Application of traditional Chinese medicine composition in preparation of medicine for preventing and treating hyperplasia of mammary glands

Abstract

The invention 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 hyperplasia of mammary glands. Research finds that the traditional Chinese medicine composition prepared from rhizoma arisaematis, radix aconiti, clove, cinnamon, radix angelicae, asarum, ligusticum wallichii, cynanchum paniculatum, frankincense, myrrh, camphor and borneol can obviously reduce the diameter, height and uterine coefficient of nipples of rats with hyperplasia of mammary glands, improve the lesion state of mammary glands, and can obviously improve the levels of sex hormones E2, P, LH and FSH of serum, which indicates that the traditional Chinese medicine composition can be used for treating hyperplasia of mammary glands. The traditional Chinese medicine composition can effectively improve the sex hormone level and the breast lesion state, and has a good treatment effect on rat mammary gland hyperplasia induced by estrogen and progesterone.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to the application of a traditional Chinese medicine composition in the preparation of a drug for preventing and treating mammary hyperplasia. Background Art

[0002] Mammary hyperplasia (MGH) is a common non-tumor and non-inflammatory benign mammary disease in clinical practice. The occurrence of this disease is closely related to the abnormal overdevelopment and regression of normal mammary glands. It is the excessive hyperplasia of epithelial cells in mammary tissue. Over time, the hyperplastic tissues accumulate to form mammary hyperplasia. This disease is mainly related to endocrine dysfunction, including the imbalance of estrogen and progesterone ratios, abnormalities in the quality and quantity of mammary sex hormone receptors, elevated prolactin, etc., and may be affected by factors such as age, menstrual history, pregnancy history, lactation history, etc. It is prone to occur in women aged 30 - 50, and 70% - 80% of women will have varying degrees of mammary hyperplasia. Its main symptoms include mammary pain, nodules or masses, and some patients will have nipple discharge. Patients may also be accompanied by symptoms such as anxiety, depression, and menstrual disorders, which have an adverse impact on the patients' lives. In addition, mammary hyperplasia may develop into epithelial atypical hyperplasia, adenoma, and ultimately induce breast cancer, and its canceration rate is 2 - 4 times higher than that of normal women.

[0003] Currently, clinical treatment often uses surgical treatment, drug treatment, non-drug treatment, etc. to relieve the clinical symptoms of patients. Among them, drug treatment is still one of the most commonly used methods. Although conventional anti-estrogen drug treatment can improve the discomfort symptoms of patients, it cannot cause pathological changes and can only relieve the symptoms of patients. Patients need to take drugs for a long time, and long-term drug use will cause adverse reactions such as bone marrow suppression and liver damage.

[0004] In view of the above problems, the traditional Chinese medicine field should actively intervene in the prevention and treatment of mammary hyperplasia, and it is of great significance to develop symptomatic prescriptions. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide the application of a traditional Chinese medicine composition in the preparation of a drug for preventing and treating mammary hyperplasia.

[0006] In order to achieve the above-mentioned invention purpose, the present invention provides the following technical solutions:

[0007] The application of a traditional Chinese medicine composition in the preparation of a drug for preventing and treating mammary hyperplasia, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight, or is made from the following raw materials in parts by weight:

[0008] 70 - 110 parts of Arisaema heterophyllum Blume, 50 - 90 parts of Aconitum carmichaelii Debx., 40 - 80 parts of Eugenia caryophyllata Thunb., 40 - 80 parts of Cinnamomum cassia Presl, 80 - 120 parts of Angelica dahurica (Fisch.) Benth. et Hook. f., 20 - 70 parts of Asarum sieboldii Miq., 50 - 90 parts of Ligusticum chuanxiong Hort., 20 - 70 parts of Cynanchum paniculatum (Bge.) Kitag., 10 - 40 parts of Olibanum, 10 - 40 parts of Myrrha, 5 - 40 parts of Camphor, 5 - 40 parts of Borneol.

