CN111514241B

CN111514241B - Traditional Chinese medicine composition for treating female hyperplasia of mammary glands and preparation method thereof

Info

Publication number: CN111514241B
Application number: CN202010495655.6A
Authority: CN
Inventors: 夏瑶宾; 耿刚; 张彩云; 孙锋英
Original assignee: Inner Mongolia Autonomous Region Hospital Of Traditional Chinese Medicine
Current assignee: Inner Mongolia Autonomous Region Hospital Of Traditional Chinese Medicine
Priority date: 2020-06-03
Filing date: 2020-06-03
Publication date: 2021-09-07
Anticipated expiration: 2040-06-03
Also published as: CN111514241A

Abstract

The invention provides a traditional Chinese medicine composition for treating female hyperplasia of mammary glands, which comprises 4 parts of Indian iphigenia bulb, 6 parts of barbed skullcap herb, 3 parts of Chinese thorowax root, 2 parts of deglued antler powder, 5 parts of green tangerine peel, 2 parts of subprostrate sophora root, 2 parts of white paeony root, 3 parts of danshen root, 4 parts of common selfheal fruit-spike and 4 parts of honeycomb. The invention is based on the characteristics of qi stagnation and blood stasis with phlegm: the prescription is prepared according to the symptoms that stagnation of liver qi, stagnation of qi, loss degree of qi and blood, stagnation of qi and blood stasis with phlegm cause obstruction of channels and collaterals of breast meridians, and lump in accumulated milk causes breast pain, and the treatment is realized by soothing liver and promoting qi circulation, activating blood and dissolving stasis, and reducing phlegm and resolving masses. Aiming at local common symptoms, the hyperplasia of mammary glands is mainly based on qi stagnation, blood stasis and phlegm coagulation, and the treatment focuses on soothing the liver, promoting the circulation of qi, reducing phlegm, removing blood stasis, resolving masses, relieving pain, and simultaneously, the traditional Chinese medicine composition is used for tonifying the kidney and regulating the thoroughfare and conception vessels. In the formula, the radix bupleuri, the pericarpium citri reticulatae viride and the radix salviae miltiorrhizae are used for soothing liver and promoting qi circulation, and activating blood and dissolving stasis as monarch drugs, the edible tulip and the barbed skullcap herb are used for eliminating phlegm, softening hardness and dissipating stagnation as ministerial drugs, the cornu cervi degelatinatum is used for nourishing liver and kidney, and regulating thoroughfare and conception vessels, and the drugs are used together to play the functions of activating qi and promoting blood circulation, and eliminating phlegm and dissipating stagnation.

Description

Traditional Chinese medicine composition for treating female hyperplasia of mammary glands and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating female hyperplasia of mammary glands and a preparation method thereof.

Background

Mastoproliferation is a benign proliferative disease of breast tissue, and takes breast lumps and pain as two main symptoms. The hyperplasia of mammary glands refers to hyperplasia of mammary glands epithelium and fibrous tissue, and the abnormality of mammary glands in quantity and shape caused by hyperplasia and involution insufficiency of different degrees, which is not tumor and inflammation.

In Yi Lin correction, cloud is the condition of qi failing to form lumps and blood failing to form lumps. In traditional medicine, the formation of mass is closely related to qi stagnation and blood stasis. Therefore, qi stagnation and blood stasis are the pathological basis for the formation of hyperplasia of mammary glands, and the leaf tianshi also considers that the disease of the breast nodules is not only related to qi stagnation and blood stasis, but also related to the position, the sequence and the severity of the invasion, so that the theory that the qi stagnation is in the channel at the beginning and the blood is injured and enters the collaterals for a long time is proposed. The liver depression is the leading cause of qi stagnation and blood stasis. The leaf Tianshi has cloud, the liver is the innate origin, the liver governs smoothing flow of qi and keeps the mind, and stagnation of liver qi can lead to stagnation of qi activity. Through research on documents in all ages, modern doctors have a general consensus on the pathogenesis of liver depression and qi stagnation. In addition, the liver is usually loose and diarrhea due to the emotional disorder, the liver pertains to wood, the spleen pertains to earth, and the wood flourishes and takes earth. Stagnation of qi and blood is caused by stagnation of liver qi, phlegm-dampness is produced internally due to spleen deficiency, and it is combined with the circulation of liver meridian of foot jueyin, and obstruction of mammary collaterals is caused for a long time. For instance, in Zhongyun' breast disease recorded in Wai Zheng Yi Piao Ling (compilation of medical records for external syndrome), it is considered as nodule due to stagnation of liver and spleen. "Su Zhu Yi thinks that women are" littley and mostly "and" partial littley negative ", and sexual love jealophobia and jealousy worry" so "complain about more than one thing", so women are mostly uncomfortable with unsmooth emotions, resulting in stagnation of liver qi and blood stasis.

Kidney-qi failing to control the Chong and ren meridians

Traditional Chinese medicine considers that one day of kidney is one of the two Chong and ren channels as an important link for maintaining the development and reproduction of women. Kidney qi transforms into Tianqi which leads to the circulation of the meridian and Taichong pulse, so that the second sexual characteristics of women, breast development and menstrual cycle are formed. On the one hand, the kidney meridian of foot-Shaoyin, the thoroughfare vessel and the conception vessel all travel to the chest and disperse, and are directly connected with the morphological structure of the breast; on the other hand, the thoroughfare and conception vessels are related to qi and blood and directly affect the development and function of mammary gland. This is the classic conclusion in the 'exterior medical record' compilation, which means that the Chong and ren meridians are the sea, the milk and the meridian respectively. Therefore, the disease is caused by the deficiency of kidney qi, the lack of source of sex-stimulating essence, the disorder of Chong and conception vessels, and the water-retention of the affected part. In the book of holy-economical theory, cloud-like herbs in women have their thoroughfare and conception vessels as the basis, and if they are out of the theory of thoroughfare and conception vessels, the thoroughfare and conception vessels do not harmonize with … …, so qi will not disperse, gather in breast, or be hard or swollen, and have pain and have a core. It is known that the deficiency of kidney qi and the disorder of Chong and ren meridians are also the direct causes of nodules of breast.

