CN115400169A

CN115400169A - An antitumor selenium-containing Chinese medicinal composition and its preparation method

Info

Publication number: CN115400169A
Application number: CN202210923929.6A
Authority: CN
Inventors: 唐晓玲; 熊林楷; 熊墨年; 余炅; 张雅静; 朱静; 孙有智; 谢欢
Original assignee: JIANGXI PROVINCIAL INSTITUTE OF TRADITIONAL CHINESE MEDICINE
Current assignee: JIANGXI PROVINCIAL INSTITUTE OF TRADITIONAL CHINESE MEDICINE
Priority date: 2022-08-02
Filing date: 2022-08-02
Publication date: 2022-11-29

Abstract

The invention develops an anti-tumor selenium-containing traditional Chinese medicine composition and a preparation method thereof, and the selenium-containing content of the prepared selenium-containing traditional Chinese medicine composition is higher than 1mg/kg by adding the selenium-rich astragalus, so that the selenium-containing traditional Chinese medicine composition has an obvious treatment effect on tumor.

Description

An antitumor selenium-containing Chinese medicinal composition and its preparation method

Technical Field

The invention belongs to the technical field of medicine research, and particularly relates to an anti-tumor selenium-containing traditional Chinese medicine composition and a preparation method thereof.

Background

Tumor refers to a new organism formed by local tissue cell proliferation under the action of various tumorigenic factors, because the new organism mostly presents space-occupying blocky protrusions, which is also called neoplasm. According to the cellular characteristics of neoplasms and the degree of harm to the body, tumors are classified into benign tumors and malignant tumors, and cancer is the general term for malignant tumors. Cancer is a malignant tumor derived from epithelial tissues and is a disease caused by the malfunction of mechanisms controlling cell growth and proliferation. In addition to uncontrolled growth, cancer cells can locally invade surrounding normal tissues and even migrate to other parts of the body via the systemic circulatory system or lymphatic system. Benign tumors are easy to remove, generally do not transfer and relapse, and only have extrusion and blocking effects on organs and tissues.

At present, the malignant tumor is mainly treated by surgical treatment, chemical treatment or radiation therapy, but the tumor cells are easy to transfer, so that the surgical treatment effect is poor and the prognosis is difficult, and the chemical treatment, the radiation therapy and the like have great harm to the human body. The Chinese medicine is more and more emphasized, and the development of the Chinese medicine theory lays a foundation for treating the tumor for a long time. The comprehensive treatment mainly based on traditional Chinese medicines has important significance for controlling the disease development of malignant tumors, improving the life quality and prolonging the life cycle.

Because the pharmacology of the traditional Chinese medicine is complex, the anticancer mechanism of the medicine is influenced by various factors, such as the variety, the producing area, the pretreatment, the processing method and the like of the traditional Chinese medicine can generate great influence on the efficacy of the traditional Chinese medicine, and the extraction method of the traditional Chinese medicine preparation also directly influences the extraction rate of the effective components in the traditional Chinese medicine.

Therefore, the invention discloses an anti-tumor selenium-containing traditional Chinese medicine composition and a preparation method thereof.

Disclosure of Invention

An anti-tumor selenium-containing traditional Chinese medicine composition comprises the following raw materials in parts by weight:

8-10 parts of selenium-enriched astragalus membranaceus, 3-5 parts of salvia miltiorrhiza, 1-2 parts of leonurus, 1-3 parts of Chinese lobelia, 1-2 parts of anoectochilus roxburghii, 1-2 parts of plantain, 1-3 parts of malva verticillata, 1-2 parts of gordon euryale seed, 1-2 parts of cherokee rose fruit, 0.1-0.3 part of chicken's gizzard-membrane and 0.5-1 part of scalding leech; the above parts are parts by mass.

Furthermore, the selenium content of the selenium-rich astragalus is higher than 500 mug/kg.

Further, the preparation method of the selenium-containing traditional Chinese medicine composition comprises the steps of mixing and decocting the raw materials, concentrating and granulating the decoction, and thus the selenium-containing traditional Chinese medicine composition is prepared.

Further, the selenium-rich astragalus membranaceus is processed by a processing technology, and the processing technology specifically comprises the following steps:

(1) Removing impurities from selenium-rich radix astragali, cleaning, moistening, slicing into thick slices, and drying;

(2) Taking the clean radix astragali slices, putting into a pot, adding 0.2-0.3 times of polypeptide water solution with mass fraction of 0.5% -0.8%, stewing until water is dry, parching with slow fire until yellow with focal spot, taking out, and cooling to obtain radix astragali Preparata.

