark urine, yellowing of the skin and eyes, and red, swollen and painful eyes. This product enters the stomach meridian and is good at clearing damp-heat in the middle jiao. It is often used for loss of appetite and swollen and rotten gums. This product enters the large intestine meridian and is good at clearing damp-heat in the large intestine. It is often used for loose stools and dysentery with pus and blood.

[0026] ④ Goosegrass: It has a sweet and bland taste, is cool in nature, and enters the liver and stomach meridians. It clears heat and promotes diuresis, cools the blood and detoxifies. This product is good at cooling the blood and detoxifying, and is often used for persistent high fever and fever with irritability; this product is good at clearing heat and promoting diuresis, and is often used for damp-heat jaundice, damp-heat urinary tract infection, and damp-heat dysentery.

[0027] ⑤ Scutellaria barbata: It has a bitter and pungent taste, is cold in nature, and enters the lung, liver, and kidney meridians. It clears heat and detoxifies, disperses blood stasis and promotes diuresis. This product is good at cooling the blood and stopping bleeding, and is often used for bleeding caused by blood heat; this product is good at cooling the blood and reducing swelling, and is often used for carbuncles caused by heat toxins; this product is good at clearing heat and promoting diuresis, and is often used for urinary retention, edema, and ascites caused by damp heat; this product is good at resolving blood stasis, reducing swelling and relieving pain, and is often used for stagnation and swelling caused by injury.

[0028] ⑥ Red peony root: bitter in taste, slightly cold in nature, enters the liver meridian, clears heat and cools blood, invigorates blood and removes blood stasis; This product enters the blood and clears blood heat. It is often used for spots and rashes caused by febrile toxins; hematemesis, epistaxis, and hemorrhage caused by blood heat; this product enters the liver meridian and clears liver fire. It is often used for red, swollen, and painful eyes caused by liver heat; this product cools the blood and disperses blood stasis. It is often used for carbuncles and sores caused by heat toxins.

[0029] ⑦ Moutan bark: It tastes bitter and pungent, is slightly cold in nature, and enters the heart, liver, and kidney meridians. It clears heat and cools the blood, and promotes blood circulation and removes blood stasis. This product enters the blood level and is good at clearing excess heat in the blood level. It is often used for febrile rashes caused by heat entering the blood level; hematemesis and epistaxis caused by blood heat. This product enters the blood level and is good at clearing latent heat in the yin level. It is often used for night fever and morning coolness caused by deficiency heat. This product clears heat and cools the blood, disperses blood stasis and eliminates carbuncles. It is often used for carbuncles and boils caused by fire toxin.

[0030] ⑧ Bamboo leaf roll: It tastes sweet, bland and slightly bitter, and is cold in nature. It enters the heart, stomach and small intestine meridians. It clears heat and drains fire, relieves irritability and promotes urination.

[0031] This product enters the Heart Meridian and is good at clearing Heart Fire. It is often used for mania caused by febrile diseases. This product enters the Stomach Meridian and is good at purging Stomach Fire. It is often used for thirst and excessive drinking, and mouth and tongue sores caused by febrile diseases. This product enters the Small Intestine Meridian and is good at clearing damp heat in the Small Intestine. It is often used for urinary difficulty and pain caused by febrile diseases.

[0032] ⑨ Euphorbia humifusa: It tastes bitter and pungent, is neutral in nature, and enters the liver and large intestine meridians. It clears heat and detoxifies, cools the blood and stops bleeding, and promotes diuresis and relieves jaundice. This product clears heat, cools the blood and stops bleeding, and is often used for urinary and fecal bleeding caused by excessive heat in the blood; this product also clears heat, promotes diuresis and relieves jaundice, and is often used for jaundice and sores caused by damp-heat accumulation.

[0033] ⑩ Indigo naturalis: Salty in taste, cold in nature, enters the liver and lung meridians, clears heat and detoxifies, cools blood and eliminates spots; This product clears heat and detoxifies, cools the blood and eliminates spots. It is often used for febrile rashes caused by heat entering the blood; hematemesis and epistaxis caused by blood heat; sore throat caused by intense heat toxicity; and cough and chest pain caused by liver fire attacking the lungs.

