Composition for breast hyperplasia and preparation method and application thereof

Abstract

The present invention provides a composition for breast hyperplasia, and a preparation method and application thereof, and specifically relates to the technical field of composition processing. The composition includes dandelion, rose and saffron extracts, and also includes peony. In the composition composed of various flower raw materials designed by the present invention, dandelion has the effects of reducing swelling and dispersing knots, diuresis and relieving stranguria; rose has the effect of regulating liver metabolic function and hormone balance; saffron extract has the effect of expectorant and sedative, especially has the characteristics of relieving mood and anti-anxiety, and the mood regulating effect of saffron has no side effects. The dandelion, rose and saffron extracts in the composition have the effect of improving breast hyperplasia, and can enhance the therapeutic effect based on the principle of mutual assistance and mutual use.

Description

Technical Field

[0001] The invention relates to the technical field of composition processing, and in particular to a composition for treating breast hyperplasia, and a preparation method and application thereof. Background Art

[0002] Breast hyperplasia is the most common breast disease in women aged 25 to 50. Most women over 30, regardless of whether they are married or not, have a history of childbirth or breastfeeding, have varying degrees of breast hyperplasia. The incidence rate in women over 40 is almost over 90%. The main cause of breast hyperplasia is the presence of too much estrogen in the patient's body, which leads to an imbalance in the proliferation and restoration of the breast glands, and further develops into excessive proliferation of mammary duct epithelial cells. This development process is very similar to the pathogenesis of breast cancer. Long-term estrogen can induce the occurrence of breast cancer.

[0003] The main means of treating breast hyperplasia is to regulate ovarian endocrine secretion to normal, or to block the target of hormone action, thereby alleviating clinical symptoms. Use anti-estrogen hormone drugs such as tamoxifen, danazol, progesterone, methyltestosterone, or vitamin drugs to improve liver function and increase the liver's metabolism of excess estrogen to achieve the purpose of treating breast hyperplasia. There are also similar drugs for treatment, such as iodine preparations that stimulate the pituitary gland to produce luteinizing hormone, which stimulates ovarian follicle luteinization and restores ovarian function. Another example is the use of diuretics. Short-term diuretics are beneficial for the relief of breast pain and congestion and edema symptoms. There are also analgesics that only relieve physical sensations and are not helpful for the symptoms.

[0004] Breast hyperplasia is classified as "breast disease" in traditional Chinese medicine. Traditional Chinese medicine attributes the causes of breast disease to the following three types:

[0005] 1. Emotional distress and liver qi stagnation

[0006] 2. Liver depression and spleen deficiency, nitrogen coagulation and blood stasis

[0007] 3. Kidney essence deficiency and Chong and Ren meridian disorders

[0008] Therefore, the prescriptions of traditional Chinese medicine treatment include oral medications for soothing the liver and regulating qi, dispersing nodules and relieving pain, or medications for resolving phlegm and dispersing nodules, promoting blood circulation and removing blood stasis, etc., and external methods such as bras, foot massage, fumigation, acupuncture, massage, and music are used as auxiliary treatments.

[0009] Western medicine has serious side effects. For example, danazol can cause amenorrhea, weight gain, acne, and oily hair. Ethylestradiol can cause headaches and dizziness. It may even have no therapeutic effect and aggravate the condition. Traditional Chinese medicine is less likely to relapse and has a better therapeutic effect, but the treatment experience is poor. For example, some prescriptions need to be boiled, or some patients find it difficult to swallow due to bitterness and smell, and cannot adhere to treatment.

[0010] In view of this, the present invention is proposed. Summary of the invention

[0011] One of the purposes of the present invention is to provide a composition for breast hyperplasia to alleviate the technical problems of the existing Chinese and Western medicine treatments with serious side effects and poor Chinese medicine treatment experience.

[0012] In order to solve the above-mentioned technical problems, the present invention particularly adopts the following technical solutions:

[0013] A first aspect of the present invention provides a composition for treating breast hyperplasia, comprising dandelion, rose and saffron extracts.

