A traditional Chinese medicine composition for treating viral cold, its preparation method and application

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating viral influenza, and its preparation method and application. The raw materials of the composition include the following components: ginseng, astragalus root, notopterygium root, pubescent angelica root, bupleurum root, peucedanum root, divaricate saposhnikovia root, cicada slough, forsythia fruit, dryopteris crassirhizoma, chuanxiong rhizome, bitter orange, platycodon root and licorice root. The mass ratio of divaricate saposhnikovia root, cicada slough and dryopteris crassirhizoma is 1.2-2:1:1.2-2. The preparation method comprises decocting all components of the raw materials with water to obtain the product. The composition of the present invention has a wide source of ingredients and a simple preparation method, and has good effects in treating viral influenza, fever, nasal congestion and runny nose, dry throat and sore throat, etc.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating viral colds, a preparation method thereof, and an application thereof. Background Art

[0002] Viral cold is a common disease among people, including common cold, influenza, viral pharyngitis, etc. It is mainly transmitted through the air or hand contact via the nasal cavity. Due to its strong infectivity, difficult-to-control transmission route, fast transmission speed, and wide transmission range, it is relatively difficult to control and causes great harm. In severe cases, there may even be cases such as severe pneumonia and respiratory failure. Currently, common western medicines for treating viral colds include antipyretic analgesics, central nervous system stimulants, nasal mucosa vasoconstrictors, highly effective antiviral drugs, etc. These drugs have a certain curative effect on patients' colds. However, commonly used drugs such as paracetamol, ibuprofen, aspirin, amantadine, etc. all have certain gastrointestinal irritation, hepatotoxicity, etc., and have relatively large side effects after continuous administration.

[0003] Traditional Chinese medicine treatment has a multi-target regulatory function and generally has small side effects.

[0004] Chinese Patent Application CN112870318A discloses a traditional Chinese medicine composition with analgesic and antiviral effects, its administration method, and preparation. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: ginseng 5 - 15, astragalus membranaceus 5 - 15, and has a certain antiviral effect.

[0005] Another Chinese Patent Application CN116077594A discloses a traditional Chinese medicine for treating respiratory virus infections. The traditional Chinese medicine includes the following raw materials in parts by weight: ephedra 45 - 55 parts, pseudostellaria heterophylla 80 - 90 parts, bupleurum chinense 63 - 73 parts, scutellaria baicalensis 63 - 73 parts, pogostemon cablin 63 - 73 parts, honeysuckle flower 80 - 90 parts, forsythia suspensa 80 - 90 parts, platycodon grandiflorum 30 - 40 parts, arctium lappa 80 - 90 parts, phragmites communis 130 - 150 parts, isatis root 63 - 73 parts, scrophularia ningpoensis 63 - 73 parts, bitter apricot kernel 25 - 35 parts, cynanchum stauntonii 63 - 73 parts. Clinically, it is mainly used to treat epidemic diseases, influenza, and common colds with wind-cold attacking the exterior and heat-toxin accumulating internally, presenting symptoms such as no sweating, aversion to sweating, fever, soreness and pain in muscles and joints, headache, sore throat, dry throat and itchy throat, dry cough with little sputum, etc.

[0006] The prior art has conducted certain research on the treatment of viral colds with traditional Chinese medicine and achieved certain effects. However, the curative effect and rapid healing ability in antipyretic, analgesic, and anti-inflammatory aspects still need to be further improved, and traditional Chinese medicine generally takes longer to take effect than western medicine and needs to be further improved. Summary of the Invention

[0007] In view of the above deficiencies, the present invention provides a traditional Chinese medicine composition for treating viral colds. The formula is concise, the ingredients are widely sourced, and the preparation method is simple. It has good effects in treating viral colds, fever, nasal congestion and runny nose, and sore throat and dry throat, and has a fast cure rate, which is superior to western medicine.

[0008] To solve the above technical problems, the technical solution adopted by the present invention is:

[0009] A traditional Chinese medicine composition for treating viral colds, the raw materials of the composition include the following components: ginseng, astragalus root, notopterygium root, pubescent angelica root, bupleurum root, purple-flowered peucedanum root, divaricate saposhnikovia root, cicada slough, forsythia fruit, dryopteris crassirhizoma rhizome, chuanxiong rhizome, immature bitter orange, platycodon root, and licorice root.

[0010] All the cut pieces used in the composition of the present invention meet the requirements of Part I of the Chinese Pharmacopoeia (2020 Edition).

