CN111514252A

CN111514252A - Traditional Chinese medicine composition, medicine, preparation method and application thereof

Info

Publication number: CN111514252A
Application number: CN202010515935.9A
Authority: CN
Inventors: 张董晓; 付娜; 东浩; 黄巧; 赵文洁; 孙宇建
Original assignee: Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital University of Medicine Sciences
Current assignee: Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital University of Medicine Sciences
Priority date: 2020-06-08
Filing date: 2020-06-08
Publication date: 2020-08-11

Abstract

The invention provides a traditional Chinese medicine composition, a medicine, a preparation method and an application thereof, and relates to the technical field of traditional Chinese medicines. Practice proves that the traditional Chinese medicine composition has good curative effect on mastitis in lactation period and non-lactation period.

Description

Traditional Chinese medicine composition, medicine, preparation method and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition, a medicine, a preparation method and application thereof.

Background

Clinically, mastitis is divided into two types, namely lactation mastitis and non-lactation mastitis. The mastitis in the lactation period is acute suppurative infection of mammary gland, is a common disease of women in the lactation period, and about 3-33% of lactation women have 1 mastitis attack, often occur 3-4 weeks after delivery, and clinically show red, swollen, hot and painful breasts, can not normally nurse, and has great influence on the body and mind of mothers and the feeding of babies. With the release of the policy of two fetuses and the increase of the living and working pressure of modern women, the age of the first lying-in women is increased, the number of people in caesarean section is increased and the like, so the incidence rate of acute mastitis in the lactation period is rapidly increased to become a common disease in the breast outpatient service. If the treatment is not timely and incorrect, the probability of the development of mastitis to the mammary abscess is obviously increased, and the mammary abscess is subjected to invasive operations such as puncture pus drawing of the mammary abscess or surgical drainage due to long treatment period, so that the body and mind of a patient are painful. Meanwhile, the milk returning rate of the patients with mammary abscess is also high, and is one of the main factors causing the failure of breast feeding.

Non-lactation mastitis mainly comprises plasma cell mastitis and granulomatous mastitis. Plasma cell mastitis is an acute inflammation induced by the loss of secretion from the teat due to crater nipple. Granulomatous mastitis is a chronic inflammatory disease with granuloma as the main pathological feature and non-caseous necrosis centered on lobule of mammary gland. Both of them are complicated and easy to repeat, and have great influence on the physical and mental health of women.

Regarding the existing treatment mode, mastitis in lactation period is a mammary gland inflammatory disease, but can be accompanied or not accompanied by bacterial infection, including mastitis in milk stasis type, non-infection type and infection type, and the common main pathogenic bacteria are staphylococcus aureus, methicillin-resistant staphylococcus aureus and the like. Antibiotics are currently the most commonly used treatment.

However, antibiotic treatment for lactating mastitis has the following drawbacks and disadvantages: (1) early lactation mastitis mostly only has local hard mass, and antibiotics cannot be used because white blood cells are normal and the body temperature is not high, and the mastitis does not meet the indication of using the antibiotics. (2) Antibiotics are often used empirically, and are administered when treatment is ineffective or when there is a drug sensitive outcome. Given that bacterial culture and susceptibility testing results are significantly later than the time of initiation of treatment, it is difficult to effectively guide mastitis administration. (3) After the antibiotic is excessively used for anti-infection treatment, qi and blood stagnation is easy to cause, inflammation is organized, a 'stiff block' is easy to form at a mammary gland part, the persistence is difficult to heal, and the treatment of diseases is not facilitated, so that lactation is influenced. (4) The simple dependence on antibiotics for treating mastitis not only easily causes drug resistance of mothers, but also clearly indicates that the 'breast feeding is not recommended during the period of using antibiotics' in the antibiotic treatment guidelines of China because the secretory metabolic condition of antibiotics in milk is unknown. This causes milk pooling to further exacerbate and mastitis symptoms to be more severe. In view of the above, and in contradiction with relevant regulations, antibiotics are subject to serious problems in treatment of mastitis in lactation period.

As for non-lactation mastitis, no better treatment scheme exists at present, and antibiotics and operations are the more common treatment means at present, but the treatment effect is poor. Aiming at non-lactation mastitis, whether plasma cell mastitis or granulomatous mastitis is an inflammatory disease, the current treatment has the disadvantages that: (1) for an inflammatory focus, surgical excision is mainly used, and particularly, when the range of pathological changes is large, the wide excision or the simple excision of the breast is performed, so that the wound is large, the appearance of the female breast is incomplete, the disease relapse is not prevented, and the other regions of the homonymous breast or the contralateral breast frequently reoccurs after the operation. The question about the operation treatment method is increasing in recent years in China and abroad. (2) For antibiotic therapy, most antibiotic therapies are ineffective because the pathogenic bacteria in the early stage are undefined and cannot be treated according to the drug sensitive outcome. Antibiotics and surgical treatments are therefore also a challenge in the treatment of non-lactating mastitis.

