A traditional Chinese medicine composition for treating infantile constipation, a preparation method thereof and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating infantile constipation and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The application aims to solve the technical problems of general treatment effect, poor treatment durability, easy recurrence after drug withdrawal and safety risk in treating infantile constipation. The application provides a traditional Chinese medicine composition for treating infantile constipation, which comprises the following raw materials according to weight parts: 1-12 parts of hemp seeds, 2-10 parts of radish seeds, 1-10 parts of immature bitter oranges, 2-10 parts of Chinese plantain, 3-11 parts of rehmannia, 1-7 parts of honeysuckle and 1-9 parts of magnolia officinalis. The traditional Chinese medicine composition can be used for treating water deficiency and dryness constipation, and can improve the symptoms of infantile constipation through the mechanism of promoting gastrointestinal peristalsis.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and in particular, relates to a traditional Chinese medicine composition for treating infantile constipation and a preparation method and application thereof. BACKGROUND

[0002] Childhood constipation refers to a condition characterized by prolonged constipation, extended defecation days, or difficulty in passing stool despite the urge to defecate. There are many causes of constipation. Simple constipation is often caused by increased water absorption in the colon. Common causes include: 1. Insufficient food intake: When children eat too little, the absorption of fluids after digestion is reduced, resulting in less residue and thinner, more concentrated stools. Prolonged insufficient food intake can lead to malnutrition, decreased or even atrophied abdominal and intestinal muscle tone, weakened contractility, and a vicious cycle that worsens constipation. 2. Inappropriate food composition: The nature of stool is closely related to the composition of food. For example, if the diet contains a lot of protein but insufficient carbohydrates, the fermentation of intestinal contents by intestinal flora is reduced, and the stool is prone to be alkaline and dry. If the diet contains more carbohydrates, the number of intestinal fermenting bacteria increases, the fermentation is enhanced, more acid is produced, and the stool is prone to be acidic, frequent, and soft. If both fat and carbohydrates are consumed, the stool will be smooth. If a large amount of calcified casein is consumed, the feces will contain a large amount of insoluble calcium soaps, resulting in large stool volume and constipation. Among carbohydrates, rice flour and wheat flour products are more likely to cause constipation than grain products. Children's picky eating habits, such as preferring meat and eating little or no vegetables, result in too little fiber in their diet, which can also easily lead to constipation. 3. Intestinal dysfunction: Irregular lifestyle and irregular bowel movements, and the lack of a conditioned reflex for defecation, commonly lead to constipation. In addition, school-aged children often do not have the habit of defecating in the morning and cannot defecate at any time during class, which is also a common cause of constipation. Frequent use of laxatives or enemas, lack of physical activity, or chronic diseases such as malnutrition, rickets, hypercalcemia, dermatomyositis, cretinism, and congenital myasthenia gravis can all cause constipation due to weakness and dysfunction of the intestinal wall muscles. Sympathetic nerve dysfunction, weak or paralyzed abdominal muscles can also often cause constipation. Taking certain medications can reduce intestinal peristalsis and cause constipation, such as anticholinergic drugs, antacids, certain anticonvulsants, diuretics, and iron supplements. 4. Physical and physiological abnormalities: Conditions such as anal fissures, anal stenosis, congenital megacolon, spina bifida, or tumors compressing the cauda equina can all cause constipation. An examination of the anus, lower spine, and perineum is necessary. Some children are constipated from birth; a family history may indicate a genetic component. 5. Psychological factors: Sudden psychological stress or abrupt changes in environment and lifestyle can also cause short-term constipation in children.Children with constipation experience reduced bowel movements, dry and hard stools, difficulty defecating, and anal pain. Sometimes, stool abrades the intestinal mucosa or anus, causing bleeding. The surface of the stool may contain small amounts of blood or mucus. They may also experience abdominal distension, lower abdominal pain, borborygmus, and excessive flatulence. Long-term constipation can lead to hemorrhoids or rectal prolapse. Because stool remains in the intestines for too long, it can also reflexively cause systemic symptoms such as loss of appetite, fatigue, dizziness, and headache. Insufficient food intake over a long period can lead to malnutrition, further aggravating constipation and creating a vicious cycle. If stool remains in the rectum for too long, it can cause local inflammation and a feeling of heaviness. Sometimes, constipated children often feel the urge to defecate but cannot empty their bowels, leading to increased bowel movements. In severe constipation, stool may become impacted, causing involuntary leakage of intestinal secretions around the dry stool, resembling fecal incontinence. Constipation is a common cause of intestinal colic.

[0003] Constipation in children leads to a poor quality of life and significantly impacts their growth and development. Chronic constipation can cause painful bowel movements, hemorrhoids, and in severe cases, anal fissures and rectal prolapse, affecting their quality of life and overall health. Western medicine treatment for functional constipation in children primarily relies on medication to stimulate intestinal motility, supplemented by bowel training, dietary adjustments, and emphasizes parental cooperation in cultivating healthy lifestyle habits. While this can provide short-term symptom relief, it often fails to address the underlying cause, resulting in limited long-term efficacy and a high relapse rate after discontinuation of medication. Traditional Chinese medicine, on the other hand, has the effect of reducing toxicity and enhancing efficacy, further ensuring treatment safety while improving treatment effectiveness.

[0004] Relevant patent documents retrieved:

[0005] This document, published in China (CN105327105A) on February 17, 2016, discloses a decoction for treating constipation, prepared from the following ingredients: 9g rhubarb, 9g immature bitter orange, 9g magnolia bark, 12g hemp seed, 12g apricot kernel, 15g white honey, 15g peony root, 12g rehmannia root, 12g scrophularia root, 12g ophiopogon root, and 6g licorice root. This decoction regulates Qi and moistens the intestines, possessing the effects of clearing heat, promoting bowel movement, and relieving constipation.

[0006] This document, published in China (CN117298193A) on December 29, 2023, discloses a traditional Chinese medicine composition that improves constipation by reversing the structure of the gut microbiota, along with its preparation method and application. The disclosed composition includes rhubarb, magnolia bark, immature bitter orange, radish seed, and rehmannia root, and contains 65 chemical components. It exhibits a significant effect in improving constipation. This composition can effectively reverse the Firmicutes / Bacteroidetes (F / B) ratio in the intestines of a constipated rat model to near-normal levels, and significantly increases the abundance of beneficial bacteria such as Bacteroidetes while decreasing the abundance of harmful bacteria such as Proteobacteria, Firmicutes, and Verrucomicrobia, thus promoting gut health.

[0007] The prior art represented by the aforementioned documents has at least the following unresolved technical problems or defects: 1. The existing technology does not focus on children as the target population, and its suitability is insufficient. The relevant evidence is as follows: The decoction for treating constipation disclosed in CN105327105A contains ingredients such as rhubarb and licorice, which are not suitable for the delicate spleen and stomach characteristics of children. Long-term use may affect children's electrolyte balance. Moreover, no flavoring agents or seasonings suitable for children are added, the bitterness is obvious, and the dosage of the decoction is difficult to control precisely, resulting in low medication compliance in children and certain safety issues.

[0008] 2. The traditional Chinese medicine composition for improving constipation disclosed in CN117298193A contains rhubarb and other ingredients, and the dosage is relatively large. It is not suitable for the delicate spleen and stomach of children, and there are safety risks in the treatment. Summary of the Invention

[0009] To address the aforementioned problems, this invention provides a traditional Chinese medicine composition for treating childhood constipation, its preparation method and application, and related technologies, to solve technical problems such as generally poor efficacy, weak duration of efficacy, easy relapse after discontinuation of medication, and safety risks associated with treatment, or combinations thereof.

