Traditional Chinese medicine composition for treating qi-deficiency cold as well as preparation and application of traditional Chinese medicine composition

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating cold due to qi deficiency, which is prepared from 15-20 parts of honeysuckle, 15-20 parts of divaricate saposhnikovia root, 15-20 parts of astragalus membranaceus, 15-20 parts of bighead atractylodes rhizome, 15-20 parts of radix pseudostellariae and 15-20 parts of reed rhizome. The invention further provides a traditional Chinese medicine compound preparation for treating qi-deficiency cold and application of the traditional Chinese medicine compound preparation.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating qi deficiency cold and a preparation and application thereof. BACKGROUND

[0002] Cold refers to the common cold, also known as acute rhinitis or upper respiratory tract infection, and is the most common acute upper respiratory tract infectious disease. Data at home and abroad shows that 30-50 year-old young adults can have 2-3 times of cold symptoms per year, and the younger the age, the more frequent the cold. Cold is defined as a short-term mild disease, and the symptoms mainly include sore throat, sneezing, headache, general malaise, chills, fever, runny nose, nasal congestion and cough, etc. Among them, nasal congestion and runny nose are the most prominent symptoms that make patients feel uncomfortable. Symptoms are rapidly relieved after 3-5 days, but the duration of symptoms such as runny nose, nasal congestion and cough is relatively long, and they can still exist after 1 week of onset. Generally speaking, if there is no decrease in immunity or combined disease, the symptoms of cold usually reach a peak in 2-3 days, gradually subside after 5 days, and the duration is usually <10 days, but some symptoms can last for more than 3 weeks. The viruses that cause common cold mainly include rhinovirus, coxsackievirus, coronavirus, parainfluenza virus, respiratory syncytial virus, etc. Cold can be recurrent, so protecting susceptible populations is an important part, and therefore, it is of great significance to strengthen the prevention and treatment of patients with qi deficiency cold who are prone to cold due to low immunity.

[0003] At present, the main performance of cold clinical syndrome, western medicine to ease the symptoms of cold and other symptomatic treatment as the main treatment goal: (1) for cold fever, sore throat and general malaise and other symptoms: often used antipyretic analgesic drugs by reducing the synthesis of prostaglandins, the body temperature regulation center produces peripheral vasodilation, sweating and heat and block the pain nerve endings, play anti-inflammatory, antipyretic, analgesic effect, representative drugs such as acetaminophen, ibuprofen. But acetaminophen overuse risk of liver damage, ibuprofen often gastrointestinal adverse reactions, nausea, vomiting, indigestion and other gastrointestinal symptoms. (2) for nasal congestion, runny nose and other common cold respiratory symptoms: often used to reduce the congestion agent drugs, by shrinking the patient's swollen nasal mucosa and nasal sinus blood vessels, ease the common cold caused by nasopharyngeal discomfort, such as pseudoephedrine, selective contraction of the upper respiratory tract blood vessels, but other vasoconstrictor drugs such as ephedrine and other like overuse, can lead to elevated blood pressure and other side effects. (3) for adult common cold, immune function in adults, if highly suspected or diagnosed respiratory syncytial virus infection, recommended with aerosol inhalation ribavirin antiviral therapy. (4) recommended zinc acetate and zinc gluconate lozenge treatment of adult common cold, should be within 24 h of the onset of symptoms, divided into oral, zinc dose ≥ 75 mg / d (but not more than 100 mg / d), against the recommended zinc-containing nasal spray topical application. (5) can be used to prevent and treat common colds vitamin C, vitamin D. For the “repeated susceptibility” of the cold patients who have not reached the clinical diagnosis of immunodeficiency disease (Immunodeficiency Disease, IDD), the common cold patients cannot be treated according to the IDD treatment method. The symptomatic treatment cannot change the nature and is easy to lead to repeated colds. Under the guidance of the overall concept and syndrome differentiation and treatment of traditional Chinese medicine, the treatment of cold due to deficiency of qi has definite effect, safety and feasibility, and has less side effects. It is the advantage of traditional Chinese medicine and has a good prospect.

[0004] Traditional Chinese medicine believes that common cold belongs to the category of exogenous disease in traditional Chinese medicine. The name of cold was first seen in Yang Shiyin's “Ren Zhai Zhi Zhi Fang” in the Song Dynasty. Cold disease is mainly caused by exogenous pathogens, and the disease is located in the lung and defense. Whether the invasion of exogenous pathogens causes the disease depends on the strength of the defense. The constitution plays an important role in the onset and pathogenesis of cold. If the constitution is weak, the spleen and lung are deficient, and the defensive system is not firm. If you are not careful, you are easy to be affected by evil. If the yang qi is deficient, the evil is easy to be affected by cold, and the evil is easy to be affected by cold. If the yang qi is deficient, the evil is easy to be affected by cold, and the evil is easy to be affected by cold. In addition, some patients have long-term repeated diseases, and the normal qi is injured, or the old and weak, the normal qi is insufficient, and the external defense is not firm, which is easy to be affected by evil and make the disease recur and the course of the disease longer.

[0005] Although the commonly used Chinese patent medicines such as Ganmaoqingre Granules and Yinqiejiedu Granules can play the effects of dispelling wind, dispelling cold and clearing heat on the external symptoms of cold, they are limited to expelling external pathogenic factors and difficult to touch the basic pathogenesis of deficiency of the spleen and lung in patients with cold due to deficiency of qi, and thus cannot improve the physical basis of unstable defensive qi and easy re-invasion of pathogenic factors. Although Shensu Pill takes into account tonifying qi and relieving the exterior, it is not targeted enough for the possible wind-heat or cold-stagnation-heat in the early stage of cold. Although Yupingfeng Bagged Tea and Buzhongyiqi Granules are mainly for tonifying, they can strengthen the healthy qi but lack the effect of expelling pathogenic factors, and thus if used recklessly in the acute stage of cold, they can cause the pathogenic factors to stay in the body and thus aggravate the disease or cause complications such as bronchitis and pneumonia. Therefore, in view of the characteristics of cold due to deficiency of qi with deficiency in origin and excess in superficiality, it is urgent to develop a Chinese medicine preparation which can tonify qi and consolidate the exterior to tonify the spleen and lung and strengthen the defensive function, and dispel wind and clear heat to expel superficial pathogenic factors and take into account the mixed cold and heat in the early stage of cold, so as to fill the gap in the treatment of cold due to deficiency of qi with Chinese patent medicines and provide more accurate and appropriate treatment options for patients. SUMMARY

[0006] The purpose of the present application is to provide a Chinese medicine composition for treating cold due to deficiency of qi and its preparation and application.

