A traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome (PRRS) and its application.

Abstract

This invention provides a traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome (PRRS) and its application. The composition comprises Scutellaria baicalensis, Anemarrhena asphodeloides, Rheum palmatum, Gypsum fibrosum, Houttuynia cordata, Mentha haplocalyx, Atractylodes lancea, Citrus reticulata peel, Poria cocos, Magnolia officinalis, Pueraria lobata, Ligustrum lucidum, Ephedra sinica, Prunus armeniaca, Gynostemma pentaphyllum, Astragalus membranaceus, Psoralea corylifolia, and Glycyrrhiza uralensis. This composition is formulated under the guidance of traditional Chinese veterinary medicine's syndrome differentiation and treatment principles. The combined effects of these herbs are significant in treating PRRS and other damp-heat diseases. Furthermore, this traditional Chinese medicine preparation does not contain antibiotics, is safe and effective, and does not induce drug resistance.

Description

Technical Field

[0001] This invention belongs to the field of veterinary traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome (PRRS) and its application. Background Technology

[0002] Porcine reproductive and respiratory syndrome (PRRS), also known as blue ear disease, is a highly contagious disease caused by the porcine reproductive and respiratory syndrome virus (PRRSV). Pigs of all breeds and ages can be infected, but pregnant sows and piglets under one month old are most susceptible. Infected and carrier pigs are important sources of infection. The main transmission routes are contact infection, airborne transmission, and semen transmission; vertical transmission through the placenta is also possible. Infected susceptible pigs experience reproductive disorders, respiratory distress, and immunosuppression. Persistent infection is a key epidemiological characteristic of PRRS, with viral shedding lasting up to 251 days. PRRS is considered a leading cause of death in pig farms, not only due to the damage and economic losses caused by the disease itself, but also because infection leads to immunosuppression, making pigs susceptible to secondary bacterial or viral infections that exacerbate symptoms and cause high mortality rates, ranging from 10% to 80%. Piglets that succumb to the disease may also suffer from stunted growth or even become runts, resulting in significant economic losses for pig farmers.

[0003] Currently, multiple strains and serotypes of porcine reproductive and respiratory syndrome (PRRS) exist in my country. Different serotypes may appear in the same pig farm, and the cross-protective effect of vaccines against different serotypes is weak, resulting in less than ideal vaccine efficacy. Furthermore, there is no specific drug for treating PRRS; most measures aim to alleviate acute symptoms, prevent secondary infections, and reduce losses, such as commonly used antibiotics like tilmicosin premix and tylosin tartrate. Research on traditional Chinese medicine (TCM) treatment for PRRS and the availability of TCMs with significant efficacy are limited. TCM preparations with effects such as clearing heat and detoxifying, relieving cough and asthma, removing dampness, promoting rash eruption, and raising yang are extremely rare. Therefore, effective prevention and control of PRRS and stabilizing the production performance of positive pig farms can bring significant economic benefits to pig farms and lead to higher production capacity in the pig farming industry.

[0004] Patent CN104547870A claims protection for a traditional Chinese medicine preparation for treating porcine reproductive and respiratory syndrome (PRRS), its preparation method, and its application. The preparation contains ephedra, apricot kernel, raw coix seed, white cardamom, pinellia, magnolia bark, tetrapanax papyriferus, talc, agastache rugosa, licorice, and atractylodes lancea. This traditional Chinese medicine preparation has a certain controlling effect on the clinical symptoms of PRRS, but it does not clearly state that the preparation has a significant effect on improving the production performance of pigs with PRRS. Furthermore, the preparation contains relatively few heat-clearing and tonifying herbs, so its effect on resolving high fever symptoms in sick pigs is not significant.

[0005] Patent CN107998332A claims protection for a traditional Chinese medicine composition and its application for treating porcine reproductive and respiratory syndrome (PRRS). The composition contains saffron, amomum villosum, perilla frutescens, rehmannia glutinosa, gastrodia elata, ganoderma lucidum polysaccharide, artemisia argyi, privet fruit, eleutherococcus senticosus, and dandelion. This traditional Chinese medicine preparation can control PRRS viremia. After 15 days of continuous administration, it reduces the PRRS immune antibody S / P value to a safe range of 0.8-1.8, improving the immune resistance of pigs. However, it does not clearly state the recovery of clinical symptoms of PRRS, the cure rate, or the relapse rate after discontinuation of the medication. Furthermore, the preparation lacks expectorants, antitussives, and bronchodilators, so its therapeutic effect on coughing and wheezing pigs may be insignificant. Also, the S / P value measured clinically has a certain lag effect on antibody levels; the S / P value measured directly after administration cannot indicate an improvement in antibody levels after medication.

[0006] Patent CN106237050A claims protection for a traditional Chinese medicine compound and its preparation method for effectively preventing and treating H1N1 and H3N2 swine influenza and porcine reproductive and respiratory syndrome (PRRS). The compound contains ephedra, scutellaria baicalensis, anemarrhena asphodeloides, fritillaria cirrhosa, apricot kernel, houttuynia cordata, mulberry bark, rhubarb, and licorice. This compound exhibits significant anti-PRRS virus effects. However, it does not explicitly describe the treatment effect of this compound on PRRS-infected pigs, and it lacks herbs for dispelling dampness and tonifying the body. Therefore, it cannot eliminate dampness from the body of PRRS-infected pigs and does not significantly improve their resistance to PRRS.

[0007] Therefore, those skilled in the art urgently need to develop a traditional Chinese medicine preparation that can simultaneously treat porcine reproductive and respiratory syndrome (PRRS), improve symptoms such as fever, cough, wheezing, and skin erythema caused by PRRS, and enhance the growth performance of affected pigs. Summary of the Invention

[0008] This invention, through extensive research and practice, provides a traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome (PRRS) and its application. This composition can be prepared as a pharmaceutical preparation and directly mixed into drinking water for convenient administration, stable efficacy, and high bioavailability. Animal experiments have demonstrated that this traditional Chinese medicine composition promotes weight gain, improves clinical symptoms, reduces PRRS inflammatory responses, and enhances the body's defense against the virus in pigs suffering from PRRS.