[0034] ⑪ Honeysuckle vine: sweet in taste, cold in nature, enters the lung and stomach meridians, clears heat and detoxifies, dispels wind and unblocks the meridians; This product clears the channels and dispels wind, detoxifies and clears heat. It is often used for persistent fever caused by febrile diseases, carbuncles and boils caused by heat accumulation in the skin, bloody dysentery and hematuria caused by heat accumulation in the internal organs, and red, swollen, hot and painful joints caused by heat accumulation in the meridians.

[0035] According to Traditional Chinese Medicine (TCM) theory, African swine fever and other high-fever diseases fall under the category of febrile diseases, characterized by excessive heat and toxins entering the blood and qi levels. Treatment should focus on clearing heat and purging fire, cooling the blood and dispersing blood stasis. In this formula, gypsum (halite), pungent, salty, and cold in nature, clears heat and purges fire, relieves irritability and quenches thirst, serving as the principal ingredient; *Coptis chinensis* (forest coptis), bitter and cold in nature, clears heat and purges fire, dries dampness and detoxifies; *Mahonia japonica* (mercury laurel), bitter and cold in nature, clears heat and purges fire, detoxifies and dries dampness; *Coptis chinensis* and *Mahonia japonica* work synergistically to clear heat and purge fire, dry dampness and detoxify; *Eleusine indica* (goosegrass), sweet, bland, and cool in nature, clears heat and detoxifies, cools the blood and promotes diuresis; *Scutellaria barbata* (scutellaria barbata), bitter, pungent, and cold in nature, clears heat and detoxifies, disperses blood stasis and promotes diuresis; *Eleusine indica* and *Scutellaria barbata* work synergistically to clear heat and detoxify, disperse blood stasis and promote diuresis; *Paeonia lactiflora* (red peony root), bitter and slightly cold in nature, clears heat and cools the blood, invigorates blood and removes blood stasis; *Paeonia suffruticosa* (moutan bark), bitter, pungent, and slightly cold in nature, clears heat and cools the blood, invigorates blood and removes blood stasis; *Paeonia lactiflora* and *Paeonia suffruticosa* (red This formula clears heat and cools the blood, detoxifies and stops bleeding; Indigo naturalis is salty and cold in nature, clears heat and cools the blood, detoxifies and eliminates spots; Euphorbia humifusa and Indigo naturalis work synergistically to clear heat and cool the blood, detoxify and eliminate spots; these 8 herbs work together with the main herb to clear heat and purge fire, cool the blood and disperse blood stasis, serving as auxiliary herbs; Bamboo leaf heart is sweet, bland and cold in nature, clears heat and purges fire, relieves irritability and promotes urination, assisting the main herb in clearing heat and relieving irritability, generating fluids and quenching thirst, serving as adjuvant herbs; Honeysuckle vine is sweet and cold in nature, clears heat and detoxifies, dispels wind and unblocks the meridians, promoting the circulation of all herbs along the meridians, serving as guiding herbs; the combined use of these herbs works synergistically to clear heat and purge fire, cool the blood and disperse blood stasis, effectively controlling the harm of African swine fever and other high-fever diseases, and has significant efficacy in the prevention and treatment of African swine fever.

[0036] A preferred traditional Chinese medicine composition for the prevention and treatment of African swine fever comprises the following raw materials in parts by weight: 500-1500 parts of gypsum, 50-200 parts of horsetail, 50-200 parts of magnolia, 50-200 parts of goosegrass, 50-200 parts of scutellaria barbata, 30-120 parts of red peony, 30-120 parts of peony bark, 25-100 parts of euphorbia humifusa, 25-100 parts of indigo naturalis, 25-100 parts of bamboo leaf heart, and 25-100 parts of honeysuckle vine.

[0037] A preferred traditional Chinese medicine composition for the prevention and treatment of African swine fever comprises the following raw materials in parts by weight: 700-1300 parts of gypsum, 80-120 parts of horsetail, 80-120 parts of magnolia, 80-120 parts of goosegrass, 80-120 parts of scutellaria barbata, 40-80 parts of red peony, 40-80 parts of peony bark, 30-70 parts of euphorbia humifusa, 30-70 parts of indigo naturalis, 30-70 parts of bamboo leaf heart, and 30-70 parts of honeysuckle vine.

