Traditional Chinese medicine patch for external care of postpartum acute mastitis and its preparation method

Abstract

This invention provides a topical herbal patch for postpartum acute mastitis and its preparation method, belonging to the field of traditional Chinese medicine pharmaceutical technology. The patch is composed of *Paris polyphylla*, *Vaccaria segetalis*, *Uncaria rhynchophylla*, *Bombyx mori*, *Mild Glauber's salt*, processed *Evodia rutaecarpa*, *Citrus aurantium*, *Cirsium japonicum*, *Smilax china*, *Siegesbeckia orientalis*, stir-fried *Melia azedarach*, and licorice. Based on a rigorous formula of principal, assistant, and adjuvant herbs, this patch significantly reduces serum TNF-α, IL-1β, and IL-6 levels in mice with postpartum mastitis, and significantly improves the overall clinical efficacy. It rapidly relieves core symptoms such as breast redness, swelling, pain, and induration, clears milk stasis, and possesses multiple effects including anti-inflammatory, anti-swelling, lactation-promoting, and analgesic properties. This herbal patch is a topical care preparation that acts directly on the affected area of ​​the breast. The drug is absorbed transdermally without gastrointestinal metabolism, and its components do not affect the infant through breast milk. This provides a safe, efficient, and convenient new topical care solution for postpartum acute mastitis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine pharmaceutical technology, specifically to a topical Chinese medicine patch for postpartum acute mastitis and its preparation method. Background Technology

[0002] Postpartum acute mastitis is a common acute inflammatory disease of the breast in postpartum lactating women, especially primiparous women 3-4 weeks postpartum. In traditional Chinese medicine, it is called "breast abscess," and its core pathogenesis includes liver qi stagnation, milk stasis, and heat toxin accumulation. Liver qi stagnation is the key pathogenesis; postpartum emotional distress leads to impaired liver function, resulting in qi stagnation, obstruction of the mammary ducts, and the resulting heat and tissue decay leading to abscess formation. Its clinical features include breast lumps, swelling, and pain, accompanied by systemic fever. After ulceration, thick pus discharge may occur. In severe cases, high fever and chills may also occur. Delayed treatment can easily progress to breast suppuration and ulceration, seriously affecting the mother's normal breastfeeding and physical and mental health, and may also lead to long-term complications such as mammary duct damage and recurrent infections. Currently, routine interventions for postpartum acute mastitis are mainly divided into two categories: Western medicine treatment and traditional Chinese medicine therapies. Western medicine mainly treats inflammation with antibiotics, antipyretics, and analgesics. While these can control inflammation in the short term, they pose risks of gastrointestinal irritation and allergies. Furthermore, these medications can be passed to the infant through breast milk, posing a safety risk to breastfeeding mothers.

[0003] Traditional Chinese medicine (TCM) treatment for postpartum acute mastitis adheres to the principle of "internal regulation and external treatment, addressing both the root cause and symptoms." Among these, external therapies have become the preferred clinical option due to their strong targeting, avoidance of gastrointestinal metabolism, and lack of breastfeeding safety concerns. Current external methods mainly include wet compresses of Chinese medicine, powdered applications, and traditional plasters. While these methods possess certain effects in clearing heat and detoxifying, dispersing nodules, and promoting lactation, they still have several drawbacks: First, wet compresses and powdered applications are cumbersome to perform, prone to leakage and staining clothing, have poor drug adhesion, significant loss of effective ingredients, and low transdermal absorption efficiency. Second, most external prescriptions lack rigorous formulation, failing to consider the postpartum constitution of "qi and blood deficiency and liver qi stagnation," focusing only on clearing heat and detoxifying while neglecting the synergistic effects of promoting lactation, dispersing nodules, and regulating liver qi, resulting in a singular therapeutic effect and slow onset of action. Third, some external preparations have poor stability, are difficult to store and carry, and cannot meet the convenience requirements of postpartum home care. Therefore, the present invention aims to provide a scientifically formulated, convenient, and effective solution for postpartum acute mastitis. Summary of the Invention

[0004] (a) Technical problems to be solved

[0005] To address the shortcomings of existing technologies, this invention provides a topical Chinese medicine patch for postpartum acute mastitis and its preparation method.

[0006] (II) Technical Solution

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] This invention provides a topical Chinese medicine patch for postpartum acute mastitis. The patch is composed of the following ingredients in parts by weight: 3-15 parts of Paris polyphylla, 10-30 parts of Vaccaria segetalis, 10-28 parts of Uncaria rhynchophylla, 3-20 parts of Bombyx mori, 3-20 parts of Glauber's salt, 3-20 parts of processed Evodia rutaecarpa, 10-28 parts of Citrus aurantium, 5-25 parts of Cirsium japonicum, 5-25 parts of Smilax china, 3-20 parts of Siegesbeckia orientalis, 3-20 parts of stir-fried Melia toosendan, and 3-15 parts of Glycyrrhiza uralensis.

[0009] Furthermore, the herbal patch is made from the following raw materials in parts by weight: 4-12 parts of Paris polyphylla, 15-25 parts of Vaccaria segetalis, 13-24 parts of Uncaria rhynchophylla, 5-15 parts of Bombyx mori, 5-15 parts of Glauber's salt, 5-15 parts of processed Evodia rutaecarpa, 13-24 parts of Citrus aurantium, 10-20 parts of Cirsium japonicum, 10-20 parts of Smilax china, 8-16 parts of Siegesbeckia orientalis, 8-16 parts of stir-fried Melia toosendan, and 6-12 parts of Glycyrrhiza uralensis.

