Traditional Chinese medicine preparations used to treat or relieve functional constipation in children.

Abstract

This invention provides a traditional Chinese medicine preparation for treating or relieving functional constipation in children, belonging to the field of traditional Chinese medicine technology. The preparation is made from raw Atractylodes macrocephala, banana root, Citrus reticulata, mulberry, Lophatherum gracile, Hovenia dulcis leaf, Ziziphus jujuba leaf, Pogostemon cablin, Citrus reticulata peel, Torreya grandis seed, and licorice. This traditional Chinese medicine preparation significantly increases the number of fecal particles in constipation model rats over 24 hours, increases fecal water content, and improves intestinal propulsion rate, thus improving intestinal peristalsis. In clinical observation, this traditional Chinese medicine preparation effectively relieves the core symptoms of children, shortens the interval between defecation, softens stool, and alleviates straining during defecation. It also improves accompanying symptoms such as abdominal distension and halitosis. After the course of treatment, bowel regularity returns, and there is no significant recurrence during follow-up, providing a new option for the clinical treatment of functional constipation in children.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine preparation for treating or relieving functional constipation in children. Background Technology

[0002] Functional constipation (FC) in children, also known as habitual constipation, is a common digestive system disease in pediatric clinics. It refers to children who have constipation symptoms, but no structural or biochemical abnormalities in the gastrointestinal tract are found through examinations such as endoscopy. Its core clinical manifestations are hard, dry, pellet-like stools, reduced frequency of bowel movements, and difficulty in defecation. In severe cases, manual assistance is required for defecation. Some children may also have symptoms such as abdominal distension, halitosis, loss of appetite, and irritability. Long-term illness can not only affect the child's nutrient absorption and growth and development, but may also cause complications such as anal fissures, hemorrhoids, and anal papillitis, reducing the child's quality of life.

[0003] Currently, the main clinical treatment for functional constipation in children is medication, supplemented by dietary adjustments and bowel habit cultivation. Commonly used Western medicines include bulk-forming laxatives, osmotic laxatives, and prokinetic agents. Among these, osmotic laxatives such as lactulose and polyethylene glycol are widely used clinically due to their rapid onset of action and relatively few side effects. However, these Western medicines are mostly symptomatic treatments, only temporarily relieving constipation symptoms and failing to address the root cause of constipation by regulating intestinal function and digestive capacity. Long-term use can easily lead to drug dependence and may even disrupt the balance of intestinal flora, causing adverse reactions such as diarrhea and bloating, which is detrimental to the child's long-term health.

[0004] In Traditional Chinese Medicine (TCM), constipation falls under the categories of "constipation," "difficulty in defecation," "spleen deficiency," "impaired bowel movement," "incomplete defecation," and "intestinal dryness." TCM believes that the main causes of constipation include dietary imbalances, emotional distress, and weakness of the body's vital energy (Qi), with the core pathogenesis being a disorder of the large intestine's transmission function. Although the primary location of the disease is the large intestine, the pathological mechanisms often involve multiple organs such as the lungs, spleen, liver, and kidneys. Based on these pathogenesis, currently used TCM formulas or preparations for treating functional constipation in children primarily focus on strengthening the spleen, moistening the intestines, clearing heat, and regulating Qi. However, existing TCM preparations still have many shortcomings: some formulations are not precisely matched, failing to fully address the physiological characteristics of children's delicate organs; some are too warming and drying, easily depleting Yin fluids, while others are too cold, easily damaging the spleen and stomach's vital energy. Some preparations lack specificity, failing to address the multiple syndromes present in children's functional constipation, resulting in limited therapeutic effects. Therefore, in view of the above-mentioned shortcomings of existing drugs for treating functional constipation in children, it is of great clinical significance and application value to develop a traditional Chinese medicine preparation that is scientifically formulated, mild in nature, effective, with few side effects, good compliance in children, can quickly relieve constipation symptoms, regulate spleen and stomach function, balance qi, and nourish yin fluids from the root cause, and is suitable for multiple types of functional constipation in children. This is also a technical problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0005] (a) Technical problems to be solved

[0006] In view of the shortcomings of the existing technology, the present invention provides a traditional Chinese medicine preparation for treating or relieving functional constipation in children.

[0007] (II) Technical Solution

[0008] To achieve the above objectives, the present invention provides the following technical solution:

[0009] On one hand, the present invention provides a traditional Chinese medicine preparation for treating or relieving functional constipation in children, the preparation being made from the following raw materials in parts by weight: 4-20 parts of raw Atractylodes macrocephala, 3-18 parts of banana root, 3-18 parts of Citrus reticulata, 3-18 parts of mulberry, 2-8 parts of Lophatherum gracile, 3-16 parts of Hovenia dulcis leaf, 3-18 parts of Ziziphus jujuba, 2-13 parts of Pogostemon cablin, 2-13 parts of Citrus reticulata peel, 3-18 parts of Torreya grandis, and 2-12 parts of Glycyrrhiza uralensis.

