Traditional Chinese medicine composition for treating infantile malnutrition and application thereof

Abstract

The invention relates to a traditional Chinese medicine composition for treating infantile malnutrition, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 7 to 15g of striga asiatica, 8 to 16g of quince, 8 to 15g of raw rhubarb, 9 to 17g of cooked rhubarb, 9 to 16g of vernonia graveolens, 7 to 13g of black semen pharbitidis, 6 to 15g of white semen pharbitidis, 6 to 15g of semen nigellae, 15 to 20g of rhizoma sparganii, 16 to 19g of curcuma zedoary, 9 to 17g of fructus amomi and 10 to 19g of pedicularis muscicola. The traditional Chinese medicine formula disclosed by the invention has the effects of removing food retention, relieving dyspepsia, strengthening the spleen and stomach and expelling parasites, and is a traditional Chinese medicine formula capable of treating the infantile malnutrition, enhancing the immunity of the organism, recuperating the physical function of children and improving the physical quality of the children. The preparation method of the powder prepared from the traditional Chinese medicine formula is inherited for a long time, the compatibility is flexible, the taking modes are various, and the curative effect is remarkable and quick.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for treating infantile malnutrition and application thereof. Background Art

[0002] Infantile malnutrition is a chronic disease caused by damage to the spleen and stomach, leading to loss of vital energy and fluid. It originates in the spleen and stomach and is associated with congenital deficiencies or emotional imbalances. Clinically, it is characterized by emaciation, a dull complexion, dry hair, lethargy or irritability, and abnormal eating habits. In ancient times, malnutrition was listed as one of the four major pediatric syndromes. From a modern medical perspective, it falls under the category of malnutrition in Western medicine.

[0003] Based on this, the present invention is proposed. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating infantile malnutrition, which can achieve the purpose of treating infantile malnutrition by exerting the effects of eliminating accumulation and strengthening the spleen.

[0005] The present invention's formula has the effects of dissipating stagnation, strengthening the spleen and stomach, and expelling parasites. It is a traditional Chinese medicine formula that can treat malnutrition in children, enhance immunity, regulate children's physical functions, and improve children's physical fitness. The powder prepared from this traditional Chinese medicine formula has a long-standing preparation method, flexible compatibility, and diverse administration methods, and has significant and rapid efficacy.

[0006] To achieve the above object, the technical solution adopted by the present invention is: A traditional Chinese medicine composition for treating infantile malnutrition comprises the following components in parts by weight: 7-15g of Strigosa Strigifolia, 8-16g of Quince, 8-15g of Raw Rhubarb, 9-17g of Cooked Rhubarb, 9-16g of Rhizoma Cyperi, 7-13g of Heichou, 6-15g of Bacchus, 6-15g of Nigella Sativa seeds, 15-20g of Trigonosciadium japonicum, 16-19g of Curcuma zedoaria, 9-17g of Amomum villosum, and 10-19g of Pedicularis edulis.

[0007] Preferably, a traditional Chinese medicine composition for treating infantile malnutrition comprises the following components in parts by weight: 10-15g of Strigosa trichotpa var. serrata, 10-15g of quince, 10-15g of raw rhubarb, 10-15g of cooked rhubarb, 10-15g of Rhizoma Cyperi, 9-13g of Heichou, 9-14g of Baici, 10-15g of Nigella cumin seeds, 16-19g of Trigonosciadium japonicum, 17-19g of Curcuma zedoaria, 10-13g of Amomum villosum, and 10-15g of Pedicularis oculata.

[0008] As a specific embodiment of the present invention, a traditional Chinese medicine composition for treating infantile malnutrition comprises the following components in parts by weight: 12g of Herba Stemonae, 12g of Quince, 12g of Raw Rhubarb, 12g of Cooked Rhubarb, 12g of Rhizoma Cyperi, 12g of Heichou, 12g of Bacchus, 12g of Nigella Sativa Seed, 18g of Trillium, 18g of Curcuma, 12g of Amomum villosum, and 10g of Artemisia selengensis.

[0009] Preferably, the traditional Chinese medicine composition further comprises excipients.