The polypeptide is sunflower disc polypeptide or soybean polypeptide.

Further, the salvia miltiorrhiza bunge is processed by a processing technology, and the processing technology specifically comprises the following steps:

(1) Collecting Saviae Miltiorrhizae radix, removing impurities and residual stem, cleaning, moistening, slicing, and drying;

(2) Adding yellow wine with the mass of 1/10 of the salvia miltiorrhiza slices, uniformly stirring, moistening until the wine is completely absorbed, putting into a stir-frying container, heating with slow fire, stir-frying to dry, taking out, and cooling to obtain the wine salvia miltiorrhiza.

Further, the preparation method of the selenium-containing traditional Chinese medicine composition comprises the following steps:

(1) Preparation of radix astragali extract

Spraying a trace amount of water solution of bacillus subtilis and 0.02-0.03 per mill of mixed strain mass fraction with yeast mass ratio of 3-5 to 1 on the mix-proportion astragalus membranaceus, and fermenting for 36-48h at 30 ℃ with heat preservation; then adding water 2-3 times of the weight of the radix astragali Preparata, heating to 70-80 deg.C, extracting for 2-3 h, and filtering to obtain a first water extract A; then, continuously adding a sodium bicarbonate water solution with the mass fraction of 0.5% -1% which is 1-2 times of the weight of the radix astragali preparata into the filter residue, heating to 60-65 ℃, extracting for 1-2 h, and filtering to obtain a second alkali extract B; then, adding 95% ethanol 1-2 times of the weight of the radix astragali Preparata into the filter residue, heating to 55-60 deg.C, extracting for 1-2 h, and filtering to obtain third ethanol extract C; mixing A, B and C to obtain radix astragali extract;

(2) Preparation of Salvia miltiorrhiza extract

Taking wine-processed salvia miltiorrhiza in a ratio, crushing into salvia miltiorrhiza powder of 50-100 meshes, adding a mixed solvent of acetone, ethanol and stearic acid monoglyceride in a volume ratio of 2-3 times of the wine-processed salvia miltiorrhiza to 2: 35-40 ℃, pressurizing to 2.2-2.5 MPa, extracting for 1-2 h, and filtering to obtain a first extracted organic phase D; then, continuously adding 60% ethanol 1-2 times of the mass of the wine salvia miltiorrhiza to the filter residue, heating to 35-40 ℃, extracting for 1-2 h, and filtering to obtain a second extraction ethanol solution E; then, continuously adding a mixed water solution of water, ethanol and tween in a volume ratio of 1-2 times of the mass of the wine salvia miltiorrhiza to the filter residue, namely, the mixed water solution is mixed with the mixed water solution of water, ethanol and tween in a volume ratio of 88; mixing D, E and F, and distilling under reduced pressure until acetone content is less than 1% in the solution system to obtain Saviae Miltiorrhizae radix extract;

(3) Mixing and crushing motherwort, chinese lobelia herb, anoectochilus roxburghii, plantain, cluster mallow fruit, gordon euryale seed and cherokee rose fruit according to the proportion, spraying an enzyme preparation water solution with the mass fraction of 0.5-1 percent and the mass of 20-30 percent of the powder, and performing enzymolysis for 6-8 h; grinding the chicken's gizzard-membrane and the scalding leech into powder, adding papain aqueous solution with the mass fraction of 0.1-0.2% and the mass of 1-2 times of the powder, and performing enzymolysis for 0.5-1 h; mixing herba Leonuri, herba Lobeliae chinensis, herba Antenoronis Neofiliformis, herba plantaginis, semen Abutili, semen euryales, fructus Rosae Laevigatae, endothelium corneum Gigeriae Galli, and Hirudo with enzymolysis, adding 8-10 times of water, decocting for 40-60 min, and filtering to obtain first decoction G; then, continuously adding water with the mass of 3-5 times of the powder into the filter residue, decocting for 20-30 min, and filtering to obtain a second decoction liquid H; mixing G and H, and adding radix astragali extract and Saviae Miltiorrhizae radix extract to obtain mother liquor I;

(4) Pounding the polygonum blue, soaking the pouched polygonum blue in water, filtering and concentrating the pouched polygonum blue until the specific gravity is 1.08-1.10 g/mL to prepare an aqueous solution of the indican, mixing the aqueous solution of the indican with the mother liquor I according to the volume ratio of 1:10-12, introducing air until the system is bluish, filtering, concentrating the mixture under reduced pressure and granulating to prepare the granular selenium-containing traditional Chinese medicine composition.

