CN114642695A

CN114642695A - Big data traditional Chinese medicine composition for regulating and controlling prostate cancer

Info

Publication number: CN114642695A
Application number: CN202011491704.5A
Authority: CN
Inventors: 华子昂; 朱美瑛; 刘宝全; 竹添; 孙宁; 王姣; 万君兴
Original assignee: Individual
Current assignee: Wanshi Biotechnology Beijing Co ltd
Priority date: 2020-12-17
Filing date: 2020-12-17
Publication date: 2022-06-21

Abstract

The invention utilizes life big data technology to excavate the key gene target of regulation and control prostate cancer, finds the active ingredient of regulation and control key gene target with network pharmacological system analysis method, screens out the candidate Chinese medicine by the active ingredient, and further optimizes the Chinese medicine of optimal network target regulation and control prostate cancer in combination with the experience of using medicine of the doctor of traditional Chinese medicine, form the Chinese medicinal composition of two-way regulation to prostate cancer oncogene and cancer suppressor gene, the cancer suppressor gene promotes the target network regulation and control of cancer suppressor gene; the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-50 parts of suberect spatholobus stem, 5-60 parts of barbed skullcap herb, 3-40 parts of Chinese thorowax root, 3-30 parts of pepperweed seed, 2-20 parts of bitter apricot seed, 10-40 parts of purslane, 5-60 parts of astragalus root, 5-60 parts of pilose asiabell root and 10-40 parts of honeysuckle flower.

Description

Big data traditional Chinese medicine composition for regulating and controlling prostate cancer

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a big-data traditional Chinese medicine composition for regulating and controlling prostate cancer.

Background

Worldwide, the incidence of prostate cancer is second among all malignancies in men; according to the data of the national cancer center, prostate cancer has become the tumor with the highest incidence in the male urinary system since 2008. Most prostate cancer patients are hormone-dependent, and currently castration therapy (surgical castration, pharmacocrine castration) is the first choice for treatment of middle and advanced stage prostate cancer. Due to a plurality of factors, most of the current diagnosis and treatment of the prostate cancer in China are in the middle and late stages, and the patients are older, so that the chance of radical surgical treatment is lost. The advantage of the medical endocrine castration treatment is that the tumor progression can be delayed, but the period of validity is short, the later stage almost develops into androgen-independent prostate cancer (castration-resistant prostate cancer), once the castration-resistant prostate cancer develops into the castration-resistant prostate cancer (including androgen-independent prostate cancer and hormone-refractory prostate cancer), a more effective treatment method is difficult to realize, the disease progression is difficult to effectively slow down through chemotherapy, radiotherapy, targeted therapy and the like, and the treatment difficulty of the current prostate cancer is also difficult; in addition, serious adverse reactions such as loss of libido, erectile dysfunction, osteoporosis, gynogenesis of male mammary gland, diarrhea, venous thrombosis and the like frequently occur to patients during treatment, and a plurality of factors such as high price and the like restrict the application of the traditional Chinese medicine.

The traditional Chinese medicine classifies prostate cancer into the categories of syndrome differentiation and treatment such as retention of urine, hematuria and abdominal mass. A plurality of existing clinical evidences show that the traditional Chinese medicine has a certain curative effect on the treatment of the prostate cancer, but the traditional Chinese medicine is mainly used based on the general experience in the past, and the effectiveness is always in a lower level due to the lack of strict scientific evidence. Based on the above reasons, there is a need to develop a new traditional Chinese medicine composition for regulating and controlling prostate cancer, which has a clear target and a definite action mechanism and has a good curative effect.

Disclosure of Invention

Aiming at the defects, the invention combines the pathogenesis of the prostate cancer, utilizes the life big data technology to excavate the key gene target point for regulating and controlling the prostate cancer, finds the active component for regulating and controlling the key gene target point by a network pharmacological system analysis method, screens out candidate traditional Chinese medicines by the active component, and further optimizes the optimal network targeted traditional Chinese medicine for regulating and controlling the prostate cancer by combining the medication experience of national medical experts to form the traditional Chinese medicine composition for regulating and controlling the oncogene and the cancer suppressor gene in two ways, inhibiting the oncogene and the prostate cancer specific gene and promoting the targeted network regulation and control of the cancer suppressor gene; the feed is prepared from the following raw materials in parts by weight: 10-50 parts of caulis spatholobi, 5-60 parts of sculellaria barbata, 3-40 parts of radix bupleuri, 3-30 parts of semen lepidii, 2-20 parts of bitter almond, 10-40 parts of purslane, 5-60 parts of astragalus mongholicus, 5-60 parts of codonopsis pilosula and 10-40 parts of honeysuckle.

