Use of traditional Chinese medicine composition in preparation of medicine for preventing and treating endometriosis

Abstract

The application relates to the technical field of traditional Chinese medicines, in particular to application of a traditional Chinese medicine composition in preparation of medicines for preventing and treating endometriosis, wherein the traditional Chinese medicine composition comprises Gleditsia sinensis L. thorns, giant knotweed, dandelion, Sargentgloryvine stem, radix codonopsis, smilax, red peony root, salvia miltiorrhiza, lindera and corydalis. Experimental results show that the number of writhing of the mice given the traditional Chinese medicine composition is significantly reduced, the volume of ectopic endometrium is significantly reduced, and the secretion of serum PGE2 and PGF2 alpha is obviously reduced, indicating that the traditional Chinese medicine composition has a good treatment effect on endometriosis.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, and particularly relates to application of a traditional Chinese medicine composition in preparation of a medicine for preventing and treating endometriosis. BACKGROUND

[0002] Endometriosis refers to endometrial tissue (glands and stroma) with growth and infiltration activity appearing in other parts of the uterus body, and is a common chronic endometrial disease. The disease incidence accounts for 10% to 15% of women of childbearing age, and shows an upward trend every year. Although it is a benign disease, it has a high recurrence rate and is difficult to cure, and seriously affects the physical and mental health and quality of life of patients. Some patients even have a series of mental symptoms such as depression, anxiety, and the like, which have a negative impact on their daily life, sexual function and interpersonal relationship.

[0003] At present, the etiology and pathological mechanism of endometriosis are not completely clear, and almost

[0004] All treatment methods for endometriosis are inhibitory rather than curative. The side effects of long-term hormone therapy for the disease are more, leading to reduced patient compliance, and surgical treatment has greater damage to patients and a high recurrence rate. Traditional Chinese medicine is an empirical medicine, and some patients with endometriosis will choose traditional Chinese medicine to improve their symptoms and relieve anxiety. Compared with hormone and surgical treatment, traditional Chinese medicine is guided by the concept of holism, can effectively relieve persistent lesions of endometriosis, and has fast effect, low recurrence rate and stable long-term efficacy. SUMMARY

[0005] Therefore, the present application provides application of a traditional Chinese medicine composition in preparation of a medicine for preventing and treating endometriosis.

[0006] In order to achieve the above-mentioned application purposes, the present application provides the following technical solutions.

[0007] The present application provides application of a traditional Chinese medicine composition in preparation of a medicine for preventing and treating endometriosis.

[0008] The traditional Chinese medicine composition comprises the following raw materials in mass parts, or is made of the following raw materials in mass parts:

[0009] Radix Paeoniae Rubra 6-10 parts, Salvia miltiorrhiza 8-15 parts, Lindera 6-10 parts and Corydalis 8-12 parts.

[0010] In some embodiments, the traditional Chinese medicine composition comprises: Gleditsia sinensis 12 parts, Giant Knotweed 8 parts, Herba Taraxaci 9.6 parts, Lignum Sargentodoxae 9.6 parts, Codonopsis 12 parts, Rhizoma Smilacis Glabrae 12 parts, Radix Paeoniae Rubra 8 parts, Radix Salviae Miltiorrhizae 12 parts, Lignum Cinnamomi 8 parts, and Rhizoma Corydalis 9.6 parts.

[0011] In some embodiments, the traditional Chinese medicine composition comprises: Gleditsia sinensis 8 parts, Giant Knotweed 6 parts, Herba Taraxaci 8 parts, Lignum Sargentodoxae 8 parts, Codonopsis 8 parts, Rhizoma Smilacis Glabrae 8 parts, Radix Paeoniae Rubra 6 parts, Radix Salviae Miltiorrhizae 8 parts, Lignum Cinnamomi 6 parts, and Rhizoma Corydalis 8 parts.

