Traditional Chinese medicine composition for treating swine fever as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine composition for treating swine fever and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 200 to 280 parts of gypsum, 150 to 220 parts of rhizoma anemarrhenae, 180 to 250 parts of radix scutellariae, 100 to 160 parts of honeysuckle flower, 180 to 250 parts of radix isatidis, 100 to 160 parts of folium isatidis, 80 to 120 parts of fructus forsythiae, 80 to 120 parts of radix scrophulariae, 80 to 120 parts of radix rehmanniae and 30 to 60 parts of liquorice root. The traditional Chinese medicine raw materials are subjected to strict composition logic and compatibility principles to obtain a novel composition which is specially used for treating swine fever and has a remarkable curative effect, the composition takes effect quickly, the death rate of piglets is reduced, the pertinence to hemorrhagic lesions is high, and the targeting of treatment is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine composition for treating classical swine fever, its preparation method and application. Background Art

[0002] Classical swine fever (African swine fever, ASF) is an acute, febrile, highly contagious disease caused by the classical swine fever virus (CSFV), and is listed as a Class A animal disease by the World Organization for Animal Health (OIE). The disease is characterized by high fever, hemorrhagic diathesis, generalized small bleeding points throughout the body, and spleen infarction, with extremely high morbidity and mortality, causing huge economic losses to the global pig industry.

[0003] Currently, the prevention and control of classical swine fever mainly rely on vaccine immunization, and there is no approved specific therapeutic drug. In terms of vaccine immunization, factors such as maternal antibody interference and immunosuppressive diseases are likely to lead to unstable immunization effects, and the recombination of wild strains and vaccine strains is likely to result in new mutant strains; in terms of drug treatment, it mainly involves the development of antiviral gene drugs, biological products such as interferon and immunoglobulin, antibiotics and chemical drugs, as well as traditional Chinese veterinary medicine. Currently, antiviral gene drugs are still in the laboratory research and development stage, and biological products such as interferon used clinically have problems such as high cost, unstable effects, and harsh storage conditions. The extensive use of antibiotics and chemical drugs has caused drug residue and drug resistance problems. Traditional Chinese veterinary medicine mainly involves drugs such as Qingwen Baidu Powder and Huanglian Jiedu Powder for relieving symptoms.

[0004] Traditional Chinese medicine believes that classical swine fever belongs to the category of "warm diseases", and the pathogenesis is the exuberance of heat-toxin and the simultaneous flaming of qi and blood. The treatment should be to clear heat and detoxify, cool the blood and stop bleeding, and strengthen the healthy qi and dispel pathogenic factors. However, among the existing traditional Chinese veterinary medicine preparations, there is still a severe lack of highly effective preparations for classical swine fever. The aforementioned Qingwen Baidu Powder, as an adjuvant treatment for livestock and poultry viral diseases, has limitations such as slow onset, weak targeting for hemorrhagic lesions, and high mortality, causing serious economic losses to livestock and poultry farming.

[0005] Based on this, the present invention proposes a traditional Chinese medicine composition with scientific formula, definite curative effect, and controllable quality, which is specifically used for the effective prevention and treatment of classical swine fever. Summary of the Invention

[0006] The present invention provides a traditional Chinese medicine composition for treating classical swine fever, its preparation method and application. Through strict formula logic and compatibility principles, a new formula specifically for treating classical swine fever with remarkable curative effects is obtained, which has a fast onset, reduces the mortality rate of piglets, has strong targeting for hemorrhagic lesions, improves the targeting of treatment, and solves the problems existing in the prior art.

[0007] One of the technical solutions adopted by the present invention is:

[0008] A traditional Chinese medicine composition for treating swine fever is provided, comprising the following raw materials in parts by weight: 200-280 parts of gypsum, 150-220 parts of anemarrhena asphodeloides, 180-250 parts of scutellaria baicalensis, 100-160 parts of honeysuckle, 180-250 parts of isatis indigotica, 100-160 parts of indigofera tinctoria, 80-120 parts of forsythia suspensa, 80-120 parts of scrophularia ningpoensis, 80-120 parts of rehmannia glutinosa, and 30-60 parts of licorice.

