A broad-spectrum anticancer pharmaceutical composition containing whole toad components and application thereof

Abstract

The present application provides a broad-spectrum anticancer drug composition containing whole toad ingredients, which is prepared from the following raw materials: 3 live toads with a total weight of 700-900 g, 4500-5000 ml of high-purity grain liquor, 30-40 g of licorice, 30-45 g of king ginseng and 10-20 g of dandelion; the live toad is an individual with a weight of more than 200 g, and contains all ingredients including toad meat, liver, toad skin and head; the present application greatly reduces the acute toxicity of toad while retaining the antitumor activity through specific pretreatment and the application of licorice. The glycyrrhizic acid in licorice combines with toad toxin to reduce the concentration of free toxin, prolong the toxin metabolism time, avoid the high blood drug concentration peak causing poisoning, the toad meat is rich in protein and polypeptide, the liver is rich in immunomodulatory substances, the toad skin has antitumor metastasis activity, and the whole ingredients have a synergistic effect. Experimental results show that the composition has a significant inhibitory effect on the diffusion of breast cancer, colon cancer and liver cancer cells.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine pharmaceutical technology, and in particular to a broad-spectrum anticancer drug composition containing whole toad components and its application. Background Technology

[0002] Cancer is a major disease that seriously threatens human health. Current treatment methods mainly include surgery, radiotherapy, and chemotherapy. However, chemotherapy drugs often have problems such as indiscriminate use, large toxic side effects, and easy development of drug resistance, which seriously affect the quality of life of patients. Therefore, the search for highly effective, low-toxicity, and multi-target natural anti-tumor drugs has become a research hotspot.

[0003] Toads, commonly known as "toads", have long been recorded in traditional Chinese medicine for their detoxifying, analgesic, and swelling-reducing effects, as well as their secretions (toad venom).

[0004] Modern pharmacological studies have shown that toads contain components such as bufotoxin and bufo lactone, which have significant anti-tumor activity.

[0005] However, most existing toad-based preparations only utilize toad venom or toad skin, which leads to resource waste. In addition, the medicinal properties of toad alone are potent and often difficult for patients to tolerate. Therefore, a broad-spectrum anticancer drug composition containing whole toad components and its application are proposed. Summary of the Invention

[0006] In view of this, embodiments of the present invention provide a broad-spectrum anticancer drug composition containing whole toad components and its application, in order to solve or alleviate the technical problems existing in the prior art, and at least provide a beneficial alternative.

[0007] The technical solution of this invention is implemented as follows: a broad-spectrum anticancer drug composition containing whole toad components, wherein the drug composition is prepared from the following raw materials in parts by weight: Three live toads, weighing a total of 700g-900g; 4500ml-5000ml of high-proof pure grain liquor; 30-40g of licorice root; 30-45g of Vaccaria segetalis; and 10-20g of dandelion. The live toad refers to an individual weighing over 200g, and includes all components including toad meat, liver, toad skin, and head.

[0008] In some embodiments, the preferred weight proportions of the active pharmaceutical ingredient are: 700g-900g of live toad, 4500ml of high-proof pure grain liquor, 30g of licorice root, 30g of Vaccaria segetalis, and 15g of dandelion; The alcohol content of the high-purity grain liquor is 60%-65% vol.

[0009] In some embodiments, the dosage form of the pharmaceutical composition is an oral medicinal wine.

[0010] A method for preparing a broad-spectrum anticancer drug composition containing whole toad components as described in any of the above claims, comprising the following steps: S1. Select 3 live toads weighing over 200g, place them in clean water and fast them for 48-72 hours to allow them to empty their gastrointestinal contents; Then remove it, gently remove the surface dirt, no dissection is required, keep the toad meat, liver, skin, head and whole body intact, and drain the water; S2. Place the processed toad at the bottom of a clean ceramic or glass container, add licorice, cowherb seed, and dandelion, then pour in high-proof pure grain liquor, steam and boil, and then put it into a sealed container. S3. Filter and separate the wine and the dregs and take them. The resulting wine is a broad-spectrum anti-cancer medicinal wine with all toad components. S4. Store the sealed container in a cool, dark place at room temperature. It is valid for one year. The container should be shaken once every 7 days to promote the dissolution of active ingredients and the conversion or neutralization of toxic components.

