CN103285230B - Pharmaceutical composition for treating pharyngitis and preparation method thereof - Google Patents
Pharmaceutical composition for treating pharyngitis and preparation method thereof Download PDFInfo
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- CN103285230B CN103285230B CN201310234092.5A CN201310234092A CN103285230B CN 103285230 B CN103285230 B CN 103285230B CN 201310234092 A CN201310234092 A CN 201310234092A CN 103285230 B CN103285230 B CN 103285230B
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Abstract
The invention provides a traditional Chinese medicine for treating acute attack of acute pharyngitis or chronic pharyngitis. The traditional Chinese medicine is prepared from rehmannia, radix ophiopogonis, radix scrophulariae, honeysuckle, fructus forsythia, scutellaria baicalensis, perfoliote knotweed herb, cortex moutan radicis, belamcanda chinensis, radix glehniae, platycodon grandiflorum and liquorice. The traditional Chinese medicine composition is anti-inflammatory, antifebrile, antalgic, antibacterial and antiviral and/or strengthens immune function, can be used for treating or relieving pharyngalgia, dry throat and cauma and/or dysphagia, and also can be applied to a medicine for preventing or treating cold, cough, sphagitis and/or amygdalitis. The invention also provides a preparation of the traditional Chinese medicine composition, as well as a preparation method and application thereof.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating pharyngitis, a preparation method and application thereof and the like.
Background
Pharyngitis is inflammation of pharyngeal mucosa and submucosal tissues, is part of upper respiratory tract infection, is generally long in course of disease and stubborn and difficult to cure, and is divided into two major types of acute pharyngitis and chronic pharyngitis. Acute pharyngitis attacks repeatedly, and chronic pharyngitis is converted from untimely treatment. It is often caused by rapid climate change, careless living, insecurity of lung and defense, hyperactivity of fire due to yin deficiency, dysfunction of lung and stomach, yin deficiency of lung, and fumigation of heat-toxin, resulting in swelling and burning of throat, heat pain, foreign body sensation or blockage of throat, and even excessive pathogenic heat leading to high fever.
The occurrence and development speed of pharyngitis diseases in China is astonishing, along with the improvement of living standard and working pressure of people, social competition is fierce, especially urban air pollution is aggravated, the number of people suffering from pharyngitis in urban people is gradually increased, and the age of people is in a descending trend. Therefore, the prevention and treatment tasks of pharyngitis are very difficult, the development of the medicine for treating pharyngitis meets the clinical requirements, and the medicine not only has direct economic benefits, but also has wide social benefits by improving the health condition of patients and improving the population health level.
Through retrieval, a document which is found to be somewhat similar to the traditional Chinese medicine formula of the invention includes, chinese patent application 99125715, which discloses a traditional Chinese medicine composition which is prepared from American ginseng, radix glehniae, radix pseudostellariae, sun-dried ginseng, raw liquorice, gynostemma pentaphylla, astragalus mongholicus, codonopsis pilosula, bighead atractylodes rhizome, rhizoma atractylodis, honey-fried licorice root, hyacinth bean, eucommia bark, schizonepeta, radix sileris, radix angelicae pubescentis, notopterygium root, rhizoma gastrodiae, stiff silkworm, perilla leaf, angelica dahurica, ephedra, uncaria, cimicifuga foetida, radix bupleuri, radix puerariae, aster, almond (bitter almond), perilla fruit, cynanchum glaucescens, inula flower (inula flower), loquat leaf, white mulberry root-bark and the like, and is used for treating diseases such as gallstone, liver and kidney essence, blood and body fluid deficiency, qi deficiency;
chinese patent application 03128371, which discloses a medicament for the treatment of acute lung injury caused by pulmonary fibrosis, which is prepared from calculus bovis, cornu saigae tataricae powder, Margarita powder, Borneolum Syntheticum, Moschus, venenum Bufonis, Realgar, fel Ursi, Coptidis rhizoma, Glycyrrhrizae radix, cortex Phellodendri, Scutellariae radix, flos Lonicerae, fructus forsythiae, radix rehmanniae, radix astragali, radix scrophulariae, folium Isatidis, cortex Lycii, herba Verbenae, rhizoma picrorhizae, radix Stellariae, bupleuri radix, rhizoma Polygoni Cuspidati, herba Houttuyniae, Scutellariae radix, Coptidis rhizoma, fructus Aurantii, cortex Phellodendri, herba Artemisiae Annuae, radix Glehniae, radix Ginseng, herba Taraxaci, Gypsum Fibrosum, radix Stemonae, and fructus Gardeniae;
chinese patent application 201010149941 discloses a Chinese medicinal composition for treating night sweat, which is prepared from radix Adenophorae, radix Glehniae, radix Changii, rhizoma Polygonati Odorati, herba Dendrobii, radix Ephedrae, radix Ophiopogonis, radix asparagi, fructus Lycii, fructus Ligustri Lucidi, carapax Trionycis, carapax et Plastrum Testudinis, fructus Schisandrae chinensis, Galla chinensis, radix rehmanniae Preparata, radix Angelicae sinensis, radix Paeoniae alba, colla Corii Asini, Magnetitum, Cinnabaris, Succinum, Os Draconis, semen Ziziphi Spinosae, Gypsum Fibrosum, rhizoma anemarrhenae, radix Puerariae, Trichosanthis radix, folium Bambusae, fructus Gardeniae, etc.
The inventor has long and arduous research and practice, and unexpectedly obtains a traditional Chinese medicine composition formula which is greatly different from the existing formula, not only can be safely and efficiently used for treating acute pharyngitis or acute attack of chronic pharyngitis, but also has the functions of anti-inflammation, antipyresis, analgesia, antibiosis, antivirus, immunity enhancement and the like, can be used for treating or relieving symptoms such as pharyngalgia, dry and burning throat and/or dysphagia, and can be used for preventing or treating cold, cough, pharyngolaryngitis and/or tonsillitis. In addition, the inventor also explores a preparation method of the traditional Chinese medicine composition, greatly simplifies the preparation process under the condition of not influencing the curative effect and the stability of the medicine, treats different raw materials simultaneously as much as possible, saves the investment of potential parallel equipment, saves the production cost and shortens the preparation process.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a novel traditional Chinese medicine composition for treating acute pharyngitis or acute attack of chronic pharyngitis. In addition, the invention also provides a preparation based on the traditional Chinese medicine composition, a preparation method, application and the like.
