A sleep-aiding and growth-aiding traditional Chinese medicine composition, a preparation method thereof and application thereof

By preparing a sleep-aiding and growth-promoting composition containing traditional Chinese medicines such as Astragalus membranaceus, stir-fried Atractylodes macrocephala, and Citrus reticulata peel, the problems of expensive and risky Western medical treatments and limited efficacy of traditional Chinese medicines have been solved. This composition has achieved the effects of improving sleep, reducing growth retardation and adenoid hypertrophy, and promoting growth hormone secretion.

CN119499340BActive Publication Date: 2025-11-21FOSHAN GAOMING DISTRICT HOSPITAL OF TRADITIONAL CHINESE MEDICINE
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Patent Information

Application Number
CN202411547446.6
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-11-01
Publication Date
2025-11-21
Estimated Expiration
2044-11-01

AI Technical Summary

Technical Problem

In existing technologies, Western medicine's growth hormone therapy is expensive and carries health risks, while traditional Chinese medicine compositions such as anti-allergy growth-promoting ointments have limited growth-promoting effects and cannot effectively improve problems such as poor sleep quality, growth retardation, short stature, and adenoid hypertrophy.

Method used

A traditional Chinese medicine composition for promoting sleep and growth is provided, which is composed of Chinese medicinal materials such as Astragalus membranaceus, stir-fried Atractylodes macrocephala, Citrus reticulata peel, and Codonopsis pilosula. It promotes the secretion of growth hormone, improves sleep quality, and treats growth retardation and adenoid hypertrophy by strengthening the spleen and kidneys, clearing the mind and calming the nerves.

Benefits of technology

It achieves the effect of simultaneously improving poor sleep quality, growth retardation and short stature, susceptibility to colds and adenoid hypertrophy, playing a role in treating multiple diseases with one medicine, promoting growth hormone secretion, enhancing immunity, and inhibiting adenoid hypertrophy and fibrosis.

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Abstract

The application discloses a traditional Chinese medicine composition for helping sleep and growth, which is mainly made of the following traditional Chinese medicine raw materials in a certain proportion: 10-30g of Huangqi, 5-15g of fried Baishu, 2-8g of Chenpi, 10-20g of Dangshen, 5-15g of Shengma, 2-8g of Chaihu, 2-8g of Dangui, 10-30g of Shengdi, 5-15g of Zhigancao, 10-20g of Huishan, 5-15g of Danpi, 5-15g of Zexie, 5-15g of Shanzhu, 1-5g of Rougui, 5-15g of Fuling, 2-8g of Roudoukou, 5-15g of Muxiang, 1-5g of Huanglian, 2-8g of Sharen, 5-15g of Shanzha, 5-15g of Shenqu, 5-15g of fried Maiya and 5-15g of fried Maiya. Correspondingly, the application further discloses a preparation method and application of the traditional Chinese medicine composition for helping sleep and growth. By adopting the application, the traditional Chinese medicine composition can simultaneously treat poor sleep quality, growth retardation, short stature, cold constitution and adenoid hypertrophy, and can treat multiple diseases by using one medicine.
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Description

TECHNICAL FIELD

[0001] The present application relates to the field of medicine, in particular to a sleep-aiding and growth-aiding traditional Chinese medicine composition, a preparation method and application thereof. BACKGROUND

[0002] With the enrichment of material and cultural life and the improvement of medical level, parents pay more and more attention to the height of children. More and more parents take children to pediatricians for consultation due to short stature. However, the attention paid to children with growth retardation, short stature and not meeting the diagnostic criteria of short stature is far less than that paid to children with short stature.

[0003] Growth retardation refers to the height of a child being lower than the 3rd percentile of the height standard of Chinese children of the same age and gender. Short stature is defined as the height of a child being between one standard deviation (or the 25th percentile) and two standard deviations (or the 3rd percentile) lower than the average height of normal children of the same age, race and gender. Children with short stature, except for those not meeting the diagnostic criteria of short stature, are similar to children with idiopathic short stature. They are also inevitably prone to negative emotions such as self-abasement and negative attitude, which can gradually evolve into psychological disorders with age, thereby seriously affecting the physical and mental health of the children. If not corrected in time, short stature can further develop into short stature, ultimately leading to impaired adult height of the children.

[0004] Growth retardation and short stature in children are the result of the combined effects of genetic factors, nutritional status, diseases and other factors. Factors affecting the growth of children can be roughly divided into two categories: congenital and acquired. Congenital factors mainly include genetic expression, hormonal environment, etc., and acquired factors mainly include economic development, medical level, child care, environmental factors, etc. Among them, environmental factors including exercise, diet and sleep have a great impact on the growth potential of children.

[0005] Currently, Western medicine mainly uses injection of growth hormone to promote the growth and development of children and adolescents and increase their height, but the effect is limited, has no positive effect on food intake, sleep and mood, is expensive and has potential health risks. Traditional Chinese medicine mainly supplements through diet, such as milk, eggs, meat with high protein content, etc., and can also take some growth-aiding traditional Chinese medicines.

[0006] For example, the prior art 1 is Professor Ju Wei's Experience in Treating Food Allergy-induced Growth Retardation in Children with Anti-allergic Growth Paste, Duan Fengyang, Chinese Medicine Research, August 2023, Vol. 36, No. 8. It discloses an anti-allergic growth paste that can treat food allergy-induced growth retardation in children. The anti-allergic growth paste is composed of Dangshen, Huangqi, Fried Baizhu, Baishao, Fuling, Shanyao, Bai Douchi, Shengdihuang, Jiushanyu, Huangjing, Tianzhu, Sangjisheng, Gouji, Xuduan, Niuxi, Gushugu, Wumei, Wuyizi, Danggui, Chuanmiao, Shencheng, Qianqi, Shiliu, Sandan, Chenpi, Chaozhisheng, Lugen, Zhimu, Zhigancao, Ejiao, Guijiajiao, and Honey.

[0007] The above anti-allergic growth paste formula contains Dangshen, Huangqi, and Shengdihuang, which tonify the lung, invigorate the spleen, and nourish the kidney, serving as the monarch drug. Fried Baizhu and Fuling invigorate the spleen, eliminate dampness, and calm the heart. Shanyao and Bai Douchi tonify the lung and spleen together. Wumei and Wuyizi astringe the lung and generate fluid. Shiliu and Macel removes food stagnation. Jiushanyu, Longyanrou, and Huangjing nourish the kidney and essence. Sangjisheng, Gushugu, and Gouji tonify the kidney, strengthen the tendon, and strengthen the bone. These are all the ministerial drugs. Qianqi, Shiliu, Xuduan, and Niuxi nourish the kidney and strengthen the bone. Danggui, Chuanmiao, and Shencheng activate blood and unblock the collaterals. Shencheng, Sangzhi, and Shengzhi relax the tendon and unblock the collaterals. Sandan and Chenpi invigorate the spleen, eliminate dampness, and regulate the stomach. Chaozhisheng moves qi and widens the middle. Zhimu, Baishao, Lugen, and Tianzhu tonify the lung, spleen, and kidney to prevent the excessive dryness of the drugs from damaging the yin. These are all the auxiliary drugs. Zhigancao invigorates the spleen and harmonizes the center, serving as the ministerial drug. Ejiao tonifies the lung and nourishes the blood. Guijiajiao and Honey nourish the yin and moisten the lung, serving as the auxiliary materials. The combination of all the drugs tonifies the lung, invigorates the spleen, nourishes the kidney, benefits the qi, strengthens the bone, and promotes growth. For repeated respiratory tract infections and cough, add Dongwengxue, Baihe, and Baibu to regulate and tonify the lung qi, benefit the lung, and stop cough. For accumulation and constipation, add Chaoqianniaoczi, Zexie, and Binlang to regulate qi, eliminate stagnation, move qi, and remove stagnation. For repeated rashes, add Xianhecao, Xiancao, and Dikucizi to clear heat, cool blood, eliminate dampness, and stop itching.

