Traditional Chinese medicine composition for treating infantile anorexia as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating infantile anorexia and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine. The traditional Chinese medicine composition for treating infantile anorexia is prepared from the following raw materials in parts by mass: 6-10 parts of codonopsis pilosula, 6-10 parts of fried rhizoma atractylodis macrocephalae, 10-12 parts of poria cocos, 20-30 parts of fried semen coicis, 3-6 parts of fructus amomi, 3-6 parts of radix aucklandiae, 3-6 parts of amomum cardamomum, 6-10 parts of pericarpium citri reticulatae, 4 parts of ginger processed pinellia, 10-20 parts of endothelium corneum gigeriae galli, 10-20 parts of fried malt, 10-20 parts of scorched hawthorn fruit, 3-6 parts of curcuma zedoary On the basis of the Sijunzi decoction and the Xiangsha Liujunzi decoction, the traditional Chinese medicine composition is prepared by continuously optimizing and screening clinical anorexia patient diseases and symptoms, and has the effects of invigorating spleen and replenishing qi, enlivening spleen and stimulating appetite, promoting digestion and relieving stagnation, and enhancing appetite. The traditional Chinese medicine composition provided by the invention is remarkable in curative effect and simple and convenient to prepare, and has a wide industrial application prospect.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating anorexia in children, and a preparation method and application thereof. Background Art

[0002] Spleen diseases are the second most common disease in pediatrics, which is closely related to the physiological and pathological characteristics of children. According to traditional Chinese medicine, children often have insufficient spleens, and their spleen and stomachs are not fully developed. Their spleen and stomachs are formed but not complete, and their qi is complete but not strong. Children are not yet intelligent, do not know how to control their diet, and are not moderate in hunger or fullness, and cannot adjust to cold or warm. Due to the lack of knowledge of infant care and health care, some parents do not add complementary foods on time during infancy; or they emphasize high-nutrition diets one-sidedly, such as overeating fatty and sweet foods, fried and roasted foods, which exceed the normal digestion capacity of children's spleen and stomach; or they are too doting, indulge their children's preferences, and eat snacks, sweets, cold foods and drinks at will; or they abuse tonic foods. There are also reasons such as children suffering from diseases and improper medication, which can damage children's spleen and stomach, causing abnormalities in reception, decomposition, and transmission of fine microorganisms, and then cause anorexia, stagnation, malnutrition and other symptoms. As the "Suwen Bi Lun" said: "If you eat too much, your intestines and stomach will be damaged." If the above-mentioned symptoms are not treated effectively in time, it will cause insufficient nourishment to other organs and lead to a variety of related diseases.

[0003] Anorexia, also known as loss of appetite, is a disease in which children have a long-term aversion to food and eat less. This disease occurs in all seasons. It is more common in children aged 1-6 years old. The incidence rate is higher in urban children. If it is not regulated and improved for a long time, it may cause the child's spleen and stomach to malfunction, insufficient qi and blood biochemistry, nutritional imbalance, slow growth and development, lack of weight gain, lack of height growth, anemia, decreased immunity, etc.

[0004] Western medicine uses digestive enzymes such as multienzyme tablets and lactase to treat anorexia in children, as well as gastrointestinal motility drugs such as metinline, which are not suitable for long-term use and can cause varying degrees of liver and kidney damage and gastrointestinal irritation. Similar Chinese patent medicines have the disadvantages of single formula and limited efficacy. Summary of the invention

[0005] In view of this, the object of the present invention is to provide a Chinese medicine composition for treating anorexia in children, which has the effects of strengthening the spleen and replenishing qi, invigorating the spleen and stimulating the appetite, digesting food and removing stagnation, and enhancing appetite.

[0006] The invention provides a traditional Chinese medicine composition for treating anorexia in children. The composition comprises the following traditional Chinese medicine raw materials in parts by weight: 6-10 parts of codonopsis pilosula, 6-10 parts of stir-fried atractylodes macrocephala, 10-12 parts of tuckahoe, 20-30 parts of stir-fried coix seeds, 3-6 parts of amomum villosum, 3-6 parts of costusroot, 3-6 parts of white cardamom, 6-10 parts of tangerine peel, 4 parts of ginger and pinellia, 10-20 parts of chicken gizzard lining, 10-20 parts of stir-fried malt, 10-20 parts of charred hawthorn, 3-6 parts of zedoaria and 3-6 parts of liquorice.

