Traditional Chinese medicine composition for treating hysteromyoma and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating hysteromyoma and a preparation method thereof, and belongs to traditional Chinese medicine compositions. Comprising the following components in parts by weight: 1-20 parts of cassia twig, 5-20 parts of poria cocos, 1-15 parts of cortex moutan, 1-15 parts of peach kernel, 1-20 parts of curcuma zedoary, 1-15 parts of rhizoma sparganii, 5-20 parts of cornu cervi degelatinatum, 1-10 parts of thunberg fritillary bulb, 1-10 parts of leech, 5-20 parts of pseudo-ginseng, 1-15 parts of angelica sinensis, 10-20 parts of turtle shell, 5-20 parts of cowherb seed and 5-20 parts of elecampane. According to the traditional Chinese medicine composition adopted by the invention, medicines with multiple functions of activating blood and diminishing swelling, relieving exterior syndrome and clearing heat, and nourishing and regulating qi are combined, so that the hysteromyoma can be eliminated, and the traditional Chinese medicine composition has the effects of regulating liver and kidney, promoting blood circulation to remove blood stasis, softening hardness to dissipate stagnation, promoting qi circulation to relieve pain and the like. The feed contains a plurality of nutrient substances such as a plurality of amino acids, trace elements, vitamin B2, vitamin B12 and the like, can promote the absorption of medicinal functional substances, and meanwhile, improves the immunity of a human body and resists diseases.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for treating uterine fibroids and a preparation method thereof. BACKGROUND

[0002] Uterine fibroids are benign tumors of the myometrium, mainly occurring in women of childbearing age and postmenopausal women. The etiology of uterine fibroids is not yet fully understood, and genetic factors, abnormal sex hormone levels, etc. may all contribute to the occurrence of uterine fibroids. The pathogenesis of uterine fibroids is complex, involving changes in some or all of estrogen, progesterone and their receptors, and changes in local polypeptide growth factors, among others. Research on estrogen and progesterone dependence has reached a consensus. Studies have shown that estrogen and progesterone, two hormones, can increase the activity of uterine arteries, and increased local estrogen levels in uterine fibroids can induce nitric oxide synthase activity, leading to uterine vascular dilation, increased blood flow, improved uterine fibroid blood supply, and promotion of tumor growth. Single estrogen modeling and estrogen-progesterone hormone modeling are two commonly used methods for establishing an induced uterine fibroid animal model, and rats are generally used to establish the model. Compared to single estrogen modeling, estrogen-progesterone hormone modeling is more stable, has a higher success rate, and is more consistent with the process of uterine fibroid occurrence and development, and is the main method used by domestic researchers to model uterine fibroids. The current main treatment methods include drug therapy and surgical treatment. Drugs include gonadotropin-releasing hormone drugs, non-steroidal anti-inflammatory drugs, hemostatic drugs, and compound oral contraceptives, which are used to improve symptoms and reduce fibroid size. In recent years, traditional Chinese medicine has gradually gained attention in the treatment of tumors and cancer. Traditional Chinese medicine regulates the balance of yin and yang in the body as a whole, and has comprehensive effects such as anti-inflammatory and detumescence, inhibition, blood circulation and metabolism promotion, etc. in all dimensions, achieving the purpose of treating cancer and tumors while improving the body's immunity, further promoting the body's self-recovery, and achieving the dual purpose of treating cancer and improving the body. A large number of clinical studies have shown that traditional Chinese medicine has unique advantages in the treatment of cancer and tumors, such as multi-component, multi-target, multi-path comprehensive action, and fewer side effects, etc. Therefore, it is of great significance to develop a traditional Chinese medicine product for uterine fibroids that has definite efficacy, high safety, and is easy to use. SUMMARY

[0003] In order to solve the above problems, the present application provides a traditional Chinese medicine composition for treating uterine fibroids and a preparation method thereof, which has good treatment effect, is easy to use, and has small side effects.

[0004] In order to achieve the above-mentioned purpose, the present application is realized by the following technical scheme: A traditional Chinese medicine composition for treating uterine fibroids, comprising the following components by weight: cassia twig 1-20 parts, poria 5-20 parts, peony root 1-15 parts, peach kernel 1-15 parts, zedoary 1-20 parts, rhizoma sparganii 1-15 parts, antler frost 5-20 parts, Zhebei 1-10 parts, leech 1-10 parts, sanqi 5-20 parts, angelica 1-15 parts, turtle shell 10-20 parts, cowslip 5-20 parts, inula 5-20 parts.