[0011] Ginseng is the dried root and rhizome of the Araliaceae plant Panax ginseng C.A.Mey.

[0012] Astragalus root is the dried root of the Leguminosae plant Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao.

[0013] Notopterygium root is the dried rhizome and root of the Umbelliferae plant Notopterygium incisum Ting ex H.T.Chang.

[0014] Pubescent angelica root is the dried root of the Umbelliferae plant Angelica pubescens Maxim. f. biserrata Shan et Yuan.

[0015] Bupleurum root is the dried root of the Umbelliferae plant Bupleurum chinense DC.

[0016] Purple-flowered peucedanum root is the dried root of the Umbelliferae plant Peucedanum praeruptorum Dunn.

[0017] Divaricate saposhnikovia root is the dried root of the Umbelliferae plant Saposhnikovia divaricata (Turcz.) Schischk.

[0018] Cicada slough is the shed cuticle when the nymph of the Cicadidae insect Cryptotympana pustulata Fabricius emerges as an adult.

[0019] Forsythia fruit is the dried fruit of the Oleaceae plant Forsythia suspensa (Thunb.) Vahl.

[0020] Mianma Guanzhong is the dried rhizome and petiole residues of Dryopteris crassirhizoma Nakai, a plant of the Dryopteris family.

[0021] Chuanxiong is the dried rhizome of Ligusticum chuanxiong Hort. of the Umbelliferae family.

[0022] Citrus aurantium is the dried unripe fruit of the Rutaceae plant Citrus aurantium L. and its cultivated varieties.

[0023] Platycodon is the dried root of Platycodon grandiflorum (Jacq.) A.DC., a plant of the Campanulaceae family.

[0024] Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch. of the legume family.

[0025] Preferably, the raw materials of the composition include the following components in parts by weight: 50-250 parts of ginseng, 150-450 parts of astragalus, 100-300 parts of notopterygium, 100-300 parts of angelica dahurica, 100-300 parts of bupleurum, 100-300 parts of peucedanum, 50-250 parts of siler, 50-200 parts of cicada shells, 100-300 parts of forsythia, 50-250 parts of cyrtomium mongolicum, 100-300 parts of ligusticum chuanxiong, 50-250 parts of fructus aurantii, 50-250 parts of platycodon and 50-250 parts of liquorice.

[0026] Preferably, the raw materials of the composition include the following components in parts by weight: 70-200 parts of ginseng, 200-400 parts of astragalus, 100-250 parts of notopterygium, 100-250 parts of angelica dahurica, 100-250 parts of bupleurum, 100-250 parts of peucedanum, 70-200 parts of siler, 50-150 parts of cicada shells, 100-250 parts of forsythia, 70-200 parts of cyrtomium mongolicum, 100-250 parts of ligusticum chuanxiong, 70-200 parts of fructus aurantii, 70-200 parts of platycodon and 70-200 parts of liquorice.

[0027] Preferably, the raw materials of the composition include the following components in parts by weight: 100-150 parts of ginseng, 250-350 parts of astragalus, 100-200 parts of notopterygium, 100-200 parts of angelica dahurica, 100-200 parts of bupleurum, 100-200 parts of peucedanum, 100-150 parts of siler, 50-100 parts of cicada shells, 100-200 parts of forsythia, 100-150 parts of cyrtomium mongolicum, 100-200 parts of ligusticum chuanxiong, 100-150 parts of fructus aurantii, 100-150 parts of platycodon and 100-150 parts of liquorice.

[0028] Preferably, the mass ratio of Saposhnikoviae Radix, Periostracum Cicadae and Dryopteridis Crassirhizomatis Rhizoma is 1.2 - 2:1:1.2 - 2.

[0029] Another object of the present invention is to provide a preparation method of the above composition, which comprises decocting all components of the raw materials with water to obtain the composition.

[0030] Preferably, the preparation method comprises adding 5 - 15 times the amount of water to all components of the raw materials, decocting 1 - 3 times, each time for 0.5 - 1.5 hours, combining the decoction liquids, filtering, and concentrating the filtrate to a relative density of 1.02 - 1.10 to obtain the composition.

[0031] A third object of the present invention is to provide a pharmaceutical preparation for treating viral cold. The raw materials of the pharmaceutical preparation include the above composition or the composition prepared by the above preparation method, and pharmaceutically acceptable excipients. The dosage form of the pharmaceutical preparation is selected from solutions, tablets, capsules, granules, powders, sprays, liniments, gels or creams.