[0008] However, the above anti-allergic growth paste is aimed at food allergy-induced growth retardation, and its growth-promoting effect is limited, with a narrow application range, and it cannot well improve the problem of short stature.

[0009] On the other hand, students in today's society have great academic pressure, poor sleep quality, poor physical fitness, and are prone to repeated colds, which is also a problem that cannot be ignored. Repeated colds can easily induce adenoid hypertrophy, and the main cause of adenoid hypertrophy is repeated acute and chronic nasopharyngitis, or inflammation of the nasal cavity, sinuses, tonsils, etc., affecting the nasopharynx, stimulating adenoid tissue proliferation. Children can have ear, nose and throat symptoms due to adenoid hypertrophy blocking the posterior naris and eustachian tube pharynx. Manifestations include mouth breathing during sleep, tongue root falling back, often snoring, sleeplessness, nasal secretions, and closed nasal tone when speaking, and speech is unclear. In addition, it may also cause respiratory tract mucosa to be stimulated by secretions flowing down, making it prone to bronchitis; non-suppurative otitis media caused by blocked eustachian tube can cause hearing loss, tympanic membrane retraction and other symptoms. Long-term adenoid hypertrophy can also affect the development of the maxillofacial bones, resulting in adenoid facies, i.e., maxillofacial dysplasia, maxillary bone elongation, high arch of the hard palate, uneven dentition, exposed upper incisors, thick lips, and lack of facial expression.

[0010] The treatment of adenoid hypertrophy mainly includes drug therapy and surgical treatment: 1. Drug therapy: For mild adenoid hypertrophy, doctors may use anti-inflammatory drugs and nasal spray hormones to treat the disease to reduce inflammation and relieve symptoms. 2. Surgical treatment: When adenoid hypertrophy causes severe respiratory obstruction, hearing loss, or recurrent secretory otitis media, doctors may recommend adenoidectomy. At present, the main surgical methods are endoscopic resection under general anesthesia and radiofrequency ablation. SUMMARY

[0011] The technical problem to be solved by the present application is to provide a traditional Chinese medicine composition for sleep aid and growth promotion, which can simultaneously treat poor sleep quality, growth retardation, short stature, susceptibility to colds, and adenoid hypertrophy, and has outstanding curative effects.

[0012] The technical problem to be solved by the present application is to provide a method for preparing the traditional Chinese medicine composition.

[0013] The technical problem to be solved by the present application is to provide a method for preparing the traditional Chinese medicine composition.

[0014] To achieve the above technical effects, the present application provides a traditional Chinese medicine composition for sleep aid and growth promotion, which is mainly prepared from the following weight ratio of traditional Chinese medicine raw materials:

[0015] Radix Astragali 10-30g, Fried Rhizoma Atractylodis 5-15g, Pericarpium Citri Reticulatae 2-8g, Radix Codonopsis 10-20g, Radix Coptidis 5-15g, Radix Angelicae Sinensis 2-8g, Radix Rehmanniae 10-30g, Fried Radix Glycyrrhizae 5-15g, Fructus Mori 10-20g, Radix Paeoniae Alba 5-15g, Rhizoma Alismatis 5-15g, Fructus Corni 5-15g, Cinnamomum Cassia 1-5g, Poria 5-15g, Myristica 2-8g, Radix Aucklandiae 5-15g, Fructus Crataegi 5-15g, Massa Medicata Fermentata 5-15g, Fried Fructus Hordei 5-15g.

[0016] As an improvement of the above-mentioned scheme, the sleep-aiding and growth-promoting traditional Chinese medicine composition is mainly made of the following weight-proportioned traditional Chinese medicine raw materials: Radix Astragali 15-25g, Fried Rhizoma Atractylodis 8-12g, Pericarpium Citri Reticulatae 3-6g, Radix Codonopsis 12-18g, Radix Coptidis 8-12g, Radix Angelicae Sinensis 3-6g, Radix Rehmanniae 15-25g, Fried Radix Glycyrrhizae 8-12g, Fructus Mori 12-18g, Radix Paeoniae Alba 8-12g, Rhizoma Alismatis 8-12g, Fructus Corni 8-12g, Cinnamomum Cassia 2-4g, Poria 8-12g, Myristica 3-6g, Radix Aucklandiae 8-12g, Fructus Crataegi 8-12g, Massa Medicata Fermentata 8-12g, Fried Fructus Hordei 8-12g.

[0017] As an improvement of the above-mentioned scheme, the sleep-aiding and growth-promoting traditional Chinese medicine composition is mainly made of the following weight-proportioned traditional Chinese medicine raw materials:

[0018] Radix Astragali 20g, Fried Rhizoma Atractylodis 10g, Pericarpium Citri Reticulatae 5g, Radix Codonopsis 15g, Radix Coptidis 10g, Radix Angelicae Sinensis 5g, Radix Rehmanniae 20g, Fried Radix Glycyrrhizae 10g, Fructus Mori 15g, Radix Paeoniae Alba 10g, Rhizoma Alismatis 10g, Fructus Corni 10g, Cinnamomum Cassia 3g, Poria 10g, Myristica 5g, Radix Aucklandiae 10g, Fructus Crataegi 10g, Massa Medicata Fermentata 10g, Fried Fructus Hordei 10g.

[0019] Correspondingly, the application also provides a preparation method of the sleep-aiding and growth-promoting traditional Chinese medicine composition, comprising:

[0020] A. weighing each traditional Chinese medicine raw material according to the prescription and soaking;

[0021] B. extracting and concentrating each traditional Chinese medicine raw material to obtain the finished product.

[0022] Correspondingly, the application also provides an application of the sleep-aiding and growth-promoting traditional Chinese medicine composition in preparing a medicine for preventing and / or treating insomnia.

[0023] Correspondingly, the application also provides an application of the sleep-aiding and growth-promoting traditional Chinese medicine composition in preparing a medicine for treating growth retardation, short stature and / or dwarfism.

[0024] Correspondingly, the application also provides application of the sleep-aiding and growth-aiding traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating adenoid hypertrophy in children.

[0025] As an improvement of the above-mentioned scheme, the medicine is an oral preparation, and the oral preparation is a paste, a decoction, a powder, a capsule, a tablet, a granule or a pill.

[0026] As an improvement of the above-mentioned scheme, the medicine comprises a pharmaceutically acceptable auxiliary material, and the auxiliary material is one or more of a disintegrating agent, an emulsifying agent, a filling agent, a flavoring agent, a humectant and a solubilizer.

[0027] The implementation of the application has the following beneficial effects:

[0028] The application strengthens the spleen and the kidney, clears the heart and tranquilizes the mind to aid growth, and uses Huangqi, Chao Baizhu, Chenpi, Zhigancao, Shanyao to strengthen the spleen and the lung, Dangshen and Dangui to regulate and supplement qi and blood, and Fuling, Muxiang, Huanglian, Sharen, Shanzha, Shenqu, Maidu, Roudoukou to strengthen the spleen and the stomach, remove food retention, stop diarrhea and other functions, and then uses Shengdi to combine with Shanzhu, Mudanpi and Zexie to protect the original constitution, nourish the kidney, produce marrow and strengthen bones, and then uses Rougui to warm the kidney water to lead the fire downward, and uses Huanglian to clear the heart and reduce the fire, so that the heart fire is reduced, the heart and the kidney are connected, sleep is strengthened, sleep quality is improved, and the secretion of growth hormone is promoted.

