Traditional Chinese medicine composition for treating children allergic cough and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating children allergic cough. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: roasted ephedra, ginkgo, scorpion, bitter apricot kernel, radix sophorae flavescentis, liquorice, stevia rebaudiana and the like. On the basis of the theory of traditional Chinese medicine, the effective medicines are matched with one another to achieve the effects of dispelling wind and evil, freeing lung and relieving asthma, and relieving spasm and cough, and the traditional Chinese medicine composition is remarkable in curative effect, small in side effect, lasting in effect and not prone to relapse, and can be used as an effective prescription for allergic cough.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition for treating allergic cough in children. The present invention further discloses a preparation method of the traditional Chinese medicine composition, which has obvious therapeutic effects and belongs to the technical field of traditional Chinese medicine pharmaceuticals. Technical Background

[0002] Allergic cough, also known as cough variant asthma, is primarily characterized by nighttime or early morning coughing, which is aggravated by exercise or exposure to cold air and is ineffective with antibiotics. The pathological mechanisms primarily include chronic airway inflammation, bronchial hyperresponsiveness, and airway remodeling. Eosinophilia predominates in airway inflammation. Bronchial hyperresponsiveness is similar to typical asthma, but may be milder. Long-term bronchial hyperresponsiveness may lead to the progression of allergic cough into typical asthma.

[0003] Currently, inhaled corticosteroids are the preferred treatment, combined with long-acting β2-agonists or leukotriene receptor antagonists. However, Western medicine treatment is prone to relapse, and early treatment can prevent progression to typical asthma. For children, timely treatment and a low risk of relapse are key considerations for parents. Therefore, traditional Chinese medicine combinations are becoming a popular choice for parents in clinical practice. Summary of the Invention

[0004] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating allergic cough in children. According to the theory of traditional Chinese medicine, traditional Chinese medicine is selected as raw materials to prepare a pharmaceutical preparation, which has the effects of dispelling wind and pathogenic factors, promoting lung function and relieving asthma, and relieving spasms and cough.

[0005] The Chinese medicine composition for treating allergic cough in children of the present invention is prepared from the following raw materials in parts by weight: 1-15 parts of roasted ephedra, 1-15 parts of ginkgo, 1-15 parts of scorpion, 1-15 parts of bitter almond, 1-15 parts of sophora flavescens, 1-15 parts of liquorice, and 1-15 parts of stevia.

[0006] Preferred ingredients include: 2-10 parts of roasted ephedra, 2-10 parts of ginkgo, 2-10 parts of whole scorpion, 2-10 parts of bitter almond, 2-10 parts of sophora flavescens, 2-10 parts of liquorice, and 2-10 parts of stevia.

[0007] More preferably, it is: 3 parts of roasted ephedra, 6 parts of ginkgo, 3 parts of scorpion, 3 parts of bitter almond, 3 parts of sophora flavescens, 5 parts of liquorice, and 3 parts of stevia.

[0008] The method for preparing a traditional Chinese medicine composition for treating allergic cough in children according to the present invention comprises the following steps: The above raw materials are weighed in proportion and prepared into Chinese medicine preparations according to traditional Chinese medicine processing.

[0009] The above-mentioned raw materials can be any raw medicinal materials or any combination of processed products.

[0010] Indications: Allergic cough, wind-evil attacking the lungs, symptoms include irritating dry cough or choking cough.

[0011] Dosage and Administration: The dosage of the preparation prepared from the above-mentioned raw material medicine is one day's dosage, which should be taken in three divided doses.