[0007] The first aspect of the present application is to provide a Chinese medicine composition for treating cold due to deficiency of qi, which is made of raw medicinal materials in the following proportions: honeysuckle 15-20 parts, wind-preventing herb 15-20 parts, radix astragali 15-20 parts, atractylodes 15-20 parts, radix pseudostellariae 15-20 parts, and rhizoma phragmitis 15-20 parts.

[0008] In a preferred embodiment, the Chinese medicine composition is made of raw medicinal materials in the following proportions: honeysuckle 16.7-18 parts, wind-preventing herb 16.7-18 parts, radix astragali 16.7-18 parts, atractylodes 16.7-18 parts, radix pseudostellariae 16.7-18 parts, and rhizoma phragmitis 16.7-18 parts.

[0009] In another preferred embodiment, the Chinese medicine composition is made of raw medicinal materials in the following proportions: honeysuckle 16.7 parts, wind-preventing herb 16.7 parts, radix astragali 16.7 parts, atractylodes 16.7 parts, radix pseudostellariae 16.7 parts, and rhizoma phragmitis 16.7 parts.

[0010] In another preferred embodiment, the Chinese medicine composition is made of raw medicinal materials in the following proportions: honeysuckle 15 parts, wind-preventing herb 15 parts, radix astragali 15 parts, atractylodes 15 parts, radix pseudostellariae 15 parts, and rhizoma phragmitis 15 parts.

[0011] In another preferred embodiment, the Chinese medicine composition is made of raw medicinal materials in the following proportions: honeysuckle 20 parts, wind-preventing herb 20 parts, radix astragali 20 parts, atractylodes 20 parts, radix pseudostellariae 20 parts, and rhizoma phragmitis 20 parts.

[0012] In another preferred embodiment, the traditional Chinese medicine composition is prepared from the following raw medicinal materials by weight: honeysuckle 18 parts, siler 18 parts, milkvetch 18 parts, atractylodes 15 parts, radix pseudostellariae 15 parts, and rhizome 15 parts.

[0013] In another preferred embodiment, the traditional Chinese medicine composition is prepared from the following raw medicinal materials by weight: honeysuckle 20 parts, siler 20 parts, milkvetch 20 parts, atractylodes 15 parts, radix pseudostellariae 15 parts, and rhizome 15 parts.

[0014] The second aspect of the present application is to provide a traditional Chinese medicine compound preparation for treating qi deficiency cold, wherein the traditional Chinese medicine compound preparation is a tea preparation, a decoction, a granule, a capsule, a tablet, or an oral liquid with the above traditional Chinese medicine composition as an active ingredient.

[0015] In a preferred embodiment, the traditional Chinese medicine compound preparation is a tea preparation or a granule.

[0016] The present application also provides the use of the above traditional Chinese medicine composition in the preparation of a medicine for treating qi deficiency cold.

[0017] The details of each aspect of the present application will be described in the subsequent chapters. The features, objects and advantages of the present application will be more apparent through the following description and claims. DETAILED DESCRIPTION

[0018] Based on the clinical experience in treating deficiency cold, the present inventors added honeysuckle, rhizome, and radix pseudostellariae to the Yupingfeng tea to obtain the prescription of the traditional Chinese medicine composition of the present application, i.e., honeysuckle, siler, milkvetch, atractylodes, radix pseudostellariae, and rhizome.

[0019] The medicinal material raw materials used by the present inventors in the process of preparing the pharmaceutical composition of the present application have the following sources: honeysuckle, Lonicera japonica Thunb. of Caprifoliaceae Lonicerae Flos or with the initial opening of the flower. Windproof, Umbelliferae Saposhnikovia divaricata (Turcz.) Schischk. The dried root of the plant. Huangqi, Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of Leguminosae The dried root of the plant. Baizhu, the dried rhizome of Atractylodes macrocephala Koidz. of Compositae. Taizishen, the dried tuber of Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm. of Caryophyllaceae. Lugen, fresh or dried rhizome of Phragmites communis Trin. of Gramineae.

[0020] Based on years of clinical experience, the present inventors believe that the lung governs the skin and hair and is in charge of respiration. If the lung qi is insufficient, the external pathogens are easy to invade from the skin or the mouth and nose. The spleen is the source of qi and blood, and if the spleen qi is deficient, the qi and blood production is insufficient, and the lung qi cannot be nourished, leading to more deficiency of the lung defensive qi, forming a vicious cycle. Deficiency of cold is mainly caused by exogenous wind, but due to the deficiency of the spleen and lung and the weakness of the external defense, the pathogenic factors are easy to stay and difficult to be dispelled, and the body is also unable to expel the external pathogens, so the disease course is often prolonged and repeated.

[0021] The traditional Chinese medicine composition of the present application has six ingredients: honeysuckle, wind-protecting herb, astragalus, atractylodes, radix pseudostellariae and reed root. The honeysuckle in the present application is pungent and cooling, and can clear heat and detoxify. It can also treat wind-heat or cold stagnation with heat. The wind-protecting herb is pungent and dispersing, and can dispel wind and relieve the exterior. It is a mild herb, and is used in combination with the honeysuckle. The two herbs are used together to treat the main symptoms of cold with low fever and aversion to cold. The astragalus is used to tonify qi and strengthen the exterior. The atractylodes is warm and can tonify qi, strengthen the spleen and the exterior. The radix pseudostellariae is mild and can tonify qi and produce saliva. It can tonify qi without causing stagnation of evil. The reed root is sweet and cold, and can clear heat from the lung and stomach. It can also treat the symptoms of wind-heat damaging the body fluid. It can also help to eliminate evil by promoting urination and downward transmission of heat. The whole prescription can both tonify and eliminate evil. The astragalus and the atractylodes can tonify the lung and the spleen. The radix pseudostellariae can tonify qi and produce saliva. The prescription can avoid damaging the yin. The wind-protecting herb is warm but not dry. It is combined with the honeysuckle and the reed root to form a combination of cold and warm herbs. The combination can eliminate evil from the exterior. The prescription can tonify without stagnation. The radix pseudostellariae and the reed root can produce saliva and moisten dryness. The reed root can promote urination and downward transmission of heat. The whole prescription can tonify qi and strengthen the exterior, eliminate wind and clear heat. It can be used to treat common cold (qi deficiency) with symptoms of aversion to wind and cold, fatigue, sneezing, runny nose, cough, low fever, pale tongue, white coating and weak pulse.

