An external use traditional Chinese medicine preparation for treating cold-stagnated blood-stasis type granulomatous lobular mastitis and a preparation method and application thereof

Abstract

The application discloses a kind of external use traditional Chinese medicine preparation for treating cold blood stasis type granulomatous lobular mastitis and preparation method, and external use traditional Chinese medicine preparation is made of the raw materials including the following medicinal materials: prepared rhizome of rehmannia, antler slice, cassia, gunpowder ginger, chuanxiong, safflower, golden cypress, radix angelicae pubescentis, spironolactone, white and so on.The external preparation formula of the application is warm and blood tonic, blood-activating and skin-regenerating, has better clinical effect of treating cold blood stasis type granulomatous lobular mastitis, can effectively reduce the size of mass in clinical test, improve patient life treatment score, reduce the pain of patient, and has greater popularization and application value.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a topical Chinese medicine ointment for treating cold-induced blood stasis type GLM, its preparation method, and its application. Background Technology

[0002] Granulomatous lobular mastitis (GLM) is a nonspecific inflammatory mastitis that primarily affects non-lactating women. It is characterized by complex etiology, a prolonged course, and frequent recurrences. Clinically, it is mainly manifested as breast lumps and pain, making treatment challenging and significantly impacting patients' quality of life and mental health. From a Traditional Chinese Medicine (TCM) perspective, cold stagnation and blood stasis are important syndrome types of GLM, clinically characterized by hard lumps, pain aggravated by cold, unchanged or dark purple skin color, and a prolonged course. In TCM theory, this disease, along with plasma cell mastitis and other non-lactating mastitis, falls under the category of "acne-related mastitis," a term first established by Gu Bohua in 1985 in his edited book, *Practical TCM Surgery*. With the evolution of modern lifestyles, GLM is showing a trend towards affecting younger women, and its long course and high recurrence rate can lead to irreversible damage to breast structure. Because its pathogenesis involves a complex interaction of multiple factors such as infection, abnormal immune regulation, and endocrine disorders, and the pathophysiological process has not been fully elucidated, this seriously restricts the formulation of effective treatment strategies.

[0003] Current Western medicine clinical treatment for GLM commonly employs glucocorticoids, antibiotics, and surgical treatments (such as lesion drainage or local debridement). While these methods can alleviate acute symptoms and reduce pain and swelling to some extent, the effects are often temporary, and the recurrence rate is high. Furthermore, these treatments have significant limitations: while glucocorticoids can control inflammation in the short term, they can easily mask the condition, lead to dependence, and symptoms are prone to rebound or even worsen after dose reduction or discontinuation; antibiotics are only suitable for cases with clear signs of infection such as elevated white blood cell count and fever, and have limited efficacy in most cases of aseptic inflammation in GLM; surgical treatment is highly invasive, has a long recovery period, a high recurrence rate, and may affect breast shape and function; some patients may even require total mastectomy, placing a severe burden on their physical and mental health. Overall, current Western medicine cannot cure GLM, and its high recurrence rate exacerbates the medical and economic burden on patients, leading to a series of problems such as missed work and psychological distress.

[0004] In contrast, Traditional Chinese Medicine (TCM) demonstrates unique advantages in treating GLM with cold-induced blood stasis. TCM emphasizes a holistic approach and syndrome differentiation, frequently employing methods such as warming the meridians and dispelling cold, promoting blood circulation and removing blood stasis, and clearing the channels and resolving stagnation, targeting the core pathogenesis of cold-induced blood stasis. This approach has accumulated rich clinical experience. Many TCM formulas and external therapies have been proven to have good efficacy with few side effects and no dependence, showing significant results in preserving breast appearance and function, shortening the course of the disease, and reducing recurrence rates. Through syndrome differentiation and treatment, TCM focuses on regulating the body's overall state and restoring the balance of Yin and Yang, thus providing an important and promising treatment option for GLM, especially for patients with the cold-induced blood stasis syndrome.

[0005] However, traditional Chinese medicine (TCM) still faces challenges in treating GLM of the cold-induced blood stasis type, especially with external therapies. First, the efficacy of external therapies is closely related to the formulation and modifications of the herbs; different formulations often lead to significant differences in efficacy. Furthermore, existing external therapies lack unified and clear standards regarding drug composition, dosage, and preparation methods, making standardized production and quality control difficult. Second, the clinical efficacy and pharmacological effects of most TCM external therapies lack systematic and objective scientific data support, and their exact effectiveness and mechanisms of action require further clarification.

[0006] Therefore, exploring safe, effective, and standardized traditional Chinese medicine (TCM) treatment plans for GLM with cold-induced blood stasis is of significant clinical importance. Based on the holistic concept of TCM, the development of TCM compound preparations that focus on warming and dispelling cold, promoting blood circulation and removing blood stasis, while also addressing pathogenic factors and strengthening the body's resistance, regulating the local inflammatory microenvironment and systemic immune balance, holds promise for breaking through current treatment bottlenecks and providing patients with more stable treatment options and lower recurrence rates. Summary of the Invention

[0007] The purpose of this invention is to address the shortcomings of existing technologies by providing an effective external application of traditional Chinese medicine for treating cold-induced blood stasis type GLM, which has the effects of warming yang and dispelling cold, reducing swelling and promoting tissue regeneration, with a high cure rate and low recurrence rate, as well as its preparation method.

[0008] The technical solution adopted in this invention is: A topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-induced blood stasis type is made from raw materials including the following medicinal materials: Prepared Rehmannia root, deer antler slices, cinnamon, prepared ginger, Sichuan lovage rhizome, safflower, phellodendron bark, angelica root, purslane, and bletilla rhizome.

[0009] Furthermore, the topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-blood stasis type is preferably made from raw materials comprising the following parts by weight: Prepared Rehmannia Root 25-35 parts, Deer Antler Slices 8-12 parts, Cinnamon 7-11 parts, Prepared Ginger 4-8 parts, Ligusticum chuanxiong 7-11 parts, Safflower 7-11 parts, Phellodendron Bark 10-14 parts, Angelica Root 4-8 parts, Purslane 25-35 parts, Bletilla Rhizome 2-4 parts.

[0010] More preferably, the topical Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-induced blood stasis type is preferably made from the following raw materials in parts by weight: 28-32 parts of Rehmannia glutinosa, 9-11 parts of deer antler slices, 8-10 parts of cinnamon, 5-7 parts of dried ginger, 8-10 parts of Ligusticum chuanxiong, 8-10 parts of safflower, 11-13 parts of Phellodendron chinense, 5-7 parts of Angelica dahurica, 28-32 parts of Portulaca oleracea, and 3-3.5 parts of Bletilla striata.

[0011] More preferably, the topical Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-blood stasis type is preferably made from the following raw materials in parts by weight: 30 parts Rehmannia glutinosa, 10 parts deer antler slices, 9 parts cinnamon, 6 parts prepared ginger, 9 parts Ligusticum chuanxiong, 9 parts safflower, 12 parts Phellodendron chinense, 6 parts Angelica dahurica, 30 parts Portulaca oleracea, and 3 parts Bletilla striata.

[0012] In this invention, the external Chinese medicine preparation can be a lotion, gel, or ointment, preferably an ointment.

