阅读说明：本技术 一种肿瘤免疫辅助治疗药物及其应用 (Tumor immunity adjuvant therapy medicine and application thereof ) 是由 钱和 胡斌 成玉梁 郭亚辉 许文倩 于 2021-02-06 设计创作，主要内容包括：本发明公开了一种肿瘤免疫辅助治疗药物及其应用,属于生物医药领域。本发明利用紫锥菊提取物作为肿瘤免疫辅助治疗药物,在放化疗过程中,既可抑制肿瘤生长,增强化药抑制效果,还能够减轻毒副作用,具有显著的增效减毒作用；并通过建立荷瘤小鼠模型评价其对荷瘤小鼠肿瘤的抑制效果。结果表明,紫锥菊可抑制肿瘤生长,提高机体免疫,增强化药抑瘤效果,且降低了化药对肝脏的毒副作用,产生良好的减毒增效作用,具有非常好的应用前景。(The invention discloses a tumor immunity adjuvant therapy medicine and application thereof, belonging to the field of biological medicines. The echinacea purpurea extract is used as a tumor immunity adjuvant therapy medicament, can inhibit tumor growth and enhance the inhibition effect of chemical drugs in the process of radiotherapy and chemotherapy, can also reduce toxic and side effects, and has obvious synergy and attenuation effects; and evaluating the inhibition effect of the tumor-bearing mouse model on the tumor of the tumor-bearing mouse by establishing the tumor-bearing mouse model. The result shows that the echinacea purpurea can inhibit the growth of tumor, improve the immunity of organisms, enhance the tumor inhibition effect of chemical drugs, reduce the toxic and side effect of the chemical drugs on the liver, generate good attenuation and synergism and have good application prospect.)

1. Application of Echinacea purpurea in preparing tumor immunity adjuvant treatment medicine for relieving toxic effect of radiotherapy and chemotherapy is provided.

2. The use according to claim 1, characterized in that the echinacea is subjected to the following treatment process: cutting whole plant of Echinacea purpurea into small segments, soaking in purified water, boiling, filtering to obtain medicinal liquid, and vacuum filtering; adding purified water into residue, decocting the residue, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating, and drying.

3. An adjuvant therapeutic agent for tumor immunity for relieving toxic effect of radiotherapy and chemotherapy, which comprises Echinacea purpurea extract; the preparation process of the echinacea purpurea extract comprises the following steps:

cutting whole plant of Echinacea purpurea into small segments, soaking in purified water, boiling, filtering to obtain medicinal liquid, and vacuum filtering; adding purified water into residue, decocting the residue, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating, and drying.

4. The tumor immunity adjuvant therapy medicament according to claim 3, wherein the dosage form of the tumor immunity adjuvant therapy medicament comprises capsule, granule, tablet, pill, powder or oral liquid dosage form.

5. The tumor immunoadjuvant treatment drug according to claim 3, further comprising any one or more of the following components: fillers, solubilizers, binders, humectants, disintegrating agents, slow-dissolving agents, absorption accelerators, wetting agents, adsorbents, lubricants and buffering agents.

6. The drug for tumor immunoadjuvant treatment according to any one of claims 3 to 5, further comprising a pharmaceutically acceptable carrier.

7. The medicament for the adjuvant therapy of tumor immunity according to claim 6, wherein the pharmaceutically acceptable carrier is selected from the group consisting of: mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, thioglycolic acid, methionine, vitamin C, EDTA disodium, calcium sodium EDTA, monovalent alkali metal carbonates, acetates, phosphates or aqueous solutions, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acids, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, starch, sucrose, mannitol, silicon derivatives, cellulose and its derivatives, alginates, gelatin, polyvinylpyrrolidone, glycerol, tween 80, agar, calcium carbonate, calcium bicarbonate, surfactants, polyethylene glycol, cyclodextrin, phospholipid materials, kaolin, talc, calcium stearate, magnesium stearate.

8. A pharmaceutical composition for treating tumors, which is characterized by comprising an immune auxiliary component and an anti-tumor active component;

the immune auxiliary component is prepared by the following method: cutting whole plant of Echinacea purpurea into small segments, soaking in purified water, boiling, filtering to obtain medicinal liquid, and vacuum filtering; adding purified water into residue, decocting the residue, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating, and drying.

