A pharmaceutical composition for treating wind-cold type common cold with stagnation in children and a preparation method and use thereof

Abstract

This invention discloses a pharmaceutical composition for treating pediatric colds with stagnation, its preparation method, and its uses. It is a preparation made from active ingredients and pharmaceutically acceptable excipients. The active ingredients are prepared from the following raw materials in the indicated weight ratios: Ephedra 4-7 parts, Bitter Almond 5-8 parts, Mulberry Bark 5-8 parts, Lycium Bark 7-10 parts, Peppermint 4-7 parts, Tangerine Peel 4-7 parts, Areca Peel 7-11 parts, Malt 10-14 parts, and Licorice 3-6 parts. The preparation is obtained by decoction with water, or by decoction with water to obtain an extract, followed by distillation to extract the volatile oil. The extract and volatile oil are then combined to obtain the final preparation. This pharmaceutical composition is widely used clinically to treat pediatric colds with stagnation, particularly pediatric colds with wind-cold and stagnation, with definite efficacy. It can also be used in the preparation of medicines for preventing and treating pediatric colds with stagnation.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition, and more specifically, to a pharmaceutical composition for treating infantile colds with stagnation, its preparation method, and its uses. Background Technology

[0002] Traditional Chinese medicine (TCM) generally classifies colds into three types: wind-cold colds, wind-heat colds, and seasonal colds. Wind-cold colds are caused by the invasion of wind-cold pathogens into the skin's surface. Symptoms include chills and fever, aversion to cold, lack of sweating, nasal congestion and runny nose, headache and body aches, cough with thin white phlegm, no thirst or preference for hot drinks, and a thin white tongue coating. Treatment should focus on dispelling wind and cold with pungent and warm herbs. Wind-heat colds are caused by the invasion of wind-heat pathogens into the skin's surface. Symptoms include fever, aversion to wind, lack of sweating or sweating, headache and distending headache, sore throat, cough with sticky yellow phlegm, nasal congestion with yellow discharge, thirst, a thin white or slightly yellow tongue coating, and a red tongue tip. Treatment should focus on dispelling wind and cold with pungent and cooling herbs. These two types differ in clinical symptoms, treatment methods, and medications.

[0003] The common cold in children is a respiratory illness caused by external pathogens, manifesting as fever, chills, nasal congestion, and runny nose. In addition to these typical symptoms, the common cold in children differs from that in adults in that it is more prone to complications such as food stagnation, fright, and phlegm, with food stagnation being the most common clinically. During the course of a cold, children may also experience belching, and in severe cases, vomiting, nausea, halitosis, abdominal distension, poor appetite, constipation, diarrhea, and a greasy, turbid tongue coating. This is a common pediatric cold with food stagnation syndrome in traditional Chinese medicine, also known as a cold with food accumulation or a cold with food retention.

[0004] Children are considered to have immature Yin and Yang constitutions, with delicate bodies, tender internal organs, and underdeveloped external Qi, making them susceptible to internal damage. Initially, due to weak spleen function, children struggle to regulate their eating, often overeating or going hungry. Parents often spoil them, favoring rich and greasy foods, and the prevailing winds allow for the consumption of cold and raw foods without restraint. Over time, this damages the middle Yang, suppressing vitality; the spleen stagnates, the stomach becomes sluggish, and intestinal stagnation occurs. Subsequently, the spleen and lungs, being interconnected, become affected by the stagnation in the spleen and stomach, causing the mother organ to become diseased and the child organ to become diseased. Clear Qi cannot ascend to the lungs, and turbid Qi cannot descend to the intestines, leading to impaired Qi transformation. Finally, because the lungs act as a protective barrier for the body, connecting internally and externally with the large intestine, internal Qi stagnation leads to disharmony of external Qi, disrupting the opening and closing of the pores and weakening the skin's defenses. Thus, external pathogens take advantage of this weakness, resulting in a condition where stagnation precedes external invasion. Or perhaps a child's internal organs are delicate, their physical constitution is not yet fully developed, their lungs are often insufficient, their defensive qi is weak, and they are unable to regulate their own body temperature, making them susceptible to external pathogens. When external pathogens attack the exterior, the defensive qi is suppressed, and the lung qi fails to circulate properly. The lungs govern the qi of the whole body, and the lung's function of dispersing and descending is related to the ascending, descending, entering, and exiting of qi throughout the body, with the spleen and stomach being the hub of this qi mechanism. If the lungs fail to disperse and descend properly, it can often affect the spleen's function of transporting and transforming qi. At the same time, if the lung qi fails to disperse and descend properly, it can also lead to the stomach's failure to harmonize and descend, causing its function of receiving and digesting food to be impaired. If there is any irregularity in eating, it will inevitably lead to internal stagnation. This is a case of external pathogens first followed by stagnation. The Qing Dynasty scholar Chen Fuzheng recorded in "Youyou Jicheng" that "(children) also have cases where they first catch a cold from wind and cold, and then suffer from food poisoning, or they first stop eating and then catch a cold from wind and cold, which is called 'cold and cold with food poisoning'." This explains the origin of the above-mentioned cold with stagnation syndrome.

