Oral liquid for regulating immunity after illness and chemotherapy and its preparation method

Abstract

The present invention discloses an oral liquid for post-illness and post-chemotherapy immune regulation and its preparation method, relating to the technical field of health care products. The oral liquid comprises the following ingredients: astragalus, ganoderma lucidum, licorice, chrysanthemum, coix seed, and oyster. By optimizing the formulation and extraction method, the oral liquid enhances immunity and mitigates adverse reactions after radiotherapy. Furthermore, the ingredients are safe, have no adverse effects on the liver, and offer enhanced storage stability for the active ingredients.

Description

Technical Field

[0001] The present invention relates to the technical field of health care products, and in particular to an oral liquid for regulating immunity after illness and chemotherapy, and a preparation method thereof. Background Art

[0002] Cytotoxicity is one of the main ways that chemotherapeutic and radiotherapy drugs inhibit the rapid growth of malignant tumors. At the same time, chemotherapeutic drugs inhibit the normal growth of bone marrow cells, causing bone marrow suppression. The main manifestations of bone marrow suppression are leukopenia, anemia, and thrombocytopenia. Therefore, leukopenia can lead to an increased risk of post-chemotherapy infection and sepsis, and is one of the important manifestations of chemotherapy-induced immunodeficiency. T lymphocytes are an important component of the body's immune system, and they are involved in important processes such as tumor immune surveillance, cell killing, and immune regulation. Chemotherapy and radiotherapy usually cause a rapid decline in the patient's immunity. Clinically, blood transfusions or cytokine drugs are often used to assist in alleviating the low immunity caused by chemotherapy, but long-term large-scale blood transfusions pose a risk of infection, and cytokine drugs have a single effect and are expensive.

[0003] Therefore, low immunity caused by radiotherapy and chemotherapy is an urgent problem to be solved in the clinical application of radiotherapy and chemotherapy drugs. At the same time, physical weakness caused by illness is also a manifestation of the failure of immunity to recover in time.

[0004] Wang Bing et al. studied the effect of Junzi Fuzheng Decoction on reducing toxicity, increasing efficacy and enhancing immunity of patients with colorectal cancer after surgery. They found that after 6 cycles of chemotherapy, the CD3 + , CD4 + , CD8 + The levels of leukemia cells in the patients with colorectal cancer were significantly increased, and the difference was statistically significant compared with the chemotherapy group alone (P < 0.05). Therefore, Junzi Fuzheng Decoction combined with chemotherapy drugs can inhibit tumor growth in patients with colorectal cancer, improve quality of life, reduce adverse reactions caused by postoperative chemotherapy, and improve patients' immune function.

[0005] Chinese patent CN101129607A discloses a traditional Chinese medicine oral liquid for treating post-chemotherapy immune impairment in esophageal cancer patients. The liquid is characterized by being composed of the following medicinal ingredients in percentage by weight: 9-11% ginseng, 18-22% astragalus, 8-10% cordyceps, 9-11% atractylodes, 14-16% poria, 8-10% liquorice, 11-13% angelica, and 14-16% wolfberry. This oral liquid for treating post-chemotherapy immune impairment in esophageal cancer patients demonstrates significant efficacy in peripheral blood immunoglobulins, serum cytokine interleukins, blood counts, and clinical symptoms, has no toxic side effects, and can reduce treatment costs for patients.

[0006] At present, there is still a shortage of health care products for post-illness weakness and immune regulation after radiotherapy and chemotherapy. Summary of the Invention

[0007] In view of this, the purpose of the present invention is to provide an oral liquid and a preparation method for regulating immunity in patients with weakness after illness and after radiotherapy and chemotherapy. By optimizing the formula and extraction method, the effect of improving immunity is enhanced and the adverse reactions after radiotherapy are alleviated. At the same time, the ingredients are safe and have no adverse effects on the liver. At the same time, the storage stability of the active ingredients is higher.

[0008] In order to achieve the above-mentioned object of the invention, the technical solution of the present invention is as follows:

[0009] In one aspect, the present invention provides an oral liquid for regulating immunity in patients with post-illness illness and after radiotherapy and chemotherapy, comprising the following ingredients: astragalus, ganoderma lucidum, liquorice, chrysanthemum, coix seed and oyster.

