Traditional Chinese medicine composition and traditional Chinese medicine preparation for clearing away heat and toxic materials, regulating qi and promoting lactation and removing stasis and diminishing swelling

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition and a traditional Chinese medicine preparation for clearing away heat and toxic materials, regulating qi and promoting lactation, and removing stasis and diminishing swelling, and the traditional Chinese medicine composition is prepared from the following raw material medicines: radix paeoniae rubra, selfheal, perilla stem, cowherb seed, fried gardenia, radix curcumae and raw liquorice. The traditional Chinese medicine composition and the traditional Chinese medicine preparation are used for clearing away heat and toxic materials, regulating qi and promoting lactation, and removing stasis and diminishing swelling according to etiology and pathogenesis of acute mastitis closely related to liver and stomach, and the curative effect on acute mastitis is remarkable.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition and a traditional Chinese medicine preparation for clearing away heat and detoxifying, regulating qi and promoting lactation, and removing blood stasis and relieving swelling. Background Art

[0002] Acute mastitis is an acute suppurative breast disease that occurs in lactating women. It is equivalent to the category of "external milk abscess" in traditional Chinese medicine. It is mainly manifested by breast swelling, pain, skin redness and lumps. Some patients will have systemic symptoms such as fever. As we all know, breastfeeding is a natural infant feeding method strongly recommended by the World Health Organization (WHO) and the United Nations International Children's Emergency Fund (UNICEF) to promote the healthy growth of infants and children around the world. In addition, some countries have established breastfed infants as a norm for assessing compliance with the right of children to fully develop their genetic growth potential. As advocated by WHO, breastfeeding is the preferred way for newborns under 6 months old, which is beneficial to both mothers and babies. Epidemiological surveys show that about 3-33% of breastfeeding women have suffered from acute mastitis, especially 6 months after delivery. If it is not treated promptly and correctly, it will seriously affect or even terminate breastfeeding, reducing the protective effect on mothers and babies.

[0003] At present, there are also some literature reports using some Chinese medicines for treating acute mastitis. In CN 115671250 A, cooked rehmannia, antler glue, cinnamon bark, roasted ginger charcoal, white mustard, ephedra, raw licorice, raw licorice, Vaccaria, Leonurus japonica, and Tubei are used to make decoctions, granules, pills, or oral liquids. In CN102784304B, small three needles, radix scutellariae, root of nobilis, rhizoma anemarrhenae, trachelospermi schrenkiana, dwarf tuo, radix scutellariae, Vaccaria, Atractylodes macrocephala, green peel, and dendrobium are used to make decoctions for oral administration; in CN108785422B, red peony root, whole trichosanthes root, dandelion, stir-fried Vaccaria, Fructus lycopersicaceae, Gleditsia sinensis, vinegar green peel, baicalin, bupleurum, and raw licorice are used to make decoctions for oral administration. Although there are still some similar Chinese medicine prescriptions for treating acute mastitis, they still do not meet the current clinical needs.

[0004] In view of this, the present invention is proposed. Summary of the invention

[0005] In order to overcome the deficiencies in the above-mentioned prior art, the present invention aims at the characteristics that the occurrence of acute mastitis is closely related to the liver and stomach, and proposes a Chinese medicine composition and Chinese medicine preparation for clearing away heat and detoxifying, regulating qi and promoting lactation, and removing blood stasis and reducing swelling, which can effectively treat acute mastitis.

[0006] The first aspect of the present invention provides a traditional Chinese medicine composition for clearing away heat and detoxifying, regulating qi and promoting lactation, removing blood stasis and relieving swelling. The traditional Chinese medicine composition is composed of the following raw materials: red peony root, selfheal, perilla stem, fenugreek, stir-fried gardenia, curcuma, and raw licorice.

[0007] As a preferred technical solution of the present invention, the Chinese medicine composition is composed of the following raw materials in parts by weight: 12-18 parts by weight of red peony root, 6-10 parts by weight of selfheal, 4-10 parts by weight of perilla stem, 4-10 parts by weight of fenugreek, 4-10 parts by weight of stir-fried gardenia, 4-10 parts by weight of curcuma, and 4-10 parts by weight of raw licorice.

[0008] As a preferred technical solution of the present invention, the Chinese medicine composition is composed of the following raw materials in parts by weight: 12-16 parts by weight of red peony root, 8-10 parts by weight of selfheal, 4-8 parts by weight of perilla stem, 4-8 parts by weight of fenugreek, 4-8 parts by weight of stir-fried gardenia, 4-8 parts by weight of curcuma, and 8-15 parts by weight of raw licorice.

[0009] As a preferred technical solution of the present invention, the Chinese medicine composition is composed of the following raw materials in parts by weight: 15-18 parts by weight of red peony root, 6-9 parts by weight of selfheal, 6-10 parts by weight of perilla stem, 6-10 parts by weight of fenugreek, 6-10 parts by weight of stir-fried gardenia, 6-10 parts by weight of curcuma, and 4-8 parts by weight of raw licorice.