[0010] The traditional Chinese medicine composition of the present invention is derived from the Hemp Seed Pill in Treatise on Febrile Diseases and the Augmented Fluid Decoction in Systematic Differentiation of Warm Diseases, and is modified in combination with the physiological characteristics of children. In the formula, stir-fried radish seeds promote digestion and resolve food stagnation, and descend qi to promote defecation, enabling the stagnant food to be digested and the qi in the fu-organs to descend; immature bitter oranges break qi to eliminate accumulation and promote defecation by inducing qi stagnation, removing the distension and fullness in the epigastric and abdominal regions. The two are used in combination to enhance the power of eliminating food stagnation and inducing qi stagnation and promoting the descending of qi in the fu-organs, and they are both the monarch drugs. Hemp seeds moisten the intestines and promote defecation without harming healthy qi, assisting the monarch drugs to increase the function of moistening and purging downward; magnolia bark promotes qi movement, soothes the middle-jiao, relieves distension and fullness. It not only assists the monarch drugs to eliminate accumulation and relieve distension, but also regulates the qi movement in the stomach and intestines, enabling the qi in the fu-organs to descend in an orderly manner. The two are both ministerial drugs, assisting the monarch drugs to enhance the effect of eliminating accumulation and promoting defecation. Raw rehmannia root and scrophularia nourish yin and clear heat, and increase fluid to moisten the intestines. They not only prevent the yin fluid from being consumed by the drugs for promoting digestion and elimination, but also treat the dry stool caused by the consumption of body fluid due to food accumulation and stagnant heat, taking into account the delicate yin constitution of children; honeysuckle clears away food accumulation and stagnant heat, preventing the heat pathogen from disturbing the mouth and tongue. The three are all assistant drugs.

[0011] In the whole formula, the elimination of food accumulation and the purging of the fu-organs are coordinated, promoting qi movement and moistening and purging are taken into account, nourishing yin and clearing heat are carried out simultaneously. It not only attacks the excess of food accumulation, but also protects the delicate yin and yang of children, enabling the qi in the fu-organs to be unobstructed without harming healthy qi. It is especially suitable for the syndrome of constipation and food accumulation in children.

[0012] Term Explanation: Unless otherwise defined, all scientific and technical terms used herein have the same meanings as those commonly understood by those skilled in the art to which the claimed subject matter pertains. Unless otherwise specified, all patents, patent inventions, and published materials cited throughout this text are incorporated herein by reference in their entirety. If there are multiple definitions of a term in this text, the definitions in this chapter shall prevail.

[0013] It should be understood that the above brief description and the following detailed description are exemplary and are only for explanation, without any limitation to the subject matter of the present invention. In the present invention, unless otherwise specifically stated, the use of the singular also includes the plural. It should also be noted that unless otherwise specified, the terms "or" and "or" used herein mean "and / or". In addition, the terms "including" and other forms, such as "comprising", "containing", and "having" are not restrictive.

[0014] The definitions of standard terms can be found in the reference "Pharmacopoeia of the People's Republic of China" (2025).

[0015] Unless otherwise specifically defined, the use of various commercially available products in this text adopts standard techniques. For example, the instructions of the manufacturer for the use of the kit can be utilized, or the implementation can be carried out in accordance with the methods known in the art or the instructions of the present invention. Generally, the above-mentioned techniques and methods can be implemented according to the descriptions in multiple general and more specific documents cited and discussed in this specification, in accordance with the conventional methods well-known in the art.

[0016] The terms "optional / arbitrary" or "optionally / arbitrarily" mean that the subsequent described event or situation may or may not occur, and this description includes the occurrence and non-occurrence of the described event or situation.

[0017] As used herein, the term "Fructus Cannabis" refers to the dried ripe fruits of Cannabis sativa L. of the Moraceae family, preferably produced in Shandong. Cannabis sativa L.

[0018] As used herein, the term "Semen Raphani" refers to the dried ripe seeds of Raphanus sativus L. of the Brassicaceae family, preferably produced in Zhejiang. Raphanus sativus L.

[0019] As used herein, the term "Cortex Magnoliae Officinalis" refers to the dried trunk bark, root bark and branch bark of Magnolia officinalis Rehd. et Wils. of the Magnoliaceae family, preferably produced in Sichuan. Magnolia officinalis Rehd.et Wils.

[0020] As used herein, the term "Fructus Aurantii Immaturus" refers to the dried young fruits of Citrus aurantium L. of the Rutaceae family, preferably produced in Jiangxi. Citrus aurantium L.

[0021] As used herein, the term "Radix Rehmanniae" refers to the fresh or dried tubers of Rehmannia glutinosa Libosch. of the Scrophulariaceae family, preferably produced in Henan. Rehmannia glutinosa Libosch.

[0022] As used herein, the term "Radix Scrophulariae" refers to the dried roots of Scrophularia ningpoensis Hemsl. of the Scrophulariaceae family, preferably produced in Zhejiang. Scrophularia ningpoensis Hemsl.

[0023] As used herein, the term "Flos Lonicerae" refers to the dried flower buds or the flowers with the first bloom of Lonicera japonica Thunb. of the Caprifoliaceae family, preferably produced in Shandong. Lonicera japonica Thunb.

[0024] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating infantile constipation, which, calculated by weight, comprises the following raw materials: 1-12 parts of Fructus Cannabis, 2-10 parts of Semen Raphani, 1-10 parts of Fructus Aurantii Immaturus, 2-10 parts of Radix Scrophulariae, 3-11 parts of Radix Rehmanniae, 1-7 parts of Flos Lonicerae and 1-9 parts of Cortex Magnoliae Officinalis.

[0025] Preferably, the traditional Chinese medicine composition, calculated by weight, comprises the following raw materials: 5-11 parts of Fructus Cannabis, 3-10 parts of Semen Raphani, 2-8 parts of Fructus Aurantii Immaturus, 2-8 parts of Radix Scrophulariae, 2-8 parts of Radix Rehmanniae, 1-6 parts of Flos Lonicerae and 3-5 parts of Cortex Magnoliae Officinalis.

[0026] Preferably, the Fructus Cannabis is selected from any value or range between 5-11 parts calculated by weight.

[0027] More preferably, the hemp seeds are selected from any value or range between 5 and 11 parts by weight, specifically from: 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts or any two of them.

[0028] Further, the hemp seeds are selected from any value or range between 5 and 11 parts by weight, specifically from 5 parts, 6 parts, 9 parts, 10 parts, 11 parts or any two of them.

[0029] Further, the hemp seeds were selected, and the weight was calculated as 9 parts.

[0030] Preferably, the radish seeds are selected from any value or range between 3 and 10 parts by weight.

[0031] More preferably, the radish seeds are selected from any value or range between 3 and 10 parts by weight, specifically from: 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts or any two of them.

[0032] More preferably, the radish seeds are selected from any value or range between 3 and 10 parts by weight, specifically from 4 parts, 5 parts, 6 parts, 7 parts or any two of them.

[0033] More preferably, the radish seeds are in the amount of 6 parts by weight.

[0034] Preferably, the Citrus aurantium is selected from any value or range between 2 and 8 parts by weight.

[0035] More preferably, the Citrus aurantium is selected from any value or range between 2 and 8 parts by weight, specifically from: 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts or any two of them.

[0036] More preferably, the Citrus aurantium is selected from any value or range between 2 and 8 parts by weight, specifically from 2 parts, 3 parts, 4 parts, 5 parts or any two of them.

[0037] More preferably, the amount of Citrus aurantium is 6 parts by weight.

[0038] Preferably, the Scrophularia ningpoensis is selected from any value or range between 2 and 8 parts by weight.

[0039] More preferably, the Scrophularia ningpoensis is selected from any value or range between 2 and 8 parts by weight, specifically from: 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts or any two of them.

[0040] More preferably, the Scrophularia ningpoensis is selected from any value or range between 2 and 8 parts by weight, specifically from 2 parts, 5 parts, 6 parts or any two of them.

[0041] More preferably, the amount of Scrophularia ningpoensis is 6 parts by weight.

[0042] Preferably, the Rehmannia glutinosa is selected from any value or range between 2 and 8 parts by weight.

[0043] More preferably, the Rehmannia glutinosa is selected from any value or range between 2 and 8 parts by weight, specifically from: 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts or any two of them.

[0044] More preferably, the Rehmannia glutinosa is selected from any value or range between 2 and 8 parts by weight, specifically from 3 parts, 4 parts, 6 parts, 8 parts or any two of them.

[0045] More preferably, the Rehmannia glutinosa is in the form of 6 parts by weight.