[0009] In the application of the present invention, the weight parts of each raw material in the traditional Chinese medicine composition are as follows:

[0010] 79 - 99 parts of Arisaema heterophyllum Blume, 57 - 77 parts of Aconitum carmichaelii Debx., 46 - 66 parts of Eugenia caryophyllata Thunb., 46 - 66 parts of Cinnamomum cassia Presl, 90 - 110 parts of Angelica dahurica (Fisch.) Benth. et Hook. f., 32 - 52 parts of Asarum sieboldii Miq., 57 - 77 parts of Ligusticum chuanxiong Hort., 32 - 52 parts of Cynanchum paniculatum (Bge.) Kitag., 18 - 28 parts of Olibanum, 18 - 28 parts of Myrrha, 11 - 31 parts of Camphor, 11 - 31 parts of Borneol.

[0011] In the application of the present invention, the weight parts of each raw material in the traditional Chinese medicine composition are: 80.1 parts of Arisaema heterophyllum Blume, 60 parts of Aconitum carmichaelii Debx., 50.1 parts of Eugenia caryophyllata Thunb., 50.1 parts of Cinnamomum cassia Presl, 90 parts of Angelica dahurica (Fisch.) Benth. et Hook. f., 37.5 parts of Asarum sieboldii Miq., 60 parts of Ligusticum chuanxiong Hort., 37.5 parts of Cynanchum paniculatum (Bge.) Kitag., 24.9 parts of Olibanum, 24.9 parts of Myrrha, 18.9 parts of Camphor, 18.9 parts of Borneol.

[0012] In the application of the present invention, the prevention and treatment include at least one of the following aspects:

[0013] Reducing the nipple diameter, nipple height and uterine coefficient, and improving the sex hormone level.

[0014] In some specific embodiments, the hormone is the hormone in serum, and the improvement of the sex hormone level includes: reducing the level of at least one of E2, LH, and FSH hormones, and / or increasing the P level.

[0015] In the application of the present invention, the traditional Chinese medicine composition can directly grind each traditional Chinese medicine material into powder, or can be an extract obtained by conventional means in the art for each traditional Chinese medicine material, etc. The traditional Chinese medicine materials used in the composition of the present invention can be the raw medicine directly ground into powder, the raw medicine ground into powder after drying, or the extract of the raw medicine. It can also be the processed product of the raw medicine, such as the processed product after processing, etc. The specific forms include the powder after grinding, the powder after drying and grinding, or its extract. In order to retain the active ingredients in the medicinal materials to a greater extent and avoid the destruction of the active ingredients by high temperature, the drying is preferably low-temperature drying.

[0016] In some embodiments, the traditional Chinese medicine composition is used in the form of powder ground after low-temperature drying. The specific preparation method includes: taking Arisaema heterophyllum Blume, Aconitum carmichaelii Debx., Eugenia caryophyllata Thunb., Cinnamomum cassia Presl, Angelica dahurica (Fisch.) Benth. et Hook. f., Asarum sieboldii Miq., Ligusticum chuanxiong Hort., Cynanchum paniculatum (Bge.) Kitag., Olibanum, and Myrrha, drying them at low temperature, then pulverizing and sieving; then adding Camphor and Borneol and mixing.

[0017] In the application of the present invention, the effective dose of the traditional Chinese medicine composition is 2.765 g to 5.529 g of crude drug per day.

[0018] Research shows that, compared with the model group, at medium and high doses, the traditional Chinese medicine composition of the present invention can significantly reduce the nipple diameter, height and uterine coefficient of rats with mammary gland hyperplasia (P < 0.01 or P < 0.05), and can significantly reduce the contents of serum E2, LH and FSH (P < 0.01), significantly increase the content of P (P < 0.01), improve the levels of serum sex hormones E2, P, and FSH, and has a significant therapeutic effect on mammary gland hyperplasia induced by estrogen combined with progesterone.

