Traditional Chinese medicine for treating autism of children

Abstract

The invention relates to a traditional Chinese medicine for treating children autism, which can effectively solve the medication problems of good curative effect and convenience for treating children autism. The preparation method comprises the following steps: disinfecting and sterilizing radix bupleuri, radix paeoniae alba, fructus aurantii, rhizoma nardostachyos, rhizoma atractylodis macrocephalae, poria cocos, codonopsis pilosula, cassia twig, rhizoma acori graminei, cistanche, rhizoma alismatis, peach kernel, safflower, scutellaria baicalensis, pinellia ternate, honey-fried licorice root, rock candy and maltose, soaking, boiling with strong fire, decocting with slow fire, filtering, heating to prepare a traditional Chinese medicine concentrated solution, adding rock candy and maltose, decocting into thick paste, pouring into a mold, shaping at room temperature to form granules, and packaging. The traditional Chinese medicine composition is rich in raw materials, easy to operate in preparation method and scientific and reasonable in compatibility according to the primary and secondary relationship of monarch, minister, assistant and guide, has the effects of soothing the liver, strengthening the spleen, tonifying the kidney, replenishing essence, inducing resuscitation and promoting intelligence, is effectively used for treating autism of children, and has huge economic and social benefits.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine for treating autism in children. Background Art

[0002] Autism, also known as autism spectrum disorder or autistic disorder (ASD), is a neurodevelopmental disorder that begins before the age of 3 and is characterized by social interaction disorders, communication disorders, and limited, stereotyped, and repetitive behaviors. Recent studies have found that in addition to the core symptoms, more than 70% of children with autism have physical illnesses, developmental disorders, or mental problems. In 2013, the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) required that in addition to the diagnosis of ASD children, the accompanying medical problems (such as epilepsy, anxiety, depression, intestinal problems, etc.) should be described. Intestinal dysfunction is a common physical symptom in children with autism. Studies have shown that the incidence of intestinal symptoms in children with autism is higher than that in normal children. Children with autism who have gastrointestinal symptoms have more severe repetitive stereotyped behaviors, problem behaviors, and emotional problems. This suggests that gastrointestinal problems in children with autism should not be ignored in clinical intervention. In recent years, scholars have found that intestinal flora imbalance plays an important role in the occurrence and development of ASD. Intestinal flora imbalance leads to the occurrence and development of ASD by affecting the brain-gut-microbiome axis. It can be seen that gastrointestinal symptoms can affect the brain development of children with autism.

[0003] So far, there is no specific drug that can cure autism or the core symptoms of children with autism. Its treatment mainly focuses on conventional rehabilitation, such as structured education, speech and sensory integration training, music therapy, behavioral intervention, etc., but the effect is limited. Most children with ASD still find it difficult to integrate into society after receiving conventional rehabilitation training. The widespread intestinal problems and secondary behavioral problems in children with autism make rehabilitation and treatment more difficult.

[0004] Traditional Chinese medicine has no records of "autism" or "autism". According to traditional Chinese medicine books, childhood autism belongs to the categories of "childhood stupor", "delayed speech", "madness", "lack of wisdom", "weak fetus", "timid fetus", "unemotional vision" and "emotionless eyes". In recent years, Chinese medicine practitioners generally believe that autism is located in the brain and is closely related to the heart, liver and kidney. The existing "Guidelines for Clinical Diagnosis and Treatment of Pediatrics in Traditional Chinese Medicine·Autism Spectrum Disorders" classifies autism into syndromes of hyperactivity of heart and liver fire, syndrome of phlegm covering the heart, syndrome of deficiency of both heart and spleen, and syndrome of insufficient kidney essence. Clinically, children with autism are often accompanied by symptoms of spleen deficiency such as anorexia, picky eating, abdominal pain, bloating, diarrhea, constipation, and symptoms of hyperactivity of the liver such as anxiety, impulsiveness, excitement, and hyperactivity. This is consistent with the modern medicine's proposal that "intestinal flora imbalance leads to the occurrence and development of ASD by affecting the brain-gut-microbiome axis". The two theories coincide in degree, but few Chinese medicine doctors start with the liver, spleen and kidney to diagnose and treat autism in children; Chinese medicine differentiation and treatment of gastrointestinal diseases has significant effect and is widely recognized by the public, but the treatment course of the disease is long, and children generally have poor compliance with Chinese herbal medicine decoctions. Chinese medicine has unique therapeutic effects in the treatment of various clinical diseases, especially in regulating the spleen and stomach, improving gastrointestinal symptoms and regulating emotions. Therefore, whether it is possible to develop a Chinese medicine for the treatment of autism in children based on the pathogenesis and actual needs of autism in children is a technical problem that needs to be seriously solved. Summary of the invention

[0005] In view of the above situation, in order to overcome the deficiencies of the prior art, the purpose of the present invention is to provide a traditional Chinese medicine for treating autism in children, which can effectively solve the medication problems and efficacy problems of autistic children, such as poor medication compliance and difficulty in taking traditional Chinese medicine for a long time.

[0006] The technical solution provided by the present invention is a traditional Chinese medicine for treating autism in children. The traditional Chinese medicine is prepared from the following raw materials by weight: 4-6 parts of bupleurum, 4-6 parts of white peony root, 4-6 parts of fructus aurantii, 4-6 parts of rhizoma nardostachys, 4-6 parts of atractylodes macrocephala, 4-6 parts of poria, 4-6 parts of codonopsis pilosula, 4-6 parts of cassia twig, 4-6 parts of calamus, 4-6 parts of cistanche deserticola, 4-6 parts of orientalis, 4-6 parts of peach kernel, 2-4 parts of safflower, 4-6 parts of scutellaria, 4-6 parts of pinellia, 4-6 parts of licorice root, 28-32 parts of crystal sugar and 1.5-2.5 parts of maltose, wherein the crystal sugar and maltose constitute the hard candy part, and the other traditional Chinese medicine components constitute the traditional Chinese medicine part. The preparation method is:

