Traditional Chinese medicine composition for preventing and treating porcine reproductive and respiratory syndrome as well as preparation method and traditional Chinese medicine preparation thereof

Abstract

The invention relates to the technical field of traditional Chinese veterinary medicines, and particularly discloses a traditional Chinese medicine composition for preventing and treating porcine reproductive and respiratory syndrome as well as a preparation method and a traditional Chinese medicine preparation thereof. The traditional Chinese medicine composition is prepared from the following components: radix codonopsis, a rhizoma atractylodis macrocephalae extract, Chinese yam, rhizoma zingiberis, an angelica sinensis extract, radix paeoniae alba, a ligusticum wallichii extract, dendrobe, a eucommia ulmoides extract, a semen cuscutae extract and radix aucklandiae. Codonopsis pilosula and atractylodes macrocephala are used for strengthening body resistance as monarch drugs, tonifying middle-Jiao and Qi, invigorating spleen and tonifying lung, so that the disease-resistant immunity of a body is enhanced; the Chinese yam and the dried ginger are used for strengthening body resistance and eliminating pathogenic factors as ministerial drugs, so that the codonopsis pilosula and the atractylodes macrocephala have the effects of strengthening body resistance and eliminating pathogenic factors and resisting viruses; eucommia ulmoides, semen cuscutae and radix aucklandiae are adopted as conductant drugs and have the functions of monarch, minister, assistant and conductant, so that the traditional Chinese medicine composition not only can harmonize all the drugs, but also can strengthen the body resistance to eliminate pathogenic factors and enhance the immune function. All the medicines in a specific ratio are combined and matched with one another, so that both the porcine reproductive and respiratory syndrome and the secondary transmission can be prevented.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese veterinary medicines, and in particular to a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs, a preparation method thereof, and a traditional Chinese medicine preparation. Background Art

[0002] Porcine reproductive and respiratory syndrome (PRRS) is an acute, highly contagious swine disease caused by the porcine reproductive and respiratory syndrome virus (PRRSV), commonly known as blue ear disease. The virus primarily attacks the pig's immune system, particularly alveolar macrophages, causing immunosuppression. It is often co-infected with porcine circovirus type 2 (PCV2) and Haemophilus parasuis, resulting in piglet mortality rates as high as 30%-50% and sow abortion rates of 20%-40%. Current prevention and control measures primarily rely on vaccines and Western medications. The mainstream vaccines include attenuated and inactivated vaccines, while Western medications primarily consist of antibiotics. Attenuated vaccines generally have the risk of reversion to virulence, and have low protection rates against mutant strains such as NADC30-like. The immune response level of inactivated vaccines is limited, and multiple vaccinations are required, which is costly. Western medicine lacks specific antiviral drugs and can only relieve symptoms but cannot eliminate the virus. Long-term use of antibiotics can easily lead to drug resistance, drug residues, and intestinal flora imbalance. The biosafety systems of small and medium-sized pig farms are imperfect, and viruses are transmitted through introduction of new species, personnel, and vehicles carrying the virus, resulting in high prevention and control costs.

[0003] Traditional Chinese medicine (TCM) possesses unique advantages in regulating immunity and alleviating inflammatory responses. However, existing TCM formulas are primarily focused on the single efficacy of "clearing heat and detoxifying," but lack multi-target interventions to address PRRSV-induced immunosuppression and lung damage, resulting in limited efficacy. Some formulas contain medications contraindicated during pregnancy, and their suitability for pregnant sows is unclear. Existing TCM patents are primarily based on empirical formulas, lack in vivo pharmacodynamic validation and safety evaluation data, and offer insufficient evidence for clinical application. Therefore, there is an urgent need to develop an effective, safe, and scalable TCM composition that could inhibit PRRSV replication through multi-targeted actions, reduce viremia, regulate immune function, alleviate immunosuppression, reduce lung inflammation, improve respiratory symptoms, enhance sow reproductive performance, and reduce piglet mortality. Summary of the Invention

[0004] In response to the above problems, the present invention provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs, a preparation method thereof, and a traditional Chinese medicine preparation. By designing the components and proportions of the traditional Chinese medicine composition, the prevention and treatment effects of blue ear disease in pigs are improved.

[0005] In order to solve the above technical problems, the technical solution provided by the present invention is: In a first aspect, the present invention provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs, comprising the following components in parts by weight: 22 to 30 parts of Codonopsis pilosula, 20 to 28 parts of Atractylodes macrocephala extract, 18 to 25 parts of Dioscorea batatas, 15 to 22 parts of dried ginger, 13 to 20 parts of Angelica sinensis extract, 13 to 20 parts of White Peony Root, 12 to 18 parts of Chuanxiong extract, 10 to 16 parts of Dendrobium candidum, 7 to 13 parts of Eucommia ulmoides extract, 7 to 13 parts of Cuscuta australis extract and 5 to 10 parts of Costus root.

[0006] Compared with the prior art, the Chinese medicine composition for preventing and treating blue ear disease provided by the present invention adopts Codonopsis pilosula and Atractylodes macrocephala (extracts) as the main ingredients to strengthen the body, replenish the middle qi, strengthen the spleen and benefit the lungs, dry dampness and promote diuresis, calm the fetus, and stop sweating, so as to enhance the body's anti-disease immunity; adopts Chinese yam and dried ginger as the auxiliary ingredients to strengthen the body and dispel pathogenic factors, which can not only assist Codonopsis pilosula and Atractylodes macrocephala (extracts) in strengthening the body, but also have the function of dispelling pathogenic factors and resisting viruses, among which Chinese yam nourishes the spleen and stomach, benefits the lungs and promotes fluid production, nourishes the kidneys and astringes essence, and dried ginger warms the middle and dispels cold, restores yang and dredges the meridians, and dry dampness and eliminates phlegm; with the addition of Chinese angelica (extract), white peony root, Chuanxiong (extract) and dendrobium, it not only enhances the function of dispelling pathogenic factors, killing bacteria, and resisting It not only has antiviral effects, but also nourishes and invigorates blood circulation, tonifies the kidneys and stabilizes pregnancy, and regulates qi and blood. Angelica (extract) nourishes and nourishes blood, invigorates blood circulation and relieves pain, moistens dryness and promotes bowel movements. White peony root calms the liver and relieves pain, nourishes blood and consolidates yin. Chuanxiong (extract) invigorates blood circulation and promotes qi, dispels wind and relieves pain. Dendrobium and Chinese yam, when combined, strengthen the spleen, replenish qi and nourish yin. Adjuvants can both invigorate qi and strengthen the body's health, clear away heat and detoxify, stimulate the immune system and enhance immune function, while also inhibiting viruses and bacteria. Eucommia (extract), Cuscuta (extract), and Aucklandia as guiding herbs harmonize the various herbs, strengthen the body's health and dispel pathogenic factors, and enhance immune function. The specific ratios of these herbs combined achieve the goal of strengthening the body's health without retaining pathogenic factors, and dispelling pathogenic factors without harming the body's health, preventing and treating blue ear disease and secondary transmission.

[0007] When blue ear disease (PRR) causes immunosuppression, Codonopsis pilosula can improve the pig's health by enhancing lymphocyte activity (due to the immunomodulatory effects of Codonopsis pilosula polysaccharides), alleviating the "vital deficiency" state of pathogenic factors. This is suitable for pigs with a long course of illness, loss of appetite, and lethargy. Following PRR, pigs often experience diarrhea and loose stools due to intestinal mucosal damage (dampness trapping the spleen). Atractylodes macrocephala extract can alleviate symptoms by clearing dampness and strengthening the spleen, reducing the risk of secondary bacterial enteritis. Combining Atractylodes macrocephala extract with Codonopsis pilosula can enhance the spleen-tonifying and qi-invigorating effects, improving digestive function in sick pigs.

