A traditional Chinese medicine composition with antipyretic effect and a preparation method and application thereof

Abstract

The application provides a traditional Chinese medicine composition with antipyretic effect and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: Bupleurum chinense 135-200 parts, Pueraria lobata 225-335 parts, Scutellaria baicalensis 180-270 parts, gypsum 300-450 parts, Arctium lappa 135-200 parts, Forsythia suspensa 180-270 parts, Artemisia annua 90-135 parts, Isatidis radix 135-200 parts, Radix Trichosanthis 135-200 parts, Radix Salviae miltiorrhizae 180-270 parts, Radix et Rhizoma Rhei 180-270 parts, Rhizoma Atractylodis 180-270 parts, Rhizoma Atractylodis 180-270 parts, Rhizoma Atractylodis 180-270 parts, Fructus Aurantii Immaturus 135-200 parts, and Radix Glycyrrhizae 50-70 parts. The various traditional Chinese medicines used in the application are matched and jointly act according to the matching principle of "monarch, minister, assistant and messenger", so as to exert excellent antipyretic and anti-inflammatory effects.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, specifically to a traditional Chinese medicine composition with antipyretic effect, its preparation method, and its application. Background Technology

[0002] Antipyretic analgesics are currently the most widely used in clinical treatment, with nonsteroidal anti-inflammatory drugs (NSAIDs) being the most prevalent, providing new avenues for the treatment of various diseases. However, long-term use of these drugs can produce various adverse reactions, commonly including damage to the central nervous system, cardiovascular system, digestive system, and organs such as the liver and kidneys. Related studies show that more than 10% of patients treated with NSAIDs die due to severe adverse drug reactions. Traditional Chinese medicine (TCM) is currently the most commonly used natural medicine in clinical treatment, possessing a multi-target comprehensive mechanism of action and fewer side effects, and has become a hot topic in antipyretic analgesic drug research. Therefore, comprehensive research on TCM compositions for antipyretic analgesia is of great significance.

[0003] Invention patent CN106853217 A discloses a novel traditional Chinese medicine composition for treating fever and its preparation method. This composition consists of 50 medicinal herbs, including kudzu root, peppermint, burdock seed, gypsum, anemarrhena rhizome, gardenia fruit, scutellaria root, scrophularia root, coptis root, fraxinus bark, sophora root, rehmannia root, peony bark, forsythia fruit, violet root, dandelion, patrinia root, rhubarb, apricot kernel, medicated leaven, immature bitter orange, angelica root, trichosanthes seed, stemona root, coltsfoot flower, antelope horn, mother-of-pearl, angelica root, and white peony root. Each capsule contains 0.4g of the medicine, and the dosage is 25 capsules three times a day. It can improve symptoms such as fever, elevated body temperature, coma, difficulty breathing, irritability, bitter taste in the mouth, and dry throat. However, the traditional Chinese medicine composition provided by this patent has drawbacks such as the large number of medicinal herbs and the relatively large daily dosage.

[0004] Invention patent CN105213809A discloses a traditional Chinese medicine oral liquid for treating persistent low-grade fever and its preparation method. It is composed of Astragalus membranaceus, Codonopsis pilosula, Polygonatum odoratum, Ophiopogon japonicus, Paeonia suffruticosa, Dioscorea opposita, Dendrobium nobile, Cynanchum paniculatum, Vitex trifolia, Adenophora stricta, Stellaria dichotoma, Saposhnikovia divaricata, Phellodendron chinense, Nelumbo nucifera stamens, Anemarrhena asphodeloides, and Glycyrrhiza uralensis, and has the effects of clearing heat and drying dampness, purging fire and detoxifying, and reducing fever and eliminating steaming sensation. However, this traditional Chinese medicine oral liquid has problems such as a cumbersome preparation process and poor efficacy for low-grade fever. Summary of the Invention

[0005] In view of this, the present invention provides a traditional Chinese medicine composition with antipyretic effect, its preparation method and application, wherein the traditional Chinese medicine composition can effectively treat exogenous low-grade fever and has excellent antipyretic and anti-inflammatory effects.

[0006] To achieve the above effects, the present invention adopts the following technical solution:

[0007] On one hand, the present invention provides a traditional Chinese medicine composition with antipyretic effect, comprising the following raw materials in parts by weight: Bupleurum chinense 135-200 parts, Pueraria lobata 225-335 parts, Scutellaria baicalensis 180-270 parts, Gypsum fibrosum 300-450 parts, Arctium lappa 135-200 parts, Forsythia suspensa 180-270 parts, Artemisia annua 90-135 parts, Isatis indigotica 135-200 parts, Trichosanthes kirilowii 135-200 parts, Adenophora stricta 180-270 parts, charred Shenqu 180-270 parts, charred Crataegus pinnatifida 180-270 parts, charred Hordeum vulgare 180-270 parts, Citrus aurantium 135-200 parts, and Glycyrrhiza uralensis 50-70 parts.

