Method for preparing Anti-tumor traditional chinese medicine compound formulation containing isoquercitrin

Abstract

A method for preparing an anti-tumor traditional Chinese medicine compound formulation containing isoquercitrin. The specific preparation steps of the anti-tumor traditional Chinese medicine compound formulation containing isoquercitrin are as follows: 8-10 g of Taxus chinensis, 6-12 g of Paris polyphylla, 15-17 g of Solanum nigrum, 3-7 g of Taraxacum officinale, 5-10 g of Angelica sinensis, 12-14 g of Poria cocos, 13-15g of Astragalus membranaceus, 8-10g of Panax ginseng,13-15g of Ganoderma lucidum, 8-10g of Scutellaria barbata, 13-15g of Sophora flavescens, 14-16g of Rabdosia rubescens, 8-12g of Panax notoginseng, 15-17g of Scleromitrion diffusum, 16-17g of Lithospermum erythrorhizon, 8-12g of Morus alba, and 13-14g of Sophora japonica. The raw material formula of the present application incorporates Morus alba and Sophora japonica, and the Morus alba and Sophora japonica are rich in isoquercitrin and have antioxidant, anti-inflammatory and potential antitumor effects, thus significantly enhancing the efficacy of the traditional Chinese medicine compound formulation. Moreover, the preparation process of the formulation is simple. After the preparation of the formulation is completed, the concentration of the isoquercitrin content can be quantitatively determined by using high-performance liquid chromatography technology, and an acute toxicity test and a long-term toxicity test are performed to ensure the safety of the formulation.

Description

Preparation method of anti-tumor traditional Chinese medicine compound preparation containing isoquercetin Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, in particular to a method for preparing an anti-tumor traditional Chinese medicine compound preparation containing isoquercetin. Background Art

[0002] Malignant tumors, also known as cancer, have become common and frequently occurring diseases that threaten human life. They are the leading cause of death among the top ten causes of urban population in my country. It is currently an urgent task for clinical oncologists to strengthen research on the treatment of malignant tumors, improve the treatment effects of various existing means, explore new treatment approaches, improve the quality of life of cancer patients, reduce the recurrence rate, and lower the mortality rate.

[0003] At present, the main treatment methods of Western medicine include surgical resection, radiotherapy, chemotherapy, immunotherapy, etc. Surgical treatment is to remove the entire tumor, which is still the main means of treating tumors, but it is only suitable for patients with early and middle-stage tumors, and is powerless for late-stage and metastatic tumors; radiotherapy is the second main means of tumor treatment, killing local tumor cells, especially tumors that are sensitive to radiation. It is the preferred treatment method and is also used for pain relief of tumor bone metastasis, but its adverse reactions are also obvious, and may even be stopped due to intolerance; chemotherapy is also an important means of tumor treatment, with systemic effects, and has certain efficacy on many tumors. It can significantly shrink tumors and prevent recurrence and metastasis, but chemotherapy also causes certain damage to normal tissue cells while killing cancer cells, and its adverse reactions are obvious;

[0004] Traditional Chinese Medicine (TCM) considers malignant tumors to be systemic diseases manifesting locally. Their occurrence, progression, recurrence, and metastasis are the localized reactions of various organismal diseases and syndromes. Their formation and transformation are a slow, gradual process. While focusing on eliminating external pathogenic factors, TCM emphasizes mobilizing and enhancing the body's own anti-cancer mechanisms—that is, adjusting the internal environment. Furthermore, TCM places particular emphasis on the role of emotions in cancer prevention and treatment. This demonstrates that TCM has a considerable understanding of cancer, having conducted meticulous clinical observations and accumulated numerous therapeutic prescriptions.

[0005] Currently, tumors are treated with anti-tumor Chinese herbal compound preparations. However, existing anti-tumor Chinese herbal compound preparations often contain multiple active ingredients, which makes their pharmacodynamic and pharmacokinetic studies relatively complex. In addition, some Chinese herbal ingredients in current Chinese herbal compound preparations may burden the liver or kidneys, especially when used in combination with chemotherapy drugs, which may increase the risk of adverse reactions.

[0006] Therefore, a method for preparing an anti-tumor Chinese medicine compound preparation containing isoquercetin is proposed to solve the above-mentioned problems. Summary of the Invention

[0007] The object of the present invention is to provide a method for preparing an anti-tumor Chinese medicinal compound preparation containing isoquercetin, so as to solve the problems raised in the above background technology.