[0010] Furthermore, the herbal patch is made from the following raw materials in parts by weight: 8 parts of Paris polyphylla, 20 parts of Vaccaria segetalis, 18 parts of Uncaria rhynchophylla, 10 parts of Bombyx mori, 10 parts of Glauber's salt, 10 parts of processed Evodia rutaecarpa, 18 parts of Citrus aurantium, 15 parts of Cirsium japonicum, 15 parts of Smilax china, 12 parts of Siegesbeckia orientalis, 12 parts of stir-fried Melia toosendan, and 9 parts of Glycyrrhiza uralensis.

[0011] This invention provides a method for preparing the traditional Chinese medicine patch, comprising the following steps:

[0012] (1) Weigh each ingredient according to the above proportions, crush hard medicinal materials into coarse powder, and cut flower, stem and leaf medicinal materials into sections for later use;

[0013] (2) Place the processed raw material in a multi-functional extraction tank, add 10 times the amount of purified water and soak for 30 min, bring to a boil over high heat and then simmer over low heat for a total of 2 times: the first time simmer for 2 h, the second time add 8 times the amount of purified water and simmer for 1.5 h, and combine the two decoctions.

[0014] (3) Filter the combined decoction with double gauze, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.10-1.30 (measured at 60℃); add 95% ethanol to the clear extract until the alcohol content reaches 70%, stir evenly, let stand and refrigerate for 24 h, take the supernatant to recover the ethanol under reduced pressure, and continue to concentrate to an extract with a relative density of 1.25-1.30 (measured at 60℃), vacuum dry and pulverize into fine powder to obtain Chinese herbal extract powder for later use;

[0015] (4) Weigh 400-700 parts of hot melt pressure-sensitive adhesive, 50-100 parts of petroleum jelly, and 30-80 parts of lanolin and place them in a water bath. Heat at a constant temperature of 80-85℃ until completely melted and stir until uniform. Slowly add the above-mentioned Chinese herbal extract powder, 10-20 parts of lauryl acetone, and 20-40 parts of menthol to the melt matrix and stir at a constant temperature for 30-40 minutes.

[0016] (5) Transfer the mixed ointment matrix to the coating machine while it is still hot, control the coating thickness to 0.5-1.0 mm, and coat it evenly on the non-woven fabric backing layer. After coating, let it cool naturally to room temperature. After the matrix is ​​completely solidified, cover it with an anti-stick isolation layer.

[0017] The pharmacological effects of each Chinese herbal raw material in the herbal patch of this invention are as follows:

[0018] Paris polyphylla: The dried rhizome of Paris polyphylla or Paris polyphylla var. yunnanensis, both belonging to the Liliaceae family. It has a bitter taste and slightly cold nature. It enters the liver meridian. It has the effects of clearing heat and detoxifying, reducing swelling and relieving pain, cooling the liver and calming the nerves. It is used for boils and carbuncles, sore throat, snake and insect bites, injuries from falls, and infantile convulsions.

[0019] Wang Bu Liu Xing: The dried, mature seeds of *Vaccaria segetalis*, a plant in the Caryophyllaceae family. It has a bitter taste and neutral properties. It enters the liver and stomach meridians. It has the effects of promoting blood circulation and regulating menstruation, promoting lactation and reducing swelling, and promoting urination and relieving strangury. It is used for amenorrhea, dysmenorrhea, insufficient lactation, mastitis with swelling and pain, and painful urination.

[0020] Cat's Claw Herb: The dried tuberous root of *Ranunculus septemlobus*, a plant in the Ranunculaceae family. It has a sweet and pungent taste, and is warm in nature. It enters the liver and lung meridians. It has the effects of resolving phlegm and dissipating nodules, detoxifying and reducing swelling. It is used for scrofula, boils and carbuncles, and snake and insect bites.

[0021] Silkworm larvae (Bombyx mori): The dried body of the 4th-5th instar larvae of the silkworm (Bombyx mori) that have died from infection (or artificial inoculation) with Beauveria bassiana. It has a salty and pungent taste, and is neutral in nature. It enters the liver, lung, and stomach meridians. It has the effects of calming wind and stopping spasms, dispelling wind and relieving pain, and resolving phlegm and dissipating nodules. It is used for liver wind with phlegm, infantile convulsions, tetanus, stroke with facial paralysis, wind-heat headache, red eyes and sore throat, itchy rashes, and mumps.

[0022] Glauber's salt: A crystalline form of Glauber's salt, a sulfate mineral, refined through processing. It mainly contains hydrated sodium sulfate (Na₂SO₄•10H₂O). It tastes salty and bitter, and is cold in nature. It enters the stomach and large intestine meridians. It has the effects of purging and relieving constipation, moistening dryness and softening hard masses, clearing heat and reducing swelling. It is used for stagnation of heat, abdominal distension and pain, constipation, and intestinal abscesses and swelling; externally, it is used to treat mastitis and hemorrhoids.

[0023] Processed Evodia Fruit: The processed product (soaked in licorice water and stir-fried) of the dried nearly ripe fruits of Evodia rutaecarpa, Evodia rutaecarpa var. officinalis or Evodia rutaecarpa var. bodinieri, Rutaceae plants. It is pungent and bitter in taste, and hot in nature. It acts on the liver, spleen, stomach and kidney meridians. It has the effects of dispersing cold and relieving pain, reducing adverse qi and stopping vomiting, and assisting yang to stop diarrhea. It is used for headache due to cold pathogen attacking jueyin meridian, abdominal pain due to cold-induced hernia, beriberi due to cold-dampness, abdominal pain during menstruation, abdominal distension and pain, vomiting and acid regurgitation, and五更 diarrhea.

[0024] Fructus Aurantii Immaturus: The processed product (stir-fried with bran) of the dried immature fruits of Citrus aurantium L. and its cultivated varieties, Rutaceae plants. It is bitter, pungent and sour in taste, and slightly cold in nature. It acts on the spleen and stomach meridians. It has the effects of regulating qi to relieve fullness, promoting qi circulation and relieving distension. It is used for qi stagnation in the chest and hypochondrium, distending pain, indigestion, retention of phlegm-fluid, and prolapse of internal organs.