Specifically, in a first aspect, the present invention provides a Chinese medicinal composition for treating acute pharyngitis or acute attack of chronic pharyngitis, which is characterized in that: the traditional Chinese medicine composition is prepared from rehmannia root, dwarf lilyturf tuber, figwort root, honeysuckle flower, weeping forsythia capsule, baical skullcap root, perfoliate knotweed herb, tree peony bark, blackberry lily, coastal glehnia root, platycodon root and liquoric root in parts by weight:
preferably, the traditional Chinese medicine composition of the first aspect of the invention is prepared from rehmannia root, dwarf lilyturf tuber, figwort root, honeysuckle flower, weeping forsythia capsule, baical skullcap root, perfoliote knotweed herb, tree peony bark, blackberry lily, coastal glehnia root, platycodon root and liquoric root in parts by weight as follows:
in order to ensure the stability and effectiveness of the curative effect, the inventor gropes the quality evaluation standard of the traditional Chinese medicine composition of the first aspect of the invention, and through a large number of batch researches, chlorogenic acid is very suitable as the quality index although the active ingredients in the traditional Chinese medicine composition are very complex. Therefore, the chlorogenic acid content of the traditional Chinese medicine composition of the first aspect of the invention is preferably not lower than 6mg/g, and more preferably not lower than 8.5 mg/g.
The present inventors have found, for a long time, that a preparation process which facilitates mass production without affecting the therapeutic effect and safety, in which various extracts can be combined or processed in parallel, and in which the steps facilitate quality control, is obtained. Therefore, the traditional Chinese medicine composition of the first aspect of the invention is preferably prepared by the following preparation method:
(1) pulverizing the mixture of flos Lonicerae and cortex moutan; or pulverizing flos Lonicerae and cortex moutan respectively, and mixing;
(2) decocting rehmannia root, radix ophiopogonis, radix scrophulariae, fructus forsythiae, scutellaria baicalensis, polygonum perfoliatum, blackberry lily, radix glehniae, platycodon grandiflorum and liquorice for 1-5 times by adding water, collecting filtrate and concentrating into clear paste;
(3) adding ethanol into the clear paste obtained in the step (2) for precipitation, collecting filtrate, concentrating, drying and crushing into powder;
(4) uniformly mixing the crushed products obtained in the step (1) and the step (3); and,
(5) and (4) detecting the content of chlorogenic acid in the mixed product obtained in the step (4), and reserving qualified products to obtain the traditional Chinese medicine composition.
Further preferably, in the above-mentioned production method,
in the step (1), the grinding is carried out to obtain fine powder which can pass through a sieve of 80-150 meshes, preferably 100-120 meshes;
in the step (2), the total weight of the water is 5-15 times of the amount of the decocted medicinal materials, preferably 10 times;
in the step (2), the decoction is carried out for 2-4 times, preferably for 3 times;
in the step (2), the time for each decoction is 0.5-3 h, preferably 1-2 h;
in the step (2), the relative density of the clear paste is 1.0-1.5 (25 ℃), preferably 1.10-1.15 (25 ℃);
in the step (3), ethanol is added during precipitation until the concentration of the ethanol is 60-80% (V/V), preferably 70% (V/V);
in the step (3), the temperature of the precipitate is 0-10 ℃, and is preferably 4 ℃;
in the step (3), the precipitation time is 12-36 h, preferably 24 h;
in the step (3), concentrating into thick paste with the relative density of 1.30-1.35 (45 ℃); and/or the presence of a gas in the gas,
in the step (5), the content of chlorogenic acid in the qualified product is not less than 6mg/g and not less than 8.5 mg/g.
In a second aspect, the present invention provides a method for preparing the Chinese medicinal composition of the first aspect of the present invention, which comprises:
(1) pulverizing the mixture of flos Lonicerae and cortex moutan; or pulverizing flos Lonicerae and cortex moutan respectively, and mixing;
(2) decocting rehmannia root, radix ophiopogonis, radix scrophulariae, fructus forsythiae, scutellaria baicalensis, polygonum perfoliatum, blackberry lily, radix glehniae, platycodon grandiflorum and liquorice for 1-5 times by adding water, collecting filtrate and concentrating into clear paste;
(3) adding ethanol into the clear paste obtained in the step (2) for precipitation, collecting filtrate, concentrating, drying and crushing into powder;
(4) uniformly mixing the crushed products obtained in the step (1) and the step (3); and,
(5) and (4) detecting the content of chlorogenic acid in the mixed product obtained in the step (4), and reserving qualified products to obtain the traditional Chinese medicine composition.
Preferably in the production method of the second aspect of the invention,
in the step (1), the grinding is carried out to obtain fine powder which can pass through a sieve of 80-150 meshes, preferably 100-120 meshes;
in the step (2), the total weight of the water is 5-15 times of the amount of the decocted medicinal materials, preferably 10 times;
in the step (2), the decoction is carried out for 2-4 times, preferably for 3 times;
in the step (2), the time for each decoction is 0.5-3 h, preferably 1-2 h;
in the step (2), the relative density of the clear paste is 1.0-1.5 (25 ℃), preferably 1.10-1.15 (25 ℃);
in the step (3), ethanol is added during precipitation until the concentration of the ethanol is 60-80% (V/V), preferably 70% (V/V);
in the step (3), the temperature of the precipitate is 0-10 ℃, and is preferably 4 ℃;
in the step (3), the precipitation time is 12-36 h, preferably 24 h;
in the step (3), concentrating into thick paste with the relative density of 1.30-1.35 (45 ℃); and/or the presence of a gas in the gas,
in the step (5), the content of chlorogenic acid in the qualified product is not less than 6mg/g and not less than 8.5 mg/g.
In a third aspect, the invention provides a traditional Chinese medicine preparation for treating acute pharyngitis or acute attack of chronic pharyngitis, which comprises the traditional Chinese medicine composition of the first aspect of the invention and optionally further comprises pharmaceutically acceptable auxiliary materials. As used herein, pharmaceutically acceptable adjuvants include pharmaceutically acceptable carriers, excipients, diluents, and the like, which are compatible with the active ingredient. The use of pharmaceutically acceptable adjuvants for the preparation of pharmaceutical formulations is well known to those skilled in the art. The Chinese medicinal preparation of the invention combines active ingredients (Chinese medicinal composition) and pharmaceutically acceptable auxiliary agents to prepare various preparations, preferably solid preparations and liquid preparations, and more preferably solid preparations. The formulations of the present invention may be in unit dosage forms such as tablets, pills, capsules (including sustained release or delayed release forms), powders, suspensions, granules, tinctures, syrups, emulsions, suspensions and the like, as well as various sustained release formulations. Preferably, the Chinese medicinal preparation of the third aspect of the present invention is an oral pharmaceutical preparation, such as granules, tablets, pills and/or capsules, most preferably pills.