[0008] To achieve the above object, the present invention provides the following technical solution: a method for preparing an anti-tumor Chinese medicine compound preparation containing isoquercetin, wherein the specific preparation steps of the anti-tumor Chinese medicine compound preparation containing isoquercetin are as follows:

[0009] Step 1, selecting and pre-treating Chinese medicinal materials: selecting 8-10g of yew, 6-12g of seven-leaf flos, 15-17g of nightshade, 3-7g of dandelion, 5-10g of angelica, 12-14g of poria, 13-15g of astragalus, 8-10g of ginseng, 13-15g of ganoderma lucidum, 8-10g of bark lotus, 13-15g of sophora flavescens, 14-16g of wintergrass, 8-12g of Panax notoginseng, 15-17g of oldenlandia diffusa, 16-17g of lithospermum officinale, 8-12g of mulberry leaf and 13-14g of sophora japonica seed; washing these Chinese medicinal materials twice with clean water to remove the dirt and other impurities inside, placing them in a drying device, controlling the temperature of the drying device to 100-120 degrees Celsius, and drying them for 3-4 hours until the water content of the Chinese medicinal materials is 5-10%;

[0010] Step 2: Pulverizing and extracting Chinese medicinal materials: Pour the dried Chinese medicinal materials into the pulverizing device and continue pulverizing for 20-30 minutes. The pulverized Chinese medicinal material particles are screened and passed through a 180-mesh sieve to obtain fine particles, which are then poured into a container and extracted with 50% ethanol.

[0011] Step 3: Separation and purification: Filter the extract using filter paper to remove solid residues, concentrate the filtrate using a vacuum concentrator, and purify the solution using column chromatography;

[0012] Step 4: preparing powder: preparing the prepared liquid medicine into powder particles to obtain a compound preparation;

[0013] Step 5. Safety Assessment: Use high-performance liquid chromatography to quantitatively determine the concentration of isoquercetin in the compound preparation, and conduct acute toxicity tests and long-term toxicity tests to ensure the safety of the preparation;

[0014] Step 6: Packaging and storage: Package the prepared preparation and store it in a dark and low-temperature environment.

[0015] Preferably, in step 2, the specific steps of extracting the Chinese medicinal material powder by ethanol are: pouring the Chinese medicinal material powder into a container, pouring in 50% ethanol solution, ensuring that the ethanol solution completely immerses the Chinese medicinal material powder, sealing the container, and placing it in a cool and ventilated place for soaking for 24-48 hours. During this period, the container needs to be shaken occasionally to ensure that the medicinal materials are fully soaked. After the soaking is completed, the liquid is retained and the ethanol is recovered to obtain the Chinese medicinal material powder extract.

[0016] Preferably, in the step three, the specific steps of using a vacuum concentrator to concentrate the filtrate are as follows: pouring the filtered traditional Chinese medicine filtrate into a concentration tank of the vacuum concentrator, starting the vacuum pump, gradually reducing the pressure in the concentration tank, lowering the boiling point of the solvent, and adjusting the vacuum degree range to -0.08MPa to -0.09MPa; starting the heating system, heating the filtrate in the concentration tank to 40°C to 60°C, and the generated solvent vapor enters the condenser, condenses into liquid under the action of cooling water, and flows into the recovery bottle, observing the change in the liquid volume in the concentration tank to judge the concentration progress, and when the concentrated liquid reaches the target concentration, turning off the heating system, continuing to maintain the vacuum for a period of time to evaporate the residual solvent, opening the discharge port of the concentration tank, and collecting the concentrated liquid into a clean container.

[0017] Preferably, the specific steps of preparing the powder are as follows: pouring the solution into a spray dryer, controlling the inlet air temperature to 100-200 degrees Celsius, and the inlet air volume to 80-90%, so that the liquid is dried into a solid, and crushing the solid to prepare a powder.