Further, the enzyme preparation in the step (3) is a mixed enzyme preparation with the mass ratio of cellulase to hemicellulase being 1.

Further, the selenium content of the selenium-containing traditional Chinese medicine composition is more than 1mg/kg.

Furthermore, the selenium-containing traditional Chinese medicine composition is taken by being mixed with warm water.

The invention has the advantages that:

1. the selenium-rich astragalus is added, so that the selenium content of the prepared selenium-containing traditional Chinese medicine composition is higher than 1mg/kg, and the selenium-containing traditional Chinese medicine composition has an obvious treatment effect on tumors, particularly has an extremely obvious effect on renal tumors;

2. according to the invention, by adjusting the preparation method of the selenium-containing traditional Chinese medicine composition, the treatment effect of the selenium-containing traditional Chinese medicine composition on renal tumor can be effectively improved; the processing technology of the selenium-rich astragalus can effectively improve the content of selenium-containing components in the selenium-containing traditional Chinese medicine composition;

3. according to the invention, the aqueous solution of the indican is added into the mother liquor, and the indican can be combined with free or small-molecule selenium-containing components and fixed in the oxidation process, so that the free or small-molecule selenium-containing components can be effectively prevented from being directly discharged into urine from the kidney, and the retention time of the selenium-containing components in the kidney and the treatment effect on renal tumors are improved.

Detailed Description

The following examples are intended to illustrate certain preferred embodiments of the present invention and are not intended to limit the scope of the invention.

Example 1

8 parts of selenium-enriched astragalus membranaceus, 3 parts of salvia miltiorrhiza, 1 part of motherwort, 1 part of Chinese lobelia, 2 parts of anoectochilus roxburghii, 1 part of plantain, 3 parts of cluster mallow seeds, 1 part of gordon euryale seeds, 1 part of cherokee rose, 0.1 part of endothelium corneum gigeriae galli and 0.5 part of leech by a scalding method; the parts are parts by mass.

The selenium-rich astragalus membranaceus is processed by a processing technology, and the processing technology specifically comprises the following steps:

(1) Taking selenium-rich radix astragali, removing impurities, cleaning, moistening, slicing into thick slices, and drying;

(2) Taking the clean radix astragali slices, putting into a pot, adding 0.2 times of sunflower disc polypeptide water solution with mass fraction of 0.8%, stewing until water is dry, parching with slow fire until yellow with focal spot, taking out, and cooling to obtain radix astragali Preparata.

The salvia miltiorrhiza bunge is processed by a processing technology, and the processing technology specifically comprises the following steps:

The preparation method of the selenium-containing traditional Chinese medicine composition comprises the following steps:

(1) Preparation of radix astragali extract

Spraying a water solution with the mass fraction of 0.02 per mill of trace bacillus subtilis and yeast in a mixed strain mass ratio of 3 to 1 on the mix-proportion astragalus membranaceus, and fermenting for 48 hours at the temperature of 30 ℃; then adding water 2 times of the weight of the radix astragali Preparata, heating to 80 deg.C, extracting for 2h, and filtering to obtain a first water extract A; then, continuously adding 1 weight time of sodium bicarbonate water solution with the mass fraction of 1 percent of the weight of the radix astragali preparata into the filter residue, heating to 65 ℃, extracting for 1 hour, and filtering to obtain a second alkali extract B; then, continuously adding 95% ethanol which is 1 time of the weight of the radix astragali Preparata into the filter residue, heating to 60 ℃, extracting for 1 hour, and filtering to obtain a third ethanol extract C; mixing A, B and C to obtain radix astragali extract;

(2) Preparation of Salvia miltiorrhiza extract

Taking wine-processed salvia miltiorrhiza in a ratio, crushing into 50-mesh salvia miltiorrhiza powder, adding a mixed solvent of acetone, ethanol and stearic acid monoglyceride in a volume ratio of 3 times that of the wine-processed salvia miltiorrhiza to (66); then, continuously adding 60% ethanol 2 times of the mass of the wine salvia miltiorrhiza to the filter residue, heating to 35 ℃, extracting for 2 hours, and filtering to obtain a second extracted ethanol solution E; then, continuously adding a mixed water solution of water, ethanol and tween in a volume ratio of 2 times of the mass of the wine salvia miltiorrhiza to the filter residue, heating to 45 ℃, extracting for 1 hour, and filtering to obtain a third extracted water solution F; mixing D, E and F, and distilling under reduced pressure until the acetone content in the solution system is less than 1% to obtain Saviae Miltiorrhizae radix extract;

