A medicament for treating infectious bursal disease and its preparation method and application

Abstract

This invention relates to a traditional Chinese medicine preparation for treating infectious bursal disease (IBD), its preparation method, and its application. The preparation comprises the following components: Astragalus membranaceus 45-50 parts, Rehmannia glutinosa 30-45 parts, Isatis indigotica 25-30 parts, Isatis tinctoria 25-30 parts, Gypsum fibrosum 10-45 parts, Lonicera japonica 10-20 parts, Forsythia suspensa 10-30 parts, Taraxacum mongolicum 10-20 parts, Atractylodes macrocephala 15-20 parts, Paeonia lactiflora 15-30 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, and Glycyrrhiza uralensis 10-30 parts. The preparation is achieved through extraction and concentration processes and is effective in treating IBD in chickens caused by both traditional infectious bursal disease virus (IBDV) and novel variant infectious bursal disease virus (nvvIBDV). This medicine significantly improves the cure rate against both traditional and variant strains, showing a particularly significant advantage in treating variant strains.

Description

Technical Field

[0001] This invention belongs to the field of disease treatment technology, and in particular relates to a drug for treating infectious bursal disease, its preparation method and application. Background Technology

[0002] Infectious bursal disease (IBD) is an acute, highly contagious poultry disease caused by infectious bursal disease virus (IBDV). It primarily affects the bursa of Fabricius and the immune system, leading to immunosuppression and high mortality. This disease is widespread in the global poultry industry, causing significant economic losses. IBD is particularly prevalent in chicks, with high morbidity and mortality rates, severely impacting flock growth, development, and production performance. In recent years, continuous viral mutations, especially the emergence of novel variant infectious bursal disease virus (nvvIBDV), have increased the complexity of the disease and the difficulty of treatment.

[0003] Currently, the main drugs available for treating infectious bursal disease (IBD) in chickens are chemically synthesized drugs and vaccines. However, these treatments are often ineffective, especially against IBD caused by mutated viruses, where existing drugs are significantly insufficient. The antigenicity and virulence of mutated viruses have changed, drastically reducing the protective effect of traditional vaccines. Furthermore, chemical drugs have limited direct inhibitory effects on the virus, easily leading to drug residues and drug resistance. Therefore, there is an urgent need to find new treatments to effectively combat IBD caused by these mutated strains.

[0004] Traditional Chinese medicine (TCM) has a long history and rich experience in treating poultry diseases. Using TCM to treat infectious bursal disease (IBD) in chickens has several advantages. First, the synergistic effect of multiple components in TCM can regulate the body's immune function holistically, enhancing disease resistance. Second, TCM has lower toxicity and side effects, is less likely to induce drug resistance, and exhibits good safety and eco-friendliness. Furthermore, many TCMs possess antiviral, anti-inflammatory, and immunomodulatory effects, showing potential therapeutic efficacy against IBD caused by novel variant viruses. Therefore, developing TCM-based formulations can provide an effective and sustainable solution for the prevention and control of IBD in chickens. Summary of the Invention

[0005] The purpose of this invention is to provide a medicament for treating infectious bursal disease, its preparation method, and its application, thereby solving the problem of treating infectious bursal disease caused by a novel variant virus.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] In a first aspect, the present invention provides a medicament for treating infectious bursal disease, wherein the raw materials for preparing the medicament are composed of the following components:

[0008] Astragalus membranaceus 45-50 parts, Rehmannia glutinosa 30-45 parts, Isatis indigotica 25-30 parts, Isatis tinctoria 25-30 parts, Gypsum 10-45 parts, Lonicera japonica 10-20 parts, Forsythia suspensa 10-30 parts, Taraxacum mongolicum 10-20 parts, Atractylodes macrocephala 15-20 parts, Paeonia lactiflora 15-30 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10-30 parts.

[0009] Furthermore, the infectious bursal disease is infectious bursal disease in chickens caused by traditional infectious bursal disease virus IBDV and novel variant infectious bursal disease virus nvvIBDV.

[0010] Furthermore, the infectious bursal disease mentioned is infectious bursal disease of chickens caused by a novel variant infectious bursal disease virus nvvIBDV.