[0018] Preferably, the specific operation of quantitatively determining the concentration of isoquercetin using high performance liquid chromatography is as follows: the sample is mixed with ethanol and treated in an ultrasonic bath for 20-30 minutes to promote the dissolution of the components, the extract is filtered through a 0.45 micron filter membrane to remove insoluble matter and other impurities, a certain amount of isoquercetin standard is accurately weighed, and a series of standard solutions of different concentrations are prepared with ethanol, such as 0.1 μg / mL, 0.5 μg / mL, 1 μg / mL, 5 μg / mL, and 10 μg / mL; the standard solutions of each concentration are injected separately, and the peak area or peak height at each concentration is recorded, with the isoquercetin concentration as the horizontal axis, and the corresponding Use the peak area or peak height as the ordinate to draw a standard curve and calculate the regression equation. Inject the treated sample solution into the HPLC system and run it according to the set chromatographic conditions. Record the retention time and peak area or peak height of isoquercetin in the sample. Use the regression equation of the standard curve to calculate the actual concentration of isoquercetin in the sample based on the peak area or peak height of isoquercetin in the sample. For diluted samples, multiply by the corresponding dilution factor to obtain the isoquercetin content in the original sample. Confirm that the standard curve has a good linear relationship within the selected concentration range. Inject the standard solution or sample of the same concentration multiple times under the same conditions to evaluate the precision of the results.

[0019] Preferably, in step six, the preparation needs to be vacuum-packed and stored under the conditions of a temperature below 20 degrees Celsius, a humidity below 60%, and no direct exposure to light.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] The raw material formula of the present application adds mulberry leaves and sophora japonica seeds, which are rich in isoquercetin, which has antioxidant, anti-inflammatory and potential anti-tumor effects, greatly improving the efficacy of the traditional Chinese medicine compound preparation;

[0022] Moreover, the preparation process of this preparation is simple. After the preparation is completed, high-performance liquid chromatography technology will be used to quantitatively determine the concentration of isoquercetin, and acute toxicity tests and long-term toxicity tests will be carried out to ensure the safety of the preparation, thereby avoiding side effects on the human body during the later medication process and no adverse risks will be generated. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 is a flow chart of the preparation of this Chinese medicine compound preparation. DETAILED DESCRIPTION

[0024] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0025] In the description of the present invention, it should be understood that the terms "upper", "lower", "front", "back", "left", "right", "top", "bottom", "inside", "outside", etc., indicating directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore should not be understood as limiting the present invention.

[0026] Please refer to Figure 1, the present invention provides a technical solution:

[0027] A method for preparing an anti-tumor Chinese medicinal compound preparation containing isoquercetin. The specific preparation steps of the anti-tumor Chinese medicinal compound preparation containing isoquercetin are as follows:

[0028] Step 1, selecting and pre-treating Chinese medicinal materials: selecting 8-10g of yew, 6-12g of seven-leaf flos, 15-17g of nightshade, 3-7g of dandelion, 5-10g of angelica, 12-14g of poria, 13-15g of astragalus, 8-10g of ginseng, 13-15g of ganoderma lucidum, 8-10g of bark lotus, 13-15g of sophora flavescens, 14-16g of wintergrass, 8-12g of Panax notoginseng, 15-17g of oldenlandia diffusa, 16-17g of lithospermum officinale, 8-12g of mulberry leaf and 13-14g of sophora japonica seed; washing these Chinese medicinal materials twice with clean water to remove the dirt and other impurities inside, placing them in a drying device, controlling the temperature of the drying device to 100-120 degrees Celsius, and drying them for 3-4 hours until the water content of the Chinese medicinal materials is 5-10%;

[0029] Step 2: Pulverizing and extracting Chinese medicinal materials: Pour the dried Chinese medicinal materials into the pulverizing device and continue pulverizing for 20-30 minutes. The pulverized Chinese medicinal material particles are screened and passed through a 180-mesh sieve to obtain fine particles, which are then poured into a container and extracted with 50% ethanol.

[0030] Step 3: Separation and purification: Filter the extract using filter paper to remove solid residues, concentrate the filtrate using a vacuum concentrator, and purify the solution using column chromatography;

[0031] Step 4: preparing powder: preparing the prepared liquid medicine into powder particles to obtain a compound preparation;

[0032] Step 5. Safety Assessment: Use high-performance liquid chromatography to quantitatively determine the concentration of isoquercetin in the compound preparation, and conduct acute toxicity tests and long-term toxicity tests to ensure the safety of the preparation;

[0033] Step 6: Packaging and storage: Package the prepared preparation and store it in a dark and low-temperature environment.