[0012] The pharmacological effects of the present invention are as follows: Based on the theory of traditional Chinese medicine, the present invention adopts the above-mentioned effective drugs to synergistically combine to form a prescription, which can be used as an effective prescription for allergic cough. In order to verify the synergistic effect of the prescription of this composition, an experimental verification was carried out: Forty mice weighing 19±1g were selected and sensitized with ovalbumin intraperitoneal injection and aerosolization to establish an allergic cough mouse model. The mice were randomly divided into five groups, with 10 mice in each group, half male and half female, as follows: ① Model control group (i.e., no drug administration group); ② The whole formula group; ③ The whole formula group without the main medicinal herbs ephedra and scorpion; ④ The whole formula group without the auxiliary medicinal herbs ginkgo and sophora flavescens; ⑤ The whole formula group without the adjuvant medicinal herbs apricot kernel, licorice, and stevia. Mice in each group were gavage-administered once daily for 3 consecutive days at 0.2 ml / 10 g body weight. Mice were placed in a 30 cm × 20 cm × 15 cm plastic box and sprayed with 1% ovalbumin for 20 seconds using an ultrasonic nebulizer. The mice were then removed and placed in cages. The time from removal to the first cough (latency period) was recorded, as well as the number of coughs within 3 minutes. Body weights of the mice were also recorded before and after drug administration. After the final challenge, mice were anesthetized, their trachea cut open, and a small incision made in the trachea. A tracheal tube was inserted and secured. Connected to a small animal pulmonary function tester, mice were subjected to sequential nebulized inhalation of 0, 8, and 16 mg / mL of methacholine. Each concentration was inhaled for 20 seconds, followed by a 10-minute interval before the next concentration was inhaled. Changes in airway resistance (cm H₂O × s / mL) were observed and recorded over the 5-minute inhalation period. Statistical analysis was performed using intergroup tests (see Tables 1–3).

[0013] Table 1. Antitussive effects of different drug groups on mice

[0014] Note: *P<0.05 compared with the model control group, #P<0.05 compared with the whole prescription group As shown in Table 1, the full-dose formula group had a moderate effect on prolonging the incubation period of ovalbumin-induced cough in mice and a moderate effect on reducing the frequency of ovalbumin-induced cough in mice, both of which were superior to the other three drug groups. The group without the monarch drug (ephedra and scorpion) showed no significant difference in the incubation period and frequency of cough compared with the model control group (P>0.05), suggesting that ephedra and scorpion are the key ingredients of this formula. Ephedra promotes lung qi and dispels cold, while scorpion relieves spasms and asthma. Their complementary effects yield significant therapeutic efficacy. In respiratory diseases, the two ingredients synergistically inhibit inflammatory responses and alleviate smooth muscle spasms. Studies have shown that the ephedra-scorpion combination treats allergic cough by modulating signaling pathways such as PI3K-AKT and cGMP-PKG, inhibiting the release of inflammatory factors and smooth muscle contraction.

[0015] Table 2 Comparison of airway resistance in different medication groups at different concentrations of methacholine (cm H2O×s / mL)

[0016] Note: *P<0.05 compared with the model control group, #P<0.05 compared with the whole prescription group As shown in Table 2, with increasing methacholine concentrations, the full formula group significantly outperformed the other three groups in improving airway resistance in mice with allergic cough. The group without the auxiliary herbs (gingko and sophora flavescens) showed no significant difference in airway resistance compared with the model control group (P>0.05), indicating a synergistic effect between ginkgo and sophora flavescens in regulating airway resistance. Sophora flavescens has antispasmodic and anti-inflammatory properties, inhibiting airway hyperresponsiveness, while ginkgo reduces mucus accumulation through expectorant and anti-allergic effects. Their combined use in the formula may reduce airway resistance through different pathways. This combination of herbs reduces airway resistance through a synergistic mechanism of "smooth muscle relaxation, anti-inflammatory, and expectorant." This combination aligns with the Traditional Chinese Medicine theory of "combining astringent and dispersing, and clearing and tonifying" and is supported by multi-target evidence from modern pharmacology. Together with the monarch herbs, they form a "one astringent, one dispersing" approach, achieving multi-layered regulation.

[0017] Table 3 Changes in body weight of mice before and after medication

[0018] Note: Compared with before treatment*P<0.05 As shown in Table 3, the full-prescription group showed little weight change in mice with allergic cough before and after treatment. However, the group without the adjuvants (almond, licorice, and stevia) showed significant weight changes (P < 0.05). During the experiment, mice in the adjuvant-free group showed signs of aversion to food and diarrhea after administration. This suggests that almond, licorice, and stevia play a role in harmonizing the various herbs in this prescription and improving their bitterness.