[0010] Preferably, the excipients include, but are not limited to, one, two or more of: a solubilizer, a disintegrant, a flavoring agent, an emulsifier, a wetting agent, a binder, a colorant, an absorption promoter, and a filler.

[0011] Preferably, the Chinese medicine composition can be processed into any dosage form including but not limited to granules, decoctions, mixtures, capsules, powders, pastes, and pills, with granules being particularly preferred.

[0012] Preferably, the Chinese medicine composition is used in the preparation of a product for treating infantile malnutrition.

[0013] Preferably, the application shows that the Chinese medicine composition has significant differences in mental state, appetite, sleep, hair, stool, complexion, diarrhea, fat thickness, infection, growth factor IGF-1, and prealbumin PA before and after treatment, but no significant difference in hemoglobin, indicating that the application has a good therapeutic effect and has no obvious effect on hemoglobin.

[0014] As a specific embodiment of the present invention, a product for treating infantile malnutrition comprises the components of the traditional Chinese medicine composition and 1-2g of a flavoring agent, preferably stevia.

[0015] As a specific embodiment of the present invention, the method for preparing a product for treating infantile malnutrition is as follows: the component Chinese herbal medicines and auxiliary materials are respectively placed in an oven at a temperature of 40-55°C and dried to a dryness of ≥85%, respectively crushed into fine powder using a Chinese medicine grinder, and then passed through a 100-mesh sieve to make the medicinal powder fine and uniform, which is convenient for taking and absorption; the fine powder of each medicinal material is placed in a clean container, and fully stirred and mixed to ensure that the components are evenly distributed.

[0016] Preferably, the dosage of the product for treating infantile malnutrition is 0.3 g for children under 5 years old, three times a day, taken with warm water; and 1.5 g for children over 5 years old, three times a day, taken with warm water; the course of treatment is 30 days; crabs, vinegar, kidney beans, raw and cold foods should be avoided; and overeating should be avoided.

[0017] Strigosa Root (Striga) is neutral in nature, with a sweet and bland taste. It enters the kidney, spleen, and liver meridians. It has the effects of calming the liver, eliminating malnutrition, strengthening the spleen and promoting digestion, and clearing heat and promoting urination. Pharmacological studies have shown that a decoction of Strigosa Root has significant inhibitory effects on Staphylococcus aureus, Carbuncle of the Carbuncle, and diphtheria in vitro, and also has a certain degree of inhibitory effect on Group B Streptococcus, Salmonella typhi, Pseudomonas aeruginosa, and Shigella dysenteriae.

[0018] Quince: Sweet, sour, and warm; it enters the lung, spleen, and stomach meridians; it dispels dampness, relieves heat, and relaxes tendons and activates blood circulation. It is used to treat heatstroke, vomiting, diarrhea, indigestion, joint pain, and gastrocnemius spasms. Pharmacological studies suggest that quince seeds contain a high amount of mucilage, which can be combined with other medicinal herbs for external application to reduce irritation and delay absorption.

[0019] Raw rhubarb is bitter and cold in nature and enters the spleen, stomach, large intestine, liver, and pericardium meridians. It has the effects of purging, clearing away heat and fire, cooling the blood and detoxifying, stopping bleeding, removing blood stasis and promoting menstruation, and promoting dampness and jaundice. Pharmacological studies suggest that raw rhubarb has antibacterial and anti-inflammatory, anti-tumor, lipid-lowering, cardiovascular protection, antioxidant, and protective properties.

[0020] Cooked rhubarb: Bitter and cold (with some relief of its coldness), it enters the stomach, large intestine, liver, and spleen meridians. It has the effects of relieving urgency, promoting blood circulation and removing blood stasis, and clearing away heat and purging fire. Pharmacological studies suggest that cooked rhubarb can regulate intestinal flora balance, improve myocardial ischemia, and have anti-inflammatory, antibacterial, and anti-tumor effects.

[0021] Rhizoma Cibotii: Warm in nature, with a sweet and bitter flavor; it enters the liver, kidney, and lung meridians; it has the effects of promoting blood circulation and relaxing tendons, dispelling wind and relieving pain, relieving coughs, relieving asthma, and removing phlegm. Pharmacological studies have shown that Rhizoma Cibotii has antitussive, expectorant, and antiasthmatic effects; it can lower rabbit arterial pressure, slow heart rate, increase myocardial contractility, increase 24-hour urine output, improve coronary artery flow, and significantly lower blood cholesterol levels; it also enhances immune function and has anti-influenza virus effects.