[0032] Preferably, the pharmaceutical preparation is a granule. The preparation method of the granule comprises adding a first excipient to the composition prepared by the preparation method according to any one of claims 5 - 6, spray - drying, and then adding a second excipient to make granules to obtain the granule.

[0033] A fourth object of the present invention is to provide the application of the above composition or the composition prepared by the above preparation method or the above pharmaceutical preparation in the preparation of a drug for treating viral cold.

[0034] Preferably, the drug can treat fever, nasal congestion and runny nose, and dryness and pain in the throat.

[0035] Compared with the prior art, the positive and beneficial effects of the present invention are as follows:

[0036] (1) The traditional Chinese medicine composition provided by the present invention has a concise formula, wide sources of ingredients, and a simple preparation method;

[0037] (2) The traditional Chinese medicine composition provided by the present invention has good effects in treating viral cold, fever, cough, etc.

[0038] (3) The prescription of the present invention supplements qi and consolidates the exterior, dispels wind, cold, and dampness, and detoxifies and expels pathogenic factors. It is used for treating headache and stiffness of the neck caused by viral infection, high fever and aversion to cold, general body aches, as well as cough, vomiting, diarrhea, etc. In the prescription, ginseng and astragalus membranaceus supplement qi and consolidate the exterior, strengthening the healthy qi and dispelling pathogenic factors, and together serve as the monarch drugs; notopterygium incisum and angelica pubescens are pungent and warm in nature, dispersing externally, dispelling wind, cold, and dampness; bupleurum chinense, peucedanum praeruptorum, ledebouriella divaricata, and cicada slough assist the main drugs in promoting the dredging of stagnation in the muscle surface, dispersing pathogenic factors and relieving pain; forsythia suspensa and dryopteris crassirhizoma detoxify and expel pathogenic factors; together they serve as the minister drugs. Platycodon grandiflorum and glycyrrhiza uralensis promote the lung qi, resolve phlegm, relieve cough, and soothe the throat; together they serve as the assistant drugs. Chuanxiong rhizoma and fructus aurantii promote blood circulation and qi movement and serve as the guiding drugs. In the whole prescription, there are both tonifying and clearing actions: ginseng and astragalus membranaceus supplement qi and strengthen the healthy qi, while forsythia suspensa and dryopteris crassirhizoma detoxify and clear heat; there are both ascending and descending actions: bupleurum chinense and fructus aurantii ascend and promote the clear yang, open the chest and promote qi movement, while platycodon grandiflorum promotes the ascending and descending of lung qi. It altogether exerts the effects of supplementing qi and consolidating the exterior, dispelling wind, cold, and dampness, and detoxifying and expelling pathogenic factors. It is applicable to the initial stage of deficiency of defensive qi, insecurity of defensive yang, external invasion of cold-dampness and toxic pathogenic factors, as well as the syndrome of failure of lung qi to disperse caused by the transformation of cold-dampness and toxic pathogenic factors into heat and congestion in the lung, epidemic toxin congesting the lung and transforming into heat, manifested as symptoms such as fever, cough, shortness of breath, chest tightness, etc., as well as the syndrome of weakness of defensive yang in the constitution, susceptibility to colds, palpitations, shortness of breath, or spontaneous sweating, aversion to wind, and weakness, etc. Detailed implementation manners

[0039] The following combines specific embodiments to further elaborate on the present invention. The following embodiments are not used to limit the present invention, but only to illustrate the present invention. The experimental methods used in the following embodiments, unless otherwise specified, and the experimental methods without specific conditions indicated in the embodiments generally follow conventional conditions. The materials, reagents, etc. used in the following embodiments, unless otherwise specified, can all be obtained from commercial channels.

[0040] Embodiment 1

[0041] For the composition of this embodiment, calculated by weight parts, the raw materials of the composition are composed of the following components: 120 parts of ginseng, 300 parts of astragalus membranaceus, 150 parts of notopterygium incisum, 150 parts of angelica pubescens, 150 parts of bupleurum chinense, 150 parts of peucedanum praeruptorum, 120 parts of ledebouriella divaricata, 85 parts of cicada slough, 150 parts of forsythia suspensa, 120 parts of dryopteris crassirhizoma, 120 parts of platycodon grandiflorum, 120 parts of glycyrrhiza uralensis, 150 parts of chuanxiong rhizoma, and 120 parts of fructus aurantii.

