A traditional Chinese medicine composition for treating postpartum milk stasis and a preparation method thereof

Abstract

The present application relates to the technical field of postpartum milk stasis, in particular to a traditional Chinese medicine composition for treating postpartum milk stasis. The traditional Chinese medicine composition is prepared by mixing radix rehmanniae preparata, pericarpium citri reticulatae, radix angelicae dahuricae, rhizoma anemarrhenae asphodeloidis, honey bran roasted atractylodes lancea, radix trichosanthis and glycyrrhiza, and then mixing the mixture with glycerol to form a paste. The paste is applied to the breasts of a patient after local heat therapy and manual massage. After treatment, the degree of breast pain, the hardness of the breasts, and the amount of milk discharge are all improved, the milk is sufficient, and the local blood circulation of the breasts is smooth. The paste is complementary to external treatment, which is helpful to improve the clinical symptoms of the puerpera and ensure the smooth progress of breastfeeding.

Description

Technical Field

[0001] This invention relates to the field of postpartum milk stasis technology, and in particular to a traditional Chinese medicine composition for treating postpartum milk stasis and its preparation method. Background Technology

[0002] Postpartum milk stasis is a common clinical problem in breastfeeding women, typically occurring at different stages postpartum and representing the initial clinical manifestation of blocked milk ducts. In traditional Chinese medicine, milk stasis is referred to as "jealous milk," caused by excessive milk production that becomes trapped within the mammary ducts, leading to symptoms such as breast swelling, hardening, and pain, with or without fever. The incidence of milk stasis is gradually increasing, reaching as high as 50% in breastfeeding women. Milk stasis is the common pathological basis for breast swelling and mastitis. If milk cannot be effectively and promptly expressed, it not only causes severe pain for the mother but may also develop into acute mastitis, and in severe cases, even lead to cessation of milk production, affecting the continuation of breastfeeding and negatively impacting the health of both mother and baby. Correctly identifying milk stasis and mastering early treatment methods are crucial for preventing mastitis.

[0003] Currently, the routine clinical treatment for postpartum milk stasis mainly includes breastfeeding guidance, combined with electric breast pumps or manual expression to promote milk flow. However, these methods are often time-consuming and laborious in practice, and the results are not ideal. For patients with severe symptoms or signs of infection, Western medicine often uses antibiotics, but antibiotics mainly target bacterial infections and do not significantly improve milk stasis itself. Traditional Chinese medicine considers milk stasis to fall under the category of "breast abscess" in TCM, emphasizing the principle of unblocking and eliminating pathogens. In particular, TCM external treatments can directly act on the affected area, resulting in more direct and effective effects.

[0004] In terms of physical therapy, clinical practice has also explored methods such as local hot compresses, rehabilitation therapy devices, and manual techniques to treat postpartum milk stasis. While these methods can alleviate symptoms to some extent, their effects are slow to take hold, short-lived, and prone to relapse. In recent years, some studies have attempted to combine reverse pressure softening with biofeedback technology to treat postpartum milk stasis, achieving some clinical efficacy. However, related research is still insufficient, lacking systematic validation and mature treatment protocols.

[0005] In summary, existing treatments for postpartum milk stasis still have unsatisfactory effects, and there is an urgent need to explore more effective milk expression treatments to improve the clinical symptoms of postpartum women and ensure the smooth progress of breastfeeding. Summary of the Invention

[0006] In view of the shortcomings of the prior art described above, the purpose of this invention is to provide a traditional Chinese medicine composition for treating postpartum milk stasis and its preparation method, so as to solve the problem that conventional treatment methods for postpartum milk stasis in the prior art are not effective.

[0007] To achieve the above and other related objectives, the present invention is obtained through the following technical solution.

[0008] The first aspect of the present invention is to provide a traditional Chinese medicine composition for treating postpartum milk stasis, the traditional Chinese medicine composition comprising the following raw materials: prepared Rehmannia glutinosa, dried tangerine peel, Angelica dahurica, prepared Arisaema heterophyllum, stir-fried Atractylodes lancea with honey and wheat bran, Trichosanthes kirilowii, and licorice.

[0009] The second aspect of the present invention is to provide a method for preparing a traditional Chinese medicine composition for treating postpartum milk stasis, comprising the following steps: mixing Rehmannia glutinosa, Citrus reticulata peel, Angelica dahurica, Arisaema heterophyllum, Atractylodes lancea stir-fried with honey, Trichosanthes kirilowii, and Glycyrrhiza uralensis, and processing them into powder, thereby obtaining the product.

[0010] A third aspect of the present invention is to provide a traditional Chinese medicine preparation for treating postpartum milk stasis, comprising the traditional Chinese medicine composition for treating postpartum milk stasis as described above.

[0011] The fourth aspect of the present invention is to provide a method for preparing a traditional Chinese medicine preparation for treating postpartum milk stasis, wherein the above-mentioned traditional Chinese medicine composition for treating postpartum milk stasis is mixed with glycerin and made into a paste to obtain a traditional Chinese medicine preparation for treating postpartum milk stasis.

[0012] The fifth aspect of the present invention is to provide a traditional Chinese medicine composition for treating postpartum milk stasis as described above and / or the use of the traditional Chinese medicine preparation as described above in the preparation of a medicament for mastitis.

[0013] As described above, the traditional Chinese medicine composition for treating postpartum milk stasis and its preparation method of the present invention have the following beneficial effects:

[0014] The traditional Chinese medicine composition described in this invention follows the principles of traditional Chinese medicine (TCM) formulation, where each ingredient works synergistically to promote lactation and disperse lumps. In use, the herbal composition is mixed with glycerin to form a paste, which is then applied topically to the breast skin. After transdermal absorption, the medicine acts directly on local tissues, promoting blood circulation, reducing swelling and pain, and dispelling wind and dampness, thus alleviating the blockage and damage to the mammary ducts caused by milk stasis and maintaining their patency. Simultaneously, through meridian conduction, it regulates the functions of the internal organs, improving the overall pathological basis of milk production and drainage. Through these dual effects, the smooth progress of subsequent breastfeeding is ensured.

