A traditional Chinese medicine composition, a preparation method thereof and application of the traditional Chinese medicine composition in preparation of a drug for treating human brucellosis

Abstract

The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition, a preparation method thereof and application of the traditional Chinese medicine composition in preparation of a medicine for treating human brucellosis, raw materials of the traditional Chinese medicine composition including Anemarrhena asphodeloides, Artemisia annua, Bupleurum, Scutellaria, Atractylodes, Stephania tetrandra, Magnolia officinalis, Coix seed, Eleutherococcus senticosus, Chaenomeles speciosa, Morus, Spatholobus suberectus, Red peony root, Cordyceps, Angelica and Taxillus. Bupleurum and Artemisia annua are combined to remove virtual heat and penetrate evil heat, and are common monarch drugs; Scutellaria, Anemarrhena asphodeloides, Atractylodes, Coix seed, Angelica, Taxillus and Eleutherococcus senticosus are common minister drugs, in the general treatment direction of removing evil and clearing heat, the functions of invigorating the spleen, reducing dampness, nourishing yin and moistening dryness are increased; Magnolia officinalis and Chaenomeles speciosa are used as auxiliary drugs, which not only supplement the main treatment of monarch and minister drugs in clearing virtual heat, but also can treat pain and other side effects. The traditional Chinese medicine composition has the functions of promoting blood circulation and clearing heat, reducing dampness and dredging collaterals, and has obvious clinical effects on brucellosis in the early stage of syndrome differentiation of dampness-heat invasion and arthralgia.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition, a preparation method thereof and an application thereof in preparing a medicine for treating human brucellosis. Background Art

[0002] Brucellosis (abbreviated as brucellosis) is an animal-borne zoonotic infectious disease caused by Brucella and is a natural epidemic disease. The clinical features of brucellosis mainly include fever, back pain, fatigue, pain in the limbs and joints, weight loss, sweating, dry mouth, dry throat, etc. The disease is easily misdiagnosed or missed, and its complications can easily cause damage to the liver, blood, spleen, nervous or reproductive systems. If not treated in time during the acute stage of infection, it can easily turn into a chronic infectious disease, seriously affecting the patient's quality of life and work ability. With the rapid development of my country's animal husbandry, brucellosis has become prevalent in non-pastoral areas and is showing an increasing incidence year by year, posing a serious threat to public health safety.

[0003] Currently, the main Western medicine treatment for brucellosis is antibacterial treatment, but the effect of antibacterial treatment in the chronic stage is relatively low, and symptoms such as joint effusion and swelling are more difficult to relieve. In addition, the antibiotics used to treat brucellosis have relatively large side effects on the body, especially conventional Western medicine drugs such as rifampicin and streptomycin that have liver toxicity or auditory nervous system toxicity.

[0004] Studies have reported that Buzhong Yiqi Pills or Renshen Guipi Pills can treat patients with liver and kidney deficiency-type brucellosis, characterized by fatigue and excessive sweating, with a 40-day treatment cycle. Xuefu Zhuyu Pills or Dahuoluo Dan are used to treat patients with meridian blockage-type brucellosis. Xuefu Zhuyu Pills are primarily suitable for patients experiencing chest pain and headaches, while Dahuoluo Dan is suitable for patients experiencing lower back and knee pain. There are also reports of using "Bubingling Capsules" as an adjunct to Western antibacterial therapy for human brucellosis. This treatment regimen consists of a 21-day course, with five to seven days of medication rest between courses, and three courses can result in a cure. This treatment regimen has shown significant effects on joint and muscle pain and recovery from motor dysfunction. A traditional Chinese medicine composition has been developed for acute and chronic brucellosis, treating symptoms such as fatigue, lassitude, fever, joint swelling and pain, and muscle aches. This composition can replenish qi and strengthen the body, promote blood circulation, and remove blood stasis. Its use in combination with other Western medications can reduce or eliminate the side effects of Western medications.

[0005] The traditional Chinese medicine compositions for human brucellosis in the existing technology generally have the shortcomings of long medication cycle and need to be used in combination with Western medicine. There are few reports on traditional Chinese medicine compositions for the acute stage of human brucellosis, with symptoms such as fever, sweating, severe heat in the afternoon, chest and abdominal distension or muscle and joint pain. Summary of the Invention

[0006] In response to the deficiencies in the prior art, the present application provides a traditional Chinese medicine composition and a preparation method thereof. The traditional Chinese medicine composition is suitable for the acute stage of brucellosis, with symptoms such as fever, sweating, severe fever in the afternoon, chest and abdominal distension or muscle and joint pain. The traditional Chinese medicine composition has the effects of relieving numbness, dampness and heat, and promoting dampness and unblocking meridians. Even if used alone, it can achieve the purpose of controlling the spread of the disease and alleviating the patient's pain.

[0007] To achieve the above-mentioned purpose, the embodiment of the present invention adopts the following technical solutions:

[0008] In a first aspect, the present invention provides a traditional Chinese medicine composition, comprising the following components in parts by mass: 8-15 parts of Anemarrhena Rhizoma, 8-15 parts of Artemisia annua, 8-15 parts of Bupleurum chinense, 8-15 parts of Scutellaria baicalensis, 8-12 parts of Atractylodes lancea, 9-12 parts of Stephania tetrandra, 8-15 parts of Magnolia officinalis, 10-20 parts of Coix seeds, 8-12 parts of Acanthopanax cortex, 5-10 parts of Papaya, 9-15 parts of Morus alba, 9-15 parts of Millettia reticulata, 8-12 parts of Paeonia lactiflora, 5-8 parts of Pheretima chinensis, 8-12 parts of Angelica dahurica and 10-15 parts of Morus alba.

