Composition for securing metal and removing food retention as well as preparation method and application of composition

Abstract

The invention relates to the technical field of tumor drugs. The invention provides a composition for securing metal and removing food retention as well as a preparation method and application thereof. The composition comprises the following raw materials in parts by weight: 20-28 parts of astragalus membranaceus, 20-28 parts of codonopsis pilosula, 13-17 parts of radix glehniae, 13-17 parts of radix ophiopogonis, 28-32 parts of oldenlandia diffusa, 28-32 parts of sculellaria barbata, 13-17 parts of thunberg fritillary bulb, 10-14 parts of ginger processed pinellia, 28-32 parts of trichosanthes kirilowii maxim and 10-14 parts of vinegar-processed schisandra chinensis. The composition for securing metal and removing food retention can effectively inhibit the growth of tumor cells, and can also be used for being matched with therapeutic drugs such as chemotherapy, so that the toxic and side effects generated by the chemotherapy drugs are reduced. The self immunity is improved while the pain of the patient is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of tumor drugs, and in particular to a gold-solidifying and accumulation-eliminating composition and a preparation method and application thereof. Background Art

[0002] Tumors are tumors formed when a cell in a local tissue loses normal regulation of its growth at the genetic level or metabolic level under the action of various carcinogenic factors, leading to abnormal clonal proliferation. Tumors are divided into benign tumors and malignant tumors. Due to the complex pathogenesis of tumors, they have become an important issue that seriously threatens human health. At present, the treatment of tumors is divided into surgical treatment, radiotherapy, chemotherapy, Chinese medicine intervention treatment, targeted therapy, immunotherapy and gene therapy, and each treatment method has its advantages and disadvantages.

[0003] Traditional Chinese medicine is a powerful weapon used by traditional Chinese medicine to prevent and treat diseases. Traditional Chinese medicine has a good effect in treating malignant tumors, whether in alleviating clinical symptoms, improving quality of life, preventing recurrence and metastasis, prolonging survival, or in coordinating with radiotherapy and chemotherapy to increase efficacy and reduce toxicity. Therefore, it is particularly important to further develop and utilize traditional Chinese medicine formulas to promote the development of traditional Chinese medicine. Summary of the invention

[0004] The purpose of the present invention is to provide a Guruxiaojin composition and its preparation method and application, so as to inhibit tumor cells, reduce the toxic and side effects of chemotherapy, and improve one's own immunity.

[0005] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0006] The invention provides a gold-solidifying and accumulation-eliminating composition, which comprises the following raw materials in parts by weight: 20-28 parts of astragalus, 20-28 parts of codonopsis, 13-17 parts of adenophora, 13-17 parts of ophiopogon, 28-32 parts of oldenlandia diffusa, 28-32 parts of scutellaria barbata, 13-17 parts of fritillaria thunbergii, 10-14 parts of pinellia ternata, 28-32 parts of trichosanthes, and 10-14 parts of vinegar schisandra.

[0007] Preferably, the composition comprises the following raw materials in parts by weight: 22-26 parts of Astragalus, 22-26 parts of Codonopsis, 14-16 parts of Glehnia littoralis, 14-16 parts of Ophiopogon japonicus, 29-31 parts of Oldenlandia diffusa, 29-31 parts of Scutellaria barbata, 14-16 parts of Fritillaria thunbergii, 11-13 parts of Pinellia ternata, 29-31 parts of Trichosanthes kirilowii, and 11-13 parts of Schisandra chinensis with vinegar.

[0008] Preferably, the composition comprises the following raw materials in parts by weight: 24 parts of Astragalus, 24 parts of Codonopsis, 15 parts of Adenophora, 15 parts of Ophiopogon, 30 parts of Oldenlandia Diffusa, 30 parts of Scutellaria Barbata, 15 parts of Fritillaria Thunbergii, 12 parts of Pinellia Rhizome, 30 parts of Trichosanthes, and 12 parts of Schisandrae Chinensis.

[0009] The present invention also provides a method for preparing the solid gold and detoxification composition, comprising the following steps:

[0010] (1) Weighing astragalus, codonopsis, glossophore, ophiopogon, oldenlandia diffusa, scutellaria barbata, fritillaria thunbergii, pinellia tuber, trichosanthes and vinegar schisandra chinensis according to proportion to obtain a mixture;

[0011] (2) soaking the mixture in water and then boiling it, filtering it to obtain a filtrate 1 and a filter residue;

[0012] (3) adding water to the filter residue and boiling it twice, and filtering to obtain filtrate 2;

[0013] (4) Mix the filtrate 1 and the filtrate 2, and concentrate them into an extract to obtain the Chinese medicine composition.

[0014] Preferably, in step (2), the mass ratio of the mixture to water is 1:8-12, the soaking time is 2-3 hours, and the decoction time is 25-35 minutes.

[0015] Preferably, in step (3), the mass ratio of the filter residue to water is 1:3-5, and the time for the secondary decoction is 10-15 min.

[0016] Preferably, the concentration in step (4) is carried out under reduced pressure, the temperature of the reduced pressure concentration is 60-64°C, and the relative density of the extract is 1.18-1.22 g / cm 3 .

[0017] The present invention also provides application of the Gujinxiaoji composition in preparing anti-tumor drugs.

[0018] The present invention also provides an anti-tumor medicine, which contains the Gujinxiaoji composition.

[0019] Preferably, the dosage form of the drug is a mixture.