[0013] The administration method of the external Chinese medicine preparation is transdermal, by fumigating the affected area with the external wash, or by applying the gel or ointment to the affected area.

[0014] This invention also provides a method for preparing the topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-blood stasis type, the method being: Take each raw material according to the formula, crush it and sieve it to obtain Chinese medicine powder; mix the Chinese medicine powder and the plaster base evenly to prepare an external plaster.

[0015] Furthermore, the plaster base is made from commonly used external excipients. Specifically, the plaster base includes sesame oil and beeswax in a mass ratio of 2 to 3:1.

[0016] The preferred mass ratio of the herbal powder to the plaster base is 1:3~4.

[0017] Preferably, the topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-blood stasis type is a topical ointment, which can be prepared by the following method: Take each raw material according to the ratio, crush and sieve to obtain Chinese medicine powder; heat sesame oil to 220℃-240℃ and boil for 20-25 minutes, filter and add beeswax, stir at 85℃-90℃ until the beeswax is completely dissolved, cool to 80℃, add Chinese medicine powder, continue stirring, cool to room temperature to obtain external ointment. The preferred mass ratio of the herbal powder, sesame oil, and beeswax is 1:2 to 3:1.

[0018] The present invention also provides the application of the aforementioned topical traditional Chinese medicine preparation in the preparation of a drug for treating granulomatous lobular mastitis of the cold-induced blood stasis type.

[0019] The present invention also provides the application of the aforementioned topical Chinese medicine preparation in the preparation of a drug for reducing breast lumps and relieving pain in patients with cold-induced blood stasis type granulomatous lobular mastitis.

[0020] In the formulation of the external Chinese medicine preparation of the present invention: Rehmannia glutinosa (processed): Sweet, slightly warm. It enters the liver and kidney meridians. It has the effects of nourishing blood and yin, replenishing essence and marrow.

[0021] Deer antler slices: Salty and warm in nature. They enter the liver and kidney meridians. They have the effects of warming kidney yang, strengthening tendons and bones, promoting blood circulation, and reducing swelling.

[0022] Cinnamon: pungent, sweet, and very hot in nature. It enters the kidney, spleen, heart, and liver meridians. It has the effects of tonifying fire and assisting yang, guiding fire back to its source, dispelling cold and relieving pain, and warming and unblocking the meridians.

[0023] Prepared ginger: pungent and hot. It enters the spleen, stomach, kidney, heart, and lung meridians. It has the effects of warming the meridians to stop bleeding and warming the middle jiao to relieve pain.

[0024] Chuanxiong (Ligusticum striatum): pungent, warm. It enters the liver, gallbladder, and pericardium meridians. It has the effects of promoting blood circulation, regulating qi, dispelling wind, and relieving pain.

[0025] Safflower: pungent, warm. It enters the heart and liver meridians. It has the effects of promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain.

[0026] Phellodendron bark: Bitter, cold. It enters the kidney and bladder meridians. It clears heat and dries dampness, and has the effects of purging fire and eliminating steaming heat, detoxifying and healing sores.

[0027] Angelica dahurica: pungent, warm. It enters the stomach, large intestine, and lung meridians. It has the effects of relieving exterior syndromes and dispelling cold, dispelling wind and relieving pain, clearing nasal passages, drying dampness and stopping leukorrhea, and reducing swelling and draining pus.

[0028] Purslane: Sour, cold. It enters the liver and large intestine meridians. It has the effects of clearing heat and detoxifying, cooling the blood and stopping bleeding, and stopping dysentery.

[0029] Bletilla striata: Bitter, sweet, and astringent; slightly cold in nature. It enters the lung, liver, and stomach meridians. It has astringent and hemostatic effects, reduces swelling, and promotes tissue regeneration.

[0030] This traditional Chinese medicine formula uses Rehmannia glutinosa (Shu Di Huang) as the principal herb, emphasizing its properties. Rehmannia glutinosa is sweet and slightly warm in nature, entering the liver and kidney meridians. Its functions include nourishing yin and blood, replenishing essence and marrow. Targeting the pathogenesis of GLM (Gastrointestinal Mellitus) of the cold-induced blood stasis type, which depletes essence and blood, Rehmannia glutinosa can ensure the source of qi and blood production and help the body expel toxins, demonstrating the important role of strengthening the body's resistance in treatment. Deer antler slices warm and tonify kidney yang, replenish essence and blood, strengthen tendons and bones, and promote blood circulation and reduce swelling. They not only assist Rehmannia glutinosa in replenishing essence and blood but also warm and unblock the blood vessels, dispersing lumps and phlegm stasis, making them a key herb for treating the lumpy stage of GLM. Cinnamon is pungent, sweet, and warm in nature, entering the heart, liver, kidney, and spleen meridians. It excels at tonifying fire and assisting yang, guiding fire back to its source. Its warming properties are stronger, penetrating deep into the blood to warm and disperse deep-seated cold stagnation. It powerfully warms and unblocks the meridians, dispels cold and relieves pain, invigorates yang qi, and resolves lumps caused by cold stagnation. Prepared ginger, bitter and pungent in taste and warm in nature, has a warming and unblocking effect when used externally, enhancing the warming and dispersing power of cinnamon and cassia bark. Ligusticum striatum, a "qi-regulating herb in the blood," can both invigorate blood and remove blood stasis, and promote qi circulation and relieve stagnation, thus dispersing the swelling of mastitis. Safflower invigorates blood, removes blood stasis, and relieves pain, enhancing the blood-invigorating and blood-stasis-removing power of Ligusticum striatum, specifically targeting blood stasis obstruction. Phellodendron bark, bitter and cold in nature, has the functions of clearing heat and drying dampness, purging fire and detoxifying; when used together, it clears heat, dries dampness, and detoxifies, preventing the warming herbs from exacerbating heat. Angelica dahurica reduces swelling and drains pus; it is an essential external medicine for sores, promoting the drainage of residual pus in the later stages and relieving pain. Bletilla striata astringes and stops bleeding, reduces swelling and promotes tissue regeneration; it promotes healing in the later stages of ulcerated and difficult-to-heal sores; even if not ulcerated, its astringent properties help reduce swelling. Purslane, as confirmed by modern pharmacological research, has good anti-inflammatory and antibacterial effects; its cold nature also balances the warming properties of the herbs in the formula, preventing excessive dryness.

[0031] The mechanism of action of the traditional Chinese medicine preparation of this invention in treating GLM of the cold-induced blood stasis type is as follows: it utilizes the therapeutic principles of warming yang, dispelling cold, reducing swelling, and promoting tissue regeneration. In the theoretical system of traditional Chinese medicine, yang qi has always been regarded as the driving force of life activities. In the treatment of granulomatous mastitis, the promoting effect of yang qi is even more crucial. A person with abundant yang qi will naturally have strong righteous qi, which can effectively resist the invasion of pathogenic factors and inhibit the spread of pathogenic toxins, thereby promoting the healing of the disease. Conversely, if yang qi is deficient, pathogenic factors can easily take advantage of the deficiency and penetrate deeper, causing the disease to become lingering and difficult to cure, and in severe cases, it may even attack the internal organs, aggravating the disease.