[0029] In addition to the good sleep-aiding and growth-aiding effects, the application can also improve the cold-susceptible constitution and has outstanding curative effects on adenoid hypertrophy.

[0030] In summary, the application can have outstanding curative effects on poor sleep quality, growth retardation, short stature, cold-susceptible constitution and adenoid hypertrophy at the same time, and can play the role of treating multiple diseases with one medicine. BRIEF DESCRIPTION OF DRAWINGS

[0031] Figure 1 The figure is a flow chart of the preparation method of the traditional Chinese medicine composition in the application. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical scheme and advantages of the application more clear, the application will be further described in detail below with reference to the drawings.

[0033] The application provides a sleep-aiding and growth-aiding traditional Chinese medicine composition, which is mainly made of the following weight-proportioned traditional Chinese medicine raw materials:

[0034] Radix Astragali 10-30g, Fried Atractylodes 5-15g, Pericarpium Citri Reticulatae 2-8g, Codonopsis 10-20g, Cimicifuga 5-15g, Bupleurum 2-8g, Angelica 2-8g, Radix Rehmanniae 10-30g, Fried Licorice 5-15g, Shanyan 10-20g, Danpi 5-15g, Alisma 5-15g, Cornus 5-15g, Cinnamon 1-5g, Poria 5-15g, Nutmeg 2-8g, Costus 5-15g, Coptis 1-5g, Amomum 2-8g, Hawthorn 5-15g, God's Dough 5-15g, Fried Malt 5-15g.

[0035] Preferably, the sleep-aiding and growth-promoting traditional Chinese medicine composition is mainly made of the following weight-proportioned traditional Chinese medicine raw materials: Radix Astragali 15-25g, Fried Atractylodes 8-12g, Pericarpium Citri Reticulatae 3-6g, Codonopsis 12-18g, Cimicifuga 8-12g, Bupleurum 3-6g, Angelica 3-6g, Radix Rehmanniae 15-25g, Fried Licorice 8-12g, Shanyan 12-18g, Danpi 8-12g, Alisma 8-12g, Cornus 8-12g, Cinnamon 2-4g, Poria 8-12g, Nutmeg 3-6g, Costus 8-12g, Coptis 2-4g, Amomum 3-6g, Hawthorn 8-12g, God's Dough 8-12g, Fried Malt 8-12g.

[0036] More preferably, the sleep-aiding and growth-promoting traditional Chinese medicine composition is mainly made of the following weight-proportioned traditional Chinese medicine raw materials:

[0037] Radix Astragali 20g, Fried Atractylodes 10g, Pericarpium Citri Reticulatae 5g, Codonopsis 15g, Cimicifuga 10g, Bupleurum 5g, Angelica 5g, Radix Rehmanniae 20g, Fried Licorice 10g, Shanyan 15g, Danpi 10g, Alisma 10g, Cornus 10g, Cinnamon 3g, Poria 10g, Nutmeg 5g, Costus 10g, Coptis 3g, Amomum 5g, Hawthorn 10g, God's Dough 10g, Fried Malt 10g.

[0038] In the sleep-aiding and growth-promoting traditional Chinese medicine composition, Radix Astragali is sweet in taste and warm in nature, and is meridian-entering lung and spleen, with the functions of tonifying qi, consolidating the exterior, promoting diuresis, removing toxin, discharging pus, and astringing and healing. Modern research has found that it contains various effective components such as glycosides, flavonoids, polysaccharides, amino acids, and trace elements, which have important guiding significance for clinical treatment. Modern research has found that Radix Astragali has various pharmacological effects, such as inhibiting inflammation, removing free radicals, inhibiting vascular endothelial monolayer permeability, protecting the cardiovascular and cerebrovascular systems, improving immunity, and resisting tumors.

[0039] Fried Atractylodes is bitter and sweet in taste and warm in nature, and is meridian-entering spleen and stomach, with the functions of invigorating the spleen and benefiting qi, drying dampness and promoting diuresis, stopping sweating, and securing the fetus. Atractylodes contains various chemical components, including sesquiterpenes and lactones, flavonoids, phenylpropanoids, alkynes and their glycosides, polysaccharides, etc. Modern pharmacological research has shown that Atractylodes has the pharmacological effects of anti-inflammatory, anti-tumor, improving gastrointestinal function, regulating the urinary system, improving nerve function, improving immunity, exciting uterine smooth muscle, and lowering blood lipids and blood sugar.

[0040] Pericarpium Citri Reticulatae, bitter, pungent, warm, lung and spleen meridian, has the effect of regulating qi and invigorating the spleen, drying dampness and reducing phlegm. Modern pharmacological studies have shown that Pericarpium Citri Reticulatae contains volatile oil, hesperidin, vitamin B, C and other ingredients, which can regulate gastrointestinal motility, promote gastric juice secretion, antioxidant, expectorant and asthma, etc.

[0041] Codonopsis, sweet, flat, spleen and lung meridian; has the effect of invigorating the spleen and lung, nourishing blood and generating fluid. Modern pharmacological studies have shown that Codonopsis contains triterpenoids, volatile oil, saponins, trace of alkaloids, polysaccharides, aspartic acid, 17 kinds of amino acids, 4 kinds of human essential macroelements (K, Na, Ca, Mg) and 7 kinds of human essential trace elements. It can regulate the stomach and intestines, protect the gastric mucosa, promote the healing of gastric ulcer, increase the body's immune function, improve the body's anti-stress ability, increase the number of red blood cells, white blood cells and hemoglobin content, inhibit platelet aggregation, strengthen the heart, regulate blood pressure, anti-myocardial ischemia, improve learning and memory, antibacterial and other effects.

[0042] Cimicifuga, bitter, slightly sweet, slightly cold, lung, spleen, stomach and large intestine meridian. It has the effect of releasing and removing rash, clearing heat and resolving toxin, and lifting yang qi. Modern pharmacological studies have shown that Cimicifuga contains a variety of sterol components: β-sitosterol, cimicifugol, cimicifugol xylose, and other components. In addition, it also contains isovanillic acid, trace of vanillic acid, caffeic acid, and furan coumarin components such as odonatol and odonatol. It has the physiological activities of inhibiting nucleotide transport, anti-virus, anti-tumor, regulating neuroendocrine function, anti-osteoporosis, and anti-inflammatory.

[0043] Radix Bupleuri, bitter, pungent, slightly cold. Liver, gallbladder and lung meridian, has the effect of dispersing and removing heat, soothing the liver and relieving depression, and lifting yang qi. Modern pharmacological studies have shown that Radix Bupleuri contains saikosaponin, sterol, volatile oil, fatty oil and polysaccharide, etc. In addition, it also contains alkaloids, flavonoids, artemisin, glucose, amino acids, etc. Pharmacological experiments have shown that Radix Bupleuri has anti-inflammatory, antipyretic, sedative, analgesic, antitussive and anticonvulsant effects; can reduce liver damage and promote bile secretion; has the effects of lowering blood pressure, reducing serum cholesterol and hemolysis; has the effects of anti-ulcer, antibacterial, antiviral, antitumor, increasing blood sugar, reducing blood fat content, and anti-radiation damage.

[0044] Angelica, sweet, pungent, warm, liver, heart and spleen meridian, has the effect of tonifying blood, regulating menstruation and relieving pain, and moistening the intestines and defecation. Modern pharmacological studies have shown that the main chemical components of Angelica are volatile oil, organic acids, polysaccharides and coumarins, etc., among which volatile oil and polysaccharides are the main active substances of Angelica. Angelica has the physiological activities of promoting hematopoiesis, anti-coagulation, lowering blood pressure, anti-inflammatory and analgesic, anti-oxidation, anti-tumor, liver and kidney protection, etc.