9. The pharmaceutical composition for treating tumor according to claim 8, wherein the anti-tumor active component comprises any one or more of the following: fluorouracil, cisplatin, paclitaxel, adriamycin, cyclophosphamide and mitomycin.

10. The pharmaceutical composition for treating tumors according to claim 8, wherein the mass ratio of the immune auxiliary component to the anti-tumor active component is 2-50: 1.

Technical Field

The invention belongs to the field of biological medicines, and particularly relates to a tumor immunity adjuvant therapy medicine and application thereof.

Background

In recent years, the morbidity and mortality of malignant tumors are on a rapid rise trend, and the human health is seriously threatened. Surgical treatment, chemotherapy and radiotherapy are common methods for the comprehensive treatment of malignant tumors, but most malignant tumors have low survival rate and bring more adverse reactions while inhibiting tumors. Causes considerable damage to normal cells of a human body, and causes various inflammatory reactions such as hepatotoxicity, digestive disorder, immunologic function reduction, bone marrow suppression, fever and the like. Therefore, there is an urgent need to find a drug which can control the growth of malignant tumor and reduce adverse reaction.

The traditional Chinese medicine plays an important role in preventing and treating tumors. In the theory of traditional Chinese medicine, tumors belong to spleen deficiency, phlegm, stasis and toxicity, and are caused by the deficiency of vital qi of an organism, invasion of exogenous pathogenic factors and dysfunction of spleen transportation and transformation to cause stasis and accumulation. Therefore, ancient formulas and modern Chinese patent medicines are commonly used for preventing and controlling tumors by using traditional Chinese medicines with the effects of strengthening body resistance and consolidating constitution, strengthening spleen and replenishing qi, clearing away heat and toxic materials, and promoting blood circulation by removing blood stasis. Such as astragalus root, pilose asiabell root, barbat skullcap, zedoary and other traditional Chinese medicines. The traditional Chinese medicines have the unique advantages of multiple target points, low toxicity, high efficiency and prevention and treatment, and have the value which cannot be underestimated in the clinical tumor prevention and treatment.

Disclosure of Invention

At present, research and application of echinacea purpurea are few, and the tumor immunity adjuvant therapy medicine mainly comprises an echinacea purpurea water extract, has the effects of tonifying qi, strengthening body resistance, clearing heat and removing toxicity, can improve the immunity and enhance the tumor therapy effect, and reduces the toxic and side effects of chemical drugs.

The first purpose of the invention is to provide the application of echinacea purpurea in preparing tumor immune adjuvant therapy medicine for relieving the toxic effect of radiotherapy and chemotherapy.

In one embodiment of the present invention, the application process includes: cutting whole plant of Echinacea purpurea into small segments, soaking in purified water, boiling, filtering to obtain medicinal liquid, and vacuum filtering; adding purified water into residue, decocting the residue, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating, and drying.

The second purpose of the invention is to provide a tumor immunity adjuvant therapy medicine for alleviating the toxic effect of radiotherapy and chemotherapy, the preparation of the medicine comprises the following processes:

cutting whole plant of Echinacea purpurea into small segments, soaking in purified water, boiling, filtering to obtain medicinal liquid, and vacuum filtering; adding purified water into residue, decocting the residue, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating, and drying.

In one embodiment of the invention, the tumor immune adjuvant therapy medicament is in a dosage form of capsules, granules, tablets, pills, powder or oral liquid.

In one embodiment of the invention, the tumor immune adjuvant therapy medicament further comprises any one or more of the following components:

(1) fillers or solubilizers, for example, starch, lactose, sucrose, glucose, mannitol, silicic acid, and the like;

(2) binders, for example, hydroxymethylcellulose, alginate, gelatin, polyvinylpyrrolidone, sucrose, gum arabic and the like;

(3) humectants, such as glycerol and the like;

(4) disintegrating agents, such as agar-agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, sodium carbonate, and the like;

(5) a slow solvent such as paraffin and the like;

(6) absorption accelerators such as quaternary ammonium compounds and the like;

(7) wetting agents such as cetyl alcohol and glyceryl monostearate and the like;

(8) adsorbents, for example, kaolin, and the like;

(9) lubricants, for example, talc, calcium stearate, solid polyethylene glycols, sodium lauryl sulfate, and the like, or mixtures thereof;

and (10) the capsule, tablet and pill can also contain buffering agent.