[0011] Furthermore, the pharmaceutical agent is prepared by the following method:

[0012] (1) Weigh different components according to the composition of the raw materials and add them to the extraction device;

[0013] (2) Add 10 times the amount of distilled water, heat to 100℃, and simmer for 1.5 hours;

[0014] (3) Filter and collect filtrate 1 and filter residue. Add 10 times the amount of distilled water to the filter residue, heat to 90°C, and decoct for 1.5 hours.

[0015] (4) Filter and collect filtrate 2. Combine filtrate 1 and filtrate 2 to obtain filtrate 3.

[0016] (5) The filtrate 3 is concentrated by rotary evaporation to 1 / 10 of its original volume to obtain the reagent.

[0017] Furthermore, the raw materials for preparing the medicine consist of the following components: 45 parts Astragalus membranaceus, 30 parts Rehmannia glutinosa, 30 parts Isatis indigotica, 30 parts Isatis tinctoria, 45 parts Gypsum fibrosum, 20 parts Lonicera japonica, 20 parts Forsythia suspensa, 20 parts Taraxacum mongolicum, 15 parts Atractylodes macrocephala, 15 parts Paeonia lactiflora, 15 parts Lilium brownii, 15 parts Anemarrhena asphodeloides, and 10 parts Glycyrrhiza uralensis.

[0018] Secondly, the present invention provides a method for preparing a medicament for treating infectious bursal disease, the method comprising the following steps:

[0019] (1) Add 45 parts of Astragalus membranaceus, 30 parts of Rehmannia glutinosa, 30 parts of Isatis indigotica, 30 parts of Isatis tinctoria, 45 parts of Gypsum fibrosum, 20 parts of Lonicera japonica, 20 parts of Forsythia suspensa, 20 parts of Taraxacum mongolicum, 15 parts of Atractylodes macrocephala, 15 parts of Paeonia lactiflora, 15 parts of Lilium brownii, 15 parts of Anemarrhena asphodeloides, and 10 parts of Glycyrrhiza uralensis to the extraction device.

[0020] (2) Add 10 times the amount of distilled water, heat to 100℃, and simmer for 1.5 hours;

[0021] (3) Filter and collect filtrate 1 and filter residue. Add 10 times the amount of distilled water to the filter residue, heat to 90°C, and decoct for 1.5 hours.

[0022] (4) Filter and collect filtrate 2. Combine filtrate 1 and filtrate 2 to obtain filtrate 3.

[0023] (5) The filtrate 3 is concentrated by rotary evaporation to 1 / 10 of its original volume to obtain the reagent.

[0024] Furthermore, the infectious bursal disease is infectious bursal disease in chickens caused by traditional infectious bursal disease virus IBDV and novel variant infectious bursal disease virus nvvIBDV.

[0025] Furthermore, the infectious bursal disease mentioned is infectious bursal disease of chickens caused by a novel variant infectious bursal disease virus nvvIBDV.

[0026] Thirdly, the present invention provides an application of a traditional Chinese medicine composition in the preparation of a drug for treating infectious bursal disease, wherein the traditional Chinese medicine composition comprises: 45-50 parts of Astragalus membranaceus, 30-45 parts of Rehmannia glutinosa, 25-30 parts of Isatis indigotica, 25-30 parts of Isatis tinctoria, 10-45 parts of Gypsum fibrosum, 10-20 parts of Lonicera japonica, 10-30 parts of Forsythia suspensa, 10-20 parts of Taraxacum mongolicum, 15-20 parts of Atractylodes macrocephala, 15-30 parts of Paeonia lactiflora, 15 parts of Lilium brownii, 15 parts of Anemarrhena asphodeloides, and 10-30 parts of Glycyrrhiza uralensis.