[0022] Heichou: Bitter and cold in nature, it enters the lung, kidney, and large intestine meridians. It has laxative effects, eliminates phlegm and fluid, and kills parasites and eliminates accumulations. Pharmacological studies suggest that Heichou has laxative effects, promotes electrolyte excretion (especially sodium), inhibits intestinal parasites, and enhances smooth muscle contraction.

[0023] Bai Chou: Bitter and cold in nature; enters the lung, kidney, and large intestine meridians; has laxative, diuretic, and parasite-killing properties. Pharmacological studies suggest that Bai Chou has laxative, diuretic, parasite-repellent, and smooth muscle stimulating effects.

[0024] Black cumin seeds: Sweet, pungent, and warm; they enter the liver and kidney meridians; they have kidney-tonifying and brain-strengthening properties, promote menstruation, promote lactation, and act as a diuretic. Pharmacological studies suggest that black cumin seeds have anti-tumor effects, increase liver enzyme levels, and have anti-pathogenic and antiparasitic properties.

[0025] Trigonosciadium japonicum: Pungent, bitter, and neutral in nature; it enters the liver and spleen meridians. It has the effects of promoting blood circulation, dissipating stagnation, and relieving pain. Pharmacological studies suggest that Trigonosciadium japonicum can reduce blood viscosity, promote blood circulation, and have anti-tumor and anti-inflammatory effects, dilate blood vessels, and lower blood pressure.

[0026] Curcuma: Pungent, bitter, and warm in nature; it enters the liver and spleen meridians; it has the effects of promoting blood circulation, promoting qi circulation, eliminating stagnation, and relieving pain. Pharmacological studies suggest that Curcuma has anti-tumor, anti-thrombotic, anti-gastric ulcer, anti-inflammatory, and analgesic effects.

[0027] Amomum villosum: Pungent and warm in nature, it enters the spleen, stomach, and kidney meridians. It has the effects of eliminating dampness and stimulating appetite, warming the middle and stopping diarrhea, and regulating qi and stabilizing pregnancy. Pharmacological studies suggest that Amomum villosum can promote gastric secretion, enhance digestion and absorption, and has anti-inflammatory and antibacterial effects.

[0028] Pedicularis mossii: Sweet, slightly bitter, and warm in nature; it enters the spleen and heart meridians. It has the effects of tonifying qi, strengthening the exterior, and calming the mind. It is used for qi and blood deficiency, physical weakness, excessive sweating, palpitations, and fatigue. Pharmacological studies suggest that medicinal plants of the genus Pedicularis mossii have antioxidant, anti-tumor, anti-fatigue, DNA repair, blood sugar lowering, and hepatoprotective properties.

[0029] Single-legged Herb is the main medicine, which improves the spleen and stomach functions from the root, eliminates stagnation and insect infestation, and is the first choice medicine for treating malnutrition.

[0030] Raw rhubarb, cooked rhubarb, and Amomum villosum serve as assistant herbs. Raw rhubarb, bitter and cold, has a strong purgative effect, quickly dispelling intestinal stagnation and helping the herb to resolve it more quickly. Processed cooked rhubarb softens its purgative effect but enhances its blood circulation and blood stasis-removing properties, improving the poor flow of qi and blood caused by malnutrition and complementing the main herbs to enhance the overall efficacy. Amomum villosum is pungent and warm in nature, entering the spleen, stomach, and kidney meridians. Its properties of dispelling dampness, stimulating appetite, warming the spleen, and arresting diarrhea can effectively improve symptoms of spleen and stomach deficiency, dampness and turbidity in the middle, and loss of appetite in children. It synergizes with the main herbs to better regulate spleen and stomach function, exerting a therapeutic effect on the accompanying symptoms of malnutrition.

