Traditional Chinese medicine composition, preparation and application for treating childhood metabolic-related fatty liver disease

Abstract

The invention discloses a Chinese medicine composition, a pharmaceutical preparation and an application for treating fatty liver disease associated with childhood metabolism, and belongs to the technical field of traditional Chinese medicine. The Chinese medicine composition is made of the following raw materials in parts by weight: 9-30 parts of Pseudostellariae Radix, 6-24 parts of Salviae Miltiorrhizae, 6-24 parts of Poriae, 5-18 parts of Atractylodes macrocephala, 4-15 parts of Crataegus pinnatifida, 4-15 parts of Millettia reticulata, 4-15 parts of Caulis Sargentodoxae, 1-12 parts of Uncaria rhynchophylla, 4-15 parts of Semen persicae, 4-15 parts of Zedoariae Radix, 3-12 parts of Citrus reticulatae, and 2-10 parts of Radix Glycyrrhizae Preparata. The total clinical efficacy of the Chinese medicine composition in treating fatty liver disease associated with childhood metabolism is better than the existing simple lifestyle improvement combined with liver protection drug treatment, and has the advantages of good compliance, small dosage, and quick effect.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition and a pharmaceutical preparation and application thereof for treating childhood metabolism-related fatty liver disease. Background Art

[0002] Metabolic-associated fatty liver disease (MAFLD) has become the most common chronic liver disease in children and is the liver manifestation of metabolic diseases. Therefore, its treatment methods should not only effectively reduce liver steatosis and related liver damage, but also improve the coexisting metabolic and cardiovascular risk factors and complications in patients with metabolic-associated fatty liver disease. Therefore, changing lifestyle through a structured intervention program of moderate diet, adjustment of dietary structure and increase of exercise is still the first-line measure and cornerstone for the treatment of metabolic-associated fatty liver disease. There is currently no effective and safe treatment for children with metabolic-associated fatty liver disease. Lifestyle adjustment is an important treatment for improving MAFLD liver damage, but it is difficult for children to adhere to it.

[0003] The information disclosed in this background technology section is only intended to enhance the understanding of the overall background of the invention and should not be regarded as an acknowledgment or any form of suggestion that the information constitutes the prior art already known to a person skilled in the art. Summary of the invention

[0004] In view of the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition, a drug preparation and an application for treating metabolic-related fatty liver disease in children. The total clinical efficacy of the traditional Chinese medicine composition in treating metabolic-related fatty liver disease in children is better than the existing treatment of simple lifestyle improvement combined with liver-protecting drugs, and has the advantages of good compliance, small dosage and rapid effect.

[0005] A first aspect of the present invention provides a traditional Chinese medicine composition for treating metabolic-related fatty liver disease in children, which is prepared from the following raw materials in parts by weight: 9-30 parts of Pseudostellariae Radix, 6-24 parts of Salvia miltiorrhiza, 6-24 parts of Poria cocos, 5-18 parts of Atractylodes macrocephala, 4-15 parts of Crataegus pinnatifida, 4-15 parts of Millettia spatholobi, 4-15 parts of Caulis Sargentodoxae, 1-12 parts of Uncaria rhynchophylla, 4-15 parts of Persica kernel, 4-15 parts of Eupatorium fortunei, 3-12 parts of Citrus reticulata, and 2-10 parts of Radix Glycyrrhizae Preparata.

[0006] In one embodiment of the present invention, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 13-26 parts of Pseudostellariae Radix, 9-21 parts of Salvia miltiorrhiza, 9-21 parts of Poria cocos, 8-16 parts of Atractylodes macrocephala, 6-13 parts of Crataegus pinnatifida, 6-13 parts of Millettia spatholobi, 6-13 parts of Caulis Sargentodoxae, 3-9 parts of Uncaria rhynchophylla, 6-13 parts of Persica kernel, 6-13 parts of Eupatorium fortunei, 5-10 parts of Citrus reticulata, and 3-9 parts of Radix Glycyrrhizae Preparata.

[0007] In one embodiment of the present invention, the traditional Chinese medicine composition is made of the following raw materials in parts by weight: 17-22 parts of Pseudostellariae Radix, 12-18 parts of Salvia miltiorrhiza, 12-18 parts of Poria, 10-14 parts of Atractylodes macrocephala, 8-10 parts of Crataegus pinnatifida, 8-10 parts of Millettia spatholobi, 8-10 parts of Caulis Sargentodoxae, 5-7 parts of Uncaria rhynchophylla, 8-10 parts of Persica kernel, 8-10 parts of Eupatorium fortunei, 8-10 parts of Citrus reticulata, and 5-7 parts of Radix Glycyrrhizae Preparata.