[0008] During the recovery period, sick pigs often experience weak spleen and stomach, poor appetite, and mild cough and asthma. Chinese yam nourishes the spleen and stomach yin fluids, replenishes lung qi, promotes digestive function recovery, and alleviates persistent respiratory symptoms. It is suitable for long-term use during the conditioning period, especially for piglets and sows. If sick pigs exhibit chills, cold limbs, watery diarrhea, and a greasy white tongue coating (a symptom of cold-dampness obstructing the spleen), dried ginger can alleviate symptoms by warming the middle and dispelling cold.

[0009] When PRRS causes miscarriage and postpartum Qi and blood deficiency in sows, Angelica sinensis extract can improve symptoms such as persistent lochia and insufficient lactation. In the chronic phase, pigs suffer from anemia and pale skin due to prolonged loss of appetite, weight loss, decreased lactation, and delayed estrus. Angelica sinensis extract can be combined with extracts of Codonopsis pilosula, Atractylodes macrocephala, Chinese yam, and dried ginger to enhance blood-tonifying effects and promote recovery. When pigs experience liver blood deficiency and spasms and convulsions (such as neurological symptoms in piglets) due to high fever or stress, White Peony Root can alleviate muscle tremors by softening the liver and relieving urgency. When PRRS leads to secondary lung blood stasis (such as difficulty breathing and pulmonary hemorrhage), Chuanxiong extract can improve pulmonary blood circulation and reduce inflammatory exudates. In the acute phase of PRRS, pigs often exhibit high fever, difficulty breathing, and fluid depletion. Dendrobium can replenish fluids and clear heat, alleviating Yin deficiency symptoms such as thirst and constipation. Dendrobium polysaccharides have immunomodulatory effects (such as promoting lymphocyte proliferation), which can improve the immunosuppression caused by blue ear disease to a certain extent. Dendrobium can be used in combination with codonopsis pilosula and Chinese yam to restore immune function in recovering pigs.

[0010] Piglets or fattening pigs suffering from kidney deficiency and hind limb weakness due to prolonged illness can benefit from Eucommia ulmoides extract to improve motor function. Blue ear disease (PRRS) can lead to decreased reproductive function in pigs, and Cuscuta australis extract can improve reproductive performance by tonifying the kidneys and replenishing essence. Sows infected with PRRS experience fetal movement disturbances and recurrent miscarriages. Combining Eucommia ulmoides extract with Cuscuta australis extract can strengthen kidney Qi during pregnancy, reduce PRRS-induced miscarriage rates, and enhance fetal health. Pigs infected with PRRS often experience loss of appetite, indigestion, and intestinal flora disturbances (due to viral damage to the intestinal mucosa, leading to secondary bacterial infection). Costus root (Muxiang) can indirectly improve the pig's physical condition by regulating gastrointestinal motility, relieving abdominal distension, and improving feeding habits. Components in costus root (Muxiang) such as costunolide and dehydrocostusolide have anti-inflammatory and antibacterial properties, potentially alleviating intestinal inflammatory responses. Combining Muxiang with extracts of Codonopsis pilosula and Atractylodes macrocephala has a synergistic effect of strengthening the spleen and replenishing Qi, improving appetite and inhibiting viral infections.

[0011] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 24 to 28 parts of Codonopsis pilosula, 22 to 26 parts of Atractylodes macrocephala extract, 18 to 23 parts of Dioscorea batatas, 17 to 22 parts of dried ginger, 13 to 18 parts of Angelica sinensis extract, 13 to 18 parts of White Peony Root, 14 to 16 parts of Chuanxiong extract, 12 to 15 parts of Dendrobium candidum, 8 to 12 parts of Eucommia ulmoides extract, 8 to 12 parts of Cuscuta australis extract and 6 to 8 parts of Costus root.

[0012] Further preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 25 to 26 parts of Codonopsis pilosula, 24 to 25 parts of Atractylodes macrocephala extract, 20 to 22 parts of Dioscorea batatas, 18 to 20 parts of dried ginger, 15 to 16 parts of Angelica sinensis extract, 15 to 16 parts of White Peony Root, 14 to 16 parts of Chuanxiong extract, 13 to 15 parts of Dendrobium candidum, 9 to 11 parts of Eucommia ulmoides extract, 9 to 11 parts of Cuscuta australis extract and 6 to 8 parts of Costus root.

[0013] Preferably, the yam is Chinese yam.

[0014] Preferably, the preparation method of the Atractylodes macrocephala extract comprises the following steps: Adding Atractylodes macrocephala to a mixed solution of propylene glycol, ethyl acetate, acetic acid and water, soaking the mixture, and extracting under reflux at 60°C to 75°C to obtain an Atractylodes macrocephala extract; Concentrating the Atractylodes macrocephala extract to obtain a thick Atractylodes macrocephala paste; The Atractylodes macrocephala thick paste is dried to obtain an Atractylodes macrocephala extract.

[0015] The present invention adopts a mixed solution of propylene glycol, ethyl acetate, acetic acid and water as the extraction solvent of Atractylodes macrocephala. Propylene glycol is a polar solvent and is miscible with water. It can increase the solubility of polysaccharides and phenolic acid components. At the same time, it serves as a co-solvent for ethyl acetate and the aqueous phase, which can improve the compatibility of the system. Ethyl acetate is a weakly polar solvent and can efficiently extract volatile oils (such as atractylodes lactone and atractylodes ketone) and fat-soluble components. Acetic acid is used to adjust the pH of the system to acidic, so that phenolic acids (such as chlorogenic acid) are in a free state, thereby improving the extraction efficiency, inhibiting enzyme activity to prevent component degradation, and enhancing the interaction between polysaccharides and the extraction solvent. Water acts as a polar base to promote the dissolution of water-soluble components (such as oligosaccharides and amino acids).

[0016] Further preferably, the mass ratio of propylene glycol, ethyl acetate and water is (4-6):(2-4):1.

[0017] More preferably, the pH of the mixed solution is 3-5 (more preferably 3.5-4.5).

[0018] The present invention has found through a large number of experiments that under specific pH conditions, the solubility of phenolic acid components in Atractylodes macrocephala is the highest and the stability of volatile oil is good.

[0019] For example, the method for preparing the mixed solution comprises the following steps: Mix propylene glycol, acetic acid and water, slowly add ethyl acetate, and stir at high speed for 5 minutes to 10 minutes to form a homogeneous mixed solution.

[0020] Further preferably, the mass volume ratio of the Atractylodes macrocephala to the mixed solution is 1 g: (6~10) mL.

[0021] More preferably, the soaking time is 30 min to 50 min.

[0022] More preferably, the temperature of the reflux extraction is 65° C. to 70° C., the number of reflux extractions is 2 to 3 times (more preferably 2 times), and the time of each reflux extraction is 40 min to 60 min.

[0023] The present invention performs reflux extraction of Atractylodes macrocephala under specific conditions, which can avoid a large amount of volatilization caused by a temperature higher than the boiling point of the solvent, while activating molecular motion and balancing extraction efficiency and purity.

[0024] For example, after the reflux extraction is completed, the method further includes: filtering the material system while hot to obtain the Atractylodes macrocephala extract. The filtration can be performed using a Buchner funnel or centrifugation.

[0025] Further preferably, the concentration is carried out using a rotary evaporator at a temperature of 40° C. to 50° C. and a vacuum degree of 0.05 MPa to 0.07 MPa.

[0026] In the preparation method of the Atractylodes macrocephala extract of the present invention, the distillate is concentrated until there are no oily droplets (GC detection shows that the residual ethyl acetate is ≤0.1%), and the ethyl acetate is collected and recovered for reuse; and then the concentration is continued to remove propylene glycol, acetic acid and water.

[0027] Further preferably, the relative density of the Atractylodes macrocephala thick paste at 50° C. is 1.1-1.15.

[0028] Preferably, the preparation method of the angelica extract comprises the following steps: Adding angelica to a mixed solution of acetone, ethyl acetate, glycerin and water, soaking, and extracting under reflux at 50°C to 65°C to obtain angelica extract; Concentrating the angelica extract to obtain a thick angelica paste; The angelica thick paste is dried to obtain the angelica extract.