[0011] The use of a pharmaceutical composition as described in any of the above claims in the preparation of a drug for treating breast cancer, colon cancer, liver cancer, and inhibiting the spread of cancer cells.

[0012] In some embodiments, the oral dose of the pharmaceutical composition is 5-15 ml per day. The initial dose is 5 ml, and to avoid adverse reactions, the dose is gradually increased to 10 ml over 7 days. Severe cases can take 15 ml once a day, half an hour after dinner. It does not irritate the stomach and intestines. Each course of treatment is 30 days, and more than 3 courses of treatment are required to observe the tumor-suppressing effect.

[0013] The embodiments of the present invention have the following advantages due to the adoption of the above technical solutions: This invention, through specific pretreatment and the application of licorice, significantly reduces the acute toxicity of toads while retaining their antitumor activity. The glycyrrhizic acid in licorice combines with toad toxins, which can reduce the concentration of free toxins, prolong the toxin metabolism time, and avoid excessively high peak blood drug concentrations that could lead to poisoning. Toad meat is rich in protein and polypeptides, the liver is rich in immunomodulatory substances, and toad skin has antitumor metastasis activity. The entire composition works synergistically, and experiments have shown that it has a significant inhibitory effect on the spread of breast cancer, colon cancer, and liver cancer cells.

[0014] The above overview is for illustrative purposes only and is not intended to be limiting in any way. Detailed Implementation

[0015] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the invention.

[0016] It is important to note that terms such as "first," "second," "symmetric," "array," "set in," and "set with" are used only to distinguish between descriptive and positional descriptions and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, features specified with terms such as "first" or "symmetric" may explicitly or implicitly include one or more of that feature; similarly, when the quantity of certain features is not limited by words such as "two" or "three," it should be noted that such features also explicitly or implicitly include one or more features.

[0017] In this invention, unless otherwise explicitly specified and limited, terms such as “installation,” “connection,” and “fixation” should be interpreted broadly; for example, they can be fixed connections, detachable connections, or integral moldings; they can be mechanical connections, direct connections, welding, or indirect connections through an intermediate medium; they can be internal connections between two components or the interaction between two components.

[0018] Example 1 This invention provides a broad-spectrum anticancer drug composition containing whole toad components, which is prepared from the following raw materials in parts by weight: Three live toads, weighing a total of 700g-900g; 4500ml-5000ml of high-proof pure grain liquor; 30-40g of licorice root; 30-45g of Vaccaria segetalis; and 10-20g of dandelion. Live toads are defined as individuals weighing over 200g each, and include all components including toad meat, liver, toad skin, and head.

[0019] In this embodiment, the preferred weight percentage of the active pharmaceutical ingredient is: 700g-900g of live toad, 4500ml of high-proof pure grain liquor, 30g of licorice root, 30g of Vaccaria segetalis, and 15g of dandelion; High-proof pure grain liquor has an alcohol content of 60%-65% vol.

[0020] In this embodiment, the specific dosage form of the pharmaceutical composition is an oral medicinal wine.

[0021] A method for preparing a broad-spectrum anticancer drug composition containing whole toad components as described in any of the above claims, comprising the following steps: S1. Select 3 live toads weighing over 200g, place them in clean water and fast them for 48-72 hours to allow them to empty their gastrointestinal contents; Then remove it, gently remove the surface dirt, no dissection is required, keep the toad meat, liver, skin, head and whole body intact, and drain the water; S2. Place the processed toad at the bottom of a clean ceramic or glass container, add licorice, cowherb seed, and dandelion, then pour in high-proof pure grain liquor, steam and boil, and then put it into a sealed container. S3. Filter and separate the wine and the dregs and take them. The resulting wine is a broad-spectrum anti-cancer medicinal wine containing all toad components. S4. Store the sealed container in a cool, dark place at room temperature. It is valid for one year. The container is shaken once every 7 days to promote the dissolution of the active ingredient and the conversion or neutralization of toxic components. The use of a pharmaceutical composition as described above in the preparation of drugs for treating breast cancer, colon cancer, liver cancer, and inhibiting the spread of cancer cells.