[0008] In one embodiment of the present invention, the Chinese medicine composition is made of the following raw materials in parts by weight: 20 parts of Pseudostellariae Radix, 15 parts of Salvia miltiorrhiza, 15 parts of Poria cocos, 12 parts of Atractylodes macrocephala, 9 parts of Crataegus pinnatifida, 9 parts of Millettia spatholobi, 9 parts of Caulis Sargentodoxae, 6 parts of Uncaria rhynchophylla, 9 parts of Persica kernel, 9 parts of Eupatorium fortunei, 9 parts of Citrus reticulata, and 6 parts of Radix Glycyrrhizae uralensis.

[0009] In the present invention, the Pseudostellaria heterophylla is the dried root of Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm. of the Caryophyllaceae family. It is distributed in Fujian, Liaoning, Inner Mongolia, Hebei, Shaanxi, Shandong, Jiangsu, Anhui, Zhejiang, Jiangxi, Henan, Hubei, Hunan, Sichuan and other places. It has the effects of invigorating qi and strengthening spleen, promoting body fluid and moistening lung. It is commonly used for spleen deficiency, fatigue, loss of appetite, weakness after illness, deficiency of qi and yin, spontaneous sweating and thirst, and dry cough due to lung dryness.

[0010] In the present invention, the salvia miltiorrhiza is the dried root and rhizome of the plant Salvia miltiorrhiza Bge. of the Labiatae family. It is dug in spring and autumn, desilted and dried. It is distributed in most parts of the country. It has the effects of promoting blood circulation and removing blood stasis, relieving pain from menstruation, clearing the heart and relieving restlessness, cooling blood and eliminating carbuncle. It is used for chest pain, abdominal pain, accumulation of masses, pain caused by heat arthralgia, restlessness and insomnia, irregular menstruation, dysmenorrhea and amenorrhea, and swelling and pain of sores.

[0011] In the present invention, the Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf. It is usually dug from July to September, the sand is removed after digging, and it is piled up to "sweate", then spread out to dry on the surface, and then "sweated" again, and repeated several times until wrinkles appear and most of the internal moisture is lost, and then dried in the shade, which is called "Poria cocos pieces"; or fresh Poria cocos is cut according to different parts, dried in the shade, and respectively called "Poria cocos blocks" and "Poria cocos slices". It has the effects of diuresis, invigorating the spleen, and calming the mind.

[0012] In the present invention, the Atractylodes macrocephala is the dried rhizome of the perennial herb Atractylodes macrocephala Koidz. of the Asteraceae family. It is cultivated in Jiangsu, Zhejiang and other places, but it grows wild in Jiangxi, Hunan and other places, mostly growing on wild hillside grasslands and under hillside forests. Atractylodes macrocephala likes cool and mild climates, has strong cold resistance, and has low soil requirements. It has the effects of replenishing qi and strengthening the spleen, drying dampness and promoting diuresis, stopping sweating, and calming the fetus.

[0013] In the present invention, the hawthorn is the dried mature fruit of the plant Crataegus pin,natiidaBge.var.major NEBr. or Crataegus pin.nati fida Bge. of the Rosaceae family. The fruit is harvested in autumn when it is ripe, sliced ​​and dried. It is mainly produced in Shandong, Henan, Hebei and Liaoning. It has the effects of digestion, stomach strengthening, qi circulation, blood stasis, turbidity removal and lipid reduction.

[0014] In the present invention, the Millettia spatholobi is the dried vine stem of Spatholobus suberectus Dunn, a plant of the Leguminosae family. It is harvested in autumn and winter, the branches and leaves are removed, sliced, and dried in the sun. It is distributed in Guangdong, Guangxi, Yunnan, etc. It has the effects of promoting blood circulation, replenishing blood, regulating menstruation and relieving pain, and relaxing muscles and tendons.

[0015] In the present invention, the sargentodoxa is the stem of Sargentodoxa cuneata (Oliv.) Rehd. & E.H.Wilson in CSSargent of the Akebia family. Sargentodoxa is native to China, concentrated in Laos and northern Vietnam abroad, and widely distributed in Shaanxi, Sichuan, Guizhou, Hubei, Hainan and other places in China, mostly growing in hillside shrubs, sparse forests and forest edges. Sargentodoxa has the effects of clearing away heat and detoxifying, promoting blood circulation, and dispelling wind and relieving pain.