[0009] To achieve the above objectives of this invention, the following technical solutions are employed:

[0010] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome (PRRS), comprising Scutellaria baicalensis, Anemarrhena asphodeloides, Rheum palmatum, Gypsum fibrosum, Houttuynia cordata, Mentha haplocalyx, Atractylodes lancea, Citrus reticulata peel, Poria cocos, Magnolia officinalis, Pueraria lobata, Ligustrum lucidum, Ephedra sinica, Prunus armeniaca, Gynostemma pentaphyllum, Astragalus membranaceus, Psoralea corylifolia, and Glycyrrhiza uralensis.

[0011] The weight parts of each raw material in the Chinese herbal composition are as follows: Scutellaria baicalensis 13-28 parts, Anemarrhena asphodeloides 12-28 parts, Rheum palmatum 1-13 parts, Gypsum fibrosum 12-25 parts, Houttuynia cordata 6-22 parts, Mentha haplocalyx 10-28 parts, Atractylodes lancea 2-16 parts, Citrus reticulata 5-22 parts, Poria cocos 5-20 parts, Magnolia officinalis 4-22 parts, Pueraria lobata 3-19 parts, Ligustrum lucidum 1-14 parts, Ephedra sinica 1-13 parts, Prunus armeniaca 5-20 parts, Gynostemma pentaphyllum 5-18 parts, Astragalus membranaceus 4-20 parts, Psoralea corylifolia 2-15 parts, and Glycyrrhiza uralensis 1-11 parts.

[0012] Preferably, the weight parts of each raw material in the traditional Chinese medicine composition are as follows: Scutellaria baicalensis 14-24 parts, Anemarrhena asphodeloides 13-25 parts, Rheum palmatum 2-10 parts, Gypsum fibrosum 14-24 parts, Houttuynia cordata 7-20 parts, Mentha haplocalyx 14-24 parts, Atractylodes lancea 3-15 parts, Citrus reticulata 8-20 parts, Poria cocos 6-18 parts, Magnolia officinalis 6-18 parts, Pueraria lobata 6-16 parts, Ligustrum lucidum 3-10 parts, Ephedra sinica 4-10 parts, Prunus armeniaca 6-15 parts, Gynostemma pentaphyllum 7-15 parts, Astragalus membranaceus 6-15 parts, Psoralea corylifolia 5-12 parts, and Glycyrrhiza uralensis 1-7 parts.

[0013] More preferably, the weight parts of each raw material in the traditional Chinese medicine composition are as follows: Scutellaria baicalensis 16-20 parts, Anemarrhena asphodeloides 16-20 parts, Rheum palmatum 5-7 parts, Gypsum fibrosum 16-20 parts, Houttuynia cordata 10-14 parts, Mentha haplocalyx 16-20 parts, Atractylodes lancea 6-8 parts, Citrus reticulata 10-14 parts, Poria cocos 8-12 parts, Magnolia officinalis 10-14 parts, Pueraria lobata 8-12 parts, Ligustrum lucidum 4-8 parts, Ephedra sinica 6-8 parts, Prunus armeniaca 8-12 parts, Gynostemma pentaphyllum 8-12 parts, Astragalus membranaceus 10-14 parts, Psoralea corylifolia 6-8 parts, and Glycyrrhiza uralensis 2-5 parts.

[0014] More preferably, the weight parts of each raw material in the traditional Chinese medicine composition are as follows: Scutellaria baicalensis 18 parts, Anemarrhena asphodeloides 18 parts, Rheum palmatum 6 parts, Gypsum fibrosum 18 parts, Houttuynia cordata 12 parts, Mentha haplocalyx 18 parts, Atractylodes lancea 8 parts, Citrus reticulata 12 parts, Poria cocos 10 parts, Magnolia officinalis 12 parts, Pueraria lobata 10 parts, Ligustrum lucidum 6 parts, Ephedra sinica 8 parts, Prunus armeniaca 10 parts, Gynostemma pentaphyllum 10 parts, Astragalus membranaceus 12 parts, Psoralea corylifolia 8 parts, and Glycyrrhiza uralensis 4 parts.

[0015] The preparation method of the traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome (PRRS) involves weighing each raw material component according to the selected weight proportions, mixing them, and then extracting them using conventional extraction methods or mixing them using conventional methods to obtain the final product.

[0016] In a second aspect, the present invention provides the use of a traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome (PRRS) in the preparation of a pharmaceutical formulation for treating PRRS.

[0017] The pharmaceutical preparation may be, but is not limited to, powder, granules, oral preparations, or soluble powder.

[0018] The dosage and administration of the drug preparation are as follows: add 400g of the traditional Chinese medicine preparation to every 1000L of water, or add 1000mL of oral liquid of traditional Chinese medicine to every 1000L of water.

[0019] In a third aspect, the present invention provides the application of a traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome (PRRS) in the preparation of a feed additive for treating PRRS, wherein 400g of the traditional Chinese medicine composition is added per 1000L of water.

[0020] The herbal composition of this invention is formulated based on the fundamental theories of traditional Chinese veterinary medicine and conforms to the principles of syndrome differentiation and treatment in traditional Chinese veterinary medicine. Porcine reproductive and respiratory syndrome (PRRS) falls under the category of "epidemic diseases" in traditional veterinary medicine. PRRS is caused by the invasion of heat-toxin-dampness pathogens into the pig's body, including the pathogenic PRRS virus and a hot and humid environment, resulting in a syndrome of damp-heat affecting the upper, middle, and lower jiao (three burners): The invasion of heat-toxin-dampness pathogens begins in the upper jiao, specifically in the Taiyin meridian of the hand, where internal damp-heat accumulates, obstructing the pores and causing the pathogenic heat to cause internal dampness and turbidity, stagnation of defensive qi, impaired lung qi circulation, and obstructed water metabolism; if the upper jiao febrile disease is left untreated, it spreads to the middle jiao. The damp-heat pathogens further penetrate inward, obstructing qi circulation, causing water retention, dampness trapping the spleen, and heat stagnating in the stomach, leading to dysfunction of the ascending and descending functions of the internal organs; the lower jiao febrile disease arises from the untreated middle jiao febrile disease, with damp-heat descending and stagnating in the lower jiao, resulting in deficiency of both the liver and kidneys.