In one embodiment of the present invention, the tumor immune adjuvant treatment drug further comprises a pharmaceutically acceptable carrier. Such pharmaceutically acceptable carriers include, but are not limited to: mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, thioglycolic acid, methionine, vitamin C, EDTA disodium, calcium sodium EDTA, monovalent alkali metal carbonates, acetates, phosphates or aqueous solutions, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acids, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, starch, sucrose, mannitol, silicon derivatives, cellulose and its derivatives, alginates, gelatin, polyvinylpyrrolidone, glycerol, tween 80, agar, calcium carbonate, calcium bicarbonate, surfactants, polyethylene glycol, cyclodextrin, phospholipid materials, kaolin, talc, calcium stearate, magnesium stearate.

In an embodiment of the present invention, the processing process of echinacea includes:

cutting the whole plant of echinacea into small sections with the length of 2-3 cm, adding purified water with the weight of 8-10 times of that of the whole plant, soaking for 20-40 min, heating and boiling for 1-3 h, filtering out medicine juice, and carrying out suction filtration. And adding 6-8 times of water, decocting the medicine residues for 1-3 hours, filtering out medicine juice, carrying out suction filtration, combining decoction liquids obtained in two times, filtering, taking supernate, concentrating to obtain an echinacea water extracting solution, and drying to obtain a solid product.

The third purpose of the invention is to provide a tumor treatment pharmaceutical composition, which comprises an immune auxiliary component and an anti-tumor active component;

the immune auxiliary component is prepared by the following method: cutting whole plant of Echinacea purpurea into small segments, soaking in purified water, boiling, filtering to obtain medicinal liquid, and vacuum filtering; adding purified water into residue, decocting the residue, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating, and drying.

In one embodiment of the present invention, the anti-tumor active component comprises: fluorouracil, cisplatin, paclitaxel, adriamycin, cyclophosphamide, mitomycin, etc.

In one embodiment of the invention, the mass ratio of the immune auxiliary component to the anti-tumor active component is 2-50: 1.

in one embodiment of the present invention, the pharmaceutical composition for treating tumor is in the form of capsule, granule, tablet, pill, powder or oral liquid.

In one embodiment of the present invention, the pharmaceutical composition for treating tumor further comprises any one or more of the following components: excipient, diluent, solubilizer, adhesive, humectant, disintegrating agent, slow-release agent, wetting agent, adsorbent, lubricant and slow-release agent.

In one embodiment of the present invention, the pharmaceutical composition for treating tumor further comprises a pharmaceutically acceptable carrier. Such pharmaceutically acceptable carriers include, but are not limited to: mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, thioglycolic acid, methionine, vitamin C, EDTA disodium, calcium sodium EDTA, monovalent alkali metal carbonates, acetates, phosphates or aqueous solutions, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acids, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, starch, sucrose, mannitol, silicon derivatives, cellulose and its derivatives, alginates, gelatin, polyvinylpyrrolidone, glycerol, tween 80, agar, calcium carbonate, calcium bicarbonate, surfactants, polyethylene glycol, cyclodextrin, phospholipid materials, kaolin, talc, calcium stearate, magnesium stearate.

The invention has the beneficial effects that:

the echinacea purpurea extract is used as a tumor immunity adjuvant therapy medicament, can inhibit tumor growth and enhance the inhibition effect of chemical medicaments in the process of radiotherapy and chemotherapy, can also reduce toxic and side effects, and has obvious synergy and attenuation effects. According to the invention, a tumor-bearing mouse model is established, and the echinacea extract is given to evaluate the inhibition effect of the echinacea extract on the tumor of the tumor-bearing mouse. The result shows that the echinacea purpurea can inhibit the growth of tumor, improve the immunity of organisms, enhance the tumor inhibition effect of chemical drugs, reduce the toxic and side effect of the chemical drugs on the liver and generate good attenuation and synergism.