[0034] In the step 2, the specific steps of extracting the Chinese medicinal material powder by ethanol are as follows: pouring the Chinese medicinal material powder into a container, pouring in 50% ethanol solution, ensuring that the ethanol solution completely immerses the Chinese medicinal material powder, sealing the container, and placing it in a cool and ventilated place to soak for 24-48 hours. During this period, the container needs to be shaken occasionally to ensure that the medicinal materials are fully soaked. After the soaking is completed, the liquid is retained and the ethanol is recovered to obtain the Chinese medicinal material powder extract.

[0035] In the step three, the specific steps of using a vacuum concentrator to concentrate the filtrate are as follows: pouring the filtered traditional Chinese medicine filtrate into a concentration tank of the vacuum concentrator, starting the vacuum pump, gradually reducing the pressure in the concentration tank, lowering the boiling point of the solvent, and adjusting the vacuum range to -0.08MPa to -0.09MPa; starting the heating system, heating the filtrate in the concentration tank to 40°C to 60°C, and the generated solvent vapor enters the condenser, condenses into liquid under the action of cooling water, and flows into the recovery bottle, observing the change in the liquid volume in the concentration tank to judge the concentration progress, and when the concentrated liquid reaches the target concentration, turning off the heating system, continuing to maintain the vacuum for a period of time to evaporate the residual solvent, opening the discharge port of the concentration tank, and collecting the concentrated liquid into a clean container.

[0036] The specific steps of preparing the powder are as follows: pouring the solution into a spray dryer, controlling the inlet air temperature to 100-200 degrees Celsius, and the inlet air volume to 80-90%, so that the liquid is dried into a solid, and then crushing the solid to prepare the powder.

[0037] The specific operation of quantitative determination of isoquercetin content using high performance liquid chromatography is as follows: the sample is mixed with ethanol and treated in an ultrasonic bath for 20-30 minutes to promote the dissolution of the components. The extract is filtered through a 0.45 micron filter membrane to remove insoluble matter and other impurities. A certain amount of isoquercetin standard is accurately weighed and a series of standard solutions of different concentrations are prepared with ethanol, such as 0.1 μg / mL, 0.5 μg / mL, 1 μg / mL, 5 μg / mL, and 10 μg / mL. The standard solutions of each concentration are injected separately, and the peak area or peak height at each concentration is recorded. The peak area or peak height corresponding to the isoquercetin concentration is used as the horizontal axis. The standard curve is drawn with the product or peak height as the vertical axis, and the regression equation is calculated. The treated sample solution is injected into the HPLC system, and the chromatographic operation is carried out according to the set chromatographic conditions. The retention time and peak area or peak height of isoquercetin in the sample are recorded. The actual concentration of isoquercetin in the sample is calculated based on the peak area or peak height of isoquercetin in the sample using the regression equation of the standard curve. For diluted samples, the isoquercetin content in the original sample needs to be obtained by multiplying the diluted sample by the corresponding dilution factor. It is confirmed that the standard curve has a good linear relationship within the selected concentration range. The standard solution or sample of the same concentration is injected multiple times under the same conditions to evaluate the precision of the results.

[0038] In step six, the preparation needs to be vacuum-packed and stored under the following conditions: a temperature below 20 degrees Celsius, a humidity below 60%, and no direct exposure to light.

[0039] Yew: Yew contains a large amount of paclitaxel, which can inhibit the development of abnormal tumor cells in the human body. It is often used clinically as an auxiliary treatment for late-stage cancer, such as breast cancer, lymphoma, and prostate cancer. It is rich in tannins, which can inhibit bacterial production and have anti-inflammatory and diuretic effects. Yew contains golden pine copper and bioflavonoids. After the human body ingests golden pine copper, it can lower blood pressure, blood lipids, and blood sugar, and can effectively prevent cardiovascular and cerebrovascular diseases.

[0040] Seven-leaf clover: Contains multiple active ingredients that can inhibit the growth and spread of tumor cells, thus having an anti-tumor effect. However, it should be noted that seven-leaf clover cannot cure tumors alone. It is more of an auxiliary treatment method, combined with other treatment methods to fight tumors together;

[0041] Solanum nigrum: The anti-tumor mechanism of action of Solanum nigrum fruit includes inhibiting tumor cell growth, inducing tumor cell apoptosis, regulating immune function, interfering with the tumor cell cycle, and enhancing killer cell activity. The solanine and other ingredients rich in Solanum nigrum fruit can penetrate deep into tumor cells and interfere with their normal metabolic processes, thereby effectively inhibiting tumor cell growth. Certain components in Solanum nigrum fruit can trigger the apoptosis mechanism of tumor cells, causing them to die on their own, thereby more effectively controlling the development of cancer.