[0010] As a preferred technical solution of the present invention, the Chinese medicine composition is composed of the following raw materials in parts by weight: 15-16 parts by weight of red peony root, 8-9 parts by weight of selfheal, 5-7 parts by weight of perilla stem, 5-7 parts by weight of fenugreek, 5-7 parts by weight of stir-fried gardenia, 5-7 parts by weight of curcuma, and 5-7 parts by weight of raw licorice.

[0011] As a preferred technical solution of the present invention, the Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts by weight of red peony root, 9 parts by weight of selfheal, 6 parts by weight of perilla stem, 6 parts by weight of fenugreek, 6 parts by weight of stir-fried gardenia, 6 parts by weight of curcuma, and 6 parts by weight of raw licorice.

[0012] During use, the raw material drug components can be mixed and then soaked in water according to the conventional decoction method of traditional Chinese medicine in the art, and then the soaked raw material drug component mixture is decocted for a certain time, and then the decoction is poured out, and then water is added to the drug residue and decocted again for a certain time, and the decoction is poured out again, and finally the two decoctions are mixed together. The decoction time is, for example, 30 minutes to 50 minutes, preferably 40 minutes.

[0013] In practical applications, the Chinese medicine composition of the present invention can be used as a Chinese medicine package and provided to patients for direct decoction to obtain a decoction, or the decoction of the Chinese medicine composition obtained by the above preparation method can be directly provided to patients for consumption.

[0014] As a preferred technical solution of the present invention, the dosage form of the Chinese medicine composition is a decoction, granules, tablets, pills or oral liquid. The Chinese medicine composition of the present invention can be prepared into a Chinese medicine oral preparation by conventional methods of Chinese medicine preparations, for example, the raw medicine is decocted in water to prepare a decoction; the decoction can also be dried to prepare a dry extract powder, and appropriate excipients are added to the extract powder, and the conventional pharmaceutical methods of those skilled in the art are used to prepare granules, tablets, pills or oral liquids.

[0015] The second aspect of the present invention provides a traditional Chinese medicine preparation, which includes the traditional Chinese medicine composition provided by the first aspect of the present invention.

[0016] As a preferred technical solution of the present invention, the Chinese medicine preparation also includes excipients, which include starch, lactose, dextrin, powdered sugar, microcrystalline cellulose, mannitol, xylitol, polyethylene glycol, calcium sulfate, calcium hydrogen phosphate, calcium carbonate, modified starch, sorbitol, polyvinyl pyrrolidone, heavy magnesium carbonate, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, methyl cellulose, ethyl cellulose, sodium carboxymethyl starch, hydroxypropyl cellulose, povidone K30, white clay, pregelatinized starch, magnesium stearate, talc, micropowder silica gel, stevioside, betaine, aspartame, glycyrrhizin, sodium saccharin, citric acid, sorbic acid, potassium sorbate, ethyl hydroxybenzoate, sucrose, starch slurry, syrup, guar gum, stevioside, sodium alginate, maltose, citric acid, malic acid, sucralose, menthol, coffee powder, monoglyceride, magnesium lauryl sulfate, beta-cyclodextrin, etc.

[0017] The present invention also provides the use of the Chinese medicine composition of the first aspect or the Chinese medicine preparation of the second aspect in the preparation of a medicine, wherein the medicine is used to prevent and / or treat the symptoms of acute mastitis, wherein the symptoms are selected from breast pain, breast lumps and poor milk discharge.

[0018] In a preferred embodiment of the present invention, the method of taking the medicine for treating acute mastitis of the present invention is: oral, twice a day. At the same time, it can be supplemented with Western medicine treatment, such as cefdinir, cefixime, cefoperazone sodium, penicillin G, mezlocillin and other antibiotics, and acetaminophen for antipyretic and analgesic. During the treatment process, combined with the changes in the patient's condition, Chinese medicine external application, acupuncture acupoints, fire needles, massage, moxibustion and other comprehensive Chinese medicine treatments are given, and at the same time, the cause of the disease is treated to control diet, regulate emotions, and supplemented with health education, and 3 days is a course of treatment.