[0020] The present invention provides a gold-solidifying and detoxifying composition and a preparation method and application thereof. The composition comprises the following raw materials in parts by weight: 20-28 parts of Astragalus, 20-28 parts of Codonopsis, 13-17 parts of Adenophora australis, 13-17 parts of Radix Ophiopogonis, 28-32 parts of Hedyotis diffusa, 28-32 parts of Scutellaria barbata, 13-17 parts of Fritillaria thunbergii, 10-14 parts of Pinellia ternata, 28-32 parts of Trichosanthes, and 10-14 parts of Schisandrae Chinensis. The gold-solidifying and detoxifying composition of the present invention can effectively inhibit the growth of tumor cells, and can also be used as a combination drug for chemotherapy, thereby reducing the toxic and side effects of chemotherapy. While reducing the pain of patients, their own immunity is improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1The complete biochemical test results of the patient in Example 1 on June 13, 2023;

[0022] Figure 2 The lung cancer tumor marker test results of the patient in Example 1 on July 5, 2023;

[0023] Figure 3 The complete biochemical test results of the patient in Example 1 on July 25, 2023;

[0024] Figure 4 The lung cancer tumor marker test results of the patient in Example 1 on July 25, 2023;

[0025] Figure 5 The imaging test results of the patient in Example 1 on July 25, 2023;

[0026] Figure 6 The imaging test results of the patient in Example 1 on September 7, 2023;

[0027] Figure 7 The complete biochemical test results of the patient in Example 2 on August 25, 2023;

[0028] Figure 8 The complete biochemical test results of the patient in Example 2 on October 13, 2023;

[0029] Fig. 9 The lung cancer tumor marker test results of the patient in Example 2 on October 13, 2023;

[0030] Fig.10 The imaging test results of the patient in Example 2 on November 23, 2023;

[0031] Fig.11 The lung cancer tumor marker test results of the patient in Example 2 on January 10, 2024;

[0032] Fig.12 These are the imaging test results of the patient in Example 2 on February 20, 2024. DETAILED DESCRIPTION

[0033] The invention provides a gold-solidifying and accumulation-eliminating composition, which comprises the following raw materials in parts by weight: 20-28 parts of astragalus, 20-28 parts of codonopsis, 13-17 parts of adenophora, 13-17 parts of ophiopogon, 28-32 parts of oldenlandia diffusa, 28-32 parts of scutellaria barbata, 13-17 parts of fritillaria thunbergii, 10-14 parts of pinellia ternata, 28-32 parts of trichosanthes, and 10-14 parts of vinegar schisandra.

[0034] In the present invention, the composition preferably includes the following raw materials in parts by weight: 22-26 parts of Astragalus, 22-26 parts of Codonopsis, 14-16 parts of Adenophora, 14-16 parts of Ophiopogon, 29-31 parts of Oldenlandia Diffusa, 29-31 parts of Scutellaria barbata, 14-16 parts of Fritillaria thunbergii, 11-13 parts of Pinellia ternata, 29-31 parts of Trichosanthes, and 11-13 parts of Schisandra chinensis.

[0035] In the present invention, the composition preferably includes the following raw materials in parts by weight: 24 parts of Astragalus, 24 parts of Codonopsis, 15 parts of Adenophora, 15 parts of Ophiopogon, 30 parts of Oldenlandia Diffusa, 30 parts of Scutellaria Barbata, 15 parts of Fritillaria Thunbergii, 2 parts of Pinellia Rhizome, 30 parts of Trichosanthes, and 12 parts of Schisandrae Chinensis.

[0036] Prescription composition

[0037] The basic pathogenesis of lung cancer is deficiency of vital energy and yin deficiency and toxicity. The treatment should be to strengthen the body, eliminate lumps and disperse stagnation. Gujin Xiaoji mixture is specially prepared, which has remarkable effect. Gujin Xiaoji mixture is suitable for primary lung cancer of vital energy deficiency, yin deficiency and toxicity type before surgery or when surgery is not suitable. It is composed of raw astragalus, codonopsis, ophiopogon, pinellia, northern adenophora, white flower oldenlandia, barbata, thunbergia, trichosanthes, and schisandra, and the auxiliary materials are stevioside and ethylparaben.

[0038] Gujinxiaoji mixture is made by adding or subtracting Maimendong decoction in "Jingui Yaolue". Huangqi in the prescription is sweet and slightly warm, and it belongs to the lung and spleen meridians, replenishing qi and strengthening the exterior, supporting sores and promoting tissue regeneration. Codonopsis is neutral in nature and sweet in taste, and it belongs to the spleen and lung meridians, replenishing spleen and lung qi, nourishing yin and producing fluid. "Ben Cao Zhengyi" says: "Dangshen can replenish spleen and stomach, moisten lung and produce fluid, and strengthen the middle qi, which is not far from ginseng. What is particularly valuable is that it can strengthen spleen and move without being dry, nourish stomach yin without being wet, moisten lung without being cold, nourish blood without being greasy, invigorate clear yang, and vibrate the middle qi without being rigid and dry." Huangqi and Codonopsis are combined to play the role of tonifying lung and spleen, replenishing qi and nourishing yin, and helping the source of qi and blood biochemical transformation. Ophiopogon is slightly cold in nature, sweet and slightly bitter in taste, and it belongs to the heart, lung and stomach meridians, nourishing yin and producing fluid, moistening lung and clearing heart. Pinellia is pungent, warm, and toxic. It enters the spleen, stomach, and lung meridians, dries dampness and resolves phlegm, relieves adverse reactions and stops vomiting, and eliminates lumps and resolves knots. Adenophora scabra is sweet, slightly bitter, and slightly cold in nature. It enters the lung and stomach meridians, nourishes yin and clears heat, benefits the stomach and produces fluid. The "New Compendium of Materia Medica" says that it "specially replenishes lung yin and clears lung fire." Hedyotis diffusa is cold in nature, slightly bitter, and sweet. It enters the stomach, large intestine, and small intestine meridians, clears heat and detoxifies, and is diuretic and relieves stranguria. Hedyotis diffusa was first recorded in the "Guangxi Chinese Materia Medica Records". Its main effects are clearing heat and removing dampness, detoxifying and eliminating carbuncle. "It is mainly used to treat carbuncle, sore, and ulcer... gastric cancer, esophageal cancer, rectal cancer, and other cancers." "Hubei Chinese Herbal Medicine Records" "clears heat and detoxifies, fights cancer and reduces swelling. It is used for cancer, etc." Scutellaria barbata is pungent, bitter, and cold in nature. It enters the lung, liver, and kidney meridians, clears heat and detoxifies, disperses blood stasis and stops bleeding, and is diuretic and reduces swelling. Chengdu's "Common Herbal Treatment Manual" states: "It treats esophageal cancer, gastric cancer, and uterine cancer." Trichosanthes is pungent, cold and slightly toxic. It enters the liver, stomach and spleen meridians, clears away heat and detoxifies, and reduces swelling and resolves nodules. "Bencao Shiyi" says: "It is used to treat carbuncle, sore, fistula, scrofula, tuberculosis, etc. Grind it with vinegar and apply it to remove acne. "Tzhe Fritillaria thunbergii" is bitter and cold. It enters the lung and heart meridians, clears away heat and resolves phlegm, resolves nodules and eliminates carbuncle. "Ben Jing Feng Yuan" says: "It is used with Indigo to treat facial ulcers, and with Forsythia suspensa to treat tuberculosis on the neck. They are all used for their functions of relieving depression, resolving nodules, and resolving phlegm and detoxifying." Trichosanthes kirilowii is sweet, slightly bitter, and cold in nature. It enters the lung, stomach and large intestine meridians, clears away heat and resolves phlegm, relieves chest tightness and resolves nodules, moisturizes and lubricates the intestines. Schisandra chinensis is warm, sour, and sweet in nature. It is astringent and astringent, replenishes qi and produces body fluid, and nourishes the kidney and calms the mind. The whole prescription uses the five methods of promoting, clearing, moistening, supplementing and descending. Supplementing is the main and secondary, clearing and dispersing are the auxiliary. It is sweet and slow in harmonizing, and it supplements both Qi and Yin, nourishes the earth and produces metal. The prescription is rigorous, which together have the effects of invigorating Qi and strengthening the foundation, eliminating lumps and dispersing accumulations.