[0007] 1. Disinfection and sterilization

[0008] Use ultraviolet fluorescent lamps to disinfect and sterilize the drug preparation workshop (drug decoction utensils, operating tables, molds, air, etc.) to ensure that the drugs are not contaminated and the quality of the drugs is guaranteed;

[0009] 2. Preparation of Chinese medicine concentrate

[0010] Soak the Chinese herbal medicine pieces in clean water at room temperature for 30-60 minutes to allow the herbs to absorb sufficient water and soften, so as to facilitate the decoction of the active ingredients. After soaking, add water to submerge the medicine surface by 4-5cm, boil over high heat, and then simmer over low heat for 15-30 minutes, filter to obtain the first liquid medicine; immerse the residue in water again, boil over high heat, and then simmer over low heat for 15-20 minutes, filter to obtain the second liquid medicine; separate the residue, combine the two liquid medicines, heat and concentrate to a Chinese herbal medicine concentrate with a relative density of 1.00-1.05g / mL;

[0011] 3. Granulation

[0012] Add the formulated amount of crystal sugar and maltose to the concentrated Chinese medicine solution, boil until it becomes a thick paste, pour it into a mold, and cool it at room temperature to form granules, each weighing 3-5g;

[0013] The granules can be made into sugar pills, sugar tablets or sugar sticks (lollipops) according to children's preferences.

[0014] The invention has abundant raw materials and is easy to operate in the preparation method. The compatibility is scientific and reasonable based on the primary and secondary relationships of monarch, minister, assistant and envoy. It has the effects of soothing the liver and strengthening the spleen, nourishing the kidney and replenishing essence, and opening up the orifices and improving intelligence. It is effectively used for treating autistic children with spleen deficiency, hyperactivity of the liver, and weak kidney qi syndrome. It is convenient to use and has good efficacy. It is a major innovation in drugs for treating autism in children and has huge economic and social benefits. DETAILED DESCRIPTION

[0015] The specific implementation modes of the present invention are described in detail below with reference to examples and specific situations.

[0016] Embodiment 1:

[0017] The invention discloses a Chinese medicine for treating autism in children. The Chinese medicine is prepared from the following raw materials by weight: 5 parts of bupleurum, 5 parts of white peony root, 5 parts of fructus aurantii, 5 parts of rhizoma nardostachys, 5 parts of atractylodes macrocephala, 5 parts of poria, 5 parts of codonopsis pilosula, 5 parts of cassia twig, 5 parts of calamus, 5 parts of cistanche deserticola, 5 parts of orientalis, 5 parts of persica, 3 parts of safflower, 5 parts of scutellaria, 5 parts of pinellia, 5 parts of licorice root, 30 parts of crystal sugar and 2 parts of maltose, wherein the crystal sugar and maltose constitute a hard candy part, and the other Chinese medicine components constitute a Chinese medicine part. The preparation method is as follows:

[0018] (1) Disinfection and sterilization

[0019] Use ultraviolet fluorescent lamps to disinfect and sterilize the drug preparation workshop (drug decoction utensils, operating tables, molds, air, etc.) to ensure that the drugs are not contaminated and the quality of the drugs is guaranteed;

[0020] (2) Preparation of Chinese medicine concentrate

[0021] The Chinese herbal medicine pieces in the compatibility are soaked in clean water at room temperature for 45 minutes to allow the medicinal materials to absorb sufficient water and soften, so as to facilitate the decoction of the medicinal ingredients. After soaking, water is added to immerse the medicinal surface by 4-5 cm, boiled over high heat, and then simmered over low heat for 18 minutes, filtered to obtain the first medicinal liquid, the medicinal residue is immersed in water again, boiled over high heat, and then simmered over low heat for 17 minutes, filtered, and the medicinal residue is separated to obtain the second medicinal liquid, the two medicinal liquids are combined, and heated and concentrated into a Chinese medicine concentrate with a relative density of 1.00-1.05g / mL;

[0022] (3) Granulation

[0023] Add the formulated amount of crystal sugar and maltose to the concentrated Chinese medicine solution, boil until it becomes a thick paste, pour it into a mold, and cool it at room temperature to form granules, each weighing 4g;

[0024] The granules can be made into sugar pills, sugar tablets or sugar sticks (lollipops) according to children's preferences.

[0025] Embodiment 2:

[0026] The invention discloses a traditional Chinese medicine for treating autism in children. The traditional Chinese medicine is prepared from the following raw materials by weight: 4 parts of bupleurum, 4 parts of white peony root, 4 parts of fructus aurantii, 4 parts of rhizoma nardostachys, 4 parts of atractylodes macrocephala, 4 parts of poria, 4 parts of codonopsis pilosula, 4 parts of cassia twig, 4 parts of calamus, 4 parts of cistanche deserticola, 4 parts of orientalis, 4 parts of persica, 2 parts of safflower, 4 parts of scutellaria, 4 parts of pinellia, 4 parts of licorice, 28 parts of crystal sugar and 1.5 parts of maltose, wherein the crystal sugar and maltose constitute a hard candy part, and the other traditional Chinese medicine components constitute a traditional Chinese medicine part. The preparation method is as follows:

[0027] (1) Disinfection and sterilization

[0028] Use ultraviolet fluorescent lamps to disinfect and sterilize the drug preparation workshop (drug decoction utensils, operating tables, molds, air, etc.) to ensure that the drugs are not contaminated and the quality of the drugs is guaranteed;

[0029] (2) Preparation of Chinese medicine concentrate

[0030] Soak the Chinese herbal medicine slices in the compatibility with clean water at room temperature for 30 minutes to allow the medicinal materials to absorb sufficient water and soften, so as to facilitate the decoction of the medicinal ingredients. After soaking, add water to immerse the medicinal surface by 4-5 cm, boil over high heat, and then simmer for 15 minutes over low heat, filter to obtain the first medicinal liquid, immerse the medicinal residue in water again, boil over high heat, and then simmer for 15 minutes over low heat, filter, separate the medicinal residue, and obtain the second medicinal liquid, combine the two medicinal liquids, and heat and concentrate them into a Chinese medicine concentrate with a relative density of 1.00-1.05g / mL;