The mammary nodules discussed by ancient people are mainly manifested by breast distension, pain and tuberculosis in the breast, and the occurrence of the disease is considered by ancient people to be closely related to the liver, spleen, kidney and Chong and ren meridians. The traditional Chinese medicine is developed to date, and the professional committee of mastopathy of the Chinese medical science society in 2002 passes the dialectical standard of hyperplasia of mammary glands, so that the disease is divided into three types, namely liver depression and qi stagnation, phlegm nodule and thoroughfare and conception vessel disorder, and among the three symptoms, the liver depression and qi stagnation syndrome accounts for 52.58-61.25 percent and is obviously higher than other symptoms. In terms of treatment, no matter stagnation of the liver and spleen or deficiency of kidney qi, disharmony of Chong and ren meridians and hyperplasia of mammary glands are formed into 'knots' or 'lumps', a dredging method is needed, and the lumps can be eliminated, so that qi is mainly regulated in terms of treatment of hyperplasia of mammary glands, as for breast diseases, a 'qi' word is not generated, the breast collaterals are dredged … …, natural qi is easy to be dredged, the nodules are easy to be dispersed, and the lumps are easy to be softened. The treatment scheme simultaneously nourishes the liver, spleen and kidney and thoroughfare and conception vessels, tonifies deficiency and unblocks collaterals to enable milk to be in free circulation with qi and blood, so that pain can be relieved, stagnation can be smooth, stagnation can be dispersed, and treatment is also performed by combining reinforcement and purgation.

At present, the traditional Chinese medicine treatment for the hyperplasia of mammary glands comprises an ancient prescription, a dialectical treatment prescription, a treatment prescription according to the menstrual cycle and a self-made prescription^[2]。

Modified ancient prescription

The former can treat breast nodules with definite curative effect according to the ancient prescription. Adding and reducing flavored Xiaoyao powder: 17g of radix bupleuri, 30g of radix paeoniae alba, 20g of pericarpium citri reticulatae viride, 20g of fructus aurantii immaturus, 20g of mint, 30g of radix curcumae, 20g of radix glycyrrhizae preparata, 20g of fingered citron, 20g of linden and 20g of angelica sinensis. Increase and decrease according to the disease: for patients with obvious swelling of limbs and parts, 20g of rhizoma alismatis, 20g of cassia twig, 20g of radix astragali and 20g of radix stephaniae tetrandrae are added; for the patients with more blood clots in menstrual blood, add vinegar-fried cattail pollen 15g, motherwort 20g, vinegar-fried trogopterus dung 15g, and agrimony 20 g; 30g of hawthorn, 15g of white mustard seed, 20g of selfheal and 35g of keel are added for patients with serious breast induration; for patients with dry mouth and tongue, dizziness, and soreness of waist and knees, herba Ecliptae 20g, fructus Ligustri Lucidi 20g, cortex moutan 20g, and radix rehmanniae 20g can be added; for chest and rib stuffiness, 15g of costustoot and 15g of sandalwood are added. 4 weeks is 1 course of treatment, and 2 courses of continuous administration. ② modified bupleuri decoction for soothing liver: 20g of radix bupleuri, 8g of dried orange peel, 14g of Sichuan peony root, 14g of fructus aurantii immaturus, 12g of white peony root, 22g of prepared rehmannia root, 17g of bighead atractylodes rhizome, 22g of medlar, 17g of radix astragali, 5g of honey-fried licorice root and 12g of rhizoma cyperi. 4 weeks is 1 course of treatment, and 2 courses of continuous administration; ③ for most patients with mammary nodules accompanied by weakness of the spleen and stomach, Shen Pu Bai Zhu san Bu Zhong Yi Qi, Jiang Wei: 25g of hyacinth beans, 32g of cover a roof with straw barleys, 20g of Chinese yam, 20g of lotus seeds, 20g of dried orange peel, 20g of bighead atractylodes rhizome, 20g of Fupu, 15g of codonopsis pilosula, 15g of platycodon grandiflorum, 15g of fructus amomi, 3 Chinese dates and 3 ginger slices, wherein the fructus amomi and the dried orange peel have the effects of refreshing the spleen, opening the lung qi by the platycodon grandiflorum, promoting diuresis, and carrying medicine upward, and have the effect of earth and gold production.

Syndrome differentiation therapeutic prescription

The syndrome differentiation treatment is a common treatment method for clinically treating the mammary nodules in the traditional Chinese medicine. Some scholars classify the traditional Chinese medicine symptoms of breast nodules into the following types: liver qi stagnation. The prescription I for treating the breast nodules is taken orally: bupleuri radix, radix Paeoniae alba, Bulbus Fritillariae Thunbergii, Prunellae Spica, Carthami flos, Saviae Miltiorrhizae radix, rhizoma Cyperi, rhizoma Pinelliae Preparata, semen Persicae, fructus Trichosanthis, semen Citri Reticulatae, and radix Angelicae sinensis; ② Chong and ren disharmony. And (3) administration of a mammary nodule eliminating prescription II for oral administration: radix rehmanniae Preparata, Corni fructus, semen Cuscutae, Prunellae Spica, thallus laminariae, spina Gleditsiae, herba Salviae chinensis, semen Persicae, fructus Lipuidambaris, Carthami flos, flos Chrysanthemi, Sargassum, colla Cornus Cervi, rhizoma Dioscoreae, and fructus Lycii. It is administered orally after meal for 2 months after 1 dose per day and 3 times per day. Another scholars uses the spleen-invigorating decoction as a basic formula for treating nodules of breast: 25g of radix astragali, 15g of codonopsis pilosula, 15g of scorched jujube kernel, 15g of polygala tenuifolia, 15g of longan aril, 15g of angelica, 15g of bighead atractylodes rhizome, 20g of linden, 8g of honey-fried licorice root, 10g of costustoot and 5 Chinese dates. The theory of traditional Chinese medicine considers that qi of spleen and stomach exists in the five internal organs, and different types of nodules of breast can be treated and relieved by strengthening spleen and stomach, so that the nodules of breast can be divided into types of damp-heat accumulated in stomach, damp turbidity obstruction in middle-jiao, damp-harassment of spleen and stomach and weakness of spleen and stomach according to the functional status of spleen and stomach, and the syndrome differentiation treatment effect is excellent.

Formula for treating according to menstrual cycle

Since the mammary nodules worsen, alleviate and disappear initially with the menstrual cycle, the traditional Chinese medicine is usually used for treatment according to the menstrual cycle. 12g of cowherb seed, 13g of radix bupleuri, 12g of angelica, 12g of Fuzhu, 15g of rhizoma sparganii, 13g of white mustard seed, 12g of radix curcumae, 14g of radix paeoniae alba, 14g of poria cocos, 13g of rhizoma atractylodis macrocephalae, 15g of fructus trichosanthis, 25g of motherwort, 25g of radix salviae miltiorrhizae, 32g of raw oyster shell, 35g of raw malt, 35g of raw hawthorn, 20g of semen coicis, 8g of pericarpium citri reticulatae, and the traditional Chinese medicine can strengthen spleen and eliminate dampness, soothe liver and regulate qi, and can take 20g of cistanche, 20g of northern lutea, 15g of herba epimedii, 15g of semen cuscutae, 13g of cornu cervi degelatinatum, 15g of radix polygoni multiflori, 13g of medlar, 14g of rhizoma atractylodis macrocephalae and 25g of radix asparagi after menstruation, so as to regulate Chongren, tonify liver, replenish qi and nourish liver and spleen. In addition, the scholars can use the liver-soothing and kidney-tonifying method to adjust and treat the nodules of breast in different menstrual cycles, and the first half period of the menstruation is treated by the Xiaoyao powder and the Erxian decoction with the added flavor so as to sooth the liver and tonify the kidney and regulate Chong and ren meridians; in the latter half period, XIAOYAO powder and bupleuri radix powder with the effects of dispersing stagnated liver qi and promoting blood circulation are used for treating.