(3) Mixing and crushing motherwort, chinese lobelia, anoectochilus roxburghii, plantain, cluster mallow fruit, gordon euryale seed and cherokee rose fruit in proportion, spraying an enzyme preparation aqueous solution with the mass fraction of 1% and the mass percentage of 20% of powder, and carrying out enzymolysis for 8 hours, wherein the enzyme preparation is a mixed enzyme preparation prepared from cellulose, hemicellulase and the weight ratio of 1; grinding the proportioned endothelium corneum gigeriae galli and the scalding leech into powder, then adding a papain aqueous solution with the mass fraction of 0.2 percent which is 1 time of the mass of the powder, and carrying out enzymolysis for 1h; mixing herba Leonuri, herba Lobeliae chinensis, herba Antenoronis Neofiliformis, herba plantaginis, semen Abutili, semen euryales, fructus Rosae Laevigatae, endothelium corneum Gigeriae Galli, and Hirudo with enzymolysis, adding 8 times of water, decocting for 60min, and filtering to obtain first decoction G; then, continuously adding water with the mass 3 times of that of the powder into the filter residue, decocting for 30min, and filtering to obtain a second decoction liquid H; mixing G and H, and adding radix astragali extract and Saviae Miltiorrhizae radix extract to obtain mother liquor I;

(4) Pounding the Polygonum tinctorium, soaking in water, filtering and concentrating to the specific gravity of 1.08g/mL to prepare an aqueous solution of the indican, mixing the aqueous solution of the indican with the mother liquor I according to the volume ratio of 1:10, introducing air until the system is bluish, filtering, concentrating under reduced pressure and granulating to prepare the granular selenium-containing traditional Chinese medicine composition.

Example 2

9 parts of selenium-enriched astragalus mongholicus, 4 parts of salvia miltiorrhiza, 2 parts of motherwort, 2 parts of Chinese lobelia, 1 part of anoectochilus roxburghii, 1 part of plantain, 2 parts of cluster mallow fruit, 1 part of gordon euryale seed, 2 parts of cherokee rose fruit, 0.2 part of endothelium corneum gigeriae galli and 0.8 part of leech by a scalding method; the above parts are parts by mass.

The selenium-rich astragalus mongholicus is processed by a processing technology, and the processing technology specifically comprises the following steps:

(2) Taking the clean radix astragali slices, putting into a pot, adding 0.25 times of sunflower disc polypeptide water solution with mass fraction of 0.6%, stewing until water is dry, parching with slow fire until yellow with focal spot, taking out, and cooling to obtain radix astragali Preparata.

(1) Preparation of radix astragali extract

Spraying a water solution with the mass fraction of 0.03 per mill of trace bacillus subtilis and yeast in a mixed strain mass ratio of 4 to 1 on the mix-proportioned radix astragali, and fermenting at 30 ℃ for 40 hours; then adding water with the weight 2.6 times of that of the radix astragali Preparata, heating to 75 ℃, extracting for 2.5h, and filtering to obtain a first water extract A; then, continuously adding a sodium bicarbonate aqueous solution with the mass fraction of 0.6 percent, which is 1.2 times of the weight of the radix astragali preparata, into the filter residue, heating to 60 ℃, extracting for 2 hours, and filtering to obtain a second alkali extract B; then, adding 95% ethanol 1.5 times of the weight of the radix astragali Preparata into the filter residue, heating to 58 deg.C, extracting for 2h, and filtering to obtain a third ethanol extract C; mixing A, B and C to obtain radix astragali extract;

(2) Preparation of Salvia miltiorrhiza extract

Taking wine-processed salvia miltiorrhiza according to a certain proportion, crushing the wine-processed salvia miltiorrhiza into salvia miltiorrhiza powder of 80 meshes, adding a mixed solvent of acetone, ethanol and stearic acid monoglyceride in a volume ratio of 2.5 times of the wine-processed salvia miltiorrhiza to the mixed solvent of 32:66, heating to 38 ℃, pressurizing to 2.5MPa, extracting for 2 hours, and filtering to obtain a first extraction organic phase D; then, continuously adding 60% ethanol with the mass of 1.6 times of that of the wine salvia miltiorrhiza to the filter residue, heating to 38 ℃, extracting for 2 hours, and filtering to obtain a second extraction ethanol solution E; then, continuously adding a mixed water solution of water, ethanol and tween in a volume ratio of 1.8 times of the mass of the wine salvia miltiorrhiza to the filter residue, heating to 47 ℃, extracting for 1 hour, and filtering to obtain a third extracted water solution F; mixing D, E and F, and distilling under reduced pressure until the acetone content in the solution system is less than 1% to obtain Saviae Miltiorrhizae radix extract;