[0010] Specifically, the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 8-16 parts of raw Atractylodes macrocephala, 7-14 parts of banana root, 7-14 parts of Citrus reticulata, 7-14 parts of mulberry, 2-5 parts of Lophatherum gracile, 6-12 parts of Hovenia dulcis leaf, 7-14 parts of water chestnut, 4-10 parts of Pogostemon cablin, 4-10 parts of Citrus reticulata peel, 7-14 parts of Torreya grandis, and 3-9 parts of licorice.

[0011] Specifically, the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 12 parts of raw Atractylodes macrocephala, 10 parts of banana root, 10 parts of Citrus reticulata, 10 parts of mulberry, 3 parts of Lophatherum gracile, 9 parts of Hovenia dulcis leaf, 10 parts of Ziziphus jujuba, 8 parts of Pogostemon cablin, 8 parts of Citrus reticulata peel, 10 parts of Torreya grandis, and 6 parts of licorice.

[0012] This invention provides the application of the traditional Chinese medicine preparation in the preparation of a drug for treating or relieving functional constipation in children.

[0013] The pharmacological effects of each Chinese herbal raw material in the Chinese herbal preparation of this invention are as follows:

[0014] Raw Atractylodes macrocephala: The dried rhizome of Atractylodes macrocephala Koidz., a plant in the Asteraceae family. It tastes bitter and sweet, and is warm in nature. It enters the spleen and stomach meridians. Functions and indications: It strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus. It is used for spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention with dizziness and palpitations, edema, spontaneous sweating, and threatened abortion.

[0015] Banana root: The rhizome of *Musabasjoo Sieb.* et Zucc., a plant in the Musaceae family. It has a cool taste and bland nature. It enters the stomach, spleen, and liver meridians. Functions and indications: Clears heat, quenches thirst, promotes urination, and detoxifies. Used for febrile diseases, restlessness, thirst, jaundice, edema, beriberi, hematuria, metrorrhagia, carbuncles, boils, and erysipelas.

[0016] Poncirus trifoliata (L.) Raf., a plant in the Rutaceae family, is an immature fruit. It has a pungent and bitter taste, and is warm in nature. It enters the liver and stomach meridians. Its functions and indications include: soothing the liver and stomach, regulating qi and relieving pain, and eliminating food stagnation. It is used for chest and rib distension, abdominal distension and pain, breast lumps, hernia pain, testicular swelling and pain, traumatic injuries, food stagnation, constipation, and uterine prolapse.

[0017] Mulberry: The dried fruit spike of *Morus alba* L., a plant in the Moraceae family. It has a sweet and sour taste and is cold in nature. It enters the heart, liver, and kidney meridians. Functions and indications: Nourishes yin and blood, promotes body fluid production, and moistens the intestines. Used for dizziness, lower back pain, tinnitus, premature graying of hair, insomnia, thirst due to fluid depletion, diabetes, and constipation due to intestinal dryness caused by liver and kidney deficiency and blood and essence deficiency.

[0018] Lophatherum gracile Brongn. (light bamboo leaf): The dried stems and leaves of this grass (Poaceae). It has a sweet and bland taste and is cold in nature. It enters the heart, stomach, and small intestine meridians. Functions and indications: Clears heat and drains fire, relieves irritability and quenches thirst, promotes urination and relieves strangury. Used for feverish thirst, scanty, dark, painful urination, and sores in the mouth and tongue.

[0019] Hovenia acerba leaf: The leaf of the plant Hovenia acerba, belonging to the Rhamnaceae family. It has a bitter taste and cool properties. It enters the stomach and liver meridians. Functions and indications: Clears heat and detoxifies, relieves irritability and quenches thirst. Used for wind-heat type common cold, hangover with thirst, vomiting, and constipation.

[0020] Water bamboo: The spindle-shaped, hypertrophic gall formed by the stimulation of the flower stalk of the gramineous plant Zizania caduciflora (Turcz. ex Trin.) Hand-Mazz. by the water bamboo smut fungus. It tastes sweet and is cold in nature. It belongs to the liver, spleen, and lung meridians. Functions and indications: Clearing heat and detoxifying, relieving vexation and thirst, promoting urination and defecation. It is used for restlessness, polydipsia, jaundice, dysentery, red eyes, and wind sores.

[0021] Cablin Potchouli Herb: The dried above-ground part of the labiate plant Pogostemon cablin (Blanco) Benth. It tastes pungent and is slightly warm in nature. It belongs to the spleen, stomach, and lung meridians. Functions and indications: Aromatically resolving turbidity, harmonizing the middle and stopping vomiting, inducing sweating and relieving summer heat. It is used for damp-turbidity obstructing the middle, fullness and distension in the epigastrium with vomiting; summer-damp exterior syndrome, initial stage of damp-warm syndrome, fever with lassitude, chest distress and discomfort; cold-damp blocking summer heat, abdominal pain with vomiting and diarrhea; nasal sinus headache.