[0019] The present invention also provides a drug for preventing and treating mammary gland hyperplasia, comprising raw materials in the following parts by weight, or made from raw materials comprising the following parts by weight:

[0020] 70 - 110 parts of Arisaema heterophyllum Blume, 50 - 90 parts of Radix Aconiti Carmichaeli, 40 - 80 parts of Flos Caryophylli, 40 - 80 parts of Cortex Cinnamomi, 80 - 120 parts of Radix Angelicae Dahuricae, 20 - 70 parts of Herba Asari, 50 - 90 parts of Rhizoma Chuanxiong, 20 - 70 parts of Herba Cynanchi Paniculati, 10 - 40 parts of Olibanum, 10 - 40 parts of Myrrha, 5 - 40 parts of Camphora, 5 - 40 parts of Borneolum Syntheticum.

[0021] The drug provided by the present invention also includes pharmaceutically acceptable excipients, such as rosin, paraffin, vaseline, liquid paraffin, etc. Those skilled in the art can select appropriate types of excipients according to needs and make the required traditional Chinese medicine dosage forms according to the conventional preparation methods in pharmacy. The dosage forms include but are not limited to decoction, granule, capsule, tablet, pill, oral liquid, tincture, syrup, suppository, gel, spray, injection, ointment, plaster, rubber plaster and cataplasm.

[0022] In the present invention, the drug is a plaster, and the preparation method of the plaster includes:

[0023] Take Arisaema heterophyllum Blume, Radix Aconiti Carmichaeli, Flos Caryophylli, Cortex Cinnamomi, Radix Angelicae Dahuricae, Herba Asari, Rhizoma Chuanxiong, Herba Cynanchi Paniculati, Olibanum, Myrrha, dry at low temperature, crush into fine powder, sieve, mix evenly to obtain medicinal powder;

[0024] Take rosin, paraffin, vaseline, liquid paraffin, heat to melt, when the temperature drops below 65 °C, add methyl salicylate, camphora, borneol and the medicinal powder in sequence, mix evenly to make a coating; use the coating to make a plaster.

[0025] The present invention provides an application of a traditional Chinese medicine composition in the preparation of a drug for preventing and treating mammary gland hyperplasia. The traditional Chinese medicine composition is prepared from Arisaema heterophyllum Blume, Radix Aconiti, Flos Caryophylli, Cortex Cinnamomi, Radix Angelicae Dahuricae, Herba Asari, Rhizoma Chuanxiong, Herba Cynanchi Paniculati, Olibanum, Myrrha, Borneolum Syntheticum, and Borneol. The experimental results show that the traditional Chinese medicine composition can significantly reduce the nipple diameter, height, and uterine coefficient of rats with mammary gland hyperplasia, improve the state of mammary gland lesions, and can significantly improve the levels of serum sex hormones E2, P, LH, and FSH. This indicates that the traditional Chinese medicine composition can effectively improve the sex hormone levels, improve the state of mammary gland lesions, and has a good therapeutic effect on mammary gland hyperplasia induced by estrogen combined with progesterone in rats. Detailed implementation manners

[0026] The present invention provides an application of a traditional Chinese medicine composition in the preparation of a drug for preventing and treating mammary gland hyperplasia. Those skilled in the art can draw on the content of this article and appropriately modify the process parameters to achieve it. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art, and they are all regarded as included in the present invention. The methods and applications of the present invention have been described through preferred embodiments, and those related can obviously make changes or appropriate changes and combinations to the methods and applications in this article without departing from the content, spirit, and scope of the present invention to implement and apply the technology of the present invention.

[0027] In this article, expressions such as "including", "having", "containing", and their grammatical synonyms should all be understood as inclusive rather than exclusive open expressions, and at the same time, the "consisting of..." scheme is also provided.

[0028] In this article, the term "and / or" includes any and all combinations of one or more of the related listed items.

[0029] In this article, regarding numerical ranges, unless otherwise specified, the above numerical ranges are considered continuous and include the minimum and maximum values of the range, as well as every point value between such minimum and maximum values. Further, when the range refers to integers, every integer between the minimum and maximum values of the range is included. In addition, when multiple ranges are provided to describe features or characteristics, these ranges can be combined.