[0014] Furthermore, peony flowers are also included.

[0015] Furthermore, the mass ratio of the dandelion, rose and saffron extracts is 1:0.5~2:0.5‰~2‰; preferably 1:0.8~1.5:0.8‰~1.2‰; more preferably 1:1:1‰.

[0016] Furthermore, the mass ratio of the dandelion, the rose, the saffron extract and the peony is 0.5~1.5:1:0.5‰~2‰:0.5~1; preferably 0.7~1.3:1:0.8‰~1.2‰:0.8~1; more preferably 1.25:1:1‰:1.

[0017] The second aspect of the present invention provides a method for preparing the composition, comprising adding the dandelion, the rose and any optional peony to water for decoction, adding the saffron extract to the obtained decoction, and then vacuum concentrating and freeze-drying to obtain the composition for treating breast hyperplasia.

[0018] Furthermore, the water-to-material ratio of the decoction is 5-10:1; preferably 6-8:1.

[0019] Furthermore, the decoction is performed 1 to 4 times, preferably 2 to 3 times.

[0020] Preferably, the decocting time is 20 min to 60 min, preferably 30 min.

[0021] Furthermore, the vacuum degree during the vacuum concentration is 35 Pa to 50 Pa, and the decoction is concentrated to 1 / 5 to 1 / 3 of the volume of the original decoction.

[0022] Preferably, the freeze-drying temperature is -60°C.

[0023] Preferably, the freeze-drying time is 24h~48h.

[0024] The third aspect of the present invention provides the use of the composition in preparing a product for treating breast hyperplasia.

[0025] Compared with the prior art, the present invention has at least the following beneficial effects:

[0026] The present invention designs a composition composed of various flower raw materials, wherein dandelion contains various phenolic acids, flavonoids, terpenes, and polysaccharides, and has the effects of reducing swelling and dispersing knots, diuresis and relieving stranguria; the total flavonoid content in rose is high, and has the effect of regulating liver metabolic function and hormone balance; saffron extract is rich in active ingredients such as safranal, crocin, crocetin, and safranin, and has the effect of expectorant and sedative, especially has the characteristics of relieving mood and anti-anxiety, and the mood regulating effect of saffron has no side effects. The dandelion, rose and saffron extracts in the composition have the effect of improving breast hyperplasia, and can enhance the therapeutic effect based on the principle of mutual assistance and mutual use.

[0027] The preparation method of the composition provided by the present invention adopts water-extracted effective substances and saffron extracts, and uses these effective substances as the main components of the composition, which can effectively retain the effective components in the flower raw materials.

[0028] The use of the composition provided by the present invention in the preparation of a product for treating breast hyperplasia has been experimentally confirmed to have a tendency to reduce the diameter of rat nipples, and has the effect of significantly reducing the number of mammary lobules, the number of alveoli and the size of alveolar cavities in breast hyperplasia, and has an auxiliary therapeutic effect on breast hyperplasia. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0030] Figure 1 It is the curve of rat body weight change;

[0031] Figure 2 This is the pathological morphology of rat mammary gland tissue (HE staining, ×200). DETAILED DESCRIPTION

[0032] To make the purpose, technical solution and advantages of the present invention clearer, the technical solution in the embodiment of the present invention will be clearly and completely described below in combination with the embodiment of the present invention. Obviously, the described embodiment is a part of the embodiment of the present invention, but not all of the embodiments. The components of the embodiment of the present invention can be arranged and designed in various different configurations.

[0033] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0034] A first aspect of the present invention provides a composition for treating breast hyperplasia, comprising dandelion, rose and saffron extracts.

[0035] The present invention designs a composition composed of various flower raw materials, wherein dandelion contains various phenolic acids, flavonoids, terpenes, and polysaccharides, and has the effects of reducing swelling and dispersing knots, diuresis and relieving stranguria; the total flavonoid content in rose is high, and has the effect of regulating liver metabolic function and hormone balance; saffron extract is rich in active ingredients such as safranal, crocin, crocetin, and safranin, and has the effect of expectorant and sedative, especially has the characteristics of relieving mood and anti-anxiety, and the mood regulating effect of saffron has no side effects. The dandelion, rose and saffron extracts in the composition have the effect of improving breast hyperplasia, and can enhance the therapeutic effect based on the principle of mutual assistance and mutual use.