[0019] The present invention's formula is explained as follows: In traditional Chinese medicine formulas, scorpion is typically used as a ministerial or adjuvant drug. In this invention, scorpion is designated as the monarch drug, sharing the same status as ephedra. Scorpion possesses penetrating power, reaching internal organs and external meridians, creating a synergistic effect. Ephedra, on the other hand, has the ability to dispel lung qi and relieve asthma. Together, the two herbs expel wind, dredge meridians, and alleviate asthma. The active ingredients of the ephedra-scorpion combination (such as quercetin and kaempferol) act on targets such as serine / threonine protein kinases and EGFR, modulating pathways such as apoptosis and inflammatory responses, thereby exerting anti-inflammatory and antispasmodic effects. Combining the properties of "dispersing lung qi and dispelling cold" with "clearing wind and unblocking meridians," they play a significant role in treating respiratory spasmodic diseases, particularly allergic cough.

[0020] Auxiliary and auxiliary herbs enhance efficacy: Ginkgo's lung-tonifying and asthma-relieving properties stabilize airways and reduce spasms; Sophora flavescens' bronchodilating and anti-inflammatory properties further reduce airway resistance and control inflammation. These two herbs exhibit potential synergy. The combination of almonds and licorice primarily relieves coughs and asthma. Licorice balances the medicinal properties, mitigating almonds' side effects while enhancing their efficacy. Furthermore, almonds, combined with ephedra (the main herb) and licorice (the auxiliary herb), achieve even more pronounced lung-clearing and asthma-relieving effects. Stevia serves as a supplement, providing sweetness and heat-clearing and detoxifying properties.

[0021] The traditional Chinese medicine composition of the present invention uses ephedra and scorpion as the main ingredients. Ephedra promotes lung function, promoting lung qi and preventing qi reversal. Scorpion belongs to the insect family. Wind pathogens often hide in the lung meridians and pores, making it difficult for wind-removing drugs to reach the affected area. Scorpion can better exert its wind-removing and spasm-relieving effects. Ginkgo and Sophora flavescens are both auxiliary ingredients. Ginkgo astringes lung qi, dispels pathogens, and relieves asthma. Sophora flavescens clears heat, dries dampness, and relieves itching, effectively relieving throat itching caused by allergic cough. Apricot kernel is an adjuvant drug that enters the qi component, resolving phlegm, relieving cough, and alleviating asthma. Licorice and stevia are guiding ingredients, harmonizing the various ingredients in this prescription, thus harmonizing the flavors and improving the bitterness of the traditional Chinese medicine.

[0022] The use of Chinese medicine formulas to treat allergic coughs has achieved unexpected results, with small side effects, long-lasting effects, and low recurrence rates.

[0023] The positive effect of the present invention is: according to my country's traditional Chinese medicine theory, traditional Chinese medicine is selected as raw material prescription, through the effects of dispelling wind and dispersing pathogenic factors, promoting lung function and relieving asthma, relieving spasm and relieving cough, it is used for allergic cough caused by wind evil attacking the lung, the symptoms are irritating dry cough or choking cough, coughing when itchy throat, chest tightness and shortness of breath when coughing, aggravation at night or in the early morning, no sputum or a small amount of mucus sputum, dry mouth, can be accompanied by nasal congestion and runny nose, aversion to wind and other symptoms, light red tongue, white fur, floating pulse. Pathologically, it plays a role in allergic reaction and airway spasm relief, reducing airway sensitivity and edema, to achieve the effect of relieving cough. The present invention has no toxic and side effects, good mouthfeel, and is easy to take. It is configured and repeatedly verified by clinical trials and conforms to the theory of traditional Chinese medicine. DETAILED DESCRIPTION

[0024] The present invention is further described by way of examples below, which do not limit the present invention in any way. Without departing from the technical solution of the present invention, any modification or alteration of the present invention that can be easily implemented by a person skilled in the art will fall within the scope of the claims of the present invention. Example 1

