Traditional Chinese medicine composition for treating weakness of spleen and stomach of children as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating children spleen and stomach weakness and a preparation method and application thereof. The traditional Chinese medicine formula provided by the invention is good in taste, and effectively solves the problem that children are difficult to take traditional Chinese medicines; the traditional Chinese medicine composition is prepared from Xiaojianzhong decoction, striga asiatica and fructus amomi, is high in clinical application safety and has a remarkable treatment effect on various diseases caused by weakness of the spleen and the stomach of children.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating spleen and stomach weakness in children, its preparation method, and its application. Background Technology

[0002] Infantile spleen and stomach deficiency is a common syndrome in pediatric illnesses, such as infantile malnutrition, tics, developmental delays, and low immunity. This syndrome is related to the physiological characteristic of children's "frequent spleen deficiency" and improper feeding practices by parents. Children, as a special group, require more nutrients to meet their rapid growth and development needs. Their growth and development rely entirely on the spleen and stomach to generate essential nutrients, and recovery from illness depends on the healthy functioning of the spleen and stomach. Furthermore, congenital deficiencies in children require postnatal spleen and stomach regulation and supplementation. Moreover, children's spleen and stomach are inherently weak and easily damaged; therefore, spleen and stomach deficiency is an important factor in pediatric diseases.

[0003] Current treatments for pediatric spleen and stomach deficiency mainly rely on traditional Chinese medicine decoctions, Western medicine adjuncts, and external therapies. External therapies primarily include pediatric massage (tonifying the spleen meridian, abdominal massage, and spinal manipulation) and acupuncture (selecting acupoints such as Zusanli, Zhongwan, and Pishu). However, their efficacy is highly dependent on the operator's technique and the accuracy of acupoint selection, limiting their widespread application at the grassroots level. Western medicine adjuncts, primarily probiotics and digestive enzymes, are commonly used, but these often "treat the symptoms but not the root cause." Probiotics only improve the intestinal flora structure and have no direct regulatory effect on the essence of "spleen deficiency," namely, poor digestive function. Micronutrient supplements (such as iron and zinc) can be helpful for anemia and growth retardation, but if the spleen and stomach's absorption function is neglected, simply "supplementing" often has limited effect and can even worsen anorexia due to gastrointestinal irritation from iron supplements. Traditional Chinese medicine decoctions, based on classic formulas such as Sijunzi Decoction, Shenling Baizhu Powder, and Yigong Powder, often have a bitter taste, leading to high rates of refusal among children. Parents frequently resort to force-feeding or adding sugar, which can easily induce vomiting and affect dosage accuracy. Furthermore, dosage calculations rely on empirical conversions, often roughly decreasing by 1 / 2 or 1 / 3 of the adult dose, without considering the physiological parameters of children's "frequent spleen deficiency and liver excess." This results in bidirectional deviations such as "different dosages for the same age" or "sufficient dosage but poor efficacy." Therefore, developing a novel traditional Chinese medicine preparation with broad coverage, pleasant taste, reasonable dosage gradients, and rapid onset of action has become a key direction for overcoming the bottleneck in the treatment of pediatric spleen and stomach weakness. Summary of the Invention

[0004] The purpose of this invention is to provide a traditional Chinese medicine composition for treating infantile malnutrition, infantile tics, developmental delay, and low immunity caused by spleen and stomach weakness.

[0005] This invention provides a traditional Chinese medicine composition for treating spleen and stomach weakness in children. By weight, the traditional Chinese medicine composition includes 5-10 parts of maltose, 5-10 parts of cinnamon twig, 5-10 parts of white peony root, 5-10 parts of ginger, 5-10 parts of jujube, 3-5 parts of prepared licorice root, 3-5 parts of *Striga asiatica*, and 3-5 parts of cardamom.

[0006] Preferably, the traditional Chinese medicine composition comprises, by weight, 5 parts maltose, 10 parts cinnamon twig, 10 parts peony root, 5 parts prepared licorice root, 10 parts jujube, 10 parts ginger, 3 parts *Striga asiatica*, and 5 parts cardamom.

[0007] Preferably, by weight, the traditional Chinese medicine composition consists of 5 parts maltose, 10 parts cinnamon twig, 10 parts peony root, 5 parts prepared licorice root, 10 parts jujube, 10 parts ginger, 3 parts *Striga asiatica*, 5 parts amomum villosum, 20 parts malt, 5 parts cicada molting, 15 parts uncaria, 20 parts medicated leaven, 15 parts dried plum, and 10 parts areca nut.