[0042] Dandelion: Dandelion can help cancer patients clear away heat and toxins, reduce swelling and resolve lumps, and improve symptoms such as fever and carbuncle caused by cancer. Some clinical studies have also shown that components in dandelion have certain anti-cancer effects. In vitro tests have found that dandelion can stimulate the body's immune function. Therefore, taking dandelion in moderation can help with both anti-cancer and cancer prevention.

[0043] Angelica: Angelica has multiple pharmacological effects, including tonifying blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is often used to treat symptoms such as blood deficiency, sallow complexion, dizziness and palpitations, irregular menstruation, amenorrhea, and dysmenorrhea. Its volatile oils, polysaccharides, and ferulic acid possess certain antioxidant, anti-inflammatory, and immunomodulatory biological activities.

[0044] Poria: The carboxymethyl polysaccharide contained in Poria can activate local cells in the affected area, forcing the activated cells in the tissues near the tumor to affect macrophages, lymphocytes or other cells and humoral factors, thereby achieving the effect of killing tumor cells;

[0045] Astragalus: Astragalus contains a variety of active ingredients, such as astragalus polysaccharides and saponins, which can promote the proliferation and activation of immune cells. Astragalus polysaccharides can significantly enhance the function of macrophages and natural killer cells, thereby enhancing the body's resistance to tumor cells. The flavonoids in astragalus have strong antioxidant properties, which can reduce the damage caused by free radicals to cells. Excessive free radicals can lead to cell mutations and cancer, so antioxidants can help prevent and delay cancer.

[0046] Ginseng: Cancer patients taking appropriate amounts of ginseng can help regulate their bodies and improve symptoms such as Qi and blood deficiency, palpitations, insomnia and forgetfulness, Qi deficiency, and weak pulse caused by cancer. Therefore, ginseng has a certain auxiliary effect in cancer prevention.

[0047] Lingzhi: When used in combination with other Chinese herbs, Lingzhi has the effects of anti-cancer, cancer prevention, liver protection, detoxification, and blood sugar reduction. It has good therapeutic effects in preventing and treating cardiovascular diseases, treating hyperlipidemia, stroke, anti-aging, and improving neurasthenia. Lingzhi can improve immunity and enhance the patient's own anti-cancer ability, and has anti-cancer and cancer prevention effects.

[0048] Scutellaria barbata: Clears away heat and detoxifies, used for various cancers, hepatitis, carbuncle swelling, etc.; acts as a diuretic and reduces swelling: used for ascites caused by liver cirrhosis, acute and chronic nephritis, etc.; dissipates blood stasis and resolves phlegm, used for scrofula, tuberculosis, etc.; acts as a blood stasis and promotes urination, used for carbuncle swelling, sore throat, snake bites, and injuries from falls;

[0049] Sophora flavescens: Cancer cells divide, spread, and compress rapidly, stimulating peripheral nerves and causing pain. The flavonoids in Sophora flavescens can relieve pain symptoms. Cancer in some patients is caused by long-term inflammation. Matrine in Sophora flavescens can inhibit the inflammatory response and promote recovery.

[0050] Rubescens: Correct use of Rubescens can help inhibit the growth of cancer cells and play an anti-cancer role, but it can only be used as an auxiliary treatment;

[0051] Panax notoginseng: Panax notoginseng contains ingredients such as ginsenoside RH2, which can play a role in cancer prevention and treatment. Panax notoginseng also has a hemostatic effect, so it has a good therapeutic effect on cancers with a tendency to bleed. Panax notoginseng is often used clinically to treat lung cancer, esophageal cancer, cervical cancer and other cancers.

[0052] Hedyotis diffusa: Hedyotis diffusa has certain anti-tumor effects. It tastes slightly bitter and has a cold nature. It enters the lung, stomach, and small intestine meridians, and has the effects of clearing heat and detoxifying, as well as promoting diuresis and relieving stranguria. It can be used to treat heat-toxic syndromes such as sores, sore throats, and snake bites. It can also treat yellow, red, and painful urine caused by stranguria.