[0016] In the present invention, the Uncaria rhynchophylla is the dried stems and branches with hooks of Uncaria rhynchophylla (Miq.) Jacks., Uncaria macrophylla Wall., Uncaria hirsuta Havil., Uncariasinensis (Oliv.) Havil. or Uncaria sessilifructus Roxb. of the Rubiaceae family. They are mainly produced in Guangxi, Jiangxi, Hunan, Zhejiang and Guangdong. They have the effects of clearing blood and calming the liver, calming wind and relieving convulsions.

[0017] In the present invention, the peach kernel is the dried mature seed of the Rosaceae plant Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch. It is widely cultivated all over the country and has the effects of promoting blood circulation and removing blood stasis, moistening the intestines and relieving constipation, and relieving cough and asthma.

[0018] In the present invention, the zelan is the dried aerial part of Lycopus lucidus Turcz.vat.hirtus Regel, a plant of the Labiatae family, which is distributed in most areas of China and has the effects of promoting blood circulation and regulating menstruation, removing blood stasis and eliminating carbuncle, promoting diuresis and reducing swelling.

[0019] In the present invention, the dried tangerine peel is the dried mature peel of the Rutaceae plant Citrus reticulata Blanco and its cultivars. The medicinal material is divided into dried tangerine peel and Guang tangerine peel. The ripe fruits are picked, the peel is peeled, and dried in the sun or at a low temperature. It is mainly produced in Sichuan, Zhejiang, and Fujian. In addition, it is also produced in Jiangxi, Hunan and other places. It has the effects of regulating qi and strengthening the spleen, drying dampness and resolving phlegm.

[0020] In the present invention, the roasted licorice root is a processed product of the dried roots and rhizomes of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of the genus Glycyrrhiza of the Leguminosae family. Licorice is widely available in China, mainly concentrated in Gansu, Xinjiang and Sichuan. It has the effects of nourishing yin and blood, invigorating qi and promoting yang, and restoring pulse and calming palpitations.

[0021] A second aspect of the present invention provides a pharmaceutical preparation for treating metabolic-related fatty liver disease in children, wherein the raw materials of the pharmaceutical preparation include the above-mentioned Chinese medicine composition or an extract thereof and pharmaceutically acceptable excipients.

[0022] In one embodiment of the present invention, the pharmaceutical preparation is one selected from decoction, oral liquid, syrup, tablet, capsule, pill, and granule.

[0023] A third aspect of the present invention provides a traditional Chinese medicine decoction for treating childhood metabolism-related fatty liver disease, wherein the raw materials of the traditional Chinese medicine decoction include the above-mentioned traditional Chinese medicine composition.

[0024] A fourth aspect of the present invention provides a method for preparing the above-mentioned Chinese medicine decoction, characterized in that the preparation method comprises the following steps:

[0025] Weigh 12 medicinal materials according to the formula, add water to the remaining 11 medicinal materials except Uncaria rhynchophylla and boil them for the first time, boil for 20-40 minutes, filter, add water to the residue and boil for the second time, add Uncaria rhynchophylla after boiling for 10-30 minutes, continue to boil for 2-10 minutes, filter, combine the two decoctions and concentrate them.

[0026] In one embodiment of the present invention, the amount of water added in the first decoction is 6-10 times the total weight of the medicinal materials. Preferably, the amount of water added in the first decoction is 8 times the total weight of the medicinal materials.

[0027] In one embodiment of the present invention, the amount of water added in the second decoction is 4-8 times the total weight of the medicinal materials. Preferably, the amount of water added in the second decoction is 6 times the total weight of the medicinal materials.

[0028] The fifth aspect of the present invention provides the use of the above-mentioned Chinese medicine composition or the above-mentioned pharmaceutical preparation or the above-mentioned Chinese medicine decoction in the preparation of a medicine for treating metabolism-related fatty liver disease in children.