[0009] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 240 parts gypsum, 180 parts anemarrhena, 200 parts scutellaria, 130 parts honeysuckle, 200 parts isatis root, 130 parts indigo leaf, 100 parts forsythia, 100 parts scrophularia, 100 parts rehmannia, and 40 parts licorice.

[0010] Furthermore, the dosage form of the traditional Chinese medicine composition is oral liquid, granules, capsules, or powder.

[0011] The second technical solution adopted in this invention is:

[0012] A method for preparing the aforementioned traditional Chinese medicine composition (oral liquid) is provided, comprising the following steps:

[0013] (1) Weigh each raw Chinese medicine according to the aforementioned weight proportions, crush the raw gypsum, and cut the remaining raw Chinese medicine into Chinese medicine slices for later use;

[0014] (2) Add 8-10 times the amount of water to the Chinese herbal medicine slices, soak for 0.5-1h, heat and decoct 3 times, each time for 1-1.5h, combine the decoctions, filter with a 200-mesh filter cloth to obtain the extract;

[0015] (3) The filtrate is concentrated under reduced pressure at a temperature of 70-80℃ and a vacuum degree of -0.04--0.06MPa to a relative density of 1.12-1.18 at 20℃ to obtain a concentrated solution;

[0016] (4) Let the concentrated liquid stand for 12-24 hours, take the supernatant and filter it through a 500-800 mesh filter cloth to obtain a clear filtrate;

[0017] (5) Add 0.2%-0.4% preservative to the filtrate, add purified water to make up to the specified volume, each 1mL is equivalent to 1.5g of raw drug, stir and mix well; after precision filtration through a 0.45μm microporous membrane, fill into the container to obtain the product.

[0018] Further, in step (1), the raw gypsum powder is pulverized and passed through a 20-mesh sieve to obtain raw gypsum coarse powder; the length of the Chinese herbal medicine slices is 2-3cm.

[0019] The third technical solution adopted in this invention is:

[0020] The application of the aforementioned traditional Chinese medicine composition in the preparation of drugs for the prevention and treatment of swine fever in piglets is provided.

[0021] Dosage and administration: Administer orally at a dose of 1 mL / kg body weight.

[0022] This invention relates to a scientifically formulated traditional Chinese medicine composition. Gypsum is the principal ingredient, being pungent, sweet, and extremely cold in nature, entering the lung and stomach meridians. It clears heat and purges fire, relieves irritability and quenches thirst, effectively clearing excess heat in the qi level, specifically targeting the primary symptom of high fever in swine fever. Anemarrhena asphodeloides and Scutellaria baicalensis are the assistant ingredients. Anemarrhena asphodeloides clears heat and purges fire, nourishes yin and moistens dryness, assisting gypsum in clearing heat while preventing excessive heat from damaging yin. Scutellaria baicalensis clears heat and dries dampness, purges fire and detoxifies, especially effective in clearing excess heat in the lungs and stomach, and also cools the blood and stops bleeding, targeting the hemorrhagic symptoms of swine fever. Honeysuckle, Isatis indigotica, Isatis tinctoria leaf, Forsythia suspensa, Scrophularia ningpoensis, and Rehmannia glutinosa are the adjuvant ingredients. Honeysuckle clears heat and detoxifies, disperses wind-heat; Isatis indigotica and Isatis tinctoria leaf clear heat and detoxify, cool the blood and eliminate spots, targeting the hemorrhagic spots on the skin in swine fever; Forsythia suspensa clears heat and detoxifies, reduces swelling and dissipates nodules; Scrophularia ningpoensis and Rehmannia glutinosa clear heat and cool the blood, nourish yin and generate fluids, assisting in clearing heat while preventing heat from entering the blood and consuming yin fluids. The combination of Isatis tinctoria leaf and Isatis root produces a synergistic effect against classical swine fever virus, particularly in its blood-cooling and spot-reducing effects, showing a highly targeted effect on the characteristic skin hemorrhagic lesions of classical swine fever in piglets. Licorice root, as the guiding herb, tonifies the spleen and replenishes qi, clears heat and detoxifies, and harmonizes the effects of other herbs. Furthermore, licorice root in this formula contains glycyrrhizic acid and glycyrrhetinic acid, which have clear glucocorticoid-like anti-inflammatory effects, effectively inhibiting systemic inflammatory response syndrome (SIRS) caused by classical swine fever virus infection. The synergistic combination of these herbs demonstrates significant therapeutic efficacy in the prevention and treatment of classical swine fever in piglets.

