Traditional Chinese medicine composition for treating mammary duct dilatation

Abstract

The invention discloses a traditional Chinese medicine composition for treating mammary duct dilatation, and relates to the technical field of traditional Chinese medicines, and the traditional Chinese medicine composition is characterized by comprising 15 parts of hawthorn, 15 parts of fried malt, 15 parts of rhizoma smilacis glabrae, 15 parts of salted rhizoma alismatis and 15 parts of dandelion. The traditional Chinese medicine composition disclosed by the invention can effectively improve clinical symptoms of mammary duct dilatation, and has the effects of relieving pain, improving the size of a dilated duct, and being stable in curative effect and few in adverse reaction.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to a traditional Chinese medicine composition for treating mammary duct dilatation. Background Technology

[0002] Mammary duct ectasia is a pathological manifestation in which the diameter of the mammary ducts exceeds the normal range. Relative or absolute dilation of the mammary ducts may be accompanied by increased secretion of substances within the ducts, and may also manifest as nipple discharge. Symptoms of mammary duct ectasia vary from person to person, but common symptoms include breast lumps, nipple retraction, nipple discharge, and non-cyclical breast pain. This condition commonly affects young and middle-aged women aged 25-45, accounting for approximately 70%-80% of breast diseases. With increasing pressure on women in modern society, the incidence rate is rising annually, making it the most common breast disease in clinical practice. Its pathogenesis remains unclear.

[0003] Currently, modern medicine primarily employs two treatment methods: drug therapy and surgery. Western medicines for treating mammary duct ectasia mainly focus on symptom relief, offering short treatment durations and good efficacy, but they also have significant toxic side effects, making long-term use undesirable. Furthermore, the condition is prone to relapse after discontinuation, resulting in unsatisfactory outcomes. Surgical treatment has strict indications; initiating surgery solely for breast pain as the primary clinical symptom risks overtreatment. Moreover, surgery cannot fundamentally resolve the problem, leading to high recurrence rates and patient resistance. Traditional Chinese medicine has become an important clinical option for treating mammary duct ectasia. Its efficacy is stable, with the potential to improve pain, reduce the size of dilated ducts, and even eliminate them, with fewer adverse reactions. Therefore, the inventors propose a traditional Chinese medicine composition for treating mammary duct ectasia. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition for treating mammary duct dilatation, which has stable efficacy and can improve pain and reduce the size of dilated ducts.

[0005] The above-mentioned technical objective of the present invention is achieved through the following technical solution:

[0006] The first aspect of the present invention provides a traditional Chinese medicine composition for treating mammary duct dilatation, comprising 15 parts hawthorn, 15 parts roasted malt, 15 parts Smilax glabra, 15 parts salted Alisma plantago-aquatica and 15 parts dandelion.

[0007] In conjunction with the first aspect, the present invention is further configured as follows: for those with symptoms, add 15 parts of rose petals if accompanied by chest tightness and rib distension, or those prone to depression and irritability.

[0008] A second aspect of the present invention also provides a method for preparing a traditional Chinese medicine composition, wherein all the above-mentioned raw materials are decocted in water to obtain the pharmaceutical composition.

[0009] A third aspect of the present invention also provides the use of any of the described traditional Chinese medicine compositions in the preparation of a medicament for treating mammary duct ectasia.

[0010] In summary, the present invention has the following beneficial effects:

[0011] The formula of the traditional Chinese medicine composition of this invention is the most rational formula obtained through repeated clinical application and practice. The various drugs work synergistically to maximize therapeutic effects. Smilax glabra clears heat, promotes diuresis, and detoxifies; Alisma plantago-aquatica promotes diuresis and eliminates dampness; Crataegus pinnatifida strengthens the stomach and regulates qi; roasted malt soothes the liver, regulates qi, and promotes lactation; Taraxacum mongolicum clears heat, detoxifies, reduces swelling, and promotes diuresis. The combined effects of these drugs soothe the liver, unblock the meridians, and promote diuresis. The traditional Chinese medicine composition of this invention can effectively improve the clinical symptoms of mammary duct dilation, reducing pain, improving the size of dilated ducts, and has stable efficacy with few adverse reactions. Detailed Implementation

[0012] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0013] Example 1:

[0014] 15g hawthorn, 15g roasted malt, 15g Smilax glabra, 10g salted Alisma plantago-aquatica, 15g dandelion.

[0015] Boil water as usual to produce 200ml per serving.