[0039] Modern pharmacological analysis

[0040] Astragalus: It is the root of Astragalus mongolica or Astragalus membranaceus, a plant of the genus Astragalus in the Leguminosae family. It has the effects of strengthening the spleen and replenishing the middle, raising yang and lifting the sunken, strengthening the body's defense system and strengthening the exterior, promoting diuresis, and removing toxins and promoting muscle regeneration. Its main components are astragalus polysaccharides, astragalus total flavonoids, and astragaloside IV, which have the effects of regulating immunity, anti-tumor, anti-oxidative stress, and improving metabolism, maintaining the body's immune balance environment from damage caused by external stimuli. Astragalus polysaccharides extracted from astragalus are considered to be one of the effective anti-tumor ingredients. Jia Beitian et al. [1] found that astragalus polysaccharides can promote the expression of CD80 and CD86 molecules on the surface of dendritic cells and the secretion of cytokines IL-12 and p-70, thereby activating T cells to secrete IL-2 and exerting an anti-tumor effect. Other studies have found [2] that astragalus polysaccharides can improve the body's immune function, target and regulate cytokines and the extracellular matrix of the tumor microenvironment, inhibit the inflammatory response of the tumor microenvironment, induce cell apoptosis, reverse chemotherapy resistance, and achieve tumor inhibition.

[0041] Codonopsis: It is the dried root of Codonopsis pilosula, Codonopsis pilosula, or Codonopsis pilosula of the Campanulaceae family. It tastes sweet and is neutral in nature. It has the effects of tonifying the middle qi, quenching thirst, strengthening the spleen and lungs, nourishing blood and promoting the production of body fluids. It contains polysaccharides, phenols, sterols, volatile oils, saponins, and trace alkaloids. It has multiple pharmacological effects such as immunomodulation, improvement of gastric ulcers, anti-inflammatory, antioxidant, regulation of glucose and lipid metabolism, and anti-tumor. Yang Zihao et al. [3] found that Codonopsis pilosula polysaccharides can effectively inhibit the proliferation of gastric cancer cells, induce cell apoptosis, and inhibit the secretion of pro-inflammatory factors. The mechanism may be related to the regulation of the miR-361-5p / TLR4 / NF-κB pathway. Liu Yunhe et al. [4] found that Codonopsis pilosula polysaccharides inhibited the growth and motility of liver cancer HepG2 cells by inhibiting the PI3K / AKT signaling pathway. Experimental research by Xu Peng et al. [5] found that Codonopsis pilosula polysaccharide (CPP) can promote the secretion of C3, C4, IgG, IgM, and IgA, the synthesis of GH, INS, and IGF-1, and the synthesis and decomposition of T3 and T4, thereby enhancing immune function.

[0042] Ophiopogon japonicus: The dried root of Ophiopogon japonicus (Ophiopogon japonicus) of the Liliaceae family has the effects of nourishing yin, promoting body fluid, moistening the lungs and relieving cough. It contains steroidal saponins, isoflavones, polysaccharides, amino acids and other ingredients, and has pharmacological effects such as protecting cardiovascular, lowering blood sugar and lipids, anti-inflammatory, antioxidant, anti-tumor, anti-aging and immunomodulatory. In an in vitro cell experiment established by Wang Yilei et al. [6], it was found that the mechanism of action of Ophiopogon japonicus saponin B extracted from Ophiopogon japonicus in inhibiting the proliferation of A549 cells may be related to inhibiting the antioxidant pathway Nrf2 / HO-1, destroying the antioxidant system of A549 cells, and promoting cell ferroptosis. Kang Zhenchao et al. [7] found that Ophiopogon japonicus saponin D can inhibit the immune escape of gastric cancer HGC-27 cells induced by lipopolysaccharide, which may be through upregulating the expression of miR-448 in cells and then inhibiting the expression of TLR4. Xu Qiuju et al. [8] found that Ophiopogon japonicus saponin B acts on human cervical cancer HeLa cells, inhibiting the phosphorylation of AKT, mTOR and p70S6K, and increasing the level of PTEN. Make it produce autophagy.