[0019] In the prescription of the Chinese medicine composition and Chinese medicine preparation of the present invention, red peony root is the monarch, bitter and cold in nature and flavor, enters the blood of liver meridian, can clear liver fire, cool blood and stop bleeding; Prunella vulgaris is the minister, has the function of dispersing stagnation and reducing swelling, and has the functions of clearing heat and detoxifying. Red peony root is matched with Prunella vulgaris, the former removes blood stasis from the blood, and the latter removes blood stasis by moving qi, which is critical for the pathogenesis of early stage of mastitis with coexistence of blood stasis and heat, and mainly blood stasis. It is supplemented with Perilla stem, Vaccaria segetalis, stir-fried Gardenia jasminoides, and Curcuma aromatica. Perilla stem has the functions of regulating qi and relieving pain, soothing the liver and relieving depression, and promoting qi and blood circulation. In the prescription, red peony root is matched with Perilla stem, the former is good at clearing the stagnant heat of blood, and can activate blood circulation and remove blood stasis, and the latter is good at promoting qi and dispersing stagnation. The two medicines are used together to play the functions of clearing heat, reducing swelling and dispersing stagnation. Stir-fried Gardenia jasminoides is bitter in taste, cold in nature, and enters the heart, lung and triple burner meridians. It has the functions of clearing heat and removing toxicity compared with raw use. Curcuma is pungent, bitter and cold, and belongs to the heart, liver and lung meridians. Curcuma can not only promote blood circulation and remove blood stasis, but also regulate qi and relieve depression. It is a qi medicine in the blood and has a good analgesic and antispasmodic effect. It is pungent, dispersing, bitter and cold in nature, and has the effects of clearing the heart, smoothing qi and reducing fire. It can be combined with fried gardenia to enhance the effect of relieving depression and relieving restlessness. Vaccaria is in the liver and stomach meridians, runs in the blood, is bitter and purgative, runs without staying, and promotes blood circulation and lactation. The drug is made into licorice, which can clear away heat and detoxify, and can also reconcile various medicines.

[0020] The Chinese medicine composition and Chinese medicine preparation of the present invention treat acute mastitis for the following mechanism of action: the occurrence of acute mastitis is closely related to the liver and stomach. The liver is responsible for regulating the flow of qi, regulating emotions, assisting the spleen and stomach to rise and fall, and regulating milk secretion. If the liver fails to regulate the flow of qi, the qi of the foot jueyin meridian is blocked, resulting in dysfunction of the spleen and stomach to rise and fall, fumigation of Yangming meridian heat, and mutual influence of liver depression and stomach heat. Therefore, in the treatment of the initial stage of this disease, attention should be paid to clearing the fire of the liver and stomach, unblocking the qi of blood stasis, and dispersing blood stasis when milk is unblocked, and eliminating toxicity when congestion is eliminated. In view of its pathogenesis, the prescription ideas are to clear away heat and toxic substances, regulate qi and promote milk secretion, and remove blood stasis and reduce swelling.

[0021] The Chinese medicine composition and Chinese medicine preparation of the present invention have the effects of clearing away heat and detoxifying, regulating qi and promoting lactation, removing blood stasis and relieving swelling. Acute mastitis patients have breast swelling and pain, or lumps, unchanged or slightly red skin color, poor milk discharge, accompanied by aversion to cold and fever, headache, body aches, thirst, constipation, normal or red tongue, thin white or thin yellow tongue coating, floating or stringy pulse, etc. The Chinese medicine preparation can be used by patients in the acute inflammatory stage who are diagnosed as qi stagnation and heat congestion.

[0022] The Chinese medicine composition and Chinese medicine preparation of the present invention have remarkable curative effect and can effectively treat acute mastitis. Compared with the Shaoyao Gualou Gancao Decoction (composed of red peony root, whole Gualou, dandelion, stir-fried Vaccaria, Fructus Liquidamina, Gleditsiae Spinosae, Vinegar Peel, Scutellariae Baicalensis, Radix Bupleuri, and Radix Glycyrrhizae) (patent No. CN108785422B), although both have red peony root, Vaccariae Spinosae, and Vinegar Peel, the dandelion, Fructus Liquidaminae, and Scutellariae Baicalensis in the Shaoyao Gualou Gancao Decoction focus on clearing away heat and detoxicating, while Fructus Liquidaminae, Vinegar Peel, and Radix Bupleuri focus on regulating qi and promoting lactation. The present invention uses Perilla stem to regulate qi and relieve pain, soothe the liver and relieve depression, and promote qi and blood circulation, and is matched with red peony root to clear the stagnant heat of the blood, and can promote blood circulation and dissipate blood stasis, and is good at promoting qi and dispersing stagnation. Stir-fried Gardenia and Curcuma can clear the heart, smooth the Qi, and reduce fire, and enhance the function of relieving depression and relieving restlessness. It is aimed at the systemic symptoms of chest tightness, depression, irritability, bitter mouth, etc. caused by liver qi stagnation, stomach heat congestion, and heat damage to body fluid in patients with acute mastitis in the acute inflammatory period. It can clear away heat and detoxify, and has the function of purging fire and relieving restlessness. In summary, Peony, Trichosanthes and Licorice Decoction focuses on clearing heat and detoxifying, promoting lactation and dispersing stagnation, while the present invention focuses on soothing the liver and relieving depression, clearing the liver and harmonizing the stomach, reflecting the overall concept and syndrome differentiation and treatment of traditional Chinese medicine, and preventing and treating infectious diseases by adjusting the state of the body, and can achieve better clinical efficacy. The two are fundamentally different in terms of the treatment principles and prescription compatibility of traditional Chinese medicine.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] The Chinese medicine composition and Chinese medicine preparation of the invention have good curative effect on acute mastitis, have reasonable formula, no toxic side effects, and safe and reliable curative effect. DETAILED DESCRIPTION

[0025] The present invention is further illustrated below through the description of specific implementation modes, but this is not a limitation of the present invention. Those skilled in the art can make various modifications or improvements based on the basic idea of ​​the present invention, but as long as they do not deviate from the basic idea of ​​the present invention, they are all within the scope of the present invention.