[0015] This invention's traditional Chinese medicine composition uses processed Arisaema heterophyllum as the principal ingredient, stir-fried Atractylodes lancea with honey and Citrus reticulata peel as assistant ingredients, and Angelica dahurica, Trichosanthes kirilowii, Rehmannia glutinosa, and Glycyrrhiza uralensis as adjuvant ingredients, working together to promote lactation and disperse stagnation. Combined with the unblocking effect of manual massage and the warming effect of local heat therapy, these three ingredients work synergistically to address the core pathogenesis of 'qi and blood stasis,' thus achieving a breakthrough in clinical efficacy. Detailed Implementation

[0016] To make the inventive objectives, technical solutions, and beneficial effects of this invention clearer, the invention will be further described in detail below with reference to embodiments. Those skilled in the art can easily understand other advantages and effects of this invention from the content disclosed in this specification.

[0017] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the specification of this invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0018] When using “including,” “having,” and “contains” as described herein, the intention is to cover non-exclusive inclusion, unless an explicit qualifying term such as “only,” “consisting of,” etc., is used, in which case another component may be added.

[0019] In this invention, the terms "preferredly," "more preferably," "better," and "even better" refer to embodiments of the invention that provide certain beneficial effects under certain circumstances. However, other embodiments may also be preferred under the same or other circumstances. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are unavailable, nor is it intended to exclude other embodiments from the scope of the invention. That is, in this invention, "preferredly," "more preferably," "better," and "even better" are merely descriptions of more effective implementations or examples, but do not constitute a limitation on the scope of protection of the invention.

[0020] In this invention, terms such as "further," "even more," and "particularly" are used for descriptive purposes and indicate differences in content, but should not be construed as limiting the scope of protection of this invention.

[0021] In this invention, "at least one" means one or more, such as one, two, or more. "Multiple" or "several" means at least two, such as two, three, etc., and "multi-layered" means at least two layers, such as two layers, three layers, etc., unless otherwise explicitly specified. In the description of this invention, "several" means at least one, such as one, two, etc., unless otherwise explicitly specified.

[0022] When a numerical range is disclosed herein, the range is considered continuous and includes the minimum and maximum values ​​of the range, as well as every value between the minimum and maximum values. Furthermore, when the range refers to integers, it includes every integer between the minimum and maximum values ​​of the range. Additionally, when multiple ranges are provided to describe a feature or characteristic, the ranges may be combined. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges to which they are incorporated.

[0023] Unless otherwise specified, all steps of this invention may be performed sequentially or randomly. For example, the method includes steps (a) and (b), indicating that the method may include steps (a) and (b) performed sequentially, or it may include steps (b) and (a) performed sequentially. For example, the method may also include step (c), indicating that step (c) may be added to the method in any order. For example, the method may include steps (a), (b), and (c), or it may include steps (a), (c), and (b), or it may include steps (c), (a), and (b), etc.

[0024] Unless otherwise stated, a singular term may include a plural term and should not be understood as having a quantity of one.

[0025] In this invention, "above" or "below" both include the number itself. For example, "below 1" includes 1.

[0026] In this invention, room temperature refers to 0~40°C, including but not limited to 10~40°C, or further to 20~30°C.

[0027] In this invention, the term "paste" refers to a semi-solid form formed by mixing the powdered traditional Chinese medicine composition with glycerin. This form has suitable viscosity and plasticity, making it easy to apply to the skin surface of the breast, and it is not prone to dripping or falling off during use. During preparation, the ratio of powder to glycerin can be adjusted according to actual needs, aiming to achieve a uniform, fine, and easily spreadable paste. The paste should be prepared fresh for each use to ensure efficacy.

[0028] A paste is a semi-solid state formed by mixing drug powder with appropriate excipients and binders (such as water, vinegar, wine, honey, glycerin, egg white, etc.). It has plasticity and adhesiveness, making it easy to apply to the skin surface.

[0029] The *Yizong Jinjian* states: "External abscesses are caused by the mother's liver and stomach qi becoming turbid, coupled with the baby's deep sleep while suckling, the cool air from the nostrils enters the breast, congeals with heat, causing swelling and pain, resulting in alternating chills and fever, irritability, and thirst." "This is a case of breast toxins formed by the congealing of damp heat in the liver and stomach." The *Wai Ke Da Cheng* states: "Mastitis is caused by stagnation of liver qi, excessive stomach fire, obstructed milk flow, and the stagnation not dissipating, which over time transforms into heat and forms abscesses." The *Feng Shi Jin Nang Mi Lu* (Feng's Secret Records of the Golden Bag), in its section on gynecology and surgery, states: "When the orifices are blocked, the milk cannot flow out, and the blood of the Yangming meridian boils, so the heat becomes severe and pus forms." Traditional Chinese medicine believes that the nipple belongs to the liver and the breast belongs to the stomach. If the mother is emotionally distressed after childbirth, the liver qi will be stagnant and the liver will fail to regulate its flow. Or if the mother eats improperly, the stomach will accumulate heat. The stagnation of heat in the liver and stomach will cause the milk ducts to become blocked, which will then turn into pus. Alternatively, the milk may accumulate and cause pus to form due to heat. Or the nipple may be broken and exposed to external pathogens. Alternatively, the heat toxins from the baby's mouth may invade the milk ducts, causing the pathogenic heat to accumulate and the flesh to rot.

[0030] Based on the "Standards for Diagnosis and Efficacy Evaluation of Surgical Diseases in Traditional Chinese Medicine" and expert consensus, it is recommended to classify it into the following 3 TCM syndrome types:

[0031] (1) Qi stagnation and heat accumulation syndrome. Main symptoms: milk stasis and lumps, skin color unchanged or slightly red, swelling and pain. Secondary symptoms: accompanied by chills and fever, headache, body aches, thirst, and constipation. Yellow tongue coating, rapid pulse.