[0046] Preferably, the honeysuckle is selected from any value or range between 1 and 6 parts by weight.

[0047] More preferably, the honeysuckle is selected from any value or range between 1 and 6 parts by weight, specifically from: 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts or any two of them.

[0048] More preferably, the honeysuckle is in the form of 3 parts by weight.

[0049] Preferably, the magnolia officinalis is selected from any value or range between 3 and 5 parts by weight.

[0050] More preferably, the Magnolia officinalis is selected from any value or range between 3 and 5 parts by weight, specifically from 3 parts, 4 parts, 5 parts or any two of them.

[0051] More preferably, the amount of Magnolia officinalis is 3 parts by weight.

[0052] Preferably, the radish seeds are roasted radish seeds.

[0053] Preferably, the Rehmannia glutinosa is raw Rehmannia glutinosa.

[0054] Preferably, the weight ratio of hemp seed, radish seed, scrophularia root and rehmannia root is selected from any value or range between 1-5:1-3:1-4:1-4.

[0055] More preferably, the weight ratio of hemp seed, radish seed, scrophularia root and rehmannia root is selected from any value or range between 1-5:1-3:1-4:1-4, specifically from: 3:2:2:2, 5:1:1:2, 2:2.4:1.6:1.6, 2:3:3:4 or any two of them.

[0056] More preferably, the weight ratio of hemp seed, radish seed, scrophularia root and rehmannia root is 3:2:2:2.

[0057] Based on further solutions to the technical problems of the present invention, or simultaneous solutions to multiple technical problems, the preferred solution in the technical solution provided in the first aspect of the present invention includes: The first priority solution is a traditional Chinese medicine composition for treating constipation in children. This solution addresses the technical problems of "mediocre therapeutic effect and large dosage" and further solves the technical problems of "poor duration of efficacy and easy relapse after discontinuation of medication".

[0058] The second priority option is a traditional Chinese medicine composition for treating constipation in children. This technical solution, in addition to addressing the technical problems of "mediocre therapeutic effect and large dosage," further solves the technical problem of "slow onset of treatment."

[0059] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: Weigh out the Chinese herbs, add water and decoct, filter to obtain the filtrate, combine the filtrates, concentrate under reduced pressure and dry to obtain the final product.

[0060] Preferably, the weight of water added for decocting is selected from any value or range between 7 and 12 times the total weight of the raw materials.

[0061] More preferably, the weight of water added for decocting is selected from any value or range between 7 and 12 times the total weight of the raw materials, specifically from: 7 times, 8 times, 9 times, 10 times, 11 times, 12 times or any two of them.

[0062] More preferably, the weight of water added for decocting is selected from any value or range between 7 and 12 times the total weight of the raw materials, specifically from: 7 times, 8 times, 9 times, 10 times or any two of them.

[0063] More preferably, the weight of water added for decocting is selected from 7 times the total weight of the raw materials.

[0064] Preferably, the number of times water is added and boiled is selected from any value or range between 2 and 5 times.

[0065] More preferably, the number of times water is added for decocting is selected from any value or range between 2 and 5 times, specifically from: 2 times, 3 times, 4 times, 5 times or any two of them.

[0066] More preferably, the boiling process is carried out twice.

[0067] Preferably, the simmering time is selected from any value or range between 0.5 and 2 hours; More preferably, the simmering time is selected from any value or range between 0.5 and 2 hours, specifically from 0.5 hours, 1 hour, 1.5 hours, 2 hours, or any two of them.

[0068] More preferably, the simmering time is 1.5 hours.

[0069] More preferably, the decocting time is 0.5 hours.

[0070] Preferably, the simmering temperature is selected from any value or range between 100-120°C.

[0071] More preferably, the simmering temperature is selected from any value or range between 100-120℃, specifically from: 100℃, 105℃, 110℃, 115℃, 120℃ or any two of them.

[0072] More preferably, the simmering temperature is selected from any value or range between 100-120℃, specifically from: 100℃, 105℃, 110℃, 115℃, 120℃ or any two of them.

[0073] More preferably, the decocting temperature is 100°C.

[0074] Preferably, the specific operation of the vacuum concentration is as follows: vacuum concentration at 80°C to a relative density of 1.15-1.20 (40-50°C).

[0075] As a preferred embodiment, the method for preparing the traditional Chinese medicine composition includes the following steps: Weigh out the Chinese herbal medicine, add water (7 times the weight of the herbal medicine), and decoct twice, the first time for 2 hours and the second time for 1.5 hours. Filter the decoction, combine the filtrates, and concentrate under reduced pressure at 80℃ to a relative density of 1.15-1.20 (40℃). After concentration under reduced pressure, dry the product to obtain the final product.

[0076] Thirdly, the present invention provides: a traditional Chinese medicine preparation for treating constipation in children, comprising the above-mentioned traditional Chinese medicine composition and pharmaceutically usable excipients or carriers.

[0077] Preferably, the dosage form of the traditional Chinese medicine preparation includes liquid preparations and solid preparations.

[0078] Preferably, the liquid preparation includes decoctions, syrups, and oral solutions.

[0079] More preferably, the liquid preparation is a syrup and / or an oral liquid.

[0080] Preferably, the solid dosage form includes mixtures, tablets, capsules, granules, decoctions, pills, and powders.

[0081] More preferably, the solid preparation is a mixture, granules, and / or a decoction.

[0082] Preferably, the excipients are selected from one or more of the following: solvents, wetting agents, suspending agents, cosolvents, diluents, flavoring agents, preservatives, fillers, disintegrants, lubricants, binders, flavoring agents, and penetration enhancers.

[0083] More preferably, the auxiliary material is a flavoring agent.

[0084] Preferably, the flavoring agent is selected from one or more of the following: peach flavoring, orange flavoring, grapefruit flavoring, tangerine flavoring, fresh orange juice flavoring, candied pineapple flavoring, Taiwanese pineapple flavoring, chocolate flavoring, Golden Delicious apple flavoring, banana juice flavoring, strawberry flavoring, green apple flavoring, and flavor improver flavoring. More preferably, the flavoring agent is peach flavoring, orange flavoring, grapefruit flavoring, or mandarin orange flavoring.

[0085] Fourthly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine preparation, comprising the following steps: The traditional Chinese medicine composition is diluted with water, centrifuged, and the centrifuged liquid is concentrated under reduced pressure. Then, excipients are added and stirred. After filtration, water is added, pH is adjusted, and the mixture is filtered again to obtain the final product.

[0086] Preferably, the specific operation of dilution with water is as follows: add water until the density is diluted to 1.05-1.07 (12°C).

[0087] Preferably, the centrifugal speed is selected from any value or range between 1000-18000 r / min.

[0088] More preferably, the centrifugal speed is selected from any value or range between 1000-17000 r / min.

[0089] Preferably, the centrifugation temperature is selected from any value or range between 10-20℃.

[0090] More preferably, the centrifugation temperature is selected from any value or range between 10-20℃, specifically from: 10℃, 12℃, 15℃, 20℃ or any two of them.

[0091] More preferably, the centrifugation temperature is 12°C.

[0092] Preferably, the specific operation of the vacuum concentration is as follows: vacuum concentration at 80°C to a relative density of 1.15-1.20 (40-50°C).

[0093] Preferably, the excipients are selected from one or more of the following: solvents, wetting agents, suspending agents, cosolvents, diluents, flavoring agents, preservatives, fillers, disintegrants, lubricants, binders, flavoring agents, and penetration enhancers.

[0094] More preferably, the auxiliary material is a flavoring agent.

[0095] Preferably, the flavoring agent is selected from one or more of the following: peach flavoring, orange flavoring, grapefruit flavoring, tangerine flavoring, fresh orange juice flavoring, candied pineapple flavoring, Taiwanese pineapple flavoring, chocolate flavoring, Golden Delicious apple flavoring, banana juice flavoring, strawberry flavoring, green apple flavoring, and flavor improver flavoring. More preferably, the flavoring agent is peach flavoring, orange flavoring, grapefruit flavoring, or strawberry flavoring.

[0096] Preferably, the pH adjuster used is hydrochloric acid, sulfuric acid, citric acid, sodium hydroxide, potassium hydroxide, sodium bicarbonate, disodium hydrogen phosphate and / or sodium dihydrogen phosphate.