[0005] At present, the marketed Chinese patent medicine for treating exogenous wind-cold and internal injury with food retention syndrome is Wushi Cha Keli, which is composed of Atractylodes lancea, Bupleurum chinense, Notopterygium incisum, Saposhnikovia divaricata, Angelica dahurica, Ligusticum chuanxiong, Pogostemon cablin, Peucedanum praeruptorum, Forsythia suspensa, Citrus reticulata Blanco, Crataegus pinnatifida, Aurantioideae fructus, Germinated Barley, Glycyrrhiza glabra, Platycodon grandiflorus, Six-Flavors Divine Curd (fried), Perilla frutescens, Magnolia officinalis and black tea. Its functions and indications are to dispel wind and relieve the exterior, promote digestion and harmonize the middle, and are used for exogenous wind-cold and internal injury with food retention syndrome, with symptoms such as aversion to cold and fever, headache and general discomfort, fullness and stuffiness in the chest and epigastrium, nausea and vomiting, abdominal pain and diarrhea. The dosage is 6 grams each time, 1 - 2 times a day. Although this traditional Chinese medicine is used to treat exogenous wind-cold and internal injury with food retention syndrome, it has many medicinal flavors, a large prescription volume, is for adult use, and there is no dosage for children in the instruction manual, so it is not convenient for children to use. The Chinese patent medicine Xiao'er Chiqiao Qingre Keli for children is composed of Forsythia suspensa, Sojae Semen Praeparatum, Mentha haplocalyx, Schizonepeta tenuifolia, Fructus Gardeniae praeparatus, Rheum palmatum, Artemisia annua, Radix Paeoniae Rubra, Areca catechu, Magnolia officinalis, Scutellaria baicalensis, Pinellia ternata, Bupleurum chinense and Glycyrrhiza glabra; its functions and indications are to dispel wind and relieve the exterior, clear heat and promote digestion, and are used for children with wind-heat cold complicated with food retention syndrome, with symptoms such as fever and cough, nasal congestion and runny nose, red and swollen throat, loss of appetite and thirst, abdominal distension and fullness, constipation or foul-smelling stools, and yellow urine. This medicine is not suitable for children with wind-cold cold complicated with food retention syndrome. Among the Chinese patent medicines for children in the latest National Health Insurance Drug List (2022 Edition), only 2 Chinese patent medicines belong to the pungent-warm exterior-relieving agents and can be used for the treatment of children's wind-cold cold, namely Xiao'er Qingre Ganmao Pian and Xiao'er Zhibao Wan. Xiao'er Qingre Ganmao Pian is composed of Notopterygium incisum, Schizonepeta tenuifolia, Saposhnikovia divaricata, Atractylodes lancea (fried), Angelica dahurica, Pueraria lobata, Ligusticum chuanxiong, Armeniaca vulgaris (fried), Rehmannia glutinosa, Scutellaria baicalensis, Glycyrrhiza glabra and artificial bezoar; its functions and indications are to induce sweating to relieve the muscles, clear heat and penetrate the exterior, and are used for fever and aversion to cold caused by accumulated heat in the zang-fu organs, no sweating on the body surface, headache and thirst, nasal congestion and cough. Xiao'er Zhibao Wan is composed of Perilla frutescens, Pogostemon cablin, Mentha haplocalyx, Notopterygium incisum, Citrus reticulata Blanco, Typhonium giganteum praeparatum, Arisaema cum Bile, Semen Sinapis Albae praeparatum, Fritillaria cirrhosa, Areca catechu, Crataegus pinnatifida praeparatum, Poria cocos, Six-Flavors Divine Curd (fried), Germinated Barley, Succinum, Borneol, Gastrodia elata, Uncaria rhynchophylla, Bombyx batryticatus (fried), Cryptotympana pustulata, Scorpio, artificial bezoar, Realgar, Talcum, Cinnabaris; its functions and indications are to dispel wind and calm the mind, resolve phlegm and promote digestion, and are used for children's wind-cold cold, retention of food and milk, fever and nasal congestion, cough with profuse phlegm, vomiting and diarrhea. It is not difficult to see that Xiao'er Qingre Ganmao Pian mainly induces sweating to relieve the muscles and clear heat and penetrate the exterior; Xiao'er Zhibao Wan mainly dispels wind and calms the mind, resolves phlegm and promotes digestion. Both of these traditional Chinese medicine compound preparations have relatively many medicinal flavors, and their drug compositions and functions and indications are not specifically for children with wind-cold cold complicated with food retention syndrome. In addition, "Xiao'er Xiaoji Zhike Koufuye" with the efficacy of promoting digestion and relieving cough belongs to the digestion-promoting and phlegm-resolving agents (not pungent-warm exterior-relieving agents) among the Chinese patent medicines for children in the latest National Health Insurance Drug List (2022 Edition). This formula is composed of Crataegus pinnatifida praeparatum, Areca catechu, Aurantioideae fructus, Eriobotrya japonica (honey-fried), Trichosanthes kirilowii, Raphanus sativus praeparatum, Lepidium apetalum praeparatum, Platycodon grandiflorus, Forsythia suspensa, Cryptotympana pustulata, and has the effects of clearing heat and purging the lung, promoting digestion and relieving cough, and is used for cough in children caused by food accumulation and phlegm-heat accumulating in the lung, which is aggravated at night, gurgling of phlegm in the throat, abdominal distension, and bad breath. Therefore, at present, there are almost no drugs available for children with wind-cold cold complicated with food retention syndrome, and there is a major unmet clinical need. Therefore, it is very necessary to develop new traditional Chinese medicines for treating children's wind-cold cold complicated with food retention syndrome, and there is a huge market demand. Summary of the Invention

[0006] The purpose of this invention is to provide a pharmaceutical composition for treating pediatric colds with stagnation, which has few ingredients, proper compatibility, and definite efficacy, and is particularly suitable for pediatric colds with stagnation due to wind-cold. Another purpose of this invention is to provide a method for preparing the pharmaceutical composition and its uses.

[0007] The pharmaceutical composition for treating infantile colds with stagnation described in this invention is a preparation made from an active ingredient and pharmaceutically acceptable excipients, wherein the active ingredient is prepared from raw materials in the following weight ratios:

[0008] Ephedra 4-7 parts, bitter almond 5-8 parts, mulberry bark 5-8 parts, lycium bark 7-10 parts, peppermint 4-7 parts, dried tangerine peel 4-7 parts, areca peel 7-11 parts, malt 10-14 parts, licorice 3-6 parts.

[0009] Preferably, it is prepared from the following raw materials in the indicated weight ratios:

[0010] Ephedra 5 parts, bitter almond 6 parts, mulberry bark 6 parts, lycium bark 9 parts, peppermint 5 parts, dried tangerine peel 5 parts, areca peel 9 parts, malt 12 parts, licorice 5 parts.

[0011] In the pharmaceutical composition of this invention, ephedra is preferably honey-processed ephedra. The preparation is an oral pharmaceutical preparation absorbed through the gastrointestinal tract.

[0012] The present invention also provides a method for preparing the above-mentioned pharmaceutical composition, which includes the following steps:

[0013] (1) Weigh the raw materials according to the weight ratio;

[0014] (2) The raw materials are boiled with water to extract them, the extracts are combined, concentrated, and prepared into a formulation;

[0015] Alternatively, the raw drug can be boiled with water to extract it, and the distilled volatile oil can be collected at the same time. The extracts can be combined, concentrated, and then combined with the volatile oil to prepare a preparation.

[0016] Alternatively, the volatile oils of peppermint and dried tangerine peel can be extracted by water distillation; the residue of peppermint and dried tangerine peel can be boiled with water and the remaining raw materials to extract the oils, and the extracts can be combined, concentrated, and then combined with the volatile oils to prepare a preparation.