[0008] The present invention also provides a method for preparing the traditional Chinese medicine composition described in the above technical solution, the method comprising: decocting each component with water and filtering to obtain the traditional Chinese medicine composition.

[0009] Preferably, the simmering process includes: bringing the mixture to a boil over high heat, then simmering over low heat for half an hour.

[0010] The present invention also provides the application of the composition described above in the preparation of a medicine for treating spleen and stomach weakness in children.

[0011] Preferably, the pediatric spleen and stomach weakness syndrome includes malnutrition, tic disorders, developmental delay, and low immunity.

[0012] Preferably, the dosage form of the drug includes decoction and / or granules.

[0013] The present invention also provides a medicine for treating spleen and stomach weakness in children, the medicine comprising the composition described in the above technical solution.

[0014] Preferably, the drug is taken twice daily for 1-2 courses of treatment; 2 weeks constitutes one course of treatment.

[0015] Beneficial effects of the present invention The traditional Chinese medicine formula provided by this invention has a pleasant taste and effectively solves the problem of children having difficulty taking traditional Chinese medicine. This formula is derived from a classic Chinese medicine prescription with added ingredients and has a high safety profile for clinical use. Compared with existing traditional Chinese medicine formulas, it is significantly effective in treating various diseases caused by spleen and stomach weakness in children.

[0016] This formula consists of Xiao Jianzhong Tang plus Du Jiao Jin and Sha Ren. Infantile malnutrition, childhood tic disorders, developmental delays, and low immunity are all related to spleen and stomach weakness and imbalance of Yin and Yang in the internal organs. Xiao Jianzhong Tang is sweet and warm, moistening the spleen and harmonizing Yin and Yang, primarily treating deficiency of both Yin and Yang, Qi and Blood; Jianzhong treats "deficiency," either spleen and stomach deficiency or deficiency of Earth element with excessive Wood element. In the formula, maltose is sweet, warm, and moistening, warming the middle Jiao, tonifying deficiency, relieving spasms and pain, serving as the principal ingredient. Cinnamon twig warms Yang Qi and dispels cold, while peony root nourishes Yin and Blood, relieves liver spasms, and stops abdominal pain; these two, one dispersing and one astringent, harmonize Ying and Wei, serving as assistant ingredients. Ginger warms the stomach and dispels cold, while jujube tonifies the spleen and replenishes Qi. Prepared licorice root tonifies Qi and harmonizes the middle Jiao, harmonizing all the ingredients, serving as adjuvant and guiding ingredients. Through the combination of these herbs, the formula can regulate spleen and stomach function. The spleen and stomach are the foundation of postnatal health and the source of qi and blood. Normal spleen and stomach function helps in the generation and distribution of qi and blood, nourishing the tendons and vessels, thereby alleviating tic symptoms, promoting growth and development, and regulating immunity. Simultaneously, their harmonizing function helps balance the body's yin and yang, reducing tic symptoms, weakened immunity, and developmental delays caused by yin-yang imbalances. The herb *Striga asiatica*, a plant in the Scrophulariaceae family, is also commonly known as *Striga asiatica*, *Ganoderma lucidum*, or *Xiao Mi Chong*. It originates from the Lingnan region and has the effect of eliminating stagnation and clearing heat. It is significantly effective for infantile diarrhea, infantile malnutrition, infantile indigestion, and jaundice-type hepatitis. This herb has a mild taste and neutral properties, making it easy to ingest. The Lingnan climate is hot and humid, and prolonged food stagnation in children easily leads to internal damp-heat. *Striga asiatica* has the effect of eliminating stagnation, clearing heat, and removing dampness, and its neutral nature makes it easy to ingest. Therefore, in Lingnan, this herb is often used alone to treat symptoms such as weak spleen and stomach in children. The formula includes Amomum villosum, which is pungent and warm, and has the functions of resolving dampness, stimulating appetite, warming the spleen, and stopping diarrhea. Amomum villosum is particularly effective in warming the stomach and dispelling cold, and is considered a "true product for harmonizing the middle qi". When all the herbs are used together, they not only warm the middle and replenish deficiency, but also relieve urgency, while also having the effect of soothing the liver and regulating the spleen, benefiting yin and yang. Using this formula can strengthen the middle qi and ensure the source of yin, yang, qi, and blood production. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the accompanying drawings used in the embodiments will be briefly described below.