The traditional Chinese medicine composition effectively grasps the key target of the prostate cancer by utilizing big data analysis and network pharmacology analysis to inhibit the oncogene of the prostate cancer and promote the cancer suppressor as the core to solve the problem of the prostate cancer, and the concrete basis is as follows.

(1) Etiology mechanism of prostate cancer

In a chronic inflammatory microenvironment, damage to prostate epithelial cells due to constant infiltration of inflammatory factors or repeated stimulation of carcinogens can lead to local atrophy of the prostate or proliferative inflammatory atrophy, with the hyperplastic epithelial cell phenotype mostly intermediate between basal cells and mature luminal cells. A few of the proliferating cells have the characteristics of stem cells, and the genomes of the proliferating cells are changed, such as the overexpression of oncogenes AR and ETV5, the fusion of ERG-TMPRSS2, the silencing of cancer suppressor genes NKX3.1, PTEN and CDKN1B and the like, so that the cells of the prostate are converted into high-grade intraepithelial neoplasia or early canceration of the prostate, and the fusion of AR mutation and ERG-TMPRSS2 and the like drive the progression of the prostate cancer.

(2) Prostate cancer key regulatory gene mining based on life big data

Based on the etiology and mechanism of the prostate cancer, the life cycle data is combined with clinical gene data to excavate 7 key genes closely related to the prostate cancer, namely AR, ERG, PTEN, TMPRSS2, CDKN1B, NKX3-1 and ETV 5; wherein the carcinogenic genes are AR, ERG, TMPRSS2, ETV 5; the cancer suppressor gene is PTEN, CDKN1B and NKX 3-1.

(3) Screening of compound traditional Chinese medicine for regulating key gene

Another patent to the first invention of the present invention: a method for screening Chinese medicinal composition with network targeting function from molecular level (202010553171.2) 'Chinese medicinal data analysis method', screens out 43 active ingredients of key gene for regulating and controlling prostatic cancer, further screens out corresponding candidate Chinese medicinal according to the 43 active ingredients, and finally determines the medicament to form the composition according to clinical experience thought of Liumin of the doctor of China.

The 43 active components for regulating and controlling the key genes of the prostatic cancer comprise: 3-methyl rhamnonin (rhamnazin), Wogonin (Wogonin), Paeonol (Paeonol), Quercetin (Quercetin), 2-heptanone (Ketone), Puerarin (Puerarin), Luteolin (Luteolin), Apigenin (Apigenin), Capsaicin (Capsaicin), sulforaphane (4-methylsulyfutyi isocyanine), Formononetin (Ononin), Formononetin (Formononetin), Calycosin (Calycosin), galangin (Jaranol), Rhamnocitrin (Rhamnoxicillin), 5-O-methyl vitamin amigoside (5-O-methyl isoflavone), 7-O-methyl isoalcohol (7-O-methyl isoflavone), microprotrusinol (2 ',4' -hydroxy-3 ' -4- (4-hydroxy-3-hydroxy-1, 4-hydroxy-3-1-hydroxy-3-4-hydroxy-3-menthyl) -1-4-hydroxy-3-4-menthyl-4-hydroxy-3-4-menthyl-3-oxo-4-hydroxy-3-1-4-hydroxy-3-1-hydroxy-3-4-3-hydroxy-3-1-4-hydroxy-3-4-3-4-hydroxy-4-3-hydroxy-4-3-hydroxy-3-4-hydroxy-3-hydroxy-4-hydroxy-4-hydroxy-one, 4-one, 3-one, 4-one, 4, 3,4, one, 3,4, one, 4, one, 4, one, castanospermin (Castanin), 8-O-methylledumycin (8-O-methylreuusi), 8-C-alpha-L-arabinobetaine (8-C-alpha-L-arabinosylluteolin), daidzin (Prunetin), Schizandrol (Schisandrin), Schizandrol (Schizandrol), chrysanthemin (Odoratin), licochalcone A (licohalcone a), equol (Vestinol), 2',4', 5-trihydroxy-7-methoxyisoflavone (Cajinin), medicamentol (Medicago), Kadsurin (Kadsurin), pseudoflavin (Psi-Baptigenin), (R) -2- (3, 4-dihydro-7-methoxy-2H-1-benzopyran-3-yl) -5-methoxyphenol (isovatin), Biochanin a (olmlein), Genistein (Genistein), Palmitic acid (Palmitic acid), estradiol (β -estradiol), β -carotene (β -carotene), arachidonic acid (arachidonic acid), Isorhamnetin (Isorhamnetin), Kaempferol (Kaempferol), sulforaphane (sulforaphane), allyl isothiocyanate (metastar oil).