In addition, the Chinese medicinal preparation of the third aspect of the present invention preferably does not include pharmaceutically acceptable auxiliary materials, i.e., consists of the Chinese medicinal composition of the first aspect of the present invention.
The dosage of the Chinese medicinal preparation can be determined according to the content of the active ingredients (Chinese medicinal composition) in the Chinese medicinal preparation and the conditions of a specific dosage form, a administration mode and an administration object, and the dosage of a human can be estimated according to animal experiments and the required content can be determined, and the pharmaceutically acceptable auxiliary dosage is not usually considered.
In a fourth aspect, the present invention provides the use of the Chinese medicinal composition of the first aspect of the present invention in the preparation of a medicament for treating acute pharyngitis or acute attack of chronic pharyngitis.
In a fifth aspect, the present invention provides the use of the composition of the first aspect of the present invention in the preparation of a medicament having anti-inflammatory, antipyretic, analgesic, antibacterial, antiviral and/or immune function enhancing effects.
In a sixth aspect, the present invention provides the use of a composition of the first aspect of the invention in the manufacture of a medicament for the treatment or alleviation of sore throat, dry burning throat and/or dysphagia.
In a seventh aspect, the present invention provides the use of the composition of the first aspect of the present invention in the preparation of a medicament for the prevention or treatment of cold, cough, pharyngolaryngitis and/or tonsillitis.
The use of the fourth, fifth, sixth and seventh aspects of the invention is supported by the experiments provided by the embodiments of the invention. Preferably in the use of the fourth, fifth, sixth and seventh aspects of the invention, the medicament is a Chinese medicinal preparation of the third aspect of the invention.
The excellent effects obtained by the present invention include: the curative effect is exact and high-efficiency, thereby effectively treating various diseases and conditions including acute pharyngitis or acute attack of chronic pharyngitis and the like; the quality is stable, safe and reliable, the dosage is small, and the adverse reaction is less, which is very beneficial to increasingly important medicine safety supervision and public quality requirements on medicines; the production steps are simple, the product quality is convenient to monitor, various crude drugs and extracts thereof can be processed in parallel or in a combined mode, and the used reagents have no special solvent, so that the time is saved, the production cost is reduced, and the requirement of large-scale production can be met.
For the sake of understanding, the present invention will be described in detail below by way of specific examples. It is to be expressly understood that the description is illustrative only and is not intended as a definition of the limits of the invention. Many variations and modifications of the present invention will be apparent to those skilled in the art in light of the teachings of this specification.
In addition, the present invention incorporates publications which are intended to more clearly describe the invention, and which are incorporated herein by reference in their entirety as if reproduced in their entirety.
Detailed Description
The present invention is further illustrated by the following examples. Unless otherwise specified, the technical means used in the examples are conventional means well known to those skilled in the art and commercially available common instruments, and can be referred to the "Chinese pharmacopoeia" and the relevant regulations and guidelines of SFDA.
Example 1 preparation of anti-cold sore-throat relieving pill
1, prescription:
2, preparing the traditional Chinese medicine composition:
taking twelve crude drugs of the above prescription, wherein honeysuckle and moutan bark are ground into fine powder, sieved (100-120 meshes) and mixed uniformly; rehmannia root, dwarf lilyturf tuber, figwort root, coastal glehnia root, weeping forsythia capsule, baical skullcap root, blackberry lily, platycodon root, liquoric root and perfoliote knotweed herb are mixed, 4 times of water in total weight of the rehmannia root, the figwort root, the coastal glehnia root and the perfoliate knotweed herb are added for decocting for 2 hours at 100 ℃, filtrate is collected, 3 times of water is added into filter residue for continuously decocting for 2 hours, the filtrate is collected, 3 times of. Mixing the filtrates, concentrating to obtain a clear paste with a relative density of 1.10-1.15 (25 ℃), adding ethanol to make the ethanol content reach 70% (V/V), standing at 4 ℃ for 24 hours, collecting the filtrate, evaporating at 40-50 ℃ to recover the ethanol, concentrating to obtain a thick paste with a relative density of 1.30-1.35 (45 ℃), drying, and pulverizing to obtain fine extract powder. And uniformly mixing the extract fine powder with the honeysuckle and tree peony bark crushed fine powder, preparing pills with a proper amount of water, drying at the temperature of 60-80 ℃, polishing, and preparing 1000g of pills to obtain the anti-cold sore-throat relieving pills.
3, identification of medicine quality:
taking 0.24g of pills, grinding, precisely weighing, placing in a 50ml brown measuring flask, adding 30ml of 50% methanol, ultrasonically extracting for 30 minutes (power is 100w, frequency is 40 Hz), cooling, diluting with 50% methanol to scale, shaking uniformly, filtering with a 0.45 mu m microporous filter membrane to obtain a detection sample, and carrying out HPLC detection (using octadecylsilane chemically bonded silica as a filler, acetonitrile-0.4% phosphoric acid (V: V =15: 85) as a mobile phase, detecting at a wavelength of 327nm and a flow rate of 1.0ml/min, and using a 50% methanol solution containing 50 mu g/ml of chlorogenic acid as a control) to obtain the content of the chlorogenic acid in the pills, wherein the content of the chlorogenic acid in the pills is not lower than 8.5 mg/g. Discard that does not meet the quality index.
EXAMPLE 2 pharmacodynamic experiment of the Chinese medicinal composition
[ test drugs ]
Name of the test drug: the Chinese medicinal composition, KANGGANLIYAN pill (hereinafter, unless indicated to the contrary, referred to as "Chinese medicinal composition"), obtained in the manner described in example 1, wherein each gram of the Chinese medicinal composition is equivalent to 2.56g of crude drug.
[ Positive control drug ]
Aspirin tablets, combined fertilizer and Jiujiu pharmaceutical Co., Ltd, specification: 0.3 g/piece, batch number: 20040513.
liyanling tablet, Changchun Jinlai pharmaceutical industry (group) Limited, Specification: 0.5 g/piece, batch number: 20040501.
moroxydine, appeasing the pharmaceutical factory in the market, specification: 0.1 g/piece, batch number: 20050113.