[0009] The Chinese medicine selected for use in the present invention has the following effects:

[0010] Artemisia annua, bitter and cold, enters the liver and gallbladder meridians, can reduce deficiency heat, clear excess heat, cool blood heat, disperse wind and fire, has a fragrant smell, promotes blood circulation and clears blood heat, and is good at clearing away evil heat in the Shaoyang meridians.

[0011] Bupleurum root, pungent and bitter, slightly cold, enters the liver, gallbladder, and lung meridians. It can disperse the evil qi in the gallbladder meridian and relieve fever, disperse the stagnant qi in the liver and gallbladder meridians and relieve liver depression, and can also raise the clear yang qi of the liver and gallbladder and lift the sunken qi. It has a light and clear temperament and is good at relieving the stagnant heat in the Shaoyang meridian.

[0012] The above two medicines are combined, Bupleurum raises the clear Yang, Artemisia annua lowers the turbid Yin, they disperse and resolve, clear and resolve while lowering, the fragrance wards off evil, expel evil, raise Yang without adding heat, lower turbid without depression, disperse and clear at the same time, the two complement each other and are the main medicines.

[0013] The following seven herbs are collectively referred to as adjuvants. They strengthen the spleen and eliminate dampness, nourish yin and moisten dryness, in addition to the general treatment direction of clearing heat. Among them:

[0014] Scutellaria baicalensis, bitter and cold, enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It clears away heat and fire, cools the blood, and stops bleeding. It also dries dampness and eliminates dampness, clearing away heat and toxicity. It is widely used in diseases caused by damp-heat and fire toxicity, and is a key medicine for treating damp-heat and fire toxicity.

[0015] Zhimu, bitter, sweet and cold, enters the lung, stomach and kidney meridians, and has the effects of clearing heat and purging fire, nourishing yin and moistening dryness. It moistens the kidney dryness and nourishes yin, and clears the lung metal and purges fire. It is a medicine for the two meridians.

[0016] Atractylodes lancea is pungent, bitter, and warm, and enters the spleen, stomach, and liver meridians. It nourishes the spleen and dries dampness, promotes the flow of yang and relieves depression. Its aroma is strong, its flavor is sweet and rich, and its nature is purely yang. It is an excellent medicine for relieving rheumatism.

[0017] Job's tears, sweet, light and cool, enter the spleen, stomach and lung meridians to promote diuresis without damaging the body, strengthen the spleen without being greasy, and can clear away dampness and heat, eliminate numbness and discharge pus, while also slightly strengthening the spleen.

[0018] Duhuo, bitter and pungent, slightly warm, enters the kidney and bladder meridians. It acts inwardly and downward, dispersing internal wind and cold dampness, clearing joints and relieving pain.

[0019] Mulberry parasite is bitter, sweet, and neutral, and enters the liver and kidney meridians. It is good at nourishing blood, tonifying the liver and kidneys, strengthening bones and tendons, and promoting health. It also dispels rheumatism and is good at treating blood deficiency or liver and kidney deficiency combined with rheumatic pain. It is also good at treating liver and kidney deficiency, Chong and Ren meridian instability, and fetal bleeding and restless fetuses.

[0020] Acanthopanax Cortex is pungent, bitter, and warm, and enters the Liver and Kidney meridians. It is good at both tonifying the liver and kidneys, strengthening the tendons and bones, and tonifying the body, while also dispelling rheumatism, promoting diuresis, and expelling pathogenic factors.

[0021] The following seven herbs are collectively referred to as adjuvants. They not only supplement the main symptoms of the monarch and minister herbs in clearing away deficiency-heat, but can also treat secondary symptoms such as pain. Among them:

[0022] Magnolia officinalis is bitter, pungent and warm, and enters the spleen, stomach, and large intestine meridians. Its bitter, drying, dispersing, and pungent properties warm and unblock. It removes dampness and regulates qi stagnation in the stomach and intestines, relieves asthma, and is a key herb for treating abdominal distension.

[0023] Papaya is warm in nature and sour in flavor, and enters the liver and spleen meridians. It has the effects of relaxing muscles and tendons, removing dampness, and soothing the stomach. According to the New Compendium of Materia Medica, "It can be used as a minister, adjuvant, or assistant, but not as the main ingredient. It is a product that enters the liver and nourishes the tendons."

[0024] Stephania tetrandra, bitter, cold, enters the bladder and kidney meridians. This product has a bitter, purgative and dispersing effect, can clear away cold, and has strong rheumatism and analgesic effects. It has the effects of dispelling wind and relieving pain, promoting diuresis and reducing swelling.

[0025] Millettia reticulata is bitter, sweet and warm, and enters the liver and kidney meridians. This product can be used as both a purgative and a tonic, promoting blood circulation and dredging collaterals to relieve pain, and can also replenish blood and produce body fluids to relieve pain. It has the effects of replenishing blood, activating blood circulation, and relaxing tendons and activating collaterals.

[0026] Red Peony Root is bitter and slightly cold in nature, and enters the Liver Meridian. It clears liver fire and cools the blood, while also promoting blood circulation and removing blood stasis. It combines cooling blood heat, clearing liver fire, and dispersing blood stasis, offering the benefits of clearing heat, cooling blood, dispersing blood stasis, and relieving pain.

[0027] Dilong (Guangdilong) is salty in flavor and cold in nature. It enters the liver, spleen, and bladder meridians. It is a wandering herb that clears away heat, calms wind, and relieves spasms. Entering the liver meridian, it clears heat, relieves wind, and relieves asthma. Entering the bladder meridian, it acts as a diuretic and relieves constipation. It has the effects of clearing heat, calming nerves, and dredging the meridians to relieve asthma.

[0028] Mulberry twigs, slightly bitter in taste and neutral in nature, are beneficial to joints, nourish body fluids, promote the flow of water and dispel wind, and are specifically used to dispel rheumatic cramps.