[0025] Herba Cirsii Japonici: The dried aerial part of Cirsium japonicum DC., Compositae plant. It is sweet and bitter in taste, and cool in nature. It acts on the heart and liver meridians. It has the effects of cooling blood for hemostasis, removing stasis and detoxicating and dissipating swelling. It is used for epistaxis, hematemesis, hematuria, hematochezia, metrorrhagia and metrostaxis, bleeding from trauma, and carbuncles and sores.

[0026] Rhizoma Smilacis Glabrae: The dried rhizome of Smilax china L., Liliaceae plant. It is sweet, slightly bitter and astringent in taste, and neutral in nature. It acts on the liver and kidney meridians. It has the effects of promoting diuresis to remove turbidity, expelling wind and relieving impediment, and detoxicating and removing stasis. It is used for stranguria with turbid discharge, profuse leukorrhea, arthralgia due to wind-dampness, and furuncles and carbuncles.

[0027] Herba Siegesbeckiae: The dried aerial part of Siegesbeckia orientalis L., Siegesbeckia pubescens Makino or Siegesbeckia glabrescens Makino, Compositae plants. It is pungent and bitter in taste, and cold in nature. It acts on the liver and kidney meridians. It has the effects of dispelling wind-dampness, promoting joint movement, and detoxicating. It is used for arthralgia due to wind-dampness, flaccidity of muscles and bones, weakness of waist and knees, paralysis of limbs, hemiplegia, and rubella and eczema.

[0028] Fried Fructus Toosendan: The processed product (stir-fried) of the dried ripe fruits of Melia toosendan Sieb. et Zucc., Meliaceae plant. It is bitter in taste, and cold in nature. It acts on the liver, small intestine and bladder meridians. It has the effects of dispersing the stagnated liver qi and clearing heat, promoting qi circulation and relieving pain, and killing parasites. It is used for stagnation of liver qi transforming into fire, distending pain in the chest and hypochondrium and abdomen, pain due to hernia, and abdominal pain due to intestinal parasites.

[0029] Radix Glycyrrhizae: The dried roots and rhizomes of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L., Leguminosae plants. It is sweet in taste, and neutral in nature. It acts on the heart, lung, spleen and stomach meridians. It has the effects of invigorating the spleen and replenishing qi, clearing heat and detoxicating, resolving phlegm and relieving cough, alleviating pain by relaxing muscles and tendons, and coordinating the actions of various drugs. It is used for weakness of the spleen and stomach, lassitude and weakness, palpitation and shortness of breath, profuse cough with copious phlegm, abdominal pain and spasm of the extremities, carbuncles and sores, and relieving toxicity and potency of drugs.

[0030] (III) Beneficial effects

[0031] This invention provides a topical Chinese medicine patch for postpartum acute mastitis and its preparation method. The patch is composed of Paris polyphylla, Vaccaria segetalis, Uncaria rhynchophylla, Bombyx batryticatus, Glauber's salt, processed Evodia rutaecarpa, Citrus aurantium, Cirsium japonicum, Smilax china, Siegesbeckia orientalis, stir-fried Melia toosendan, and Glycyrrhiza uralensis. The formula uses Paris polyphylla and Vaccaria segetalis as the principal herbs. Paris polyphylla clears heat and detoxifies, reduces swelling and relieves pain, targeting the symptoms of postpartum acute mastitis with excessive heat and toxins, redness, swelling, heat and pain. It can directly penetrate the mammary ducts, clear deep heat and toxins, dissipate stagnation, and quickly relieve breast distension and pain. Vaccaria segetalis invigorates blood circulation, promotes lactation and reduces swelling, targeting the symptoms of postpartum milk stasis and blocked mammary ducts causing breast fullness and insufficient milk flow. The combination of these two herbs, one clearing and the other guiding, one eliminating and the other unblocking, works synergistically to clear heat and detoxify, promote lactation and dissipate stagnation, directly addressing the core pathogenesis of postpartum acute mastitis. With cat's claw herb, silkworm pupae, mirabilite, and immature bitter orange as assistant herbs, cat's claw herb resolves phlegm and dissipates nodules, detoxifies and reduces swelling; silkworm pupae calm wind and stop spasms, dispel wind and relieve pain, resolve phlegm and dissipate nodules. The two herbs work together to specifically target hard lumps in the breast, dissipating phlegm and clearing the meridians; mirabilite pupae purges and promotes bowel movement, moistens dryness and softens hard masses, clears heat and reduces swelling, softening and dissipating hard lumps caused by milk stasis; immature bitter orange regulates qi and relieves chest tightness, promotes circulation and relieves distension, alleviating the feeling of breast fullness, and also regulates the qi mechanism of the middle jiao, assisting the spleen and stomach in digestion. Each of the four assistant herbs has its own strengths, which not only enhance the heat-clearing, detoxifying, lactation-promoting and nodule-dissipating effects of the principal herb, but also regulate the qi mechanism of the spleen and stomach and restrain the bias of the principal herb, making it suitable for the postpartum spleen and stomach weakness. This formula uses Cirsium japonicum, Smilax china, Siegesbeckia orientalis, processed Evodia rutaecarpa, and stir-fried Melia toosendan as adjuvant herbs. Cirsium japonicum cools the blood, stops bleeding, disperses blood stasis, detoxifies, and reduces swelling, thus assisting the principal herbs in enhancing their heat-clearing and detoxifying effects. It also helps to resolve blood stasis and promote blood circulation, cool the blood, and stop bleeding in cases of prolonged postpartum milk stasis. Smilax china dispels wind and dampness, detoxifies, disperses blood stasis, reduces swelling, and relieves pain. Siegesbeckia orientalis dispels wind and dampness, unblocks meridians, and clears heat and detoxifies. Together, they not only help the principal and adjuvant herbs reduce local swelling and toxins in the breast but also clear blockages in the meridians. For rheumatism, this formula prevents the spread of pathogenic factors. Prepared Evodia rutaecarpa dispels cold, relieves pain, soothes the liver, lowers qi, warms the middle jiao, and dries dampness, preventing cold-natured drugs from damaging postpartum yang qi. It also warms and unblocks the meridians, ensuring the entire formula is neither too cold nor too stagnant. Fried Melia toosendan soothes the liver, clears heat, promotes qi circulation, and relieves pain, assisting the assistant herbs in soothing the liver and regulating qi, alleviating breast distension and pain caused by liver qi stagnation. These five adjuvant herbs assist the principal and assistant herbs from different angles, comprehensively covering the pathogenesis of postpartum acute mastitis. Licorice is used as the guiding herb. Licorice is sweet and neutral in nature, tonifying the spleen and stomach, nourishing qi and blood, protecting postpartum qi, and preventing excessive dispersion and coldness of other herbs from damaging qi and blood. It also harmonizes the properties of other herbs in the formula, making them balanced. Furthermore, it guides the herbs directly to the mammary ducts, helping to expel internal heat toxins and stagnation.