[0016] Example 2:

[0017] 15g hawthorn, 15g roasted malt, 15g Smilax glabra, 10g salted Alisma plantago-aquatica, 15g dandelion, 15g rose.

[0018] Boil water as usual to produce 200ml per serving.

[0019] The medicinal materials used in this invention:

[0020] Smilax glabra: sweet, bland, and neutral in nature. It enters the liver and stomach meridians. It detoxifies, eliminates dampness, and promotes joint mobility. It is used for limb contractures and muscle and bone pain caused by syphilis and mercury poisoning; damp-heat urinary tract infections, leukorrhea, carbuncles, scrofula, and scabies. Smilax glabra is the principal ingredient in the composition of this invention.

[0021] Alisma plantago-aquatica: Sweet, bland, and cold in nature. It enters the kidney and bladder meridians. It promotes urination and eliminates dampness, clears heat, resolves turbidity, and lowers lipids. It is used for dysuria, edema, diarrhea with scanty urine, phlegm retention and dizziness, painful urination due to heat, and hyperlipidemia. Salt-processed Alisma plantago-aquatica is prepared by stir-frying slices of Alisma plantago-aquatica according to the salt-processing method (General Rule 0213) until dry.

[0022] Malt: Sweet, neutral. Enters the spleen and stomach meridians. Promotes digestion, strengthens the spleen and stomach, reduces lactation and relieves bloating. Used for indigestion, abdominal distension and pain, spleen deficiency with poor appetite, milk stasis, breast distension and pain, weaning, liver stagnation with hypochondriac pain, and liver and stomach qi pain. Raw malt strengthens the spleen and stomach, soothes the liver and promotes qi circulation. Used for spleen deficiency with poor appetite and milk stasis. Fried malt promotes digestion, reduces lactation, and relieves indigestion. Used for indigestion and weaning. Charred malt promotes digestion and resolves stagnation. Used for indigestion and abdominal distension and pain. Fried malt: Take clean malt, fry according to the stir-frying method (General Rule 0213) until brownish-yellow, cool, and sift to remove ash. Salted Alisma and malt are used as adjuvants in the composition of this invention.

[0023] Hawthorn: Sour, sweet, slightly warm. It enters the spleen, stomach, and liver meridians. It aids digestion, strengthens the stomach, promotes qi circulation, disperses blood stasis, and reduces lipids. It is used for food stagnation due to excessive meat consumption, abdominal distension, diarrhea and abdominal pain, amenorrhea due to blood stasis, postpartum blood stasis, stabbing pain in the heart and abdomen, chest pain, hernia pain, and hyperlipidemia. Roasted hawthorn has enhanced digestive and stagnation-relieving effects. It is used for food stagnation due to excessive meat consumption and incomplete diarrhea. Hawthorn is used as an adjuvant in the composition of this invention.

[0024] Dandelion: Bitter, sweet, and cold in nature. It enters the liver and stomach meridians. It clears heat and detoxifies, reduces swelling and dissipates nodules, and promotes urination. It is used for boils, carbuncles, mastitis, scrofula, red eyes, sore throat, lung abscess, intestinal abscess, damp-heat jaundice, and painful urination due to heat. Dandelion is used as an adjuvant in the composition of this invention.

[0025] The modern pharmacological studies of the medicinal materials in the traditional Chinese medicine composition of this application are as follows:

[0026] Roasted malt: It has strong anti-inflammatory, antioxidant, and anti-tumor effects and enhances immune function; roasted malt contains substances similar to bromocriptine, which can inhibit prolactin secretion and has a milk-suppressing effect.

[0027] Dandelion: Its main active ingredients include flavonoids, terpenes, phenolic acids, coumarins, and sterols, which can inhibit bacteria, reduce inflammation, fight oxidation, fight tumors, promote diuresis, combat allergies, protect the heart, and promote bile secretion and liver protection. "Dandelion is often used to treat breast diseases." Traditional Chinese medicine believes that the nipples and breasts of women are closely related to the liver and stomach meridians; therefore, dandelion has unique advantages in treating breast diseases.

[0028] Hawthorn: It has immunomodulatory effects, enhancing the body's immune function. The flavonoids and other components in hawthorn have significant antioxidant effects, effectively scavenging free radicals and delaying cell aging, playing an important role in preventing cardiovascular diseases and fighting cancer. Certain components in hawthorn, such as vitexin, isocortin, ursolic acid, and hawthorn acid, have anti-cancer activity, exerting anti-tumor effects through multiple mechanisms. Hawthorn has antibacterial properties, inhibiting the growth of various pathogenic microorganisms, such as Staphylococcus aureus, Escherichia coli, and Salmonella. Hawthorn also has hypotensive, hypoglycemic, antibacterial, and anti-inflammatory effects. Its flavonoids, such as rutin and catechins, have anti-inflammatory effects, inhibiting the production and release of inflammatory factors and providing anti-inflammatory protection.

