Traditional Chinese medicine composition for preventing, relieving or treating postpartum body deficiency combined acute mastitis

Abstract

The invention provides a traditional Chinese medicine composition for preventing, relieving or treating postpartum body deficiency and acute mastitis, which is prepared from the following raw materials: 28-32 parts of dandelion, 28-32 parts of houttuynia cordata, 13-17 parts of white mulberry root-bark, 13-17 parts of moutan bark, 16-20 parts of dried rehmannia root, 10-14 parts of angelica sinensis body, 8-12 parts of mulberry leaf, 8-12 parts of lophatherum gracile, 13-17 parts of astragalus membranaceus, 10-14 parts of salvia miltiorrhiza, 10-14 parts of rhizoma atractylodis, 8-12 parts of ginseng and 8-12 parts of ginger. , 8-12 parts by weight of jujube, and 4-8 parts by weight of raw licorice. A clear monarch, minister, assistant and guide compatibility system is constructed, the effects of the formula in prevention and treatment of postpartum body deficiency and acute mastitis are synergistically exerted, all the components are medicinal and edible traditional Chinese medicine components or traditional Chinese medicine components capable of being used as health-care products, the side effects of the medicine are greatly reduced, lactation is not affected, and the curative effect is good. The traditional Chinese medicine can be widely applied to acute mastitis under various conditions, especially postpartum weakness combined acute mastitis.

Description

Technical Field

[0001] The invention relates to the technical field of pharmaceutical compositions, and in particular to a traditional Chinese medicine composition for preventing, alleviating or treating postpartum physical weakness combined with mastitis and a pharmaceutical use thereof. Background Art

[0002] Mastitis is an acute suppurative disease with symptoms such as redness, swelling and pain in the breast, poor milk discharge, and pus formation. It is common in postpartum breastfeeding women, especially primiparas. Postpartum women are already in a weak state. When mastitis occurs, it will greatly affect the normal breastfeeding function, which has a great impact on both the mother and the baby. For simple mastitis, there are currently a large number of Chinese and Western medicines available for treatment, but for mothers, the use of drugs may bring great side effects and may have toxic side effects on breastfeeding.

[0003] Chinese patent application CN106421081A discloses a Chinese medicine composition for treating mastitis and a preparation method thereof, wherein the Chinese medicine composition is prepared from 20-40 parts of Houttuynia cordata, 10-30 parts of Trichosanthes, 8-25 parts of Semen Persicae, 20-40 parts of Taraxacum mongolicum, and 10-30 parts of Flos Lonicerae. The article claims that the whole prescription is coordinated with each other, and has the effects of eliminating carbuncle, draining pus, reducing swelling and dispersing nodules. It is used for the treatment of mastitis. It is safe and effective, and has the effects of eliminating carbuncle, draining pus, reducing swelling and dispersing nodules. The formula is scientific and reasonable, the process is simple, the taste is good, and the cost is low.

[0004] The document discloses that Houttuynia cordata eliminates carbuncle and discharges pus, and Taraxacum officinale eliminates swelling and resolves nodules, which are the main drugs in the prescription; Trichosanthes kirilowii relieves chest tightness and resolves nodules, and Honeysuckle clears away heat and detoxifies as the ministers. This prescription only uses Houttuynia cordata and Taraxacum officinale as the main drugs, and Trichosanthes kirilowii and Honeysuckle as the ministers. The combination of the main and ministers is not reasonable, the prescription is not comprehensive, and includes some Chinese medicines such as Trichosanthes kirilowii that are not on the list of medicine and food or health food. The five herbs in this prescription are all cold in nature, with too much clearing and purging, and insufficient warming and nourishing. In fact, it is not suitable for patients with breast abscess and postpartum physical weakness, and even less for patients with breast abscess and breastfeeding; and Trichosanthes kirilowii can cause abdominal distension, abdominal pain, cold stomach, and aggravate dry mouth and throat. People with spleen and stomach deficiency, yang deficiency, and body fluid deficiency should not take it.

[0005] Chinese patent application CN108272954A discloses a medicine for treating mastitis and a preparation method thereof. The medicine is prepared from fenugreek, radix scutellariae, tongcao, honeysuckle, forsythia, red peony root, moutan bark, citrus leaf, dandelion, antler, scutellaria baicalensis, arctium bark, fritillaria cirrhosa, root of trichosanthes, angelica, angelica dahurica, liquorice, ligusticum chuanxiong, astragalus, green peel and platycodon in a certain weight ratio. The medicine has the functions of promoting blood circulation and menstruation, promoting labor and lactation, reducing swelling and astringing sores, clearing away heat and detoxifying, and resolving phlegm and reducing swelling. The medicine is used to treat mastitis with rapid effect, good efficacy and no recurrence.

[0006] The article disclosed that the formula contains the main herb, which has the functions of promoting blood circulation and menstruation, promoting childbirth and lactation, and reducing swelling and healing sores; the main herb, which has the functions of clearing away heat and detoxifying, and promoting lactation; and the main herb, which has the functions of clearing away heat and detoxifying, and dispersing nodules and reducing swelling. The formula uses the main herb as the main herb, and the main herb and the main herb as the ministers. The main herb is too heavy, and the same medicine is repeatedly used. For example, the main herb, the main herb, the main herb, the main herb, and the main herb are all menstruation-promoting and lactation-promoting medicines. The formula also uses burdock and radix trichosanthis, which have the side effects of being bitter and cold and hurting the stomach and causing allergies. In fact, it is not suitable for patients with mastitis and postpartum physical weakness, and even less suitable for patients with mastitis who are breastfeeding.

