Chinese medicine compound composition for treating anti-mammary gland hyperplasia, its preparation method and application

Abstract

The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine compound composition for resisting mammary gland hyperplasia, a preparation method and application thereof. The traditional Chinese medicine compound composition comprises a traditional Chinese medicine composition and probiotics, the mass ratio of the traditional Chinese medicine composition to the probiotics is 10-12:1, the probiotics comprises lactobacillus plantarum, red tea bacteria, yeast bacteria and acetic acid bacteria, the mass ratio of the lactobacillus plantarum, the red tea bacteria, the yeast bacteria and the acetic acid bacteria is 7-9:7-9:0.5-1.5:0.5-1.5, and the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 parts of sweet ground ivy, 5-15 parts of dandelion, 15-25 parts of honeysuckle, 5-15 parts of angelica, and 5-15 parts of bupleurum. The traditional Chinese medicine compound composition and the traditional Chinese medicine preparation for resisting mammary gland hyperplasia prepared by taking the traditional Chinese medicine compound composition as an active ingredient can resist mammary gland hyperplasia and regulate intestinal flora. The traditional Chinese medicine preparation for resisting mammary gland hyperplasia is additive-free, and has important application in products for resisting mammary gland hyperplasia.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine compound composition for treating mammary gland hyperplasia and a preparation method and application thereof. BACKGROUND

[0002] Mammary gland hyperplasia is a pathological phenomenon that fibrosis is caused by excessive hyperplasia or incomplete involution of mammary gland due to imbalance of estrogen and progesterone, which causes mammary gland pain and disorder of tissue structure. Mammary gland hyperplasia can be divided into five types, i.e. lobular hyperplasia, ductal hyperplasia, fibroadenosis, fibrosis nodule and cystic hyperplasia. In China, the incidence of mammary gland hyperplasia accounts for 70-80% of all mammary gland diseases, and it mainly occurs in women aged 25-45 years old, and the incidence of the disease has a trend of younger and younger with the modernization of society. The disease is a major enemy of the health of Chinese people.

[0003] Mammary gland disease is affected by many factors, and mammary gland hyperplasia is also a risk factor for breast cancer. According to the GLOBOCAN 2020 global cancer statistics, breast cancer has ranked first, so early intervention of mammary gland hyperplasia plays a very important role. In addition to the common clinical symptoms of breast lumps and nipple discharge, mammary gland hyperplasia can also cause emotional problems such as irritability, which seriously endangers the physical health and happiness index of people all over the world. Therefore, mammary gland hyperplasia has become a major scientific problem affecting the national economy and people's livelihood of the world, and should be paid attention to by scientific research.

[0004] At present, there are still great limitations in the clinical intervention means for mammary gland hyperplasia. The treatment of mammary gland hyperplasia is mainly surgical treatment, and local resection of hyperplastic glands and dilated mammary ducts is adopted in surgical treatment, which is easy to cause retention of part of breast metabolites, thereby affecting the health of the breast. And after resection of the glands, it may cause upper limb nerve injury, causing upper limb swelling, upper limb venous thrombosis and other symptoms. Therefore, in today's higher standard for human health, although many new methods to reduce the damage to the body have appeared in surgical treatment, the essence of breast surgery is to use resection as a means of governance, and its damage is self-evident. Therefore, it is particularly important to find and develop some natural, good treatment effect and less adverse reaction anti-mammary gland hyperplasia drugs.

[0005] At present, some relevant researches use traditional Chinese medicine to treat mammary gland hyperplasia and have made some progress. The relevant researches are as follows: Su JQ et al. randomly divided 80 cases of mammary gland hyperplasia patients into groups, the control group was given oral tamoxifen, and the test group was given traditional Chinese medicine Xiaoyao Powder (Radix Bupleuri 12g, Radix Paeoniae Alba 15g, Fructus Trichosanthis 20g, Rhizoma Pinelliae 15g, Rhizoma Atractylodis Macrocephalae 15g, Fructus Aurantii Immaturus 12g, Radix Angelicae Sinensis 15g, Poria cocos 15g, Rhizoma Cyperi 15g, Fritillariae 15g, Radix Glycyrrhizae 6g, Radix Curcumae 15g) on the basis of treatment of the control group, and the effect was evaluated after 2 months. It was found that the total effective rate of the test group was 97.5%, which was obviously better than the total effective rate of 80% of the control group.

[0006] Zhao Ruping et al. studied 100 cases of women diagnosed with breast hyperplasia, the control group used the conventional tamoxifen tablets combined with vitamin A treatment method, the test group further combined with Xiajinrukang pills (Radix Bupleuri, Radix Paeoniae Rubra, Hairy-leafed Szechwan Lovage Rhizome, Radix Paeoniae Alba, Bulbus Fritillariae Cirrhosae, Fructus Aurantii, Rhizoma Corydalis, Radix Curcumae, Rhizoma Curcumae, Rhizoma Alpiniae Officinarum, Rhizoma Anemarrhenae, Rhizoma Pinelliae, Rhizoma Zedoariae, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Radix Angelicae Sinensis) treatment, continuously taking for 2 menstrual cycles, it is found that the total effective rate of the control group is 82% which is worse than that of the test group 96%.

[0007] Qiu Juan et al. explored the treatment effect of Runing granules (Radix Paeoniae Rubra, Radix Bupleuri, Rhizoma Zedoariae, Radix Paeoniae Alba, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Fructus Aurantii, Radix Paeoniae Rubra, Radix Angelicae Sinensis) on liver stagnation and phlegm coagulation type breast hyperplasia patients, 86 patients were included in the study and randomly divided into groups, the control group orally took toremifene citrate, and the test group orally took toremifene citrate and Runing granules, it is found that the total effective rate of the test group is 97.67%, and the adverse reaction rate is 6.98%, while the total effective rate of the control group is 79.07%, and the adverse reaction rate is 25.58%, the test group is better than the control group in terms of effective rate and adverse reaction.

[0008] From the above research, it can be seen that using traditional Chinese medicine to resist breast hyperplasia is feasible. However, the existing technology of traditional Chinese medicine preparation in resisting breast hyperplasia has the problems of long treatment time and serious side effects, which leads to the effect not being very satisfactory. SUMMARY

[0009] In order to solve the problem of long treatment time and serious side effects of traditional Chinese medicine preparation in resisting breast hyperplasia in the prior art, which leads to the effect not being very satisfactory, a traditional Chinese medicine compound composition for resisting breast hyperplasia and its preparation method and application are provided. In order to achieve the above-mentioned purpose, the technical scheme is as follows:

[0010] The present application provides a kind of traditional Chinese medicine compound composition for resisting breast hyperplasia, the traditional Chinese medicine compound composition includes traditional Chinese medicine composition and probiotics, the mass ratio of the traditional Chinese medicine composition and the probiotics is 10-12:1;

[0011] The probiotics include Lactobacillus plantarum, red tea bacteria, yeast bacteria and acetic acid bacteria, and the mass ratio of Lactobacillus plantarum, red tea bacteria, yeast bacteria and acetic acid bacteria is 7-9:7-9:0.5-1.5:0.5-1.5;

[0012] The traditional Chinese medicine composition is composed of the following raw materials by weight fraction: 5-15 parts of sweet earth, 5-15 parts of dandelion, 15-25 parts of honeysuckle, 5-15 parts of angelica, 5-15 parts of bupleurum.