[0043] Pinellia: The active ingredients include pinellia alkaloids, polysaccharides, stigmasterol, baicalin, baicalin, etc., which have pharmacological effects such as protecting cardiovascular, lowering blood sugar and lipids, anti-inflammatory, antioxidant, anti-tumor, anti-aging and immunomodulatory. Studies [9] have found that pinellia polysaccharides can significantly increase the activity of superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) enzymes in mouse serum, reduce malondialdehyde (MDA) levels, and inhibit the proliferation of tumor cells. Zhang Ci'an et al.

[10] inhibited the expression of V-ATPase and sodium hydrogen exchange protein 1 (NHE1), and reversed the intracellular alkaline and external acid microenvironment.

[0044] Glehnia littoralis: It is the root of the Umbelliferae plant Coralleaf. It has the effects of nourishing yin, clearing the lungs, removing phlegm and relieving cough. Its main components include polysaccharides, coumarins, polyacetylenes, lignans, phenolic acids, etc. It has multiple pharmacological activities such as immunomodulation, anti-tumor, antioxidant, and anti-inflammatory. Wang Zhenfei et al.

[11] found that Glehnia littoralis acts on lung cancer cells, inhibiting the migration and infiltration of lung cancer cells by increasing the synthesis and secretion of TIMP2 in lung cancer cells. Dong Fang et al.

[12] found that the active ingredient bergamot lactone extracted from Glehnia littoralis can effectively inhibit the growth of gastric cancer cells and induce cell apoptosis, with the most significant effect at a concentration of 100 mg·L-1.

[0045] Hedyotis diffusa: The whole herb of Hedyotis diffusa of the Rubiaceae family. It is used for lung heat, cough, sore throat, intestinal carbuncle, furuncle, snake bite, hot and painful stranguria, edema, dysentery, enteritis, damp-heat jaundice, and cancer. It mainly contains cyclopentadiene ether terpenes, flavonoids, anthraquinones, polysaccharides, and organic acids, and has pharmacological effects such as anti-tumor, anti-inflammatory, antioxidant activity, and immunomodulation. Wang Ting et al.

[13] found that the chloroform and ethyl acetate extracts of Hedyotis diffusa showed good inhibitory effects on A549 cell proliferation. Wang Zengxiu et al.

[14] found that 2-hydroxy-3-methylanthraquinone, the active ingredient of Hedyotis diffusa, can block the signal transduction pathway related to IL-6, thereby inhibiting the growth of human hepatocellular carcinoma cells. Zhou Linshui et al.

[15] found that Hedyotis diffusa can inhibit the PI3K / Akt pathway to inhibit the proliferation of EGFR-TKIs-resistant A549 cells, leading to the blockade of the G0 / G1 phase of A549 cells and promoting the apoptosis of A549 cells.

[0046] Scutellaria barbata: The dried whole herb of Scutellaria barbata, a plant of the Lamiaceae family. It is used to treat boils, sore throat, injuries from falls, edema, jaundice, and snake and insect bites. It contains a variety of anti-tumor active ingredients such as flavonoids, polysaccharides, and diterpenes. Modern pharmacology has confirmed that it can be used to treat a variety of cancers. Yuan Wenting et al.

[16] conducted an experimental study and found that the expression of PI3K, Akt, and mTOR proteins in pancreatic cancer rats treated with Scutellaria barbata extract was significantly reduced compared with the blank control group, indicating that Scutellaria barbata extract promoted pancreatic cancer cell apoptosis by regulating the PI3K / Akt signaling pathway. Fan Yanyan et al.

[17] found that the components of the Herba Hedyotis diffusae-Scutellaria barbata drug pair could inhibit the proliferation of gastric cancer SGC-7901 cells, and the mechanism of inducing tumor cell apoptosis was related to the activation of mitochondrial autophagy and the activation of the mitochondrial apoptosis signaling pathway. Ding Hong et al.

[18] found that Scutellaria barbata extract could significantly induce the activation of STAT3 signaling, reduce the expression of SKP2, and inhibit cell proliferation.

[0047] Trichosanthes: It is the fruit of the plant Trichosanthes kirilowii of the Cucurbitaceae family. It has the effects of clearing away heat and removing phlegm, relieving chest tightness and dispersing stagnation, and moistening the intestines. The main components are triterpenoid saponins, and it also contains volatile oils, sterols, flavonoids, organic acids, amino acids, trace elements, etc. Trichosanthes protein extracted from its root tuber is a natural and effective Chinese medicine extract that is widely used in clinical treatment. Zhuang Jing et al.

[19] found that trichosanthes protein can induce apoptosis and inhibit proliferation of A549 cells. The mechanism is that the dynamic balance between disaggregation and aggregation of lung adenocarcinoma A549 cells changes, and the cytoskeleton microtubule structure is changed, which is drug concentration and treatment time dependent. Another study

[20] confirmed that trichosanthes protein can activate the C-Jun amino-terminal kinase (JNK) signal transduction pathway and downregulate the expression of Bcl-2 protein, which will induce apoptosis in A549 lung cancer cells. In an in vitro cell experiment established by Deng Xinyan et al.

[21] , it was found that trichosanthes protein can downregulate Caspase-9, Caspase-3 and PARP proteins, thereby inducing apoptosis of gastric cancer cells. It is speculated that its mechanism may be related to the activation of the EKT signaling pathway.

[0048] Fritillaria thunbergii: It is the dried bulb of Fritillaria thunbergii, a plant of the Liliaceae family. It has the effects of clearing away heat, resolving phlegm and relieving cough, detoxifying, dispersing nodules and eliminating carbuncle. It includes alkaloids, polysaccharides, total saponins, flavonoid components and volatile components, and has the functions of relieving cough, removing phlegm and relieving asthma, analgesic and anti-inflammatory, anti-ulcer, antioxidant, anti-tumor and reversing tumor cell resistance. Tang Guangyi et al.

[22] used Western blotting to detect the effect of anti-cancer Chinese medicine based on Fritillaria thunbergii on the subcutaneous transplanted tumor model of human colorectal cancer cells HT-29 in nude mice and found that it can significantly inhibit PKC and PKC in colorectal cancer tissue and promote PKC protein, and has a good inhibitory effect on colorectal cancer. Li Dongyun et al.