[0027] Furthermore, the composition of the traditional Chinese medicine composition is as follows: 45 parts of Astragalus membranaceus, 30 parts of Rehmannia glutinosa, 30 parts of Isatis indigotica, 30 parts of Isatis tinctoria, 45 parts of Gypsum fibrosum, 20 parts of Lonicera japonica, 20 parts of Forsythia suspensa, 20 parts of Taraxacum mongolicum, 15 parts of Atractylodes macrocephala, 15 parts of Paeonia lactiflora, 15 parts of Lilium brownii, 15 parts of Anemarrhena asphodeloides, and 10 parts of Glycyrrhiza uralensis.

[0028] The infectious bursal disease mentioned refers to infectious bursal disease in chickens caused by the traditional infectious bursal disease virus IBDV and the novel variant infectious bursal disease virus nvvIBDV.

[0029] Furthermore, the infectious bursal disease mentioned is infectious bursal disease of chickens caused by a novel variant infectious bursal disease virus nvvIBDV.

[0030] Fourthly, the present invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for inhibiting infectious bursal disease virus, characterized in that the composition comprises: 45-50 parts of Astragalus membranaceus, 30-45 parts of Rehmannia glutinosa, 25-30 parts of Isatis indigotica, 25-30 parts of Isatis tinctoria, 10-45 parts of Gypsum fibrosum, 10-20 parts of Lonicera japonica, 10-30 parts of Forsythia suspensa, 10-20 parts of Taraxacum mongolicum, 15-20 parts of Atractylodes macrocephala, 15-30 parts of Paeonia lactiflora, 15 parts of Lilium brownii, 15 parts of Anemarrhena asphodeloides, and 10-30 parts of Glycyrrhiza uralensis.

[0031] Furthermore, the composition of the traditional Chinese medicine composition is as follows: 45 parts of Astragalus membranaceus, 30 parts of Rehmannia glutinosa, 30 parts of Isatis indigotica, 30 parts of Isatis tinctoria, 45 parts of Gypsum fibrosum, 20 parts of Lonicera japonica, 20 parts of Forsythia suspensa, 20 parts of Taraxacum mongolicum, 15 parts of Atractylodes macrocephala, 15 parts of Paeonia lactiflora, 15 parts of Lilium brownii, 15 parts of Anemarrhena asphodeloides, and 10 parts of Glycyrrhiza uralensis.

[0032] The infectious bursal disease mentioned refers to infectious bursal disease in chickens caused by the traditional infectious bursal disease virus IBDV and the novel variant infectious bursal disease virus nvvIBDV.

[0033] Furthermore, the infectious bursal disease mentioned is infectious bursal disease of chickens caused by a novel variant infectious bursal disease virus nvvIBDV.

[0034] The beneficial effects of this invention are as follows:

[0035] The medicament for treating infectious bursal disease provided by this invention exhibits significant synergistic effects among its components. In particular, the combination of key components such as Astragalus membranaceus, Lonicera japonica, Forsythia suspensa, Isatis indigotica, and Isatis tinctoria var. indica enhances the drug's immunomodulatory, antiviral, and heat-clearing and detoxifying functions. This synergistic effect not only effectively improves the body's immunity but also inhibits viral replication and promotes viral clearance, thus enabling the drug to demonstrate significant therapeutic efficacy against both traditional and variant strains.

[0036] The formulation in Example 1, through precise ingredient ratios and optimized combination, exhibits stronger antiviral activity against the novel variant infectious bursal disease virus (nvvIBDV). The experimental results in Tables 1 and 2 show that Example 1 demonstrates superior inhibitory effects against the variant strain compared to other examples (2-6) and comparative examples (1-10), particularly in reducing viral shedding and increasing cure rates. This indicates that the ingredient ratios in Example 1 are particularly suitable for combating more virulent and drug-resistant variant viruses, producing unexpected technical benefits. Detailed Implementation

[0037] Example 1

[0038] This embodiment provides a traditional Chinese medicine preparation for treating variant infectious bursal disease.

[0039] This medicine comprises the following components:

[0040] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 45 parts, Lonicera japonica 20 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0041] The preparation method of this drug is as follows:

[0042] (1) Weigh out the different components according to the formula and add them to the extraction tank;

[0043] (2) Add 10 times the amount of distilled water, heat to 100℃, and simmer for 1.5 hours;

[0044] (3) Filter and collect filtrate 1 and filter residue. Add 10 times the amount of distilled water to the filter residue, heat to 90°C, and decoct for 1.5 hours.