[0013] The application further provides a preparation method of the traditional Chinese medicine compound composition for resisting breast hyperplasia, which comprises the following steps:

[0014] S1, ingredients of the traditional Chinese medicine composition are weighed according to a formula, crushed, mixed, and a traditional Chinese medicine composition is obtained; or ingredients of the traditional Chinese medicine composition are weighed according to a formula, water is added for decoction, and the decoction liquid is sequentially filtered and concentrated to a volume of the filtered decoction liquid being reduced by one-third, and a traditional Chinese medicine composition is obtained;

[0015] S2, the traditional Chinese medicine composition obtained in S1 is sterilized;

[0016] S3, after sterilization, the sterilized traditional Chinese medicine composition is mixed with probiotics in the formula, probiotic fermentation is carried out, the fermentation liquid is collected and concentrated, and a traditional Chinese medicine compound composition is obtained.

[0017] Preferably, in S1, the ingredients are crushed and treated and then passed through a 40-mesh sieve.

[0018] Preferably, in S2, high-temperature steam sterilization is repeated 2-3 times, each sterilization lasts for 0.5-1.5 hours, and the sterilization temperature is 80-100 DEG C.

[0019] Preferably, in S3, during probiotic fermentation, the sterilized traditional Chinese medicine composition is taken into a bacterial culture bottle, mixed, placed in a constant-temperature incubator at 36-38 DEG C, and fermented for 6-8 days.

[0020] Preferably, in S3, on the 7th-9th day of fermentation, the fermentation liquid is filtered, the filtered liquid is collected, bottled and concentrated, and a traditional Chinese medicine compound composition is obtained.

[0021] The application further provides application of the traditional Chinese medicine compound composition in preparation of a medicine for resisting breast hyperplasia.

[0022] The application further provides a traditional Chinese medicine preparation for resisting breast hyperplasia, which takes the traditional Chinese medicine compound composition in claim 1 as an active ingredient and is supplemented with a pharmaceutically acceptable adjuvant or carrier.

[0023] The application further provides a traditional Chinese medicine preparation for resisting breast hyperplasia, which takes the traditional Chinese medicine compound composition in claim 1 as an active ingredient and is supplemented with a pharmaceutically acceptable adjuvant or carrier.

[0024] Compared with the prior art, the application has the following beneficial effects:

[0025] 1. The present application provides a kind of traditional Chinese medicine compound composition for anti-mammary gland hyperplasia, the traditional Chinese medicine compound composition has the advantages of short course of treatment, quick effect in treating mammary gland hyperplasia disease, and almost no toxic side effects to human body, and green, healthy traditional Chinese medicine raw materials are used, and it has good therapeutic effect on anti-mammary gland hyperplasia disease.The present application aims at the severe situation of mammary gland hyperplasia disease at present, adopts traditional Chinese medicine composition (sweet ground, angelica, honeysuckle, dandelion, radix bupleuri prescription), among them, radix bupleuri soothes liver and relieves depression, and removes evil from outside; Sweet ground detoxifies and relieves blood stasis; Dandelion resolves phlegm and eliminates mass, and relieves heat; Auxiliary medicine and monarch medicine adjust and smooth breath; Angelica has the effects of promoting blood circulation, removing blood stasis, regulating qi and unblocking meridians, soothing liver and regulating qi.The traditional Chinese medicine composition has good anti-mammary gland hyperplasia effect.Based on the fermentation of probiotics, the present application has the effects of regulating intestinal flora, green, healthy and effective anti-mammary gland hyperplasia disease, and has great social significance and value.

[0026] 2, The present application uses a plurality of probiotics to jointly ferment, regulates the abundance of intestinal flora, and enhances the effect of traditional Chinese medicine composition on anti-mammary gland hyperplasia.The strains used for fermentation are all probiotics, and the red tea fungus, yeast, lactobacillus plantarum and acetic acid bacillus have good fermentation effect on medicinal materials.

[0027] Red tea fungus: its bacterial membrane is similar to the skin of jellyfish, so it is called "sea treasure", red tea fungus contains some polysaccharides, tea polyphenols, low oligoisomaltooligosaccharides and theophylline, which can improve human immunity, enhance the resistance of the body; Increase the number of T-lymphocytes and B-lymphocytes, and improve the defense ability of the body.

[0028] Yeast vinegar bacteria: a kind of single-cell fungus, can help digest the contents in gastrointestinal tract, reduce the burden of gastrointestinal tract, and protect human digestive system.At the same time, yeast contains a large amount of glucose, which can provide energy for human body and promote human metabolism.

[0029] Lactobacillus plantarum is a round-ended straight bacillus, which can produce a large amount of bacteriostatic substances such as organic acids, bacteriocins and hydrogen peroxide, improve the immunity of the body, and promote the absorption and digestion of nutritional substances in the body.

[0030] Acetic acid bacillus is a kind of short bacillus, which contains rich organic acids, can stimulate brain nerves, secrete digestive enzymes, enhance the function of gastrointestinal digestion of patients, and improve the utilization rate of drugs; It contains protein, vitamin B and other nutrients, has the effects of antioxidant, protecting digestive system and promoting human metabolism. DETAILED DESCRIPTION OF DRAWINGS

[0031] Figure 1 The specific operation flow chart of the traditional Chinese medicine compound composition (traditional Chinese medicine composition) in the present application for studying the diversity of intestinal flora in mouse feces.

[0032] Figure 2Figure of the effect of the traditional Chinese medicine compound composition (traditional Chinese medicine composition) on HE staining of breast tissue in the application, wherein MA: acinus; MD: duct; LI: mammary lobule; a: blank group; b: model group; c: Xiaozhen Pill group; d: low-dose traditional Chinese medicine composition decoction of Tian Diding group; e: medium-dose traditional Chinese medicine composition decoction of Tian Diding group; f: high-dose traditional Chinese medicine composition decoction of Tian Diding group; g: low-dose traditional Chinese medicine compound composition group; h: medium-dose traditional Chinese medicine compound composition group; i: high-dose traditional Chinese medicine compound composition group.

[0033] Figure 3 Figure of the effect of the traditional Chinese medicine compound composition (traditional Chinese medicine composition) on serum hormones of mice with breast hyperplasia in the application, wherein a: estradiol; b: progesterone; c: follicle-stimulating hormone; d: prolactin; Blank: blank group; Model: model group; A: low-dose traditional Chinese medicine composition decoction of Tian Diding group; B: medium-dose traditional Chinese medicine composition decoction of Tian Diding group; C: high-dose traditional Chinese medicine composition decoction of Tian Diding group; D: low-dose traditional Chinese medicine compound composition group; E: medium-dose traditional Chinese medicine compound composition group; F: high-dose traditional Chinese medicine compound composition group; G: positive control (Xiaozhen Pill) group; *, compared with the model group, P less than 0.05.

[0034] Figure 4 Figure of the effect of the traditional Chinese medicine compound composition (traditional Chinese medicine composition) on the diversity of intestinal flora in the feces of mice in the application, wherein Phylum, Class, Order, Family, Genus, and Species represent phylum, class, order, family, genus, and species, respectively.

[0035] Figure 5 Figure of the effect of the traditional Chinese medicine compound composition (traditional Chinese medicine composition) on short-chain fatty acids in the feces of mice in the application, wherein a: acetic acid; b: propionic acid; c: isobutyric acid; d: butyric acid; e: isovaleric acid; f: valeric acid; g: caproic acid. DETAILED DESCRIPTION

[0036] The application will be described in detail below with reference to the accompanying drawings and specific examples, but should not be understood as limiting the application. If not specifically stated, the technical means used in the following examples are conventional means familiar to those skilled in the art, and the materials, reagents, etc. used in the following examples, if not specifically stated, can be obtained from commercial channels.