[0032] (2) Heat-toxin syndrome. Main symptoms: high fever, breast swelling and pain, red and hot skin, softening of the lump, and a tactile sensation. Or, after incision and drainage, drainage is poor, redness, swelling, heat and pain do not subside, and there is a "spreading cyst" phenomenon. Secondary symptoms: red tongue, yellow and greasy coating, and rapid and forceful pulse.

[0033] (3) Deficiency of vital energy and lingering toxin syndrome. Main symptoms: Although the swelling and pain of the breast are mild after suppuration, the pus from the wound continues to flow, the pus is thin and clear, healing is slow, or a milk fistula may form. Secondary symptoms: General weakness, pale complexion, or persistent low-grade fever, and reduced appetite. Pale tongue, thin coating, and weak pulse.

[0034] In traditional Chinese medicine theory, acute suppurative mastitis is a mastitis caused by the accumulation of milk stasis leading to heat, stagnation of heat toxins, and obstruction of qi and blood. Symptoms include breast swelling and pain, elevated local skin temperature, and the appearance of poorly defined nodules. Sometimes, the local skin is red, swollen, hot, and painful, with more pronounced nodules and increased tenderness. It may also be accompanied by chills, high fever, headache, weakness, swollen axillary lymph nodes, a red or greasy tongue coating (white or yellow), and a rapid, forceful, slippery, or wiry pulse. This invention utilizes methods that clear heat and detoxify, promote qi and blood circulation, promote lactation and dissipate nodules, and promote the elimination of toxins. Each group of herbs has a distinct function and works synergistically, fully leveraging the unique, analytical, and scientific research methodology of traditional Chinese medicine—like a strategic deployment of troops—to dissipate or rapidly ulcerate nodules, achieving good therapeutic effects and providing a new option for clinical medication. It can effectively treat mastitis or acute suppurative mastitis caused by milk stasis and heat accumulation, heat toxin accumulation, and blood stasis, providing a new option for clinical medication.

[0035] The first aspect of the present invention is to provide a traditional Chinese medicine composition for treating postpartum milk stasis, the traditional Chinese medicine composition comprising the following raw materials: prepared Rehmannia glutinosa, dried tangerine peel, Angelica dahurica, prepared Arisaema heterophyllum, stir-fried Atractylodes lancea with honey and wheat bran, Trichosanthes kirilowii, and licorice.

[0036] Traditional Chinese medicine believes that breast milk is derived from blood, and its production and secretion depend on the coordinated functions of the liver, spleen, kidneys, lungs, and other internal organs, as well as the abundance of qi and blood. Qi is considered the commander of blood; when qi flows, blood flows, and when blood flows, breast milk flows smoothly. Under normal circumstances, when the functions of the internal organs are balanced and qi and blood are sufficient, breast milk can be secreted and discharged normally. Postpartum women experience a sudden deficiency of qi and blood, leading to dysfunction of the internal organs. Insufficient qi to generate blood results in inadequate blood production, and stagnant qi and blood lead to obstructed milk ducts, resulting in milk stasis. Based on this pathogenesis, treatment should focus on regulating the functions of the internal organs and replenishing qi and blood.

[0037] This traditional Chinese medicine composition, made from Rehmannia glutinosa, Citrus reticulata peel, Angelica dahurica, processed Arisaema heterophyllum, Atractylodes lancea stir-fried with honey and wheat bran, Trichosanthes kirilowii root, and Glycyrrhiza uralensis, has the effect of promoting lactation and resolving lumps. It is often used for postpartum women with milk stasis and has the functions of relieving exterior syndromes and dispelling cold, reducing swelling and relieving pain, regulating qi and strengthening the spleen. Processed Arisaema heterophyllum (principal herb): dries dampness and resolves phlegm, dispels wind and relieves spasms; Atractylodes lancea stir-fried with honey and wheat bran (assistant herb): dries dampness and strengthens the spleen, dispels wind and cold, and is a key herb for treating dampness obstructing the middle jiao due to spleen deficiency; Citrus reticulata peel: regulates qi and strengthens the spleen, dries dampness and resolves phlegm. "Treat phlegm by first treating qi." Tangerine peel helps resolve phlegm by regulating qi, and also acts as an adjuvant to the principal herb, addressing potential concurrent symptoms such as "upward flow of stomach qi and abdominal distension." Angelica dahurica is an adjuvant herb: it dispels wind, relieves pain, reduces swelling, and drains pus. Trichosanthes kirilowii (an adjuvant herb): it clears heat, generates fluids, reduces swelling, and drains pus. Rehmannia glutinosa (an adjuvant herb): it nourishes yin and blood, counteracts the harshness of warming and drying herbs, and prevents depletion of body fluids. Licorice root (a guiding herb): it harmonizes the herbs, invigorates qi, and detoxifies. This formula is used to treat mastitis caused by milk stasis leading to heat, accumulation of heat toxins, and stagnation of qi and blood. Symptoms include breast distension and pain, high local skin temperature, indistinct nodules, or even local redness, swelling, heat, and pain with more pronounced induration and increased tenderness, sometimes accompanied by chills, high fever, headache, weakness, swollen axillary lymph nodes, a red or greasy tongue coating (white or yellow), and a rapid, forceful, slippery, or wiry pulse. By combining various Chinese herbal ingredients in treatment, breast tenderness can be relieved, symptoms can be improved, the stability of the therapeutic effect can be enhanced, and adverse reactions and recurrence rates can be reduced.