[0012] In some embodiments, the traditional Chinese medicine composition comprises: Gleditsia sinensis 15 parts, Giant Knotweed 10 parts, Herba Taraxaci 12 parts, Lignum Sargentodoxae 12 parts, Codonopsis 15 parts, Rhizoma Smilacis Glabrae 15 parts, Radix Paeoniae Rubra 10 parts, Radix Salviae Miltiorrhizae 15 parts, Lignum Cinnamomi 10 parts, and Rhizoma Corydalis 12 parts.

[0013] In the present application, the preparation method of the traditional Chinese medicine composition comprises the following steps:

[0014] reflux extraction 1-3 times, each time for 0.5-2.5 hours, filter, combine the filtrates, and obtain an alcohol extract;

[0015] reflux extraction 1-3 times, each time for 0.5-2.5 hours, filter, combine the filtrates, and obtain an alcohol extract;

[0016] combine the alcohol supernatant and the alcohol extract, reduce pressure and concentrate to obtain an extract, add 1-3 times the weight of water to the extract, mix, stand for 24-36 hours, take the supernatant, dry, and crush.

[0017] In the present application, the prevention and treatment comprises: reducing the volume of ectopic endometrium, reducing the level of prostaglandin, and / or reducing the number of painful writhing.

[0018] In some embodiments, the prostaglandin is prostaglandin in serum, and the prostaglandin comprises PGE2 and / or PGF2α.

[0019] In the present application, the effective dose of the traditional Chinese medicine composition for treating endometriosis is 201.6g-403.2g of crude drug per day.

[0020] The present application also provides a medicine for preventing and treating endometriosis, comprising the following raw materials by mass parts, or prepared from the following raw materials by mass parts:

[0021] Gleditsia sinensis 8-15 parts, giant knotweed 6-10 parts, dandelion 8-12 parts, Sargentodoxa 8-12 parts, codonopsis 8-15 parts, smilax 8-15 parts, red peony root 6-10 parts, salvia 8-15 parts, lindera 6-10 parts, and corydalis 8-12 parts.

[0022] After the traditional Chinese medicine composition in the application is prepared according to the above proportions and preparation method, conventional pharmaceutical adjuvants in traditional Chinese medicine preparation can be added, and conventional pharmaceutical methods in pharmacy are adopted to prepare the required traditional Chinese medicine preparation, including but not limited to granules, capsules, pills, tablets, and suppositories.

[0023] The application provides application of a traditional Chinese medicine composition in preparation of a medicine for preventing and treating endometriosis, and the traditional Chinese medicine composition comprises Gleditsia sinensis, giant knotweed, dandelion, Sargentodoxa, codonopsis, smilax, red peony root, salvia, lindera, and corydalis. Experimental results show that the number of writhing of a mouse given the traditional Chinese medicine composition is significantly reduced, the volume of ectopic endometrium is significantly reduced, and the secretion of serum PGE2 and PGF2α is obviously reduced, indicating that the traditional Chinese medicine composition has a good treatment effect on endometriosis. DETAILED DESCRIPTION

[0024] The application provides application of a traditional Chinese medicine composition in preparation of a medicine for preventing and treating endometriosis. Those skilled in the art can refer to the content herein and appropriately improve process parameters to realize. It is particularly pointed out that all similar replacements and changes are obvious to those skilled in the art, and they are regarded as included in the application. The method and application of the application have been described through preferred embodiments, and relevant personnel can obviously make changes or appropriate changes and combinations to the method and application herein without departing from the content, spirit, and scope of the application, to realize and apply the technology of the application.

[0025] As described above, the application aims to provide application of a traditional Chinese medicine composition in preparation of a medicine for preventing and treating endometriosis;

[0026] The traditional Chinese medicine composition comprises the following raw materials in mass parts, or is prepared from the following raw materials in mass parts:

[0027] Gleditsia sinensis 8-15 parts, giant knotweed 6-10 parts, dandelion 8-12 parts, Sargentodoxa 8-12 parts, codonopsis 8-15 parts, smilax 8-15 parts, red peony root 6-10 parts, salvia 8-15 parts, lindera 6-10 parts, and corydalis 8-12 parts.