[0018] Figure 1 This is a schematic diagram of a patient after acupuncture at the four suture points in Example 2 of the present invention. Detailed Implementation

[0019] To further illustrate the present invention, the solutions provided by the present invention will be described in detail below with reference to the accompanying drawings and embodiments, but these should not be construed as limiting the scope of protection of the present invention.

[0020] Example 1 Xu, male, 6 years old. He sought medical treatment on January 13, 2020.

[0021] Chief complaint: The child is hyperactive and presents with involuntary neck turning and head shaking, accompanied by frequent blinking and eyebrow squinting. He was three months old when he sought medical attention (on behalf of the patient).

[0022] Present Illness: Three months ago, after recovering from a cough caused by an external cold, the child began to involuntarily turn his neck, open his mouth, shake his head, and blink frequently. These symptoms initially went unnoticed by the family. Later, the symptoms worsened, accompanied by eyebrow twitching, sniffling, and involuntary coughing and throat clearing. Treatment for a cold and rhinitis was ineffective, and the child sought medical attention. In addition to the above symptoms, the patient appeared thin and hyperactive, with poor concentration, a bluish complexion, especially around the lips, irritability, frequent crying spells, poor appetite, yellow urine, and pellet-like stools. He preferred to sleep on his stomach. His tongue was slightly enlarged, with a red tip and edges, a slightly dark tongue body, a thin white coating, and a slightly yellow and greasy coating at the root. His pulse was rapid.

[0023] The prescription is as follows: Cicada slough 10g, prepared Pinellia ternata 6g, Magnolia officinalis 6g, Perilla frutescens 5g, Poria cocos 10g, fresh ginger 3 slices, Rehmannia glutinosa 10g, Tetrapanax papyriferus 3g, Glycyrrhiza uralensis 5g, Uncaria rhynchophylla 10g (added later), Lophatherum gracile 5g (added later), Gardenia jasminoides 6g, Lilium brownii 20g, Morus alba 10g. Decoct in water for 7 doses, 100mL, twice daily, half an hour after meals.

[0024] Talk to their parents, advising them to reduce screen time, spend more time outdoors, offer more praise and less criticism, ensure they go to bed before 10 p.m., and avoid raw or cold foods and drinks.

[0025] January 21, 2020 After the first course of medication, the patient's symptoms lessened, the cough disappeared, the frequency of tics decreased, and there was no obvious cough without prompting, but the tics worsened upon prompting, especially blinking. The patient's mood improved, appetite and sleep improved slightly, bowel movements were normal (once daily), the tongue was slightly enlarged with a slightly red tip, a slightly dark tongue body, and a thin white coating, and the pulse was slightly rapid. The prescription was not changed due to its effectiveness; however, mulberry leaves and bamboo leaves were removed, and 15g of malt was added. The patient continued this treatment for another week.

[0026] February 1, 2020 After the second consultation and medication, the symptoms had basically disappeared. Considering the child's weight loss and occasional irritability, and to further protect the spleen and stomach, the following prescription was given: 5g maltose, 10g cinnamon twig, 10g peony root, 5g prepared licorice root, 10g jujube, 10g ginger, 3g *Striga asiatica*, 5g amomum villosum (added later), 20g malt, 5g cicada slough, 15g uncaria rhynchophylla, 20g medicated leaven, 15g dried plum, 10g areca nut. Decoct in water and take 100mL twice daily, half an hour after meals.