[0007] Chinese patent application CN103638392A discloses a Chinese medicine composition for treating mastitis, and the weight parts of its constituent raw materials are: 4-6 of Houttuynia cordata, 2-4 of Taraxacum mongolicum, 4-6 of Scutellaria barbata, 1-2 of Gleditsia sinensis, 2-3 of Herba Lycopodii, 5-7 of Musa oleracea, 2-4 of Rhizoma Duchesneae, 1-2 of Duchesnea indica, 1-2 of Citrus cotyledon, 7-9 of Herba Ramieae, 3-5 of Flos Rosae Rugosae, 1-3 of Herba Lycopodii, 4-6 of Herba Coptidis, 2-4 of Caulis Scutellariae, 5-8 of Rhizoma Cyperi, 2-4 of Fructus Hordei Germinatus, 1-3 of Herba Violae, and 2-4 of Caulis Nigellae. The article claims that the present invention has the effects of clearing away heat and detoxicating, cooling blood and relieving swelling, dispersing stagnation and relieving pain, and eliminating carbuncle and dispersing knots, and can effectively prevent and treat mastitis, and the present invention has the advantages of rapid action, obvious therapeutic effect, low cost, and no toxic and side effects.

[0008] The article does not disclose any principle of the formula composition of monarch, minister, assistant and envoy, and its compatibility cannot be clearly known. The entire formula is complex; and the herbs such as Herba Paniculae, Herba Kumadis, Herba Zygophyllae, Herba Diatomatis, Herba Glutinosae are not included in the Chinese Pharmacopoeia, and their efficacy has not been proven, which may cause multiple side effects. Therefore, the formula is not suitable for patients with mastitis and postpartum weakness, and even less suitable for patients with mastitis and breastfeeding.

[0009] The disclosures of the above patent documents are incorporated herein by reference. Although the Chinese medicine formulas for treating mastitis disclosed in the above patent documents claim to have certain curative effects on mastitis, most of them are only for mastitis itself, without special consideration of the health of pregnant women with postpartum weakness and breastfeeding safety. The adopted prescriptions are not comprehensive or reasonable, and include some non-medicine and food homologous ingredients, non-health food ingredients, and non-pharmacopoeial ingredients, which may bring some complications or side effects, and have a negative impact on the already weak parturients and infants. They are not suitable for patients with mastitis and postpartum weakness, and are even less suitable for patients with mastitis and breastfeeding. Summary of the invention

[0010] In order to solve the deficiencies of the prior art, the present invention adopts the following technical solutions:

[0011] On the one hand, the present invention provides a traditional Chinese medicine composition for preventing, alleviating or treating postpartum physical weakness combined with mastitis, which is prepared from the following raw materials: 28-32 parts of dandelion, 28-32 parts of houttuynia cortex, 13-17 parts of mulberry bark, 13-17 parts of peony bark, 16-20 parts of raw rehmannia root, 8-12 parts of mulberry leaf, 8-12 parts of lophatherum gracile, and 10-14 parts of atractylodes, all measured by weight.

[0012] Preferably, the Chinese medicine composition is prepared from the following raw materials: 30 parts of dandelion, 30 parts of houttuynia cortex, 15 parts of mulberry bark, 15 parts of peony bark, 18 parts of raw rehmannia root, 10 parts of mulberry leaf, 10 parts of lophatherum gracile, and 12 parts of atractylodes, all measured by weight.

[0013] Further preferably, the raw materials of the traditional Chinese medicine composition also include 10-14 parts of angelica root, 13-17 parts of astragalus, 10-14 parts of salvia miltiorrhiza, 8-12 parts of ginseng, 8-12 parts of ginger, 8-12 parts of jujube, and 4-8 parts of raw licorice, all measured by weight.

[0014] Preferably, the angelica root is 12 parts, astragalus is 15 parts, salvia miltiorrhiza is 12 parts, ginseng is 10 parts, ginger is 10 parts, jujube is 10 parts, and raw licorice is 6 parts, all by weight.

[0015] In a second aspect, the present invention provides a traditional Chinese medicine preparation for preventing, alleviating or treating postpartum physical weakness combined with mastitis, the active ingredient of which is the above-mentioned traditional Chinese medicine composition.

[0016] Preferably, the preparation is an extract, granule, decoction, pill, powder, oral solution, capsule, tablet, syrup, mixture or tea prepared according to a conventional method.

[0017] More preferably, the preparation is a granule.

[0018] In a third aspect, the present invention also provides a method for preparing the Chinese medicine preparation, comprising coarsely crushing the weight portion of the medicine, mixing with water and extracting for multiple times, filtering and combining the filtrate, and then adding auxiliary materials to prepare granules.

[0019] In a fourth aspect, the present invention also provides the use of the Chinese medicine composition or the Chinese medicine preparation in the preparation of a medicament for preventing, alleviating or treating postpartum physical weakness combined with mastitis.

[0020] The ingredients selected for the Chinese medicine composition of the present invention are all commonly used traditional Chinese herbal medicine ingredients, and all are very safe Chinese medicines that are both medicinal and edible or can be used in health foods. They are all natural ingredients that are harmless to human health, especially for the health of postpartum women with physical weakness and infants, and have no side effects and do not affect breastfeeding.

[0021] Multiple experimental studies and clinical trials have shown that the Chinese medicinal and edible herbal composition of the present invention has a higher therapeutic effect on mastitis model animals than traditional positive control drugs, and has almost no toxic side effects.