[0022] In this embodiment, the specific oral dosage of the drug composition is 5-15 ml per day, taken once a day half an hour after dinner. It does not irritate the stomach and intestines. Each course of treatment lasts for 30 days, and more than 3 courses of treatment are required to observe the tumor-suppressing effect.

[0023] In this embodiment, specifically, I. Analysis of the Theory of "Monarch, Minister, Assistant, and Guide" in Traditional Chinese Medicine In the principles of traditional Chinese medicine prescription, drugs are divided into principal, assistant, adjuvant, and guide drugs, each with its own function to achieve the best therapeutic effect. The principal ingredient: Live toad (whole toad) has the effect of attacking poison and dispersing nodules, using poison to fight poison; Position: The main ingredient in the formula, with the largest dosage, plays a core therapeutic role; Principle: Toads are pungent, cool, and poisonous. Traditional Chinese medicine believes that cancer is often caused by "accumulation of toxins and stagnation of phlegm and blood stasis." Toads have extremely strong effects in "detoxifying, relieving pain, reducing swelling, and dissipating nodules." Large toads weighing over 200g are selected, including the entire toad (meat, liver, skin, and head), to utilize its complete biological activity, "fighting poison with poison," directly targeting cancerous toxins and dissipating tumor masses.

[0024] The herb in question: Wang Bu Liu Xing (Semen Vaccariae) has the effects of promoting blood circulation, removing blood stasis, regulating menstruation, and relieving pain; Position: To assist the principal drug and enhance its therapeutic effect; Principle: Cancer patients often suffer from "qi stagnation and blood stasis", which manifests as fixed and unmoving lumps and pain. Wang Bu Liu Xing is warm in nature and pungent in taste. It is good at promoting blood circulation, removing blood stasis and relieving pain. It can help toads clear the stagnation in the tumor area and improve microcirculation. On the one hand, it helps the medicine to reach the lesion directly, and on the other hand, it can relieve the severe pain caused by cancer. Adjuvant herbs: Licorice and dandelion have the effects of clearing heat and detoxifying, and harmonizing the properties of other herbs; Its role is to limit the toxicity of the principal drug and eliminate accompanying symptoms; The role of licorice: This is the most crucial "detoxifying agent" in this formula. Licorice is sweet and neutral in nature, and can "harmonize the effects of other herbs". In this formula, it plays two key roles: Firstly, it serves as a detoxification agent, utilizing glycyrrhizic acid to precipitate or bind with toad toxins, thereby reducing the toad's potent toxicity and preventing poisoning. Secondly, it protects the stomach, relieving the irritation of the gastrointestinal tract caused by toads and preventing nausea and vomiting.

[0025] The effects of dandelion: It is cold in nature, bitter and sweet in taste, and enters the liver and stomach meridians. It has the functions of clearing heat and detoxifying, reducing swelling and dissipating nodules. Breast cancer and liver cancer are mostly related to liver stagnation and fire. Dandelion can clear the heat toxins in the body and assist toads in reducing swelling. Moreover, its cold nature can counteract the warm and dry nature of toads and Wang Bu Liu Xing, and prevent damage to Yin. Using high-proof pure grain liquor: It has the effect of guiding the medicine to its proper channels and enhancing its efficacy. Position: Solvent and guiding agent; Principle: Alcohol is very hot in nature and can promote the flow of qi and blood and unblock the meridians. In this formula, alcohol is not only a solvent, but also a fat-soluble anti-tumor active ingredient (such as bufotoxin) in the toad's body that can be extracted efficiently. At the same time, alcohol, as a "guide drug," can direct the medicinal power directly to the affected area (such as the liver meridian), accelerate blood circulation, and promote drug absorption, achieving the effect of "the medicine borrowing the power of alcohol, and alcohol assisting the medicine's efficacy."

[0026] II. Modern Pharmacological Mechanisms of "Reduced Toxicity and Enhanced Efficacy" Synergistic effect mechanism (1+1>2) Whole toads provide a broad spectrum of anti-tumor components (such as bufotoxin and bufotoxin lactone), which can directly induce apoptosis in cancer cells.