[0045] (4) Filter and collect filtrate 2. Combine filtrate 1 and filtrate 2 to obtain filtrate 3.

[0046] (5) The filtrate 3 was concentrated by rotary evaporation to 1 / 10 of its original volume to obtain a traditional Chinese medicine for treating variant infectious bursal disease.

[0047] Example 2

[0048] This embodiment provides a traditional Chinese medicine preparation for treating variant infectious bursal disease.

[0049] This medicine comprises the following components:

[0050] Astragalus membranaceus 50 parts, Rehmannia glutinosa 25 parts, Isatis indigotica 25 parts, Isatis tinctoria 25 parts, Gypsum 45 parts, Lonicera japonica 20 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 20 parts, Paeonia lactiflora 15 parts, Lilium brownii 20 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0051] The preparation method is the same as in Example 1.

[0052] Example 3

[0053] This embodiment provides a traditional Chinese medicine preparation for treating variant infectious bursal disease.

[0054] This medicine comprises the following components:

[0055] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 45 parts, Lonicera japonica 10 parts, Forsythia suspensa 10 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 20 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 25 parts.

[0056] The preparation method is the same as in Example 1.

[0057] Example 4

[0058] This embodiment provides a traditional Chinese medicine preparation for treating variant infectious bursal disease.

[0059] This medicine comprises the following components:

[0060] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 45 parts, Lonicera japonica 10 parts, Forsythia suspensa 30 parts, Taraxacum mongolicum 10 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 25 parts, Glycyrrhiza uralensis 10 parts.

[0061] The preparation method is the same as in Example 1.

[0062] Example 5

[0063] This embodiment provides a traditional Chinese medicine preparation for treating variant infectious bursal disease.

[0064] This medicine comprises the following components:

[0065] Astragalus membranaceus 45 parts, Rehmannia glutinosa 45 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 10 parts, Lonicera japonica 10 parts, Forsythia suspensa 30 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 30 parts.

[0066] The preparation method is the same as in Example 1.

[0067] Example 6

[0068] This embodiment provides a traditional Chinese medicine preparation for treating variant infectious bursal disease.

[0069] This medicine comprises the following components:

[0070] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 30 parts, Lonicera japonica 20 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 30 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0071] The preparation method is the same as in Example 1.

[0072] Comparative Example 1

[0073] This comparative example provides a traditional Chinese medicine preparation lacking Astragalus membranaceus.

[0074] This traditional Chinese medicine preparation includes the following components:

[0075] 30 parts Rehmannia glutinosa, 30 parts Isatis indigotica, 30 parts Isatis tinctoria, 45 parts Gypsum, 20 parts Lonicera japonica, 20 parts Forsythia suspensa, 20 parts Taraxacum mongolicum, 15 parts Atractylodes macrocephala, 15 parts Paeonia lactiflora, 15 parts Lilium brownii, 15 parts Anemarrhena asphodeloides, and 10 parts Glycyrrhiza uralensis.

[0076] The preparation method is the same as in Example 1.

[0077] Comparative Example 2

[0078] This comparative example provides a traditional Chinese medicine preparation lacking Isatis tinctoria leaves.

[0079] This traditional Chinese medicine preparation includes the following components:

[0080] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Gypsum 45 parts, Lonicera japonica 20 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0081] The preparation method is the same as in Example 1.

[0082] Comparative Example 3

[0083] This comparative example provides a traditional Chinese medicine preparation lacking honeysuckle.

[0084] This traditional Chinese medicine preparation includes the following components:

[0085] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 45 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0086] The preparation method is the same as in Example 1.

[0087] Comparative Example 4

[0088] This comparative example provides a traditional Chinese medicine preparation lacking Forsythia suspensa.

[0089] This traditional Chinese medicine preparation includes the following components:

[0090] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 45 parts, Lonicera japonica 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0091] The preparation method is the same as in Example 1.

[0092] Comparative Example 5

[0093] This comparative example provides a traditional Chinese medicine preparation lacking Isatis root.