[ test animals ]
Kunming species mice and Wistar rats: purchased from the research center of experimental animals in new medical science of Changchun Gansu, certificate number: SCXK (Ji) 2003-.
Fertilization of shared chicken 9 days chicken embryo: purchased from a biologicals institute of vinca.
[ PRODUCTS ] OF MUTANCE
Streptococcus pneumoniae, b hemolytic streptococcus, staphylococcus aureus (ATCC 25925), pseudomonas aeruginosa, influenza virus: model a 1. The above germs and virus strains were purchased from the pathogenic microorganism research laboratory of the basic medical college of Jilin university and used under control.
[ test methods and results ]:
anti-inflammatory experiment
1. Influence on the swelling of the foot sole of a rat caused by egg white
50 healthy Wister rats are taken, and the weight of each rat is 160-200 g. Randomly dividing into 5 groups, each group comprises 10 animals, and comprises (1) a control group (purified water 10 ml/kg); 0.4g/kg of aspirin group; ③ 3g/kg of the high-dose group of the traditional Chinese medicine composition; fourthly, the dosage group in the traditional Chinese medicine composition is 2 g/kg; fifthly, the low dose of the traditional Chinese medicine composition is 1 g/kg. The preparation is administered by gavage for 7 days. 0.1ml of 10% egg white solution is injected subcutaneously into right hind foot sole per one foot to cause inflammation, the volume change of the hind foot sole is measured by a volumetric method respectively at 30min, 60min, 120min and 240min before and after causing inflammation, so that the volume change of the hind foot before and after inflammation is swelling degree, the swelling percentage and the swelling inhibition rate are calculated according to the following formulas, and the swelling rates and the inhibition rates of different groups are compared. Experimental results the results of comparing each dosing group with the model control group are shown in table 1.
Swelling rate (%) = (volume of postinflammatory metatarsal-volume of pro-inflammatory metatarsal)/volume of pro-inflammatory metatarsal × 100%
Inhibition (%) = (control group average swelling rate-administration group average swelling rate)/control group average swelling rate × 100%
The experimental results are as follows: 0.1ml of 10% egg white is injected subcutaneously to the right hind foot sole of a rat to prepare an experimental swelling model, after administration of the traditional Chinese medicine composition, the foot swelling caused by egg white inflammation can be obviously reduced, the effect of large dose and medium dose is more obvious, and the traditional Chinese medicine composition has significant difference (P is less than 0.05, and P is less than 0.001) compared with a model control group. The traditional Chinese medicine composition is proved to have obvious improvement effect on a chicken egg white inflammatory foot swelling model.
TABLE 1 influence of the Chinese medicinal composition on the footpad swelling and inhibition rate of normal rats
Comparison with the control group: p <0.05; p < 0.01; p < 0.001.
2. Influence on increase of permeability of capillary vessels in abdominal cavity of mouse caused by acetic acid
50 Kunming mice are taken, half of the female and half of the male are respectively, the weight is 20-22 g, the mice are randomly divided into 5 groups, and 10 mice are taken in each group. A normal control group (purified water 20 ml/kg); ② the high-dose group of the traditional Chinese medicine composition is 6g/kg (30 percent of traditional Chinese medicine composition suspension is 20 ml/kg); ③ 4g/kg of the Chinese medicinal composition middle dose group (20 percent of Chinese medicinal composition suspension is 20 ml/kg); fourthly, the low dose group of the traditional Chinese medicine composition is 2g/kg (20 ml/kg of 10 percent traditional Chinese medicine composition suspension), and the comparison group of the Liyanling tablets is 4g/kg (20 ml/kg of 20 percent suspension). The preparation is administered by intragastric administration according to the above dosage, after the last administration for 30min for 7 days, mice are injected with 0.1ml/10g of physiological saline solution of Iwensilan 0.5% via tail vein, and then injected with 0.2 ml/mouse of acetic acid solution 0.6% via abdominal cavity, and the mice are killed by pulling vertebra after 20min, the abdominal cavity is cut, and the washing liquid is sucked out by washing the abdominal cavity with 6ml of physiological saline several times. Mixing the washing solutions, adding normal saline to 10ml, centrifuging at 3000rpm for 15min, taking supernatant, performing colorimetry at wavelength of 590nm, and determining optical density of animal abdominal cavity washing solution. Experimental results the dosing groups and model control groups were compared and t-test treatment was performed between groups, the results are shown in table 2.
The experimental results are as follows: 0.6% acetic acid solution 0.2 ml/mouse abdominal cavity injection can prepare the mouse peritoneal capillary permeability increase model, the traditional Chinese medicine composition administration can obviously inhibit the mouse peritoneal capillary permeability increase caused by acetic acid, the high dose effect is more obvious, and compared with the model control group, the obvious difference (P is less than 0.01). The traditional Chinese medicine composition has obvious inhibition effect on the increase of the permeability of the capillary vessels in the abdominal cavity of the mouse caused by acetic acid.
Table 2 inhibitory effect of the Chinese medicinal composition on increase of capillary permeability caused by acetic acid in mice.
Comparison with the control group: p <0.05; p < 0.01.
Second, antipyretic experiment
1. Effect on the body temperature changes of the rat fever model caused by endotoxin
50 normal rats with half male and female body weight of 200-220 g are taken, the body temperature of the tested rat is measured for 3 times continuously, and the patient with stable body temperature is used for the test. Randomly dividing into 5 groups, each group comprises 10 Chinese medicinal compositions, wherein the high-dose group of the Chinese medicinal compositions is 3 g/kg; ② 2g/kg of the traditional Chinese medicine composition; ③ 1g/kg of the low-dose group of the traditional Chinese medicine composition; 0.4g/kg of aspirin group; control group, purified water with the same volume. The preparation is administered by intragastric administration for 3 days, and 30min after the last administration is performed, 50EU/kg Escherichia coli endotoxin is injected via tail vein. The body temperature is measured once every 30min, and is measured once every 60min after 120min, and the observation is continuously carried out for 360 min. The temperature changes of the animals in each group were compared at different time points. The data of each group are expressed as mean plus minus standard deviation, and t test treatment is carried out between groups, and the results are shown in Table 3.
The experimental result shows that in a rat fever model test caused by 50EU/kg escherichia coli endotoxin tail vein injection, the traditional Chinese medicine composition can obviously reduce the rise value of the body temperature of a rat caused by endotoxin after administration, the effect of large dose and medium dose is more obvious, and the traditional Chinese medicine composition has obvious difference (P is less than 0.05, and P is less than 0.01) compared with a model control group, which indicates that the traditional Chinese medicine composition has obvious inhibition effect on the rise of the body temperature of the rat caused by endotoxin.