[0008] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: Bupleurum chinense 150-185 parts, Pueraria lobata 250-310 parts, Scutellaria baicalensis 200-250 parts, Gypsum fibrosum 330-410 parts, Arctium lappa 150-185 parts, Forsythia suspensa 200-250 parts, Artemisia annua 100-125 parts, Isatis indigotica 150-185 parts, Trichosanthes kirilowii 150-185 parts, Adenophora stricta 200-250 parts, charred Shenqu 200-250 parts, charred Crataegus pinnatifida 200-250 parts, charred Hordeum vulgare 200-250 parts, Citrus aurantium 150-185 parts, and Glycyrrhiza uralensis 55-65 parts.

[0009] The method for preparing the traditional Chinese medicine composition with antipyretic effect according to the present invention includes the following steps:

[0010] (1) Take 15 medicinal materials, including Bupleurum chinense, Pueraria lobata, Scutellaria baicalensis, Gypsum fibrosum, Arctium lappa, Forsythia suspensa, Artemisia annua, Isatis indigotica, Trichosanthes kirilowii, Adenophora stricta, charred Shenqu, charred hawthorn, charred malt, Citrus aurantium, and Glycyrrhiza uralensis, put them in a container, add water and decoct for the first time, filter, and obtain extract a and residue a.

[0011] (2) Add water to the filter residue a in step (1) for a second decoction, filter, and obtain extract b and filter residue b;

[0012] (3) Combine extract a and extract b, concentrate them, and you will get the final product.

[0013] Furthermore, in step (1), the amount of water added is 8-12 times the total amount of the Chinese medicinal materials, and the first decoction time is 1-2 hours. More preferably, in step (1), the amount of water added is 10 times the total amount of the Chinese medicinal materials, and the first decoction time is 1.5 hours.

[0014] Furthermore, in step (2), the amount of water added is 6-10 times the total amount of the Chinese medicinal materials, and the second decoction time is 1-2 hours. More preferably, in step (2), the amount of water added is 8 times the total amount of the Chinese medicinal materials, and the second decoction time is 1.5 hours.

[0015] Further, the concentration in step (3) includes reduced-pressure concentration. More preferably, the relative density of the clear extract obtained after concentration is within the range of 1.05 - 1.10 (60 °C).

[0016] On the other hand, the present invention provides a preparation containing the traditional Chinese medicine composition, or a preparation containing the traditional Chinese medicine composition prepared by the above preparation method. Conventional excipients are added to the traditional Chinese medicine composition and made into clinically acceptable granule, capsule, tablet, pill, oral liquid, paste, injection, suppository and gel according to conventional processes.

[0017] Further, a drying process is required when preparing the granules. The drying methods include but are not limited to spray drying, hot air drying, and vacuum drying. More preferably, the inlet air temperature of the spray drying is 175 °C - 185 °C, the outlet air temperature is 85 °C - 95 °C, and it is in powder form after drying; the drying temperature of the hot air drying is 80 - 100 °C, and it is in granular and powder form after drying; the drying temperature of the vacuum drying is 40 - 60 °C, and it is in block form after drying.

[0018] The present invention also provides the use of the above traditional Chinese medicine composition preparation in the preparation of a drug with antipyretic effect.

[0019] Further, controlling the types and dosages of raw materials within the scope of the present invention can achieve excellent effects in treating low fever and anti-inflammation.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] 1. The compatibility relationship of the traditional Chinese medicine composition of the present invention is as follows: In the formula, Bupleuri Radix is pungent in taste and cold in nature, which can disperse the surface and reduce fever, mainly enters the Shaoyang meridian to relieve the pathogenic factors in the Shaoyang meridian; Puerariae Lobatae Radix is pungent in taste and cool in nature, which can relieve the muscles and reduce fever, mainly enters the Yangming meridian to relieve the pathogenic factors entering the interior; the two are used together to relieve the exterior and reduce fever, and are used as the monarch drugs together. Scutellariae Radix and Gypsum Fibrosum mainly enter the lung and stomach to clear the heat of the Taiyin and Yangming meridians, Arctii Fructus and Forsythiae Suspensae disperse wind-heat and clear heat and detoxify, and the four drugs assist the monarch drugs to relieve the exterior and clear heat and are used as the ministerial drugs. Artemisiae Annuae Herba and Isatidis Radix clear the latent heat in the yin aspect and the heat in the nutrient and blood aspects, Trichosanthis Radix and Glehniae Radix clear heat and purge fire, promote the production of body fluid and relieve thirst, Jiao Sanxian (Jiao Liushenqu, Jiao Crataegi Fructus, Jiao Hordei Germinatus) strengthen the spleen and stomach to promote digestion, Aurantii Fructus Immaturus breaks qi and eliminates accumulation, dissipates phlegm and relieves fullness, and the eight drugs are all used as adjuvant drugs. Glycyrrhizae Radix regulates the actions of various drugs and is used as the guiding drug. The combination of various drugs together can achieve the effects of dispersing wind and relieving the exterior, clearing heat and detoxifying. It is used for wind-heat exterior syndrome and interior accumulation of heat-toxin syndrome.