[0042] The preparation method is as follows:

[0043] For the above 14 herbs, add 10 times the amount of water, decoct twice, each time for 1 hour, combine the decoction liquids, filter, and concentrate the filtrate to a clear paste with a relative density of 1.02 - 1.10 to obtain.

[0044] The granule of the present invention: First, add 5% of dextrin based on the feeding amount to the clear paste for spray drying to obtain the spray-dried powder; then add 38.5% of dextrin based on the quality of the granule to be prepared and mix evenly for dry granulation to obtain the granule.

[0045] Embodiment 2

[0046] The composition of this embodiment is composed of the following components in parts by weight: 50 parts of ginseng, 150 parts of astragalus, 100 parts of notopterygium, 100 parts of angelica dahurica, 100 parts of bupleurum, 100 parts of peucedanum, 50 parts of siler, 50 parts of cicada shells, 100 parts of forsythia, 50 parts of cyperus rotundus, 100 parts of ligusticum chuanxiong, 50 parts of fructus aurantii, 50 parts of platycodon and 50 parts of liquorice.

[0047] The preparation method is as follows:

[0048] Add 10 times the amount of water to the above 14 ingredients, boil twice, each time for 1 hour, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.02-1.10.

[0049] The granules of the present invention are: the clear paste is firstly added with 5% dextrin for spray drying to obtain spray-dried powder; the dextrin is then added for the second time to obtain 38.2% of the particle mass, and the mixture is dry granulated to obtain the granules.

[0050] Example 3

[0051] The raw materials of the composition of this embodiment are composed of the following components in parts by weight: 250 parts of ginseng, 450 parts of astragalus, 300 parts of notopterygium, 300 parts of angelica dahurica, 300 parts of bupleurum, 300 parts of peucedanum, 250 parts of siler, 200 parts of cicada shells, 300 parts of forsythia, 250 parts of cyperus rotundus, 300 parts of ligusticum chuanxiong, 250 parts of fructus aurantii, 250 parts of platycodon and 250 parts of liquorice.

[0052] The preparation method is as follows:

[0053] Add 10 times the amount of water to the above 14 ingredients, boil twice, each time for 1 hour, combine the decoctions, filter, and concentrate the filtrate to a clear paste with a relative density of 1.02-1.10.

[0054] The granules of the present invention are as follows: the clear paste is firstly added with 5% dextrin for spray drying to obtain spray-dried powder; and then dextrin is added for the second time to obtain 39.0% dextrin by mass of particles, mixed and dry granulated to obtain granules.

[0055] Comparative Example 1

[0056] The prescription of this comparative example is: 120g of Angelica dahurica, 120g of Notopterygium wilfordii, 120g of Ligusticum chuanxiong, 120g of Bupleurum chinense, 120g of Citrus aurantium, 120g of Platycodon grandiflorum, 120g of Peucedanum peucedanum, 120g of Poria cocos, 60g of Licorice root, 60g of Ginger, 60g of Menthus fragrans, and 120g of Ginseng.

[0057] The preparation method is as follows:

[0058] The above medicinal herbs are added with 10 times the amount of water, decocted twice, each time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.02 - 1.10. Then, 5% of dextrin based on the feeding amount is added and spray-dried to obtain the spray-dried powder.

[0059] Comparative Example 2

[0060] The difference between this comparative example and Example 1 lies in that the raw materials of the composition are composed of the following components: 120 parts of ginseng, 300 parts of astragalus membranaceus, 150 parts of notopterygium incisum, 150 parts of angelica pubescens, 150 parts of bupleurum chinense, 150 parts of peucedanum praeruptorum, 120 parts of ginger, 85 parts of mentha haplocalyx, 150 parts of forsythia suspensa, 120 parts of honeysuckle, 120 parts of platycodon grandiflorum, 120 parts of licorice, 150 parts of ligusticum wallichii, and 120 parts of fructus aurantii.

[0061] The preparation method is as follows:

[0062] The above 14 herbs are added with 10 times the amount of water, decocted twice, each time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.02 - 1.10. Then, 5% of dextrin based on the feeding amount is added and spray-dried to obtain the spray-dried powder.

[0063] Comparative Example 3

[0064] For the composition of this comparative example, by weight, the raw materials of the composition are composed of the following components: 120 parts of ginseng, 300 parts of astragalus membranaceus, 150 parts of notopterygium incisum, 150 parts of angelica pubescens, 150 parts of bupleurum chinense, 150 parts of peucedanum praeruptorum, 120 parts of ledebouriella seseloides, 120 parts of cicada slough, 150 parts of forsythia suspensa, 85 parts of dryopteris crassirhizoma, 120 parts of platycodon grandiflorum, 120 parts of licorice, 150 parts of ligusticum wallichii, and 120 parts of fructus aurantii.