Self-simulation square

Chinese patent contains more than 1000 Chinese medicinal compositions and takes an internal self-made prescription for treating hyperplasia of mammary glands. The representative efficacy is: invigorating qi and nourishing blood, dispersing stagnated liver qi, relieving depression and tranquilization, and balancing endocrine (representing patent CN 106389807A); resolving stagnation, regulating meridians, dispelling blood stasis, and clearing away core to treat hyperplasia of mammary glands (patent CN 106237237A); promoting blood circulation, removing blood stasis, dredging channels, resolving hard mass, dispersing stagnated liver qi, dredging collaterals, dredging mammary duct, activating qi-flowing, relieving pain, calming endogenous wind, relieving spasm, clearing heat, removing blood stasis, etc. (representing patent CN 105456570A); has the efficacies of soothing liver and relieving depression, nourishing blood and strengthening spleen, clearing heat and removing blood stasis, clearing heart and cooling blood, eliminating carbuncle and dissipating stagnation, activating blood and removing blood stasis and relieving pain, and has obvious curative effect on various mammary gland hyperplasia caused by endocrine dyscrasia, qi stagnation and blood stasis (representing patent CN 105079198A); soothing liver, relieving depression, strengthening spleen and promoting qi circulation (representing patent CN 104906509A); in summary: has the effects of soothing liver, softening liver, promoting blood circulation, nourishing blood, promoting qi circulation, removing stasis, dredging collaterals, removing blood stasis, balancing endocrine, nourishing five internal organs, benefiting vital essence and energy (representing patent CN104840804A) and the like, and can effectively relieve the symptoms of hyperplasia of mammary glands, such as breast pain, breast lumps, nipple discharge, menstrual disorder, emotional change and the like.

For the treatment of hyperplasia of mammary glands, the self-prepared prescription is effective, but the application range is limited, and the requirement cannot be met. In addition, the western medicine (tamoxifen) has no obvious curative effect and obvious side effect, the limitation of operation treatment is realized, and the advantages of the traditional Chinese medicine theory and symptomatic treatment are obvious. The traditional Chinese medicine preparation for treating the hyperplasia of mammary glands with different symptoms is developed, the status of the traditional Chinese medicine in the treatment of the hyperplasia of mammary glands is established, the action mechanism of the traditional Chinese medicine is clarified, the popularization and application value of the traditional Chinese medicine is clarified, the proved prescription of the traditional Chinese medicine becomes a resource, the influence of the traditional Chinese medicine is improved, the traditional Chinese medicine is developed, the popularization and application of the traditional Chinese medicine are promoted and applied to the country and even the world, and the traditional Chinese medicine is a macroscopic development trend of the traditional Chinese medicine for treating the hyperplasia of mammary glands.

Disclosure of Invention

The invention aims to solve the technical problem of providing a traditional Chinese medicine composition for treating female hyperplasia of mammary glands with qi stagnation, blood stasis and phlegm, which has the effects of soothing liver, regulating qi, clearing heat, removing toxicity, softening hardness and dissipating stagnation and is mainly used for treating stagnation of liver-qi and phlegm coagulation; clinical experimental research shows that the medicine composition has the curative effect of treating hyperplasia of mammary glands superior to that of the orally taken mammary nodule eliminating capsule and has the functions of softening hardness, dissipating stagnation, activating collaterals, eliminating fatigue, diminishing swelling and relieving pain. In addition, the invention also provides a preparation method of the traditional Chinese medicine composition for treating female hyperplasia of mammary glands.

In order to solve the technical problems, the embodiment of the invention provides a traditional Chinese medicine composition for treating female hyperplasia of mammary glands, which comprises the following Chinese herbal medicine components in parts by weight:

2-6 parts of edible tulip, 4-10 parts of barbed skullcap herb, 2-5 parts of radix bupleuri, 1-3 parts of cornu cervi degelatinatum, 3-8 parts of green tangerine peel, 1-3 parts of subprostrate sophora, 1-3 parts of white paeony root, 2-5 parts of salvia miltiorrhiza, 2-6 parts of selfheal and 2-6 parts of honeycomb.

Preferably, the traditional Chinese medicine composition for treating female hyperplasia of mammary glands comprises the following Chinese herbal medicine components in parts by weight:

4 parts of edible tulip, 6 parts of barbed skullcap herb, 3 parts of radix bupleuri, 2 parts of cornu cervi degelatinatum, 5 parts of green tangerine peel, 2 parts of subprostrate sophora, 2 parts of white paeony root, 3 parts of salvia miltiorrhiza, 4 parts of selfheal and 4 parts of honeycomb.

The invention is based on the characteristics of qi stagnation and blood stasis with phlegm: the prescription is prepared according to the symptoms that stagnation of liver qi, stagnation of qi, loss degree of qi and blood, stagnation of qi and blood stasis with phlegm cause obstruction of channels and collaterals of breast meridians, and lump in accumulated milk causes breast pain, and the treatment is realized by soothing liver and promoting qi circulation, activating blood and dissolving stasis, and reducing phlegm and resolving masses. Aiming at local common symptoms, the hyperplasia of mammary glands is mainly based on qi stagnation, blood stasis and phlegm coagulation, and the treatment focuses on soothing the liver, promoting the circulation of qi, reducing phlegm, removing blood stasis, resolving masses, relieving pain, and simultaneously, the traditional Chinese medicine composition is used for tonifying the kidney and regulating the thoroughfare and conception vessels. The capsule is based on qi stagnation, blood stasis and phlegm coagulation aiming at hyperplasia of mammary glands, in the formula, radix bupleuri, pericarpium citri reticulatae viride and radix salviae miltiorrhizae are used as monarch drugs, the edible tulip and the sculellaria barbata are used as ministerial drugs for reducing phlegm, softening hardness and dissipating stagnation, the cornu cervi degelatinatum is used for tonifying liver and kidney and regulating Chong and ren meridians, and the drugs are used together to play the functions of promoting qi and activating blood, reducing phlegm and dissipating stagnation.