[0022] The pharmaceutical composition of the present application can be prepared by conventional methods in the art, for example: (1) six ingredients such as honeysuckle are broken into powder with a broken screen plate with a hole diameter of 2 mm. After breaking, sterilization by irradiation is performed. The electron beam irradiation dose of the honeysuckle, reed root, astragalus and atractylodes powder is 5-10 KGy. The electron beam irradiation dose of the radix pseudostellariae and the wind-protecting herb powder is 10-20 KGy. After sterilization, all the powders are poured into a mixing machine and run at a speed of 10-20 r / min for 30-60 min. After mixing, tea leaf filter paper is used for packaging, and a bagged tea is obtained.

[0023] The traditional Chinese medicine composition of the present application can tonify qi and strengthen the exterior, eliminate wind and clear heat. It has a definite effect, is convenient to use, has small side effects, is low in cost, is convenient to carry, can fill the blank in the treatment of common cold (qi deficiency) in Chinese patent medicines, and can provide a new convenient and fast choice for patients.

[0024] The traditional Chinese medicine composition in the present application has the following advantages compared with the Yupingfeng tea bag in treating qi deficiency cold: for the typical symptoms of qi deficiency cold patients such as aversion to wind and cold, low fever, nasal congestion, runny nose, cough and fatigue, while retaining the effects of tonifying qi and consolidating the exterior of Huangqi, Baizhu and Fangfeng, the composition is innovatively combined with Jinyinhua, Lugen to clear heat and remove pathogenic factors, and Taizishen to tonify both qi and yin, forming a complex mechanism of "tonifying and clearing, and clearing and removing". The composition can not only significantly improve the fever symptoms (the antipyretic effect is better than that of the Yupingfeng tea bag, P≤0.05), effectively relieve cough (reduce the frequency of cough by 38.2%), but also enhance the phagocytic function of mononuclear macrophages (the phagocytic index is increased by 10.5% compared with the Yupingfeng tea bag, P≤0.05), and regulate immune function. The composition not only makes up for the deficiency of the Yupingfeng tea bag in simple warming and tonifying which is easy to cause dryness and heat, but also overcomes the defect of traditional exterior-releasing drugs in ignoring the deficiency of the body, realizes the synergistic effect of strengthening the body resistance and removing pathogenic factors, and has better clinical applicability and symptom targeting for patients with qi deficiency cold with repeated upper respiratory tract infection and prolonged course.

[0025] The present application will be further described in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present application but not to limit the scope of the present application. The experimental methods in the following examples are not specified, which are usually carried out according to the conventional conditions or the conditions recommended by the manufacturers. Unless otherwise specified, all percentages, ratios, proportions, or parts are by weight.

[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art. In addition, any method and material similar or equivalent to those described herein can be used in the present application. The preferred methods and materials described herein are only for demonstration.

[0027] The above features mentioned in the present application, or the features mentioned in the examples, can be combined arbitrarily. All the features disclosed in the present patent specification can be used with any combination, and each feature disclosed in the specification can be replaced by any alternative feature which can provide the same, equivalent or similar purpose. Therefore, unless otherwise specified, the disclosed features are only general examples of equivalent or similar features.

[0028] Example 1

[0029] Take Jinyinhua 16.7g, Fangfeng 16.7g, Huangqi 16.7g, Baizhu 16.7g, Taizishen 16.7g, and Lugen 16.7g.

[0030] The preparation method is as follows: the six medicinal decoction pieces of honeysuckle and the like are broken into medicinal powder, and the broken screen plate aperture is 2 mm. After breaking, sterilization by irradiation is carried out, and the electron beam irradiation dose of the medicinal powder of honeysuckle, siberian ginseng, Chinese milkvetch and atractylodes is 6 KGy; the electron beam irradiation dose of the medicinal powder of common ginseng and siler herb is 15 KGy. After sterilization, all the medicinal powder is poured into a mixing machine, runs for 40 min at a rotating speed of 15 r / min, is mixed uniformly, is connected out, is packed with tea leaf filter paper, is sealed, and bagged tea is obtained.

[0031] The administration method is as follows: after being soaked in boiling water for 10 min, it is drunk.

[0032] Example Two

[0033] Take honeysuckle 15 g, siler herb 15 g, Chinese milkvetch 15 g, atractylodes 15 g, common ginseng 15 g, and siberian ginseng 15 g.

[0034] The preparation method and the administration method are the same as in example one.

[0035] Example Three

[0036] Take honeysuckle 20 g, siler herb 20 g, Chinese milkvetch 20 g, atractylodes 20 g, common ginseng 20 g, and siberian ginseng 20 g.

[0037] The preparation method and the administration method are the same as in example one.

[0038] Example Four

[0039] Take honeysuckle 18 g, siler herb 18 g, Chinese milkvetch 18 g, atractylodes 15 g, common ginseng 15 g, and siberian ginseng 15 g.

[0040] The preparation method and the administration method are the same as in example one.

[0041] Example Five

[0042] Take honeysuckle 20 g, siler herb 20 g, Chinese milkvetch 20 g, atractylodes 15 g, common ginseng 15 g, and siberian ginseng 15 g.

[0043] The preparation method and the administration method are the same as in example one.

[0044] Example Six

[0045] Take honeysuckle 16.7 g, siler herb 16.7 g, Chinese milkvetch 16.7 g, atractylodes 16.7 g, common ginseng 16.7 g, and siberian ginseng 16.7 g.

[0046] The preparation method is as follows: the six medicinal decoction pieces of honeysuckle and the like are broken into medicinal powder, and the broken screen plate aperture is 2 mm. After breaking, sterilization by irradiation is carried out, and the electron beam irradiation dose of the medicinal powder of honeysuckle, siberian ginseng, Chinese milkvetch and atractylodes is 6 KGy; the electron beam irradiation dose of the medicinal powder of common ginseng and siler herb is 15 KGy. After sterilization, all the medicinal powder is poured into a mixing machine, runs for 40 min at a rotating speed of 15 r / min, is mixed uniformly, is connected out, is packed with tea leaf filter paper, is sealed, and bagged tea is obtained.

[0047] The administration method is as follows: the granules are dissolved in water and administered orally.

[0048] Example Seven

[0049] Take honeysuckle 15g, wind-preventing 15g, astragalus 15g, atractylodes 15g, radix pseudostellariae 15g, and reed root 15g.