[0065] The preparation method is as follows:

[0066] The above 14 herbs are added with 10 times the amount of water, decocted twice, each time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.02 - 1.10. Then, 5% of dextrin based on the feeding amount is added and spray-dried to obtain the spray-dried powder.

[0067] Comparative Example 4

[0068] For the composition of this comparative example, by weight, the raw materials of the composition are composed of the following components: 120 parts of ginseng, 300 parts of astragalus membranaceus, 150 parts of notopterygium incisum, 150 parts of angelica pubescens, 150 parts of bupleurum chinense, 150 parts of peucedanum praeruptorum, 120 parts of ledebouriella seseloides, 150 parts of forsythia suspensa, 205 parts of dryopteris crassirhizoma, 120 parts of platycodon grandiflorum, 120 parts of licorice, 150 parts of ligusticum wallichii, and 120 parts of fructus aurantii.

[0069] The preparation method is as follows:

[0070] The above 13 herbs are added with 10 times the amount of water and decocted twice, each time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.02 - 1.10. Then, 5% of dextrin based on the amount of the raw materials added is added for spray drying to obtain the spray-dried powder.

[0071] Comparative Example 5

[0072] For the composition of this comparative example, calculated by weight parts, the raw materials of the composition are composed of the following components: 120 parts of ginseng, 300 parts of astragalus membranaceus, 150 parts of notopterygium incisum, 150 parts of angelica pubescens, 150 parts of bupleurum chinense, 150 parts of peucedanum praeruptorum, 120 parts of ledebouriella seseloides, 205 parts of cicada slough, 150 parts of forsythia suspensa, 120 parts of platycodon grandiflorum, 120 parts of licorice, 150 parts of ligusticum wallichii, and 120 parts of aurantii fructus immaturus.

[0073] The preparation method is as follows:

[0074] The above 13 herbs are added with 10 times the amount of water and decocted twice, each time for 1 hour. The decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.02 - 1.10. Then, 5% of dextrin based on the amount of the raw materials added is added for spray drying to obtain the spray-dried powder.

[0075] Experiment 1. Clinical Efficacy

[0076] 1.1 Selection and Grouping of Subjects

[0077] 100 cases were outpatients in our hospital, all of whom met the diagnostic criteria for western medicine cold and the diagnostic criteria for exogenous diseases of the pattern of pathogenic heat invading the lung in traditional Chinese medicine. After informed consent, they were randomly divided into a treatment group and a control group, with 50 cases in each group. In the control group, there were 22 males and 28 females; the age range was 6 - 59 years old. In the treatment group, there were 23 males and 27 females; the age range was 4 - 53 years old. After statistical analysis of the gender and age of the two groups of patients, there were no statistically significant differences (P > 0.05).

[0078] 1.2 Diagnostic Criteria

[0079] The diagnostic criteria for western medicine cold refer to the "Guiding Principles for Clinical Research of New Chinese Medicines" (2002 edition) and relevant standards in western and traditional Chinese medicine textbooks.

[0080] (1) Clinical manifestations: mainly local symptoms, with or without obvious systemic symptoms;

[0081] (2) Local symptoms: sneezing, nasal congestion, runny nose, cough, sometimes cough and sore throat;

[0082] (3) Systemic symptoms: aversion to cold and fever, general discomfort, headache, limb soreness, etc.;

[0083] (4) The white blood cell count is normal or low.

[0084] The diagnostic criteria for traditional Chinese medicine syndrome differentiation refer to the standards in the "Guiding Principles for Clinical Research of New Chinese Medicines".

[0085] (1) Main symptoms: ① Severe fever; ② Slight aversion to wind; ③ Difficult sweating; ④ Dry throat or red, swollen and painful throat; ⑤ Nasal congestion and runny yellow turbid discharge;

[0086] (2) Secondary symptoms: ① Headache and body pain; ② Cough; ③ Thirst:

[0087] (3) Tongue and pulse: The tongue is pale red or has red edges and tip, the tongue coating is thin or light yellow, and the pulse is floating and rapid.

[0088] The diagnosis can be made if the patient has two of the main symptoms ①②, any one of ③④⑤, and any one of the secondary symptoms ①②③, as well as tongue and pulse.