[0029] The present invention adopts a mixed solution of acetone, ethyl acetate, glycerol and water as an extraction solvent for angelica sinensis. Acetone is used as the main solvent to extract fat-soluble components (such as ferulic acid); ethyl acetate is used as an auxiliary solvent to enhance the solubility of ester components; glycerol can adjust the polarity of the extraction solvent and increase the stability of the extraction system; water is used as a polar base to promote the dissolution of water-soluble components (such as polysaccharides).

[0030] Further preferably, the mass ratio of acetone, ethyl acetate, glycerol and water is (4-5):(2-3):(0.5-1):(1-2).

[0031] Further preferably, the mass volume ratio of the angelica sinensis to the mixed solution is 1 g: (8-10) mL.

[0032] More preferably, the soaking time is 30 min to 45 min.

[0033] More preferably, the reflux extraction is performed 2 to 3 times (more preferably 2 times), and the time for each reflux extraction is 1.5 h to 2 h.

[0034] The present invention performs reflux extraction of angelica sinensis under specific conditions, which can ensure that the mixed solution is in a slightly boiling state, activate molecular motion, and balance the extraction efficiency and purity.

[0035] For example, after the reflux extraction is completed, the method further includes filtering the material system while hot to obtain the angelica extract. The filtration can be performed using a Buchner funnel or centrifugation.

[0036] Further preferably, the concentration is carried out using a rotary evaporator at a temperature of 40° C. to 50° C. and a vacuum degree of 0.08 MPa to 0.1 MPa.

[0037] Further preferably, the relative density of the angelica thick paste at 60° C. is 1.15-1.2.

[0038] Preferably, the preparation method of the Chuanxiong extract comprises the following steps: S1. Add Chuanxiong Rhizome to water, soak, connect to volatile oil extractor, boil over high heat and keep it at a low boil for 3-4 hours to obtain volatile oil and medicinal residue; S2. Add the medicinal residue to water, boil over high heat, then simmer over low heat to obtain a water extract of Chuanxiong; S3, concentrating the water extract of Chuanxiong, and mixing it with the volatile oil to obtain a Chuanxiong thick paste; S4. Drying the Chuanxiong thick paste to obtain a Chuanxiong extract.

[0039] Further preferably, in S1, the mass volume ratio of Chuanxiong to water is 1 g: (8-10) mL.

[0040] Further preferably, in S1, the soaking time is 45 min to 60 min.

[0041] Further preferably, in S2, the mass volume ratio of the medicinal residue to water is 1 g: (6-10) mL.

[0042] Further preferably, in S2, the decoction is performed 2 to 3 times (more preferably 2 times), and the decoction time for each time is 1.3 h to 1.8 h.

[0043] For example, in S2, after combining the decoctions, the step further includes: filtering the decoctions to obtain a water extract of Chuanxiong.

[0044] Further preferably, in S3, the relative density of the Chuanxiong thick paste at 60°C is 1.2-1.3.

[0045] Preferably, the preparation method of the Eucommia ulmoides extract comprises the following steps: Add Eucommia ulmoides into water and soak it. Adjust the pH of the soaking solution to 8-9. Boil it over high heat and then simmer it over low heat to obtain the Eucommia ulmoides aqueous extract. Concentrating the Eucommia ulmoides aqueous extract to obtain an Eucommia ulmoides thick paste; The Eucommia ulmoides thick paste is dried to obtain the Eucommia ulmoides extract.

[0046] Further preferably, the mass volume ratio of the Eucommia ulmoides to water is 1 g: (8-10) mL.

[0047] For example, sodium hydroxide solution is used to adjust the pH of the soaking solution to promote the dissolution of eucommia glycosides.

[0048] More preferably, the soaking time is 30 min to 40 min.

[0049] More preferably, the decoction is performed 2 to 3 times (more preferably 2 times), and the decoction time for each time is 1.5 to 2 hours.

[0050] For example, after combining the decoctions, the process further comprises: centrifuging the decoctions at 3000 rpm to 4000 rpm for 15 minutes, taking the supernatant, and obtaining the Eucommia ulmoides aqueous extract.

[0051] Further preferably, the relative density of the Eucommia ulmoides thick paste at 60° C. is 1.15-1.2.

[0052] Further preferably, after the concentration, the process further comprises: precipitating impurities with an ethanol aqueous solution, and filtering to obtain a thick Eucommia paste.

[0053] For example, the mass concentration of the ethanol aqueous solution is 60% to 70%.

[0054] Preferably, the preparation method of the Cuscuta seeds extract comprises the following steps: Add dodder seeds into water, soak, boil over high heat, then simmer over low heat to obtain dodder seed water extract; Concentrating the dodder seed water extract to obtain a dodder seed thick paste; The dodder seed paste is dried to obtain a dodder seed extract.

[0055] Further preferably, the mass volume ratio of the dodder seeds to water is 1 g: (10-12) mL.

[0056] More preferably, the soaking time is 50 min to 60 min.

[0057] More preferably, the decoction is performed 2 to 3 times (more preferably 2 times), and the decoction time for each time is 1.8 to 2.2 hours.

[0058] For example, after combining the decoctions, the method further includes: filtering the decoctions under pressure (at a pressure of 0.1 MPa to 0.2 MPa) to obtain a Cuscuta seed water extract.

[0059] Further preferably, the relative density of the dodder seed paste at 60° C. is 1.2-1.25.

[0060] Further preferably, the Codonopsis pilosula is prepared by honey roasting, the Atractylodes macrocephala, Chinese yam and white peony root are prepared by bran frying, the Dendrobium is prepared by blanching, the Eucommia ulmoides is prepared by salt roasting, the Cuscuta chinensis is prepared by salt processing, and the dried ginger, Chinese angelica, Ligusticum chuanxiong, Dendrobium and costus root are used raw.

[0061] The present invention can change the texture of the medicinal material, remove some impurities, increase the content of effective ingredients, thereby enhancing the therapeutic effect and better exerting the synergistic effect of the components; at the same time, it is conducive to storage.

[0062] For example, the honey-roasting method of Codonopsis pilosula includes the following steps: Take clean Codonopsis pilosula slices and mix them with refined honey (the mass ratio of honey to water is 1:0.5-1:1). Simmer until the honey is completely absorbed. Then fry over low heat until the surface is yellow-brown and no longer sticky. This is the Codonopsis pilosula. The mass ratio of Codonopsis pilosula slices to refined honey is 10:(2.2-3).

[0063] For example, the bran-frying method of Atractylodes macrocephala, Chinese yam or white peony root comprises the following steps: Sprinkle bran into a hot wok. When it starts to smoke, add slices of Atractylodes macrocephala, Chinese yam, or white peony root. Stir-fry until the surface turns dark yellow (the bran is burnt black). Sieve out the bran to obtain Atractylodes macrocephala, Chinese yam, or white peony root. The mass ratio of Atractylodes macrocephala, Chinese yam, or white peony root to bran is 10:(1-1.5), respectively.

[0064] For example, the method for scalding dendrobium includes the following steps: Place river sand or talcum powder in a pot and heat over high heat until flexible. Add clean, dried dendrobium segments and stir-fry until the surface swells and the color deepens (to a dark yellow or slightly burnt spot). Sieve out the sand to obtain the dendrobium. The mass ratio of dendrobium to river sand or talcum powder is 1:4-6.

[0065] For example, the salt-roasting method of Eucommia ulmoides comprises the following steps: Take pieces of Eucommia ulmoides, mix them with salt water (the mass ratio of salt to water is 1:4~1:5), and simmer until the salt water is absorbed. Stir-fry over medium heat until the threads are easy to break and the surface is charred black. This is how you get Eucommia ulmoides.

[0066] For example, the method for preparing salt of Cuscuta australis comprises the following steps: Take dodder seeds, add salt water (the mass ratio of salt to water is 1:4~1:5), mix well, boil until it cracks, and dry it in the sun to get dodder seeds.