2. Influence on animal model body temperature change of rabbit fever caused by endotoxin
40 rabbits with qualified body temperature are taken, the male and female parts are respectively, and the weight is 2-3 kg. Randomly dividing the traditional Chinese medicine composition into 5 groups, wherein each group comprises 8 Chinese medicine compositions, and the high-dose group of the traditional Chinese medicine compositions is 2 g/kg; ② the traditional Chinese medicine composition has a dosage of 1 g/kg; ③ the low dose group of the traditional Chinese medicine composition is 0.5 g/kg; 0.3g/kg of aspirin group; control group, purified water with the same volume. The preparation is administered by intragastric administration for 3 days, and 30min after the last administration is performed, 5EU/kg Escherichia coli endotoxin is injected via ear edge vein, body temperature is measured once at intervals of 30min, and body temperature is measured once at intervals of 60min after 120min, and the continuous observation is performed for 360 min. The temperature changes of the animals in each group were compared at different time points. The data of each group are expressed as mean plus minus standard deviation, and t test treatment is performed between groups, and the results are shown in Table 4.
The experimental results are as follows: 5EU/kg escherichia coli endotoxin ear vein injection can be used for preparing a rabbit fever animal model, the traditional Chinese medicine composition can obviously reduce the body temperature of a rabbit fever caused by 5EU/kg escherichia coli endotoxin, the large dose and the medium dose effect are more obvious, and the traditional Chinese medicine composition has obvious difference (P is less than 0.05, and P is less than 0.01) compared with a model control group, so that the traditional Chinese medicine composition has an obvious inhibition effect on the increase of the rabbit body temperature caused by endotoxin.
TABLE 3 comparison of the temperature changes of the rat fever model caused by endotoxin with the pharmaceutical composition
Comparison with the control group: p <0.05; p < 0.01; p < 0.001.
TABLE 4 comparison of the pharmaceutical compositions to the body temperature changes of the rabbit heating model
Comparison with the control group: p <0.05; p < 0.01; p < 0.001.
Third, analgesic experiment
1. Twisting body method
50 Kunming mice with half male and female and 18-22 g weight are taken and are bred adaptively for 3 days in a laboratory, and the mice are randomly divided into 5 groups of 10 mice each. The control group is purified water 20 ml/kg; 0.6g/kg of aspirin group; ③ 2g/kg of the low-dose group of the traditional Chinese medicine composition; fourthly, the dosage group in the traditional Chinese medicine composition is 4 g/kg; fifthly, the high dosage group of the traditional Chinese medicine composition is 6 g/kg. Each group was administered by gavage 1 time a day for 5 consecutive days. After 30min of the last administration, 0.1ml/10g of 0.7% acetic acid solution is injected into the abdominal cavity, the times of mouse writhing reaction (mouse abdomen is attached to the ground, concaved, hind limbs are stretched and twisted) within 10min after the acetic acid administration are observed and recorded, the experimental results of each administration group and the purified water group are compared, t test treatment is carried out between the groups, and the results are shown in table 5.
As shown in table 5, the Chinese medicinal composition has a certain effect of alleviating writhing response of mice stimulated by acetic acid, and has significant difference (P <0.01 or P < 0.001) compared with the purified water injection.
TABLE 5 Effect of Chinese medicinal compositions on mouse writhing frequency
Comparison with the control group: p < 0.01; p < 0.001.
2. Tenderness therapy
Taking 50 qualified rats with half male and female parts and weight of 160-200 g, randomly dividing the rats into 5 groups, and 10 rats in each group. Comparing group, 10ml/kg pure water; 0.4g/kg of aspirin group; ③ 1g/kg of the low-dose group of the traditional Chinese medicine composition; fourthly, the dosage group in the traditional Chinese medicine composition is 2 g/kg; fifthly, the traditional Chinese medicine composition is in a high dose group of 3 g/kg. Each group was administered by gavage 1 time a day for 5 consecutive days. After the administration period is finished, the pain threshold values of the rats at 30min, 60min and 120min after administration are respectively measured by a YLS-3E tenderness apparatus. Comparing the pain threshold change conditions of different administration groups. Treatment with t-test between groups, results are shown in Table 6.
As shown in Table 6, the Chinese medicinal composition group has a certain inhibition effect on pain caused by physical factors, and the obvious difference (P <0.01 or P < 0.001) compared with the control group shows that the Chinese medicinal composition has an analgesic effect on pain caused by physical factors of rats.
TABLE 6 Effect of Chinese medicinal compositions on animal pain threshold (tenderness method)（N=10）
Comparison with the control group: p <0.05; p < 0.01; p < 0.001.
The experimental observation of the analgesic effect of the traditional Chinese medicine composition by the two analgesic effect experimental methods of the writhing method and the analgesic effect shows that the traditional Chinese medicine composition has obvious analgesic effect, and the analgesic effect is enhanced along with the increase of the dosage in the experiment.
Fourth, experiment of antibacterial and antiviral actions
(I) test of antiviral Effect
1. In vivo antiviral Effect test
60 Kunming mice are selected, half of the mice are female and half of the mice, and the weight of the mice is 18 to 20 grams. Experimental animals were randomly divided into 6 groups of 10 animals each. Influenza virus control group, purified water 20 ml/kg; ② the virolin control group 1 is 25 mg/kg; ③ 12.5mg/kg of the virolin control group 2; fourthly, 6g/kg of 1 group in the traditional Chinese medicine composition; fifthly, 4g/kg for 2 groups of the traditional Chinese medicine composition. Sixthly, 2g/kg of the traditional Chinese medicine composition in 3 groups. The administration is carried out by continuous gavage for 3 days according to the dosages of each group, and 30 mul/mouse (A1 type, hemagglutination titer 1: 240) of influenza virus is dripped into each group of mice nasally under ether light anesthesia 4h after the last administration. Animals were observed for 7 days for morbidity and mortality and the results were recorded. The results are detailed in Table 7.
As shown in Table 7, the mortality of the animals administered with the Chinese medicinal composition is obviously lower than that of the negative control group, and the mortality is obviously reduced along with the increase of the dosage. The traditional Chinese medicine composition can obviously reduce the death rate of mice infected by influenza viruses and has obvious protection effect on animals infected with the influenza viruses.