[0097] More preferably, the pH adjuster is selected from one or more of sodium hydroxide, hydrochloric acid, citric acid, and sodium bicarbonate.

[0098] Preferably, the pH adjustment range is selected from any value or range between 4 and 7.5.

[0099] More preferably, the pH adjustment range is selected from any value or range between 4 and 7.5, specifically from: 4, 4.5, 5.3, 5.8, 6, 6.5, 7, 7.5 or any two of them.

[0100] More preferably, the pH adjustment range is selected from any value or range between 4 and 7.5, specifically from: 4.0, 5.1, 5.3, 5.5, 5.8 or any two of them.

[0101] More preferably, the pH is 5.8.

[0102] Preferably, the hydration solution of the traditional Chinese medicine preparation has a relative density of 1.0-1.2.

[0103] Fifthly, the present invention provides the application of the above-mentioned traditional Chinese medicine composition or preparation in the preparation of a medicine for treating pediatric constipation.

[0104] Preferably, the drug is a drug for improving constipation and / or lubricating the bowel passage in children.

[0105] Examples 1-7 of this invention at least support the protection scope of the content of the traditional Chinese medicine composition components involved in claim 1.

[0106] Regarding the content of components in the traditional Chinese medicine composition involved in claim 1. The technical feature “one of the raw materials of the traditional Chinese medicine composition and its weight parts are 1-12 parts of hemp seed” is summarized from the corresponding technical feature in the foregoing explanation and / or Examples 1-7, where the weight parts of hemp seed are 1 part, 4 parts, 5 parts, 6 parts, 9 parts, 10 parts, 11 parts, 12 parts, etc., and is derived from the common feature “the raw materials and their weight parts of the traditional Chinese medicine composition for treating constipation in children”. Therefore, those skilled in the art can reasonably presume that the technical feature "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children is 1-12 parts by weight of hemp seed", the technical means with a subordinate concept that is basically equivalent to it, and the technical means that can replace "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children is 1-12 parts by weight of hemp seed" based on the existing technical level and conventional technical means and common knowledge should all fall within the protection scope of claim 1. For example, if other technical features remain unchanged, replacing "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children is 1-12 parts by weight of hemp seed" with 3 parts by weight of hemp seed, it still falls within the protection scope of claim 1 of this invention.

[0107] The technical feature “one of the raw materials of the traditional Chinese medicine composition and its weight parts are 2-10 parts of radish seed” is summarized from the corresponding technical features of radish seed weight parts of 2, 4, 5, 6, 7, 10 parts in the foregoing explanation and / or Examples 1-7, which are summarized from the common feature “the raw materials and their weight parts of the traditional Chinese medicine composition for treating constipation in children”. Therefore, those skilled in the art can reasonably presume that the technical feature "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children is 2-10 parts by weight of radish seed", the technical means with a subordinate concept that is basically equivalent to it, and the technical means that can replace "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children is 2-10 parts by weight of radish seed" based on the existing technical level and conventional technical means and common knowledge should all fall within the protection scope of claim 1. For example, if other technical features remain unchanged, replacing "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children is 2-10 parts by weight of radish seed" with 9 parts by weight of radish seed, etc., still falls within the protection scope of claim 1 of this invention.

[0108] The technical feature “one of the raw materials of the traditional Chinese medicine composition and its weight parts are 1-10 parts of immature bitter orange” is summarized from the corresponding technical feature of immature bitter orange weight parts of 1, 2, 3, 4, 5, 6, 7, 10 parts in the foregoing explanation and / or Examples 1-7, which is derived from the common feature “the raw materials and their weight parts of the traditional Chinese medicine composition for treating constipation in children”. Therefore, those skilled in the art can reasonably presume that the technical feature "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children is 1-10 parts by weight of Citrus aurantium", the technical means with a subordinate concept that is basically equivalent to it, and the technical means that can replace "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children is 1-10 parts by weight of Citrus aurantium" based on the existing technical level and conventional technical means and common knowledge should all fall within the protection scope of claim 1. For example, if other technical features remain unchanged, replacing "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children is 1-10 parts by weight of Citrus aurantium" with 8 parts by weight of Citrus aurantium, etc., still falls within the protection scope of claim 1 of this invention.

[0109] The technical feature "one of the raw materials of the traditional Chinese medicine composition and its weight parts are 2-10 parts of Scrophularia ningpoensis" is derived from the corresponding technical features in the foregoing explanation and / or Examples 1-7, where the weight parts of Scrophularia ningpoensis are 2, 4, 5, 6, or 10 parts, and summarized from the common feature "the raw materials of the traditional Chinese medicine composition for treating constipation in children and their weight parts". Therefore, those skilled in the art can reasonably infer that the technical feature "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 2-10 parts of Scrophularia ningpoensis", its subordinate concept is substantially equivalent to it, and technical means that can replace "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 2-10 parts of Scrophularia ningpoensis" based on the existing technical level and conventional technical means and common knowledge should all fall within the protection scope of claim 1. For example, if other technical features remain unchanged, replacing "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 2-10 parts of Scrophularia ningpoensis" with 9 parts of Scrophularia ningpoensis, etc., still falls within the protection scope of claim 1 of this invention.

[0110] The technical feature "one of the raw materials of the traditional Chinese medicine composition and its weight parts are 3-11 parts of Rehmannia glutinosa" is derived from the corresponding technical features in the foregoing explanation and / or Examples 1-7, where the weight parts of Rehmannia glutinosa are 3, 4, 5, 6, 8, and 11 parts, and summarized from the common feature "the raw materials of the traditional Chinese medicine composition for treating constipation in children and their weight parts". Therefore, those skilled in the art can reasonably infer that the technical feature "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 3-11 parts of Rehmannia glutinosa", its subordinate concepts, and technical means that can replace "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 3-11 parts of Rehmannia glutinosa" based on existing technology and conventional technical means and common knowledge should all fall within the protection scope of claim 1. For example, replacing "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 3-11 parts of Rehmannia glutinosa" with 7 parts of Rehmannia glutinosa while keeping other technical features unchanged still falls within the protection scope of claim 1 of this invention.

[0111] The technical feature "one of the raw materials of the traditional Chinese medicine composition and its weight parts are 1-7 parts of honeysuckle" is derived from the corresponding technical feature in the foregoing explanation and / or Examples 1-7, where the weight parts of honeysuckle are 1, 2, 3, 4, 5, 7, etc., summarized from the common feature "the raw materials of the traditional Chinese medicine composition for treating constipation in children and their weight parts". Therefore, those skilled in the art can reasonably infer that the technical feature "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 1-7 parts of honeysuckle", its subordinate concept is basically equivalent to it, and the technical means that can replace "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 1-7 parts of honeysuckle" based on the existing technical level and conventional technical means and common knowledge should all fall within the protection scope of claim 1. For example, if other technical features remain unchanged, replacing "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 1-7 parts of honeysuckle" with 6 parts of honeysuckle by weight, it still falls within the protection scope of claim 1 of this invention.

[0112] The technical feature "one of the raw materials of the traditional Chinese medicine composition and its weight parts are 1-9 parts of Magnolia officinalis" is derived from the corresponding technical features in the foregoing explanation and / or Examples 1-7, where the weight parts of Magnolia officinalis are 1, 3, 4, 5, and 9 parts, and summarized from the common feature "the raw materials of the traditional Chinese medicine composition for treating constipation in children and their weight parts". Therefore, those skilled in the art can reasonably infer that the technical feature "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 1-12 parts of Magnolia officinalis", its subordinate concepts are substantially equivalent to it, and technical means that can replace "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 1-9 parts of Magnolia officinalis" based on existing technology and conventional technical means and common knowledge should all fall within the protection scope of claim 1. For example, if other technical features remain unchanged, replacing "one of the raw materials of the traditional Chinese medicine composition for treating constipation in children and its weight parts are 1-9 parts of Magnolia officinalis" with 6 parts of Magnolia officinalis by weight still falls within the protection scope of claim 1 of this invention.