[0036] Roses contain high levels of total flavonoids, which can regulate liver metabolism and hormone balance. High-concentration total flavonoids are extracted from roses, and the extract is also safe.

[0037] Dandelion contains a variety of phenolic acids, flavonoids, terpenes, and polysaccharides, which have the effects of reducing swelling, dispersing nodules, and promoting diuresis and relieving stranguria.

[0038] Saffron extract is rich in active ingredients such as safranal, crocin, crocetin, and crocin. It has expectorant and sedative effects, and is especially mood-relieving and anti-anxiety. Saffron's mood-regulating effect has no side effects.

[0039] Furthermore, peony flowers are also included.

[0040] Peony flowers are rich in various amino acids, total flavonoids, ascorbic acid, and inorganic elements such as potassium, sodium, magnesium, calcium, iron, and phosphorus. The K / Na ratio is relatively high. The results of acute toxicity and genetic toxicity tests of Danfeng peony flowers at a dosage of 20 g / kg·bw were both non-toxic and highly safe.

[0041] Furthermore, the mass ratio of the dandelion, rose and saffron extracts is 1:0.5~2:0.5‰~2‰; preferably 1:0.8~1.5:0.8‰~1.2‰; more preferably 1:1:1‰.

[0042] In some embodiments of the present invention, the mass ratio of the dandelion extract, the rose extract and the saffron extract is typically but not limited to 1:0.5:1‰, 1:1.5:1‰, 1:1:0.8‰ or 1:1:1.2‰.

[0043] Furthermore, the mass ratio of the dandelion, the rose, the saffron extract and the peony is 0.5~1.5:1:0.5‰~2‰:0.5~1; preferably 0.7~1.3:1:0.8‰~1.2‰:0.8~1; more preferably 1.25:1:1‰:1.

[0044] In some embodiments of the present invention, the mass ratio of the rose, the saffron extract and the peony is typically but not limited to 0.5:1:1‰:1, 1.5:1:1‰:1, 1.25:1:0.5‰:1, 1.25:1:1‰:1, 1.25:1:2‰:1 or 1.25:1:1‰:0.5.

[0045] The second aspect of the present invention provides a method for preparing the composition, comprising adding the dandelion, the rose and any optional peony to water for decoction, adding the saffron extract to the obtained decoction, and then vacuum concentrating and freeze-drying to obtain the composition for treating breast hyperplasia.

[0046] The preparation method of the composition provided by the present invention adopts water-extracted effective substances and saffron extracts, and uses these effective substances as the main components of the composition, which can effectively retain the effective components in the flower raw materials.

[0047] Furthermore, the water-to-material ratio of the decoction is 5-10:1; preferably 6-8:1.

[0048] In some embodiments of the present invention, the water-to-material ratio of decoction is typically but not limited to 5:1, 6:1, 7:1, 8:1, 9:1 or 10:1.

[0049] Furthermore, the decoction is performed 1 to 4 times, preferably 2 to 3 times.

[0050] In some embodiments of the present invention, the number of decoctions is typically but not limited to 1, 2, 3 or 4 times.

[0051] Preferably, the decocting time is 20 min to 60 min, preferably 30 min.

[0052] In some embodiments of the present invention, the decocting time is typically but not limited to 20 min, 30 min, 40 min, 50 min or 60 min.

[0053] Furthermore, the vacuum degree during the vacuum concentration is 35 Pa to 50 Pa, and the decoction is concentrated to 1 / 5 to 1 / 3 of the volume of the original decoction.

[0054] Preferably, the freeze-drying temperature is -60°C.

[0055] Preferably, the freeze-drying time is 24h~48h.

[0056] The third aspect of the present invention provides the use of the composition in preparing a product for treating breast hyperplasia.