[0026] Example

[0027] Example 1

[0028] Step 1: Weigh 15 parts by weight of red peony root, 9 parts by weight of selfheal, 6 parts by weight of perilla stem, 6 parts by weight of vaccaria, 6 parts by weight of stir-fried gardenia, 6 parts by weight of curcuma, and 6 parts by weight of raw licorice, then mix the raw drugs, soak them in water for 30 minutes, and set aside;

[0029] Step 2: Boil the raw material mixture in step 1 for 40 minutes, pour out the decoction, then add water to the residue, boil again for 40 minutes, pour out the decoction, and mix the two decoctions together to obtain the product.

[0030] Examples 2-10 are Chinese medicine compositions prepared according to the preparation method of Example 1 and the drug components in the following table.

[0031] Example 1 2 3 4 5 6 7 8 9 10 Red Peony Root 15 17 14 16 18 12 15 17 13 12 Prunella vulgaris 9 8 9 7 7 10 8 10 6 6 Perilla stalk 6 7 8 9 10 9 5 4 8 10 Vaccaria 6 4 5 9 8 7 7 9 6 10 Fried Gardenia 6 5 8 10 7 9 6 10 9 4 Turmeric 6 10 7 6 8 4 5 9 7 10 Raw licorice 6 7 5 6 8 9 7 10 4 8

[0032] Embodiment 11

[0033] The Chinese medicine compositions of Examples 1-10 are prepared into Chinese medicine preparations according to conventional methods. The dosage form of the Chinese medicine preparations is decoction, granules, tablets, pills or oral liquids.

[0034] Test example

[0035] Clinical Data

[0036] 1. Case data

[0037] 1.1 Case source: 216 patients who visited the outpatient department of breast surgery of the Third Affiliated Hospital of Beijing University of Chinese Medicine from July 2023 to July 2024 were selected.

[0038] 1.2 Diagnostic criteria

[0039] 1.2.1 Western medicine diagnostic criteria

[0040] 1.2.1.1 The diagnostic criteria of Western medicine are formulated in accordance with the diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Lactation Mastitis in China 2020":

[0041] (1) In lactating women, painful lumps may appear in the breasts, the skin may not be red or may be slightly red, and milk secretion may be poor, which may be accompanied by systemic symptoms such as chills and fever.

[0042] (2) Related auxiliary examinations: White blood cell and neutrophil counts may increase.

[0043] 1.2.2 TCM diagnostic criteria

[0044] 1.2.2.1 The diagnostic criteria for acute mastitis due to qi stagnation and heat congestion were formulated with reference to the “Diagnosis and Efficacy Standards for TCM Diseases and Syndromes” issued by the State Administration of Traditional Chinese Medicine.

[0045] Breast swelling and pain, or lumps, unchanged or slightly red skin color, poor milk discharge, accompanied by chills and fever, headache, body aches, thirst, and constipation.

[0046] Qi stagnation and heat congestion syndrome:

[0047] Main symptoms: (1) Milk stasis and clots; (2) Unbearable swelling and pain in the breast; (3) Rapid and stringy pulse.

[0048] Secondary symptoms: (1) Skin color remains unchanged or is slightly red; (2) Chills and fever; (3) Headache or body aches; (4) Thirst and constipation.

[0049] Tongue and pulse: normal or red tongue, thin white or thin yellow tongue coating, floating or stringy pulse.

[0050] 1.2.3 Inclusion criteria

[0051] (1) Meet the diagnostic criteria for lactation mastitis.

[0052] (2) The course of the disease is within 72 hours and the ultrasound examination report shows no abscess cavity.

[0053] (3) Local pain at the time of enrollment (Visual analogue seal (VAS score ≥ 4)).

[0054] (4) Body temperature >37.2°C, maximum body temperature within 24 hours <40°C.

[0055] (5) White blood cell count in routine blood test>12×109 / L;

[0056] (6) Volunteer to participate in the study and sign the informed consent.

[0057] 1.2.4 Exclusion criteria

[0058] (1) Patients with other breast or metabolic diseases who are unable to breastfeed;

[0059] (2) Those who have taken medication to treat this acute suppurative mastitis.

[0060] (3) History of allergy to cephalosporin antibiotics and history of antibiotic abuse.