[0017] Alternatively, the raw drug can be extracted by boiling it in water, while simultaneously collecting the distilled volatile oil. The extracts are combined, concentrated, and precipitated with ethanol. The supernatant is then used to remove the ethanol before being combined with the volatile oil to prepare a formulation.

[0018] The pharmaceutical composition described in this invention is widely used in clinical practice to treat pediatric colds with stagnation syndrome, especially pediatric colds with wind-cold syndrome with stagnation syndrome, with definite curative effect, and can be used in the preparation of medicines for the prevention and treatment of pediatric colds with wind-cold syndrome with stagnation syndrome.

[0019] Based on long-term clinical experience and traditional Chinese medicine theory, the applicant believes that the TCM treatment of childhood colds with stagnation syndrome should focus on clearing the lungs and relieving cough, regulating qi and resolving stagnation, so as to achieve harmony between the exterior and interior, clearing the lungs and spleen, and unblocking the stomach and intestines, thus achieving a complete cure. Therefore, this invention uses ephedra and bitter almond as the chief ingredients, combined with raw licorice to form San'ao Decoction to clear wind, clear the lungs, relieve cough and asthma. Among them, ephedra releases the exterior, clears the lungs, and relieves asthma; bitter almond moistens the lungs, lowers qi, resolves phlegm, and relieves cough. Mulberry bark and lycium bark are used as assistant ingredients, combined with raw licorice to form Xiebai Powder to open up stagnation, clear the lungs, and moisten the intestines. Among them, mulberry bark clears the lungs and drains heat, while lycium bark moistens the lungs and unblocks the intestines, preventing both the transformation of stagnation into heat and the damage of accumulated heat to the lungs. The chief and assistant ingredients work in harmony, restoring the function of clearing the exterior and descending the interior of the upper jiao, clearing wind externally and unblocking the bowels internally. The formula uses peppermint, dried tangerine peel, areca peel, and malt as adjuvants. Peppermint, being pungent and cool, disperses and helps ephedra to penetrate the exterior, clearing the upper burner. Dried tangerine peel, bitter, pungent, and warm, regulates qi, strengthens the spleen, dries dampness, and resolves phlegm, helping bitter apricot kernel to lower qi, resolve phlegm, and regulate the middle burner. Areca peel, pungent and warm, promotes water metabolism, lowers qi, and soothes the middle burner, allowing mulberry bark and lycium bark to clear the lungs without harming the middle burner, purging the lungs, reaching the stomach and intestines, and clearing the lower burner. Malt, sweet and neutral, strengthens the stomach and aids digestion. Combined with the above herbs, it clears the exterior and interior, and clears the three burners to eliminate stagnation. Licorice is used as the adjuvant, serving three purposes: first, to moderate the properties of the herbs to suit the child's constitution; second, to strengthen the spleen and stomach to regulate the upper and lower burners; and third, to harmonize the taste to appeal to children. Overall, the formula is mild and balanced in nature, specifically designed for children's young bodies. It functions to disperse external pathogens, clear the lungs and stop coughing, resolve internal stagnation, harmonize the stomach and eliminate turbidity, targeting the pathogenesis of colds with stagnation. It is administered in granules for convenient use.

[0020] Further pharmacodynamic studies and clinical trial results show that the pharmaceutical composition of the present invention is effective in treating infantile colds with stagnation syndrome, and has good clinical value and market prospects. Detailed Implementation

[0021] The present invention will be further described in detail below through specific embodiments. However, this should not be construed as limiting the scope of protection of the present invention to the following examples. Various substitutions or modifications made based on ordinary technical knowledge and conventional methods in the art without departing from the above-described technical concept of the present invention should be included within the scope of the present invention.

[0022] Example 1

[0023] Take 5 kg of honey-processed ephedra, 6 kg of bitter almond, 6 kg of mulberry bark, 9 kg of lycium bark, 5 kg of peppermint, 5 kg of dried tangerine peel, 9 kg of areca peel, 12 kg of malt, and 5 kg of licorice. Add water and decoct twice. Add 12 times the amount of water for the first decoction and 10 times the amount of water for the second decoction. Each decoction lasts for 2 hours. Collect the distilled volatile oil. Encapsulate the oil with cyclodextrin using conventional methods. Set the encapsulated oil aside. Filter the oil, combine the filtrates, concentrate, dry, add the encapsulated oil, and add appropriate amounts of dextrin and other excipients using conventional methods. Mix well and prepare granules.

[0024] Example 2

[0025] Take 5 kg of honey-processed ephedra, 6 kg of bitter almond, 6 kg of mulberry bark, 9 kg of lycium bark, 5 kg of peppermint, 5 kg of dried tangerine peel, 9 kg of areca peel, 12 kg of malt, and 5 kg of licorice. Add water and decoct twice. Add 10 times the amount of water for the first decoction and 8 times the amount of water for the second decoction. Each decoction lasts for 2 hours. Filter the decoction, combine the filtrates, concentrate, dry, add appropriate amounts of excipients according to conventional methods, mix well, and make into granules.

[0026] Example 3

[0027] Take 4 kg of honey-processed ephedra, 8 kg of bitter almond, 5 kg of mulberry bark, 7 kg of lycium bark, 7 kg of peppermint, 7 kg of dried tangerine peel, 11 kg of areca peel, 14 kg of malt, and 6 kg of licorice. Add water and decoct twice. Add 13 times the amount of water for the first decoction and 10 times the amount of water for the second decoction. Each decoction takes 2 hours. Filter the decoction, combine the filtrates, concentrate and dry them. Add an appropriate amount of excipients according to conventional methods, mix well, and make granules.

[0028] Example 4

[0029] Take 4 kg of peppermint and 4 kg of dried tangerine peel, add water and distill to extract the volatile oil. Encapsulate the volatile oil with cyclodextrin using conventional methods, and set the encapsulation compound aside. Combine the peppermint and dried tangerine peel residue with 7 kg of ephedra, 5 kg of bitter almond, 8 kg of mulberry bark, 10 kg of lycium bark, 7 kg of areca peel, 10 kg of malt, and 3 kg of licorice root. Boil twice with water, adding 10 times the amount of water for the first decoction and 8 times the amount of water for the second decoction, each time for 1.5 hours. Filter, combine the filtrates, concentrate, dry, add the encapsulation compound, add appropriate excipients using conventional methods, mix well, and prepare granules.