[0037] Example 1

[0038] An anti-breast hyperplasia traditional Chinese medicine compound composition, comprising a traditional Chinese medicine composition and probiotics, and the ratio of the traditional Chinese medicine composition to the probiotics is 10:1 (the amount of probiotics added in 60 g of the traditional Chinese medicine composition is 2.4 g of Lactobacillus plantarum, 2.4 g of red tea bacteria, 0.6 g of yeast bacteria, and 0.6 g of acetic acid bacteria, respectively).

[0039] The traditional Chinese medicine composition is composed of 10g of sweet earth, 10g of dandelion, 20g of honeysuckle, 10g of angelica, and 10g of bupleurum.

[0040] The preparation method of the traditional Chinese medicine compound composition for resisting breast hyperplasia includes the following steps:

[0041] S1, 10g of sweet earth, 10g of dandelion, 20g of honeysuckle, 10g of angelica, and 10g of bupleurum are taken respectively, and they are crushed and treated respectively, crushed and passed through a 40-mesh sieve, and mixed to obtain a traditional Chinese medicine composition.

[0042] S2, the traditional Chinese medicine composition is placed in a high-temperature steam sterilization pot and subjected to high-temperature sterilization at 100°C, and the high-temperature steam sterilization is repeated for 3 times, and each sterilization lasts for 1 hour.

[0043] S3, 60g of the traditional Chinese medicine composition after high-temperature steam sterilization is placed in a sterilized bacterial culture bottle on an ultra-clean bench, 2.4g of lactobacillus plantarum, 2.4g of red tea fungus, 0.6g of yeast, 0.6g of acetic acid bacillus microorganism, and 120ml of sterile water are added, and fully stirred and mixed, and finally sealed with a sealing film and stored in a constant temperature incubator at 37°C, fermented for 7 days, on the 8th day of fermentation, the fermentation liquid is filtered to remove the dregs, and the filtrate is vacuum freeze-dried to obtain a traditional Chinese medicine compound composition.

[0044] Example 2

[0045] A traditional Chinese medicine compound composition for resisting breast hyperplasia includes a traditional Chinese medicine composition and probiotics, and the ratio of the traditional Chinese medicine composition to the probiotics is 11:1 (the amount of probiotics added in 35g of the traditional Chinese medicine composition is 1.4g of lactobacillus plantarum, 1.4g of red tea fungus, 0.19g of yeast, and 0.19g of acetic acid bacillus).

[0046] The traditional Chinese medicine composition is composed of 5g of sweet earth, 5g of dandelion, 15g of honeysuckle, 5g of angelica, and 5g of bupleurum.

[0047] The preparation method of the traditional Chinese medicine compound composition for resisting breast hyperplasia includes the following steps:

[0048] S1, 5g of sweet earth, 5g of dandelion, 15g of honeysuckle, 5g of angelica, and 5g of bupleurum are taken respectively, and they are crushed and treated respectively, crushed and passed through a 40-mesh sieve, and mixed to obtain a traditional Chinese medicine composition.

[0049] S2, the traditional Chinese medicine composition is placed in a high-temperature steam sterilization pot and subjected to high-temperature sterilization at 100°C, and the high-temperature steam sterilization is repeated for 3 times, and each sterilization lasts for 1 hour.

[0050] S3, 35g of the traditional Chinese medicine composition after high-temperature steam sterilization is placed in a sterilized bacterial culture bottle on a clean bench, 1.4g of lactobacillus plantarum, 1.4g of red tea fungus, 0.19g of yeast, 0.19g of acetic acid bacteria and 120ml of sterile water are added, and fully stirred and mixed, and finally sealed with a sealing film, stored in a constant temperature incubator at 37°C, fermented for 7 days, on the 8th day of fermentation, the fermentation liquid is filtered, the dregs are filtered out, and the filtrate is vacuum freeze-dried to obtain the traditional Chinese medicine compound composition.

[0051] Example 3

[0052] A traditional Chinese medicine compound composition for resisting breast hyperplasia, comprising a traditional Chinese medicine composition and probiotics, the ratio of the traditional Chinese medicine composition to the probiotics being 12:1 (the amount of probiotics added in 85g of the traditional Chinese medicine composition being 3.4g of lactobacillus plantarum, 3.4g of red tea fungus, 0.28g of yeast and 0.28g of acetic acid bacteria respectively).

[0053] The traditional Chinese medicine composition is composed of the following raw materials: 15g of sweet earth, 15g of dandelion, 25g of honeysuckle, 15g of angelica, and 15g of bupleurum.

[0054] The preparation method of the traditional Chinese medicine compound composition for resisting breast hyperplasia comprises the following steps:

[0055] S1, 15g of sweet earth, 15g of dandelion, 25g of honeysuckle, 15g of angelica and 15g of bupleurum are respectively crushed and treated, and then sieved through a 40-mesh sieve to obtain a traditional Chinese medicine composition.

[0056] S2, the traditional Chinese medicine composition is placed in a high-temperature steam sterilization pot and subjected to high-temperature sterilization at 100°C, and the high-temperature steam sterilization is repeated for 3 times, each time for 1 hour.

[0057] S3, 85g of the traditional Chinese medicine composition after high-temperature steam sterilization is placed in a sterilized bacterial culture bottle on a clean bench, 3.4g of lactobacillus plantarum, 3.4g of red tea fungus, 0.28g of yeast, 0.28g of acetic acid bacteria and 120ml of sterile water are added, and fully stirred and mixed, and finally sealed with a sealing film, stored in a constant temperature incubator at 37°C, fermented for 7 days, on the 8th day of fermentation, the fermentation liquid is filtered, the dregs are filtered out, and the filtrate is vacuum freeze-dried to obtain the traditional Chinese medicine compound composition.

[0058] Example 4

[0059] A traditional Chinese medicine compound composition for resisting breast hyperplasia, comprising a traditional Chinese medicine composition and probiotics, the ratio of the traditional Chinese medicine composition to the probiotics being 11:1 (the amount of probiotics added in 55g of the traditional Chinese medicine composition being 2.33g of lactobacillus plantarum, 2.33g of red tea fungus, 0.17g of yeast and 0.17g of acetic acid bacteria respectively).

[0060] The traditional Chinese medicine composition is composed of 5g sweet earth, 10g dandelion, 20g honeysuckle, 10g angelica, and 10g bupleurum.

[0061] The preparation method of the traditional Chinese medicine compound composition for resisting breast hyperplasia includes the following steps:

[0062] S1, respectively take 5g sweet earth, 10g dandelion, 20g honeysuckle, 10g angelica, and 10g bupleurum, and crush them respectively, then pass them through a 40-mesh sieve, and mix to obtain a traditional Chinese medicine composition.

[0063] S2, the traditional Chinese medicine composition is placed in a high-temperature steam sterilization pot and sterilized at 100℃, and the high-temperature steam sterilization is repeated for 3 times, each time for 1 hour.

[0064] S3, 55g of the traditional Chinese medicine composition after high-temperature steam sterilization is placed in a sterilized bacterial culture bottle on a clean bench, 2.33g of lactobacillus plantarum, 2.33g of red tea bacteria, 0.17g of yeast bacteria, 0.17g of acetic acid bacteria, and 120ml of sterile water are added, and stirred thoroughly, then sealed with a sealing film, and stored in a constant temperature incubator at 37℃, and fermented for 7 days, on the 8th day of fermentation, the fermented liquid is filtered to remove the dregs, and the filtrate is vacuum freeze-dried to obtain a traditional Chinese medicine compound composition.

[0065] Example 5

[0066] A traditional Chinese medicine compound composition for resisting breast hyperplasia includes a traditional Chinese medicine composition and probiotics, and the ratio of the traditional Chinese medicine composition to the probiotics is 10:1 (the amount of probiotics added in 55g of the traditional Chinese medicine composition is respectively 2.36g of lactobacillus plantarum, 2.36g of red tea bacteria, 0.39g of yeast bacteria, and 0.39g of acetic acid bacteria).