[0010] Preferably, the oral liquid comprises the following ingredients in parts by weight: 10-20 parts of astragalus, 10-20 parts of ganoderma, 10-20 parts of liquorice, 7-14 parts of chrysanthemum, 5-10 parts of coix seed and 5-10 parts of oyster.

[0011] Further preferably, the oral liquid comprises the following ingredients in parts by weight: 15 parts of astragalus, 15 parts of ganoderma, 15 parts of liquorice, 10 parts of chrysanthemum, 5 parts of coix seed and 5 parts of oyster.

[0012] In another aspect, the present invention provides a method for preparing the oral liquid, comprising the following steps:

[0013] (1) Add water to the formulated amount of coix seed and oyster, adjust the pH to 7.5-10, extract 2-4 times, and combine to obtain an extract;

[0014] (2) applying the extract obtained in step (1) to a macroporous resin column and eluting with 20-35% aqueous ethanol, 40-50% aqueous ethanol, and 75-85% aqueous ethanol, collecting 40-50% of the eluate, drying, and completely removing the solvent to obtain a solid;

[0015] (3) Add the formulated amount of Astragalus, Ganoderma lucidum, Licorice, and Chrysanthemum to water and boil for 2-4 times, combine the filtrates, and concentrate to a density of 1.02-1.10 g / cm 3 , get the extract;

[0016] (4) Mix the solid matter, extract and water to adjust the solid content to 5-20%, add crystal sugar, stir and dissolve to obtain the oral solution.

[0017] Preferably, in step (1), the extraction conditions are: adding 5-10 times the total weight of the medicinal materials in water each time, extracting at 50-90°C for 4-6 hours, more preferably adding 8 times the total weight of the medicinal materials in water each time, extracting at 75°C for 5 hours.

[0018] Preferably, in step (1), the pH is adjusted to 8.0.

[0019] Preferably, in step (1), the extraction is performed twice.

[0020] Preferably, in step (2), the macroporous resin is selected from AB-8 macroporous resin or DA201-C macroporous resin, and more preferably DA201-C macroporous resin.

[0021] Preferably, step (2) is specifically as follows: the filtrate obtained in step (1) is applied to a macroporous resin column at a flow rate of 0.5-1.5 BV / h, and eluted with 20-35% ethanol aqueous solution, 40-50% ethanol aqueous solution, and 75-85% ethanol aqueous solution in sequence, with the elution volume being 2-4 BV, 40-50% of the eluate is collected, dried, and the solvent is completely removed to obtain a solid.

[0022] Preferably, step (2) is specifically as follows: the filtrate obtained in step (3) is applied to a macroporous resin column at a flow rate of 0.8 BV / h, and eluted with 30% ethanol aqueous solution, 45% ethanol aqueous solution, and 82% ethanol aqueous solution in sequence, with the elution volume being 2 BV, 45% of the eluate is collected, dried, and the solvent is completely removed to obtain a solid.

[0023] Preferably, in step (3), the decoction extraction is specifically as follows: first adding 10-20 times the weight of the medicinal material in water, extracting for 3-5 hours, filtering, adding 5-15 times the weight of the residue in water again, extracting for 1-3 hours, and combining the filtrate.

[0024] Further preferably, in step (3), the decoction extraction is specifically as follows: adding 15 times the weight of the medicinal material in water for the first time, extracting for 4 hours, filtering, adding 10 times the weight of the filter residue again in water, extracting for 2 hours, and combining the filtrate.

[0025] Preferably, in step (4), the solid content is 10%.

[0026] Preferably, in step (4), the crystal sugar content is 0.5-5% of the oral solution, more preferably 3%.

[0027] The beneficial effects of the present invention are:

[0028] (1) The present invention uses astragalus, ganoderma lucidum, liquorice, chrysanthemum, coix seed and oyster in a specific proportion, which has good effects of improving immunity and alleviating adverse reactions after radiotherapy.

[0029] (2) The oral liquid of the present invention is prepared using a specific preparation process, which significantly improves the effect of the oral liquid and improves the stability of the active ingredients, ensuring the quality of the oral liquid is stable under long-term storage. No preservatives are added, and the safety is high. The optimized preparation process obtains a product with better immunity-enhancing effect. DETAILED DESCRIPTION

[0030] In order to make the technical means, creative features, purpose and efficacy of the present invention easy to understand, the present invention is further illustrated below in conjunction with specific examples, but the following examples are only preferred embodiments of the present invention, not all. Based on the examples in the implementation manner, other embodiments obtained by those skilled in the art without making creative work are all within the scope of protection of the present invention. In the following examples, unless otherwise specified, the operating methods used are all conventional operating methods, the equipment used are all conventional equipment, and the equipment and materials used in each embodiment are all the same.