[0031] (3) Granulation

[0032] Add the formulated amount of crystal sugar and maltose to the concentrated Chinese medicine solution, boil until it becomes a thick paste, pour it into a mold, and cool it at room temperature to form granules, each weighing 3g;

[0033] Embodiment 3:

[0034] The invention discloses a traditional Chinese medicine for treating autism in children. The traditional Chinese medicine is prepared from the following raw materials by weight: 6 parts of bupleurum, 6 parts of white peony root, 6 parts of fructus aurantii, 6 parts of rhizoma nardostachys, 6 parts of atractylodes macrocephala, 6 parts of poria, 6 parts of codonopsis pilosula, 6 parts of cassia twig, 6 parts of calamus, 6 parts of cistanche deserticola, 6 parts of orientalis, 6 parts of peach kernel, 4 parts of safflower, 6 parts of scutellaria, 6 parts of pinellia, 6 parts of licorice root, 32 parts of crystal sugar and 2.5 parts of maltose, wherein the crystal sugar and maltose constitute a hard candy part, and the other traditional Chinese medicine components constitute a traditional Chinese medicine part. The preparation method is as follows:

[0035] (1) Disinfection and sterilization

[0036] Use ultraviolet fluorescent lamps to disinfect and sterilize the drug preparation workshop (drug decoction utensils, operating tables, molds, air, etc.) to ensure that the drugs are not contaminated and the quality of the drugs is guaranteed;

[0037] (2) Preparation of Chinese medicine concentrate

[0038] The Chinese herbal medicine pieces in the compatibility are soaked in clean water at room temperature for 60 minutes to allow the medicinal materials to absorb sufficient water and soften, so as to facilitate the decoction of the medicinal ingredients. After soaking, water is added to immerse the medicinal surface by 4-5 cm, boiled over high heat, and then simmered over low heat for 20 minutes, filtered to obtain the first medicinal liquid, the medicinal residue is immersed in water again, boiled over high heat, and then simmered over low heat for 20 minutes, filtered, and the medicinal residue is separated to obtain the second medicinal liquid, the two medicinal liquids are combined, and heated and concentrated into a Chinese medicine concentrate with a relative density of 1.00-1.05g / mL;

[0039] (3) Granulation

[0040] Add the formulated amount of crystal sugar and maltose to the concentrated Chinese medicine solution, boil until it becomes a thick paste, pour it into a mold, and cool it at room temperature to form granules, each weighing 5g;

[0041] Embodiment 4:

[0042] The invention discloses a Chinese medicine for treating autism in children. The Chinese medicine is prepared from the following raw materials by weight: 4 parts of bupleurum, 6 parts of white peony root, 4 parts of fructus aurantii, 6 parts of rhizoma nardostachys, 4 parts of atractylodes macrocephala, 6 parts of poria, 4 parts of codonopsis pilosula, 6 parts of cassia twig, 4 parts of calamus, 6 parts of cistanche deserticola, 4 parts of orientalis, 6 parts of persica, 2 parts of safflower, 6 parts of scutellaria, 4 parts of pinellia, 6 parts of licorice root, 28 parts of crystal sugar and 2.5 parts of maltose, wherein the crystal sugar and maltose constitute a hard candy part, and the other Chinese medicine components constitute a Chinese medicine part. The preparation method is as follows:

[0043] (1) Disinfection and sterilization

[0044] Use ultraviolet fluorescent lamps to disinfect and sterilize the drug preparation workshop (drug decoction utensils, operating tables, molds, air, etc.) to ensure that the drugs are not contaminated and the quality of the drugs is guaranteed;

[0045] (2) Preparation of Chinese medicine concentrate

[0046] Soak the Chinese herbal medicine slices in the compatibility with clean water at room temperature for 30 minutes, so that the medicinal materials absorb sufficient water and soften, so as to facilitate the decoction of the medicinal ingredients. After soaking, add water to immerse the medicinal surface by 4-5 cm, boil over high heat, and then simmer over low heat for 20 minutes, filter to obtain the first medicinal liquid, immerse the medicinal residue in water again, boil over high heat, and then simmer over low heat for 15 minutes, filter, separate the medicinal residue, and obtain the second medicinal liquid, combine the two medicinal liquids, and heat and concentrate them into a Chinese medicine concentrate with a relative density of 1.00-1.05g / mL;

[0047] (3) Granulation

[0048] Add the formulated amount of rock sugar and maltose to the concentrated Chinese medicine solution, boil until it becomes a thick paste, pour it into a mold, and cool it at room temperature to form granules, each weighing 3g.

[0049] Example 5

[0050] The invention discloses a traditional Chinese medicine for treating autism in children. The traditional Chinese medicine is prepared from the following raw materials by weight: 6 parts of bupleurum, 4 parts of white peony root, 6 parts of fructus aurantii, 4 parts of rhizoma nardostachys, 6 parts of atractylodes macrocephala, 4 parts of tuckahoe, 6 parts of codonopsis pilosula, 4 parts of cassia twig, 6 parts of calamus, 4 parts of cistanche deserticola, 6 parts of orientalis, 4 parts of peach kernel, 4 parts of safflower, 4 parts of scutellaria, 6 parts of pinellia, 4 parts of licorice root, 32 parts of crystal sugar and 1.5 parts of maltose, wherein the crystal sugar and maltose constitute a hard candy part, and the other traditional Chinese medicine components constitute a traditional Chinese medicine part. The preparation method is as follows:

[0051] (1) Disinfection and sterilization

[0052] Use ultraviolet fluorescent lamps to disinfect and sterilize the drug preparation workshop (drug decoction utensils, operating tables, molds, air, etc.) to ensure that the drugs are not contaminated and the quality of the drugs is guaranteed;

[0053] (2) Preparation of Chinese medicine concentrate

[0054] The Chinese herbal medicine pieces in the compatibility are soaked in clean water at room temperature for 60 minutes to allow the medicinal materials to absorb sufficient water and soften, so as to facilitate the decoction of the medicinal ingredients. After soaking, water is added to immerse the medicinal surface by 4-5 cm, boiled over high heat, and then simmered over low heat for 15 minutes, filtered to obtain the first medicinal liquid, the medicinal residue is immersed in water again, boiled over high heat, and then simmered over low heat for 20 minutes, filtered, and the medicinal residue is separated to obtain the second medicinal liquid, the two medicinal liquids are combined, and heated and concentrated into a Chinese medicine concentrate with a relative density of 1.00-1.05g / mL;

[0055] (3) Granulation

[0056] Add the formulated amount of rock sugar and maltose to the concentrated Chinese medicine solution, boil until it becomes a thick paste, pour it into a mold, and cool it at room temperature to form granules, each weighing 5g.