[0032] This invention's herbal patch relies on a rigorous formulation based on the principles of monarch, minister, assistant, and guide herbs, and, combined with animal efficacy tests and clinical efficacy verification, possesses the following beneficial effects:

[0033] 1. The herbal patch of this invention can significantly reduce the serum levels of three key inflammatory factors, TNF-α, IL-1β, and IL-6, in mice with a postpartum mastitis model, thereby blocking the inflammatory progression of postpartum mastitis from the root cause.

[0034] 2. The herbal patch of this invention can significantly improve the overall clinical efficacy rate, quickly relieve core symptoms such as breast redness, swelling, pain, and induration, effectively clear stagnant milk, and effectively reduce inflammatory indicators such as serum CRP and WBC. It has multiple effects of anti-inflammatory, swelling-reducing, lactation-promoting, and analgesic properties, and takes effect faster and has a more definite curative effect.

[0035] This invention relates to a traditional Chinese medicine patch, which is a topical nursing preparation. It is applied topically and acts directly on the lesion site of the breast. The drug is absorbed through the skin without being metabolized in the gastrointestinal tract, and the drug components will not affect the infant through breast milk, fully meeting the safe medication needs of breastfeeding women. At the same time, the patch is easy to use and convenient for postpartum home care, greatly improving patient compliance. It provides a safe, efficient, and convenient new topical nursing solution for postpartum acute mastitis. Attached Figure Description

[0036] Figure 1 The serum levels of TNF-α, IL-1β, and IL-6 in mice from each group were compared. Note: Compared with the sham-operated group, * P<0.05, ** P<0.01; compared with the model control group, # P<0.05, ## P<0.01. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0038] Example 1

[0039] A topical herbal patch for postpartum acute mastitis, comprising the following ingredients by weight: 8 parts Paris polyphylla, 20 parts Vaccaria segetalis, 18 parts Uncaria rhynchophylla, 10 parts Bombyx batryticatus, 10 parts Glauber's salt, 10 parts processed Evodia rutaecarpa, 18 parts Citrus aurantium, 15 parts Cirsium japonicum, 15 parts Smilax china, 12 parts Siegesbeckia orientalis, 12 parts stir-fried Melia toosendan, and 9 parts Glycyrrhiza uralensis. The preparation method of the herbal patch includes the following steps:

[0040] (1) Weigh each ingredient according to the above proportions, crush hard medicinal materials into coarse powder, and cut flower, stem and leaf medicinal materials into sections for later use;

[0041] (2) Place the processed raw material in a multi-functional extraction tank, add 10 times the amount of purified water and soak for 30 min, bring to a boil over high heat and then simmer over low heat for a total of 2 times: the first time simmer for 2 h, the second time add 8 times the amount of purified water and simmer for 1.5 h, and combine the two decoctions.

[0042] (3) Filter the combined decoction with double gauze, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.10-1.30 (measured at 60℃); add 95% ethanol to the clear extract until the alcohol content reaches 70%, stir evenly, let stand and refrigerate for 24 h, take the supernatant to recover the ethanol under reduced pressure, and continue to concentrate to an extract with a relative density of 1.25-1.30 (measured at 60℃), vacuum dry and pulverize into fine powder to obtain Chinese herbal extract powder for later use;

[0043] (4) Weigh 500 parts of hot melt pressure-sensitive adhesive, 60 parts of petroleum jelly and 50 parts of lanolin and place them in a water bath. Heat at a constant temperature of 80-85℃ until completely melted and stir until uniform. Slowly add the above-mentioned Chinese herbal extract powder, 15 parts of lauryl acetone and 25 parts of menthol to the melted matrix and stir at a constant temperature for 30-40 minutes.

[0044] (5) Transfer the mixed ointment matrix to the coating machine while it is still hot, control the coating thickness to 0.5-1.0 mm, and coat it evenly on the non-woven fabric backing layer. After coating, let it cool naturally to room temperature. After the matrix is ​​completely solidified, cover it with an anti-stick isolation layer.

[0045] Example 2

[0046] The difference between this embodiment and Embodiment 1 is that the herbal patch is made from the following raw materials in parts by weight: 3 parts of Paris polyphylla, 10 parts of Vaccaria segetalis, 10 parts of Uncaria rhynchophylla, 3 parts of Bombyx mori, 3 parts of Glauber's salt, 3 parts of processed Evodia rutaecarpa, 10 parts of Citrus aurantium, 5 parts of Cirsium japonicum, 5 parts of Smilax china, 3 parts of Siegesbeckia orientalis, 3 parts of stir-fried Melia toosendan, and 3 parts of Glycyrrhiza uralensis.