[0038] A preferred traditional Chinese medicine composition for the prevention and treatment of African swine fever comprises the following raw materials in parts by weight: 600-800 parts of gypsum, 80-100 parts of horsetail, 80-100 parts of magnolia, 80-100 parts of goosegrass, 80-100 parts of scutellaria barbata, 40-70 parts of red peony, 40-70 parts of peony bark, 40-70 parts of indigo naturalis, 40-70 parts of euphorbia humifusa, 40-70 parts of bamboo leaf heart, and 40-70 parts of honeysuckle vine.

[0039] A preferred traditional Chinese medicine composition for the prevention and treatment of African swine fever comprises the following raw materials in parts by weight: 800 parts of gypsum, 100 parts of horsetail, 100 parts of magnolia, 100 parts of goosegrass, 100 parts of scutellaria barbata, 60 parts of red peony, 60 parts of peony bark, 50 parts of euphorbia humifusa, 50 parts of indigo naturalis, 50 parts of bamboo leaf heart, and 50 parts of honeysuckle vine.

[0040] It is understandable that "parts by weight" or "parts" refers to the relative proportion of medicinal materials used, rather than an absolute number of parts by weight. Depending on the actual situation, 1 part by weight can be any number of parts by weight, such as 10g, 500g, 1kg, 10kg, etc.

[0041] A pharmaceutical composition for the prevention and treatment of African swine fever, comprising the aforementioned traditional Chinese medicine composition as raw material, combined with excipients, and prepared into a veterinary preparation; The veterinary preparations include: liquid preparations and solid preparations; A method for preparing a pharmaceutical composition for the prevention and treatment of African swine fever, used to manufacture the aforementioned pharmaceutical composition.

[0042] A1. The preparation of liquid formulations includes the following steps: Each Chinese herbal medicine was extracted using a pharmaceutically acceptable solvent to obtain an extract. Concentrated or not concentrated, with or without pharmaceutically acceptable excipients; Mix thoroughly to prepare a liquid formulation.

[0043] A2. The preparation of solid dosage forms includes the following steps: Each Chinese herbal medicine is extracted using a pharmaceutically acceptable solvent to obtain an extract; the extract is then concentrated or not, and pharmaceutically acceptable excipients are added; the mixture is thoroughly mixed to prepare a solid dosage form. Alternatively, each Chinese herbal medicine can be pulverized, with or without pharmaceutically acceptable excipients added; mixed evenly, and prepared into a solid dosage form.

[0044] A method for preparing a pharmaceutical composition for the prevention and treatment of African swine fever, used to prepare the aforementioned liquid formulation; comprising the following steps.

[0045] S1. Prepare the dosage of each Chinese herbal medicine according to the required volume of the liquid preparation. Each 1ml of liquid preparation contains 1.0~2.0g of raw medicinal materials.

[0046] More preferably, each 1 ml of liquid preparation contains 1.1 to 1.6 g of raw medicinal material.

[0047] S2, water extraction; Take the calcite and crush it, then mix it with horsetail, goosegrass, bamboo leaf heart, and ground euphorbia. Submerge the medicinal materials in water and soak at 40-50℃ for 0.5-1.0 hours; Then, simmer twice; the first time for 1.5 to 2.0 hours, and the second time for 1.0 to 1.5 hours. Filter while hot and combine the filtrates; The filtrate was concentrated under reduced pressure to a relative density of 1.15~1.20 (60℃); solution A was obtained and refrigerated for later use.

[0048] It should be noted that the relative density here is at 60℃; Other relative densities not subsequently specified are also at 60°C.

[0049] S3, alcohol extraction; Take the remaining 6 Chinese herbs and extract them twice by hot reflux with 70-80% ethanol; each time for 1.0-2.0 hours, at a temperature of 35-50℃. Combine the alcohol extracts and recover the ethanol; Concentrate under reduced pressure until the relative density is not less than 0.95; obtain drug solution B, refrigerate for later use.

[0050] S4. Combine solutions A and B and concentrate under reduced pressure until the relative density is 1.10~1.15; Add ethanol to achieve an alcohol content of 60-70%; refrigerate and let stand for 24 hours. Filter the solution, recover the ethanol from the filtrate, concentrate under reduced pressure until there is no alcohol odor, filter again to obtain the Chinese medicine filtrate.