[0022] Exocarpium Citri Grandis: The immature or nearly mature dried outer pericarp of the rutaceous plant Citrus grandis 'Tomentosa' or Citrus grandis (L.) Osbeck. It tastes pungent and bitter and is warm in nature. It belongs to the lung and spleen meridians. Functions and indications: Regulating qi and relieving distension, drying dampness and resolving phlegm. It is used for profuse cough with phlegm, food retention and alcohol injury, nausea and fullness and discomfort.

[0023] Chinese torreya seeds: The dried mature seeds of the taxaceae plant Torreya grandis Fort. It tastes sweet and is neutral in nature. It belongs to the lung, stomach, and large intestine meridians. Functions and indications: Killing parasites and eliminating accumulation, moistening the lung and relieving cough, moistening dryness and promoting defecation. It is used for ancylostomiasis, ascariasis, taeniasis, abdominal pain due to worm accumulation, infantile malnutrition, dry cough due to lung dryness, and constipation.

[0024] Licorice Root: The dried root and rhizome of the leguminous plants Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. It tastes sweet and is neutral in nature. It belongs to the heart, lung, spleen, and stomach meridians. Functions and indications: Tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasm and pain, and harmonizing various medicinal herbs. It is used for weakness of the spleen and stomach, lassitude and fatigue, palpitation and shortness of breath, profuse cough with phlegm, spasm and pain in the epigastrium and extremities, carbuncles and sores, and relieving the toxicity and potency of medicinal herbs.

[0025] (III) Beneficial effects

[0026] This invention provides a traditional Chinese medicine preparation for treating or relieving functional constipation in children. The preparation is made from raw Atractylodes macrocephala, banana root, Citrus reticulata, mulberry, Lophatherum gracile, Hovenia dulcis leaf, water chestnut, Pogostemon cablin, Citrus reticulata peel, Torreya grandis seed, and licorice. While functional constipation in children manifests as abnormal large intestine motility, its root cause lies in spleen and stomach weakness. This formula strictly adheres to the principles of traditional Chinese medicine's principal, assistant, and adjuvant herbs, using raw Atractylodes macrocephala as the principal herb. Atractylodes macrocephala is considered the "primary herb for tonifying qi and strengthening the spleen," with a sweet and bitter taste, warm nature, and entry into the spleen and stomach meridians. Its core functions are to strengthen the spleen and replenish qi, dry dampness and promote urination, and moisten the intestines to relieve constipation. It can both tonify the spleen and stomach, fundamentally improving insufficient body fluid production, and gently moisten the intestines, avoiding the damage to the spleen and stomach's vital energy caused by bitter and cold purgatives. It is suitable for children with functional constipation due to spleen and stomach weakness and intestinal dryness and fluid deficiency. The formula uses banana root, tangerine peel, mulberry, and bamboo leaves as assistant herbs. Banana root is cold in nature but not drastic, and has the functions of clearing heat and purging fire, promoting body fluid and quenching thirst, and promoting urination and bowel movements. It can clear residual heat in the intestines, replenish intestinal fluids, assist raw Atractylodes macrocephala in moistening waste and promoting transmission, and at the same time promote urination to unblock the triple burner and promote the excretion of damp heat. Tangerine peel is pungent and warm, and can soothe the liver and regulate qi, relieve qi stagnation caused by liver dysfunction, and promote qi circulation and eliminate stagnation in the spleen and stomach, assisting raw Atractylodes macrocephala in strengthening the spleen and promoting digestion. Mulberry is sweet, cold, and moistening, and can replenish the fluids of the large intestine, moisten waste and help it move downward, and nourish the yin of the liver and kidneys, taking into account the yin deficiency in children, and relieving symptoms of fluid deficiency such as dry mouth and dry stools associated with constipation. Lophatherum gracile clears heat and purges fire, promotes urination and relieves strangury, and generates fluids and quenches thirst. It can assist the principal ingredient in enhancing its heat-clearing and dampness-removing effects, relieving intestinal heat accumulation, and also alleviating dry mouth and thirst in children caused by intestinal heat and fluid deficiency. Hovenia dulcis leaves, water bamboo shoots, patchouli, tangerine peel, and torreya seeds are used as adjuvant ingredients. Hovenia dulcis leaves are neutral in nature, assisting mulberry and banana root in generating fluids and moistening dryness, replenishing intestinal fluids, and also stimulating appetite and digestion, improving loss of appetite and abdominal distension caused by constipation. Water bamboo shoots are cold in nature, clearing residual heat, moistening the intestines, and regulating the three jiaos, assisting the principal and adjuvant ingredients in relieving intestinal dryness and constipation; moreover, its mild texture does not harm the spleen and stomach. Patchouli dispels dampness, harmonizes the middle jiao, regulates qi, and soothes the stomach. Citrus reticulata peel regulates qi, relieves chest congestion, dries dampness, resolves phlegm, and promotes digestion. The combination of these two herbs enhances their ability to regulate qi and eliminate stagnation, alleviating symptoms of constipation such as abdominal distension, belching, and difficulty in defecation. Torreya grandis kills parasites, eliminates stagnation, moistens dryness, and promotes bowel movements. It not only improves constipation caused by spleen and stomach stagnation but also assists the principal and assistant herbs in promoting bowel movement. Licorice is used as the guiding herb. Licorice is sweet and neutral in nature, possessing the effects of tonifying qi and the middle jiao, clearing heat and detoxifying, and harmonizing the effects of other herbs. On one hand, it assists Atractylodes macrocephala in strengthening the spleen and qi, enhancing spleen and stomach function; on the other hand, it harmonizes the overall formula's hot and cold properties, balancing warm and dry, and reducing the mild purgative effect of Lophatherum gracile, preventing excessive purgation from damaging the spleen and stomach. Furthermore, it helps clear residual heat in the intestines, guiding the other herbs to the spleen, stomach, and large intestine meridians, enhancing the overall formula's effects of moistening the intestines, promoting bowel movements, strengthening the spleen, and eliminating stagnation.