[0029] Metabolic fatty liver disease in children belongs to the category of "fullness", "liver fullness", "liver addiction" and "liver jaundice" in traditional Chinese medicine. Due to the complexity and diversity of the disease, most Chinese medicine practitioners have different understandings of the etiology and pathogenesis of fatty liver. After continuous summarization by successive generations of Chinese medicine practitioners, it can be mainly summarized as pathogenic factors such as diet, fatigue, emotions, physical weakness, obesity, etc., which lead to liver qi stagnation, spleen dysfunction, phlegm and dampness, blood stasis, spleen and kidney deficiency. It is believed that the disease is mostly located in the liver, spleen and kidney. Weak spleen and dysfunction of spleen are easily injured by diet, resulting in damp heat. In pathological conditions, the liver is damaged and the liver is incapable of functioning, so it cannot be dredged and regulated, which further leads to the production of pathological products such as phlegm and blood stasis. Phlegm, heat, stasis, turbidity and dampness are mutually entangled, accumulating in the liver and spleen, and the body's qi and blood circulation is abnormal, which ultimately leads to the occurrence of this disease.

[0030] The inventors, guided by the theory of liver and collateral disease, combined with many years of clinical practice, found that when using traditional Chinese medicine to treat children's metabolic-related fatty liver disease, invigorating the spleen and eliminating dampness, unblocking collaterals and removing blood stasis are the key to treatment. The Chinese medicine composition of the present invention uses Salvia miltiorrhiza and Radix Pseudostellariae as the main medicines to unblock collaterals and invigorate the spleen. Poria, Atractylodes macrocephala, and Crataegus pinnatifida help Radix Pseudostellariae to strengthen the spleen, eliminate dampness, and eliminate stagnation; Uncaria rhynchophylla, Caulis Spatholobi, and Millettia spatholobi help Salvia miltiorrhizae to promote blood circulation, remove blood stasis, and unblock collaterals, Millettia spatholobi replenishes blood and promotes blood circulation, unblocks liver collateral stagnation, and replenishes liver collateral qi and blood. Caulis Spatholobi can promote liver collateral qi and blood, clear gastrointestinal stasis, and Uncaria rhynchophylla can clear liver collateral stagnation and heat, and eliminate long-term stagnant food. Peach kernel and Ze Lan are used to promote blood circulation and diuresis, dry dampness and resolve phlegm; and Tangerine peel promotes qi and eliminates stagnation, wakes up the spleen and helps transportation, so that it is replenished without stagnation. Roasted Licorice is a guiding drug that invigorates qi and harmonizes the middle, and harmonizes all medicines.

[0031] The use of the Chinese medicine composition of the present invention for interventional treatment of children with metabolic-related fatty liver disease can help patients lose weight and body fat, improve liver function and sugar and lipid metabolism indicators, and promote recovery from the disease. The Chinese medicine composition of the present invention significantly improves the children's weight, BMI, waist circumference, waist-to-hip ratio, body fat mass, and laboratory indicators such as ALT, AST, Chol, HDL, LDL, Ins, HOMA-IR, liver function, sugar and lipid metabolism function and other clinical indicators. The total clinical efficacy of treating metabolic-related fatty liver disease in children is better than the existing simple lifestyle improvement combined with liver protection drug treatment, and has the advantages of good compliance, small dosage, quick effect, etc., and no adverse reactions are observed. DETAILED DESCRIPTION

[0032] Unless explicitly stated otherwise, throughout the specification and claims, the term “comprise” or variations such as “include” or “comprising”, etc., will be understood to include the stated elements or components but not to exclude other elements or components.

[0033] The technical solution of the present invention is described below by specific embodiments. It should be understood that one or more steps mentioned in the present invention do not exclude the existence of other methods and steps before and after the combination step, or other methods and steps can be inserted between these explicitly mentioned steps. It should also be understood that these examples are only used to illustrate the present invention and are not used to limit the scope of the present invention. Unless otherwise specified, the numbering of each method step is only for the purpose of identifying each method step, and does not limit the order of arrangement of each method or limit the scope of implementation of the present invention. The change or adjustment of the relative relationship thereof can also be regarded as the scope of implementation of the present invention without substantial changes in the technical content.

[0034] The sources of the raw materials and instruments used in the examples are not particularly limited and can be purchased from the market or prepared according to conventional methods known to those skilled in the art.