[0022] After extensive screening and research, according to the meridians and functions of each Chinese medicinal material, combined with the currently known research results on mastitis treatment, and strictly in accordance with the principle of "monarch, minister, assistant and messenger" compatibility, the preferred formula of the present invention was finally screened. The present invention constructs a clear "monarch, minister, assistant and messenger" compatibility system, synergistically exerts the role of the formula in the prevention and treatment of mastitis, and can be widely applied to mastitis of various individuals and symptoms, especially mastitis complicated by postpartum physical weakness.

[0023] The preparation and use of the prescription of the present invention are extremely convenient. All the Chinese medicinal materials are simply mixed, then boiled and extracted with water, and then the filtrate is taken. There is no need to add other solvents with toxic side effects or use other preparation processes that may destroy the effective components of the Chinese medicinal materials. For the convenience of storage and use, conventional auxiliary materials can be added to make granules, which can be taken with warm water. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 The results of microscopic observation of the effects of the test drug of the present invention on the pathological changes of the mammary gland tissues of mice with mastitis are shown. DETAILED DESCRIPTION

[0025] The specific embodiments of the present invention are further described in detail below. However, it will be understood by those skilled in the art that the present invention is not limited to these embodiments, and those skilled in the art may modify or replace certain technical features of these embodiments, as long as they can still achieve the same purpose of the present invention, solve the same technical problems, and achieve the same technical effects, they still fall within the scope of protection claimed by the appended claims of the present invention.

[0026] The term "deep-rooted breast carbuncles" used in this article refers to an acute suppurative disease characterized by redness, swelling, pain, and poor milk discharge, which results in pus formation and carbuncle. It is common in postpartum breastfeeding women, especially primiparas, and is commonly known as milk sores. The current traditional Chinese medicine treatment methods include:

[0027] For qi stagnation and heat accumulation, use Gualou Niubang Decoction (formula: Gualou Ren 12-15g, Niu Bang Zi 9-12g, Trichosanthes Knot 9-12g, Scutellaria Baicalensis 9-12g, Gardenia 9-12g, Honeysuckle 9-12g, Forsythia suspensa 9-12g, Gleditsia sinensis 9-12g, Citrus aurantium 3-6g, Tangerine peel 3-6g, Bupleurum 3-6g, Raw Licorice 3-6g) with additions and subtractions; for severe milk stagnation, add Vaccaria segetalis, Rhizoma Smilacis Glabrae, and Rhizoma Lophatheri to promote milk secretion; for parturients with milk stagnation after weaning, add raw burdock, hawthorn, and raw malt to stimulate milk secretion; for those with persistent postpartum lochia, add Radix Angelicae Sinensis, Rhizoma Chuanxiong, and Leonurus japonicus to dispel blood stasis; for those with obvious breast lumps, add Radix Angelicae Sinensis, Radix Paeoniae Rubra, and Rhizoma Pruni to promote blood circulation and dispel blood stasis; for those with constipation, add raw rhubarb and hemp seed to promote bowel movements.

[0028] For severe heat and toxicity, use Tounong San (formula: 4 qian of Astragalus, 1 qian of Panicum (fried and ground), 3 qian of Chuanxiong, 2 qian of Angelica, 1.5 qian of Gleditsia sinensis) with added ingredients. For severe heat, add Gypsum, Rhizoma Anemarrhenae, Flos Lonicerae, and Herba Taraxaci to clear away heat and detoxify.

[0029] For the condition of deficiency of the body and retention of evil, use Toli Xiaodu Powder (the formula is 1 qian of ginseng, 1 qian of astragalus (fried), 1 qian of angelica (washed with wine), 1 qian of Chuanxiong, 1 qian of peony (fried), 1 qian of Atractylodes (fried), 1 qian of tangerine peel, 1 qian of Poria, 7 fen of honeysuckle, 7 fen of forsythia, 7 fen of white angelica, 5 fen of licorice) with additions and subtractions.

[0030] Traditional Chinese herbal medicine ingredients in my country often have unexpected effects on many diseases that Western medicine is helpless against, and have fewer side effects. However, due to the complex ingredients of Chinese herbal medicine, it is difficult to separate its pure effective ingredients according to the standards of Western medicine, and it cannot be effectively promoted. The applicant company has rich experience in Chinese medicine research, diagnosis and treatment, and production and promotion. The inventor team organized by the applicant has explored a large number of Chinese herbal medicine ingredients in the practice of mastitis prevention and treatment, and compared and screened the effective composition formula of the present invention to obtain the Chinese medicine composition of the present invention. The compatibility composition and ideas of the formula have not been mentioned in the prevention and treatment of mastitis, especially postpartum physical weakness complicated with mastitis.

[0031] The term "dandelion" used in this article is a Chinese medicine raw material (see Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China), which is the dried whole herb of Taraxacum mongolicum Hand.-Mazz., Taraxacumborealisinense Kitam., or several plants of the same genus in the Asteraceae family. It is dug when the flowers first bloom from spring to autumn, and the impurities are removed, washed, and dried. It tastes bitter and sweet, is cold in nature, and enters the liver and stomach meridians. The functions and indications are clearing away heat and detoxifying, reducing swelling and dispersing nodules, and promoting diuresis and relieving stranguria; it is used for carbuncle swelling and poison, breast abscess, scrofula, red eyes, sore throat, lung abscess, intestinal abscess, damp-heat jaundice, hot stranguria and astringent pain, etc.

[0032] The term "Houttuynia cordata" used in this article is a Chinese medicinal material (see Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China), which is the fresh whole herb or dried aerial part of the plant Houttuynia cordata of the Saururaceae family. It tastes spicy, is slightly cold in nature, and belongs to the lung meridian. Its functions and indications are clearing away heat and detoxifying, eliminating carbuncle and draining pus, and promoting diuresis and relieving stranguria; it is used for lung carbuncle vomiting pus, phlegm-heat cough, heat dysentery, heat stranguria, carbuncle swelling, sores, etc.