[0061] (4) Combined with serious heart, liver, kidney and other diseases (laboratory indicators are more than twice the normal indicators).

[0062] (5) Those with comorbid mental disorders, epilepsy, cognitive impairment, or other serious diseases.

[0063] (6) Those who have other infectious diseases and are currently taking Chinese medicine or antibiotics.

[0064] (7) Women who become pregnant during breastfeeding.

[0065] (8) Participate in other clinical research.

[0066] (9) The researcher considers the person unsuitable to participate in this study due to other reasons.

[0067] 1.2.5 Elimination criteria

[0068] (1) The case did not meet the inclusion / exclusion criteria and should not have been randomized.

[0069] (2) The subjects violated the protocol's combined medication regulations, were incorrectly grouped, or had poor treatment compliance.

[0070] 1.2.6 Termination / Exit Test Criteria

[0071] (1) During the clinical trial, the subject has a body temperature ≥40°C.

[0072] (2) During the clinical trial, ultrasound showed the formation of breast abscess.

[0073] (3) When the subject experiences an adverse event.

[0074] (4) Patients with other diseases that affect the efficacy of the medication, or other serious complications.

[0075] 2. Research Methods

[0076] 2.1 Treatment methods

[0077] (1) 216 patients who met the criteria were randomly divided into a treatment group and a control group, with 108 patients in each group. The treatment group was treated with Chinese herbal decoction and Western medicine antibiotic simulants, while the control group was treated with Western medicine antibiotics and Chinese herbal decoction simulants. The course of treatment was 3 days.

[0078] (2) The composition of the Chinese medicine decoction is: red peony root 15g, selfheal 9g, perilla stem 6g, Vaccaria segetalis 6g, stir-fried gardenia 6g, curcuma 6g, raw liquorice 6g. The above drugs are made into granules by the Chinese medicine pharmacy of the Third Affiliated Hospital of Beijing University of Chinese Medicine. Usage and dosage: 2 times a day, 1 pack each time. The course of treatment is 3 days.

[0079] (3) Western medicine antibiotic treatment: Cefdinir Dispersible Tablets: Sinopharm Zhijun (Shenzhen) Pharmaceutical Co., Ltd., national medicine approval number H20100147, dosage is 100 mg per tablet, usage and dosage: 3 times a day, 1 tablet each time, and the course of treatment is 3 days.

[0080] (4) Chinese herbal decoction placebo: The placebo is composed of bittering agents, etc., does not contain the active ingredients of the test drug, and its color, taste, and smell are similar to those of the Chinese herbal decoction. Take 1 pack twice a day, and the course of treatment is 3 days.

[0081] (5) Cefdinir Dispersible Tablets Simulator: A simulator that simulates the size and color of Cefdinir Dispersible Tablets (mainly composed of starch, lactose, etc.). Take 1 tablet 3 times a day for a course of 3 days.

[0082] (6) All subjects were given health education, including diet, emotion regulation, and breastfeeding knowledge. Based on the 2020 "Guidelines for the Diagnosis and Treatment of Lactation Mastitis in China", this study recommends that patients continue breastfeeding during fever and treatment, and encourages subjects to breastfeed their babies, breastfeed frequently, and suck milk frequently to actively promote milk discharge.

[0083] 2.2 Blind Design

[0084] 2.2.1 Blind setting

[0085] A double-blind method was used to blind the participating physicians, clinical follow-up personnel, data entry managers, statistical analysts, and patients. The double simulation technology of drugs was used. The treatment group used Chinese herbal decoction combined with cefdinir dispersible tablets as a simulated drug; the control group used Chinese herbal decoction simulated drug combined with cefdinir dispersible tablets.

[0086] 2.2.2 Randomization scheme concealment

[0087] The doctors who collected clinical cases for enrollment were unaware of the random grouping scheme, but only knew the total sequence number of the selected cases, the Chinese medicine decoctions and cefdinir dispersible tablets, and the numbering of the drugs according to the blind bottom; patients received the numbered drugs according to the order of enrollment. Neither the clinicians nor the patients knew the two-level blind bottom. The first-level blind bottom was the random number and the I and II codes; the therapeutic drugs corresponding to I and II were the second-level blind bottom. The two were kept separately by the two groups of personnel. The drugs were numbered by a dedicated person according to the first and second-level blind bottoms. When filling out the case report form, the doctors who followed up clinically only had the enrollment number and drug number of the enrolled patients; they did not know the first-level blind bottom and the second-level blind bottom. The clinical monitor's review included whether there were any missing items in the case report form. The third party was entrusted as the packager, and only the drug packager knew the first and second-level blind bottoms, and the blind bottoms were handed over to the researchers after the study was completed.

[0088] 2.2.3 Blind Breaking Rules

[0089] In an emergency situation where a serious adverse event occurs, the researcher needs to clarify which drugs the patient is taking, and the researcher will ask the drug packager.