Traditional Chinese medicine considers that lactation mastitis belongs to the field of acute mastitis in traditional Chinese medicine, the traditional Chinese medicine has obvious advantages in treatment of lactation mastitis, and has a good substitution effect on antibiotics, but no traditional Chinese medicine preparation for treating lactation mastitis is on the market at present. Mastitis in lactation period develops rapidly, and due to the lack of convenient and quick traditional Chinese medicines, the optimal treatment period is often delayed, so that the disease condition develops, and patients are forced to recover milk. Therefore, the research and development of the traditional Chinese medicine with definite clinical curative effect and definite evidence not only has great significance for treating the disease, but also can effectively ensure the implementation of breast feeding, promote the health of mothers and infants and concern the quality of the next generation growth. The non-lactation mastitis belongs to the scope of acne-type acute mastitis in traditional Chinese medicine, and the traditional Chinese medicine for treating granulomatous mastitis has the advantages of less wound, small destruction, low recurrence rate and the like, and gradually becomes the main treatment method of the granulomatous mastitis at present.

Therefore, it becomes necessary and urgent to explore the traditional Chinese medicine in China and research and develop a traditional Chinese medicine composition and a medicine with good curative effects on lactation mastitis and non-lactation mastitis so as to alleviate the defects of the existing western medicine treatment means in treatment of the lactation mastitis and the non-lactation mastitis.

In view of the above, the present invention is particularly proposed.

Disclosure of Invention

The first purpose of the invention is to provide a traditional Chinese medicine composition which has the effects of clearing away heat and toxic materials, eliminating stagnation and curing carbuncle. Practice proves that the traditional Chinese medicine composition has good curative effect on mastitis in lactation period and non-lactation period.

The second purpose of the invention is to provide a medicine prepared from the traditional Chinese medicine composition.

The third purpose of the invention is to provide a preparation method of the medicine, which has the advantages of simple operation, easy application and the like.

The fourth purpose of the invention is to provide the traditional Chinese medicine composition or the application of the medicine in preparing a medicine for treating mastitis.

In order to achieve the above purpose of the present invention, the following technical solutions are adopted:

the invention provides a traditional Chinese medicine composition which comprises the following components in parts by weight:

5-15 parts of dandelion, 5-15 parts of fructus forsythiae, 5-15 parts of snakegourd fruit, 3-9 parts of schizonepeta spike, 5-10 parts of red paeony root, 5-15 parts of cortex moutan, 5-10 parts of lalang grass rhizome and 5-12 parts of burdock.

Further, the traditional Chinese medicine composition comprises the following components in parts by weight:

10-15 parts of dandelion, 10-15 parts of fructus forsythiae, 10-15 parts of snakegourd fruit, 6-9 parts of schizonepeta spike, 8-10 parts of red peony root, 10-15 parts of cortex moutan, 8-10 parts of cogongrass rhizome and 8-12 parts of burdock.

Furthermore, the traditional Chinese medicine composition comprises the following components in parts by weight:

15 parts of dandelion, 15 parts of fructus forsythiae, 15 parts of snakegourd fruit, 9 parts of schizonepeta spike, 10 parts of red paeony root, 10 parts of cortex moutan, 10 parts of lalang grass rhizome and 12 parts of burdock.

The invention provides a medicine prepared from the traditional Chinese medicine composition.

Furthermore, the dosage form of the medicine is any one of decoction, granules, powder, capsules or oral liquid.

The invention provides a preparation method of the medicine, which comprises the following steps:

uniformly mixing the raw materials according to the formula ratio, and adding water for decoction to obtain a medicine;

further, the water adding decoction comprises the following steps: adding water into the mixed raw materials, and carrying out first decoction to obtain a first decoction liquid; adding water into the decocted raw materials again, and decocting for the second time to obtain a second decoction; mixing the second decoction with the first decoction to obtain a medicine;

preferably, the reaction conditions of the first decoction at least satisfy at least one of the following: the decocting temperature is 100-110 ℃, the decocting time is 20-35 min, and the mass ratio of the decocted liquid is 0.2-0.5 g/mL;

more preferably, the reaction conditions of the first decoction at least satisfy at least one of the following: the decocting temperature is 100 deg.C, the decocting time is 30min, and the decocting liquid mass ratio is 0.3 g/mL;

preferably, the reaction conditions of the second decoction at least satisfy at least one of the following: the decocting temperature is 100-110 ℃, the decocting time is 20-25 min, and the mass ratio of the decocted liquid is 0.15-0.5 g/mL;

more preferably, the reaction conditions of the second decoction at least satisfy at least one of the following: the decocting temperature is 100 deg.C, the decocting time is 20min, and the decocting liquid mass ratio is 0.2 g/mL.

Further, the preparation method also comprises the step of soaking the mixed raw materials before adding water for decoction;

preferably, the soaking time is 20-40 min, preferably 30 min;

preferably, the mass ratio of the soaked feed liquid is 0.1 g/mL-0.25 g/mL; preferably 0.15g/mL to 0.2 g/mL.