[0067] In a second aspect, the present invention provides a method for preparing the traditional Chinese medicine composition for preventing and treating blue ear disease in pigs, comprising the following steps: Weigh each component according to the designed ratio, and ultrafinely grind Codonopsis pilosula, Chinese yam, dried ginger, white peony root, dendrobium and costus root to obtain a mixed material; The mixed material, Atractylodes macrocephala extract, Angelica sinensis extract, Ligusticum chuanxiong extract, Eucommia ulmoides extract and Cuscuta australis extract are mixed to obtain a traditional Chinese medicine composition.

[0068] In a third aspect, the present invention provides a traditional Chinese medicine preparation for preventing and treating blue ear disease in pigs, including the traditional Chinese medicine composition for preventing and treating blue ear disease in pigs.

[0069] Preferably, the traditional Chinese medicine preparation comprises the traditional Chinese medicine composition and excipients.

[0070] Further preferably, the mass ratio of the traditional Chinese medicine composition to the excipient is (9-10):(0.1-1).

[0071] Preferably, the traditional Chinese medicine preparation comprises at least one of granules or powders.

[0072] The present invention has the following beneficial effects: Known as a "magic qi-tonifying medicine," Codonopsis pilosula treats spleen and stomach weakness, poor appetite and diarrhea, lung deficiency and cough, fatigue and weakness, and Qi deficiency and collapse. It has a powerful spleen-tonifying and Qi-invigorating effect, boosting pigs' immunity and strengthening their bodies to better resist disease. Atractylodes macrocephala treats spleen deficiency and diarrhea, edema, spontaneous sweating, and fetal restlessness. It significantly strengthens the spleen and Qi, eliminates dampness, and promotes diuresis, eliminating internal dampness.

[0073] Chinese yam is used to treat spleen and stomach weakness, loss of appetite, spleen deficiency diarrhea, asthenia cough, spermatorrhea, leukorrhea, and frequent urination. It tonifies the spleen, lungs, and kidneys, replenishes qi and nourishes yin, and can strengthen pigs' constitution, improving their resistance and making them less susceptible to disease. Dried ginger is a meridian-warming Chinese herb that treats stomach cold, poor appetite, cold intestinal diarrhea, cold pain, cold extremities, wind-cold-dampness arthritis, and cough and asthma caused by phlegm and fluid. It enhances the yang-warming and cold-dispersing properties of the herb and helps regulate cold and blood stasis in pigs.

[0074] Angelica sinensis, known as the "holy blood tonic," is used to treat blood deficiency, strain, blood stasis, pain, trauma, carbuncles, ulcers, constipation, and postpartum disorders. It nourishes and invigorates blood circulation, improving pigs' hematopoiesis, increasing oxygen levels in the blood, and boosting their immunity. White peony root is used to treat liver yin deficiency, deficiency-heat, diarrhea, abdominal pain, and limb cramps. It nourishes blood and regulates menstruation, treating symptoms such as chlorosis and dizziness caused by blood deficiency, and helps maintain the balance of qi and blood in pigs. Chuanxiong is used to treat trauma, qi and blood stasis, retained placenta, postpartum blood stasis, and rheumatic pain. It invigorates blood circulation and invigorates qi, treating pain caused by blood stasis and qi stagnation. It also dilates blood vessels and improves circulation. Dendrobium nourishes stomach yin and clears stomach heat. It is suitable for dry mouth, thirst, dull pain in the stomach, dry retching and hiccups caused by stomach yin deficiency. It nourishes kidney yin and reduces virtual fire. It can treat soreness of waist and knees, hot flashes, night sweats, dizziness and blurred vision caused by kidney yin deficiency, and improve thirst and loss of appetite caused by insufficient stomach yin. It can also nourish the yin of the liver and kidneys, and relieve blurred vision and weak waist and legs caused by kidney deficiency.

[0075] Eucommia ulmoides is a traditional Chinese medicine that nourishes the liver and kidneys and strengthens the tendons and bones. It is primarily used to treat kidney deficiency-induced low back pain, lumbar weakness, rheumatic pain, and fetal dysphoria. By boosting kidney function, it can treat symptoms such as low back and knee weakness, impotence, and also helps improve pig reproductive capacity. Cuscuta chinensis is a traditional Chinese medicine that nourishes the kidneys and replenishes essence. It is primarily used to treat spermatorrhea caused by kidney deficiency, low back and hip weakness, frequent urination, fetal dysphoria, blurred vision caused by kidney deficiency, and diarrhea caused by spleen and kidney deficiency. It can treat symptoms such as low back pain and impotence, and also helps improve pig reproductive capacity. Costus root is known for promoting the flow of qi in the spleen and stomach, making it a key remedy for abdominal distension, belching, and loss of appetite caused by spleen and stomach qi stagnation. It can relieve abdominal pain and tenesmus caused by large intestinal qi stagnation, or flank pain caused by liver and gallbladder qi stagnation. It also strengthens the spleen and stomach's transport and transformation functions and eliminates food stagnation. It is suitable for treating food stagnation, indigestion, and chest and abdominal distension.

[0076] In the present invention, propylene glycol, ethyl acetate, acetic acid and water, as well as acetone, ethyl acetate, glycerol and water have a synergistic effect, and the synergistic extraction of volatile oils, phenolic acids and some polysaccharides is achieved through polarity gradient compounding.

[0077] Animal experiments have confirmed that the traditional Chinese medicine composition for preventing and treating blue ear disease in pigs provided by the present invention can inhibit and eliminate the blue ear virus, has excellent effects in controlling miscarriage and death, can increase the survival rate of piglets to 93.6%, can significantly inhibit viral replication, improve the reproductive performance of sows, and has a good effect on inhibiting pigs from coughing and panting, providing a safe and efficient new option for the prevention and control of blue ear disease in pigs, and its efficacy is significantly better than existing products. DETAILED DESCRIPTION

[0078] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0079] In an embodiment of the present invention, the honey-roasting method of Codonopsis pilosula comprises the following steps: Take clean codonopsis slices and mix them with refined honey (the mass ratio of honey to water is 1:0.8). Simmer until the honey is completely absorbed. Then fry over low heat until the surface is yellow-brown and no longer sticky. This is the codonopsis. The mass ratio of codonopsis slices to refined honey is 10:2.5.

[0080] In an embodiment of the present invention, the method for frying Atractylodes macrocephala with bran comprises the following steps: Sprinkle bran into a hot wok, add Atractylodes macrocephala slices when it starts to smoke, and stir-fry until the surface turns dark yellow (the bran is burnt black). Sieve out the bran to obtain Atractylodes macrocephala. The mass ratio of Atractylodes macrocephala to bran is 10:1.5 respectively.

[0081] In an embodiment of the present invention, the method for frying Chinese yam with bran comprises the following steps: Sprinkle bran into a hot wok. When it starts to smoke, add yam slices and stir-fry until the surface turns dark yellow (the bran is burnt black). Sieve out the bran to get the yam. The mass ratio of yam to bran is 10:1.2 respectively.

[0082] In an embodiment of the present invention, the method for frying white peony root with bran comprises the following steps: Sprinkle bran into a hot wok. When it starts to smoke, add white peony root slices and stir-fry until the surface turns dark yellow (the bran is burnt black). Sieve out the bran to obtain white peony root. The mass ratio of white peony root to bran is 10:1.

[0083] In an embodiment of the present invention, the method for scalding dendrobium comprises the following steps: Place river sand in a pot and heat over high heat until it becomes flexible. Add clean, dried dendrobium segments and stir-fry until the surface swells and the color deepens (to a dark yellow or slightly burnt spot). Sieve out the sand to obtain the dendrobium. The mass ratio of dendrobium to river sand is 1:5.

[0084] In an embodiment of the present invention, the salt-roasting method of Eucommia ulmoides comprises the following steps: Take Eucommia ulmoides chunks and mix them with salt water (the mass ratio of salt to water is 1:4). Let it sit until the salt water is completely absorbed. Stir-fry over medium heat until the strands break easily and the surface is charred black. This is the Eucommia ulmoides. The mass ratio of Eucommia ulmoides chunks to salt water is 100:2.