[0021] In the herbal composition of this invention, Scutellaria baicalensis is bitter and cold, clearing heat and drying dampness, purging fire and detoxifying; Anemarrhena asphodeloides is bitter, sweet, and cold, clearing heat and purging fire, generating fluids and moistening dryness, clearing lung heat, cooling stomach heat, and purging kidney fire, together serving as the principal herbs; Rheum palmatum is bitter and cold, purging and eliminating accumulations, clearing heat and purging fire, cooling blood and detoxifying, removing blood stasis and promoting menstruation; Gypsum fibrosum is pungent, sweet, and slightly cold, clearing heat and purging fire, relieving irritability and quenching thirst; Houttuynia cordata is pungent, slightly bitter, and slightly cold, clearing heat and detoxifying, eliminating carbuncles and draining pus; Mentha haplocalyx is pungent and cool, clearing heat and detoxifying, eliminating carbuncles and draining pus, promoting urination and relieving strangury, these four herbs together serve as the assistant herbs, enhancing the heat-clearing and detoxifying effects of the principal herbs; Atractylodes lancea is pungent, bitter, and warm, drying dampness and strengthening the spleen, dispelling wind and cold; Citrus reticulata is bitter, pungent, and warm, regulating qi and strengthening the spleen, drying dampness and resolving phlegm; Poria cocos is sweet, bland, and neutral, promoting diuresis. Water-draining, spleen-strengthening, and mind-calming herbs; Magnolia officinalis (bitter, pungent, warm) dries dampness, eliminates phlegm, lowers qi, and relieves fullness; Pueraria lobata (sweet, pungent, cool) relieves muscle tension, reduces fever, promotes rash eruption, generates fluids, quenches thirst, raises yang, and stops diarrhea; Ephedra sinica (pungent, slightly bitter, warm) induces sweating, relieves exterior syndromes, clears the lungs, relieves asthma, promotes urination, and reduces swelling; Prunus armeniaca (bitter, slightly warm) lowers qi, stops cough, relieves asthma, moistens the intestines, and promotes bowel movement; Ligustrum lucidum (sweet, bitter, cool) tonifies the liver and kidneys, strengthens tendons and bones; Gynostemma pentaphyllum (bitter, cold) reduces inflammation, detoxifies, stops cough, and eliminates phlegm; Astragalus membranaceus (sweet, slightly warm) strengthens the spleen, tonifies the middle jiao, raises yang, lifts prolapse, benefits wei qi, and consolidates the exterior; Psoralea corylifolia (bitter, pungent, warm) tonifies the kidneys, strengthens yang, consolidates essence, reduces urination, warms the spleen, stops diarrhea, and promotes qi circulation and relieves asthma. All are adjuvant herbs; Glycyrrhiza uralensis (sweet, neutral) tonifies the spleen, benefits qi, clears heat, detoxifies, eliminates phlegm, stops cough, relieves spasms and pain, and harmonizes the other herbs. It is the guiding herb. When used together, these herbs work synergistically to clear heat and detoxify, relieve cough and promote rash eruption, strengthen the spleen and clear the lungs, and dry dampness and promote yang.

[0022] The formulation principle of this invention is: clearing heat and detoxifying, relieving cough and promoting rash eruption, strengthening the spleen and clearing the lungs, drying dampness and raising yang, clearing, purging and purging damp heat in the upper, middle and lower jiao, and treating the lungs, spleen and kidneys at the same time.

[0023] The beneficial effects of this invention are:

[0024] 1. The traditional Chinese medicine composition of the present invention is composed of 18 kinds of traditional Chinese medicines. It is free of antibiotics, has no drug resistance, is safe and reliable, and has the effects of clearing heat and detoxifying, relieving cough and promoting rash eruption, strengthening the spleen and clearing the lungs, drying dampness and raising yang. It can effectively treat pigs with PRRS by regulating the body itself and inhibiting PRRS virus.

[0025] 2. The traditional Chinese medicine composition of the present invention has a simple preparation process and convenient administration method. The obtained drug preparation can be used by mixing with feed or by drinking water, and the bioavailability of the preparation is high.

[0026] 3. The traditional Chinese medicine composition of the present invention can also alleviate the slow growth of pigs caused by porcine reproductive and respiratory syndrome (PRRS) and improve the growth performance of sick pigs. Detailed Implementation

[0027] The embodiments of the present invention will be described in detail below with reference to the examples. The following examples are only used to illustrate the present invention and should not be regarded as limiting the scope of the present invention.

[0028] Example 1

[0029] The traditional Chinese medicine preparation of the present invention comprises, by weight, the raw medicinal materials as follows:

[0030] Scutellaria baicalensis 24 parts, Anemarrhena asphodeloides 25 parts, Rheum palmatum 10 parts, Gypsum fibrosum 24 parts, Houttuynia cordata 20 parts, Mentha haplocalyx 24 parts, Atractylodes lancea 15 parts, Citrus reticulata 20 parts, Poria cocos 18 parts, Magnolia officinalis 18 parts, Pueraria lobata 16 parts, Ligustrum lucidum 10 parts, Ephedra sinica 10 parts, Prunus armeniaca 15 parts, Gynostemma pentaphyllum 15 parts, Astragalus membranaceus 15 parts, Psoralea corylifolia 12 parts, Glycyrrhiza uralensis 7 parts.

[0031] Its preparation process is as follows:

[0032] (1) Weigh the required raw medicinal materials according to weight, mix the above raw medicinal materials and add them to the extraction tank. Add 10 times the amount of water to soak the raw medicinal materials for 45 minutes, heat to boiling, extract for 2 hours, filter, collect filtrate I, and set aside.