[0045] Rehmanniae Radix, cold in nature, sweet and bitter in flavor, is attributed to the heart, liver and kidney channels, and has the effects of clearing heat and cooling blood, nourishing yin and generating fluid. Rehmanniae Radix mainly contains iridoid glycosides, benzene glycols and phenylethanoid glycosides, in addition to triterpenes, flavonoids, lignans, phenolic acids and other compounds. Pharmacological studies have shown that Rehmanniae Radix has significant regulatory effects on the blood system, cardiovascular system, central nervous system and immune system, and also has the effects of regulating blood sugar and blood lipids, anti-aging, anti-tumor, antibacterial, anti-gastric ulcer and protecting gastric mucosa.

[0046] Radix Glycyrrhizae Preparata, sweet in flavor and neutral in nature, is attributed to the heart, lung, spleen and stomach channels, and has the effects of tonifying the spleen and stomach and benefiting qi and restoring pulse. Glycyrrhizae Radix has more than 400 chemical compounds, including flavonoids, triterpenes, coumarins and stilbenes. Modern pharmacological studies have shown that Radix Glycyrrhizae Preparata has a wide range of pharmacological effects, such as anti-tumor, anti-inflammatory, antibacterial, anti-viral, neuroprotective and liver protection.

[0047] Radix Dioscoreae, sweet in flavor and neutral in nature, is attributed to the spleen, lung and kidney channels, and has the effects of tonifying the spleen and stomach, generating fluid, benefiting the lung and tonifying the kidney. Modern pharmacological studies have shown that Dioscoreae Radix is rich in nutrients such as saponins, mucilage, choline, starch, sugars, proteins, amino acids, vitamin C and various trace elements, making it an ideal food for convalescence. Dioscoreae Radix contains amylase and polyphenol oxidase, which is beneficial to the digestive and absorptive function of the spleen and stomach; it also contains a large amount of mucoprotein, vitamins and trace elements, which can lower blood sugar, prevent blood lipid deposition in blood vessel walls and prevent cardiovascular diseases; it can also promote the proliferation of T lymphocytes, enhance immune function, delay cell aging and prolong life.

[0048] Cortex Moutan, bitter and pungent in flavor and slightly cold in nature, is attributed to the heart, liver and kidney channels, and has the effects of clearing heat and cooling blood, promoting blood circulation and removing blood stasis. Modern pharmacological studies have shown that Cortex Moutan contains a variety of chemical components, including phenolic and glycoside components, monoterpenes and their glycosides, triterpenes, organic acids, flavonoids and coumarins, in addition to a large amount of polysaccharides and volatile oils. Cortex Moutan has a variety of effects, such as strong antibacterial and anti-inflammatory, anti-tumor, anti-arrhythmic, hypoglycemic, immune system activation and cardiovascular protection.

[0049] Alisma Orientalis, sweet and bland in flavor and cold in nature, is attributed to the kidney and bladder channels, and has the effects of promoting water excretion, removing dampness, reducing heat and resolving turbidity. Alisma Orientalis mainly contains alisol A and B acetate, in addition to volatile oils, alkaloids, asparagin, choline, lecithin and fatty acids. Modern pharmacological studies have confirmed that Alisma Orientalis has obvious diuretic effects, and also has the effects of lowering blood lipids, lowering blood pressure, dilating coronary arteries, relieving cough, reducing sputum, preventing fatty liver, preventing blood clotting and preventing cancer.

[0050] Cornus officinalis, bitter, slightly warm, liver, kidney. Has the effect of invigorating the liver and kidney, astringent. Modern pharmacological studies show that the main chemical components of cornus officinalis polysaccharide, ring ene furan, mushroom, etc., have hypoglycemic, anti-inflammatory, antioxidant, anti-aging, anti-tumor, neuroprotective, liver and kidney protection and other pharmacological activities.

[0051] Cinnamomum cassia, bitter, sweet, hot, kidney, spleen, heart, liver, main effect of warming blood, fire, Yang, dispelling cold pain. Cinnamon contains volatile components such as cinnamyl aldehyde and non-volatile components such as polysaccharides, diterpenes, polyphenols, flavonoids. Modern pharmacological studies show that cinnamon has antibacterial, antioxidant, anti-inflammatory, anticancer, hypoglycemic and other biological activities.

[0052] Poria cocos, sweet, neutral, has the effect of water and dampness, spleen, heart. Modern research shows that the main chemical components of Poria cocos are terpenes, polysaccharides, sterols, fatty acids, etc., which can play the roles of anti-tumor, anti-inflammatory, antioxidant, liver protection, immune regulation, etc.

[0053] Myristica, bitter, warm. Spleen, stomach, large intestine. Has the effect of warming the center, moving qi, astringent intestine and stopping diarrhea. Modern pharmacological research shows that myristica mainly contains volatile oil, fatty oil, lignans and other components, not only plays a role in the treatment of digestive system diseases such as liver protection, anti-gastric ulcer and antidiarrheal, but also has the pharmacological effects of regulating the nervous system and cardiovascular, reducing blood sugar, anti-cancer, anti-inflammatory analgesia, etc.

[0054] Saussurea, bitter, warm, spleen, stomach, large intestine, Sanjiao, gallbladder, has the effect of qi and pain, spleen and food digestion. Saussurea mainly contains volatile oil, modern pharmacological research shows that Saussurea has the effects of improving gastrointestinal function, promoting gallbladder contraction, anti-inflammatory, anti-ulcer, anti-tumor, improving myocardial infarction and angina, etc.

[0055] Berberis, bitter, cold, heart, spleen, stomach, liver, gallbladder, large intestine, has the effect of clearing heat and dampness, purging fire and detoxification. Its chemical components mainly include alkaloids, lignans, flavonoids, acidic components, etc. Modern pharmacological research shows that Berberis has the pharmacological effects of protecting cardiovascular and cerebrovascular, reducing blood sugar, anti-inflammatory, anti-tumor, etc.

[0056] Amomum, warm, bitter, spleen, stomach, kidney, has the effect of wetting and opening the stomach, warming the spleen and stopping diarrhea, regulating qi and stabilizing the fetus. Amomum mainly contains volatile oil components such as borneol and camphor. Modern pharmacological research shows that this product has the effects of anti-ulcer, inhibiting gastric acid secretion, promoting gastrointestinal movement, inhibiting platelet aggregation, analgesia, anti-inflammatory, cholagogic, antioxidant, immune function regulation, etc.

[0057] Hawthorn, warm, sweet, sour, spleen, stomach, liver, with the function of digestion and digestion of food stagnation, qi and blood stasis. Modern pharmacological studies have found that hawthorn mainly contains flavonoids, including hypericin, quercetin, flavonoid polymers; organic acids, including citric acid, hawthorn acid, etc., also contains lactone, sugar and glycosides. Modern pharmacological studies have found that hawthorn has the effects of promoting fat digestion, protecting the heart, lowering blood pressure, lowering lipid, antioxidant, improving immunity, antibacterial, anti-tumor and other effects.

[0058] God's recipe, sweet, pungent, warm. Spleen, stomach. Has the effect of strengthening the spleen and stomach, digestion and accumulation. Studies have shown that God's recipe mainly contains yeast, enzymes, vitamin B complex, ergosterol, volatile oil, glycosides and other chemical components. Modern pharmacological studies have shown that God's recipe has the effects of promoting gastrointestinal peristalsis, improving appetite, regulating intestinal flora, enhancing immune function, antibacterial, protecting the intestinal tract, and stopping diarrhea.