[0022] 2. The functions and indications of the traditional Chinese medicine composition of the present invention are to disperse wind and relieve the exterior, clear heat and detoxify. It is used for fever, sore throat, cough, joint soreness, dry mouth, dry tongue, dry stools and red urine, fever of the hands and feet, herpes simplex, and low fever after exogenous pathogen invasion presenting the above syndromes caused by wind-heat exterior syndrome and interior accumulation of heat-toxin.

[0023] 3. The preparation method of the traditional Chinese medicine composition in this application is simple to operate, can reduce the toxicity of raw materials, improve the bioavailability of raw materials, reduce the loss of effective components in raw materials, reduce production costs, and improve economic benefits. Detailed Implementation

[0024] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0025] Unless otherwise specified, the test methods or experimental methods described in the following examples are all conventional methods; unless otherwise specified, the raw materials and additives are obtained from conventional commercial sources or prepared by conventional methods.

[0026] The following is a description of the medicinal materials used in this invention, including their source, origin, and parts used:

[0027] Northern Bupleurum: This product is the dried root of Bupleurum chinense DC., a plant of the Apiaceae family. It is harvested in spring and autumn, and the stems, leaves, and soil are removed before drying.

[0028] Kudzu root: This product is the dried root of Pueraria lobata (Willd.) Ohwi, a plant belonging to the legume family. It is commonly known as wild kudzu. It is harvested in autumn and winter, and while fresh, cut into thick slices or small pieces; then dried.

[0029] Scutellaria baicalensis: This product is the dried root of Scutellaria baicalensis Georgi, a plant of the Lamiaceae family. It is harvested in spring and autumn, and the fibrous roots and soil are removed. After sun-drying, the rough outer skin is removed by pounding, and then it is dried in the sun.

[0030] Gypsum: This product is a sulfate mineral gypsum group gypsum, mainly containing hydrated calcium sulfate (CaSO4·2H2O). After mining, impurities and mud are removed.

[0031] Burdock seeds: This product is the dried, mature fruit of *Arctium lappa* L., a plant in the Asteraceae family. The fruit clusters are harvested in autumn when ripe, dried in the sun, the fruits are threshed, impurities are removed, and then dried again.

[0032] Forsythia: This product is the dried fruit of Forsythia suspensa (Thunb.) Vahl, a plant of the Oleaceae family. It is harvested in autumn when the fruit is just ripe and still green. Impurities are removed, it is steamed, and then dried in the sun. It is commonly known as "Qingqiao".

[0033] Sweet wormwood: This product is the dried above-ground part of Artemisia annua L., a plant of the Compositae family. It is harvested when the flowers are in full bloom in autumn, the old stems are removed, and it is dried in the shade.

[0034] Isatis root: This product is the dried root of Isatis indigotica Fort., a plant of the Cruciferae family. It is dug in autumn, the sediment is removed, and it is dried in the sun.

[0035] Trichosanthes root: This product is the dried root of Trichosanthes kirilowii Maxim. or Trichosanthes rosthornii Harms, plants of the Cucurbitaceae family. It is dug in autumn and winter, washed, the outer skin is removed, cut into sections or longitudinally divided into petals, and dried.

[0036] Glehnia root: This product is the dried root of Glehnia littoralis Fr. Schmidt ex Miq., a plant of the Umbelliferae family. It is dug in summer and autumn, the fibrous roots are removed, washed, slightly aired, scalded in boiling water, the outer skin is removed, and dried. Or it can be washed and directly dried.

[0037] Fried Liushenqu: Take Liushenqu and stir-fry it according to the stir-frying method (General Rules 0213, Section IV of Chinese Pharmacopoeia 2020 Edition) until the outer surface is dark brown and the inside is dark brown. The processing method of Liushenqu is to crush bitter apricot seeds and adzuki beans into coarse powder, mix it with flour, add the fresh juice of Polygonum hydropiper, Xanthium sibiricum, and Artemisia annua, knead it into a granular soft material that forms a ball when pinched and scatters when thrown, place it in a mold and press it into flat square blocks, wrap it tightly with abutilon leaves, put it in a box, stack it in a "pin" shape, cover it with fresh Artemisia annua, maintain an appropriate temperature (30 - 37 °C) and humidity (70 - 80%), ferment for 4 - 6 days, take it out when a yellowish-white mold coat appears on the medicine surface, cut it into 2.5 cm square pieces, and dry it to obtain the product.

[0038] Fried Hawthorn Fruit: Take clean hawthorn fruit and stir-fry it according to the stir-frying method (General Rules 0213, Section IV of Chinese Pharmacopoeia 2020 Edition) until the surface is dark brown and the inside is yellowish-brown. Hawthorn is the dried ripe fruit of Crataegus pinnatifida Bge. var. major N. E. Br. or Crataegus pinnatifida Bge., plants of the Rosaceae family. It is harvested when the fruit is ripe in autumn, sliced, and dried.