[0053] Lithospermum officinale: It can clear heat and toxins from the body and help reduce the inflammatory response of cancer patients. It is used for choriocarcinoma, leukemia, lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer, and fever and bleeding caused by cancer.

[0054] Mulberry leaves: Mulberry leaves have antiviral and anti-tumor effects, can inhibit chromosome mutation and gene mutation, prevent the formation of cancer cells, and enhance the body's immunity; the morin in mulberry leaves has anti-cancer activity, and the vitamins in them have an inhibitory effect on mutagens;

[0055] Sophora japonica seeds: Sophora japonica seeds have the effect of clearing and cooling the blood, effectively removing waste from the blood, and also have anti-cancer and anti-cancer effects. Sophora japonica seeds are rich in selenium, which can effectively promote the body's metabolism, enhance the body's immunity, and effectively reduce the phenomenon of hair loss in patients during radiotherapy. Sophora japonica seeds also have antibacterial and anti-inflammatory effects, which can effectively kill bacteria.

[0056] Example 1:

[0057] The specific preparation steps of the anti-tumor Chinese medicinal compound preparation containing isoquercetin are as follows:

[0058] Step 1, Chinese medicinal materials selection and pretreatment: select 8g of yew, 6g of seven-leaf gentian, 15g of nightshade, 3g of dandelion, 5g of angelica, 12g of Poria, 13g of Astragalus, 8g of ginseng, 13g of Ganoderma lucidum, 8g of Scutellaria barbata, 13g of Sophora flavescens, 14g of Rubescens, 8g of Panax notoginseng, 15g of Hedyotis diffusa, 16g of Lithospermum officinale, 8g of mulberry leaf and 13g of Sophora japonica seed; wash these Chinese medicinal materials twice with clean water to remove the internal dirt and other impurities, place them in the interior of a drying device, control the temperature of the drying device to 100 degrees Celsius, and continue drying for 3 hours until the water content of the Chinese medicinal materials is 5%;

[0059] Step 2: Pulverizing and extracting Chinese medicinal materials: Pour the dried Chinese medicinal materials into the pulverizing device and continue pulverizing for 20 minutes. The pulverized Chinese medicinal material particles are screened and passed through a 180-mesh sieve to obtain fine particles, which are then poured into a container and extracted with 50% ethanol.

[0060] Step 3: Separation and purification: Filter the extract using filter paper to remove solid residues, concentrate the filtrate using a vacuum concentrator, and purify the solution using column chromatography;

[0061] Step 4: preparing powder: preparing the prepared liquid medicine into powder particles to obtain a compound preparation;

[0062] Step 5. Safety Assessment: Use high-performance liquid chromatography to quantitatively determine the concentration of isoquercetin in the compound preparation, and conduct acute toxicity tests and long-term toxicity tests to ensure the safety of the preparation;

[0063] Step 6: Packaging and storage: Pack the prepared preparation and store it in a dark and low-temperature environment;

[0064] Example 2:

[0065] The specific preparation steps of the anti-tumor Chinese medicinal compound preparation containing isoquercetin are as follows:

[0066] Step 1, Chinese medicinal materials selection and pretreatment: select 9g of yew, 9g of seven-leaf flos, 16g of nightshade, 5g of dandelion, 7.5g of angelica, 13g of Poria, 14g of Astragalus, 9g of ginseng, 14g of Ganoderma lucidum, 9g of Scutellaria barbata, 14g of Sophora flavescens, 15g of Rubescens, 10g of Panax notoginseng, 16g of Hedyotis diffusa, 16.5g of Lithospermum officinale, 10g of mulberry leaf and 13.5g of Sophora japonica seed; wash these Chinese medicinal materials twice with clean water to remove the internal dirt and other impurities, place them in the interior of a drying device, control the temperature of the drying device to 110 degrees Celsius, and continue drying for 3.5 hours until the water content of the Chinese medicinal materials is 7.5%;

[0067] Step 2: Pulverizing and extracting Chinese medicinal materials: Pour the dried Chinese medicinal materials into the pulverizing device and continue pulverizing for 25 minutes. The pulverized Chinese medicinal material particles are screened and passed through a 180-mesh sieve to obtain fine particles, which are then poured into a container and extracted with 50% ethanol.

