WO2020252757A1 - Composition pharmaceutique destinée à la lutte contre la peste porcine africaine, et extraction, injection et utilisation associée - Google Patents

Composition pharmaceutique destinée à la lutte contre la peste porcine africaine, et extraction, injection et utilisation associée Download PDF

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WO2020252757A1
WO2020252757A1 PCT/CN2019/092159 CN2019092159W WO2020252757A1 WO 2020252757 A1 WO2020252757 A1 WO 2020252757A1 CN 2019092159 W CN2019092159 W CN 2019092159W WO 2020252757 A1 WO2020252757 A1 WO 2020252757A1
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swine fever
african swine
extract
preventing
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PCT/CN2019/092159
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English (en)
Chinese (zh)
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许启太
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海南今珠农业发展有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/074—Ganoderma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/59—Menispermaceae (Moonseed family), e.g. hyperbaena or coralbead
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/85—Verbenaceae (Verbena family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/19—Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Definitions

  • the present invention relates to the technical field of veterinary medicine, in particular to a pharmaceutical composition for preventing and treating African swine fever, its extract, injection and application.
  • African swine fever (English name: African swine fever, abbreviation: ASF) is an acute, hemorrhagic, and severe infectious disease caused by the African swine fever virus infecting domestic pigs and various wild boars (such as African wild boar, European wild boar, etc.). African swine fever does not infect humans, nor does it infect animals other than pigs, but it has a mortality rate of 100% for pigs. At present, there is no effective vaccine and treatment medicine in the world. Only culling and purification measures can be taken. African Swine Fever appeared in Kenya, south of Africa's sub-Saharan Desert in 1921. It has spread globally since the middle of the 20th century.
  • African swine fever is the "No. 1 killer" to the global pig industry. China is a major producer and consumer of pork, with about 700 million pigs sold every year, accounting for about 50% of the world's consumption. African swine fever has seriously affected the development of the pork industry and even affected people's daily diet.
  • Hainan is rich in tropical plant resources. There are more than 4,000 tropical plants, accounting for 30% of the country's total. It is also one of the six hotspots of biodiversity in the world. Hainan is known as the "natural medicine library". Among these green plants, there are more than 2500 kinds of medicinal plants that are closely related to human health, more than 600 kinds of unique plants, and more than 500 kinds of plants included in the pharmacopoeia.
  • Plant polysaccharides are compounds composed of many monosaccharides with the same or different structures through glycosidic bonds. Plant polysaccharides are widely present in plant organisms. At present, 100 plant polysaccharides have been isolated and extracted.
  • Plant polysaccharides have a variety of biological effects, including immune regulation, anti-tumor, lowering blood sugar, lowering blood fat, anti-radiation, anti-virus, anti-aging and other functions. Plant polysaccharides promote the body's specific immunity and non-specific immunity, improve the body's disease resistance and resistance, and can also be used as an immune booster in conjunction with vaccines, which can significantly improve the protection of the vaccine and the body's disease resistance. It can also induce the production of interferon (IFN) and produce antiviral effects.
  • IFN interferon
  • the present invention proposes a pharmaceutical composition for preventing and treating African swine fever, its extract, injection and application.
  • a pharmaceutical composition for preventing and treating African swine fever comprising the following raw materials in parts by weight: 10-30 parts of Ganoderma lucidum, 4-12 parts of Jindiluo, and beef tendon fruit 4-12 servings, 30-50 servings of betel nut, 4-12 servings of nude flower purple bead, 4-12 servings of Diwurong, 4-12 servings of Nepenthes.
  • the pharmaceutical composition comprises the following raw materials in parts by weight: 18-22 parts of Ganoderma lucidum, 6-10 parts of Jindiluo, 6-10 parts of beef tendon, 36-44 parts of betel nut, and 6-10 parts of nude flower purple beads. Servings, 6-10 servings of groundwater, 6-10 servings of Nepenthes.
  • the pharmaceutical composition includes the following raw materials in parts by weight: 20 parts of Ganoderma lucidum, 8 parts of Jindiluo, 8 parts of beef tendon, 40 parts of betel nut, 8 parts of nude flower purple bead, 8 parts of dianthus, and Nepenthes 8 servings.
  • a pharmaceutical extract for preventing and treating African swine fever comprises the pharmaceutical composition for preventing and treating African swine fever of the present invention.
  • the preparation method of the pharmaceutical extract for preventing and treating African swine fever includes the following steps:
  • the Ganoderma lucidum extract and the betel nut extract and the mixed extract are mixed to prepare a drug extract for preventing and treating African swine fever.
  • a medicinal injection for preventing and treating African swine fever comprises the drug extract for preventing and treating African swine fever of the present invention.