[0047] Example 3

[0048] The difference between this embodiment and Embodiment 1 is that the herbal patch is made from the following raw materials in parts by weight: 15 parts of Paris polyphylla, 30 parts of Vaccaria segetalis, 28 parts of Uncaria rhynchophylla, 20 parts of Bombyx mori, 20 parts of Glauber's salt, 20 parts of processed Evodia rutaecarpa, 28 parts of Citrus aurantium, 25 parts of Cirsium japonicum, 25 parts of Smilax china, 20 parts of Siegesbeckia orientalis, 20 parts of stir-fried Melia toosendan, and 15 parts of Glycyrrhiza uralensis.

[0049] Example 4

[0050] The difference between this embodiment and Embodiment 1 is that the herbal patch is made from the following raw materials in parts by weight: 5 parts of Paris polyphylla, 12 parts of Vaccaria segetalis, 12 parts of Uncaria rhynchophylla, 5 parts of Bombyx mori, 5 parts of Glauber's salt, 6 parts of processed Evodia rutaecarpa, 13 parts of Citrus aurantium, 7 parts of Cirsium japonicum, 8 parts of Smilax china, 6 parts of Siegesbeckia orientalis, 4 parts of stir-fried Melia toosendan, and 5 parts of Glycyrrhiza uralensis.

[0051] Example 5

[0052] The difference between this embodiment and Embodiment 1 is that the herbal patch is made from the following raw materials in parts by weight: 10 parts of Paris polyphylla, 21 parts of Vaccaria segetalis, 18 parts of Uncaria rhynchophylla, 12 parts of Bombyx mori, 9 parts of Glauber's salt, 10 parts of processed Evodia rutaecarpa, 18 parts of Citrus aurantium, 14 parts of Cirsium japonicum, 16 parts of Smilax china, 12 parts of Siegesbeckia orientalis, 8 parts of stir-fried Melia toosendan, and 10 parts of Glycyrrhiza uralensis.

[0053] Example 6

[0054] The difference between this embodiment and Embodiment 1 is that the herbal patch is made from the following raw materials in parts by weight: 13 parts of Paris polyphylla, 28 parts of Vaccaria segetalis, 25 parts of Uncaria rhynchophylla, 18 parts of Bombyx mori, 18 parts of Glauber's salt, 17 parts of processed Evodia rutaecarpa, 26 parts of Citrus aurantium, 22 parts of Cirsium japonicum, 22 parts of Smilax china, 18 parts of Siegesbeckia orientalis, 16 parts of stir-fried Melia toosendan, and 12 parts of Glycyrrhiza uralensis.

[0055] Example 7

[0056] The difference between this embodiment and Embodiment 1 is that the herbal patch is made from the following raw materials in parts by weight: 12 parts of Paris polyphylla, 25 parts of Vaccaria segetalis, 22 parts of Uncaria rhynchophylla, 15 parts of Bombyx mori, 15 parts of Glauber's salt, 13 parts of processed Evodia rutaecarpa, 23 parts of Citrus aurantium, 20 parts of Cirsium japonicum, 19 parts of Smilax china, 15 parts of Siegesbeckia orientalis, 12 parts of stir-fried Melia toosendan, and 10 parts of Glycyrrhiza uralensis.

[0057] Example 8

[0058] The difference between this embodiment and Embodiment 1 is that the herbal patch is made from the following raw materials in parts by weight: 8 parts of Paris polyphylla, 15 parts of Vaccaria segetalis, 14 parts of Uncaria rhynchophylla, 8 parts of Bombyx mori, 6 parts of Glauber's salt, 7 parts of processed Evodia rutaecarpa, 16 parts of Citrus aurantium, 9 parts of Cirsium japonicum, 10 parts of Smilax china, 8 parts of Siegesbeckia orientalis, 6 parts of stir-fried Melia toosendan, and 8 parts of Glycyrrhiza uralensis.

[0059] Experimental Example 1

[0060] 1 Experimental Methods

[0061] 1.1 Experimental Drugs

[0062] All test substances used in this experiment were prepared according to the preparation method described in Example 1. The pharmaceutical composition of each test substance is as follows, with each part by weight calculated as 1 g:

[0063] Test substance 1: 8 parts of Paris polyphylla, 20 parts of Vaccaria segetalis, 18 parts of Uncaria rhynchophylla, 10 parts of Bombyx mori, 10 parts of Glauber's salt, 10 parts of processed Evodia rutaecarpa, 18 parts of Citrus aurantium, 15 parts of Cirsium japonicum, 15 parts of Smilax china, 12 parts of Siegesbeckia orientalis, 12 parts of stir-fried Melia toosendan, and 9 parts of Glycyrrhiza uralensis.

[0064] Test substance 2: 20 parts of Vaccaria segetalis, 10 parts of Bombyx mori, 10 parts of Glauber's salt, 10 parts of processed Evodia rutaecarpa, 18 parts of Citrus aurantium, 15 parts of Cirsium japonicum, 15 parts of Smilax china, 12 parts of Siegesbeckia orientalis, 12 parts of stir-fried Melia toosendan, and 9 parts of Glycyrrhiza uralensis.

[0065] Test substance 3: 8 parts of Paris polyphylla, 18 parts of Uncaria rhynchophylla, 10 parts of Bombyx mori, 10 parts of Glauber's salt, 10 parts of processed Evodia rutaecarpa, 18 parts of Citrus aurantium, 15 parts of Cirsium japonicum, 12 parts of Siegesbeckia orientalis, and 9 parts of Glycyrrhiza uralensis.