[0031] Hei Chou, Bai Chou, San Leng, Ze Zhu, Quince, and Mossy Pedicularis serve as adjuvants. Hei Chou and Bai Chou (Pharbitidis seeds), though toxic, have significant laxative and insecticidal properties, further enhancing the elimination of intestinal stagnation and parasite accumulation, complementing the main and auxiliary herbs in strengthening the therapeutic effect. San Leng and Ze Zhu promote blood circulation, eliminate stagnation and relieve pain, and assist with cooked rhubarb in improving qi and blood stasis. Quince and Mossy Pedicularis address secondary symptoms such as limb discomfort and rheumatic symptoms that may accompany the child. Furthermore, Amomum villosum serves as an adjuvant, its warming properties counteracting the bitter and cold nature of raw rhubarb to prevent excessive damage to the spleen and stomach.

[0032] The guiding drug is black seed, which can guide the various drugs in the prescription to act on the relevant internal organs, so that the drugs can reach the diseased area accurately; at the same time, its function of promoting menstruation and urination helps to harmonize the various drugs, promote the better use of the drugs, promote the circulation and metabolism of qi and blood throughout the body, and thus promote the recovery of malnutrition.

[0033] When treating malnutrition, this group of herbs works through the exquisite combination of monarch, minister, assistant and guiding ingredients, each performing its own function and cooperating with each other to jointly exert therapeutic effects, thereby achieving the purpose of treating malnutrition. It can improve malnutrition symptoms in children such as emaciation, sallow and dry face, bloated abdomen, exposed blue veins, loss of appetite, and irregular bowel movements.

[0034] The excipients used in the present invention include, but are not limited to, one, two or more of solubilizers, disintegrants, flavorings, emulsifiers, wetting agents, adhesives, colorants, absorption promoters, and fillers, wherein the drugs used in the solubilizers, disintegrants, flavorings, emulsifiers, wetting agents, adhesives, colorants, absorption promoters, and fillers are all commonly used drugs in traditional Chinese medicine.

[0035] Compared with the prior art, the present invention has the following beneficial effects: 1. The Chinese medicine composition of the present invention is in line with the pathogenesis of infantile malnutrition, and the whole prescription has the effects of removing blood stasis, eliminating accumulation, and invigorating the spleen with aromatic properties.

[0036] 2. The Chinese medicine composition of the present invention can significantly improve the TCM symptoms of children with malnutrition, and its therapeutic effect is significantly better than conventional treatment. DETAILED DESCRIPTION

[0037] The technical solutions and effects of the present invention are further described below in conjunction with specific embodiments, but the protection scope of the present invention is not limited thereto.

[0038] In the examples of the present invention, the above medicinal materials were all from the Chinese medicine pharmacy of a hospital in Henan Province.

[0039] Example 1 This embodiment provides a method for preparing a product (Kanji Powder) for treating infantile malnutrition using a traditional Chinese medicine composition: Material preparation Prepare the medicinal materials of single-legged gold, quince, raw rhubarb, cooked rhubarb, dragon fruit, black radix, white radix, black seed, three-edged sword, zedoary, amomum, and moss-grown artemisia according to the dosage specified in the prescription.

[0040] Processed medicinal materials Single-legged gold: Strictly clean, pick out impurities, wash quickly with clean water and dry thoroughly.

[0041] Quince: Clean, dry, and cut into small pieces or thin slices for easy crushing.

[0042] Raw rhubarb: Select high-quality rhubarb, wash it, dry it, and cut it into thin slices or small pieces for later use.

[0043] Cooked rhubarb: Take raw rhubarb slices or pieces, mix them with rice wine, and let it simmer until the wine is absorbed. Place it in a steaming container and steam until it turns black inside and out. Take it out and dry it.

[0044] Gua Shan Long: Clean, dry, and cut into small sections or pieces.

[0045] Black and white morning glory: Wash the seeds of the morning glory (black and white morning glory), dry them in the sun, and slightly fry them to enhance their aroma and help digestion. Fry until the surface is slightly bulging and the color is darker.

[0046] Nigella seeds: clean and stir-fry, and let the stir-fried Nigella seeds cool.