(3) Mixing and crushing motherwort, chinese lobelia, anoectochilus roxburghii, plantain, cluster mallow fruit, gordon euryale seed and cherokee rose fruit according to the proportion, spraying an enzyme preparation aqueous solution with the mass fraction of 0.8 percent and the mass percentage of 25 percent of the powder, and carrying out enzymolysis for 7 hours, wherein the enzyme preparation is a mixed enzyme preparation with the mass ratio of cellulase to hemicellulase being 1; grinding the chicken's gizzard-membrane and the scalding leech into powder, adding a papain aqueous solution with the mass fraction of 0.18 percent which is 1.5 times of the mass of the powder, and carrying out enzymolysis for 1 hour; mixing herba Leonuri, herba Lobeliae chinensis, herba Antenoronis Neofiliformis, herba plantaginis, semen Abutili, semen euryales, fructus Rosae Laevigatae, endothelium corneum Gigeriae Galli, and Hirudo by scalding, adding 9 times of water, decocting for 60min, and filtering to obtain first decoction G; then, continuously adding water with the weight 4 times that of the powder into the filter residue, decocting for 30min, and filtering to obtain a second decoction liquid H; mixing G and H, and adding radix astragali extract and Saviae Miltiorrhizae radix extract to obtain mother liquor I;

(4) Pounding the Polygonum tinctorium, soaking in water, filtering and concentrating to the specific gravity of 1.10 g/mL to prepare an aqueous solution of the indican, mixing the aqueous solution of the indican according to the volume ratio of the indican aqueous solution to the mother solution I of 1.12, introducing air until the system is bluish, filtering, concentrating under reduced pressure and granulating to prepare the granular selenium-containing traditional Chinese medicine composition.

Example 3

10 parts of selenium-enriched astragalus membranaceus, 5 parts of salvia miltiorrhiza, 2 parts of leonurus, 3 parts of Chinese lobelia, 1 part of anoectochilus roxburghii, 2 parts of plantain, 1 part of cluster mallow fruit, 2 parts of gordon euryale seed, 2 parts of cherokee rose fruit, 0.3 part of chicken's gizzard-membrane and 1 part of scalding leech; the above parts are parts by mass.

(2) Taking the clean astragalus membranaceus slices, placing the clean astragalus membranaceus slices into a pot, adding 0.3-time soybean polypeptide aqueous solution with the mass fraction of 0.5%, stewing until the water is dry, frying the mixture with slow fire until the mixture is yellow and has a focal spot, taking the mixture out, and cooling the mixture to obtain the roasted astragalus membranaceus.

(1) Preparation of radix astragali extract

Spraying a trace amount of bacillus subtilis and an aqueous solution with the mass fraction of 0.03 per mill of mixed strains of 5 mass percent of yeast and 1 mass percent of the yeast on the mix-proportion astragalus, and fermenting for 36 hours at the temperature of 30 ℃; then adding water with the weight 3 times of that of the radix astragali Preparata, heating to 70 ℃, extracting for 3h, and filtering to obtain a first water extract A; then, continuously adding a sodium bicarbonate aqueous solution with the mass fraction of 0.5 percent, which is 2 times of the weight of the radix astragali preparata, into the filter residue, heating to 60 ℃, extracting for 2 hours, and filtering to obtain a second alkali extract B; then, continuously adding 95% ethanol 2 times of the weight of the radix astragali Preparata into the filter residue, heating to 55 ℃, extracting for 2h, and filtering to obtain a third ethanol extract C; mixing A, B and C to obtain radix astragali extract;