[23] detected the effects of compound Fritillaria thunbergii drug serum on the proliferation and apoptosis of mouse lymphocyte line (L1210 / CDDP) and found that different doses of compound Fritillaria thunbergii granules containing drug serum groups all had the effect of inhibiting L1210 / CDDP cell proliferation and promoting cell apoptosis, and the promotion was dose-dependent.

[0049] Schisandra chinensis: It is the dried mature fruit of the Magnoliaceae plant Schisandra chinensis. It has the effects of astringency, invigorating qi and promoting body fluid, and nourishing the kidney and calming the mind. Modern pharmacology has confirmed that Schisandra extracts such as Schisandraein A, Schisandraein B, Schisandraein C, Schisandrae polysaccharides and Schisandrae gomisin have certain anti-tumor effects. Shen Yiyi et al.

[24] found that Schisandraein A inhibited the migration and invasion of pancreatic cancer cells. The mechanism of action was related to the inhibition of EGFR-SRC signaling pathway and the reduction of the expression of focal adhesion-related proteins p-Y397FAK and p-Y181Paxillin. Kang Ye et al.

[25] found that Schisandraein B upregulated the expression of Bax and Caspase-3 proteins, inhibited the expression of Bcl-2 protein, thereby inhibiting the proliferation of triple-negative breast cancer cell lines and promoting their apoptosis.

[0050] References:

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[25] Kang Ye, Wang Tao, Huo Yunlong, et al. Schisandrin B affects the proliferation and apoptosis of triple-negative breast cancer by activating Caspase-3[J]. Advances in Anatomical Sciences, 2019, 25(4): 414-416+421.

[0074] The present invention also provides a method for preparing the solid gold and detoxification composition, comprising the following steps:

[0075] (1) Weighing astragalus, codonopsis, glossophore, ophiopogon, oldenlandia diffusa, scutellaria barbata, fritillaria thunbergii, pinellia tuber, trichosanthes and vinegar schisandra chinensis according to proportion to obtain a mixture;

[0076] (2) soaking the mixture in water and then boiling it, filtering it to obtain a filtrate 1 and a filter residue;

[0077] (3) adding water to the filter residue and boiling it twice, and filtering to obtain filtrate 2;

[0078] (4) Mix the filtrate 1 and the filtrate 2, and concentrate them into an extract to obtain the Chinese medicine composition.

[0079] In the present invention, the mass ratio of the mixture to water in step (2) is preferably 1:8-12, more preferably 1:10, the soaking time is preferably 2-3 hours, more preferably 2.5 hours, and the decoction time is preferably 25-35 minutes, more preferably 30 minutes.

[0080] In the present invention, the mass ratio of the filter residue to water in step (3) is preferably 1:3-5, more preferably 1:4, and the time for the secondary decoction is preferably 10-15 min, more preferably 12-13 min.

[0081] In the present invention, the concentration in step (4) is preferably concentrated under reduced pressure, the temperature of the concentrated under reduced pressure is preferably 60 to 64°C, more preferably 62°C, and the relative density of the extract is preferably 1.18 to 1.22 g / cm 3 , more preferably 1.20 g / cm 3 .

[0082] In the present invention, the Chinese medicine extract obtained in step (4) can be further processed, and pharmaceutically acceptable excipients can be added for configuration, and then prepared into tinctures, mixtures, syrups, tablets, powders, capsules, granules, pills, etc. according to specific needs.

[0083] As a preferred clinical application, the drug mixture is prepared into tablets and powders, and the specific preparation method is as follows:

[0084] The drug composition mixture was prepared according to the above method, and the mixture was precooled in a -80°C refrigerator, and vacuum-dried using a SCIENTZ-10N / C small freeze dryer, with the following parameters set: cold trap temperature -60°C, sample temperature 20°C, vacuum degree 1000Pa, and running time set according to the degree of freeze-drying (it is advisable that the drug mixture is completely turned into powder). Finally, the Gujin Xiaoji composition powder was obtained.

[0085] As a clinical preference, the powder of the Gujin Xiaoji composition is further prepared into tablets.

[0086] The present invention also provides application of the Gujinxiaoji composition in preparing anti-tumor drugs.

[0087] The present invention also provides an anti-tumor medicine, which contains the Gujinxiaoji composition.

[0088] In the present invention, the dosage form of the drug is preferably a mixture.

[0089] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0090] Example 1

[0091] A method for preparing a gold-solidifying and accumulation-eliminating composition comprises the following steps:

[0092] (1) weighing raw materials according to the mass ratio of 20 parts of Astragalus, 20 parts of Codonopsis, 17 parts of Glehnia littoralis, 17 parts of Radix Ophiopogonis, 32 parts of Hedyotis diffusa, 28 parts of Scutellaria barbata, 17 parts of Fritillaria thunbergii, 10 parts of Pinellia ternata, 28 parts of Trichosanthes, and 14 parts of Schisandra chinensis to obtain a mixture;

[0093] (2) adding 8 times the mass of water to the mixture, soaking it for 3 h, boiling it for 25 min, and filtering it to obtain filtrate 1 and filter residue;

[0094] (3) adding 5 times the weight of water to the filter residue and boiling it for a second time for 15 min, and filtering to obtain filtrate 2;

[0095] (4) Filtrate 1 and filtrate 2 were mixed and concentrated under reduced pressure at 64°C to a concentration of 1.22 g / cm 3 The Chinese medicine composition is obtained by mixing the extract.

[0096] Example 2

[0097] A method for preparing a gold-solidifying and accumulation-eliminating composition comprises the following steps:

[0098] (1) weighing raw materials according to the mass ratio of 28 parts of Astragalus, 28 parts of Codonopsis, 13 parts of Glehnia littoralis, 13 parts of Radix Ophiopogonis, 28 parts of Hedyotis diffusa, 32 parts of Scutellaria barbata, 13 parts of Fritillaria thunbergii, 14 parts of Pinellia ternata, 32 parts of Trichosanthes, and 10 parts of Schisandra chinensis to obtain a mixture;

[0099] (2) adding 12 times the mass of water to the mixture, soaking it for 2 h, boiling it for 35 min, and filtering it to obtain filtrate 1 and filter residue;

[0100] (3) adding 3 times the weight of water to the filter residue and boiling it for a second time for 10 min, and filtering to obtain filtrate 2;

[0101] (4) Filtrate 1 and filtrate 2 were mixed and concentrated under reduced pressure at 60°C to a concentration of 1.18 g / cm 3 The Chinese medicine composition is obtained by mixing the extract.