[0005] Further, the traditional Chinese medicine composition for treating uterine fibroids of the present application comprises the following components by weight: cassia twig 5-10 parts, poria 10-20 parts, peony root 5-10 parts, peach kernel 5-10 parts, zedoary 10-20 parts, rhizoma sparganii 5-10 parts, antler frost 10-20 parts, Zhebei 1-10 parts, leech 1-10 parts, sanqi 10-20 parts, angelica 5-10 parts, turtle shell 10-20 parts, cowslip 10-20 parts, inula 10-20 parts.

[0006] Further, the traditional Chinese medicine composition for treating uterine fibroids of the present application comprises the following components by weight: cassia twig 5-10 parts, poria 10-20 parts, peony root 5-10 parts, peach kernel 5-10 parts, zedoary 10-20 parts, rhizoma sparganii 5-10 parts, antler frost 10-20 parts, Zhebei 1-10 parts, leech 1-10 parts, sanqi 10-20 parts, angelica 5-10 parts, turtle shell 10-20 parts, cowslip 10-20 parts, inula 10-20 parts.

[0007] The present application also discloses a preparation method of the traditional Chinese medicine composition for treating uterine fibroids, comprising the following steps: Step (1), mixing the cassia twig, poria, peony root, peach kernel, zedoary, rhizoma sparganii, antler frost, Zhebei, leech, sanqi, angelica, turtle shell, cowslip and inula decoction pieces, and grinding them into fine powder with a particle size of 10-100 μm by using a ball mill; Step (2), freezing the fine powder at a temperature of-15-5℃ for 3-5 days, and taking it out for standby; Step (3), mixing the frozen fine powder and water, and putting them into an autoclave for first decoction, high-pressure decoction for 15-30 min, cooling to 35-60℃, and then filtering to obtain an initial filtrate; adding boiling water to the filter residue, and decocting it on a low fire for 30-40 min, decocting for 1-2 times, and filtering to obtain a secondary filtrate; mixing the initial filtrate and the secondary filtrate to obtain the traditional Chinese medicine composition.

[0008] Further, the pressure of the autoclave in step (3) of the preparation method is 0.2-0.3 MPa.

[0009] Further, the amount of water added in the first decoction in step (3) of the preparation method is 5-8 times the volume of the fine powder.

[0010] Further, the boiling water added in step (3) of the preparation method is 2-5 times the volume of the residue.

[0011] Further, the traditional Chinese medicine composition in step (3) of the preparation method is concentrated to obtain an extract traditional Chinese medicine composition, or is concentrated and dried to obtain a powdery or granular traditional Chinese medicine composition.

[0012] Further, the extract traditional Chinese medicine composition is added with a pharmaceutical excipient to prepare a pill, and the powdery traditional Chinese medicine composition is added with a pharmaceutical excipient to prepare a tablet.

[0013] The traditional Chinese medicine composition for treating uterine fibroids and the preparation method have the following beneficial effects: (1) The traditional Chinese medicine composition used in the present application can eliminate uterine fibroids by combining drugs with the functions of promoting blood circulation to remove stasis, relieving the exterior and clearing heat, and tonifying and regulating qi, and has the effects of regulating liver and kidney, promoting blood circulation to remove blood stasis, softening and resolving hard masses, and regulating qi to relieve pain. The composition contains various nutrients such as amino acids, trace elements, vitamin B2, vitamin B 12 , and other nutrients, which can promote the absorption of medicinal efficacy substances and improve the body's immunity to fight diseases.

[0014] (2) The traditional Chinese medicine composition in the present application contains amygdalin, ginsenoside F1, ursolic acid, panaxatriol, dihydrodamascone, and 2-isopropyl malic acid, which can act on the same target point as uterine fibroids and exert a pharmacodynamic effect on the disease target point. It can down-regulate the expression of estrogen and progesterone in uterine fibroids through multiple metabolic pathways and multiple targets, effectively eliminating uterine fibroids and related cancers.

[0015] (3) The present application can reduce the side effects of treatment: based on the principles of overall regulation and syndrome differentiation of traditional Chinese medicine, the formula is expected to regulate the internal environment of the body, reduce the side effects during drug treatment, and improve the treatment experience and quality of life of patients. DETAILED DESCRIPTION

[0016] In order for those skilled in the art to better understand the present application, the technical solutions of the present application will be described in detail below in conjunction with the embodiments. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of the present application.