The 9 Chinese medicaments which are correspondingly regulated and controlled optimally are screened according to the active ingredients and the medication experience of the national medical specialist: caulis spatholobi, barbed skullcap herb, radix bupleuri, semen lepidii, bitter almond, purslane, astragalus, codonopsis pilosula and honeysuckle are determined, and the dosage of the traditional Chinese medicine composition is determined, so that the traditional Chinese medicine composition provided by the invention is formed, and the traditional Chinese medicine composition specifically comprises the following components: 10-50 parts of caulis spatholobi, 5-60 parts of sculellaria barbata, 3-40 parts of radix bupleuri, 3-30 parts of semen lepidii, 2-20 parts of bitter almond, 10-40 parts of purslane, 5-60 parts of astragalus mongholicus, 5-60 parts of codonopsis pilosula and 10-40 parts of honeysuckle.

(4) Network pharmacological analysis of compositions

The big data traditional Chinese medicine composition for regulating and controlling the prostate cancer carries out targeted regulation and control on oncogenes and cancer suppressor genes of the prostate cancer through the network effect of 'multiple traditional Chinese medicines-multiple components-multiple targets', wherein the active components and the targeted action relation of the traditional Chinese medicine composition are shown in a table 1, and the network pharmacological action is shown in a figure 1.

TABLE 1 relationship between active ingredients and targeting effect of Chinese medicinal composition

Network pharmacological analysis shows that the 9 traditional Chinese medicine compositions of the invention can act on oncogene AR except bitter apricot kernel, wherein 31 active ingredients have AR regulation function; the Chinese medicinal materials for regulating oncogene ERG are radix Codonopsis and semen Lepidii, wherein 2 active ingredients have ERG regulating effect; the Chinese medicinal materials for regulating and controlling oncogene TMPRSS2 include bupleuri radix, flos Lonicerae, herba Portulacae, herba Scutellariae Barbatae, semen Lepidii, and radix Codonopsis, wherein 5 active ingredients have TMPRSS2 regulating and controlling effect; the Chinese medicine for regulating and controlling oncogene ETV5 is bitter almond, and its active component beta-estradiol has the function of regulating and controlling ETV 5; the Chinese medicine for regulating and controlling cancer suppressor gene CDKN1B is bupleuri radix, and its active component, puerarin, has CDKN1B regulating and controlling effect; the traditional Chinese medicine for regulating and controlling the cancer suppressor gene NKX3-1 is astragalus mongholicus, radix bupleuri, honeysuckle, purslane, sculellaria barbata and semen lepidii, and the quercetin which is a common active ingredient has a CDKN1B regulation and control effect; all the traditional Chinese medicines have the function of regulating and controlling cancer suppressor gene PTEN, wherein 5 active ingredients have the function of regulating and controlling PTEN; the 9 traditional Chinese medicines are matched to form system regulation and control on key gene targets of the prostate cancer. Network pharmacological analysis shows that the composition has a clear action target network, a clear molecular mechanism and a network regulation and control effect of a system.