[0085] In an embodiment of the present invention, the method for preparing salt of Cuscuta australis comprises the following steps: Take dodder seeds, add salt water (the mass ratio of salt to water is 1:5), mix well, boil until it cracks, and dry it in the sun to get dodder seeds.

[0086] In the present invention, materials not otherwise specified are all commercially available products.

[0087] Example 1 This embodiment provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs, comprising the following components in parts by weight: 26 parts of Codonopsis pilosula, 25 parts of Atractylodes macrocephala extract, 21 parts of Dioscorea opposita, 20 parts of dried ginger, 16 parts of Angelica sinensis extract, 15 parts of White Peony Root, 15 parts of Chuanxiong Rhizome extract, 14 parts of Dendrobium candidum, 10 parts of Eucommia ulmoides extract, 10 parts of Cuscuta australis extract and 7 parts of Costus root.

[0088] The preparation method of the above-mentioned Chinese medicine composition comprises the following steps: S100, preparing each raw material component: Codonopsis pilosula is prepared by roasting with honey, Atractylodes macrocephala, Chinese yam and white peony root are prepared by frying with bran, Dendrobium is prepared by blanching, Eucommia ulmoides is prepared by roasting with salt, Cuscuta australis is prepared by salt, and dried ginger, Chinese angelica, Chuanxiong, Dendrobium and costus root are used raw.

[0089] S200, extracting Atractylodes macrocephala, Angelica sinensis, Chuanxiong, Eucommia ulmoides and Cuscuta australis respectively: S201. Preparation method of Atractylodes macrocephala extract: Add Atractylodes macrocephala to a mixed solution of propylene glycol, ethyl acetate, acetic acid, and water (the mass ratio of propylene glycol, ethyl acetate, and water is 5:3:1, the pH of the mixed solution is 3.5, and the mass volume ratio of Atractylodes macrocephala to the mixed solution is 1 g:10 mL). Soak for 30 minutes. The first reflux extraction was performed at 65°C, and the mixture was filtered while hot after 40 minutes. The mixed solution was added to the filter residue again, with the mass volume ratio of the filter residue to the mixed solution being 1g:6mL. The second reflux extraction was performed at 70°C, and the mixture was filtered while hot after 60 minutes. The two extracts were combined (i.e., the filtrate) to obtain the Atractylodes macrocephala extract. The Atractylodes macrocephala extract was concentrated using a rotary evaporator at 40°C and -0.06 MPa (GC detection of ethyl acetate residue ≤ 0.1%) to obtain a thick Atractylodes macrocephala paste with a relative density of 1.1 at 50°C. The thick paste of Atractylodes macrocephala is dried to obtain the Atractylodes macrocephala extract.

[0090] S202. Preparation method of angelica extract: Add angelica to a mixed solution of acetone, ethyl acetate, glycerol, and water (the mass ratio of acetone, ethyl acetate, glycerol, and water is 5:3:1:1) and the mass volume ratio of angelica to the mixed solution is 1 g:10 mL), and soak for 30 minutes. Reflux extraction was performed at 55°C for 2 times. After the first reflux extraction for 2 hours, the above mixed solution was added (keeping the total volume of the two reflux extractions the same). After the first reflux extraction for 1.5 hours, the mixture was filtered while hot to obtain the angelica extract. The angelica extract was concentrated using a rotary evaporator at 40°C and -0.1 MPa (GC detection of ethyl acetate residue ≤ 0.1%) to obtain an angelica paste with a relative density of 1.15 at 60°C. The angelica thick paste is dried to obtain the angelica extract.

[0091] S203. Preparation method of Chuanxiong extract: Add Chuanxiong rhizome to water at a mass volume ratio of 1 g:8 mL and soak for 45 min. Connect the volatile oil extractor, boil over high heat and then keep it at a low boil for 3 hours to obtain volatile oil and medicinal residue; Add the medicinal residue to water at a mass volume ratio of 1 g:6 mL. Bring to a boil over high heat, then simmer for 2 times, each time for 1.5 h. Combine the decoctions and filter to obtain the water extract of Chuanxiong. The water extract of Chuanxiong is concentrated and then mixed with volatile oil to obtain a Chuanxiong thick paste with a relative density of 1.2 at 60°C; The Chuanxiong thick paste is dried to obtain the Chuanxiong extract.

[0092] S204. Preparation method of Eucommia ulmoides extract: Add Eucommia ulmoides into water with a mass volume ratio of Eucommia ulmoides to water of 1 g:8 mL and soak for 30 min. Adjust the pH of the soaking solution to 8, boil it over high heat, then simmer it for two times, each time for 1.5 hours. Combine the decoctions, centrifuge them at 3000 rpm for 15 minutes, and collect the supernatant to obtain the Eucommia ulmoides aqueous extract. The Eucommia ulmoides aqueous extract was concentrated, impurities were precipitated with a 60 wt % ethanol aqueous solution, and the solution was filtered to obtain an Eucommia ulmoides thick paste having a relative density of 1.15 at 60° C.; The Eucommia ulmoides thick paste is dried to obtain the Eucommia ulmoides extract.

[0093] S205. Preparation method of Cuscuta seed extract: Add dodder seeds to water at a mass volume ratio of 1 g to 10 mL and soak for 50 minutes. After boiling over high heat, simmer for 2 times, each time for 1.8 hours. Combine the decoctions and filter under pressure (pressure of 0.2 MPa) to obtain the Cuscuta australis aqueous extract. The dodder seed water extract is concentrated to obtain a dodder seed thick paste having a relative density of 1.2 at 60°C; The dodder seed paste is dried to obtain the dodder seed extract.

[0094] It should be noted that this embodiment does not limit the order of S201 to S205.

[0095] S300, weighing each component according to the designed ratio, ultrafinely grinding Codonopsis pilosula, Chinese yam, dried ginger, white peony root, dendrobium and costus root to obtain a mixed material; The mixed material, Atractylodes macrocephala extract, Angelica sinensis extract, Ligusticum chuanxiong extract, Eucommia ulmoides extract and Cuscuta australis extract are mixed to obtain a traditional Chinese medicine composition.

[0096] Example 2 This embodiment provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs, comprising the following components in parts by weight: 25 parts of Codonopsis pilosula, 25 parts of Atractylodes macrocephala extract, 20 parts of Dioscorea opposita, 20 parts of dried ginger, 15 parts of Angelica sinensis extract, 15 parts of White Peony Root, 15 parts of Chuanxiong extract, 15 parts of Dendrobium candidum, 10 parts of Eucommia ulmoides extract, 10 parts of Cuscuta australis extract and 8 parts of Costus root.

[0097] The preparation method of the above-mentioned Chinese medicine composition comprises the following steps: S100, preparing each raw material component: The same as S100 in Example 1, which will not be described in detail.

[0098] S200, extracting Atractylodes macrocephala, Angelica sinensis, Chuanxiong, Eucommia ulmoides and Cuscuta australis respectively: S201. Preparation method of Atractylodes macrocephala extract: Add Atractylodes macrocephala to a mixed solution of propylene glycol, ethyl acetate, acetic acid, and water (the mass ratio of propylene glycol, ethyl acetate, and water is 6:2:1, the pH of the mixed solution is 4.2, and the mass volume ratio of Atractylodes macrocephala to the mixed solution is 1 g:9 mL). Soak for 50 minutes. The first reflux extraction was performed at 65°C, and the mixture was filtered while hot after 45 minutes. The mixed solution was added to the filter residue again, with the mass volume ratio of the filter residue to the mixed solution being 1g:6mL. The second reflux extraction was performed at 75°C, and the mixture was filtered while hot after 50 minutes. The two extracts (i.e., the filtrate) were combined to obtain the Atractylodes macrocephala extract. The Atractylodes macrocephala extract was concentrated using a rotary evaporator at 50°C and -0.06 MPa (GC detection of ethyl acetate residue ≤ 0.1%) to obtain a thick Atractylodes macrocephala paste with a relative density of 1.15 at 50°C. The thick paste of Atractylodes macrocephala is dried to obtain the Atractylodes macrocephala extract.