[0017] Example 1 A traditional Chinese medicine composition for treating uterine fibroids, comprising the following components by weight: cassia twig 8 parts, poria 15 parts, peony root 9 parts, peach kernel 8 parts, zedoary 15 parts, rhizoma sparganii 10 parts, antler cream 15 parts, Zhebei 5 parts, leech 5 parts, sanqi 15 parts, angelica 5 parts, turtle shell 15 parts, herba epimedii 15 parts, inula 15 parts.

[0018] Cassia twig: It belongs to the drug for relieving superficies, inducing perspiration to expel pathogens from the body, warming meridians, promoting blood circulation for removing blood stasis, and dispelling cold and relieving pain. It can make other drugs resolve tumors while ensuring the health of the body.

[0019] Poria: It is used for edema, oliguria, dizziness and palpitation due to phlegm-dampness, spleen deficiency, poor appetite, diarrhea, restlessness, insomnia and palpitation. It can be combined with various drugs. Poria has the functions of clearing heat and resolving toxins, benefiting the spleen and stomach, and soothing the heart and calming the nerves. Modern medical research shows that it has antibacterial effect and can enhance the body's immune function. Poria polysaccharide has obvious anti-tumor and liver-protecting effects.

[0020] Peony root: It is combined with turtle shell to have the effect of reducing heat and tonifying yin. Peony root itself has the effect of improving immunity and has a significant preventive effect on damage to abdominal adhesions, avoiding other abdominal diseases during the treatment of uterine fibroids, and effectively ensuring the treatment of uterine fibroids.

[0021] Peach kernel: It is a blood-activating drug that can dilate blood vessels and increase blood flow, as well as promote blood circulation and remove blood stasis. It can also protect the liver during the treatment of uterine fibroids and avoid damage to the liver caused by other drugs.

[0022] Zedoary: It is a blood-activating and tonifying drug that breaks blood and moves qi, eliminates stagnation and relieves pain. It is used for treating masses and accumulation, abdominal pain, undigested food, blood stasis, postpartum abdominal pain, and pain caused by falls and injuries. Zedoary contains zedoary oil, which has anti-tumor effect. In addition to directly killing tumors, zedoary oil can enhance the immunogenicity of tumor cells, thereby inducing or promoting the body's immune rejection reaction to tumors. It also has protective effects on the liver and kidneys, ensuring the balance of various organs in the body.

[0023] Rhizoma sparganii: It is a blood-activating drug that has an excitatory effect on the uterus. When combined with zedoary, it can effectively eliminate uterine fibroids.

[0024] Antler cream: It tonifies yang and contains various amino acids that can nourish the kidneys, promote the absorption of useful substances such as sugar, amino acids, and trace elements in the body, regulate the balance of the body, and accelerate the elimination of metabolic products in the body, thereby promoting the swelling of uterine fibroids.

[0025] Zhebei: It is a heat-clearing and toxin-resolving drug that treats lung abscess, laryngeal obstruction, scrofula, and abscesses. It contains Zhebei alkaloids that can make the uterus active, enhance the vitality of the uterus, and promote the absorption of the uterus to the acting drugs.

[0026] Leech: blood circulation drugs, containing protein, polypeptide, trace elements and fatty acid oxygen, and by a plurality of amino acids composed of low molecular weight polypeptide, can effectively promote other drugs to play the role of drug, but also has the function of health care, and there are higher content of zinc, can improve human immunity, has anti-cancer function.

[0027] Sanqi: the present application mainly adopts Sanqi root, has the effect of regulating qi and stopping bleeding, promoting blood circulation and detumescence and analgesia, Angelica: tonic, blood and blood, improve immunity, has anti-cancer effect, can enhance the activity of the uterus, is beneficial to the stable contraction and excitation of the uterus, is beneficial to the dispersion of uterine fibroids.

[0028] Turtle shell; improve human immunity, can inhibit the proliferation of connective tissue, so it can eliminate the mass, has anti-tumor effect, especially abdominal tumor.

[0029] Tetragonal seed: blood circulation drugs, blood circulation and mass, can significantly prolong the effect of blood clotting time, reduce the effect of blood viscosity, so as to improve the flow of blood in the body, accelerate the transportation of metabolites, improve the formation of metabolism, and help the dispersion of uterine fibroids.