(5) Medical verification

Caulis spatholobi: bitter, sweet and warm, entering liver and kidney channels to activate blood and enrich blood, regulate menstruation and relieve pain, relax tendons and activate collaterals; can be used for treating anemia, thrombocytopenia, and leukopenia due to cancer.

Barbed skullcap herb: pungent, bitter and cold, entering lung, liver and kidney meridians, clearing heat and removing toxicity, removing blood stasis and inducing diuresis; the extract can inhibit prostate cancer cell proliferation.

Bupleurum root: pungent, bitter and slightly cold, entering liver, gallbladder and lung meridians, dispersing and abating fever, soothing liver-qi stagnation, and lifting yang qi; the saikosaponin has proliferation inhibiting and apoptosis inducing effects on prostate cancer DU145 cells.

Semen lepidii: pungent, bitter and cold in property, entering lung and bladder meridians, purging lung to relieve asthma, and inducing diuresis to alleviate edema; has cytotoxic effect on prostate cancer cells.

Bitter apricot seeds: bitter and slightly warm; has small toxicity, enters lung and large intestine channels, lowers qi, relieves cough and asthma, and moistens intestine to relieve constipation, and is used for treating cough and asthma, fullness in chest and excessive phlegm, and constipation due to intestinal dryness; amygdalin promotes apoptosis of prostate cancer cells.

Purslane: sour and cold, entering liver and large intestine channels, clearing away heat and toxic material, cooling blood and stopping bleeding, and stopping dysentery; commonly used anticancer drugs.

Honeysuckle flower: sweet and cold, entering lung, heart and stomach meridians, clearing away heat and toxic material, and dispelling wind and heat; has cancer cytotoxicity, and can inhibit DNA synthesis of cancer cells.

Astragalus root: sweet and slightly warm, entering lung and spleen channels, tonifying qi and raising yang, consolidating superficial resistance and arresting sweating, inducing diuresis to alleviate edema, promoting the production of body fluid and nourishing blood, activating stagnancy and removing obstruction of qi, expelling toxin and discharging pus, healing sore and promoting granulation; improve the immunity of the organism and promote the proliferation of immune cells.

Codonopsis pilosula: sweet and neutral, spleen and lung channels, spleen and lung tonifying, blood nourishing and body fluid production promoting; improving immunity and activating immunocyte activity.

The 9 traditional Chinese medicines are used together to promote blood circulation to remove blood stasis, clear away heat and toxic materials, strengthen the body resistance and consolidate the constitution, and are suitable for regulating and controlling the prostatic cancer. Therefore, the composition design of the invention is formed according to life big data, and simultaneously accords with the traditional Chinese medicine theory and pharmacological research results.

The invention has the beneficial effects that: firstly, the invention finds key gene targets of the prostate cancer from the etiology mechanism through a big data tool and a network pharmacology analysis method, further finds compounds for regulating the key gene targets, further screens out candidate traditional Chinese medicines, and finally forms the composition of the invention by combining Liu-Yi Engineers with clinical experience thought, wherein the composition mining process forms a compact corresponding relation of gene-compound-traditional Chinese medicine-physical sign, and carries out systematic regulation and control on the molecular layer for the symptoms by using a regulation and control network of multiple targets, multiple compounds and multiple traditional Chinese medicines, so that the invention has the advantages of science, comprehensiveness and systematicness; secondly, the composition performs multidimensional network regulation and control on cancer related oncogenes and cancer suppressor genes, and has the advantage of precise targeted regulation and control.

Drawings

FIG. 1 network pharmacological relationship diagram of Chinese medicinal composition for regulating and treating prostatic cancer

In the figure, the triangle nodes represent traditional Chinese medicines, the circle nodes represent compounds, and the diamond nodes represent gene targets; the size of the node and the number of the edges both represent direct action relations between the node and other nodes, and the larger the node is, the more the edges are, the more important the node is in the network; some compounds in the figure are marked by numbers, and the compounds are shown in Table 2 in comparison with the numbers.