[0028] In the application, the preparation method of the traditional Chinese medicine composition comprises

[0029] Corydalis, giant knotweed, 6-10 times the amount of 60%-80% ethanol are added, and reflux extraction is performed 1-3 times, each time for 0.5-2.5 hours, filtration is performed, and the filtrates are combined to obtain an alcohol extract;

[0030] The Gleditsia sinensis, Taraxacum mongolicum, Sargentodoxa, Codonopsis pilosula, Smilax china, Radix Paeoniae Rubra, Salvia miltiorrhiza, Lindera, 10-15 times the amount of water decoct 1-4 times, 1-3 hours each time, filter, combine the filtrate, reduce pressure concentration, add ethanol to the alcohol content of 60%, stand for 24-36 hours, collect the alcohol precipitation supernatant;

[0031] The alcohol precipitation supernatant and the alcohol extract are combined, and the extract is obtained by reducing pressure concentration. Water is added to 1-3 times the weight of the extract, mixed, and stood for 24-36 hours. The supernatant is dried, pulverized, and added with conventional pharmaceutical excipients. The desired traditional Chinese medicine dosage form is prepared by using conventional methods in pharmacy.

[0032] In some specific embodiments, the preparation method of the traditional Chinese medicine composition comprises:

[0033] Rhizoma Corydalis, Polygonum cuspidatum, 10 times the amount of 60% ethanol, reflux extraction 3 times, 1.5 hours each time, filter, combine the filtrate, and obtain the alcohol extract;

[0034] Gleditsia sinensis, Taraxacum mongolicum, Sargentodoxa, Codonopsis pilosula, Smilax china, Radix Paeoniae Rubra, Salvia miltiorrhiza, Lindera, 10 times the amount of water, decoct 3 times, 1.5 hours each time, filter, combine the filtrate, reduce pressure concentration to the extract with a relative density of 1.08-1.12 (60°C-70°C), add ethanol to make the alcohol content of the liquid medicine reach 60%, stand for 24 to 36 hours. The alcohol precipitation supernatant is combined with the alcohol extract, and the extract is obtained by reducing pressure concentration to a relative density of 1.04-1.06 (60°C-70°C). Water is added to 1 times the weight of the extract, mixed, and stood for 24 to 36 hours. The supernatant is reduced pressure concentrated to the extract with a relative density of 1.12-1.18 (60°C-70°C), spray dried, pulverized, and added with an appropriate amount of dextrin and stevioside. Dry granulation is performed to prepare 1000 g of granules.

[0035] Unless otherwise specified, the following experiments are carried out under conventional conditions or manufacturer's recommended conditions. The raw materials or excipients used, and the reagents or instruments used, are conventional products that can be obtained on the market. Unless otherwise specified, all percentages, ratios, proportions, or parts are by weight.

[0036] Unless otherwise defined, all professional and scientific terms used herein have the same meaning as understood by those skilled in the art. In addition, any method and material similar or equivalent to those described can be applied to the present application.

[0037] The present application is further described below in conjunction with examples:

[0038] Preparation of the traditional Chinese medicine composition in Example 1

[0039] The granules of the traditional Chinese medicine composition are prepared from the following raw materials by weight: Gleditsia sinensis 15 parts, giant knotweed 10 parts, dandelion 12 parts, Sargentodoxa 12 parts, Codonopsis pilosula 15 parts, Smilax china 15 parts, red peony root 10 parts, Salvia miltiorrhiza 15 parts, Lindera 10 parts, Corydalis 12 parts.