[0033] (2) Add 10 times the amount of water to the dregs of the raw medicinal materials, heat to a boil, extract for 1.5 hours, filter, and combine with filtrate I to obtain the extract;

[0034] (3) Concentrate the extract to contain 1g of raw medicinal material per mL;

[0035] (4) The concentrate is spray-dried to obtain the dry powder of the Chinese herbal extract;

[0036] (5) Add appropriate amounts of excipients sucrose and dextrin to the dry powder of Chinese herbal extract, mix evenly so that each gram contains 2.5g of raw medicinal material, then spray an appropriate amount of 75% ethanol to make a soft material that can be formed into a ball when squeezed and dispersed when pinched, place it in a swing granulator to make granules, and after drying, granulation and packaging, the Chinese herbal preparation of the present invention is obtained, and the dosage form is granules.

[0037] Example 2

[0038] The traditional Chinese medicine preparation of the present invention comprises, by weight, the raw medicinal materials as follows:

[0039] Scutellaria baicalensis 22 parts, Anemarrhena asphodeloides 22 parts, Rheum palmatum 8 parts, Gypsum fibrosum 22 parts, Houttuynia cordata 18 parts, Mentha haplocalyx 22 parts, Atractylodes lancea 14 parts, Citrus reticulata 18 parts, Poria cocos 16 parts, Magnolia officinalis 16 parts, Pueraria lobata 14 parts, Ligustrum lucidum 10 parts, Ephedra sinica 10 parts, Prunus armeniaca 14 parts, Gynostemma pentaphyllum 14 parts, Astragalus membranaceus 15 parts, Psoralea corylifolia 10 parts, Glycyrrhiza uralensis 6 parts.

[0040] The preparation process is as follows: weigh the required raw medicinal materials according to their weight, crush the raw medicinal materials separately, pass them through an 80-mesh sieve, and mix them evenly to obtain the Chinese medicine powder of the present invention.

[0041] Example 3

[0042] The traditional Chinese medicine preparation of the present invention comprises, by weight, the raw medicinal materials as follows:

[0043] Scutellaria baicalensis 18 parts, Anemarrhena asphodeloides 18 parts, Rheum palmatum 6 parts, Gypsum fibrosum 18 parts, Houttuynia cordata 12 parts, Mentha haplocalyx 18 parts, Atractylodes lancea 8 parts, Citrus reticulata 12 parts, Poria cocos 10 parts, Magnolia officinalis 12 parts, Pueraria lobata 10 parts, Ligustrum lucidum 6 parts, Ephedra sinica 8 parts, Prunus armeniaca 10 parts, Gynostemma pentaphyllum 10 parts, Astragalus membranaceus 12 parts, Psoralea corylifolia 8 parts, Glycyrrhiza uralensis 4 parts.

[0044] Its preparation process is as follows:

[0045] (1) Weigh the required raw medicinal materials according to weight, mix the above raw medicinal materials and add them to the extraction tank. Add 10 times the amount of water to soak the raw medicinal materials for 45 minutes, heat to boiling, extract for 2 hours, filter, collect filtrate I, and set aside.

[0046] (2) Add 10 times the amount of water to the dregs, heat to boiling, extract for 2 hours, filter, and combine with filtrate I to obtain the extract;

[0047] (3) Concentrate the extract to contain 1g of raw medicinal material per mL;

[0048] (4) The concentrate is spray-dried to obtain the dry powder of the Chinese herbal extract;

[0049] (5) Add appropriate amounts of excipients sucrose and dextrin to the dry powder of Chinese herbal extract, mix evenly so that each gram contains 2.5g of raw medicinal material, then spray an appropriate amount of 75% ethanol to make a soft material that can be formed into a ball when squeezed and dispersed when pinched, place it in a swing granulator to make granules, and after drying, granulation and packaging, the Chinese herbal preparation of the present invention is obtained, and the dosage form is granules.

[0050] Example 4

[0051] The traditional Chinese medicine preparation of the present invention comprises, by weight, the raw medicinal materials as follows:

[0052] Scutellaria baicalensis 14 parts, Anemarrhena asphodeloides 13 parts, Rheum palmatum 2 parts, Gypsum fibrosum 14 parts, Houttuynia cordata 7 parts, Mentha haplocalyx 14 parts, Atractylodes lancea 3 parts, Citrus reticulata 8 parts, Poria cocos 6 parts, Magnolia officinalis 6 parts, Pueraria lobata 6 parts, Ligustrum lucidum 3 parts, Ephedra sinica 4 parts, Prunus armeniaca 6 parts, Gynostemma pentaphyllum 7 parts, Astragalus membranaceus 6 parts, Psoralea corylifolia 5 parts, Glycyrrhiza uralensis 1 part.

[0053] Its preparation process is as follows:

[0054] (1) Weigh the required raw medicinal materials according to weight, mix the above raw medicinal materials and add them to the extraction tank. Add 10 times the amount of water to soak for 40 minutes, heat to boiling, extract by boiling for 2.5 hours, filter, collect filtrate I, and set aside.

[0055] (2) Add 10 times the amount of water to the dregs of the raw medicinal materials, heat to a boil, extract for 1.5 hours, filter, and combine with filtrate I to obtain the extract;

[0056] (3) Concentrate the extract to contain 1g of raw medicinal material per mL;

[0057] (4) The concentrate is spray-dried to obtain the dry powder of the Chinese herbal extract;

[0058] (5) Add an appropriate amount of sucrose powder (80 mesh) to the dry powder of Chinese herbal extract, mix evenly so that each gram contains 2.5g of raw medicinal material. After packaging, the Chinese herbal preparation of the present invention is obtained, and the dosage form is soluble powder.