[0090] 2.2.4 Data Unblinding

[0091] After the database is verified to be correct, the principal investigator, statistical analyst and blind keeper lock the database. After locking, the data file is not allowed to be changed, and the database is saved for reference; then the first unblinding is carried out, and the I and II codes are written. The database is handed over to the statistical analyst. After the statistical analysis is completed, the second unblinding is carried out, and which of the two groups is the treatment group or the control group is marked in this unblinding.

[0092] 2.3 Pharmaceutical packaging

[0093] According to the requirements of the clinical plan, the course of treatment for the observation cases in this trial is 3 days, and the clinical trial drugs are distributed to the subjects on day 0. The trial drugs (including the treatment group and the control group) are uniformly named "Shaogan Sanyong Granules" and "Cefdinir Dispersible Tablets". The treatment group contains 6 packets of Shaogan Sanyong Granules and 1 bag of tablet simulation drugs (each bag contains 9 tablets of Cefdinir Dispersible Tablets Simulation Drugs). The control group contains 6 packets of Shaogan Sanyong Granules placebo and 1 bag of Cefdinir Dispersible Tablets Simulation Drugs (each bag contains 9 tablets of Cefdinir Dispersible Tablets). The packaging of the treatment group and the control group is the same. The drug name (special drug for clinical research), indications, drug number, specifications, usage and dosage, drug use method, storage method and drug supply unit, etc. must be printed on the drug packaging boxes of both groups.

[0094] 2.2 Observation indicators

[0095] 2.2.1 General Information

[0096] (1) Demographic data: gender, ethnicity, age, height, weight, occupation, education level, hBMI, number of pregnancies, number of births, mode of delivery, allergy history, and menstrual history.

[0097] (2) Disease-related information: chief complaint, course of disease, history of allergies, past medical history, comorbidities, medication status, duration of breastfeeding, breastfeeding status (exclusive breast milk, mixed feeding, pure milk powder), course of disease, history of acute mastitis, history of mastitis medication, family history of breast disease, and history of underlying diseases.

[0098] 2.2.2 Safety indicators

[0099] (1) Monitor physiological indicators such as blood pressure, heart rate, respiratory rate, and pulse.

[0100] (2) Routine blood test, liver function test, kidney function test, etc.

[0101] (3) Closely observe the infant's response during treatment and follow-up, and record any milk refusal, vomiting, diarrhea, etc. in detail in the patient log card.

[0102] (4) Adverse events.

[0103] 2.2.3 Efficacy indicators

[0104] (1) Body temperature;

[0105] (2) breast pain score;

[0106] (3) breast tissue edema tension and skin redness and swelling scores;

[0107] (4) breast lump area;

[0108] (5) TCM syndrome score;

[0109] (6) determination of inflammatory markers;

[0110] (7) recovery rate;

[0111] (8) Recurrence rate.

[0112] 2.3 Efficacy evaluation standards (formulated with reference to the "Guiding Principles for Clinical Research of New Chinese Medicines" and "Chinese Disease Diagnosis and Efficacy Standards")

[0113] 2.3.1 Body temperature

[0114] The subjects used an electronic thermometer to measure the armpit temperature every 4 hours and recorded it in the log card. The difference in temperature recovery time within 0-3 days and the difference in temperature maintenance within 4-6 days were compared between the two groups.

[0115] 2.3.2 Breast pain score

[0116] The visual analogue scale (VAS) was used to ask patients to give their own pain scores according to the numbers on the pain scale. The VAS scores of the most painful episodes of the day were measured to compare the pain levels of the two groups.

[0117] 2.3.3 Breast tissue edema tension and skin redness and swelling scores:

[0118]

[0119] 2.3.4 Determination of breast lump area

[0120] The location and area of ​​the tumor were recorded and measured using a breast tumor surface positioning film (produced by Suzhou Lushi Medical Technology Co., Ltd.). The film was made of a transparent self-adhesive soft film. The center hole was the center of the circle, and the angle of the lesion and the distance from the nipple center were marked on the circumference and rays. The boundary of the tumor was recorded on the membrane with a marking pen and the area of ​​the tumor was calculated (length cm × width cm). The measurements were taken on the 0th and 3rd days of treatment.

[0121] 2.3.5 Determination of cure rate and efficacy:

[0122] The local inflammatory symptoms disappeared, including the disappearance of breast lumps and pain. The body temperature remained normal, and there was no obvious fluid dark area on ultrasound examination. The number of days of recovery was recorded.

[0123] 2.3.6 Determination of recurrence rate:

[0124] After the treatment period, a follow-up visit was conducted for 3 days. In this study, patients who were evaluated as "cured" and had redness, swelling and pain in the same breast position again without obvious inducement 3 days after the end of the trial were defined as recurrence.