[0027] Wang Bu Liu Xing (Semen Vaccariae) can improve the hypoxic state of tumor tissue. Tumor tissue is usually rich in blood vessels but has a disordered structure, making it difficult for drugs to penetrate. After Wang Bu Liu Xing improves microcirculation, it can enable toad toxins to enter the tumor more efficiently, increasing the intracellular drug concentration.

[0028] Dandelion polysaccharides have immunomodulatory effects, activating macrophages and working with toad toxins to kill residual and spreading cancer cells.

[0029] Toxicity control mechanism (safety valve) Combating cardiotoxicity: Toad toxins have a cardiotonic glycoside-like effect, and excessive amounts can lead to arrhythmia or even cardiac arrest. Glycyrrhizic acid and its hydrolysis product glycyrrhetinic acid in licorice have corticosteroid-like effects, which can combat arrhythmia and protect myocardial cells, forming the first "safety line of defense".

[0030] Counteracting gastrointestinal reactions: Toads are highly irritating and can easily cause vomiting. Licorice and dandelion can protect the gastric mucosa, reduce the incidence of nausea and vomiting, and improve patients' medication compliance.

[0031] Solvent extraction equilibrium: High-proof liquor (60-65 degrees) can effectively extract fat-soluble anti-tumor components, while dissolving the effective components of licorice and Vaccaria segetalis. Under the combined action of alcohol and glycyrrhizic acid, the highly toxic toad venom undergoes partial degradation or transformation, reducing its toxicity while preserving its anti-tumor activity.

[0032] III. Targeting Principles for Specific Cancers Breast cancer: Traditional Chinese medicine believes it is mostly caused by liver qi stagnation; The formula contains Wang Bu Liu Xing, which enters the liver meridian to invigorate blood circulation; Pu Gong Ying, which enters the liver and stomach meridians to clear heat and detoxify; and Chan Toad, which reduces swelling and dissipates nodules. The three ingredients work together to target the mammary gland meridians.

[0033] Liver cancer: The liver governs the free flow of Qi. Toad enters the liver meridian, and when combined with dandelion to clear liver heat, and vaccaria seed to resolve liver stasis, and white wine to guide the medicine into the blood, it has a targeted effect on liver tumors and ascites due to cirrhosis.

[0034] Colon cancer: The six internal organs function by ensuring unobstructed flow; Toads can detoxify and clear stagnation, relieving intestinal obstruction; Wang Bu Liu Xing (Semen Vaccariae) invigorates blood circulation and improves intestinal wall circulation; and licorice harmonizes and reduces irritation to the intestinal mucosa.

[0035] In this embodiment, specifically, three healthy live Chinese toads (each weighing about 220g) are placed in clean water for three days, with the water changed daily to encourage them to excrete their feces.

[0036] After removing the toad, rinse its body surface repeatedly with warm water. Place the whole toad (including meat, liver, skin, and head) into a 5L glass bottle, add 30g of licorice root, 30g of Vaccaria segetalis, and 15g of dandelion, pour in 4500-5000ml of 60-65 degree pure grain liquor, seal the bottle, and then steam it.

[0037] Safety control and toxicity avoidance programs Pretreatment: Emptying the feed container and cleaning the surface.

[0038] Licorice neutralization: Glycyrrhetinic acid in licorice has hormone-like effects and can counteract arrhythmias caused by toad toxins.

[0039] Dosage restrictions: A maximum daily dose is set. Clinical trials have shown that a single dose of 50ml can cause symptoms such as sinus bradycardia and vomiting in patients. Therefore, the safe dose is strictly controlled at 10-20ml / day.

[0040] Example 2 This invention provides a method for preparing a broad-spectrum anticancer drug composition containing whole toad components, which can also be achieved through the following steps: 1. Each toad weighs 200-300 grams, requiring 3 toads, 30-40g of licorice root, 30-45g of Vaccaria segetalis, 10-20g of dandelion, and 4500ml-5000ml of high-proof pure grain liquor (60%-65% vol). 2. After that, put water in a large iron pot and steam it. Place a steaming rack on the water, and then place a porcelain pot on the steaming rack. Put the toad, Chinese medicine and white wine into the porcelain pot. Use steam to heat the porcelain pot. After the water boils for 45-50 minutes, about 1200-1300ml of medicinal wine will remain. Filter the toad and medicine residue and store it at low temperature. 3. Take 5-15ml daily. For first-time users, start with 5ml to avoid adverse reactions and gradually increase to 10ml over 7 days. Severe cases can take 15ml. In addition to its inhibitory effect on cancer, it also has a therapeutic effect. There are cases of complete cure of liver cancer cell tumors the size of a bean.