TABLE 7 Effect of Chinese medicinal compositions on lethality of influenza Virus infected animals
2. In vitro influenza virus action experiment
Taking 28 normally developed chicken embryos (fertilized for 9 days), randomly dividing the chicken embryos into 7 groups of 4 chicken embryos. The specific grouping is as follows: three concentrations (1 mg/ml, 0.5mg/ml and 0.25 mg/ml) of the positive control drug of the moroxydine are divided into three groups, and three concentrations (2.2 mg/ml, 1.1mg/ml and 0.55 mg/ml) of the test drug of the traditional Chinese medicine composition are divided into three groups. A virus control (one concentration) was also set. Taking the chick embryo back, observing whether the chick embryo grows normally under an egg inspection lamp, drawing the position of an air chamber, sterilizing, tapering a small hole at a position without a large blood vessel beside the air chamber by using a sterile vertebra, respectively injecting test medicaments and positive control medicaments with different concentrations into allantoic cavities by 0.1 ml/piece (injecting sterile normal saline into a control group), and sealing the small hole. The culture was continued at 36 ℃ for 48 h. The next day, the growth of the chick embryos was observed and 0.1 ml/egg of influenza virus was injected. And (5) continuing culturing. The growth of the chick embryos was observed every day, and the dead chick embryos within 24h were discarded. Taking out after three days of culture, and placing in a refrigerator at 4 ℃. Allantoic fluid is taken the next day, and the influenza virus titer is detected by a ball agglutination test method.
The experimental results are as follows: as shown in Table 8, the three concentrations of the Chinese medicinal composition have different degrees of virus inhibiting effect, and the virus inhibiting effect is more obvious along with the increase of the dosage.
TABLE 8 Effect of Chinese medicinal compositions on influenza Virus potency in vitro
(II) antibacterial action
50 Kunming mice are taken, half of the mice are female and half of the mice, and the weight of the mice is 18 to 20 grams. After three days of observation, the groups were randomly divided into 5 groups of 10 individuals. 1-3 groups are three different concentrations (6 g.kg) of the tested Chinese medicinal composition‐1、4g·kg‐1、2g·kg‐1) The 4 groups are Liyanling tablet positive drug controls, and the 5 groups are bacteria negative controls. Three days before the infection of bacteria, except the bacteria control group, the other 4 groups are administered by intragastric administration according to different medicines and different concentrations (20 ml. kg)‐1). The negative control group was given the same volume of purified water. After the last administration for 4 hours, the staphylococcus aureus liquid with the tested 100 percent lethal dose is injected into the abdominal cavity for 0.5 ml/body. Mice were observed for mortality (%) 7 days after infection.
The experimental results are as follows: as shown in table 9. The traditional Chinese medicine composition can obviously reduce the lethality of mice infected with staphylococcus aureus, and shows that the traditional Chinese medicine composition has a certain protection effect on mice infected with lethal staphylococcus aureus.
TABLE 9 protective action of Chinese medicinal composition on lethal dose of Staphylococcus aureus infected mouse
Fifth, experiment of immunoregulation
(I) specific immunization experiments
1. Effect on delayed allergic reaction in mice caused by dinitrochlorobenzene
50 Kunming mice are taken, half of the Kunming mice are male and female, and the weight of the Kunming mice is 20-24 g. Randomly divided into 5 groups of 10, each, marked, weighed, and body weight recorded. The control group is purified water 20 ml/kg; ② a positive control group, a Liyanling tablet control group is 4 g/kg; ③ 2g/kg of the low-dose group of the traditional Chinese medicine composition; fourthly, the dosage group in the traditional Chinese medicine composition is 4 g/kg; fifthly, the high dosage group of the traditional Chinese medicine composition is 6 g/kg. All animals were subcutaneously injected with a 1.25% dinitrochlorobenzene-acetone solution, 0.02 ml/mouse, for sensitization. And (5) beginning intragastric administration according to the corresponding medicines and dosages of each group 24 hours after sensitization, wherein the administration is carried out once a day and is continuously carried out for 9 days. On day 10, a 1.25% dinitrochlorobenzene-acetone solution was injected at 0.02 ml/mouse pad into the right foot and the left foot with the same amount of acetone solution. After 38h, the animals were sacrificed, and both feet were cut from the ankle joints and weighed individually with an electronic balance. The difference in weight of the two feet was compared as the degree of swelling of the feet, and the results of t-test treatment between the groups are shown in Table 10.
The experimental results are as follows: as shown in Table 10, the swelling values of the feet of the mice in the high-dose group and the middle-dose group are obviously higher than those of the control group (P is less than 0.05), which indicates that the traditional Chinese medicine composition has a certain promotion effect on the animal cellular immune response.
TABLE 10 influence of the Chinese medicinal composition on delayed allergic reaction of mice caused by dinitrochlorobenzene
Comparison with the control group: p < 0.05.
2. Effect on animal humoral immune function (hemolysin antibody method)
(1) Experimental animals and groups:
50 Kunming mice are taken, the weight is 20-24 g, and the weight is half of the weight of the Kunming mice. The groups were randomly divided into 5 groups of 10.
(2) Test methods and procedures
Preparing chicken erythrocyte suspension: 1ml of blood was taken from the inferior vein of chicken wings. The erythrocytes were washed three times with physiological saline, and then chicken erythrocytes were prepared into a 5% suspension for later use.
② preparation of guinea pig complement: the guinea pig is bled by heart, centrifuged at 3000rpm/min for 20min, and the serum is diluted with physiological saline 1:10 for use.
(3) Methods and dosages of administration
Each group of mice was intraperitoneally injected with 0.2 ml/mouse of a 5% chicken red blood cell suspension. Then, administration was started at the following doses: the traditional Chinese medicine composition 1 group is 6 g/kg; the traditional Chinese medicine composition 2 group is 4 g/kg; the traditional Chinese medicine composition 3 groups are 2 g/kg; a positive control group, 4g/kg Liyanling tablets; normal control group, purified water 20 ml/kg.
Continuously administering for 10 days, collecting mouse eyeball and collecting blood, adding the blood into 0.5ml centrifuge tube, centrifuging at 3000rpm/min for 15min, and diluting serum with physiological saline 100 times.
(4) Test method
50 test tubes are taken and numbered in a test tube rack. 1ml of each mouse serum was added to the test tube. 0.5ml of 5% chicken blood erythrocyte suspension is added into each test tube. 0.5ml of 10% guinea pig serum was added to each tube. After the sample addition was completed, all the tubes were placed in a 37 ℃ incubator for incubation for 30 min. After the incubation, the reaction was stopped by placing the mixture in a refrigerator (0 ℃ C.). Placing the test tube into a centrifuge, centrifuging at 3000rpm/min for 20min, and collecting supernatant. The Optical Density (OD) value of each sample was measured at a wavelength of 540nm using a 7550 spectrophotometer without adding a serum sample as a blank.