[0030] Example 5

[0031] Take 5 kg of ephedra, 6 kg of bitter almond, 6 kg of mulberry bark, 9 kg of lycium bark, 5 kg of peppermint, 5 kg of dried tangerine peel, 9 kg of areca peel, 12 kg of malt, and 5 kg of licorice. Add water and decoct twice. For the first decoction, add 10 times the amount of water and decoct for 2 hours. For the second decoction, add 8 times the amount of water and decoct for 1 hour. Collect the distilled aromatic water (volatile oil) for later use. Filter, combine the filtrates, concentrate to a relative density of approximately 1.15-1.20, add ethanol to achieve an alcohol content of 70%, stir thoroughly, let stand, collect the ethanol supernatant, filter, recover the ethanol, concentrate, add the above aromatic water, and prepare an oral liquid using conventional methods.

[0032] Common cold in children with wind-cold and food stagnation syndrome (common cold in children with food stagnation) often manifests as fever, chills, cough, nasal congestion and runny nose, loss of appetite, halitosis, abdominal distension, constipation or foul-smelling stools, and a thick, greasy tongue coating. The main clinical symptoms are cough, fever, loss of appetite, constipation, or foul-smelling stools (i.e., insufficient gastric motility). This formula has a well-balanced composition and clinical efficacy shows that it has antitussive, expectorant, antipyretic, and gastrointestinal motility-promoting effects.

[0033] The following pharmacodynamic studies illustrate the beneficial effects of the pharmaceutical compositions of the present invention.

[0034] Test substance (test drug): Take the drug prepared in Example 1 and prepare a suspension of the required concentration with 0.5% carboxymethyl cellulose (CMC). The dosage is calculated based on the original drug (unit: g / kg). Unless otherwise specified, the "%" representing the content in this invention indicates the mass fraction.

[0035] I. Experimental Study on Antitussive Effect

[0036] 1.1 Effects on citric acid-induced cough response in guinea pigs

[0037] Guinea pigs weighing 250–300g, both male and female, were selected. First, a screening process was conducted by placing the animals in a 5000ml glass jar and nebulizing 17.5% citric acid using an ultrasonic nebulizer (2ml / min) for 1 minute. The number of coughs within 5 minutes was counted from the start of nebulization. Animals coughing more than 10 times within 5 minutes were selected as test animals. Then, 50 qualified guinea pigs were randomly divided into 5 groups based on cough frequency, weight, and sex: a model group (distilled water), small, medium, and large dose groups of the test drug (1.34, 2.69, and 5.37g / kg / day), and a cough syrup group (3ml / kg / day), with 10 animals in each group. The drugs were administered by gavage once daily for 3 consecutive days. A cough suppression test was conducted 60 minutes after the last administration (using the same method as screening), counting the number of coughs and the latency period of cough onset within 5 minutes for each animal. SPSS 10.0 for Windows was used for statistical analysis. The values ​​are expressed as X±SD. The results were analyzed by t' test, and P<0.05 was considered statistically significant (Table 1).

[0038] Table 1. Effect of the drug of the present invention on citrate-induced cough response in guinea pigs (X±SD)

[0039] Group Dosage (g / kg / d) Number of animals (individuals) Incubation period (s) Coughing frequency / 5min Model distilled water 10 56.3±10.6 27.2±8.5 low-dose group of experimental drug 1.34 10 65.4±11.3 20.8±7.4 medium dose group of the test drug 2.69 10 88.5±32.8* 17.2±8.3* High-dose group of experimental drug 5.37 10 97.4±40.5* 16.3±6.7* Acute Bronchitis Syrup Group 3ml / kg / d 10 96.8±42.7* 16.8±6.3*

[0040] Note: Compared with the model group: *P<0.05, **P<0.01

[0041] As shown in Table 1, the medium and high dose groups of the test drug significantly prolonged the latency period of citric acid-induced cough in guinea pigs, which was statistically significant compared with the model group; the medium and high dose groups of the test drug significantly reduced the number of coughs induced by citric acid in guinea pigs, which was statistically significant compared with the model group; the low dose group of the test drug showed a trend of prolonging the latency period of cough in guinea pigs and reducing the number of coughs.

[0042] 1.2 Effects on sulfur dioxide-induced cough response in mice

[0043] Sixty mice weighing 20–22 g (both male and female) were used. The mice were randomly divided into five groups: a model group (distilled water), small, medium, and large dose groups of the test drug (2.16, 4.32, and 8.64 g / kg / day, respectively), and a cough syrup group (4.5 ml / kg / day), with 12 mice in each group. The mice were administered the drug twice daily by gavage for two consecutive days. Sixty minutes after the last administration, the mice were placed in a sealed bell jar (2000 ml) and 20 ml of SO2 gas was injected. The cough latency period and the number of coughs within 3 minutes were immediately observed and recorded. Data were statistically analyzed using SPSS 10.0 for Windows. Values ​​are expressed as mean ± standard deviation (X±SD). Results were analyzed using the t-test, with P < 0.05 considered statistically significant (Table 2).

[0044] Table 2. Effects of the drug of the present invention on ammonia-induced cough response in mice (X±SD)

[0045] Group Dosage (g / kg / d) Number of animals (individuals) Incubation period (s) Coughing frequency / 3min Model group distilled water 12 58.6±13.4 49.0±12.4 low-dose group of experimental drug 2.16 12 62.5±12.3 41.7±14.8 medium dose group of the test drug 4.32 12 73.7±25.1* 35.8±13.2* High-dose group of experimental drug 8.64 12 75.9±14.3* 37.1±10.9* Acute Bronchitis Syrup Group 4.5ml / kg / d 12 76.1±16.1* 37.3±11.4*

[0046] Note: Compared with the model group: *P<0.05, **P<0.01

[0047] As shown in Table 2, the medium and high dose groups of the test drug significantly prolonged the latency period of sulfur dioxide-induced cough in mice, which was statistically significant compared with the model group; the medium and high dose groups of the test drug significantly reduced the number of coughs induced by sulfur dioxide in mice, which was statistically significant compared with the model group; the low dose group of the test drug showed a trend of prolonging the latency period of sulfur dioxide-induced cough in mice and reducing the number of coughs in mice.

[0048] The above test results indicate that the drug used in this study has a good antitussive effect.