The preparation method of the traditional Chinese medicine composition for treating female hyperplasia of mammary glands comprises the following steps:

(1) pulverizing Pseudobulbus Cremastrae Seu pleiones, cornu Cervi Degelatinatum, pericarpium Citri Reticulatae viride, radix Sophorae Tonkinensis, radix Paeoniae alba, and radix Salviae Miltiorrhizae into fine powder;

(2) respectively decocting Spica Prunellae, nidus Vespae, herba Scutellariae Barbatae, and bupleuri radix with 5 times of water, filtering, mixing decoctions, and concentrating under reduced pressure to obtain extract;

(3) and (3) uniformly stirring the fine powder obtained in the step (1) and the extract obtained in the step (2), drying, crushing, granulating and encapsulating to obtain the capsule.

In the step (2), the decocting times are 3 times, and each time is 1 h.

The technical scheme of the invention has the following beneficial effects:

the invention has the effects of soothing liver, regulating qi, clearing away heat and toxic materials, and softening and resolving hard mass, and is mainly used for treating liver depression, blood stasis and phlegm. Is used for treating breast nodules, goiter, scrofula and other diseases, and has definite curative effect and high safety. Clinical experimental research shows that the medicine composition has the curative effect of treating hyperplasia of mammary glands superior to that of orally taken mammary nodule eliminating capsule, and has the functions of softening and resolving hard mass, activating collaterals to eliminate blood stasis, eliminating swelling and relieving pain.

Drawings

FIG. 1 is a liver function index map before and after treatment according to the present invention;

FIG. 2 is a graph of renal function indicators before and after treatment according to the present invention;

FIG. 3 blood routine test index

FIG. 4 electrocardiogram detection indexes

FIG. 5 urine routine test index

FIG. 6 is a B-ultrasonic view of the mammary gland of patient 1 before treatment;

FIG. 7 is a B-ultrasonic view of the mammary gland of patient 1 after treatment;

FIG. 8 is a B-ultrasonic view of the mammary gland of patient 2 prior to treatment;

FIG. 9 is a B-ultrasonic view of the breast after treatment of patient 2;

FIG. 10 is a first ultrasound B view of the mammary gland of patient 3 prior to treatment;

FIG. 11 is a first breast ultrasound B view of patient 3 after treatment;

FIG. 12 is a B-ultrasonic view of the mammary gland of patient 4 prior to treatment;

FIG. 13 is a B-ultrasonic view of the mammary gland of patient 4 after treatment;

FIG. 14 is a photograph of HE staining of spleen and mammary gland of rats in normal group;

FIG. 15 is a photograph showing the expression of the bioeffective substance contained in the capsule of the present invention.

Detailed Description

In order to make the technical problems, technical solutions and advantages to be solved by the present invention clearer, the following detailed description is given with reference to specific embodiments.

The invention relates to a traditional Chinese medicine composition for treating female hyperplasia of mammary glands, which comprises the following Chinese herbal medicine components in parts by weight:

The invention preferably comprises the following components:

The preparation method of the traditional Chinese medicine composition with the preferable composition comprises the following steps:

pulverizing Pseudobulbus Cremastrae Seu pleiones, cornu Cervi Degelatinatum, pericarpium Citri Reticulatae viride, radix Sophorae Tonkinensis, radix Paeoniae alba, and Saviae Miltiorrhizae radix into fine powder, decocting Prunellae Spica, nidus Vespae, herba Scutellariae Barbatae, and bupleuri radix with 5 times of water for 3 times (1 hr each time), filtering, mixing filtrates, and concentrating under reduced pressure to obtain extract; mixing the fine powder and the extract, drying, pulverizing, granulating, and making into capsule.

The capsule of the invention has clinical curative effect of treating hyperplasia of mammary glands

1. Clinical study protocol

According to the diagnosis and treatment standard of mammary gland hyperplasia of the eighth meeting of the mastopathy professional committee of the Chinese medical science society, the standard and the exclusion standard are included, verification cases are selected for research. The patients are divided into 40 capsules (treatment group) and 13 capsules of selfheal (control group) by adopting a random and positive drug control method. The medicine taking method comprises the following steps: the capsule group of the present invention: 4 granules each time, 0.4g each granule, 2 times per day; selfheal capsule group: 2 granules each time, 0.35g each granule, 2 times per day; a2-month menstruation period is a course of treatment. Observation indexes: the change of breast pain and hyperplasia lumps of mammary glands before and after treatment, the total integral of symptom signs, the integral of pain and the integral of accompanying symptoms take 4 weeks as an observation time phase; serum estradiol (E2), progesterone (P), Prolactin (PRL), estrogen receptor alpha (era), estrogen receptor beta 1(ER β 1), and Progesterone Receptor (PRB) levels during the pre-and post-treatment menstrual luteal phases (morning fasting blood draw test). Meanwhile, the safety of the medicine is evaluated by detecting liver function, kidney function and heart function.

Ultrasonic observation content: the boundary, morphology, internal echo, presence or absence of fine-spotted hyperechogenic calcifications, presence or absence of posterior echo attenuation, semi-quantitative grading of blood flow signal Adler, and internal arterial blood flow index.

1.1 differentiation of the syndromes according to the Chinese medicine

The main symptoms are: local pain in the breast (nature: stabbing pain); the lump boundary of the part of the breast is not clear and the texture is tough; the tongue tip has macula, the tongue is dark red or purple, and even the sublingual vessels are rough and swollen;

the secondary symptoms are as follows: the relationship between local focus or mass of breast and menstrual cycle or mood is not obvious; the pulse is wiry, slippery or astringent. Chest harmony, oppression and irritability, heaviness and lassitude.

1.2 integration of TCM syndrome

On day 0, treatment 4 and 8 weeks, were recorded.

1.3B-ultrasonic examination (B-ultrasonic examination of a part of patients)

The examination and recording were performed once each on day 0 and on the 8 th week of treatment.

1.4 evaluation index and examination of safety

General physical examination: the examination and recording were performed on day 0, 4 th and 8 th weeks after the treatment.

Blood and urine routine: the examination was performed once on day 0 and on the 8 th week of treatment.

Liver function (ALT), kidney function (BuN, cr), electrocardiogram: the examination was performed once on day 0 and on the 8 th week of treatment.

Adverse events: recording is carried out at any time.

1.5 therapeutic efficacy criteria

1.5.1 determination of curative Effect on mammary gland hyperplasia

The clinical cure is as follows: the breast pain and breast lumps disappear.

The effect is shown: the breast pain disappears or becomes mild and the breast mass shrinks 1/2.

The method has the following advantages: the breast pain disappeared or alleviated, moderate to mild, severe to moderate, and the breast mass narrowed 1/2.

And (4) invalidation: the breast pain does not decrease or worsen, and the breast mass does not decrease or increase.

1.5.2 scoring criteria:

refer to the clinical research guiding principle of new Chinese medicine for treating cystic hyperplasia of breast.