[0007] Preferably, the Chinese medicinal raw materials include the following parts by weight:

[0008] 6-8 parts of Codonopsis pilosula, 6-8 parts of stir-fried Atractylodes macrocephala, 10-11 parts of Poria cocos, 20-27 parts of stir-fried Coix seeds, 3-5 parts of Amomum villosum, 3-5 parts of costusroot, 3-5 parts of white cardamom, 6-8 parts of dried tangerine peel, 4 parts of Pinellia ternata, 14-20 parts of chicken gizzard lining, 14-20 parts of stir-fried malt, 14-20 parts of charred hawthorn, 4-6 parts of Curcuma zedoaria and 4-6 parts of liquorice.

[0009] Preferably, the Chinese medicinal raw materials include the following parts by weight:

[0010] 6 parts of Codonopsis pilosula, 6 parts of stir-fried Atractylodes macrocephala, 10 parts of Poria cocos, 20 parts of stir-fried Coix seeds, 3 parts of Amomum villosum, 3 parts of Aucklandia lappa, 3 parts of White Cardamom, 6 parts of Tangerine peel, 4 parts of Pinellia ternata, 20 parts of Chicken gizzard lining, 20 parts of stir-fried malt, 20 parts of charred Hawthorn, 6 parts of Curcuma zedoaria and 6 parts of Licorice.

[0011] The present invention provides a method for preparing the Chinese medicine composition for treating anorexia in children, comprising the following steps:

[0012] The Chinese medicinal raw materials of the Chinese medicinal composition are decocted with water, and the decoction is collected to obtain the Chinese medicinal composition.

[0013] Preferably, the mass ratio of the Chinese medicinal raw material to water is 1:(7-9);

[0014] The decoction temperature is 90-100° C.; the decoction is performed twice; and the decoction time is 35-40 min / time.

[0015] The invention provides a medicine for treating anorexia in children, comprising a traditional Chinese medicine composition obtained by the preparation method and pharmaceutically acceptable auxiliary materials.

[0016] Preferably, the drug comprises at least one of the following dosage forms: granules, oral solution, pills, capsules and tablets.

[0017] Preferably, the auxiliary materials in the granules include dextrin and sucrose; the mass ratio of dextrin to sucrose is (0.5-1.5): (1.5-2.5);

[0018] In the traditional Chinese medicine composition, based on 2 parts by mass of the extracted dry matter, the mass portion of the dextrin is 0.5 to 1.5 parts, and the mass portion of the sucrose is 1.5 to 2.5 parts.

[0019] The present invention provides a method for preparing the medicine, comprising the following steps: removing moisture from the traditional Chinese medicine composition obtained by the preparation method to obtain a traditional Chinese medicine extract;

[0020] The Chinese medicine extract, dextrin, sucrose and 85% ethanol aqueous solution are mixed and granulated, and dried to obtain granules.

[0021] The present invention provides the Chinese medicine composition for treating anorexia in children or the use of the Chinese medicine composition obtained by the preparation method in preparing a medicine for treating anorexia in children; the anorexia in children includes the syndrome of food accumulation caused by deficiency of spleen and stomach qi.

[0022] The invention provides a Chinese medicine composition for treating anorexia in children, comprising the following Chinese medicine raw materials by weight: 6-10 parts of Codonopsis pilosula, 6-10 parts of stir-fried Atractylodes macrocephala, 10-12 parts of Poria cocos, 20-30 parts of stir-fried Coix seeds, 3-6 parts of Amomum villosum, 3-6 parts of Aucklandia lappa, 3-6 parts of White cardamom, 6-10 parts of dried orange peel, 4 parts of Pinellia ternata, 10-20 parts of Chicken gizzard lining, 10-20 parts of stir-fried malt, 10-20 parts of charred hawthorn, 3-6 parts of Curcuma zedoaria and 3-6 parts of Licorice. The invention is based on the classic prescriptions Sijunzi Decoction (Taiping Huimin Hejiju Fang) and Xiangsha Liujunzi Decoction (Gujin Mingyi Fanglun), according to the physiological and pathological characteristics of children, the etiology and pathogenesis of children's spleen diseases, combined with the many years of clinical diagnosis and treatment experience of the contributor, and then the relevant drugs are selected, supplemented and flavored to form the prescription. The invention discloses a Chinese medicine for treating anorexia in children. The Chinese medicine for treating anorexia in children is safe and effective ...