The invention provides the traditional Chinese medicine composition or the application of the medicine in preparing a medicine for treating mastitis.

Further, the mastitis includes lactation mastitis and non-lactation mastitis;

preferably, the non-lactation mastitis comprises non-lactation plasma cell mastitis and granulomatous mastitis.

Compared with the prior art, the invention has the beneficial effects that:

according to the traditional Chinese medicine composition provided by the invention, dandelion and fructus forsythiae which have the effects of clearing heat and removing toxicity, and eliminating swelling and dissipating binds are used as monarch drugs, red paeony root and cortex moutan which have the effects of clearing heat and cooling blood, and activating blood and dissipating swelling are used as ministerial drugs, and medicines which have the effects of dispelling wind heat and eliminating swelling and eliminating binds, such as schizonepeta spike, burdock, trichosanthes kirilowii maxim and rhizoma imperatae, are used as assistant drugs, and the medicinal materials and the dosage of the medicinal materials used in each component are adjusted through repeated tests for more than ten years, so that a unique formula is formed; meanwhile, the traditional Chinese medicine composition also has a good antibacterial effect. Practice proves that the traditional Chinese medicine composition has good curative effect on mastitis in lactation period and non-lactation period.

The medicine prepared from the traditional Chinese medicine composition provided by the invention has good effects of clearing heat and removing toxicity, and eliminating stagnation and curing carbuncle.

The preparation method of the medicine provided by the invention comprises the steps of uniformly mixing the raw materials according to the formula amount, and adding water for decoction to obtain the medicine; the preparation method has the advantages of simple operation, easy application and the like.

The traditional Chinese medicine composition or the medicine provided by the invention can be widely applied to the preparation process of mastitis treatment medicines.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments, and it should be understood that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

According to one aspect of the invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

The pharmacological and flavor functions of the raw material medicine components used in the invention are as follows:

dandelion: alias herba crotalariae, herba Veronicae Didyma, HUALANG, etc., and can be used as perennial herb of Compositae. Herba Taraxaci has effects of clearing away heat and toxic materials, promoting diuresis and resolving hard mass, and can be used for treating lymphadenitis, lymphoid tuberculosis, furunculosis, swelling, acute conjunctivitis, acute tonsillitis, acute bronchitis, gastritis, hepatitis, cholecystitis and urinary tract infection. The dandelion in the traditional Chinese medicine composition is used as a monarch drug, and has good effects of clearing heat and removing toxicity, and relieving swelling and dissipating stagnation.

Fructus forsythiae: fructus forsythiae is bitter in nature and slightly cold in taste, enters heart, lung and gallbladder meridians, and has the effects of clearing heat, removing toxicity, eliminating stagnation and relieving swelling. It is commonly used for fever due to heat or excessive toxic heat. Meanwhile, modern pharmacology indicates that fructus forsythiae has a relatively prominent effect in inhibiting escherichia coli and staphylococcus aureus, so that the traditional Chinese medicine composition has a certain bacteriostatic effect.

The dandelion and the forsythia are used as monarch drugs in the traditional Chinese medicine composition, and the traditional Chinese medicine composition has good effects of clearing heat and removing toxicity, and relieving swelling and dissipating stagnation.

Typical but non-limiting preferred embodiments of the above dandelion are: 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts and 15 parts; typical but non-limiting preferred embodiments of the above-described forsythia suspense are: 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts and 15 parts;

red peony root: is dry root of Paeonia lactiflora pall or Paeonia veitchii Walker of Ranunculaceae, has bitter taste and slightly cold property, enters liver channel, and has effects of clearing heat, cooling blood, removing blood stasis and relieving pain. It is commonly indicated for heat entering nutrient-blood, warm toxicity and macula, hematemesis and epistaxis, conjunctival congestion and swelling pain, liver depression and hypochondriac pain, amenorrhea and dysmenorrhea, addiction and abdominal pain, etc.

Cortex moutan: is dried root bark of Paeonia suffruticosa Andr. Bitter and pungent, slightly cold, enter heart, liver and kidney meridians, and have the effects of clearing heat and cooling blood, and activating blood circulation to dissipate blood stasis. It is commonly indicated for heat entering nutrient-blood, warm toxicity, macula, hematemesis, epistaxis, night fever, early coolness, anhidrosis, and steaming bone.

The red paeony root and the cortex moutan in the traditional Chinese medicine composition are used as ministerial drugs, so that the traditional Chinese medicine composition has good effects of clearing heat, cooling blood, promoting blood circulation and diminishing swelling, and meanwhile, the modern pharmacology shows that the cortex moutan and the red paeony root extract have certain inhibiting effect on test bacteria such as staphylococcus aureus, swine fecal streptococcus and the like, so that the traditional Chinese medicine composition has certain antibacterial effect.