[0102] Example 3

[0103] A method for preparing a gold-solidifying and accumulation-eliminating composition comprises the following steps:

[0104] (1) weighing raw materials according to the mass ratio of 24 parts of Astragalus, 24 parts of Codonopsis, 15 parts of Glehnia littoralis, 15 parts of Radix Ophiopogonis, 30 parts of Hedyotis diffusa, 30 parts of Scutellaria barbata, 15 parts of Fritillaria thunbergii, 12 parts of Pinellia ternata, 30 parts of Trichosanthes, and 12 parts of Schisandra chinensis to obtain a mixture;

[0105] (2) adding 10 times the mass of water to the mixture, soaking it for 2.5 hours, boiling it for 30 minutes, and filtering it to obtain filtrate 1 and filter residue;

[0106] (3) adding 4 times the weight of water to the filter residue and boiling it for a second time for 13 min, and filtering to obtain filtrate 2;

[0107] (4) Filtrate 1 and filtrate 2 were mixed and concentrated under reduced pressure at 62°C to a concentration of 1.20 g / cm 3 The Chinese medicine composition is obtained by mixing the extract.

[0108] Test Example 1

[0109] The patient, Sun XX, female, 76 years old. On August 18, 2022, she was diagnosed with right lung small cell lung cancer in another hospital and received 6 cycles of single-agent etoposide chemotherapy. In February 2023, she was examined for recurrence and was admitted to our department for further treatment. She was replaced with irinotecan hydrochloride injection 100mgd1,8 + slulizumab injection 300mgd0,q3w. The patient's chest CT imaging and blood tests showed that chemotherapy combined with the auxiliary treatment of the Gujin Xiaoji mixture prepared in Example 1 had reduced the patient's lung tumor compared with before, biochemistry showed no significant changes in liver and kidney function, and tumor marker tests were lower than before. It significantly reflects that the Gujin Xiaoji composition (mixture) has the function of inhibiting tumors, reducing toxicity, improving chemotherapy toxicity and side effects, being non-toxic to the patient's liver and kidneys, and enhancing the patient's anti-tumor immunity. See the specific examination results for details. Figures 1 to 6 .

[0110] Test Example 2

[0111] The patient is Yu XX, female, 54 years old. In June 2023, a puncture tissue biopsy was performed in our hospital because of the enlargement of the left cervical lymph node. The pathological diagnosis was micropapillary adenocarcinoma, and the immunohistochemistry was consistent with lung cancer metastasis. On June 10, 2023, pemetrexed + nedaplatin + bevacizumab were treated, and on June 14, 2023, a bone ECT scan diagnosed L1 vertebral bone metastasis. Tissue gene testing showed EGFR exon 21 L858R mutation, and ametinib + bevacizumab treatment was performed. During the treatment, the Gujin Xiaoji composition (mixture) prepared in Example 1 was used in combination, and the treatment has lasted for more than 10 months. The patient's chest CT images and laboratory tests were better than before, and the tumor treatment effect was significant. The Gujin Xiaoji composition (mixture) combined with targeted drugs and anti-angiogenic therapy showed a good tumor suppression effect, had no toxic side effects on the patient's liver and kidneys, and the patient's tumor markers were reduced and the immune function was improved. See the specific examination results. Figures 7 to 12 .

[0112] Test Example 3

[0113] Patient Jing XX, male, 71 years old. In December 2021, a physical examination revealed a mass in the left upper lobe of the lung. On December 21, he underwent VATS left upper lobectomy + mediastinal lymph node dissection under general anesthesia. Postoperative pathological diagnosis was poorly differentiated adenocarcinoma, and tissue gene testing showed no mutation. On January 28, 2022, 4 cycles of pemetrexed 800mgD1 + carboplatin 500mgD1, q3w were started. During the follow-up period of treatment, the Gujin Xiaoji mixture prepared in Example 3 was used for adjuvant treatment. The chest CT images and biochemical / tumor marker examinations of the patient's treatment follow-up showed that the lung tumor was removed, and there were no signs of tumor recurrence and metastasis. Laboratory tests showed a decrease in tumor markers, no toxic damage to liver and kidney function and electrolytes, and improved immune function of the patient.

[0114] Test Example 4

[0115] Patient Zhou XX, male, 77 years old. In October 2020, a physical examination revealed a mass in the basal segment of the right lower lobe, and the puncture biopsy pathology showed poorly differentiated squamous cell carcinoma. On November 30, 2020, CT-guided percutaneous microwave ablation of lung tumors was performed in our hospital; in November 2021, a chest CT reexamination showed that the right lower lobe mass was larger than before, and percutaneous microwave ablation of lung tumors was performed under CT guidance on November 05; in November 2022, a chest enhanced CT showed that the right lower lobe mass was roughly the same as that on September 27, 2022, and the mediastinal lymph node enlargement was similar to that before. Combined with the patient's specific condition and systemic underlying diseases, local radical radiotherapy was given to the right lung mass and mediastinal lymph node. During the entire treatment period, the patient was treated with the Gujin Xiaoji mixture prepared in Example 2 as an auxiliary treatment. The chest CT images, biochemistry, and tumor marks during the follow-up treatment of the patient showed that the Gujin Xiaoji mixture was safe, could cooperate with tumor ablation and radiotherapy, could inhibit tumor proliferation, improve immune function, and reduce the efficacy of treatment side effects.