[0033] The term "mulberry bark" used in this article is a Chinese medicine raw material (see Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China). It is the dried root bark of Morus alba L., a plant of the Moraceae family. The roots are dug from the end of autumn when the leaves fall to the next spring before budding, the yellow-brown rough bark is scraped off, the root bark is peeled off longitudinally, and it is dried in the sun. It tastes sweet, is cold in nature, and belongs to the lung meridian. The functions and indications are to purge the lungs and relieve asthma, promote diuresis and reduce swelling; it is used for lung heat, asthma, cough, edema, fullness, and oliguria, and edema of the face and skin.

[0034] The term "Paeonia suffruticosa" used in this article is a Chinese medicine raw material (see Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China), which is the dried root bark of the Ranunculaceae plant Paeonia suffruticosa. It tastes bitter and pungent, is slightly cold in nature, and enters the heart, liver, and kidney meridians. Its functions and indications are to clear away heat and cool blood, and to promote blood circulation and remove blood stasis; it is used for heat entering the blood, fever and rashes, vomiting blood and epistaxis, night heat and morning coolness, no sweating and bone steaming, amenorrhea and dysmenorrhea, injuries and pains from falls, carbuncles, sores, etc.

[0035] The term "sheng dihuang" used in this article is a Chinese medicine raw material (see Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China). It is the fresh or dried root of the plant Rehmannia glutinosa of the Scrophulariaceae family. The root that is slowly baked to about 80% dry is called "sheng dihuang". It tastes sweet, is cold in nature, and enters the heart, liver, and kidney meridians. Its functions and indications are to clear away heat and cool blood, nourish yin and produce body fluid; it is used for heat entering the blood, fever caused by warm toxins, vomiting blood and epistaxis, yin damage caused by febrile diseases, red tongue and thirst, constipation caused by body fluid damage, fever caused by yin deficiency, bone steaming and fatigue fever, and internal heat and thirst.

[0036] The term "mulberry leaf" used in this article is a Chinese medicine raw material (see Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China), which is the dried leaves of Morus alba L., a plant of the Moraceae family. It is harvested after the first frost, impurities are removed, and it is dried in the sun. It tastes sweet and bitter, is cold in nature, and enters the lung and liver meridians. Its functions and indications are to dispel wind-heat, clear the lungs and moisten dryness, clear the liver and improve eyesight; it is used for wind-heat colds, lung heat and dry coughs, dizziness and headaches, red and blurred eyes, etc.

[0037] The term "Lophatherum gracile Brongn" used in this article is a Chinese medicine raw material (see Part 1 of the 2020 edition of the Pharmacopoeia of the People's Republic of China). It is the dried stems and leaves of the Gramineae plant Lophatherum gracile Brongn., which are harvested in summer before the flowering spikes and dried in the sun. It tastes sweet and light, is cold in nature, and enters the heart, stomach, and small intestine meridians. Its functions and indications are to clear away heat and purge fire, relieve restlessness and quench thirst, and promote diuresis and relieve stranguria; it is used for fever and thirst, short, red, and painful urination, and sores in the mouth and tongue.

[0038] The term "Atractylodes" used in this article is a Chinese medicinal raw material (see Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China), which is the dried rhizome of Atractylodes lancea (Thunb.) DC. or Atractylodes chinensis (DC.) Koidz. of the Asteraceae family. It is dug in spring and autumn, removed from mud and sand, dried in the sun, and the fibrous roots are knocked off. It tastes pungent and bitter, is warm in nature, and enters the spleen, stomach, and liver meridians. The functions and indications are to dry dampness and strengthen the spleen, dispel wind and cold, and improve eyesight; it is used for dampness blocking the middle jiao, abdominal distension, diarrhea, edema, beriberi, rheumatism, colds, night blindness, blurred vision, etc.

[0039] The term "angelica body" used herein refers to the main root of the Chinese medicinal material Angelica sinensis (see Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China). Angelica sinensis is the dried root of the Umbelliferae plant Angelica sinensis (Oliv.) Diels. It can be divided into several parts according to different parts, namely Angelica head, Angelica body (main root) and Angelica tail (branch root). The present invention prefers Angelica body part; it is excavated in late autumn, the fibrous roots and mud are removed, and after the water evaporates slightly, it is tied into small bundles, put on the shed, and slowly smoked dry with fireworks. It tastes sweet and spicy, is warm in nature, and belongs to the liver, heart, and spleen meridians. The functions and indications are: nourishing blood and activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relieving constipation. It is used for blood deficiency and sallow complexion, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, injuries caused by falls, carbuncle sores, dry intestines and constipation, and wine angelica activates blood circulation and dredges the menstruation; it is used for amenorrhea and dysmenorrhea, rheumatic arthralgia, injuries caused by falls, etc.

[0040] The term "Huangqi" used in this article is a Chinese medicine raw material (see Part 1 of the 2020 edition of the Pharmacopoeia of the People's Republic of China). It is the root of the leguminous plant Astragalus membranaceus. It is dug in spring or autumn, and the soil and whiskers are removed. It is dried to 60% to 70% and then tied and dried to make medicine. It tastes sweet and is slightly warm in nature. It enters the spleen and lung meridians. The functions and indications are: replenishing qi and strengthening the exterior, expelling toxins and pus, diuresis, and promoting tissue regeneration; it is used for qi deficiency and fatigue, chronic diarrhea and prolapse of the anus, spontaneous sweating, edema, uterine prolapse, chronic nephritis proteinuria, diabetes, and wounds that do not heal for a long time.