[0099] S202. Preparation method of angelica extract: Add angelica to a mixed solution of acetone, ethyl acetate, glycerol, and water (the mass ratio of acetone, ethyl acetate, glycerol, and water is 4:3:1:2, and the mass volume ratio of angelica to the mixed solution is 1 g:8 mL), and soak for 45 minutes. Reflux extraction was performed at 60°C for 2 times. After the first reflux extraction for 2 hours, the above mixed solution was added (keeping the total volume of the two reflux extractions the same). After the first reflux extraction for 1.5 hours, the mixture was filtered while hot to obtain the angelica extract. The angelica extract was concentrated using a rotary evaporator at 50°C and -0.08 MPa (GC detection of ethyl acetate residue ≤ 0.1%) to obtain an angelica paste with a relative density of 1.2 at 60°C. The angelica thick paste is dried to obtain the angelica extract.

[0100] S203. Preparation method of Chuanxiong extract: Add Chuanxiong rhizome to water at a mass volume ratio of 1 g:10 mL and soak for 60 min. Connect the volatile oil extractor, boil over high heat and keep it at a low boil for 4 hours to obtain volatile oil and medicinal residue; Add the medicinal residue to water at a mass volume ratio of 1 g:8 mL. Bring to a boil over high heat, then simmer for 2 times, each time for 1.5 h. Combine the decoctions and filter to obtain the water extract of Chuanxiong. The water extract of Chuanxiong is concentrated and then mixed with volatile oil to obtain a Chuanxiong thick paste with a relative density of 1.3 at 60°C; The Chuanxiong thick paste is dried to obtain the Chuanxiong extract.

[0101] S204. Preparation method of Eucommia ulmoides extract: Add Eucommia ulmoides into water with a mass volume ratio of Eucommia ulmoides to water of 1 g:10 mL and soak for 40 min. Adjust the pH of the soaking solution to 9, boil it over high heat, then simmer it twice over low heat, each time for 2 hours. Combine the decoctions, centrifuge them at 4000 rpm for 15 minutes, and collect the supernatant to obtain the Eucommia ulmoides aqueous extract. The Eucommia ulmoides aqueous extract was concentrated, impurities were precipitated with 70 wt % ethanol aqueous solution, and the mixture was filtered to obtain an Eucommia ulmoides thick paste having a relative density of 1.2 at 60° C.; The Eucommia ulmoides thick paste is dried to obtain the Eucommia ulmoides extract.

[0102] S205. Preparation method of Cuscuta seed extract: Add dodder seeds to water at a mass volume ratio of 1 g to 12 mL and soak for 60 min. After boiling over high heat, simmer for 2 more times, each time for 2.2 hours. Combine the decoctions and filter under pressure (at a pressure of 0.1 MPa) to obtain the Cuscuta australis aqueous extract. The dodder seed water extract is concentrated to obtain a dodder seed thick paste having a relative density of 1.25 at 60°C; The dodder seed paste is dried to obtain the dodder seed extract.

[0103] It should be noted that this embodiment does not limit the order of S201 to S205.

[0104] S300, weighing each component according to the designed ratio, ultrafinely grinding Codonopsis pilosula, Chinese yam, dried ginger, white peony root, dendrobium and costus root to obtain a mixed material; The mixed material, Atractylodes macrocephala extract, Angelica sinensis extract, Ligusticum chuanxiong extract, Eucommia ulmoides extract and Cuscuta australis extract are mixed to obtain a traditional Chinese medicine composition.

[0105] Example 3 This embodiment provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs, comprising the following components in parts by weight: 30 parts of Codonopsis pilosula, 28 parts of Atractylodes macrocephala extract, 25 parts of Dioscorea opposita, 22 parts of dried ginger, 20 parts of Angelica sinensis extract, 20 parts of White Peony Root, 18 parts of Ligusticum chuanxiong extract, 16 parts of Dendrobium candidum, 13 parts of Eucommia ulmoides extract, 13 parts of Cuscuta australis extract and 10 parts of Costus root.

[0106] The preparation method of the above-mentioned traditional Chinese medicine composition is similar to that of Example 1, except that: in the preparation method of the Atractylodes macrocephala extract, the mass ratio of propylene glycol, ethyl acetate and water is 4.5:4:1; in the preparation method of the Angelica sinensis extract, the mass ratio of acetone, ethyl acetate, glycerol and water is 5:2:0.5:2, which will not be repeated.

[0107] Example 4 This embodiment provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs, comprising the following components in parts by weight: 22 parts of Codonopsis pilosula, 20 parts of Atractylodes macrocephala extract, 18 parts of Dioscorea opposita, 15 parts of dried ginger, 13 parts of Angelica sinensis extract, 13 parts of White Peony Root, 12 parts of Ligusticum chuanxiong extract, 10 parts of Dendrobium candidum, 7 parts of Eucommia ulmoides extract, 7 parts of Cuscuta australis extract and 5 parts of Costus root.

[0108] The preparation method of the above-mentioned Chinese medicine composition is the same as that in Example 1 and will not be repeated here.

[0109] Example 5 This embodiment provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs. The components and contents of the traditional Chinese medicine composition are the same as those in Example 1 and will not be repeated here.

[0110] The preparation method of the Chinese medicine composition is similar to that of Example 1, except that in step S201, in the preparation method of the Atractylodes macrocephala extract, propylene glycol is replaced with ethanol of equal mass, and the temperature of the two reflux extractions is changed to 85° C. The remaining steps are the same as those of Example 1 and are not repeated here.

[0111] Example 6 This embodiment provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs. The components and contents of the traditional Chinese medicine composition are the same as those in Example 1 and will not be repeated here.

[0112] The preparation method of the Chinese medicine composition is similar to that of Example 1, except that in step S202, in the preparation method of the angelica extract, acetone is replaced with an equal mass of ethyl acetate, and the temperature of the two reflux extractions is changed to 80° C. The remaining steps are the same as those of Example 1 and are not repeated here.

[0113] Comparative Example 1 This comparative example provides a Chinese medicine composition for preventing and treating blue ear disease in pigs, which is similar to Example 2 except that it does not contain dried ginger. The remaining components and contents are the same as those in Example 2 and are not further described.

[0114] The preparation method of the above-mentioned traditional Chinese medicine composition is similar to that of Example 2, except that dried ginger is not added in S300, which will not be described in detail.

[0115] Comparative Example 2 This comparative example provides a Chinese medicine composition for preventing and treating blue ear disease in pigs, which is similar to Example 2 except that it does not contain Dendrobium and Chuanxiong extracts. The remaining components and contents are the same as those in Example 2 and are not further described.

[0116] The preparation method of the above-mentioned traditional Chinese medicine composition is similar to that of Example 2, except that the extraction of Chuanxiong is omitted in S200, and the extracts of Dendrobium and Chuanxiong are not added in S300, which will not be described again.

[0117] Comparative Example 3 This comparative example provides a Chinese medicine composition for preventing and treating blue ear disease in pigs, which is similar to Example 2 except that it does not contain Eucommia ulmoides extract, Cuscuta australis extract, and Aucklandia lappa. The remaining components and contents are the same as those in Example 2 and are not further described.

[0118] The preparation method of the above-mentioned traditional Chinese medicine composition is similar to that of Example 2, except that the extraction of Eucommia ulmoides and Cuscuta chinensis is omitted in S200, and Eucommia ulmoides extract, Cuscuta chinensis extract and Costus root are not added in S300, which will not be repeated here.

[0119] Comparative Example 4 This comparative example provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs. The composition is similar to Example 2, except that the Eucommia ulmoides extract and costus root extract are replaced with an equal mass of Cuscuta chinensis extract, i.e., the Cuscuta chinensis extract is used in an amount of 28 parts. The remaining components and contents are the same as those in Example 2 and are not further described.