[0038] Processed Arisaema (also known as ginger-processed Arisaema or processed star) is the dried tuber of Arisaema heterophyllum, processed with alum, ginger, and other auxiliary materials. The purpose of processing is to reduce its toxicity and enhance its effects of drying dampness, resolving phlegm, dispelling wind, and relieving spasms. Honey-braised Atractylodes lancea involves mixing honey water with wheat bran, letting it cool until slightly moist, then frying it in a hot pan until it turns a deep yellow color and smokes. Atractylodes lancea slices are then added and quickly stir-fried. The mixture is cooked until it turns a deep yellow to a dark yellow color, then the wheat bran is sifted out and the mixture is allowed to cool. Wheat bran absorbs oil and mitigates dryness; honey is sweet and moistening, enhancing its tonifying effect and further restraining the warming and drying properties of Atractylodes lancea.

[0039] In some embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-15 parts of Rehmannia glutinosa (processed), 5-15 parts of Citrus reticulata peel, 5-15 parts of Angelica dahurica, 5-15 parts of Arisaema heterophyllum (processed), 5-15 parts of Atractylodes lancea (stir-fried with honey and wheat bran), 5-15 parts of Trichosanthes kirilowii, and 3-8 parts of Glycyrrhiza uralensis.

[0040] In some embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-8 parts of Rehmannia glutinosa (processed), 5-8 parts of Citrus reticulata peel, 5-8 parts of Angelica dahurica, 5-8 parts of Arisaema heterophyllum (processed), 5-8 parts of Atractylodes lancea (stir-fried with honey and wheat bran), 5-8 parts of Trichosanthes kirilowii, and 3-5 parts of Glycyrrhiza uralensis.

[0041] In some embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 8-10 parts of Rehmannia glutinosa (processed), 8-10 parts of Citrus reticulata peel, 8-10 parts of Angelica dahurica, 8-10 parts of Arisaema heterophyllum (processed), 8-10 parts of Atractylodes lancea (stir-fried with honey and wheat bran), 8-10 parts of Trichosanthes kirilowii, and 5-8 parts of Glycyrrhiza uralensis.

[0042] In some embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-15 parts of Rehmannia glutinosa (processed), 10-15 parts of Citrus reticulata peel, 10-15 parts of Angelica dahurica, 10-15 parts of Arisaema heterophyllum (processed), 10-15 parts of Atractylodes lancea (stir-fried with honey and wheat bran), 10-15 parts of Trichosanthes kirilowii, and 5-8 parts of Glycyrrhiza uralensis.

[0043] In some embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 9 parts Rehmannia glutinosa, 9 parts Citrus reticulata peel, 9 parts Angelica dahurica, 9 parts Arisaema heterophyllum, 9 parts Atractylodes lancea stir-fried with honey and wheat bran, 9 parts Trichosanthes kirilowii, and 4 parts Glycyrrhiza uralensis.

[0044] In some embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 11 parts Rehmannia glutinosa, 11 parts Citrus reticulata peel, 11 parts Angelica dahurica, 11 parts Arisaema heterophyllum, 11 parts Atractylodes lancea stir-fried with honey and wheat bran, 11 parts Trichosanthes kirilowii, and 6 parts Glycyrrhiza uralensis.

[0045] In some embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts Rehmannia glutinosa, 10 parts Citrus reticulata peel, 10 parts Angelica dahurica, 10 parts Arisaema heterophyllum, 10 parts Atractylodes lancea stir-fried with honey and wheat bran, 10 parts Trichosanthes kirilowii, and 5 parts Glycyrrhiza uralensis.

[0046] In some embodiments of the present invention, the traditional Chinese medicine composition is a topical preparation. The topical preparation of the present invention can be any dosage form known in the art suitable for transdermal drug delivery, including but not limited to plasters, poultices, gels, ointments, emulsions, sprays, films, liniments, lotions, tinctures, pastes, aerosols, foams, liposomes, microemulsions, and transdermal patches. Those skilled in the art can select appropriate dosage forms based on conventional processes without requiring creative effort.

[0047] In some embodiments of the present invention, the topical formulation of the present invention may incorporate pharmaceutically acceptable carriers conventional in the art, depending on the dosage form requirements. These carriers include, but are not limited to: matrices (such as water-soluble matrices, lipid-soluble matrices, emulsion matrices), transdermal penetration enhancers (such as azone, oleic acid, menthol, propylene glycol, laurocapram, etc.), thickeners (such as carbomer, hydroxypropyl methylcellulose, xanthan gum), emulsifiers, preservatives, pH adjusters, antioxidants, and solvents (such as water, ethanol, propylene glycol). Those skilled in the art can rationally select the type and amount of the above-mentioned carriers based on the conventional processes of the chosen dosage form, without requiring any inventive effort.

[0048] The second aspect of the present invention is to provide a method for preparing a traditional Chinese medicine composition for treating postpartum milk stasis, comprising the following steps: mixing Rehmannia glutinosa, Citrus reticulata peel, Angelica dahurica, Arisaema heterophyllum, Atractylodes lancea stir-fried with honey, Trichosanthes kirilowii, and Glycyrrhiza uralensis, and processing them into powder, thereby obtaining the product.

[0049] In some embodiments of the present invention, the particle size of the powder can be within a range conventional in the art. Specifically, the particle size of the powder is 80-200 mesh. For example, 80-100 mesh, 100-120 mesh, 120-140 mesh, 140-170 mesh, 170-200 mesh.

[0050] A third aspect of the present invention is to provide a traditional Chinese medicine preparation for treating postpartum milk stasis, comprising the traditional Chinese medicine composition for treating postpartum milk stasis as described above.

[0051] In some embodiments of the invention, a tertiary adhesive is also included; the tertiary adhesive is selected from one or more of water, vinegar, wine, honey, egg white, or glycerin. Glycerin is preferred.

[0052] In some embodiments of the present invention, the mass ratio of the traditional Chinese medicine composition to the adhesive is 1:0.8-1. For example, it is 1:0.8-0.9 or 1:0.9-1.