[0068] Step 3: Separation and purification: Filter the extract using filter paper to remove solid residues, concentrate the filtrate using a vacuum concentrator, and purify the solution using column chromatography;

[0069] Step 4: preparing powder: preparing the prepared liquid medicine into powder particles to obtain a compound preparation;

[0070] Step 5. Safety Assessment: Use high-performance liquid chromatography to quantitatively determine the concentration of isoquercetin in the compound preparation, and conduct acute toxicity tests and long-term toxicity tests to ensure the safety of the preparation;

[0071] Step 6: Packaging and storage: Pack the prepared preparation and store it in a dark and low-temperature environment;

[0072] Example 3:

[0073] The specific preparation steps of the anti-tumor Chinese medicinal compound preparation containing isoquercetin are as follows:

[0074] Step 1, Chinese medicinal materials selection and pretreatment: select yew 10g, seven-leaf flos 12g, nightshade 17g, dandelion 7g, angelica 10g, Poria 14g, astragalus 15g, ginseng 10g, ganoderma lucidum 15g, Scutellaria barbata 10g, Sophora flavescens 15g, winter rubescens 16g, Panax notoginseng 12g, Hedyotis diffusa 17g, Lithospermum officinale 17g, mulberry leaf 12g and Sophora japonica 14g; wash these Chinese medicinal materials twice with clean water to remove the internal dirt and other impurities, place them in the inside of a drying device, control the temperature of the drying device to 120 degrees Celsius, and continue drying for 4 hours until the water content of the Chinese medicinal materials is 10%;

[0075] Step 2: Pulverizing and extracting Chinese medicinal materials: Pour the dried Chinese medicinal materials into the pulverizing device and continue pulverizing for 30 minutes. The pulverized Chinese medicinal material particles are screened and passed through a 180-mesh sieve to obtain fine particles, which are then poured into a container and extracted with 50% ethanol.

[0076] Step 3: Separation and purification: Filter the extract using filter paper to remove solid residues, concentrate the filtrate using a vacuum concentrator, and purify the solution using column chromatography;

[0077] Step 4: preparing powder: preparing the prepared liquid medicine into powder particles to obtain a compound preparation;

[0078] Step 5. Safety Assessment: Use high-performance liquid chromatography to quantitatively determine the concentration of isoquercetin in the compound preparation, and conduct acute toxicity tests and long-term toxicity tests to ensure the safety of the preparation;

[0079] Step 6: Packaging and storage: Package the prepared preparation and store it in a dark and low-temperature environment.

[0080] The above shows and describes the basic principles and main features of the present invention and the advantages of the present invention. For those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and the present invention can be implemented in other specific forms without departing from the spirit or basic characteristics of the present invention; therefore, no matter from which point of view, the embodiments should be regarded as exemplary and non-restrictive. The scope of the present invention is limited by the appended claims rather than the above description. Therefore, it is intended that all changes that fall within the meaning and scope of the equivalent elements of the claims are included in the present invention, and any figure signs in the claims should not be regarded as limiting the claims involved.

[0081] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A method for preparing an anti-tumor Chinese medicinal compound preparation containing isoquercetin, characterized in that: The specific preparation steps of the anti-tumor Chinese medicinal compound preparation containing isoquercetin are as follows: Step 1, selecting and pre-treating Chinese medicinal materials: selecting 8-10g of yew, 6-12g of seven-leaf flos, 15-17g of nightshade, 3-7g of dandelion, 5-10g of angelica, 12-14g of poria, 13-15g of astragalus, 8-10g of ginseng, 13-15g of ganoderma lucidum, 8-10g of bark lotus, 13-15g of sophora flavescens, 14-16g of wintergrass, 8-12g of Panax notoginseng, 15-17g of oldenlandia diffusa, 16-17g of lithospermum officinale, 8-12g of mulberry leaf and 13-14g of sophora japonica seed; washing these Chinese medicinal materials twice with clean water to remove the dirt and other impurities inside, placing them in a drying device, controlling the temperature of the drying device to 100-120 degrees Celsius, and drying them for 3-4 hours until the water content of the Chinese medicinal materials is 5-10%; Step 2: Pulverizing and extracting Chinese medicinal materials: Pour the dried Chinese medicinal materials into the pulverizing device and continue pulverizing for 20-30 minutes. The pulverized Chinese medicinal material particles are screened and passed through a 180-mesh sieve to obtain fine particles, which are then poured into a container and extracted with 50% ethanol. Step 3: Separation and purification: Filter the extract using filter paper to remove solid residues, concentrate the filtrate using a vacuum concentrator, and purify the solution using column chromatography; Step 4: preparing powder: preparing the prepared liquid medicine into powder particles to obtain a compound preparation; Step 5. Safety Assessment: Use high-performance liquid chromatography to quantitatively determine the concentration of isoquercetin in the compound preparation, and conduct acute toxicity tests and long-term toxicity tests to ensure the safety of the preparation; Step 6: Packaging and storage: Package the prepared preparation and store it in a dark and low-temperature environment.