[0040] The ten medicinal materials are treated by ethanol reflux extraction and water extraction. The giant knotweed and Corydalis are extracted by reflux extraction with 10 times the amount of 60% ethanol for 3 times, 1.5 hours each time, filtered, the filtrates are combined, and the ethanol extract is prepared and used; the other eight medicinal materials are decocted with 10 times the amount of water for 3 times, 1.5 hours each time, filtered, the filtrates are combined, concentrated under reduced pressure to a relative density of 1.08-1.12 (60°C-70°C) of the extract, ethanol is added to make the alcohol content of the medicinal liquid reach 60%, and the mixture is left to stand for 24 to 36 hours. The supernatant of the alcohol precipitation is taken, combined with the alcohol extract, concentrated under reduced pressure to a relative density of 1.04-1.06 (60°C-70°C) of the extract, 1 times the weight of water is added to the extract, mixed, left to stand for 24 to 36 hours, the supernatant is taken, concentrated under reduced pressure to a relative density of 1.12-1.18 (60°C-70°C) of the extract, spray dried, pulverized, dry granulated with the addition of appropriate amounts of dextrin and stevioside, and 1000g of granules are prepared, which are the traditional Chinese medicine composition.

[0041] Therapeutic effect of the traditional Chinese medicine composition in experimental example 2 on endometriosis in rats

[0042] 1. Experimental materials

[0043] 1.1 Animals

[0044] 50 SPF SD rats, healthy and non-pregnant females, body weight 200-220g, purchased from Hangzhou Medical College, production license number: SCXK(Zhejiang)2019-0002.

[0045] 1.2 Drugs

[0046] The traditional Chinese medicine composition prepared in example 1 is prepared by Jiangsu Kangle Pharmaceutical Co., Ltd.

[0047] 1.3 Instruments and reagents

[0048] Refrigerator (Haier Company, model: BCD-51OWDEM); electronic balance (Mettler Toledo, model: ME55 / 02); purified water instrument (Germany Millipore Company, model: Milli-Q Plus); animal weight scale (Shanghai Xiangguan Electronic Weighing Instrument Co., Ltd., model: ACX-SC-DA); multifunctional enzyme microplate reader (Perkin Elmer, model: Inspire); PGE2, PGF2α ELISA detection kit (Nanjing Chuangbo Biological Technology Co., Ltd.); sodium pentobarbital (Sigma Company, item number 57-33-0); sodium chloride injection (Shaanxi Shengao Animal Pharmaceutical Co., Ltd.)

[0049] 2. Dose design

[0050] The clinical daily dose of the traditional Chinese medicine composition is 201.6g of crude drug per day. According to the body surface area conversion method, the equivalent dose of rats is 201.6g of crude drug per 60kg*6.2=20.83g of crude drug per kg. The dose is set as the medium dose group, the low dose group is 10.42g of crude drug per kg, and the high dose group is 41.66g of crude drug per kg.

[0051] 3. Experimental method

[0052] After adaptive feeding for 1 week, the rats were randomly divided into normal group, model group and traditional Chinese medicine composition high, medium and low dose groups, 10 rats in each group. The model group and the drug administration group were anesthetized by intraperitoneal injection of 2.5% sodium pentobarbital solution, fixed, skinned, and disinfected. The abdominal cavity was opened in the middle of the lower abdomen, the uterus was separated, part of the right uterine horn tissue was cut and the endometrium was stripped, 2 pieces of 5mm*5mm area were taken by biopsy punch, and were transplanted at the mesenteric artery blood vessel, as far as possible from the incision. Gentamicin was used to flush the abdominal cavity, and the abdomen was closed layer by layer and sutured. Within 3 days after the operation, the rats were injected with 0.1mL gentamicin intraperitoneally to prevent infection. After 4 weeks of modeling, the rats were opened to observe that the grafts were oval or round nodules with a height of ≥2mm, and a large number of blood vessels were formed on the surface, and were closely adhered to the surrounding tissue, indicating that the modeling was successful, and a total of 50 rats were successfully modeled. Another 10 rats were used as a sham operation group, only the uterus tissue was cut and then sutured. After 4 weeks of modeling, the drug administration was started, and the sham operation group and the model group rats were given 0.9% sodium chloride solution by gavage, once a day, for 28 consecutive days.