[0053] The fourth aspect of the present invention is to provide a method for preparing a traditional Chinese medicine preparation for treating postpartum milk stasis, wherein the above-mentioned traditional Chinese medicine composition for treating postpartum milk stasis is mixed with glycerin and made into a paste to obtain a traditional Chinese medicine preparation for treating postpartum milk stasis.

[0054] This invention involves applying a traditional Chinese medicine composition for promoting lactation and resolving lumps (i.e., the traditional Chinese medicine preparation of this application) externally to the skin of the breast. After transdermal absorption, the medicine can directly act on local tissues, exerting effects such as promoting blood circulation, removing blood stasis, reducing swelling and relieving pain, and dispelling wind and dampness. This reduces the blockage and damage to the mammary ducts caused by stagnation, keeping the mammary ducts unobstructed. At the same time, the medicine further regulates the functions of the internal organs through meridian conduction, improving the pathological basis of milk production and discharge as a whole.

[0055] Clinical observation results showed that after treatment, the patients' breast pain, breast firmness, and milk output were significantly improved compared to before treatment. The patients had sufficient milk secretion and smooth blood and qi circulation in the breast area. These results indicate that the traditional Chinese medicine preparation described in this application, when used in conjunction with external treatments (manual massage and local heat therapy), can exert a synergistic effect, jointly promoting milk output and symptom relief.

[0056] Based on this, this treatment method can alleviate postpartum anxiety and irritability caused by breast discomfort and breastfeeding problems, reducing the impact of negative postpartum emotions on physical and mental recovery. By ensuring unobstructed milk ducts, it ensures smooth breastfeeding, allowing the baby to receive sufficient breast milk to meet their nutritional needs for growth and development, and preventing insufficient milk supply from affecting breastfeeding.

[0057] The fifth aspect of the present invention is to provide a traditional Chinese medicine composition for treating postpartum milk stasis as described above and / or the use of the traditional Chinese medicine preparation as described above in the preparation of a medicament for mastitis.

[0058] In some embodiments of the present invention, the drug is used as follows: after manual massage and local heat therapy, the drug is applied to the affected area.

[0059] In some embodiments of the present invention, the temperature of the local heat therapy is 30-60℃, preferably 30-40℃, 40-50℃, or 50-60℃; the duration of each session is 10-20 minutes, for example, 10-15 minutes or 15-20 minutes; and the heat therapy is performed 1-2 times daily, for example, once or twice. The method of local heat therapy is selected from one of the following: hot towel compress, breast therapy device heat therapy, or far-infrared physiotherapy. The heat therapy site is the affected breast skin, i.e., the area of ​​breast lumps and pain.

[0060] In some embodiments of the present invention, the manual massage is kneading method or pressing method. Specifically, the massage steps are as follows: (1) Apply massage oil on both hands, and massage the Taiyin Lung Meridian, Pericardium Meridian, and少阴 Heart Meridian of the patient's hand from the proximal end to the distal end, and massage each meridian for more than 15 times; (2) Acupoint massage: Select Quchi acupoint, Hegu acupoint, Shaoze acupoint, and Tanzhong acupoint for kneading, and knead each acupoint for 15-20 times. (3) Acupoint patting: Select Tianquan acupoint and pat it with an empty palm until the local skin of the patient turns red. (4) Breast squeezing: Remove the towel wet applied on the patient's breast, hold the patient's breast with one hand, and place the thumb, index finger, and middle finger of the other hand on the nipple and areola of the patient, in the shape of a newborn sucking, and perform three-finger sucking on the nipple and areola of the patient for 15-20 times. Select Rugen acupoint, Yingchuang acupoint, Tianxi acupoint, and Shenfeng acupoint for kneading, and knead each acupoint for 15-20 times. Then use the three-finger sucking method until the patient's nipple becomes soft. Separate the thumb and four fingers and place them at the Rugen and Yingchuang acupoints of the patient, and squeeze from the patient's acupoint along the direction of the mammary duct towards the nipple with appropriate strength, and use the same method to squeeze the Tianxi and Shenfeng acupoints of the patient. Note that the squeezing time for one breast should not exceed 15 minutes. And squeeze the contralateral breast of the patient with the same method.

[0061] In some embodiments of the present invention, the usage method of the drug includes: first perform manual massage and local heat therapy operations, and then prepare the traditional Chinese medicine composition into powder, mix it with glycerol to form a paste, and apply it on the skin of the affected breast.

[0062] The specific administration frequency of the drug composition in the present invention can be determined by those skilled in the art through known techniques and by observing the results obtained under similar conditions.

[0063] In some embodiments of the present invention, the administration frequency of the drug is 1-3 times a day; for example, it can be 1 time a day, 2 times a day, 3 times a day, with a 3-day course of treatment. Each time is 1-3 hours.

[0064] In some embodiments of the present invention, according to the degree of breast swelling and milk stasis, apply 1-2 patches of traditional Chinese medicine on one breast. Apply the drug evenly on a 6*7 cm or 10*12 cm medical breathable film and apply it on the breast skin, with a thickness of 0.15-0.25 cm, and the area of the applied medicine should exceed the edge of the mass and the red and swollen area by more than 2 cm. Among them, each patch of the traditional Chinese medicine composition includes the following raw materials in weight: 5-15 g of prepared rehmannia root, 5-15 g of dried tangerine peel, 5-15 g of angelica dahurica, 5-15 g of processed pinellia ternata, 5-15 g of honey-fried atractylodes lancea, 5-15 g of trichosanthes kirilowii maximowicz, and 3-8 g of licorice root.

[0065] The present invention will be further illustrated by the following examples, but the scope of the present invention is not limited thereby.

[0066] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the present invention, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. All reagents or instruments whose manufacturers are not specified are conventional products that can be purchased commercially. In addition to the specific methods, equipment, and materials used in the embodiments, based on the knowledge of the prior art possessed by one of ordinary skill in the art and the description of this invention, any prior art methods, equipment, and materials similar to or equivalent to those described, used, and materials in the embodiments of this invention may be used to implement this invention.