[0059] Example 5

[0060] The traditional Chinese medicine preparation of the present invention comprises, by weight, the raw medicinal materials as follows:

[0061] Scutellaria baicalensis 16 parts, Anemarrhena asphodeloides 16 parts, Rheum palmatum 5 parts, Gypsum fibrosum 16 parts, Houttuynia cordata 10 parts, Mentha haplocalyx 16 parts, Atractylodes lancea 6 parts, Citrus reticulata 10 parts, Poria cocos 8 parts, Magnolia officinalis 10 parts, Pueraria lobata 8 parts, Ligustrum lucidum 4 parts, Ephedra sinica 6 parts, Prunus armeniaca 8 parts, Gynostemma pentaphyllum 8 parts, Astragalus membranaceus 10 parts, Psoralea corylifolia 6 parts, Glycyrrhiza uralensis 2 parts.

[0062] Its preparation process is as follows:

[0063] (1) Weigh the required raw medicinal materials according to weight, mix the above raw medicinal materials and add them to the extraction tank. Add 10 times the amount of water to soak the raw medicinal materials for 45 minutes, heat to boiling, extract by boiling for 1.5 hours, filter, collect filtrate I, and set aside.

[0064] (2) Add 10 times the amount of water to the dregs of the raw medicinal materials, heat to a boil, extract for 1.5 hours, filter, and combine with filtrate I to obtain the extract;

[0065] (3) Concentrate the extract to contain 1g of raw medicinal material per mL;

[0066] (4) The concentrate is spray-dried to obtain the dry powder of the Chinese herbal extract;

[0067] (5) Add appropriate amounts of excipients sucrose and dextrin to the dry powder of Chinese herbal extract, mix evenly so that each gram contains 2.5g of raw medicinal material, then add water to make a soft material, place it in a swing granulator to make granules, and after drying, granulation and packaging, the Chinese herbal preparation of the present invention is obtained, and the dosage form is granules.

[0068] Example 6

[0069] The traditional Chinese medicine preparation of the present invention comprises, by weight, the raw medicinal materials as follows:

[0070] Scutellaria baicalensis 26 parts, Anemarrhena asphodeloides 26 parts, Rheum palmatum 12 parts, Gypsum fibrosum 25 parts, Houttuynia cordata 22 parts, Mentha haplocalyx 26 parts, Atractylodes lancea 16 parts, Citrus reticulata 22 parts, Poria cocos 20 parts, Magnolia officinalis 20 parts, Pueraria lobata 18 parts, Ligustrum lucidum 12 parts, Ephedra sinica 12 parts, Prunus armeniaca 18 parts, Gynostemma pentaphyllum 16 parts, Astragalus membranaceus 18 parts, Psoralea corylifolia 14 parts, Glycyrrhiza uralensis 10 parts.

[0071] Its preparation process is as follows:

[0072] (1) Weigh the required raw medicinal materials according to weight, mix the above raw medicinal materials and add them to the extraction tank. Add 10 times the amount of water to soak the raw medicinal materials for 30 minutes, heat to boiling, extract by boiling for 2.5 hours, filter, collect filtrate I, and set aside.

[0073] (2) Add 10 times the amount of water to the dregs of the raw medicinal materials, heat to boiling, extract for 2.5 hours, filter, and combine with filtrate I to obtain the extract;

[0074] (3) Concentrate the extract to contain 1g of raw medicinal material per mL, add 0.3% potassium sorbate and dissolve evenly to obtain the oral liquid of traditional Chinese medicine.

[0075] Comparative Example 1

[0076] A traditional Chinese medicine preparation for treating porcine reproductive and respiratory syndrome (PRRS), wherein the components and their weights in the preparation are as follows: 200g ephedra, 250g apricot kernel, 350g raw coix seed, 200g white cardamom, 200g pinellia, 300g magnolia bark, 50g tetrapanax papyriferus, 100g talc, 100g agastache rugosa, 50g licorice, and 200g atractylodes lancea.

[0077] The preparation process is as follows: After mixing the above raw materials, mix them with water in an amount of 5 times the total weight of the raw materials, decoct at 60-100℃ for 30 minutes, filter, decoct the residue with an equal amount of water once more, combine the two filtrates, and concentrate to 1g / mL.

[0078] The above formulation and process are based on Example 2 of patent CN104547870A.

[0079] Comparative Example 2

[0080] A traditional Chinese medicine compound preparation for treating porcine reproductive and respiratory syndrome (PRRS) comprises the following components in parts by weight: 6 parts Schizonepeta tenuifolia, 10 parts Saposhnikovia divaricata, 6 parts Bupleurum chinense, 6 parts Peucedanum praeruptorum, 6 parts Notopterygium incisum, 6 parts Angelica pubescens, 6 parts Panax ginseng rootlets, 6 parts Arctium lappa, 6 parts Citrus aurantium, 6 parts Poria cocos, 6 parts Platycodon grandiflorus, 6 parts Ligusticum chuanxiong, 6 parts Glycyrrhiza uralensis, 6 parts Mentha haplocalyx, 6 parts Scutellaria baicalensis, and 6 parts Trichosanthes kirilowii.

[0081] The above formulation and its process are as shown in Example 1 of patent CN104474083A.

[0082] Comparative Example 3

[0083] A traditional Chinese medicine compound for the effective prevention and treatment of H1N1 and H3N2 swine influenza and porcine reproductive and respiratory syndrome (PRRS), wherein the components and their weights in the traditional Chinese medicine compound are as follows: Ephedra 200g, Scutellaria baicalensis 200g, Anemarrhena asphodeloides 90g, Fritillaria cirrhosa 90g, Prunus armeniaca 90g, Houttuynia cordata 90g, Morus alba root bark 90g, Rheum palmatum 90g, and Glycyrrhiza uralensis 60g.

[0084] The preparation process is as follows: Weigh and combine the Chinese medicinal materials in the formula, crush them to 20 mesh, add 2000g of water, soak for 1 hour, heat to boiling, decoct for 30 minutes, filter, and reserve filtrate I. Add an equal amount of water to the dregs, heat to boiling, filter, and combine with filtrate I to obtain the extract. Under normal pressure and vacuum conditions, filter and concentrate the extract, and make up to 1000mL to obtain the concentrate. Sterilize and store the concentrate.