[0113] In this invention, Examples 1-4 at least support the protection scope of the ratio of hemp seed, radish seed, scrophularia and rehmannia involved in claim 4.

[0114] The technical feature “the weight ratio of hemp seed, radish seed, scrophularia and rehmannia is 1-5:1-3:1-4:1-4” is summarized from the corresponding technical features in the foregoing explanation and / or Examples 1-4, such as the weight ratio of hemp seed, radish seed, scrophularia and rehmannia as 3:2:2:2, 5:1:1:2, 2:2.4:1.6:1.6, 2:3:3:4, etc., which are derived from the common feature “the ratio of hemp seed, radish seed, scrophularia and rehmannia”. Therefore, those skilled in the art can reasonably presume that the technical feature “the weight ratio of hemp seed, radish seed, scrophularia and rehmannia is 1-5:1-3:1-4:1-4”, its subordinate concept and the technical means that are basically equivalent to it, and the technical means that can replace “the weight ratio of hemp seed, radish seed, scrophularia and rehmannia is 1-5:1-3:1-4:1-4” based on the existing technical level and conventional technical means and common knowledge, should all fall within the protection scope of claim 4. For example, if “the weight ratio of hemp seed, radish seed, scrophularia and rehmannia is 1-5:1-3:1-4:1-4” is replaced with the weight ratio of hemp seed, radish seed, scrophularia and rehmannia is 4:1:1:1, etc., while other technical features remain unchanged, it still falls within the protection scope of claim 1 of this invention.

[0115] The beneficial effects of this invention are as follows: The present invention has at least the following beneficial effects: 1. Compared with existing technologies, this invention has better technical effects in shortening the time for the first black stool to be expelled in a dehydrated constipation model: According to experimental tests, the present invention shortens the time for the first black stool to be expelled in the dehydrated constipation model from more than 450 minutes in the prior art to less than 436 minutes, such as 436.83 minutes for test sample 1.

[0116] 2. Compared with the prior art, the present invention has better technical effects in improving the small intestine propulsion rate: According to experimental tests, the present invention increases the small intestinal propulsion rate from about 77% in the prior art to more than 86%, such as 86.52% for test sample 1.

[0117] 3. Compared with existing technologies, this invention has better technical effects in improving the colonic propulsion rate: According to experimental tests, the present invention increases the colonic propulsion rate from about 30% in the prior art to more than 35%, such as 35.77% for test sample 1.

[0118] 4. Compared with existing technologies, this invention uses stir-fried radish seeds and immature bitter orange as the principal herbs, supplemented with hemp seeds, magnolia bark, rehmannia root, scrophularia root, honeysuckle, etc., focusing on a combination of eliminating food stagnation, promoting bowel movements, nourishing yin and clearing heat, making it especially suitable for children with immature yin and yang constitutions. It avoids the use of strong purgative ingredients such as rhubarb, reducing irritation to children's spleen and stomach and improving medication safety. Furthermore, it adds pediatric-appropriate taste enhancers to improve medication compliance. Detailed Implementation

[0119] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0120] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all instruments, devices, equipment, reagents, products, etc., used in the embodiments of the present invention are obtained through conventional commercial means.

[0121] Example 1: Preparation of a traditional Chinese medicine composition for treating childhood constipation The components of the traditional Chinese medicine, by weight, are: 9 parts hemp seed, 6 parts stir-fried radish seed, 6 parts immature bitter orange, 6 parts scrophularia root, 6 parts rehmannia root, 3 parts honeysuckle and 3 parts magnolia bark; Preparation method: Weigh out the Chinese medicine, add water and decoct it. The amount of water should be 7 times the weight of the Chinese medicine. Decoction is carried out twice, the first time for 2 hours and the second time for 1.5 hours. Filter the decoction, combine the filtrates and concentrate them under reduced pressure at 80℃ to a relative density of 1.15-1.20 (40℃). After concentration under reduced pressure, dry the decoction to obtain a dry powder.

[0122] Example 2: Preparation of a traditional Chinese medicine composition for treating childhood constipation The components of the traditional Chinese medicine, by weight, are: 10 parts hemp seeds, 2 parts stir-fried radish seeds, 10 parts immature bitter orange, 2 parts scrophularia root, 4 parts rehmannia root, 5 parts honeysuckle, and 4g magnolia bark; Preparation method: Weigh out the Chinese medicine, add water and decoct it. The amount of water should be 10 times the weight of the Chinese medicine. Decoction is carried out 3 times: 1 hour for the first time, 1.5 hours for the second time, and 1.5 hours for the third time. Filter the decoction, combine the filtrates and concentrate them under reduced pressure at 80℃ to a relative density of 1.15-1.20 (40℃). After concentration under reduced pressure, dry the decoction to obtain a dry powder.

[0123] Example 3: Preparation of a traditional Chinese medicine composition for treating childhood constipation The components of the traditional Chinese medicine, by weight, are: 5 parts hemp seed, 6 parts stir-fried radish seed, 6 parts immature bitter orange, 4 parts scrophularia root, 4 parts rehmannia root, 4 parts honeysuckle, and 5 parts magnolia bark; Preparation method: Weigh out the Chinese medicine, add water and decoct it. The amount of water should be 8 times the weight of the Chinese medicine. Decoction is carried out twice, the first time for 1.5 hours and the second time for 0.5 hours. Filter the solution, combine the filtrates and concentrate them under reduced pressure at 80℃ to a relative density of 1.15-1.20 (40℃). After concentration under reduced pressure, dry the solution to obtain a dry extract powder.

[0124] Example 4: Preparation of a traditional Chinese medicine composition for treating childhood constipation The components of the traditional Chinese medicine, by weight, are: 4 parts hemp seed, 6 parts stir-fried radish seed, 2 parts immature bitter orange, 6 parts scrophularia root, 8 parts rehmannia root, 3 parts honeysuckle and 5 parts magnolia bark; Preparation method: Weigh out the Chinese medicine, add water and decoct it. The amount of water should be 9 times the weight of the Chinese medicine. Decoction is carried out twice, for 2 hours the first time and 2 hours the second time. Filter the decoction, combine the filtrates and concentrate them under reduced pressure at 80℃ to a relative density of 1.15-1.20 (40℃). After concentration under reduced pressure, dry the powder to obtain a dry extract.

[0125] Comparative Example 1 This is a modified version of the formula Ma Zi Ren Wan from *Shang Han Lun* and Zeng Ye Tang from *Wen Bing Tiao Bian*, specifically: The Chinese herbal medicine components by weight are: 3 parts of immature bitter orange, 9 parts of hemp seed, 3 parts of magnolia bark, 5 parts of scrophularia root, 6 parts of rehmannia root, 5 parts of white peony root, 4 parts of apricot kernel, 4 parts of ophiopogon root, 5 parts of white honey, and 2 parts of licorice root; the remaining steps are the same as in Example 1.

[0126] Comparative Example 2 The difference from Example 1 is that one of the principal herbs, Fructus Aurantii Immaturus, has been removed. Specifically: The Chinese herbal medicine components, by weight, are: 9 parts hemp seed, 6 parts stir-fried radish seed, 6 parts scrophularia root, 6 parts rehmannia root, 3 parts honeysuckle, and 3 parts magnolia bark; the remaining steps are the same as in Example 1.

[0127] Comparative Example 3 The difference from Example 1 is that one of the auxiliary herbs, Magnolia officinalis, has been removed, specifically: Nine parts hemp seeds, six parts stir-fried radish seeds, six parts immature bitter orange, six parts scrophularia root, six parts rehmannia root, and three parts honeysuckle; the remaining steps are the same as in Example 1.

[0128] Comparative Example 4 The difference from Example 1 is that the adjuvant herb Rehmannia glutinosa has been removed, specifically: Nine parts hemp seeds, six parts stir-fried radish seeds, six parts immature bitter orange, six parts scrophularia root, six parts rehmannia root, and three parts honeysuckle; the remaining steps are the same as in Example 1.