[0116] Test Example 5

[0117] Patient Wu XX, male, 50 years old. On January 19, 2019, enhanced chest CT scan at an external hospital showed a space-occupying lesion in the mediastinum, consistent with the manifestation of a malignant tumor, and considered the possibility of lymphoma or mediastinal lung cancer with superior vena cava tumor thrombus. On January 21, 2019, percutaneous mediastinal biopsy showed poorly differentiated carcinoma, which was consistent with small cell lung cancer in combination with immunohistochemistry. From January 26, 2019 to April 22, 2019, he received 5 cycles of EP chemotherapy in our department. On May 8, 2020, he received whole-brain radiotherapy combined with oral temozolomide capsules. During the treatment and follow-up of the patient, the Gujin Xiaoji mixture prepared in Example 2 was continuously used as an auxiliary. On March 5, 2024, the chest CT showed interstitial changes in both lungs, which were not significantly changed compared with November 28, 2023; small nodules in both lungs, similar to the previous film; enlarged mediastinal lymph nodes; emphysema and bullae in the septum of both upper lungs; and a small amount of pericardial effusion. At present, the patient is in good general condition after using Gujin Xiaoji mixture, the tumor is under control, the liver and kidney functions are normal, and the tumor markers are lower than before.

[0118] Test Example 6

[0119] Patient Lu XX, male, 75 years old. In April 2022, chest CT revealed a mass in the left lung. On April 22, 2022, bronchoscopic biopsy pathology showed: squamous cell carcinoma of the left upper lobe, and pathology of the 7th group lymph node puncture biopsy showed metastasis of squamous cell carcinoma of the lung. After comprehensive evaluation, 6 cycles of tislelizumab 200mgD1+albumin paclitaxel 200mgD1,8+carboplatin 400mgD1,Q3W combined with traditional Chinese medicine Gujin Xiaoji mixture were given for treatment. Follow-up was performed until April 2023. Chest CT was reviewed again, considering that the mediastinal lymph nodes were enlarged compared with the previous one. After comprehensive evaluation, anlotinib 10mg D1-14,Q3W was given in combination with the traditional Chinese medicine Gujin Xiaoji mixture prepared in Example 3 for treatment. Follow-up was performed until September 2023. Chest CT and laboratory tests of the patient showed good treatment effect. On June 14, 2023, the patchy shadow in the left lower lung of the chest CT was significantly smaller than that on April 16, 2023, and the overall lung lesions were stable. On September 1, 2023, the chest CT showed further improvement compared with the previous time. The results of the patient's tumor marker tests were lower than before, and some changes were not significant. Liver and kidney function and related tests did not show any toxic side effects of the combined Chinese medicine.

[0120] Test Example 7

[0121] Patient Dong XX, male, 68 years old. In March 2020, chest CT diagnosed a nodule in the left upper lobe of the lung, with a size of 1.4cm*2cm. Excluding surgical contraindications, thoracoscopic wedge resection of the left upper lobe tumor + mediastinal lymph node sampling was performed under general anesthesia on April 2, 2020. Postoperative pathology showed: invasive micropapillary adenocarcinoma in the left upper lobe of the lung, focally with mucinous cell differentiation, distant from the main part of the tumor with intra-alveolar dissemination, and focal invasion of the tumor around the tracheal cartilage. The fifth group of lymph nodes sent for examination showed cancer tissue infiltration. The patient did not receive systemic treatment after surgery. In December 2021, a mass was found in the right neck. In January 2022, a puncture biopsy of the mass in the right neck was performed under the guidance of color Doppler ultrasound. Combined with the original lung pathology and clinical, lung lesions metastasis were considered, and immunohistochemistry showed large cell neuroendocrine carcinoma. EP chemotherapy was given on February 25, 2022, and AP chemotherapy was changed in May 2022. During chemotherapy, the patient was treated with the Gujin Xiaoji mixture prepared in Example 3. Follow-up chest CT and related laboratory tests showed good results. The chest CT on June 1, 2022 showed that the right supraclavicular soft tissue was smaller than that on April 14, 2022, and the rest was stable. Tumor markers were lower than before, and biochemical examinations showed that liver and kidney function was stable, with no liver and kidney toxicity or side effects.

[0122] Test Example 8

[0123] Patient Leng XX, female, 48 years old. In January 2022, chest CT showed a large amount of effusion in the right pleural cavity and was admitted to the hospital for treatment. On February 28, 2022, pleural effusion puncture and pathological examination showed tumor cells, combined with immunohistochemistry to show pulmonary adenocarcinoma. On March 18, 2022, 50mg of loboplatin + 300mg of bevacizumab were given for pleural perfusion treatment, 800mg of pemetrexed was given for D1 chemotherapy on March 20, 2022, and 200mg of sindilimab was given for D1, Q3W immunotherapy on March 23, 2022. In October 2022, chest CT showed lung cancer in the right middle lobe of the lung and the metastasis of the right lung, pleura, right hilar and mediastinal lymph nodes was larger than that on August 3, 2022. In October 2022, the patient was treated in our hospital for 6 cycles of pemetrexed disodium 700mg D2 + carboplatin 350mg D2 + bevacizumab 700mg D1 + tirilizumab 200mg D0 maintenance treatment, and then replaced with osimertinib 80mg PO QD + bevacizumab 700mg D1 maintenance treatment. During the maintenance treatment in our hospital, the patient was assisted by the solid gold detoxification mixture prepared in Example 3. The treatment follow-up chest CT and laboratory tests showed good treatment effects. On January 17, 2024, the chest CT showed that the right middle lobe lung cancer and the intrapulmonary, pleural, right hilar and mediastinal lymph nodes were smaller than those on December 13, 2023. On March 11, 2024, the follow-up chest CT examination showed that the lung lesions were smaller than before, and the remaining lungs were stable and improved. The patient's tumor markers continued to decrease steadily, and liver and kidney function tests showed no drug toxicity and side effects.