[0030] As described above, the present invention provides an application of a traditional Chinese medicine composition in the preparation of a drug for preventing and treating mammary gland hyperplasia;

[0031] The traditional Chinese medicine composition includes the following raw materials in parts by weight, or is made from the following raw materials in parts by weight:

[0032] 70 - 110 parts of raw Arisaema heterophyllum Blume, 50 - 90 parts of raw Aconitum carmichaelii Debx., 40 - 80 parts of cloves, 40 - 80 parts of cinnamon, 80 - 120 parts of Angelica dahurica (Fisch.) Benth. et Hook., 20 - 70 parts of Asarum sieboldii Miq., 50 - 90 parts of Ligusticum chuanxiong Hort., 20 - 70 parts of Cynanchum paniculatum (Bunge) Kitagawa, 10 - 40 parts of prepared frankincense, 10 - 40 parts of prepared myrrh, 5 - 40 parts of camphor, 5 - 40 parts of borneol.

[0033] The present invention also provides a preparation method of the traditional Chinese medicine composition, including:

[0034] Take raw Arisaema heterophyllum Blume, raw Aconitum carmichaelii Debx., cloves, cinnamon, Angelica dahurica (Fisch.) Benth. et Hook., Asarum sieboldii Miq., Ligusticum chuanxiong Hort., Cynanchum paniculatum (Bunge) Kitagawa, prepared frankincense, prepared myrrh, after low-temperature drying, pulverize and sieve, and mix with camphor and borneol to obtain.

[0035] The present invention also provides a preparation method of the drug for preventing and treating mammary gland hyperplasia, the dosage form of the drug is a plaster, and its preparation method includes:

[0036] Take raw Arisaema heterophyllum Blume, raw Aconitum carmichaelii Debx., cloves, cinnamon, Angelica dahurica (Fisch.) Benth. et Hook., Asarum sieboldii Miq., Ligusticum chuanxiong Hort., Cynanchum paniculatum (Bunge) Kitagawa, prepared frankincense, prepared myrrh, low-temperature dry, pulverize into fine powder, sieve, mix evenly to obtain the medicine powder for standby; separately take rosin, paraffin, vaseline, liquid paraffin, heat to melt, when the temperature drops below 65 °C, sequentially add methyl salicylate, camphor, borneol and the above-mentioned medicine powder and mix evenly to make a coating, and perform plaster coating, cutting, lining, and slicing to make a plaster.

[0037] Specifically, the preparation method of the above-mentioned plaster includes:

[0038] Take 267 g of raw Arisaema heterophyllum Blume, 200 g of raw Aconitum carmichaelii Debx., 167 g of cloves, 167 g of cinnamon, 300 g of Angelica dahurica (Fisch.) Benth. et Hook., 125 g of Asarum sieboldii Miq., 200 g of Ligusticum chuanxiong Hort., 125 g of Cynanchum paniculatum (Bunge) Kitagawa, 83 g of prepared frankincense, 83 g of prepared myrrh, low-temperature dry, pulverize into fine powder, sieve, mix evenly to obtain the medicine powder for standby; separately take 267 g of rosin, 1330 g of paraffin, 800 g of vaseline, 233 g of liquid paraffin, heat to about 100 °C to melt, when the temperature drops to 100 °C, sequentially add 160 g of methyl salicylate, 63 g of camphor, 63 g of borneol and the above-mentioned medicine powder and mix evenly to make a coating, and perform plaster coating, cutting, lining, and slicing to make a plaster.

[0039] In the present invention, the traditional Chinese medicine composition and the drug can significantly reduce the nipple diameter, height and uterine coefficient of rats with mammary gland hyperplasia, improve the mammary gland lesion state, and can significantly improve the levels of serum sex hormones E2, P, LH and FSH, suggesting that the traditional Chinese medicine composition and its drug can effectively improve the sex hormone level, improve the mammary gland lesion state, and have a good therapeutic effect on estrogen combined with progesterone-induced mammary gland hyperplasia in rats.

[0040] The test materials used in the present invention are all ordinary commercially available products and can be purchased in the market.