Breast pain:

0 minute: none;

and 2, dividing: pain is dull pain or scurrying pain, which stops working when going;

and 4, dividing: pain with tenderness and obvious distending pain;

6 min: pain is either a drop or prick with marked tenderness.

Tumor mass:

0 minute: none;

and 2, dividing: the unilateral or bilateral breast lumps are single small lumps, or are granular and have small range, or are rope objects, are softer and are limited in one quadrant;

and 4, dividing: the mass is large, or is in the shape of a sheet or a disc, which affects the breasts, but the range is in two quadrants;

6 min: large mass, multiple cystic nodules, involvement of double breasts, in more than two quadrants.

Chest and rib distending pain:

0 minute: none;

1 minute: slight chest and costal distending pain, stopping in time;

and 2, dividing: the chest and rib distending pain can be tolerated and persists;

and 3, dividing: the distending pain of the chest and the rib is hard to endure.

Dysphoria and irritability:

0 minute: none;

1 minute: impatience occasionally occurs;

and 2, dividing: irritability and anger;

and 3, dividing: restlessness and irritability make it difficult to control itself.

1.5.3 the traditional Chinese medicine syndrome curative effect judgment standard:

the curative effect of the syndrome of traditional Chinese medicine is judged according to an integral method.

The efficacy index ((n) ═ i [ (pre-treatment integral-post-treatment integral) ÷ pre-treatment integral ] × 100%.

And (3) clinical control: the traditional Chinese medicine syndrome integral is reduced by more than or equal to 90 percent;

the effect is shown: the traditional Chinese medicine syndrome integral is reduced by more than or equal to 70 percent and less than 90 percent;

the method has the following advantages: the traditional Chinese medicine syndrome integral is reduced by more than or equal to 30 percent;

and (4) invalidation: the traditional Chinese medicine syndrome integral is reduced by less than 30 percent.

2 results of clinical study

The capsule of the invention has the influence on the human mammary gland hyperplasia lumps and symptoms

TABLE 1 patient lump assessment score statistics

Note: compared with the t test group, the tumor score of the patients in the treatment group is obviously reduced after treatment, p is less than 0.05, compared among the groups, p is more than 0.05, and the difference has no statistical significance.

TABLE 2 patient nodule area statistics

Note: compared with the t test group, the tumor areas of the patients in the treatment group are obviously reduced after treatment, p is less than 0.05, and the difference has statistical significance. The area of the tumor in the control group was increased, and the difference was not statistically significant. The comparison between groups, p >0.05, showed no statistical significance of the differences.

TABLE 3 patient pain score statistics

Note: compared with the t test group, the pain scores of the patients in the treatment group are obviously reduced after treatment, and p is less than 0.00. Compared among groups, p is less than 0.001, and the difference has statistical significance. The control group had no statistical significance for the reduction in score.

TABLE 4 Scoring statistics for patients with chest pain

Note: compared with the t test group, the chest pain relieving score of the patients in the treatment group is obviously reduced after treatment, p is less than 0.01, compared among the groups, p is less than 0.001, and the difference has statistical significance. The control group had no statistical significance for the reduction in score.

TABLE 5 patient dysphoria and irritability score statistics

Note: through comparison among the t test groups, the dysphoria and irritability scores of patients in the treatment groups are obviously reduced after treatment, p is less than 0.01, compared among the groups, p is less than 0.001, and the difference has statistical significance. The control group had an increased score and was not statistically significant.

The influence of the capsule of the invention on the development link of the hyperplasia of mammary glands

TABLE 6 Capsule of the invention versus estradiol E in peripheral blood of patients₂Influence of the amount

Note: compared with the t test group, the content of estradiol of the treated patients is obviously reduced, p is less than 0.04, and the difference has statistical significance. There was no significant difference between the control and the group.

TABLE 7 Effect of the capsules of the invention on the progesterone content in the peripheral blood of patients

Note: there was no statistical difference in progesterone levels after treatment in both groups, compared between the t-test and the descriptive test groups and between the groups.

TABLE 8 Effect of the capsules of the invention on the ratio of estradiol E2 to progesterone P content in the peripheral blood of patients

Note: compared with the t test group, the content ratio of the estradiol E2 to the progesterone P of the treated patients is obviously reduced, P is less than 0.04, and the difference has statistical significance. Compared with groups by t-test descriptive test, p is more than 0.05, and has no significant difference.

TABLE 9 Capsule of the invention for HT in peripheral blood of patients₅、ERβ、Erβ1、Erα、BK、VEGF、LXA₂Influence of content of

Note: p < 0.01, p < 0.04, p <0.05

After 8 weeks of treatment, the blood levels of HT5, Er alpha, BK and VEGF in patients in a treatment group are obviously reduced by p less than 0.01-0.05. LXA2 ER beta and Er beta 1, the level is obviously increased by p < 0.04 and p < 0.05. The difference is statistically significant.

3. The safety detection significance and the result of the invention are as follows:

3.1 liver function 5 indexes and selection significance:

alanine Aminotransferase (ALT): can sensitively respond to the damage of the liver cells and the damage degree. Serum ALT is most sensitive when the drug causes acute hepatocyte injury.

Aspartate Aminotransferase (AST): can sensitively respond to the damage of the liver cells and the damage degree. AST is elevated to a degree exceeding alt in chronic hepatitis and liver cirrhosis, so AST mainly reflects the degree of liver damage.

Serum L-R-glutamyl transpeptidase (GGT): can sensitively reflect damage of liver cells and damage degree, and when liver cell membranes are damaged or cells are dead, the blood concentration of GGT is increased.

Serum alkaline phosphatase (ALP): ALP is present in hepatocytes and sensitively reflects the presence or absence of damage to hepatocytes and the extent of damage, and the blood concentration of ALP increases when the hepatocyte membrane is damaged or cells are necrotic.

Total Bilirubin (TBLL): total bilirubin values reflect hepatic secretory and excretory function when there is drug-toxic hepatitis, an increase in TBLL can occur.

Liver function indices before and after treatment are shown in FIG. 1, in which 0 and 8 represent 0 week and 8 weeks.

After 8 weeks of administration, the liver function 5 indexes are compared in the group by t test, and the indexes before and after treatment have no statistical difference (p is more than 0.05).

3.2 renal function 4 indexes and their selective meanings:

urea UA: as an end product of human protein metabolism. Glomerular filtration, in which 40% is absorbed by the proximal tubule, the absorption by the distal tubule depends on the urine volume and is finally excreted from the urine, and spring welcome depends on the concentration of UA in the blood, the glomerular filtration function (indirect index).