[0085] The above formulation and process are based on the specific implementation method described in the specification of patent CN106237050A.

[0086] Experimental Example 1: In vitro antiviral efficacy test

[0087] 1. Experimental Objective

[0088] Verify the anti-PRRS virus effect of the product of this invention.

[0089] 2. Test materials

[0090] Experimental cells and viruses: monkey kidney cells, highly pathogenic porcine reproductive and respiratory syndrome virus (PRRSV).

[0091] Test drugs: The samples used in this experiment were provided by the Traditional Chinese Veterinary Medicine R&D Center of the Pharmaceutical Research Institute of Tianjin Ruipu Biotechnology Co., Ltd. The test group consisted of Example 1 (1000g / bag, batch number: 20220301), Example 3 (1000g / bag, batch number: 20220303), Example 4 (1000g / bag, batch number: 20220304), Comparative Example 1 (1000mL / bottle, batch number: 20220307), and Comparative Example 3 (1000mL / bottle, batch number: 20220309); Ribavirin was produced by a commercially available manufacturer (50mg / bag, batch number: 200312).

[0092] Preparation of test samples: Samples from Examples 1, 3, and 4 were dissolved in DMEM basal medium to a concentration of 1 g of raw medicinal material / mL, filtered through a 0.22 μm filter membrane, and set aside. The products from Comparative Examples 1 and 3 were centrifuged at 3000 rpm for 10 min, and the supernatant was collected and filtered through a 0.22 μm filter membrane. Ribavirin was dissolved in DMEM basal medium to a concentration of 10 mg / mL, filtered through a 0.22 μm filter membrane, and set aside.

[0093] 3. Test methods

[0094] 3.1 Inhibitory effect of drugs on viruses: Examples 1, 3, and 4, Comparative Examples 1 and 3, and the positive control drug ribavirin (concentration of 5 mg raw material / mL for Examples 1, 3, and 4 and Comparative Examples 1 and 3; ribavirin concentration of 0.1 mg / mL) were diluted with culture medium. Virus solution was first inoculated into 96-well cell culture plates confluent with monolayer cells, 100 μL / well, and incubated at 37°C for 2 hours. The virus solution was then discarded. Next, drug solution was added, 100 μL / well, with each concentration repeated in 5 wells. After incubation at 37°C for 4 hours, the drug solution was discarded. 100 μL of cell maintenance medium was added to each well, and the cells were cultured for another 5 days. The OD value of each well was measured using the CCK8 assay.

[0095] 3.2 Drug blocking effect on virus: After the cells grew into a monolayer in the 96-well plate, each drug group was added with 100 μL of drug solution per well, with 5 wells for each concentration. After incubation at 37°C for 4 hours, the drug solution was discarded, and virus solution was added at 100 μL per well. After incubation at 37°C for 2 hours, the virus solution was discarded, and 100 μL of cell maintenance medium was added to each well. The cells were cultured for another 5 days, and the OD value of each well was measured by CCK8 assay.

[0096] 3.3 Direct inactivation of the virus by the drug: After the cells grew into a monolayer in the 96-well plate, each drug group was added with 100 μL of drug solution per well and 100 μL of virus solution per well. Each concentration was repeated in 5 wells. After incubation at 37°C for 4 hours, the culture medium was discarded, and 100 μL of cell maintenance medium was added to each well. The cells were cultured for another 5 days, and the OD value of each well was measured by the CCK8 method.

[0097] At the same time, a blank control group (containing cells and culture medium) and a virus model group (containing cells, culture medium, and porcine reproductive and respiratory syndrome virus) were set up.

[0098] 3.4 Calculate according to the formula: The protective rate of the drug against virus-infected cells = (OD value of drug-treated group - OD value of virus model group) / (OD value of blank control group - OD value of virus model group) × 100%.

[0099] 4. Test Results

[0100] As shown in Table 1, ribavirin, as a positive control drug, has a protection rate of over 50% against PRRSV-infected cells, demonstrating effective protection. Example 3 shows a protection rate of over 20% against PRRSV-infected cells, effectively protecting infected cells.

[0101] Table 1. Cell protection rate (%) of different drugs

[0102] Group Inhibition blocking effect Direct inactivation Example 1 (5 mg / mL) 15.4 26.5 19.8 Example 3 (5 mg / mL) 29.0 30.3 43.0 Example 4 (5 mg / mL) 20.3 19.5 23.9 Ribavirin (0.1 mg / mL) 51.6 62.1 58.7 Comparative Example 1 (5 mg / mL) 15.7 24.5 22.0 Comparative Example 3 (5 mg / mL) 28.3 25.9 20.4

[0103] Note: The protection rate of the drug against virus-infected cells = (OD value of drug-treated group - OD value of virus model group) / (OD value of blank control group - OD value of virus model group) × 100%; Cell protection rate: 10%-20% low protection rate, 20%-30% relatively high protection rate, >30% high protection rate.

[0104] 5. Conclusion

[0105] The above experimental results show that the traditional Chinese medicine preparation of the present invention has a significant antiviral effect against porcine reproductive and respiratory syndrome virus (PRRSV). It achieves its antiviral purpose by blocking viral adsorption to cells and inhibiting viral replication within cells, and also has a strong killing effect on the virus itself. Regarding the inhibitory, blocking, and direct inactivation effects of the drug on the virus, the product of Example 3, in particular, achieves a protection rate of 29%, 30.3%, and 43% against infected cells, respectively, which is superior to the effects of other examples and comparative examples.

[0106] Experiment Example 2: Effects of Experiment 2 on Growth Performance and Clinical Symptoms of Pigs with Porcine Reproductive and Respiratory Syndrome (PRRS)

[0107] 1. Test materials

[0108] Experimental animals: Landrace pigs, half male and half female; age: 35 days old, healthy piglets; weight: 8±0.8 kg.

[0109] Test drugs: Example 2 (1000g / bag, batch number: 20220302), Example 3 (1000g / bag, batch number: 20220303), Comparative Example 1 (1000mL / bottle, batch number: 20220307), Comparative Example 2 (1000g / bag, batch number: 20220308).

