A traditional Chinese medicine composition for treating attention deficit hyperactivity disorder in children and its application

Abstract

The present invention discloses a traditional Chinese medicine composition for treating attention deficit hyperactivity disorder in children. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: raw dragon bone 15-20, raw oyster 15-20, prepared rehmannia root 6-9, tortoise plastron 6-9, acorus tatarinowii 6-9, prepared polygala root 6-9, semen carthami 6-9, poria 9-15, fructus tritici 15-20, angelica sinensis 6-9, schizandra chinensis 3-6, radix ophiopogonis 6-9, asparagus cochinchinensis 6-9, magnetite 15-20, and Chinese yam 15-20. The traditional Chinese medicine composition of the present invention has been clinically studied and tested, and it is proved that it can effectively improve the clinical symptoms of children such as distracted mind, anxiety, psychosomatic disorder, timidity and fearfulness, and poor memory, improve the quality of life of children, and has no toxic and side effects and good safety, and can be used for treating attention deficit hyperactivity disorder in children.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition for treating attention deficit hyperactivity disorder (ADHD) in children and its application. Background Art

[0002] Attention Deficit Hyperactivity Disorder (ADHD), also known as hyperkinetic disorder in children, is a chronic neurodevelopmental disorder mainly manifested by difficulties in concentrating, hyperactivity, impulsivity, etc., and is common in children. Epidemiological studies in recent years have shown that the global prevalence of ADHD is 3%-7%, and the prevalence in China has reached 6.26%. ADHD has a negative impact on children's quality of life, academic performance, self-esteem level, and social and family relationships, and is also associated with a variety of childhood mental illnesses such as bipolar disorder, oppositional defiant disorder, conduct disorder, substance use disorder, and eating disorder. In addition, it is also related to anxiety and depression, and is even considered one of the risk factors for suicide.

[0003] Currently, the first-line drugs for treating ADHD are mainly methylphenidate, atomoxetine, etc. However, through clinical research, it has been found that the incidence of their adverse reactions is relatively high, including loss of appetite, dry mouth, palpitations, sleep problems, etc. Compared with Western medicine, traditional Chinese medicine not only has stable curative effects but also has fewer side effects, and has thus become another way to treat ADHD, with unique advantages.

[0004] Pediatrics of the Xu family believes that the syndromes of ADHD mostly belong to the syndrome of "insufficiency of kidney yin and hyperactivity of heart yang" in traditional Chinese medicine. The overall pathogenesis of ADHD is the disharmony between yin and yang. Insufficiency of kidney yin in the lower part and hyperactivity of heart yang in the upper part lead to yin-yang imbalance and disharmony between water and fire, resulting in scattered mind, hyperactivity, and excessive talking. In "Plain Questions - Treatise on the Six Microscopic Pathways", it is said that "when there is hyperactivity, there will be harm, and it is necessary to have restraint to achieve transformation and generation", and it is also said that "under the monarch fire, yin essence should follow". For the syndrome of insufficient kidney water and excessive heart fire, according to the principle of the mutual rooting and mutual use of yin and yang, substances with the effects of suppressing yang, suppressing and calming, and nourishing yin should be used to reduce the excessive fire, tonify the insufficient yin and yang, and restore the normal state of the mutual transformation of water, fire, yin, and yang. Based on this, the traditional Chinese medicine composition of the present invention, also known as Longmu Ningxin Decoction hereinafter, uses raw dragon bone, raw oyster, and calcined magnetite with the effects of suppressing yang and calming the mind as the monarch drugs, and uses rehmannia root, tortoise shell, ophiopogon root, and asparagus root to nourish yin and tonify the kidney as the minister drugs. It is assisted by acorus tatarinowii, prepared polygala root, poria, wheat, and angelica to calm the mind and soothe the nerves, and Dioscorea opposita to protect the spleen and stomach. Schisandra chinensis and Alpinia oxyphylla are used as the envoy drugs to regulate the five zang-organs. The whole formula together exerts the effects of astringing yin and suppressing yang, calming the mind and nourishing the kidney. Good curative effects have been obtained in the previous clinical application observations. Therefore, further relevant clinical trials are designed to evaluate the curative effect of Longmu Ningxin Decoction in treating attention deficit hyperactivity disorder in children, with the expectation of improving the effectiveness and safety of traditional Chinese medicine in treating ADHD. Summary of the Invention

[0005] In view of the lack of traditional Chinese medicine in the treatment of attention deficit hyperactivity disorder (ADHD) in children and the above-mentioned deficiencies of the existing technologies, according to the embodiments of the present invention, it is desired to provide a traditional Chinese medicine composition for treating ADHD in children, in order to provide an effective treatment means for ADHD in children, and can effectively improve the clinical symptoms of children with ADHD and improve the quality of life.