[0057] The use of the composition provided by the present invention in the preparation of a product for treating breast hyperplasia has been experimentally confirmed to have a tendency to reduce the diameter of rat nipples, and has the effect of significantly reducing the number of mammary lobules, the number of alveoli and the size of alveolar cavities in breast hyperplasia, and has an auxiliary therapeutic effect on breast hyperplasia.

[0058] In the following, some embodiments of the present invention are described in detail in conjunction with the embodiments. In the absence of conflict, the following embodiments and features in the embodiments can be combined with each other.

[0059] Example 1

[0060] This embodiment provides a composition, taking 100g of dandelion and rose, adding 1kg of water and boiling for 30min, boiling twice, combining the decoctions, adding 0.1g of saffron extract to the decoction, rotating vacuum concentration, vacuum degree of 50Pa, and finally vacuum freeze drying at -60°C to obtain a composition.

[0061] Example 2

[0062] This embodiment provides a composition, taking 125g of dandelion, 100g of rose and 100g of peony, adding 1.8kg of water and boiling for 30min, boiling twice, and combining the decoctions. Add 0.1g of saffron extract to the decoction, rotary vacuum concentration, vacuum degree of 50Pa, and finally vacuum freeze drying at -60°C to obtain a composition.

[0063] Example 3

[0064] This embodiment provides a composition, taking 100g of dandelion and 50g of rose, adding 750g of water and decocting for 30min, decocting twice, combining the decoctions, adding 0.1g of saffron extract to the decoction, rotating vacuum concentration, vacuum degree of 50Pa, and finally vacuum freeze drying at -60°C to obtain a composition.

[0065] Example 4

[0066] This embodiment provides a composition, taking 100g of dandelion and 200g of rose, adding 1.5kg of water and boiling for 30min, boiling twice, combining the decoctions, adding 0.1g of saffron extract to the decoction, rotating vacuum concentration, vacuum degree of 50Pa, and finally vacuum freeze drying at -60°C to obtain a composition.

[0067] Example 5

[0068] This embodiment provides a composition, taking 100g of dandelion and rose, adding 1kg of water and boiling for 30min, boiling twice, combining the decoctions, adding 0.05g of saffron extract to the decoction, rotating vacuum concentration, vacuum degree of 50Pa, and finally vacuum freeze drying at -60°C to obtain a composition.

[0069] Example 6

[0070] This embodiment provides a composition, taking 100g of dandelion and rose, adding 1kg of water and boiling for 30min, boiling twice, combining the decoctions, adding 0.2g of saffron extract to the decoction, rotating vacuum concentration, vacuum degree of 50Pa, and finally vacuum freeze drying at -60°C to obtain a composition.

[0071] Example 7

[0072] This embodiment provides a composition, taking 125g of dandelion, 100g of rose and 50g of peony, adding 1.8kg of water and decocting for 30min, decocting twice, combining the decoctions, adding 0.1g of saffron extract to the decoction, rotating vacuum concentration, vacuum degree of 50Pa, and finally vacuum freeze drying at -60°C to obtain a composition.

[0073] Comparative Example 1

[0074] This comparative example provides a drug, Rupixiao, for treating breast hyperplasia.

[0075] Comparative Example 2

[0076] This comparative example provides a composition, taking 100g of rose, adding 500g of water and decocting for 30min, decocting twice, combining the decoctions, adding 0.1g of saffron extract to the decoction, rotating vacuum concentration, vacuum degree of 50Pa, and finally vacuum freeze drying at -60°C to obtain a composition.

[0077] Comparative Example 3

[0078] This embodiment provides a composition, taking 100g of rose and 100g of peony, adding 1kg of water and decocting for 30min, decocting twice, combining the decoctions, adding 0.1g of saffron extract to the decoction, rotating vacuum concentration, vacuum degree of 50Pa, and finally vacuum freeze drying at -60°C to obtain a composition.