[0129] Study on the effect of traditional Chinese medicine composition on dehydration and constipation model in young KM mice (Example 1) (1) Experimental methods Experimental animals, grouping, modeling, and administration: Several 3-4 week old SPF-grade KM mice, half male and half female, weighing 15±2g. After the quarantine period, a number of animals were randomly selected and given routine feed and water, while the remaining animals were given only feed and deprived of water for approximately 72 hours. After modeling, some mice showed piloerection symptoms, and animals with a weight loss of more than 3g were considered to have successfully modeled the disease. Animals that successfully modeled the disease were randomly grouped according to weight into model control group, commercial control group, and test product groups. Six animals that were routinely given feed and water served as the normal control group. The drug component of the traditional Chinese medicine composition prepared in Example 1 was used as test product group 1, the drug component of the traditional Chinese medicine composition prepared in Example 2 was used as test product group 2, the drug component of the traditional Chinese medicine composition prepared in Example 3 was used as test product group 3, and the drug component of the traditional Chinese medicine composition prepared in Example 4 was used as test product group 4. The drug groups of the traditional Chinese medicine compositions prepared in Comparative Examples 1-4 were divided into Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4, with 6 mice in each group. Specific dosing information is shown in Table 1 below: Table 1 Dosage Design Table

[0130] After grouping, the normal control group and the model control group were given pure water by gavage, the commercially available control group was given Xiao Mi Tong Heji by gavage, and the test sample groups 1-4 and comparative examples 1-4 were given the corresponding Chinese herbal composition by gavage. The administration volume of each group was 10 mL / kg / time, and the administration was twice a day with an interval of about 5 hours.

[0131] (2) Experimental results Compared with the normal control group, the time for excreting the first black feces in each model group was significantly prolonged (P < 0.01), indicating successful model establishment. Compared with the model control group, the time for excreting the first black feces in the commercially available control group, the test product group, and the comparative group was shortened. The shortening of the time in the commercially available control group, the test product group, and some of the comparative groups was statistically significant (P < 0.01 or P < 0.05). The test product group 1 showed the greatest reduction in the time for excreting the first black feces, and there was a significant difference between it and the comparative groups (P < 0.01 or P < 0.05), indicating that the formulation of this invention is more effective than the formulations in the comparative groups in improving dehydration and constipation in young KM mice.

[0132] Under the experimental conditions, after the traditional Chinese medicine compositions prepared in Examples 1-4 were administered orally to young KM mice with a dehydration-induced constipation model, the animals in each group were in good general condition and no drug-related abnormal reactions were observed.

[0133] Table 2. Effects of traditional Chinese medicine composition on the dehydration and constipation model in young KM mice (Mean±SD)

[0134] Note: n=6 for each group. ## P < 0.01, compared with the normal control group; P < 0.05 P<0.01, compared with the model control group; ^ P < 0.05, each group was compared with the test sample group 1.

[0135] Study on the effect of traditional Chinese medicine composition on small intestinal propulsion in young KM mice (Example 2) (1) Experimental methods 1. Experimental animals, grouping and administration: Several 3-4 week old SPF-grade KM mice, half male and half female, weighing 15±2g, were randomly divided into the following groups after the quarantine period: blank control group, commercially available control group, and the administration groups of the traditional Chinese medicine compositions prepared in Examples 1-4, namely test sample group 1, test sample group 2, test sample group 3, and test sample group 4, respectively; the administration groups of the traditional Chinese medicine compositions prepared in Comparative Examples 1-4, namely comparative example group 1, comparative example group 2, comparative example group 3, and comparative example group 4, respectively, with 6 mice in each group.

[0136] Animals were administered the medication on the day of grouping. The blank control group was given pure water by gavage, while the commercially available control group was given the undiluted pediatric antacid by gavage. Each of the treatment groups was given the corresponding solution by gavage. The dosage volume for each group was 20 mL / kg, administered twice daily for 7 consecutive days, with an interval of at least 5 hours between doses. An additional dose was administered during gastric emptying and small intestinal propulsion tests. The number of days of administration is expressed as Dn, e.g., D7 represents the 7th day of administration. Specific administration information is shown in Table 3 below. Table 3 Dosage Design Table

[0137] (2) Experimental results Compared with the blank control group, the small intestinal propulsion rate of the commercially available control group, the test product group, and the comparative group all showed an increasing trend. Among them, the increase in the commercially available control group and the test product group was statistically significant (P < 0.01 or P < 0.05). The test product group 1 had the highest small intestinal propulsion rate, showing the best effect in improving small intestinal motility, and there was a significant difference between it and the comparative group (P < 0.01 or P < 0.05), indicating that the formulation of this invention is more effective than the comparative group in improving small intestinal motility in young KM mice.

[0138] Under the experimental conditions, after the traditional Chinese medicine compositions prepared in Examples 1-4 were administered orally to young KM mice, the animals in each group were in good general condition and no drug-related abnormal reactions were observed.

[0139] Table 4. Effects of traditional Chinese medicine composition on small intestinal propulsion in young KM mice (Mean±SD, %)

[0140] Note: n=6 for each group. P < 0.05 P<0.01, compared with the blank control group; ^ P < 0.05 ^^ P < 0.01, each group was compared with the test sample group 1.

[0141] Example 3: Study on the effect of traditional Chinese medicine composition on a loperamide hydrochloride-induced constipation model in young KM mice. (1) Experimental methods Experimental animals, grouping, modeling, and administration: Several 3-4 week old SPF-grade KM mice, half male and half female, weighing 15±2g, were randomly divided into the following groups after the quarantine period: normal control group, model control group, commercially available control group, administration group of traditional Chinese medicine compositions prepared in Examples 1-4, and administration group of traditional Chinese medicine compositions prepared in Comparative Examples 1-4. Among them, the administration component of the traditional Chinese medicine composition prepared in Example 1 was used as test sample group 1, the administration component of the traditional Chinese medicine composition prepared in Example 2 was used as test sample group 2, the administration component of the traditional Chinese medicine composition prepared in Example 3 was used as test sample group 3, the administration component of the traditional Chinese medicine composition prepared in Example 4 was used as test sample group 4, and the administration components of the traditional Chinese medicine compositions prepared in Comparative Examples 1-4 were used as Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4, with 6 mice in each group. On the day of modeling, all animals were fasted for approximately 16 hours but allowed free access to water. The normal control group was administered 0.5% CMC-Na solution by gavage at 5 mL / kg, while the other groups were administered loperamide hydrochloride solution (5 mg / kg) by gavage. Drug administration began the following day. The normal and model control groups were administered pure water by gavage, while the commercially available control group was administered a children's diaphoretic compound by gavage. The drug administration groups were administered the corresponding solutions by gavage at a volume of 10 mL / kg per administration. Administration continued for 7 days, twice daily, with an interval of at least 5 hours between administrations. Specific administration information is shown in Table 5 below. Table 5 Dosage Design Table

[0142] (2) Experimental results Compared with the normal control group, the time to excrete the first black feces in the model control group was significantly increased (P < 0.01), indicating successful model establishment. Compared with the model control group, the time to excrete the first black feces in the commercially available control group, the test product group, and the comparative group was shortened. The shortening of the time in the commercially available control group, the test product group, and some of the comparative groups was statistically significant (P < 0.01 or P < 0.05). The test product group 1 showed the greatest shortening of the time to excrete the first black feces, and there was a significant difference between it and the comparative groups (P < 0.01 or P < 0.05), indicating that the formulation of this invention is more effective than the comparative groups in improving constipation induced by loperamide hydrochloride in young KM mice.

[0143] Under the experimental conditions, after the traditional Chinese medicine compositions prepared in Examples 1-4 were administered orally to loperamide hydrochloride to induce constipation in young KM mice, the animals in each group were in good general condition and no drug-related abnormal reactions were observed.

[0144] Table 6. Effects of traditional Chinese medicine composition on the constipation model induced by loperamide hydrochloride in young KM mice (Mean±SD)

[0145] Note: n=6 for each group.## P < 0.01, compared with the normal control group; P < 0.05 P<0.01, compared with the model control group; ^ P < 0.05, each group was compared with the test sample group 1.