[0049] II. Experimental Study on Expectorant Effect

[0050] 2.1 Effect on phenol red secretion in mouse trachea

[0051] Sixty mice weighing 20–22 g (both male and female) were randomly divided into five groups: a model group (distilled water), small, medium, and large dose groups of the experimental drug (2.16, 4.32, and 8.64 g / kg / day, respectively), and a bronchodilator syrup group (4.5 ml / kg / day), with 12 mice in each group. The mice were administered the drug twice daily by gavage for three consecutive days. One hour after the last administration, a 0.5% phenol red saline solution (125 mg / kg) was injected intraperitoneally. Thirty minutes after the injection, the mice were euthanized by cervical dislocation, fixed in a dorsal position, and the skin was incised along the midline of the neck to expose the trachea. A thread was inserted under the cricoid cartilage for later use. A small incision was made in the trachea under the cricoid cartilage, and a tracheal irrigation needle was inserted centripetally to a depth of approximately 0.5 cm and then ligated and fixed. The trachea was flushed with 0.5 mL of 5% sodium bicarbonate solution, and the flushing was repeated slowly 10 times. The washes were combined and centrifuged. The supernatant was collected and the OD value was measured by a UV-Vis spectrophotometer. The OD value was used to indirectly represent the amount of phenol red excreted. SPSS 10.0 for Windows was used for statistical analysis. The values ​​are expressed as X±SD. The results were analyzed by t' test. P<0.05 was considered statistically significant (Table 3).

[0052] Table 3. Effects of the drug of the present invention on phenol red excretion in mouse trachea (X±SD)

[0053] Group Dosage (g / kg / d) Number of animals (individuals) Tracheal phenol red secretion (ug / ml) Model group distilled water 12 1.53±1.04 Low-dose group 2.16 12 2.41±1.12 In the trial, the dosage group 4.32 12 2.46±1.13* High-dose group in the experiment 8.64 12 2.48±1.01* Acute Bronchitis Syrup Group 4.5ml / kg / d 12 2.47±1.08*

[0054] Note: Compared with the model group: *P<0.05, **P<0.01

[0055] As shown in Table 3, the medium and high doses of the test drug significantly increased the amount of phenol red excreted from the trachea of ​​mice, which was statistically significant compared with the model group; the low dose group of the test drug showed a trend of increasing the amount of phenol red excreted from the trachea of ​​mice. This indicates that the test drug has an expectorant effect.

[0056] III. Experimental Study on Antipyretic Effect

[0057] 3.1 Effects of brewer's yeast on fever induced in rats

[0058] Rats weighing 200–250 g (both male and female) were used. Body temperature was measured three times on the day of the experiment. Fifty rats with body temperature fluctuations not exceeding 0.3℃ were selected and randomly divided into five groups: a model group (distilled water), small, medium, and large dose groups of the experimental drug (1.68, 3.36, and 6.72 g / kg / d, respectively), and an ibuprofen group (27.5 mg / kg / d). Each group consisted of ten rats. 0.6 ml / 100 g body weight of 10% fresh brewer's yeast was subcutaneously injected into the back of each rat. Rectal temperature was measured every hour. Drug administration began when the rectal temperature rose above 1.0℃, and was continued every hour for four consecutive hours after administration. Data were statistically analyzed using SPSS 10.0 for Windows. Values ​​are expressed as X±SD, and results were analyzed using the t' test. P < 0.05 was considered statistically significant (Table 4).

[0059] Table 4. Effects of the drug of the present invention on fever induced by brewer's yeast in rats (n=10, X±SD)

[0060]

[0061] Note: Compared with the model group: *P<0.05, **P<0.01

[0062] As shown in Table 4, the high, medium, and low dose groups in the experimental group significantly inhibited the rise in body temperature 2 hours after administration, with the high dose group showing the most significant effect, which was statistically significant compared with the model group. This indicates that the experimental drug has a good antipyretic effect.

[0063] IV. Experimental Study on its Propulsion Effect on the Digestive Tract

[0064] 4.1 Effects on small intestinal motility in mice

[0065] Sixty mice weighing 20–22 g (both male and female) were randomly divided into five groups: a model group (distilled water), small, medium, and large dose groups of the experimental drug (2.16, 4.32, and 8.64 g / kg / day, respectively), and a group receiving Jianpi Xiaoshi Wan (4.20 g / kg / day). Each group consisted of 12 mice. Mice were administered the drug once daily by gavage for three consecutive days. Mice that had been fasted for 24 hours were then given the drug plus 0.2 ml / 10 g of Evans blue solution. After 30 minutes, the mice were euthanized by cervical dislocation. The mesentery was separated from the abdominal cavity, and the intestinal segment from the pylorus to the ileocecal junction was cut and placed on a tray. The small intestine was stretched into a straight line, and its length was measured as the "total small intestine length." The distance from the pylorus to the leading edge of the Evans blue solution was taken as the "distance Evans blue propagated in the intestine." The percentage of Evans blue propulsion was calculated using the formula: "Small bowel propulsion percentage = Distance from pylorus to the front edge of Evans blue (cm) / Total length of small bowel (cm) × 100%". Statistical analysis was performed using SPSS 10.0 for Windows. Values ​​are expressed as mean ± SD. Results were analyzed using the t-test, with P < 0.05 considered statistically significant (Table 5).

[0066] Table 5. Effect of the drug of the present invention on the small intestinal propulsion rate in mice (X±SD)

[0067] Group Dosage (g / kg / d) Number of animals (individuals) Small intestinal propulsion rate (%) Model group distilled water 12 65.3±8.7 Low-dose group 2.16 12 78.4±6.2* In the trial, the dosage group 4.32 12 84.2±6.8* High-dose group in the experiment 8.64 12 82.8±5.2* Jianpi Xiaoshi Pills 4.20 12 82.6±4.7*

[0068] Note: Compared with the model group: *P<0.05, **P<0.01

[0069] As shown in Table 5, the large, medium, and small dose groups in the experimental group significantly improved the small intestinal propulsion rate, which was statistically significant compared with the model group. This indicates that the experimental drug has a promoting effect on small intestinal peristalsis.