[0057] According to the composition given in the above embodiment, any amount of Chinese medicine can be prepared as needed. The given embodiment is only used to illustrate the specific implementation mode of the present invention, rather than to limit the protection scope of the present invention. The technical core protected by the present invention is the Chinese medicine composition.

[0058] In the above-mentioned drug combinations, wherein:

[0059] Bupleurum: slightly cold in nature, bitter in taste. Enters the liver meridian, gallbladder meridian, and lung meridian. Soothes the liver and relieves depression, raises Yang Qi, and relieves fever.

[0060] White Peony Root: slightly cold in nature, bitter and sour in taste. Enters the liver meridian and spleen meridian. Softens the liver and relieves pain, calms liver yang, nourishes blood and regulates menstruation, and restrains yin and stops sweating.

[0061] Citrus aurantium: warm in nature, bitter, pungent and sour in taste. Enters the spleen and stomach meridians. Regulates qi, relieves fullness, relieves stagnation and relieves bloating.

[0062] Nardostachys grandiflora: warm in nature, pungent and sweet in taste. Enters the spleen and stomach meridians. Regulates qi and relieves pain, relieves depression and invigorates the spleen.

[0063] Atractylodes macrocephala: warm in nature, sweet and bitter in taste. Enters the spleen and stomach meridians. Strengthens the spleen, replenishes qi, dries dampness and promotes diuresis, and stops sweating.

[0064] Poria: neutral in nature, sweet and light in taste. It enters the heart meridian, lung meridian, spleen meridian, and kidney meridian. It can promote diuresis and eliminate dampness, strengthen the spleen and calm the mind.

[0065] Codonopsis: neutral in nature, sweet in taste. Enters the spleen and lung meridians. Replenishes qi, strengthens the spleen and lungs.

[0066] Cinnamon twig: spicy, sweet, warm in nature. It enters the bladder meridian, heart meridian, and lung meridian. It has the functions of releasing the exterior, relieving muscles, warming the meridians and dredges the blood vessels, and promoting yang and transforming qi.

[0067] Acorus calamus: slightly warm in nature, pungent and bitter in taste. Enters the heart meridian and stomach meridian. Opens the mind and dispels phlegm, awakens the mind and improves intelligence, eliminates dampness and harmonizes the stomach.

[0068] Cistanche deserticola: warm in nature, sweet and salty in taste. Enters the kidney meridian and large intestine meridian. Replenishes kidney yang, improves essence and blood, moistens the intestines and promotes bowel movements.

[0069] Alisma: cold in nature, sweet and light in taste. Enters the kidney meridian and bladder meridian. Promotes diuresis, eliminates dampness, and relieves heat.

[0070] Peach kernel: neutral in nature, bitter and sweet in taste. Enters the heart meridian, liver meridian, and large intestine meridian. Promotes blood circulation, eliminates phlegm, moistens the intestines and promotes bowel movements.

[0071] Safflower: warm in nature, pungent in taste. Enters the heart meridian and liver meridian. Promotes blood circulation, relieves blood stasis and relieves pain.

[0072] Scutellaria baicalensis: cold in nature, bitter in taste. Enters the lung meridian, gallbladder meridian, spleen meridian, large intestine meridian, small intestine meridian. Clears away heat and dampness, purges fire and detoxifies, and stops bleeding.

[0073] Pinellia: warm in nature, pungent in taste, toxic. Enters the spleen meridian, stomach meridian, and lung meridian. Drys dampness and resolves phlegm, relieves adverse reactions and stops vomiting, and eliminates lumps and resolves masses.

[0074] Roasted Licorice: neutral in nature, sweet in taste. It enters the heart meridian, stomach meridian, spleen meridian, and lung meridian. It can tonify the middle and relieve urgency, replenish qi and restore pulse, and harmonize the medicinal properties.

[0075] Rock sugar: neutral in nature, sweet in taste. It enters the spleen meridian and lung meridian, replenishes qi, nourishes yin and lungs, relieves cough and resolves phlegm.

[0076] Maltose: warm in nature, sweet in taste. Enters the spleen and stomach meridians. Replenishes qi, strengthens the spleen and harmonizes the stomach.

[0077] The above components are combined according to the principles of traditional Chinese medicine and the primary and secondary relationships of monarch, minister, assistant and envoy. They are scientific and reasonable, and their functions are interrelated and compatible with each other. In the formula:

[0078] Bupleurum is used to soothe the liver and relieve depression, raise Yang Qi, and unblock Qi. White peony root is used to astringe Yin and soften the liver, relieve liver urgency, and is used together with Bupleurum, one soothing and the other astringing. Citrus aurantium is used to regulate Qi and relieve fullness, promote Qi circulation and eliminate stagnation, and is used together with Bupleurum, one ascending and the other descending, regulating Qi. Nardostachys grandiflora is used to regulate Qi, awaken the spleen and relieve depression, and is used together with Bupleurum, regulating Qi. The four herbs are collectively the main herbs.

[0079] Codonopsis pilosula is sweet and warm, replenishes qi, nourishes the spleen and stomach, Atractylodes macrocephala replenishes qi and strengthens the spleen, Poria strengthens the spleen and eliminates dampness, and cinnamon twig warms and dredges the meridians, helps yang and transforms qi, and is the ministerial drug;

[0080] Peach kernel and safflower can invigorate blood circulation and dissipate stasis, Scutellaria baicalensis can clear away heat and dry dampness, Pinellia ternata can dry dampness and resolve phlegm, Cistanche deserticola can nourish the kidney and replenish essence, Alisma orientalis can promote diuresis and eliminate dampness, Acorus calamus can open the mind and dissipate phlegm, wake up the mind and improve intelligence, and they are all adjuvant drugs;

[0081] Roasted licorice root can nourish the middle qi, strengthen the spleen and stomach, generate qi and blood, and harmonize the properties of the medicine, so it is an adjuvant drug.