[0146] Example 4: Study on the effect of traditional Chinese medicine composition on colonic propulsion in young SD rats (1) Experimental methods Experimental animals, grouping, modeling, and administration: 3-5 week old SD rats, half male and half female, weighing 100±10g. After the quarantine period, they were randomly divided into the following groups: blank control group, commercially available control group, administration group of traditional Chinese medicine compositions prepared in Examples 1-4, and administration group of traditional Chinese medicine preparations prepared in Comparative Examples 1-4. Among them, the administration component of the traditional Chinese medicine composition prepared in Example 1 was used as test sample group 1, the administration component of the traditional Chinese medicine composition prepared in Example 2 was used as test sample group 2, the administration component of the traditional Chinese medicine composition prepared in Example 3 was used as test sample group 3, the administration component of the traditional Chinese medicine composition prepared in Example 4 was used as test sample group 4, and the administration components of the traditional Chinese medicine preparations prepared in Comparative Examples 1-4 were used as Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4, with 6 rats in each group.

[0147] Animals in each group were fasted overnight for approximately 16 hours after 7 days (14 times) of drug administration (water was not prohibited). Before modeling, the fasting weight of each animal was measured, and the corresponding control / traditional Chinese medicine preparation was administered according to the group. 30 minutes later, propofol injection was administered via the tail vein at a dose of approximately 20 mg / kg. The hair on the animal's abdomen was removed using a shaver, and an incision was made along the midline to open the abdominal cavity. The junction of the cecum and colon was located, and the junction was closed with an arterial clamp. Chinese ink was injected, with a volume of 0.5 mL per animal. The arterial clamp was then released, the timing was started, and the abdominal cavity was closed.

[0148] Animals were given medication on the day of grouping. The blank control group was given pure water by gavage, the commercially available control group was given the corresponding solution / suspension by gavage, and each of the treatment groups was given the corresponding solution by gavage. The dosage volume for each group was 10 mL / kg, and the administration was carried out continuously for 7 days, twice a day, with an interval of no less than 5 hours between each administration. Specific administration information is shown in Table 7 below: Table 7 Dosage Design Table

[0149] (2) Experimental results Compared with the blank control group, the colonic propulsion rate of the commercially available control group, the test product group, and the comparative group all showed an increasing trend. Among them, the increase in the commercially available control group and the test product group was statistically significant (P < 0.01 or P < 0.05). The test product group 1 had the highest colonic propulsion rate, showing the best effect in promoting the propulsion of colonic contents, and there was a significant difference between it and the comparative group (P < 0.01 or P < 0.05), indicating that the formulation of this invention is more effective than the comparative group in promoting the propulsion of colonic contents in young SD rats.

[0150] Under the experimental conditions, after the traditional Chinese medicine compositions prepared in Examples 1-4 were administered orally to young SD rats, the animals in each group were in good general condition and no drug-related abnormal reactions were observed.

[0151] Table 8. Effects of traditional Chinese medicine composition on colonic propulsion in young SD rats (Mean±SD)

[0152] Note: n=6 for each group. P < 0.05 P<0.01, compared with the blank control group; ^ P < 0.05, each group was compared with the test sample group 1.

[0153] Example 5: Preparation of a traditional Chinese medicine preparation for treating childhood constipation The components of the traditional Chinese medicine, by weight, are: 12 parts hemp seeds, 2 parts stir-fried radish seeds, 7 parts immature bitter orange, 2 parts scrophularia root, 3 parts rehmannia root, 7 parts honeysuckle, and 1 part magnolia bark; Preparation method: (1) Weigh the Chinese medicine and add water to decoct. The amount of water should be 7 times the weight of the Chinese medicine. Decoction is performed 4 times. The first time is 2 hours, the second time is 0.5 hours, the third time is 0.5 hours, and the fourth time is 1 hour. Filter the decoction, combine the filtrates, and concentrate them under reduced pressure at 80°C to a relative density of 1.15-1.20 (40°C) to obtain the extract. (2) Dilute the extract with water to a density of 1.02-1.05 (12℃), centrifuge at 10000r / min and 12℃ for 10min, take the centrifuged liquid and concentrate it under reduced pressure at 80℃ to a relative density of 1.15-1.20 (40℃), then add peach flavoring and stir, filter, and then add water to a relative density of 1.0-1.2. Adjust the pH to 5.1 with hydrochloric acid and sodium hydroxide (pH adjuster) and filter again to obtain the final product.

[0154] Example 6: Preparation of a traditional Chinese medicine preparation for treating childhood constipation The components of the traditional Chinese medicine, by weight, are: 1 part hemp seed, 10 parts stir-fried radish seed, 1 part immature bitter orange, 10 parts scrophularia root, 11 parts rehmannia root, 1 part honeysuckle and 9 parts magnolia bark; Preparation method: (1) Weigh the Chinese medicine and add water to decoct. The amount of water is 8 times the weight of the Chinese medicine. Decoction is carried out 3 times. The first time is 0.5 hours, the second time is 2 hours, and the third time is 1 hour. Filter and combine the filtrates. Then concentrate under reduced pressure at 80℃ to a relative density of 1.15-1.20 (40℃) to obtain the extract. (2) Dilute the extract with water to a density of 1.02-1.05 (12℃), centrifuge at 17000r / min and 20℃ for 10min, take the centrifuged liquid and concentrate it under reduced pressure at 80℃ to a relative density of 1.15-1.20 (40℃), then add orange flavoring and stir, filter, and add water to a relative density of 1.0-1.2. Adjust the pH to 5.5 with citric acid and sodium bicarbonate (pH adjuster) and filter again to obtain the final product.

[0155] Example 5: Study on the effect of traditional Chinese medicine preparations on a dehydration-induced constipation model in young KM mice. (1) Experimental methods Experimental animals, grouping, modeling, and administration: Several 3-4 week old SPF-grade KM mice, half male and half female, weighing 15±2g. After the quarantine period, a number of animals were randomly selected and given routine feed and water, while the remaining animals were given feed only and deprived of water for approximately 72 hours. After modeling, some mice showed piloerection symptoms, and animals with a weight loss of more than 3g were considered to have successfully modeled the disease. The successfully modeled animals were randomly grouped according to weight into a model control group, a commercially available control group, and each test product group. Six animals that were routinely given feed and water served as a normal control group. Five test product groups were administered the traditional Chinese medicine composition prepared in Example 5, and six test product groups were administered the traditional Chinese medicine composition prepared in Example 6, with six mice in each group. Specific administration information is shown in Table 9 below: Table 9 Dosage Design Table

[0156] After grouping, the normal control group and the model control group were given pure water by gavage, the commercially available control group was given Xiao Mi Tong He Ji by gavage, and the test sample group was given the corresponding traditional Chinese medicine preparation by gavage. The administration volume of each group was 10 mL / kg / time, and the administration was carried out twice a day with an interval of about 5 hours.

[0157] (2) Experimental results Compared with the normal control group, the time to excretion of the first black feces was significantly prolonged in all model groups (P < 0.01); compared with the model control group, the time to excretion of the first black feces was significantly shortened in the commercially available control group and in groups 5 and 6 of the test product (P < 0.05 or P < 0.01). Moreover, compared with the time to excretion of the first black feces in the commercially available control group, the time to excretion of the first black feces was significantly shortened in groups 5 and 6 of the test product.

[0158] Under the experimental conditions, after the traditional Chinese medicine preparations prepared in Examples 5 and 6 were administered orally to young KM mice with a dehydration-induced constipation model, the animals in each group were in good general condition and no drug-related abnormal reactions were observed.

[0159] Table 10 Effects of traditional Chinese medicine preparations on a dehydration-induced constipation model in young KM mice (Mean±SD)

[0160] Note: n=6 for each group. ## P < 0.01, compared with the normal control group; P < 0.05 P<0.01, compared with the model control group.