[0023] The beneficial effects of this invention are:

[0024] 1. The traditional Chinese medicine composition of this invention is a comprehensive formula that breaks through the traditional single treatment approach of "clearing heat and detoxifying". It adopts the combination of "clearing heat and consolidating the body" to address the root cause of hemorrhagic lesions in organs. It works together to clear heat and detoxify, cool the blood and stop bleeding, nourish yin and strengthen the body. It targets the pathogenesis of swine fever as "excessive heat and toxins and burning of both qi and blood", and achieves the therapeutic effect of effective resistance to swine fever virus and enhanced immunity.

[0025] 2. The traditional Chinese medicine composition of this invention, when used for swine fever, exhibits significant therapeutic efficacy, rapid onset of action, and enhanced therapeutic targeting compared to existing traditional Chinese medicine treatments. It is particularly effective against hemorrhagic lesions caused by swine fever infection, a characteristic not found in existing adjunctive therapies for swine fever. Swine fever-infected piglets treated with the traditional Chinese medicine composition of this invention show significantly improved survival rates and a markedly shorter body temperature recovery period. Compared to positive control drugs and the drug-free control group designed in the study, pathological tissue lesions are significantly milder. Therefore, using the traditional Chinese medicine composition of this invention for the prevention and treatment of swine fever infection, as a potential highly effective treatment, can significantly improve the current situation of a lack of effective treatments for this disease. Detailed Implementation

[0026] To clearly illustrate the technical features of this solution, the invention will be described in detail below through specific implementation methods.

[0027] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of this application.

[0028] The following embodiments are for illustrative purposes only and are not intended to limit the scope of this application. Experimental methods in the following embodiments that do not specify specific conditions can be performed according to experimental manuals or conventional conditions in the art, or by referring to known experimental methods in the art. Unless otherwise specified, all methods are conventional methods in the art.

[0029] Example 1

[0030] The prescription for this traditional Chinese medicine oral liquid used to treat swine fever is as follows:

[0031] Gypsum 240g, Anemarrhena asphodeloides 180g, Scutellaria baicalensis 200g, Lonicera japonica 130g, Isatis indigotica 200g, Isatis tinctoria 130g, Forsythia suspensa 100g, Scrophularia ningpoensis 100g, Rehmannia glutinosa 100g, Glycyrrhiza uralensis 40g.

[0032] Preparation method: (1) Weigh each of the above 10 Chinese medicines according to the prescription weight; crush the raw gypsum and pass it through a 20-mesh sieve to obtain coarse powder, and cut the remaining medicinal materials into Chinese medicine slices with a length of 2-3cm;

[0033] (2) Add 8 times the amount of drinking water, soak for 0.5 hours, heat and boil 3 times, 1 hour each time, combine the decoctions, and filter with a 200-mesh filter cloth;

[0034] (3) The filtrate was concentrated under reduced pressure at 70-80℃ and a vacuum of -0.05MPa to a relative density of about 1.15 (20℃) to obtain a concentrated solution;

[0035] (4) Let the concentrated liquid stand for 12 hours, take the supernatant and filter it through a 500-mesh filter cloth to obtain a clear filtrate;

[0036] (5) Add water to 1000mL of the clarified filtrate, add 0.3% sodium benzoate (3g), stir and mix well; filter through a 0.45μm microporous membrane for precision, fill (10mL / bottle), seal, and the product is obtained.

[0037] The oral liquid of traditional Chinese medicine prepared above is equivalent to 1.5g of raw medicinal material per 1mL, with a pH value of 5.2 and a relative density of 1.09.

[0038] Example 2

[0039] The prescription for this traditional Chinese medicine oral liquid used to treat swine fever is as follows:

[0040] 200 parts gypsum, 150 parts anemarrhena, 180 parts scutellaria, 100 parts honeysuckle, 180 parts isatis root, 100 parts indigo leaf, 80 parts forsythia, 80 parts scrophularia, 80 parts rehmannia, and 30 parts licorice.

[0041] The preparation method is the same as the preparation process in Example 1.