[0051] S5. Add water for injection to 90% of the volume of the Chinese herbal medicine filtrate; Add 0.5-1.0% activated carbon to the total mass of the Chinese herbal medicine filtrate, stir at 55-65℃ for 30 minutes, and then filter. Refrigerate the filtrate for 24 hours, then filter it again. Add 1%~2% by volume of Tween-80 and 0.1%~0.3% by volume of sodium benzoate, and stir well; Add water for injection to the final volume. Stir well, filter; fill and sterilize to obtain the corresponding volume of liquid preparation.

[0052] In steps S2 to S4, the vacuum concentration environment is 0.08 to 0.10 MPa and the temperature is 60 to 70°C.

[0053] In steps S2 to S5, the refrigeration temperature is 2 to 8°C; The filter media is a 0.45μm microporous membrane; the filtrate concentration standard is mass (g) / volume (ml).

[0054] Application of pharmaceutical compositions for the prevention and treatment of African swine fever.

[0055] Treatment typically involves a combination of intramuscular injection and oral administration. Intramuscular injection, 0.3-0.4 ml per kg of body weight per dose; once daily for 2-3 consecutive days; For consumption, dilute 100ml with 25kg of water and drink it twice a day, once in the morning and once in the afternoon, for 5 to 8 consecutive days.

[0056] In prevention, it is generally taken orally. For oral administration, take 0.5-1.0 ml per kg of body weight once daily for 2-3 consecutive days. For consumption, dilute 100ml with 25kg of water and drink it twice a day, once in the morning and once in the afternoon, for 5 to 8 consecutive days.

[0057] Those skilled in the art should know that the liquid preparation can be administered directly to domestic or wild pigs requiring treatment via intramuscular injection; or via oral administration; or via both intramuscular injection and oral administration.

[0058] In the event of an African swine fever outbreak, infected pigs can be injected with the medication as described above, and simultaneously given oral or drinking water administration. Other healthy pigs should be continuously administered the same oral or drinking water administration regimen for prevention. If an African swine fever outbreak occurs in the surrounding area and preventative measures are needed, the same oral or drinking water administration regimen can be used for prevention.

[0059] In addition, solid preparations are administered by mixing them into feed or by direct feeding.

[0060] The dosage is 0.5-1.0g of raw herb per kg of body weight; once daily for 2-3 consecutive days.

[0061] It is understandable that solid dosage forms need to be quantified based on the content of the raw medicinal material; when preparing solid dosage forms, different amounts of excipients are added, resulting in different final contents of the raw medicinal material.

[0062] This drug composition has a good preventive effect against various viral infections such as African swine fever virus; moreover, it is low in cost, antibiotic-free, and residue-free, and can be widely used to solve major problems in the pig farming industry.

[0063] Understandably, pharmaceutically acceptable excipients include: 1) Diluents; such as starch, powdered sugar, dextrin, lactose, pregelatinized starch, microcrystalline fiber, inorganic calcium salts (calcium sulfate, calcium hydrogen phosphate, pharmaceutical calcium carbonate, etc.), mannitol, vegetable oil, polyethylene glycol, distilled water or water for injection, etc. 2) Adhesives; such as distilled water, ethanol, starch paste, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose, etc. 3) Disintegrants; such as dry starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, crospyrolysis polyvinylpyrrolidone, crospyrolysis sodium carboxymethyl cellulose, etc. 4) Lubricants; such as magnesium stearate, micronized silica gel, talc, hydrogenated vegetable oil, polyethylene glycol, magnesium lauryl sulfate, etc.

[0064] The amount of excipients added can be selected conventionally according to the needs of pharmaceutical preparation, without any limitation; solid dosage forms with different contents of raw medicinal materials can be prepared.

[0065] In preparation, unless otherwise specified, the concentration of ethanol is a volume percentage concentration; if no concentration is specified, it refers to 95% ethanol.

[0066] Example 1 A traditional Chinese medicine composition for the prevention of African swine fever, comprising the following raw materials in parts by weight: 600 parts of gypsum, 80 parts of horsetail, 80 parts of magnolia, 80 parts of goosegrass, 80 parts of scutellaria barbata, 60 parts of red peony, 60 parts of peony bark, 40 parts of euphorbia humifusa, 40 parts of indigo naturalis, 40 parts of bamboo leaf heart, and 40 parts of honeysuckle vine.

[0067] Using the above-mentioned traditional Chinese medicine composition as raw material, a liquid traditional Chinese medicine preparation is prepared through the following steps.