[0047] Trigonella lanceolata and Curcuma zedoaria: Wash and soak Trigonella lanceolata and Curcuma zedoaria, slice thinly, and dry. For vinegar preparation, take Trigonella lanceolata and Curcuma zedoaria slices, add vinegar, mix well, simmer thoroughly, and stir-fry in a pan over low heat until slightly dry. Remove and air-dry. Vinegar preparation enhances their blood circulation, blood stasis, and pain-relieving properties.

[0048] Amomum villosum: Take Amomum villosum and remove impurities. Use the ginger method to take clean Amomum villosum, add ginger juice, mix well, stew thoroughly, and stir-fry over low heat until dry.

[0049] Moss-grown Pedicularis truncatum: clean, dry and remove residual impurities.

[0050] Crushing and mixing: put the processed Chinese herbal medicines of Strigosa Strigifolia, Quince, Raw Rhubarb, Cooked Rhubarb, Rhizoma Cyperi, Heichou, Bichou, Nigella Sativa, Trillium, Curcuma, Amomum villosum, and Pedicularis edulis into an oven at a temperature of 40-55℃ and dry them to a dryness of ≥85%. Use a Chinese medicine grinder to crush them into fine powder, and then pass them through a 100-mesh sieve to make the medicinal powder fine and uniform, which is convenient for taking and absorption.

[0051] Place the fine powder of each herbal ingredient into a clean container and stir thoroughly to mix them evenly to ensure that the ingredients are evenly distributed.

[0052] Quality Inspection Appearance inspection: Observe the color and texture of the drug, which should be uniform and without obvious impurities, lumps or discoloration.

[0053] Particle size inspection: Take an appropriate amount of sample and check whether its particle size meets the requirements. Most of the powder should be able to pass through the specified sieve.

[0054] Content determination: High performance liquid chromatography is used to determine the content of the main ingredients to ensure that the content of each medicinal material in the prescription meets the standard requirements and to ensure the quality and efficacy of the medicine.

[0055] Packaging and storage: Pack the qualified Kanjisan with clean and sterile packaging materials, such as aluminum foil bags or glass bottles, and pack them in 5g portions.

[0056] Store in a cool, dry, ventilated place, avoid direct sunlight and humid environment to prevent the drug from deteriorating.

[0057] The above is the general preparation method of Ganji San. During the preparation process, the relevant specifications and standards for drug production should be strictly observed to ensure the safety, effectiveness and quality controllability of the drug.

[0058] Example 2 Clinical data 1 Case selection 1.1 Sixty preschool children were enrolled in the Department of Traditional Chinese Medicine of a hospital in Henan Province. This study complied with the requirements of the Medical Ethics Committee.

[0059] 1.2 Diagnostic criteria In Western medicine, the diagnostic criteria for pediatric malnutrition in Zhu Futang's Practical Pediatrics (8th edition, People's Medical Publishing House, 2015) include: ① No weight gain or weight loss, gradual loss of subcutaneous abdominal fat, lower than normal height, and poor appetite; ② Loose and loss of skin elasticity, or muscle laxity and atrophy; ③ Abnormal mood, irritability, or apathy; ④ May be accompanied by anemia, various vitamin deficiencies, and nutritional edema; ⑤ Low immunity and susceptibility to infection.

[0060] From the perspective of traditional Chinese medicine: (1) thin body, weight lower than the normal standard for children of the same age, slow height growth; (2) sallow or pale complexion; (3) loss of appetite, or anorexia, pica; (4) mental depression or irritability; (5) sparse or dry hair; (6) distended or sunken abdomen, irregular bowel movements.

[0061] 1.3 Inclusion, Exclusion, and Termination Criteria Inclusion criteria: (1) children aged 1-8 years; (2) children who meet the diagnostic criteria for malnutrition in traditional Chinese medicine; (3) children who agree and sign the informed consent form.

[0062] Exclusion criteria: (1) Children with non-malnutrition diseases; (2) Children with complex comorbidities, such as serious diseases of the heart, liver, kidney, or other important organs; (3) Children with serious systemic diseases such as malignant tumors and blood system diseases; (4) Children who are allergic to any of the drug ingredients in the malnutrition powder; (5) Children who have used other drugs that have similar effects to the malnutrition powder or may affect its efficacy; (6) Children with severe mental illness; (7) Parents and children who do not cooperate.