The experimental results are as follows: compared with a control group, the animal serum OD value of the traditional Chinese medicine composition administration group is not obviously different from that of the control group, which shows that the traditional Chinese medicine composition with the experimental dosage has no obvious influence on the humoral immunity function of normal animals. The specific results are shown in Table 11.
TABLE 11 Effect of Chinese medicinal compositions on animal humoral immune function
(II) nonspecific Immunity test
Effect of non-mouse reticuloendothelial phagocytic function
50 Kunming mice are taken, half of the female mice and half of the male mice are respectively female mice, the weight of the mice is 18-20 g, the mice are randomly divided into 5 groups, and 10 mice are taken in each group. A normal control group, purified water 20 ml/kg; ② a positive control group, a Liyanling tablet control group is 4 g/kg; ③ 2g/kg of the low-dose group of the traditional Chinese medicine composition; fourthly, the dosage group in the traditional Chinese medicine composition is 4 g/kg; fifthly, the high dosage group of the traditional Chinese medicine composition is 6 g/kg. Performing intragastric administration according to the corresponding medicines and dosage of each group, continuously administering for 7 days once a day, and injecting India ink 0.05ml/10g through tail vein 30min after the last administration; 20ul of blood was taken from the retroorbital vein with a pipette 1min and 5min after injection. Dissolved in 2ml of 0.1% Na2CO3Shaking the solution evenly. Pre-heated 7550 spectrophotometer at 675nm with 0.1% Na2CO3The solution is used as a blank to measure the optical density value (OD value) of each sample, and the phagocytic index K and the phagocytic activity alpha are calculated, and t test treatment is carried out among groups.
The experimental results are as follows: the phagocytic index of the animal phagocyte in the administration group of the traditional Chinese medicine composition is significantly different from that in the control group (P is less than 0.05 and more than 0.01) and the phagocytic activity is obviously improved (P is less than 0.05 and more than 0.01), which shows that the traditional Chinese medicine composition has a certain promotion effect on the phagocytic function of the animal mononuclear phagocyte. The specific results are shown in Table 12.
TABLE 12 Effect of Chinese medicinal compositions on non-specific immune function in mice
Comparison with the control group: p <0.05, P < 0.01.
[ experimental conclusion ]:
1. the traditional Chinese medicine composition has obvious improvement effect on a rat inflammatory foot swelling model caused by egg white, and has obvious inhibition effect on the increase of the permeability of mouse abdominal capillary vessels caused by acetic acid, and the traditional Chinese medicine composition has certain anti-inflammatory effect.
2. Has obvious inhibiting effect on animal body temperature rise of a rat or rabbit fever model caused by endotoxin, and shows that the traditional Chinese medicine composition has antipyretic effect.
3. Has certain inhibition effect on pain caused by chemical factors and pain caused by physical factors, and shows that the traditional Chinese medicine composition has certain analgesic effect.
4. In the aspect of immune regulation, the compound has certain promotion effect on the immune function of animal cells and the phagocytic function of mononuclear cells, and has no obvious influence on the humoral immune function of animals.
5. The in vitro antiviral test result shows that the traditional Chinese medicine composition can improve the titer of anti-influenza virus; in vivo antiviral tests show that the traditional Chinese medicine composition obviously reduces the death rate of mice infected by influenza virus, and the traditional Chinese medicine composition has a good inhibition effect on the influenza virus.
6. In-vivo antibacterial tests show that the traditional Chinese medicine composition can obviously reduce the death rate of mice infected by staphylococcus aureus with lethal dose, which indicates that the traditional Chinese medicine composition has antibacterial effect.
In conclusion, the traditional Chinese medicine composition has the functions of clearing away heat and toxic materials, resisting inflammation, relieving pain and regulating the immune function of the organism.
EXAMPLE 3 Long-term toxicity test in animals with the traditional Chinese medicine composition
The Chinese medicinal composition prepared in example 1 was administered twice a day to Wistar rats by gavage in an amount of 5.25 g.kg‐1Body weight (folded crude drug: 13.44 g.kg)‐1Body weight), 3.75 g/kg‐1Body weight (folded crude drug amount: 9.6 g.kg)‐1Body weight), 2.25 g.kg‐1Body weight (folded crude drug amount: 5.76 g.kg)‐1Body weight). The dose cannot be increased due to the limitation of the administration concentration and the administration volume. The daily dose of the drug was equivalent to the clinically planned dose (0.21 g/kg)‐1Body weight) of the cells were administered by gavage continuously for 12 weeks at 50 times, 35.7 times, and 21.4 times, and reversibility observation was carried out for 2 weeks.
The results show that the traditional Chinese medicine composition has good oral safety as the tested animals do not have toxic reaction related to drug toxicity when the traditional Chinese medicine composition is administrated and observed for 12 weeks and reversibility observation for 2 weeks under the dosage which is 50 times, 35.7 times and 21.4 times of the clinical planned dosage.
Claims (16)
1. A traditional Chinese medicine composition for treating acute pharyngitis or acute attack of chronic pharyngitis is characterized in that: the traditional Chinese medicine composition is prepared from rehmannia root, dwarf lilyturf tuber, figwort root, honeysuckle flower, weeping forsythia capsule, baical skullcap root, perfoliate knotweed herb, tree peony bark, blackberry lily, coastal glehnia root, platycodon root and liquoric root in parts by weight:
wherein the chlorogenic acid content of the Chinese medicinal composition is not less than 6 mg/g.
2. The traditional Chinese medicine composition of claim 1, characterized in that: the traditional Chinese medicine is prepared from rehmannia root, dwarf lilyturf tuber, figwort root, honeysuckle flower, weeping forsythia capsule, baical skullcap root, perfoliate knotweed herb, tree peony bark, blackberry lily, coastal glehnia root, platycodon root and liquoric root in parts by weight:
3. the traditional Chinese medicine composition of claim 1, characterized in that: wherein the chlorogenic acid content of the Chinese medicinal composition is not less than 8.5 mg/g.