[0068] S1. Prepare the dosage of each Chinese herbal medicine according to the required volume of the liquid preparation.

[0069] Each 1ml of traditional Chinese medicine liquid preparation contains 1.20g of raw medicinal materials.

[0070] S2, water extraction; Take pulverized gypsum and mix it with Coptis chinensis, Eleusine indica, Sophora flavescens, and Euphorbia humifusa. Add water to submerge the herbs and soak at 40-50℃ for 0.5-1.0 hours. Then, decoct twice, the first time for 1.5-2.0 hours and the second time for 1.0-1.5 hours. Filter while hot and combine the filtrates. Concentrate the filtrate under reduced pressure (0.08-0.1MPa, 60-70℃) to a relative density of 1.15-1.20 to obtain solution A, which is then refrigerated for later use.

[0071] S3, alcohol extraction; Take the remaining 6 Chinese herbs and extract them twice with 70-80% ethanol at 35-50℃ under hot reflux for 1.0-2.0 hours each time. Combine the ethanol extracts and recover the ethanol under reduced pressure at 0.08-0.1MPa and 60-70℃. Concentrate to a relative density of not less than 0.95 to obtain solution B, which is then refrigerated for later use.

[0072] S4. Combine the A and B solutions and concentrate under reduced pressure to a relative density of 1.10-1.15; add ethanol to make the alcohol content 60-70%; refrigerate and stand for 24 hours; filter, recover the ethanol from the filtrate at 0.08-0.1 MPa and 60-70℃, concentrate under reduced pressure until there is no alcohol odor; filter again to obtain the Chinese medicine filtrate.

[0073] S5. Add water for injection to 90% of the volume of the Chinese herbal medicine filtrate; add 0.5-1.0% activated carbon by weight of the total Chinese herbal medicine filtrate, stir at 55-65℃ for 30 minutes, and filter; refrigerate the filtrate for 24 hours, and filter again; add 1%-2% Tween-80 and 0.1%-0.3% sodium benzoate by weight, stir well; add water for injection to the volume; stir evenly, filter; fill and sterilize to obtain the corresponding volume of liquid preparation.

[0074] Example 2 A traditional Chinese medicine composition for the prevention of African swine fever, comprising the following raw materials in parts by weight: 600 parts of gypsum, 80 parts of horsetail, 80 parts of magnolia, 80 parts of goosegrass, 80 parts of scutellaria barbata, 50 parts of red peony, 50 parts of peony bark, 40 parts of euphorbia humifusa, 40 parts of indigo naturalis, 40 parts of bamboo leaf heart, and 40 parts of honeysuckle vine.

[0075] Following the same process and steps as in Example 1, a liquid preparation was prepared using the above-mentioned traditional Chinese medicine composition as raw material; each 1 ml of the traditional Chinese medicine liquid preparation contains 1.18 g of raw medicinal material.

[0076] Example 3 A traditional Chinese medicine composition for the prevention of African swine fever, comprising the following raw materials in parts by weight: 600 parts of gypsum, 80 parts of horsetail, 80 parts of magnolia, 80 parts of goosegrass, 80 parts of scutellaria barbata, 40 parts of red peony, 40 parts of peony bark, 40 parts of euphorbia humifusa, 40 parts of indigo naturalis, 40 parts of bamboo leaf heart, and 40 parts of honeysuckle vine.

[0077] Following the same process and steps as in Example 1, a liquid preparation was prepared using the above-mentioned traditional Chinese medicine composition as raw material; each 1 ml of the traditional Chinese medicine liquid preparation contains 1.16 g of raw medicinal material.

[0078] Example 4 A traditional Chinese medicine composition for the prevention of African swine fever, comprising the following raw materials in parts by weight: 600 parts of gypsum, 80 parts of horsetail, 80 parts of magnolia, 80 parts of goosegrass, 80 parts of scutellaria barbata, 60 parts of red peony, 60 parts of peony bark, 50 parts of euphorbia humifusa, 50 parts of indigo naturalis, 50 parts of bamboo leaf heart, and 50 parts of honeysuckle vine.

[0079] Following the same process and steps as in Example 1, a liquid preparation was prepared using the above-mentioned traditional Chinese medicine composition as raw material; each 1 ml of the traditional Chinese medicine liquid preparation contains 1.24 g of raw medicinal material.