[0067] Example

[0068] Example 1

[0069] This embodiment provides a traditional Chinese medicine preparation for treating postpartum milk stasis, comprising a traditional Chinese medicine composition and glycerin. The traditional Chinese medicine composition comprises the following raw materials by weight: 10g of prepared Rehmannia glutinosa, 10g of dried tangerine peel, 10g of Angelica dahurica, 10g of prepared Arisaema heterophyllum, 10g of stir-fried Atractylodes lancea with honey and wheat bran, 10g of Trichosanthes kirilowii, and 5g of Glycyrrhiza uralensis. The mass ratio of the traditional Chinese medicine composition to glycerin is 1:0.9.

[0070] This embodiment provides a method for preparing a traditional Chinese medicine preparation for treating postpartum milk stasis, including the following steps: mixing Rehmannia glutinosa, Citrus reticulata peel, Angelica dahurica, Arisaema heterophyllum, Atractylodes lancea stir-fried with honey, Trichosanthes kirilowii, and Glycyrrhiza uralensis to form a powder, then mixing it with glycerin to form a paste, thus obtaining the traditional Chinese medicine preparation for treating postpartum milk stasis.

[0071] The following clinical data and typical cases illustrate the efficacy of the traditional Chinese medicine preparation for treating postpartum milk stasis in Example 1 of this application.

[0072] I. Clinical observation of the formula for promoting lactation and eliminating lumps in this invention for treating milk stasis.

[0073] 1. Clinical Data: A total of 336 outpatients and inpatients who experienced milk stasis during postpartum breastfeeding from January 2023 to September 2025 were selected. Inclusion criteria: ① Singleton full-term pregnancy; ② Breast engorgement and milk stasis during postpartum breastfeeding; ③ No abnormalities in vital organs such as the heart, liver, and kidneys; ④ Voluntary enrollment, with informed consent obtained and signed before enrollment. Exclusion criteria: ① Mastitis, congenital breast defects, or other diseases damaging breast tissue; ② Communication difficulties, sensory impairments, etc. Patients were randomly divided into a treatment group (n=168) and a control group (n=168). The age of the treatment group was 20-46 (30.84±0.49) years, with a disease duration of 2-5 (3.48±0.05) days. The age of the control group was 21-43 (29.53±0.45) years, with a disease duration of 1-6 (3.68±0.09) days. There were no statistically significant differences in age and disease duration.

[0074] Symptom characteristics:

[0075] During breastfeeding, the affected breast begins to feel engorged and painful, especially during breastfeeding. Local skin temperature is high, milk flow is impaired, and lumps may or may not be present, or indistinct lumps may appear. In severe cases, the local skin may be red, swollen, hot, and painful, with more pronounced lumps and increased tenderness. Systemic symptoms may be mild or accompanied by general malaise, poor appetite, chest tightness, and irritability. Then, the breast hardens, and the lump gradually enlarges. At this point, significant systemic symptoms may appear, such as high fever, chills, headache, general weakness, and constipation. An abscess often forms within 4-5 days, causing throbbing pain in the breast, and the local skin becomes red, swollen, and translucent. The tongue is red or greasy with a white or yellow coating, and the pulse is rapid and forceful, or slippery or wiry. When pus forms, the center of the lump softens and fluctuates upon palpation. Acute mastitis is often accompanied by enlarged and tender axillary lymph nodes on the affected side; the total white blood cell count and neutrophil count are increased.

[0076] II. Efficacy Evaluation Criteria

[0077] The efficacy evaluation criteria were formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and the "Clinical Disease Diagnosis, Cure and Improvement Standards".

[0078] ① Cured: After treatment, the local lump in the patient's breast completely disappeared, the redness, swelling, heat and pain disappeared, there were no other systemic symptoms such as fever, the nipple pores were open, and the milk flowed smoothly;

[0079] ②Significant effect: After treatment, the area of ​​the local lump in the patient's breast was reduced by ≥1 / 2, the redness, swelling, heat and pain were significantly reduced, and the milk flow was basically unobstructed;

[0080] ③ Effective: After treatment, the area of ​​the local lump in the patient's breast decreased by ≥1 / 3, the redness, swelling, heat and pain were slightly relieved, the milk ducts were partially open, and the amount of milk was small;

[0081] ④ Ineffective: After treatment, the local breast mass of the patient shrinks by less than 1 / 3 or shows no obvious change, the redness, swelling, heat and pain remain the same as before, the milk ducts are blocked, and milk cannot flow out.

[0082] Total effective rate (%) = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0083] III. Treatment methods

[0084] Control group (physical therapy group): Only manual massage (kneading method or pressing method, 30 minutes each time) and local heat therapy (hot towel application, temperature 45°C, 15 minutes each time) are performed, once a day, and 3 days is a treatment course. The local hot towel application operation is as follows: A hot towel can be used for application, 15 minutes each time, 3 to 4 times a day. The manual massage operation is as follows: ① Meridian dredging: Apply massage oil to both hands and massage the Lung Meridian of Hand-Taiyin, Pericardium Meridian of Hand-Jueyin, and Heart Meridian of Hand-Shaoyin of the patient from the proximal end to the distal end, and massage each meridian more than 15 times; ② Acupoint massage: Select Quchi (LI11), Hegu (LI4), Shaoze (SI1), and Tanzhong (CV17) for kneading, and knead each acupoint 15 times. ③ Acupoint patting: Select Tianquan (PC2) and pat it with an open palm until the local skin of the patient turns red. ④ Breast squeezing: Remove the towel wet applied to the patient's breast, hold the patient's breast with one hand, and place the thumb, index finger, and middle finger of the other hand on the nipple and areola of the patient, in the shape of a newborn sucking, and perform three-finger sucking on the nipple and areola of the patient, 15 times. Select Rugen (ST18), Yingchuang (ST16), Tianxi (SP18), and Shenfeng (KI23) for kneading, and knead each acupoint 15 times. Then use the three-finger sucking method until the patient's nipple becomes soft. Separate the thumb and four fingers and place them at the Rugen and Yingchuang acupoints of the patient, and squeeze from the acupoint of the patient along the direction of the mammary duct towards the nipple with appropriate force, and use the same method to squeeze the Tianxi and Shenfeng acupoints of the patient. Note that the squeezing time for one breast should not exceed 15 minutes. And squeeze the contralateral breast of the patient with the same method.