[0023] The present invention also provides a medicine for treating anorexia in children, and further limits the dosage form to granules. The granules use the above-mentioned Chinese medicine composition as the active ingredient of the medicine, and use dextrin and sucrose as auxiliary materials. They not only have the effects of strengthening the spleen and replenishing qi, waking up the spleen and stimulating the appetite, digesting food and removing stagnation, and enhancing appetite, but also are easy to carry, have a small dosage, good taste, and are easy to take. Children have high compliance with medication, and are easy to carry when traveling, thereby greatly improving the clinical treatment effect. DETAILED DESCRIPTION

[0024] The invention provides a traditional Chinese medicine composition for treating anorexia in children. The composition comprises the following traditional Chinese medicine raw materials in parts by weight: 6-10 parts of codonopsis pilosula, 6-10 parts of stir-fried atractylodes macrocephala, 10-12 parts of tuckahoe, 20-30 parts of stir-fried coix seeds, 3-6 parts of amomum villosum, 3-6 parts of costusroot, 3-6 parts of white cardamom, 6-10 parts of tangerine peel, 4 parts of ginger and pinellia, 10-20 parts of chicken gizzard lining, 10-20 parts of stir-fried malt, 10-20 parts of charred hawthorn, 3-6 parts of zedoaria and 3-6 parts of liquorice.

[0025] In the present invention, the Chinese medicine composition for treating anorexia in children preferably includes the following Chinese medicine raw materials in parts by weight: 6-8 parts of Codonopsis pilosula, 6-8 parts of stir-fried Atractylodes macrocephala, 10-11 parts of Poria cocos, 20-27 parts of stir-fried Coix seeds, 3-5 parts of Amomum villosum, 3-5 parts of Aucklandia lappa, 3-5 parts of White cardamom, 6-8 parts of dried tangerine peel, 4 parts of Pinellia ternata, 14-20 parts of chicken gizzard lining, 14-20 parts of stir-fried malt, 14-20 parts of charred hawthorn, 4-6 parts of Curcuma zedoaria and 4-6 parts of Licorice, and more preferably 6-7 parts of Codonopsis pilosula, 6-7 parts of stir-fried Atractylodes macrocephala, 10 parts of Poria cocos, 20-27 parts of stir-fried Coix seeds, 3-5 parts of Amomum villosum, 3-5 parts of Aucklandia lappa, 3-5 parts of White cardamom, 6-8 parts of dried tangerine peel, 4 parts of Ginger Pinellia, 14-20 parts of Chicken gizzard lining, 14-20 parts of stir-fried malt, 14-20 parts of charred Hawthorn, 4-6 parts of Curcuma zedoaria and 4-6 parts of Licorice. ~24 parts, 3-4 parts of Amomum villosum, 3-4 parts of costus root, 3-4 parts of white cardamom, 6-7 parts of tangerine peel, 4 parts of ginger pinellia, 18-20 parts of chicken's gizzard lining, 18-20 parts of stir-fried malt, 18-20 parts of charred hawthorn, 5-6 parts of Curcuma and 5-6 parts of licorice, and most preferably include the following parts by mass of Chinese medicinal raw materials: 6 parts of Codonopsis pilosula, 6 parts of stir-fried Atractylodes macrocephala, 10 parts of Poria, 20 parts of stir-fried Coix seeds, 3 parts of Amomum villosum, 3 parts of costus root, 3 parts of white cardamom, 6 parts of tangerine peel, 4 parts of ginger pinellia, 20 parts of chicken's gizzard lining, 20 parts of stir-fried malt, 20 parts of charred hawthorn, 6 parts of Curcuma and 6 parts of licorice.