[0059] Fried wheat, sweet, flat, spleen, stomach, with the effect of promoting digestion, spleen and stomach, back milk and swelling.

[0060] The chemical components of malt mainly include polysaccharides, enzymes, alkaloids, vitamins, amino acids, proteins, flavonoids, folic acid, phenols and other chemical components. Modern pharmacological studies have shown that malt has antioxidant, anti-tumor, back milk, lactation, digestion, regulation of intestinal flora, liver protection, hypoglycemic, anti-inflammatory and other functional activities.

[0061] Traditional Chinese medicine believes that the growth and development of the human body is closely related to the function of the spleen and kidney. Spleen is responsible for transportation and digestion, and its main function is to digest and absorb food to provide sufficient nutrients for the body. Kidney is responsible for bone marrow and promotes the growth and development of bones. If the function of the spleen and kidney is out of balance, it will affect the growth and development of children. Therefore, strengthening the spleen and kidney is of great significance to promote the growth of children.

[0062] The sleep and growth promoting paste provided by the embodiment of the present application can cultivate the body and protect the essence, strengthen the spleen and kidney, clear the heart and calm the mind to promote growth. Huangqi, chaobaizhu, chenpi, zhigancao, shanyao strengthen the spleen and lung, dangshen and angelica regulate qi and blood, and fuling, muxiang, huanglian, sharen, shanzha, shenqu, mayi, roudoukou, together with the functions of strengthening the spleen and stomach, digestion and swelling, and stopping diarrhea. Shengdi is combined with shanzhu, mudanpi and zexie to protect the original body, nourish the kidney, and strengthen the bone marrow. Through the use of rougui, kidney water is used to guide the fire downward, and huanglian is used to clear the heart and lower the fire, so that the heart fire is lowered, the heart and kidney are connected, the sleep is strengthened, the sleep quality is improved, and the secretion of growth hormone is promoted. In summary, the present application can balance yin and yang, nourish the body and reduce the fire, so that the little fire is slowly generated, the yin and yang are balanced, the blood is abundant, the airway is smooth, the muscles are smooth, and the bone marrow is generated, thereby achieving good sleep and growth promotion, and effectively treating poor sleep quality, insomnia, growth retardation and short stature and other problems.

[0063] In addition, the application has the effects of anti-inflammation, anti-virus, anti-tissue fibrosis, etc., can inhibit the formation of fibrosis on the surface of the enlarged adenoids to some extent, and the clinical test proves that the traditional Chinese medicine composition can effectively improve the clinical symptoms such as nasal congestion, mouth breathing, snoring during sleep, reduce the volume of the enlarged adenoids, effectively avoid the repeated troubles of the children suffering from the disease, and has outstanding curative effects on children with cold constitution.

[0064] Preferably, the use amount ratio of the Myristicae Fructus and the Aucklandiae Radix is 1:(2-3), the Myristicae Fructus is matched with the Aucklandiae Radix, which can play a good role in invigorating the spleen, the use amount ratio of the Cimicifugae Rhizoma, the Bupleuri Radix and the Cinnamomi Cassiae Ramulus is 10:(4-6):(2-3), which can achieve the regulation of the kidney and the spleen, and the use amount ratio of the Cinnamomi Cassiae Ramulus and the Coptidis Rhizoma is 1:(1-2), which can achieve the downward transmission of the fire and the heart fire clearing, thereby playing a good role in sleep aiding and growth aiding. More preferably, the use amount ratio of the Myristicae Fructus and the Aucklandiae Radix is 1:2, the use amount ratio of the Cimicifugae Rhizoma, the Bupleuri Radix and the Cinnamomi Cassiae Ramulus is 10:5:3, and the use amount ratio of the Cinnamomi Cassiae Ramulus and the Coptidis Rhizoma is 1:1.

[0065] In conclusion, the application has the effects of benefiting the kidney, aiding growth, invigorating the spleen and qi, and soothing the nerves, and has obvious curative effects on the following children:

[0066] 1. Suitable for children aged 3-14 years old;

[0067] 2. Children with growth and development retardation and relatively slow reaction, wherein the growth and development retardation includes growth retardation, short stature and / or dwarfism;

[0068] 3. Children with thin stature, anorexia, indigestion and food retention;

[0069] 4. Children with poor resistance, easy to catch a cold and cough;

[0070] 5. Children with unstable sleep, easy to wake up and poor sleep quality.

[0071] Correspondingly, the application further provides a preparation method of the traditional Chinese medicine composition for sleep aiding and growth aiding,

[0072] A. The traditional Chinese medicine raw materials are weighed according to the formula and soaked;

[0073] B. The traditional Chinese medicine raw materials are extracted and concentrated to obtain the finished product.

[0074] In some preferred embodiments, the preparation method of the traditional Chinese medicine composition for sleep aiding and growth aiding comprises:

[0075] S101. The traditional Chinese medicine raw materials are weighed according to the formula and soaked;

[0076] S102. The traditional Chinese medicine raw materials are extracted and concentrated to obtain a paste;

[0077] S103, the paste is divided and cooled to obtain a finished product.

[0078] Preferably, step S101 comprises:

[0079] The ingredients are weighed according to the prescription, and Astragalus, Fried Atractylodes, Tangerine Peel, Codonopsis, Cimicifuga, Bupleurum, Angelica, Rehmannia, Licorice, Poria, Coptis, Hovenia, Cinnamon, Poria cocos, Berberis, Crataegus, God's recipe, Fried wheat is first put into and soaked, then add nutmeg, costus, and sand ginger and soak.

[0080] Preferably, the present application extracts and concentrates each traditional Chinese medicine raw material by mixing drug concentration, and removes part of the solvent in the medicinal liquid to obtain a concentrated liquid with higher concentration. The specific concentration method can be realized by homogenization method, spray method, atomization method, evaporation method, reduced pressure distillation method, etc., but is not limited thereto.

[0081] The sleep-aiding and growth-aiding traditional Chinese medicine composition paste obtained in this embodiment can be added with sugar and honey, etc., and then packaged using transparent packaging materials, 20g per package, 2 packages per dose. It is stored at room temperature and taken one dose at a time. The paste of the present application is not easy to deteriorate and mold when stored at room temperature for 30 days, and the quality of the remaining paste is not affected after the outer package is opened.

[0082] In some preferred embodiments, the sleep-aiding and growth-aiding traditional Chinese medicine composition preparation method comprises:

[0083] S101, the ingredients are weighed according to the prescription, and Astragalus, Fried Atractylodes, Tangerine Peel, Codonopsis, Cimicifuga, Bupleurum, Angelica, Rehmannia, Licorice, Poria, Coptis, Hovenia, Cinnamon, Poria cocos, Berberis, Crataegus, God's recipe, Fried wheat is first put into and soaked, then add nutmeg, costus, and sand ginger and soak.

[0084] S102, Astragalus, Fried Atractylodes, Tangerine Peel, Codonopsis, Cimicifuga, Bupleurum, Angelica, Rehmannia, Licorice, Poria, Coptis, Hovenia, Cinnamon, Poria cocos, Berberis, Crataegus, God's recipe, Fried wheat is first boiled for 5-30 minutes;

[0085] S103, then add nutmeg, costus, and sand ginger and boil for 5-10 minutes to obtain a finished product.

[0086] It should be noted that the traditional Chinese medicine composition of the present application can also be prepared into other dosage forms, such as decoction, powder, capsule, tablet, granule or pill, etc., and the embodiments thereof are not limited to the embodiments of the present application. Correspondingly, the preparation method can be adjusted accordingly according to different dosage forms.