[0031] Example 1

[0032] The pharmaceutical formulation of embodiment 1 is as follows:

[0033] 15 parts of Astragalus, 15 parts of Ganoderma Lucidum, 15 parts of Licorice, 10 parts of Chrysanthemum, 5 parts of Coix Seed, and 5 parts of Oyster.

[0034] Follow these steps to prepare:

[0035] (1) Add water to the formulated amount of coix seed and oyster, adjust the pH to 8.0, extract twice, adding 8 times the total weight of the medicinal materials in water each time, extract at 75°C for 5 hours, and combine the extracts;

[0036] (2) The extract obtained in step (1) was applied to a DA201-C macroporous resin column at a flow rate of 0.8 BV / h, and eluted with 30% ethanol aqueous solution, 45% ethanol aqueous solution, and 82% ethanol aqueous solution in sequence, with an elution volume of 2 BV each. 45% of the eluate was collected and dried to completely remove the solvent to obtain a solid;

[0037] (3) Add water to the formula amount of Astragalus, Ganoderma lucidum, Licorice, and Chrysanthemum, and boil them. First, add 15 times the weight of the medicinal materials in water, extract for 4 hours, filter, add 10 times the weight of the residue in water again, extract for 2 hours, combine the filtrates, and concentrate to a density of 1.02-1.10 g / cm 3 , get the extract;

[0038] (4) The solid matter, extract and water are mixed to adjust the solid content to 10%, and crystal sugar is added to an amount of 3% of the oral solution, and stirred to dissolve to obtain the oral solution.

[0039] Example 2

[0040] The pharmaceutical formulations of embodiment 2 are as follows:

[0041] 10 parts of Astragalus, 20 parts of Ganoderma Lucidum, 20 parts of Licorice, 7 parts of Chrysanthemum, 5 parts of Coix Seed, and 5 parts of Oyster.

[0042] The preparation method is the same as that of Example 1.

[0043] Example 3

[0044] The pharmaceutical formulations of embodiment 3 are as follows:

[0045] 20 parts of Astragalus, 10 parts of Ganoderma Lucidum, 10 parts of Licorice, 14 parts of Chrysanthemum, 10 parts of Coix Seed, and 10 parts of Oyster.

[0046] The preparation method is the same as that of Example 1.

[0047] Comparative Example 1

[0048] The drug formula of Comparative Example 1 is as follows:

[0049] 25 parts of Astragalus, 20 parts of Ganoderma Lucidum, 5 parts of Licorice, 5 parts of Chrysanthemum, 2 parts of Coix Seed, and 8 parts of Oyster.

[0050] The preparation method is the same as that of Example 1.

[0051] Comparative Example 2

[0052] Comparative Example 2 drug formulation is as follows:

[0053] 10 parts of Astragalus, 10 parts of Ganoderma Lucidum, 20 parts of Licorice, 15 parts of Chrysanthemum, 9 parts of Coix Seed, and 1 part of Oyster.

[0054] The preparation method is the same as that of Example 1.

[0055] Example 4

[0056] The pharmaceutical formulations of embodiment 4 are as follows:

[0057] 15 parts of Astragalus, 15 parts of Ganoderma Lucidum, 15 parts of Licorice, 10 parts of Chrysanthemum, 5 parts of Coix Seed, and 5 parts of Oyster.

[0058] Follow these steps to prepare:

[0059] (1) Add water to the formulated amount of coix seed and oyster, adjust the pH to 8.0, extract twice, add 5 times the total weight of the medicinal materials in water each time, extract at 50°C for 6 hours, and combine the extracts;

[0060] (2) The extract obtained in step (1) was applied to a DA201-C macroporous resin column at a flow rate of 1.5 BV / h, and eluted with 35% ethanol aqueous solution, 50% ethanol aqueous solution, and 85% ethanol aqueous solution in sequence, with an elution volume of 4 BV each. 50% of the eluate was collected and dried to completely remove the solvent to obtain a solid;

[0061] (3) Add 20 times the weight of the medicinal materials to the decocted ingredients in water, extract for 5 h, filter, add 5 times the weight of the filtrate to the residue, extract for 1 h, combine the filtrates, and concentrate to a density of 1.02-1.10 g / cm 3 , get the extract;

[0062] (4) The solid matter, extract and water are mixed to adjust the solid content to 10%, and crystal sugar is added to an amount of 3% of the oral solution, and stirred to dissolve to obtain the oral solution.