[0082] Adding rock sugar and maltose can help to replenish qi, nourish yin and strengthen the spleen, improve the taste, and facilitate shaping, making it easier for children to take, thereby improving efficacy and compliance with medication.

[0083] The combination of these medicines can help soothe the liver and strengthen the spleen, nourish the kidney and replenish the essence, and open the mind and improve intelligence. In this study, after nearly half a year of oral administration of Chinese medicine sugar pills, the abnormal behavior problems and spleen and stomach discomfort symptoms of the children in the treatment group were significantly improved compared with those in the control group, with good efficacy, and the test achieved very good beneficial technical effects. The relevant test materials are as follows (taking Example 1 as an example):

[0084] 1. Source of cases

[0085] A total of 120 children with autism who were diagnosed with spleen deficiency, hyperactivity of the liver, and kidney qi deficiency and were admitted to the hospital from August 2020 to August 2022 were selected as research subjects.

[0086] Inclusion criteria: Meet the DSM-V diagnostic criteria for autism spectrum disorder in children, Chinese medicine diagnosis of spleen deficiency, liver hyperactivity, and kidney qi deficiency, and Western medicine diagnosis of autism in children; age ranges from 2 to 7 years old; parents of the children understand and sign the informed consent form and agree to participate in the experiment.

[0087] Exclusion criteria: patients who have received other drug treatments; patients with schizophrenia, depression and other mental disorders; patients with severe heart failure, respiratory failure, renal failure, liver failure; patients who are unable to cooperate with the trial and have incomplete data. The patients were randomly divided into a control group and a treatment group, with 60 cases in each group.

[0088] The content of the trial was approved by the Ethics Committee, and the children and their families were aware of the trial and methods and voluntarily cooperated.

[0089] 2. Observation indicators and scoring criteria

[0090] 2.1. Symptom score: A self-made symptom score quantitative table was used, and the observed symptoms were anorexia, picky eating, abdominal pain, diarrhea (or squeezing stool), constipation, vomiting, anger, hyperactivity, etc., where 0 was no such symptom, 2 was symptom, 4 was obvious symptoms, and 6 was severe symptoms. The higher the total score, the more obvious the symptoms.

[0091] 2.2, Autism Behavior Checklist (ABC): ABC has 57 items, involving autistic patients' feelings, behaviors, emotions, language, self-care and other symptoms, which can be summarized into 5 factors: sensory S (9 items, 30 points in total), social R (12 items, 35 points in total), physical movement B (12 items, 28 points in total), language L (13 items, 31 points in total) and self-care S (11 items, 25 points in total). Each item is given a different score according to its different load in the scale, ranging from 1 point to 4 points; for any item, as long as the child has the performance of the item, regardless of the severity of the symptoms, the score of the item can be obtained, and the result is finally evaluated according to the total score of all items. The method of evaluating the results: a total score of less than 53 points is a negative screening, a total score between 53-67 points is a positive screening, and a total score of 68 points or more can assist in the diagnosis of autism. The higher the total score of the scale, the more severe the autistic behavioral symptoms.

[0092] 2.3. Childhood Autism Rating Scale (CARS): CARS consists of 15 items, each of which is scored from 1 to 4, with 4 being the most severe. The meaning of each score is "age-appropriate behavior", "mild abnormality", "moderate abnormality", and "severe abnormality". Each score has a specific description, and different scorers are as consistent as possible. The maximum score of the scale is 60 points. A total score of less than 30 points is considered non-autistic; a total score of 36 points or more, and at least 5 items are scored above 3 points, is considered severe autism; a total score of 30-36 points, and less than 5 items are scored below 3 points, is considered mild-moderate autism.

[0093] 2.4. Assessment of children's problem behaviors in the Chinese-Psycho-Educational Profile-3 (C-PEP-3) for children with autism spectrum disorders and related developmental disorders. This assessment is filled out by the child's caregiver based on the child's recent performance. There are 11 common problem behaviors, and each problem behavior is divided into 3 scoring options, namely 2 points for no problem, 1 point for mild or moderate problem, and 0 point for severe problem.

[0094] 2.5. Autism Treatment Evaluation Checklist (ATEC): This scale has 77 items, including 4 subscales: expression / language communication, social skills, perception / cognitive ability, and health / physiological behavior. The expression / language communication and perception / cognitive ability subscales are scored in reverse according to the three-level standard of 2, 1, and 0, and the meaning of each level is "none, occasional, and frequent"; the social skills subscale is scored in a positive way according to the three-level standard of 0, 1, and 2, and the meaning of each level is "none, occasional, and frequent"; the health / physiology / behavior subscale is scored in a positive way according to the four-level standard of 0, 1, 2, and 3, and the meaning of each level is "none, mild, moderate, and severe". The maximum score of the scale is 154 points.

[0095] 2.6. Efficacy scoring criteria

[0096] The degree of reduction in the Autism Treatment Evaluation Scale (ATEC) score before and after treatment was used as the efficacy evaluation criterion. A reduction of more than 15 points in the ATEC score after treatment compared with the ATEC score before treatment (reduction ≥ 15 points) was considered markedly effective, a reduction between 5-15 points (5 points ≤ reduction < 15 points) was considered effective, and a reduction below 5 points (reduction < 5 points) was considered ineffective.

[0097] 3. Treatment options

[0098] 3.1. Treatment group: conventional rehabilitation treatment + oral administration of the product of the present invention, 3 times a day, 1 capsule each time, sublingually, for 6 consecutive months, and statistical efficacy;

[0099] 3.2. Control group: conventional rehabilitation treatment, using structured training, speech therapy, behavior correction, educational training, sensory integration training, Orff music therapy, etc., once a day, 5 consecutive days of treatment per week, 2 days of rest, for 6 consecutive months, and statistical efficacy.