[0066] Test substance 4: 8 parts of Paris polyphylla, 20 parts of Vaccaria segetalis, 18 parts of Uncaria rhynchophylla, 10 parts of Glauber's salt, 15 parts of Cirsium japonicum, 15 parts of Smilax china, 12 parts of Siegesbeckia orientalis, 12 parts of stir-fried Melia toosendan, and 9 parts of Glycyrrhiza uralensis.

[0067] Test substance 5: 8 parts of Paris polyphylla, 20 parts of Vaccaria segetalis, 18 parts of Uncaria rhynchophylla, 10 parts of Bombyx mori, 10 parts of processed Evodia rutaecarpa, 18 parts of Citrus aurantium, 15 parts of Smilax chinaberry, 12 parts of stir-fried Melia toosendan, and 9 parts of Glycyrrhiza uralensis.

[0068] 1.2 Grouping, Modeling, and Drug Administration of Experimental Animals

[0069] Seventy-two healthy 8-week-old SPF-grade BALB / c mice were selected, including 48 females and 24 males, with a body weight of 24±2 g. After one week of acclimatization, the mice were mated overnight in a 2:1 female-to-male ratio. Modeling experiments were conducted after the females gave birth. 72 hours postpartum, the mothers and pups were separated and fasted for 3 hours before being randomly divided into a sham-operated group, a model control group, a positive control group, and test substance groups 1-5, with six mice in each group.

[0070] Female mice were anesthetized with isoflurane gas and fixed in a supine position with their nipples exposed. After local disinfection with alcohol swabs, the nipple tips were cut off by 1 mm to fully expose the mammary ducts. Except for the sham-operated group, 50 μL of 0.2 g / L lipopolysaccharide (LPS) was injected into the mammary ducts of all other groups using a microsyringe to establish the model. After injection, the mammary glands were massaged to ensure even distribution of the injected solution.

[0071] Drug intervention began the day after successful model establishment and continued for 7 days, once daily, with each application lasting 6 hours. The positive control group received 100 mg / kg body weight of ceftriaxone sodium; for test drug groups 1-5, the corresponding traditional Chinese medicine patches were precisely applied to the mammary gland area of ​​the mice modeling, with local hair removed and the skin disinfected with alcohol before application to ensure close adhesion between the patch and the skin without falling off; the sham surgery group and the model control group received only an equal area of ​​blank matrix patch, with the operation procedure and application time being consistent with the test drug groups.

[0072] 1.3 Detection of serum inflammatory factors in mice using ELISA

[0073] After the last administration, all mice were fasted for 12 h and anesthetized with isoflurane gas. Blood samples were collected using the orbital blood sampling method. After the blood samples were allowed to stand, they were centrifuged at 3500 rpm for 15 min at 4 °C and the serum supernatant was separated. The serum levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6) were detected strictly in accordance with the instructions of the ELISA kit.

[0074] 1.4 Statistical Methods

[0075] Data analysis was performed using GraphPad Prism 8.0 statistical software. All data are expressed as mean ± standard deviation. One-way ANOVA was used for comparisons among multiple groups, and P < 0.05 was considered statistically significant.

[0076] 2 Results

[0077] Depend on Figure 1 It was found that, compared with the sham-operated group, the serum levels of TNF-α, IL-1β, and IL-6 in the model control group were significantly increased, with highly statistically significant differences (P<0.01), indicating that the mouse model of postpartum mastitis was successfully established. Compared with the model control group, the serum levels of TNF-α, IL-1β, and IL-6 in test substance groups 1-2 and 4 were significantly decreased, with highly statistically significant differences (P<0.01); the serum levels of TNF-α and IL-6 in test substance group 3 were significantly decreased (P<0.05 or P<0.01), and the IL-1β level showed a decreasing trend, but the difference was not statistically significant (P>0.05); the serum level of TNF-α in test substance group 5 was significantly decreased (P<0.01), and the levels of IL-1β and IL-6 showed a decreasing trend, but the difference was not statistically significant (P>0.05).

[0078] 3. Conclusion

[0079] This experiment established an LPS-induced mouse model of postpartum mastitis and evaluated the anti-inflammatory efficacy of the herbal patch of this invention using serum TNF-α, IL-1β, and IL-6 as key inflammatory factors. The results showed that all five tested herbal patches exhibited varying degrees of anti-inflammatory activity, with patch group 1 showing the most significant anti-inflammatory effect, simultaneously and significantly reducing serum TNF-α, IL-1β, and IL-6 levels in mice. This result indicates that the rational combination of the herbs in the herbal patch of this invention is the core of achieving synergistic anti-inflammatory and targeted treatment of postpartum mastitis. The absence of any herb directly weakens its overall anti-inflammatory efficacy, confirming the scientific basis of the principal, assistant, adjuvant, and guide formula in this invention.

[0080] Experimental Example 2

[0081] 1. Materials and Methods

[0082] 1.1 General Information

[0083] Seventy patients with postpartum acute mastitis were selected as the study subjects according to the inclusion and exclusion criteria. They were randomly divided into a control group and an observation group, with 35 patients in each group. The general characteristics of the two groups were compared (Table 1), and there were no statistically significant differences between the two groups, indicating that they were comparable.

[0084] Table 1 General information of the two groups of patients

[0085]

[0086] 1.2 Inclusion and Exclusion Criteria

[0087] Inclusion criteria: women aged 22-40 years who are postpartum and lactating; who meet the diagnostic criteria for acute postpartum mastitis (stasis stage / early stage of heat toxicity), with redness, swelling and pain in one or both breasts, palpable lumps, and obstructed milk flow; disease duration ≤72 hours, not progressing to the suppurative and ulcerated stage; and who voluntarily participate in this study and sign an informed consent form.