[0050] The preparation method and administration method are the same as in Example Six.

[0051] Example Eight

[0052] Take honeysuckle 20g, wind-preventing 20g, astragalus 20g, atractylodes 20g, radix pseudostellariae 20g, and reed root 20g.

[0053] The preparation method and administration method are the same as in Example Six.

[0054] Example Nine

[0055] Take honeysuckle 18g, wind-preventing 18g, astragalus 18g, atractylodes 15g, radix pseudostellariae 15g, and reed root 15g.

[0056] The preparation method and administration method are the same as in Example Six.

[0057] Example Ten

[0058] Take honeysuckle 20g, wind-preventing 20g, astragalus 20g, atractylodes 15g, radix pseudostellariae 15g, and reed root 15g.

[0059] The preparation method and administration method are the same as in Example Six.

[0060] Example Eleven Animal Test of Traditional Chinese Medicine Composition for Treating Deficiency Cold

[0061] 1. Test Study on Anti-pyretic Effect on Rats

[0062] Experimental Animals: SD rats

[0063] Experimental Drug: The traditional Chinese medicine composition is prepared according to Example Six, ground through an 80-mesh sieve, and made into dry paste powder without adding excipients.

[0064] Experimental method: The quarantine observation qualified and the eliminated body temperature fluctuation too large SD rats were randomly divided into 3 groups, namely normal control group, model control group, traditional Chinese medicine composition group (0.95g / kg, about equivalent to adult clinical daily use amount 1 times) 10 in each group, half male and half female. The above multiples are converted according to the body weight-surface area equivalent dose conversion method. The traditional Chinese medicine composition group is given traditional Chinese medicine composition, and the rest of the groups are given ultrapure water. The dosages are all 10mL / kg, once a day, continuously for 3 days, 1 hour after the third day of administration, except for the blank group, the rest of the groups are intraperitoneally injected with LPS solution (20μg / kg, 1mL / kg), and the body temperature is measured once before modeling and once every 1 hour after modeling, a total of 6 times.

[0065] Statistical method: SPSS21.0 for windows statistical software is used for statistical analysis. For measurement data, one-way classification ANOVA (one-way-classification ANOVA) of single factor ANOVA is used, and t test is used for pairwise comparison. P<0.05 is used as the evaluation standard of statistical difference. For count data, rate and constituent ratio are used, and x 2 test is used. P≤0.05 is used as the evaluation standard of statistical difference.

[0066] Experimental results: As shown in Table 1, (1) under the conditions of this test, the body temperature of the model rats increased significantly 1, 2, 3 and 4 hours after intraperitoneal injection of LPS, and the body temperature decreased 5 and 6 hours after intraperitoneal injection of LPS. It shows that the rat fever model is successfully constructed. (2) Compared with the model control group, after 3 days of prophylactic administration, the traditional Chinese medicine composition group can significantly inhibit the body temperature rise of the fever rat model 2, 3 and 4 hours after administration (P≤0.01 or P≤0.05), which shows that the traditional Chinese medicine composition of the application has obvious antipyretic effect.

[0067] In summary, the traditional Chinese medicine composition of the application has obvious down-regulation effect on the body temperature rise of rats caused by LPS 2, 3 and 4 hours after prophylactic administration, which shows that the traditional Chinese medicine composition of the application has antipyretic effect.

[0068] Table 1 LPS injection 1-6 hours body temperature results of rats in each group (n=10)

[0069]

[0070] Note: compared with the normal control group, * indicates P≤0.05, and ** indicates P≤0.01; compared with the model control group, # indicates P≤0.05, and ## indicates P≤0.01.

[0071] 2Experimental study on the influence on cough guinea pig model

[0072] Experimental animals: Hartley guinea pigs

[0073] Experimental drug: The traditional Chinese medicine composition is prepared according to Embodiment Six, is pulverized through an 80-mesh screen, is not added with excipients, is made into a dry paste powder, and is obtained.

[0074] Experimental method: The Hartley guinea pigs that pass quarantine observation are subjected to citric acid-induced cough screening, are randomly divided into three groups, namely, a normal control group, a model control group, and a traditional Chinese medicine composition group (0.82 g / kg, about equivalent to 1 times of a daily clinical dosage of an adult), 10 guinea pigs in each group, and half of them are male and half of them are female. The above multiples are all converted according to the body weight-body surface area equivalent dose conversion method. The traditional Chinese medicine composition group is given the traditional Chinese medicine composition, and the remaining groups are given ultrapure water. The dosages are all 10 mL / kg, and the guinea pigs are given drugs once a day, and the drug administration is continuously performed for 3 days. One hour after the last drug administration, the guinea pigs are placed in a whole-body atomization exposure system, a 17.5% citric acid solution is sprayed into the guinea pigs at a speed of 0.2 mL / min, the spraying is performed for 6 min, and the cough latency period and the cough frequency within 6 min of the guinea pigs are observed and recorded.

[0075] Statistical method: The same as the "antipyretic effect test research on rats" in this embodiment.

[0076] Experimental results: As shown in Table 2, (1) under the conditions of this test, the model guinea pigs appear severe cough, panting and salivation symptoms after being sprayed with a 17.5% citric acid solution. It is shown that the guinea pig cough model of this test is successfully constructed. (2) compared with the model control group, the traditional Chinese medicine composition group can significantly prolong the cough latency period of the guinea pigs and significantly reduce the cough frequency (P≤0.01) after being given drugs for 3 days, and has obvious antitussive effect.

[0077] In summary, the traditional Chinese medicine composition of the present application has obvious remission effect on the cough symptoms of guinea pigs caused by a 17.5% citric acid solution after being given drugs for 3 days, and it is shown that the traditional Chinese medicine composition of the present application has antitussive effect.

[0078] Table 2: Results of citric acid-induced cough latency period and cough frequency of guinea pigs , n=10

[0079]

[0080] Note: Compared with the model control group, * represents P≤0.05, and ** represents P≤0.01.

[0081] 3. Test research on mouse monocyte-macrophage function determination

[0082] Experimental animals: ICR mice

[0083] Experimental drug: The traditional Chinese medicine composition was prepared according to Example Six, crushed through an 80-mesh sieve, and then made into a dry paste powder without excipients.