[0030] Inula: heat-clearing and detoxifying and anti-inflammatory, has the effect of reducing blood pressure, and is used with tetragonal seed, peach kernel and the like, can balance the blood, avoid the occurrence of side effects such as hypertension and dizziness during the medication process.

[0031] In the formula of the present application, cassia twig warms and unblocks blood vessels, and tuckman benefits water and removes dampness. The two drugs are one warm and unblock, and one damp and remove. The warm and unblock can dispel cold evil, and the damp and remove can benefit dampness. Together, cold evil is dispelled from the skin, and damp evil is removed from the urine. Therefore, cassia twig and tuckman are used as the monarch drugs. Women often have melancholy, and not only blood is partial to stasis, but also qi is partial to stagnation. Therefore, three-pronged is partial to regulating qi, and zedoary and tetragonal seed are partial to activating blood. The three drugs are used together, and are the key drugs for activating blood, removing blood stasis and regulating qi. Leech enters blood to break blood stasis, and angelica also enters blood to activate blood and supplement blood, and is the qi drug in blood. Sanqi activates blood and removes blood stasis and stops bleeding, and is especially suitable for people with uterine fibroids and uterine bleeding. Danpi removes mass, and peach kernel breaks mass. The seven drugs are mainly used to eliminate pathogenesis, and are the minister drugs. Uterus is one of the reproductive organs, and kidney is the main reproductive organ. Uterine fibroids are often chronic and long-term diseases, and long-term diseases can affect kidney. Therefore, patients with this disease often have kidney deficiency. Therefore, deer horn cream and turtle shell are used to warm and tonify kidney yang. In the treatment of blood stasis, traditional Chinese medicine often emphasizes the treatment of phlegm and stasis, and dampness stagnation is easy to form phlegm. Therefore, zhebeimu and inula are used to remove stagnation and phlegm, and are used together with the previous blood activating drugs to treat phlegm and stasis.

[0032] Example 2

[0033] A traditional Chinese medicine composition for treating uterine fibroids, comprising the following components by weight: cassia 5 parts, tuckahoe 10 parts, peony root 5 parts, peach kernel 5 parts, zedoary 10 parts, rhizoma sparganii 5 parts, antler cream 10 parts, Zhebei 3 parts, leeches 5 parts, sanqi 10 parts, angelica 5 parts, turtle shell 10 parts, cowslip 10 parts, inula 10 parts.

[0034] Example 3

[0035] A traditional Chinese medicine composition for treating uterine fibroids, comprising the following components by weight: cassia 10 parts, tuckahoe 20 parts, peony root 10 parts, peach kernel 10 parts, zedoary 20 parts, rhizoma sparganii 10 parts, antler cream 20 parts, Zhebei 8 parts, leeches 10 parts, sanqi 20 parts, angelica 10 parts, turtle shell 20 parts, cowslip 20 parts, inula 20 parts.

[0036] Example 4

[0037] A preparation method of a traditional Chinese medicine composition for treating uterine fibroids, comprising the following steps: Step (1), the cassia, tuckahoe, peony root, peach kernel, zedoary, rhizoma sparganii, antler cream, Zhebei, leeches, sanqi, angelica, turtle shell, cowslip, inula decoction pieces are mixed, and a ball mill is used to grind into fine powder with a particle size of about 100 μm; Step (2), the fine powder is frozen at a temperature of-15℃ for 3 days, and taken out for standby; Step (3), the frozen fine powder and water are mixed and put into a high-pressure kettle for the first time, the water is added in an amount of 8 times the volume of the fine powder, the pressure of the high-pressure kettle is set to 0.2 MPa, high-pressure cooking is carried out for 30 min, and after cooling to 40℃, the initial filtrate is obtained by filtration, the residue is added with 3 times the volume of boiling water, and the residue is cooked on medium heat for 30-40 min, the cooking is carried out twice, and the secondary filtrate is obtained by filtration; the initial filtrate and the secondary filtrate are mixed to obtain the traditional Chinese medicine composition.