[0027] Case Analysis 1. This case is also a combination of childhood tic disorder and lily disease. The child's tongue tip is reddish, and the tongue body is slightly swollen, indicating excessive heart fire and phlegm-dampness. "Strange diseases are often caused by phlegm," and the phlegm-fire disturbs the mind, clouding the spirit and triggering liver wind. "All dizziness and vertigo belong to the liver," thus manifesting as tics, which may include sniffing, nose twitching, hyperactivity, and blinking. Lily disease is caused by heart and lung yin deficiency and internal heat, resulting in symptoms such as restlessness and disordered eating and behavior. Its symptoms are bitter taste in the mouth, dark urine, and weak, rapid pulse due to yin deficiency and internal heat. Nourishing the heart and lungs, and benefiting yin and clearing heat are the basic principles for treating lily disease. However, the symptoms of lily disease caused by different reasons and in patients with different constitutions vary, and treatment should be individualized, "treating according to the symptoms." In this case, a modified Banxia Houpu Decoction combined with Daochi Powder and Lily and Rehmannia Decoction was used, a simple and effective prescription. Dao Chi San purges the heart fire, while Gardenia strengthens its fire-purging function; Ban Xia Hou Po Tang regulates Qi, relieves stagnation, resolves phlegm, and dissipates nodules; Bai He combined with Di Huang to form Bai He Di Huang Tang, which nourishes the heart and lungs, benefits Yin, and clears heat. Gou Teng and Chan Tui are added to calm wind, relieve spasms, clear heat, and soothe the liver; Sang Ye disperses wind-heat to treat cough, and Sang Ye can also enter the liver, clearing the liver and improving eyesight.

[0028] 2. Tics are related to imbalances in the Yin and Yang of the internal organs. Treatment of childhood tics should focus on protecting the spleen and stomach. Xiao Jian Zhong Tang (Minor Decoction for Strengthening the Middle Jiao) has the effects of warming the middle jiao, tonifying deficiency, harmonizing the interior, and relieving spasms. In this formula, maltose, sweet and warm in nature, warms the middle jiao, tonifies deficiency, relieves spasms, and stops pain; it is the chief ingredient. Cinnamon twig warms Yang Qi, and white peony root nourishes Yin and blood; these two, one dispersing and one astringent, harmonize Ying and Wei, serving as assistant ingredients. Prepared licorice root, jujube, and ginger strengthen the spleen and stomach. Through the combination of these herbs, the function of the spleen and stomach can be regulated. The spleen and stomach are the foundation of acquired constitution and the source of Qi and blood production. Normal spleen and stomach function helps in the generation and distribution of Qi and blood, nourishing the tendons and vessels, thereby alleviating tic symptoms. At the same time, its harmonizing effect on Ying and Wei also helps balance the Yin and Yang of the body, reducing tics caused by Yin-Yang imbalance. Adding Uncaria rhynchophylla and Cicadae Periostracum helps to calm wind, relieve spasms, clear heat, and soothe the liver; malt and medicated leaven harmonize the spleen and stomach; dried plum is sour and astringent, and neutral in nature. Its astringent properties may help to tighten tendons and control abnormal muscle twitching in cases of muscle spasms. Areca nut has the effect of promoting qi circulation and resolving stagnation, regulating the spleen and stomach's qi mechanism, improving their digestive function, and ensuring normal distribution of qi, blood, and body fluids, thereby nourishing the tendons and reducing the recurrence of twitching.

[0029] Example 2 Patient: Zhao, male, 5 years old.

[0030] Initial consultation: August 12, 2023.

[0031] The child was thin and had a picky appetite, prompting the doctor to seek treatment from various sources. An abdominal ultrasound revealed enlarged mesenteric lymph nodes. The child had previously been treated with antibiotics and a combination of traditional Chinese and Western medicine, but the treatment was ineffective. Examination revealed that the child was significantly thin, weighing 15kg and 98cm tall, with a sallow and slightly bluish complexion, poor appetite, restless sleep, occasional teeth grinding, and was prone to catching colds and coughs. The child also experienced occasional periumbilical pain, irritability, loose stools with occasional undigested food, a pale tongue with a white and greasy coating, and a deep and thready pulse.

[0032] When needles were applied to the four suture points, a pale yellow, viscous substance was expelled from each point. Figure 1 As shown.

[0033] The prescription is as follows: Codonopsis pilosula 10g, Atractylodes macrocephala 10g, Poria cocos 10g, Desmodium styracifolium 5g, Quisqualis indica 6g, Prunus mume 6g, Hordeum vulgare 15g, Hordeum vulgare 15g, Gizzard lining of chicken 6g, Massa fermentata 10g, Forsythia suspensa 6g, Citrus aurantium 6g, Glycyrrhiza uralensis 5g.

[0034] After taking four doses, the child's spirits were relatively good, his appetite increased slightly, and he felt happy after eating. His sleep was not good, but he did not grind his teeth at night. The frequency of abdominal pain decreased, but he still had loose stools. The above prescription was continued with the addition of 10g of raw dragon bone and 5g of dried tangerine peel. He continued to take seven doses and was given bloodletting at the four seams again.