[0029] Smilax glabra has a wide range of pharmacological activities in terms of antioxidation, antitumor, anti-inflammatory and antibacterial, and immunomodulation

[14] . Flavonoids have in vivo antioxidant activity, which can increase the activity expression of glutathione peroxidase, carnitine acyltransferase and fatty acid β-oxidase, and reduce the content of malondialdehyde; astilbin and polysaccharides in Smilax glabra can inhibit the secretion of inflammatory factors NO and TNF-α by LPS-induced RAW264.7 macrophages, inhibit the expression of inflammatory genes iNOS and TNF-α mRNA, thereby inhibiting the excessive inflammatory response of macrophages and having anti-inflammatory effects; Smilax glabra can promote the proliferation of lymphocytes in the blood, improve cellular immunity and humoral immunity, stimulate the production of tumor necrosis factor and interferon-α, and enhance the function of the immune system.

[0030] Alisma plantago-aquatica: Its chemical components mainly include triterpenoids, sesquiterpenoids, phenylpropanoids, diterpenoids, sugars, and volatile oils, among which triterpenoids are its main active ingredients. Modern pharmacological studies have shown that Alisma plantago-aquatica has pharmacological effects such as diuresis, anticancer, anti-cardiovascular and cerebrovascular disease, anti-inflammation, lipid regulation, hypoglycemia, improvement of liver function, and anti-osteoporosis.

[0031] Experimental Example 1:

[0032] (1) Diagnostic criteria

[0033] 1) Western medicine diagnostic criteria:

[0034] Referring to the "Expert Consensus on the Clinical Diagnosis and Treatment of Breast Hyperplasia Using Integrated Traditional Chinese and Western Medicine" and the Western medical diagnostic criteria for mammary duct ectasia in "Western Medicine Surgery":

[0035] ① Clinical manifestations: Breast pain of varying degrees, including swelling, stabbing, or dull pain, related to menstruation and emotional changes; or localized, non-menstrual cyclical pain. Single or multiple granular nodules, cord-like nodules, and localized or diffuse glandular thickening can be felt in one or both breasts. These nodules vary in shape and may enlarge, shrink, harden, or soften with changes in the menstrual cycle or emotional state. Some patients may experience nipple discharge or itching; the discharge is usually a pale yellow, colorless, or milky white serous fluid, with bloody discharge being rare.

[0036] ② Ultrasound findings: Mammary ducts are arranged radially around the nipple. When they converge at the nipple, the lumen narrows and becomes branched. Normal mammary ducts are closed during non-lactation periods, with an inner diameter of approximately 1 mm. Most breast tissue does not show ductal walls or dark areas within the lumen; occasionally, fine linear hyperechoic areas may be seen within some ducts. In late pregnancy and lactation, dilated mammary ducts may appear as tubular dark areas with thin, double-line hyperechoic walls. Tubular dark areas of ducts are usually not visible in the outer zone of the breast during lactation. Currently, there is no universally accepted standard for mammary duct inner diameter; however, a diameter greater than 2 mm is generally considered mammary duct dilation.

[0037] 2) Traditional Chinese Medicine Diagnostic Criteria

[0038] Referring to the "Expert Consensus on Clinical Diagnosis and Treatment of Breast Hyperplasia with Integrated Traditional Chinese and Western Medicine," the "Traditional Chinese Medicine Surgery" (edited by Chen Hongfeng, Shanghai Science and Technology Press, 2021) on mastopathy, and the diagnostic criteria of "Modern Traditional Chinese Medicine Breast Diseases" (edited by Lin Yi and Tang Hanjun, People's Medical Publishing House, 2003):

[0039] Traditional Chinese Medicine Syndrome Types:

[0040] 1. Liver Qi stagnation syndrome

[0041] Diagnostic criteria: Patients with two or more primary symptoms plus two secondary symptoms.

[0042] Main symptoms: ① Breast swelling, throbbing, and stabbing pain; ② Breast lump, appearing as a single, soft mass with significant tenderness; ③ The lump is related to menstruation and emotional changes; ④ Accompanied by significant mental and emotional changes.