Typical but non-limiting preferred embodiments of the above-mentioned red peony root are: 5 parts, 6 parts, 7 parts, 8 parts, 9 parts and 10 parts; typical but non-limiting preferred embodiments of the cortex moutan are as follows: 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts and 15 parts;

schizonepeta spike: pungent and slightly warm herbs enter lung and liver meridians. Has the functions of relieving exterior syndrome, dispelling wind, promoting eruption and eliminating sore. It is commonly used for cold, headache, measles, rubella and early stage of pyocutaneous disease.

And (3) burdock: has the effects of dispelling wind and heat, ventilating and promoting eruption, relieving sore throat and eliminating stagnation, and removing toxic substance and detumescence. It belongs to the category of exterior-releasing herbs that disperse wind-heat, and is commonly used for wind-heat type common cold, early stage of warm disease, measles without adequate eruption, carbuncle, swelling and sore.

In the traditional Chinese medicine composition, the schizonepeta spike and the burdock serve as adjuvant drugs, so that the traditional Chinese medicine composition has the effect of dispelling wind heat, and further dispels the wind heat and eliminates sore swelling.

Typical but non-limiting preferred embodiments of the above schizonepeta spike are: 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts and 9 parts; typical but non-limiting preferred embodiments of the above burdock fruit are: 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts and 12 parts.

And (3) snakegourd fruit: fructus Trichosanthis has effects of moistening lung, eliminating phlegm, resolving hard mass and moistening intestine, and can be used for treating phlegm heat cough, thoracic obstruction and thoracic obstruction, lung flaccidity hemoptysis, diabetes, jaundice, constipation and early stage carbuncle swelling.

Cogongrass rhizome: is dried rhizome of Cymbopogon citratus of Gramineae. Lalang grass rhizome is sweet in nature and cold in flavor, enters lung, stomach and bladder channels, has effects of cooling blood, stopping bleeding, clearing heat and promoting urination, and is used for treating blood heat hematemesis, epistaxis, hematuria, fever polydipsia, lung heat cough, stomach heat emesis, damp-heat jaundice, edema oliguria, stranguria with astringency and pain, etc.

The schizonepeta spike and the burdock serve as adjuvant drugs in the traditional Chinese medicine composition, the traditional Chinese medicine composition has the effects of clearing heat, resolving masses and resolving carbuncle, and particularly, the trichosanthes kirilowii Maxim and the cogongrass rhizome are used together, so that heat can be relieved from stool and urine, and the effects of clearing heat and removing toxicity of the traditional Chinese medicine composition are further enhanced; meanwhile, modern pharmacology indicates that the cogongrass rhizome extract has a certain inhibiting effect on gram-positive bacteria, gram-negative bacteria and fungi, so that the traditional Chinese medicine composition has a certain antibacterial effect.

Typical but non-limiting preferred embodiments of the above snakegourd fruit are: 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts and 15 parts; typical but non-limiting preferred embodiments of the aforementioned cogongrass rhizome are: 5 parts, 6 parts, 7 parts, 8 parts, 9 parts and 10 parts.

Meanwhile, the traditional Chinese medicine holds that the liver of a woman is used as the congenital factor, mastitis patients mostly have a history of emotional disorder, liver qi stagnation, heat transformation for a long time, liver fire is vigorous, heat evil fumigates the skin, skin temperature is increased, skin color is red, local swelling occurs frequently, and pain is obvious; stagnation of liver qi can lead to qi stagnation and blood stasis, stagnation of phlegm and blood stasis, and formation of visible lumps; the heat is generated after the long-term stasis, the flesh becomes pus and enters the abscess stage; then, the wound is broken into a leak, which means that the wound can be drained for a long time and cannot be healed, which is the late stage of the wound. Although the disease is divided into acute stage, swollen stage, abscess stage and ulceration stage, the intrinsic heat of liver meridian is the basic pathogenesis throughout. The traditional Chinese medicine composition is mainly used for clearing heat and removing toxicity, wherein the heat-clearing and detoxifying method can be used for cooling blood and removing carbuncle in acute stage when local swelling is severe; clearing away heat and toxic materials in the swelling stage to relieve swelling and dissipate stagnation; clearing away heat and toxic materials to promote pus discharge; in the post ulceration stage, the heat-clearing and detoxifying method assists in clearing away the residual toxins. Therefore, the heat-clearing and detoxifying effects of the traditional Chinese medicine composition can cover the whole course of treatment.

In a preferred embodiment of the invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

In the preferred embodiment, the traditional Chinese medicine composition comprises the following components in parts by weight:

In the invention, the drug effect of the traditional Chinese medicine composition is further optimized by further adjusting and optimizing the dosage proportion of the raw materials of each component.

According to one aspect of the invention, the medicine is prepared from the traditional Chinese medicine composition.

The medicine prepared from the traditional Chinese medicine composition provided by the invention has good effects of clearing heat and removing toxicity, cooling blood and eliminating carbuncle.

In a preferred embodiment of the present invention, the dosage form of the drug is any one of decoction, granules, powder, capsules or oral preparation.

As a preferable embodiment, the medicine can be processed into one of decoction, granules, powder, capsules or oral liquid, so that the advantages of multiple using dosage forms and wide application range of the medicine are realized.