[0085] The specific operation of the experimental group (treatment group) of the present invention is as follows:

[0086] (1) First, perform local heat therapy and manual massage operations, and then apply the traditional Chinese medicine preparation prepared in Example 1 to the breast induration and pain area of the affected part once a day for 1 hour each time. Three days is a treatment course. The local hot compress operation is as follows: A hot towel can be used for hot compress for 15 minutes each time, 3 to 4 times a day. The manual massage operation is as follows: Kneading method or pressing method: Apply massage oil to both hands and massage the Lung Meridian of Hand-Taiyin, Pericardium Meridian of Hand-Jueyin, and Heart Meridian of Hand-Shaoyin of the patient from the proximal end to the distal end, with each meridian massaged more than 15 times; ② Acupoint massage: Select Quchi (LI11), Hegu (LI4), Shaoze (SI1), and Tanzhong (CV17) for kneading, with each acupoint kneaded 15 times. ③ Acupoint patting: Select Tianquan (PC2) and pat it with an empty palm until the local skin of the patient turns red. ④ Breast squeezing: Remove the towel wet applied to the patient's breast. Hold the patient's breast with one hand and place the thumb, index finger, and middle finger of the other hand on the nipple and areola of the patient, in a shape similar to a newborn sucking, and perform three-finger sucking on the nipple and areola of the patient for 15 times. Select Rugen (ST18), Yingchuang (ST16), Tianxi (SP18), and Shenfeng (KI23) for kneading, with each acupoint kneaded 15 times. Then use the three-finger sucking method until the patient's nipple becomes soft. Separate the thumb and four fingers and place them at the Rugen and Yingchuang acupoints of the patient. Apply appropriate force to squeeze from the acupoint of the patient along the direction of the mammary duct towards the nipple, and use the same method to squeeze the Tianxi and Shenfeng acupoints of the patient. Note that the squeezing time for one breast should not exceed 15 minutes. And use the same method to squeeze the contralateral breast of the patient. The external application operation of the traditional Chinese medicine preparation for promoting milk secretion and dissipating nodules is as follows: Mix the traditional Chinese medicine preparation into a paste and evenly apply it on a 6*7 cm medical breathable film and apply it to the breast skin with a thickness of 0.15 cm. The area of the applied medicine should exceed the edge of the mass and the red and swollen area by more than 2 cm.

[0087] IV. Statistical methods

[0088] Data processing was implemented using SPSS 25.0 version statistical software. Measurement data conforming to a normal distribution were expressed in the form of , and the independent samples t-test was used for comparison between groups; count data were expressed as rates or constituent ratios, and data processing was performed using the chi-square test. A P value < 0.05 was considered to indicate a statistically significant difference.

[0089] V. Treatment results

[0090] Table 1 Comparison of treatment effects between two groups of postpartum milk stasis patients

[0091]

[0092] After chi-square test, χ² = 180.877, P value < 0.001, indicating a significant difference in the effective rate of treatment effects between two groups of postpartum milk stasis patients.

[0093] This drug composition was used to treat 168 patients with milk stasis, and good results were achieved. The treatment time varied slightly depending on the severity of each patient's condition and physical condition, but symptoms generally improved significantly within about three days.

[0094] According to the above treatment criteria, among the 168 patients, 149 were cured, with a cure rate of 88.69%; 7 showed significant efficacy, accounting for 4.17%; 5 showed some effect, accounting for 2.98%; and 7 showed no significant effect (ineffective), accounting for 4.17%. The overall effective rate reached 95.83%.

[0095] V. Typical Cases

[0096] Case 1: A 29-year-old female patient, G1P1 (i.e., primiparous, one pregnancy, one delivery), presented three days postpartum with bilateral nipple retraction, sudden breast engorgement and pain, especially during breastfeeding, lumps in the breasts, poor milk flow, poor appetite, chest tightness, irritability, and general malaise. Subsequently, the breasts hardened, the lumps gradually enlarged, and she experienced general weakness, chills, fever, and headache. The local skin was red, swollen, and translucent, and the axillary lymph nodes were also enlarged and tender. She presented to the breastfeeding clinic. Examination revealed breast engorgement and pain with hard lumps, increased tenderness, elevated local skin temperature, significant redness, swelling, heat, and pain, enlarged axillary lymph nodes, a red tongue with a yellow coating, and a wiry, rapid pulse, indicative of mastitis. Her temperature was 38.6 degrees Celsius. Physical examination and blood routine test: white blood cell count 12.2×10^9 / L, neutrophils 86%, CRP 48mg / L. Breast ultrasound: thickening of glandular tissue in the upper outer quadrant of both breasts, decreased echogenicity, abundant peripheral blood flow signal, and a small amount of hypoechoic fluid. After examination, local heat therapy was applied for 15 minutes, followed by manual massage for 30 minutes. The paste-like traditional Chinese medicine preparation from Example 1 was evenly applied onto a 10*12cm medical breathable film and then applied to the breast nodules and painful areas, with a thickness of 0.25 cm. The application area should extend at least 2 cm beyond the edge of the lump and redness, with the nipple and areola exposed. The dressing was left on for 3 hours. A scientific diet was provided, and relevant precautions were explained. The patient received treatment once daily. After 3 days, the symptoms significantly improved, the local breast lumps softened, and the body temperature returned to normal. The patient's skin appeared normal, and the axillary lymph nodes were of normal size. There was tenderness upon palpation. Examination of the tongue and pulse revealed a still-red and moist tongue, and a smooth pulse without any adverse signs, only a slightly slippery feel. After 5 days, the symptoms completely disappeared, and the patient showed signs of recovery. Subsequent physical examination revealed no abnormalities.