(2) Preparation of Salvia miltiorrhiza extract

Taking wine-processed salvia miltiorrhiza, crushing into salvia miltiorrhiza powder of 100 meshes, adding a mixed solvent of acetone, ethanol and stearic acid monoglyceride in a volume ratio of 2 times of the wine-processed salvia miltiorrhiza to be 32; then, continuously adding 60% ethanol with the mass of 1 time of that of the wine salvia miltiorrhiza to the filter residue, heating to 40 ℃, extracting for 1 hour, and filtering to obtain a second extracted ethanol solution E; then, continuously adding a mixed water solution of water, ethanol and tween in a volume ratio of 1 time of the mass of the wine salvia miltiorrhiza to 88; mixing D, E and F, and distilling under reduced pressure until the acetone content in the solution system is less than 1% to obtain Saviae Miltiorrhizae radix extract;

(3) Mixing and crushing motherwort, chinese lobelia, anoectochilus roxburghii, plantain, cluster mallow fruit, gordon euryale seed and cherokee rose fruit according to the proportion, spraying an enzyme preparation aqueous solution with the mass fraction of 0.5 percent and the mass percentage of 30 percent of the powder, and carrying out enzymolysis for 6 hours, wherein the enzyme preparation is a mixed enzyme preparation with the mass ratio of cellulase to hemicellulase of 1; grinding the proportioned chicken's gizzard-membrane and the scalding leech into powder, then adding papain aqueous solution with the mass fraction of 0.1 percent which is 2 times of the mass of the powder, and carrying out enzymolysis for 0.5h; mixing herba Leonuri, herba Lobeliae chinensis, herba Antenoronis Neofiliformis, herba plantaginis, semen Abutili, semen euryales, fructus Rosae Laevigatae, endothelium corneum Gigeriae Galli, and Hirudo with enzymolysis, adding 10 times of water, decocting for 40min, and filtering to obtain first decoction G; then, continuously adding water with the mass 5 times of that of the powder into the filter residue, decocting for 20min, and filtering to obtain a second decoction liquid H; mixing G and H, and adding radix astragali extract and Saviae Miltiorrhizae radix extract to obtain mother liquor I;

Example 4

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared by mixing and decocting raw materials, concentrating the decoction, and granulating to obtain selenium-containing traditional Chinese medicine composition; the raw material proportion and the processing technology are the same as those in the embodiment 2.

Comparative example 1

An anti-tumor Chinese medicinal composition, wherein the astragalus root is common astragalus root, and the rest process is the same as in example 2.

Comparative example 2

An anti-tumor selenium-containing Chinese medicinal composition is prepared by processing selenium-rich radix astragali, and processing the same as in example 2.

Comparative example 3

An anti-tumor selenium-containing Chinese medicinal composition is prepared by processing selenium-rich radix astragali without adding sunflower disc polypeptide water solution, and the rest process is the same as in example 2.

Comparative example 4

An anti-tumor selenium-containing Chinese medicinal composition, wherein the Salvia miltiorrhiza Bunge is not processed, and the rest process is the same as in example 2.

Comparative example 5

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared by directly preparing an astragalus extract in the step (1) by using a method of decocting 3 times of water to prepare the astragalus extract, wherein the amount of the water used is the same as that of the solvent used in 3 times of the embodiment 2, and the rest processes are the same as those of the embodiment 2.

Comparative example 6

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared by the preparation method of the astragalus extract in the step (1), wherein a mixed strain aqueous solution is not sprayed and fermented, and the rest processes are the same as in the embodiment 2.

Comparative example 7

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared in the step (1) of preparing the astragalus extract, an equal amount of water is used for replacing a sodium bicarbonate water solution in the second extraction, and the rest processes are the same as in the example 2.

Comparative example 8

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared by the steps of (1) preparing the astragalus extract, wherein 95% ethanol is replaced by equal amount of water during the third extraction, and the rest processes are the same as those in the example 2.

Comparative example 9

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared by the preparation method of the selenium-containing traditional Chinese medicine composition, wherein in the preparation of the salvia miltiorrhiza extract in the step (2), a mixed solvent is not applied to pressure extraction to prepare a first extracted organic phase D, and the rest processes are the same as those in the embodiment 2.

Comparative example 10

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared by the preparation method of the red sage root extract in the step (2), wherein the mixed solvent for extracting the organic phase D for the first time is prepared without adding stearic acid monoglyceride, and the rest processes are the same as those in the embodiment 2.

Comparative example 11

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared, wherein in the preparation method of the salvia miltiorrhiza extract in the step (2), tween is not added into a mixed aqueous solution for preparing the third extraction aqueous solution F, and other processes are the same as in the example 2.

Comparative example 12

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared by the same process as in example 2 except that an enzyme preparation aqueous solution is not sprayed in the step (3).