[0063] Example 5

[0064] The pharmaceutical formulation of embodiment 5 is as follows:

[0065] 15 parts of Astragalus, 15 parts of Ganoderma Lucidum, 15 parts of Licorice, 10 parts of Chrysanthemum, 5 parts of Coix Seed, and 5 parts of Oyster.

[0066] Follow these steps to prepare:

[0067] (1) Add water to the formulated amount of coix seed and oyster, adjust the pH to 8.0, extract twice, adding 10 times the total weight of the medicinal materials in water each time, extract at 90°C for 4 hours, and combine the extracts;

[0068] (2) The extract obtained in step (1) was loaded onto a DA201-C macroporous resin column at a flow rate of 0.5 BV / h and eluted sequentially with 20% ethanol aqueous solution, 40% ethanol aqueous solution, and 75% ethanol aqueous solution, each with an elution volume of 2 BV. 40% of the eluate was collected and dried to completely remove the solvent to obtain a solid;

[0069] (3) Add water to the formula amount of Astragalus, Ganoderma lucidum, Licorice, and Chrysanthemum, and boil them. First, add 10 times the weight of the medicinal materials in water, extract for 3 hours, filter, add 15 times the weight of the residue in water again, extract for 3 hours, combine the filtrate, and concentrate to a density of 1.02-1.10 g / cm 3 , get the extract;

[0070] (4) The solid matter, extract and water are mixed to adjust the solid content to 10%, and crystal sugar is added to an amount of 3% of the oral solution, and stirred to dissolve to obtain the oral solution.

[0071] Example 6

[0072] The difference from Example 1 is that AB-8 macroporous resin is used in step (2), and the rest are the same.

[0073] Comparative Example 3

[0074] The difference from Example 1 is that in step (2), the eluate of 30% ethanol water is collected to prepare a solid, and the rest are the same.

[0075] Comparative Example 4

[0076] The difference from Example 1 is that in step (2), the eluate of 82% ethanol water is collected to prepare a solid, and the rest are the same.

[0077] Comparative Example 5

[0078] (1) Add the formulated amount of coix seed, oyster, astragalus, ganoderma, licorice, and chrysanthemum into water and boil. First, add 15 times the weight of the medicinal materials in water and extract for 4 hours. Filter. Add 10 times the weight of water to the residue again and extract for 2 hours. Combine the filtrates and concentrate to a density of 1.02-1.10 g / cm 3 , get the extract;

[0079] (2) Mix the extract and water, adjust the solid content to 10%, add crystal sugar, the crystal sugar content is 3% of the oral solution, stir and dissolve, and obtain the oral solution.

[0080] Comparative Example 6

[0081] (1) Add water to the formulated amount of coix seed, oyster, astragalus, ganoderma, licorice, and chrysanthemum, adjust the pH to 8.0, extract twice, adding 8 times the total weight of the medicinal materials in water each time, extract at 75°C for 5 hours, and combine the extracts;

[0082] (2) The extract obtained in step (1) was applied to a DA201-C macroporous resin column at a flow rate of 0.8 BV / h, and eluted with 30% ethanol aqueous solution, 45% ethanol aqueous solution, and 82% ethanol aqueous solution in sequence, with an elution volume of 2 BV each. 45% of the eluate was collected and dried to completely remove the solvent to obtain a solid;

[0083] (3) The solid matter, extract and water are mixed to adjust the solid content to 10%, and crystal sugar is added to an amount of 3% of the oral solution, and stirred to dissolve to obtain the oral solution.