[0067] The traditional Chinese medicine composition is composed of 10g sweet earth, 5g dandelion, 20g honeysuckle, 10g angelica, and 10g bupleurum.

[0068] The preparation method of the traditional Chinese medicine compound composition for resisting breast hyperplasia includes the following steps:

[0069] S1, respectively take 10g sweet earth, 5g dandelion, 20g honeysuckle, 10g angelica, and 10g bupleurum, and crush them respectively, then pass them through a 40-mesh sieve, and mix to obtain a traditional Chinese medicine composition.

[0070] S2, the traditional Chinese medicine composition is placed in a high-temperature steam sterilization pot and sterilized at 100℃, and the high-temperature steam sterilization is repeated for 3 times, each time for 1 hour.

[0071] S3, 100g of the traditional Chinese medicine composition after high-temperature steam sterilization is placed in a sterilized bacterial culture bottle on a clean bench, 2.57g of Lactobacillus plantarum, 2.57g of red tea fungus, 0.43g of yeast, 0.43g of acetic acid bacteria and 120ml of sterile water are added, and fully stirred and mixed, and finally sealed with a sealing film and stored in a constant temperature incubator at 37℃, fermented for 7 days, on the 8th day of fermentation, the fermentation liquid is filtered to filter out the dregs, and the filtrate is vacuum freeze-dried to obtain the traditional Chinese medicine compound composition.

[0072] Example 6

[0073] A traditional Chinese medicine compound composition for resisting breast hyperplasia, comprising a traditional Chinese medicine composition and probiotics, the ratio of the traditional Chinese medicine composition to the probiotics being 12:1 (the amount of probiotics added in 72g of the traditional Chinese medicine composition is respectively 2.57g of Lactobacillus plantarum, 2.57g of red tea fungus, 0.43g of yeast and 0.43g of acetic acid bacteria).

[0074] The traditional Chinese medicine composition is composed of the following raw materials: 10g of sweet earth, 10g of dandelion, 15g of honeysuckle, 10g of angelica, and 10g of bupleurum.

[0075] The preparation method of the traditional Chinese medicine compound composition for resisting breast hyperplasia comprises the following steps:

[0076] S1, 10g of sweet earth, 10g of dandelion, 15g of honeysuckle, 10g of angelica and 10g of bupleurum are respectively taken and crushed, and then sieved through a 40-mesh sieve to obtain a traditional Chinese medicine composition.

[0077] S2, the traditional Chinese medicine composition is placed in a high-temperature steam sterilization pot and subjected to high-temperature sterilization at 100℃, and the high-temperature steam sterilization is repeated for 3 times, each time for 1 hour.

[0078] S3, 100g of the traditional Chinese medicine composition after high-temperature steam sterilization is placed in a sterilized bacterial culture bottle on a clean bench, 2.57g of Lactobacillus plantarum, 2.57g of red tea fungus, 0.43g of yeast, 0.43g of acetic acid bacteria and 120ml of sterile water are added, and fully stirred and mixed, and finally sealed with a sealing film and stored in a constant temperature incubator at 37℃, fermented for 7 days, on the 8th day of fermentation, the fermentation liquid is filtered to filter out the dregs, and the filtrate is vacuum freeze-dried to obtain the traditional Chinese medicine compound composition.

[0079] Example 7

[0080] A traditional Chinese medicine compound composition for resisting breast hyperplasia comprises a traditional Chinese medicine composition and probiotics, and the ratio of the traditional Chinese medicine composition to the probiotics is 10:1 (the amount of the probiotics added in 60.2 g of the traditional Chinese medicine composition is respectively 2.58 g of lactobacillus plantarum, 2.58 g of red tea bacteria, 0.43 g of yeast bacteria and 0.43 g of acetic acid bacteria).

[0081] The traditional Chinese medicine composition is composed of 10.1 g of sweet earth, 10.1 g of dandelion, 20 g of honeysuckle, 5 g of angelica and 10 g of bupleurum.

[0082] The preparation method of the traditional Chinese medicine compound composition for resisting breast hyperplasia comprises the following steps:

[0083] S1, 10.1 g of sweet earth, 10.1 g of dandelion, 20 g of honeysuckle, 5 g of angelica and 10 g of bupleurum are respectively taken and crushed, and then sieved through a 40-mesh sieve to obtain a traditional Chinese medicine composition.

[0084] S2, the traditional Chinese medicine composition is placed in a high-temperature steam sterilization pot and subjected to high-temperature sterilization at 100℃, and the high-temperature steam sterilization is repeated for 3 times, and each time the sterilization lasts for 1 hour.

[0085] S3, 60.2 g of the traditional Chinese medicine composition after high-temperature steam sterilization is placed in a sterilized bacterial culture bottle on a super-clean bench, 2.58 g of lactobacillus plantarum, 2.58 g of red tea bacteria, 0.43 g of yeast bacteria, 0.43 g of acetic acid bacteria and 120 ml of sterile water are added, and then fully stirred and mixed, and finally sealed with a sealing film and stored in a constant-temperature incubator at 37℃, and fermented for 7 days, and on the 8th day of fermentation, the fermentation liquid is filtered to remove the dregs, and the filtrate is vacuum freeze-dried to obtain a traditional Chinese medicine compound composition.

[0086] Example 8

[0087] A traditional Chinese medicine compound composition for resisting breast hyperplasia comprises a traditional Chinese medicine composition and probiotics, and the ratio of the traditional Chinese medicine composition to the probiotics is 10:1 (the amount of the probiotics added in 60 g of the traditional Chinese medicine composition is respectively 2.8 g of lactobacillus plantarum, 2.8 g of red tea bacteria, 0.2 g of yeast bacteria and 0.2 g of acetic acid bacteria).

[0088] The traditional Chinese medicine composition is composed of 10 g of sweet earth, 10 g of dandelion, 20 g of honeysuckle, 10 g of angelica and 5 g of bupleurum.

[0089] The preparation method of the traditional Chinese medicine compound composition for resisting breast hyperplasia comprises the following steps:

[0090] S1, 10 g of sweet earth, 10 g of dandelion, 20 g of honeysuckle, 10 g of angelica and 5 g of bupleurum are respectively taken and crushed, and then sieved through a 40-mesh sieve to obtain a traditional Chinese medicine composition.

[0091] S2, the traditional Chinese medicine composition is placed in a high-temperature steam sterilization pot and subjected to high-temperature sterilization at 100°C, and the high-temperature steam sterilization is repeated for 3 times, with each sterilization lasting for 1 hour.

[0092] S3, 60g of the traditional Chinese medicine composition after high-temperature steam sterilization is placed in a sterilized bacterial culture bottle on an ultra-clean bench, 2.8g of lactobacillus plantarum, 2.8g of red tea bacteria, 0.2g of yeast, 0.2g of acetic acid bacteria microorganisms and 120ml of sterile water are added, and fully stirred and mixed, and finally sealed with a sealing film, stored in a constant temperature incubator at 37°C, fermented for 7 days, on the 8th day of fermentation, the fermentation liquid is filtered to filter out the dregs, and the filtrate is vacuum freeze-dried to obtain the traditional Chinese medicine compound composition.

[0093] Example 9

[0094] A traditional Chinese medicine compound composition for resisting breast hyperplasia, comprising a traditional Chinese medicine composition and probiotics, the ratio of the traditional Chinese medicine composition to the probiotics being 12:1 (the amount of probiotics added in 66g of the traditional Chinese medicine composition is respectively 2.4g of lactobacillus plantarum, 2.4g of red tea bacteria, 0.35g of yeast and 0.35g of acetic acid bacteria).