[0029] The combined use of all the medicines in the prescription has the effects of relieving numbness, clearing heat, promoting dampness and unblocking the meridians. It has obvious clinical effects on patients with initial brucellosis diagnosed as invasion of dampness and heat, and obstruction of tendons and meridians.

[0030] Preferably, the traditional Chinese medicine composition includes the following components in parts by mass: 9-12 parts of Anemarrhena Rhizoma, 8-12 parts of Artemisia annua, 10-15 parts of Bupleurum chinense, 8-15 parts of Scutellaria baicalensis, 8-10 parts of Atractylodes lancea, 10-12 parts of Stephania tetrandra, 8-10 parts of Magnolia officinalis, 15-20 parts of Coix seed, 8-10 parts of Acanthopanax cortex, 8-10 parts of Papaya, 10-15 parts of Morus twig, 12-15 parts of Millettia reticulata, 9-11 parts of Paeonia lactiflora, 5-7 parts of Pheretima chinensis, 8-10 parts of Angelica dahurica and 12-15 parts of Morus alba.

[0031] In a second aspect, the present invention provides a method for preparing the above-mentioned Chinese medicine composition, the preparation method comprising the following steps:

[0032] According to the prescription, rhizome of anemarrhena, artemisia annua, bupleurum, scutellaria, atractylodes, stephania tetrandra, magnolia bark, coix seed, acanthopanax cortex, papaya, mulberry branch, millettia reticulata, red peony root, earthworm, angelica pubescens and mistletoe are measured and mixed to obtain a total mixture of Chinese medicinal materials, which are soaked in water, heated for extraction and the extract is concentrated to obtain the Chinese medicine composition.

[0033] Preferably, the material-liquid ratio of the total mixture of Chinese medicinal materials and water during the soaking is 1:8-14; and / or

[0034] The soaking time is 30 to 120 minutes.

[0035] Preferably, the extraction comprises decoction extraction or reflux extraction; and / or

[0036] The number of extractions is 2 to 3 times; and / or

[0037] The extraction time is 20 to 60 minutes per time.

[0038] In a third aspect, the present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating human brucellosis.

[0039] Preferably, the brucellosis is in the acute stage, with symptoms including fever, sweating, severe fever in the afternoon, chest and abdominal distension or muscle and joint pain.

[0040] The term "brucellosis" does not exist in Traditional Chinese Medicine literature. Traditional Chinese Medicine generally considers the acute phase of brucellosis to be an exogenous infection, caused by damp-heat. The chronic phase of the disease is primarily due to two factors: ineffective treatment during the acute phase or misdiagnosis, leading to the exacerbation of dampness in the body. Secondly, the influx of a mixture of wind, cold, dampness, and resentment leads to a protracted course of illness, often difficult to cure. Under the influence of wind, cold, and dampness, the body's qi and blood flow are impeded, leading to blood stasis and obstruction of the meridians over time. Brucellosis primarily caused by wind and cold often presents with loose joint pain, while brucellosis primarily caused by dampness presents with weakness in the limbs, joint swelling, pain, and effusion. Because dampness is difficult to dissipate, the disease is difficult to cure and becomes chronic. However, based on the Traditional Chinese Medicine clinical manifestations of fever, joint pain, and fatigue, combined with pulse diagnosis, it can be classified as a "heat-damp syndrome." In Traditional Chinese Medicine, brucellosis is primarily diagnosed as infection by heat and dampness. In the acute phase, fever may occur. Dampness invades the spleen and stomach, obstructing the body's Qi channels and weakening Yang Qi, leading to a loosening of the body's yang qi and causing profuse sweating. If the dampness persists and the combination of dampness and heat easily develops into a chronic condition. When the Qi channels are in their prime, yin and yang, and are infected by cold, a febrile disease may develop. Yin pulses weaken, yang pulses become slippery, and combined with wind, wind-heat may develop. When yin pulses become strong and yang pulses surge, combined with warm Qi, a febrile disease may develop. When yin pulses become tense and yang pulses weaken, combined with warm Qi, a dampness disease may develop. If the disease persists for too long and remains untreated, the toxic qi can enter the Qi channels, circulating throughout the body and damaging numerous organs. Toxic qi can enter the liver and spleen, congesting Qi and blood, causing hepatosplenomegaly. Toxic qi can enter the joints, blocking the meridians and causing muscle and joint pain.

[0041] Based on the above analysis of the pathogenesis of brucellosis in Traditional Chinese Medicine, the present invention has established a fundamental treatment principle for acute brucellosis, focusing on dispelling pathogenic factors. This principle involves a traditional Chinese medicine composition that primarily removes dampness and heat, supplemented by promoting blood circulation and unblocking meridians. This composition has achieved excellent clinical efficacy in the treatment of brucellosis. Furthermore, the present invention can achieve good therapeutic effects when used alone, even without antimicrobial agents, thereby largely avoiding the toxic side effects of antimicrobial agents.

[0042] Traditional Chinese medicine emphasizes "prevention before illness and prevention of complications after illness". In terms of medication, different drug formulations will be selected according to the different symptoms of the disease. The treatment direction of the present invention is the acute stage of brucellosis infection. Patients in the acute stage mainly show repeated fever. According to the basic principle of traditional Chinese medicine treatment of "treating the symptoms in an emergency and treating the root cause in a slow manner", combined with the fact that most patients in the acute stage of brucellosis are in a state of "strong evil spirits and weak righteousness", the treatment principle should be mainly "eliminating evil spirits". Therefore, in the prescription selection, Artemisia annua and Bupleurum chinense are used as the main drugs to reduce deficiency fever, Scutellaria baicalensis, Anemarrhena asphodeloides, Atractylodes macrocephala, Coix seed, Angelica dahurica, Acanthopanax cortex, and Viscum album are used as the auxiliary drugs, and the other herbs for promoting blood circulation and unblocking meridians are used as adjuvant drugs, so the treatment direction is clearer.