[0124] Test Example 9

[0125] Patient Liu XX, male, 77 years old. On October 27, 2022, an enhanced chest CT scan at an external hospital revealed a mass in the left lower lobe of the lung and enlarged mediastinal lymph nodes, which was considered malignant. On November 9, 2022, a lung tumor puncture biopsy pathological diagnosis of primary lung adenocarcinoma was made. The patient was not given systemic treatment and was treated with the Gujin Xiaoji mixture prepared in Example 3 in our hospital. On February 23, 2023, combined with the patient's treatment effect and chemotherapy contraindications, pemetrexed disodium 800mgD1,Q3W+bevacizumab 700mg was started for treatment, followed by chemotherapy combined with targeted traditional Chinese medicine Gujin Xiaoji mixture for maintenance treatment. The follow-up chest CT and laboratory tests of the patient showed that the mass in the left lower lobe of the chest CT on February 27, 2024 was stable compared with the November 23, 2023 film, and the remaining lung lesions were stable and improved compared with the previous one. Tumor markers and liver and kidney function tests showed that the combined use of Gujin Xiaoji Decoction was effective. Tumor markers were steadily decreasing, no liver and kidney damage was shown, and the toxic side effects of chemotherapy and targeted therapy were improved, and the patient's immune function was enhanced.

[0126] The above test cases show that Gujin Xiaoji Mixture has significant advantages in treating lung tumor lesions. The multi-line combined treatment of all patient populations and lung tumor types and treatment methods fully demonstrates the superiority of Gujin Xiaoji Mixture in inhibiting tumor proliferation and growth; improving the toxic side effects of chemotherapy, targeting, immunity, ablation, radiotherapy and other treatment methods, improving the patient's immune function, reducing the toxicity of existing anti-tumor treatments, and prolonging the patient's survival time. The examination and test results of many trial patients fully demonstrate the safety, effectiveness, immunity, toxicity reduction, synergistic and efficient anti-tumor effect of Gujin Xiaoji Mixture in clinical use, which deserves better clinical research and promotion.

[0127] It can be seen from the above embodiments that the present invention provides a kind of solid gold and detoxification composition and its preparation method and application, the composition comprises the following raw materials in parts by weight: 20-28 parts of Astragalus, 20-28 parts of Codonopsis, 13-17 parts of Adenophora, 13-17 parts of Radix Ophiopogonis, 28-32 parts of Hedyotis diffusa, 28-32 parts of Scutellaria barbata, 13-17 parts of Fritillaria thunbergii, 28-32 parts of Trichosanthes, and 10-14 parts of Schisandrae Chinensis. The solid gold and detoxification composition of the present invention can effectively inhibit the growth of tumor cells, and can also be used as a matching drug for chemotherapy, radiotherapy, targeting, and microwave ablation therapy, thereby reducing the toxic and side effects of chemotherapy, radiotherapy, targeting, etc. While reducing the patient's pain, it improves their own immunity and helps tumor patients survive longer.

[0128] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A gold-solidifying and stagnation-eliminating composition, It is characterized in that The composition comprises the following raw materials in parts by weight: 20-28 parts of astragalus, 20-28 parts of codonopsis, 13-17 parts of adenophora, 13-17 parts of ophiopogon, 28-32 parts of oldenlandia diffusa, 28-32 parts of scutellaria barbata, 13-17 parts of fritillaria thunbergii, 10-14 parts of pinellia ternata, 28-32 parts of trichosanthes, and 10-14 parts of vinegar schisandra.

2. The solid gold eliminating composition according to claim 1, It is characterized in that The composition comprises the following raw materials in parts by weight: 22-26 parts of astragalus, 22-26 parts of codonopsis, 14-16 parts of adenophora, 14-16 parts of ophiopogon, 29-31 parts of oldenlandia diffusa, 29-31 parts of scutellaria barbata, 14-16 parts of fritillaria thunbergii, 11-13 parts of pinellia ternata, 29-31 parts of trichosanthes, and 11-13 parts of vinegar schisandra.

3. The solid gold eliminating composition according to claim 1, It is characterized in that The composition comprises the following raw materials in parts by weight: 24 parts of astragalus, 24 parts of codonopsis, 15 parts of adenophora, 15 parts of ophiopogon, 30 parts of oldenlandia diffusa, 30 parts of scutellaria barbata, 15 parts of fritillaria thunbergii, 12 parts of pinellia ternata, 30 parts of trichosanthes, and 12 parts of vinegar schisandra.

4. A method for preparing the solid gold and detoxifying composition according to any one of claims 1 to 3, It is characterized in that The steps include: (1) Weighing astragalus, codonopsis, glossophore, ophiopogon, oldenlandia diffusa, scutellaria barbata, fritillaria thunbergii, pinellia tuber, trichosanthes and vinegar schisandra chinensis according to proportion to obtain a mixture; (2) soaking the mixture in water and then boiling it, filtering it to obtain a filtrate 1 and a filter residue; (3) adding water to the filter residue and boiling it twice, and filtering to obtain filtrate 2; (4) Mix the filtrate 1 and the filtrate 2, and concentrate them into an extract to obtain the Chinese medicine composition.

5. The preparation method according to claim 4, It is characterized in that In step (2), the mass ratio of the mixture to water is 1:8-12, the soaking time is 2-3 hours, and the decoction time is 25-35 minutes.

6. The preparation method according to claim 5, It is characterized in that In step (3), the mass ratio of the filter residue to water is 1:3-5, and the time of the secondary decoction is 10-15 minutes.

7. The preparation method according to any one of claims 4 to 6, It is characterized in that The concentration in step (4) is carried out under reduced pressure, the temperature of the reduced pressure concentration is 60-64° C., and the relative density of the extract is 1.18-1.22 g / cm 3 .

8. Use of the Gujin Xiaoji composition according to any one of claims 1 to 3 or the Gujin Xiaoji composition prepared by the preparation method according to any one of claims 4 to 7 in the preparation of anti-tumor drugs. 9.An anti-tumor drug, It is characterized in that The medicine contains the Gujin Xiaoji composition according to any one of claims 1 to 3 or the Gujin Xiaoji composition prepared by the preparation method according to any one of claims 4 to 7.

10. The drug according to claim 9, It is characterized in that The dosage form of the medicine is a mixture.

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