TABLE 2 comparison of Compounds with numbers

Number of	Compound (I)
		MOL000373	5-O-Methylvisammioside
MOL000436	(Z)-1-(2,4-dihydroxyphenyl)-3-(3,4-dihydroxyphenyl)prop-2-en-1-one
		MOL008388	4-methylsulfinylbutyl isothiocyanate
MOL000378	7-O-methylisomucronulatol
		MOL000470	8-C-α-L-arabinosylluteolin

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example (A)

Example 1

A big data traditional Chinese medicine composition for regulating and controlling prostate cancer is prepared from the following raw materials by weight: 10 parts of caulis spatholobi, 5 parts of sculellaria barbata, 3 parts of radix bupleuri, 3 parts of semen lepidii, 2 parts of bitter almond, 10 parts of purslane, 5 parts of astragalus membranaceus, 5 parts of codonopsis pilosula and 10 parts of honeysuckle.

Example 2

A big data traditional Chinese medicine composition for regulating and controlling prostate cancer is prepared from the following raw materials by weight: 20 parts of caulis spatholobi, 20 parts of sculellaria barbata, 20 parts of radix bupleuri, 20 parts of semen lepidii, 20 parts of bitter almond, 20 parts of purslane, 20 parts of astragalus membranaceus, 20 parts of codonopsis pilosula and 20 parts of honeysuckle.

Example 3

A big data traditional Chinese medicine composition for regulating and controlling prostate cancer is prepared from the following raw materials by weight: 20 parts of caulis spatholobi, 30 parts of sculellaria barbata, 10 parts of radix bupleuri, 10 parts of semen lepidii, 10 parts of bitter almond, 30 parts of purslane, 15 parts of astragalus membranaceus, 20 parts of codonopsis pilosula and 25 parts of honeysuckle.

Example 4

A big data traditional Chinese medicine composition for regulating and controlling prostate cancer is prepared from the following raw materials by weight: 50 parts of caulis spatholobi, 60 parts of sculellaria barbata, 40 parts of radix bupleuri, 30 parts of semen lepidii, 20 parts of bitter almond, 40 parts of purslane, 60 parts of astragalus mongholicus, 60 parts of codonopsis pilosula and 40 parts of honeysuckle.

(II) functional verification of the product of the embodiment

A first part: sample preparation method

The traditional Chinese medicine for regulating and controlling the prostate cancer is prepared by the following methods in example 1, example 2, example 3 and example 4:

s1 selecting caulis Spatholobi, herba Scutellariae Barbatae, bupleuri radix, semen Lepidii, semen Armeniacae amarum, herba Portulacae, radix astragali, radix Codonopsis, and flos Lonicerae;

s2 weighing caulis Spatholobi, herba Scutellariae Barbatae, bupleuri radix, semen Lepidii, semen Armeniacae amarum, herba Portulacae, radix astragali, radix Codonopsis, and flos Lonicerae respectively according to the proportion of the examples, adding 8-10 times of water, leaching at 97-98 deg.C for 1h, filtering with 200 mesh sieve to obtain filtrate;

s3 adding 5-10 times of water into the residue, leaching at 97-98 deg.C for 1h, and filtering with 200 mesh sieve to obtain filtrate;

s4 mixing the filtrates, concentrating if necessary, precipitating, filtering with 200 mesh sieve, and collecting the filtrate;

s5, fixing the volume and mixing uniformly; meanwhile, according to the requirement, a proper amount of sweetening agent, sour agent and essence and spice can be added to modify the taste;

s6 filtering, filling and sterilizing to obtain the finished product.

A second part: effect verification

First, effect on human prostatic cancer PC3 apoptosis

1. Experimental methods

Human prostate cancer PC3 cells were cultured in a humidified incubator at 37 ℃ under 5% CO 2. Culturing in DMEM culture medium (containing 10% FBS, 1 u/ml penicillin, 1 g/ml streptomycin), and collecting cells in logarithmic growth phase at 3 × 10⁵The density of each cell was seeded at 25 cm²In a culture dish; example set: after the adherence, the liquid medicine is changed into DMEM culture solution containing 10mL of liquid medicine/culture dish and 10% of fetal calf serum in different embodiments; control group: after the adherence, the culture medium was changed to DMEM containing 10% fetal bovine serum only. Cells were collected after 24 h of culture for each group, treated with an apoptosis detection kit, and tested with a flow cytometer. Statistical analysis is carried out by adopting an SPSS statistical program to pair a t test method, wherein P is less than 0.05 and represents significant difference, and P is less than 0.01 and represents very significant difference.