[0039] Fried Fructus Hordei Germinatus: Take clean Fructus Hordei Germinatus and stir-fry it according to the stir-frying method (General Rules 0213, Section IV of Chinese Pharmacopoeia 2020 Edition) until it is dark brown, let it cool, and sieve out the ash. Fructus Hordei Germinatus is the processed product of the mature fruit of Hordeum vulgare L., a plant of the Gramineae family, after germination and drying. After soaking the wheat grains in water, maintain appropriate temperature and humidity. When the young buds grow to about 5 mm, dry them in the sun or at low temperature.

[0040] Citrus aurantium L. (a type of sour orange) and its cultivated varieties or Citrus sinensis Osbeck (a sweet orange) are dried young fruits of the Rutaceae family. The fallen fruits are collected in May and June, impurities are removed, and the fruits are cut in half horizontally from the middle. They are then sun-dried or dried at low temperature. Smaller fruits are directly sun-dried or dried at low temperature.

[0041] Licorice: This product is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., both belonging to the Fabaceae family. It is harvested in spring and autumn, the fibrous roots are removed, and it is then sun-dried.

[0042] Example 1

[0043] A traditional Chinese medicine composition with antipyretic effect is composed of the following raw materials in parts by weight: Bupleurum chinense 167 parts, Pueraria lobata 280 parts, Scutellaria baicalensis 223.5 parts, Gypsum 373 parts, Arctium lappa 167 parts, Forsythia suspensa 223.5 parts, Artemisia annua 112 parts, Isatis indigotica 167 parts, Trichosanthes kirilowii 167 parts, Adenophora stricta 223.5 parts, charred Shenqu 223.5 parts, charred Crataegus pinnatifida 223.5 parts, charred Hordeum vulgare 223.5 parts, Citrus aurantium 167 parts, Glycyrrhiza uralensis 60 parts.

[0044] The preparation method of the traditional Chinese medicine composition granules with antipyretic effect is as follows:

[0045] (1) Weigh out 15 medicinal materials according to the proportion: Bupleurum chinense, Pueraria lobata, Scutellaria baicalensis, Gypsum fibrosum, Arctium lappa, Forsythia suspensa, Artemisia annua, Isatis indigotica, Trichosanthes kirilowii, Adenophora stricta, charred Shenqu, charred hawthorn, charred malt, Citrus aurantium, and Glycyrrhiza uralensis. Place them in a decoction container, add water equal to 10 times the total amount of Chinese medicinal materials, decoct for 1.5 hours, filter, and obtain extract a and residue a.

[0046] (2) Add water equal to 8 times the total amount of Chinese medicinal materials to the filter residue a in step (1) and decoct for 1.5 hours. Filter to obtain extract b and filter residue b.

[0047] (3) After combining extract a and extract b, the extract is concentrated under reduced pressure to a relative density of 1.05 (60℃) to obtain a clear extract. The clear extract is dried by spray drying with an inlet air temperature of 175℃~185℃ and an outlet air temperature of 85℃~95℃. Then, dextrin accounting for 5wt% of the total amount of the Chinese medicine composition is added, mixed well, and then passed through a 12-mesh sieve for dry granulation to obtain a Chinese medicine composition granule with antipyretic effect.

[0048] Example 2

[0049] A traditional Chinese medicine composition with antipyretic effect is composed of the following raw materials in parts by weight: 135 parts of Bupleurum chinense, 335 parts of Pueraria lobata, 180 parts of Scutellaria baicalensis, 450 parts of Gypsum fibrosum, 135 parts of Arctium lappa, 270 parts of Forsythia suspensa, 90 parts of Artemisia annua, 200 parts of Isatis indigotica, 135 parts of Trichosanthes kirilowii, 270 parts of Adenophora stricta, 180 parts of charred Shenqu (medicated leaven), 270 parts of charred Crataegus pinnatifida, 180 parts of charred Hordeum vulgare, 200 parts of Citrus aurantium, and 50 parts of Glycyrrhiza uralensis.

[0050] The preparation method is the same as in Example 1.

[0051] Example 3

[0052] A traditional Chinese medicine composition with antipyretic effect is composed of the following raw materials in parts by weight: 200 parts of Bupleurum chinense, 225 parts of Pueraria lobata, 270 parts of Scutellaria baicalensis, 300 parts of Gypsum fibrosum, 200 parts of Arctium lappa, 180 parts of Forsythia suspensa, 135 parts of Artemisia annua, 135 parts of Isatis indigotica, 200 parts of Trichosanthes kirilowii, 180 parts of Adenophora stricta, 270 parts of charred Shenqu (medicated leaven), 180 parts of charred Crataegus pinnatifida, 270 parts of charred Hordeum vulgare, 135 parts of Citrus aurantium, and 70 parts of Glycyrrhiza uralensis.