[0027] Pharmacodynamic studies were conducted using a rat model of constipation, and clinical observations were performed on children with functional constipation of different syndrome types to verify the efficacy and safety of the traditional Chinese medicine preparation of this invention. Results showed that the traditional Chinese medicine preparation significantly increased the number of fecal particles in constipated rats over 24 hours, increased fecal water content, and improved intestinal propulsion rate, thus improving intestinal peristalsis in a dose-dependent manner. In clinical observation, the preparation effectively relieved the core symptoms of children, shortened the interval between defecation, softened feces, and alleviated straining during defecation. It also improved accompanying symptoms such as abdominal distension and halitosis. After the course of treatment, bowel regularity returned, and no significant recurrence was observed during follow-up, providing a new option for the clinical treatment of functional constipation in children. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0029] Example 1

[0030] A traditional Chinese medicine preparation for treating or relieving functional constipation in children is made from the following ingredients in parts by weight: 12 parts of raw Atractylodes macrocephala, 10 parts of banana root, 10 parts of Citrus reticulata, 10 parts of mulberry, 3 parts of Lophatherum gracile, 9 parts of Hovenia dulcis leaf, 10 parts of Ziziphus jujuba, 8 parts of Pogostemon cablin, 8 parts of Citrus reticulata peel, 10 parts of Torreya grandis, and 6 parts of licorice.

[0031] Example 2

[0032] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 18 parts of raw Atractylodes macrocephala, 15 parts of banana root, 15 parts of Citrus reticulata, 15 parts of mulberry, 6 parts of Lophatherum gracile, 13 parts of Hovenia dulcis leaf, 15 parts of water chestnut, 11 parts of Pogostemon cablin, 11 parts of Citrus reticulata peel, 15 parts of Torreya grandis, and 10 parts of licorice.

[0033] Example 3

[0034] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 20 parts of raw Atractylodes macrocephala, 18 parts of banana root, 18 parts of Citrus reticulata, 18 parts of mulberry, 8 parts of Lophatherum gracile, 16 parts of Hovenia dulcis leaf, 18 parts of water chestnut, 13 parts of Pogostemon cablin, 13 parts of Citrus reticulata peel, 18 parts of Torreya grandis, and 12 parts of licorice.

[0035] Example 4

[0036] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 6 parts of raw Atractylodes macrocephala, 4 parts of banana root, 5 parts of Citrus reticulata, 4 parts of mulberry, 2 parts of Lophatherum gracile, 5 parts of Hovenia dulcis leaf, 4 parts of water chestnut, 4 parts of Pogostemon cablin, 4 parts of Citrus reticulata peel, 5 parts of Torreya grandis, and 3 parts of licorice.

[0037] Example 5

[0038] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 4 parts of raw Atractylodes macrocephala, 3 parts of banana root, 3 parts of Citrus reticulata, 3 parts of mulberry, 2 parts of Lophatherum gracile, 3 parts of Hovenia dulcis leaf, 3 parts of water chestnut, 2 parts of Pogostemon cablin, 2 parts of Citrus reticulata peel, 3 parts of Torreya grandis, and 2 parts of licorice.

[0039] Example 6

[0040] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 8 parts of raw Atractylodes macrocephala, 5 parts of banana root, 5 parts of Citrus reticulata, 5 parts of mulberry, 3 parts of Lophatherum gracile, 6 parts of Hovenia dulcis leaf, 6 parts of water chestnut, 5 parts of Pogostemon cablin, 6 parts of Citrus reticulata peel, 5 parts of Torreya grandis, and 4 parts of licorice.

[0041] Example 7

[0042] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 15 parts of raw Atractylodes macrocephala, 12 parts of banana root, 12 parts of Citrus reticulata, 12 parts of mulberry, 5 parts of Lophatherum gracile, 10 parts of Hovenia dulcis leaf, 12 parts of water chestnut, 9 parts of Pogostemon cablin, 9 parts of Citrus reticulata peel, 12 parts of Torreya grandis, and 8 parts of licorice.