[0100] Statistical Analysis

[0101] The research data were entered into Excel for data organization and then statistically analyzed using IBM SPSS26.0. If the measurement data satisfied the normal distribution, the independent sample t-test was used; if it did not satisfy the normal distribution, the rank sum test was used; the chi-square test was used for categorical variables; P < 0.05 was considered statistically significant.

[0102] 4.1 Comparison of symptom scores between the two groups before and after treatment

[0103] Before treatment, there was no significant difference in the syndrome scores between the two groups of children, and the difference was not statistically significant (P>0.05); after treatment, the syndrome scores of the treatment group were significantly lower than those of the control group, and the difference was statistically significant (P<0.05) (see Table 1).

[0104] Table 1 Comparison of syndrome scores between the two groups of children before and after treatment ( n=60)

[0105]

[0106] 4.2 Comparison of Autism Behavior Scale (ABC) scores between the two groups before and after treatment

[0107] Before treatment, there was no significant difference in ABC scores between the two groups of children, and the difference was not statistically significant (P>0.05); after treatment, the ABC score of the treatment group was significantly lower than that of the control group, and the difference was statistically significant (P<0.05) (see Table 2).

[0108] Table 2 Comparison of ABC scores between the two groups before and after treatment ( n=60)

[0109]

[0110] 4.3 Comparison of Childhood Autism Rating Scale (CARS) scores between the two groups before and after treatment

[0111] Before treatment, there was no significant difference in the CARS scores between the two groups of children, and the difference was not statistically significant (P>0.05); after treatment, there was no significant difference in the CARS scores between the treatment group and the control group, and the difference was not statistically significant (P>0.05) (see Table 3).

[0112] Table 3 Comparison of CARS scores between the two groups before and after treatment ( n=60)

[0113]

[0114] 4.4 Comparison of C-PEP-3 problem behavior scores between the two groups before and after treatment

[0115] Before treatment, there was no significant difference in the problem behavior scores between the two groups of children, and the difference was not statistically significant (P>0.05); after treatment, the problem behavior scores of the treatment group were significantly higher than those of the control group, and the difference was statistically significant (P<0.05) (see Table 4).

[0116] Table 4 Comparison of C-PEP-3 scores between the two groups before and after treatment ( n=60)

[0117]

[0118] 4.5 Comparison of Autism Treatment Evaluation Scale (ATEC) scores between the two groups before and after treatment

[0119] Before treatment, there was no significant difference in ATEC scores between the two groups of children, and the difference was not statistically significant (P>0.05); after treatment, the ATEC scores of the treatment group were significantly lower than those of the control group, and the difference was statistically significant (P<0.05) (see Table 5).

[0120] Table 5 Comparison of ATEC scores between the two groups before and after treatment ( n=60)

[0121]

[0122] 4.6 Comparison of the efficacy of the Autism Treatment Evaluation Scale (ATEC) between the two groups after treatment

[0123] After treatment, 19 cases in the control group were significantly effective, with a significant efficiency rate of 31.7%; 39 cases were effective, with an effective rate of 65.0%; 2 cases were ineffective, with an ineffective rate of 3.3%; 53 cases in the treatment group were significantly effective, with a significant efficiency rate of 88.3%; 6 cases were effective, with an effective rate of 10.0%; 1 case was ineffective, with an ineffective rate of 1.7%. The difference was statistically significant (P < 0.05) (see Table 6).

[0124] Table 6 Comparison of ATEC efficacy between the two groups of children after treatment (%, n = 60)

[0125]

[0126] V. Conclusion

[0127] Autism is a complex neurodevelopmental disorder. In addition to its core symptoms, it is often accompanied by behavioral and gastrointestinal problems, which cause autistic children to lack prerequisite skills, have difficulty sitting still, be unable to follow simple instructions, lack eye contact, be unresponsive when called, have poor joint attention, and have poor imitation skills, which in turn leads to poor language comprehension and expression skills.

[0128] In traditional Chinese medicine theory, the kidney is the foundation of the innate, the root of the five internal organs; the spleen is the foundation of the acquired, the source of qi and blood production; the liver is the general's official, responsible for dredging, regulating emotions, and promoting digestion. "Suwen·Qibinglun Pian" says: "The kidney stores essence, the essence fills the bones and produces marrow, and the marrow gathers to form the brain." That is, the brain marrow is produced by the essence of the kidney, and the kidney essence is sufficient, and the brain marrow is full. "Lingshu·Wuluo Jinye Bie" says: "The body fluids of the five grains, which are harmoniously combined into paste, penetrate into the bone cavity, nourish the brain marrow, and flow down to the pubic region." That is, the essence of water and grain transformed by the spleen and stomach nourishes the essence of the brain. The brain is the viscera of the primordial spirit, responsible for mental activities and sensory movement. The Treatise on Blood Symptoms says: "The nature of wood is to regulate and release. When food and qi enter the stomach, it all depends on the liver's wood qi to regulate and release it, and then the food and water are transformed." The liver regulates and releases, which can promote the spleen's transportation and transformation, and make the spleen rise and stomach fall in coordination. If the liver is not smooth and the regulation is abnormal, the spleen and stomach's ascending and descending functions will be disordered. Children's liver is often in excess, and the emotional and behavioral problems of ASD children themselves further cause the liver's regulation and release. The liver's regulation and release affects the spleen and stomach's transportation and transformation, resulting in gastrointestinal discomfort. The large intestine's transmission is dysfunctional, and the spleen and stomach qi is stagnant, which further affects the liver's regulation and release function. Spleen deficiency will produce phlegm, and phlegm will cover the clear orifices, causing mental disorder and strange behavior. Phlegm blocks the middle jiao and qi is stagnant, which will cause spleen and stomach transportation and transformation disorders, manifested as loss of appetite, picky eating, nausea and vomiting. Phlegm and qi are accumulated in the lower part, and the intestinal transmission is dysfunctional, and the intestinal flora is imbalanced, resulting in abdominal pain, diarrhea, constipation and other gastrointestinal disorders. In this application, before treatment, the two groups of children with autism generally had gastrointestinal symptoms such as anorexia, picky eating, constipation, abdominal pain, diarrhea, and many behavioral problems. In recent years, studies have shown that the intestine uploads information to the brain through the neuroendocrine system, immune system, and other pathways, and the brain regulates the intestinal system through the autonomic nervous system and enteric nervous system. The two are closely linked and play an important role in the physiological and pathological mechanisms of the human body. Studies have shown that intestinal flora can play an important role in human brain development, behavioral development, and gene expression through the gut-brain axis composed of the nervous, immune, and endocrine systems. This is the bidirectional signal regulation between the intestine and the brain, namely the "brain-gut axis."