  • the preparation method of the pharmaceutical injection includes the following steps: take the above-mentioned Ganoderma lucidum extract, betel nut extract, and mixed extract, mix, add water for injection to fully dissolve, add 0.8-1.2ml benzyl alcohol, 0.8- 1.2ml Tween-80, adjust the pH value to 6.8 ⁇ 7.2 with NaOH solution, add water for injection to make the volume; add 0.4% ⁇ 0.6% injection activated carbon to remove heat source, stir well for 20 ⁇ 30min, and filter repeatedly after dissolution To clarify, take the filtrate, let it cool for 20-28h, filter, fill it in an ampoule, autoclave at 121°C for 10-20 minutes, and test it to obtain a drug injection. Each 1ml injection contains 1.8 equivalent of original medicinal materials. ⁇ 2.2g.
  • compositions for preventing and treating African swine fever according to any one of the present invention in the preparation of a medicine for preventing or/and curing and preventing African swine fever.
  • Ganoderma It is the fruiting body of the porous castor family fungus Ganoderma lucidum.
  • Ganoderma lucidum a native medicinal material of Hainan, is rich in Ganoderma lucidum polysaccharides.
  • Jindiluo It is an insectivorous plant widely distributed in tropical and subtropical areas of Asia, Africa and Oceania. It is mostly found in coastal areas or islands.
  • the Grass Compendium records Jindiluo: mountain miasma poisoning and poisoning. , Yigenyanshengjiufu a money dagger, that is the solution (Shizhen).
  • Gooseberry It is the root of Gooseberry, a plant of the bitter wood family, distributed in Hainan and Guangdong. It has the effect of clearing away heat and preventing malaria.
  • Betel nut It is the seed of the palm plant Areca catechu L., a precious tropical plant in Hainan. It is located at the top of my country's five major southern medicines and contains alkaloids and polysaccharides.
  • Nude flower purple bead It belongs to the Verbena family, from shrubs to small trees. It is distributed in Hainan, Guangdong and other places in my country. It has the functions of hemostasis, invigorating blood, hemostasis, removing heat, and detoxification. "Materia Medica Supplements” records: detoxification Ulcer, throat numbness, swelling, dysplasia, snake worm sting, rabies poison.
  • the ground is not tolerant of cold and bitter in taste, has the functions of clearing away heat, detoxifying, cutting malaria, and analgesic. It is an authentic medicinal material in Hainan.
  • Nepenthes It is a tropical carnivorous plant. Its origin is mainly in the tropical regions of the Old World. It is distributed in Hainan, Guangdong and Guangxi in my country. It has the functions of clearing lungs, moisturizing dryness, running water, and detoxifying.
  • the present invention aims at African swine fever originating in tropical regions.
  • the selected medicinal materials are all produced in the tropical or subtropical regions of Hainan.
  • the main components of the pharmaceutical composition of the present invention are natural polysaccharide complexes in tropical plants and South China Sea organisms, which can be directly Inhibit the virus from attaching to cells, entering cells and virus replication process, in addition, through indirect action, that is, by enhancing the body's antiviral immunity to exert its antiviral effect.
  • the pharmaceutical composition of the present invention can enhance the functions of macrophages and T cells, increase the number of E-ring forming cells, induce cytokines, and promote the production of interleukin 2 (IL-2) to produce in animals Endogenous IFN to achieve antiviral purpose.
  • IFN inducer can enhance the functions of macrophages and T cells, increase the number of E-ring forming cells, induce cytokines, and promote the production of interleukin 2 (IL-2) to produce in animals Endogenous IFN to achieve antiviral purpose.
  • IL-2 interleukin 2
  • the pharmaceutical composition of the present invention has a preventive effect on various viral infections such as African swine fever virus, has high efficiency and low toxicity, and at the same time enhances the body's antioxidant level, inhibits fat oxidation in muscles, reduces cell membrane damage, improves flesh color, and reduces dripping. Loss etc.
  • the components of the pharmaceutical composition of the present invention have a synergistic effect, jointly inhibit the African swine fever virus, and have a significant effect on the treatment of African swine fever, with a cure rate of over 80.0% and up to 90.0%.
  • the pharmaceutical composition of the present invention can cure or prevent African swine fever, has low cost, can be widely used, and can solve major problems in the pork industry.
  • a pharmaceutical composition for preventing and treating African swine fever which comprises the following raw materials in parts by weight: 10 parts of Ganoderma lucidum, 4 parts of Jindiluo, 12 parts of beef tendon, 50 parts of betel nut, 4 parts of nude flower purple beads, Ground can not accommodate 4 parts, 12 parts of Nepenthes.
  • the above-mentioned raw materials are prepared according to conventional methods (for example, direct water extraction or alcohol extraction), and the extracts are prepared into injections according to conventional methods. Each 1ml injection contains 2.0g equivalent to the original medicinal materials.
  • a pharmaceutical composition for preventing and treating African swine fever comprising the following raw materials in parts by weight: 30 parts of Ganoderma lucidum, 12 parts of Jindiluo, 4 parts of beef tendon, 30 parts of betel nut, 12 parts of nude flower purple beads, There are 12 parts of ground can not, 4 parts of Nepenthes.
  • the above-mentioned raw materials are prepared according to conventional methods (for example, direct water extraction or alcohol extraction), and the extracts are prepared into injections according to conventional methods. Each 1ml injection contains 2.0g equivalent to the original medicinal materials.
  • a pharmaceutical composition for preventing and treating African swine fever comprising the following raw materials in parts by weight: 18 parts of Ganoderma lucidum, 6 parts of Jindiluo, 10 parts of beef tendon, 44 parts of betel nut, 10 parts of nude flower purple beads, There are 6 parts of ground not tolerance and 6 parts of Nepenthes.