According to one aspect of the present invention, a method for preparing the above-mentioned medicament comprises the steps of:

In a preferred embodiment of the present invention, the preparation method of the powder further comprises the steps of decocting, distilling, and collecting the precipitate after distillation;

in a preferred embodiment of the present invention, the method for preparing the oral liquid further comprises a step of distillation after decoction, or a step of ethanol extraction or other organic solvent purification after decoction, and a step of purification of individual Chinese medicine monomers.

In a preferred embodiment of the present invention, the decocting with water comprises the steps of: adding water into the mixed raw materials, and carrying out first decoction to obtain a first decoction liquid; adding water into the decocted raw materials again, and decocting for the second time to obtain a second decoction; mixing the second decoction with the first decoction to obtain a medicine;

in a preferred embodiment of the present invention, the reaction conditions of the first decoction at least satisfy at least one of the following conditions: the decocting temperature is 100-110 ℃, the decocting time is 20-35 min, and the mass ratio of the decocted liquid is 0.2-0.5 g/mL;

typical but non-limiting preferred embodiments of the above first decoction are: 102 ℃, 104 ℃, 106 ℃, 108 ℃, 109 ℃ and 110 ℃; typical but non-limiting preferred embodiments of the above first decoction are: 25min, 26min, 28min, 30min, 32min, 34min and 35 min;

in the above preferred embodiment, the reaction conditions of the first decoction at least satisfy at least one of the following: the decocting temperature is 100 deg.C, the decocting time is 30min, and the decocting liquid mass ratio is 0.3 g/mL;

in a preferred embodiment of the present invention, the reaction conditions of the second decoction at least satisfy at least one of the following conditions: the decocting temperature is 100-110 ℃, the decocting time is 20-25 min, and the mass ratio of the decocted liquid is 0.15-0.5 g/mL;

typical but non-limiting preferred embodiments of the above-mentioned second decoction are: 102 ℃, 104 ℃, 106 ℃, 108 ℃, 109 ℃ and 110 ℃; typical but non-limiting preferred embodiments of the above-mentioned second decoction are: 20min, 21min, 22min, 23min, 24min and 25 min;

in the above preferred embodiment, the reaction conditions of the second decoction at least satisfy at least one of the following: the decocting temperature is 100 deg.C, the decocting time is 20min, and the decocting liquid mass ratio is 0.2 g/mL.

In a preferred embodiment of the present invention, the preparation method further comprises the step of soaking the mixed raw materials before decocting with water;

as a preferred embodiment, before decocting with water, soaking the mixed raw materials can fully soak the raw materials, so that the effective components can be extracted into the decoction liquid as much as possible during the decoction.

In the preferred embodiment, the soaking time is 20-40 min, preferably 30 min;

typical but non-limiting preferred embodiments of the above soaking time are: 20min, 25min, 30min, 35min, 38min and 40 min;

in a preferred embodiment, the mass ratio of the soaking solution to the soaking solution is 0.15g/mL to 0.2 g/mL.

According to one aspect of the invention, the traditional Chinese medicine composition or the application of the medicine in preparing a medicine for treating mastitis is provided.

In a preferred embodiment of the invention, the mastitis comprises lactation mastitis and non-lactation mastitis;

The technical solution of the present invention will be further described with reference to examples and comparative examples.

Example 1

A traditional Chinese medicine composition comprises the following components in grams by mass:

15g of dandelion, 5g of fructus forsythiae, 15g of snakegourd fruit, 3g of schizonepeta spike, 10g of red paeony root, 5g of cortex moutan, 10g of lalang grass rhizome and 5g of burdock.

The preparation method of the medicine comprises the following steps:

uniformly mixing the raw materials according to the formula ratio, and soaking in 500ml of normal-temperature water for 20min to ensure that all the raw materials are completely soaked in the water; then, carrying out first decoction, boiling with strong fire, then decocting with slow fire for 25min, and taking 200ml of juice to obtain a first decoction; adding 300ml of water into the decocted raw materials again, decocting for the second time, decocting for 25min with slow fire after boiling with strong fire, and taking 200ml of decoction to obtain a second decoction; and mixing the second decoction with the first decoction to obtain the decoction.

Example 2

5g of dandelion, 5g of fructus forsythiae, 5g of snakegourd fruit, 9g of schizonepeta spike, 5g of red paeony root, 15g of cortex moutan, 5g of lalang grass rhizome and 12g of burdock.

The preparation method of the medicine comprises the following steps:

uniformly mixing the raw materials according to the formula ratio, and soaking in 500ml of normal-temperature water for 40min to ensure that all the raw materials are completely soaked in the water; then, carrying out first decoction, boiling with strong fire, then decocting for 35min with slow fire, and taking 200ml of juice to obtain a first decoction; adding 300ml of water into the decocted raw materials again, decocting for the second time, decocting for 20min with slow fire after boiling with strong fire, and taking 200ml of decoction to obtain a second decoction; and mixing the second decoction with the first decoction to obtain the decoction.