[0097] Case 2: A 41-year-old female patient, G2P1, 1-0-1-1 (primiparous woman, 2 pregnancies, 1 miscarriage, 1 delivery), exclusively breastfed, presented 5 days post-cesarean section with left breast engorgement and tenderness, palpable lumps, elevated skin temperature, and poor milk flow. Her newborn cried and refused to suckle. Using a breast pump only yielded a small amount of milk. She also experienced swollen and tender axillary lymph nodes, general weakness, and poor sleep. She presented to the breastfeeding clinic. Examination revealed normal development of both breasts, but the left breast was red, swollen, and painful, with lumps of varying sizes and significant local skin tenderness. Enlarged left axillary lymph nodes were also present. Her tongue was red with a yellow coating, and her pulse was wiry and rapid, indicating mastitis. Her temperature was 36.8 degrees Celsius. Blood tests showed a white blood cell count of 8.6 × 10^9 / L, neutrophils 56%, and CRP of 18 mg / L. Breast ultrasound showed no significant abnormalities in either breast. Immediately after the consultation, local heat therapy was applied (a hot towel was applied to both breasts at 50℃ for 15 minutes on each side). After removing the towel, manual massage (kneading method, 15 minutes on each side) was performed. Afterward, a paste-like formula for promoting lactation and reducing lumps was mixed and evenly applied to a 6*7cm medical breathable patch, 0.15cm thick, extending at least 2cm beyond the edges of the lumps and redness, with the nipple and areola exposed. The patch was left on for 1 hour. Instructions were given on proper breastfeeding methods, a healthy diet, suspending the intake of meat-based soups, drinking plenty of warm water, and other relevant precautions. The patient received treatment once daily. After 2 days, symptoms significantly improved, the local breast lumps softened, and body temperature returned to normal. The local skin appeared normal, and the axillary lymph nodes were of normal size. Examination of the tongue and pulse revealed a red and moist tongue, and a floating, thready, and weak pulse. Physical examination revealed no abnormalities.

[0098] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating postpartum milk stasis, characterized in that, The traditional Chinese medicine composition includes the following raw materials: Rehmannia glutinosa (processed), Citrus reticulata peel, Angelica dahurica, Arisaema heterophyllum (processed), Atractylodes lancea (stir-fried with honey and wheat bran), Trichosanthes kirilowii, and Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition for treating postpartum milk stasis according to claim 1, characterized in that: The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-15 parts of Rehmannia glutinosa (processed), 5-15 parts of Citrus reticulata peel, 5-15 parts of Angelica dahurica, 5-15 parts of Arisaema heterophyllum (processed), 5-15 parts of Atractylodes lancea (stir-fried with honey and wheat bran), 5-15 parts of Trichosanthes kirilowii, and 3-8 parts of Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition for treating postpartum milk stasis according to claim 2, characterized in that: The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts Rehmannia glutinosa, 10 parts Citrus reticulata peel, 10 parts Angelica dahurica, 10 parts Arisaema heterophyllum, 10 parts Atractylodes lancea stir-fried with honey and wheat bran, 10 parts Trichosanthes kirilowii, and 5 parts Glycyrrhiza uralensis.

4. The traditional Chinese medicine composition for treating postpartum milk stasis according to claim 1, characterized in that: The traditional Chinese medicine composition is a topical preparation; preferably, the topical preparation is a transdermal drug delivery preparation.

5. The traditional Chinese medicine composition for treating postpartum milk stasis according to claim 4, characterized in that: The topical preparation is one of the following: plaster, poultice, gel, ointment, powder, emulsion, spray, film, liniment, tincture, oil, paste, aerosol, foam, liposome gel, or microemulsion gel.

6. The traditional Chinese medicine composition for treating postpartum milk stasis according to claim 5, characterized in that: The traditional Chinese medicine composition further includes a pharmaceutically acceptable carrier; preferably, the pharmaceutically acceptable carrier is selected from one or more of pharmaceutically acceptable solvents, matrices, transdermal penetration enhancers, thickeners, emulsifiers, preservatives, pH adjusters, or antioxidants.

7. A method for preparing a traditional Chinese medicine composition for treating postpartum milk stasis as described in any one of claims 1-6, characterized in that, The process includes the following steps: mixing prepared Rehmannia root, dried tangerine peel, Angelica dahurica, prepared Arisaema heterophyllum, stir-fried Atractylodes lancea with honey, Trichosanthes kirilowii, and licorice root, and processing them into powder.

8. A traditional Chinese medicine preparation for treating postpartum milk stasis, characterized in that: The traditional Chinese medicine composition for treating postpartum milk stasis as described in any one of claims 1-6 is included; preferably, it further includes an adhesive; more preferably, the mass ratio of the traditional Chinese medicine composition to the adhesive is 1:0.8-1; and / or, the adhesive is selected from one or more of water, vinegar, wine, honey, egg white or glycerin.

9. A method for preparing a traditional Chinese medicine preparation for treating postpartum milk stasis, characterized in that: The traditional Chinese medicine composition for treating postpartum milk stasis according to any one of claims 1-6 is mixed with glycerin and made into a paste to obtain a traditional Chinese medicine preparation for treating postpartum milk stasis.

10. The use of the traditional Chinese medicine composition for treating postpartum milk stasis as described in any one of claims 1-6 and / or the use of the traditional Chinese medicine preparation as described in claim 8 in the preparation of a medicament for mastitis; preferably, the medicament is used by applying it to the affected area after manual massage and local heat therapy.

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