[0026] In the present invention, the Chinese medicine composition uses Codonopsis pilosula as the main drug, which is sweet and mild in nature, mainly enters the spleen and lung meridians, has the effects of tonifying the spleen and lung, nourishing blood and promoting body fluid, and is a good medicine for tonifying the middle and replenishing qi. In case of spleen and stomach qi deficiency and disorder of transportation and transformation, stir-fried Atractylodes macrocephala is used to strengthen the spleen and dry dampness, which not only helps Codonopsis pilosula to tonify the qi of the spleen and stomach, but also strengthens the transportation and transformation of the spleen to help the source of postnatal metabolism, and with its bitter and dry nature, it dries dampness to benefit the spleen, which is especially suitable for the spleen's nature of liking dryness and hating dampness. The spleen is responsible for transporting and transforming water and dampness. When the spleen and stomach are weak, dampness and turbidity are easy to stagnate, which can easily block the qi and cause abnormal rise and fall of the spleen and stomach qi. Therefore, Poria cocos and fried coix seed are used together to strengthen the spleen and stop diarrhea, promote water and eliminate dampness; Amomum villosum and white cardamom are used together to eliminate dampness and promote qi, warm the middle and stop vomiting, and help digestion and appetite; Tangerine peel and ginger Pinellia are used together, which are pungent and fragrant, warm and unblock, bitter and dry, promote qi and eliminate bloating, dry dampness and resolve phlegm, harmonize the stomach and stop vomiting; costus root is pungent and bitter It has a strong aromatic smell and can regulate the three energizers. It is especially good at regulating the qi stagnation of the spleen and stomach, promoting qi and relieving pain, strengthening the spleen and digesting food, and is a good product for promoting qi, regulating the middle and relieving pain; charred hawthorn, chicken gizzard lining, and fried malt are all digestive drugs, and can also dissolve various food accumulation syndromes such as greasy, meat, rice, flour, potato, and taro milk, and have the functions of digesting food and eliminating accumulation, strengthening the spleen and appetizing, and harmonizing the middle; Curcuma zedoaria is pungent, dispersing, bitter, and purging, can promote qi and relieve pain, digest food and eliminate accumulation, and is used to treat abdominal distension and pain caused by indigestion. Licorice is an adjuvant, which not only helps Codonopsis pilosula and fried Atractylodes macrocephala to replenish the middle and benefit qi, but also harmonizes various medicines. In an embodiment of the present invention, the Chinese medicine raw materials are purchased from a number of pharmaceutical companies that supply Chinese medicine slices to Shaanxi Provincial Hospital of Traditional Chinese Medicine.

[0027] The invention provides a method for preparing the Chinese medicine composition for treating anorexia in children, comprising the following steps: decocting the Chinese medicine raw materials of the Chinese medicine composition with water, and collecting the decoction to obtain the Chinese medicine composition.

[0028] In the present invention, the mass ratio of the Chinese medicine raw material to water is preferably 1:(7-9), more preferably 1:8. The decoction temperature is 90-100°C, more preferably 100°C. The number of decoctions includes 2 times, more preferably 2 times. The decoction time is 35-40 min / time, more preferably 40 min / time.

[0029] The invention provides a medicine for treating anorexia in children, comprising a traditional Chinese medicine composition obtained by the preparation method and pharmaceutically acceptable auxiliary materials.

[0030] In the present invention, the drug includes at least one of the following dosage forms: granules, oral liquid, pills, capsules and tablets. The excipients in the granules preferably include dextrin and sucrose. The mass ratio of dextrin to sucrose is (0.5-1.5): (1.5-2.5), more preferably 1:2. In the Chinese medicine composition, based on 2 parts by mass of the extracted dry matter, the mass part of dextrin is preferably 0.5-1.5 parts, more preferably 1 part. The mass part of sucrose is preferably 1.5-2.5 parts, more preferably 2 parts.

[0031] The present invention provides a method for preparing the medicine, comprising the following steps: removing moisture from the traditional Chinese medicine composition obtained by the preparation method to obtain a traditional Chinese medicine extract;

[0032] The Chinese medicine extract, dextrin, sucrose and 85% ethanol aqueous solution are mixed and granulated, and dried to obtain granules.