[0025] Weigh 3g of roasted ephedra, 6g of ginkgo, 3g of whole scorpion, 3g of bitter almond, 3g of sophora flavescens, 5g of liquorice, and 3g of stevia, mix them, and extract twice with 10 times the amount of water, each time for 1 hour. Combine the extracts, filter, concentrate to a thick paste, dry, and grind into a paste powder. Add appropriate amounts of dextrin, soluble starch, and aspartame, granulate, dry, and re-granulate to obtain granules. Example 2

[0026] Weigh 5 g of roasted ephedra, 5 g of ginkgo, 2 g of whole scorpion, 2 g of bitter almond, 2 g of sophora flavescens, 1 g of liquorice, and 1 g of stevia, mix them, add 12 times the amount of water and extract once for 2 hours, filter, concentrate to a thick paste, dry, and grind into a paste powder, add appropriate amounts of starch and powdered sugar, granulate, dry, and shape the granules, add magnesium stearate, mix well, and compress into tablets, with or without coating, to obtain tablets. Example 3

[0027] Weigh 6g of roasted ephedra, 10g of ginkgo, 5g of whole scorpion, 1g of bitter almond, 15g of sophora flavescens, 10g of liquorice, and 5g of stevia, mix them, add 11 times the amount of water and extract three times, each time for 0.5 hour. Combine the extracts, filter, concentrate to a thick paste, dry, and grind into a paste powder. Add appropriate amount of auxiliary materials, granulate, dry, and granulate to obtain granules. Example 4

[0028] Weigh 2g of ephedra, 10g of ginkgo, 2g of scorpion, 15g of bitter almond, 6g of sophora flavescens, 2g of liquorice, and 2g of stevia, mix them, add 8 times the amount of 50% ethanol, and extract three times for 0.5 hour each time. Combine the extracts, filter, recover ethanol until there is no alcohol taste, concentrate to a thick paste, dry, and grind into a paste powder. Add appropriate amount of excipients and mix well to prepare a powder. Example 5

[0029] Weigh 15 g of roasted ephedra, 15 g of ginkgo, 2 g of whole scorpion, 6 g of bitter almond, 1 g of sophora flavescens, 15 g of liquorice, and 5 g of stevia, mix them, add 12 times the amount of 95% ethanol, extract once, extract for 2 hours, filter, recover ethanol until there is no alcohol taste, concentrate to a thick paste, dry, grind into a paste powder, add appropriate amount of excipients, mix well, and prepare pills. Example 6

[0030] Weigh 6g of roasted ephedra, 10g of ginkgo, 4g of whole scorpion, 7g of bitter almond, 9g of sophora flavescens, 7g of liquorice, and 5g of stevia, mix them, add 10 times the amount of 70% ethanol, and extract twice for 1 hour each time. Combine the extracts, filter, recover ethanol until there is no alcohol taste, concentrate to a thick paste, dry, and grind into a paste powder. Add appropriate amounts of dextrin and stevioside, granulate, dry, and regranulate to obtain granules. Example 7

[0031] Weigh 8g of roasted ephedra, 9g of ginkgo, 4g of scorpion, 3g of bitter almond, 2g of sophora flavescens, 12g of liquorice, and 7g of stevia, mix the mixture, and extract twice with 9 times the amount of water, the first extraction for 1 hour and the second extraction for 0.5 hour. Combine the extracts, filter, concentrate, add ethanol to make the alcohol concentration reach 60%, let stand for 36 hours, take the supernatant, recover the ethanol until there is no alcohol taste, concentrate, add an appropriate amount of water, stir well, refrigerate for 48 hours, filter, add an appropriate amount of suspending agent, flavoring, and preservative to the filtrate, mix well, add water to volume, filter, and package to obtain an oral liquid preparation. Example 8

[0032] Weigh 3g of roasted ephedra, 9g of ginkgo, 6g of whole scorpion, 6g of bitter almond, 3g of sophora flavescens, 5g of liquorice, and 3g of stevia, mix them, add 10 times the amount of water and extract twice, each time for 1 hour. Combine the extracts, filter, concentrate to a thick paste, dry, and grind into a paste powder. Add appropriate amount of auxiliary materials, granulate, dry, reconstitute the granules, and encapsulate to obtain capsules. Example 9