[0032] The topical ointment formulation of this invention is of uniform quality, stable, easy to store and use, and has high patient dependence. This topical preparation can significantly shorten the course of GLM (Gastrointestinal Mellitus) of the cold-stasis type, alleviate patient suffering, and improve patients' quality of life. Compared to oral Chinese medicine, the topical preparation directly targets the affected area and avoids the discomfort associated with traditional oral Chinese medicine decoctions. Compared to oral glucocorticoids, it has fewer side effects and higher patient compliance. This invention can spare patients the pain of surgery and acupuncture, and can maximize the protection of the function and aesthetics of women's breasts. In clinical trials, this invention has effectively reduced the size of lumps, improved patients' quality of life scores, and reduced patient suffering, demonstrating significant potential for widespread application.

[0033] In summary, the topical formulation of this invention warms and nourishes the blood, promotes blood circulation and tissue regeneration, and has a good clinical effect in treating cold-induced blood stasis type GLM. Compared with existing Western medicines, it has the advantages of simple preparation, convenient application, low price, good efficacy, high safety, few side effects, and higher compliance. Therefore, it has good commercial value and prospects. Attached Figure Description

[0034] Figure 1 Comparison of average GMDAI values ​​in GLM patients with cold-induced blood stasis.

[0035] Figure 2 Comparison of the average longest diameter of ultrasound lesions in patients with cold-induced blood stasis type GLM.

[0036] Figure 3 Comparison of WHOQOL average values ​​for GLM patients with cold-induced blood stasis. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of this application clearer, the embodiments of this application will be described in detail below with reference to examples. It should be noted that, unless otherwise specified, the embodiments and features in the embodiments of this application can be arbitrarily combined with each other. Example 1

[0038] Take the following raw materials in the specified proportions: 1260g of Rehmannia glutinosa (processed), 420g of deer antler slices, 252g of dried ginger (processed), 378g of Ligusticum chuanxiong, 378g of cinnamon, 378g of safflower, 378g of Scutellaria baicalensis, 252g of Angelica dahurica, 168g of Bletilla striata, 504g of Phellodendron chinense, and 1260g of Portulaca oleracea. Grind these materials in a pulverizer. To ensure the uniformity of the powder and the fineness of the subsequent ointment preparation, further sieve the resulting coarse powder through a 100-mesh sieve to obtain a mixed powder of traditional Chinese medicine composition with the required particle size.

[0039] Measure 14.6L of sesame oil and place it in a jacketed kettle. Render the oil at a high temperature of 230℃ for 20 minutes. After rendering, immediately filter the hot sesame oil through a 200-mesh sieve to thoroughly remove any insoluble impurities, charred particles, and residual plant fibers.

[0040] Keep the filtered pure hot sesame oil heated, add 5.4 kg of beeswax, stir continuously and maintain the temperature at 85℃-90℃ until the beeswax is completely melted and forms a homogeneous oil phase matrix with the sesame oil.

[0041] Remove the oil and wax mixture from the heat and allow it to cool naturally while continuously and slowly stirring to accelerate cooling. The critical feeding point is when the thermometer shows that the material temperature has precisely dropped to 80°C. Add the prepared herbal powder composition evenly and slowly, and use a mechanical stirrer to maintain a constant speed and stir in the same direction.

[0042] After the ingredients are added, continue stirring the paste and transfer it to the cooling section to allow it to cool down slowly. Stirring should continue until the paste has completely cooled to room temperature to obtain the final paste. Example 2

[0043] Clinical application ① Research Design and Principles Research type: Experimental research.

[0044] Design principles: The operation was optimized by referring to the scientific principles of randomized controlled trials and taking into account actual clinical conditions.

[0045] Diagnostic criteria: Western Medicine Diagnostic Criteria: Based on the diagnostic criteria outlined in the "Expert Consensus on the Diagnosis and Treatment of Non-Lactating Mastitis," "Modern Diagnosis and Treatment of Breast Diseases," and the "Chinese Expert Consensus on Pathological Diagnosis of Granulomatous Lobular Mastitis (2024 Edition)," the following criteria were established: Medical History and Symptoms: More common in non-lactating women, with a prolonged course. Painless or dull-smelling nodules or lumps appear in the breast, with indistinct borders, a firm and resilient texture, and may adhere to the skin. Occasionally, nipple retraction or nipple discharge may be present. There is no typical local redness, swelling, heat, or pain. Auxiliary Examinations: Breast ultrasound: Presents as a poorly defined, irregularly shaped hypoechoic or heterogeneous echogenic mass with disordered internal echoes. Dilated ducts may be visible, and posterior echoes may be unchanged or attenuated. (Final diagnosis requires biopsy and pathological examination to confirm granulomatous lobular mastitis.) Traditional Chinese Medicine (TCM) Diagnostic and Differentiation Criteria: These criteria were formulated with reference to the "Expert Consensus on TCM Diagnosis and Treatment of Granulomatous Mastitis (2023 Edition)," the "TCM Disease and Syndrome Diagnosis and Efficacy Standards," the TCM Syndrome Scoring Table for Cold-Heat Stasis Type Granulomatous Mastitis, and the clinical experience of the mentor. Primary Symptom: Breast lump, unchanged skin color, hard and tough to the touch, may adhere to the skin; dull or aching pain in the lump, relieved by warmth. Secondary Symptoms: Cold limbs, aversion to cold; pale or sallow complexion; fatigue; pale and swollen or dark tongue with a white, greasy coating; deep and thready or deep and slow pulse. A diagnosis can be made if two of the primary symptoms and two of the secondary symptoms are present.

[0046] ② Research subjects and grouping Source: 80 patients diagnosed with granulomatous lobular mastitis of the Breast Disease Center of Zhejiang Provincial Hospital of Traditional Chinese Medicine, who were diagnosed with cold-induced blood stasis syndrome.

[0047] Grouping method: Intervention group: Received external application of Yanghe Tongmai Ointment (the ointment prepared in Example 1) and internal administration of Zicao Xiaoyong Decoction.

[0048] Control group: Only received oral administration of Zi Cao Xiao Yong Tang.

[0049] ③ Intervention measures Intervention group: External application: Yanghe Tongmai Ointment (the ointment prepared in Example 1), once daily for 8 hours each time. Internal administration: Zicao Xiaoyong Decoction (Zicao 9g, Rehmannia glutinosa 15g, Ephedra sinica 6g, Glycyrrhiza uralensis 6g, Zingiber officinale 6g, Mustard seed 9g, Deer antler slices 9g, Phragmites communis 30g, Turtle shell 15g, Angelica dahurica 12g), one dose daily, decocted in water and taken in two divided doses. The above treatment continued for 2 months.

[0050] Control group: Oral administration of Zi Cao Xiao Yang Tang (same as above), one dose per day, decocted in water and taken twice daily. Treatment course: Treatment lasted for 2 months.

[0051] ④ Observation and evaluation points: before treatment (0 months), during treatment (1 month), and after treatment (2 months).

[0052] ⑤ Observation indicators The primary observational indicator was the Disease Activity Index (GMDAI) for granulomatous lobular mastitis.