[0125] 2.3.7 Criteria for determining efficacy of TCM syndromes

[0126] Markedly effective: The main and secondary symptoms basically or completely disappeared, and the symptom score after treatment was 0 or decreased by ≥70%.

[0127] Effective: The symptom score decreased by ≥30% after treatment.

[0128] Ineffective: The symptom score decreased by less than 30% after treatment.

[0129] Aggravation: The score after treatment exceeds the score before treatment.

[0130] 2.4 Statistical analysis

[0131] The full analysis set (FAS) and per-protocol set (PPS) were used for the main efficacy indicators; the full analysis set was used for baseline demographics and other characteristics, and the per-protocol set was used for other efficacy indicators; the safety set (SS) was used for safety indicators. SPSS25.0 was used for statistical analysis of data. For baseline statistical analysis, measurement data were expressed as mean ± standard deviation, t test was performed for data that met normal distribution, non-parametric test was performed for non-normal distribution, chi-square test was used for categorical data, and non-parametric test was used if it met one-way order at the same time; analysis of variance or non-parametric test was used for inter-group comparison in efficacy analysis, and the least significant difference method was used for pairwise comparison analysis if there were differences between groups. For outcome indicators of categorical data types, the number of cases (n) and percentage (%) were used for description, and chi-square test / Fisher's exact probability method was used for comparison of rates among the three groups, and non-parametric test was used if it met one-way order at the same time. Rank sum test was used for rank data, and chi-square test was used for count data. The research results were analyzed and P < 0.05 indicated statistical significance.

[0132] 3. Test results

[0133] 3.1 General data analysis

[0134] The trial initially enrolled 226 cases, including 113 in the control group and 113 in the treatment group. During the trial, 3 cases in the control group were found to not meet the inclusion criteria and were excluded, and 4 cases dropped out due to voluntary withdrawal or withdrawal midway; 1 case dropped out of the treatment group due to refusing to take traditional Chinese medicine and being discharged midway, and 2 cases who did not take the medicine according to the prescribed course of treatment were excluded. After the end of the trial, there were 216 cases that met the research criteria.

[0135] There was no statistically significant difference in age, breastfeeding time, and disease course between the treatment group and the control group.

[0136] Table 1 Distribution of age, breastfeeding time and disease course in the treatment group and the control group

[0137]

[0138] Note: After testing, *P>0.05, #P>0.05, △P>0.05

[0139] 3.2 Efficacy analysis

[0140] 3.2.1 Comparison of the efficacy of temperature

[0141] As shown in Table 2, the comparison of the body temperature efficacy between the treatment group and the control group showed that the treatment group was superior to the control group (P<0.05), and the difference was statistically significant.

[0142] Table 2 Comparison of body temperature efficacy between the treatment group and the control group

[0143]

[0144] Note: After testing, compared with the treatment group before treatment, △P>0.05, compared with the group before treatment, *P<0.05, compared with the difference of the treatment group, #P<0.05.

[0145] 3.2.2 Comparison of therapeutic effects on breast pain

[0146] As shown in Table 3, the treatment group was superior to the control group in terms of the efficacy of breast pain (P<0.05), and the difference was statistically significant.

[0147] Table 3 Comparison of efficacy of breast pain between treatment group and control group

[0148]

[0149] Note: After testing, compared with the treatment group before treatment, △P>0.05, compared with the group before treatment, *P<0.05, compared with the difference of the treatment group, #P<0.05.

[0150] 3.2.3 Comparison of therapeutic effects on breast tissue edema tension and skin redness and swelling

[0151] As shown in Table 4, the comparison of the therapeutic effect of breast tissue edema tension between the treatment group and the control group showed that the treatment group was superior to the control group (P < 0.05), and the difference was statistically significant.

[0152] Table 4 Comparison of the efficacy of breast tissue edema tension and skin redness and swelling between the treatment group and the control group

[0153]

[0154] Note: After testing, compared with the treatment group before treatment, △P>0.05, compared with the group before treatment, *P<0.05, compared with the difference of the treatment group, #P<0.05.

[0155] 3.2.4 Comparison of therapeutic effects by breast lump area

[0156] As shown in Table 5, the comparison of the therapeutic effect of breast lump area between the treatment group and the control group showed that the treatment group was better than the control group (P<0.05), and the difference was statistically significant.

[0157] Table 5 Comparison of therapeutic effect on breast mass area between treatment group and control group

[0158]

[0159] Note: After testing, compared with the treatment group before treatment, △P>0.05, compared with the group before treatment, *P<0.05, compared with the difference of the treatment group, #P<0.05.

[0160] 3.2.5 Comparison of efficacy of inflammatory indicators

[0161] As shown in Table 6, the inflammatory indexes, white blood cell counts and neutrophil counts of the patients in the treatment group and the control group were compared, and the differences were statistically significant (P<0.05).