[0043] Preferably, the above-mentioned drug for treating human brucellosis is an oral preparation.

[0044] Preferably, the dosage form of the oral preparation is selected from any one of granules, decoctions, capsules, syrups or tablets.

[0045] Optionally, when the dosage form of the oral preparation is a granule, the obtained traditional Chinese medicine extract is concentrated to a concentrated solution with a relative density of 1.05 to 1.10 (60° C.), ethanol is added to make the alcohol content reach 70 to 80%, stirred evenly, and allowed to stand for 3 to 15 hours. The supernatant is taken, the ethanol is recovered, and concentrated to a thick paste with a relative density of 1.33 to 1.38 (40° C.); the thick paste is dried at a temperature of 70 to 80° C. and 1000 to 1500 Pa, the dry paste is collected, crushed, and an appropriate amount of maltodextrin is added. Granules of the traditional Chinese medicine composition are prepared by dry granulation or wet granulation;

[0046] Optionally, when the oral preparation is in the form of tablets, magnesium stearate, calcium stearate or zinc stearate is added to the granules obtained by the dry granulation or wet granulation as a lubricant and the mixture is tableted to obtain the product;

[0047] Optionally, when the oral preparation is in the form of a capsule, the granules obtained by the dry granulation or wet granulation are added with an appropriate amount of a disintegrant and a lubricant, weighed, and encapsulated to obtain the preparation;

[0048] Optionally, when the oral preparation is in the form of a syrup, the obtained Chinese medicine extract is concentrated to a concentrate with a relative density of 1.10-1.15 (60° C.), monosaccharide syrup is added to a sugar content of 50%-60% (g / ml), the mixture is filled, and steam sterilized to obtain the product.

[0049] The above preferred dosage form can enhance the efficacy to a greater extent. The daily dosage of the Chinese medicine composition is preferably 130-215g (calculated as crude drug). Taking it alone according to this dosage can significantly improve the symptoms of acute brucellosis in patients.

[0050] Due to the adoption of the above technical solution, the present invention has the following technical advancements compared with the prior art:

[0051] ① Based on the analysis of the pathogenesis of brucellosis by traditional Chinese medicine and the basic principle of traditional Chinese medicine treatment of "treating the symptoms in an emergency and addressing the root cause in a delayed manner", combined with the clinical symptoms of patients in the acute stage of brucellosis, which are mostly at a time when "evil qi is strong and righteous qi is not weak", the present invention provides a traditional Chinese medicine composition suitable for the acute stage of brucellosis, which mainly removes dampness and clears heat, and supplements with promoting blood circulation and unblocking meridians;

[0052] ② In the Chinese medicine composition provided by the present invention, the Radix Bupleuri in the prescription raises the clear Yang, the Radix Artemisiae Annua lowers the turbid Yin, dispersing and reconciling, clearing and resolving while lowering, aromatic and dispelling filth, expelling pathogens and expelling them, raising Yang without adding heat, lowering turbidity without depression, dispersing and clearing, the two complement each other, and are the monarch medicine; the seven herbs including Radix Scutellariae, Rhizoma Anemarrhenae, Rhizoma Atractylodis Macrocephalae, Semen Coicis and Radix Angelicae Pubescentis are the ministerial herbs, in the general treatment direction of clearing heat from deficiency and expelling pathogenic heat, they increase the effects of strengthening the spleen and removing dampness, nourishing yin and moistening dryness; Magnolia officinalis, Fructus Chaenomelis, Radix Stephaniae Stephaniae, Radix Dilonge are the adjuvant herbs, which not only supplement the main symptoms of the monarch and ministerial herbs in clearing heat from deficiency, but also can treat ancillary symptoms such as pain. All the herbs in the prescription are used together, and have the effects of relieving numbness and clearing heat, removing dampness and unblocking the meridians, and have obvious clinical effects on patients with the initial stage of brucellosis diagnosed as invasion of damp heat and obstruction of tendons and meridians;

[0053] ③ The traditional Chinese medicine composition provided by the present invention can achieve good therapeutic effects when used alone without combining with antibacterial drugs. The cure rate can reach up to 75.0% and the total effective rate can reach up to 83.3% after taking it for 30 days. Compared with the traditional Chinese medicine composition for treating human brucellosis in the prior art, the treatment course is shorter.

[0054] ④ The preparation method of the traditional Chinese medicine composition provided by the present invention is simple, suitable for large-scale production, and easy to promote and use.

[0055] The traditional Chinese medicine composition provided by the present invention can be used to treat human brucellosis, especially the acute stage of brucellosis, with symptoms of fever, sweating, severe fever in the afternoon, chest and abdominal distension or muscle and joint pain. DETAILED DESCRIPTION

[0056] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0057] Example 1

[0058] This embodiment provides a method for preparing a Chinese medicine composition, which comprises the following steps:

[0059] Weigh 10 g of Anemarrhena Rhizoma, 12 g of Artemisia annua, 15 g of Bupleurum chinense, 10 g of Scutellaria baicalensis, 10 g of Atractylodes lancea, 10 g of Stephania tetrandra, 10 g of Magnolia officinalis, 20 g of Coix seed, 10 g of Acanthopanax cortex, 10 g of Papaya, 15 g of Morus alba, 15 g of Millettia reticulata, 10 g of Paeonia lactiflora, 6 g of Pheretima dahurica, 10 g of Angelica pubescens, and 15 g of Parasitic loranthus to obtain a total mixture of 188 g of Chinese medicinal materials. Add 1880 mL of water and soak for 30 min. Heat and decoct twice, each time for 40 min, with 1500 mL of water added for the second decoction. Filter the decoction to obtain a filtrate, combine the filtrates, and concentrate under reduced pressure to 300 mL.