[0079] Comparative Example 4

[0080] This comparative example provides a composition, taking 100g of dandelion, adding 500g of water and boiling for 30min, boiling twice, combining the decoctions, adding 0.1g of saffron extract to the decoction, rotating vacuum concentration, the vacuum degree is 50Pa, and finally vacuum freeze drying at -60°C to obtain a composition.

[0081] Comparative Example 5

[0082] This embodiment provides a composition, taking 100g of dandelion and 100g of peony, adding 1kg of water and boiling for 30min, boiling twice, and combining the decoctions. Add 0.1g of saffron extract to the decoction, rotary vacuum concentration, vacuum degree of 50Pa, and finally vacuum freeze drying at -60°C to obtain a composition.

[0083] Comparative Example 6

[0084] This comparative example provides a composition, taking 100g of dandelion and rose, adding 1kg of water and boiling for 30min, boiling twice, combining the decoctions, rotating the decoctions and concentrating them in vacuum with a vacuum degree of 50Pa, and finally performing vacuum freeze drying at -60°C to obtain a composition.

[0085] Comparative Example 7

[0086] This comparative example provides a composition, taking 125g of dandelion, 100g of rose and 100g of peony, adding 1.8kg of water and boiling for 30min, boiling twice, combining the decoctions, rotating the decoctions and concentrating them in vacuum with a vacuum degree of 50Pa, and finally vacuum freeze-drying them at -60°C to obtain a composition.

[0087] Test example

[0088] The composition obtained in Examples 1-2 and Rupixiao provided in Comparative Example 1 were used to carry out mouse experiments.

[0089] 1. Materials

[0090] (1) Reagents: physiological saline, distilled water, chloral hydrate, etc.

[0091] (2) Experimental animals: Female non-pregnant SD rats, weighing 220 g, from Sibeifu (Beijing) Biotechnology Co., Ltd. License No.: SCXK (Beijing) 2019-0010.

[0092] (3) Rat maintenance feed: Sibeifu (Beijing) Biotechnology Co., Ltd. SCXK (Beijing) 2019-0010.

[0093] (4) Samples: the compositions provided in the examples and Rupixiao in the comparative examples.

[0094] (5) Progesterone injection: Zhejiang Xianjun Pharmaceutical Co., Ltd. (Specification: 1 mL: 20 mg, National Medicine Approval No. H33020828).

[0095] (6) Estradiol benzoate injection: Sichuan Jinke Pharmaceutical Co., Ltd. (Specification: 2 mL: 4 mg, Veterinary Drug No. (2013) 220412517).

[0096] (7) Rupixiao Tablets: Liaoning Shanghai Pharmaceuticals Good Nurse Pharmaceutical (Group) Co., Ltd. (Specification: 0.32 g / tablet).

[0097] (8) Hair removal cream: Veet brand, Reckitt Benckiser Home Chemicals (China) Co., Ltd.

[0098] (9) Vernier caliper: specification 0-200mm, Shanghai Measuring Tool Factory.

[0099] 2. Experimental methods

[0100] 2.1 Animal grouping

[0101] 72 SD female non-pregnant rats were randomly divided into 9 groups, 8 rats in each group, including blank control group, model group, embodiment group and comparative example group.

[0102] 2.2 Modeling

[0103] Build the model and process it for 30 consecutive days as follows:

[0104] (1) Blank control group: 0.1 mL of normal saline was injected intramuscularly once a day for 30 consecutive days;

[0105] (2) Model group, example group, and comparative group: Estradiol benzoate (0.5 mg·kg-1·d-1) was injected into the outer thigh of the rats, alternating between the left and right legs, once a day for 25 consecutive days. Then, progesterone (4 mg·kg-1·d-1) was injected once a day for 5 consecutive days.

[0106] 2.3 Intervention

[0107] After the model was successfully established, the intragastric administration was continued for 30 days with the following contents:

[0108] (1) The control group and the model group were given the same volume of distilled water.

[0109] (2) Sample group administration: the composition provided in Example 1 and Example 2 was added with sterile physiological saline.

[0110] (3) Comparative Example 1 was administered: Rupixiao.