[0041] The term "Danshen" used in this article is a Chinese medicine raw material (see Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China), which is the dried root and rhizome of the Labiatae plant Salvia miltiorrhiza Bge., which is excavated in spring and autumn, removed from mud and sand, and dried. It tastes bitter, is slightly cold in nature, and enters the heart and liver meridians. Its functions and indications are: promoting blood circulation and removing blood stasis, relieving pain through menstruation, clearing the heart and eliminating restlessness, cooling blood and eliminating carbuncle; it is used for chest pain, epigastric pain, accumulation of masses, heat arthralgia and pain, restlessness and insomnia, irregular menstruation, dysmenorrhea and amenorrhea, sores and swelling and pain, etc.

[0042] The term "ginseng" used in this article is a Chinese medicine raw material (see Part 1 of the 2020 edition of the Pharmacopoeia of the People's Republic of China), which is the dried root and rhizome of the Araliaceae plant Panax ginseng CAMey. It is mostly dug in autumn, washed and dried in the sun or oven. It is sweet, slightly bitter, slightly warm in nature, and enters the spleen, lung, heart, and kidney meridians. The functions and indications are: greatly replenishing vital energy, restoring pulse and consolidating deficiency, tonifying the spleen and lungs, promoting fluid and nourishing blood, calming the mind and improving intelligence; used for physical weakness and wanting to lose weight, cold limbs and weak pulse, spleen deficiency and poor appetite, lung deficiency and asthma and cough, thirst due to fluid loss, internal heat and thirst, qi and blood deficiency, long-term illness and weakness, palpitations and insomnia, impotence and cold uterus, etc.

[0043] The term "ginger" used in this article is a Chinese medicine raw material (see Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China). It is the fresh rhizome of the ginger plant Zingiber officinale Rosc., which is dug in autumn and winter, and the fibrous roots and mud are removed. It tastes spicy and is slightly warm in nature. It enters the lung, spleen, and stomach meridians. Its functions and indications are: dispelling cold, warming the middle and stopping vomiting, resolving phlegm and relieving cough, and detoxifying fish and crabs; it is used for colds caused by wind and cold, vomiting caused by stomach cold, cough caused by cold phlegm, and poisoning caused by fish and crabs.

[0044] The term "jujube" used in this article is a Chinese medicine raw material (see Part I of the 2020 edition of the Pharmacopoeia of the People's Republic of China). It is the dried mature fruit of the rhamnaceae plant Ziziphus jujuba Mill., which is harvested when the fruit is ripe in autumn and dried in the sun. It tastes sweet and is warm in nature. It enters the spleen, stomach, and heart meridians. Its functions and indications are: tonifying the middle and replenishing qi, nourishing blood and calming the mind; it is used for spleen deficiency, poor appetite, fatigue, loose stools, and women's irritability.

[0045] The term "raw licorice" used in this article refers to the dried common licorice (see Part 1 of the 2020 edition of the Pharmacopoeia of the People's Republic of China) of the Chinese medicine raw material (roasted licorice is made by adding honey to raw licorice). Licorice is the dried root and rhizome of the leguminous plants Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L., which are dug in spring and autumn, the fibrous roots are removed, and they are dried in the sun. It tastes sweet, is neutral in nature, and enters the heart, lung, spleen, and stomach meridians. The functions and indications are: tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving pain, and harmonizing various medicines; it is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough and sputum, acute pain in the abdomen and limbs, carbuncle, sore, and relieve drug toxicity and potency.

[0046] This formula has been screened and studied in large quantities, according to the meridians and known effects of each Chinese medicinal material, combined with the currently known research results on mastitis, strictly in accordance with the principle of "monarch, minister, assistant and messenger" compatibility, and finally screened out the preferred formula of the present invention. The present invention uses dandelion, houttuynia, peony bark, and raw rehmannia as monarch medicines, clearing away heat and detoxifying, dispersing knots and eliminating carbuncle, and mainly clearing away heat and plague toxins in the blood; using mulberry bark, mulberry leaf, light bamboo leaf, and atractylodes as ministers, promoting water and infiltrating dampness, soothing wind and relieving exterior symptoms, and clearing away dampness and heat on the surface of qi; using ginseng, angelica, astragalus, and jujube as adjuvants, qi and blood are supplemented together; using salvia miltiorrhiza, ginger, and liquorice as messengers, promoting blood circulation and unblocking meridians, accelerating detoxification and eliminating carbuncle, and can be used to remove postpartum lochia, coordinate various medicines, constitute a clear "monarch, minister, assistant and messenger" compatibility system, and synergistically play the role of the formula in the prevention and treatment of mastitis, and can be widely applied to various mastitis, especially mastitis complicated by postpartum physical weakness.

[0047] The term "granules" used in this article refers to a dry granular preparation with a certain particle size formed by mixing the raw material and suitable excipients. Granules can be swallowed directly or mixed into water for oral administration. Granules are classified into soluble granules (commonly known as granules), suspension granules, effervescent granules, enteric-coated granules, sustained-release granules and controlled-release granules. In addition to the main drug, the composition of the granules may also contain appropriate amounts of excipients such as flavoring agents, fragrances, colorants, dispersants and preservatives as needed. Wet granulation and dry granulation are common methods for preparing granules, and wet granulation is currently the main method for preparing granules; modern granulation techniques, such as fluidized granulation, high-speed stirring granulation, centrifugal granulation and other technologies can also be applied to the preparation of granules.