Example 3

10g of dandelion, 15g of fructus forsythiae, 10g of snakegourd fruit, 9g of schizonepeta spike, 8g of red paeony root, 10g of cortex moutan, 8g of lalang grass rhizome and 12g of burdock.

The preparation method of the medicine comprises the following steps:

uniformly mixing the raw materials according to the formula ratio, and soaking in 500ml of normal-temperature water for 25min to ensure that all the raw materials are completely soaked in the water; then, carrying out first decoction, boiling with strong fire, then decocting for 28min with slow fire, and taking 200ml of juice to obtain a first decoction; adding 300ml of water into the decocted raw materials again, decocting for the second time, decocting with slow fire for 21min after boiling with strong fire, and taking 200ml of decoction to obtain a second decoction; and mixing the second decoction with the first decoction to obtain the decoction.

Example 4

15g of dandelion, 10g of fructus forsythiae, 15g of snakegourd fruit, 3g of schizonepeta spike, 10g of red paeony root, 15g of cortex moutan, 10g of lalang grass rhizome and 8g of burdock.

The preparation method of the medicine comprises the following steps:

uniformly mixing the raw materials according to the formula ratio, and soaking in 500ml of normal-temperature water for 35min to ensure that all the raw materials are completely soaked in the water; then, carrying out first decoction, boiling with strong fire, then decocting for 32min with slow fire, and taking 200ml of juice to obtain a first decoction; adding 300ml of water into the decocted raw materials again, decocting for the second time, decocting for 22min with slow fire after boiling with strong fire, and taking 200ml of decoction to obtain a second decoction; and mixing the second decoction with the first decoction to obtain the decoction.

Example 5

The preparation method of the medicine comprises the following steps:

uniformly mixing the raw materials according to the formula ratio, and soaking in 500ml of normal-temperature water for 30min to ensure that all the raw materials are completely soaked in the water; then, carrying out first decoction, boiling with strong fire, then decocting for 30min with slow fire, and taking 200ml of juice to obtain a first decoction; adding 300ml of water into the decocted raw materials again, decocting for the second time, decocting for 20min with slow fire after boiling with strong fire, and taking 200ml of decoction to obtain a second decoction; and mixing the second decoction with the first decoction to obtain the decoction.

Example 6

This example is the same as example 5 except that the decoction is further processed into powder.

The preparation method of the powder comprises the following steps: decocting, distilling, and collecting precipitate.

Example 7

This example is the same as example 5 except that it further comprises the step of preparing the decoction into an oral liquid.

The specific preparation steps of the oral liquid are as follows: decocting, distilling, or decocting, extracting with ethanol, or decocting, and purifying with other organic solvents, including purifying individual Chinese medicinal monomers.

Comparative example 1

3 parts of dandelion, 3 parts of fructus forsythiae, 15 parts of snakegourd fruit, 9 parts of schizonepeta spike, 10 parts of red paeony root, 10 parts of cortex moutan, 10 parts of lalang grass rhizome and 12 parts of burdock.

A medicament prepared from the Chinese medicinal composition, and the preparation method of the medicament is the same as example 5.

The difference between this comparative example and example 5 is that the contents of the components dandelion and forsythia suspensa are out of the range of compatibility of the present invention.

Comparative example 2

15 parts of dandelion, 15 parts of fructus forsythiae, 15 parts of snakegourd fruit, 9 parts of schizonepeta spike, 3 parts of red paeony root, 3 parts of cortex moutan, 10 parts of lalang grass rhizome and 12 parts of burdock.

The difference between the comparative example and the example 5 is that the contents of the components of the red paeony root and the cortex moutan are not in the compatible range of the invention.

Comparative example 3

15 parts of fructus forsythiae, 15 parts of fructus trichosanthis, 9 parts of schizonepeta spike, 10 parts of red paeony root, 10 parts of cortex moutan, 10 parts of lalang grass rhizome and 12 parts of great burdock achene.

This comparative example is different from example 5 in that dandelion is not within the composition range of the present invention.

Experimental example 1

The traditional Chinese medicine composition has the effects of clearing heat and removing toxicity, eliminating stagnation and eliminating carbuncle, and has a good curative effect on mastitis in lactation. The age of the clinic visit of the mammary gland department in Beijing traditional Chinese medicine hospital is 21-36 years old; the effect experiment of the medicine prepared in the example 5 is carried out on 400 lactation mastitis patients with the disease course of 0.5-6 days.

The specific method comprises the following steps:

(1) and diagnosis standard: reference is made to 'standard of curative effect for diagnosis of disease and symptoms of traditional Chinese medicine' and 'science of surgery of traditional Chinese medicine' issued by medical administration in 2012. Cracked nipple, stabbing pain of nipple during lactation; secondly, the milk duct is blocked, the milk is not discharged smoothly or the breast feeding is improper, so that the milk is stagnated; thirdly, the local part of the breast forms a mass, the skin color is reddish, the skin is slightly hot, and the breast is accompanied by tenderness; fourthly, fever with chills and aching headache are often accompanied; the total number of leucocytes and neutrophils is increased or not increased.