[0043] Example 8

[0044] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 10 parts of raw Atractylodes macrocephala, 7 parts of banana root, 8 parts of Citrus reticulata, 7 parts of mulberry, 4 parts of Lophatherum gracile, 8 parts of Hovenia dulcis leaf, 8 parts of Ziziphus jujuba, 6 parts of Pogostemon cablin, 6 parts of Citrus reticulata peel, 8 parts of Torreya grandis, and 6 parts of Glycyrrhiza uralensis.

[0045] Comparative Example 1

[0046] The difference between this comparative example and Comparative Example 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 10 parts banana root, 10 parts tangerine peel, 10 parts mulberry, 3 parts bamboo leaves, 9 parts Japanese raisin tree leaves, 10 parts water chestnut, 8 parts patchouli, 8 parts dried tangerine peel, 10 parts torreya nuts, and 6 parts licorice.

[0047] Comparative Example 2

[0048] The difference between this comparative example and Comparative Example 1 is that the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 12 parts of raw Atractylodes macrocephala, 10 parts of mulberry, 9 parts of Hovenia dulcis leaf, 10 parts of water chestnut, 8 parts of Pogostemon cablin, 8 parts of Citrus reticulata peel, 10 parts of Torreya grandis fruit, and 6 parts of licorice.

[0049] Experimental Example 1

[0050] 1. Materials

[0051] 1.1 Experimental Drugs

[0052] The traditional Chinese medicine preparation of the present invention, the drugs of Comparative Example 1 group and Comparative Example 2 group were prepared according to the formulas described in Example 1, Comparative Example 1, and Comparative Example 2 respectively (each weight part is calculated as 1 g). Preparation method: After the raw materials are crushed, they are respectively added with distilled water and extracted by ultrasonic for 30 min, and then concentrated to a crude drug content of 1.0 g / mL to obtain.

[0053] Lactulose Oral Solution: Specification: 100 mL: 50 g; Manufacturer: Dalian Merro Traditional Chinese Medicine Factory Co., Ltd.; Approval Number of State Drug Standard: H20093300.

[0054] Maren Runchang Pills: Specification: 6 g / pill; Manufacturer: Tongrentang Pharmaceutical Factory of Beijing Tongrentang Co., Ltd.; Approval Number of State Drug Standard: Z11020159; Before use, it is dissolved in physiological saline to make a suspension for gavage.

[0055] 1.2 Experimental Animals

[0056] 64 SPF-grade SD rats, half male and half female, with a body weight of 180 - 220 g, were purchased from Henan Spex Biotechnology Co., Ltd. They were raised in a SPF-grade animal room, and the feeding conditions were: temperature 22 - 25°C, relative humidity 50% - 60%, circadian rhythm 12 h / 12 h, free diet and water. After one week of adaptive feeding, subsequent experiments were carried out.

[0057] 2. Methods

[0058] 2.1 Animal Grouping and Drug Administration

[0059] After 1 week of adaptive feeding of rats, 8 rats were randomly selected as the normal control group, and the remaining rats were subjected to model establishment. The rats in the model establishment group were gavaged with 1.5 mg / mL compound diphenoxylate suspension at a dose of 10 mL / kg, once a day for 7 consecutive days. After successful model establishment, the rats in the model establishment group were randomly divided into a model control group, a lactulose group, a Maren Runchang Pills group, a low-dose traditional Chinese medicine preparation group, a high-dose traditional Chinese medicine preparation group, a Comparative Example 1 group, and a Comparative Example 2 group, with 8 rats in each group. Each group of rats was administered by gavage, the administration volume was 10 mL / kg, once a day for 7 consecutive days, and the administration doses are shown in Table 1.

[0060] Table 1 Drug Administration of Each Group of Rats

[0061]

[0062] 2.2 Detection Indexes

[0063] 2.2.1 Fecal particle number and moisture content

[0064] After the drug administration was completed, three rats from each group were randomly selected and placed in metabolic cages. Their defecation was observed and the number of feces excreted within 24 hours was recorded. The total weight of the feces excreted by the rats within 24 hours was weighed, which was the wet weight of the feces. After drying in an oven, the feces were weighed again, which was the dry weight of the feces. The water content of the feces in each group was calculated. Fecal water content (%) = (wet weight of feces - dry weight of feces) / wet weight of feces × 100%.

[0065] 2.2.2 Intestinal propulsion rate

[0066] After the last administration, three rats were randomly selected from each group and administered semi-solid rice paste (containing charcoal powder) by gavage at a dose of 10 mL / kg. Thirty minutes later, the rats were euthanized by cervical dislocation. The abdomen was quickly dissected, and the small intestine (from the pylorus to the ileocecal junction) was separated. The total length of the intestine was measured after straightening and recorded as L0, and the length of the charcoal powder entering the small intestine from the pylorus was recorded as L1. The intestinal propulsion rate of each group was calculated. Intestinal propulsion rate (%) = L1 / L0 × 100%.