[0053] 4. Detection index

[0054] 4.1 EMS rat ectopic endometrial lesion volume detection

[0055] After the last administration for 24h, the rats were sacrificed, the abdominal cavity was opened, and the volume of the ectopic endometrial lesions of the rats in each group was measured and calculated by using a vernier caliper.

[0056] 4.2 ELISA method for detecting the levels of PGE2 and PGF2a in rat serum

[0057] After the rats were sacrificed, blood was taken from the abdominal aorta and placed in a 4℃ refrigerator for 3h, then centrifuged at 3000r / min for 15min (centrifugation radius 12.5cm), and the supernatant was taken to detect the levels of PGE2 and PGF2a by using an ELISA kit.

[0058] 5. Experimental results

[0059] The results of ectopic endometrial volume of rats after modeling are shown in Table 1. Compared with the normal group, the ectopic endometrial volume of rats in the model group was significantly increased (P<0.001); compared with the model group, the ectopic endometrial volume of the high and medium dose groups of the traditional Chinese medicine composition was significantly reduced (P<0.01, P<0.001).

[0060] The results of serum ELISA detection are shown in Table 2. Compared with the normal group, the expression of PGE2 and PGF2α in the serum of rats in the model group was significantly increased (P<0.01, P<0.001); compared with the model group, the PGE2 level in the high dose group of the traditional Chinese medicine composition was significantly decreased (P<0.01), and the PGF2α level in the high and medium dose groups of the traditional Chinese medicine composition was significantly decreased (P<0.01, P<0.001).

[0061] Table 1 Ectopic endometrial volume of rats in each group n=10

[0062]

[0063] Note: compared with the model group, **P<0.01, ***P<0.001.

[0064] Table 2 Serum PGE2 and PGF2α levels of endometriosis rats in each group n=10

[0065]

[0066] Note: compared with the model group, *P<0.05, **P<0.01, ***P<0.001.

[0067] Therapeutic effect of traditional Chinese medicine composition on endometriosis in mice in experimental example 3

[0068] 1. Experimental materials

[0069] 1.1 Animals

[0070] 50 female clean grade BALB / c mice, 6-8 weeks old, 4-5 days of sexual cycle, body weight 18-22g, purchased from Hangzhou Medical College, production license number: SCXK(Zhe)2019-0002.

[0071] 1.2 Drugs

[0072] The traditional Chinese medicine composition prepared in Example 1, Jiangsu Kangyuan Pharmaceutical Co., Ltd.

[0073] 1.3 Instruments and reagents

[0074] Refrigerator (Haier Company, Model: BCD-51OWDEM); Electronic balance (Mettler Toledo, Model: ME55 / 02); Purified water instrument (Milli-Q Plus, Germany); Animal weight scale (Shanghai Xiangguan Electronic Weighing Instrument Co., Ltd., Model: ACX-SC-DA); Multifunctional enzyme microplate reader (Perkin Elmer, Model: Inspire); PGE2, PGF2a ELISA detection kit (Nanjing Chuanbo Biotechnology Co., Ltd.)

[0075] 2. Dose design

[0076] The clinical daily dose of the traditional Chinese medicine composition is 201.6 g of crude drug per day. According to the body surface area conversion method, the equivalent dose of mice is 201.6 g / 60 kg*12.3 = 41.32 g of crude drug / kg. This dose is set as the medium dose group, the low dose group is 20.66 g of crude drug / kg, and the high dose group is 82.64 g of crude drug / kg.