[0070] 4.2 Effects on gastric emptying in mice

[0071] Sixty mice weighing 20–22 g (both male and female) were randomly divided into five groups: a model group (distilled water), small, medium, and large dose groups of the experimental drug (2.16, 4.32, and 8.64 g / kg / d, respectively), and a group receiving Jianpi Xiaoshi Pills (4.20 g / kg / d). Each group consisted of 12 mice. Fifty minutes after administration, each group was administered 0.1 ml / 10 g of 0.1% methyl orange solution by gavage. Twenty minutes later, the mice were euthanized by dislocation, and the stomach was removed and placed in a small beaker. 10 ml of distilled water was added, and the stomach was cut open along the greater curvature with small scissors. The stomach contents were thoroughly washed into the distilled water. The pH was adjusted to 6.0–6.5 with 5% sodium bicarbonate solution, and the contents were transferred to a graduated centrifuge tube and centrifuged at 2000 rpm for 10 minutes. The supernatant was collected and the optical density of the solution was measured using a 722s spectrophotometer, zeroed with distilled water. This measurement was taken as the optical density of methyl orange in the stomach. Take 0.2 ml of 0.1% methyl orange, add 10 ml of distilled water, shake well, and measure its optical density as the baseline methyl orange optical density. Calculate the methyl orange gastric residue rate according to the following formula: Methyl orange gastric residue rate (%) = (gastric methyl orange optical density / baseline methyl orange optical density) × 100%. Statistical analysis was performed using SPSS 10.0 for Windows. Values ​​are expressed as X ± SD. The results were analyzed using the t' test, and P < 0.05 was considered statistically significant (Table 6).

[0072] Table 6. Effects of the drug of the present invention on gastric emptying in mice (X±SD)

[0073] Group Dosage (g / kg / d) Number of animals (individuals) Methyl orange gastric residue rate (%) Model group distilled water 12 36.2±5.6 Low-dose group 2.16 12 33.3±5.9 In the trial, the dosage group 4.23 12 25.9±3.9* High-dose group in the experiment 8.46 12 24.8±4.7* Jianpi Xiaoshi Pills Group 4.20 12 25.7±5.3*

[0074] Note: Compared with the model group: *P<0.05, **P<0.01

[0075] As shown in Table 6, the high and medium dose groups of the test drug significantly reduced the gastric residual rate of methyl orange and promoted gastric motility, which was statistically significant compared with the model group; the low dose group of the test drug showed a trend of reducing the gastric residual rate of methyl orange. This indicates that the test drug has the effect of promoting gastric emptying in mice.

[0076] In summary, the test substance (test drug) significantly prolonged the cough latency period and reduced the frequency of coughing in experimental animals; significantly increased the amount of phenol red excreted from the trachea of ​​experimental animals; had a good antipyretic effect on fever induced by brewer's yeast in experimental animals; significantly increased the small intestinal propulsion rate and promoted small intestinal peristalsis in experimental animals; and significantly increased the gastric emptying rate in experimental animals. These findings suggest that the test substance has antitussive, expectorant, antipyretic, and gastrointestinal motility-promoting effects, providing a good pharmacodynamic basis for the clinical application of the drug composition of this invention in children with wind-cold type common cold with stagnation syndrome.

[0077] The following further clinical trial results demonstrate the beneficial effects of the present invention.

[0078] I. Materials and Methods

[0079] 1.1 General Information

[0080] Sixty children with symptoms of common cold with stagnation, admitted between October 2022 and April 2023, were randomly divided into an experimental group (n=30, 1 dropout, 29 actually enrolled) and a control group (n=30, 2 dropouts, 28 actually enrolled). The experimental group consisted of 12 males and 17 females, aged 1 to 8 years (mean 4.27 ± 0.32 years); the control group consisted of 10 males and 18 females, aged 1 to 8 years (mean 4.38 ± 0.41 years). There were no statistically significant differences in pre-treatment general characteristics between the two groups (P>0.05).

[0081] 1.2 Inclusion and Exclusion Criteria

[0082] 1.2.1 Inclusion criteria:

[0083] 1) The Western medical diagnosis is consistent with the diagnostic criteria for the common cold in "Pediatrics";

[0084] 2) The TCM diagnosis conforms to the "Guidelines for the Diagnosis and Treatment of Common Cold in Children with Traditional Chinese Medicine" and is used for children with wind-cold type common cold with stagnation syndrome, presenting with symptoms such as cough, chills, fever, nasal congestion and runny nose, loss of appetite, halitosis, abdominal distension, constipation or foul-smelling stool, and thick, greasy tongue coating. Main symptoms: cough, fever, loss of appetite, constipation or foul-smelling stool. Secondary symptoms: chills, nasal congestion and runny nose, halitosis, abdominal distension, thick, greasy tongue coating.

[0085] 3) Within 48 hours of onset.

[0086] 1.2.2 Exclusion criteria:

[0087] 1) Individuals in the early stages of acute infectious diseases: such as pharyngeal conjunctival fever, herpetic pharyngitis, measles, and roseola infantum;

[0088] 2) Those who experience convulsions or seizures;

[0089] 3) Those suffering from purulent tonsillitis;

[0090] 4) Patients with acute bronchitis.

[0091] 1.3 Preparation of decoctions and treatment methods

[0092] 1.3.1 Preparation of decoction:

[0093] Prescription: Honey-processed ephedra 5g, bitter almond 6g, mulberry bark 6g, lycium bark 9g, peppermint 5g (added later), dried tangerine peel 5g, areca peel 9g, malt 12g, licorice root 5g. Take 5 doses of the prescription, decoct according to standard methods, add appropriate amount of water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 20 minutes, filter the liquid; add appropriate amount of water again, bring to a boil over high heat, then simmer over low heat for 15 minutes, filter the liquid; combine the two decoctions (approximately 650-700ml) and divide into 130ml bags, containing approximately 62g of raw herbs. This decoction is slightly sweet, has a good taste, is easily accepted by children, and has good compliance.

[0094] 1.3.2 Treatment methods:

[0095] 1) Experimental group: Children take the above-mentioned decoction of the drug composition of the present invention. Children aged one to two years take 15ml once, children aged three to four years take 20ml once, children aged five to seven years take 30ml once, and children aged eight years and above take 40ml once; 3 times a day.

[0096] 2) Control group: Children took Xiaoji Zhike Oral Liquid for 1 to 2 years old, 10ml once, 15ml once, 20ml once, and 30ml once, for children over 8 years old; 3 times a day.

[0097] 1.3.3 Treatment course: 5 days.