[0041] The present invention will be further described below in conjunction with embodiments:

[0042] Example 1 Preparation of the composition of the present invention

[0043] Prescription: 267g raw arisaema, 200g raw Chuanwu, 167g cloves, 167g cinnamon, 300g angelica dahurica, 125g asarum, 200g chuanxiong, 125g Cynanchum chinense, 83g processed frankincense, 83g processed myrrh, 63g camphor, and 63g borneol.

[0044] The preparation method of the Chinese medicine composition plaster is as follows:

[0045] Take the above twelve raw materials, except camphor and borneol, take ten other raw materials such as arisaema, dry at low temperature, crush into fine powder, sieve, mix evenly, and set aside. Take another 267g of rosin, 1330g of paraffin, 800g of vaseline, and 233g of liquid paraffin, heat to about 100°C, melt, and when the temperature drops to 60°C, add 160g of methyl salicylate, camphor, borneol and the above powders in turn, mix evenly, make a coating, apply ointment, cut into sections, cover and slice, and make a plaster with a size of 10cm*13cm.

[0046] Example 2 Therapeutic effect of Chinese medicine composition on estrogen and progesterone-induced mammary hyperplasia model in rats

[0047] 1. Experimental Materials

[0048] 1.1 Animals

[0049] SD rats, female, SPF grade, 50, weighing 160-180 g, were purchased from Sibeifu (Suzhou) Biotechnology Co., Ltd., animal certificate number: SCXK (Su) 2022-0006.

[0050] Breeding environment: room temperature 20-26℃, relative humidity controlled at 40-70%, and breeding density of 5 per cage.

[0051] 1.2 Drugs

[0052] Traditional Chinese medicine composition, prepared by the method of Example 1, Jiangsu Kanion Pharmaceutical Co., Ltd.; Estradiol benzoate (Ningbo No. 2 Hormone Factory, batch number: 200806); Progesterone (Zhejiang Xianju Pharmaceutical Co., Ltd., batch number: EB2160); Normal saline (Sinopharm Chemical Reagent Co., Ltd., batch number: B21120704); Rat estrogen (estrogen, E2), progesterone (progesterone, P), luteinizing hormone (luteinizing hormone, LH), follicle stimulating hormone (follicle stimulating hormone, FSH) enzyme-linked immunosorbent assay (enzymelinkedimmunosorbent assay, ELISA) kits, all produced by Shanghai Enzyme-linked Biotechnology Co., Ltd.

[0053] 1.3 Instruments

[0054] Animal weighing scale (Shanghai Xiangchuan Electronic Weighing Instrument Co., Ltd., model: CX-SC-DA); Electronic balance (Sartorius Scientific Instrument Co., model: BS224S); Purified water instrument (Millipore Corporation, Germany, model: Milli-Q Plus); Low-temperature centrifuge (Eppendorf Company, Germany, model: 5804R); Microplate reader (Molecular Devices, USA, model: Flexstation3).

[0055] 2. Dose Design

[0056] The maximum daily dose of the traditional Chinese medicine composition is 5.529 g / day for 3 patches at a time. According to the body surface area conversion method, the equivalent dose for rats is 0.6 g / kg / d. According to the 1 / 4:1 / 2:1 dosing method, the low dose is 0.15 g / kg / d, the medium dose is 0.3 g / kg / d, and the corresponding patch areas for the high dose are 8 cm 2 (2*4), the medium dose is 4 cm 2 (2*2), the low dose is 1 cm 2 (2*1).

[0057] 3. Experimental Methods

[0058] SD rats were adaptively fed for 3 days with free access to feed and water. They were randomly divided into a normal control group, a model control group, high, medium, and low dose groups of the traditional Chinese medicine composition, with 10 rats in each group.