Comparative example 13

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared in the step (3) of the preparation method, the chicken's gizzard-membrane and the scalding leech are not subjected to enzymolysis by using a papain aqueous solution, and the rest processes are the same as those in the embodiment 2.

Comparative example 14

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared by the preparation method of the selenium-containing traditional Chinese medicine composition, wherein in the step (4), an aqueous solution of indican is not added, and the rest process is the same as that in the embodiment 2.

Comparative example 15

An anti-tumor selenium-containing traditional Chinese medicine composition is prepared by the same process as in example 2 except that air is not introduced in the step (4) in the preparation method of the selenium-containing traditional Chinese medicine composition.

And (3) effect testing:

the raw materials used in the above embodiments and comparative examples have the same batch, wherein the selenium content of the selenium-rich astragalus root is detected to be 860 mug/kg, and the selenium content of the traditional Chinese medicine composition in the embodiments and the comparative examples is detected.

1. Taking mouse renal carcinoma cell RuCa in logarithmic growth phase, digesting with 0.25% trypsin, washing, centrifuging, and adjusting cell concentration to 6 × 10 with physiological saline ⁴ The cells are inoculated in a 96-well plate, and a normal saline control group and an administration group are arranged, wherein each group has 3 multiple wells; 50 μ L per well, 3 replicates per drug concentration were inoculated. After the experimental group is set, the culture is carried out for 48 hours at 35 ℃. Mixing the Chinese medicinal composition with waterThe drug solution was administered at a concentration of 50. Mu.g/mL, and 50. Mu.L of the drug solution was applied to a 96-well plate inoculated with cells to give a final concentration of 25. Mu.g/mL in each group. mu.L of WST-1 solution was added to each well 4h before the termination of the experiment, and the absorbance (OD) at a wavelength of 440nm for each set was determined on a mu-Quant microplate assay. The growth inhibition (%) of each group was calculated.

GI (growth inhibition) = (1-OD administration group/OD control group) × 100%

2. Mouse kidney cancer cell RuCa is inoculated to the subcutaneous axilla of the mouse, and the cell inoculation amount is 1 multiplied by 10 ⁷ Per mL, i.e., 0.1mL was intraperitoneally injected, and used after 3 passages in mice after inoculation to form transplantable tumors. 100 BABL/C-nu mice are taken, the age of the mice is 3-5 weeks, the weight of the mice is 22-28g, and the mice are half female and half male. The second day after inoculation was weighed and randomized by body weight into 20 groups, one of which was negative. The tested drug group is administrated by intraperitoneal injection, 25 mg/kg/time, once a day and 15 times of continuous administration; the negative group was injected with the same amount of normal saline once a day in the abdominal cavity and weighed before administration.

Detecting 24h urine protein on the first day of administration; the mouse 24h urine was collected 15 times after the administration, the urine protein concentration was measured, and the 24h urine protein: 24h urine protein = protein concentration x urine volume, while urine selenium concentration was measured.

The experiment was stopped after dosing was completed, the mice were sacrificed by cervical dislocation and weighed, and the renal index was calculated by weighing the renal weight: kidney index (mg/g) = kidney weight (mg)/mouse weight (g).

Then, the tumor was removed and the tumor inhibition (%) was calculated. Tumor inhibition (%) = [1- (average tumor weight in administration group/average tumor weight in negative group) ] × 100%.

TABLE 1

TABLE 2

And finally: the above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that are within the spirit and principle of the present invention are intended to be included in the scope of the present invention.

Claims

1. An anti-tumor selenium-containing traditional Chinese medicine composition is characterized in that: the selenium-containing traditional Chinese medicine composition comprises the following raw materials in parts by weight:

2. The anti-tumor selenium-containing traditional Chinese medicine composition according to claim 1, which is characterized in that: the selenium content of the selenium-rich astragalus is higher than 500 mug/kg.

3. The anti-tumor selenium-containing traditional Chinese medicine composition according to claim 1, which is characterized in that: the preparation method of the anti-tumor selenium-containing traditional Chinese medicine composition comprises the steps of mixing and decocting all the raw materials, concentrating and granulating the decoction, and thus obtaining the selenium-containing traditional Chinese medicine composition.

4. The anti-tumor selenium-containing Chinese medicinal composition according to claim 1, which is characterized in that: the selenium-rich astragalus mongholicus is processed by a processing technology, and the processing technology specifically comprises the following steps:

5. The anti-tumor selenium-containing traditional Chinese medicine composition according to claim 4, which is characterized in that: the polypeptide is sunflower disc polypeptide or soybean polypeptide.