2. Analysis of results

TABLE 3 apoptosis results of PC3 cells

Group of	The apoptosis rate%
		Control group	3.4±0.47
Example 1	19.4±0.64
		Example 2	39.6±0.72
Example 3	52.3±0.85
		Example 4	48.6±0.93

Flow cytometry analysis results show that the natural apoptosis rate of PC3 cells is (1.4 +/-0.47)%, the apoptosis rate of PC3 cells induced by each group after the medicinal liquid in the embodiment of the invention is added is increased to different degrees, the apoptosis rate is the highest as that in the embodiment 3, and the difference is statistically significant compared with a control group (P is less than 0.05).

Second, Effect on mouse prostate transplantable tumors

1. Experimental Material

30 BALB/c nu/nu male nude mice age 4-6 weeks, weight 12-18g, SPF grade; the prostate cancer cell PC3 was routinely subcultured.

2. Test method

Preparation of a nude mouse transplantation tumor model: using RP-MI-1640 complete medium containing 10% fetal calf serum at 37 deg.C and 5% CO₂Culturing PC3 cells in incubator, collecting PC3 cells in logarithmic growth phase, processing, and making into 2 × 10⁶Injecting 0.2mL of prostate cancer cell strain PC3 cell suspension to the neck and back of BALB/c male nude mice subcutaneously under aseptic condition; after one week, 30 tumor-bearing mice with tumor size of 0.4cm × 0.4cm × 0.4cm were selected and randomly divided into the example group (n = 24) and the blank control group (n = 6), and there was no significant difference in the size of the tumor volume between the two groups.

Administration: the treatment group is injected with 4 g/kg of the traditional Chinese medicine liquid in each embodiment group in the abdominal cavity every day, and the control group is injected with normal saline for 3 weeks continuously; two groups were fed normally.

And (3) detection: blood is collected from the eyeballs of the mice, and the PSA level of the mice is detected by adopting a full-automatic chemiluminescence immunoassay system. Mice were sacrificed and tumors were completely harvested and the primary tumor was weighed using an electronic balance. Statistical analysis is carried out by adopting an SPSS statistical program to match a t test method, wherein P is less than 0.05, which shows that the significant difference exists, and P is less than 0.01, which shows that the significant difference exists.

3. Analysis of results

The tumor weight of the mice treated by the liquid medicine injected in each embodiment is smaller than that of the control group, and the PSA index has a remarkable reduction trend, which shows that the composition has a good inhibition effect on the occurrence and development of prostate cancer tumors.

TABLE 4 Effect on tumor size and PSA

Group of	Tumor (g)	PSA（ng/mL）
			Control group	3.56±0.16	8.26±0.44
Example 1	2.79±0.15	5.23±0.36*
			Example 2	2.37±0.09*	4.67±0.33*
Example 3	1.24±0.12*	3.55±0.75*
			Example 4	1.88±0.17*	4.18±0.49*

Note: p <0.05 compared to control group.

Third, clinical effects

1. Inclusion criteria for case diagnosis

Compliance with prostate cancer diagnostic criteria: the prostate cancer is confirmed by pathology; T3N0M0 any G; T4N0M0 any G; any TN1M0 any G; any T any NM1 any G, T3 was not resistant to the operator.

Inclusion criteria were: the pathological result of the puncture biopsy is confirmed to be prostate cancer, and the prostate cancer is confirmed to be stage III and IV prostate cancer by combining with imaging examination, and is not suitable for radical operation. Estimating the survival time to be more than 12 months; can adhere to the treatment scheme and can accept the follow-up patients; the age is less than 90 years; voluntarily signs an informed consent and voluntarily participates in clinical experimenters.

2. Exclusion criteria

Allergic constitution or allergic to the developed drugs; patients with severe combined symptoms, cerebral, hepatic, renal and hematopoietic disorders, pain disorders and psychosis; patients with primary malignancies other than prostate adenocarcinoma; allergic constitution is allergic to the traditional Chinese medicine decoction; it belongs to the end stage of tumor, in which many organs are failing and there is no therapeutic value.