[0035] Example 1

[0036] A Chinese medicine composition for treating metabolic-related fatty liver disease in children is prepared from the following raw materials in parts by weight: 20 parts of Pseudostellariae Radix, 15 parts of Salviae Miltiorrhizae, 15 parts of Poria, 12 parts of Atractylodes macrocephala, 9 parts of Crataegus pinnatifida, 9 parts of Millettia spatholobi, 9 parts of Caulis Sargentodoxae, 6 parts of Uncaria rhynchophylla, 9 parts of Semen persicae, 9 parts of Zedoariae rhizome, 9 parts of Tangerine peel, and 6 parts of Radix Glycyrrhizae Radix. The Chinese medicine composition is prepared into a decoction. The specific preparation method is as follows: 12 medicinal materials are weighed according to the formula, and the remaining 11 medicinal materials except Uncaria rhynchophylla are decocted with water for the first time, and the amount of water added is 8 times the total weight of the medicinal materials, decocted for 30 minutes, filtered, and the residue is decocted with water for the second time, and the amount of water added is 6 times the total weight of the medicinal materials. After decocting for 15 minutes, Uncaria rhynchophylla is added, and the decocting is continued for 5 minutes, filtered, and the two decoctions are combined and concentrated to 200-300 parts by weight.

[0037] Example 2

[0038] A Chinese medicine composition for treating metabolic-related fatty liver disease in children is prepared from the following raw materials in parts by weight: 30 parts of Radix Pseudostellariae Radix, 6 parts of Radix Salviae Miltiorrhizae, 10 parts of Poriae, 18 parts of Atractylodes macrocephalae, 4 parts of Fructus Crataegi, 4 parts of Caulis Spatholobi, 4 parts of Caulis Sargentodoxae, 12 parts of Uncaria rhynchophyllae, 15 parts of Semen Persicae, 15 parts of Herba Eupatorii, 3 parts of Pericarpium Citri Reticulatae, and 6 parts of Radix Glycyrrhizae Preparata. The Chinese medicine composition is decocted and extracted according to the method of implementation 1, and the decoction is added with auxiliary materials to prepare an oral solution.

[0039] Example 3

[0040] A Chinese medicine composition for treating metabolic-related fatty liver disease in children is prepared from the following raw materials in parts by weight: 9 parts of Radix Pseudostellariae, 24 parts of Radix Salviae Miltiorrhizae, 24 parts of Poriae, 5 parts of Atractylodes macrocephalae, 15 parts of Crataegus pinnatifida, 6 parts of Caulis Spatholobi, 10 parts of Caulis Sargentodoxae, 1 part of Uncaria rhynchophyllae, 4 parts of Semen Persicae, 4 parts of Herba Eupatorii, 12 parts of Pericarpium Citri Reticulatae, and 10 parts of Radix Glycyrrhizae Preparata. The Chinese medicine composition is decocted and extracted according to the method of implementation 1, and the decoction is added with auxiliary materials to prepare a syrup.

[0041] Example 4

[0042] A Chinese medicine composition for treating metabolic-related fatty liver disease in children is prepared from the following raw materials in parts by weight: 30 parts of Radix Pseudostellariae Radix, 10 parts of Radix Salviae Miltiorrhizae, 6 parts of Poriae, 12 parts of Atractylodes Macrocephalae, 9 parts of Fructus Crataegi, 9 parts of Caulis Spatholobi, 15 parts of Caulis Sargentodoxae, 3 parts of Uncaria Rhynchophyllae, 9 parts of Semen Persicae, 9 parts of Herba Eupatorii, 9 parts of Pericarpium Citri Reticulatae, and 6 parts of Radix Glycyrrhizae Preparata. The Chinese medicine composition is decocted and extracted according to the method of implementation 1, and the decoction is added with auxiliary materials to prepare granules.

[0043] Example 5

[0044] A Chinese medicine composition for treating metabolic-related fatty liver disease in children is prepared from the following raw materials in parts by weight: 20 parts of Radix Pseudostellariae Radix, 12 parts of Radix Salviae Miltiorrhizae, 12 parts of Poriae, 12 parts of Atractylodes Macrocephalae, 9 parts of Fructus Crataegi, 15 parts of Caulis Spatholobi, 12 parts of Caulis Sargentodoxae, 9 parts of Uncaria Rhynchophyllae, 6 parts of Semen Persicae, 12 parts of Herba Eupatorii, 6 parts of Pericarpium Citri Reticulatae, and 2 parts of Radix Glycyrrhizae Preparata. The Chinese medicine composition is decocted and extracted according to the method of implementation 1, and the decoction is added with auxiliary materials to prepare tablets.