[0084] Result detection

[0085] 1. Animal experiments

[0086] 1.1 Lymphocyte transformation rate

[0087] Detection method: Male mice weighing 18-22 g were acclimated for one week and randomly divided into 10 groups. The experimental groups were administered the compositions prepared in Examples 1-6 and Comparative Examples 1-6, respectively, at a dose of 30 mL / kg / day. The control group was administered an equal amount of normal saline, with 0.6 mL of water administered orally. On the first and third days after administration, each mouse was intramuscularly injected with 6 mg / kg of phytohemagglutinin. On the sixth day, blood slides were collected, stained with Wright's stain, and examined under a microscope. The results are as follows:

[0088]

[0089]

[0090] In the table, compared with the control group, *P < 0.05, **P < 0.01.

[0091] The results show that the oral liquid prepared in the embodiment of the present invention can significantly improve the conversion rate of lymphocytes, and the degree of improvement is significantly better than that of the comparative example.

[0092] 1.2 Protective effect on immunosuppressed mice

[0093] Female mice weighing 18-22g were adaptively raised for one week and randomly divided into 10 groups. The experimental group was administered the compositions prepared in Examples 1-6 and Comparative Examples 1-6, respectively, at a dose of 30mL / kg / day. The control group and the model group were administered with an equal amount of normal saline, and 0.6mL of water was irrigated and administered orally. Except for the control group, the remaining groups were intraperitoneally injected with cyclophosphamide 40mg / kg for two consecutive days after 3 weeks of administration. After 4 weeks of gavage, the mice were killed by despondency, the thymus and spleen were removed, the surface dirt was removed with filter paper, weighed, and the thymus index and spleen index were calculated.

[0094]

[0095]

[0096] In the table, *P<0.05 compared with the control group; #P<0.05 compared with the model group.

[0097] The results showed that the oral liquids prepared in Examples 1-6 of the present invention could significantly increase the thymus index and spleen index of immunosuppressed mice.

[0098] 1.3 Protective effect on FLV-infected mice

[0099] Female SPF BALB / C mice weighing 18-22 g were adaptively raised for one week and randomly divided into 10 groups per group. Except for the control group, the remaining groups were intraperitoneally injected with FLV (Friend murine leukemia virus). Administration began one day after virus injection. Mice infected with FLV will rapidly develop severe immunodeficiency. The experimental groups were administered with the compositions prepared in Examples 1-6 and Comparative Examples 1-6, respectively, at a dose of 30 mL / kg / day. The control group and the model group were administered with an equal amount of normal saline and 0.6 mL of water orally. Three weeks after infection, the mice were sacrificed by dislocation, and the spleens were aseptically removed and placed in a small dish containing an appropriate amount of sterile Hanks solution. The spleens were gently shredded with tweezers and filtered through a 200-mesh sieve to prepare a single-cell suspension for mouse NK cell activity testing.

[0100]

[0101]

[0102] In the table, *P<0.05, **P<0.01 were compared between the model group and the control group; #P<0.05, ##P<0.01 were compared between the model group and the control group.

[0103] The results showed that both the Example and the Comparative Example could significantly increase the NK cell activity of mice infected with FLV. From the perspective of specific activity values, the Example had more advantages.

[0104] 2. Clinical trials

[0105] Observation subjects: Patients diagnosed with tumors by histopathology or cytology, receiving radiotherapy 5 times a week, with a primary lesion dose of 800-1000 CGY / week, mainly patients with nasopharyngeal carcinoma, lung cancer, etc.

[0106] Observation method: 60 patients were divided into two groups. The treatment group was given the oral solution prepared in Example 1, starting to drink it two days before the start of radiotherapy, 30 mL × 5 times a day for 4 weeks. The control group was not given any medicine. The radiotherapy response of the subjects was recorded every week.

[0107] 1. Check and record the total white blood cell count.

[0108] 2. Observe six symptoms: dizziness, nausea, vomiting, dry throat, sore throat and congestion of oral mucosa.

[0109] The total white blood cell count results are as follows:

[0110] Group Number of cases Before radiotherapy 3 weeks of radiotherapy Rate of change control group 30 6640±1300 5270±1200 20.6％ Treatment group 30 6760±1400 6520±1600 3.6％

[0111] The results showed that the decrease in the total white blood cell count of patients who drank the oral solution of Example 1 was significantly reduced.

[0112] The statistics of the number of cases of radiotherapy reaction are as follows:

[0113]

[0114]

[0115] The results showed that after drinking the oral liquid of Example 1, the number of patients experiencing dizziness, nausea, vomiting, dry throat, sore throat and oral mucosal congestion decreased significantly.