[0120] The preparation method of the above-mentioned traditional Chinese medicine composition is similar to that of Example 2, except that the extraction of Eucommia ulmoides is omitted in S200, and Eucommia ulmoides extract and Costus root are not added in S300, which will not be described in detail.

[0121] Comparative Example 5 This comparative example provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs (an existing commercially available traditional Chinese medicine composition), comprising the following components in parts by weight: 15 parts of honeysuckle, 15 parts of forsythia, 20 parts of isatis root, 12 parts of scutellaria, 20 parts of houttuynia cordata, 6 parts of ephedra, 10 parts of apricot kernel, 30 parts of gypsum (fried first), and 6 parts of liquorice.

[0122] Comparative Example 6 This comparative example provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs (an existing commercially available traditional Chinese medicine composition), comprising the following components in parts by weight: 15 parts of Codonopsis pilosula, 12 parts of Atractylodes macrocephala, 12 parts of Poria cocos, 20 parts of Dioscorea batatas, 10 parts of lotus seeds, 20 parts of Coix seeds, 6 parts of Platycodon grandiflorum, and 6 parts of Licorice.

[0123] Comparative Example 7 This comparative example provides a traditional Chinese medicine composition for preventing and treating blue ear disease in pigs (an existing commercially available traditional Chinese medicine composition), comprising the following components in parts by weight: 30 parts of astragalus, 20 parts of isatis root, 15 parts of epimedium, 15 parts of ligustrum lucidum fruit, and 12 parts of atractylodes.

[0124] Verification test 1. Acute toxicity test Acute toxicity tests were conducted on the Chinese medicine compositions provided in Examples 1 to 6 of the present invention. Mice were used as experimental animals to observe the oral toxicity of the Chinese medicine compositions in the test animals. The mice were divided into six groups (Groups 1 to 6, respectively), with 10 mice in each group. The mice were administered orally according to group. The Chinese medicine compositions were dissolved in distilled water, with an initial dose of 0.005 g / kg. The mice were administered at 100, 200, 300, 400, and 500 times the clinical daily dose. After seven days of observation, the mice in each group were tested for hair, behavior, urination, body weight, organ weight, blood count, liver and kidney function, blood sugar, and blood lipids. Pathological examinations of the organs were performed, and no toxic reactions were observed (no significant changes in the organs of the mice were observed, relevant indicators were within normal ranges, and pathological examinations were normal). The test results indicate that the Chinese medicine compositions provided by the present invention did not cause mortality in the test animals, indicating that the Chinese medicine compositions provided by the present invention have a high safety profile in the oral acute toxicity test in mice.

[0125] 2. Evaluation test of clinical treatment effect of blue ear disease (1) A pig farm in Jitan Town, Dengzhou City, Henan Province, had 417 sick nursery pigs (around 60 days old). The main symptoms were: difficulty breathing, coughing, runny nose, cyanosis, hypoxia, elevated body temperature (40°C-41.5°C), depression, lethargy, huddling, slow response to stimuli, emaciation, rough and matted fur, and some piglets vomited and had diarrhea, with yellow or grayish-white, thin, and paste-like feces. Serum antibody testing confirmed that they were infected with blue ear disease.

[0126] Nursery pig medication regimen: 408 sick nursery pigs were randomly divided into 12 groups, each with 34 pigs. Each group was fed the Chinese herbal compositions of Examples 1-2 and Comparative Examples 1-7 of Examples 5-6, along with a pure feed (blank control group). The Chinese herbal composition was mixed into the feed at a mass ratio of 0.4% for 10 consecutive days. Pigs that refused to eat the feed were orally administered the Chinese herbal composition with water. During the feeding process, each piggery was kept clean, hygienic, well-ventilated, and kept at a suitable temperature. All groups maintained consistent feeding and management practices.

[0127] After stopping the drug, continue to feed the sick nursery pigs for 20 days and observe the recovery of the sick nursery pigs. Recovered: All symptoms disappear and everything returns to normal; Effective: Most symptoms disappear, but some symptoms remain during the treatment period; Ineffective: No significant improvement was seen after taking the medicine.

[0128] The test results are shown in Table 1 (Examples 3 and 4 can also achieve the same effect as Example 2).

[0129] Table 1 Treatment effects of nursery pigs

[0130] (2) A pig farm in Huai'an City, Jiangsu Province, had 1,282 piglets (before and after weaning) with symptoms including difficulty breathing (abdominal breathing), rapid panting, coughing, and sneezing. Some piglets had viscous secretions from their nasal cavities, body temperatures rose to 40°C to 41°C, and they were listless, had no appetite, and huddled together for warmth. The tips of their ears, extremities, and tails were cyanotic or had bluish-purple patches. Serum antibody testing confirmed the diagnosis of PRRS.

[0131] Piglet medication regimen: 1,200 piglets were randomly divided into 12 groups, each with 100 piglets. Each group was fed the Chinese herbal compositions of Examples 1-2 and Comparative Examples 1-7 of Examples 5-6, along with a pure feed (blank control group). The Chinese herbal composition was mixed into the feed at a mass ratio of 0.3% for 14 consecutive days. Pigs that refused to eat the feed were orally administered the Chinese herbal composition with water. During the feeding process, the pig house in each group was kept clean, hygienic, well-ventilated, and kept at a suitable temperature. Feeding and management conditions were maintained consistently across all groups.

[0132] After stopping the drug, continue to feed the piglets for 15 days and observe the recovery of the sick piglets. Recovered: All symptoms disappear and everything returns to normal; Effective: Most symptoms disappear, but some symptoms remain during the treatment period; Ineffective: No significant improvement was seen after taking the medicine.

[0133] The test results are shown in Table 2 (Examples 3 and 4 can also achieve the same effect as Example 1).

[0134] Table 2 Treatment effect of piglets

[0135] (3) A pig farm in Yuanyang County, Yunnan Province, had 503 sick pregnant sows. The main symptoms were: some sows had miscarriages, some sows gave birth prematurely, and some gave birth to stillborn, mummified, or weak piglets. Among the piglets born normally, the proportion of weak piglets increased. They also had breathing difficulties and movement disorders; their body temperature rose to 40℃~41℃, and they were depressed, had anorexia, had breathing difficulties, coughed, and had increased nasal secretions. Some pigs had cyanosis of the ears and abdominal skin. After serum antibody testing, they were diagnosed with blue ear disease.

[0136] Pregnant sow medication regimen: 490 pregnant sows were randomly divided into 7 groups, each with 70 pigs. Each group was fed the Chinese herbal composition of Example 2, Examples 5-6, and Comparative Examples 5-7, along with a pure feed (blank control group). The Chinese herbal composition was mixed into the feed at a mass ratio of 0.5% for 15 consecutive days. Pigs that refused to eat the feed were orally administered the Chinese herbal composition with water. During the feeding process, each piggery was kept clean, hygienic, well-ventilated, and kept at a suitable temperature. All groups maintained consistent feeding and management practices.

[0137] After 15 days, the number of aborted pigs, tear spot ratio, S / P value in each group, as well as various indicators of piglets in the delivery room during subsequent delivery, were observed. The test results are shown in Table 3 (Examples 1, 3-4 can also achieve effects comparable to those of Example 2).

[0138] Table 3 Treatment effect of pregnant sows

[0139] (4) A pig farm in Dengzhou City, Henan Province, had over 1,500 sick fattening pigs. Symptoms included mild to moderate coughing, wheezing, and rapid breathing. A few pigs experienced a temporary rise in body temperature (39.5°C to 40.5°C), decreased appetite, slowed growth, reduced feed conversion rate, and prolonged time to market. Serum antibody testing confirmed the diagnosis of blue ear disease (PRRS). Preventive vaccination with an inactivated PRRS vaccine was administered, but the results were less than ideal, with some fattening pigs still experiencing the disease.

[0140] Medication scheme: The Chinese medicine composition prepared in Example 1 was mixed into the feed at a mass ratio of 0.5%, and the drug was stopped after 15 consecutive days. Blood was drawn for testing at intervals of 3 days, and the test results showed that both swine fever and blue ear were negative.