Uric acid UREA: uric acid is the end product of purine metabolism in the body, with the purines being derived in small part from food and in large part from nucleic acid breakdown of body tissues. Serum uric acid is partly bound to proteins and mostly exists in free form. Most of serum uric acid is filtered by glomeruli and is reabsorbed by 98-100% of proximal tubules, so that the clearance rate of uric acid is low under normal conditions. (Indirect index)

Blood Creatinine (CREA): creatinine is the end product of muscle acid metabolism in the human body and is primarily filtered by the glomerulus and excreted with the urine without substantial reabsorption. Under the condition of stable food exogenous intake, the concentration of creatinine in blood depends on the glomerular filtration capability, and the method is the most common method for clinically detecting the glomerular filtration function. (Indirect index)

Carbon dioxide binding force (CO)₂cp): carbon dioxide binding capacity refers to the amount of carbon dioxide present as bicarbonate ions in the plasma. The determination of the carbon dioxide binding force lies in the observation of the alkali reserves in the body to understand the acid-base equilibrium condition in the body. Excessive acid can cause acidosis, excessive alkali can cause alkalosis, and acidosis is more common than alkalosis in clinic.

The detection of the renal function detection index aims to investigate the change of the glomerular filtration function, the renal tubule secretion function and the pH value after the capsule is used. The results show that the indexes before and after treatment have no statistical difference (p is more than 0.05) through comparison in the t test group. Indicating that the capsules of the present invention are safe for kidney function.

Renal function indices before and after treatment are shown in FIG. 2, where 0 and 8 represent

weeks

0 and 8.

3.3 blood routine

Table 10 effect of capsules on blood routine:

the invention detects 28 items of blood routine of patients before and after treatment (see figure 3)

The Red Blood Cells (RBC), Hemoglobin (HGB), Mean Platelet Volume (MPV), and large platelet ratio (P-LCR) were significantly elevated after 8 weeks of treatment, with the differences statistically significant, but within the normal range. It is presumed that an increase in hemoglobin is advantageous for improving the blood stasis symptom. (p < 0.01, p < 0.04)

Table 10 effect of the capsules of the invention on blood routine: red Blood Cells (RBC), Hemoglobin (HGB), Mean Platelet Volume (MPV), large platelet ratio (P-LCR)

Note: p < 0.01, p < 0.04

The capsules of the invention up-regulated Red Blood Cells (RBC), Hemoglobin (HGB), Mean Platelet Volume (MPV), and large platelet ratio (P-LCR) values by in-t-test group comparison. The difference between p and 0.01 and p and 0.04 has statistical significance.

3.4 Electrocardiogram

The invention detects the sinus rhythm before and after the treatment of the electrocardiogram item (shown in figure 4) of the patient before and after the treatment, and has no obvious change and no statistical difference. Some patients have improved symptoms of treatment for sinus arrhythmia, ST segment changes, etc.

3.5 urinary routine

The invention detects 26 items of routine blood of patients before and after treatment (see figure 5)

Compared with the t test group, the indexes have no significant difference, and the difference has no statistical significance (p is more than 0.05).

TABLE 11 Effect of the capsules of the invention on ovarian, uterine and splenic factors in female rats

Note: p is more than 0.05

After administration, the weights of spleen, uterus and ovary of rats are in normal ranges, no significant difference exists through t test among groups, and no statistical difference exists through variance analysis of splenomegaly histopathological detection, occurrence of central periarterial sheath of splenomegaly and occurrence of splenomegaly and marginal zone body density. The capsules of the invention proved to be safe.

Conclusion

Clinical researches show that the capsule has obvious treatment effect on hyperplasia of mammary glands, the symptoms are relieved or disappeared after treatment, the total effective rate on breast pain is 82.50%, the total effective rate on tumor is 68.00%, the total effective rate on the principal syndrome is 88.29%, the total effective rate on traditional Chinese medicine symptoms is 88.29%, the total curative rate on diseases is 5%, and the total effective rate is 90.71%. The conventional comparison of the electrocardiogram and the blood of liver function and kidney function of patients before and after treatment and animal experiment research show that the medicine is safe.

Biological effects of the capsules of the invention: the medicine has the following pain indexes in peripheral blood of patients: serotonin (HT5), Bradykinin (BK); the estrogen index is as follows: estrogen receptor beta (ER β), estrogen receptor beta subtype (ER β 1), estrogen receptor alpha (ER α); nodal growth index: vascular Endothelial Growth Factor (VEGF); inflammatory indices: influence of LXA2

After 8 weeks of treatment: the capsule can lower HT5 value, p is less than 0.01; the value of Er alpha is less than 0.04; BK value, p < 0.05; VEGF value, p < 0.01; the values of ER beta and ER beta 1 are up-regulated, and p is less than 0.01; LXA2 values, p <0.05, the differences were statistically significant.

The indexes of promoting blood circulation and removing blood stasis are as follows: comparing the index difference before and after treatment of the test group, the Red Blood Cell (RBC), Hemoglobin (HGB), platelet average volume (MPV) and large platelet ratio (P-LCR) values of the capsule after treatment are obviously increased, P is less than 0.02 and P is less than 0.00, and the difference has statistical significance.

Case display:

patient 1: segmental lady

The color of breast B-ultrasound before and after treatment of the patient is compared, as shown in FIGS. 6 and 7, and it can be seen that the nodules of the patient disappeared after treatment.

Patient 2: lu women

The color of breast B-ultrasound before and after treatment of the patient is shown in FIGS. 8 and 9, and it can be seen that the nodules of the patient disappeared after treatment.

Patient 3: qin woman

The color of breast B-ultrasound before and after treatment of the patient is shown in FIGS. 10-13, and it can be seen that after treatment, the nodules are reduced or disappeared after the treatment of the patient with multiple nodules.

And (4) observing rat mammary tissue sections under an HE staining mirror, and arranging rat mammary duct epithelium, ductal cavities, acinus cavities, lobules, acinus in the lobules and excretions in the cavities of the lobules in each group.

Mechanism research scheme

Rat model study protocol: 70 female adult rats are randomly divided into a blank control group, a model control group, a nodules of breast control group and a Tamoxifen (TMS) control group, and the capsule of the invention is divided into a high-dose group, a medium-dose group and a low-dose group. After injecting estradiol benzoate injection into the muscle for 25 continuous days, injecting progesterone injection into the muscle for 5 continuous days, establishing a mammary gland hyperplasia animal model, and observing the morphological change of the mammary gland tissue of the rat model under a microscope. After the success of the model building is confirmed, the medicine treatment is respectively carried out. The first capsule high, medium and low dose groups of the invention respectively infuse the stomach of experimental rats according to the high, medium and low dose concentrations, and the mammary nodule eliminating group infuses the stomach with mammary nodule eliminating suspension. The normal group and the model group were administered distilled water for drenching the stomach for 30 consecutive days. After the last administration, the rats were fasted and kept for 12 hours, and 20% urethane was injected into the abdominal cavity to anesthetize the rats.