[0094] This traditional Chinese medicine preparation includes the following components:

[0095] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Gypsum 45 parts, Lonicera japonica 20 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0096] The preparation method is the same as in Example 1.

[0097] Comparative Example 6

[0098] This example provides a traditional Chinese medicine preparation that uses Codonopsis pilosula as a substitute for Astragalus membranaceus.

[0099] This traditional Chinese medicine preparation includes the following components:

[0100] Codonopsis pilosula 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 45 parts, Lonicera japonica 20 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0101] The preparation method is the same as in Example 1.

[0102] Comparative Example 7

[0103] This example provides a traditional Chinese medicine preparation that uses purslane as a substitute for Isatis tinctoria leaf.

[0104] This traditional Chinese medicine preparation includes the following components:

[0105] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Portulaca oleracea 30 parts, Gypsum 45 parts, Lonicera japonica 20 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0106] The preparation method is the same as in Example 1.

[0107] Comparative Example 8

[0108] This example provides a traditional Chinese medicine preparation that uses chrysanthemum as a substitute for honeysuckle.

[0109] This traditional Chinese medicine preparation includes the following components:

[0110] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 45 parts, Chrysanthemum morifolium 20 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0111] The preparation method is the same as in Example 1.

[0112] Comparative Example 9

[0113] This example provides a traditional Chinese medicine preparation that uses mulberry leaves as a substitute for forsythia.

[0114] This traditional Chinese medicine preparation includes the following components:

[0115] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 45 parts, Lonicera japonica 20 parts, Morus alba 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0116] The preparation method is the same as in Example 1.

[0117] Comparative Example 10

[0118] This example provides a traditional Chinese medicine preparation that uses perilla as a substitute for isatis root.

[0119] This traditional Chinese medicine preparation includes the following components:

[0120] Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Perilla frutescens 30 parts, Isatis indigotica 30 parts, Gypsum 45 parts, Lonicera japonica 20 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

[0121] The preparation method is the same as in Example 1.

[0122] Experimental testing: Differences in cure rates for chickens with infectious bursal disease when using different drugs

[0123] Experimental steps:

[0124] Experimental materials:

[0125] Strains: Standard infectious bursal disease virus (IBDV), novel variant infectious bursal disease virus (nvvIBDV);

[0126] Experimental animals: 350 21-day-old SPF chicks, purchased from Boehringer Ingelheim Viton Biotechnology Co., Ltd., Beijing;

[0127] Animal grouping: 350 21-day-old SPF chickens were randomly divided into 35 groups: groups challenged with conventional IBDV virus (Examples 1-6, Comparative Examples 1-10); groups challenged with mutant strains (Examples 1-6, Comparative Examples 1-10).

[0128] Meanwhile, a traditional IBDV infection control group, a variant strain control group, and a healthy control group were set up, with 10 animals in each group. The drug treatment group, infection control group, and healthy control group were housed in different isolators to prevent cross-infection.

[0129] Challenge and administration: Before administration, SPF chickens were nasally inoculated with 0.3 mL of IBDV strain and nvvIBDV strain (containing 104-EID50 / 0.3 mL). 24 hours after inoculation, the chickens were orally administered the virus by gavage. The administration was repeated for 5 days, once a day.

[0130] Cure rate and survival rate were determined by recording the number of deaths 2–5 days after IBDV and variant strain inoculation. Before administration, the number of infected chickens exhibiting lethargy and depression was measured; chickens showing improved spirit and feed intake 5 days after administration were recorded as recovered chickens. Cure rate (%) = (Number of recovered chickens / Number of infected chickens) × 100%.

[0131] Table 1. Differences in cure rates after different drug treatments

[0132]

[0133]

[0134]

[0135] As can be seen from Table 1, the drug prepared in Example 1 has the best therapeutic effect on infectious bursal disease in chickens, achieving a 100% cure rate for both traditional and variant strains of infectious bursal disease in chickens.