[0089] 1.3 Drug treatment methods in each group

[0090] The 50 patients in the control group included in this study were treated with Ginseng Baidu Capsules (Healthy Pharmaceuticals China Co., Ltd.) on the basis of conventional Western medicine antiviral treatment, 3 capsules each time, 3 times a day; the 50 patients in the treatment group were treated with the granules prepared by the composition of Example 1 of the present invention, 20g each time, 3 times a day. The course of treatment was 3 days, and the clinical treatment effects of the two groups were compared and evaluated after the treatment.

[0091] 1.4 TCM symptom scoring method (different weights are given according to the main and secondary symptoms):

[0092] According to the severity of the symptoms, the main symptoms are scored as 0, 3, 6, 9; the secondary symptoms are scored as 0, 1, 2, 3; the tongue and pulse are not scored. For example:

[0093] (1) Fever (body temperature): ① Normal: 37.2℃ or below; ② Mild: 37.3-37.9℃; ③ Moderate: 38.0-38.5℃; ④ Severe: 38.6℃ or above.

[0094] (2) Throat pain: ① None; ② Occasional throat pain; ③ Between mild and severe symptoms; ④ Severe throat pain causing difficulty in swallowing.

[0095] (3) Nasal congestion: ① None; ② Only one side of the nasal cavity is blocked; ③ Both nasal cavities are blocked; ④ Both nasal cavities are blocked, and mouth breathing occurs, affecting sleep.

[0096] (4) Runny nose: ① None; ② Occasionally; ③ Between mild and severe symptoms; ④ Severe, affecting daily life.

[0097] (5) Cough: ① None; ② Occasional cough, no impact on daily life; ③ Between mild and severe symptoms; ④ Frequent coughing within 24 hours, affecting life and sleep.

[0098] 1.5 Criteria for determining efficacy

[0099] Evaluation criteria for the efficacy of traditional Chinese medicine for treating wind-heat syndrome of cold.

[0100] The curative effect index N = ((score before treatment - score after treatment) / score before treatment) × 100%

[0101] Cured: All symptoms disappear after treatment, and the curative effect index N of the syndrome score ≥ 95%;

[0102] Markedly effective: All symptoms are significantly alleviated after treatment, and the curative effect index N of the syndrome score ≥ 70% and < 95%;

[0103] Effective: All symptoms are somewhat alleviated after treatment, and the curative effect index N of the syndrome score ≥ 30% and < 70%;

[0104] Ineffective: All symptoms are not alleviated or are aggravated after treatment, and the curative effect index N of the syndrome score < 30%.

[0105] 1.6 Treatment results

[0106] (1) The comparison of the curative effects between the two groups is shown in Table 1.

[0107] Table 1 Evaluation of the time to the onset of antipyretic effect and the time to complete antipyretic effect in two groups

[0108]

[0109] There were statistically significant differences in the time to the onset of antipyretic effect and the time to complete antipyretic effect between groups (P < 0.05).

[0110] The time to the onset of antipyretic effect: The time from taking the medicine to a decrease in body temperature by 0.5°C or more;

[0111] The time to complete antipyretic effect: The body temperature drops below 37.3°C after taking the medicine and remains above for more than 24 hours.

[0112] (2) The evaluation results of the curative effects of individual symptoms are shown in Table 2.

[0113] Table 2 Evaluation results of the curative effects of individual symptoms

[0114]

[0115]

[0116] Note: There were statistically significant differences between groups in fever (P < 0.01), nasal congestion and runny nose (P < 0.05), and dry throat and sore throat (P < 0.05); there were no statistically significant differences between groups in headache and body pain, cough, and thirst.

[0117] Experiment 2. Pharmacodynamic experiments of antipyretic, analgesic, and anti-inflammatory effects

[0118] (I) Antipyretic effect

[0119] Selection of rabbits: Healthy rabbits (weighing about 1.5 kg) were placed in a breeding room at a room temperature of 20 - 25°C and a relative humidity of 40% - 60% for adaptive breeding for 3 days before being used in the experiment. The body temperature was measured once a day for 3 consecutive days, and rabbits with a body temperature between 38.6 - 39.5°C and a body temperature change of no more than 0.3°C were selected for the preparation of the fever model.

[0120] Grouping: 60 rabbits with qualified body temperature were evenly grouped according to the mean value of the basic body temperature of the experiment, and were divided into 10 dose groups including a blank control group, a model control group, Example 1 - 3 groups, and Comparative Example 1 - 5 groups, with 6 rabbits in each group.