[0141] On the first day of treatment, the pigs had fever, coughing, wheezing, and a low spirit. On the third day, symptoms had eased, with the coughing and wheezing less severe. On the fifth day, their overall condition improved, their appetite increased, and their spirits recovered considerably. On the seventh day, their spirits improved significantly, with a noticeable increase in feed intake. On the ninth day, the coughing and wheezing had essentially disappeared, fever had disappeared, and their spirits were good. On the fifteenth day, customers reported that these sub-healthy pigs had recovered well, their spirits were normal, and their fur was smooth and shiny. The farm owner was very satisfied with the results and planned to continue adjusting the sows and nursery pigs.

[0142] (5) A pig farm in Xinji City, Hebei Province, had 458 sick sows and 880 nursery pigs (140 of which were seriously ill). Serum antibody testing confirmed the diagnosis of blue ear disease. Various prevention and control methods were used, but the results were unsatisfactory.

[0143] Medication scheme: The Chinese medicine composition prepared in Example 2 was mixed into the feed at a mass ratio of 1%, and the drug was stopped after 15 consecutive days. Blood was drawn for testing at intervals of 3 days, and the test results showed that both swine fever and blue ear were negative.

[0144] On the 10th day of medication, the purple color of the pigs' ears had faded, and some pigs' ears were red. The conjunctival flushing and eye swelling disappeared, and some pigs showed slight redness and cyanosis around the eyes. The feed intake of the majority of the pigs improved, and their spirits were good, with no high fever or loss of appetite. The symptoms of 70 seriously ill nursery pigs in the isolation pen had significantly improved. After 15 days of medication and 3 days of drug withdrawal, the sows' overall condition was stable, and no swelling or purple inguinal lymph nodes were found in the newborn piglets. 293 of the 313 newborn piglets from 24 litters survived, and the spirits of the piglets in the farrowing room improved significantly. The nursery pigs were in ideal condition, with no new cases and normal feed intake.

[0145] In summary, the Chinese medicine composition provided by the present invention has been experimentally confirmed to have significant efficacy and stable and reliable quality. The Chinese medicine composition can be prepared in different dosage forms and is easy to carry and take. The present invention gives full play to the unique advantages of traditional Chinese veterinary medicine, improves the effect of preventing and treating blue ear disease in pigs, ensures the healthy development of the pig farming industry, reduces the large-scale morbidity and mortality of pigs caused by blue ear disease, and improves the economic benefits of pig farms. Replacing chemical drugs with traditional Chinese veterinary drugs solves the problems of environmental pollution caused by chemical drug residues, damage to animal health, and endangerment of food safety.

[0146] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions or improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A Chinese medicinal composition for preventing and treating blue ear disease in pigs, characterized in that: The invention comprises the following components in parts by weight: 22 to 30 parts of Codonopsis pilosula, 20 to 28 parts of Atractylodes macrocephala extract, 18 to 25 parts of Dioscorea batatas, 15 to 22 parts of dried ginger, 13 to 20 parts of Angelica sinensis extract, 13 to 20 parts of White Peony Root, 12 to 18 parts of Ligusticum chuanxiong extract, 10 to 16 parts of Dendrobium candidum, 7 to 13 parts of Eucommia ulmoides extract, 7 to 13 parts of Cuscuta australis extract and 5 to 10 parts of Costus root.

2. The Chinese medicinal composition for preventing and treating blue ear disease according to claim 1, wherein The preparation method of the Atractylodes macrocephala extract comprises the following steps: Adding Atractylodes macrocephala to a mixed solution of propylene glycol, ethyl acetate, acetic acid and water, soaking the mixture, and extracting the mixture under reflux at 60°C to 75°C to obtain an Atractylodes macrocephala extract; Concentrating the Atractylodes macrocephala extract to obtain a thick Atractylodes macrocephala paste; The Atractylodes macrocephala thick paste is dried to obtain an Atractylodes macrocephala extract.

3. The Chinese medicinal composition for preventing and treating blue ear disease according to claim 1, wherein The preparation method of the angelica extract comprises the following steps: Adding angelica to a mixed solution of acetone, ethyl acetate, glycerin and water, soaking, and extracting under reflux at 50°C to 65°C to obtain angelica extract; Concentrating the angelica extract to obtain a thick angelica paste; The angelica thick paste is dried to obtain the angelica extract.

4. The Chinese medicinal composition for preventing and treating blue ear disease according to claim 2, wherein The mass ratio of propylene glycol, ethyl acetate and water is (4-6):(2-4):1, and the pH of the mixed solution is 3-5; The mass volume ratio of the Atractylodes macrocephala to the mixed solution is 1 g: (6-10) mL; The number of reflux extractions is 2 to 3 times, and the time for each reflux extraction is 40 to 60 minutes; The relative density of the Atractylodes macrocephala thick paste at 50° C. is 1.1-1.

15.

5. The Chinese medicinal composition for preventing and treating blue ear disease according to claim 3, characterized in that: The mass ratio of acetone, ethyl acetate, glycerin and water is (4-5):(2-3):(0.5-1):(1-2); The mass volume ratio of the angelica sinensis to the mixed solution is 1g: (8-10)mL; The number of reflux extractions is 2 to 3 times, and the time for each reflux extraction is 1.5 to 2 hours; The relative density of the angelica thick paste at 60° C. is 1.15-1.

2.

6. The Chinese medicinal composition for preventing and treating blue ear disease according to any one of claims 1 to 3, characterized in that The preparation method of the Chuanxiong extract comprises the following steps: Add Chuanxiong to water, soak, connect to volatile oil extractor, boil over high heat and keep it at a low boil for 3h~4h to obtain volatile oil and medicinal residue; Add the medicinal residue to water, boil over high heat, then simmer over low heat to obtain the water extract of Chuanxiong; The water extract of Chuanxiong is concentrated and then mixed with the volatile oil to obtain a thick paste of Chuanxiong; The Chuanxiong thick paste is dried to obtain a Chuanxiong extract.

7. The Chinese medicinal composition for preventing and treating blue ear disease according to any one of claims 1 to 3, characterized in that The preparation method of the Eucommia ulmoides extract comprises the following steps: Add Eucommia ulmoides into water and soak it. Adjust the pH of the soaking solution to 8-9. Boil it over high heat and then simmer it over low heat to obtain the Eucommia ulmoides aqueous extract. Concentrating the Eucommia ulmoides aqueous extract to obtain an Eucommia ulmoides thick paste; The Eucommia ulmoides thick paste is dried to obtain the Eucommia ulmoides extract.

8. The Chinese medicinal composition for preventing and treating blue ear disease according to any one of claims 1 to 3, characterized in that The preparation method of the Cuscuta seeds extract comprises the following steps: Add dodder seeds into water, soak, boil over high heat, then simmer over low heat to obtain dodder seed water extract; Concentrating the dodder seed water extract to obtain a dodder seed thick paste; The dodder seed paste is dried to obtain a dodder seed extract.

9. The method for preparing the traditional Chinese medicine composition for preventing and treating blue ear disease according to any one of claims 1 to 8, characterized in that: The following steps are involved: Weigh each component according to the designed ratio, and ultrafinely grind Codonopsis pilosula, Chinese yam, dried ginger, white peony root, dendrobium and costus root to obtain a mixed material; The mixed material, Atractylodes macrocephala extract, Angelica sinensis extract, Ligusticum chuanxiong extract, Eucommia ulmoides extract and Cuscuta australis extract are mixed to obtain a traditional Chinese medicine composition.

10. A Chinese medicinal preparation for preventing and treating blue ear disease in pigs, characterized in that: A Chinese medicine composition for preventing and treating blue ear disease in pigs comprising the Chinese medicine composition for preventing and treating blue ear disease according to any one of claims 1 to 8, or a Chinese medicine composition prepared by the preparation method of the Chinese medicine composition for preventing and treating blue ear disease according to claim 9.

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