Drawings

FIG. 1 is a graph of the body weight change of mice treated with different treatments; wherein, the blank group (C), the tumor-bearing animal model group (M), the echinacea group (Ep), the fluorouracil group (P), the echinacea and fluorouracil group (Ep + P); in comparison with the blank set, the results,^*P＜0.05，^**P＜0.01。

FIG. 2 is a graph showing the trend of tumor volume changes in mice treated with different treatment modalities; wherein, the tumor-bearing animal model group (M), the echinacea group (Ep), the fluorouracil group (P), the echinacea and fluorouracil group (Ep + P); in comparison with the set of models,^#P＜0.05，^##P＜0.01，^###P＜0.001。

FIG. 3 is a graph comparing the results of organ index size comparison of mice treated with different treatment methods; wherein, the blank group (C), the tumor-bearing animal model group (M), the echinacea group (Ep), the fluorouracil group (P), the echinacea and fluorouracil group (Ep + P); in comparison with the blank set, the results,^*p is less than 0.05; in comparison with the set of models,^#P＜0.05，^##P＜0.01。

FIG. 4 is a graph comparing the results of tumor index size of mice treated with different treatment modalities; wherein, the tumor-bearing animal model group (M), the echinacea group (Ep), the fluorouracil group (P), the echinacea and fluorouracil group (Ep + P); in comparison with the set of models,^#P＜0.05，^##P＜0.01。

FIG. 5 is a comparison of liver function results for mice treated in different ways; wherein, the blank group (C), the tumor-bearing animal model group (M), the echinacea group (Ep), the fluorouracil group (P), the echinacea and fluorouracil group (Ep + P); in comparison with the blank set, the results,^*P＜0.05，^***p is less than 0.001; in comparison with the set of models,^###P＜0.001。

Detailed Description

The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by those skilled in the art after reading the disclosure of the present invention, and equivalents fall within the scope of the appended claims.

Example 1:

cutting whole plant of Echinacea purpurea into 2-3 cm segments, weighing 200g, adding purified water 8 times of Echinacea purpurea, soaking for 40min, heating to boil for 2 hr, filtering to obtain medicinal liquid, and vacuum filtering. Adding purified water 6 times of Echinacea purpurea into the residue, decocting for 1 hr, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating the supernatant under reduced pressure to obtain extract, lyophilizing to obtain powder, adding adjuvant, and making into tablet.

Example 2:

cutting whole plant of Echinacea purpurea into 2-3 cm segments, weighing 200g, adding purified water 9 times of Echinacea purpurea, soaking for 30min, heating to boil for 3 hr, filtering to obtain medicinal liquid, and vacuum filtering. Adding purified water 7 times the weight of Echinacea purpurea into the residue, decocting for 1 hr, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating under reduced pressure to obtain extract, lyophilizing, pulverizing into fine powder, and making into capsule.

Example 3:

cutting whole plant of Echinacea purpurea into 2-3 cm segments, weighing 200g, adding 10 times of purified water, soaking for 30min, heating to boil for 2 hr, filtering to obtain filtrate, and vacuum filtering. Adding purified water 8 times the weight of Echinacea purpurea into the residue, decocting for 2 hr, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating under reduced pressure to obtain extract, lyophilizing to obtain powder, adding adjuvant, and making into tablet.

Example 4:

cutting whole plant of Echinacea purpurea into 2-3 cm segments, weighing 200g, adding purified water 8 times of Echinacea purpurea, soaking for 40min, heating to boil for 1 hr, filtering to obtain medicinal liquid, and vacuum filtering. Adding purified water 6 times of Echinacea purpurea into the residue, decocting for 1 hr, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating the supernatant under reduced pressure to obtain extract, lyophilizing to obtain powder, adding adjuvant, and making into tablet.

Example 5:

cutting whole plant of Echinacea purpurea into 2-3 cm segments, weighing 200g, adding purified water 9 times of Echinacea purpurea, soaking for 30min, heating to boil for 3 hr, filtering to obtain medicinal liquid, and vacuum filtering. Adding purified water 8 times the weight of Echinacea purpurea into the residue, decocting for 1 hr, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating under reduced pressure to obtain extract, lyophilizing, pulverizing into fine powder, and making into capsule.

Example 6:

cutting whole plant of Echinacea purpurea into 2-3 cm segments, weighing 200g, adding 10 times of purified water, soaking for 20min, heating to boil for 2 hr, filtering to obtain filtrate, and vacuum filtering. Adding purified water 7 times of Echinacea purpurea into the residue, decocting for 1 hr, filtering, vacuum filtering, mixing decoctions, filtering, collecting supernatant, concentrating under reduced pressure to obtain extract, lyophilizing to obtain powder, adding adjuvant, and making into tablet.