[0045] Test example: Observation on the clinical efficacy of the Chinese medicine composition of the present invention in treating metabolic-related fatty liver disease in children

[0046] 1 Clinical trial design

[0047] 1.1 General Information

[0048] A total of 116 children with metabolic-related fatty liver disease admitted to the outpatient department and ward of our hospital from January 2023 to December 2023 were selected and randomly divided into a Chinese medicine group of 58 cases and a Western medicine group of 58 cases. There were 41 males and 17 females in the Chinese medicine group, with a minimum age of 6.3 years and a maximum age of 17.9 years, with an average age of 12.87±2.61 years; there were 58 cases in the Western medicine group, including 35 males and 23 females, with a minimum age of 7.3 years and a maximum age of 17 years, with an average age of 12.08±2.48 years. There was no statistically significant difference in age and gender between the two groups of children (P>0.05).

[0049] 1.2 Inclusion and Exclusion Criteria

[0050] 1.2.1 Inclusion criteria

[0051] ① Those who meet the diagnostic criteria for childhood obesity and childhood metabolic-related fatty liver disease, and whose TCM syndrome differentiation meets the criteria for spleen deficiency and blood stasis; ② Alanine aminotransferase (ALT) greater than the normal range; ③ Aged 6-18 years; ④ No history of taking other Chinese and Western medicines 4 weeks before enrollment; ⑤ The child himself or his family with guardianship rights carefully reads and fully understands the contents of the informed consent form.

[0052] 1.2.2 Exclusion criteria

[0053] ① Dual or multiple etiology fatty liver disease or MAFLD combined with other liver diseases: a. Drug-induced liver disease, including Chinese herbal medicine and dietary supplements; b. Viral hepatitis (confirmed by serology and virology); c. Autoimmune liver disease: including autoimmune hepatitis, primary biliary cholangitis and primary sclerosing cholangitis; ② Patients with tumors or related chronic complications; ③ Patients with severe systemic diseases such as cardiovascular, cerebral, renal and hematopoietic systems.

[0054] 1.3 Treatment methods

[0055] The Chinese medicine group was given the Chinese medicine decoction of Example 1 orally, and the specific dosage was: <7 years old, 50ml / time, twice a day; 7-12 years old, 100ml / time, twice a day; 13-18 years old, 150ml each time, twice a day. Control group (ie, Western medicine group): Glucuronolactone tablets 300mg / d, oral in three times, 100mg each time. Concomitant intervention method: Both groups were given lifestyle intervention treatment, that is, both groups of subjects were given the same health education for not less than 30min before the test: ① Dietary control (refer to the dietary energy requirements of Chinese residents, reasonably arrange the dietary structure, balance the nutritional intake, avoid oversatiation, oversweet, oversalty, and overgreasy diet); ② Exercise (increase the amount of exercise, not less than 140min of moderate-intensity exercise per week); ③ Go to bed early (go to bed before 22:30). At the same time, the children and their parents in the group need to join the project group management group to supervise and record the implementation of the healthy lifestyle of the children.

[0056] 1.4 Observation indicators and detection methods

[0057] 1.4.1 Observation indicators

[0058] The improvement of clinical symptoms, clinical efficacy of TCM and related laboratory indicators of the two groups of children were compared, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), glutamyl transpeptidase (GGT), total cholesterol (Chol), triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), fasting blood glucose (GLU), fasting insulin (Ins), fasting C-peptide, glycosylated hemoglobin (HbA1c), etc. The insulin resistance index was calculated according to the following formula: insulin resistance index HOMA-IR = fasting blood glucose × fasting insulin / 22.5.

[0059] 1.4.2 Clinical efficacy criteria:

[0060] Recovery: ALT returns to normal, body fat percentage decreases, and HOMA-IR returns to normal (boys ≤ 2.67, girls ≤ 2.22);

[0061] Significantly effective: ALT decreased by >50% compared with before treatment, body fat percentage decreased, and HOMA-IR improved compared with before treatment;

[0062] Effective: ALT decreased compared with before treatment, body fat percentage decreased or HOMA-IR improved compared with before treatment;

[0063] Ineffective: ALT did not decrease compared with before treatment, or ALT decreased compared with before treatment but body fat percentage and HOMA-IR did not improve.

[0064] 1.4.3 Statistical methods

[0065] SPSS 22.0 statistical software was used. Normally distributed quantitative data were expressed as x±s, and skewed quantitative data were expressed as M(Q1, Q3). The quantitative data were compared using t-test or rank sum test, and the enumeration data were compared using χ2 test.