[0033] The invention removes moisture from the traditional Chinese medicine composition obtained by the preparation method to obtain a traditional Chinese medicine dry paste.

[0034] In the present invention, the method for removing moisture preferably comprises combining the decoctions prepared by the above technical solution and concentrating them to an extract with a relative density of 1.30 to 1.35 (60° C. to 65° C.). The concentrating method preferably comprises rotary evaporation.

[0035] After obtaining the Chinese medicine extract, the invention mixes the Chinese medicine extract, dextrin, sucrose and an ethanol aqueous solution with a volume concentration of 85% to prepare granules, and then dries the mixture to obtain granules.

[0036] In the present invention, the Chinese medicine extract is mixed with part of dextrin and sucrose, dried, and crushed to obtain a mixed powder, which is then mixed with the remaining dextrin and sucrose and an ethanol aqueous solution with a volume concentration of 85% for granulation. The volume ratio of the ethanol aqueous solution with a volume concentration of 85% to the total mass of the mixed powder, dextrin and sucrose is preferably 0.3ml:1g, and more preferably 0.35ml:1g. The present invention has no special restrictions on the granulation method, and a granulation method well known in the art can be used. The drying is preferably drying. The drying temperature is preferably 55-65°C, and more preferably 60°C. The granules are preferably 4g / bag, and more preferably 6g / bag. The preparation process of the present invention is simple and stable, and has broad prospects for industrial application.

[0037] The present invention provides the Chinese medicinal composition for treating anorexia in children or the use of the Chinese medicinal composition obtained by the preparation method in preparing a medicine for treating anorexia in children.

[0038] In the present invention, the drug is clinically used for children with anorexia, vomiting, hiccups, stagnation, abdominal pain, diarrhea and other diseases. The symptoms are that the children do not want to eat, vomit after eating, vomit sour and rotten food, have abdominal pain, loose stools, indigestion, pale red tongue, white or thick and greasy fur, stringy and slippery pulse. Fingerprints are pale. The syndrome belongs to spleen and stomach qi deficiency and food accumulation syndrome. The application scheme is obtained by a large number of explorations and summaries in clinical practice, and it has good clinical efficacy in the following weight ranges in the dosage of each prescription.

[0039] In the present invention, the drug is taken with warm water; the dosage of the drug is preferably divided according to age: 0-1 years old: 1 / 4-1 / 3 bag each time; >1 year old <2 years old: 0.5 bag each time; >2 years old <3 years old: 1 bag each time; >3 years old <6 years old: 1.5 bags each time; >6 years old: 2 bags each time. 2 to 3 times a day.

[0040] The following is a detailed description of a Chinese medicine composition for treating anorexia in children provided by the present invention, as well as its preparation method and application, in conjunction with the embodiments. However, they should not be construed as limiting the scope of protection of the present invention.

[0041] Example 1

[0042] Preparation method of Chinese medicine composition granules for treating anorexia in children

[0043] 1. Formula of Chinese medicine composition

[0044] Accurately weigh the following Chinese medicinal raw materials in parts by weight: 30g of Amomum villosum, 30g of costus root, 30g of white cardamom, 60g of Codonopsis pilosula, 60g of Atractylodes macrocephala fried with bran, 100g of Poria cocos, 60g of dried tangerine peel, 40g of Pinellia ternata with ginger, 200g of stir-fried chicken gizzard lining, 200g of stir-fried malt, 200g of charred hawthorn, 60g of Curcuma zedoaria with vinegar, 200g of stir-fried Coix seeds with bran, and 60g of licorice tablets.