[0053] The preparation method is the same as in Example 1.

[0054] Example 4

[0055] A traditional Chinese medicine composition with antipyretic effect is composed of the following raw materials in parts by weight: 150 parts of Bupleurum chinense, 310 parts of Pueraria lobata, 200 parts of Scutellaria baicalensis, 410 parts of Gypsum fibrosum, 150 parts of Arctium lappa, 250 parts of Forsythia suspensa, 100 parts of Artemisia annua, 185 parts of Isatis indigotica, 150 parts of Trichosanthes kirilowii, 250 parts of Adenophora stricta, 200 parts of charred Shenqu (medicated leaven), 250 parts of charred Crataegus pinnatifida, 200 parts of charred Hordeum vulgare, 185 parts of Citrus aurantium, and 55 parts of Glycyrrhiza uralensis.

[0056] The preparation method is the same as in Example 1.

[0057] Example 5

[0058] A traditional Chinese medicine composition with antipyretic effect is composed of the following raw materials in parts by weight: 185 parts of Bupleurum chinense, 250 parts of Pueraria lobata, 250 parts of Scutellaria baicalensis, 330 parts of Gypsum fibrosum, 185 parts of Arctium lappa, 200 parts of Forsythia suspensa, 125 parts of Artemisia annua, 150 parts of Isatis indigotica, 185 parts of Trichosanthes kirilowii, 200 parts of Adenophora stricta, 250 parts of charred Shenqu (medicated leaven), 200 parts of charred Crataegus pinnatifida, 250 parts of charred Hordeum vulgare, 150 parts of Citrus aurantium, and 65 parts of Glycyrrhiza uralensis.

[0059] The preparation method is the same as in Example 1.

[0060] Example 6

[0061] A traditional Chinese medicine composition with antipyretic effect is composed of the following raw materials in parts by weight: Bupleurum chinense 167 parts, Pueraria lobata 280 parts, Scutellaria baicalensis 223.5 parts, Gypsum 373 parts, Arctium lappa 167 parts, Forsythia suspensa 223.5 parts, Artemisia annua 112 parts, Isatis indigotica 167 parts, Trichosanthes kirilowii 167 parts, Adenophora stricta 223.5 parts, charred Shenqu 223.5 parts, charred Crataegus pinnatifida 223.5 parts, charred Hordeum vulgare 223.5 parts, Citrus aurantium 167 parts, Glycyrrhiza uralensis 60 parts.

[0062] The preparation method of the capsule of the traditional Chinese medicine composition with antipyretic effect is as follows:

[0063] (1) Weigh out 15 medicinal materials according to the proportion: Bupleurum chinense, Pueraria lobata, Scutellaria baicalensis, Gypsum fibrosum, Arctium lappa, Forsythia suspensa, Artemisia annua, Isatis indigotica, Trichosanthes kirilowii, Adenophora stricta, charred Shenqu, charred hawthorn, charred malt, Citrus aurantium, and Glycyrrhiza uralensis. Place them in a decoction container, add water equal to 10 times the total amount of Chinese medicinal materials, decoct for 1.5 hours, filter, and obtain extract a and residue a.

[0064] (2) Add water equal to 8 times the total amount of Chinese medicinal materials to the filter residue a in step (1) and decoct for 1.5 hours. Filter to obtain extract b and filter residue b.

[0065] (3) After combining extract a and extract b, the extract is concentrated under reduced pressure to a relative density of 1.05 (60℃) to obtain a clear extract. The clear extract is dried by spray drying with an inlet air temperature of 175℃~185℃ and an outlet air temperature of 85℃~95℃. Then, 6wt% of dextrin is added to the total amount of the traditional Chinese medicine composition, mixed well, and then passed through a 12-mesh sieve for dry granulation. An appropriate amount of magnesium stearate is added, mixed well, and then filled into capsules to obtain a traditional Chinese medicine composition capsule with antipyretic effect.

[0066] Example 7

[0067] A traditional Chinese medicine composition with antipyretic effect is composed of the following raw materials in parts by weight: Bupleurum chinense 167 parts, Pueraria lobata 280 parts, Scutellaria baicalensis 223.5 parts, Gypsum 373 parts, Arctium lappa 167 parts, Forsythia suspensa 223.5 parts, Artemisia annua 112 parts, Isatis indigotica 167 parts, Trichosanthes kirilowii 167 parts, Adenophora stricta 223.5 parts, charred Shenqu 223.5 parts, charred Crataegus pinnatifida 223.5 parts, charred Hordeum vulgare 223.5 parts, Citrus aurantium 167 parts, Glycyrrhiza uralensis 60 parts.