(2) Case inclusion criteria: meets the diagnosis standard of initial acute mastitis, and is suitable for women in lactation period.

(3) Case exclusion criteria: for formation of breast abscesses; complicated with malignant or benign tumor of breast; patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, liver diseases, kidney diseases, hemopoietic system diseases, etc., or mental disease.

(4) The treatment method comprises the following steps: 400 patients are treated by adopting the decoction prepared in the example 5, and the specific taking method is that 300ml of decoction is taken per day by 2 times of oral administration, 150 ml/time, and the decoction is taken for 3-7 days.

(II) specific detection indexes are as follows:

(1) breast pain: patients give their pain scores based on their own numbers of degrees graded against a "scale" of pain sensation using Visual Analogue Scale (VAS). 0-10 represents pain of different degrees, 0 is no pain, 1-3 is mild pain, 4-6 is moderate pain, and 7-10 is severe pain. And judging the pain time and the improvement degree of the patient according to the patient log card.

(2) And improvement of the size of the agglomeration before and after treatment: according to the palpation judgment of the clinician, the physician palpates the mass and marks the quadrant in which it is located. The maximum length and width are measured and recorded. Wherein, the general symptoms disappear, and the breast lumps disappear to be healed; the general symptoms disappear, the local pain is relieved, and the breast lumps are reduced to be improved; none of the signs of symptoms improved to be ineffective.

(3) Body temperature improvement: the body temperature returns to normal after treatment and is healed; the body temperature did not improve to be ineffective.

(4) And the curative effect judgment standard is as follows: the symptoms of the whole body disappear, the body temperature is normal, and the lumps disappear to be cured; the symptoms of the whole body disappear, the agglomeration is reduced, and the local swelling and pain is relieved to be improved; the mass is not eliminated, the body temperature is not improved, and the disease is ineffective when the disease progresses to the abscess stage. The above-mentioned main observation indexes were recorded 1 time on the treatment day and treatment 3 d.

(III) the test results are as follows:

(1) and improvement of breast pain after treatment: 361 cases of pain before treatment, 322 cases of pain scores of VAS after treatment, 31 cases of pain scores of 1, 6 cases of pain scores of less than 1, no improvement for 2 cases and 99.44 percent of effective rate.

(2) Improvement of lump size after treatment: 400 cases of lumps exist before treatment, 323 cases of lumps disappear after treatment, 42 cases of lumps are reduced by more than or equal to 1/2, 29 cases of lumps are reduced by more than or equal to 1/3 but less than 1/2, the lumps are reduced by less than 1/36 cases, and the effective rate is 98.5%.

(3) And improvement of body temperature after treatment: 201 cases of fever before treatment, 195 cases of fever recovery and 6 cases of fever, with the effective rate of 97.01%.

(4) And the clinical curative effect condition of the patient: for 400 patients, 318 patients are cured, 79 patients are improved, 5 patients are not effective, and the effective rate is 98.75%.

According to the experimental example 1, the mastitis patient in the lactation period is taken as an observation object, the curative effect of the traditional Chinese medicine composition for treating acute mastitis in the lactation period is objectively evaluated according to comparison of body temperature, breast lump size, redness range, VAS pain score, breast ultrasound, milk excretion condition, recovery time, general symptoms, syndrome accumulation and the like before and after treatment, and the mastitis patient in the lactation period is found to have better effects on defervescence, lump reduction, red swelling range, patient pain reduction, breast milk secretion smoothness improvement, laboratory index improvement and the like. And the breast feeding can be continued during the administration period. The early clinical practice has satisfactory curative effect, has good substitution effect on antibiotics, and is a safe and reliable traditional Chinese medicine which is in line with clinical practice and is simple, convenient and feasible for treating mastitis in lactation.

Experimental example 2

The traditional Chinese medicine composition has the effects of clearing heat and removing toxicity, eliminating stagnation and eliminating carbuncle, and has a good curative effect on non-lactation mastitis. At present, 102 non-lactation mastitis patients who are treated by coarse needle puncture pathological diagnosis and confirmed antibiotic treatment failure in the department of mammary gland of Beijing medical hospital of capital medical university are specially selected to carry out effect experiments by adopting the medicine prepared in the example 5.

The specific method comprises the following steps:

102 cases of decoction prepared in the embodiment 5 are treated, and the specific taking method is that 300ml of decoction is taken per day, the decoction is taken orally for 2 times, 150ml is taken per time, and the taking time is 19-89 days.

(II) specific detection indexes are as follows:

(1) the traditional Chinese medicine symptom sign score table is established according to relevant standards in traditional Chinese medicine disease diagnosis curative effect standard, traditional Chinese medicine new drug clinical research guiding principle, issued by the administration of traditional Chinese medicine in 1994, and the traditional Chinese medicine symptom sign score table is used for recording integral conditions of symptom signs by an integral method respectively 1 day, 1 week, 2 weeks, 3 weeks, 4 weeks and 1 month before treatment, and mainly comprises breast swelling, breast red swelling, pain, abscess formation, nipple depression and breast fistula.