[0048] In addition to granules, according to actual needs, the composition of the present invention can also be made into any other suitable traditional Chinese medicine dosage form, including but not limited to tablets, capsules, granules, pills, pastes, powders, syrups, oral solutions, mixtures, decoctions, wines, teas and fluid extracts, etc. The preparation methods of these dosage forms are well known in the art.

[0049] Example 1 Preparation of Chinese medicine composition extract

[0050] The extract is prepared according to the provisions and requirements of General Chapter 0189 "Fluid Extracts and Extracts" in Part IV of the 2020 edition of the Chinese Pharmacopoeia. The specific steps include:

[0051] Accurately weigh the raw Chinese medicine in parts by weight, grind it roughly, add 10-12 times the weight of water, decoct and extract twice, each time for 1-2 hours, filter and combine the decoctions, and concentrate them into an extract with a density of 1.15-1.25 (50°C).

[0052] Example 2 Preparation and use of Chinese medicine composition granules

[0053] The granules were prepared according to the provisions and requirements of the General Chapter 0104 "Granules" of the Fourth Part of the 2020 Edition of the Chinese Pharmacopoeia. The specific steps include: adding an appropriate amount of excipients (starch, dextrin, etc.) to the above-mentioned extract prepared in Example 1, mixing for 15 minutes, granulating with a 16-mesh sieve, drying at 70±5°C for 120 minutes, granulating, and packaging.

[0054] In this embodiment, the raw Chinese medicines are used in an amount of 30g of dandelion, 30g of houttuynia, 15g of mulberry bark, 15g of peony bark, 18g of rehmannia root, 12g of angelica root, 10g of mulberry leaf, 10g of lophatherum gracile, 15g of astragalus, 12g of salvia miltiorrhiza, 12g of atractylodes, 10g of ginseng, 10g of ginger, 10g of jujube, and 6g of raw licorice to make 45g granules, and 15g of each bag is packaged to obtain the granules of the present invention.

[0055] When used, just take the granules with warm water. For treatment, pregnant women should take 1 bag 3 times a day. For prevention, take half of the above treatment dose.

[0056] Example 3 Pharmacodynamics test of Chinese medicine composition granules

[0057] The following experiment was conducted at the Institute of Pharmacology and Toxicology of Sichuan Academy of Traditional Chinese Medicine, and a test report was obtained from Sichuan Academy of Traditional Chinese Medicine, which proved that the granules of the present invention have a good analgesic effect and have a certain preventive and therapeutic effect on mouse mastitis caused by LPS.

[0058] Test reagents, subjects and environment:

[0059] Test drug: The granule sample of the present invention was prepared according to Example 2 of the present invention, with batch number 20240501, and provided to the testing unit, and named TS2024-1 in the test report. 1g of the powder is equivalent to 2.4g of the original drug, and the test dose is calculated based on the original drug g / kg. Before use, add a small amount of 0.5% CMC-Na and grind it evenly, and prepare a suspension of corresponding concentration for use.

[0060] Lipopolysaccharide (LPS): specification L2880-25MG, batch number 0000287009, Escherichia coli 055:B5, SIGMA.

[0061] Dexamethasone acetate tablets: batch number LB22172, specification 0.75 mg, Zhejiang Xianjun Pharmaceutical Co., Ltd.

[0062] Sodium chloride injection: specification 550ml, 4.5g, batch number L23110714, Sichuan Kelun Pharmaceutical Co., Ltd.

[0063] Phosphate buffered saline (PBS): pH 7.4, specification 500 mL, batch number 20231107, Guangdong Yiyou Biotechnology Co., Ltd.

[0064] The experimental animals were Kunming mice, SPF grade, 8 weeks old, provided by the Animal Experiment Center of Sichuan University, production license number SCXK (Sichuan) 2024-0026.

[0065] Stereo microscope, WYT-ET, Weiyi Optoelectronics (Tianjin) Co., Ltd.

[0066] The experiment used the SPF barrier system of the Institute of Pharmacology and Toxicology of Sichuan Academy of Traditional Chinese Medicine. The indoor temperature was 20-22°C, the relative humidity was 40%-70%, and the lighting was alternating between light and dark for 12 hours. The certificate number was SYXK(Chuan)2023-100. Free drinking water was provided. The standard feed was provided by the Experimental Animal Center of Sichuan Academy of Traditional Chinese Medicine. The ethical review resolution number for experimental animals is: DWSYLL-2024-120.

[0067] The effect of TS2024-1 on acetic acid-induced writhing reaction in mice was determined as follows:

[0068] Fifty 18-22g male KM mice were randomly divided into the model group after adaptive feeding, and the western medicine positive drug aspirin 0.1g / kg, TS2024-1 8.0 original drug g / kg, TS2024-1 16.0 original drug g / kg, TS2024-1 32.0 original drug g / kg. The corresponding drug was gavaged at 10mL / kg, and the model group was gavaged with an equal volume of solvent, twice a day for 5 consecutive times. 50min after the last administration, 0.8% glacial acetic acid solution (0.1mL / 10g) was injected intraperitoneally to establish the model. The number of twisting of mice in each group within 5 to 20min after modeling was observed and recorded. All data were expressed as mean ± standard deviation (±s), and SPSS20.0 software was used for one-way analysis of variance and rank sum test.

[0069] As shown in Table 1, within 15 minutes after intraperitoneal injection of 0.7% acetic acid, TS2024-1 16.0 and 32.0 g / kg of native drug can significantly reduce the number of body twisting in mice, proving that it has a certain analgesic effect, which is statistically significant compared with the model group.