3. Research method

Grouping: the simple western medicine treatment is taken as a control group, the composition of the embodiment 1-4 is taken as a verification group 1-4, and each group comprises 15 cases.

The treatment method comprises the following steps: western medicine treatment, selecting goserelin acetate 3.6mg, or goserelin 3.6mg for subcutaneous injection, and injecting once every 28 days; bicalutamide tablets 50mg are orally taken one tablet per day; the treatment period is 3 months. For traditional Chinese medicine treatment, the compositions of embodiments 1-4 of the invention are all: 30 ml/time, 3 times a day; the administration is continued for 3 months.

4. Evaluation of detection

Closely observing and following two groups of patients for 3 months, detecting the levels of prostate specific antigen (tPSA), serum testosterone (T) at the time of group entry, 1 month and 3 months of treatment; statistical analysis is carried out by adopting an SPSS statistical program to match a t test method, wherein P is less than 0.05, which shows that the significant difference exists, and P is less than 0.01, which shows that the significant difference exists.

5. Analysis of results

The level of tPSA and T of the prostate cancer patient is abnormally increased, the level of tPSA and T can sensitively reflect the current disease change of the patient, and the judgment of the prognosis is more objective. The results in table 5 show that both tPSA and T were reduced after treatment compared to those before treatment; the example group was more effective in reducing PSA and T levels than the control group compared to the pre-treatment group.

TABLE 5 comparison of tPSA with T before and after treatment

Note: p <0.05 compared to control.

Fourth, conclusion

The invention utilizes big data mining and network pharmacology analysis methods to combine clinical evidence experience of national doctors to screen out a big data traditional Chinese medicine composition for regulating and controlling prostate cancer, and in vitro cell experiments, mouse experiments and clinical verification show that the traditional Chinese medicine composition has obvious apoptosis promoting effect on prostate cancer PC3 cells, has inhibiting effect on the occurrence and development of tumors, effectively reduces the level of tPSA and T of patients and has good clinical effect.

Any combination of the summary of the invention and the detailed description in this specification, including any preceding description, is not intended to be exhaustive or to limit the scope of the invention to the precise form disclosed, and all such combinations are not intended to be considered limiting. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. The big data traditional Chinese medicine composition for regulating and controlling the prostate cancer is characterized by being prepared from the following raw materials in parts by weight: 10-50 parts of suberect spatholobus stem, 5-60 parts of barbed skullcap herb, 3-40 parts of Chinese thorowax root, 3-30 parts of pepperweed seed, 2-20 parts of bitter apricot seed, 10-40 parts of purslane, 5-60 parts of astragalus root, 5-60 parts of pilose asiabell root and 10-40 parts of honeysuckle flower.

2. The big data traditional Chinese medicine composition for regulating and controlling prostate cancer according to claim 1, wherein the composition comprises 9 traditional Chinese medicines, 43 core active ingredients and 7 key gene targets for regulating and controlling prostate cancer.

3. The Chinese medicinal composition of claim 2, which regulates 7 key gene targets of prostate cancer, and mainly regulates 4 oncogenes AR, TMPRSS2, ERG, ETV5, 3 cancer suppressor genes CDKN1B, NKX3-1, and PTEN.