(2) And the curative effect judgment standard is as follows:

the total integral value of symptoms is reduced by more than or equal to 90 percent in clinical recovery. The effect is shown: total integral value of symptoms is reduced by less than 90 percent and is more than 70 percent; the method has the following advantages: the total integral value of symptoms is reduced by less than 70 percent and is more than or equal to 30 percent; and (4) invalidation: the total integral value of symptoms decreased < 30%, or the range of lesions expanded.

The observed data were statistically analyzed using SPSS17.0 software. The measurement data is tested by t, and the counting data is tested by x 2. Differences of P <0.05 were statistically significant.

(III) the experimental results are as follows:

(1) after treatment, the total clinical effective rate of the patients in the group is 98%, the clinical cure rate is 72%, the significant efficiency is 26% and the ineffective rate is 2%.

(2) After treatment, the observation indexes comprise clinical indications of breast lumps, breast red and swollen, pain, abscess formation, nipple depression, breast fistulas and the like, the clinical indications are obviously improved compared with those before treatment, the total integral of symptoms before treatment is (16.0 +/-4.2) points, the total integral after treatment is (2.2 +/-1.3) points, and the difference before and after treatment has statistical significance (P is less than 0.05).

(3) And recurrence of disease: the follow-up visit is 6-8 months, and the follow-up visit mode comprises an outpatient follow-up visit and a telephone follow-up visit. 98 patients had no ipsilateral recurrence, and 3 patients had contralateral recurrence and continued treatment.

As can be seen from the above experimental example 2, the non-lactation mastitis patient who fails in antibiotic treatment is observed, and the traditional Chinese medicine composition has good effects of reducing the range of red swelling and lump, reducing abnormal low-echo area under ultrasound, reducing pain score and reducing fever. The cure and remission rate of the patients who fail to treat the antibiotics is still high. Can rapidly improve general and local symptoms.

In conclusion, the traditional Chinese medicine composition provided by the invention adopts dandelion and fructus forsythiae which have the effects of clearing heat and removing toxicity, and eliminating swelling and dissipating stagnation as monarch drugs, is supplemented with red paeony root and cortex moutan which have the effects of clearing heat and cooling blood, and activating blood and dissipating swelling as ministerial drugs, and also adopts the drugs with the effects of dispelling wind heat and relieving swelling and eliminating stagnation, such as schizonepeta spike, burdock, trichosanthes kirilowii maxim and rhizoma imperatae, as adjuvant drugs to form a unique formula, and has the effects of clearing heat and removing toxicity, dissipating stagnation and eliminating carbuncle; meanwhile, the traditional Chinese medicine composition also has a good antibacterial effect. Practice proves that the traditional Chinese medicine composition has good curative effect on mastitis in lactation period and non-lactation period.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. The traditional Chinese medicine composition is characterized by comprising the following components in parts by weight:

2. The traditional Chinese medicine composition according to claim 1, which comprises the following components in parts by weight:

3. The traditional Chinese medicine composition according to claim 1, which comprises the following components in parts by weight:

4. A medicament prepared from the Chinese medicinal composition of any one of claims 1 to 3.

5. The medicament of claim 4, wherein the dosage form of the medicament is any one of decoction, granules, powder, capsules or oral preparations.

6. A process for the preparation of a medicament according to claim 4 or 5, comprising the steps of:

the raw materials with the formula ratio are evenly mixed and decocted by adding water to obtain the medicine.

7. The method for preparing a medicament according to claim 6, wherein the decocting with water comprises the steps of: adding water into the mixed raw materials, and carrying out first decoction to obtain a first decoction liquid; adding water into the decocted raw materials again, and decocting for the second time to obtain a second decoction; mixing the second decoction with the first decoction to obtain a medicine;

preferably, the reaction conditions of the first decoction at least satisfy at least one of the following: the decocting temperature is 100-110 ℃, the decocting time is 20-35 min, and the decocting material-liquid ratio is 0.2-0.5 g/mL;

more preferably, the reaction conditions of the second decoction at least satisfy at least one of the following: the decocting temperature is 100 ℃, the decocting time is 20min, and the mass ratio of the decocted liquid is 0.2 g/mL-0.5 g/mL.

8. The method for preparing a pharmaceutical composition according to claim 6, further comprising the step of soaking the mixed materials before decocting with water;

preferably, the soaking time is 20-40 min, preferably 30 min;

preferably, the ratio of the soaked materials to the liquid is 0.1 g/mL-0.25 g/mL; preferably 0.15g/mL to 0.2 g/mL.

9. Use of a Chinese medicinal composition according to any one of claims 1-3 or a medicament according to claim 4 or 5 in the preparation of a medicament for the treatment of mastitis.

10. The use of claim 9, wherein the mastitis comprises lactating mastitis and non-lactating mastitis;

preferably, the non-lactation mastitis comprises plasma cell mastitis and granulomatous mastitis.