[0084] Experimental method: The quarantine-observed qualified ICR mice were randomly divided into two groups, i.e. a negative control group and a traditional Chinese medicine composition group (1.37 g / kg, about equivalent to 1 of the adult clinical daily proposed dose), 10 in each group, half male and half female. The above multiples were all converted according to the body weight-body surface area equivalent dose conversion method. The traditional Chinese medicine composition group was given the traditional Chinese medicine composition, and the negative control group was given ultrapure water. The dosages were both 20 mL / kg, once a day, and the administration was continuously performed for 7 days. Two hours after the last administration, 4-fold diluted Indian ink (10 mL / kg) was injected into the tail vein of each mouse according to the body weight, and the timing was started immediately after the injection of the ink. Two and 10 minutes after the injection of the ink, blood was taken for the detection of the phagocytic index.

[0085] Statistical method: The same as the "antipyretic effect test research on rats" under Example Eleven.

[0086] Experimental results: As shown in Table 3, compared with the negative control group, the traditional Chinese medicine composition group could significantly increase the phagocytic index of the mice after 7 days of preventive administration, indicating that the drug could enhance the phagocytic function of mononuclear macrophages and accelerate the clearance rate of carbon particles (P≤0.01). It is shown that the traditional Chinese medicine composition of the present application has the efficacy of improving the innate immune function.

[0087] In summary, under the conditions of the present test, the traditional Chinese medicine composition of the present application can accelerate the clearance of carbon particles in the blood, enhance the phagocytic ability of mononuclear macrophages of mice, and improve the innate immune function.

[0088] Table 3 Results of carbon clearance of mononuclear macrophages of mice , n=10

[0089]

[0090] Note: Compared with the model control group, * indicates P≤0.05, and ** indicates P≤0.01.

[0091] Example Twelve Comparative study of traditional Chinese medicine composition and literature formula

[0092] Experimental drug: The traditional Chinese medicine composition was prepared according to Example Eleven.

[0093] Literature formula: Yupingfeng bagged tea (Huangqi 1000 g, Fangfeng 333 g, Baizhu (fried) 333 g) was prepared according to the method disclosed in the literature (State Pharmacopoeia Commission. Chinese Pharmacopoeia; Part I [M]. Beijing: China Medical Science and Technology Press, 2020:783.).

[0094] 1 Comparative study of antipyretic effect test on rats

[0095] Experimental animals: SD rats

[0096] Experimental method: The quarantine observation qualified and removed the body temperature fluctuation of SD rats was randomly divided into 4 groups, namely normal control group, model control group, traditional Chinese medicine composition group (0.95g / kg, about equivalent to 1 times of the adult clinical daily proposed dose), literature recipe group (0.81g / kg, about equivalent to 1 times of the adult clinical daily proposed dose), 10 in each group, half male and half female. The above multiples are converted according to the body weight-surface area equivalent dose conversion method. The traditional Chinese medicine composition group and the literature recipe group are respectively given corresponding drugs by gavage, and the rest of each group is given ultrapure water. The volume of each group is 10mL / kg, once a day, for 3 consecutive days, 1 hour after the third day of administration, except for the blank group, the rest of each group is injected with LPS solution (20μg / kg, 1mL / kg) intraperitoneally, and the body temperature is measured once before modeling and once every 1 hour after modeling, a total of 6 times.

[0097] Statistical method: same as example eleven.

[0098] Experimental results: as shown in table 4. Compared with the model control group, after 3 days of preventive administration, the literature recipe group can significantly inhibit the body temperature rise of the fever rat model at 3 and 4 hours after administration (P≤0.05); the traditional Chinese medicine composition of the application can significantly inhibit the body temperature rise of the fever rat model at 2, 3 and 4 hours after administration (P≤0.01 or P≤0.05). Compared with the literature recipe group, the traditional Chinese medicine composition of the application can significantly inhibit the body temperature rise of the fever rat model at 2 and 3 hours after administration, which is significantly better than the literature recipe group (P≤0.01 or P≤0.05), indicating that the antipyretic effect of the traditional Chinese medicine composition of the application is better than that of the literature recipe.

[0099] Table 4: Body temperature of rats in each group after LPS injection (1-6 hours) , n=10)

[0100]

[0101] Note: compared with the normal control group, * indicates p≤0.05, ** indicates p≤0.01; compared with the model control group, # indicates p≤0.05, ## indicates p≤0.01; compared with the literature recipe group, && indicates P≤0.01, & indicates P≤0.05.

[0102] 2. Comparison of the effects of the traditional Chinese medicine composition on the cough guinea pig model

[0103] Experimental animals: Hartley guinea pigs

[0104] Experimental method: The Hartley guinea pigs that passed quarantine observation were screened for citric acid-induced cough. After screening, they were randomly divided into 4 groups, namely, normal control group, model control group, traditional Chinese medicine composition group (0.82 g / kg, about equivalent to 1 times of the adult clinical daily dosage), and literature formula group (0.70 g / kg, about equivalent to 1 times of the adult clinical daily dosage), with 10 in each group and half male and half female. The above multiples were converted according to the body weight-body surface area equivalent dose conversion method. The traditional Chinese medicine composition group and the literature formula group were given corresponding drugs by gavage, and the other groups were given ultrapure water. The volume of drug administration in each group was 10 mL / kg, once a day, for 3 consecutive days. One hour after the last administration, the guinea pigs were placed in a whole-body aerosol exposure system and sprayed with a 17.5% citric acid solution at a rate of 0.2 mL / min. The spraying lasted for 6 min, and the latency period and the number of coughs within 6 min were observed and recorded.

[0105] Statistical method: Same as Example XI.

[0106] Experimental results: As shown in Table 5. Compared with the model control group, the traditional Chinese medicine composition group and the literature formula group could significantly prolong the cough latency period and significantly reduce the number of coughs (P≤0.01) after 3 days of preventive administration. There was no significant difference between the two groups.

[0107] Table 5 Results of citric acid-induced cough latency period and cough frequency in guinea pigs (n=10)

[0108]

[0109] Note: Compared with the model control group, # indicates P≤0.05, and ## indicates P≤0.01.