[0088] Exclusion criteria: Patients with purulent or ulcerated breast tissue, or those with other breast diseases such as breast hyperplasia or fibroadenoma; patients with allergies to the Chinese medicines and excipients used in this study or those with allergic constitutions; patients with underlying diseases such as severe liver or kidney dysfunction, cardiovascular or cerebrovascular diseases, or coagulation disorders; patients who have used antibiotics, anti-inflammatory analgesics, or galactagogues within 72 hours prior to treatment; and patients with poor compliance who are unable to complete the various test indicators.

[0089] 1.3 Treatment methods

[0090] None of the patients progressed to the suppurative stage, so no antibiotics were used. Both groups of patients received basic routine treatment, and then the grouped treatment was implemented on this basis.

[0091] Basic routine treatment: (1) Breastfeeding guidance: Instruct patients to breastfeed on demand and maintain a regular breastfeeding frequency; after breastfeeding, use a breast pump or manual method to empty the remaining milk and reduce milk stasis.

[0092] (2) Daily care: Instruct the patient to drink plenty of water, eat light and high-protein foods, and avoid spicy, greasy and cold foods; at the same time, ensure sufficient sleep and keep a cheerful mood; avoid pressure or squeezing of the breast.

[0093] Control group: In addition to basic routine intervention, dandelion granules were taken orally, one sachet (specification: 15 g) three times a day for 7 consecutive days.

[0094] Observation group: In addition to the control group, the herbal patch of the present invention (prepared according to the weight ratio and method described in Example 1) was applied. The method of application of the patch is as follows: clean the breast skin and dry it, apply the patch to the red, swollen and hardened area of ​​the breast, once a day, for 6-8 hours each time, for 7 consecutive days.

[0095] 1.4 Observation Indicators

[0096] 1.4.1 Clinical efficacy

[0097] Efficacy evaluation criteria were formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines".

[0098] Recovery: The redness, swelling, pain, and lumps in the breast completely disappear; milk drainage is smooth; general discomfort symptoms subside; and inflammatory markers return to normal.

[0099] Significant effect: Breast redness, swelling and pain are significantly relieved, nodules shrink by ≥70%, milk excretion is basically unobstructed, and inflammatory indicators are significantly improved;

[0100] Effective: Breast redness, swelling and pain are relieved, lumps shrink by 30%-70%, milk excretion is smoother than before, and inflammatory indicators are improved;

[0101] Ineffective: Symptoms, signs, and inflammatory markers do not improve or even worsen.

[0102] Overall effective rate = (Number of cured cases + Number of cases with significant improvement + Number of effective cases) / Total number of cases × 100%

[0103] 1.4.2 Pain Intensity Score

[0104] The degree of breast pain in the two groups of patients was assessed using the Visual Analogue Scale (VAS) before and after treatment. The score ranged from 0 to 10, with higher scores indicating more severe pain.

[0105] 1.4.3 Breast Symptom Score

[0106] The hardness of the breast lump, milk excretion, and local skin color and temperature were scored before and after treatment in both groups of patients. The total score was calculated by adding up the scores of each item. The lower the total score, the better the breast symptoms.

[0107] Breast lump hardness: 0 points (no lump); 3 points (soft, slightly harder than normal glandular tissue); 6 points (firm like the tip of the nose); 9 points (hard like the forehead).

[0108] Milk excretion status: 0 points (normal milk excretion); 3 points (mostly normal milk excretion); 6 points (milk is excreted, but not smoothly); 9 points (difficulty in milk excretion).

[0109] Local skin color and temperature: 0 points (normal skin color, no local heat sensation); 3 points (normal skin color, slight local heat sensation); 6 points (slightly red skin color or local burning sensation); 9 points (bright red skin color, unbearable local burning sensation).

[0110] 1.4.4 Serum CRP and WBC levels

[0111] Fasting venous blood was collected from both groups of patients in the morning before and after treatment. Serum C-reactive protein (CRP) and white blood cell count (WBC) levels were measured using a fully automated biochemical analyzer and a blood cell analyzer.

[0112] 1.5 Statistical Methods

[0113] Data analysis was performed using GraphPad Prism 8.0 statistical software. All data are expressed as mean ± standard deviation. Paired t-tests were used for comparisons within groups before and after treatment, and independent samples t-tests were used for pairwise comparisons between groups. Count data were expressed as percentages (%) and analyzed using the χ² test. P < 0.05 was considered statistically significant.

[0114] 2 Results

[0115] 2.1 Clinical efficacy

[0116] As shown in Table 2, the total effective rate of clinical treatment in the observation group was 94.29%, which was significantly higher than that in the control group (77.14%) (P<0.05), indicating that the herbal patch of the present invention can significantly improve the clinical treatment effect of postpartum acute mastitis.

[0117] Table 2 Comparison of clinical efficacy between the two groups

[0118]

[0119] 2.2 Comparison of VAS pain scores

[0120] As shown in Table 3, there was no statistically significant difference in VAS scores between the two groups before treatment (P>0.05). After treatment, although the VAS score in the control group decreased, the difference was not statistically significant (P>0.05), while the VAS score in the observation group decreased significantly (P<0.01). In the inter-group comparison after treatment, the VAS score in the observation group was significantly lower than that in the control group (P<0.01), indicating that the herbal patch of the present invention has a significant analgesic effect and can effectively relieve breast pain symptoms in patients with postpartum acute mastitis.

[0121] 2.3 Comparison of breast symptom scores

[0122] As shown in Table 3, there was no significant difference in the total breast symptom scores between the two groups before treatment (P>0.05); after treatment, the total breast symptom scores of both groups decreased significantly (P<0.05), and the comparison between the groups showed that the total breast symptom score of the observation group was significantly lower than that of the control group (P<0.05), indicating that the herbal patch of the present invention can more effectively eliminate breast nodules, promote milk drainage, and relieve local redness, swelling and burning sensation.