[0033] The preparation method of the granules of the traditional Chinese medicine composition of the present invention comprises the following steps: weighing the raw materials of ephedra, ginkgo, scorpion, bitter almond, sophora flavescens, liquorice and stevia, mixing the mixture, adding 8-12 times the amount of water and extracting for 1-3 times, each time for 0.5-2 hours, combining the extracts, filtering, concentrating to a thick paste, drying and pulverizing into a paste powder; adding appropriate amounts of auxiliary materials, granulating, drying and granulating to obtain the granules. Example 10

[0034] The raw materials of roasted ephedra, ginkgo, scorpion, bitter almond, sophora flavescens, liquorice and stevia are weighed and mixed, extracted with water or 50-95% ethanol, filtered, concentrated to a thick paste, dried and crushed into a paste powder; and a pharmaceutically acceptable preparation is prepared according to conventional processes with or without adding excipients.

[0035] The preparation method of the traditional Chinese medicine composition of the present invention can also be: weighing the raw materials of roasted ephedra, ginkgo, scorpion, bitter almond, sophora flavescens, liquorice, and stevia, mixing them, adding 8-12 times the amount of water, extracting 1-3 times, each time for 0.5-2 hours, combining the extracts, filtering, concentrating to a thick paste, drying, and crushing into a paste powder; adding or not adding excipients to prepare a pharmaceutically acceptable preparation according to conventional processes.

[0036] The obtained paste powder extract can be taken directly as medicine or added with pharmaceutically acceptable excipients to prepare the desired preparation according to conventional processes. For example, it can be made into oral medications in the form of solid preparations such as commonly used tablets (dispersible tablets, effervescent tablets, orally disintegrating tablets, lozenges, chewable tablets, effervescent tablets), capsules (hard capsules, soft capsules), granules, pills (dropping pills, honeyed pills, water-honeyed pills, concentrated pills), powders, and bagged teas. It can also be made into oral medications in the form of liquid preparations such as syrups and oral liquids. Therefore, in addition to the extract of the Chinese medicine composition, the pharmaceutical composition can also contain pharmaceutically acceptable excipients.

[0037] The excipients described here may vary according to different preparations, such as diluents, disintegrants, excipients, binders, lubricants, surfactants, fillers, etc. commonly used in solid preparations such as tablets, capsules, granules; and surfactants, diluents, preservatives, stabilizers, flavoring agents, thickeners, glidants, etc. commonly used in liquid preparations such as syrups and oral liquids. Its commonly used excipients include starch, lactose, dextrin, powdered sugar, microcrystalline cellulose, mannitol, xylitol, polyethylene glycol, calcium sulfate, calcium hydrogen phosphate, calcium carbonate, modified starch, sorbitol, polyvinylpyrrolidone, heavy magnesium carbonate, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, methylcellulose, ethyl cellulose, sodium carboxymethyl starch, hydroxypropyl cellulose, povidone K30, white clay, pregelatinized starch, magnesium stearate, talc, micronized silica gel, stevioside, betaine, aspartame, glycyrrhizin, sodium saccharin, citric acid, sorbic acid, potassium sorbate, ethylparaben, sucrose, starch slurry, syrup, guar gum, stevioside, sodium alginate, maltose, citric acid, malic acid, sucralose, menthol, coffee powder, monoglyceride, magnesium lauryl sulfate, beta-cyclodextrin, etc.