[0136] Comparison between Example 1 and Example 2:

[0137] Astragalus: Example 1 contained 45 portions, and Example 2 contained 50 portions. Although the amount of Astragalus increased, the change in its proportion affected the coordination of other components;

[0138] Rehmannia glutinosa: Example 1 contained 30 parts, and Example 2 contained 25 parts. The higher proportion of Rehmannia glutinosa in Example 1 may enhance the yin-nourishing effect and help restore the body's immunity.

[0139] Compared with Example 3: Example 1:

[0140] Honeysuckle and Forsythia: In Example 3, the amount of honeysuckle and forsythia was reduced to 10 parts and 10 parts respectively, which may significantly reduce the antiviral ability and affect the overall effect.

[0141] Licorice: 10 parts in Example 1 and 25 parts in Example 3. Although the addition of licorice helps to harmonize the medicinal properties, excessive amounts may inhibit the effects of other components.

[0142] Compared with Example 4: Example 1:

[0143] Forsythia: In Example 4, the amount of Forsythia was increased to 30 parts, which may lead to an imbalance in the heat-clearing and detoxifying effects of the formula and interfere with the overall synergy of the drugs.

[0144] Gypsum: In Example 1, the amount of gypsum was 45 parts, while in Example 4 it was reduced to 30 parts. This may reduce the effectiveness in clearing heat toxins and affect resistance to mutant strains.

[0145] Compared with Example 5: Example 1:

[0146] Gypsum: When the amount of gypsum in Example 5 was reduced to 10 parts, the heat-clearing effect was greatly weakened, which may lead to insufficient inhibition of the virus.

[0147] Rehmannia: In Example 5, the amount of Rehmannia was increased to 45 parts. Although the tonic effect was enhanced, the resistance to viruses was relatively weakened.

[0148] Comparison between Example 1 and Example 6

[0149] Red peony root: In Example 6, the amount of red peony root was increased to 30 parts, which may enhance the blood-activating effect, but may not necessarily increase the antiviral effect.

[0150] Gypsum: In Example 6, the amount of gypsum was 30 parts, which reduced the heat-clearing efficacy compared to the 45 parts in Example 1, and therefore may have resulted in poor efficacy against mutant strains.

[0151] Overall, Example 1 demonstrates superior overall efficacy due to its reasonable balance in clearing heat, detoxifying, and replenishing qi, especially when targeting mutant strains, resulting in unexpected technical effects.

[0152] Compared to Example 1, Comparative Examples 1-5 showed a significant decrease in the therapeutic effects on infectious bursal disease in chickens caused by both traditional and variant strains. This indicates that the missing components in Comparative Examples 1-5 had a significant impact on the overall efficacy of the drugs. In particular, the absence of key immune-enhancing and antiviral components such as Astragalus membranaceus, Lonicera japonica, Forsythia suspensa, and Isatis indigotica made these drugs significantly less effective against variant strains than those in Example 1.

[0153] Compared to Example 1, Comparative Examples 6 (using Codonopsis pilosula instead of Astragalus membranaceus), 7 (using Portulaca oleracea instead of Isatis indigotica), 8 (using Chrysanthemum morifolium instead of Lonicera japonica), 9 (using Morus alba leaves instead of Forsythia suspensa), and 10 (using Perilla frutescens instead of Isatis indigotica) showed significantly reduced overall efficacy compared to Example 1 due to the absence or substitution of certain components. In particular, the key roles of Astragalus membranaceus, Lonicera japonica, Forsythia suspensa, and Isatis indigotica in immunomodulation, antiviral activity, and heat-clearing and detoxifying were weakened, resulting in a significantly lower therapeutic effect against mutant strains compared to Example 1. This difference in components directly impacted the overall efficacy of the medication.

[0154] In summary, Example 1, due to its unique combination of ingredients and optimized ratios, exhibits significant synergistic effects among its components, demonstrating unexpected technical benefits. It has a marked advantage in treating infectious bursal disease caused by mutant strains and can effectively improve the overall efficacy of the drug.

[0155] Experimental testing

[0156] After the observation period, necropsy was performed on 10 birds in each group. The bursa of Fabricius was harvested and weighed along with the chicken's body weight. The bursa of Fabricius tissue was then ground to extract RNA, which was then quantified by qRT-PCR according to the kit instructions. Organ lesions were also observed.