[0116] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. An oral liquid for regulating immunity in patients with post-illness illness and after radiotherapy and chemotherapy, characterized in that: The oral liquid is prepared from the following raw materials: 10-20 parts of astragalus, 10-20 parts of ganoderma lucidum, 10-20 parts of liquorice, 7-14 parts of chrysanthemum, 5-10 parts of coix seed and 5-10 parts of oyster; The preparation method comprises the following steps: (1) Add water to the formulated amount of coix seed and oyster, adjust the pH to 7.5-10, extract 2-4 times, and combine to obtain the extract; (2) The extract obtained in step (1) is applied to a macroporous resin column and eluted with 20-35% ethanol aqueous solution, 40-50% ethanol aqueous solution, and 75-85% ethanol aqueous solution in sequence, 40-50% of the eluate is collected, dried, and the solvent is completely removed to obtain a solid; (3) Add the formulated amount of Astragalus, Ganoderma lucidum, Licorice, and Chrysanthemum to water and boil for 2-4 times, combine the filtrates, and concentrate to a density of 1.02-1.10 g / cm 3 , get the extract; (4) Mix the solid matter, extract and water, adjust the solid content to 5-20%, add crystal sugar, stir and dissolve, and obtain the oral solution.

2. The oral liquid according to claim 1, characterized in that The oral liquid is prepared from the following raw materials in parts by weight: 15 parts of astragalus, 15 parts of ganoderma lucidum, 15 parts of liquorice, 10 parts of chrysanthemum, 5 parts of coix seed and 5 parts of oyster.

3. The method for preparing the oral liquid according to any one of claims 1 to 2, characterized in that: The following steps are involved: (1) Add water to the formulated amount of coix seed and oyster, adjust the pH to 7.5-10, extract 2-4 times, and combine to obtain the extract; (2) The extract obtained in step (1) is applied to a macroporous resin column and eluted with 20-35% ethanol aqueous solution, 40-50% ethanol aqueous solution, and 75-85% ethanol aqueous solution in sequence, 40-50% of the eluate is collected, dried, and the solvent is completely removed to obtain a solid; (3) Add the formulated amount of Astragalus, Ganoderma lucidum, Licorice, and Chrysanthemum to water and boil for 2-4 times, combine the filtrates, and concentrate to a density of 1.02-1.10 g / cm 3 , get the extract; (4) Mix the solid matter, extract and water, adjust the solid content to 5-20%, add crystal sugar, stir and dissolve, and obtain the oral solution.

4. The preparation method according to claim 3, characterized in that In step (1), the extraction conditions are as follows: adding 5-10 times the total weight of the medicinal materials in water each time, extracting at 50-90° C. for 4-6 hours; the extraction times are 2 times.

5. The preparation method according to claim 3, characterized in that In step (1), the pH is adjusted to 8.

0.

6. The preparation method according to claim 3, characterized in that In step (2), the macroporous resin is selected from AB-8 macroporous resin or DA201-C macroporous resin.

7. The preparation method according to claim 6, characterized in that The macroporous resin is DA201-C macroporous resin.

8. The preparation method according to claim 3, characterized in that Step (2) is specifically as follows: the extract obtained in step (1) is applied to a macroporous resin column at a flow rate of 0.5-1.5 BV / h, and eluted with 20-35% ethanol aqueous solution, 40-50% ethanol aqueous solution, and 75-85% ethanol aqueous solution in sequence, with the elution volume being 2-4 BV, 40-50% of the eluate is collected, dried, and the solvent is completely removed to obtain a solid.

9. The preparation method according to claim 8, characterized in that Step (2) is specifically as follows: the extract obtained in step (1) is applied to a macroporous resin column at a flow rate of 0.8 BV / h, and eluted with 30% ethanol aqueous solution, 45% ethanol aqueous solution, and 82% ethanol aqueous solution in sequence, with the elution volume being 2 BV each, and 45% of the eluate is collected, dried, and the solvent is completely removed to obtain a solid.

10. The preparation method according to claim 3, characterized in that In step (3), the decoction extraction is specifically as follows: firstly, adding water in an amount of 10-20 times the weight of the medicinal material, extracting for 3-5 hours, filtering, adding water in an amount of 5-15 times the weight of the residue again, extracting for 1-3 hours, and combining the filtrate.

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