[0038] Example 5

[0039] A preparation method of a traditional Chinese medicine composition for treating uterine fibroids, comprising the following steps: Step (1), the cassia, tuckahoe, peony root, peach kernel, zedoary, rhizoma sparganii, antler cream, Zhebei, leeches, sanqi, angelica, turtle shell, cowslip, inula decoction pieces are mixed, and a ball mill is used to grind into fine powder with a particle size of about 100 μm; Step (2), the fine powder is frozen at a temperature of-10℃ for 3 days, and taken out for standby; Step (3), the frozen fine powder and water are mixed and put into a high-pressure kettle for the first time boiling, the water is added in the first time boiling in an amount of 5 times the volume of the fine powder, the pressure of the high-pressure kettle is set to 0.2 MPa, high-pressure boiling is carried out for 30 min, and after cooling to 35℃, filtration is carried out to obtain an initial filtrate, the filter residue is added with 5 times the volume of boiling water, and the filter residue is boiled for 30-40 min on a low fire, the boiling is carried out twice, and filtration is carried out to obtain a secondary filtrate; the initial filtrate and the secondary filtrate are mixed, and then concentrated to obtain the extract traditional Chinese medicine composition.

[0040] In this embodiment, the extract traditional Chinese medicine composition can also be added to starch to prepare pills.

[0041] Example 6

[0042] A preparation method of a traditional Chinese medicine composition for treating uterine fibroids, comprising the following steps: Step (1), the Guizhi, Fuling, Danpi, Taoren, E Zhusheye, Sanleng, Lujiaoshuang, Zhebeimu, Shuijinhui, Sanqi, Danggui, Biejia, Wangfurlong, Tuohuoxian decoction pieces are mixed, and a ball mill is used to grind into fine powder with a particle size of about 100 μm; Step (2), the fine powder is frozen at a temperature of-5℃ for 5 days, and taken out for standby; Step (3), the frozen fine powder and water are mixed and put into a high-pressure kettle for the first time boiling, the water is added in the first time boiling in an amount of 8 times the volume of the fine powder, the pressure of the high-pressure kettle is set to 0.3 MPa, high-pressure boiling is carried out for 30 min, and after cooling to 60℃, filtration is carried out to obtain an initial filtrate, the filter residue is added with 3 times the volume of boiling water, and the filter residue is boiled for 30-40 min on a low fire, the boiling is carried out twice, and filtration is carried out to obtain a secondary filtrate; the initial filtrate and the secondary filtrate are mixed, concentrated and dried to obtain a powdery traditional Chinese medicine composition or a granular traditional Chinese medicine composition.

[0043] The powdery traditional Chinese medicine composition in this embodiment can be compressed into tablets to prepare tablets.

[0044] In order to reflect the compatibility between components in this formula, the differences between the comparative examples and the formulas of examples 1-3 are shown in Table 1, in order to highlight the differences, only the differences with example 1 are filled in

[0045] Comparative examples 1-7 (D1-D7) adopt the preparation method of example 4 to obtain a traditional Chinese medicine composition in the form of decoction, and the traditional Chinese medicine composition in the form of decoction is concentrated and dried to obtain an extract powder.

[0046] Comparative example 8 (D8): the same formula as example 1 is used, and the preparation method adopts conventional boiling for 3 times, and the extract powder is obtained by concentrating and drying.

[0047] To further verify the therapeutic effect of uterine fibroids in the present application, we conducted animal experiments on the formulations of Examples 1-3 and Comparative Examples (D1-D8) and Comparative Examples, all of which used the experimental procedures of Example 1 as follows: Model establishment: The rats were quarantined and adaptively fed for one week, and 0.1 mL of progesterone injection (specification 1 mL: 20 mg) and estradiol benzoate injection (specification 4 mg / 2 mL) were injected into the medial thigh muscle of each rat every day, with the two legs being injected alternately, for a total of 8 weeks, to establish a SD rat uterine fibroid model. After evaluating the success of the model, the successfully modeled rats were screened out, The experimental animals were divided into 15 groups, with 6 rats in each group. Among them were a blank group, a model group C, Example 2-3 groups and Comparative Example 1-8 groups, Example 1 low-dose A (extract powder concentration 8.80%), Example 1 medium-dose B group (extract powder concentration 17.6%), and Example 1 high-dose E group (extract powder concentration 35.2%). Among them, Examples 1-3 and Comparative Examples 1-8 were all configured into high-dose (extract powder concentration 35.2%) drug solution. They were all given 10 mL / kg by gavage; the model group C was given 10 mL / kg of normal saline by gavage; after 30 days of gavage, the rats were sacrificed, serum samples were extracted, and the rat uterus and ovaries were promptly removed and weighed; (I) Calculate the uterine wet weight, uterine coefficient, and ovarian coefficient; Compared with the blank group, the uterine weight of the model group C rats increased significantly, and the uterine coefficient increased significantly. Compared with the model group C, the uterine weight of the rats in the drug administration groups decreased, and the uterine coefficient decreased, with a statistically significant difference (p<0.05), as shown in Table 2.