[0006] According to an embodiment, a traditional Chinese medicine composition for treating ADHD in children provided by the present invention is made from the following raw materials in parts by weight: 15-20 parts of raw fossil fragments, 15-20 parts of raw oyster, 6-9 parts of prepared rehmannia root, 6-9 parts of tortoise plastron, 6-9 parts of acorus tatarinowii rhizome, 6-9 parts of prepared polygala root, 6-9 parts of semen alpiniae oxyphyllae, 9-15 parts of poria with hostwood, 15-20 parts of fructus tritici levis, 6-9 parts of angelica sinensis, 3-6 parts of schisandra chinensis, 6-9 parts of radix ophiopogonis, 6-9 parts of radix asparagi, 15-20 parts of magnetite, 15-20 parts of Chinese yam.

[0007] According to one embodiment, in the traditional Chinese medicine composition for treating ADHD in children of the present invention, the parts by weight of each raw material are preferably: 15 parts of raw fossil fragments, 15 parts of raw oyster, 6 parts of prepared rehmannia root, 6 parts of tortoise plastron, 6 parts of acorus tatarinowii rhizome, 6 parts of prepared polygala root, 6 parts of semen alpiniae oxyphyllae, 9 parts of poria with hostwood, 15 parts of fructus tritici levis, 6 parts of angelica sinensis, 3 parts of schisandra chinensis, 6 parts of radix ophiopogonis, 6 parts of radix asparagi, 15 parts of magnetite, 15 parts of Chinese yam.

[0008] According to one embodiment, in the traditional Chinese medicine composition for treating ADHD in children of the present invention, the traditional Chinese medicine composition is mixed with pharmaceutically acceptable pharmaceutical excipients to form tablets, pills, granules, powders, ointments or powders.

[0009] There is no particularity in the preparation method of the traditional Chinese medicine composition of the present invention. The usual method in the art is adopted, and the above 15 kinds of medicinal materials are weighed according to parts by weight, decocted in water for oral administration, once in the morning and once in the evening.

[0010] Through clinical research and experimental application, it is proved that the traditional Chinese medicine composition of the present invention can effectively improve the clinical symptoms of children such as distractibility, anxiety, psychosomatic disorder, timidity and fear, poor memory, etc., improve the quality of life of children, and has no toxic and side effects, good safety, and can be used for the treatment of ADHD in children.

[0011] The pharmacological action of the traditional Chinese medicine composition of the present invention is as follows: aiming at the pathogenesis characteristics of kidney yin deficiency and heart yang hyperactivity and the physiological characteristics of immature yin and yang in children with ADHD, based on the principle of mutual rooting and mutual use of yin and yang, using the products of suppressing yang and nourishing yin to reduce the excessive fire, tonify the insufficient yin and yang, and restore the normal state of the mutual control and transformation of water, fire, yin and yang, so as to treat ADHD caused by kidney yin deficiency and heart yang hyperactivity, and fundamentally pay attention to regulating yin and yang to achieve the balance of yin and yang.

[0012] Compared with the prior art, the traditional Chinese medicine composition of the present invention has appropriate compatibility, and has the effects of astringing yin and subduing yang, calming the mind and nourishing the kidney. It is used to treat attention deficit hyperactivity disorder in children, and can effectively improve symptoms such as distraction, anxiety, psychosomatic disorder, timidity and fearfulness, poor memory, learning difficulties, spontaneous sweating and night sweating, appetite, and sleep in children. In addition, the traditional Chinese medicine composition of the present invention is made of pure traditional Chinese medicine, has no toxic and side effects, and is easily accepted by children and their families. Detailed implementation manners

[0013] The present invention will be further described below in conjunction with specific embodiments. These embodiments should be understood as only for illustrating the present invention and not for limiting the protection scope of the present invention. After reading the content recorded in the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent changes and modifications also fall within the scope defined by the claims of the present invention.

[0014] In the following embodiments of the present invention, the experimental methods not specifically marked are all common experimental methods in the art.

[0015] In the following embodiments of the present invention, the reagents not specifically marked are all commercially available.

[0016] Embodiment 1

[0017] Weigh 15 g of raw dragon bone, 15 g of raw oyster, 6 g of prepared rehmannia root, 6 g of tortoise plastron, 6 g of acorus tatarinowii rhizome, 6 g of prepared polygala root, 6 g of semen brassicae, 9 g of poria with hostwood, 15 g of fructus tritici levis, 6 g of angelica sinensis, 3 g of schisandra chinensis, 6 g of ophiopogon japonicus, 6 g of asparagus cochinchinensis, 15 g of magnetite, and 15 g of Chinese yam. Decoct with the usual method and set aside. Take 1 dose per day, once in the morning and once in the evening.