[0110] 3 Comparison of mouse monocyte-macrophage function determination test

[0111] Experimental animals: ICR mice

[0112] Experimental method: The ICR mice that passed quarantine observation were randomly divided into 2 groups, namely, negative control group, traditional Chinese medicine composition group (1.37 g / kg, about equivalent to 1 times of the adult clinical daily dosage), and literature formula group (1.17 g / kg, about equivalent to 1 times of the adult clinical daily dosage), with 10 in each group and half male and half female. The above multiples were converted according to the body weight-body surface area equivalent dose conversion method. The traditional Chinese medicine composition group and the literature formula group were given corresponding drugs by gavage, and the other groups were given ultrapure water. The volume of drug administration in each group was 20 mL / kg, once a day, for 7 consecutive days. Two hours after the last administration, the mice in each group were injected with 4 times diluted Indian ink (10 mL / kg) from the mouse tail vein according to their body weight. The timing started immediately after the ink injection. At 2 and 10 min after the ink injection, blood was taken for phagocytic index detection.

[0113] Results: As shown in Table 6. Compared with the negative control group, the traditional Chinese medicine composition group and the literature formula group can significantly increase the phagocytosis index of mice (P≤0.01 or P≤0.05) after 7 days of preventive administration. The traditional Chinese medicine composition group significantly improves the phagocytosis index of mice, which is significantly better than that of the literature formula group (P≤0.05), indicating that the traditional Chinese medicine composition of the application enhances the phagocytosis of mononuclear macrophages of mice and improves the effect of innate immune function better than the literature formula.

[0114] Table 6 Carbon clearance results of mouse mononuclear macrophages , n=10)

[0115]

[0116] Note: Compared with the negative control group, # represents P≤0.05, and ## represents P≤0.01; compared with the literature formula group, && represents P≤0.01, and & represents P≤0.05.

[0117] Example XIII Comparative study of traditional Chinese medicine composition and disassembled formula

[0118] Experimental drugs: The traditional Chinese medicine composition is prepared according to Example XI.

[0119] Disassembled formula 1: Drug composition: 16.7g of Fangfeng, 16.7g of Huangqi, 16.7g of Baishu, 16.7g of Taizishen, and 16.7g of Lugeng.

[0120] Disassembled formula 2: Drug composition: 16.7g of Jinyinhua, 16.7g of Huangqi, 16.7g of Baishu, 16.7g of Taizishen, and 16.7g of Lugeng.

[0121] Disassembled formula 3: Drug composition: 16.7g of Jinyinhua, 16.7g of Fangfeng, 16.7g of Baishu, 16.7g of Taizishen, and 16.7g of Lugeng.

[0122] Disassembled formula 4: Drug composition: 16.7g of Jinyinhua, 16.7g of Fangfeng, 16.7g of Huangqi, 16.7g of Taizishen, and 16.7g of Lugeng.

[0123] Disassembled formula 5: Drug composition: 16.7g of Jinyinhua, 16.7g of Fangfeng, 16.7g of Huangqi, 16.7g of Baishu, and 16.7g of Lugeng.

[0124] Disassembled formula 6: Drug composition: 16.7g of Jinyinhua, 16.7g of Fangfeng, 16.7g of Huangqi, 16.7g of Baishu, 16.7g of Taizishen, and 16.7g of Lugeng.

[0125] Preparation method of disassembled formula drug: prepared according to the method of Example XI.

[0126] 1 Comparison of antipyretic effect test on rats

[0127] Experimental animals: SD rats

[0128] Experimental method: The quarantine observation qualified and removed the body temperature fluctuation of SD rats was randomly divided into normal control group, model control group, traditional Chinese medicine composition group (0.95g / kg, about equivalent to the adult clinical daily dose of 1 times), each disassembled prescription group (disassembled prescription 1, disassembled prescription 2, disassembled prescription 3, disassembled prescription 4, disassembled prescription 5, disassembled prescription 6, 0.79g / kg, about equivalent to the adult clinical daily dose of 1 times), 10 in each group, half male and half female. The above multiples are converted according to the body weight-surface area equivalent dose conversion method. The traditional Chinese medicine composition group and each disassembled prescription group were given corresponding drugs by gavage, and the rest of the groups were given ultrapure water. The dose was 10mL / kg, once a day, for 3 consecutive days. One hour after the third day of administration, except for the blank group, which was injected with an equal volume of normal saline, the rest of the groups were injected with LPS solution (20μg / kg, 1mL / kg) intraperitoneally. Body temperature was measured once before modeling and once every hour after modeling, for a total of 6 times.

[0129] Statistical method: same as example eleven.

[0130] Experimental results: as shown in table 7. Compared with the model control group, disassembled prescription 1 could significantly inhibit the body temperature rise of the fever rat model 3 hours after administration (P≤0.05), disassembled prescription 2 could significantly inhibit the body temperature rise of the fever rat model 2 hours after administration (P≤0.05), disassembled prescription 3 and 4 could significantly inhibit the body temperature rise of the fever rat model 2 and 3 hours after administration (P≤0.05), disassembled prescription 5 and 6 could significantly inhibit the body temperature rise of the fever rat model 2, 3 and 4 hours after administration (P≤0.01 or P≤0.05), but any disassembled prescription with less than one herb had a treatment effect inferior to that of the traditional Chinese medicine composition.

[0131] Table 7 LPS injection 1-6 hours of rat body temperature results (n=10)

[0132]

[0133] Note: compared with the normal control group, * indicates P≤0.05, ** indicates P≤0.01; compared with the model control group, # indicates P≤0.05, ## indicates P≤0.01.

[0134] 2 Comparison of the effects of cough guinea pig models

[0135] Experimental animals: Hartley guinea pigs

[0136] Experimental method: The Hartley guinea pigs that passed quarantine observation were subjected to citric acid-induced cough screening, and after screening, they were randomly divided into 4 groups, namely normal control group, model control group, traditional Chinese medicine composition group (0.82 g / kg, about equivalent to 1 times of the adult clinical daily proposed dose), each disassembled prescription group (disassembled prescription 1, disassembled prescription 2, disassembled prescription 3, disassembled prescription 4, disassembled prescription 5, disassembled prescription 6, 0.68 g / kg, about equivalent to 1 times of the adult clinical daily proposed dose), 10 in each group, half male and half female. The above multiples are converted according to the body weight-body surface area equivalent dose conversion method. The traditional Chinese medicine composition group and each disassembled prescription group were given corresponding drugs by gavage, and the other groups were given ultrapure water. The dosages of each group were 10 mL / kg, once a day, for 3 consecutive days. One hour after the last administration, the guinea pigs were placed in a whole-body aerosol exposure system, and a citric acid solution with a volume fraction of 17.5% was sprayed at a speed of 0.2 mL / min for 6 min, and the cough latency and the number of coughs within 6 min were observed and recorded.

[0137] Statistical method: same as example eleven.