[0059] A rat model of mammary gland hyperplasia was established using estrogen and progesterone. Except for the rats in the normal group, all the other rats were intramuscularly injected with 0.5 mg / kg / d estradiol benzoate on the lateral muscles of the hindlimbs for 25 consecutive days, and then intramuscularly injected with 5 mg / kg / d progesterone on the lateral muscles of the hindlimbs for 5 consecutive days, for a total of 30 days. Before and after modeling, the diameter and height of the rat nipples were measured, and the appearance changes of the rat mammary gland tissue were observed. After modeling, the diameter and height of the rat nipples were significantly increased compared with those before modeling, and the mammary gland tissue showed swelling, indicating that the rat model of mammary gland hyperplasia was successfully established. After successful modeling, the chest hair of the treatment group was shaved to expose the second pair of mammary glands, and the plaster was applied externally to the breasts and fixed with paper tape, replaced every other day for a total of 3 days.

[0060] Before and after treatment, the diameter and height of the left and right two nipples of the second pair of rats were accurately measured with a vernier caliper. The animals were sacrificed on the second day after the last administration, and the rat uterus was removed. The body weight and uterine weight of the rats were measured with an electronic balance, and the uterine index was calculated by dividing the uterine weight by the body weight. Blood was taken from the abdominal aorta of rats in each group, and the serum was separated, and the contents of serum E2, P, LH and FSH were detected respectively.

[0061] 4. Statistical methods

[0062] The results were statistically processed using the t-test.

[0063] 5. Experimental results

[0064] 5.1 Effects on the mammary gland and uterus of the rat model of mammary gland hyperplasia induced by estrogen combined with progesterone Compared with the normal group, the nipple diameter, height and uterine index of the rats in the model group were significantly increased (P < 0.01). Compared with the model group, the nipple diameter, height and uterine coefficient of the medium- and high-dose experimental groups were significantly decreased, and the differences were statistically significant (P < 0.05, P < 0.01); although the nipple diameter, height and uterine coefficient of the low-dose experimental group decreased compared with the model group, the differences were not statistically significant (all P > 0.05). The results are shown in Table 1.

[0065] Table 1 Effects on the nipple diameter, height and uterine coefficient of rats in each group ( n = 10)

[0066]

[0067] Note: Compared with the normal control group, ## P < 0.01; compared with the model control group, * P < 0.05,

[0068] ** P < 0.01.

[0069] 5.2 Effects on the serum sex hormone levels of the rat model of mammary gland hyperplasia induced by estrogen combined with progesterone

[0070] Compared with the normal group, there were significant differences in the contents of E2, P, LH and FSH in the serum of rats in the model group (P < 0.01). Compared with the model group, the contents of E2, LH and FSH in the serum of rats in the high-dose and medium-dose groups of the traditional Chinese medicine composition were significantly decreased (P < 0.01), and the content of P was significantly increased (P < 0.01). The results are shown in Table 2.

[0071] Table 2 Effects of the contents of sex hormones E2, P, LH and FSH in the serum of rats in each group ( n = 10)

[0072]

[0073] Note: Compared with the normal control group, ## P < 0.01; compared with the model control group, ** P < 0.01.

[0074] 6. Test conclusion

[0075] The high-dose and medium-dose groups of the traditional Chinese medicine composition can significantly reduce the nipple diameter, height and uterine coefficient, improve the state of mammary gland lesions, and can significantly improve the levels of serum sex hormones E2, P, LH and FSH, suggesting that the traditional Chinese medicine composition has a good therapeutic effect on estrogen combined with progesterone-induced mammary gland hyperplasia in rats.

[0076] The above is only the preferred embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. Use of a traditional Chinese medicine composition in the preparation of a medicament for preventing and treating mammary gland hyperplasia, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight, or is made from the following raw materials in parts by weight: Arisaema heterophyllum Blume 70 - 110 parts, Radix Aconiti 50 - 90 parts, Flos Caryophylli 40 - 80 parts, Cortex Cinnamomi 40 - 80 parts, Radix Angelicae Dahuricae 80 - 120 parts, Herba Asari 20 - 70 parts, Rhizoma Chuanxiong 50 - 90 parts, Herba Cynanchi Paniculati 20 - 70 parts, Olibanum 10 - 40 parts, Myrrha 10 - 40 parts, Borneolum Syntheticum 5 - 40 parts, Borneol 5 - 40 parts.