[0121] Drug administration: The dry powder of the compositions prepared in Example 1 - 3 and Comparative Example 1 - 5 was made into aqueous solutions respectively, with a concentration of 5.6 g of crude drug / 5 ml. Each administration group was given the corresponding solution by gavage at 5.6 g of crude drug / kg / 5 ml once. The blank control group and the model control group were given distilled water by gavage under the same conditions. 1 hour after gavage, except for the blank control group, the other groups were injected with endotoxin at 250 ng / kg / ml through the marginal ear vein for model establishment, and the body temperature was measured at 1 h, 2 h, 3 h, and 4 h after model establishment respectively. The blank control group was injected with normal saline under the same conditions.

[0122] Statistical analysis: The difference between the body temperature at different time points after model establishment and the body temperature before model establishment was used as an index of body temperature change, and the results were statistically processed by the t - test for inter - group comparison.

[0123] The results are shown in Table 3.

[0124] Table 3

[0125]

[0126]

[0127] Note: Compared with the blank control group, #: P < 0.01; compared with the model control group, **: P < 0.01, *: P < 0.05.

[0128] The body temperature of the rabbits in the model control group showed a steady increase after intravenous injection of endotoxin, and there were extremely significant differences at each time point compared with the blank control group (P < 0.01); the body temperature of the rabbits in the Example groups began to rise slowly at 1 h, and there were significant differences at 2 h compared with the model control group (P < 0.01, P < 0.05); there were significant differences at 4 h for each administration group compared with the model control group (P < 0.05).

[0129] (2) Analgesic effect

[0130] Mouse screening: Fill the water bath tank with water so that the water surface touches the hot plate. Adjust the water temperature and control it at 55 ± 0.5 °C. The hot plate needs to be preheated for 10 minutes before the experiment. Place ICR mice (18 - 22 g, female) on the hot plate and record the time (seconds) from when the mice are placed on the hot plate until they lick their hind paws as the pain threshold of the mice. Any mice with a pain threshold less than 5 seconds, greater than 30 seconds, or those that jump are discarded.

[0131] Grouping: Select 108 mice with qualified pain thresholds (5 - 30 seconds), and randomly divide them into 9 groups according to body weight, namely the blank control group, Example 1 - 3 groups, and Comparative Example 1 - 5 groups, with 12 mice in each group.

[0132] Drug administration: Prepare the dry powder of the compositions prepared in Example 1 - 3 and Comparative Example 1 - 5 into aqueous solutions respectively, with a concentration of 16.5 g of crude drug / 20 ml. The Example 1 - 3 groups and the Comparative Example 1 - 5 groups are given the corresponding solutions by gavage at a dose of 16.5 g of crude drug / kg / 20 ml, and the blank control group is given an equal volume of distilled water by gavage. Measure the pain thresholds of the mice in each group 2 and 3 hours after gavage. If the mice still show no response after 60 seconds, their pain threshold is calculated as 60 seconds.

[0133] The results are shown in Table 4:

[0134] Table 4

[0135]

[0136]

[0137] Note: Compared with the blank control group, **: P < 0.01, *: P < 0.05; compared with Example 1 group, #: P < 0.05.

[0138] Compared with the blank control group, 2 and 3 hours after drug administration, the pain thresholds of the mice in each drug - administered group increased. There were extremely significant differences in each Example group at 2 hours (P < 0.01); there was a significant difference in Comparative Example 3 group (P < 0.05); compared with Example 1 group, there were significant differences in other Comparative Example groups (P < 0.05)

[0139] (III) Anti - inflammatory effect

[0140] Grouping: 90 ICR mice are randomly divided into 9 groups according to body weight, namely the blank control group, Example 1 - 3 groups, and Comparative Example 1 - 5 groups, with 10 mice in each group.

[0141] Administration: The dry powder of the compositions prepared in Examples 1-3 and Comparative Examples 1-5 was made into an aqueous solution with a concentration of 16.5 g of crude drug / 20 ml. The groups of Examples 1-3 and Comparative Examples 1-5 were given the corresponding solutions by gavage at 16.5 g of crude drug / kg / 20 ml, and the blank control group was given an equal volume of distilled water by gavage. 2 hours after gavage, 50 μl of croton oil mixed inflammatory agent (2% croton oil, prepared by adding 73% ether, 5% distilled water, and 20% absolute ethanol) was evenly applied to both sides of the right ear of each group of mice. 2 hours after inflammation induction, each group was gavaged with the corresponding drug again. 4 hours after inflammation induction, a punch with a diameter of 8 mm was used to cut and weigh the left and right ears, and the weight difference between the left and right ears was used as the swelling degree.