[0067] 2.3 Statistical Methods

[0068] All experimental data were analyzed using GraphPad Prism 8.0 statistical software. Quantitative data are expressed as mean ± standard deviation. One-way ANOVA was used for comparisons between groups. A p-value < 0.05 was considered statistically significant, and a p-value < 0.01 was considered extremely statistically significant.

[0069] 3 Results

[0070] 3.1 Fecal pellet number and moisture content

[0071] Table 2 shows that, compared with the normal control group, the number of fecal particles in the model control group was significantly reduced (P<0.01), and the fecal water content was significantly decreased (P<0.01), indicating that the rat constipation model was successfully established. Compared with the model control group, the number of fecal particles in the lactulose group, the hemp seed laxative pill group, the low-dose group of the traditional Chinese medicine preparation, and the high-dose group of the traditional Chinese medicine preparation all increased to varying degrees, and the fecal water content was also significantly increased (P<0.05 or P<0.01). Among them, the improvement effect of the high-dose group of the traditional Chinese medicine preparation was comparable to that of the lactulose group, and its number of fecal particles and water content in the 24-hour period were close to the level of the normal control group. Although the number of fecal particles and water content in the comparative groups 1 and 2 were improved to some extent compared with the model control group, the improvement effect was not as good as that in the low-dose group of the traditional Chinese medicine preparation. This suggests that the traditional Chinese medicine preparation of the present invention can improve intestinal function and relieve constipation from the root cause, and the formulation is scientific and reasonable, with each component working synergistically to lubricate the intestines and promote bowel movements.

[0072] 3.2 Intestinal propulsion rate

[0073] As can be seen from Table 2, compared with the normal control group, the intestinal propulsion rate of the rats in the model control group was significantly decreased (P<0.01), indicating that the intestinal peristalsis function of the rats was significantly weakened after modeling. Compared with the model control group, the intestinal propulsion rates of the rats in the lactulose group, the Maren Runchang Pills group, the low-dose traditional Chinese medicine preparation group and the high-dose traditional Chinese medicine preparation group were all significantly increased (P<0.05 or P<0.01). Among them, the intestinal propulsion rate of the high-dose traditional Chinese medicine preparation group increased most significantly, was better than the Maren Runchang Pills group, was comparable to the lactulose group, and was close to the level of the normal control group. Although the intestinal propulsion rates of the rats in Comparative Example 1 group and Comparative Example 2 group were improved compared with the model control group, the improvement degree was lower than that of the low-dose traditional Chinese medicine preparation group, suggesting that the traditional Chinese medicine preparation of the present invention has significant advantages in promoting intestinal peristalsis and increasing the intestinal propulsion rate, and shows a certain dose-dependence.

[0074] Table 2 Comparison of the number of fecal pellets, water content and intestinal propulsion rate of rats in each group

[0075]

[0076] 4 Conclusion

[0077] The traditional Chinese medicine preparation of the present invention can significantly increase the number of fecal pellets in constipated rats in 24 hours, increase the fecal water content rate, effectively increase the intestinal propulsion rate, improve the intestinal peristalsis function of rats, and shows an obvious dose-dependence. The improvement effect of the high-dose group is comparable to that of the clinically commonly used drug lactulose, and is better than that of Maren Runchang Pills. In summary, through the scientific compatibility of monarch, minister, assistant and envoy, the various medicinal materials of the traditional Chinese medicine preparation of the present invention act synergistically to jointly play the effects of moistening the intestines and relieving constipation, strengthening the spleen and regulating qi, providing a new safe and efficient solution for the treatment of children's functional constipation.

[0078] Test Example 2

[0079] Typical clinical cases

[0080] Case 1: Yang XX, male, 6 years old, first diagnosis on December 3, 2024. Chief complaint: Dry stools and difficult defecation for more than 4 months, aggravated for 2 weeks. The child had abnormal defecation without obvious cause 4 months ago, the frequency significantly decreased, from once a day originally to once every 2-3 days, the feces were dry and granular, defecation was laborious, and accompanied by anal fissure bleeding in severe cases. Usually had a strong appetite, liked to eat meat and fried foods, and ate less vegetables and fruits. The symptoms were aggravated in the recent 2 weeks, the defecation interval was 3-4 days, the stools were dry and hard, the anal pain was obvious during defecation, accompanied by dry mouth and bad breath, irritability and easy waking at night, and short and yellow urine. The current symptoms showed that the child had a relatively red complexion, abdominal distension, no tenderness, and normal bowel sounds. The tongue was red, the tongue coating was yellow and thick and greasy, and the pulse was slippery and rapid.