[0129] According to the guidance of traditional Chinese medicine theory and combined with clinical experience, the present invention takes soothing the liver and strengthening the spleen, nourishing the kidney and replenishing the essence, and opening up the orifices and improving intelligence as the treatment principles. In the prescription, Bupleurum soothes the liver and relieves depression, raises Yang Qi, and unblocks the Qi mechanism; Peony restrains Yin and softens the liver, relieves the liver and relieves urgency, and is used with Bupleurum, one soothing and the other restraining; Citrus aurantium regulates Qi and relieves fullness, promotes Qi and eliminates stagnation, and is used together with Bupleurum, one ascending and the other descending, regulating the Qi mechanism; Nardostachys grandiflora regulates Qi, wakes up the spleen and relieves depression, and is used together with Bupleurum to regulate the Qi mechanism of the middle jiao, and the four medicines are the monarch medicine; Codonopsis pilosula is sweet and warm to invigorate Qi, invigorates the spleen, and is used together with Bupleurum to regulate the Qi mechanism of the middle jiao, and the four medicines are the monarch medicine; Codonopsis pilosula is sweet and warm to invigorate Qi, invigorates the spleen, and is used together with Bupleurum to regulate the Qi mechanism of the middle jiao, and the four medicines are the minister medicine; Codonopsis pilosula is sweet and warm to invigorate Qi, invigorates the spleen, and is used together with Bupleurum to regulate the Qi mechanism of the middle jiao, and the four medicines are the minister medicine; Refreshing and improving intelligence; they are all adjuvant drugs; roasted licorice root can replenish vital energy, strengthen the spleen and stomach, produce qi and blood, and can harmonize the properties of the medicine. It is an adjuvant drug, and is combined with rock sugar and maltose to replenish the middle and benefit the vital energy, nourish yin and strengthen the spleen, improve the taste, and is convenient for children to take. All the medicines together have the functions of soothing the liver and strengthening the spleen, nourishing the kidney and replenishing the essence, opening the orifices and improving intelligence. In particular, it is made into sugar granules (granules) through a specific preparation method, has a good taste, is deeply loved by children, is convenient to use, and has good effects. Experiments have shown that the total effective rate is as high as 98.3%, especially the significant effective rate is much higher than that of the control group, and the significant effective rate is increased by more than 2.7 times. The significant technical progress is obvious. It is very suitable for the treatment of autism in children. It is a major innovation in the treatment of autism in children, with huge economic and social benefits.

Claims

1. A Chinese medicine for treating autism in children, the Chinese medicine is made of the following raw materials by weight: 4-6 parts of bupleurum, 4-6 parts of white peony root, 4-6 parts of fructus aurantii, 4-6 parts of rhizoma nardostachys, 4-6 parts of atractylodes macrocephala, 4-6 parts of poria, 4-6 parts of codonopsis pilosula, 4-6 parts of cinnamon twig, 4-6 parts of calamus, 4-6 parts of cistanche deserticola, 4-6 parts of orientalis, 4-6 parts of persica, 2-4 parts of safflower, 4-6 parts of scutellaria, 4-6 parts of pinellia, 4-6 parts of licorice, 28-32 parts of crystal sugar and 1.5-2.5 parts of maltose, wherein: Rock sugar and maltose constitute the hard candy part, and the remaining Chinese medicine components constitute the Chinese medicine part. The preparation method is: (1) Disinfection and sterilization Use ultraviolet fluorescent lamps to disinfect and sterilize the drug preparation workshop (drug decoction utensils, operating tables, molds, air, etc.) to ensure that the drugs are not contaminated and to ensure drug quality; (2) Preparation of Chinese medicine concentrate Soak the Chinese herbal medicine pieces in clean water at room temperature for 30-60 minutes to allow the herbs to absorb sufficient water and soften, so as to facilitate the decoction of the active ingredients. After soaking, add water to submerge the medicine surface by 4-5cm, boil over high heat, and then simmer over low heat for 15-30 minutes, filter to obtain the first liquid medicine; immerse the residue in water again, boil over high heat, and then simmer over low heat for 15-20 minutes, filter to obtain the second liquid medicine; separate the residue, combine the two liquid medicines, heat and concentrate to a Chinese herbal medicine concentrate with a relative density of 1.00-1.05g / mL; (3) Granulation Add the prescribed amount of rock sugar and maltose to the concentrated Chinese medicine solution, boil until it becomes a thick paste, pour it into a mold, and cool it at room temperature to form granules, each weighing 3-5g; The granules can be made into sugar pills, sugar tablets or sugar sticks according to children's preferences.

2. The Chinese medicine for treating autism in children according to claim 1, characterized in that: The Chinese medicine is prepared from the following raw materials by weight: 5 parts of bupleurum, 5 parts of white peony root, 5 parts of fructus aurantii, 5 parts of rhizoma nardostachys, 5 parts of atractylodes macrocephala, 5 parts of poria, 5 parts of codonopsis pilosula, 5 parts of cassia twig, 5 parts of calamus, 5 parts of cistanche deserticola, 5 parts of orientalis, 5 parts of persica, 3 parts of safflower, 5 parts of scutellaria, 5 parts of pinellia, 5 parts of licorice root, 30 parts of crystal sugar and 2 parts of maltose; The method for preparing the Chinese medicine concentrated liquid is as follows: soaking the Chinese medicine pieces in the compatibility with clean water at room temperature for 45 minutes, so that the medicinal materials absorb sufficient water and soften, so as to facilitate the dissolution of effective components in water; after soaking, adding water to immerse the medicinal surface by 4-5 cm, boiling with high heat, decocting with low heat for 18 minutes, filtering to obtain the first medicinal liquid, immersing the medicinal residue with water again, boiling with high heat, decocting with low heat for 17 minutes, filtering to obtain the second medicinal liquid, combining the two filtrates, and heating and concentrating to obtain the Chinese medicine concentrated liquid with a relative density of 1.00-1.05 g / mL.