[0142] The results are shown in Table 5:

[0143] Table 5

[0144]

[0145]

[0146] Note: Compared with the blank control group, **: P < 0.01, *: P < 0.05.

[0147] Compared with the blank control group, the ear swelling degree of each administration group decreased, and there were statistical differences in the Example groups and Comparative Example 3 group (P < 0.01, P < 0.05).

[0148] The above-described embodiments only represent several implementation manners of the present invention, and the description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention should be subject to the appended claims.

Claims

1. A traditional Chinese medicine composition for treating viral cold, characterized in that, it is made from the following raw materials by weight: 50 - 250 parts of ginseng, 150 - 450 parts of astragalus root, 100 - 300 parts of notopterygium root, 100 - 300 parts of pubescent angelica root, 100 - 300 parts of bupleurum root, 100 - 300 parts of peucedanum root, 50 - 250 parts of ledebouriella root, 50 - 200 parts of cicada slough, 100 - 300 parts of forsythia fruit, 50 - 250 parts of dryopteris crassirhizoma, 100 - 300 parts of chuanxiong rhizome, 50 - 250 parts of immature bitter orange, 50 - 250 parts of platycodon root and 50 - 250 parts of licorice root; The mass ratio of ledebouriella root, cicada slough and dryopteris crassirhizoma is 1.2 - 2:1:1.2 - 2.

2. The composition according to claim 1, characterized in that, it is made from the following raw materials by weight: 70 - 200 parts of ginseng, 200 - 400 parts of astragalus root, 100 - 250 parts of notopterygium root, 100 - 250 parts of pubescent angelica root, 100 - 250 parts of bupleurum root, 100 - 250 parts of peucedanum root, 70 - 200 parts of ledebouriella root, 50 - 150 parts of cicada slough, 100 - 250 parts of forsythia fruit, 70 - 200 parts of dryopteris crassirhizoma, 100 - 250 parts of chuanxiong rhizome, 70 - 200 parts of immature bitter orange, 70 - 200 parts of platycodon root and 70 - 200 parts of licorice root.

3. The composition according to claim 1, characterized in that, it is made from the following raw materials by weight: 100 - 150 parts of ginseng, 250 - 350 parts of astragalus root, 100 - 200 parts of notopterygium root, 100 - 200 parts of pubescent angelica root, 100 - 200 parts of bupleurum root, 100 - 200 parts of peucedanum root, 100 - 150 parts of ledebouriella root, 50 - 100 parts of cicada slough, 100 - 200 parts of forsythia fruit, 100 - 150 parts of dryopteris crassirhizoma, 100 - 200 parts of chuanxiong rhizome, 100 - 150 parts of immature bitter orange, 100 - 150 parts of platycodon root and 100 - 150 parts of licorice root.

4. A preparation method of the composition according to any one of claims 1 - 3, characterized in that, it includes decocting all the raw materials with water to obtain the composition.

5. The preparation method according to claim 4, characterized in that, the preparation method includes adding 5 - 15 times the amount of water to all the raw materials, decocting for 1 - 3 times, each time for 0.5 - 1.5 hours, combining the decoction liquids, filtering, and concentrating the filtrate to a relative density of 1.02 - 1.10 to obtain the composition.

6. A pharmaceutical preparation for treating viral cold, characterized in that, the pharmaceutical preparation is made from the composition according to any one of claims 1 - 3 or the composition prepared by the preparation method according to any one of claims 4 - 5, and pharmaceutically acceptable excipients, and the dosage form of the pharmaceutical preparation is selected from solution, tablet, capsule, granule, powder, spray, liniment, gel or cream.

7. The pharmaceutical preparation according to claim 6, characterized in that, the pharmaceutical preparation is a granule, and the preparation method of the granule includes adding excipients to the composition prepared by the preparation method according to any one of claims 4 - 5 to make granules.

8. Use of the composition according to any one of claims 1-3, or the composition prepared by the preparation method according to any one of claims 4-5, or the pharmaceutical preparation according to any one of claims 6-7, in the preparation of a medicament for treating viral cold; the medicament can treat fever, nasal congestion and runny nose, and dryness and pain in the throat.

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