4. The 43 core active ingredients for modulating prostate cancer according to claim 2, wherein the active ingredients comprise: 3-methyl rhamnonin (rhamnazin), Wogonin (Wogonin), Paeonol (Paeonol), Quercetin (Quercetin), 2-heptanone (Ketone), Puerarin (Puerarin), Luteolin (Luteolin), Apigenin (Apigenin), Capsaicin (Capsaicin), sulforaphane (4-methylsulyfutyi isocyanine), Formononetin (Ononin), Formononetin (Formononetin), Calycosin (Calycosin), galangin (Jaranol), Rhamnocitrin (Rhamnoxicillin), 5-O-methyl vitamin amigoside (5-O-methyl isoflavone), 7-O-methyl isoalcohol (7-O-methyl isoflavone), microprotrusinol (2 ',4' -hydroxy-3 ' -4- (4-hydroxy-3-hydroxy-1, 4-hydroxy-3-1-hydroxy-3-4-hydroxy-3-menthyl) -1-4-hydroxy-3-4-menthyl-4-hydroxy-3-4-menthyl-3-oxo-4-hydroxy-3-1-4-hydroxy-3-1-hydroxy-3-4-3-hydroxy-3-1-4-hydroxy-3-4-3-4-hydroxy-4-3-hydroxy-4-3-hydroxy-3-4-hydroxy-3-hydroxy-4-hydroxy-4-hydroxy-one, 4-one, 3-one, 4-one, 4, 3,4, one, 3,4, one, 4, one, 4, one, castanospermin (Castanin), 8-O-methyl ledum (8-O-methyl reyusi), 8-C-alpha-L-arabinobetaine (8-C-alpha-L-arabinosylluteolin), daidzin (Prunetin), Schizandrol (Schizandrin), Schizandrol (Schizandrol), coumarine (oxydarin), licochalcone A (licohalcone a), equol (Vestinol), 2',4', 5-trihydroxy-7-methoxyisoflavone (Cajinin), alfalfa lactone (medicol), Kadsurin (Kadsurin), pseudoindigoid (Psi-Baptigenin), (R) -2- (3, 4-dihydro-7-methoxy-2H-1-benzopyran-3-yl) -5-methoxyphenol (Istivan), Biochanin a (olmlein), Genistein (Genistein), Palmitic acid (Palmitic acid), estradiol (β -estradiol), β -carotene (β -carotene), arachidonic acid (arachidonic acid), Isorhamnetin (Isorhamnetin), Kaempferol (Kaempferol), sulforaphane (sulforaphane), allyl isothiocyanate (metastar oil).

5. The core active ingredient for regulating prostate cancer according to claim 2, wherein Luteolin (Luteolin), Formononetin (Ononin), Formononetin (Formononetin), Calycosin (Calycosin), 2',4', 3, 4-tetrahydroxychalcone ((Z) -1- (2,4-dihydroxyphenyl) -3- (3,4-dihydroxyphenyl) prop-2-en-1-one), Castanin (Castanin), 8-O-methylleydi (8-O-methylreusis), 8-C-alpha-L-arabinobetaine (8-C-alpha-L-arabinobetaine), daidzin (Prunetin), methanol (Schisandrin), Schizanol (Schizandrol), aromatic membrane (edoxin), chalcone (glycyrrhetin), dihydrochalcone (Luteolin), 2', 4-tetrahydrochalcone (Castanin), Castanin (Castanin), castanospermin, castanospermine (castanosperminin), and other compounds (schizandrin), such as a, Equidofol (Vestinol), 2',4', 5-trihydroxy-7-methoxyisoflavone (Cajinin), lucernolide (Medicago), Kadsurin (Kadsurin), pseudoindoxanthin (Psi-Baptigenin), (R) -2- (3, 4-dihydro-7-methoxy-2H-1-benzopyran-3-yl) -5-methoxyphenol (isospatvan), biochanin A (Olmelin), Apigenin (Apigenin), Quercetin (Quercetin), 3-methylhydroamnin (Rhamnazin), Wogonin (Wogonin), Isorhamnetin (Isohamnetin), Kaempferol (Kaempferol), galangin (Rananol), rhamniferin (Rhamnocin), 5-O-methylretinol (5-O-methylamethoside), and purslane-7-methylosol (5-O-methylamethol-7-methylosol (purslane-7-O-isopropylenol), The compound is prepared by reacting on oncogene with phenol (microclonlatol), sulforaphane (4-methylsulfmylbutyi isocyanide), sulforaphane (sulforaphane), Capsaicin (Capsaicin), 2-heptanone (Ketone), allyl isothiocyanate (mustard oil), beta-carotene (beta-carotene) and estradiol (beta-radiodiol); genistein (Genistein), Palmitic acid (Palmitic acid), Paeonol (Paeonol), Quercetin (Quercetin), arachidonic acid (arachidonic acid), and Puerarin (Puerarin), and act on cancer suppressor gene.

6. The use of the Chinese medicinal composition of claim 1 in prostate cancer regulation is protected.