[0095] The traditional Chinese medicine composition is composed of the following raw materials: 12g of sweet earth, 12g of dandelion, 18g of honeysuckle, 12g of angelica, and 12g of bupleurum.

[0096] The preparation method of the traditional Chinese medicine compound composition for resisting breast hyperplasia comprises the following steps:

[0097] S1, 12g of sweet earth, 12g of dandelion, 18g of honeysuckle, 12g of angelica and 12g of bupleurum are respectively crushed and treated, and then sieved through a 40-mesh sieve to obtain a traditional Chinese medicine composition.

[0098] S2, the traditional Chinese medicine composition is placed in a high-temperature steam sterilization pot and subjected to high-temperature sterilization at 100°C, and the high-temperature steam sterilization is repeated for 3 times, with each sterilization lasting for 1 hour.

[0099] S3, 60g of the traditional Chinese medicine composition after high-temperature steam sterilization is placed in a sterilized bacterial culture bottle on an ultra-clean bench, 2.8g of lactobacillus plantarum, 2.8g of red tea bacteria, 0.2g of yeast, 0.2g of acetic acid bacteria microorganisms and 120ml of sterile water are added, and fully stirred and mixed, and finally sealed with a sealing film, stored in a constant temperature incubator at 37°C, fermented for 7 days, on the 8th day of fermentation, the fermentation liquid is filtered to filter out the dregs, and the filtrate is vacuum freeze-dried to obtain the traditional Chinese medicine compound composition.

[0100] Comparative Example 1

[0101] A sweet earth Ding traditional Chinese medicine composition decoction for resisting mammary gland hyperplasia, the raw material of the sweet earth Ding traditional Chinese medicine composition decoction is a traditional Chinese medicine composition, and the traditional Chinese medicine composition is composed of the following raw materials: 10 g of sweet earth Ding, 10 g of dandelion, 20 g of honeysuckle, 10 g of angelica, and 10 g of bupleurum.

[0102] The preparation method of the above-mentioned sweet earth Ding traditional Chinese medicine composition decoction for resisting mammary gland hyperplasia comprises the following steps:

[0103] 10 g of sweet earth Ding, 10 g of dandelion, 20 g of honeysuckle, 10 g of angelica, and 10 g of bupleurum are respectively taken, 6 times of water is added for decoction (temperature: 80-100 DEG C), decoction is carried out twice, each time for 1 hour, the decoction filtrate is combined, and vacuum freeze-drying (temperature: -70 DEG C, time: 48 h) is carried out to obtain the sweet earth Ding traditional Chinese medicine composition decoction.

[0104] The anti-mammary gland hyperplasia effect of the traditional Chinese medicine composition provided by the present application is described below by taking the traditional Chinese medicine compound composition prepared in Example 1 and the sweet earth Ding traditional Chinese medicine composition decoction prepared in Comparative Example 1 as examples. The raw materials of Example 1 and Comparative Example 1 are both traditional Chinese medicine compositions, and they are obtained by two different processing methods. The traditional Chinese medicine compound composition of Example 1 is obtained by fermenting the traditional Chinese medicine composition by probiotics, and the traditional Chinese medicine composition of Comparative Example 1 is obtained by directly extracting the traditional Chinese medicine composition by water.

[0105] 1. Method

[0106] 54 female Kunming mice are selected, and are adaptively fed in a laboratory environment for 7 days, the feeding temperature is 20±2 DEG C, the humidity is constant and appropriate, and the 12 / 12 h day-night rhythm is maintained. After 7 days of adaptation, the mice are randomly divided into 9 groups, namely a blank control (Control) group, a model (Model) group, a Xiaozhengwan (XZW) group, a sweet earth Ding traditional Chinese medicine composition decoction low-dose (TDDD) group, a sweet earth Ding traditional Chinese medicine composition decoction medium-dose (TDDZ) group, a sweet earth Ding traditional Chinese medicine composition decoction high-dose (TDDH) group, a traditional Chinese medicine compound composition low-dose (WSWD) group, a traditional Chinese medicine compound composition medium-dose (WSWZ) group, and a traditional Chinese medicine compound composition high-dose (WSWH) group.

[0107] Except for the blank control group, the other groups were breast hyperplasia modeling; after the modeling was successful, except for the blank control group, the other groups were administered after the modeling was completed: the positive control group (Xiaozhengwan group), the sweet earth medicine composition water decoction low dose (TDDD) group, the sweet earth medicine composition water decoction medium dose (TDDZ) group, the sweet earth medicine composition water decoction high dose (TDDH) group, the traditional Chinese medicine compound composition low dose (WSWD) group, the traditional Chinese medicine compound composition medium dose (WSWZ) group, and the traditional Chinese medicine compound composition high dose (WSWH) group were all administered with sweet earth medicine composition decoction by gavage, and the normal group and the model group were administered with 0.2 ml / d of normal saline by gavage. The treatment lasted for one month, and the administration of each group is shown in Table 1.

[0108] Table 1: Grouping and administration of mice

[0109]

[0110] Establishment of breast hyperplasia mouse model: the mice were intraperitoneally injected with benzoic acid estradiol injection 0.5 mg / kg / d, continuously for 25 days, and then were intramuscularly injected with progesterone injection 5 mg / kg / d, continuously for 5 days.

[0111] 2. Detection

[0112] 2.1 Sampling: after the last administration, all mice were fasted for 12 hours without water. The next morning at 9:00, after the last weighing, the mice were cut off the two ends of the whiskers using surgical instruments, and the eyeball blood 1.0 ml was taken and placed in a 1 mL coagulation separation tube. After standing at room temperature for 20 minutes, centrifugation was performed at 4℃ and 3000 r, and then the centrifuged serum was taken and stored at -80℃ for standby. After the blood sampling was completed, the mice were sacrificed, and the breasts of the mice in each group were removed.

[0113] 2.2 HE staining of breast tissue:

[0114] The breast tissues of each group of mice taken above were respectively subjected to HE staining, and the steps of HE staining were as follows: fixation-dehydration-embedding-sectioning-deparaffination-staining-dehydration-permeation-mounting, and the detailed operation was as follows: the cut mouse breast tissues were fixed in 4% paraformaldehyde for 24 hours, and then gradiently dehydrated: 70% ethanol solution for 30 minutes-80% ethanol solution for 30 minutes-95% ethanol solution for 30 minutes-anhydrous ethanol for 60 minutes-dimethylbenzene for 60 minutes-dimethylbenzene for 60 minutes-paraffin for 60 minutes (including embedding), and then the embedded mouse breast tissues were sectioned by a microtome, and then deparaffinated: dimethylbenzene for 10 minutes-dimethylbenzene for 10 minutes-anhydrous ethanol for 5 minutes-anhydrous ethanol for 5 minutes-85% ethanol for 5 minutes-70% ethanol for 5 minutes-pure water for 5 minutes; after deparaffination, staining was performed: hematoxylin for 4 minutes-rinse with tap water for 10 minutes-hydrochloric acid ethanol differentiation for 3 seconds-rinse with tap water for 10 minutes-ethyl red for 1 minute; after staining, general dehydration and permeation were performed, and then the sections were mounted, and microscopic observation was performed, and the experimental results are shown in Figure 2 .

[0115] 2.3 Estrogen (E), progesterone (P), follicle-stimulating hormone (FSH) detection:

[0116] Into the coated microwells coated with hormone antibodies, the samples (centrifuged serum), standard (Shanghai Tongwei Co., Ltd.), and HRP-labeled detection antibodies (Shanghai Tongwei Co., Ltd.) were sequentially added, incubated, and thoroughly washed. Color development was performed with substrate TMB, which was converted into blue under the catalysis of peroxidase and into final yellow under the action of acid. The color depth was positively correlated with the FSH, E in the sample and negatively correlated with P. The absorbance (OD value) was measured at 450 nm wavelength by an enzyme-labeled instrument, and the sample concentration was calculated, and the experimental results are shown in Figure 3 .