[0081] Western medicine diagnosis: Functional constipation in children. Traditional Chinese medicine diagnosis: Constipation – Food stagnation syndrome. Analysis: Children often have a weak spleen and poor digestive function. In addition, improper diet, especially excessive consumption of rich and fatty foods, damages the spleen and stomach, leading to impaired digestion and stagnation in the middle jiao (middle burner). This stagnation generates heat, which accumulates internally, depleting body fluids and causing intestinal dryness, resulting in dry stools and constipation lasting several days. The stagnation also obstructs the flow of qi, causing abdominal distension. The heat disturbs the mind, leading to restlessness at night and hot palms and soles. A red tongue with a thick, greasy yellow coating and a slippery, rapid pulse are all signs of food stagnation.

[0082] Treatment plan: Administer the herbal preparation of this invention, prescription: 6g of raw Atractylodes macrocephala, 5g of banana root, 5g of Citrus reticulata, 5g of mulberry, 1.5g of Lophatherum gracile, 4.5g of Hovenia dulcis leaf, 5g of Ziziphus jujuba, 4g of Pogostemon cablin, 4g of Citrus reticulata peel, 5g of Torreya grandis, and 3g of Glycyrrhiza uralensis. One dose per day, decocted in water, taken in two divided doses while warm, for a course of 2 weeks. Simultaneously, instruct parents to adjust the child's diet, discontinue snacks, fried foods, and sweets, increase the intake of leafy green vegetables, and have the child drink 100mL of warm water on an empty stomach every morning, and massage the abdomen clockwise twice daily for 5 minutes each time.

[0083] Efficacy observation: After 3 days of medication, the child excreted a large amount of dark brown, soft, sticky, and foul-smelling stool, and abdominal distension was significantly reduced. After 5 days of medication, the stool turned yellow, soft, and formed, and the frequency of bowel movements stabilized at once every 1-2 days. After 1 week of medication, the child's stool was formed and soft, once a day, and the anal pain disappeared. At the follow-up visit after 2 weeks of treatment, the child's bowel movements were regular, the stool was soft and formed, there was no difficulty in defecation, the complexion was rosy, the tongue was pale red, and the coating was thin and white. After discontinuing the medication, dietary management continued. At the follow-up visit 3 months later, the child's bowel movements were regular, once a day, the stool characteristics were normal, and there was no recurrence.

[0084] Case 2: Shi, male, 9 years old, first visit on November 15, 2024. Chief complaint: Irregular bowel movements and difficulty defecating for 1 year, with constipation worsening for 1 week. The child developed abnormal bowel movements 1 year ago, with alternating episodes of constipation and loose stools. When the stool was hard, bowel movements occurred every 2-3 days with difficulty; when loose, bowel movements occurred 2-3 times daily, sticky and unsatisfying, accompanied by a feeling of incomplete evacuation. The child was overweight and habitually consumed cold drinks, sweets, and raw fruits and vegetables, accompanied by abdominal distension, a sticky feeling in the mouth, heaviness in the body, fatigue, and drowsiness. For the past week, bowel movements had become dry, with no bowel movements for 3 days, worsening abdominal distension, phlegm upon waking, and a sallow and dull complexion. Current symptoms: The child's complexion was sallow and dull, the abdomen was full, soft to the touch, and non-tender. The tongue was large, pale red with teeth marks on the edges, and the coating was thick and greasy white. The pulse was soft and slippery.

[0085] Western medicine diagnosis: Functional constipation in children. Traditional Chinese medicine diagnosis: Constipation – Spleen deficiency with dampness retention syndrome. Analysis: Children often have a weak spleen, and excessive consumption of raw, cold, sweet, and greasy foods further damages the spleen's yang energy, leading to impaired digestion and absorption. Internal retention of dampness obstructs the flow of qi, preventing the separation of clear and turbid fluids, resulting in either dry or loose stools and difficulty in defecation. Spleen deficiency leads to insufficient production of qi and blood, resulting in fatigue, drowsiness, and poor appetite; dampness retention causes lethargy, a sticky mouth, a thick, greasy tongue coating, and a soft, slippery pulse. This is a syndrome of deficiency in the root and excess in the branch, a mixed deficiency-excess pattern.

[0086] Treatment plan: Administer the herbal preparation of this invention, prescription: 9g of raw Atractylodes macrocephala, 7.5g of banana root, 7.5g of Citrus reticulata, 7.5g of mulberry, 3g of Lophatherum gracile, 2.3g of Hovenia dulcis leaf, 7.5g of water chestnut, 6g of Pogostemon cablin, 6g of Citrus reticulata peel, 7.5g of Torreya grandis, and 4.5g of Glycyrrhiza uralensis. One dose per day, decocted in water, taken warm in two divided doses, for a course of 3 weeks. Instruct the patient to immediately stop consuming cold drinks, avoid raw and cold fruits, sweets, and fatty foods, and engage in appropriate daily exercise (jogging, skipping rope) to help dispel dampness.