[0077] 3. Experimental method

[0078] 50 BALB / c female mice were randomly divided into normal group, model group, traditional Chinese medicine high dose group, medium and low dose group, 10 in each group. All mice were given estradiol valerate tablets 0.5 mg / kg by gavage 2 days before operation to make the mice in the same estrus phase at the time of operation. Except for the normal group, the animals in each group were operated on endometriosis, and 10% urethane anesthesia 25 mL·kg -1 , ip, fixed on the operating table, abdominal disinfection; open the abdominal cavity, ligate the left uterine ovary and vaginal end of the mouse, then cut it, cut it into 2 pieces (5 mm x 5 mm) longitudinally, and sew it on the bilateral abdominal wall. 1-3 days after operation, ip, penicillin 1.7 million U·kg -1 , postoperative intramuscular injection of estradiol benzoate 0.05 mL·mouse -1 once to promote the growth of ectopic endometrium. The normal group opened the abdomen to find the left uterus, then sutured the abdominal incision. All mice were given gentamicin by intramuscular injection for 3 consecutive days after operation to prevent infection. The animals in the administration group were given gavage once·d -1 , the control group and the model group were given distilled water 20 mL·kg-1, and the administration was continued for 4 weeks.

[0079] 4. Detection index

[0080] 4.1 Observation of pain response in mice

[0081] 1 hour after the last administration, each group of mice was injected with 0.6% acetic acid 0.2 mL per mouse, and the number of writhing times within 20 min was recorded.

[0082] 4.2 Detection of EMS mouse ectopic endometrial lesion volume

[0083] The abdominal cavity of the mouse was opened layer by layer, the ectopic lesion morphology was observed, and the ectopic lesion volume was measured and calculated with a vernier caliper (length x width x height, unit: mm). 3

[0084] 4.3 ELISA kit for detecting PGE2 and PGF2a levels in mouse serum

[0085] After the observation of writhing, 5% chloral hydrate (6 ml / kg) was injected intraperitoneally for anesthesia, and about 2 ml of blood was collected by decapitation, centrifuged at 3000 r / min for 15 min, and the serum was separated and stored at -80°C. The PGE2 and PGF2a levels in the serum were detected according to the ELISA kit instructions.

[0086] 5. Experimental results

[0087] The writhing times of mice in each group are shown in Table 3. Compared with the model group, the writhing times of the high and medium dose groups of the traditional Chinese medicine composition were significantly reduced (P<0.05, P<0.001).

[0088] After modeling, the lesion site of the mouse appeared a translucent cyst with a diameter of 5-8 mm, with liquid accumulation and vascular formation, indicating successful modeling. The ectopic endometrial volume of mice in each group is shown in Table 4. Compared with the model group, the ectopic endometrial volume of the high dose group of the traditional Chinese medicine composition was significantly reduced (P<0.001).

[0089] The serum ELISA detection results are shown in Table 5. Compared with the normal group, the PGE2 and PGF2a expression in the serum of the model group mice was significantly increased (P<0.01); compared with the model group, the PGE2 level in the low, medium and high dose groups of the traditional Chinese medicine composition was significantly decreased (P<0.01, P<0.001); compared with the model group, the PGF2a level in the high dose group of the traditional Chinese medicine composition was significantly decreased (P<0.01).

[0090] Table 3: Wringing times of mice in each group n=10

[0091]

[0092]

[0093] Note: Compared with the model group, *P<0.05, ***P<0.001.

[0094] Table 4: Ectopic endometrial volume of mice in each group n=10

[0095]

[0096] ​Note: compared with the model group, *P<0.05, **P<0.01, ***P<0.001

[0097] Table 5 PGE2, PGF2α levels of endometriosis mice in each group n=10

[0098]

[0099] Note: compared with the model group, *P<0.05, **P<0.01, ***P<0.001

[0100] 6. Test conclusion

[0101] The ectopic endometrial volume of rats in the high and medium dose groups of the traditional Chinese medicine composition is significantly reduced, and the serum PGE2 and PGF2α levels are obviously decreased; the writhing frequency of mice in the high dose group of the traditional Chinese medicine composition is significantly reduced, the ectopic endometrial volume is significantly reduced, and the secretion of serum PGE2 and PGF2α is obviously reduced, which indicates that the traditional Chinese medicine composition has a good treatment effect on endometriosis.