[0048] Compared with the control group, the serum estradiol concentration and serum progesterone level of the model group C rats increased significantly, and the difference was statistically significant (P<0.05). Compared with the model group, the serum estradiol concentration and serum progesterone concentration of the rats in the low, medium and high dose groups of the formulation of Example 1 of the present application were significantly reduced, and the difference was statistically significant (P<0.05), and the high dose group of the formulation of Example 1 of the present application had a more obvious effect than the low and medium dose groups of the Xiaoliu Fang, as shown in Table 3.

[0049]

[0050] As can be seen from Table 3, the formulation of the present application can inhibit the levels of E2, P, ER and PR in the serum of uterine fibroid model rats, reduce the uterine coefficient, and improve the pathological state of the uterus.

[0051] (II) Histopathological examination of uterine tissue, Fresh tissues were fixed in paraformaldehyde, stained with hematoxylin-eosin (HE), and examined under a light microscope. The microscopic observations were combined with the pathological histological changes of the uterus and ovary in this experiment. The pathological changes of the uterus included thickening of the endometrium with squamous epithelial metaplasia, thickening of the myometrium, inflammatory cell infiltration, and cystic and dilated glands. The main pathological changes of the ovary were atrophy, lack of corpus luteum, and reduced follicles. The results are as follows (1) In the model group C, the myometrium was significantly thickened (smooth muscle cells were hyperplastic and hypertrophic, the nuclei were large, the muscle cells were interlaced and arranged in disorder), the endometrium was slightly thickened, and the glands were reduced.

[0052] (2) In Examples 1-3, the myometrium was not significantly thickened, a small amount of mucosal squamous epithelial metaplasia was observed, the endometrium was slightly thickened, and the glands were normal. (3) In Comparative Examples 1-7, the myometrium was thickened to a certain extent, the smooth muscle cells were hyperplastic and hypertrophic, the nuclei were large, the muscle cells were interlaced and arranged in disorder, the endometrium was slightly thickened, and the glands were reduced. In several formulations, the presence of cassia twig, poria cocos, zedoary, sparganium stoloniferum, leech, panax notoginseng, and peony resulted in a more obvious effect on the elimination of uterine fibroids, but the effect was poor due to the lack of assistance from other formulations. It was found that the components in the present application interacted with each other and were indispensable for achieving a good effect on the elimination of uterine fibroids.

[0053] (4) In Example 1, the low-dose A group showed that the myometrium was not significantly thickened, mucosal squamous epithelial metaplasia was observed, the endometrium was thickened, and the glands were reduced.

[0054] (5) In Example 1, the middle-dose B group showed that the myometrium was not significantly thickened, a small amount of mucosal squamous epithelial metaplasia was observed, and the glands were reduced.

[0055] (6) In Example 1, the high-dose E group showed that the uterine mucosal epithelial structure was normal, the myometrium was not significantly thickened, and the glands were normal.

[0056] (7) In Comparative Example 8, the myometrium was not significantly thickened, a part of the mucosal squamous epithelial metaplasia was observed, the endometrium was slightly thickened, and the glands were reduced. Comparative Example 8 used the same formulation as Example 1, but the preparation method was different. Comparative Example 8 was prepared by conventional decoction, while Example 1 was prepared by the special method of the present application, and the therapeutic effect of the traditional Chinese medicine composition obtained by the special method was better.

[0057] Example 7 The therapeutic effect data of the traditional Chinese medicine composition on humans are as follows: This study selected 150 cases of patients from January 2024 to July 2024 in the Department of Traditional Chinese Medicine of the Fifth Affiliated Hospital of Xinjiang Medical University, all patients were divided into control group and four treatment groups by random number table method, 30 cases in each group. The average age of patients in the treatment group was (34.6±2.3) years old, and the average tumor diameter was (3.3±0.8) cm; the average age of patients in the control group was (34.0±2.2) years old, and the average tumor diameter was (3.4±1.2) cm. There was no significant difference in general data of patients in the four groups (P>0.05), which was comparable. This study was approved by the hospital ethics committee.