[0117] 2.4 Prolactin (PRL) detection:

[0118] (1) Standard wells, blank wells, and sample wells were respectively set: 100 μL of the standard (Wuhan Elabscience Biotechnology Co., Ltd.) was added to the standard wells, 100 μL of the standard & sample diluent (Wuhan Elabscience Biotechnology Co., Ltd.) was added to the blank wells, and 100 μL of centrifuged serum was added to the rest of the wells. The enzyme-labeled plate was covered with film, and incubated at 37°C for 90 minutes.

[0119] (2) The liquid in the wells was shaken out, 100 μL of biotinylated antibody working solution (Wuhan Elabscience Biotechnology Co., Ltd.) was added to each well, the enzyme-labeled plate was covered with film, and incubated at 37°C for 1 hour.

[0120] (3) Shake off the liquid in the hole, add 350 μL of washing liquid to each hole, soak for 1-2 minutes, and absorb or shake off the liquid in the enzyme-labeled plate. Dry on thick filter paper. Repeat this plate washing step 3 times.

[0121] (4) Add 100 μL of enzyme binding working solution (Wuhan Elabscience Biotechnology Co., Ltd.) to each hole. Add a film to the enzyme-labeled plate and incubate at 37°C for 30 minutes.

[0122] (5) Shake off the liquid in the hole, wash the plate 5 times, and the method is the same as step (3).

[0123] (6) Add 90 μL of substrate solution (Wuhan Elabscience Biotechnology Co., Ltd.) (TMB) to each hole. Add a film to the enzyme-labeled plate and incubate at 37°C for about 15 minutes.

[0124] (7) Add 50 μL of stop solution (Wuhan Elabscience Biotechnology Co., Ltd.) to each hole to stop the reaction.

[0125] (8) Immediately measure the optical density (OD value) of each hole at 450 nm wavelength with an enzyme-labeled instrument. Calculate the sample concentration. The experimental results are shown in Figure 3 .

[0126] 2.5 Effect of Chinese medicine compound composition (Chinese medicine composition) on intestinal flora of mice:

[0127] Mouse treatment: Collect the feces of mice in the treatment group before treatment, half a month after treatment, and after treatment. After the mice defecate freely, collect the feces in sterile centrifuge tubes. The sample usually needs about 1 g, and the minimum is not less than 0.2 g. Immediately after sample collection, store in a -80°C freezer for low-temperature preservation, and transport with dry ice.

[0128] (1) Effect of Chinese medicine compound composition (Chinese medicine composition) on intestinal flora diversity of mouse feces:

[0129] The main operation is as follows: The flora diversity analysis is performed by Shanghai ZK New Life Biological Technology Co., Ltd. Based on the characteristics of the amplified 16S region, a small fragment library is constructed and double-end sequencing is performed using the Paired-End method based on the sequencing platform. By filtering, OTUs (Operational Taxonomic Units) clustering, species annotation, and abundance analysis of Reads splicing, the species composition of the sample can be revealed, and further differences between mouse intestinal flora DNA can be mined to screen for differential flora. The basic operation process is shown in Figure 1 , and the experimental results are shown in Figure 4 .

[0130] (2) Effect of Chinese medicine compound composition (Chinese medicine composition) on short-chain fatty acids in mouse feces:

[0131] Fecal short-chain fatty acid determination was entrusted to Shanghai Luming Biotechnology Company. The basic steps of the experiment are as follows:

[0132] ① Metabolite extraction: thaw the mouse feces on ice, take 30 mg of mouse feces into a 2 mL glass centrifuge tube. Add 900 μL of 0.5% phosphoric acid, shake and mix for 2 min; centrifuge at 14000g for 10 min, take 800 μL of supernatant, add an equal amount of ethyl acetate for extraction, shake and mix for 22 min, centrifuge at 14000g for 10 min; take 600 μL of the upper organic phase, add 4-methylvaleric acid as an internal standard with a final concentration of 500 μM, mix and add to the injection bottle, enter the GC-MS detection, the injection amount is 1 μL, the split ratio is 10:1, split injection, the chromatographic conditions are as follows.

[0133] ② Perform chromatography-mass spectrometry: chromatography conditions are performed using Agilent DB-FFAP capillary column (30mx250μmx0.25μm) gas chromatography system for separation. Programmed temperature: initial temperature 90℃; increase the temperature to 160℃ at 10℃ / min; then increase the temperature to 240℃ at 40℃ / min and maintain for 5 min. The carrier gas is helium, and the carrier gas flow rate is 1.0 mL / min. A QC sample is set every certain number of experimental samples in the sample queue to detect and evaluate the stability and repeatability of the system; mass spectrometry conditions: mass spectrometry is performed using 5977B MSD mass spectrometer.

[0134] ③ Extract the chromatographic peak area and retention time using MSD ChemStation software. Draw the calibration curve and calculate the content of short-chain fatty acids in the sample. The experimental results are shown in Figure 5 .

[0135] There are mainly 7 kinds of short-chain fatty acids, including acetic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, pentanoic acid and hexanoic acid.

[0136] 3、Results

[0137] 3.1 The effect of traditional Chinese medicine compound composition (traditional Chinese medicine composition) on HE staining of breast tissue Figure 2 ):

[0138] By observing Figure 2 (Figure MA is alveolus; MD is duct; LI is mammary lobule) HE staining of each group of mouse mammary gland hyperplasia morphology can be found:

[0139] The blank group (a) has normal duct lumen shape, less alveolar number in mammary lobule, and no diffuse hyperplasia change.

[0140] Compared with the model group (b), the positive control group (c) has a greater degree of reduction in the number of mammary lobules, a certain degree of reduction in the number of alveoli, and a certain degree of shrinkage of the duct orifice; compared with the model group (b), the positive control Qianzhenwan group (c) has a certain degree of improvement in the degree of mammary gland hyperplasia in mice.

[0141] Compared with the model group (b), the sweet earth Ding traditional Chinese medicine composition decoction low dose group (d), sweet earth Ding traditional Chinese medicine composition decoction medium dose group (e), sweet earth Ding traditional Chinese medicine composition decoction high dose group (f) have a greater degree of reduction in the number of mammary lobules, a greater degree of reduction in the number of alveoli, and a certain degree of shrinkage of the duct orifice after treatment; with the increase of the dose, the diffuse hyperplasia of mammary gland tissue is improved; compared with the positive control group (c), the three groups of sweet earth Ding traditional Chinese medicine composition decoction low dose group (d), sweet earth Ding traditional Chinese medicine composition decoction medium dose group (e), sweet earth Ding traditional Chinese medicine composition decoction high dose group (f) have a greater degree of improvement in the degree of mammary gland hyperplasia in mice.

[0142] Compared with the model group (b), the traditional Chinese medicine compound composition low dose group (g), the traditional Chinese medicine compound composition medium dose group (h), and the traditional Chinese medicine compound composition high dose group (i) have a significant reduction in the number of mammary lobules, a significant reduction in the number of alveoli, and a significant shrinkage of the duct orifice after treatment; with the increase of the dose, the diffuse hyperplasia of mammary gland tissue is significantly improved; compared with the positive control group (c), the three groups of traditional Chinese medicine compound composition low dose group (g), traditional Chinese medicine compound composition medium dose group (h), and traditional Chinese medicine compound composition high dose group (i) have an increased degree of improvement in the degree of mammary gland hyperplasia in mice; compared with the three groups of sweet earth Ding traditional Chinese medicine composition decoction low dose group (d), sweet earth Ding traditional Chinese medicine composition decoction medium dose group (e), and sweet earth Ding traditional Chinese medicine composition decoction high dose group (f), the three groups of traditional Chinese medicine compound composition low dose group (g), traditional Chinese medicine compound composition medium dose group (h), and traditional Chinese medicine compound composition high dose group (i) have an increased degree of improvement in the degree of mammary gland hyperplasia in mice.