[0087] Correspondingly, the present application also provides a sleep-aiding and growth-aiding traditional Chinese medicine composition for preventing and / or treating insomnia.

[0088] Correspondingly, the present application also provides a sleep-aiding and growth-aiding traditional Chinese medicine composition for preventing and / or treating insomnia.

[0089] Accordingly, the application also provides a use of the sleep-aiding and growth-aiding traditional Chinese medicine composition in the preparation of a medicine for preventing and / or treating adenoid hypertrophy in children. Preferably, the medicine is an oral preparation, which is a paste, a decoction, a powder, a capsule, a tablet, a granule or a pill.

[0090] The medicine comprises a pharmaceutically acceptable adjuvant, which is one or more of a disintegrant, an emulsifier, a filler, a flavoring agent, a humectant and a solubilizer.

[0091] The application is further illustrated below with specific examples

[0092] Example 1

[0093] Radix Astragali 10g, Fried Rhizoma Atractylodis 5g, Pericarpium Citri Reticulatae 2g, Radix Codonopsis 10g, Radix Coptidis 5g, Radix Bupleuri 2g, Radix Angelicae Sinensis 2g, Radix Rehmanniae 10g, Radix Glycyrrhizae 5g, Fructus Mori 10g, Radix Paeoniae Alba 5g, Rhizoma Alpiniae Officinarum 5g, Rhizoma Anemarrhenae 1g, Rhizoma Anemarrhenae 5g, Fructus Amomi Rotundus 2g, Fructus Crataegi 5g, Massa Medicata Fermentata 5g, Fried Fructus Hordei Germinatus 5g.

[0094] Preparation method: according to the above formula, Radix Astragali, Fried Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Radix Codonopsis, Radix Coptidis, Radix Bupleuri, Radix Angelicae Sinensis, Radix Rehmanniae, Radix Glycyrrhizae, Fructus Mori, Radix Paeoniae Alba, Rhizoma Alpiniae Officinarum, Rhizoma Anemarrhenae, Fructus Amomi Rotundus, Fructus Crataegi, Fried Fructus Hordei Germinatus are first added into ethanol solution, mixed and soaked for 2-4h, and then Rhizoma Anemarrhenae, Fructus Amomi Rotundus are added and soaked for 5-20min; then extracted twice by reflux, 2h / time, the extracted liquid is combined and concentrated, and finally the paste is collected and 3.0g of adjuvant sugar and 1.0g of honey are added, and the paste is divided, cooled and packed to obtain the sleep-aiding and growth-aiding paste.

[0095] Example 2

[0096] Radix Astragali 20g, Fried Rhizoma Atractylodis 10g, Pericarpium Citri Reticulatae 5g, Radix Codonopsis 15g, Radix Coptidis 10g, Radix Bupleuri 10g, Radix Angelicae Sinensis 5g, Radix Rehmanniae 20g, Radix Glycyrrhizae 10g, Fructus Mori 15g, Radix Paeoniae Alba 10g, Rhizoma Alpiniae Officinarum 5g, Rhizoma Anemarrhenae 10g, Fructus Amomi Rotundus 5g, Fructus Crataegi 10g, Massa Medicata Fermentata 10g, Fried Fructus Hordei Germinatus 10g.

[0097] Preparation method: according to the above formula, Radix Astragali, Fried Rhizoma Atractylodis, Pericarpium Citri Reticulatae, Radix Codonopsis, Radix Coptidis, Radix Bupleuri, Radix Angelicae Sinensis, Radix Rehmanniae, Radix Glycyrrhizae, Fructus Mori, Radix Paeoniae Alba, Rhizoma Alpiniae Officinarum, Rhizoma Anemarrhenae, Fructus Amomi Rotundus, Fructus Crataegi, Fried Fructus Hordei Germinatus are first added into ethanol solution, mixed and soaked for 2-4h, and then Rhizoma Anemarrhenae, Fructus Amomi Rotundus are added and soaked for 5-20min; then extracted twice by reflux, 2h / time, the extracted liquid is combined and concentrated, and finally the paste is collected and 3.0g of adjuvant sugar and 1.0g of honey are added, and the paste is divided, cooled and packed to obtain the sleep-aiding and growth-aiding paste.

[0098] Example 3

[0099] Astragalus membranaceus 30g, stir-fried Atractylodes macrocephala 15g, Citrus reticulata peel 8g, Codonopsis pilosula 20g, Cimicifuga foetida 15g, Bupleurum chinense 8g, Angelica sinensis 8g, Rehmannia glutinosa 30g, prepared Glycyrrhiza uralensis 15g, Dioscorea opposita 20g, Paeonia suffruticosa 15g, Alisma plantago-aquatica 15g, Cornus officinalis 15g, Cinnamomum cassia 5g, Poria cocos 15g, Myristica fragrans 8g, Aucklandia lappa 15g, Coptis chinensis 5g, Amomum villosum 8g, Crataegus pinnatifida 15g, Massa fermentata 15g, stir-fried Hordeum vulgare 15g.

[0100] Preparation method: According to the above formula, add Astragalus membranaceus, stir-fried Atractylodes macrocephala, Citrus reticulata peel, Codonopsis pilosula, Cimicifuga foetida, Bupleurum chinense, Angelica sinensis, Rehmannia glutinosa, prepared Glycyrrhiza uralensis, Dioscorea opposita, Paeonia suffruticosa, Alisma plantago-aquatica, Cornus officinalis, Cinnamomum cassia, Poria cocos, Coptis chinensis, Crataegus pinnatifida, and stir-fried malt to an ethanol solution and soak for 2-4 hours. Then add nutmeg, Aucklandia lappa, and Amomum villosum and soak for 5-20 minutes. Then reflux extract twice, 2 hours each time. Combine the extracts and concentrate. Finally, collect the paste and add 4.8g of maltose and 2.0g of honey as excipients. Package and cool the paste to obtain the sleep aid and growth-promoting paste.

[0101] Example 4

[0102] Astragalus membranaceus 15g, stir-fried Atractylodes macrocephala 8g, Citrus reticulata peel 5g, Codonopsis pilosula 15g, Cimicifuga foetida 8g, Bupleurum chinense 6g, Angelica sinensis 6g, Rehmannia glutinosa 15g, prepared Glycyrrhiza uralensis 10g, Dioscorea opposita 15g, Paeonia suffruticosa 8g, Alisma plantago-aquatica 8g, Cornus officinalis 8g, Cinnamomum cassia 2g, Poria cocos 8g, Myristica fragrans 5g, Aucklandia lappa 8g, Coptis chinensis 2g, Amomum villosum 5g, Crataegus pinnatifida 8g, Massa fermentata 8g, stir-fried Hordeum vulgare 8g.

[0103] Preparation method: According to the above formula, add Astragalus membranaceus, stir-fried Atractylodes macrocephala, Citrus reticulata peel, Codonopsis pilosula, Cimicifuga foetida, Bupleurum chinense, Angelica sinensis, Rehmannia glutinosa, prepared Glycyrrhiza uralensis, Dioscorea opposita, Paeonia suffruticosa, Alisma plantago-aquatica, Cornus officinalis, Cinnamomum cassia, Poria cocos, Coptis chinensis, Crataegus pinnatifida, and stir-fried malt to an ethanol solution and soak for 2-4 hours. Then add nutmeg, Aucklandia lappa, and Amomum villosum and soak for 5-20 minutes. Then reflux extract twice, 2 hours each time. Combine the extracts and concentrate. Finally, collect the paste and add 3.0g of maltose and 1.0g of honey as excipients. Package and cool the paste to obtain the sleep aid and growth-promoting paste.