[0138] Experimental results: as shown in Table 8. Compared with the model control group, the traditional Chinese medicine composition group and each disassembled prescription group significantly prolonged the cough latency of guinea pigs and significantly reduced the number of coughs (P≤0.01 or P≤0.05); but any disassembled prescription with one less herb had a treatment effect inferior to that of the traditional Chinese medicine composition.

[0139] Table 8 Results of citric acid-induced cough latency and cough frequency in guinea pigs (n=10)

[0140]

[0141] Note: compared with the model control group, # represents P≤0.05, and ## represents P≤0.01.

[0142] 3 Comparison of mouse monocyte-macrophage function determination test

[0143] Experimental animals: ICR mice

[0144] Experimental method: The quarantine observation qualified ICR mice were randomly divided into 2 groups, namely negative control group, traditional Chinese medicine composition group (1.37 g / kg, about equivalent to 1 times of adult clinical daily proposed dose), each disassembled prescription group (disassembled prescription 1, disassembled prescription 2, disassembled prescription 3, disassembled prescription 4, disassembled prescription 5, disassembled prescription 6, 1.14 g / kg, about equivalent to 1 times of adult clinical daily proposed dose), 10 in each group, half male and half female. The above multiples are converted according to the body weight-body surface area equivalent dose conversion method. The traditional Chinese medicine composition group and each disassembled prescription group were given corresponding drugs by gavage, and the rest of each group was given ultrapure water. The dose was 20 mL / kg, once a day, for 7 days. Two hours after the last administration, each group of mice was injected with 4 times diluted Indian ink (10 mL / kg) from the mouse tail vein according to body weight. The ink was injected immediately, and the time was counted. 2, 10 min after the ink injection, the blood was taken to detect the phagocytic index.

[0145] Statistical method: same as example eleven.

[0146] Experimental results: as shown in Table 9. Compared with the negative control group, after 7 days of preventive administration, the traditional Chinese medicine composition group and the disassembled prescription group can significantly increase the phagocytic index of mice (P≤0.01 or P≤0.05). But the treatment effect of any disassembled prescription with one less medicine is not as good as that of the traditional Chinese medicine composition.

[0147] Table 9 Results of carbon clearance of mouse monocyte-macrophage (n=10)

[0148]

[0149] Note: compared with the negative control group, # represents P≤0.05, and ## represents P≤0.01.

[0150] Example fourteen Clinical comparison study of traditional Chinese medicine composition and yupingfeng tea bag

[0151] 1. Clinical data and methods

[0152] 1.1 Research object

[0153] All patients with common cold (qi deficiency syndrome) who visited the outpatient department of Shandong University of Traditional Chinese Medicine Affiliated Hospital (Shandong Provincial Hospital of Traditional Chinese Medicine).

[0154] 1.2 Diagnostic criteria

[0155] 1.2.1 Western diagnostic criteria

[0156] Refer to the diagnostic criteria for common cold in the 2023 Clinical Practice Guidelines for Diagnosis and Treatment of Adult Common Cold: acute onset of sore throat, nasal congestion, runny nose, sneezing, cough, chills, fever, headache, and muscle soreness, and prominent symptoms of nasal congestion and runny nose, suggesting a diagnosis of cold, and differentiating it from other diseases that can cause nasal congestion and runny nose.

[0157] 1.2.2 TCM syndrome differentiation criteria

[0158] Refer to the Guidelines for Diagnosis and Treatment of Common Cold in Traditional Chinese Medicine (2015 Edition) combined with the functional indications of the traditional Chinese medicine composition of the present application.

[0159] Main symptoms and tongue and pulse: nasal congestion, runny nose, fever, aversion to wind and cold, shortness of breath, fatigue, weakness, spontaneous sweating, aggravation with movement, aversion to wind and cold, and susceptibility to cold, pale tongue, and slow pulse.

[0160] Secondary symptoms: fine or weak pulse.

[0161] Diagnosis: (1) aversion to wind and cold or concurrent fever; (2) nasal congestion and runny nose; (3) weakness or fatigue or shortness of breath, aggravated by movement; (4) spontaneous sweating, aggravated by movement; (5) aversion to wind and cold or susceptibility to cold; (6) pale tongue or fine or slow or weak pulse. Possessing one of (1) and (2), plus two of (3), (4), (5), and (6).

[0162] 1.2.3 Inclusion criteria

[0163] Subjects must meet all the following criteria to be eligible for this study.

[0164] (1) Age 18-65 years (inclusive), gender not limited;

[0165] (2) Meet the Western medical diagnostic criteria for common cold;

[0166] (3) Meet the TCM syndrome differentiation criteria for common cold (qi deficiency syndrome);

[0167] (4) Disease duration (time from the onset of the first symptom) ≤ 48 hours at randomization;

[0168] (5) Informed consent and signature of informed consent form.

[0169] 1.2.4 Exclusion criteria

[0170] Subjects meeting any of the following criteria will not be included in this study.

[0171] (1) Combined with upper respiratory tract diseases such as influenza, acute herpetic pharyngitis, acute laryngitis, acute laryngospasm, acute epiglottitis, acute pharyngoconjunctival fever, acute bacterial sinusitis, purulent tonsillitis, and allergic rhinitis (onset period) that affect efficacy evaluation.

[0172] (2) Bronchitis, pneumonia, bronchial asthma (onset), bronchiectasis and other lower respiratory tract diseases that affect the evaluation of efficacy assessed by researchers.

[0173] (3) Axillary temperature > 38.5℃ at the time of screening.

[0174] (4) White blood cell count > 1.2 times the upper limit of the normal reference value, or neutrophil percentage > 75%, and the researchers consider it to be a bacterial infection.

[0175] (5) ALT, AST > 1.5 times the upper limit of the normal reference value; SCr > upper limit of normal reference value.

[0176] (6) Other drugs for treating cold or influenza have been used during this course of treatment, such as antiviral drugs, traditional Chinese medicine decoction or Chinese patent medicine, etc., and the researchers consider that they may affect the evaluation of efficacy.

[0177] (7) Combined with other serious primary diseases of important organs such as heart, liver, kidney, blood system, digestive system, endocrine system, etc., combined with neurological and mental disorders that cannot or do not want to cooperate.

[0178] (8) Known or suspected allergy to the components of the test drug, or allergic constitution.

[0179] (9) Pregnant or preparing to be pregnant women, lactating women.

[0180] (10) Combined with legally prescribed disabilities (blind, deaf, mute, intellectual disability, mental disorders, etc.).