[0087] Treatment efficacy observation: After one week of medication, the child's abdominal distension lessened, and bowel movements occurred once every 1-2 days, still without sticky or soft stools, but the feeling of straining during defecation disappeared. After two weeks of medication, the child's stools gradually became formed, the child reported improved mental state, the sticky feeling in the mouth disappeared, and the tongue coating became thin and white. At the follow-up visit after three weeks of medication, the child's stools were formed and soft, occurring once daily, the complexion improved, the tongue was pale red with a thin white coating, and the teeth marks decreased. At the follow-up visit three months after stopping medication, the child's bowel movements were regular and formed, occurring once daily, and the child's mental state and appetite had significantly improved, with stable weight.

[0088] Case 3: Zhou, female, 13 years old, first visit on March 10, 2025. Chief complaint: Constipation and difficulty in defecation for 5 months, accompanied by irritability and belching. The child developed constipation due to high academic pressure and irregular eating habits, defecating once every 3-5 days. The stool was dry and hard, and defecation was difficult. She also experienced irritability, frequent belching, dry mouth and throat, poor appetite, poor sleep, and scanty yellow urine. Current symptoms: The child's abdomen was soft and flat without tenderness, her tongue was red with little moisture and a thin yellow coating, and her pulse was thready and rapid.

[0089] Western medicine diagnosis: Functional constipation in children. Traditional Chinese medicine diagnosis: Constipation – Liver-Stomach disharmony, intestinal dryness and fluid deficiency syndrome. Key diagnostic points: The child's emotional distress leads to impaired liver function, liver-stomach disharmony, and stagnation of Qi, resulting in constipation, belching, irritability, and anger. Long-term constipation causes fluid deficiency and intestinal dryness, leading to hard stools, dry mouth and throat. Liver-stomach disharmony affects spleen and stomach function, resulting in poor appetite. A red tongue with little coating, a thin yellow coating, and a wiry, thready pulse are all signs of liver-stomach disharmony and intestinal dryness and fluid deficiency.

[0090] Treatment plan: Administer the traditional Chinese medicine preparation of this invention, prescription: 12g of raw Atractylodes macrocephala, 10g of banana root, 10g of Citrus reticulata, 10g of mulberry, 3g of Lophatherum gracile, 9g of Hovenia dulcis leaf, 10g of Ziziphus jujuba, 8g of Pogostemon cablin, 8g of Citrus reticulata peel, 10g of Torreya grandis, and 6g of Glycyrrhiza uralensis. One dose per day, decocted in water, taken orally in two divided doses, for a course of 3 weeks; simultaneously, provide psychological counseling to relieve academic pressure, instruct the patient to maintain a regular diet, develop regular bowel habits, and engage in appropriate exercise.

[0091] Efficacy observation: After one week of medication, the child's irritability and belching symptoms lessened, dry mouth was relieved, bowel movement intervals shortened to once every 2-3 days, and stool texture softened. After two weeks of medication, the child had one bowel movement daily, with soft, formed stools and smooth defecation. Irritability and belching symptoms essentially disappeared, appetite improved, sleep improved, tongue turned pale red, and coating became thin and white. After three weeks of medication, the child's bowel movements became regular, once daily; emotions were stable, tongue and pulse were normal, and the child resumed normal school life. A follow-up two months after discontinuation of medication showed that although the child still experienced academic pressure, bowel movements remained regular, and constipation did not recur.

[0092] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine preparation for treating or relieving functional constipation in children, characterized in that, The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 4-20 parts of raw Atractylodes macrocephala, 3-18 parts of banana root, 3-18 parts of Citrus reticulata, 3-18 parts of mulberry, 2-8 parts of Lophatherum gracile, 3-16 parts of Hovenia dulcis leaf, 3-18 parts of Ziziphus jujuba, 2-13 parts of Pogostemon cablin, 2-13 parts of Citrus reticulata peel, 3-18 parts of Torreya grandis, and 2-12 parts of Glycyrrhiza uralensis.

2. The traditional Chinese medicine preparation according to claim 1, characterized in that, The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 8-16 parts of raw Atractylodes macrocephala, 7-14 parts of banana root, 7-14 parts of Citrus reticulata, 7-14 parts of mulberry, 2-5 parts of Lophatherum gracile, 6-12 parts of Hovenia dulcis leaf, 7-14 parts of water chestnut, 4-10 parts of Pogostemon cablin, 4-10 parts of Citrus reticulata peel, 7-14 parts of Torreya grandis, and 3-9 parts of licorice.

3. The traditional Chinese medicine preparation according to claim 1, characterized in that, The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 12 parts of raw Atractylodes macrocephala, 10 parts of banana root, 10 parts of Citrus reticulata, 10 parts of mulberry, 3 parts of Lophatherum gracile, 9 parts of Hovenia dulcis leaf, 10 parts of Ziziphus jujuba, 8 parts of Pogostemon cablin, 8 parts of Citrus reticulata peel, 10 parts of Torreya grandis, and 6 parts of licorice.

4. The use of the traditional Chinese medicine preparation according to any one of claims 1 to 3 in the preparation of a medicament for treating or relieving functional constipation in children.

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