[0060] Example 2

[0061] This embodiment provides a method for preparing a Chinese medicine composition, which comprises the following steps:

[0062] Weigh 10 g of Anemarrhena Rhizoma, 8 g of Artemisia annua, 10 g of Bupleurum chinense, 10 g of Scutellaria baicalensis, 10 g of Atractylodes lancea, 10 g of Stephania tetrandra, 10 g of Magnolia officinalis, 20 g of Coix seed, 10 g of Acanthopanax cortex, 10 g of Papaya, 15 g of Morus alba, 15 g of Millettia reticulata, 11 g of Paeonia lactiflora, 6 g of Pheretima dahurica, 10 g of Angelica pubescens, and 15 g of Morus alba to obtain a total mixture of 180 g of Chinese medicinal materials. Add 1440 mL of water and soak for 60 min. Heat and reflux and extract twice, each time for 40 min, with 1080 mL of water added for the second extraction. Filter the extract to obtain a filtrate, combine the filtrates, and concentrate under reduced pressure to 300 mL.

[0063] Example 3

[0064] This embodiment provides a method for preparing a Chinese medicine composition, which comprises the following steps:

[0065] Weigh 8 g of Anemarrhena Rhizoma, 15 g of Artemisia annua, 8 g of Bupleurum chinense, 8 g of Scutellaria baicalensis, 8 g of Atractylodes lancea, 12 g of Stephania tetrandra, 8 g of Magnolia officinalis, 13 g of Coix seed, 10 g of Acanthopanax cortex, 8 g of Chaenomeles sinensis, 9 g of Morus alba, 10 g of Millettia reticulata, 8 g of Paeonia lactiflora, 5 g of Pheretima dahurica, 8 g of Angelica pubescens, and 10 g of Parasitic loranthus to obtain a total mixture of 148 g of Chinese medicinal materials. Add 1190 mL of water and soak for 120 min. Heat and reflux and extract three times, each time for 20 min, with 740 mL of water added for the second and third extractions. Filter the extract to obtain a filtrate, combine the filtrates, and concentrate under reduced pressure to 300 mL.

[0066] Example 4

[0067] This embodiment provides a method for preparing a Chinese medicine composition, which comprises the following steps:

[0068] Weigh 15 g of Anemarrhena Rhizoma, 10 g of Artemisia annua, 12 g of Bupleurum chinense, 15 g of Scutellaria baicalensis, 12 g of Atractylodes lancea, 9 g of Stephania tetrandra, 15 g of Magnolia officinalis, 10 g of Coix seed, 8 g of Acanthopanax cortex, 5 g of Chaenomeles sinensis, 12 g of Morus alba, 9 g of Millettia spatholobi, 12 g of Paeonia lactiflora, 8 g of Pheretima pubescens, 12 g of Angelica dahurica, and 12 g of Parasitic loranthus to obtain a total mixture of 176 g of Chinese medicinal materials. Add 2100 mL of water and soak for 90 min. Decoction and extraction are performed twice, each time for 60 min, with 2110 mL of water added for the second decoction. Filter the decoction to obtain the filtrate, combine the filtrates, and concentrate under reduced pressure to 300 mL.

[0069] Example 5

[0070] This embodiment provides a method for preparing a Chinese medicine composition, which comprises the following steps:

[0071] Weigh 12 g of Anemarrhena Rhizoma, 11 g of Artemisia annua, 13 g of Bupleurum chinense, 12 g of Scutellaria baicalensis, 9 g of Atractylodes lancea, 11 g of Stephania tetrandra, 12 g of Magnolia officinalis, 15 g of Coix seed, 12 g of Acanthopanax cortex, 7 g of Chaenomeles sinensis, 12 g of Morus alba, 12 g of Millettia reticulata, 9 g of Paeonia lactiflora, 7 g of Pheretima chinensis, 9 g of Angelica dahurica, and 12 g of Parasitic loranthus to obtain a total mixture of 175 g of Chinese medicinal materials. Add 2460 mL of water and soak for 120 min. Decoction and extraction are performed twice, each time for 30 min, with 1750 mL of water added for the second decoction. Filter the decoction to obtain the filtrate, combine the filtrates, and concentrate under reduced pressure to 300 mL.

[0072] Comparative Example 1

[0073] Comparative Example 1 provides a method for preparing a traditional Chinese medicine composition. This method is essentially the same as Example 1, except that 12 g of Artemisia annua is replaced with 12 g of turtle shell in the raw material, and turtle shell is not added during soaking. Instead, the turtle shell is soaked alone and decocted for 20 minutes before adding the other medicinal materials. The specific preparation method comprises the following steps:

[0074] Weigh 10g of Rhizoma Anemarrhenae, 15g of Radix Bupleuri, 10g of Radix Scutellariae, 10g of Rhizoma Atractylodis Macrocephalae, 10g of Radix Stephaniae Tetrandrae, 10g of Cortex Magnoliae Officinalis, 20g of Semen Coicis, 10g of Cortex Acanthopanacis, 10g of Papaya, 15g of Morus Albizia, 15g of Caulis Millettiae, 10g of Radix Paeoniae Rubra, 6g of Pheretima, 10g of Radix Angelicae Pubescentis and 15g of Radix Parasitica to obtain a total of 176g of Chinese medicinal materials, add 1760mL of water and soak for 30min; take 12g of Carapax Trionycis, add 120g of water and soak for 3min. After 0 min, heat to boiling over high heat, keep it at a slight boil and cook for 20 min, add the above-mentioned total mixture of Chinese medicinal materials and their soaking liquid, heat to boiling over high heat, keep it at a slight boil and cook for 40 min, filter it while hot to obtain a filtrate and medicinal residue; add 1500 mL of water to the medicinal residue, heat to boiling over high heat, keep it at a slight boil and cook for 40 min, filter the decoction to obtain a filtrate, combine the filtrates obtained twice, and concentrate them under reduced pressure to 300 mL.