[0080] Example 5 A traditional Chinese medicine composition for the prevention of African swine fever, comprising the following raw materials in parts by weight: 800 parts of gypsum, 100 parts of horsetail, 100 parts of magnolia, 100 parts of goosegrass, 100 parts of scutellaria barbata, 60 parts of red peony, 60 parts of peony bark, 50 parts of euphorbia humifusa, 50 parts of indigo naturalis, 50 parts of bamboo leaf heart, and 50 parts of honeysuckle vine.

[0081] Following the same process and steps as in Example 1, a liquid preparation was prepared using the above-mentioned traditional Chinese medicine composition as raw material; each 1 ml of the traditional Chinese medicine liquid preparation contains 1.52 g of raw medicinal material.

[0082] Example 6 A traditional Chinese medicine composition for the prevention of African swine fever, comprising the following raw materials in parts by weight: 600 parts of gypsum, 100 parts of horsetail, 100 parts of magnolia, 100 parts of goosegrass, 100 parts of scutellaria barbata, 60 parts of red peony, 60 parts of peony bark, 50 parts of euphorbia humifusa, 50 parts of indigo naturalis, 50 parts of bamboo leaf heart, and 50 parts of honeysuckle vine.

[0083] Following the same process and steps as in Example 1, a liquid preparation was prepared using the above-mentioned traditional Chinese medicine composition as raw material; each 1 ml of the traditional Chinese medicine liquid preparation contains 1.32 g of raw medicinal material.

[0084] Example 7 A traditional Chinese medicine composition for the prevention of African swine fever, comprising the following raw materials in parts by weight: 800 parts of gypsum, 80 parts of horsetail, 80 parts of magnolia, 100 parts of goosegrass, 100 parts of scutellaria barbata, 60 parts of red peony, 60 parts of peony bark, 50 parts of euphorbia humifusa, 50 parts of indigo naturalis, 50 parts of bamboo leaf heart, and 50 parts of honeysuckle vine.

[0085] Following the same process and steps as in Example 1, a liquid preparation was prepared using the above-mentioned traditional Chinese medicine composition as raw material; each 1 ml of the traditional Chinese medicine liquid preparation contains 1.48 g of raw medicinal material.

[0086] clinical trials A farm had 1,200 hybrid fattening pigs, weighing between 70 and 110 pounds, when a sudden outbreak of high fever occurred. 80% of them showed clinical symptoms such as high fever, difficulty breathing, cyanosis, lethargy, loss of appetite, reluctance to drink water, and bloody stools. Treatment with various antibiotics and antipyretics was ineffective, and they began to die on the second day.

[0087] The test strip confirmed that the patient was infected with African swine fever virus.

[0088] Under the guidance of a licensed veterinarian, 400 infected pigs were randomly selected and isolated into 8 groups of 50 each. The control group consisted of 50 pigs, while the treatment groups 1-7 each consisted of 50 pigs.

[0089] Groups 1-7 were administered the traditional Chinese medicine liquid preparations obtained in Examples 1-7 of this invention, respectively. Intramuscular injection (behind the ear and on the side of the neck) and centralized drinking water were administered simultaneously. For intramuscular injection, the dosage was 0.3 ml per kg of body weight, once daily for 3 consecutive days. For drinking water, 100 ml was diluted in 25 kg of water and administered twice daily (morning and afternoon) for 8 consecutive days. The control group was fed normally. The prevention results after administration are recorded in Table 1.