[0110] Virus: Porcine reproductive and respiratory syndrome virus (PRRSV) (highly pathogenic strain).

[0111] 2. Test Methods

[0112] 2.1 Grouping and Treatment: Thirty-six healthy piglets that were double-negative for PRRS were selected and acclimatized for one week. They were then randomly divided into six groups of six piglets each. The control group (6 piglets) received 2.5 mL of physiological saline (fed with a normal diet) via nasal drops. The remaining groups each received an appropriate amount of diluted PRRS virus solution via nasal drops to establish a model (the nasal drop dose was determined by the viral titer used in piglets whose serum tested positive for PRRS and showed clinical signs of coughing and wheezing 7 days after challenge). The piglets were then divided into the model group (fed with a normal diet), Example 2 group (0.1% of the virus was mixed with feed for 14 consecutive days), Example 3 group (0.025% of the virus was mixed with feed for 14 consecutive days), Comparative Example 1 group (0.1% of the virus was mixed with feed for 14 consecutive days), and Comparative Example 2 group (0.3% of the virus was mixed with feed for 14 consecutive days). The piglets in each group were housed in different negative pressure chambers.

[0113] 2.2 Record and observe clinical symptoms daily.

[0114] 2.3 Record the body weight of pigs in each group 7 days after viral invasion, 7 days after drug administration, 14 days after drug administration, and 14 days after drug withdrawal.

[0115] 2.4 After 14 days of drug withdrawal, blood samples were collected to detect the serum levels of IL-1β, IFN-α, and TNF-α.

[0116] 2.5 After 14 days of drug withdrawal, a pathological autopsy was performed for observation.

[0117] 3. Test Results

[0118] 3.1 Clinical observation

[0119] Throughout the experiment, the model group exhibited significant clinical symptoms such as reduced feed intake, coughing, and wheezing. After 7 days of administration, most pigs in Example 3 group had their diet return to normal, and their coughing and wheezing symptoms were alleviated. After 14 days of administration, all pigs in Examples 2 and 3 groups showed no disappearance of coughing and wheezing symptoms. After 14 days of administration, 50% of pigs in Comparative Example 1 group and 20% of pigs in Comparative Example 2 group showed a reduction in coughing and wheezing symptoms.

[0120] 3.2 Weight gain

[0121] Seven days after challenge, compared with the control group, the weight gain rate of pigs in all challenge groups was lower, indicating that 7-14 days after challenge with PRRSV has a significant impact on the organism. At 7 days, 14 days after drug administration, and 14 days after drug withdrawal, the weight gain rates of Example 2 and Example 3 groups were superior to those of Comparative Examples 1 and 2. Among them, Example 3 group showed the most significant weight gain effect, with a weight gain rate 14 days after drug withdrawal that was 33.4% higher than the model group, 21.17% higher than Comparative Example 1, and 27.44% higher than Comparative Example 2.

[0122] Table 2. Weight gain rate of pigs in each experimental group

[0123]

[0124] 3.3 Results of inflammatory factor levels

[0125] As shown in Table 3, compared with the blank group, the serum levels of IL-1β and TNF-α in the model group of porcine reproductive and respiratory syndrome (PRRS) pigs were significantly increased, while the IFN-α level was significantly decreased (P<0.01). Compared with the model group, the serum levels of IL-1β in PRRS pigs in Examples 2 and 3 and Comparative Example 1 were significantly decreased (P<0.01), the serum levels of IFN-α in PRRS pigs in Examples 2 and 3 were significantly increased (P<0.01 or P<0.05), and the serum levels of TNF-α in PRRS pigs in Examples 2 and 3 were significantly decreased (P<0.01).

[0126] Table 3. Levels of inflammatory factors in each group

[0127] Group IL-1β (pg / mL) IFN-α (pg / mL) TNF-α (pg / mL) Blank group 57.85±6.29 33.87±2.75 154.48±14.62 Model group <![CDATA[127.20±11.85 ** ]]> <![CDATA[26.21±1.98 ** ]]> <![CDATA[221.08±19.81 ** ]]> Example 2 group <![CDATA[79.01±8.02 ## ]]> <![CDATA[30.10±2.84 # ]]> <![CDATA[166.47±15.12 ## ]]> Example 3 Group <![CDATA[65.69±5.24 ## ]]> <![CDATA[34.05±2.69 ## ]]> <![CDATA[159.26±14.17 ## ]]> Comparative Example 1 <![CDATA[77.36±7.12 ## ]]> <![CDATA[29.67±2.41 * ]]> 182.26±19.35 Comparative Example 2 <![CDATA[101.76±9.18 ** ]]> <![CDATA[28.69±1.83 * ]]> <![CDATA[201.47±13.20 ** ]]>

[0128] Note: Compared with the control group, ** indicates a highly significant difference (P<0.01), and * indicates a significant difference (P<0.05). Compared with the model group, ## indicates a highly significant difference (P<0.01), and # indicates a significant difference (P<0.05).

[0129] 3.4 Pathological autopsy observation

[0130] The blank control group and groups 2 and 3 of Examples showed no significant pathological changes in the lungs, spleen, liver, kidneys, and lymph nodes of the pigs. The model group pigs had pleural effusion, severe swelling and congestion of the inguinal lymph nodes, congestion and muscular degeneration of the lungs, and severe hemorrhage at the edge of the spleen. The pigs in control group 1 had mild swelling and congestion of the inguinal lymph nodes and muscular degeneration of the lungs. The pigs in control group 2 had a small amount of pleural effusion, swelling and congestion of the inguinal lymph nodes, and congestion of the lungs.