[0063] Exclusion criteria: other complications and comorbidities during treatment; poor compliance or even voluntary discontinuation of treatment; severe adverse reactions.

[0064] Termination criteria: The study must be terminated due to major safety issues or other reasons.

[0065] 2 Research Methods 2.1 Treatment methods The treatment group was given the Chinese medicine composition of the present invention for treatment, the medicinal materials of the prescription included 12g of Strigosa Root, 12g of Quince, 12g of Raw Rhubarb, 12g of Cooked Rhubarb, 12g of Rhizoma Cyperi, 12g of Heichou, 12g of Baichou, 12g of Nigella Sativa Seed, 18g of Trigonosciadium japonicum, 18g of Curcuma zedoaria, 12g of Amomum villosum, 10g of Moss Pedicularis edulis, and 1g of Stevia rebaudiana, which was one dose.

[0066] Dosage: Children under 5 years old: 0.3g, three times a day, washed down with warm water; children over 5 years old: 1.5g, three times a day, washed down with warm water; course of treatment is 30 days; avoid crabs, vinegar, kidney beans, raw and cold foods; avoid overeating.

[0067] 2.2 Observation indicators Main outcome measures: The main symptom scoring criteria include sallow complexion, weight loss, poor appetite, and abdominal distension.

[0068] 3. Criteria for determining efficacy 3.1 Criteria for evaluating efficacy (1) Symptom grading and quantitative standards were developed with reference to the 2002 edition of the “Guiding Principles for Clinical Research of New Chinese Medicines” and the 2017 edition of the “Practice of Clinical Trial Design of Chinese Medicines” to develop a symptom scoring scale.

[0069] Table 3-1: Assessment Table for the Quantity and Score of Malnutrition

[0070] 4 Case data A total of 60 sample data were selected, and various indicators were tested and recorded. After a period of treatment with this project, the data were tested and recorded again, as shown in Table 4-1 and Table 4-2.

[0071] Table 4-1 Data before treatment

[0072] Table 4-2 Post-treatment data

[0073] Note: The numerical increase level is based on the lowest value of the two groups (0).

[0074] 5 Results 5.1 Comparison of body weight before and after treatment After analysis, the significance of the difference P =0.005<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-6.752 b ,P =0.000<0.05, the difference is statistically significant.

[0075] Table 5-1 Comparison of body weight before and after treatment

[0076] 5.2 Comparison of height before and after treatment After analysis, the significance of the difference P =0.000<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-6.759 b , P =0.000<0.05, the difference is statistically significant.

[0077] Table 5-2 Comparison of height before and after treatment

[0078] 5.3 Comparison of mental scores before and after treatment After analysis, the significance of the difference P =0.000<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-6.980 b , P =0.000<0.05, the difference is statistically significant, and it can be considered that there is a significant difference in mental state before and after treatment.

[0079] Table 5-3 Comparison of mental scores before and after treatment

[0080] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0081] 5.4 Comparison of appetite scores before and after treatment After analysis, the significance of the difference P =0.000<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-7.027 b , P =0.000<0.05, the difference is statistically significant, and it can be considered that there is a significant difference in appetite before and after treatment.

[0082] Table 5-4 Comparison of appetite scores before and after treatment

[0083] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0084] 5.5 Comparison of sleep scores before and after treatment After analysis, the significance of the difference P =0.000<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-6.978 b , P =0.000<0.05, the difference is statistically significant, and it can be considered that there is a significant difference in sleep before and after treatment.

[0085] Table 5-5 Comparison of sleep scores before and after treatment

[0086] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0087] 5.6 Comparison of hair scores before and after treatment After analysis, the significance of the difference P =0.000<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-6.958 b , P =0.000<0.05, the difference is statistically significant, and it can be considered that there is a significant difference in hair before and after treatment.

[0088] Table 5-6 Comparison of hair scores before and after treatment

[0089] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0090] 5.7 Comparison of stool scores before and after treatment After analysis, the significance of the difference P =0.000<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-6.952 b , P =0.000<0.05, the difference is statistically significant, and it can be considered that there is a significant difference in stool before and after treatment.