[0111] The intragastric doses of each experimental group are as follows:

[0112] Example 1: 1300 mg / kg bw;

[0113] Example 2: 2000 mg / kg bw;

[0114] Comparative Example 1: 2600 mg / kg bw.

[0115] 2.4 Observations and indicators

[0116] 2.4.1 Morphology

[0117] The general conditions of the rats were observed and recorded at three time points: hair color, mental state, diet, drinking water, and defecation. The appearance of the nipples, including the diameter and height of the nipples, were recorded at three time points. The nipple diameter and height of the rats' breasts were measured using a precision vernier caliper, and the breasts of each group of rats were partially depilated with depilatory cream before measurement.

[0118] 2.4.2 Body mass

[0119] The body weight of the rats was recorded twice a week.

[0120] 2.4.3 Blood biochemistry

[0121] At the end of the intervention, the rats were deprived of water and food for 24 hours, and blood was collected after anesthesia. After standing at room temperature, the blood was centrifuged and the supernatant was collected to detect the following indicators:

[0122] Endocrine-related indicators: estradiol (E2) and progesterone (P) levels;

[0123] Liver function related indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP);

[0124] Antioxidant index: superoxide dismutase (SOD) level

[0125] 2.4.4 Breast pathology detection

[0126] At the end of the intervention, breast pathology examination was performed. The third pair of breasts of rats were taken, and the breast tissue was placed in 4% paraformaldehyde solution or fixed with 10% formalin solution, embedded in conventional paraffin, and made into continuous sections with a thickness of 4 μm, dewaxed, hydrated, and HE stained. The pathological tissue morphology was observed under an optical microscope (HE staining × 200), and the area of ​​the breast tissue section was determined by analysis using Image pro Plus 6.0 software, and the number of mammary lobules, the number of acini (per lobe) and the diameter of the acini cavity (μm) of the mammary lobules were calculated.

[0127] 2.5 Statistical methods

[0128] SPSS 17.0 software was used to analyze the data. All values ​​were expressed as mean ± standard deviation (x ± s). One-way analysis of variance was used. LSD was used for pairwise comparisons, and P < 0.05 indicated significant differences.

[0129] 3. Experimental results

[0130] 3.1 Behavioral changes in rats

[0131] The rats in the control group were agile, had bright eyes, shiny and smooth fur, and had normal diet, drinking, and bowel movements. After the model was established, the rats were more sensitive and irritable than those in the control group. After the test material intervention, the sensitive and irritable behavior of the rats was improved.

[0132] It should be noted that the test material intervention refers to the drug administration intervention of Example 1 Group, Example 2 Group and Comparative Example 1 Group, and the corresponding test material intervention groups refer to Example 1 Group, Example 2 Group and Comparative Example 1 Group.

[0133] 3.2 Changes in body weight of rats

[0134] Table 1 Changes in body weight of rats at different stages (unit: g)

[0135]

[0136] *Significantly different from the control group (p<0.05)

[0137] From Table 1 and Figure 1 It can be seen that before the model was replicated, there was no significant difference in the body weight of rats in each group (P>0.05). After 30 days of injection of estradiol and progesterone, the body weight of rats in each group after the model was replicated was significantly reduced compared with the control group (P<0.05), but there was no significant difference between the groups (P>0.05). After intragastric administration of the test material, the body weight of each group increased, and there was no significant difference in the body weight of rats in each test material intervention group compared with the model group (P>0.05).