[0068] The preparation method of the traditional Chinese medicine composition tablet with antipyretic effect is as follows:

[0069] (1) Weigh out 15 medicinal materials according to the proportion: Bupleurum chinense, Pueraria lobata, Scutellaria baicalensis, Gypsum fibrosum, Arctium lappa, Forsythia suspensa, Artemisia annua, Isatis indigotica, Trichosanthes kirilowii, Adenophora stricta, charred Shenqu, charred hawthorn, charred malt, Citrus aurantium, and Glycyrrhiza uralensis. Place them in a decoction container, add water equal to 10 times the total amount of Chinese medicinal materials, decoct for 1.5 hours, filter, and obtain extract a and residue a.

[0070] (2) Add water equal to 8 times the total amount of Chinese medicinal materials to the filter residue a in step (1) and decoct for 1.5 hours. Filter to obtain extract b and filter residue b.

[0071] (3) After combining extract a and extract b, the extract is concentrated under reduced pressure to a relative density of 1.05 (60℃) to obtain a clear extract. The clear extract is dried by spray drying with an inlet air temperature of 175℃~185℃ and an outlet air temperature of 85℃~95℃. Then, dextrin accounting for 1wt% of the total amount of the traditional Chinese medicine composition is added, mixed well, and then passed through a 12-mesh sieve for dry granulation. After adding an appropriate amount of magnesium stearate and mixing well, the mixture is compressed into tablets to obtain a traditional Chinese medicine composition tablet with antipyretic effect.

[0072] Comparative Example 1

[0073] A traditional Chinese medicine composition with antipyretic effect is composed of the following raw materials in parts by weight: 300 parts of Bupleurum chinense, 180 parts of Pueraria lobata, 223.5 parts of Scutellaria baicalensis, 373 parts of Gypsum fibrosum, 167 parts of Arctium lappa, 150 parts of Forsythia suspensa, 112 parts of Artemisia annua, 167 parts of Isatis indigotica, 250 parts of Trichosanthes kirilowii, 223.5 parts of Adenophora stricta, 223.5 parts of charred Shenqu (medicated leaven), 150 parts of charred Crataegus pinnatifida, 223.5 parts of charred Hordeum vulgare, 167 parts of Citrus aurantium, and 60 parts of Glycyrrhiza uralensis.

[0074] The preparation method is the same as in Example 1.

[0075] Comparative Example 2

[0076] A traditional Chinese medicine composition with antipyretic effect is composed of the following raw materials in parts by weight: 167 parts chrysanthemum, 280 parts kudzu root, 223.5 parts scutellaria baicalensis, 373 parts gardenia, 167 parts burdock fruit, 223.5 parts forsythia, 112 parts artemisia annua, 167 parts isatis root, 167 parts anemarrhena asphodeloides, 223.5 parts dendrobium, 223.5 parts charred medicated leaven, 223.5 parts charred hawthorn, 223.5 parts charred malt, 167 parts tangerine peel, and 60 parts licorice.

[0077] The preparation method is the same as in Example 1.

[0078] Comparative Example 3

[0079] A traditional Chinese medicine composition with antipyretic effect is composed of the following raw materials in parts by weight: 447 parts of Bupleurum chinense, 223.5 parts of Scutellaria baicalensis, 373 parts of gypsum, 167 parts of Arctium lappa, 223.5 parts of Forsythia suspensa, 112 parts of Artemisia annua, 167 parts of Isatis indigotica, 167 parts of Trichosanthes kirilowii, 223.5 parts of Adenophora stricta, 223.5 parts of charred Shenqu (medicated leaven), 223.5 parts of charred Crataegus pinnatifida, 223.5 parts of charred Hordeum vulgare, 167 parts of Citrus aurantium, and 60 parts of Glycyrrhiza uralensis.

[0080] The preparation method is the same as in Example 1.

[0081] Comparative Example 4

[0082] A traditional Chinese medicine composition with antipyretic effect is composed of the following raw materials in parts by weight: Bupleurum chinense 167 parts, Pueraria lobata 280 parts, Gypsum 596.5 parts, Arctium lappa 167 parts, Forsythia suspensa 223.5 parts, Artemisia annua 112 parts, Isatis indigotica 167 parts, Trichosanthes kirilowii 167 parts, Adenophora stricta 223.5 parts, charred Shenqu 223.5 parts, charred Crataegus pinnatifida 223.5 parts, charred Hordeum vulgare 223.5 parts, Citrus aurantium 167 parts, and Glycyrrhiza uralensis 60 parts.

[0083] The preparation method is the same as in Example 1.

[0084] I. Pharmacological tests (efficacy test to determine the antipyretic and anti-inflammatory effects in low-fever model rats):

[0085] Experimental animals: SD rats, male, weighing 200-220g.

[0086] Main reagents:

[0087] Bacterial lipopolysaccharide (LPS), Sigma, catalog number L2880;

[0088] Enzyme-linked immunosorbent assay kit for rat tumor necrosis factor α (TNF-α), Kelu (Wuhan) Biotechnology Co., Ltd., catalog number ELK1396;

[0089] Interleukin-1β (IL-1β) Enzyme-Linked Immunosorbent Assay Kit, Wuhan Huamei Biotechnology Co., Ltd., Catalog No. CSB-E08053h-1S.