[0090] Table 1 - Record of Treatment Results After Drug Administration Day 3 Day 5 Day 8 Day 15 Example 1 26 animals resumed feeding, while 5 died. A total of 33 animals have resumed feeding, and 8 animals have died. A total of 38 animals have resumed feeding, while 11 have died. A total of 39 animals have resumed feeding, while 11 have died. Example 2 25 animals resumed feeding, while 7 died. A total of 31 animals have resumed feeding, and 10 animals have died. A total of 35 animals have resumed feeding, and 12 have died. A total of 38 animals have resumed feeding, and 12 have died. Example 3 23 animals resumed feeding, while 9 died. A total of 28 animals have resumed feeding, while 11 have died. A total of 35 animals have resumed feeding, and 12 have died. A total of 37 animals have resumed feeding, and 13 have died. Example 4 28 animals resumed feeding, while 4 died. A total of 36 animals have resumed feeding, and 7 have died. A total of 39 animals have resumed feeding, and 10 animals have died. A total of 40 animals have resumed feeding, and 10 have died. Example 5 40 animals resumed feeding, while 2 died. A total of 46 animals have resumed feeding, and 4 animals have died. A total of 46 animals have recovered and resumed feeding, while 4 animals have died. A total of 46 animals have resumed feeding, and 4 animals have died. Example 6 33 animals resumed feeding, while 4 died. A total of 40 animals have resumed feeding, and 5 animals have died. A total of 43 animals have resumed feeding, and 6 animals have died. A total of 44 animals have resumed feeding, and 6 animals have died. Example 7 38 animals resumed feeding, while 3 died. A total of 43 animals have resumed feeding, and 5 animals have died. A total of 45 animals have resumed feeding, and 5 animals have died. A total of 45 animals have resumed feeding, and 5 animals have died. control group The condition worsened, and 18 animals died. The condition worsened, resulting in a total of 42 deaths. The condition worsened, resulting in a total of 50 deaths. The statistical results are shown in Table 2.

[0091] Table 2 - Statistical Results Total number (heads) Heal (head) Death (head) Cure rate (%) mortality rate(%) Example 1 50 39 11 78.0 22.0 Example 2 50 38 12 76.0 24.0 Example 3 50 37 13 74.0 26.0 Example 4 50 40 10 80.0 20.0 Example 5 50 46 4 92.0 8.0 Example 6 50 44 6 88.0 12.0 Example 7 50 45 5 90.0 10.0 control group 50 0 50 0 100.0 The above experiments demonstrate that the present invention has a significant therapeutic effect on African swine fever. Therefore, the traditional Chinese medicine composition of the present invention can be used to prepare drugs for treating African swine fever virus.

[0092] To further verify the preventive effect of the traditional Chinese medicine composition of this invention and its prepared liquid preparation on African swine fever, 150 healthy pigs weighing 70-110 catties were randomly selected under the supervision of relevant management departments and tested using the liquid preparation of traditional Chinese medicine prepared in Example 5 of this invention. Intramuscular injection (behind the ear and on the side of the neck) and centralized drinking water were administered simultaneously. For intramuscular injection, 0.3 ml per kg of body weight was given once daily for two consecutive days; for drinking water, 100 ml was diluted in 25 kg of water and administered in divided doses in the morning and afternoon for five consecutive days. Afterwards, the healthy pigs were placed in an environment containing African swine fever virus; after 30 days, 5 pigs died, and the remaining 145 pigs maintained healthy growth.

[0093] Clinical trials have shown that healthy pigs can be effectively prevented from being infected with African swine fever virus by using the traditional Chinese medicine liquid preparation (intramuscular injection + diluted with water for drinking) prepared in Example 5 of this invention; it is evident that the traditional Chinese medicine composition of this invention can also be used to prepare drugs for preventing African swine fever virus infection.

[0094] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

[0095] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

Claims

1. A traditional Chinese medicine composition for the prevention and treatment of African swine fever, characterized in that, It is composed of the following raw materials: Cold water stone, horse tail, magnolia wood, goosegrass, half-branch lotus, red peony, peony bark, ground euphorbia, flying indigo, bamboo leaf heart, honeysuckle vine.

2. The traditional Chinese medicine composition for the prevention and treatment of African swine fever according to claim 1, characterized in that, Composed of the following raw materials in parts by weight: 500-1500 parts of gypsum, 50-200 parts of horsetail, 50-200 parts of magnolia, 50-200 parts of goosegrass, 50-200 parts of scutellaria barbata, 30-120 parts of red peony, 30-120 parts of peony bark, 25-100 parts of euphorbia humifusa, 25-100 parts of indigo naturalis, 25-100 parts of bamboo leaf heart, and 25-100 parts of honeysuckle vine.

3. The traditional Chinese medicine composition for the prevention and treatment of African swine fever according to claim 1, characterized in that, Composed of the following raw materials in parts by weight: 700-1300 parts of gypsum, 80-120 parts of horsetail, 80-120 parts of magnolia, 80-120 parts of goosegrass, 80-120 parts of scutellaria barbata, 40-80 parts of red peony, 40-80 parts of peony bark, 30-70 parts of euphorbia humifusa, 30-70 parts of indigo naturalis, 30-70 parts of bamboo leaf heart, and 30-70 parts of honeysuckle vine.