[0045] 2. Preparation method

[0046] The above Chinese medicinal materials are mixed, 8 times the weight of water is added, and the mixture is boiled at 100° C. for 1.5 hours, and the residue and the decoction are separated; the residue is boiled again with water for 1.5 hours, and the decoction and the residue are separated; the residue is boiled again with water for 1.5 hours, and the decoction is separated; the three decoctions are combined to obtain a decoction;

[0047] The decoction is concentrated to a relative density of 1.30 to 1.35 (60° C. to 65° C.) by rotary evaporation to obtain a Chinese medicine extract;

[0048] The Chinese medicine extract is mixed with an appropriate amount of dextrin and sucrose (mass ratio 1:2), dried at 60°C, crushed and sieved through a 100-mesh sieve, and the obtained Chinese medicine mixed powder is then fully mixed with dextrin and sucrose (mass ratio 1:2) to make the final Chinese medicine extract dry powder mixed with dextrin and sucrose in a mass ratio of 2:1:2. The uniformly mixed Chinese medicine mixture is mixed with 85% ethanol aqueous solution for granulation, dried at 60°C, made into 1000g, and granulated to obtain Chinese medicine granules.

[0049] Example 2

[0050] Preparation method of Chinese medicine composition granules for treating anorexia in children

[0051] 1. Formula of Chinese medicine composition

[0052] Accurately weigh the following Chinese medicinal raw materials in parts by weight: 60g of Amomum villosum, 60g of costusroot, 60g of white cardamom, 100g of Codonopsis pilosula, 100g of Atractylodes macrocephala fried with bran, 120g of Poria cocos, 100g of dried tangerine peel, 40g of Pinellia ternata with ginger, 100g of fried chicken gizzard lining, 100g of fried malt, 100g of charred hawthorn, 30g of Curcuma zedoaria with vinegar, 300g of Coix seed fried with bran, and 30g of licorice tablets.

[0053] 2. Preparation method

[0054] The Chinese medicine composition granules were prepared according to the preparation method of Example 1.

[0055] Example 3

[0056] Preparation method of Chinese medicine composition granules for treating anorexia in children

[0057] 1. Formula of Chinese medicine composition

[0058] Accurately weigh the following Chinese medicinal raw materials in parts by weight: 40g of Amomum villosum, 40g of costusroot, 40g of white cardamom, 80g of Codonopsis pilosula, 80g of Atractylodes macrocephala fried with bran, 110g of Poria cocos, 80g of dried tangerine peel, 40g of Pinellia ternata with ginger, 150g of stir-fried chicken gizzard lining, 150g of stir-fried malt, 150g of charred hawthorn, 40g of Curcuma zedoaria with vinegar, 150g of stir-fried Coix seeds with bran, and 40g of licorice tablets.

[0059] 2. Preparation method

[0060] The Chinese medicine composition granules were prepared according to the preparation method of Example 1.

[0061] Example 4

[0062] Clinical efficacy verification of the Chinese medicine composition granules prepared in Examples 1 to 3

[0063] 1. Clinical observation of anorexia in children

[0064] 1.1 General Information

[0065] Ten children with anorexia due to spleen and stomach qi deficiency and food accumulation syndrome who met the clinical standard requirements were collected from pediatric outpatient clinic (Shaanxi Provincial Hospital of Traditional Chinese Medicine). The general data of the children, such as age, course of disease, and severity of the disease, were compared, and there was no statistically significant difference (P>0.05), which showed that the children were comparable.

[0066] 1.2 Diagnostic criteria

[0067] 1.2.1 Western medicine diagnostic criteria

[0068] Western medical diagnostic criteria (refer to Zhu Futang Practical Pediatrics, 9th edition, edited by Wang Tianyou et al., People's Medical Publishing House): Anorexia

[0069] 1) Age: children under 14 years old;

[0070] 2) Disease duration: 2 months or more.

[0071] 3) Significant decrease in appetite, loss of appetite or even refusal to eat, and significantly reduced food intake compared to the pasta, rice, bread and other cereal foods for children under 3 years old, and less than 50 grams of cereal foods for children over 3 years old. At the same time, the intake of meat, eggs, milk, etc. is very small. The height and weight of children are lower than the normal average level for the same age, and there is no obvious increase in height and weight during the anorexia period.

[0072] 3) Trace elements: deficiency of vitamin B and trace element zinc.

[0073] 1.2.2 Standards for TCM Syndrome Differentiation

[0074] Diagnostic criteria for TCM syndromes (refer to "Chinese Pediatrics" (New Century Fifth Edition 2021) edited by Zhao Xia and Li Xinmin and "Guidelines for Clinical Research of New Chinese Medicines" 2002).