[0131] 4. Conclusion

[0132] The inflammatory factor IL-1β plays an important role in innate immunity. It has been reported that the HP-PRRSV strain can activate the NLRP3 inflammasome, inducing IL-1β production. Overexpression of IL-1β can cause lung lesions, damage to immune organs, and systemic vasculitis and secondary infections. In PRRSV-infected organisms, IFN-α has functions such as resisting viral proliferation and immunomodulation. Therefore, IL-1β and IFN-α cytokines in anti-PRRSV immunity were selected for detection. The experimental results show that the herbal preparations in Examples 2 and 3 of this invention can reduce the inflammatory response in porcine reproductive and respiratory syndrome (PRRS), enhance the body's defense against the virus, significantly promote weight gain in PRRSV-affected pigs, and alleviate pathological changes in tissues and organs. Among them, the herbal preparation in Example 3 showed the best effect.

[0133] Trial Example 3: Clinical Efficacy Trial

[0134] 1. Test materials

[0135] Experimental animals: 32 replacement gilts from a pig farm in Shandong Province. Their body temperature rose to about 40℃-41℃, and they coughed, sneezed, and wheezed. Some pigs had difficulty breathing, their skin turned red, and there were red marks on their abdomen. Their feces were dry or diarrheal. They were diagnosed with porcine reproductive and respiratory syndrome (PRRS).

[0136] Test drugs: The samples for this experiment were provided by the Traditional Chinese Veterinary Medicine R&D Center of the Pharmaceutical Research Institute of Tianjin Ruipu Biotechnology Co., Ltd., namely Example 3 (1000g / bag, batch number: 20220303) and Comparative Example 1 (1000mL / bottle, batch number: 20220307).

[0137] 2. Test Methods

[0138] 2.1 Treatment: The sick pigs were randomly divided into two groups. The two groups were treated with 0.025% of the traditional Chinese medicine preparation provided in Example 3 of this invention in drinking water, while the control group was treated with 0.1% of the product in drinking water. The treatment was carried out for two consecutive weeks.

[0139] 2.2 Observe and record clinical symptoms daily and score them.

[0140] 2.3 Detect and record body temperature.

[0141] 3. Test Results

[0142] 3.1 Clinical symptom score

[0143] The scoring is based on clinical symptoms, and the scoring criteria are set as follows:

[0144] Table 4 Scoring Criteria

[0145]

[0146] The clinical symptom scores of the two experimental groups showed that the symptom scores were high before treatment. After 7 days of administration, the clinical symptom scores of both groups showed a decreasing trend, with the clinical symptom score of Example 3 group being lower than that of Comparative Example 1 group. After 14 days of administration and 14 days of withdrawal, there were no significant clinical symptoms in Example 3 group. This indicates that Example 3 of the present invention can significantly improve the clinical symptoms of porcine reproductive and respiratory syndrome (PRRS) pigs compared with Comparative Example 1.

[0147] Table 5. Average clinical symptom scores (points) of the two groups of pigs.

[0148] Group Pre-drug score 7-day score after drug administration 14-day score after drug administration 14-day score after drug withdrawal Example 3 Group 5±1.49 1.8±1.14 0 0 Comparative Example 1 4.8±1.52 4.2±0.75 1.2±0.64 0.6±0.89

[0149] 3.2 Results of body temperature changes

[0150] The body temperature monitoring results of the two experimental groups showed that the body temperature was in a state of moderate fever before the administration of the drug; after 7 days of administration, the body temperature of the Example 3 group showed a downward trend; after 14 days of administration and 14 days after the drug was discontinued, the body temperature of the Example 3 group was normal. Compared with the Comparative Example 1, the body temperature can be quickly and effectively regulated to normal, indicating that Example 3 of the present invention can significantly improve the high fever symptoms of pigs with porcine reproductive and respiratory syndrome (PRRS).

[0151] Table 6. Average body temperature (°C) of pigs in the two groups.

[0152] Group Before administration 7 days after administration 14 days of administration Discontinue medication for 14 days Example 3 Group 40.6±0.33 40.2±0.29 39.2±0.27 39.2±0.24 Comparative Example 1 40.7±0.34 40.7±0.39 40.3±0.31 39.5±0.19

[0153] 4. Conclusion

[0154] As can be seen from the above experimental results, Example 3 of the present invention can significantly improve the clinical symptoms of porcine reproductive and respiratory syndrome (PRRS) in pigs, such as coughing, wheezing, runny nose, diarrhea, and high fever.

[0155] While specific embodiments of the present invention have been described above, those skilled in the art should understand that the specific embodiments described are merely illustrative and not intended to limit the scope of the present invention. Equivalent modifications and variations made by those skilled in the art in accordance with the spirit of the present invention should be covered within the scope of protection of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome, characterized in that, The weight parts of each raw material in the traditional Chinese medicine composition: Huangqi 4-20 parts, Buguzhi 2-15 parts, Gancao 1-11 parts.

2. The traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome according to claim 1, characterized in that, The weight parts of each raw material in the traditional Chinese medicine composition: Huangqi 4-20 parts, Buguzhi 2-15 parts, Gancao 1-11 parts. 3.The traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome according to claim 2, characterized in that, The weight parts of each raw material in the traditional Chinese medicine composition: Huangqi 4-20 parts, Buguzhi 2-15 parts, Gancao 1-11 parts.

4. The traditional Chinese medicine composition for treating porcine reproductive and respiratory syndrome according to claim 3, characterized in that, The weight parts of each raw material in the traditional Chinese medicine composition: Huangqi 4-20 parts, Buguzhi 2-15 parts, Gancao 1-11 parts.

5. The traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The preparation method of the traditional Chinese medicine composition for treating swine blue ear disease comprises the following steps: taking each raw material component according to the selected weight parts, mixing, and then extracting according to a conventional extraction method or mixing according to a conventional method, so as to obtain the traditional Chinese medicine composition.

6. The use of the traditional Chinese medicine composition for treating swine blue ear disease according to any one of claims 1-4 in the preparation of a pharmaceutical preparation for treating swine blue ear disease.

7. Use according to claim 6, characterized in that, The pharmaceutical preparation is a powder or granules.

8. The use of the traditional Chinese medicine composition for treating swine blue ear disease according to any one of claims 1-4 in the preparation of a feed additive for treating swine blue ear disease.

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