[0123] Table 3 Comparison of breast VAS scores and total breast symptom scores between the two groups of patients

[0124]

[0125] Note: Compared with the group before treatment. * P<0.05, ** P<0.01.

[0126] 2.4 Serum inflammatory marker levels

[0127] As shown in Table 4, there was no significant difference in serum CRP and WBC levels between the two groups before treatment (P>0.05); after treatment, serum CRP and WBC levels in both groups decreased significantly (P<0.05 or P<0.01), and the inter-group comparison showed that the levels of the above inflammatory indicators in the observation group were significantly lower than those in the control group (P<0.05 or P<0.01), indicating that the herbal patch of the present invention can work synergistically with oral medication to further inhibit the body's inflammatory response and has a more prominent anti-inflammatory effect.

[0128] Table 4 Comparison of serum CRP and WBC levels between the two groups of patients

[0129]

[0130] Note: Compared with the group before treatment. * P<0.05, ** P<0.01.

[0131] 3. Conclusion

[0132] This trial targeted postpartum acute mastitis patients in the non-suppurative stage. In addition to routine intervention and oral administration of dandelion granules, the application of this invention's herbal patch significantly improved the overall clinical efficacy, alleviated symptoms such as breast pain, redness, and induration, and facilitated milk flow. Simultaneously, it effectively reduced serum CRP and WBC levels, demonstrating significant anti-inflammatory, anti-swelling, lactation-promoting, and analgesic effects. Compared to oral medication alone, the combined use of the patch achieves a synergistic effect of "oral + external," targeting the affected breast area and providing a rapid and effective treatment option for postpartum acute mastitis.

[0133] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A topical Chinese medicine patch for postpartum acute mastitis, characterized in that, The herbal patch is composed of the following ingredients in parts by weight: 3-15 parts of Paris polyphylla, 10-30 parts of Vaccaria segetalis, 10-28 parts of Uncaria rhynchophylla, 3-20 parts of Bombyx mori, 3-20 parts of Glauber's salt, 3-20 parts of processed Evodia rutaecarpa, 10-28 parts of Citrus aurantium, 5-25 parts of Cirsium japonicum, 5-25 parts of Smilax china, 3-20 parts of Siegesbeckia orientalis, 3-20 parts of stir-fried Melia toosendan, and 3-15 parts of Glycyrrhiza uralensis.

2. The topical Chinese medicine patch for postpartum acute mastitis according to claim 1, characterized in that, The herbal patch is made from the following raw materials in parts by weight: 4-12 parts of Paris polyphylla, 15-25 parts of Vaccaria segetalis, 13-24 parts of Uncaria rhynchophylla, 5-15 parts of Bombyx mori, 5-15 parts of Glauber's salt, 5-15 parts of processed Evodia rutaecarpa, 13-24 parts of Citrus aurantium, 10-20 parts of Cirsium japonicum, 10-20 parts of Smilax china, 8-16 parts of Siegesbeckia orientalis, 8-16 parts of stir-fried Melia toosendan, and 6-12 parts of Glycyrrhiza uralensis.

3. The topical Chinese medicine patch for postpartum acute mastitis according to claim 1, characterized in that, The herbal patch is made from the following ingredients in parts by weight: 8 parts of Paris polyphylla, 20 parts of Vaccaria segetalis, 18 parts of Uncaria rhynchophylla, 10 parts of Bombyx mori, 10 parts of Glauber's salt, 10 parts of processed Evodia rutaecarpa, 18 parts of Citrus aurantium, 15 parts of Cirsium japonicum, 15 parts of Smilax china, 12 parts of Siegesbeckia orientalis, 12 parts of stir-fried Melia toosendan, and 9 parts of Glycyrrhiza uralensis.

4. The method for preparing the traditional Chinese medicine patch according to any one of claims 1 to 3, characterized in that, Includes the following steps: (1) Weigh each ingredient according to the above proportions, crush hard medicinal materials into coarse powder, and cut flower, stem and leaf medicinal materials into sections for later use; (2) Place the processed raw material in a multi-functional extraction tank, add 10 times the amount of purified water and soak for 30 min, bring to a boil over high heat and then simmer over low heat for a total of 2 times: the first time simmer for 2 h, the second time add 8 times the amount of purified water and simmer for 1.5 h, and combine the two decoctions. (3) Filter the combined decoction with double gauze, concentrate the filtrate under reduced pressure to a clear extract with a relative density of 1.10-1.30 (measured at 60℃); add 95% ethanol to the clear extract until the alcohol content reaches 70%, stir evenly, let stand and refrigerate for 24 h, take the supernatant to recover the ethanol under reduced pressure, and continue to concentrate to an extract with a relative density of 1.25-1.30 (measured at 60℃), vacuum dry and pulverize into fine powder to obtain Chinese herbal extract powder for later use; (4) Weigh 400-700 parts of hot melt pressure-sensitive adhesive, 50-100 parts of petroleum jelly, and 30-80 parts of lanolin and place them in a water bath. Heat at a constant temperature of 80-85℃ until completely melted and stir until uniform. Slowly add the above-mentioned Chinese herbal extract powder, 10-20 parts of lauryl acetone, and 20-40 parts of menthol to the melt matrix and stir at a constant temperature for 30-40 minutes. (5) Transfer the mixed ointment matrix to the coating machine while it is still hot, control the coating thickness to 0.5-1.0 mm, and coat it evenly on the non-woven fabric backing layer. After coating, let it cool naturally to room temperature. After the matrix is ​​completely solidified, cover it with an anti-stick isolation layer.

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