[0066] 2 Results

[0067] 2.1 Changes in weight, BMI, waist circumference, waist-to-hip ratio, and body fat mass before and after medication in the two groups of children

[0068] There was no statistically significant difference in weight, BMI, waist circumference, waist-hip ratio, and body fat mass between the Chinese medicine group and the Western medicine group before treatment (P>0.05). After 8 weeks of treatment, the weight, BMI, waist circumference, and waist-hip ratio of the two groups decreased compared with before treatment, but there was no statistical difference (p>0.05); the body fat mass level decreased compared with before treatment, and there was a statistical difference (p<0.05). The difference between the two groups before and after the intervention was compared. The results showed that compared with the Western medicine group 8 weeks after treatment, the weight, BMI, waist circumference, and waist-hip ratio of the Chinese medicine group decreased more significantly after treatment (p<0.05), as shown in Table 1.

[0069] Table 1 Body weight, BMI, waist circumference, waist-to-hip ratio, and body fat mass in the two groups before and after treatment

[0070]

[0071] ( △ Compared with the same group at week 0, p<0.05; ★ The difference between the two groups before and after the intervention (p<0.05)

[0072] 2.2 Changes of laboratory indicators in the two groups of children before and after treatment

[0073] There was no significant difference in the values ​​of ALT, AST, GGT, Chol, TG, HDL, LDL, GLU, Ins, fasting C-peptide, and HbA1c between the Chinese medicine group and the Western medicine group before treatment (P>0.05). Eight weeks after treatment, the levels of ALT, AST, Chol, LDL, Ins, and HOMA-IR in the Chinese medicine group decreased compared with those before treatment, and the comparison within the group was statistically significant (p<0.05). Although the levels of GGT, TG, LDL, GLU, C-peptide, and HbA1c decreased compared with those before treatment, there was no statistical difference (p>0.05); the level of HDL increased after treatment compared with that before treatment, and there was a statistical difference (p>0.05); the difference between the two groups before and after the intervention was compared, and the results showed that compared with the Western medicine group 8 weeks after treatment, the decrease in ALT, AST, GGT, Chol, and HOMA-IR was more significant (p<0.05), as shown in Table 2, Table 3, and Table 4.

[0074] Table 2 Liver function of the two groups before and after treatment

[0075]

[0076] ( △ Compared with the same group at week 0, p<0.05; ★ The difference between the two groups before and after the intervention (p<0.05)

[0077] Table 3 Blood lipid indexes of the two groups before and after treatment

[0078]

[0079] ( △ Compared with the same group at week 0, p<0.05; ★ The difference between the two groups before and after the intervention (p<0.05)

[0080] Table 4 Blood sugar indexes of the two groups before and after treatment

[0081]

[0082] ( △ Compared with the same group at week 0, p<0.05; ★ The difference between the two groups before and after the intervention (p<0.05)

[0083] 2.3 Overall clinical efficacy of the two groups of children:

[0084] Before and after treatment, the total effective rate of the Chinese medicine group was 93.1%, and the total effective rate of the Western medicine group was 87.93%. Fisher's exact probability method analysis showed that there was a difference in the efficacy between the two groups (p<0.05), see Table 5.

[0085] Table 5 Improvement of clinical criteria in the two groups of children

[0086]

[0087] ( ★ Comparison between the two groups (p<0.05)

[0088] In summary, it can be seen that the Chinese medicine of the present invention significantly improves clinical indicators such as body weight, BMI, waist circumference, waist-to-hip ratio, body fat mass, laboratory indicators such as ALT, AST, Chol, HDL, LDL, Ins, HOMA-IR, liver function, and glucose and lipid metabolism function. The total clinical effective rate of treating metabolic-related fatty liver disease in children is better than that of existing Western medicine treatments such as glucuronolactone tablets, and has the advantages of good compliance, small dosage, and rapid effect. There are no reports of adverse reactions, and the Chinese medicine can become a new therapeutic drug for the clinical treatment of metabolic-related fatty liver disease in children.

[0089] The foregoing description of specific exemplary embodiments of the present invention is for the purpose of illustration and demonstration. These descriptions are not intended to limit the present invention to the precise form disclosed, and it is clear that many changes and variations can be made based on the above teachings. The purpose of selecting and describing the exemplary embodiments is to explain the specific principles of the present invention and its practical application, so that those skilled in the art can realize and utilize various different exemplary embodiments of the present invention and various different selections and changes. The scope of the present invention is intended to be limited by the claims and their equivalents.