[0075] Spleen and stomach qi deficiency and food accumulation syndrome:

[0076] Main symptoms: loss of appetite, indigestion of food, thin body, fatigue and weakness in limbs, pale tongue, thin white tongue coating, and slow and weak pulse.

[0077] Secondary symptoms: sallow complexion, loose stools with undigested food, bad breath, occasional nausea or vomiting, foul-smelling stools, abdominal pain, pale red tongue, thick and greasy tongue coating, and thready pulse.

[0078] 1.3 Inclusion criteria

[0079] 1) Meet the Western medicine criteria for indigestion;

[0080] 2) Meet the diagnostic criteria of anorexia, spleen and stomach qi deficiency and food accumulation in traditional Chinese medicine;

[0081] 3) Age: under 14 years old;

[0082] 4) Voluntarily sign the informed consent form.

[0083] 1.4 Exclusion criteria

[0084] 1) Exclude children with similar symptoms such as acute and chronic gastroenteritis, acute and chronic hepatitis, etc.;

[0085] 2) Those with allergic constitution or allergies to multiple drugs, or those with a history of allergy to the components of the trial drugs;

[0086] 3) Those who have used other drugs to treat the disease after the onset of the disease;

[0087] 4) Failure to take medication as prescribed makes it impossible to determine the efficacy, or incomplete data makes it impossible to determine the efficacy.

[0088] 1.5 Treatment

[0089] Dosage and Administration: Take the Chinese medicine composition granules prepared in Examples 1 to 3 with warm water. 0-1 years old: 1 / 4-1 / 3 bag each time; >1 year old <2 years old: 0.5 bag each time; >2 years old <3 years old: 1 bag each time; >3 years old <6 years old: 1.5 bags each time; >6 years old: 2 bags each time. 2-3 times a day. Or follow the doctor's advice.

[0090] Note:

[0091] 1. Eat a light diet during medication.

[0092] 2. People who are allergic to this product are forbidden to use it, and those with allergic constitution should use it with caution.

[0093] 3. It is forbidden to use this product when its properties change.

[0094] 4. Please keep this product out of reach of children.

[0095] 5. If you are using other medicines, please consult your physician or pharmacist before using this product.

[0096] 1.6 Efficacy evaluation criteria

[0097] The symptom score is obtained using the clinical observation scale (see Appendix 2 to Table 4).

[0098] According to the symptom scores, the patients were divided into the efficacy index, namely, cured, markedly effective, effective and ineffective:

[0099] Recovery: Clinical symptoms disappear or almost disappear, and the efficacy index is ≥95%.

[0100] Markedly effective: Clinical symptoms were significantly improved, with efficacy index ≥ 70%.

[0101] Effective: Clinical symptoms are partially improved, with efficacy index ≥ 30%.

[0102] Ineffective: There is no significant improvement in clinical symptoms or they may even worsen, and the syndrome score decreases by less than 30%.

[0103] Wherein, therapeutic index (nimodipine method) = (symptom score before treatment - symptom score after treatment) / symptom score before treatment × 100%.

[0104] 1.7 Treatment results are shown in Table 1.

[0105] Table 1 Comparison results of clinical efficacy observation

[0106] Group Case cure Significant effect efficient invalid Total Effectiveness Treatment Group 120 96 20 4 0 100％ Control group 120 50 30 21 19 84.17％

[0107] Note: Total effective rate = (number of cured patients + markedly effective patients + effective patients) ÷ total number of patients × 100%.

[0108] From the clinical experimental results in Table 1, it can be seen that the total effective rate of the treatment group of the present invention is 100%, and the clinical symptoms of most patients have been significantly improved. Specifically, the appetite of the children after treatment is significantly improved compared with before treatment, the food intake increases, and the picky eating phenomenon disappears. The spirit is improved, the complexion changes from sallow to ruddy, the bowel movements are normal, the night rest is stable, and the weight increases.