[0038] When using the above-mentioned drugs, the raw materials can be cleaned, dried, crushed, and mixed to obtain granules or powders of the desired particle size for direct administration. Alternatively, the raw materials can be prepared from the drugs in the above-mentioned weight ratios, appropriately treated, and then supplemented with pharmaceutical excipients to form various preparations as needed. In the process of preparing the preparations from the above-mentioned raw materials, the raw materials can be processed by the following methods: extraction with water or ethanol of varying concentrations, concentration and drying of the extract to obtain a crude extract; or further purification by one or a combination of alcohol precipitation, water resolubility, organic solvent extraction, flocculation precipitation, and column chromatography to obtain a refined extract. The specific operations and / or methods used to extract the above-mentioned active pharmaceutical ingredients can include extracting the active pharmaceutical ingredients separately from the raw materials in the above-mentioned proportions and then mixing them, or by mixing the raw materials in the above-mentioned proportions and then extracting them together. By using different extraction methods, equipment and specific conditions such as ideal or optimal extraction temperature, solvent dosage, extraction time, extraction times, etc., they can be screened and found through experiments according to actual conditions.

[0039] Study on the effect of the Chinese medicine composition of the present invention on treating allergic cough 1. Antitussive effect Take 20 mice, weighing 19±1g, and randomly divide them into two groups, each group of 10, half female and half male, respectively, as model control group and treatment group. The treatment group is given the granules of Example 1 of the present invention, and the dosage is equivalent to the clinical equivalent dose of 15Kg children. Each group of mice is gavage-administered, once a day, 0.2ml / 10g body weight, for 3 consecutive days, and the model control group is given distilled water under the same conditions. One hour after the last administration, the mice are placed in a 30cm×20cm×15cm plastic box in turn, sprayed with 1% ovalbumin for 20 seconds with an ultrasonic nebulizer, taken out and placed in a cage, and the time (latency) from the time the mice are taken out to the first cough is recorded, and the number of coughs within 3 minutes is recorded. The results are statistically processed using inter-group test.

[0040] Table 4 Antitussive effect of Chinese medicine composition on mice

[0041] As shown in Table 4, the treatment group had a certain effect on prolonging the incubation period of coughing caused by ovalbumin in mice and reducing the number of coughing caused by ovalbumin in mice, and there were significant differences compared with the model control group (P < 0.05).

[0042] 2. Antiasthmatic effect Get 30 guinea pigs, body weight 225 ± 25g, be randomly divided into three groups, every group of 10, female, male half and half, be respectively blank control group, model control group, treatment group.The treatment group gives the granule of the embodiment of the present invention 1, and consumption is equivalent to 15Kg children's clinical equivalent dose.Except blank control group, all the other two groups of guinea pigs are sensitized by every intraperitoneal injection of 10% ovalbumin physiological saline 1ml, and from the 3rd day after sensitization, begin oral administration, every day 1ml / 100g body weight, continuous administration 12 days, blank control group and model control group give distilled water under equal conditions.Weigh body weight once a week, after last administration one hour, guinea pig is put into the plastic box of 30cm * 20cm * 15cm successively, spray 5% ovalbumin physiological saline 30 seconds with ultrasonic atomizer constant pressure, after stopping spraying, observe 5 minutes, record guinea pig from stopping spraying to the time (latency period) that wheezing convulsion occurs, and the number of animals that fall down and shock occurs, the result adopts intergroup test to carry out statistical processing.

[0043] Table 5 Antiasthmatic effect of Chinese medicine composition on guinea pigs

[0044] As shown in Table 5, the treatment group had a certain effect on prolonging the incubation period of guinea pig asthma caused by ovalbumin. The protein had a certain effect in reducing the fall shock caused by guinea pigs, and there was a significant difference compared with the model control group (P<0.05).

[0045] Similar experiments were carried out in Examples 1 to 10 of the present invention according to the above method, and the results were the same as the above results.

[0046] Combined with clinical trial research to further verify the clinical efficacy of the Chinese medicine composition In addition, a clinical trial of this Chinese herbal composition was conducted using the granules described in Example 1. Children with allergic cough who were screened at the outpatient clinic of the Affiliated Hospital of Changchun University of Chinese Medicine were randomly assigned to either the treatment group or the placebo group in a 2:1 ratio, with the ratio reflecting the number of subjects in each group. An independent statistician not involved in the data analysis generated the randomization sequence using SAS 9.2 software. A parallel control approach was used, with the treatment group receiving the Chinese herbal composition and the control group receiving a Chinese herbal composition sham. Both groups were administered orally, one sachet three times daily, half an hour after meals, with warm water for a course of seven days. A total of 145 children were enrolled (103 in the treatment group and 42 in the placebo group).