[0053] Secondary observation indicators: breast lump hardness evaluation (Grade 1 = soft texture like normal glandular tissue, 3 points; Grade 2 = firm texture like the tip of the nose, 6 points; Grade 3 = firm texture like the forehead, 9 points), quality of life (WHOQOL-BREF), recurrence status (whether it recurs within 1 year).

[0054] Safety indicators: Record local or systemic adverse reactions.

[0055] Clinical research results: Eighty patients with cold-induced blood stasis type GLM who met the inclusion and exclusion criteria were randomly divided into an intervention group and a control group, with 40 patients in each group. Researchers recorded the patients' basic information and disease changes during their visits. The average age of patients in the intervention group was (33.85±4.06) years, and that in the control group was (33.55±4.40) years; there was no statistically significant difference in age between the two groups (t=0.317, P=0.657). Regarding reproductive history, 37 patients (92.5%) in the intervention group and 35 patients (87.5%) in the control group had a history of childbirth; there was no statistically significant difference between the groups (χ²). 2 =0.556, P=0.712). Regarding breastfeeding history, 35 cases (87.5%) in the intervention group and 32 cases (80.0%) in the control group had a history of breastfeeding, and there was no statistically significant difference between the groups (χ² = 0.556, P = 0.712). 2 =0.827, P=0.363). Regarding the side of the affected breast, in the intervention group, 24 cases (60.0%) were unilateral and 16 cases (40.0%) were bilateral, while in the control group, 21 cases (52.5%) were unilateral and 19 cases (47.5%) were bilateral. There was no statistically significant difference between the groups (χ²). 2=0.458, P=0.498). These results indicate that the two groups of patients were comparable in baseline characteristics such as age, reproductive history, lactation history, and the side of the affected breast (P>0.05), demonstrating good clinical comparability. See Table 1 for detailed data.

[0056] Table 1 Clinical data of GLM patients Regarding the primary outcome measure, the topical herbal ointment of this invention significantly reduced disease activity and lesion size in patients with cold-induced blood stasis type GLM. Data showed ( Figure 1 After two months of treatment, the mean GMDAI score of patients in the intervention group decreased from 21.475 at the initial visit to 8.575, a reduction of 60.07%, which was significantly better than the 40.66% reduction in the control group at the same time point. This suggests that the external treatment regimen has better timeliness in controlling disease activity.

[0057] Regarding secondary outcome measures, the maximum diameter of the lesion also showed significant improvement. Figure 2 In the intervention group, the mean longest diameter of the lesion under ultrasound decreased from the initial 3.80 cm to 2.01 cm, a reduction of 36.5%, while in the control group it only decreased from 3.90 cm to 2.47 cm, a reduction of 20.8%. This further confirms that the ointment has a clear therapeutic effect in promoting the absorption of local lesions and controlling the progression of inflammation.

[0058] In terms of quality of life assessment ( Figure 3 Two months after treatment, patients in the intervention group showed general improvement in their scores across the physical, psychological, social, and environmental domains of the WHOQOL questionnaire compared to before treatment. Specifically, their scores in the physical domain increased from 12.85 to 13.21, the psychological domain from 12.91 to 13.47, the social domain from 14.11 to 14.58, and the environmental domain from 13.63 to 14.31. The improvement in all domains was significantly greater than that in the control group at the same time point, with particularly noticeable improvements in the psychological and social domains. This indicates that the treatment not only improved local symptoms but also had a positive impact on the patients' overall physical and mental health and the recovery of their social function. Example 3

[0059] The following are some typical clinical cases. Patient 1: Ms. Zhang, 33 years old, developed symptoms in her right breast in January 2025.

[0060] First diagnosis on February 19, 2025: A mass in the right breast with pain for more than one month was discovered. The patient had a mass in the right breast during menstruation on January 1, 2025, without pain or fever. On February 4, 2025, the patient visited the Second Affiliated Hospital of Zhejiang University School of Medicine, and chronic mastitis was considered. From that day on, dexamethasone was given orally three times a day at a dose of 1.5 mg for three consecutive days, then twice a day at a dose of 1.5 mg for three consecutive days, and then twice a day at a dose of 0.75 mg for three consecutive days. The patient stopped taking the hormone on February 16, 2025. After stopping the drug, the breast pain of the patient worsened. The patient visited the Second Affiliated Hospital of Zhejiang University School of Medicine again on February 18, 2025, and the hormone dosage was increased again to 1.5 mg orally twice a day. When the patient visited our hospital, the patient was still taking 1.5 mg twice a day. The symptoms at the first diagnosis showed a mass in the upper outer quadrant of the right breast, with a size of about 5.0 * 3.0 cm, firm texture, unclear boundary, good mobility, accompanied by dark red skin, no fluctuation, no ulceration, and axillary lymph nodes could be palpable. To make a definite diagnosis, breast puncture biopsy was performed. The routine pathological report showed: (right breast) chronic suppurative mastitis with granuloma formation. Traditional Chinese medicine diagnosis: Acne-like breast carbuncle; Western medicine diagnosis: Chronic mastitis. The treatment principle was to warm yang and disperse cold, and promote blood circulation and dredge collaterals. The patient was treated with the Zicao Xiaoyong Decoction by the warming and dredging method, for a total of 28 doses, one dose per day, two decoctions per dose, and one decoction each half hour after breakfast and lunch.

[0061] Follow-up visit on March 30, 2025: The mass in the right breast of the patient was smaller than before, with a size of about 4.0 * 3.0 cm, firm texture, unclear boundary, good mobility, accompanied by dark red skin, no fluctuation, no ulceration, and axillary lymph nodes could be palpable. The Zicao Xiaoyong Decoction was given again, for 28 doses, one dose per day, two decoctions per dose, and one decoction each half hour after breakfast and lunch.

[0062] The patient regularly visited the doctor and took the above traditional Chinese medicine from March 30, 2025 to June 29, 2025. The mass still existed, but the reduction speed was slow.

[0063] Follow-up visit on June 29, 2025: The mass in the right breast of the patient was smaller than before, with a size of about 3.0 * 3.0 cm, accompanied by dark red skin and a sense of fluctuation, no ulceration. Breast ultrasound examination showed: Multiple hypoechoic areas in the right breast (the largest one was about 3.0 * 1.3 cm), BI-RADS-3, considered to be inflammation. The Zicao Xiaoyong Decoction was given again, for 28 doses, one dose per day, two decoctions per dose, and one decoction each half hour after breakfast and lunch. At the same time, the traditional Chinese medicine paste of Example 1 was used externally. A suitable-sized gauze was taken, and the traditional Chinese medicine paste was evenly applied on the gauze, with a thickness of 5.0 mm of the paste, covering the mass in the right breast, and the coverage area needed to be larger than the mass area. The external traditional Chinese medicine paste was used 8 hours a day, once a day. It was continuously used for 28 days.

[0064] Follow-up visit on July 29, 2025: The mass in the right breast of the patient was smaller than before, with a size of about 2.5 * 2.0 cm. The Zicao Xiaoyong Decoction was given again, for 28 doses, one dose per day, two decoctions per dose, and one decoction each half hour after breakfast and lunch. At the same time, the external traditional Chinese medicine paste of this patent was used continuously for 28 days.