[0058] Treatment method: the patients in the control group were given oral administration of Guizhifuling capsule (Jiangsu Kangyuan Pharmaceutical Co., Ltd., National Drug Standard Z10950005), 3 pills / time, 3 times / d, and the treatment course was 3 months; the patients in treatment group 1 were given oral administration of the traditional Chinese medicine composition formula of Example 1 of the present application (30 cases), the patients in treatment group 2 were given oral administration of Example 2 of the present application (30 cases), the patients in treatment group 3 were given oral administration of Example 3 of the present application (30 cases), and the patients in treatment group 4 were given oral administration of decoction of Comparative Example 8 of the present application (30 cases); one dose per day, taken in the morning and evening, and the treatment course was 3 months.

[0059] Observation index and determination of curative effect: (1) The clinical effective rates of patients in the two groups were observed and compared, and the evaluation indexes were mainly carried out according to the "Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine", and the curative effects were divided into three grades of marked effect, effect and invalid.

[0060] Marked effect: the tumor and clinical symptoms completely disappeared after treatment; Effect: the volume of uterine fibroids was reduced by 50% after treatment, and the clinical symptoms were improved; Invalid: the volume of uterine fibroids and clinical symptoms were not improved after treatment; Total effective rate (%) = (marked effect + effective) number of cases / total number of cases × 100%.

[0061] (2) The volume of uterine fibroids and the volume of uterus of patients in the two groups before and after treatment were compared; the specific data were measured and calculated by ultrasonic measurement: Uterine volume = 0.523 × product of 3 three-dimensional radiuses of uterus; Uterine fibroid volume = 0.523 × product of 3 three-dimensional radiuses of uterine fibroids.

[0062] (3) The occurrence of adverse reactions (dizziness, headache, anorexia, breast pain) of patients in the two groups during treatment was observed and recorded, and the incidence of adverse reactions of each group was calculated; Adverse reaction rate (%) = adverse reaction occurrence number / total number of cases in each group × 100%. The results are shown in Table 4;

[0063] As can be seen from Table 4, the effects of the treatment groups 1-4 are higher than that of the control group, indicating that the treatment effect of the traditional Chinese medicine composition is good. In comparison between the treatment groups 1-3 and the treatment group 4, the treatment groups 1-3 adopt the specific method of the present application, i.e., grinding into powder first and then decocting after freezing; while the treatment group 4 adopts the conventional decocting method of Comparative Example 8. From the treatment effect, the traditional Chinese medicine composition prepared by the specific preparation process of the present application has better effect than that prepared by the conventional decocting method.

[0064] Before treatment, the uterine fibroid volumes and uterine volumes of the four groups of patients had no statistically significant difference (P>0.05). After treatment, the uterine fibroid volumes and uterine volumes of the four groups of patients were significantly reduced, and the difference was statistically significant (P<0.05), and the uterine fibroid volumes and uterine volumes of the treatment groups were significantly smaller than those of the control group, and the difference was statistically significant (P<0.05). The results are shown in Table 5.

[0065] As can be seen from Table 5, after treatment, the uterine fibroid volumes and uterine volumes of the patients in the control group and the treatment groups were significantly reduced, and the difference was statistically significant (P<0.05), and the uterine fibroid volumes and uterine volumes of the treatment groups were significantly smaller than those of the control group.

[0066] Comparison of adverse reactions of patients During the treatment, the adverse reaction rate of the treatment group 1 was 3.33%, of which 1 case had breast distending pain; the adverse reaction rate of the treatment group 2 was 6.67%, of which 1 case had dizziness and poor appetite, and 1 case had breast distending pain; the adverse reaction rate of the treatment group 3 was 6.67%, of which 1 case had dizziness and poor appetite, and 1 case had breast distending pain; the adverse reaction rate of the treatment group 4 was 10%, of which 1 case had dizziness and headache, 1 case had poor appetite, and 1 case had breast distending pain; the adverse reaction rate of the control group was 20%, of which 2 cases had dizziness and headache, 1 case had poor appetite, and 3 cases had breast distending pain.