[0035] Follow-up visit: The patient had no obvious symptoms. Xiao Jian Zhong Tang with added ingredients was prescribed for 14 doses to continue regulating the spleen and stomach.

[0036] Add 5g maltose, 10g cinnamon twig, 10g peony root, 5g prepared licorice root, 10g jujube, 10g ginger, 3g *Striga asiatica*, and 5g cardamom later.

[0037] Case Analysis This case presents as infantile malnutrition due to spleen and stomach deficiency, internal stagnation, and a mixture of deficiency and excess. This condition often develops from infantile malnutrition syndrome. Children often have weak spleens, and excessive consumption of rich and fatty foods leads to spleen and stomach deficiency, impaired digestion, resulting in significant emaciation, low weight, and poor appetite. Damage to the spleen and stomach leads to loss of body fluids, malnutrition, causing a sallow complexion, sparse and yellow hair, and internal stagnation of qi, resulting in abdominal pain. Impaired spleen function leads to difficulty in separating clear and turbid substances, resulting in loose stools containing undigested food, a pale tongue with a white, greasy coating, and a deep, thready pulse. Therefore, the treatment focuses on strengthening the spleen and stomach, eliminating stagnation, and regulating the spleen. By regulating the spleen and stomach, improving digestion, and restoring qi and blood and body fluids, an experienced formula for treating infantile malnutrition is prescribed.

[0038] Explanation: In this formula, Quisqualis indica is a key herb for expelling roundworms, killing parasites, eliminating food stagnation, and relieving pain; Prunus mume astringes the intestines, stops diarrhea, promotes saliva production, and expels roundworms. Together, they expel and expel roundworms, treating infantile malnutrition, abdominal pain, vomiting, and diarrhea caused by intestinal parasites; Atractylodes macrocephala strengthens the spleen and promotes the production of spleen-tonifying qi; malt, germinated barley, and chicken gizzard membrane promote digestion, invigorate the spleen and stomach, and also soothe the liver and regulate qi; Massa fermentata has a strong digestive effect and also relieves exterior symptoms, especially suitable for treating food stagnation combined with external pathogens; Citrus aurantium regulates qi and eliminates food stagnation; Forsythia suspensa clears heat and detoxifies, effectively clearing heat caused by food stagnation in the upper and middle jiao, and also clearing the heart and relieving irritability; Glycyrrhiza uralensis harmonizes the effects of the other herbs. The entire formula is a remedy for strengthening the spleen and stomach, eliminating food stagnation, and regulating spleen function. After taking this prescription for 4 doses, the patient's appetite increased, and their complexion and spirit improved. The frequency of abdominal pain decreased, but loose stools persisted, indicating that the spleen was not functioning properly and that phlegm and dampness had not been eliminated. Therefore, the prescription was continued with the addition of raw dragon bone to promote sleep and growth, and dried tangerine peel to regulate qi, strengthen the spleen, and dry dampness, in order to regulate and consolidate the condition. As a result, all symptoms subsided.

[0039] The ancient medical text *Xiao'er Yaozheng Zhijue* states that "malnutrition is a disease of the spleen and stomach, caused by the loss of body fluids." Treatment for malnutrition focuses on strengthening the spleen and stomach, and eliminating stagnation. During treatment, it is important to avoid prolonged use of stagnation-eliminating and anthelmintic drugs; it is recommended to discontinue use once the condition improves, and then focus on regulating the spleen and stomach in the later stages. Therefore, the Xiao Jianzhong Tang formula, with the addition of *Du Jiao Jin* and *Sha Ren*, is used to warm the middle jiao, tonify deficiency, alleviate urgency, soothe the liver, regulate the spleen, and nourish yin and yang.

[0040] Test Example 3 This study selected a total of 120 effective cases of children with spleen and stomach deficiency, including 69 males and 51 females. The youngest patient was 1 year old and the oldest was 12 years old. The shortest course of disease was 2 months and the longest was 2 years.

[0041] The clinical manifestations of the disease include: Loss of appetite, reduced food intake, or picky eating; Irregular bowel movements: loose stools, stools that are hard at first and then loose, stools that are sometimes loose and sometimes hard, or constipation and hard stools; disturbed sleep; Slow to speak and reluctant to talk; Abdominal bloating and pain, abdominal bloating after meals or in the afternoon; sallow complexion; Repeated external infections; The tongue is pale or swollen, and the pulse is thin and weak or the fingerprints are pale.