3. The Chinese medicine for treating autism in children according to claim 1, characterized in that: The Chinese medicine is prepared from the following raw materials by weight: 4 parts of bupleurum, 4 parts of white peony root, 4 parts of fructus aurantii, 4 parts of rhizoma nardostachys, 4 parts of atractylodes macrocephala, 4 parts of poria, 4 parts of codonopsis pilosula, 4 parts of cassia twig, 4 parts of calamus, 4 parts of cistanche deserticola, 4 parts of orientalis, 4 parts of persica, 2 parts of safflower, 4 parts of scutellaria, 4 parts of pinellia, 4 parts of licorice, 28 parts of crystal sugar and 1.5 parts of maltose; The method for preparing the Chinese medicine concentrated liquid is as follows: soaking the Chinese medicine pieces in the combination with clean water at room temperature for 30 minutes, so that the medicinal materials absorb sufficient water and soften, so as to facilitate the dissolution of effective components in water; after soaking, adding water to immerse the medicinal surface by 4-5 cm, boiling with high heat, decocting with low heat for 15 minutes, filtering to obtain the first medicinal liquid, immersing the medicinal residue with water again, boiling with high heat, decocting with low heat for 15 minutes, filtering to obtain the second medicinal liquid, combining the two filtrates, and heating and concentrating to obtain the Chinese medicine concentrated liquid with a relative density of 1.00-1.05 g / mL.

4. The Chinese medicine for treating autism in children according to claim 1, characterized in that: The Chinese medicine is prepared from the following raw materials by weight: 6 parts of bupleurum, 6 parts of white peony root, 6 parts of fructus aurantii, 6 parts of rhizoma nardostachys, 6 parts of atractylodes macrocephala, 6 parts of poria, 6 parts of codonopsis pilosula, 6 parts of cinnamon twig, 6 parts of calamus, 6 parts of cistanche deserticola, 6 parts of orientalis, 6 parts of persica, 4 parts of safflower, 6 parts of scutellaria, 6 parts of pinellia, 6 parts of licorice root, 32 parts of crystal sugar and 2.5 parts of maltose; The method for preparing the Chinese medicine concentrated liquid is as follows: soaking the Chinese medicine pieces in the combination with clean water at room temperature for 60 minutes, so that the medicinal materials absorb sufficient water and soften, so as to facilitate the dissolution of effective components in water; after soaking, adding water to immerse the medicinal surface by 4-5 cm, boiling with high heat, decocting with low heat for 20 minutes, filtering to obtain the first medicinal liquid, immersing the medicinal residue with water again, boiling with high heat, decocting with low heat for 20 minutes, filtering to obtain the second medicinal liquid, combining the two filtrates, and heating and concentrating to obtain the Chinese medicine concentrated liquid with a relative density of 1.00-1.05 g / mL.

5. The Chinese medicine for treating autism in children according to claim 1, characterized in that: The Chinese medicine is prepared from the following raw materials by weight: 4 parts of bupleurum, 6 parts of white peony root, 4 parts of fructus aurantii, 6 parts of rhizoma nardostachys, 4 parts of atractylodes macrocephala, 6 parts of poria, 4 parts of codonopsis pilosula, 6 parts of cassia twig, 4 parts of calamus, 6 parts of cistanche deserticola, 4 parts of orientalis, 6 parts of persica, 2 parts of safflower, 6 parts of scutellaria, 4 parts of pinellia, 6 parts of licorice root, 28 parts of crystal sugar and 2.5 parts of maltose; The method for preparing the Chinese medicine concentrated liquid is as follows: soaking the Chinese medicine pieces in the compatibility with clean water at room temperature for 30 minutes, so that the medicinal materials absorb sufficient water and soften, so as to facilitate the dissolution of effective ingredients in water; after soaking, adding water to immerse the medicinal surface by 4-5 cm, boiling with high heat, decocting with low heat for 20 minutes, filtering to obtain the first medicinal liquid, immersing the medicinal residue with water again, boiling with high heat, decocting with low heat for 15 minutes, filtering to obtain the second medicinal liquid, combining the two filtrates, and heating and concentrating to obtain the Chinese medicine concentrated liquid with a relative density of 1.00-1.05 g / mL.

6. The Chinese medicine for treating autism in children according to claim 1, characterized in that: The Chinese medicine is prepared from the following raw materials by weight: 6 parts of bupleurum, 4 parts of white peony root, 6 parts of fructus aurantii, 4 parts of rhizoma nardostachys, 6 parts of atractylodes macrocephala, 4 parts of tuckahoe, 6 parts of codonopsis pilosula, 4 parts of cassia twig, 6 parts of calamus, 4 parts of cistanche deserticola, 6 parts of orientalis, 4 parts of peach kernel, 4 parts of safflower, 4 parts of scutellaria, 6 parts of pinellia, 4 parts of licorice root, 32 parts of crystal sugar and 1.5 parts of maltose; The method for preparing the Chinese medicine concentrated solution is as follows: soaking the Chinese medicine pieces in the combination with clean water at room temperature for 60 minutes, so that the medicine absorbs sufficient water and softens, so as to facilitate the dissolution of effective components in water; after soaking, adding water to immerse the medicine surface by 4-5 cm, boiling with high heat, decocting with low heat for 15 minutes, filtering to obtain the first medicinal solution, immersing the medicine residue with water again, boiling with high heat, decocting with low heat for 20 minutes, filtering to obtain the second medicinal solution, combining the two filtrates, and heating and concentrating to obtain the Chinese medicine concentrated solution with a relative density of 1.00-1.05 g / mL.

Images