[0065] From July 29, 2025 to October 29, 2025, the patient regularly visited the doctor and took traditional Chinese medicine orally and applied traditional Chinese medicine ointment topically, and the mass gradually decreased.

[0066] Follow-up visit on October 29, 2025: The mass in the right breast of the patient was significantly smaller than before. The size of the mass was approximately 1.0 * 1.0 cm. It was firm in texture, with good mobility. There was no dark red skin, no fluctuation, no rupture, and axillary lymph nodes were palpable. Reexamination of breast ultrasound showed: Multiple hypoechoic areas in the right breast (the larger one was approximately 1.6 * 0.8 cm), BI-RADS-3, considered to be inflammation. The inflammation had improved significantly, and it was instructed to stop applying the external traditional Chinese medicine ointment. Zicao Xiaoyong Decoction was given, 28 doses, decocted in the same way as before, to consolidate the curative effect.

[0067] Patient 2: Zheng Mou, female, 28 years old, developed the disease in the right breast in September 2024.

[0068] First visit on October 9, 2024: A mass in the right breast with pain had been found for more than half a month. After breast trauma on September 23, 2024, the patient had a mass in the right breast with pain and no fever. She then went to Wuxi Traditional Chinese Medicine Hospital for treatment. Breast ultrasound examination showed: A hypoechoic mass in the right breast (at the 2 o'clock position, about 2.6 * 1.1 cm in size), inflammation was possible; Ductal dilation in both breasts, BI-RADS-2; Enlargement of the right lymph nodes. Percutaneous biopsy was performed, and routine pathology showed: Acute and chronic inflammation in the right breast tissue, tending to be granulomatous lobular mastitis. For drug treatment, anti-infection treatment was given, and traditional Chinese medicine was taken orally and Qingbao Powder was applied topically. Incision and drainage were performed on October 6, 2024. The symptoms at the first visit were a mass in the middle and inner quadrants of the right breast, with a size of about 6.0 * 5.0 cm, firm in texture, unclear boundary, good mobility, accompanied by dark red skin, with fluctuation, with rupture. The right breast was filled with vaseline gauze at the middle and inner incision, and yellow purulent fluid flowed out. The incised drainage area was about 1.0 * 0.5 cm, and axillary lymph nodes were palpable. Traditional Chinese medicine diagnosis: Acne-like mastitis; Western medicine diagnosis: Chronic mastitis. Treatment principle: Warming yang and dispelling cold, promoting blood circulation and dredging collaterals. Zicao Xiaoyong Decoction was used for treatment by the warming and dredging method, a total of 28 doses, one dose per day, two decoctions per dose, one decoction half an hour after breakfast and lunch respectively.

[0069] On November 3, 2024: The mass in the right breast of the patient was smaller than before, with a size of about 5.0 * 5.0 cm, firm in texture, unclear boundary, good mobility, accompanied by dark red skin, no fluctuation, no rupture, and axillary lymph nodes were palpable. Zicao Xiaoyong Decoction was given again, 28 doses, one dose per day, two decoctions per dose, one decoction half an hour after breakfast and lunch respectively.

[0070] From November 3, 2024 to June 6, 2025, the patient regularly visited the doctor and took the above traditional Chinese medicine, and the mass still existed, but the reduction speed was slow.

[0071] June 1, 2025: The mass in the patient's right breast has decreased compared to before. The size of the mass is approximately 4.0*2.0 cm. It is firm in texture, softer overall than before, with unclear boundaries, good mobility, accompanied by redness of the skin, no fluctuation, and ulceration. Axillary lymph nodes are palpable. Breast ultrasound shows multiple hypoechoic areas in the right breast (the larger one is approximately 3.0*1.3 cm), BI-RADS-3, considered to be inflammation. Again, Zicao Xiaoyong Decoction is administered, 28 doses, one dose per day, two decoctions per dose, one decoction half an hour after breakfast and lunch respectively. At the same time, the traditional Chinese medicine paste of Example 1 is used externally. Take a gauze of appropriate size, evenly apply the traditional Chinese medicine paste on the gauze, with a paste thickness of 5.0 mm, cover the mass in the right breast, and the coverage area should be larger than the mass area. The external traditional Chinese medicine paste is used for 8 hours per day, once a day. Continuously use for 28 days.

[0072] Follow-up visit on July 13, 2025: The mass in the patient's right breast has decreased compared to before. The size of the mass is approximately 3.0*2.0 cm. Again, Zicao Xiaoyong Decoction is administered, 28 doses, one dose per day, two decoctions per dose, one decoction half an hour after breakfast and lunch respectively. At the same time, the external traditional Chinese medicine paste of this patent is used, continuously use for 28 days.

[0073] Follow-up visit on August 17, 2025: The mass in the patient's right breast has decreased compared to before. The size of the mass is approximately 3.0*2.0 cm. Multiple hypoechoic areas in the right breast (the larger one is approximately 3.0*1.3 cm), BI-RADS-3, considered to be inflammation. Again, Zicao Xiaoyong Decoction is administered, 28 doses, one dose per day, two decoctions per dose, one decoction half an hour after breakfast and lunch respectively. At the same time, the external traditional Chinese medicine paste of this patent is used, continuously use for 28 days.

[0074] The patient regularly visited the doctor, took traditional Chinese medicine, and used the external traditional Chinese medicine paste from July 13, 2025 to October 5, 2025, and the mass gradually decreased.

[0075] Follow-up visit on October 5, 2025: No obvious mass is palpable in the patient's right breast. Breast ultrasound reexamination shows multiple hypoechoic areas in the right breast (the larger one is approximately 0.7*0.4 cm), BI-RADS-3, considered to be inflammation. The inflammation has improved significantly, and it is instructed to stop using the external traditional Chinese medicine paste. Zicao Xiaoyong Decoction is administered, 28 doses, with the decocting method the same as before, to consolidate the curative effect.

[0076] Patient 3, Weng Mou, female, 33 years old, suffered from the disease in the left breast in August 2024.

[0077] First diagnosis on February 23, 2025: A mass in the left breast was discovered more than 6 months ago. In August 2024, a mass accompanied by pain appeared in the lower inner quadrant of the left breast without obvious inducement, and there was no fever. The pathological result of the thick needle biopsy in Shangyu Traditional Chinese Medicine Hospital of Shaoxing in January 2025 showed a tendency of granulomatous lobular mastitis, and traditional Chinese medicine treatment was given, but the effect was not good. Due to breast pain, the patient visited our hospital on February 8, 2025. After taking traditional Chinese medicine and applying the cooling ointment externally, the pain was relieved. The symptoms at the first diagnosis showed that a mass could be felt respectively around the areola of the upper inner and lower inner parts of the left breast, with the ranges being approximately 2.0*2.0 cm and 3.0*1.0 cm respectively. The mass was firm in texture, with unclear boundaries, good mobility, accompanied by skin flushing, local fluctuation, punctate ulceration, and axillary lymph nodes could be felt. Traditional Chinese medicine diagnosis: Acne-like breast carbuncle; Western medicine diagnosis: Chronic mastitis. The treatment principle is to warm yang and dispel cold, and promote blood circulation and dredge collaterals. The Ziyuan Xiaoyong Decoction was used for treatment according to the warming and dredging method, with a total of 28 doses, one dose per day, two doses per dose, and one dose half an hour after breakfast and lunch respectively.