Example 7:

1. materials:

(1) cell lines: mouse Hepa1-6 hepatoma cells were provided by Shanghai Life sciences institute of Chinese academy of sciences.

(2) Reagent: DMEM-H medium, fetal bovine serum, antibiotics were purchased from Gibco, USA; phosphate Buffered Saline (PBS), 0.25% pancreatin-0.02% ethylenediaminetetraacetic acid (EDTA) were purchased from Thermo corporation, USA;

(3) medicine preparation: fluorouracil for injection (Shanxi Pude pharmaceutical Co., Ltd.) and Echinacea was purchased from Kangda Co., Ltd., Qingzhou, Shandong, and the extract of Echinacea was used as a test drug in example 3.

(4) Instrument and environment: an ultra-clean workbench, a CO2 constant-temperature incubator, a biological inverted microscope, a centrifuge, a vacuum freeze dryer (ScientZ), and an animal barrier of the experimental animal center of the university in south of the Yangtze river.

(5) Experimental animals: 30 SPF grade C57BL/6 mice, weighing 20-22g, male, were supplied by Shanghai Ling Biotech, Inc. The license number of the experimental animal: SYXK (threo) 2016-.

2. The experimental method comprises the following steps:

(1) cell culture: reviving the liver cancer cell Hepa1-6, culturing in a CO2 constant temperature incubator, observing the cell morphology, and carrying out passage on the cell after the cell state is good and grows to 90%.

(2) Cell inoculation: collecting cultured cells, adjusting cell density to 2X 10 with sterile physiological saline⁷one/mL, 0.1mL of cell suspension was taken at 2X 10⁶A single Hepa1-6 cell was inoculated subcutaneously into the left axilla of a mouse, and the needle was left for 1min, after which the state of the mouse was observed daily at regular intervals. And the tumor growth was observed daily and the tumor volume was measured using a vernier caliper.

(3) Administration to experimental animals: mice were fed with standard feed and, after one week of acclimation, were randomly divided into five groups, blank (normal mice, C), tumor-bearing animal model group (M), echinacea group (Ep), fluorouracil group (P), echinacea and fluorouracil group (Ep + P). Except for the blank group, the other four groups of mice were inoculated with Hepa1-6 hepatoma cells according to the cell inoculation method. The following day, the animals were dosed daily for three weeks with an amount of echinacea extract.

(4) The administration mode comprises the following steps: the fluorouracil group is injected into the abdominal cavity at 10mg/kg/d daily, and the injection amount is 0.1mL/10 g. The echinacea group is intragastrically administered at 2g/kg/d daily, and the intragastrically administered amount is 0.1mL/10 g. Mode of administration of echinacea purpurea with fluorouracil group (Ep + P): the dose of the echinacea purpurea in the stomach irrigation is the same as that of the echinacea purpurea group, and the dose of the fluorouracil in the abdominal cavity injection is the same as that of the fluorouracil group.

The blank group and the model group were perfused with normal saline daily. During the observation period the animals were routinely housed, fed water ad libitum, and the body weight of the mice was recorded.

(5) Animal treatment: after the last administration, the animals are fasted for 12h without water prohibition, after the eyes are picked and blood is collected, the mice are killed by cervical dislocation method, the tumor, the liver and the spleen are separated, the mass is precisely weighed, and the organ index and the tumor volume [ tumor volume (mm)³) Long diameter x short diameter²×50％]Centrifuging the obtained serum at 4 deg.C and 3500r/min for 15min, and detecting liver function index including total serumBilirubin (TBIL), aspartate Aminotransferase (AST).

(6) The statistical method comprises the following steps: statistical analysis is carried out by adopting SPSS 21.0 statistical software, and the difference with P less than 0.05 has statistical significance by adopting ANOVO one-way variance analysis.

3. Analysis of results

(1) The body weights of the mice were recorded, and the specific results are shown in table 1, and the body weights of the animals in the respective groups change with time in a trend as shown in fig. 1.