[0041] In this embodiment, specifically, multiple patients with breast cancer and colon cancer metastasis experienced varying degrees of reduction or cessation of cancer cell development after taking the medicine, effectively prolonging the quality of life and lifespan of cancer patients. The longest-serving patient to take this medicine was a breast cancer patient who took it for 7 years, during which cancer cells that had spread to the liver were eliminated and cancer cells that had spread to the spine stopped developing.

[0042] In this embodiment, specifically, Experiment 1: In vitro antitumor activity assay (MTT method) Experimental methods: Human breast cancer cells (MCF-7), human colon cancer cells (HCT-116), human liver cancer cells, and normal human liver cells (LO2) in logarithmic growth phase were seeded in 96-well plates.

[0043] A blank control group, a positive control group (5-Fu injection), and low, medium, and high dose groups of the drug of this invention were set up.

[0044] After 48 hours of culture, absorbance (OD value) was measured, and cell inhibition rate and half-maximal inhibitory concentration (IC50) were calculated.

[0045] Table 1: Inhibitory effect of the pharmaceutical composition of the present invention on in vitro cultured tumor cells (n=6) As shown in Table 1, the pharmaceutical composition of the present invention exhibits significant inhibitory effects on the proliferation of all three types of cancer cells in a dose-dependent manner. Notably, its damage to normal hepatocytes (LO2) is significantly lower than that to tumor cells, indicating that it has a certain degree of target selectivity, which is superior to the traditional chemotherapy drug 5-FU.

[0046] Cell lines and concentration gradients: Three common solid tumor cell lines—breast cancer (MCF-7), colon cancer (HCT-116), and liver cancer (HepG2)—as well as normal hepatocytes (LO2) were selected as controls. Three concentration gradients of 25 μg / mL, 50 μg / mL, and 100 μg / mL were set up to cover low, medium, and high dose ranges, reflecting the dose-response relationship. Inhibition rate and IC50: The inhibition rate is expressed as "mean ± standard deviation" (n=6), and the IC50 is the half-maximal inhibitory concentration (calculated by fitting the concentration-inhibition rate curve). The smaller the value, the stronger the drug's ability to kill tumor cells. Positive control and statistical difference: Compared with commonly used clinical chemotherapy drugs (such as 5-fluorouracil), the drug composition of the present invention showed a significant statistical difference in the inhibition rate of tumor cells (P<0.05 or P<0.01), proving its anti-tumor activity; Safety in normal cells: At a high concentration of 100 μg / mL, the inhibition rate against normal hepatocytes (LO2) was only 12.5%, with an IC50 > 500 μg / mL, which is much higher than the IC50 value of tumor cells, indicating that the drug has extremely low toxicity to normal cells and good selectivity.

[0047] Experiment 2: In vivo tumor growth inhibition and anti-metastasis experiment (mouse model) Experimental methods: H22 hepatocellular carcinoma-bearing mouse model and CT26 colon cancer lung metastasis model were established. The tumor-bearing mice were randomly divided into model group (physiological saline), positive control group (cyclophosphamide CTX), low-dose group of the present invention (5ml / kg), and high-dose group of the present invention (10ml / kg).

[0048] After 21 days of continuous oral administration, the tumor was removed and weighed after sacrifice, and the tumor inhibition rate was calculated; lung metastasis nodules were counted in the lung metastasis model.

[0049] Table 2: Effects of the pharmaceutical composition of the present invention on the growth of H22 hepatocellular carcinoma xenografts (n=10, ) Note: Compared with the model group, *P<0.05, **P<0.01 Table 2 shows that the tumor inhibition rate of the high-dose group of the present invention reached 62.1%, which is comparable to the effect of the chemotherapy drug CTX.

[0050] The key difference is that mice in the CTX group experienced weight loss and spleen atrophy (decreased immunity), while mice in the drug group of this invention experienced weight gain and spleen index increase, indicating that the drug composition can significantly improve the body's immune function while inhibiting tumors, with fewer side effects.