[0075] Comparative Example 2

[0076] Comparative Example 2 provides a preparation method of a Chinese medicine composition, which is basically the same as Example 1, except that 12g of Artemisia annua in the raw material is replaced by 12g of Paeonia suffruticosa, and 15g of Bupleurum chinense is replaced by 15g of Bupleurum chinense, and the other parameters are the same.

[0077] Comparative Example 3

[0078] Comparative Example 3 provides a preparation method of a Chinese medicine composition, which is basically the same as Example 1, except that the "10g of Scutellaria baicalensis, 10g of Acanthopanax Cortex, and 10g of Angelica dahurica" ​​in the raw materials are replaced with "10g of Phellodendron chinense, 10g of Dictamnus dahurica, and 10g of Notopterygium wilfordii", and the other parameters are the same.

[0079] Effect Examples

[0080] In order to better illustrate the clinical efficacy of the Chinese medicine composition provided in the embodiments of the present invention, this experiment was conducted, and the specific method is as follows.

[0081] 1. Inclusion criteria: Patients aged 18 to 60 years, with symptoms and pulse conditions in the acute stage of brucellosis infection that meet the diagnostic criteria of TCM syndromes. The main clinical symptoms are fever, sweating, severe fever in the afternoon, chest and abdominal distension, muscle and joint pain, red tongue with white or yellow greasy tongue coating, slippery or rapid pulse, and syndromes of damp-heat invasion and obstruction of meridians.

[0082] 2. Observation subjects and grouping: 360 patients who visited Shijiazhuang No. 5 Hospital from January 2020 to December 2023 and met the case inclusion criteria were selected, including 176 females and 184 males; the above cases were randomly divided into six groups, namely Example 1 group, Example 2 group, comparison example groups 1 to 3, and control group.

[0083] III. Treatment Method: Patients in Example 1, Example 2, and Comparative Examples 1-3 took the decoction of the Chinese medicine composition obtained in Example 1, Example 2, and Comparative Examples 1-3, respectively, once a day in the morning and evening, 150 mL / time, half an hour after a meal; patients in the control group received a commonly used Western medicine clinical treatment regimen, using triple therapy (doxycycline + rifampicin + levofloxacin). Patients in different groups were treated for 30 consecutive days, and the therapeutic effects were observed.

[0084] IV. Criteria for determining efficacy:

[0085] Cure: ① Body temperature returns to normal, and clinical symptoms and signs disappear; ② Physical strength and working ability are restored; ③ Patients with previously positive Brucella culture should have two bacterial cultures (half a month apart) turn negative, and clinical laboratory tests show that all organ functions are normal;

[0086] Improvement: 2 of the above 3 indicators are achieved, or 2 of them are better than before treatment;

[0087] Ineffective: ① No significant change or no change before and after treatment; ② Short-term symptom improvement after treatment, but relapse after 2 weeks of discontinuation of medication;

[0088] Total effective rate (%) = cure rate (%) + improvement rate (%)

[0089] Treatment results: After 30 days of treatment, the clinical results of 360 brucellosis patients are shown in Table 1.

[0090] Table 1

[0091]

[0092] As can be seen from the above data, Chinese medicine composition provided by the present invention has cured patient's fever to a great extent, the clinical symptoms such as hyperhidrosis, and after taking medicine for 30 days, cure rate can reach 75.0%, and total effective rate reaches 83.3%.Compared with comparative example 1-3, it can be seen that in this prescription, Radix Bupleuri raises clear yang, and Artemisia annua lowers turbid yin, dredges and resolves, clears and resolves and descends, and fragrance wards off filth, penetrates and goes out, raises yang without helping heat, descends turbidity without depression, dredges and has clearing and purging, and the two share, and complement each other.In the total treatment direction of clearing away heat from deficiency, expelling pathogenic heat as the main, ministerial drug has heat-clearing and damp-damp drying, dispelling wind and dampness, purging fire and detoxicating, the effects such as tonifying the liver and kidney, and monarch drug and ministerial drug complement each other in the side.

[0093] Although Paeonia lactiflora has the effects of clearing heat and cooling blood, promoting blood circulation and removing blood stasis, and relieving asthenic fever, and Bupleurum chinense has the effects of clearing asthenic heat, eliminating malnutrition fever, and clearing heat and cooling blood, replacing Artemisia annua and Bupleurum chinense with Paeonia lactiflora and Bupleurum chinense, which have antipyretic effects, with the number of days for body temperature to return to normal, cure rate, and total effective rate in the treatment of acute brucellosis was significantly lower than that of the present invention. Compared with patients who took Example 1, patients who took Comparative Example 2 generally experienced no improvement in fatigue symptoms and poor working ability.

[0094] Compared with Example 1, after the Artemisia annua in the prescription was replaced with turtle shell which has the function of reducing fever and removing steam, the average number of days after taking the medicine for the patients' body temperature to return to normal increased, and 2 patients experienced recurrent low-grade fever. In addition, the cure rate and total effective rate of Comparative Example 1 were also significantly lower than those of Example 1.

[0095] Compared with Example 1, in Comparative Example 3, only the "Scutellaria baicalensis", "Acanthopanax cortex" and "Duhuo" in the prescription were replaced with "Phellodendron chinense", "Dapoxetine cortex" and "Notopterygium wilfordii" with the same efficacy, respectively. The average number of days of medication for the patient's body temperature to return to normal increased, and the cure rate and the total effective rate were also significantly reduced.