[0104] Example 5

[0105] Astragalus membranaceus 18g, stir-fried Atractylodes macrocephala 12g, Citrus reticulata peel 6g, Codonopsis pilosula 12g, Cimicifuga foetida 12g, Bupleurum chinense 6g, Angelica sinensis 6g, Rehmannia glutinosa 20g, prepared Glycyrrhiza uralensis 12g, Dioscorea opposita 18g, Paeonia suffruticosa 12g, Alisma plantago-aquatica 12g, Cornus officinalis 12g, Cinnamomum cassia 3g, Poria cocos 12g, Myristica fragrans 6g, Aucklandia lappa 12g, Coptis chinensis 4g, Amomum villosum 6g, Crataegus pinnatifida 12g, Massa fermentata 12g, stir-fried Hordeum vulgare 12g.

[0106] Preparation method: according to the above formula, first add the ethanol solution into Astragalus, fried atractylodes, dried tangerine or orange peel, codonopsis, cimicifuga, bupleurum, angelica, rehmannia, honey-fried licorice, hawthorn, peony, alisma, cornus, cassia, poria, coptis, hawthorn, fried wheat, then soak for 2-4h, add nutmeg, saffron, soak for 5-20min; then reflux extraction 2 times, 2h / time, combine the extract and concentrate, finally collect the paste and add auxiliary material jujube sugar 3.2g and honey 1.5g, pack, cool paste to get sleep aid and growth paste.

[0107] Example 6

[0108] Astragalus 25g, fried atractylodes 12g, dried tangerine or orange peel 4g, codonopsis 18g, cimicifuga 14g, bupleurum 7g, angelica 7g, rehmannia 25g, honey-fried licorice 12g, hawthorn 18g, peony 14g, alisma 14g, cornus 14g, cassia 4g, poria 14g, nutmeg 7g, saffron 14g, coptis 4g, hawthorn 14g, medicated leaven 14g, fried wheat 14g.

[0109] Preparation method: according to the above formula, first add the ethanol solution into Astragalus, fried atractylodes, dried tangerine or orange peel, codonopsis, cimicifuga, bupleurum, angelica, rehmannia, honey-fried licorice, hawthorn, peony, alisma, cornus, cassia, poria, coptis, hawthorn, fried wheat, then soak for 2-4h, add nutmeg, saffron, soak for 5-20min; then reflux extraction 2 times, 2h / time, combine the extract and concentrate, finally collect the paste and add auxiliary material jujube sugar 3.2g and honey 1.5g, pack, cool paste to get sleep aid and growth paste.

[0110] Comparative example 1

[0111] Select commercially available stomachic and digestion oral liquid, the main components are radix pseudoginseng, dried tangerine or orange peel, yam, malt (fried), hawthorn.

[0112] I. The sleep aid and growth paste obtained in example 2 is used to study the growth experiment, as follows:

[0113] 1. Research goal:

[0114] Through the observation and analysis of the research project, and the comparison of the curative effect with the control group, the difference between the two is compared, and the clinical curative effect, safety and clinical application value of sleep aid and growth paste on children with short stature are discussed. The sleep aid and growth paste of example 2 is 20g / pack, 2 packs for a dose. Store at room temperature, take one dose each time.

[0115] 2. Research method:

[0116] 60 cases of children with short stature were selected according to the standard, and were divided into observation group and treatment group according to the treatment time. The observation group was treated with the sleep-aiding and growth-aiding paste prepared by example 2 of the application, one dose after breakfast and dinner; the control group was treated with stomach-healthy and digestion-aiding oral liquid, 10ml each time, twice a day. After 12 months of continuous treatment, the height, weight, BMI, growth rate, cognition and intelligence scores were compared before and after treatment, and the differences in curative effects between the two groups were evaluated.

[0117] 3 Research object:

[0118] From February 1, 2023 to February 1, 2024, 60 children with short stature aged 6-8 years old were selected in the Disease Prevention Department of Foshan Gao Ming District Hospital of Traditional Chinese Medicine. The 60 cases meeting the inclusion criteria were divided into observation group and control group according to the random number table method, 30 cases in each group.

[0119] 4 Western medicine inclusion criteria for short stature:

[0120] According to the 2005 national height standard and the "Guidelines for the Diagnosis and Treatment of Short Stature Children", children with height between one standard deviation (or 25th percentile) and two standard deviations (or 3rd percentile) of normal children of the same age, race and gender are defined as short stature;

[0121] The body proportions are symmetrical, the birth length and weight are within the normal range of the same gestational age:

[0122] The difference between bone age and actual age is not more than 1 year;

[0123] GH stimulation test: GH peak value ≥10ug / L.

[0124] 5 Other inclusion criteria:

[0125] (1) Children with short stature aged 6-8 years old;

[0126] (2) The test person and the legal guardian know and sign the informed consent form.

[0127] 6 Exclusion criteria

[0128] Any of the following is excluded:

[0129] (1) Acute and chronic diseases caused by various reasons.

[0130] (2) Combined with severe heart, lung, brain, liver, kidney and other systemic diseases.

[0131] 7 General information

[0132] The gender of 15 boys and 15 girls in the sleep aid group was compared, and the age of 16 boys and 14 girls in the Jianwei Xiaoshi oral liquid group was compared. The difference was not statistically significant (P>0.05), and the comparison was comparable. Table 1, 2. The weight of the children in the sleep aid group was (19.63±1.58) kg; the height was (115.28±4.03) cm; the BMI was (14.75±0.63); the Montreal Cognitive Assessment Scale (MoCA) was (20.27±1.41); the weight of the children in the Jianwei Xiaoshi oral liquid group was (19.09±1.29) kg; the average height was (114.6±3.77) cm; the BMI was (18.72±23.11); the Montreal Cognitive Assessment Scale (MoCA) was (19.87±1.50); see Table 3. After comparison, the difference between the two groups was not statistically significant (P>0.05), and the comparison was comparable.

[0133] Table 1 Gender of the two groups before treatment

[0134]

[0135] Table 2 Age of the two groups before treatment

[0136]

[0137] Table 3 Body weight, height, BMI, and MoCA scale score of the two groups before treatment

[0138]

[0139] 8 Observation index:

[0140] The height, weight, BMI, and growth rate of the two groups before and after treatment were observed;

[0141] The cognitive and intelligence scores of the two groups before and after treatment were compared, and the Montreal Cognitive Assessment Scale (MoCA) was used to evaluate the cognitive function. The scale mainly includes: attention, naming ability, memory, abstract thinking ability, and delayed memory ability. The total score is 30 points, and the cognitive function is considered normal when the score is > 26.

[0142] 9 Statistical analysis

[0143] SPSS 26.0 software was used to process the data recorded in this study. Count data was expressed as cases (%), and χ 2 test was used for comparison between groups. Measurement data was expressed as , and t test was used. When P<0.05, the difference between the groups was considered comparable.

[0144] 10Results

[0145] The height, weight and BMI of the two groups were increased after treatment. The indicators of the Zhenzheng Zhaochang Paste group were significantly higher than those of the Jianwei Xiaoshi Oral Liquid group, and the difference between the groups was significant (P <0.05). See Table 4.

[0146] Table 4 Body weight, height and BMI of the two groups after treatment

[0147]

[0148] The MoCA of the two groups was increased after treatment, and the improvement of the Zhenzheng Zhaochang Paste group was higher than that of the Jianwei Xiaoshi Oral Liquid group (P <0.05), and the difference between the groups was significant. After taking medicine, the growth rate of the two groups was compared (P <0.05), and the difference between the groups was significant. See Table 5.