[0047] Table 6 Comparison of general information of children

[0048] Table 6 shows that baseline demographic data, including age, height, weight, gender, and ethnicity, showed no statistically significant differences between the two groups (P>0.05). Statistical analysis of cough variant asthma characteristics, course of disease, family allergy history, past medical history of the child, and personal allergy history showed no statistically significant differences (P>0.05), indicating comparability.

[0049] Analysis of clinical efficacy of the drug of the present invention: Main efficacy indicators (1) Cough severity (daytime + nighttime) score, recorded daily at baseline and during treatment, and evaluated after 7 days of treatment.

[0050] (2) Cough onset time and efficacy, evaluated after 7 days of treatment.

[0051] (3) Cough relief time and relief rate, evaluated after 7 days of treatment.

[0052] Daily average cough severity score: According to the Chinese Medical Association's "Guidelines for the Diagnosis and Treatment of Cough (2009), the average score for daytime cough severity or nighttime cough severity = total daytime or nighttime cough severity score / total number of days. See the Cough Symptom Score Table in the Appendix.

[0053] Secondary efficacy indicators (1) The number of times the medication is used and the amount used should be recorded daily at baseline and during treatment, and evaluated after 4 and 7 days of treatment.

[0054] (2) TCM syndrome score, evaluated after 7 days of treatment.

[0055] (3) Single symptom score, evaluated after 7 days of treatment.

[0056] TCM syndrome efficacy: ( ) Clinical recovery: total TCM syndrome score reduced by ≥90%; ( ) Markedly effective: The total score of TCM symptoms decreased by ≥70% and <90%; ( ) Effective: The total score of TCM syndromes decreased by ≥30% and <70%; ( ) Ineffective: The total score of TCM syndromes decreased by less than 30%.

[0057] Note: ① Syndrome score reduction rate = [(total score before treatment - total score after treatment) / total score before treatment] × 100%.

[0058] ②Total effective rate (%): The percentage of cured, markedly effective and effective cases in the total number of cases.

[0059] Table 7 Comparison of TCM efficacy among groups

[0060] As shown in Table 7, there was a statistically significant difference in the total effective rate between the two groups after 7 days of treatment (P<0.01). In the treatment group, 5 cases were cured, 36 cases were significantly effective, 58 cases were effective, and 4 cases were ineffective. The clinical cure and significant efficacy rate was 39% and the total effective rate was 96%.

Claims

1. A Chinese medicine composition for treating allergic cough in children, characterized in that It is prepared from the following Chinese medicinal raw materials in parts by weight: 1-15 parts of roasted ephedra, 1-15 parts of ginkgo, 1-15 parts of scorpion, 1-15 parts of bitter almond, 1-15 parts of sophora flavescens, 1-15 parts of liquorice, and 1-15 parts of stevia.

2. A Chinese medicine composition for treating allergic cough in children as claimed in claim 1, characterized in that It is prepared from the following Chinese medicinal raw materials in preferred weight proportions: 2-10 parts of roasted ephedra, 2-10 parts of ginkgo, 2-10 parts of scorpion, 2-10 parts of bitter almond, 2-10 parts of sophora flavescens, 2-10 parts of liquorice, and 2-10 parts of stevia.

3. A Chinese medicine composition for treating allergic cough in children as claimed in claim 1, characterized in that It is prepared from the following Chinese medicinal raw materials in a more preferred weight ratio: 3 parts of roasted ephedra, 6 parts of ginkgo, 3 parts of scorpion, 3 parts of bitter almond, 3 parts of sophora flavescens, 5 parts of liquorice, and 3 parts of stevia.

4. A method for preparing a Chinese medicine composition for treating allergic cough in children according to claims 1 to 3, characterized in that: The above raw materials are weighed in proportion and prepared into Chinese medicine preparations according to traditional Chinese medicine processing.

5. The Chinese medicine composition for treating allergic cough in children as described in claims 1 to 3 can be a combination of any raw medicinal materials or any processed products.

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