[0051] Table 3: Inhibitory effect on the CT26 colon cancer lung metastasis model (n=8) The data in Table 3 strongly support the claim of this invention to "inhibit the spread of cancer cells." The high-dose group showed a significant reduction in lung metastatic nodules, confirming that the drug composition has anti-metastatic activity.

[0052] Experiment 3: Clinical observation data (breast cancer, colon cancer, liver cancer) Case data: 45 patients with intermediate and advanced cancer diagnosed by pathology between 2018 and 2022 were selected, including 15 cases of breast cancer, 15 cases of colon cancer and 15 cases of liver cancer. All patients gave up or could not tolerate chemotherapy and voluntarily took the medicinal wine of this invention.

[0053] Treatment plan: Take the medicinal wine prepared in Example 1 of this invention orally, 10ml once a day after meals, for 3 months as one course of treatment.

[0054] Efficacy evaluation criteria: Complete remission (CR): The tumor completely disappears and is maintained for more than 4 weeks.

[0055] Partial remission (PR): The total maximum diameter of the tumor is reduced by ≥30%.

[0056] Stable (SD): Tumor shrinkage does not reach PR or increase does not reach PD.

[0057] Progression (PD): The total maximum diameter of the tumor increases by ≥20% or new lesions appear.

[0058] Table 4: Statistical Table of Clinical Efficacy Observation (n=45) Clinical data show that the pharmaceutical composition of this invention has a good control effect on breast cancer, colon cancer and liver cancer, with an overall disease control rate (DCR) as high as 82.2%, which confirms its application value of "broad-spectrum anti-cancer".

[0059] Experiment 4: Safety and Toxicity Control Verification Experimental Methods: To verify the scientific validity of the "licorice compatibility for toxicity reduction" and the "upper limit of dosage," an acute toxicity experiment was conducted on mice. Mice were divided into a whole toad wine group (without licorice) and a whole formula group of this invention (containing licorice), and mortality was observed over 7 days.

[0060] Table 5: Results of Acute Toxicity Tests (LD50 Determination) Table 5 demonstrates that the addition of licorice significantly increased the median lethal dose (LD50) of the drug (P<0.01) and reduced toxicity by approximately 2.7 times. This provides a very large safety window for the clinically safe oral dose (10-20 ml / day), strongly supporting the claims regarding safety compatibility in the claims.

[0061] In this embodiment, specifically, Human tolerability clinical trials 1. Experimental Design: Single-dose escalation trial Experimental objective: To explore the maximum tolerated dose (MTD) of a single dose of medicinal wine containing whole toad ingredients in humans and to determine the safety window.

[0062] Subjects: A total of 30 healthy volunteers aged 18-65 years with normal body mass index and early-stage cancer patients were selected and divided into 6 dose groups, with 5 people in each group.

[0063] Dosage regimen: Subjects were given a single oral dose of the medicinal wine of this invention on an empty stomach or 2 hours after a meal, and adverse reactions were observed within 24 hours.

[0064] 2. Experimental data recording (supporting the establishment of the upper limit of the dose) The table below details the incidence and specific symptoms of adverse reactions in subjects of different dosage groups. This data directly supports the dosage limits set in the claims: Table 6: Results of human tolerance observation of different doses of medicinal wine after a single oral administration (n=5 / group) 3. Key Data Analysis and Supporting Logic ① Data supporting the claim that "a single dose of 50ml causes a toxic reaction": According to the data in Table 6, when the single oral dose reaches 50ml, the incidence of adverse reactions reaches 100% (5 / 5).

[0065] Gastrointestinal toxicity: All subjects experienced severe vomiting, which is due to the strong emetic effect of bufotoxin (toad venom) stimulating the chemoreceptor zone in the medulla oblongata.

[0066] Cardiotoxicity: Electrocardiogram monitoring showed that all subjects in the 50ml group had sinus bradycardia, with heart rates generally below 50 beats / min, accompanied by premature ventricular contractions. This is a typical manifestation of cardiac conduction block caused by excessive cardiac glycosides in toad toxins.

[0067] Supporting conclusion: A single dose of 50ml can cause symptoms such as sinus bradycardia and vomiting in patients, confirming that this dose has entered the toxic zone and its use is strictly prohibited.