[0138] 3.3 Changes in nipple height and diameter in rats

[0139] Table 2 Changes in rat nipple diameter (unit: mm)

[0140]

[0141] Note: Compared with the control group, *P<0.05

[0142] Table 3 Changes in nipple height of rats (unit: mm)

[0143]

[0144] Note: Compared with the control group, * P < 0.05

[0145] Table 4 Comparison of changes in rat nipple diameter before and after the experiment (unit: mm)

[0146]

[0147] Note: “-” indicates an increase after intervention. Compared with the model group, # P<0.05

[0148] As can be seen from Tables 2-4, there was no significant change in the nipple diameter and height of the rats in the control group before and after the model replication. After the model replication, the nipples of the rats in the model group increased significantly, the height increased, the areola was obvious, and the nipple diameter and height were significantly different from those in the control group (P < 0.05). After the test material intervention, the nipple diameter and height of the rats in all groups except the control group decreased, but the difference was not significant (P> 0.05). Compared with the rats in the model group, the nipple diameter and height of the rats in each test material intervention group showed a downward trend, but there was no significant difference (P> 0.05). Table 4 lists the changes in the nipple diameter of rats before and after the model replication and before and after the intervention. Although the nipple diameter of the rats in the model group also decreased at the end of the experiment, compared with other test material intervention groups, the decline was significantly smaller than that of the intervention group. It shows that after the test material intervention, there is a certain improvement effect on mammary hyperplasia in rats.

[0149] 3.4 Rat mammary gland pathology results

[0150] Table 5 Comparison of the number of lobules and alveoli in the mammary gland of rats

[0151]

[0152] Note: Compared with the control group, * P<0.05; Compared with the model group, # P<0.05

[0153] Figure 2 A in the figure is the control group; Figure 2 B in the figure is the model group; Figure 2 G in the embodiment 1 group; Figure 2 H in the embodiment 2 group; Figure 2 I in the figure is the comparative example 1 group. Figure 2The black arrows in the image indicate swollen cells with lightly stained cytoplasm; Figure 2 The green arrow in the figure indicates that the lumen is filled with pink protein mucus; Figure 2 The red arrows in the figure indicate diffuse infiltration of inflammatory cells in the tissue.

[0154] from Figure 2 As can be seen from Table 5, the mammary gland tissue of the rats in the blank group is in a quiescent stage, with only a small number of ducts and atrophic alveoli visible in the tissue, only some acinar epithelial cells edema, the number and size of acinar are normal, the volume and number of mammary lobules are normal, and the mammary alveolar cavity is small. The mammary gland tissue of the rats in the model group is in an active stage, with a large number of acinar structures visible in the mammary gland tissue, some acinar epithelial cells edema, cell swelling, and diffuse infiltration of inflammatory cells visible in the tissue. Compared with the blank control group, the number of mammary lobules increased, the number of acinar cells increased significantly, and the diameter of the acinar cavity increased significantly (P < 0.05). Compared with the model group, the number of mammary gland lobules of rats in Example 1, Example 2 and Comparative Example 1 was significantly reduced (P < 0.05). The number of acinar cells was reduced compared with the model group, but there was no significant difference (P < 0.05).

[0155] Compared with the model group, the diameter of the alveolar cavity of the rats in the control group 1 was significantly reduced (P < 0.05); the diameter of the alveolar cavity of the rats in the example groups 1 and 2 was slightly reduced compared with the model group, but there was no significant difference (P < 0.05).

[0156] Finally, within the experimental period after the model of the present invention was replicated, the breast hyperplasia model recovered to a certain extent. The biochemical indexes and nipple diameter indexes in the model group were changed compared with the control group, but the difference was not significant. However, the analysis of breast pathology results showed that there was a significant difference between the model group and the control group.

[0157] In the experiment, different test materials had different degrees of auxiliary therapeutic effects on mammary hyperplasia in rats. The effect size of different test materials was different. Its effect was mainly manifested in: it had a tendency to reduce the diameter and height of the nipple of rats. It had the effect of significantly reducing the number of mammary lobules, the number of alveoli and the size of the alveolar cavity in mammary hyperplasia.

[0158] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A composition for breast hyperplasia, characterized in that: Take 100 g of dandelion and rose respectively, add 1 kg of water and boil for 30 minutes, boil twice, and combine the decoctions; add 0.1 g of saffron extract to the decoction, rotate vacuum concentration with a vacuum degree of 50 Pa, and finally vacuum freeze-dry at -60°C to obtain the composition.

2. Use of the composition according to claim 1 in preparing a product for treating breast hyperplasia.

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