[0078] Follow-up visit on March 23, 2025: The mass in the left breast of the patient was more stable than before, with multiple ulcerations, and purulent and bloody fluid exudation was visible. The Ziyuan Xiaoyong Decoction was given again, 28 doses, one dose per day, two doses per dose, and one dose half an hour after breakfast and lunch respectively.

[0079] The patient regularly visited and took the above-mentioned traditional Chinese medicine from March 23, 2025 to June 15, 2025, and the mass still existed, but the reduction speed was slow.

[0080] Follow-up visit on June 15, 2025: Breast ultrasound examination showed multiple hypoechoic areas in the left breast (the larger one was approximately 4.3*1.2 cm (at the 3 o'clock direction, deep to the nipple), BI-RADS category 3, considered to be inflammation). The Ziyuan Xiaoyong Decoction was given again, 28 doses, one dose per day, two doses per dose, and one dose half an hour after breakfast and lunch respectively. At the same time, the traditional Chinese medicine ointment in Example 1 was used. A piece of gauze of appropriate size was taken, and the traditional Chinese medicine ointment was evenly applied on the gauze with a thickness of 5.0 mm, and it was covered on the mass in the right breast, and the coverage area needed to be larger than the mass area. The traditional Chinese medicine ointment was used externally for 8 hours per day, once a day. It was continuously used for 28 days.

[0081] Follow-up visit on June 29, 2025: The mass at the outer lower areola of the left breast of the patient was smaller than before, with a range of approximately 3.0*2.0 cm. The Ziyuan Xiaoyong Decoction was given again, 28 doses, one dose per day, two doses per dose, and one dose half an hour after breakfast and lunch respectively. At the same time, the traditional Chinese medicine ointment of this patent was used, and it was continuously used for 28 days.

[0082] The patient regularly visited and took traditional Chinese medicine and used the traditional Chinese medicine ointment externally from June 29, 2025 to October 12, 2025, and the mass gradually decreased.

[0083] Follow-up visit on October 12, 2025: The mass in the left breast areola of the patient has shrunk compared to before, with a size of approximately 1.5 * 1.0 cm. It is firm, with unclear boundaries, good mobility, scar hyperplasia, no skin redness, no fluctuation, no rupture, and axillary lymph nodes can be felt. Reexamination of breast ultrasound shows multiple mixed and hypoechoic masses in the left breast (the largest is approximately 1.6 * 1.1 cm at the 3 o'clock position), BI-RADS category 3, considered to be inflammation. The inflammation has improved significantly, and it is instructed to stop using the external traditional Chinese medicine paste. Given Zicao Xiaoyong Decoction, 28 doses, with the decocting method the same as before, to consolidate the curative effect.

[0084] Patient 4: Jin, female, 33 years old, onset in the left breast in January 2025.

[0085] First visit on April 6, 2025: A mass in the left breast with pain has been found for more than 3 months. The patient had a normal vaginal delivery of a child at 37 weeks in December 2024. In January 2025, left breast milk stasis occurred, accompanied by fever, with the highest body temperature of 40°C. Given intravenous drip of cephalosporin and breast milk dredging treatment, and the body temperature gradually returned to normal. On February 4, 2025, the patient came to our hospital for treatment, and was given oral traditional Chinese medicine treatment and breast milk dredging (the last breast milk dredging time was April 5, 2025). Now, reexamination of breast ultrasound shows: lactating breast, BI-RADS category 1; mixed echo mass in the left breast (at the 3 o'clock position, size approximately 4.3 * 2.8 cm), BI-RADS category 3, considered to be a milk accumulation mass; hypoechoic area in the left breast (at the 12 o'clock position, range approximately 5.00 * 0.7 cm), BI-RADS category 3, considered to be inflammation. The symptoms at the first visit showed that a 6.0 * 5.0 cm mass could be felt under the left breast, firm, with unclear boundaries, skin rupture, accompanied by skin redness, and axillary lymph nodes could be felt. Traditional Chinese medicine diagnosis: acne-like mastitis; Western medicine diagnosis: chronic mastitis. Treatment is based on warming yang and dispelling cold, promoting blood circulation and dredging collaterals. Given Zicao Xiaoyong Decoction for warm dredging treatment, a total of 28 doses, one dose per day, two decoctions per dose, one decoction half an hour after breakfast and lunch respectively.

[0086] Follow-up visit on May 4, 2025: The mass in the left breast of the patient has decreased compared to before, with a size of approximately 4.0 * 4.0 cm. It is firm, with unclear boundaries, good mobility, accompanied by dark red skin, no fluctuation, no rupture, and axillary lymph nodes can be felt. Again given Zicao Xiaoyong Decoction, 28 doses, one dose per day, two decoctions per dose, one decoction half an hour after breakfast and lunch respectively.

[0087] The patient regularly visited and took the above traditional Chinese medicine from May 4, 2025 to July 30, 2025, and the mass still existed, with a slow reduction rate.

[0088] Follow-up visit on July 30, 2025: The mass in the patient's left breast was basically the same as before. The size of the mass was approximately 4.0*4.0 cm, accompanied by dark red skin and a sense of fluctuation, without rupture. Breast ultrasound examination showed multiple hypoechoic masses in the left breast (the larger ones were approximately 3.4*0.9 cm and 2.2*2.2 cm respectively), BI-RADS-3, suggesting inflammation. Again, Zicao Xiaoyong Decoction was administered, 28 doses, one dose per day, each dose divided into two parts, one part taken half an hour after breakfast and the other part taken half an hour after lunch. At the same time, the external-use traditional Chinese medicine paste of this patent was used. A gauze of appropriate size was taken, and the traditional Chinese medicine paste was evenly applied on the gauze. The thickness of the paste was 5.0 mm. It was covered on the mass in the right breast, and the coverage area needed to be larger than the mass. The external-use traditional Chinese medicine paste was used for 8 hours per day, once a day. It was used continuously for 28 days.

[0089] Follow-up visit on August 31, 2025: The size of the mass in the patient's left breast was approximately 2.0*2.0 cm, accompanied by dark red skin, without a sense of fluctuation, without rupture. Again, Zicao Xiaoyong Decoction was administered, 28 doses, one dose per day, each dose divided into two parts, one part taken half an hour after breakfast and the other part taken half an hour after lunch. At the same time, the external-use traditional Chinese medicine paste of this patent was used. A gauze of appropriate size was taken, and the traditional Chinese medicine paste was evenly applied on the gauze. The thickness of the paste was 5.0 mm. It was covered on the mass in the right breast, and the coverage area needed to be larger than the mass. The external-use traditional Chinese medicine paste was used for 8 hours per day, once a day. It was used continuously for 28 days.

[0090] The patient regularly visited the doctor, took traditional Chinese medicine, and used the external-use traditional Chinese medicine paste from July 30, 2025 to October 29, 2025, and the mass gradually decreased.