[0157] Table 2

[0158]

[0159]

[0160] As can be seen from the results in Table 2, consistent with the results obtained in Table 1, the amount of toxin excreted by the traditional strain and the mutant strain in Example 1 was significantly lower than that in other examples and comparative examples. This indicates that the drug prepared in Example 1 has a significant inhibitory effect on both the traditional IBDV strain and the mutant nvvIBDV strain. Furthermore, compared with Examples 2-6, it can be found that although Examples 2-6 also have a relatively good inhibitory effect on the traditional strain, the inhibitory effect on the mutant strain is relatively average.

[0161] The above results demonstrate that the combination of Astragalus membranaceus, Lonicera japonica, and Forsythia suspensa in the drug formulation of Example 1 enhanced the body's immunity, inhibited viral replication, and accelerated viral clearance. Furthermore, Isatis indigotica and Isatis tinctoria significantly reduced viral shedding through direct antiviral action and toxin removal. The synergistic effect of these components resulted in Example 1 exhibiting excellent therapeutic effects against both traditional and variant strains.

[0162] Examples 2-6 differ from Example 1 in their ingredient ratios. For example, the amounts of Astragalus membranaceus, Rehmannia glutinosa, Isatis indigotica, and gypsum fibrosum have been adjusted, or the content of certain components (such as honeysuckle and forsythia suspensa) has been reduced. These adjustments result in a weakening of the drug's immunomodulatory and antiviral capabilities when fighting viruses, especially when facing the variant strains of this invention.

[0163] Therefore, the formulation of Example 1, through precise ingredient ratios and optimized combinations, is particularly suitable for combating variant strains with stronger infectivity and the ability to evade the host's immune system. The ingredient combination of Example 1 can significantly enhance the host's immune response and directly interfere with the viral replication process, exhibiting a higher inhibitory effect.

[0164] Compared to Example 1, Comparative Examples 1-10 showed a significant decrease in immunomodulatory and antiviral efficacy after the absence or replacement of some key formulation components, especially when facing more challenging variant strains, where the therapeutic effect was even less ideal. This indicates that the component combination in Example 1 has a significant synergistic effect, with each component supporting each other in enhancing the body's immunity, clearing heat and detoxifying, and inhibiting viral replication, forming an effective overall therapeutic effect. Once some components are removed or replaced, this synergistic effect is disrupted, leading to a significant decrease in the drug's efficacy in treating both conventional and variant strains.

[0165] Therefore, the success of Example 1 lies not only in the individual effects of each component, but also in their precise proportions and synergistic effects. The scientific basis of this combination enables the drug to exhibit unexpectedly superior efficacy in enhancing immune function, fighting viruses, and controlling mutant strains; however, once this balance is disrupted, the overall efficacy of the drug is significantly reduced.

Claims

1. A drug for treating infectious bursal disease in chickens caused by variant infectious bursal disease virus (NVVIBDV), characterized in that, The raw materials for preparing the pharmaceutical preparation consist of the following components: Astragalus membranaceus 45-50 parts, Rehmannia glutinosa 30-45 parts, Isatis indigotica 25-30 parts, Isatis tinctoria 25-30 parts, Gypsum 10-45 parts, Lonicera japonica 10-20 parts, Forsythia suspensa 10-30 parts, Taraxacum mongolicum 10-20 parts, Atractylodes macrocephala 15-20 parts, Paeonia lactiflora 15-30 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10-30 parts; The pharmaceutical preparation is prepared by the following method: (1) Weigh different components according to the composition of the raw materials and add them to the extraction device; (2) Add 10 times the amount of distilled water, heat to 100℃, and simmer for 1.5 hours; (3) Filter and collect filtrate 1 and filter residue. Add 10 times the amount of distilled water to the filter residue, heat to 90°C, and decoct for 1.5 hours. (4) Filter and collect filtrate 2, combine filtrate 1 and filtrate 2 to obtain filtrate 3; (5) The filtrate 3 is concentrated by rotary evaporation to 1 / 10 of its original volume to obtain the drug.