[0018] Embodiment 2

[0019] Weigh 15 g of raw dragon bone, 15 g of raw oyster, 6 g of prepared rehmannia root, 6 g of tortoise plastron, 6 g of acorus tatarinowii rhizome, 6 g of prepared polygala root, 6 g of semen brassicae, 9 g of poria with hostwood, 15 g of fructus tritici levis, 6 g of angelica sinensis, 3 g of schisandra chinensis, 6 g of ophiopogon japonicus, 6 g of asparagus cochinchinensis, 15 g of magnetite, and 15 g of Chinese yam. It is made into granules by Sichuan New Green Pharmaceutical Technology Development Co., Ltd. Take 1 grid each time, once in the morning and once in the evening.

[0020] Embodiment 3

[0021] Weigh 15 g of raw dragon bone, 15 g of raw oyster, 6 g of prepared rehmannia root, 6 g of tortoise plastron, 6 g of acorus tatarinowii rhizome, 6 g of prepared polygala root, 6 g of semen brassicae, 9 g of poria with hostwood, 15 g of fructus tritici levis, 6 g of angelica sinensis, 3 g of schisandra chinensis, 6 g of ophiopogon japonicus, 6 g of asparagus cochinchinensis, 15 g of magnetite, and 15 g of Chinese yam. It is made into granules by Sichuan New Green Pharmaceutical Technology Development Co., Ltd. Take 2 grids each time, once in the morning and once in the evening.

[0022] Embodiment 4

[0023] Weigh 20 g of raw fossil fragments of dragon bone, 20 g of raw oyster shell, 9 g of prepared rehmannia root, 9 g of tortoise plastron, 9 g of acorus tatarinowii rhizome, 9 g of processed polygala root, 9 g of semen brassicae, 15 g of poria with hostwood, 20 g of wheat, 9 g of angelica sinensis, 5 g of schisandra chinensis, 9 g of ophiopogon japonicus, 9 g of asparagus cochinchinensis, 20 g of magnetite, and 20 g of Chinese yam. They are made into granules by Sichuan New Green Pharmaceutical Technology Development Co., Ltd. Take 1 dose each time, once in the morning and once in the evening.

[0024] Example 5

[0025] Weigh 20 g of raw fossil fragments of dragon bone, 20 g of raw oyster shell, 9 g of prepared rehmannia root, 9 g of tortoise plastron, 9 g of acorus tatarinowii rhizome, 9 g of processed polygala root, 9 g of semen brassicae, 15 g of poria with hostwood, 20 g of wheat, 9 g of angelica sinensis, 6 g of schisandra chinensis, 9 g of ophiopogon japonicus, 9 g of asparagus cochinchinensis, 20 g of magnetite, and 20 g of Chinese yam. Decoct them in water by the usual method and set aside. Take it once at 7 p.m.

[0026] Experimental Example - Clinical Observation on the Treatment of Attention Deficit Hyperactivity Disorder in Children with Longmu Ningxin Decoction.

[0027] 1. Case Selection

[0028] Recruit 100 children with attention deficit hyperactivity disorder who meet the inclusion and exclusion criteria and seek medical treatment in the outpatient department from July 2022 to October 2023. Randomly divide them into a traditional Chinese medicine group (50 cases) and a western medicine group (50 cases) for clinical observation.

[0029] (1) Western Medicine Diagnostic Criteria

[0030] Refer to the diagnostic criteria for attention deficit hyperactivity disorder in children in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) by the American Psychiatric Association (2013) (see Appendix A for details).

[0031] Disease severity grading: Refer to the diagnostic criteria for attention deficit hyperactivity disorder in children in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) by the American Psychiatric Association (2013). [6]

[0032] Mild: There are very few symptoms beyond those required for diagnosis, and the symptoms cause minor impairment in social or occupational functioning.

[0033] Moderate: The symptoms or functional impairment are between "mild" and "severe".

[0034] Severe: There are more symptoms beyond those required for diagnosis, or there are several particularly severe symptoms, or the symptoms cause significant impairment in social or occupational functioning.

[0035] (2) Traditional Chinese Medicine Diagnostic Criteria

[0036] Refer to the "Clinical Guidelines for Traditional Chinese Pediatrics - Attention Deficit Hyperactivity Disorder in Children (Revised)" issued in 2017.