  • the above-mentioned raw materials are prepared according to conventional methods (for example, direct water extraction or alcohol extraction) to prepare extracts, and the extracts are prepared into injections according to conventional methods. Each 1ml injection is equivalent to 2.0g of original medicinal materials.
  • a pharmaceutical composition for preventing and treating African swine fever comprising the following raw materials in parts by weight: 22 parts of Ganoderma lucidum, 10 parts of Jindiluo, 6 parts of beef tendon, 36 parts of betel nut, 6 parts of nude flower purple beads, 10 parts of ground can not accommodate 10 parts of Nepenthes.
  • the above-mentioned raw materials are prepared according to conventional methods (for example, direct water extraction or alcohol extraction), and the extracts are prepared into injections according to conventional methods. Each 1ml injection contains 2.0g equivalent to the original medicinal materials.
  • a pharmaceutical composition for preventing and treating African swine fever comprising the following raw materials in parts by weight: 20 parts of Ganoderma lucidum, 8 parts of Jindiluo, 8 parts of beef tendon, 40 parts of betel nut, 8 parts of nude flower purple beads, Ground can not accommodate 8 parts, 8 parts of Nepenthes.
  • the above-mentioned raw materials are prepared according to conventional methods (for example, direct water extraction or alcohol extraction), and the extracts are prepared into injections according to conventional methods. Each 1ml injection contains 2.0g equivalent to the original medicinal materials.
  • betel nut extract take the prescription amount of dried betel nut and crush it, add 8 times the weight of betel nut, soak for 60 minutes, assist with ultrasonic 200W, extract 60 minutes below 60°C, add 0.2% betel nut special enzyme for betel nut to enzymolysis , Adjust the pH to 5.5, enzymatically digest at 55°C for 2h, filter, centrifuge at 3500r/min for 12min, take the supernatant, filter in multiple stages, concentrate the filtrate to a relative density of 1.11, add 95v/v% ethanol to make the alcohol content 50 %, stand at 3°C for 24h, centrifuge at 3500r/min for 12min, take the supernatant, concentrate to a relative density of 1.11, and vacuum dry below 60°C to obtain betel nut extract;
  • the formula of the pharmaceutical composition of this example is the same as that of Example 6, and the difference from Example 6 is that the Ganoderma lucidum extract, betel nut extract and mixed extract prepared by the above method are taken, mixed, and dissolved in water for injection, and each 150ml is added 1.0ml benzyl alcohol, 1.0ml Tween-80, adjust the pH to 7.0 with NaOH solution, add water for injection to make the volume; add 0.5% mass fraction of injection activated carbon (that is, 0.5g activated carbon dissolved in 100ml of sterile water) Heat source, stir well for 25min, after dissolving, filter repeatedly until clear, take the filtrate, cool it for 24h, filter (0.22um nylon microporous membrane), fill it in an ampoule, autoclave at 121°C for 15 minutes, check, Obtained injection, each 1ml injection contains 2.0g equivalent to the original medicinal materials.
  • the Ganoderma lucidum extract, betel nut extract and mixed extract prepared by the above method are taken, mixed, and
  • a farm has a batch of live pigs, sows of 1-5 gestational age and Duroc boars, weighing 50-200kg, some of them have high fever, breathing difficulties, cough, runny nose and eye secretions, skin cyanosis, depression, anorexia, The sow has symptoms such as abortion. Treatment with a variety of antibiotics and antipyretics was ineffective and he died on the 8th day. Symptoms and necropsy confirmed infection with African swine fever.
  • 420 sick pigs of this batch were randomly selected as the administration group. They were divided into 7 groups, each with 60 pigs. The injections prepared in Examples 1-7 of the present invention were used respectively.
  • pigs were injected intramuscularly (neck side behind the base of the ear), 20ml/time (40ml/time for a body weight of more than 100kg), used 3 times in a row, the interval between the two intramuscular injections was 2 days, and the first intramuscular injection was doubled. Twenty sick pigs from this batch were randomly selected and fed as a control group.
  • Example 1 60 48 12 80.0% 20.0%
  • Example 2 60 48 12 80.0% 20.0%
  • Example 3 60 50 10 83.3% 16.7%
  • Example 4 60 49 11 81.7% 18.3%
  • Example 5 60 52 8 86.7% 13.3%
  • Example 6 60 53 7 88.3% 11.7%
  • Example 7 60 54 6 90.0% 10.0% Control group 20 0 20 0.0% 100.0%
  • the above-mentioned clinical test shows that the pharmaceutical composition of the present invention has a significant effect on the treatment of African swine fever, with a cure rate of over 80.0% and up to 90.0%.
  • the pharmaceutical composition of the invention can effectively inhibit the deterioration of the disease, restore appetite, restore the damaged vitality of the body, and restore normal growth and development. It can be seen that the pharmaceutical composition of the present invention can be applied to the preparation of drugs for treating African swine fever virus.
  • Example 7 of the present invention 60 healthy pigs were randomly selected, and the injection prepared in Example 7 of the present invention was used for the experiment.
  • the pigs were injected intramuscularly (the base of the ear and the neck side), 20ml/time (with a weight of more than 100kg) 40ml/time).
  • the healthy pigs were placed in the African swine fever virus environment. 25 days later, 2 died and 58 remained healthy and grew normally.
  • Clinical trials have shown that healthy pigs injected with the injection prepared in Example 7 of the present invention can prevent infection of African swine fever virus.
  • the pharmaceutical composition of the present invention can also be used to prepare drugs for preventing infection of African swine fever virus.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
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Abstract