[0042] The TCM syndrome scoring criteria are shown in Table 1.

[0043] Table 1. Traditional Chinese Medicine Syndrome Scoring Standards

[0044] 120 children were randomly divided into 4 groups and given combination formulas 1-4 respectively.

[0045] Combination 1: 5-10g maltose, 5-10g cinnamon twig, 5-10g white peony root, 5-10g ginger, 5-10g jujube, 3-5g prepared licorice root; Combination 2: 5-10g maltose, 5-10g cinnamon twig, 5-10g white peony root, 5-10g ginger, 5-10g jujube, 3-5g prepared licorice root, 3-5g *Striga asiatica*; Combination 3: 5-10g maltose, 5-10g cinnamon twig, 5-10g white peony root, 5-10g ginger, 5-10g jujube, 3-5g prepared licorice root, 3-5g amomum villosum; Combination 4: 5-10g maltose, 5-10g cinnamon twig, 5-10g white peony root, 5-10g ginger, 5-10g jujube, 3-5g prepared licorice root, 3-5g *Striga asiatica*, 3-5g amomum villosum.

[0046] The observation indicators include: (1) Safety observation: General information, including name, gender, age; record vital signs (body temperature, respiration, blood pressure, heart rate) and adverse drug reactions.

[0047] (2) Observation of therapeutic effect: Observe the changes in symptoms of the children after taking the medicine; the changes in TCM syndrome scores, with the main symptoms scored as 0, 2, 4, and 6 points, and the secondary symptoms scored as 0, 1, 2, and 3 points. Scores were made based on the patients' actual symptoms, and the changes in scores after taking the medicine were observed.

[0048] Efficacy assessment criteria 1. Criteria for Evaluating the Therapeutic Effect of Traditional Chinese Medicine Syndromes The efficacy evaluation standards were formulated based on the "Guiding Principles for Clinical Research on New Traditional Chinese Medicine Drugs" promulgated by the Ministry of Health in 2002.

[0049] The efficacy index is calculated as follows: [(Pre-treatment score - Post-treatment score) / Pre-treatment score] × 100%, expressed as a percentage.

[0050] Evaluation criteria: Clinical cure: efficacy index ≥90%; Significant efficacy: Therapeutic effect index ≥70%; Effective: Therapeutic efficacy index ≥ 30%; Ineffective: Therapeutic index <30%.

[0051] 2) Safety evaluation standards ① Level 1: No adverse reactions occurred, and safety indicators were normal; ② Level II: Mild adverse reactions occurred, but safety indicators were normal; ③ Level 3: Moderate adverse reactions occur, or safety indicators show abnormalities; ④ Level 4: Serious adverse reactions or significantly abnormal safety indicators.

[0052] Statistical analysis Establish a clinical data database: Use Excel 2010 software to record the basic information of the subjects and their symptom scores before and after treatment.

[0053] Statistical analysis will be performed using SPSS 25.0 statistical analysis software. All statistical tests will be two-tailed tests. P A value greater than 0.05 was considered statistically insignificant. P <0.05 indicates that the difference is statistically significant. P <0.01 indicates a statistically significant difference. Measurement data for each group of subjects will be expressed as mean ± standard deviation (SD). Statistical description is performed. For data that satisfy normality and homogeneity of variance, the t-test is used, while for data that do not satisfy normality and homogeneity of variance, and for comparisons of ordinal data, the rank-sum test is used. P A difference of <0.05 is statistically significant.

[0054] Research Results Cases included: A total of 120 effective cases of children with spleen and stomach deficiency were selected in this study, and the gender, age, course of disease, and symptoms before and after medication were analyzed in these 120 children.

[0055] The comparison of age, gender, and disease course among the four groups of children is shown in Tables 2-4.

[0056] Table 2 Comparison of ages among the four groups of children

[0057] As shown in Table 2, t-tests on the ages of the four groups of patients showed no significant differences in distribution. P (>0.05), making them comparable.