[0090] Main instruments: electronic thermometer, enzyme-linked immunosorbent assay (ELISA) reader.

[0091] Experimental Methods: Male rats, 200-220g, had their rectal temperature measured twice daily (morning and afternoon) for 3 consecutive days. Animals with an average rectal temperature between 37-38℃ and a fluctuation range within 0.3℃ were considered qualified. Ninety qualified animals were randomly divided into nine groups of ten each, based on their average rectal temperature: a blank control group, a control group, groups of Examples 1-3, and groups of Comparative Examples 1-4. Groups of Examples 1-3 were administered the granules of the composition from Examples 1-3 (15g crude drug / kg, administration volume 20ml / kg) by gavage. Groups of Comparative Examples 1-4 were administered the granules of the composition from Comparative Examples 1-4 (15g crude drug / kg, administration volume 20ml / kg) by gavage. The blank control group and the control group were administered an equal volume of distilled water by gavage. This was repeated for 5 consecutive days. Rectal temperature was measured 30 minutes after the last administration. Except for the blank control group, all other groups received an intraperitoneal injection of LPS 50μg / kg. The rectal temperature of rats in each group was measured at 1h, 2h, 3h, 4h and 5h after injection, and the difference was calculated. The animals were sacrificed, and blood was collected from the abdominal aorta. Plasma TNF-α and IL-1β were measured by ELISA.

[0092] During the experiment, all rats were kept in the same living environment and under the same feeding conditions. Before the experiment, all rats underwent acclimatization feeding for 3 days. During the experiment, the rats were given sufficient food and water and were allowed to eat and drink freely. The light and dark cycle was 12 hours, the room temperature was 20-24°C, the humidity was 40-60%, and the ventilation was 10-20 times / hour.

[0093] Statistical methods: SPSS 23.0 was used for statistical analysis, and the results are described as mean and standard deviation.

[0094] Experimental results:

[0095] Table 1. Changes in anal temperature of rats in each group

[0096]

[0097] Note: Compared with the blank group, ** P < 0.01; compared with the control group, # P < 0.05 ## P < 0.01; compared with Example 1 group, △ P < 0.05.

[0098] Table 2 Effects of inflammatory factors

[0099]

[0100]

[0101] Note: Compared with the blank group, * P < 0.05 ** P < 0.01; compared with the control group, # P < 0.05 ## P < 0.01; compared with Example 1 group, △ P < 0.05.

[0102] Analysis: The efficacy test in this invention uses an LPS-induced fever model. After entering the body, LPS stimulates macrophages, transmitting signals that induce the production of large amounts of inflammatory mediators, attracting neutrophil aggregation. The LPS-induced fever model is similar to the fever caused by infectious inflammation in clinical practice and belongs to the classic fever model.

[0103] This invention uses an LPS-induced fever model to detect changes in rectal temperature in rats after modeling, thereby determining the regulatory effect of the traditional Chinese medicine composition on the fever model. Results show that:

[0104] In the control group, the rectal temperature of rats injected with LPS gradually increased after intraperitoneal injection, and the difference in rectal temperature from 1 hour after administration was significantly different from that of the blank group (P < 0.01), indicating that the model was successfully established. In the example group, the temperature of rats injected with LPS began to decrease 3 hours after intraperitoneal injection and continued to decrease until 5 hours. The difference in rectal temperature from 3 to 5 hours was significantly different from that of the control group (P < 0.01). In the comparative group, the temperature of rats injected with LPS began to decrease 4 hours after intraperitoneal injection, and the temperature decrease slowed down at 5 hours. The temperature decrease from 4 to 5 hours was significantly lower than that in Example 1 (P < 0.05).

[0105] Each example group significantly reduced the plasma TNF-α and IL-1β concentrations in animals with persistent fever (P < 0.05, P < 0.01), and compared with each comparative group, the Example 1 group had a more significant effect on reducing TNF-α and IL-1β concentrations (P < 0.05).

[0106] II. Clinical Trials

[0107] 1. Case selection

[0108] The 50 patients diagnosed with the common cold had a persistent low-grade fever, with body temperature between 37.2 and 38.0°C, and symptoms such as sweating, headache, sore throat, general weakness and aches, fever, and loss of appetite.

[0109] 2. Pre-treatment comparability testing

[0110] Patients were randomly divided into a control group and a treatment group, with 25 patients in each group. The control group consisted of 13 males and 12 females, aged 18-32 years; the treatment group consisted of 11 males and 14 females, aged 17-30 years. There were no significant differences in general characteristics between the two groups (P>0.05), making them comparable.

[0111] 3. Treatment Plan

[0112] 3.1. Control Group

[0113] The oral administration of the traditional Chinese medicine composition granules of Comparative Example 2 is 18g each time, 3 times a day, for 3 consecutive days.