2. The method for preparing an anti-tumor Chinese medicinal compound preparation containing isoquercetin according to claim 1, wherein: In the step 2, the specific steps of extracting the Chinese medicinal material powder by ethanol are as follows: pouring the Chinese medicinal material powder into a container, pouring in 50% ethanol solution, ensuring that the ethanol solution completely immerses the Chinese medicinal material powder, sealing the container, and placing it in a cool and ventilated place to soak for 24-48 hours. During this period, the container needs to be shaken occasionally to ensure that the medicinal materials are fully soaked. After the soaking is completed, the liquid is retained and the ethanol is recovered to obtain the Chinese medicinal material powder extract.

3. The method for preparing an anti-tumor Chinese medicinal compound preparation containing isoquercetin according to claim 1, wherein: In the step three, the specific steps of using a vacuum concentrator to concentrate the filtrate are as follows: pouring the filtered traditional Chinese medicine filtrate into a concentration tank of the vacuum concentrator, starting the vacuum pump, gradually reducing the pressure in the concentration tank, lowering the boiling point of the solvent, and adjusting the vacuum range to -0.08MPa to -0.09MPa; starting the heating system, heating the filtrate in the concentration tank to 40°C to 60°C, and the generated solvent vapor enters the condenser, condenses into liquid under the action of cooling water, and flows into the recovery bottle, observing the change in the liquid volume in the concentration tank to judge the concentration progress, and when the concentrated liquid reaches the target concentration, turning off the heating system, continuing to maintain the vacuum for a period of time to evaporate the residual solvent, opening the discharge port of the concentration tank, and collecting the concentrated liquid into a clean container.

4. The method for preparing an anti-tumor Chinese medicinal compound preparation containing isoquercetin according to claim 1, wherein: The specific steps of preparing the powder are as follows: pouring the solution into a spray dryer, controlling the inlet air temperature to 100-200 degrees Celsius, and the inlet air volume to 80-90%, so that the liquid is dried into a solid, and then crushing the solid to prepare the powder.

5. The method for preparing an anti-tumor Chinese medicinal compound preparation containing isoquercetin according to claim 1, wherein: The specific operation of quantitative determination of isoquercetin content using high performance liquid chromatography is as follows: the sample is mixed with ethanol and treated in an ultrasonic bath for 20-30 minutes to promote the dissolution of the components. The extract is filtered through a 0.45 micron filter membrane to remove insoluble matter and other impurities. A certain amount of isoquercetin standard is accurately weighed and a series of standard solutions of different concentrations are prepared with ethanol, such as 0.1 μg / mL, 0.5 μg / mL, 1 μg / mL, 5 μg / mL, and 10 μg / mL. The standard solutions of each concentration are injected separately, and the peak area or peak height at each concentration is recorded. The peak area or peak height corresponding to the isoquercetin concentration is used as the horizontal axis. The standard curve is drawn with the product or peak height as the vertical axis, and the regression equation is calculated. The treated sample solution is injected into the HPLC system, and the chromatographic operation is carried out according to the set chromatographic conditions. The retention time and peak area or peak height of isoquercetin in the sample are recorded. The actual concentration of isoquercetin in the sample is calculated based on the peak area or peak height of isoquercetin in the sample using the regression equation of the standard curve. For diluted samples, the isoquercetin content in the original sample needs to be obtained by multiplying the diluted sample by the corresponding dilution factor. It is confirmed that the standard curve has a good linear relationship within the selected concentration range. The standard solution or sample of the same concentration is injected multiple times under the same conditions to evaluate the precision of the results.

6. The method for preparing an anti-tumor Chinese medicinal compound preparation containing isoquercetin according to claim 1, wherein: In step six, the preparation needs to be vacuum-packed and stored under the following conditions: a temperature below 20 degrees Celsius, a humidity below 60%, and no direct exposure to light.

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