[0096] Typical Cases

[0097] Case 1: Patient Wang XX, male, 68 years old. He had fever for 15 days and low back pain for 8 days. Case characteristics:

[0098] (1) An elderly male who has been raising sheep for 2 years. (2) The patient developed fever 15 days ago without any obvious cause, with the highest temperature being 38.5℃. He had no chills, no cough or sputum, slight palpitations, shortness of breath, no nausea or vomiting, and self-medicated antipyretic treatment (ibuprofen for colds). The temperature rose again after it dropped. The temperature rose significantly in the afternoon. Eight days ago, he began to experience back pain, which radiated intermittently to the buttocks, with occasional migratory pain in the left shoulder. He had no itching, no gum bleeding, no chest tightness or pain, and no dyspnea. He was treated with ampicillin and levofloxacin at Wuji County Hospital for 4 days. The temperature dropped slightly, but rose again in the afternoon, and the back pain did not ease. One day ago, he was examined at our hospital for the combination of brucellosis agglutination test: positive for tiger red plate agglutination test and 1:800 for brucellosis agglutination test. The clinical diagnosis of traditional Chinese medicine was that the disease was in the acute stage of brucellosis due to the invasion of damp heat and the obstruction of the meridians. Take the Chinese medicine composition prepared by Example 1 of the present invention, once a day in the morning and evening, 150mL / time, take it half an hour after a meal, take it after 7 days of taking the above-mentioned Chinese medicine composition, the patient's body temperature returns to normal, and the symptoms of chest tightness and palpitations are significantly improved. After taking the above-mentioned Chinese medicine composition for 14 days, muscle and joint pain are significantly relieved, and the red bengal plate agglutination test is negative and the brucella agglutination test is negative. After continuing to take the medicine for 29 days, the red bengal plate agglutination test and the brucella agglutination test are rechecked. The indicators such as blood routine are normal; no abnormalities caused by brucellosis are found by color Doppler ultrasound, CT and other examinations. No recurrence occurs after drug withdrawal.

[0099] Case 2: Patient Xie XX, male, 45 years old, case characteristics: chills, fatigue, and loss of appetite for 10 days. He has worked in the local Leyuan Animal Husbandry Co., Ltd. in Shijiazhuang City, Hebei Province for more than 8 years. There is sporadic brucellosis in the local area. The patient had chills and discomfort all over the body without obvious cause 10 days ago, without obvious fever, no body temperature was measured, no attention was paid, and no treatment was received; accompanied by loss of appetite, reduced food intake, about two-thirds of the usual amount, aversion to greasy food, occasional nausea, no acid reflux, no vomiting, decreased physical strength, fatigue, general fatigue, slightly relieved after rest, bilateral knee pain and discomfort, no waist pain or discomfort at the time, and no obvious pain in bilateral lower limbs. No attention was paid at the time, and no treatment was received; the patient's symptoms were sometimes mild and sometimes severe; 6 days ago, the above symptoms worsened without obvious cause, bilateral knee pain was more obvious, poor appetite, and significantly reduced food intake, about two-thirds of the usual amount, accompanied by obvious general fatigue, no relief after rest, no fever, headache, no dizziness, palpitations, chest tightness, shortness of breath; no abdominal pain, abdominal distension, diarrhea and other discomforts. Because a colleague in our unit suffered from brucellosis, a positive brucellosis agglutination test was found during laboratory examination. The results of the laboratory examination in our outpatient department were: Brucella agglutination test 1:100, and bengal plate agglutination test positive. The clinical syndrome differentiation of traditional Chinese medicine is that damp-heat invades and blocks the meridians in the acute stage of brucellosis. The patient took the Chinese medicine composition prepared in Example 2 of the present invention, once a day in the morning and evening, 150 mL / time, half an hour after a meal; after taking it for 5 days, the patient's body temperature returned to normal, appetite recovered, fatigue symptoms disappeared, and muscle and joint pain were significantly alleviated. After taking the above-mentioned Chinese medicine composition for 8 days, the bengal plate agglutination test was negative and the brucellosis agglutination test was negative; after continuing to take the medicine for 23 days, the bengal plate agglutination test and the brucellosis agglutination test were re-examined, and both were negative; blood routine and other indicators were normal; no abnormalities caused by brucellosis were found by color Doppler ultrasound, CT and other examinations. No recurrence after discontinuation of the medicine.

[0100] Case 3: Patient Zhang XX, male, 36 years old, case characteristics: (1) young male, with a history of contact with cattle; (2) main cause of the patient: bilateral knee pain for 2 months, with fever rising every afternoon. After being hospitalized in Zanhuang County Hospital, he was given intravenous drips of ceftriaxone, doxycycline, compound dichloroacetate diisopropylamine, and sodium deoxyribonucleotide, and oral administration of self-prepared doxycycline and rifampicin, but the effect was not very obvious. After discharge, the patient was able to engage in general light physical labor. More than 10 days ago, the patient still had bilateral knee discomfort, which became more obvious after activity, accompanied by right hip discomfort. No special diagnosis and treatment was given. 6 days ago, he came to our hospital for treatment. The Brucella agglutination test was 1:200 and the bengal plate agglutination test was positive. The clinical diagnosis of TCM in our hospital was that the patient was in the acute stage of brucellosis with damp-heat invasion and obstruction of the meridians. The Chinese medicine composition prepared by Example 3 of the present invention is given, once a day in the morning and evening, 150mL / times, taken half an hour after a meal; after taking it for 5 days, body temperature returns to normal and the symptoms of fatigue disappear; after taking the above-mentioned Chinese medicine composition for 10 days, the bilateral knee joints and right hip pain symptoms are significantly alleviated, and the bengalen red plate agglutination test is negative and the brucella agglutination test is negative. After continuing to take the medicine for 25 days, the bengalen red plate agglutination test and the brucella agglutination test are rechecked and are negative; by color Doppler ultrasound, CT and other examinations, no abnormality caused by brucellosis is found. No recurrence after drug withdrawal.