L'invention concerne une composition pharmaceutique destinée à la lutte contre la peste porcine africaine, et une extraction, une injection et l'utilisation associée. La composition pharmaceutique comprend les matières premières suivantes en parties en poids : de 10 à 30 parties de ganoderme, de 4 à 12 parties de Drosera burmannii, de 4 à 12 parties de Harrisonia perforata, de 30 à 50 parties de noix d'arec, de 4 à 12 parties de Callicarpa nudiflora, de 4 à 12 parties de racine de Stephania epigaea et de 4 à 12 parties de nepenthes. La composition pharmaceutique offre un effet de lutte efficace sur la peste porcine africaine, peut être largement utilisée pour prévenir le virus de la peste porcine africaine, et résout un problème majeur de l'industrie du porc.
PCT/CN2019/092159 2019-06-19 2019-06-20 Composition pharmaceutique destinée à la lutte contre la peste porcine africaine, et extraction, injection et utilisation associée WO2020252757A1 (fr)

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CN201910529164.6A CN110101783A (zh) 2019-06-19 2019-06-19 一种防治非洲猪瘟的药物组合物及其提取物、注射液和应用

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CN110585357A (zh) * 2019-10-10 2019-12-20 成都兴旺动物药业有限公司 一种预防非洲猪瘟的药物组合物及其注射液和应用
CN110559363A (zh) * 2019-10-15 2019-12-13 郑州赛科药业科技有限公司 一种防治非洲猪瘟的中药复方发酵口服液及其制备工艺
CN111150787A (zh) * 2020-01-21 2020-05-15 许启太 一种中兽药预混剂及其制备方法
CN111544447A (zh) * 2020-05-27 2020-08-18 海南今珠农业发展有限公司 一种中药多糖、制备方法及其应用

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