[0162] Table 6 Comparison of the efficacy of inflammatory indicators in the treatment group and the control group

[0163]

[0164] Note: After testing, compared with the treatment group before treatment, △P>0.05, compared with the group before treatment, *P<0.05, compared with the difference of the treatment group, #P<0.05.

[0165] 3.2.6 Comparison of cure rate

[0166] As shown in Table 7, there was no statistically significant difference in the cure rate between the treatment group and the control group (P>0.05).

[0167] Table 7 Comparison of cure rate between the treatment group and the control group

[0168]

[0169] Note: P>0.05 using rank sum test.

[0170] 3.2.7 Comparison of recurrence rate

[0171] As shown in Table 8, there was no statistically significant difference in the recurrence rate between the treatment group and the control group (P>0.05).

[0172] Table 8 Comparison of recurrence rate between treatment group and control group

[0173]

[0174] Note: P>0.05 using rank sum test.

[0175] 3.2.8 Comparison of TCM Syndrome Therapy

[0176] As shown in Table 9, before treatment, the treatment group and the control group had a comparison of P>0.05, and the difference was not statistically significant, which was comparable. The intra-group comparison between the treatment group and the control group was P<0.05, and the difference was statistically significant. After treatment, the scores of both the treatment group and the control group decreased, but the difference in the treatment group was greater than that in the control group, P<0.05, and the effect of the treatment group was better than that of the control group.

[0177] Table 9 Comparison of total scores before and after TCM syndrome treatment (mean ± standard deviation)

[0178]

[0179] Note: After testing, compared with the treatment group before treatment, △P>0.05, compared with the group before treatment, *P<0.05, compared with the difference of the treatment group, #P<0.05.

[0180] 3.3 Safety index results

[0181] After the end of the clinical trial, 3 patients in the treatment group had local redness of the breast skin, but no obvious skin lesions were found on the breast, which was considered to be related to the lactation auxiliary device. The other patients had no other obvious adverse reactions. The statistical analysis results of the safety of the two groups of patients showed that there was no significant difference in safety between the treatment group and the control group (P>0.05).

[0182] According to the above test results, the Chinese medicine composition and Chinese medicine preparation of this embodiment have a good therapeutic effect on acute mastitis and can significantly improve and eliminate the adverse symptoms caused by acute mastitis in patients.

[0183] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein by equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for clearing away heat and detoxifying, regulating qi and promoting lactation, removing blood stasis and relieving swelling, characterized in that: The Chinese medicine composition is composed of the following raw materials: red peony root, selfheal, perilla stem, fenugreek, stir-fried gardenia, curcuma, and raw liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 12-18 parts by weight of red peony root, 6-10 parts by weight of selfheal, 4-10 parts by weight of perilla stem, 4-10 parts by weight of fenugreek, 4-10 parts by weight of stir-fried gardenia, 4-10 parts by weight of curcuma, and 4-10 parts by weight of raw liquorice.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is composed of the following raw materials in parts by weight: 12-16 parts by weight of red peony root, 8-10 parts by weight of selfheal, 4-8 parts by weight of perilla stem, 4-8 parts by weight of fenugreek, 4-8 parts by weight of stir-fried gardenia, 4-8 parts by weight of curcuma, and 8-15 parts by weight of raw liquorice.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 15-18 parts by weight of red peony root, 6-9 parts by weight of selfheal, 6-10 parts by weight of perilla stem, 6-10 parts by weight of fenugreek, 6-10 parts by weight of stir-fried gardenia, 6-10 parts by weight of curcuma, and 4-8 parts by weight of raw liquorice.

5. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 15-16 parts by weight of red peony root, 8-9 parts by weight of selfheal, 5-7 parts by weight of perilla stem, 5-7 parts by weight of fenugreek, 5-7 parts by weight of stir-fried gardenia, 5-7 parts by weight of curcuma, and 5-7 parts by weight of raw liquorice.

6. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 15 parts by weight of red peony root, 9 parts by weight of selfheal, 6 parts by weight of perilla stem, 6 parts by weight of fenugreek, 6 parts by weight of stir-fried gardenia, 6 parts by weight of curcuma, and 6 parts by weight of raw liquorice.

7. The Chinese medicine composition according to claim 1, characterized in that: The dosage form of the Chinese medicine composition is decoction, granules, tablets, pills or oral liquid.

8. A Chinese medicine preparation, characterized in that: The Chinese medicine preparation comprises the Chinese medicine composition according to any one of claims 1-7.

9. The Chinese medicine preparation according to claim 8, characterized in that: The traditional Chinese medicine preparation also includes auxiliary materials.

10. Use of the Chinese medicine composition according to any one of claims 1 to 7 or the Chinese medicine preparation according to claim 8 or 9 in preparing medicines, characterized in that: The medicine is used for preventing and / or treating symptoms of acute mastitis, wherein the symptoms are selected from breast distending pain, breast lumps and poor milk discharge.

Images