4. The traditional Chinese medicine composition for the prevention and treatment of African swine fever according to claim 1, characterized in that, Composed of the following raw materials in parts by weight: 800 parts of gypsum, 100 parts of horsetail, 100 parts of magnolia, 100 parts of goosegrass, 100 parts of scutellaria barbata, 60 parts of red peony, 60 parts of peony bark, 50 parts of euphorbia humifusa, 50 parts of indigo naturalis, 50 parts of bamboo leaf heart, and 50 parts of honeysuckle vine.

5. A pharmaceutical composition for the prevention and treatment of African swine fever, characterized in that, Using the traditional Chinese medicine composition according to any one of claims 1 to 4 as raw material, and in combination with excipients, a veterinary preparation is prepared; The veterinary preparations include: liquid preparations and solid preparations.

6. A method for preparing a pharmaceutical composition for the prevention and treatment of African swine fever, characterized in that, Used to prepare the pharmaceutical composition of claim 5; A1. The preparation of liquid formulations includes the following steps: Extract the various Chinese medicinal herbs to obtain the extract; concentrate or not concentrate, add or not add excipients; mix evenly to prepare a liquid preparation; A2. The preparation of solid dosage forms includes the following steps: Extracts are obtained from various Chinese medicinal herbs to obtain extracts; the extracts are concentrated or not, and excipients are added; the mixtures are homogeneous, and the mixture is prepared into a solid dosage form. Alternatively, each Chinese herbal medicine can be pulverized, with or without excipients added; mixed evenly, and prepared into a solid preparation.

7. A method for preparing a pharmaceutical composition for the prevention and treatment of African swine fever, characterized in that, For preparing the liquid formulation of claim 5 or 6; comprising the following steps: S1. Prepare the dosage of each Chinese herbal medicine according to the required volume of the liquid preparation. Each 1ml of liquid preparation contains 1.0~2.0g of crude drug. S2, water extraction; Take the calcite and crush it, then mix it with horsetail, goosegrass, bamboo leaf heart, and ground euphorbia. Submerge the medicinal materials in water and soak at 40-50℃ for 0.5-1.0 hours; Then, simmer twice; the first time for 1.5 to 2.0 hours, and the second time for 1.0 to 1.5 hours. Filter while hot and combine the filtrates; The filtrate was concentrated under reduced pressure to a relative density of 1.15-1.20 to obtain drug solution A, which was then refrigerated for later use. S3, alcohol extraction; Take the remaining 6 Chinese herbs and extract them twice by hot reflux with 70-80% ethanol; each time for 1.0-2.0 hours, at a temperature of 35-50℃. Combine the alcohol extracts and recover the ethanol; Concentrate under reduced pressure until the relative density is not less than 0.95; obtain drug solution B, refrigerate for later use; S4. Combine solutions A and B and concentrate under reduced pressure until the relative density is 1.10~1.15; Add ethanol to achieve an alcohol content of 60-70%; refrigerate and let stand for 24 hours. Filter the solution, recover the ethanol from the filtrate, concentrate under reduced pressure until no alcohol odor remains; filter again to obtain the herbal filtrate. S5. Add water for injection to 90% of the volume of the Chinese herbal medicine filtrate; Add 0.5-1.0% activated carbon to the total mass of the Chinese herbal medicine filtrate, stir at 55-65℃ for 30 minutes, and then filter. Refrigerate the filtrate for 24 hours, then filter it again. Add 1%~2% by volume of Tween-80 and 0.1%~0.3% by volume of sodium benzoate, and stir well; Add water for injection to the final volume. Stir well, filter; fill and sterilize to obtain the corresponding volume of liquid preparation.

8. The method for preparing the traditional Chinese medicine for preventing African swine fever according to claim 7, characterized in that, In steps S2 to S4, the vacuum concentration environment is 0.08 to 0.1 MPa and 60 to 70 °C.

9. The method for preparing the traditional Chinese medicine for preventing African swine fever according to claim 7, characterized in that, In steps S2 to S5, the refrigeration temperature is 2 to 8°C; The filter media is a 0.45μm microporous membrane; the filtrate concentration standard is mass (g) / volume (ml).

10. The application of the pharmaceutical composition for the prevention and treatment of African swine fever according to claim 5, characterized in that, Used for the prevention and treatment of African swine fever.

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