[0068] ② Data supporting the statement that "the safe dosage is strictly controlled within 10-20ml": According to the data in Table 6: 10ml group: No adverse reactions were reported, and electrocardiograms were normal, proving that the dosage was completely within the safe range and suitable for long-term use.

[0069] 20ml group: Only mild dizziness occurred (1 case), which was transient and could be relieved on its own without special treatment. No pathological changes were found on the electrocardiogram. Although this dose is the upper limit of safety, it is set as the upper limit of the therapeutic dose considering the risk of accumulation with long-term use.

[0070] 30ml group: Although no serious dangers occurred, the adverse reaction rate increased to 60%, and slight changes in electrocardiogram were observed. Therefore, 30ml was set as the maximum daily dose and an absolute red line for clinical use.

[0071] ④ Safety verification for long-term use (supporting the feasibility of "long-term use") To further verify the safety of the "10-20ml / day" regimen in long-term anticancer treatment, a continuous dosing observation was conducted for 3 months.

[0072] Table 7: Cumulative toxicity monitoring of long-term use (10-20 ml / day) (n=20) The above experimental data fully demonstrate that the medicinal wine of the present invention has a clear therapeutic window, and a single dose of 50ml is a toxic dose, which can lead to severe cardiac and gastrointestinal toxicity. A daily dose of 10-20 ml not only does not produce cumulative toxicity, but also ensures that the active ingredients of the drug maintain a steady concentration in the blood, thereby achieving the therapeutic goal of "inhibiting diffusion and gradually restoring".

[0073] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the technical scope disclosed in the present invention, and these should all be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A broad-spectrum anticancer drug composition containing whole toad components, characterized in that, The pharmaceutical composition is prepared from the following parts by weight of active pharmaceutical ingredient: Three live toads, weighing a total of 700g-900g; 4500ml-5000ml of high-proof pure grain liquor; 30-40g of licorice root; 30-45g of Vaccaria segetalis; and 10-20g of dandelion. The live toad refers to an individual weighing over 200g, and includes all components including toad meat, liver, toad skin, and head.

2. The broad-spectrum anticancer drug composition containing whole toad components according to claim 1, characterized in that, The preferred weight proportions of the active pharmaceutical ingredient are: 700-900g of live toad, 4500ml of high-proof pure grain liquor, 30g of licorice root, 30g of Vaccaria segetalis, and 15g of dandelion; The alcohol content of the high-purity grain liquor is 60%-65% vol.

3. The broad-spectrum anticancer drug composition containing whole toad components according to claim 1 or 2, characterized in that, The dosage form of the pharmaceutical composition is an oral medicinal wine.

4. A method for preparing a broad-spectrum anticancer drug composition containing whole toad components as described in any one of claims 1-3, characterized in that, Includes the following steps: S1. Select 3 live toads weighing over 200g, place them in clean water and fast them for 48-72 hours to allow them to empty their gastrointestinal contents; Then remove it, gently remove the surface dirt, no dissection is required, keep the toad meat, liver, skin, head and whole body intact, and drain the water; S2. Place the processed whole toad at the bottom of a clean ceramic or glass container, add licorice, Wangbuliuxing, and dandelion, then pour in high-proof pure grain liquor, steam and boil, and then put it into a sealed container. S3. Filter and separate the wine and the dregs and take them. The resulting wine is a broad-spectrum anti-cancer medicinal wine with all toad components. S4. Store the sealed container in a cool, dark place at room temperature. It is valid for one year. The container should be shaken once every 7 days to promote the dissolution of active ingredients and the conversion or neutralization of toxic components.

5. The use of a pharmaceutical composition according to any one of claims 1-3 in the preparation of a drug for treating breast cancer, colon cancer, liver cancer, and inhibiting the spread of cancer cells.

6. The application according to claim 5, characterized in that, The oral dosage of the drug composition is 5-15 ml per day. The initial dose is 5 ml, and to avoid adverse reactions, the dose is gradually increased to 10 ml over 7 days. Severe cases can take 15 ml once a day, half an hour after dinner. It does not irritate the stomach and intestines. Each course of treatment is 30 days, and more than 3 courses of treatment are required to observe the tumor-suppressing effect.

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