[0043] Secondary symptoms: ① Depression; ② Irritability; ③ With or without distending pain in the hypochondriac region; ④ Pale red tongue with a thin white or yellow coating and a wiry pulse.

[0044] 2. Liver Qi Stagnation and Phlegm Accumulation Syndrome

[0045] Diagnostic criteria: Patients with two or more primary symptoms plus two secondary symptoms.

[0046] Main symptoms: ① Breast lump, firm but not firm; ② Distending or stabbing pain, symptoms fluctuate with mood; ③ With or without chest tightness and rib distension; ④ Prone to depression and irritability;

[0047] Secondary symptoms: ① Insomnia and excessive dreaming; ② Irritability and bitter taste in the mouth; ③ Pale red tongue with a thin white or yellow coating, and a wiry, thready or slippery pulse.

[0048] (2) Inclusion criteria

[0049] ① Meets the diagnostic criteria for mammary duct ectasia;

[0050] ② Initial onset of illness;

[0051] ③ Female patients who are not pregnant or breastfeeding;

[0052] ④ Patients diagnosed with liver qi stagnation syndrome or liver phlegm stagnation syndrome;

[0053] ⑤ Women aged 18 to 60 (inclusive);

[0054] ⑥ No congenital heart disease, severe intracranial injury, breast cancer, diabetes, severe liver and kidney dysfunction, etc.

[0055] ⑦ Within one month prior to enrollment, the individual had not received hormone therapy, anti-tuberculosis drugs, immunotherapy, or similar treatments.

[0056] ⑧ Voluntarily participate in this clinical trial, have signed an informed consent form, and meet the observation requirements of the medical ethics committee;

[0057] (3) Exclusion criteria

[0058] ① Women under the age of 18 or over the age of 60.

[0059] ② Patients who relapse after treatment.

[0060] ③Pregnant or breastfeeding female patients;

[0061] ④ Patients whose syndrome differentiation does not fall under the categories of liver qi stagnation syndrome or liver phlegm stagnation syndrome;

[0062] ⑤ Patients with concurrent plasma cell mastitis or granulomatous mastitis;

[0063] ⑥ Other breast diseases: acute mastitis during lactation, breast tuberculosis, benign breast tumors, and breast cancer, etc.;

[0064] ⑦ Those with infectious diseases; those with cardiovascular or cerebrovascular diseases, liver or kidney dysfunction; those with severe endocrine and hematopoietic system diseases, other immune system diseases, mental disorders, or those who cannot cooperate with treatment;

[0065] ⑧ People with allergies or a history of allergies to any component of the test drug;

[0066] ⑨ Patients who have also participated in other clinical trials.

[0067] (4) Exit Criteria

[0068] 1) Case dropout criteria

[0069] ① Patients whose condition worsens during the experiment, and who or their families request to withdraw or whose withdrawal is decided by the researchers.

[0070] ② Subjects explicitly withdraw from the trial; or, although not explicitly withdrawing, are lost to follow-up due to ceasing medication and examinations. (Case dropout management: Any case that withdraws from the trial should be followed up as much as possible, especially those withdrawing for safety reasons. Continued follow-up monitoring and recording of the subject's outcomes are essential. A study summary form should be completed for all withdrawn cases, stating the reason for withdrawal, such as: perceived inadequacy of treatment; intolerance of certain adverse reactions; or loss to follow-up without explanation. Original medical and research records should be retained. Further medical treatment may be provided to withdrawn subjects in accordance with relevant guidelines and their wishes.)

[0071] ③ Patients who experience serious adverse events, have concurrent illnesses or special physiological changes, and are not suitable to continue treatment.

[0072] ④During the experiment, poor subject compliance affected the evaluation of effectiveness and safety.

[0073] ⑤ Patients who detach spontaneously during the experiment due to ineffectiveness should be included in the efficacy analysis; patients who complete 1 / 2 course of treatment should be considered as having detached spontaneously; patients who complete more than 1 / 2 course of treatment should be included in the efficacy analysis.

[0074] ⑥ During treatment, there was combination therapy outside the prescribed range, especially the combination therapy with drugs that have a significant impact on the test drug, which affected the assessment of efficacy and safety.

[0075] ⑦ Cases of patients who withdrew from the trial before the course of treatment was completed, were lost to follow-up, or died for various other reasons.

[0076] ⑧ Incomplete data, affecting the judgment of validity and safety.

[0077] 2) Case exclusion and trial termination criteria

[0078] ① When serious adverse reactions or complications occur during treatment;

[0079] ② When another disease suddenly occurs that requires urgent treatment or when special physiological changes occur that make it unsuitable to continue this clinical observation.