[0109] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

[0110] Table 2 Anorexia syndrome score table

[0111]

[0112] Table 3 Grading and Quantification Table of Anorexia Symptoms in Children (Before Treatment)

[0113]

[0114] Table 4 Grading and Quantification Table of Anorexia Symptoms in Children (After Treatment)

[0115]

Claims

1. A Chinese medicine composition for treating anorexia in children, characterized in that: Including the following Chinese medicine raw materials by weight: 6-10 parts of Codonopsis pilosula, 6-10 parts of stir-fried Atractylodes macrocephala, 10-12 parts of Poria cocos, 20-30 parts of stir-fried Coix seeds, 3-6 parts of Amomum villosum, 3-6 parts of costusroot, 3-6 parts of white cardamom, 6-10 parts of dried tangerine peel, 4 parts of Pinellia ternata, 10-20 parts of chicken gizzard lining, 10-20 parts of stir-fried malt, 10-20 parts of charred hawthorn, 3-6 parts of Curcuma zedoaria and 3-6 parts of liquorice.

2. The Chinese medicine composition for treating anorexia in children according to claim 1, characterized in that: Including the following Chinese medicine raw materials by weight: 6-8 parts of Codonopsis pilosula, 6-8 parts of stir-fried Atractylodes macrocephala, 10-11 parts of Poria cocos, 20-27 parts of stir-fried Coix seeds, 3-5 parts of Amomum villosum, 3-5 parts of costusroot, 3-5 parts of white cardamom, 6-8 parts of dried tangerine peel, 4 parts of Pinellia ternata, 14-20 parts of chicken gizzard lining, 14-20 parts of stir-fried malt, 14-20 parts of charred hawthorn, 4-6 parts of Curcuma zedoaria and 4-6 parts of liquorice.

3. The Chinese medicine composition for treating anorexia in children according to claim 1 or 2, characterized in that: Including the following Chinese medicine raw materials by weight: 6 parts of Codonopsis pilosula, 6 parts of stir-fried Atractylodes macrocephala, 10 parts of Poria cocos, 20 parts of stir-fried Coix seeds, 3 parts of Amomum villosum, 3 parts of Aucklandia lappa, 3 parts of White Cardamom, 6 parts of Tangerine peel, 4 parts of Pinellia ternata, 20 parts of Chicken gizzard lining, 20 parts of stir-fried malt, 20 parts of charred Hawthorn, 6 parts of Curcuma zedoaria and 6 parts of Licorice.

4. A method for preparing the Chinese medicine composition for treating anorexia in children according to any one of claims 1 to 3, characterized in that: The following steps are involved: The Chinese medicinal raw materials of the Chinese medicinal composition are decocted with water, and the decoction is collected to obtain the Chinese medicinal composition.

5. The preparation method according to claim 4, characterized in that: The mass ratio of the Chinese medicinal material to water is 1:(7-9); The decoction temperature is 90-100° C.; the decoction is performed twice; and the decoction time is 35-40 min / time.

6. A drug for treating anorexia in children, characterized in that: The invention comprises a traditional Chinese medicine composition obtained by the preparation method according to claim 4 or 5 and pharmaceutically acceptable excipients.

7. The drug for treating anorexia in children according to claim 6, characterized in that: The medicine comprises at least one of the following dosage forms: granules, oral solution, pills, capsules and tablets.

8. The drug for treating anorexia in children according to claim 7, characterized in that: The auxiliary materials in the granules include dextrin and sucrose; the mass ratio of dextrin to sucrose is (0.5-1.5): (1.5-2.5); In the traditional Chinese medicine composition, based on 2 parts by mass of the extracted dry matter, the mass portion of the dextrin is 0.5 to 1.5 parts, and the mass portion of the sucrose is 1.5 to 2.5 parts.

9. A method for preparing the drug according to any one of claims 6 to 8, characterized in that: The method comprises the following steps: removing water from the Chinese medicine composition obtained by the preparation method according to claim 4 or 5 to obtain a Chinese medicine extract; The Chinese medicine extract, dextrin, sucrose and 85% ethanol aqueous solution are mixed and granulated, and dried to obtain granules.

10. Use of the Chinese medicine composition for treating anorexia in children according to any one of claims 1 to 3 or the Chinese medicine composition obtained by the preparation method according to claim 4 or 5 in preparing a drug for treating anorexia in children; The anorexia in children includes the syndrome of food accumulation due to deficiency of spleen and stomach qi.

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