[0098] 1.4 Efficacy Evaluation Criteria

[0099] 1.4.1 Clinical efficacy of the two groups: Referencing the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs"

[0100] 1) Cured: Symptoms and signs disappear, observation indicators return to normal, and total score decreases by ≥95%;

[0101] 2) Significant effect: Symptoms and signs disappear, observation indicators return to near normal, and total score decreases by ≥70%;

[0102] 3) Effective: Symptoms and signs partially disappear, but the observed indicators do not return to normal, and the total score decreases by ≥30% and <70%;

[0103] 4) Ineffective: If symptoms do not improve significantly or worsen, or if Western medicine is added, the total score decreases by <30%.

[0104] Overall treatment effectiveness rate = cure rate + significant effect rate + effective rate.

[0105] The cure rate = the cure rate + the efficacy rate.

[0106] 1.4.2 The time for the main symptoms to subside in the two groups: The time for the main symptoms of cough, fever, loss of appetite, constipation or foul-smelling stool to subside was compared.

[0107] 1.4.3 TCM syndrome scores for two groups: Referring to the "Guiding Principles for Clinical Research of New Chinese Medicines", the main symptoms of cough, fever, loss of appetite, constipation or foul-smelling stool were scored as 0, 2, 4 and 6 before and after treatment to indicate no condition, mild, moderate and severe condition.

[0108] Table 7. TCM Syndrome Scoring Table for Main Symptoms

[0109] Traditional Chinese Medicine Syndrome Scoring None (points) Mild (points) Moderate (points) Severe (minutes) cough 0 2 4 6 fever 0 2 4 6 Anorexia 0 2 4 6 Constipation or foul-smelling stool 0 2 4 6

[0110] 1.5 Statistical Methods

[0111] SPSS 20.0 statistical software was used. Count data were expressed as rates (%), and the chi-square test was performed for comparisons between groups. Continuous data were expressed as X±SD, and independent samples t-tests were performed for comparisons between groups and paired samples t-tests were performed for comparisons within groups. P<0.05 was considered statistically significant.

[0112] II. Results

[0113] 2.1 Clinical efficacy

[0114] After treatment, the total effective rate in the experimental group was 96.55%, and the total effective rate in the control group was 85.71%; the cure rate in the experimental group was 72.41%, and the cure rate in the control group was 57.14%; the cure rate in the experimental group was 86.21%, and the cure rate in the control group was 67.86%. All three differences were statistically significant (P<0.05), as shown in Table 8.

[0115] Table 8 Comparison of clinical efficacy between the two groups

[0116] Group Number of examples Overall efficiency Cure rate (%) Expected success rate (%) Significant efficiency (%) Effectiveness (%) Inefficiency (%) control group 28 24(85.71％) 16(57.14％) 19(67.86％) 3(10.71％) 5(17.85％) 4(14.28％) experimental group 29 28(96.55％)* 21(72.41％)* 25(86.21％)* 4(13.79％) 3(10.34％)* 1(03.44％)*

[0117] Note: Compared with the control group: *P<0.05, **P<0.01

[0118] 2.2 Time for main symptoms to subside

[0119] After treatment, the time for cough to subside, fever to subside, anorexia to subside, and constipation or foul-smelling stool to subside in the experimental group was earlier than that in the control group, and the differences were statistically significant (P<0.05), as shown in Table 9.

[0120] Table 9 Comparison of the time (days) for resolution of major symptoms between the two groups

[0121] Group Number of examples Cough subsides time Fever subsidence time Anorexia remission time Time for constipation or foul-smelling stool to subside control group 28 2.63±0.23 2.58±0.51 2.67±0.26 3.03±0.42 experimental group 29 2.35±0.53* 1.52±0.13* 2.02±0.37* 1.82±0.13*

[0122] Note: Compared with the control group: *P<0.05, **P<0.01

[0123] 2.3 Traditional Chinese Medicine Syndrome Scoring

[0124] After treatment, the scores of TCM syndromes such as cough, fever, loss of appetite, constipation or foul-smelling stool in the experimental group were significantly lower than those in the control group, and the difference was statistically significant (P<0.05), as shown in Table 10.

[0125] Table 10 Comparison of TCM syndrome scores between the two groups

[0126]

[0127] Note: Compared with the control group: *P<0.05, **P<0.01

[0128] III. Adverse Reactions

[0129] One child in each of the two groups experienced mild nausea and vomiting.

[0130] IV. Summary of Clinical Trials

[0131] The experimental group showed significant clinical efficacy in treating infantile common cold with stagnation syndrome, with a total effective rate of 96.55%, a cure rate of 72.41%, and a significant improvement rate of 86.21%. In the early stages, it promoted the resolution of clinical symptoms such as cough, fever, loss of appetite, constipation, or foul-smelling stools, and significantly improved the TCM syndrome. The difference compared to the control group was statistically significant, and no obvious adverse reactions were observed. This suggests that the drug composition (decoction) of this invention has the effects of clearing the lungs and relieving cough, regulating qi and resolving stagnation, and has good clinical application value in treating infantile common cold with stagnation syndrome.

[0132] The following specific clinical practice cases demonstrate the beneficial effects of the present invention.

[0133] Case 1: Yan XX, a 3.5-year-old boy, caught a cold after overeating while visiting relatives. He presented with chills, fever (38.2 degrees Celsius), cough, runny nose, loss of appetite, abdominal distension, and foul-smelling stools. The diagnosis was infantile common cold with stagnation syndrome. A prescription of 5 doses was given: 4g of honey-processed ephedra, 8g of bitter almond, 5g of mulberry bark, 7g of lycium bark, 7g of peppermint (added later), 7g of dried tangerine peel, 11g of areca peel, 14g of malt, and 6g of licorice. The above prescription was decocted using standard methods, with an appropriate amount of water added and soaked for 30 minutes. First, bring to a boil over high heat, then simmer over low heat for 20 minutes, and filter the liquid. Then, add an appropriate amount of water again, bring to a boil over high heat, then simmer over low heat for 15 minutes, and filter the liquid again. The two decoctions were combined and taken warm 3-4 times daily, approximately 20ml each time. After 2 days of treatment, the child's cough significantly decreased, chills improved, body temperature returned to normal, and the foul-smelling stool lessened. After 5 consecutive days of treatment, the above symptoms completely improved: cough disappeared, body temperature returned to normal, runny nose stopped, abdominal distension improved, appetite increased, and bowel movements returned to normal.