[0042] Example 3

[0043] The prescription for this traditional Chinese medicine oral liquid used to treat swine fever is as follows:

[0044] 280 parts gypsum, 220 parts anemarrhena, 250 parts scutellaria, 160 parts honeysuckle, 250 parts isatis root, 160 parts indigo leaf, 120 parts forsythia, 120 parts scrophularia, 120 parts rehmannia, and 60 parts licorice.

[0045] The preparation method is the same as the preparation process in Example 1.

[0046] Efficacy test:

[0047] The following will take the oral liquid of traditional Chinese medicine in Example 1 as an example, design a formula with missing flavor, and compare it with the positive control group to examine the efficacy of the oral liquid of traditional Chinese medicine in this example.

[0048] I. Experimental Grouping

[0049] Group A (Example 1);

[0050] Group B: The prescription for this Chinese herbal oral liquid is the same as that in Example 1, except that licorice is removed;

[0051] Group C: The prescription for this Chinese herbal oral liquid is the same as that in Example 1, except that licorice is replaced with an equal amount of jujube;

[0052] Group D: The prescription for this oral liquid of traditional Chinese medicine is the same as that in Example 1, except that Daqingye is replaced with an equal amount of Andrographis paniculata.

[0053] Group E (positive control group): Commercially available Qingwen Jiedu San (Chinese Veterinary Pharmacopoeia formula), used according to the instructions;

[0054] Group F (model control group): Infected but not treated;

[0055] G (blank control group): No infection, no medication.

[0056] The above-mentioned drugs were prepared into oral liquids of traditional Chinese medicine according to the preparation method in Example 1.

[0057] II. Test Methods

[0058] The piglets were divided into groups according to the above experimental groupings, with 10 healthy 40-day-old piglets in each group. Each group of piglets was intramuscularly injected with CSFV Shimen strain (10 mg / L). ^5 TCID50 / head), administration begins 24 hours after challenge.

[0059] The drug group was given 1 mL of the corresponding drug per kg of body weight orally daily for 7 consecutive days.

[0060] The positive control group was fed with Qingwen Jiedu San according to the dosage instructions.

[0061] Clinical symptoms were observed daily, and changes in piglet body temperature were recorded. Survival rates were also calculated. After the experiment, pathological necropsy was performed, and the spleen and lymph nodes were scored using a 0-4 scale, with higher scores indicating more severe lesions.

[0062] III. Test Results

[0063]

[0064] As shown in Table 1, the oral liquid prepared from the complete formula of Example 1 of this invention significantly improved the survival rate of piglets infected with classical swine fever compared to the positive control group (85.0% vs 65.0%, p<0.05), and shortened the body temperature recovery time by 1.8 days. The survival rates of Group B (without licorice) and Group D (with Indigofera tinctoria replacement) decreased to 55.0% and 50.0% respectively, significantly lower than Group A (p<0.01), demonstrating that licorice plays a key role in harmonizing the effects of other herbs, and the replacement of Indigofera tinctoria shows that the formula as a whole has a synergistic effect, and its components are irreplaceable. Pathological histological examination showed that the hemorrhagic lesions in the spleen and lymph nodes of Group A were significantly milder than those in the licorice-deficient group and the positive control group, indicating a stronger therapeutic targeting of hemorrhagic lesions caused by classical swine fever infection.

[0065] To further verify the efficacy of the traditional Chinese medicine oral liquid in this invention, based on the experimental methods in section "II" above, the traditional Chinese medicine oral liquid in Example 1 was divided into three dosage groups: high, medium, and low. Its efficacy was compared with that of Qingwen Jiedu San and Huangqi Polysaccharide Injection, both commercially available positive control drugs for swine fever. The specific experimental groupings and methods are as follows:

[0066] 1. Experimental Groups:

[0067] Group A (High-dose group of Example 1): Oral solution of the present invention, dose 2 mL / kg body weight;

[0068] Group B (dose group in Example 1): Oral solution of the present invention, dose 1 mL / kg body weight;

[0069] Group C (Low-dose group of Example 1): Oral solution of the present invention, dose 0.5 mL / kg body weight;

[0070] Group D (Qingwen Jiedu Powder Group): Commercially available Qingwen Jiedu Powder, used according to the recommended dosage in the instructions;

[0071] Group E (Astragalus Polysaccharide Injection Group): Commercially available Astragalus Polysaccharide Injection, 0.2 mL / kg intramuscular injection;

[0072] Group F (positive control group): Infected but not treated;

[0073] Group G (blank control group): No infection, no medication.