Sampling and observing indexes of mammary gland specimen: and (3) taking down the No. 2 pair of bilateral breasts of the rat by a wedge, observing pathological changes of mammary tissues of each group of rats under an optical microscope, staining the mammary tissues by an immunohistochemical method, and carrying out semi-quantitative analysis on the content of receptors while observing the expression conditions of estrogen receptors alpha and beta 2(ER alpha and ER beta 2), progestational hormone receptors (PRB) and Androgen Receptors (AR) in the mammary tissues of the rats. The expression conditions of fas and fasl proteins of mammary tissues of rats in each group are detected by an immunohistochemical technology, and the expression conditions of survivin (anti-apoptosis gene), caspase-8 (pro-apoptosis gene) and caspase3mRNA are detected by an immunohistochemical method.

The protein expression degree of Vascular Endothelial Growth Factor (VEGF) and Basic Fibroblast Growth Factor (BFGF) of mammary tissue of each group of rats is detected. Analyzing the correlation between the abnormal expression of the angiogenesis factor and the hyperplasia of mammary glands, and observing the pathological morphological change of the mammary gland tissues of each group of rats by using HE staining. Organ coefficient: preparing skin at lower abdomen, cutting off skin and muscle layer at 5mm above pubic symphysis, exposing internal organs, finding uterus and ovary at both sides, taking out thymus and spleen, and weighing spleen, uterus and ovary with electronic balance; calculating organ coefficients

The index detection method comprises the following steps:

immunohistochemical examination of mammary receptor expression: detecting the expression conditions of ER alpha, ER beta, PRB, fas, fasl, Survivin, caspase-8, VEGF and BFGF in mammary tissue of a rat.

ELISA for detecting serum hormone levels

Detection of serum E2, P, PRL levels

Pathological examination of the breast

The mammary gland is put into 10% formaldehyde solution and dehydrated by conventional 95% ethanol. Paraffin embedding, slicing, HE staining, and observing the arrangement of ductal epithelium of the mammary gland of each group of rats, the number of acini in ductal cavity, acinus cavity, lobule and lobule after HE staining of the mammary tissue section of the rat by an optical biological microscope.

1 Material

1.1 the basic prescription of the medicine comprises Indian iphigenia bulb, barbed skullcap herb, Chinese thorowax root, cornu cervi degelatinatum, subprostrate sophora, white paeony root, red-rooted salvia root, green tangerine peel, common selfheal fruit-spike and honeycomb (the traditional Chinese medicine decoction pieces are purchased from traditional Chinese medicine decoction piece limited company in Anguo, and the batch numbers are 20171119, 20171201, 20180106, 20171018, 20170613,20171201,20170601,20171213, 20170828, 20171214 and 20171114 respectively). The decoction pieces are identified as genuine products, the original formula is prepared from 2kg of crude drug, decocting with water for 2 times, each time for 30min, mixing decoctions, filtering, drying to obtain dry extract, 1g of the dry extract is equivalent to 4.69g of the crude drug, pulverizing into fine powder, sealing, and storing in-20C refrigerator. Before use, the required concentration is prepared by water respectively. Estradiol benzoate injection for veterinary use (manufactured by Ningbo second hormone works, batch No. 20180420); progesterone injection (manufactured by Ningbo second hormone works, lot 180225; Prunellae Spica Capsule (Liaoning good Nurse drug industry Co., Ltd., lot 100202; tamoxifen tablet (Sichuan Disfitt drug industry Co., Ltd., lot 1706020).

1.2 animals SPF-grade female wister non-pregnant rats, 9 weeks old, purchased from the Life academy of sciences of inner Mongolia university, certification number SCXK (inner) 2018-; the animals are all raised in an animal room in the protective environment of the inner Mongolia traditional Chinese medicine institute, and during the experiment, the animals can freely drink water and eat the water, the room temperature is 20-25 ℃, the humidity is 40% -70%, the illumination period is light and dark, the illumination period is 12 hours each, and the ventilation is good.

2 method

2.1 Observation of serum hormone levels and mammary gland pathology in rats

2.1.1 model making refers to the classic mammary gland hyperplasia model making method, and adopts the rat to inject 0.5mg.kg of estradiol benzoate in the muscle^-11 (qd) daily for 25 consecutive days, followed by an intramuscular injection of 4mg.kg of progesterone^－1.d^－1And 5d in succession. The structure and the form of the mammary tissue of the animal are observed under a light mirror after the model is built, and the mammary acinar hyperplasia is selected as the main judgment basis for the success of the model building according to the pathological diagnosis standard in the preparation standard of the mammary hyperplasia animal model.

2.1.2 grouping and administration after successful modeling, rats were randomly divided into 7 groups according to body mass, namely a normal group, a model group, a high, medium and low dose capsule of the invention and a selfheal group. The clinical application dose of the capsule formula is 0.95g of crude drug per day, calculated according to the mass of 60kg of an adult, and the equivalent dose of a rat is 0.0158g^-1.d^-1The low, medium and various dosage groups of the capsule formula of the invention are sequentially set up in rats, and the dosage is 0.063, 0.316 and 0.632g.kg respectively^-1.d^-1(ii) a The clinical application dose of the selfheal is 0.023g.kg^-1.d^-1The equivalent dose of rat is about 0.092g.kg^-1.d^-1The clinical application dose of tamoxifen is 0.003g.kg^-1.d^-1The equivalent dose of rat is about 0.018g.kg^-1.d^-1The gavage amount of the mice is 10mL/kg according to the standard, the mice are gavage for 1 time every day, and the mice in the normal group and the mice in the model group are gavage for 28 days continuously with the same amount of water every day.

3 content

3.1 Observation of mammary gland histopathology

Fixing with 10% formaldehyde, selecting fixed specimen, treating with tissue dehydrator, embedding paraffin to obtain paraffin block, cutting into 3m tissue slices, performing HE staining, sealing with neutral gum, and observing animal mammary gland tissue structure and shape under light mirror. According to the pathological diagnosis standard in the preparation standard of the mammary gland hyperplasia animal model, the experiment takes the acinar hyperplasia as the main judgment basis, and establishes a pathological scoring standard according to the weight degree of the acinar hyperplasia, and the mammary gland tissue has no diagnosis standard change, which is 0 point; the number of mammary gland tissue acinus is slightly increased and is 3 points; the number of mammary gland tissue acinus is slightly increased, and the mild hyperplasia is 6 points; the number of mammary gland tissue acinus is obviously increased, and the moderate hyperplasia is 9 points; the number of mammary gland tissue acinus is obviously increased, and the severe hyperplasia is 12 points.