[0102] The above examples of the present application are only examples for clearly illustrating the present application, and are not limitations on the embodiments of the present application. Based on the above description, other different forms of changes or variations can be made by those skilled in the art. Here, all the embodiments cannot be exhausted. Any modification, equivalent replacement and improvement made within the spirit and principle of the present application should be included in the protection scope of the claims of the present application.

Claims

1. The use of a traditional Chinese medicine composition in the preparation of a medicament for preventing and treating endometriosis. The traditional Chinese medicine composition is made from the following raw materials in parts by mass: Gleditsia sinensis 8-15 parts, Polygonum cuspidatum 6-10 parts, Taraxacum mongolicum 8-12 parts, Sargentodoxa cuneata 8-12 parts, Codonopsis pilosula 8-15 parts, Smilax riparia 8-15 parts, Radix Paeoniae Rubra 6-10 parts, Salvia miltiorrhiza 8-15 parts, Lindera aggregata 6-10 parts, and Corydalis vanishing 8-12 parts.

2. Use according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by mass: Gleditsia sinensis 12 parts, Polygonum cuspidatum 8 parts, Taraxacum mongolicum 9.6 parts, Sargentodoxa cuneata 9.6 parts, Codonopsis pilosula 12 parts, Smilax riparia 12 parts, Radix Paeoniae Rubra 8 parts, Salvia miltiorrhiza 12 parts, Lindera aggregata 8 parts, and Corydalis vanishing 9.6 parts.

3. Use according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by mass: Gleditsia sinensis 8 parts, Polygonum cuspidatum 6 parts, Taraxacum mongolicum 8 parts, Sargentodoxa cuneata 8 parts, Codonopsis pilosula 8 parts, Smilax riparia 8 parts, Radix Paeoniae Rubra 6 parts, Salvia miltiorrhiza 8 parts, Lindera aggregata 6 parts, and Corydalis vanishing 8 parts.

4. Use according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by mass: Gleditsia sinensis 15 parts, Polygonum cuspidatum 10 parts, Taraxacum mongolicum 12 parts, Sargentodoxa cuneata 12 parts, Codonopsis pilosula 15 parts, Smilax riparia 15 parts, Radix Paeoniae Rubra 10 parts, Salvia miltiorrhiza 15 parts, Lindera aggregata 10 parts, and Corydalis vanishing 12 parts.

5. The use according to any one of claims 1 to 4, characterized in that, The preparation method of the traditional Chinese medicine composition comprises the following steps: Sargentodoxa cuneata, and Corydalis vanishing are added to 6-10 times the amount of 60%-80% ethanol, and reflux extraction is performed 1-3 times, each time for 0.5-2.5 hours, and the filtrate is combined to obtain an alcohol extract; Gleditsia sinensis, Taraxacum mongolicum, Sargentodoxa cuneata, Codonopsis pilosula, Smilax riparia, Radix Paeoniae Rubra, Salvia miltiorrhiza, and Lindera aggregata are added to 10-15 times the amount of water, and decoction is performed 1-4 times, each time for 1-3 hours, and the filtrate is combined, concentrated under reduced pressure, and then ethanol is added to a content of 60%, and the mixture is left to stand for 24-36 hours, and the supernatant of the alcohol precipitation is collected; The supernatant of the alcohol precipitation and the alcohol extract are combined, concentrated under reduced pressure to obtain an extract, 1-3 times the weight of water is added to the extract, and the mixture is left to stand for 24-36 hours, and the supernatant is dried and pulverized.

6. Use according to claim 1, characterized in that, The dosage form of the medicament includes granules, capsules, pills, or tablets.

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