[0091] Table 5-7 Comparison of stool scores before and after treatment

[0092] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0093] 5.8 Comparison of color scores before and after treatment After analysis, the significance of the difference P =0.000<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-7.346 b , P =0.000<0.05, the difference is statistically significant, and it can be considered that there is a significant difference in complexion before and after treatment.

[0094] Table 5-8 Comparison of color scores before and after treatment

[0095] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0096] 5.9 Comparison of diarrhea scores before and after treatment After analysis, the significance of the difference P =0.000<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-5.099b, P =0.000<0.05, the difference is statistically significant, and it can be considered that there is a significant difference in diarrhea before and after treatment.

[0097] Table 5-9 Comparison of diarrhea scores before and after treatment

[0098] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0099] 5.10 Comparison of fat thickness scores before and after treatment After analysis, the fat thickness syndrome scores were all 0 before treatment and all 1 after treatment. It can be considered that there is a significant difference in fat thickness before and after treatment.

[0100] 5.11 Comparison of infection scores before and after treatment After analysis, the significance of the difference P =0.000<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-2.646 b , P =0.008<0.05, the difference is statistically significant, and it can be considered that there is a significant difference in infection before and after treatment.

[0101] Table 5-11 Comparison of infection scores before and after treatment

[0102] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0103] 5.12 Comparison of total TCM syndrome scores before and after treatment After analysis, the significance of the difference P =0.000<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-6.785 b , P =0.000<0.05, the difference is statistically significant, and it can be considered that there is a significant difference in the total score of TCM symptoms before and after treatment.

[0104] Table 5-12 Comparison of total TCM syndrome scores before and after treatment

[0105] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0106] 5.13 Comparison of IGF-1 (growth factor) before and after treatment After analysis, the significance of the difference P =0.003<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-6.752 b , P =0.000<0.05, the difference is statistically significant, and it can be considered that there is a significant difference in growth factors before and after treatment.

[0107] Table 5-13 Comparison of IGF-1 (growth factor) before and after treatment

[0108] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0109] 5.14 Comparison of PA (prealbumin) before and after treatment After analysis, the significance of the difference P =0.003<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-6.683 b , P=0.000<0.05, the difference is statistically significant, and it can be considered that there is a significant difference in PA (prealbumin) before and after treatment.

[0110] Table 5-14 Comparison of PA (prealbumin) before and after treatment

[0111] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0112] 5.15 Comparison of hemoglobin before and after treatment After analysis, the significance of the difference P =0.000<0.1, so the difference does not conform to the normal distribution, so the signed rank test of paired design should be used. After testing, the test statistic Z =-1.620 b , P =0.105<0.05, the difference was not statistically significant, and it was considered that there was no significant difference in hemoglobin before and after treatment.

[0113] Table 5-15 Comparison of hemoglobin before and after treatment

[0114] Among them, a. Wilcoxon signed-rank test, b. Based on negative ranks.

[0115] 5.16 As shown in Table 5-16, the symptom scores and indicators of IGF-1 (growth factor) and PA (prealbumin) before and after treatment did not conform to the normal distribution. Therefore, the Mann-Whitney U rank sum test was used, and the results showed that there were significant differences ( P <0.05), indicating that this treatment method has a good therapeutic effect. Among them, hemoglobin does not conform to the normal distribution, so the Mann-Whitney U rank sum test was used, and the results showed that there was no significant difference ( P >0.05), indicating that the treatment method has no significant effect on hemoglobin.

[0116] After the treatment, the scores of various TCM symptoms were lower than those before treatment, and all P The difference was statistically significant when the value was <0.05, indicating that the treatment had an improvement effect on infantile malnutrition and the efficacy was significant.

[0117] Table 5-16 Analysis of symptoms and indicators

[0118] 5. In terms of biochemical testing, current studies have shown that insulin-like growth factor-1 (IGF-1) and prealbumin (PA) are the most sensitive indicators for evaluating malnutrition in children.

[0119] (1) IGF-1 is a polypeptide with a structure and function similar to insulin. It has a molecular weight of 7.6 kDa and is a single-chain basic protein containing 70 amino acids. It is secreted by the liver and multiple other tissues, and its synthesis is regulated by growth hormone (GH). IGF-1 has the function of promoting bone growth and regulating protein metabolism. Studies have shown that IGF-1 is a marker of growth rate and a sensitive indicator of nutritional status. It is considered to be one of the sensitive indicators reflecting growth and development.