2. The application according to claim 1, wherein The weight parts of each raw material are: Arisaema heterophyllum Blume 79 - 99 parts, Radix Aconiti 57 - 77 parts, Flos Caryophylli 46 - 66 parts, Cortex Cinnamomi 46 - 66 parts, Radix Angelicae Dahuricae 90 - 110 parts, Herba Asari 32 - 52 parts, Rhizoma Chuanxiong 57 - 77 parts, Herba Cynanchi Paniculati 32 - 52 parts, Olibanum 18 - 28 parts, Myrrha 18 - 28 parts, Borneolum Syntheticum 11 - 31 parts, Borneol 11 - 31 parts.

3. The application according to claim 2, wherein The weight parts of each raw material are: Arisaema heterophyllum Blume 80.1 parts, Radix Aconiti 60 parts, Flos Caryophylli 50.1 parts, Cortex Cinnamomi 50.1 parts, Radix Angelicae Dahuricae 90 parts, Herba Asari 37.5 parts, Rhizoma Chuanxiong 60 parts, Herba Cynanchi Paniculati 37.5 parts, Olibanum 24.9 parts, Myrrha 24.9 parts, Borneolum Syntheticum 18.9 parts, Borneol 18.9 parts.

4. The application according to any one of claims 1 to 3, characterized in that, The prevention and treatment includes at least one of the following aspects: Reducing nipple diameter, nipple height and uterine coefficient, and improving sex hormone levels.

5. The application according to claim 4, characterized in that, The hormone is the hormone in serum, and the improvement of sex hormone levels includes: reducing the level of at least one of E2, LH, and FSH hormones, and / or increasing the P level.

6. The application according to any one of claims 1 to 5, characterized in that, The preparation method of the traditional Chinese medicine composition includes: taking Arisaema heterophyllum Blume, Radix Aconiti, Flos Caryophylli, Cortex Cinnamomi, Radix Angelicae Dahuricae, Herba Asari, Rhizoma Chuanxiong, Herba Cynanchi Paniculati, Olibanum, and Myrrha, drying them at low temperature, pulverizing and sieving; then adding Borneolum Syntheticum and Borneol and mixing.

7. The application according to any one of claims 1 to 6, characterized in that The effective dose of the traditional Chinese medicine composition is 2.765 g - 5.529 g of crude drug per day.

8. A drug for preventing and treating mammary gland hyperplasia, characterized in that, Comprises the following raw materials in parts by weight, or is made from the following raw materials in parts by weight: Arisaema heterophyllum Blume 70 - 110 parts, Radix Aconiti 50 - 90 parts, Flos Caryophylli 40 - 80 parts, Cortex Cinnamomi 40 - 80 parts, Radix Angelicae Dahuricae 80 - 120 parts, Herba Asari 20 - 70 parts, Rhizoma Chuanxiong 50 - 90 parts, Herba Cynanchi Paniculati 20 - 70 parts, Olibanum 10 - 40 parts, Myrrha 10 - 40 parts, Borneolum Syntheticum 5 - 40 parts, Borneol 5 - 40 parts.

9. The drug according to claim 8, characterized in that, Its dosage form includes decoction, granule, capsule, tablet, pill, oral liquid, tincture, syrup, suppository, gel, spray, injection, ointment, plaster, rubber plaster or cataplasm.

10. The drug according to claim 9, characterized in that, The dosage form of the drug is a plaster, and the preparation method of the plaster includes: Taking Arisaema heterophyllum Blume, Radix Aconiti, Flos Caryophylli, Cortex Cinnamomi, Radix Angelicae Dahuricae, Herba Asari, Rhizoma Chuanxiong, Herba Cynanchi Paniculati, Olibanum, and Myrrha, drying them at low temperature, pulverizing them into fine powder, sieving, and mixing to obtain medicinal powder; Taking rosin, paraffin, vaseline, and liquid paraffin, heating them to melt, and when the temperature drops below 65°C, successively adding methyl salicylate, Borneolum Syntheticum, Borneol, and the medicinal powder and mixing to make a coating; using the coating to make a plaster.

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