[0070] Table 1 Effects of TS2024-1 on acetic acid writhing reaction in mice

[0071]

[0072] Compared with the model group, **p<0.01.

[0073] The effect of TS2024-1 on LPS-induced mastitis in mice was determined as follows:

[0074] After adaptive feeding, 80 female mice and 40 male mice were housed in a female-male ratio of 2:1 to mate and conceive. 5-7 days after delivery, the female mice were randomly divided into 6 groups, 10 in each group, namely normal group, model group, positive drug (dexamethasone 5mg / kg) group, TS2024-1 small, medium and large dose groups (8.0g original drug / kg, 16.0g original drug / kg, 32.0g original drug / kg). The normal group and the model group were gavaged with an equal volume of 0.5% CMC-Na solution, and the other groups were gavaged with the corresponding drugs. The drug was administered once 1 hour before modeling, and once each at 6h, 12h after modeling and 1h before sampling, for a total of 4 times. The mother mice and mice were separated 1.5h before modeling. During modeling, mice were anesthetized, hair was removed around the fourth pair of nipples, 75% ethanol was used to wipe the area around the mammary glands, and sterilized tweezers were used to gently pick up the fourth pair of right nipples of mice, and the tip of the nipples was cut off about 1 mm to expose the mammary ducts. LPS was dissolved in phosphate buffered saline (PBS) to 0.5 mg / mL. Under a stereomicroscope, except for the normal group injected with an equal amount of PBS, the other groups were injected with LPS 50 μL / mouse through the mammary ducts. After 24 hours, the mice were killed by cervical dislocation, and the fourth pair of right mammary glands of the mice were peeled off and fixed with 10% formaldehyde solution for pathological histological examination.

[0075] Lipopolysaccharide is the main component of the outer membrane of the cell wall of Escherichia coli. It can activate mononuclear macrophages, endothelial cells, epithelial cells, etc. to synthesize and release a variety of cytokines and inflammatory mediators through the cell signal transduction system. As a model for inducing mastitis, it has good consistency and repeatability. For the establishment of LPS-induced mastitis model, please refer to the following references: 1) Barham W, Sherrill T, Connelly L, et al. Intraductal injection of LPS as a mouse model of mastitis: signaling visualized via an NF-κB reporter transgenic [J]. J Vis Exp. 2012; (67): e4030 and 2) Jie Yingying, Hu Xuequan, Cui Jingchun, et al. Establishment of lipopolysaccharide-induced mastitis model in lactating SD rats [J]. Advances in Veterinary Medicine, 2017, 38 (2): 46-50.

[0076] After paraffin embedding, sectioning and HE staining, the mammary tissue was scored blindly by a pathologist according to the criteria in Table 2. The scoring criteria were based on the following references: 1) Kuang Haixue, Cui Na, Zhang Yanan, et al. Effect of scomycetin on lipopolysaccharide-induced mastitis in mice [J]. Chinese Journal of Experimental Traditional Chinese Medicine, 2020, 26(14): 65-71 and 2) Shanckelford C, Long G, Wolf J. Qualitative and quantitative analysis of nonneoplastic lesions intoxicology studies [J]. Toxicol Pathol, 2002, 30(1): 93-96.

[0077] Table 2 Histological grading standards for breast lesions

[0078]

[0079]

[0080] from Figure 1 As shown in Table 3, the control group ( Figure 1 A): Slight inflammatory cell infiltration in breast tissue. Most specimens had intact tissue morphology, no obvious inflammatory cell infiltration, and no hemorrhage or edema in the interstitium. Model group ( Figure 1 B): Moderate to severe inflammatory cell infiltration and moderate to severe interstitial edema in breast tissue, compared with the control group, the difference was statistically significant. Figure 1 F) Moderate to severe inflammatory cell infiltration and mild to severe interstitial edema in breast tissue were observed. Compared with the model group, the severity of the lesions was alleviated; the grading score of interstitial edema was significantly reduced, which was statistically significant compared with the model group.

[0081] Table 3 Effect of TS2024-1 on mammary gland histopathological scores in mastitis mice

[0082]

[0083] Compared with the model group, *p<0.05; **p<0.01.

[0084] Mastitis is a common disease in mammals during lactation, with an incidence of about 50% in primiparas. Mastitis is a type of mastitis, and the former often refers to acute mastitis that occurs during lactation. Mastitis mainly occurs in lactating women, and is caused by bacterial invasion and local infection due to factors such as blocked mammary ducts and nipple damage; while mastitis refers to inflammation of mammary tissue. The mastitis model obtained in this experiment using postpartum mice can be used to prove the efficacy of mastitis. At present, antibiotics such as penicillin and cephalosporins are often used for clinical treatment. Although the effect is significant, patients cannot breastfeed during treatment, and long-term use is prone to drug resistance.

[0085] The above experimental results of the present invention show that TS2024-1 has a good analgesic effect compared with the negative control and the positive control commonly used in the industry, and has a good preventive and therapeutic effect on mouse mastitis caused by LPS.

[0086] Example 4 Acute toxicity test of Chinese medicine composition granules

[0087] The following test was conducted at the Institute of Pharmacology and Toxicology of Sichuan Academy of Traditional Chinese Medicine, and a test report was obtained from Sichuan Academy of Traditional Chinese Medicine, which proved that the granules of the present invention had no obvious acute toxic effects at the dosage used.

[0088] Test reagents, subjects and environment:

[0089] Experimental drugs: According to Example 2 of the present invention, the granule sample of the present invention is prepared, with batch number 20240501, and provided to the testing unit, and named TS2024-1 in the test report. Among them, 1g of powder is equivalent to 2.4g of original drug, and the test dose is calculated based on g / kg of original drug. Before use, add a small amount of 0.5% CMC-Na and grind it evenly, and prepare it into a maximum concentration solution for use.