[0114] 3.2. Treatment Group

[0115] The oral administration of the traditional Chinese medicine composition granules of Example 1 is 18g each time, 3 times a day, for 3 consecutive days.

[0116] 3.3 Observation indicators and efficacy evaluation criteria

[0117] The clinical efficacy and post-treatment body temperature of the two groups of patients were observed.

[0118] A patient is considered cured if their highest body temperature is <37℃, and all clinical symptoms have completely disappeared without recurrence.

[0119] The patient's body temperature was <37.5℃ and clinical symptoms improved, indicating significant efficacy.

[0120] The patient's body temperature has decreased but is not lower than 37.5℃, and some symptoms are still present, indicating that the treatment is effective.

[0121] The patient's fever and clinical symptoms did not improve, and even worsened, so the treatment was ineffective.

[0122] Overall effective rate = (cured + significantly effective + effective) / total number of cases × 100%

[0123] 4. Results Analysis

[0124] Table 3 Comparison of clinical efficacy between the two groups of patients

[0125]

[0126] Note: Compared with the treatment group * P < 0.05.

[0127] Table 4 Comparison of body temperature changes between the two groups of patients

[0128] Group Number of examples Antipyretic onset time (h) Complete fever reduction time (h) control group 25 3.34±1.55* 37.21±16.59* Treatment group 25 2.85±1.02 30.64±15.75

[0129] Note: Compared with the treatment group * P < 0.05.

[0130] The results show that the composition of the present invention is more effective and reduces fever faster in treating colds and fever.

[0131] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition having an antipyretic effect, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Bupleurum chinense 135-200 parts, Pueraria lobata 225-335 parts, Scutellaria baicalensis 180-270 parts, Gypsum fibrosum 300-450 parts, Arctium lappa 135-200 parts, Forsythia suspensa 180-270 parts, Artemisia annua 90-135 parts, Isatidis radix 135-200 parts, Radix trichosanthis 135-200 parts, Radix salviae miltiorrhizae 180-270 parts, Focussed Shenzhou-6 180-270 parts, Focussed Shanzha 180-270 parts, Focussed Maiya 180-270 parts, Citrus aurantium 135-200 parts, and Glycyrrhiza 50-70 parts.

2. The traditional Chinese medicine composition having antipyretic effect according to claim 1, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Bupleurum chinense 135-200 parts, Pueraria lobata 225-335 parts, Scutellaria baicalensis 180-270 parts, Gypsum fibrosum 300-450 parts, Arctium lappa 135-200 parts, Forsythia suspensa 180-270 parts, Artemisia annua 90-135 parts, Isatidis radix 135-200 parts, Radix trichosanthis 135-200 parts, Radix salviae miltiorrhizae 180-270 parts, Focussed Shenzhou-6 180-270 parts, Focussed Shanzha 180-270 parts, Focussed Maiya 180-270 parts, Citrus aurantium 135-200 parts, and Glycyrrhiza 50-70 parts.

3. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 or 2, characterized in that, The method comprises the following steps: (1) taking Bupleurum chinense, Pueraria lobata, Scutellaria baicalensis, Gypsum fibrosum, Arctium lappa, Forsythia suspensa, Artemisia annua, Isatidis radix, Radix trichosanthis, Radix salviae miltiorrhizae, Focussed Shenzhou-6, Focussed Shanzha, Focussed Maiya, Citrus aurantium, and Glycyrrhiza, and placing them in a container to perform first decocting with water, filtering to obtain extract a and residue a; (2) adding water to the residue a in step (1) to perform second decocting, filtering to obtain extract b and residue b; (3) combining the extract a and the extract b, and concentrating to obtain the traditional Chinese medicine composition.

4. The preparation method of the traditional Chinese medicine composition according to claim 3, characterized in that, The amount of water added in step (1) is 8-12 times the total amount of the traditional Chinese medicine materials, and the first decocting is performed for 1-2 hours.

5. The preparation method of the traditional Chinese medicine composition according to claim 3, characterized in that, The amount of water added in step (2) is 6-10 times the total amount of the traditional Chinese medicine materials, and the second decocting is performed for 1-2 hours.

6. The preparation method of the traditional Chinese medicine composition according to claim 3, characterized in that, The relative density of the clear extract obtained after the concentration in step (3) is in the range of 1.05-1.

10.

7. A preparation comprising the traditional Chinese medicine composition having antipyretic effect according to any one of claims 1-2 or a preparation comprising the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 3-6, characterized in that, The traditional Chinese medicine composition is prepared by adding conventional excipients and using conventional processes to prepare clinically acceptable granules, capsules, tablets, pills, and oral liquids.

8. Use of the traditional Chinese medicine composition of any one of claims 1-2 or prepared by the preparation method of any one of claims 3-6 or the preparation of the traditional Chinese medicine composition of claim 7 in the preparation of a medicine with antipyretic effect.

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