[0134] Case 2: Li XX, a 6-year-7-month-old girl, developed nasal congestion, runny nose, low-grade fever, cough, and constipation after catching a cold. She took antiviral granules at home for two days, but her condition did not improve; instead, her cough worsened and her temperature rose to 38.5 degrees Celsius. She sought medical attention promptly. She was diagnosed with pediatric wind-cold common cold with stagnation syndrome and was prescribed a 5-dose formula: Honey-processed ephedra 7g, bitter almond 5g, mulberry bark 8g, lycium bark 10g, peppermint 4g (added later), tangerine peel 4g, areca peel 7g, malt 10g, and licorice root 3g. Soak the above-mentioned prescription drugs in an appropriate amount of water for 30 minutes, bring to a boil over high heat, then simmer over low heat for 20 minutes, and filter out the liquid. Add an appropriate amount of water again, bring to a boil over high heat, then simmer over low heat for 15 minutes, and filter out the liquid. Combine the two liquids and take about 30 ml each time, 3-4 times a day. After 2 days of taking the medicine, the child's cough was significantly relieved, the body temperature dropped and basically returned to normal (37.0 degrees Celsius), nasal congestion and runny nose were reduced, and bowel movements improved. After taking the medicine for 5 consecutive days, the above symptoms were completely relieved, the body temperature returned to normal, the cough disappeared, the runny nose stopped, and the bowel movements returned to normal.

[0135] Case 3: Child Cheng XX, a boy, 5 years and 4 months old, usually has a good appetite and frequently experiences abdominal distension, constipation, or foul-smelling stools. This time, due to exposure to cold water, he developed a severe cough, expectoration of clear, thin white phlegm, nasal congestion and runny nose, halitosis, abdominal distension, loss of appetite, and foul-smelling stools. He was diagnosed with infantile common cold with wind-cold syndrome and given a prescription of 5 doses: Honey-processed ephedra 6g, bitter almond 7g, mulberry bark 6g, lycium bark 8g, peppermint 5g (added later), tangerine peel 6g, areca peel 8g, malt 10g, and licorice root 5g. Add an appropriate amount of water to the above-mentioned prescription drugs, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 20 minutes, and filter out the liquid; add an appropriate amount of water again, bring to a boil over high heat, then simmer over low heat for 15 minutes, and filter out the liquid; combine the two liquids, and take 3-4 times a day, about 30ml each time. After taking the medicine for 2 days, the child's cough improved significantly, abdominal distension improved significantly, nasal congestion and runny nose were reduced, and bowel movements basically returned to normal. After taking the medicine for 5 consecutive days, the above symptoms were completely improved, the cough disappeared, the runny nose stopped, the child's diet returned to normal, the abdominal distension disappeared, the child's appetite increased, and bowel movements returned to normal.

[0136] In summary, pharmacodynamic studies have shown that the pharmaceutical composition of this invention can significantly prolong the cough latency period and reduce the frequency of coughing in experimental animals; significantly increase the amount of phenol red excreted from the trachea of ​​experimental animals; have a good antipyretic effect on fever induced by brewer's yeast in experimental animals; significantly increase the small intestinal propulsion rate and promote small intestinal peristalsis in experimental animals; and significantly increase the gastric emptying rate in experimental animals, indicating that the composition of this invention has antitussive, expectorant, antipyretic, and gastrointestinal motility-promoting effects. Further clinical trial results show that the composition (decoction) of this invention has significant clinical efficacy in treating pediatric colds with stagnation syndrome. In the early stages, it can promote the resolution of clinical symptoms such as cough, fever, anorexia, constipation, or foul-smelling stools in children, significantly improve TCM syndromes, and has no obvious adverse reactions; indicating that the composition of this invention has the effects of clearing the lungs and relieving cough, regulating qi and resolving stagnation, and is effective in treating pediatric colds with stagnation syndrome, with good clinical application value and market prospects.

[0137] Although the invention has been described herein with reference to illustrative embodiments, it should be understood that many other modifications and implementations can be devised by those skilled in the art, which will fall within the scope and spirit of the principles disclosed herein. More specifically, various variations and modifications can be made to the components and / or layout of the subject matter combination within the scope of this disclosure. Besides variations and modifications to the components and / or layout, other uses will be apparent to those skilled in the art.

Claims

1. A pharmaceutical composition for treating wind-cold type common cold with stagnation in children, characterized in that: It is a preparation prepared from effective components and pharmaceutically acceptable adjuvants, wherein the effective components are prepared from raw medicinal materials with the following weight ratio: ​ Ephedrae herba 5 parts, Amygdali amara 6 parts, Mori Cortex 6 parts, Lycii Radicis Pericarpium 9 parts, Herba Menthae 5 parts, Citri Reticulatae Pericarpium 5 parts, Pericarpium Arecae 9 parts, Hordei Fructus 12 parts, Glycyrrhizae Radix 5 parts.

2. The pharmaceutical composition of claim 1, wherein: The preparation is an oral drug preparation absorbed through the gastrointestinal tract.

3. A process for the preparation of a pharmaceutical composition as claimed in claim 1, characterized in that: It comprises the following operation steps: (1) weighing raw medicinal materials according to the weight ratio; (2) extracting the raw medicinal materials with water, combining the extract, concentrating, and preparing the preparation.

4. A process for the preparation of a pharmaceutical composition according to claim 1, characterized in that: It comprises the following operation steps: (1) weighing raw medicinal materials according to the weight ratio; (2) extracting the raw medicinal materials with water, collecting the distilled volatile oil at the same time, combining the extract, concentrating the extract, and preparing the preparation with the volatile oil.

5. A process for the preparation of a pharmaceutical composition according to claim 1, characterized in that: It comprises the following operation steps: (1) weighing raw medicinal materials according to the weight ratio; (2) distilling volatile oil from Herba Menthae and Citri Reticulatae Pericarpium, extracting the rest of the raw medicinal materials with water, combining the extract, concentrating the extract, and preparing the preparation with the volatile oil.

6. A process for the preparation of a pharmaceutical composition according to claim 1, characterized in that: Extracting the raw medicinal materials with water, collecting the distilled volatile oil at the same time, combining the extract, concentrating the extract, adding ethanol for precipitation, removing ethanol from the supernatant, and preparing the preparation with the volatile oil.

7. Use of the pharmaceutical composition of claim 1 in the preparation of a medicine for preventing and treating infantile wind-cold cold with stagnation.

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