[0120] (2) Serum albumin and prealbumin (PA) are also currently considered important indicators that can reflect the body's nutritional status. Prealbumin is a plasma transport protein that precedes albumin during plasma protein electrophoresis. PA has a short half-life and changes in the early stages of malnutrition. It recovers within a week after malnutrition is corrected, making it a sensitive indicator.

[0121] (3) Routine blood tests can also reflect the condition of malnutrition in children. In children with malnutrition, hemoglobin and red blood cell count are often reduced.

[0122] 7. Safety analysis: During the treatment period of this study, the children did not experience obvious discomfort and no adverse reactions occurred, indicating that this treatment method is relatively safe.

[0123] In summary, the present invention can effectively improve the clinical symptoms of children and enhance their quality of life.

[0124] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating infantile malnutrition, characterized in that: The traditional Chinese medicine composition comprises the following components in parts by weight: 7-15g of Strigosa Striga, 8-16g of Quince, 8-15g of Raw Rhubarb, 9-17g of Cooked Rhubarb, 9-16g of Rhizoma Cyperi, 7-13g of Heichou, 6-15g of Bacchus, 6-15g of Nigella Sativa seeds, 15-20g of Trigonosciadium japonicum, 16-19g of Curcuma zedoaria, 9-17g of Amomum villosum, and 10-19g of Pedicularis edulis.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition comprises the following components in parts by weight: 10-15g of strigas root, 10-15g of quince, 10-15g of raw rhubarb, 10-15g of cooked rhubarb, 10-15g of rhizoma scoparia, 9-13g of black schizonepeta, 9-14g of white schizonepeta, 10-15g of black cumin seeds, 16-19g of trigonosciadium japonicum, 17-19g of zedoaria, 10-13g of amomum villosum, and 10-15g of moss-grown artemisia selengensis.

3. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition comprises the following components in parts by weight: 12g of strigastrifolia, 12g of quince, 12g of raw rhubarb, 12g of cooked rhubarb, 12g of rhizoma scoparia, 12g of black schizonepeta, 12g of white schizonepeta, 12g of black cumin seeds, 18g of trigonosciadium japonicum, 18g of zedoaria, 12g of amomum villosum, and 10g of moss-grown artemisia selengensis.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that The traditional Chinese medicine composition also includes auxiliary materials.

5. The Chinese medicine composition according to claim 4, characterized in that The auxiliary materials include, but are not limited to, one, two or more of a solubilizer, a disintegrant, a flavoring agent, an emulsifier, a wetting agent, a binder, a colorant, an absorption promoter, and a filler.

6. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that The Chinese medicine composition can be processed into any dosage form including but not limited to granules, decoctions, mixtures, capsules, powders, pastes, and pills, with granules being particularly preferred.

7. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that The invention relates to an application of the traditional Chinese medicine composition in preparing a product for treating infantile malnutrition.

8. The Chinese medicine composition according to claim 7, characterized in that The product for treating infantile malnutrition comprises the components of the traditional Chinese medicine composition and 1-2g of flavoring agent.

9. The Chinese medicine composition according to claim 8, characterized in that The method for preparing a product for treating infantile malnutrition is as follows: the component Chinese herbal medicines and auxiliary materials are placed in an oven at a temperature of 40-55°C and dried to a dryness of ≥85%, respectively, crushed into fine powder using a Chinese medicine grinder, and then passed through a 100-mesh sieve to make the medicinal powder fine and uniform, which is convenient for taking and absorption; the fine powder of each medicinal material is placed in a clean container, and thoroughly stirred and mixed to ensure that the components are evenly distributed.

10. The Chinese medicine composition according to claim 9, characterized in that The product for treating infantile malnutrition is taken as follows: 0.3 g for children under 5 years old, three times a day, washed down with warm water; 1.5 g for children over 5 years old, three times a day, washed down with warm water; the course of treatment is 30 days; the patient should avoid eating crabs, vinegar, kidney beans, raw and cold foods; and overeating.

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