2. The pharmaceutical preparation according to claim 1, characterized in that, The raw materials for preparing the medicine consist of the following components: 45 parts Astragalus membranaceus, 30 parts Rehmannia glutinosa, 30 parts Isatis indigotica, 30 parts Isatis tinctoria, 45 parts Gypsum fibrosum, 20 parts Lonicera japonica, 20 parts Forsythia suspensa, 20 parts Taraxacum mongolicum, 15 parts Atractylodes macrocephala, 15 parts Paeonia lactiflora, 15 parts Lilium brownii, 15 parts Anemarrhena asphodeloides, and 10 parts Glycyrrhiza uralensis.

3. A method for preparing a drug for treating infectious bursal disease in chickens caused by variant infectious bursal disease virus (NVVIBDV), characterized in that, The preparation method includes the following steps: (1) Add 45 parts of Astragalus membranaceus, 30 parts of Rehmannia glutinosa, 30 parts of Isatis indigotica, 30 parts of Isatis tinctoria, 45 parts of Gypsum fibrosum, 20 parts of Lonicera japonica, 20 parts of Forsythia suspensa, 20 parts of Taraxacum mongolicum, 15 parts of Atractylodes macrocephala, 15 parts of Paeonia lactiflora, 15 parts of Lilium brownii, 15 parts of Anemarrhena asphodeloides, and 10 parts of Glycyrrhiza uralensis to the extraction device. (2) Add 10 times the amount of distilled water, heat to 100℃, and simmer for 1.5 hours; (3) Filter and collect filtrate 1 and filter residue. Add 10 times the amount of distilled water to the filter residue, heat to 90°C, and decoct for 1.5 hours. (4) Filter and collect filtrate 2, combine filtrate 1 and filtrate 2 to obtain filtrate 3; (5) The filtrate 3 is concentrated by rotary evaporation to 1 / 10 of its original volume to obtain the drug.

4. The application of a traditional Chinese medicine composition in the preparation of a drug for treating infectious bursal disease in chickens caused by variant infectious bursal disease virus nvvIBDV, characterized in that, The composition of the traditional Chinese medicine is as follows: Astragalus membranaceus 45-50 parts, Rehmannia glutinosa 30-45 parts, Isatis indigotica 25-30 parts, Isatis tinctoria 25-30 parts, Gypsum fibrosum 10-45 parts, Lonicera japonica 10-20 parts, Forsythia suspensa 10-30 parts, Taraxacum mongolicum 10-20 parts, Atractylodes macrocephala 15-20 parts, Paeonia lactiflora 15-30 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10-30 parts.

5. The application according to claim 4, characterized in that, The composition of the traditional Chinese medicine is as follows: Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 45 parts, Lonicera japonica 20 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

6. The application of a traditional Chinese medicine composition in the preparation of a drug for inhibiting the variant infectious bursal disease virus (NVV) IBDV, characterized in that, The composition of the traditional Chinese medicine is as follows: Astragalus membranaceus 45-50 parts, Rehmannia glutinosa 30-45 parts, Isatis indigotica 25-30 parts, Isatis tinctoria 25-30 parts, Gypsum fibrosum 10-45 parts, Lonicera japonica 10-20 parts, Forsythia suspensa 10-30 parts, Taraxacum mongolicum 10-20 parts, Atractylodes macrocephala 15-20 parts, Paeonia lactiflora 15-30 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10-30 parts.

7. The application according to claim 6, characterized in that, The composition of the traditional Chinese medicine is as follows: Astragalus membranaceus 45 parts, Rehmannia glutinosa 30 parts, Isatis indigotica 30 parts, Isatis tinctoria 30 parts, Gypsum 45 parts, Lonicera japonica 20 parts, Forsythia suspensa 20 parts, Taraxacum mongolicum 20 parts, Atractylodes macrocephala 15 parts, Paeonia lactiflora 15 parts, Lilium brownii 15 parts, Anemarrhena asphodeloides 15 parts, Glycyrrhiza uralensis 10 parts.

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