Effect of the capsules of the invention on rat mammary Pathology

The mammary gland of the normal group is not hyperplastic, the model group has slight to moderate mammary gland acinus hyperplasia, mild to severe acinus cavity expansion and mild to moderate acinus secretion, and secretion can be seen in a mammary duct; the hyperplasia of mammary glands of the low-dose group and the selfheal group are reduced to different degrees, which is expressed by the number of lobules of mammary glands, and compared with the model group, the capsules of the invention have obviously reduced middle, diameter and quantity of endocrine in glandular cavities. Compared with the normal group, the increase of the pathological integral of the mammary gland of the model group obviously reduces the average number of acinus, and the straight P of the acinus is less than 0.05. See fig. 14.

3.2 immunohistochemistry assay for expression of breast tissue receptor: expression of ER α, ER β, PRB, fas, fasl, Survivin, caspase-8, VEGF, BFGF is shown in Table 12.

TABLE 12 modulation of the expression of bioeffective substances by the capsules of the invention

VEGF

SURVIVIN

PRB

FASL

FAS

ERβ

ERα

CASPASE

EFGF

A

1117.25± 113.95

384.25±82.29

212.89± 35.72

860.22± 51.09

1891.44±29.65

192.00±42.23

431.22± 33.70

1872.88±136.04

570.29±69.43

B

1805.50±49.79

1384.37±67.64

596.28± 52.00

1634.50± 33.42

1157.75±29.33

907.87±45.99

630.00± 31.52

728.00±48.38

612.71±77.01

C

1632.00±38.45

1225.12± 100.70

734.25± 55.94

1605.70± 70.49

945.00±90.36

1240.75±59.42

777.11± 52.88

782.89±30.10

672.38±53.63

D

1254.88±58.78

514.87±53.66

342.14± 14.55

717.75± 25.15

1698.71± 120.06

322.86±112.62

545.00± 32.25

1694.00±56.01

438.00±76.06

E

1693.29±63.87

1291.57± 123.41

682.33± 68.71

1339.50± 94.79

1278.67±54.09

1018.00± 124.29

692.28± 41.64

1342.83±98.40

578.33±50.20

F

1495.71±55.99

1184.50±91.70

731.17± 30.56

1289.00± 44.26

1269.00±61.24

929.75±55.96

593.29± 20.63

1098.00±71.16

570.29±73.23

G

1129.13±50.65

661.37±30.48

252.88± 40.46

730.44± 52.39

1564.25±32.90

494.87±48.63

434.00± 29.15

1666.14±58.86

562.25±41.65

As a result: the protein expression levels of Vascular Endothelial Growth Factor (VEGF) and basic fibroblast growth factor (bFGF) in mammary tissue of each group of rats were examined. Positive expression degree of VEGF, the low dose group is similar to the normal group and is obviously lower than other groups with P < 0.001), and the expression degree is also increased by increasing the dosage of the medicine; the positive expression degree of BFGF, the low dose group is similar to the normal group and other groups, is obviously higher than the tamoxifen group, and the difference has statistical significance (P is less than 0.01); the positive expression degree of estrogen receptor beta (Er beta) is similar to that of tamoxifen group in the low-dose group, and is obviously lower than that in other groups; the positive expression degree of estrogen receptor alpha (Er alpha), the low-dose group of the capsule is obviously lower than other groups, and the difference has statistical significance (P is less than 0.00-0.05) and is similar to that of a normal group; the PRB positive expression degree is similar to that of the normal group and obviously lower than that of other groups, the difference has statistical significance ((P < 0.02-0.001), the SURVIV positive expression degree is similar to that of the triphenoxyamine group and obviously lower than that of other groups, the difference has statistical significance ((P < 0.001), the CASPASE-8 positive expression degree is obviously higher than that of other groups, the difference has statistical significance ((P < 0.001), the positive expression degree of FASL is similar to that of the normal group and the tamoxifen group and obviously lower than that of other groups, the difference has statistical significance ((P < 0.001)), the positive expression degree of FAS is similar to that of the tamoxifen group and obviously higher than that of other groups, and the difference has statistical significance ((P < 0.02-0.001) is shown in the result of figure 15.

And (4) conclusion: 1. compared with the curative effect of two groups of patients with hyperplasia of mammary glands, the capsule has no significant difference (p is more than 0.05) in the sizes of the lumps, the effect of improving chest pain and dysphoria and irritability of the capsule is obviously superior to that of the selfheal capsule, and the difference has statistical significance (p is less than 0.05).

2. The capsule provided by the invention can obviously improve symptoms such as breast distending pain, mass size, mood fluctuation, chest and hypochondrium swelling and stuffiness, dysphoria, testiness, heavy body, lassitude, dark red tongue and the like of a subject, and has significant significance on difference before and after administration through statistical treatment, so that the capsule provided by the invention has an obvious effect on hyperplasia of mammary glands (liver depression, qi stagnation and phlegm coagulation syndrome), and can effectively improve the survival quality of patients.

3. The application of the medicine proves that the medicine has obvious improvement effect on B ultrasonic examination, which shows that the capsule of the invention can obviously improve the pathological changes of patients with hyperplasia of mammary glands.

4. The capsule of the invention can improve the hyperplasia degree of mammary gland tissue; can regulate HT in blood of patient₅、ERβ、Erβ1、Erα、BK、VEGF、LXA₂Horizontal; can regulate the expression of ER alpha, ER beta, PRB, fas, fasl, Survivin, caspase-8, VEGF and BFGF protein in mammary tissue of rat with hyperplasia of mammary glands, thereby reducing the hyperplasia injury of mammary tissue of human and rat.

5. The research detects blood, urine, stool, electrocardiogram, liver function and kidney function before and after treatment of the subject, and no obvious adverse reaction is found in the result. In this study, rats were examined for spleen, ovary, uterine weight and spleen histopathology, and as a result, the capsules of the present invention were not significantly different from the normal group ((p > 0.05)). The capsule has definite effect, has excellent curative effect on hyperplasia of mammary glands and is worthy of clinical popularization.

While the foregoing is directed to the preferred embodiment of the present invention, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention as defined in the appended claims.

Claims

1. The traditional Chinese medicine composition for treating female hyperplasia of mammary glands is characterized by being prepared from the following Chinese herbal medicine components in parts by weight:

2. The traditional Chinese medicine composition for treating female hyperplasia of mammary glands according to claim 1, which is prepared from the following Chinese herbal medicine components in parts by weight:

3. The preparation method of the traditional Chinese medicine composition for treating female hyperplasia of mammary glands according to any one of claims 1 or 2, which is characterized by comprising the following steps:

(2) decocting Prunellae Spica, nidus Vespae, herba Scutellariae Barbatae, and bupleuri radix in water, filtering, mixing decoctions, and concentrating under reduced pressure to obtain extract;

4. The method for preparing a Chinese medicinal composition for treating female mammary gland hyperplasia according to claim 3, wherein in the step (2), the decoction is performed 3 times, each for 1 hour.