[0181] (11) Suspected or confirmed history of alcohol or drug abuse.

[0182] (12) Participated in other intervention clinical trials within the past 3 months.

[0183] (13) Researchers consider that they are not suitable for participating in this clinical trial.

[0184] 1.2.5 Sample size estimation

[0185] Refer to the relevant formula in Medical Statistics, 6th edition. From the effectiveness point of view, according to the statistical requirements, the superiority test is adopted, double-sided test, α = 0.05, β = 0.2, the expected average efficiency is 0.90, and the number of cases is estimated to be 126. Considering the drop-out factor, this trial is 140 cases, and the control drug group and the test drug group are 70 cases respectively.

[0186] 1.3 Drug treatment

[0187] Control group: give the Jade Screen Wind bag bubble tea treatment, specifications: 3g / bag. After boiling water immersion 15 minutes drink. 2 bags at a time, 2-3 times a day.

[0188] Test drug group: give the invention of traditional Chinese medicine composition, 2 bags each time, 200 milliliters of boiling water immersion 10 minutes after drinking. 2 bags every 2 bags for 3 times. 3 times a day.

[0189] The traditional Chinese medicine composition is prepared according to the dosage of implementation one, produced by Suzhou Wusongjiang Pharmaceutical Co., Ltd. All medicinal materials are broken into medicinal powder respectively, and the broken screen plate aperture is 2 mm. After breaking, sterilization by irradiation is carried out, and the electron beam irradiation dose of honeysuckle, siberian ginseng, radix astragali and atractylodes lancea medicinal powder is 6 KGy; the electron beam irradiation dose of prince seng and wind medicinal powder is 15 KGy. After sterilization, all medicinal powder is poured into a mixing machine, which runs at a speed of 15 r / min for 40 min, is mixed uniformly, is connected out, is packed with tea filter paper, is sealed, and bagged tea is obtained. 2 bags each time, 200 milliliters of boiling water immersion 10 minutes after drinking. 2 bags every 2 bags for 3 times. 3 times a day.

[0190] Both groups are treated for 14 days.

[0191] 1.4 Observation index

[0192] (1) Disease cure time: after taking medicine, the median time of the subjects reaching the disease cure standard (body temperature returning to normal, all symptoms and signs (nasal congestion, runny nose, cough, sore throat) disappearing, and maintaining for more than 24h).

[0193] (2) Disease cure rate after taking medicine for 3 days, 5 days, 7 days and ending: after taking medicine for 3 days, 5 days, 7 days and ending, the proportion of subjects reaching the disease cure standard.

[0194] (3) Single symptom disappearance time: after taking medicine, the median time of each single symptom of the subjects reaching the disappearance standard (symptom score is 0, and maintaining for more than 24h).

[0195] (4) Body temperature recovery time after taking medicine: after taking medicine, the median time of the subjects' body temperature (axillary temperature) falling to ≤37.3℃ and maintaining for ≥24h after the first taking of medicine.

[0196] (5) Single symptom disappearance rate after taking medicine for 3 days, 5 days, 7 days and ending: after taking medicine, the proportion of subjects whose each single symptom reached the disappearance standard (symptom score was 0, and maintaining for more than 24h).

[0197] (6) Change value and change rate of TCM syndrome score after taking medicine ending compared with baseline.

[0198] (7) TCM syndrome effective rate after taking medicine ending: the proportion of subjects whose TCM syndrome score total score decreased by ≥50% compared with baseline after taking medicine ending.

[0199] (8) Complication (bronchitis, pneumonia, post-cold cough, etc.) incidence rate.

[0200] (9) Proportion and dosage of emergency drug use.

[0201] 2. Results

[0202] As shown in Table 10, a total of 140 cases of post-infection cough were collected, 70 cases in each of the test drug group and the control drug group, wherein the total effective rate of the test drug group was 88.57%, which was significantly improved compared with the control drug group, with a statistical difference (P≤0.05).

[0203] Table 10 Comparison of clinical curative effects of two groups / cases

[0204]

[0205] Aspects of the present application have been described above. However, it should be understood that equivalent changes and modifications can be made by those skilled in the art without departing from the spirit of the present application, and such changes and modifications also fall within the scope of the appended claims of the present application.

Claims

1. A Chinese medicine composition for treating qi deficiency cold, characterized in that: The medicine is prepared from the following raw materials in parts by weight: 15-20 parts of honeysuckle, 15-20 parts of siler, 15-20 parts of astragalus, 15-20 parts of atractylodes, 15-20 parts of pseudoginseng, and 15-20 parts of reed rhizome.

2. The Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 16.7-18 parts of honeysuckle, 16.7-18 parts of siler, 16.7-18 parts of astragalus, 16.7-18 parts of atractylodes, 16.7-18 parts of pseudoginseng, and 16.7-18 parts of reed rhizome.

3. The Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 16.7 parts of honeysuckle, 16.7 parts of siler, 16.7 parts of astragalus, 16.7 parts of atractylodes, 16.7 parts of pseudoginseng, and 16.7 parts of reed rhizome.

4. The Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15 parts of honeysuckle, 15 parts of siler, 15 parts of astragalus, 15 parts of atractylodes, 15 parts of pseudoginseng, and 15 parts of reed rhizome.

5. The Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20 parts of honeysuckle, 20 parts of siler, 20 parts of astragalus, 20 parts of atractylodes, 20 parts of pseudoginseng and 20 parts of reed rhizome.

6. The Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 18 parts of honeysuckle, 18 parts of siler, 18 parts of astragalus, 15 parts of atractylodes, 15 parts of pseudoginseng and 15 parts of reed rhizome.

7. The Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20 parts of honeysuckle, 20 parts of siler, 20 parts of astragalus, 15 parts of atractylodes, 15 parts of pseudoginseng and 15 parts of reed rhizome.

8. A Chinese medicinal compound preparation for treating qi deficiency cold, characterized in that: The Chinese medicine compound preparation is a tea, decoction, granule, capsule, tablet, or oral liquid with the Chinese medicine composition described in claim 1, 2, 3, 4, 5, 6, or 7 as the active ingredient.

9. The Chinese medicinal compound preparation according to claim 8, characterized in that: The traditional Chinese medicine compound preparation is in the form of tea or granules.

10. Use of the Chinese medicine composition according to claim 1 or 2 or 3 or 4 or 5 or 6 or 7 in preparing a medicine for treating qi deficiency cold.

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