[0058] Table 3 Comparison of disease course among four groups of children

[0059] Table 4 Comparison of gender among the four groups of children

[0060] The genders of the four groups of children were analyzed separately. Group 1 and Group 2, P =0.602>0.05; Group 1 and Group 3, P =0.592>0.05; Group 1 and Group 4, P =0.436>0.05; Group 2 and Group 3, P =0.292>0.05; Group 2 and Group 4, P =0.796>0.05; Groups 3 and 4, P =0.190>0.05, no significant difference ( P(>0.05), making them comparable.

[0061] Table 5 shows a comparison of the efficacy index of symptoms before and after medication in the four groups of children.

[0062] Table 5 Comparison of symptoms before and after medication in four groups of children

[0063] The total scores of the four groups of symptoms before treatment were analyzed by a t-test. Group 1 and Group 2... P =0.194>0.05; Group 1 and Group 3, P =0.079>0.05; Group 1 and Group 4, P =0.584>0.05; Group 2 and Group 3, P =0.669>0.05; Group 2 and Group 4, P =0.073>0.05; Group 3 and Group 4, P =0.024>0.05, indicating no statistically significant difference, suggesting that the symptoms of the four groups were comparable before treatment; after treatment, t-tests were performed between group 4 and groups 1, 2, and 3 respectively. Group 4 compared with group 1, P =0.000 < 0.05; Group 4 and Group 2, P =0.000 < 0.05; Group 4 and Group 3, P =0.000 < 0.05, which is statistically significant. It is believed that group 4 is significantly better than groups 1, 2 and 3 in terms of improvement in syndrome scores.

[0064] Table 6. Observation of the therapeutic effects of different combinations of the traditional Chinese medicine composition of the present invention

[0065] The chi-square test was used to compare group 4 with group 1. P =0.015<0.05; Comparing group 4 and group 2, P =0.030<0.05; Comparing group 4 and group 3, P =0.030<0.05. The herbal composition of this invention has a significantly different cure rate compared with compositions 1, 2, and 3.

[0066] Security Analysis During the medication period, no significant abnormalities were observed in the body temperature, heart rate, respiration, or other indicators of the four groups of children, and no abnormal symptoms such as diarrhea or allergies occurred; at the same time, no related adverse events were observed.

[0067] Through clinical observation and research on 120 children with spleen and stomach deficiency, the formula of this invention can effectively improve the clinical symptoms caused by spleen and stomach deficiency in children, and has a significant effect on strengthening the spleen and stomach and improving the function of internal organs. At the same time, there are no adverse reactions.

[0068] Although the above embodiments have provided a detailed description of the present invention, they are only some embodiments of the present invention, and not all embodiments. People can obtain other embodiments based on these embodiments without creative effort, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating spleen and stomach weakness in children, characterized in that, The traditional Chinese medicine composition comprises, by weight, 5-10 parts maltose, 5-10 parts cinnamon twig, 5-10 parts white peony root, 5-10 parts ginger, 5-10 parts jujube, 3-5 parts prepared licorice root, 3-5 parts *Striga asiatica*, and 3-5 parts cardamom.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises, by weight, 5 parts maltose, 10 parts cinnamon twig, 10 parts peony root, 5 parts prepared licorice root, 10 parts jujube, 10 parts ginger, 3 parts *Striga asiatica*, and 5 parts cardamom.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition, by weight, consists of 5 parts maltose, 10 parts cinnamon twig, 10 parts peony root, 5 parts prepared licorice root, 10 parts jujube, 10 parts ginger, 3 parts *Striga asiatica*, 5 parts amomum villosum, 20 parts malt, 5 parts cicada slough, 15 parts uncaria, 20 parts medicated leaven, 15 parts dried plum, and 10 parts areca nut.

4. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method includes: decocting each component with water and filtering to obtain a traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that, The simmering process includes: bringing the water to a boil over high heat, then simmering over low heat for half an hour.

6. The use of the composition of claim 1 in the preparation of a medicament for treating spleen and stomach weakness in children.

7. The application according to claim 6, characterized in that, The aforementioned pediatric spleen and stomach deficiency syndrome includes infantile malnutrition, infantile tics, developmental delay, and low immunity in children.

8. The application according to claim 6, characterized in that, The dosage forms of the drug include decoctions and / or granules.

9. A medicine for treating spleen and stomach weakness in children, characterized in that, The drug comprises the composition of claim 1.

10. The medicament according to claim 4, characterized in that, The medication is taken twice daily for 1-2 courses of treatment; one course of treatment lasts 2 weeks.

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