[0080] ③ Those with poor compliance who fail to seek follow-up visits in a timely manner or provide relevant information for case reports;

[0081] ④ Other violations of inclusion criteria or compliance with exclusion criteria were found in the study.

[0082] ⑤ Patients who request a change of treatment plan during treatment.

[0083] (5) Research Design

[0084] A single-center, prospective cohort study method was adopted, and medical ethics principles were implemented in accordance with the recommendations of the Declaration of Helsinki as revised by the 48th World Medical Congress in 1996.

[0085] Twenty female patients with mammary duct ectasia who visited Professor Hu Jinhui's outpatient clinic at the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine between December 1, 2024, and May 1, 2025, were included in this study. After inclusion, the patients took this traditional Chinese medicine composition, one dose daily, prepared by conventional decoction (200ml per dose), twice daily, half an hour after meals. The treatment period was four weeks.

[0086] (6) Efficacy and Results

[0087] 1) Therapeutic indicators

[0088] Before and after treatment, ultrasound examinations were performed on the patient's breasts, and the diameters of the mammary ducts (in mm) were recorded in two groups. The duct diameter measured by ultrasound was as follows: the dilated duct during the ultrasound examination before treatment was selected as the target duct, and the maximum diameter of the target duct before and after treatment was calculated (the inner diameter of the duct perpendicular to the duct wall was measured at the maximum inner diameter section of the duct). The maximum diameter was used to represent the size of the target duct (in mm).

[0089] Statistical methods: All data were processed using SPSS 25.0 statistical software. Statistical analysis was performed after data entry and verification. For continuous data, descriptive analysis was conducted using mean ± standard deviation (x±S), minimum, maximum, percentage, and median. Pairwise comparisons were performed, and normality tests were conducted. If normality was confirmed, a t-test was performed; otherwise, a rank-sum test was used. For categorical data, descriptive analysis was conducted using proportions and rates, followed by a chi-square test. For ordinal data, pairwise comparisons were performed using the rank-sum test. A p-value < 0.05 was considered statistically significant.

[0090] 2) Results

[0091] This study included 20 female patients, aged 26–50 years, with a mean age of 37.65 ± 6.48 years. Before treatment, the diameter of the mammary ducts was 2.435 ± 0.58 mm; after treatment, the diameter was 1.975 ± 0.69 mm. Compared with before treatment, the diameter of the mammary ducts decreased significantly after treatment, and the difference was statistically significant (P < 0.05).

[0092] Typical Case 1:

[0093] Ms. Peng, 34 years old, first visited the clinic on January 15, 2025. An ultrasound examination revealed widening of the mammary ducts in both breasts, approximately 2.8 mm in the right breast and approximately 2.5 mm in the left breast. Based on traditional Chinese medicine diagnosis, she was treated with a decoction of 15g hawthorn, 15g roasted malt, 15g Smilax glabra, 10g Alisma plantago-aquatica (salted), and 15g dandelion, prepared in 200ml of water per dose. A follow-up ultrasound on February 19, 2025, showed slightly widened mammary ducts, approximately 1.7 mm in the right breast and approximately 1.3 mm in the left breast, with a significant reduction in duct diameter.

[0094] Typical Case 2:

[0095] Ms. Wu, 55 years old, first visited the clinic on February 13, 2025. An ultrasound examination revealed widening of the left mammary duct, with the widest point in the left breast measuring approximately 3.1 mm. Following a Traditional Chinese Medicine (TCM) diagnosis, she was treated with a decoction of 15g hawthorn, 15g roasted malt, 15g Smilax glabra, 10g Alisma plantago-aquatica (salted), and 15g dandelion, prepared in 200ml of water per dose. A follow-up ultrasound on March 20, 2025, showed slightly widened left mammary ducts, with the widest point in the left breast measuring approximately 2.5 mm, and a significant reduction in the diameter of the mammary ducts.

[0096] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating mammary duct dilatation, characterized in that: It includes 15 parts hawthorn, 15 parts roasted malt, 15 parts Smilax glabra, 15 parts salted Alisma plantago-aquatica, and 15 parts dandelion.

2. The traditional Chinese medicine composition for treating mammary duct dilatation according to claim 1, characterized in that: It also includes 15 roses.

3. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-2, characterized in that: All the raw materials were decocted in water to obtain the pharmaceutical composition.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-2 in the preparation of a medicament for treating mammary duct dilatation.