[0091] Follow-up visit on October 29, 2025: The size of the mass in the patient's left breast was approximately 0.5*0.5 cm, with a firm texture and good mobility. There was no dark red skin, no sense of fluctuation, no rupture, and axillary lymph nodes were palpable. Reexamination of breast ultrasound showed multiple hypoechoic areas in the left breast (at the 12 o'clock position, with a size of approximately 1.7*0.3 cm), BI-RADS-3. The inflammation had improved significantly, and it was instructed to stop using the external-use traditional Chinese medicine paste. Zicao Xiaoyong Decoction was administered, 28 doses, with the decoction method the same as before, to consolidate the curative effect.

[0092] Patient 5: Wang Mou, female, 32 years old, the right breast became ill in March 2024.

[0093] First diagnosis on June 2, 2024: A mass in the left breast with pain for more than 3 months was found. In March 2024, after being hit by the child, the patient had pain and a mass in the left breast. So on April 24, 2024, the patient went to Zhejiang Provincial People's Hospital. Breast B-ultrasound showed: Breast dysplasia (hyperplasia was considered first); Hypoechoic area in the left breast (about 0.85*0.22*0.61 cm in the area below the nipple, with scattered slit-like dark areas visible inside; about 0.44*0.17*0.34 mm in the area outside the nipple), suggesting a high possibility of local inflammation with abscess formation. Further examination was recommended; Left axillary lymph nodes were detected, and the cortex was thickened. The hospital treated with dexamethasone 0.75 mg twice a day and cephalosporin continuously for 2 weeks, but the pain did not improve significantly. The patient went to the Second Affiliated Hospital of Zhejiang University on May 11, 2024. Dexamethasone was adjusted to 1.50 mg three times a day and cephalosporin was continuously treated for 1 week, and the mass decreased compared with before. The symptoms at the first diagnosis showed a mass in the middle and lower quadrants of the left breast, about 8.0*3.0 cm in size, firm in texture, unclear in boundary, with good mobility, accompanied by skin redness, a sense of fluctuation, and a rupture, about 2.0*1.0 cm in size. Axillary lymph nodes were palpable. TCM diagnosis: Comedonal mastitis; Western medicine diagnosis: Chronic mastitis. The treatment principle was to warm yang and dispel cold, and activate blood circulation and dredge collaterals. The patient was treated with the Ziyin Xiaoyong Decoction by the warming-through method, a total of 28 doses, one dose per day, two doses per dose, one dose half an hour after breakfast and lunch respectively.

[0094] Follow-up visit on July 14, 2024: The mass in the patient's left breast was basically the same as before, about 8.0*3.0 cm in size, firm in texture, unclear in boundary, with good mobility, accompanied by skin redness, a sense of fluctuation, and a rupture, about 2.0*1.0 cm in size. Axillary lymph nodes were palpable. The Ziyin Xiaoyong Decoction was given again, 28 doses, one dose per day, two doses per dose, one dose half an hour after breakfast and lunch respectively.

[0095] The patient regularly visited and took the above traditional Chinese medicine from July 14, 2024 to June 15, 2025. The mass still existed and the reduction speed was slow.

[0096] Follow-up visit on June 29, 2025: The mass in the patient's left breast decreased compared with before. The size of the mass was about 6.0*3.0 cm, accompanied by dark red skin, a sense of fluctuation, and a rupture, about 1.0*1.0 cm in size. Breast ultrasound showed: Multiple hypoechoic areas in the left breast (the larger one was about 4.1*1.1 cm), BI-RADS-3, considered inflammation. The Ziyin Xiaoyong Decoction was given again, 28 doses, one dose per day, two doses per dose, one dose half an hour after breakfast and lunch respectively. At the same time, the external-use traditional Chinese medicine paste of this patent was used. A gauze of appropriate size was taken, and the traditional Chinese medicine paste was evenly applied on the gauze with a thickness of 5.0 mm, covered on the mass in the right breast, and the coverage area needed to be larger than the mass area. The external-use traditional Chinese medicine paste was used for 8 hours every day, once a day. It was continuously used for 28 days.

[0097] Follow-up visit on August 3, 2025: The mass in the patient's left breast was approximately 5.0*2.0 cm in size. Zi Cao Xiao Yong Decoction was prescribed again, 28 doses, one dose per day, with two decoctions per dose, one decoction half an hour after breakfast and the other half an hour after lunch. At the same time, the traditional Chinese medicine plaster of this patent was applied externally for 28 consecutive days.

[0098] The patient regularly visited the doctor and took traditional Chinese medicine and applied the traditional Chinese medicine plaster externally from August 3, 2025 to October 12, 2025, and the mass gradually decreased.

[0099] Follow-up visit on October 12, 2025: The mass in the patient's left breast was significantly smaller than before. The size of the mass was approximately 2.5*1.0 cm. It was firm in texture, with good mobility, no dark red skin, no fluctuation, no ulceration, and axillary lymph nodes were palpable. The inflammation had improved significantly, and it was instructed to stop using the traditional Chinese medicine plaster externally. Zi Cao Xiao Yong Decoction was prescribed, 28 doses, with the same decoction method as before, to consolidate the curative effect.

[0100] Patient 6: Zhang Mou, female, 36 years old, developed the disease in the right breast in November 2024.

[0101] First visit on June 15, 2025: A lump and pain in the right breast were discovered more than 7 months ago. The patient developed a lump and pain in her right breast after an external impact in November 2024. On November 2, 2024, she visited the Municipal Women and Children's Hospital, where a breast ultrasound showed bilateral lobular hyperplasia and a cystic nodule in the left breast (approximately 0.5*0.4*0.4cm in the lower inner quadrant), BI-RADS-2. She was advised to consult a specialist at a higher-level hospital. On the same day, she visited the First Affiliated Hospital of Zhejiang University and was treated with Honghua Xiaoyao tablets and Rukuai Xiao granules. The pain improved after taking the medication, but the lump did not disappear. On November 29, 2024, the patient experienced recurrent fever for one week, with body temperature remaining between 38.5℃ and 39℃. Therefore, on December 5, 2025, a blood routine test and CRP test were performed at the First Affiliated Hospital of Zhejiang University: white blood cell count 11.46, neutrophils 76.2, CRP 85.7. After initial screening for thyroid diseases, viral and bacterial infections, blood disorders, tuberculosis, and tumors, including negative antinuclear antibodies, tumor markers, and thyroid function tests, a PET-CT scan was performed on December 26, 2024. The scan revealed a mass-like soft tissue density shadow with punctate calcifications and increased FDG metabolism in the right breast area, requiring differentiation between infection and tumor. Ultrasound and biopsy were recommended. Multiple enlarged lymph nodes with increased FDG metabolism were also observed in the right axilla; close follow-up was recommended to rule out metastasis. The left axillary lymph nodes showed slightly increased FDG metabolism; close follow-up was also recommended. In January 2025, the patient underwent a right breast mass biopsy at Zhejiang University First Affiliated Hospital. The routine pathology report returned on January 20, 2025, showing: (left breast biopsy) a small patch of benign breast tissue; (right breast mass biopsy) suppurative inflammation with granuloma formation; (right axillary lymph node biopsy) reactive lymph node hyperplasia. From January 6, 2025, the patient received treatment with baricitinib (Ailemin) at Zhejiang University First Affiliated Hospital. On April 24, 2025, a breast ultrasound at Zhejiang University First Affiliated Hospital revealed multiple cystic nodules with ductal wall thickening in the right breast (approximately 3.3*2.8cm and 5.9*2.4cm), poor sound transmission, rich blood supply, and suggestive of inflammation; multiple hypoechoic to anechoic lesions in the left breast (approximately 0.6*0.4cm in the 6 o'clock position), BI-RADS category 2-3; a large lymph node was detected in the right axilla. Initial examination revealed one mass in each of the outer and middle quadrants of the right breast, approximately 3.0*3.0cm and 6.0*4.0cm respectively, firm in texture, with indistinct borders, good mobility, accompanied by dark red skin, fluctuation, no ulceration, and palpable axillary lymph nodes. Traditional Chinese Medicine diagnosis: comedo mastitis; Western Medicine diagnosis: chronic mastitis. Treatment principle: warming yang and dispelling cold, promoting blood circulation and unblocking collaterals. I was treated with Zicao Xiaoyong Decoction, a total of 28 doses, one dose per day, two doses per dose, one dose half an hour after breakfast and lunch.