6. The anti-tumor selenium-containing traditional Chinese medicine composition according to claim 1, which is characterized in that: the salvia miltiorrhiza bunge is processed by a processing technology, and the processing technology specifically comprises the following steps:

7. The anti-tumor selenium-containing Chinese medicinal composition according to claim 1, which is characterized in that: the preparation method of the anti-tumor selenium-containing traditional Chinese medicine composition comprises the following steps:

(1) Preparation of radix astragali extract

Spraying a trace amount of bacillus subtilis on the mix-proportion radix astragali preparata, namely spraying an aqueous solution with the mass fraction of 0.02-0.03 per mill of mixed strains of 3-5 yeast by mass percent; then adding water 2-3 times of the weight of the radix astragali Preparata, heating to 70-80 deg.C, extracting for 2-3 h, and filtering to obtain a first water extract A; then, continuously adding a sodium bicarbonate water solution with the mass fraction of 0.5% -1% which is 1-2 times of the weight of the radix astragali preparata into the filter residue, heating to 60-65 ℃, extracting for 1-2 h, and filtering to obtain a second alkali extract B; then, adding 95% ethanol 1-2 times of the weight of the radix astragali Preparata into the filter residue, heating to 55-60 deg.C, extracting for 1-2 h, and filtering to obtain third ethanol extract C; mixing A, B and C to obtain radix astragali extract;

(2) Preparation of Salvia miltiorrhiza extract

Taking wine-processed salvia miltiorrhiza in a ratio, crushing into salvia miltiorrhiza powder of 50-100 meshes, adding a mixed solvent of acetone, ethanol and stearic acid monoglyceride in a volume ratio of 2-3 times of the wine-processed salvia miltiorrhiza to 2: 35-40 ℃, pressurizing to 2.2-2.5 MPa, extracting for 1-2 h, and filtering to obtain a first extracted organic phase D; then, continuously adding 60% ethanol 1-2 times of the mass of the wine salvia miltiorrhiza to the filter residue, heating to 35-40 ℃, extracting for 1-2 h, and filtering to obtain a second extraction ethanol solution E; then, continuously adding a mixed water solution of water, ethanol and tween in a volume ratio of 1-2 times of the mass of the wine salvia miltiorrhiza to the filter residue, namely, the mixed water solution is mixed with the mixed water solution of water, ethanol and tween in a volume ratio of 88; mixing D, E and F, and distilling under reduced pressure until the acetone content in the solution system is less than 1% to obtain Saviae Miltiorrhizae radix extract;

(3) Mixing and crushing motherwort, chinese lobelia, anoectochilus roxburghii, plantain, cluster mallow fruit, gordon euryale seed and cherokee rose fruit according to the proportion, spraying an enzyme preparation water solution with the mass fraction of 0.5-1 percent and the mass of 20-30 percent of the powder, and performing enzymolysis for 6-8 h; grinding the chicken's gizzard-membrane and the scalding leech into powder, adding papain aqueous solution with the mass fraction of 0.1-0.2% and the mass of 1-2 times of the powder, and performing enzymolysis for 0.5-1 h; mixing herba Leonuri, herba Lobeliae chinensis, herba Antenoronis Neofiliformis, herba plantaginis, semen Abutili, semen euryales, fructus Rosae Laevigatae, endothelium corneum Gigeriae Galli, and Hirudo with enzymolysis, adding 8-10 times of water, decocting for 40-60 min, and filtering to obtain first decoction G; then, continuously adding water with the mass of 3-5 times of the powder into the filter residue, decocting for 20-30 min, and filtering to obtain a second decoction liquid H; mixing G and H, and adding radix astragali extract and Saviae Miltiorrhizae radix extract to obtain mother liquor I;

8. The anti-tumor selenium-containing Chinese medicinal composition according to claim 7, which is characterized in that: and (4) preparing the enzyme preparation in the step (3) from cellulase to hemicellulase in a mass ratio of 1.

9. The anti-tumor selenium-containing Chinese medicinal composition according to any one of claims 1 to 8, which is characterized in that: the selenium content of the selenium-containing traditional Chinese medicine composition is more than 1mg/kg.

10. The anti-tumor selenium-containing Chinese medicinal composition according to any one of claims 1 to 8, which is characterized in that: the selenium-containing traditional Chinese medicine composition is taken with warm water.