[0161] Example 7: Preparation of a traditional Chinese medicine preparation for treating childhood constipation Preparation 1: First, take 6 parts hemp seed, 5 parts stir-fried radish seed, 3 parts immature bitter orange, 6 parts scrophularia root, 8 parts rehmannia root, 3 parts honeysuckle, and 3 parts magnolia bark. Add 7 times the weight of the medicinal materials in water, decoct twice, the first time for 2 hours and the second time for 1.5 hours, filter, and combine the filtrates. Concentrate the combined filtrate under reduced pressure below 80℃ to a relative density of 1.15-1.20 (40℃), stop concentration, and obtain an extract. Centrifuge the extract (10000 r / min), add water to a relative density of 1.02-1.05 (12℃), centrifuge again, concentrate the centrifuged liquid under reduced pressure below 80℃ to a relative density of 1.15-1.20 (40℃), add grapefruit flavoring and stir, filter, add water to 1000 ml, adjust the pH to 5.8 with sodium bicarbonate and hydrochloric acid, filter, and obtain the composition of the present invention.

[0162] Preparation Method 2: First, take 9 parts hemp seed, 6 parts stir-fried radish seed, 5 parts immature bitter orange, 6 parts scrophularia root, 4 parts rehmannia root, 5 parts honeysuckle, and 4 parts magnolia bark. Add 10 times the weight of the medicinal materials in water and decoct three times: 1 hour for the first time, 1.5 hours for the second time, and 1.5 hours for the third time. Filter and combine the filtrates. Concentrate the combined filtrate under reduced pressure below 80°C to a relative density of 1.16 (50°C), then stop the concentration to obtain an extract. Add water to bring the relative density to 1.05-1.07 (12°C), centrifuge (11000 r / min), and concentrate the centrifuged liquid under reduced pressure below 80°C to a relative density of 1.15-1.20 (40°C). Add strawberry flavoring and stir, filter, add water to 1000 ml, adjust the pH to 5.3 with sodium bicarbonate and hydrochloric acid, and filter to obtain the composition of this invention.

[0163] Preparation Method 3: First, take 10 parts hemp seeds, 7 parts stir-fried radish seeds, 4 parts immature bitter orange, 5 parts scrophularia root, 3 parts rehmannia root, 4 parts honeysuckle, and 5 parts magnolia bark. Add 8 times the weight of the medicinal materials in water, decoct twice, the first time for 1.5 hours and the second time for 0.5 hours. Filter and combine the filtrates. Concentrate the combined filtrate under reduced pressure below 80°C to a relative density of 1.15-1.17 (50°C), stop concentration, and obtain an extract. Dilute with water to a relative density of 1.05-1.07 (12°C), centrifuge (10500 r / min), concentrate the centrifuged liquid under reduced pressure below 80°C to a relative density of 1.15-1.20 (40°C), add chocolate flavoring and pineapple flavoring, stir, filter, add water to 1000 ml, adjust the pH to 5.3 with sodium hydroxide and hydrochloric acid, filter, and obtain the composition of the present invention.

[0164] Preparation Method 4: First, take 5 parts hemp seed, 4 parts stir-fried radish seed, 2 parts immature bitter orange, 2 parts scrophularia root, 3 parts rehmannia root, 2 parts honeysuckle, and 3 parts magnolia bark. Add 9 times the weight of the medicinal materials in water, and decoct twice, the first time for 2 hours and the second time for 2 hours. Filter and combine the filtrates. Concentrate the combined filtrate under reduced pressure below 80℃ to a relative density of 1.15-1.17 (50℃), stop the concentration, and obtain an extract. Centrifuge (11000 r / min), add mandarin orange flavoring and stir, filter, adjust the pH to 4.0 with citric acid, add water to 900 ml, filter, and obtain the composition of the present invention.

[0165] Preparation 5: First, take 11 parts hemp seed, 7 parts stir-fried radish seed, 4 parts immature bitter orange, 5 parts scrophularia root, 6 parts rehmannia root, 1 part honeysuckle, and 4 parts magnolia bark. Add 7 times the weight of the medicinal materials in water and decoct four times: 2 hours for the first time, 0.5 hours for the second time, 0.5 hours for the third time, and 1 hour for the second time. Filter and combine the filtrates. Concentrate the combined filtrate under reduced pressure below 80°C until the relative density is 1.15-1.17 (50°C). Stop the concentration to obtain an extract. Centrifuge (10000 r / min), add green apple flavoring and stir, filter, adjust the pH to 5.1 with sodium hydroxide and hydrochloric acid, add water to 800 ml, filter, and obtain the composition of the present invention.

[0166] Preparation Method 6: First, take 5 parts hemp seed, 4 parts stir-fried radish seed, 5 parts immature bitter orange, 5 parts scrophularia root, 5 parts rehmannia root, 3 parts honeysuckle, and 5 parts magnolia bark. Add 8 times the weight of the medicinal materials in water and decoct three times: 0.5 hours the first time, 2 hours the second time, and 1 hour the third time. Filter and combine the filtrates. Concentrate the combined filtrate under reduced pressure below 80°C to a relative density of 1.15-1.17 (50°C), then stop the concentration to obtain an extract. Add water to a relative density of 1.05-1.07 (12°C), centrifuge (12000 r / min), and concentrate the centrifuged liquid under reduced pressure below 80°C to a relative density of 1.15-1.20 (40°C). Add grapefruit flavoring and stir, filter, add water to 1000 ml, adjust the pH to 5.5 with sodium hydroxide and citric acid, and filter to obtain the composition of this invention.

[0167] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for treating constipation in children, characterized in that, The ingredients, by weight, include the following: 1-12 parts hemp seed, 2-10 parts radish seed, 1-10 parts immature bitter orange, 2-10 parts scrophularia root, 3-11 parts rehmannia root, 1-7 parts honeysuckle flower, and 1-9 parts magnolia bark.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The ingredients, by weight, include the following: 5-11 parts hemp seed, 3-10 parts radish seed, 2-8 parts immature bitter orange, 2-8 parts scrophularia root, 2-8 parts rehmannia root, 1-6 parts honeysuckle flower, and 3-5 parts magnolia bark.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The radish seeds mentioned are stir-fried radish seeds, and the rehmannia root mentioned is raw rehmannia root.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The weight ratio of hemp seed, radish seed, scrophularia root and rehmannia root is 1-5:1-3:1-4:1-4.

5. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, Includes the following steps: Weigh out the Chinese herbs, add water and decoct, filter to obtain the filtrate, combine the filtrates, concentrate under reduced pressure and dry to obtain the final product; The weight of water added for decocting is 7-12 times the total weight of the raw materials, and the decocting is performed 2-5 times.

6. A traditional Chinese medicine preparation for treating constipation in children, characterized in that, The traditional Chinese medicine composition includes the traditional Chinese medicine composition according to any one of claims 1-4 or the traditional Chinese medicine composition prepared by the preparation method according to claim 5, and is made with pharmaceutically usable excipients or carriers.

7. The traditional Chinese medicine preparation according to claim 6, characterized in that, The dosage forms of the traditional Chinese medicine preparations include liquid preparations and solid preparations; The liquid preparations include decoctions, syrups, and oral solutions; The solid dosage forms include mixtures, tablets, capsules, granules, decoctions, pills, and powders; The excipients are selected from one or more of the following: solvents, wetting agents, suspending agents, solubilizers, diluents, flavoring agents, preservatives, fillers, disintegrants, lubricants, binders, flavoring agents, and penetration enhancers. The flavoring agent is selected from one or more of the following: peach flavoring, orange flavoring, grapefruit flavoring, tangerine flavoring, fresh orange flavoring, candied pineapple flavoring, Taiwanese pineapple flavoring, chocolate flavoring, apple flavoring, banana flavoring, strawberry flavoring, green apple flavoring, and flavor improver flavoring.

8. The method for preparing the traditional Chinese medicine preparation according to any one of claims 6-7, characterized in that, Includes the following steps: The traditional Chinese medicine composition is diluted with water, centrifuged, and the centrifuged liquid is concentrated under reduced pressure. Then, excipients are added and stirred. After filtration, water is added, pH is adjusted, and the mixture is filtered again to obtain the final product.

9. The preparation method according to claim 8, characterized in that, The pH adjustment agent used is hydrochloric acid, sulfuric acid, citric acid, sodium hydroxide, potassium hydroxide, sodium bicarbonate, disodium hydrogen phosphate, and / or sodium dihydrogen phosphate; the pH range is 4-7.

5.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-4 or the traditional Chinese medicine preparation according to any one of claims 6-7 in the preparation of a medicine for treating pediatric constipation.

Images