4. The traditional Chinese medicine composition of claim 1, characterized in that: the preparation method comprises the following steps:
(1) pulverizing the mixture of flos Lonicerae and cortex moutan; or pulverizing flos Lonicerae and cortex moutan respectively, and mixing;
(2) decocting rehmannia root, radix ophiopogonis, radix scrophulariae, fructus forsythiae, scutellaria baicalensis, polygonum perfoliatum, blackberry lily, radix glehniae, platycodon grandiflorum and liquorice for 1-5 times by adding water, collecting filtrate and concentrating into clear paste;
(3) adding ethanol into the clear paste obtained in the step (2) for precipitation, collecting filtrate, concentrating, drying and crushing into powder;
(4) uniformly mixing the crushed products obtained in the step (1) and the step (3);
(5) and (4) detecting the content of chlorogenic acid in the mixed product in the step (4), and keeping a qualified product, wherein the content of chlorogenic acid in the qualified product is not lower than 6mg/g, so that the traditional Chinese medicine composition is prepared.
5. The traditional Chinese medicine composition of claim 4, which is characterized in that: wherein,
in the step (1), the crushing is carried out to obtain fine powder which can pass through a sieve of 80-150 meshes;
in the step (2), the total weight of the water is 5-15 times of the amount of the decocted medicinal materials;
in the step (2), the decoction is divided into 2-4 times of decoction;
in the step (2), the time for each decoction is 0.5-3 h;
in the step (2), the relative density of the clear paste at 25 ℃ is 1.0-1.5;
in the step (3), ethanol is added during precipitation until the ethanol concentration is 60-80% (V/V);
in the step (3), the temperature of the precipitate is 0-10 ℃;
in the step (3), the precipitation time is 12-36 h;
in the step (3), concentrating to a thick paste with the relative density of 1.30-1.35 at 45 ℃;
in step (5), the chlorogenic acid content of the qualified product is not less than 8.5 mg/g.
6. The traditional Chinese medicine composition of claim 5, which is characterized in that: wherein,
in the step (1), the crushing is carried out to obtain fine powder which can pass through a sieve of 100-120 meshes;
in the step (2), the total weight of the water is 10 times of the amount of the decocted medicinal materials;
in the step (2), the decoction is divided into 3 times of decoction;
in the step (2), the time for each decoction is 1-2 h;
in the step (2), the relative density of the clear paste at 25 ℃ is 1.10-1.15;
in the step (3), ethanol is added during precipitation until the ethanol concentration is 70% (V/V);
in the step (3), the temperature of the precipitation is 4 ℃;
in step (3), the time for precipitation was 24 h.
7. The preparation method of the traditional Chinese medicine composition of claim 3, which is characterized by comprising the following steps: the preparation method comprises the following steps:
(1) pulverizing the mixture of flos Lonicerae and cortex moutan; or pulverizing flos Lonicerae and cortex moutan respectively, and mixing;
(2) decocting rehmannia root, radix ophiopogonis, radix scrophulariae, fructus forsythiae, scutellaria baicalensis, polygonum perfoliatum, blackberry lily, radix glehniae, platycodon grandiflorum and liquorice for 1-5 times by adding water, collecting filtrate and concentrating into clear paste;
(3) adding ethanol into the clear paste obtained in the step (2) for precipitation, collecting filtrate, concentrating, drying and crushing into powder;
(4) uniformly mixing the crushed products obtained in the step (1) and the step (3);
(5) and (4) detecting the content of chlorogenic acid in the mixed product in the step (4), and keeping a qualified product, wherein the content of chlorogenic acid in the qualified product is not lower than 8.5mg/g, so as to obtain the traditional Chinese medicine composition.
8. The method for preparing the traditional Chinese medicine composition of claim 7, which is characterized in that: wherein,
in the step (1), the crushing is carried out to obtain fine powder which can pass through a sieve of 80-150 meshes;
in the step (2), the total weight of the water is 5-15 times of the amount of the decocted medicinal materials;
in the step (2), the decoction is divided into 2-4 times of decoction;
in the step (2), the time for each decoction is 0.5-3 h;
in the step (2), the relative density of the clear paste at 25 ℃ is 1.0-1.5;
in the step (3), ethanol is added during precipitation until the ethanol concentration is 60-80% (V/V);
in the step (3), the temperature of the precipitate is 0-10 ℃;
in the step (3), the precipitation time is 12-36 h;
in the step (3), concentrating to a thick paste with the relative density of 1.30-1.35 at 45 ℃;
in step (5), the chlorogenic acid content of the qualified product is not less than 8.5 mg/g.
9. The method for preparing the traditional Chinese medicine composition of claim 8, which is characterized in that: wherein,
in the step (1), the crushing is carried out to obtain fine powder which can pass through a sieve of 100-120 meshes;
in the step (2), the total weight of the water is 10 times of the amount of the decocted medicinal materials;
in the step (2), the decoction is divided into 3 times of decoction;
in the step (2), the time for each decoction is 1-2 h;
in the step (2), the relative density of the clear paste at 25 ℃ is 1.10-1.15;
in the step (3), ethanol is added during precipitation until the ethanol concentration is 70% (V/V);
in the step (3), the temperature of the precipitation is 4 ℃;
in step (3), the time for precipitation was 24 h.
10. A traditional Chinese medicine preparation for treating acute pharyngitis or acute attack of chronic pharyngitis is characterized in that: which comprises the traditional Chinese medicine composition of any one of claims 1 to 6 and also comprises pharmaceutically acceptable auxiliary materials.
11. The traditional Chinese medicine preparation of claim 10, which is characterized in that: it is an oral pharmaceutical preparation.
12. The traditional Chinese medicine preparation of claim 11, which is characterized in that: it is in the form of granule, tablet, syrup, suspension, pill or capsule.
13. A traditional Chinese medicine preparation for treating acute pharyngitis or acute attack of chronic pharyngitis is characterized in that: which comprises the traditional Chinese medicine composition of any one of claims 1 to 6 and does not comprise pharmaceutically acceptable auxiliary materials.
14. Use of the Chinese medicinal composition of any one of claims 1 to 6 in the preparation of a medicament for treating acute pharyngitis or acute attack of chronic pharyngitis.
15. Use of the Chinese medicinal composition of any one of claims 1 to 6 for the preparation of a medicament having an anti-inflammatory effect, an antipyretic effect, an analgesic effect, an antibacterial effect, an antiviral effect and/or an immune function enhancing effect.
16. Use of a Chinese medicinal composition as claimed in any one of claims 1 to 6 in the manufacture of a medicament for the treatment or alleviation of sore throat, dry burning of the throat and/or dysphagia.
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