TABLE 1 weights of mice in each group

The body weights of the mice were recorded every two days, and the body weights of the respective groups were plotted against time as shown in FIG. 1. The results show that compared with the blank group, the body weight of the mice inoculated with the tumor is reduced, the tumor is gradually increased while the body weight of the mice in the model group is reduced, and the body weight of the mice has no obvious difference with the body weight of the administration group.

(2) Tumor size was measured at different times for each group of animals as shown in table 2, and the corresponding trend over time is shown in figure 2.

TABLE 2 tumor size in groups of mice

A mouse liver cancer model is established by a method of subcutaneous inoculation of liver cancer cells, and clinical common antitumor therapeutic drugs fluorouracil are adopted as chemotherapeutic drugs.

The results show that after the model group mice are inoculated with the liver cancer cells, the tumors are gradually enlarged, and the growth of the tumors can be effectively inhibited by the administration of the drug. The combination of the echinacea extract and the fluorouracil has stronger inhibiting effect than the combination of the echinacea extract or the fluorouracil which is singly used, and generates good synergistic effect.

(3) The results of measuring the index of the organs (liver, spleen and kidney) of each group of animals are shown in table 3 and fig. 3, and the specific results are shown in table 3 and fig. 3, wherein the weights of the liver, spleen and kidney of the mice are weighed after the mice are sacrificed, and the organ coefficients of each group of mice are calculated and compared.

The organ index size specifically means: the ratio of the weight of the liver, the spleen and the kidney in the viscera to the weight of the liver, the spleen and the kidney in the viscera is a common index in toxicological experiments, and the research is used for evaluating the toxic effect of the tumor on the viscera of the mouse and the intervention effect of the medicament on the mouse through the index of the viscera.

TABLE 3 organ index size of each group of mice

The results show that the liver index and the kidney index of each group of mice have no significant difference, but the organ quality after the administration tends to be reduced. Spleen indexes of mice in each group are obviously different, spleen colors of the mice in the model group are black, the weights of the mice are increased, the mice are obviously different from those in the blank group, and different degrees of callback appear after administration, wherein the echinacea purpurea extract can obviously callback the spleen indexes, and the effect of the echinacea purpurea extract combined with fluorouracil callback is more obvious and is close to that in the blank group. The echinacea purpurea extract can play a good role in immunoregulation, and simultaneously enhance the efficacy of the chemical drugs, thereby achieving the effects of synergism and attenuation.

(4) And measuring the tumor index results of the animals in each group, weighing the tumor weight of the mice after the mice are sacrificed, and calculating and comparing the tumor index of the mice of various groups of inoculated tumors. Specific results are shown in table 4 and fig. 4.

The tumor index size specifically refers to: the ratio of the tumor weight to the body weight reflects the severity of the tumor and the intervention effect of the drug on the mouse tumor.

TABLE 4 tumor index size in groups of mice

The result shows that the administration can reduce the growth of the tumor to a certain extent, and the echinacea extract can be combined with the administration to obviously inhibit the size of the tumor and can effectively prevent the occurrence of the tumor and control the development of the tumor.

(5) Serum liver function indexes of animals of each group are detected, and Total Bilirubin (TBIL) and glutamic-oxalacetic transaminase (AST) of serum liver function indexes of mice of each group are detected by a full-automatic biochemical analyzer. Specific results are shown in table 5 and fig. 5.

TABLE 5 liver function values of the mice of each group

The results show that the TBIL and AST content of the model group mice is obviously increased, and different degrees of callback appear after administration, wherein, the influence of the fluorouracil group on the liver function is relatively large, the regulation and control function is weaker, the influence on the liver can be obviously reduced by the administration of the echinacea purpurea extract and the fluorouracil, the damage to normal cells of an organism is reduced, and the attenuation and synergism effects are exerted.

The result of the evaluation of the inhibition effect of the echinacea purpurea extract on the tumor and the comparison of the inhibition effect with the treatment effect after the combined chemical drug shows that the combined use effect of the echinacea purpurea extract and the anti-tumor chemical drug fluorouracil is better than that of the single drug administration, the toxic and side effect of the chemical drug on the organism is reduced, the immune function of the organism is improved, and the result proves that the echinacea purpurea extract can be clinically applied as the tumor immune adjuvant treatment drug.

The technical solutions provided by the embodiments of the present invention are described in detail above, and the embodiments of the present invention are described herein by using specific examples, which are only used for convenience of describing the present invention and do not limit the present invention in any form.