[0074] 2. Test methods:

[0075] All piglets in the above groups were injected intramuscularly with CSFV Shimen strain (10). ^5 TCID50 / head), administered 24 hours after challenge and for 7 consecutive days. Clinical symptoms were observed daily, rectal temperature was measured, and mortality was recorded. Necropsy was performed on dead pigs to observe pathological changes in the spleen and lymph nodes.

[0076] After the experiment, the surviving pigs underwent pathological histological examination, and the scoring criteria were the same as those for the experimental method described in section "II" above.

[0077] 3. The test results are shown in Table 2 below.

[0078]

[0079] As shown in Table 2, the survival rate of the medium and high dose groups of the oral Chinese medicine solution of this invention was significantly higher than that of the Qingwen Jiedu San group and the Huangqi polysaccharide injection group (p<0.05). The body temperature recovery time was shortened by 1.8 days and 2.2 days, respectively, and the pathological histological score was significantly reduced, with a more significant reduction in viral titer. This demonstrates that the present invention is significantly superior to existing positive control drugs in terms of therapeutic effect.

[0080] Target animal safety testing:

[0081] Healthy 30-day-old piglets were selected and divided into 3 groups of 10 piglets each. They were administered the oral solution of this invention by gavage at 1, 3, and 5 times the recommended dose (1 mL / kg), respectively, for 7 consecutive days. A blank control group was also set up using healthy piglets of the same age.

[0082] During the observation period, the piglets in each dosage group showed normal mental state, feed intake, and feces, and there were no deaths.

[0083] There were no significant differences in hematological and blood biochemical indicators compared with the blank control group (p>0.05), indicating that the oral liquid of traditional Chinese medicine of the present invention is safe for piglets.

[0084] The present invention has been described in detail above. The specific embodiments described above should not be construed as limiting the scope of protection of the present invention. Any alternative modifications or variations made to the embodiments of the present invention by those skilled in the art will fall within the scope of protection of the present invention. Any aspects of the present invention not described in detail are well-known techniques to those skilled in the art.

Claims

1. A traditional Chinese medicine composition for treating swine fever, characterized in that, The ingredients include the following parts by weight: gypsum 200-280 parts, anemarrhena 150-220 parts, scutellaria baicalensis 180-250 parts, honeysuckle 100-160 parts, isatis root 180-250 parts, indigo leaf 100-160 parts, forsythia 80-120 parts, scrophularia 80-120 parts, rehmannia glutinosa 80-120 parts, and licorice 30-60 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The ingredients include the following parts by weight: 240 parts gypsum, 180 parts anemarrhena, 200 parts scutellaria, 130 parts honeysuckle, 200 parts isatis root, 130 parts indigo leaf, 100 parts forsythia, 100 parts scrophularia, 100 parts rehmannia, and 40 parts licorice.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is oral liquid, granules, capsules or powder.

4. The method for preparing the traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, The following steps are included: (1) Weigh each raw Chinese medicine according to the aforementioned weight proportions, crush the raw gypsum, and cut the remaining raw Chinese medicine into Chinese medicine slices for later use; (2) Add 8-10 times the amount of water to the Chinese herbal medicine slices, soak for 0.5-1h, heat and decoct 3 times, 1-1.5h each time, combine the decoctions, filter to obtain the extract; (3) The filtrate is concentrated under reduced pressure at a temperature of 70-80℃ and a vacuum degree of -0.04--0.06MPa to a relative density of 1.12-1.18 to obtain a concentrated solution; (4) Let the concentrated liquid stand for 12-24 hours, take the supernatant and filter it through a 500-800 mesh filter cloth to obtain a clear filtrate; (5) Add 0.2%-0.4% preservative to the filtrate, add purified water to make up the volume, stir and mix well, and fill into the container to obtain the final product.

5. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for the prevention and treatment of swine fever in piglets.

6. The application according to claim 5, characterized in that, The traditional Chinese medicine composition is an oral liquid.

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