[0102] Follow-up visit on June 29, 2025: A mass measuring approximately 6.0*5.0cm was palpable in the central area of ​​the patient. The patient was again given Zicao Xiaoyong Decoction, 28 doses, one dose per day, two doses per dose, one dose half an hour after breakfast and lunch.

[0103] The patient regularly visited the doctor and took the above traditional Chinese medicine from June 29, 2025 to July 13, 2025. The mass still existed and the reduction rate was slow.

[0104] Follow-up visit on July 13, 2025: During the follow-up visit of the patient, a mass could be felt in the middle and outer, middle and inner quadrants of the right breast, with a size of about 3.0*3.0 cm and 4.0*3.0 cm respectively. The texture was firm, the boundary was unclear, the mobility was acceptable, accompanied by dark red skin and a sense of fluctuation, without ulceration, and axillary lymph nodes could be felt. The patient was treated with Zicao Xiaoyong Decoction for a total of 28 doses, one dose per day, and each dose was divided into two parts, one part half an hour after breakfast and the other half an hour after lunch. At the same time, the external-use traditional Chinese medicine paste of this patent was given. A piece of gauze of appropriate size was taken, and the traditional Chinese medicine paste was evenly applied on the gauze with a thickness of 5.0 mm and covered on the mass of the right breast, and the coverage area needed to be larger than the mass area. The external-use traditional Chinese medicine paste was used for 8 hours every day, once a day. It was continuously used for 28 days.

[0105] The patient regularly visited the doctor and took traditional Chinese medicine and used the external-use traditional Chinese medicine paste from July 13, 2025 to December 17, 2025, and the mass gradually decreased.

[0106] Follow-up visit on December 17, 2025: Local thickening could be felt in the middle and outer, upper and inner parts of the right breast, and no obvious mass was felt. Ultrasound examination showed multiple hypoechoic areas in the right breast (the larger one was about 0.8*0.4 cm (at the 3 o'clock direction)), BI-RADS category 3, considered to be inflammation. The inflammation had improved significantly, and it was instructed to stop using the external-use traditional Chinese medicine paste. Zicao Xiaoyong Decoction was given for 28 doses, and the decocting method was the same as before to consolidate the curative effect.

[0107] Based on the above results, it can be seen that the external-use traditional Chinese medicine paste of the present invention can significantly reduce the disease activity score, shrink the lesion volume, and improve the quality of life of patients in multiple dimensions during the treatment of GLM, reflecting the treatment characteristics of taking into account both the local and the whole, and synchronously improving symptoms and functions. Its onset time is earlier and the curative effect trend is consistent, indicating that this external treatment plan has good clinical application value in the comprehensive management of GLM.

Claims

1. A topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-induced blood stasis type, characterized in that... Made from raw materials including the following medicinal materials: Prepared Rehmannia root, deer antler slices, cinnamon, prepared ginger, Sichuan lovage rhizome, safflower, phellodendron bark, angelica root, purslane, and bletilla rhizome.

2. The topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-induced blood stasis type as described in claim 1, characterized in that... Made from the following raw materials in parts by weight: Prepared Rehmannia Root 25-35 parts, Deer Antler Slices 8-12 parts, Cinnamon 7-11 parts, Prepared Ginger 4-8 parts, Ligusticum chuanxiong 7-11 parts, Safflower 7-11 parts, Phellodendron Bark 10-14 parts, Angelica Root 4-8 parts, Purslane 25-35 parts, Bletilla Rhizome 2-4 parts.

3. The topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-induced blood stasis type as described in claim 2, characterized in that... It is made from the following ingredients in parts by weight: 28-32 parts Rehmannia glutinosa, 9-11 parts deer antler slices, 8-10 parts cinnamon, 5-7 parts prepared ginger, 8-10 parts Ligusticum chuanxiong, 8-10 parts safflower, 11-13 parts Phellodendron chinense, 5-7 parts Angelica dahurica, 28-32 parts Portulaca oleracea, and 3-3.5 parts Bletilla striata.

4. The topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-induced blood stasis type as described in claim 3, characterized in that... It is made from the following ingredients in parts by weight: 30 parts Rehmannia glutinosa, 10 parts deer antler slices, 9 parts cinnamon, 6 parts dried ginger, 9 parts Ligusticum chuanxiong, 9 parts safflower, 12 parts Phellodendron chinense, 6 parts Angelica dahurica, 30 parts Portulaca oleracea, and 3 parts Bletilla striata.

5. The topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-induced blood stasis type as described in claim 1, characterized in that... The external Chinese medicine preparation is an external ointment.

6. The topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-induced blood stasis type as described in claim 5, characterized in that... The external Chinese medicine preparation is an external ointment, which is prepared by the following method: Take each raw material according to the formula, crush it and sieve it to obtain Chinese medicine powder. Mix the Chinese medicine powder and the plaster base evenly to prepare an external plaster.

7. The topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-coagulation and blood stasis type as described in claim 6, characterized in that... The plaster base includes sesame oil and beeswax in a mass ratio of 2-3:1; the mass ratio of the traditional Chinese medicine powder to the plaster base is 1:3-4.

8. The topical traditional Chinese medicine preparation for treating granulomatous lobular mastitis of the cold-induced blood stasis type as described in claim 7, characterized in that... External application of traditional Chinese medicine preparations is a topical ointment, prepared according to the following method: Take each raw material according to the formula, crush and sieve to obtain Chinese medicine powder; heat sesame oil to 220℃-240℃ and boil for 20-25 minutes, filter and add beeswax, stir at 85℃-90℃ until the beeswax is completely dissolved, stir and cool down to 80℃, add Chinese medicine powder, continue stirring, cool to room temperature to obtain external ointment.

9. The use of the topical Chinese medicine preparation as described in any one of claims 1 to 8 in the preparation of a medicament for treating granulomatous lobular mastitis of the cold-induced blood stasis type.

10. The use of the topical Chinese medicine preparation as described in any one of claims 1 to 8 in the preparation of a drug for reducing breast lumps and relieving pain caused by cold-induced blood stasis type granulomatous lobular mastitis.

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