[0143] The above results show that:

[0144] (1) Compared with the blank group, the model group showed obvious typical symptoms of breast hyperplasia. After treatment with the low, medium and high doses of the sweet earth medicine composition decoction and the low, medium and high doses of the traditional Chinese medicine compound composition, the symptoms of breast hyperplasia in mice were obviously improved, which proved that the sweet earth medicine composition decoction and the traditional Chinese medicine compound composition (i.e. the two different processing methods of the traditional Chinese medicine composition) could improve the symptoms of breast hyperplasia in mice, i.e. the traditional Chinese medicine compound composition (traditional Chinese medicine composition) provided by the application could improve the symptoms of breast hyperplasia in mice.

[0145] (2) The treatment effects of the low, medium and high doses of the sweet earth medicine composition decoction and the low, medium and high doses of the traditional Chinese medicine compound composition on the symptoms of breast hyperplasia in mice were better than that of the positive control Xiaozhen pill group; the treatment effects of the low, medium and high doses of the traditional Chinese medicine compound composition on the symptoms of breast hyperplasia in mice were better than that of the low, medium and high doses of the sweet earth medicine composition decoction.

[0146] (3) Within the same treatment time, the treatment effects of the low, medium and high doses of the sweet earth medicine composition decoction and the low, medium and high doses of the traditional Chinese medicine compound composition on the symptoms of breast hyperplasia in mice were better than that of the positive control group; and the treatment effects of the low, medium and high doses of the traditional Chinese medicine compound composition on the symptoms of breast hyperplasia in mice were better than that of the low, medium and high doses of the sweet earth medicine composition decoction.

[0147] 3.2 The influence of the traditional Chinese medicine compound composition (traditional Chinese medicine composition) on the serum E (estradiol), P (progesterone), FSH (follicle-stimulating hormone) and PRL (prolactin) of breast hyperplasia mice Figure 3 ):

[0148] (1) As shown in Figure 3 (Figures a: estradiol; b: progesterone; c: follicle-stimulating hormone; d: prolactin), compared with the blank group, the E (estradiol) level of the model group mice was significantly increased.

[0149] Compared with the model group, the E (estradiol) levels of the low, medium and high doses of the sweet earth medicine composition decoction group, the low, medium and high doses of the traditional Chinese medicine compound composition group and the positive control group were decreased; among them, the E (estradiol) level of the low, medium and high doses of the sweet earth medicine composition decoction group was decreased the most, followed by the low, medium and high doses of the traditional Chinese medicine compound composition group (except for the high dose group of the traditional Chinese medicine compound composition, which had the largest decrease in the E (estradiol) level among all groups), and finally the positive control group.

[0150] The above results show that the low, medium and high dose groups of the sweet earth medicine composition decoction and the low, medium and high dose groups of the traditional Chinese medicine compound composition are better than the positive control group in reducing the level of E (estradiol) in mice; the low, medium and high dose groups of the sweet earth medicine composition decoction are better than the low, medium and high dose groups of the traditional Chinese medicine compound composition in reducing the level of E (estradiol) in mice, but the low, medium and high dose groups of the sweet earth medicine composition decoction reduce the level of E (estradiol) in mice to a lower level than the model group, and the effect is not as good as that of the low, medium and high dose groups of the traditional Chinese medicine compound composition.

[0151] (2) by Figure 3 (Wherein a: estradiol; b: progesterone; c: follicle stimulating hormone; d: prolactin) can be known that compared with the blank group, the level of progesterone in the model group of mice is increased.

[0152] Compared with the model group, the levels of progesterone in the low, medium and high dose groups of the sweet earth medicine composition decoction, the low, medium and high dose groups of the traditional Chinese medicine compound composition and the positive control group are increased; among them, the progesterone level in the low, medium and high dose groups of the sweet earth medicine compound composition is the highest, followed by the low, medium and high dose groups of the sweet earth medicine composition decoction (except for the medium dose group of the sweet earth medicine composition decoction), and finally the positive control group (the increase in the low and high dose groups of the traditional Chinese medicine compound composition is lower than that of the positive control group, which may be related to the low content of effective drugs).

[0153] The above results show that the low, medium and high dose groups of the sweet earth medicine composition decoction and the low, medium and high dose groups of the traditional Chinese medicine compound composition are better than the positive control group in reducing the level of E (estradiol) in mice; the low, medium and high dose groups of the sweet earth medicine composition decoction are better than the low, medium and high dose groups of the traditional Chinese medicine compound composition in reducing the level of E (estradiol) in mice, but the low, medium and high dose groups of the sweet earth medicine composition decoction reduce the level of E (estradiol) in mice to a lower level than the model group, and the effect is not as good as that of the low, medium and high dose groups of the traditional Chinese medicine compound composition.

[0154] (3) by Figure 3 (Wherein a: estradiol; b: progesterone; c: follicle stimulating hormone; d: prolactin) can be known that compared with the blank group, the level of progesterone in the model group of mice is increased.

[0155] Compared with the model group, the levels of progesterone in the low, medium and high dose groups of the sweet earth medicine composition decoction, the low, medium and high dose groups of the traditional Chinese medicine compound composition and the positive control group are increased; among them, the progesterone level in the low, medium and high dose groups of the sweet earth medicine compound composition is the highest, followed by the low, medium and high dose groups of the sweet earth medicine composition decoction (except for the medium dose group of the sweet earth medicine composition decoction), and finally the positive control group (the increase in the low and high dose groups of the traditional Chinese medicine compound composition is lower than that of the positive control group, which may be related to the low content of effective drugs).

[0156] The above results show that the low, medium and high dose groups of the sweet earth medicine composition water decoction and the positive control group are better than the low, medium and high dose groups of the traditional Chinese medicine compound composition in increasing the level of follicle stimulating hormone in mice. The low, medium and high dose groups of the sweet earth medicine composition water decoction are better than the positive control group in increasing the level of follicle stimulating hormone in mice, but the low, medium and high dose groups of the sweet earth medicine composition water decoction and the positive control group are too high in increasing the level of follicle stimulating hormone in mice compared with the model group, and the effect is not as good as the low, medium and high dose groups of the traditional Chinese medicine compound composition.

[0157] (4) by Figure 3 (Where a: estradiol; b: progestin; c: follicle stimulating hormone; d: prolactin) can be known that compared with the blank group, the prolactin level of the model group mice is reduced.

[0158] Compared with the model group, the prolactin levels of the low, medium and high dose groups of the sweet earth medicine composition water decoction, the low, medium and high dose groups of the traditional Chinese medicine compound composition and the positive control group are reduced; among them, the prolactin level of the low, medium and high dose groups of the sweet earth medicine composition water decoction is reduced the most, followed by the positive control group, and finally the low, medium and high dose groups of the traditional Chinese medicine compound composition (the reduction degree of the medium and high dose groups of the traditional Chinese medicine compound composition is greater than that of the positive control group, which may be related to the excessive content of effective drugs contained).

[0159] The above results show that the low, medium and high dose groups of the sweet earth medicine composition water decoction and the positive control group are better than the low, medium and high dose groups of the traditional Chinese medicine compound composition in reducing the level of prolactin in mice, but the low, medium and high dose groups of the sweet earth medicine composition water decoction and the positive control group are too low in reducing the level of prolactin in mice compared with the model group, and the effect is not as good as the low, medium and high dose groups of the traditional Chinese medicine compound composition.