Claims

1. A Chinese medicine composition for treating metabolic-related fatty liver disease in children, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 9-30 parts of Pseudostellariae Radix, 6-24 parts of Salvia miltiorrhiza, 6-24 parts of Poria cocos, 5-18 parts of Atractylodes macrocephala, 4-15 parts of Crataegus pinnatifida, 4-15 parts of Millettia spatholobi, 4-15 parts of Sargentodoxae, 1-12 parts of Uncaria rhynchophylla, 4-15 parts of Persicae persica, 4-15 parts of Eupatorium fortunei, 3-12 parts of Citrus reticulatae and 2-10 parts of Radix Glycyrrhizae Preparata.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 13-26 parts of Pseudostellariae Radix, 9-21 parts of Salvia miltiorrhiza, 9-21 parts of Poria cocos, 8-16 parts of Atractylodes macrocephala, 6-13 parts of Crataegus pinnatifida, 6-13 parts of Millettia spatholobi, 6-13 parts of Sargentodoxae, 3-9 parts of Uncaria rhynchophylla, 6-13 parts of Persicae persica, 6-13 parts of Eupatorium fortunei, 5-10 parts of Citrus reticulatae and 3-9 parts of Radix Glycyrrhizae Preparata.

3. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 17-22 parts of Pseudostellariae Radix, 12-18 parts of Salvia miltiorrhiza, 12-18 parts of Poria cocos, 10-14 parts of Atractylodes macrocephala, 8-10 parts of Crataegus pinnatifida, 8-10 parts of Millettia spatholobi, 8-10 parts of Sargentodoxae, 5-7 parts of Uncaria rhynchophylla, 8-10 parts of Persicae persica, 8-10 parts of Eupatorium fortunei, 8-10 parts of Citrus reticulatae and 5-7 parts of Radix Glycyrrhizae Preparata.

4. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 20 parts of Pseudostellariae Radix, 15 parts of Salvia miltiorrhiza, 15 parts of Poria cocos, 12 parts of Atractylodes macrocephala, 9 parts of Crataegus pinnatifida, 9 parts of Millettia spatholobi, 9 parts of Sargentodoxae, 6 parts of Uncaria rhynchophylla, 9 parts of Persicae persica, 9 parts of Eupatorium herb, 9 parts of Citrus reticulatae and 6 parts of Radix Glycyrrhizae Radix et Rhizoma.

5. A pharmaceutical preparation for treating metabolic-related fatty liver disease in children, characterized in that: The raw materials of the pharmaceutical preparation are composed of the Chinese medicine composition or extract thereof according to any one of claims 1 to 4 and pharmaceutically acceptable excipients.

6. The pharmaceutical preparation according to claim 5, characterized in that The pharmaceutical preparation is one selected from decoction, oral liquid, syrup, tablet, capsule, pill and granule.

7. A Chinese medicinal decoction for treating metabolic-related fatty liver disease in children, characterized in that: The raw materials of the Chinese medicine decoction are composed of the Chinese medicine composition according to any one of claims 1 to 4.

8. The method for preparing the Chinese medicinal decoction according to claim 7, characterized in that: The preparation method comprises the following steps: Weigh 12 medicinal materials according to the formula, add water to the remaining 11 medicinal materials except Uncaria rhynchophylla and boil them for the first time, boil for 20-40 minutes, filter, add water to the residue and boil for the second time, add Uncaria rhynchophylla after boiling for 10-30 minutes, continue to boil for 2-10 minutes, filter, combine the two decoctions and concentrate them.

9. The preparation method according to claim 8, characterized in that: The amount of water added in the first decoction is 6-10 times the total weight of the medicinal materials; And / or, the amount of water added in the second decoction is 4-8 times the total weight of the medicinal materials.

10. The preparation method according to claim 8, characterized in that: The amount of water added in the first decoction is 8 times the total weight of the medicinal materials.

11. The preparation method according to claim 8, characterized in that: The amount of water added in the second decoction is 6 times the total weight of the medicinal materials.

12. Use of the Chinese medicine composition according to any one of claims 1 to 4, the pharmaceutical preparation according to claim 5 or 6, or the Chinese medicine decoction according to claim 7 in the preparation of a medicament for treating metabolic-related fatty liver disease in children.

Images