[0090] The experimental animals were KM mice, half male and half female, SPF grade, weighing 18-22 g, provided by the Experimental Animal Center of Sichuan University, and the animal production license was: SCXK(Sichuan)2024-0026.

[0091] JA1003A electronic balance, Shanghai Jingtian Electronic Instrument Co., Ltd.

[0092] The experiment used the SPF barrier system of the Institute of Pharmacology and Toxicology of Sichuan Academy of Traditional Chinese Medicine. The indoor temperature was 20-22°C, the relative humidity was 40%-70%, and the lighting was alternating between light and dark for 12 hours. The certificate number was SYXK(Chuan)2023-100. Free drinking water was provided. The standard feed was provided by the Experimental Animal Center of Sichuan Academy of Traditional Chinese Medicine. The ethical review resolution number for experimental animals is: DWSYLL-2024-120.

[0093] The acute toxicity of TS2024-1 to mice was determined as follows:

[0094] The preliminary test found that mice were gavaged with the maximum concentration (0.7g / mL, extract) and the maximum volume (0.4mL / 10g) of TS2024-1, and there was no abnormal reaction or death. Therefore, the maximum tolerance of TS2024-1 was determined: 40 mice weighing 18-22g were taken, half male and half female, and randomly divided into a treatment group and a control group. Fasting but not water for 16h before administration. The treatment group was gavaged with the maximum concentration and maximum volume of TS2024-1 suspension, and the control group was given an equal volume of solvent. The drug was administered again at an interval of 6h, and a total of 2 times, so that the total daily dose reached 136.0 original drug g / kg. The poisoning reactions and deaths of mice within 14 days after administration were observed and recorded. At the end of the experiment, the animals were weighed, the heart, liver, spleen, lung, and kidney were weighed, and the organ index was calculated. The results are shown in Tables 4 and 5. All data are expressed as mean ± standard deviation (±s), and SPSS20.0 software was used for one-way analysis of variance and rank sum test.

[0095] Table 4 Effects of TS2024-1 on the body weight of mice (g, n=10, )

[0096]

[0097] The mice had no abnormal reaction after administration. As shown in Table 4, there was no statistical difference in the weight gain of the mice after administration compared with the control group.

[0098] Table 5 Effects of TS2024-1 on organ indexes of mice (n=20, )

[0099]

[0100] No abnormality was found in the organs of mice after anatomical observation. As shown in Table 5, there was no statistical difference in the organ index of mice after administration compared with the control group. Under the experimental conditions, the maximum tolerance of oral TS2024-1 in mice was 136.0 g / kg of the original drug (equivalent to 88.3 times the clinical human dose). At this dose, the animals had no obvious toxic reaction, indicating that the drug had no obvious acute toxic effect.

[0101] The above is only a preferred specific implementation of the present invention. The common knowledge of the known specific structures and characteristics is not described here. Those skilled in the art will be familiar with these contents. It should be pointed out that for those skilled in the art, without departing from the spirit of the present invention, several modifications and improvements can be made to the implementation scheme, which should also be regarded as the protection scope of the present invention, as long as they do not affect the implementation of the scheme of the present invention.

Claims

1. A Chinese medicine composition for preventing, alleviating or treating postpartum physical weakness combined with mastitis, which is prepared from the following raw materials: 28-32 parts of dandelion, 28-32 parts of houttuynia cortex, 13-17 parts of mulberry bark, 13-17 parts of peony bark, 16-20 parts of raw rehmannia root, 8-12 parts of mulberry leaf, 8-12 parts of lophatherum gracile, and 10-14 parts of atractylodes, all by weight.

2. The Chinese medicine composition according to claim 1 is prepared from the following raw materials: 30 parts of dandelion, 30 parts of houttuynia cortex, 15 parts of mulberry bark, 15 parts of peony bark, 18 parts of raw rehmannia root, 10 parts of mulberry leaf, 10 parts of lophatherum gracile, and 12 parts of atractylodes, all by weight.

3. The Chinese medicine composition according to claim 1 or 2, wherein the raw materials also include 10-14 parts of angelica root, 13-17 parts of astragalus, 10-14 parts of salvia miltiorrhiza, 8-12 parts of ginseng, 8-12 parts of ginger, 8-12 parts of jujube, and 4-8 parts of raw licorice, all by weight.

4. The Chinese medicine composition according to claim 3, wherein the angelica root 12 parts, astragalus 15 parts, salvia miltiorrhiza 12 parts, ginseng 10 parts, ginger 10 parts, jujube 10 parts, and raw liquorice 6 parts, all by weight.

5. A Chinese medicine preparation for preventing, alleviating or treating postpartum physical weakness combined with mastitis, wherein the effective ingredient is the Chinese medicine composition according to any one of claims 1 to 4.

6. The Chinese medicine preparation according to claim 5, which is an extract, granules, decoction, pills, powder, oral solution, capsule, tablet, syrup, mixture or tea prepared according to conventional methods. The Chinese medicine preparation according to claim 6 , which is a granule.

8. The method for preparing the Chinese medicine preparation according to claim 7, comprising: coarsely crushing the medicine in the weight portion, mixing with water and extracting for multiple times, filtering and combining the filtrate, and then adding auxiliary materials to prepare granules.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine preparation according to any one of claims 5 to 7 in the preparation of a medicament for preventing, alleviating or treating postpartum physical weakness combined with mastitis.

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