[0160] 3.3 The effect of traditional Chinese medicine compound composition (traditional Chinese medicine composition) on the diversity of fecal intestinal flora in mice Figure 4

[0161] From the Venn petal diagram in Figure 4 , it can be known that compared with the model group, the intestinal flora content of the medium and high dose groups of the sweet earth medicine composition water decoction and the medium and high dose groups of the traditional Chinese medicine compound composition is significantly increased. The community structure component diagram shows the community structure of each sample or group in detail. According to the species annotation results, the top 10 species with the largest abundance at each classification level (Phylum, Class, Order, Family, Genus, Species) of each sample or group are selected to generate a species relative abundance column cumulative chart. From the community structure component diagram of intestinal flora, it can be known that the main bacterial species of each group sample are bacteroides, clostridium, lactobacillus, etc.

[0162] ​3.4 The effect of the traditional Chinese medicine compound composition (traditional Chinese medicine composition) on the short-chain fatty acids in the feces of mice Figure 5

[0163] The metabolite concentrations of the 7 SCFAs of the mice in different groups, as shown by the height and scale value of the column chart, the dose of the traditional Chinese medicine compound composition has a greater effect on the SCFA content in the intestines of the mice, among the 7 fatty acids, the acetic acid content of the mice in each group is the highest, followed by propionic acid.

[0164] In summary, from the effect of the traditional Chinese medicine compound composition (traditional Chinese medicine composition) on the HE staining of breast tissue, it can be seen that, compared with the model group, the number of lobules and the number of acini of the mice in the administration groups (including the traditional Chinese medicine compound composition and the traditional Chinese medicine composition) are reduced, and the orifice of the breast duct is also reduced, and with the increase of the dose, the diffuse hyperplasia of the breast tissue is improved; the traditional Chinese medicine compound composition and the traditional Chinese medicine composition are better than Xiaozhen Pill in improving the breast hyperplasia of the mice; the traditional Chinese medicine compound composition is better than the traditional Chinese medicine composition in improving the breast hyperplasia of the mice. At the same time, when Xiaozhen Pill is used for treatment, side effects such as …… may occur, while when the traditional Chinese medicine compound composition of the present application is used for treatment, the above-mentioned side effects do not occur.

[0165] From the effect of the traditional Chinese medicine compound composition (traditional Chinese medicine composition) on the E, P, FSH and PRL in the serum of the breast hyperplasia mice, it can be seen that, compared with the model group, the E (estradiol) level is reduced, the P (progesterone) level is increased, the FSH (follicle-stimulating hormone) level is increased, and the PRL (prolactin) level is reduced to the most appropriate degree in the traditional Chinese medicine compound composition group.

[0166] From the effect of the traditional Chinese medicine compound composition (traditional Chinese medicine composition) on the intestinal flora of the mice, it can be seen that there is a significant change in the intestinal flora of the mice after administration, as shown by the colony structure component diagram, the main constituent bacteria of the samples in each group are Clostridium, Clostridium, Lactobacillus, etc., and Lactobacillus is a probiotic bacteria in the intestines; from the effect of the traditional Chinese medicine compound composition (traditional Chinese medicine composition) on the short-chain fatty acids in the feces of the mice, it can be seen that the dose of the traditional Chinese medicine compound composition has a greater effect on the SCFA content in the intestines of the mice, among the 7 fatty acids, the acetic acid content of the mice in each group is the highest, followed by propionic acid. The above results all show that the traditional Chinese medicine compound composition of the present application has a significant anti-breast hyperplasia effect.

[0167] Compared with the existing surgical treatment of breast hyperplasia, the traditional Chinese medicine compound composition provided by the present application can resist breast hyperplasia by increasing immunity and regulating the body. At the same time, the traditional Chinese medicine compound composition has the advantages of short treatment course and rapid effect in treating breast hyperplasia diseases, and almost has no toxic and side effects on the human body, and uses green and healthy traditional Chinese medicine raw materials, and has a good therapeutic effect on resisting breast hyperplasia.

[0168] ​The preparation process of the traditional Chinese medicine compound composition adopts multiple probiotics combined fermentation, adjusts the abundance of intestinal flora, and enhances the effect of simple traditional Chinese medicine composition on anti-mammary gland hyperplasia.

[0169] It should be noted that when the present application claims involve numerical ranges, both endpoints of each numerical range and any number between the two endpoints can be selected. In order to prevent repetition, the present application describes preferred embodiments.

[0170] Although preferred embodiments of the present application have been described, those skilled in the art will be able to make additional changes and modifications to these embodiments once they have been informed of the basic inventive concept. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications falling within the scope of the present application.

[0171] Obviously, those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations of the present application fall within the scope of the claims of the present application and their equivalents, the present application also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine compound composition for treating breast hyperplasia, characterized in that, The traditional Chinese medicine compound composition is made from a traditional Chinese medicine composition and probiotics, and the mass ratio of the traditional Chinese medicine composition to the probiotics is 10:

1. The amounts of probiotics added to the 60g traditional Chinese medicine composition are as follows: 2.4g Lactobacillus plantarum, 2.4g kombucha, 0.6g yeast, and 0.6g acetic acid bacteria. The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10 parts sweet violet, 10 parts dandelion, 20 parts honeysuckle, 10 parts angelica, and 10 parts bupleurum.

2. The method for preparing a traditional Chinese medicine compound composition for anti-mastopathy according to claim 1, characterized in that, Includes the following steps: S1. Weigh each raw material of the traditional Chinese medicine composition according to the formula, crush and mix them to obtain the traditional Chinese medicine composition; or weigh each raw material of the traditional Chinese medicine composition according to the formula, add water and decoct, filter and concentrate the decoction in sequence until the volume of the filtered decoction is reduced by one-third to obtain the traditional Chinese medicine composition. S2. Sterilize the traditional Chinese medicine composition obtained in S1; S3. After sterilization, the sterilized Chinese medicine composition is mixed with the probiotics in the formula, and probiotic fermentation is carried out. The fermentation liquid is filtered and collected, and then concentrated to obtain the Chinese medicine compound composition.

3. The method for preparing a traditional Chinese medicine compound composition for anti-mastopathy according to claim 2, characterized in that, In S1, all raw materials are crushed and then passed through a 40-mesh sieve.

4. The method for preparing a traditional Chinese medicine compound composition for anti-mastopathy according to claim 2, characterized in that, In S2, high-temperature steam sterilization is repeated 2-3 times, with each sterilization lasting 0.5-1.5 hours and the sterilization temperature being 80-100℃.

5. The method for preparing a traditional Chinese medicine compound composition for anti-mastopathy according to claim 2, characterized in that, In S3, when carrying out probiotic fermentation, the sterilized Chinese medicine composition is placed in a bacterial culture bottle, mixed well, and placed in a constant temperature incubator at 36~38℃ for 6~8 days of fermentation.

6. The method for preparing a traditional Chinese medicine compound composition for anti-mastopathy according to claim 2, characterized in that, In S3, on the 7th to 9th day of fermentation, the fermentation liquid is filtered, and the filtrate is collected, bottled, and concentrated to obtain the traditional Chinese medicine compound composition.

7. The use of the traditional Chinese medicine compound composition as described in claim 1 in the preparation of an anti-mastopathy drug.

8. A traditional Chinese medicine preparation for treating breast hyperplasia, characterized in that, It uses the traditional Chinese medicine compound composition as described in claim 1 as the active ingredient, and is supplemented with pharmaceutically acceptable excipients or carriers.

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