[0067] Reference in this text to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the application. The appearances of the phrase in various places in the specification are not necessarily all referring to the same embodiment, nor are they necessarily mutually exclusive of one another. It is expressly understood that the embodiments described herein are merely examples from among a great variety of embodiments that can be claimed as falling within the scope of the application, as explicitly and implicitly reflected by the appended claims.

[0068] It should be pointed out finally that the embodiments disclosed by the present application are only the preferred embodiments of the present application, and are only used to illustrate the technical solutions of the present application, but not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that the technical solutions recorded in the foregoing embodiments can be modified, or some technical features can be replaced equivalently; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A traditional Chinese medicine composition for treating uterine fibroids, characterized in that: The weight parts of the following components are included: cassia 1-20 parts, tuckahoe 5-20 parts, peony root 1-15 parts, peach kernel 1-15 parts, zedoary 1-20 parts, rhizoma sparganii 1-15 parts, deer antler velvet 5-20 parts, Zhejiang fritillary 1-10 parts, leech 1-10 parts, notoginseng 5-20 parts, angelica 1-15 parts, turtle shell 10-20 parts, cowslip 5-20 parts, inula 5-20 parts. ​ 2. The traditional Chinese medicine composition for treating uterine fibroids according to claim 1, characterized in that: The weight parts of the following components are included: cassia 5-10 parts, tuckahoe 10-20 parts, peony root 5-10 parts, peach kernel 5-10 parts, zedoary 10-20 parts, rhizoma sparganii 5-10 parts, deer antler velvet 10-20 parts, Zhejiang fritillary 1-10 parts, leech 1-10 parts, notoginseng 10-20 parts, angelica 5-10 parts, turtle shell 10-20 parts, cowslip 10-20 parts, inula 10-20 parts.

3. The traditional Chinese medicine composition for treating uterine fibroids according to claim 1, characterized in that: The weight parts of the following components are included: cassia 8 parts, tuckahoe 15 parts, peony root 9 parts, peach kernel 8 parts, zedoary 15 parts, rhizoma sparganii 10 parts, deer antler velvet 15 parts, Zhejiang fritillary 5 parts, leech 5 parts, notoginseng 15 parts, angelica 5 parts, turtle shell 15 parts, cowslip 15 parts, inula 15 parts.

4. A method for preparing the traditional Chinese medicine composition for treating uterine fibroids according to any one of claims 1-3, characterized in that: The following steps are included: Step (1), the cassia, tuckahoe, peony root, peach kernel, zedoary, rhizoma sparganii, deer antler velvet, Zhejiang fritillary, leech, notoginseng, angelica, turtle shell, cowslip, inula decoction pieces are mixed, and a ball mill is used to grind into fine powder with a particle size of 10 μm-100 μm; Step (2), the fine powder is frozen at a temperature of-15℃ to-5℃ for 3-5 days, and taken out for standby; Step (3), the frozen fine powder and water are mixed and put into a high-pressure kettle for the first time, high-pressure cooking for 15 min-30 min, cooling to 35℃-60℃, and then filtering to obtain an initial filtrate, the residue is added with boiling water and simmered for 30-40 min, and the residue is simmered for 1-2 times, and then filtered to obtain a secondary filtrate; the initial filtrate and the secondary filtrate are mixed to obtain a traditional Chinese medicine composition.

5. The preparation method of the traditional Chinese medicine composition for treating uterine fibroids according to claim 4, characterized in that: The pressure of the high-pressure kettle in step (3) is 0.2 MPa-0.3 MPa.

6. The preparation method of the traditional Chinese medicine composition for treating uterine fibroids according to claim 4, characterized in that: The amount of water added in the first time in step (3) is 5-8 times the volume of the fine powder.

7. The preparation method of the traditional Chinese medicine composition for treating uterine fibroids according to claim 4, characterized in that: The boiling water added in step (3) is 2-5 times the volume of the residue.

8. The preparation method of the traditional Chinese medicine composition for treating uterine fibroids according to claim 4, characterized in that: The traditional Chinese medicine composition in step (3) is concentrated to obtain an extract traditional Chinese medicine composition, or dried to obtain a powdery or granular traditional Chinese medicine composition.

9. The preparation method of the traditional Chinese medicine composition for treating uterine fibroids according to claim 8, characterized in that: The extract traditional Chinese medicine composition is added with pharmaceutical excipients to prepare into pills, and the powdery traditional Chinese medicine composition is added with pharmaceutical excipients to prepare into tablets.

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