[0149] Table 5 MoCA scale score and growth rate after treatment

[0150]

[0151] II. The Zhenzheng Zhaochang Paste obtained in Example 2 was selected for experimental study of sleep aid, as follows:

[0152] The sleep status of students was investigated using the Sleep Disturbance Scale for Children (SDSC) compiled by Bruni et al. with a Cronbach's coefficient of 0.81. The scale consists of 26 questions, with scores of 1, 2, 3, 4, and 5 corresponding to "never", "occasionally (1-2 times per month)", "sometimes (1-2 times per week)", "often (3-5 times per week)", and "always (every day)", respectively. The total score of the scale is 26-130, with higher scores indicating poorer sleep quality. A score of >39 is considered to have sleep disorder, and a score of >50 is considered to have moderate to severe sleep disorder.

[0153] After comparing before and after treatment, both groups improved. In the Zhenzheng Zhaochang Paste group, there were 17 cases of sleep disorder and 13 cases of moderate to severe sleep disorder before treatment, and after treatment, the overall improvement was 17 cases of normal sleep, 12 cases of sleep disorder, and 1 case of moderate to severe sleep disorder. In the Jianwei Xiaoshi Oral Liquid group, there were 17 cases of sleep disorder and 13 cases of moderate to severe sleep disorder before treatment, and after treatment, the overall improvement was 5 cases of normal sleep, 17 cases of sleep disorder, and 8 cases of moderate to severe sleep disorder. See Table 6. Sleep status breakdown table.

[0154] Table 6 Sleep status breakdown table

[0155]

[0156] By comparison, before treatment, the two groups of children sleep disturbance scale (Sleep Disturbance Scale for Children, SDSC), P>0.05, no difference between groups. After treatment, P<0.05, the two groups are comparable, see Table 7.

[0157] Table 7 Sleep Disturbance Scale for Children (SDSC)

[0158]

[0159] III. The following is selected from the sleep aid cream obtained in Example 2, and the experimental study of adenoid hypertrophy treatment is as follows:

[0160] TCM syndrome is one of the important outcome indicators of TCM clinical efficacy evaluation. TCM syndrome efficacy evaluation scale under the mode of disease and syndrome can provide basis for objective evaluation of TCM syndrome efficacy. This time, according to the main symptoms and secondary symptoms quantitative scoring, the main symptoms (nasal congestion, snoring, open mouth breathing, etc.) are scored as 0, 2, 4, and 6 points according to the four grades of no, mild, moderate, and severe, and the secondary symptoms (cough, inattention, enuresis, etc.) are scored as 0 and 2 points according to the two grades of no and yes. The efficacy evaluation mainly refers to the relevant standards in "Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine (Trial)", and the TCM syndrome efficacy is divided into four grades of recovery, significant effect, effectiveness, and invalidity. Among them, recovery: clinical symptoms and signs disappear or basically disappear, syndrome score reduction rate ≥95%; significant effect: clinical symptoms and signs are significantly improved, 70%≤syndrome score reduction rate<95%; effective: clinical symptoms and signs are improved, 30%≤syndrome score reduction rate<70%; invalid: clinical symptoms and signs have no obvious improvement, even aggravation, syndrome score reduction rate<30%. According to the Nimodipine algorithm, the TCM syndrome score reduction rate=(pre-treatment score-post-treatment score) / pre-treatment score.

[0161] By comparing the two groups, the total effective rate of the sleep aid cream group was 96.67%, see Table 8, which was significantly higher than that of the Jianwei Xiaoshi oral liquid group, which may be because the main effect of Jianwei Xiaoshi oral liquid is to tonify the spleen and promote digestion, and it has no effect on improving ventilation.

[0162] Table 8 TCM syndrome score reduction rate and total effective rate

[0163]

[0164] The TCM syndrome scores of adenoid hypertrophy in both groups were improved after treatment, and the sleep-aiding and growth-promoting paste group was improved more than the stomach-healthy and digestion-aiding oral liquid group, P<0.05, and the difference between groups was comparable, as shown in Table 9. Among them, the sleep-aiding and growth-promoting paste group had 14 cases of inattention, 3 cases of cured symptoms, and 11 cases of improved symptoms; 9 cases of enuresis, 6 cases of cured, and 3 cases of improved; children's inattention and enuresis were significantly improved, but the problem still existed.

[0165] Table 9 TCM syndrome scores of adenoid hypertrophy

[0166]

[0167] Four, the sleep-aiding and growth-promoting paste obtained in Example 2 was used for experimental research on the treatment of upper respiratory tract infection, as follows:

[0168] Upper respiratory tract infection is the most common acute infectious disease in pediatrics, which is caused by the invasion of pathogens to the nose, pharynx, larynx and other parts of children to cause acute inflammation. The disease can occur throughout the year, and the incidence is higher during seasonal transition. By observing the number of annual diseases in the two groups, including acute nasopharyngitis, tonsillitis, acute upper respiratory tract infection, etc., the two groups were compared before and after treatment. Before treatment, P>0.05, the difference between groups was comparable; after treatment, the sleep-aiding and growth-promoting paste group was improved more than the stomach-healthy and digestion-aiding oral liquid group, P<0.05, and the comparability was shown in Table 10.

[0169] Table 10 Number of upper respiratory tract infections per year

[0170]

[0171] Conclusion: After taking the sleep-aiding and growth-promoting paste, the symptoms of adenoid hypertrophy and the number of annual upper respiratory tract infections were significantly reduced.

[0172] The above is the preferred embodiment of the present application. It should be noted that for ordinary skilled persons in the art, without departing from the principles of the present application, several improvements and refinements can be made, which are also considered within the scope of protection of the present application.

Claims

1. A traditional Chinese medicine composition for promoting sleep and growth, characterized in that, The sleep-aiding and growth-promoting traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials in the indicated weight ratios: Astragalus membranaceus 20g, stir-fried Atractylodes macrocephala 10g, Citrus reticulata peel 5g, Codonopsis pilosula 15g, Cimicifuga foetida 10g, Bupleurum chinense 5g, Angelica sinensis 5g, Rehmannia glutinosa 20g, prepared Glycyrrhiza uralensis 10g, Dioscorea opposita 15g, Paeonia suffruticosa 10g, Alisma plantago-aquatica 10g, Cornus officinalis 10g, Cinnamomum cassia 3g, Poria cocos 10g, Myristica fragrans 5g, Aucklandia lappa 10g, Coptis chinensis 3g, Amomum villosum 5g, Crataegus pinnatifida 10g, Massa fermentata 10g, stir-fried Hordeum vulgare 10g.

2. A method for preparing the traditional Chinese medicine composition as described in claim 1, characterized in that, include: A. Weigh out each Chinese herbal medicine ingredient according to the formula and soak them; B. Extract and concentrate the various Chinese medicinal materials to obtain the finished product.

3. The use of the traditional Chinese medicine composition as described in claim 1 in the preparation of a medicament for the prevention and / or treatment of insomnia.

4. The use of the traditional Chinese medicine composition as described in claim 1 in the preparation of a medicament for treating growth retardation, short stature, and / or dwarfism.

5. The use of the traditional Chinese medicine composition as described in claim 1 in the preparation of a medicament for the prevention and / or treatment of adenoid hypertrophy in children.

6. The application as described in any one of claims 3-5, characterized in that, The drug is an oral preparation, which may be an ointment, decoction, powder, capsule, tablet, granule or pill.

7. The application as described in any one of claims 3-5, characterized in that, The drug includes pharmaceutically acceptable excipients, which are one or more of the following: disintegrants, emulsifiers, fillers, flavoring agents, humectants, and solubilizers.