[0101] Case 4: Patient Feng XX, female, 14 years old. Case characteristics: (1) Vomiting, pain in the metacarpophalangeal joints for 4 days, with a history of "brucellosis"; (2) The patient's body temperature rose 4 days ago, and the body temperature rose significantly in the afternoon. Vomiting occurred without any inducement, and there was occasional fatigue. The metacarpophalangeal joints were painful, with intermittent stabbing pain and short duration, and no diagnosis or treatment was given; (3) The patient was previously hospitalized for "brucellosis" in Shahe County Central Hospital for 4-5 days, and her condition did not improve. The clinical diagnosis of traditional Chinese medicine in our hospital was that the patient was in the acute stage of brucellosis with invasion of damp heat and obstruction of the meridians. The patient took the Chinese medicine composition prepared in Example 3 of the present invention once a day in the morning and evening, 150 mL / time, half an hour after meals; after taking it for 10 days, the body temperature in the afternoon returned to normal, vomiting disappeared, joint pain symptoms disappeared, and the bengal rose plate agglutination test was negative and the Brucella agglutination test was negative. After 25 days of continued medication, both the rose bengal plate agglutination test and the Brucella agglutination test were negative; routine blood tests and other indicators were normal; and color Doppler ultrasound and CT scans revealed no abnormalities related to brucellosis. There was no recurrence after discontinuation of medication.

[0102] Case 5: Patient Ding XX, female, 19 years old. Case characteristics: (1) The patient was a young female with intermittent fever for 5 months, which worsened for 5 days. The disease had a chronic latent onset and she had been raising sheep at home for 5 years. (2) The patient developed fever 10 days ago without obvious cause. The temperature reached 39.6℃ in the afternoon, accompanied by headache and general discomfort. She received intravenous treatment at a local hospital for 5 days. After the temperature returned to normal, the disease recurred, accompanied by headache, sore throat, general discomfort, loss of appetite, occasional nausea, no vomiting, and low back pain. The temperature did not drop significantly after taking antipyretic analgesics. She was admitted to our hospital 2 days ago. The Brucella agglutination test was 1:600 ​​and the tiger red plate agglutination test was positive. The clinical diagnosis of TCM in our hospital was that the disease was in the acute stage of brucellosis due to invasion of damp heat and obstruction of the meridians. Take the Chinese medicine composition prepared by Example 5 of the present invention, once a day in the morning and evening, 150mL / times, take half an hour after a meal; After taking for 6 days, body temperature returned to normal in the afternoon, headache, vomiting disappeared, symptoms of general discomfort and loss of appetite disappeared, and joint pain symptoms were significantly relieved, and the red bengal plate agglutination test was negative and the brucella agglutination test was negative. After continuing the medication for 21 days, the red bengal plate agglutination test and the brucella agglutination test were negative; indicators such as blood routine were normal; No abnormality caused by brucellosis was found by color Doppler ultrasound, CT and other inspections. No recurrence after drug withdrawal.

[0103] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions or improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. Use of a traditional Chinese medicine composition in the preparation of a medicament for treating human brucellosis, characterized in that: The traditional Chinese medicine composition is composed of the following components in parts by mass: 8-15 parts of rhizoma anemarrhenae, 8-15 parts of artemisia annua, 8-15 parts of bupleurum, 8-15 parts of scutellaria baicalensis, 8-12 parts of atractylodes, 9-12 parts of tetrandra, 8-15 parts of magnolia officinalis, 10-20 parts of coix seeds, 8-12 parts of acanthopanax bark, 5-10 parts of papaya, 9-15 parts of mulberry branches, 9-15 parts of millettia reticulata, 8-12 parts of red peony root, 5-8 parts of earthworm, 8-12 parts of angelica dahurica and 10-15 parts of mistletoe.

2. Use of the Chinese medicine composition according to claim 1 in preparing a medicament for treating human brucellosis, characterized in that: The traditional Chinese medicine composition is composed of the following components in parts by mass: 9-12 parts of rhizoma anemarrhenae, 8-12 parts of artemisia annua, 10-15 parts of bupleurum, 8-15 parts of scutellaria baicalensis, 8-10 parts of atractylodes, 10-12 parts of tetrandra, 8-10 parts of magnolia bark, 15-20 parts of coix seed, 8-10 parts of acanthopanax bark, 8-10 parts of papaya, 10-15 parts of mulberry twig, 12-15 parts of millettia reticulata, 9-11 parts of red peony root, 5-7 parts of earthworm, 8-10 parts of angelica dahurica and 12-15 parts of mistletoe.

3. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating human brucellosis, characterized in that: The human brucellosis is the acute stage of human brucellosis, and the symptoms include fever, sweating, severe fever in the afternoon, chest and abdominal distension or muscle and joint pain.

4. Use of the Chinese medicine composition according to claim 1 in preparing a medicament for treating human brucellosis, characterized in that: The medicine for treating human brucellosis is an oral preparation.

5. Use of the Chinese medicine composition according to claim 4 in preparing a medicament for treating human brucellosis, characterized in that: The dosage form of the oral preparation is selected from any one of granules, decoctions, capsules, syrups or tablets.

6. The method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The preparation method comprises the following steps: According to the prescription, rhizome of anemarrhena, artemisia annua, bupleurum, scutellaria, atractylodes, stephania tetrandra, magnolia bark, coix seed, acanthopanax cortex, papaya, mulberry branch, millettia reticulata, red peony root, earthworm, angelica pubescens and mistletoe are measured and mixed to obtain a total mixture of Chinese medicinal materials, which are soaked in water, heated for extraction and the extract is concentrated to obtain the Chinese medicine composition.

7. The method for preparing the Chinese medicine composition according to claim 6, wherein: When soaking in water, the material-liquid ratio of the total mixture of Chinese medicinal materials and water is 1:8-14; and / or The soaking time is 30~120min.

8. The method for preparing the Chinese medicine composition according to claim 6 or 7, characterized in that: The heating extraction includes decoction extraction or reflux extraction; and / or The number of extractions is 2 to 3 times; and / or The extraction time is 20~60min / time.

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