[0037] Kidney yin deficiency and relatively exuberant heart yang: Inattention, mental distraction, excessive talking and hyperactivity, impulsive and willful behavior, poor memory, procrastination in homework, backward academic performance, timidity and easy fear, or spontaneous sweating and night sweating, difficulty in falling asleep, or nocturnal enuresis, dry stools, red tongue, thin white or thin yellow coating, thready and rapid pulse.

[0038] (3) Inclusion criteria

[0039] 1) Meeting the western medicine diagnosis and traditional Chinese medicine syndrome differentiation criteria for moderate childhood ADHD. 2) Aged 6 - 14 years old, regardless of gender. 3) Not having taken other Chinese and western medicines related to attention deficit hyperactivity disorder 2 weeks before entering the clinical study. 4) Not having participated in other clinical studies in the past 3 months. 5) The children and their parents give informed consent and are able to accept the prescribed treatment plan (such as medication time, visit frequency, etc.).

[0040] (4) Exclusion criteria

[0041] 1) Those who do not meet the inclusion criteria; 2) Those with severe organic diseases such as cardiovascular and cerebrovascular (especially those with abnormal cardiac function and structure), liver, kidney, hematopoietic system, nervous system (epilepsy), etc.; 3) Those with hyperactive symptoms caused by severe mental, pervasive developmental disorders, mental illnesses such as childhood schizophrenia, mental retardation, mania, autism spectrum disorder, specific learning skill developmental disorders, etc.; 4) Hearing or vision impairment; 5) Those allergic to the test drug; 6) Those who participated in other drug clinical studies in the past 3 months; 7) Those with poor compliance and unable to strictly implement the regulations of this study; 8) Patients who have used monoamine oxidase inhibitors in the past 2 weeks; 9) Patients with severe gastrointestinal stenosis (pathological or iatrogenic), dysphagia or obvious difficulty in swallowing tablets; 10) Glaucoma patients and patients with Tourette syndrome.

[0042] (5) Criteria for exclusion, withdrawal and termination of the trial:

[0043] 1) Those who do not take medicine as prescribed; 2) Those with incomplete clinical data, affecting the evaluation of curative effect; 3) Those who have adverse reactions during the research process; 4) Those who terminate the trial on their own due to personal reasons.

[0044] 2. Trial methods

[0045] Group A (western medicine group): Methylphenidate hydrochloride controlled-release tablets

[0046] Methylphenidate hydrochloride controlled-release tablets (Concerta): Using methylphenidate hydrochloride controlled-release tablets from ALZA Corporation, USA, with a dose of 18 mg, taken once a day in the morning. Continuously taken for 12 weeks to evaluate the curative effect.

[0047] Group B (traditional Chinese medicine group): Oral administration of traditional Chinese medicine Longmu Ningxin Decoction

[0048] Composition of Longmu Ningxin Decoction: 15 g of raw fossil fragments of dragon's bone, 15 g of raw oyster shell, 6 g of prepared rehmannia root, 6 g of tortoise plastron, 6 g of acorus gramineus rhizome, 6 g of prepared polygala root, 6 g of semen brassicae, 9 g of poria with hostwood, 15 g of wheat, 6 g of angelica sinensis, 3 g of schisandra chinensis, 6 g of ophiopogon japonicus, 6 g of asparagus cochinchinensis, 15 g of magnetite, 15 g of Chinese yam.

[0049] Use the granule produced by Sichuan New Green Pharmaceutical Technology Development Co., Ltd., one dose per day, twice a day. Take it with warm water after meals and take it continuously for 12 weeks to evaluate the curative effect.

[0050] Course of treatment and observation time points

[0051] Course of treatment: The course of treatment for each group is 12 weeks.

[0052] Observation time points: d0, d29, d85.

[0053] 3. Observation indicators

[0054] (1) Questionnaire assessment

[0055] 1) SNAP-IV Rating Scale (parent version);

[0056] 2) Conners' Rating Scales for Children (parent);

[0057] 3) Weiss Functional Impairment Rating Scale;

[0058] (2) TCM syndrome score scale

[0059]

[0060] 4. Curative effect evaluation criteria

[0061] (1) Disease curative effect judgment criteria

[0062] Refer to the criteria in "Clinical Therapeutics of Children with ADHD".

[0063] Use the SNAP-IV Rating Scale (parent version), and calculate the score reduction rate according to the nimodipine method to evaluate the curative effect: Score reduction rate = (pre-treatment score - post-treatment score) / pre-treatment score * 100%

[0064] Clinical control: After treatment, the SNAP-IV score decreases by ≥ 90%, the adaptability and social function can return to normal, the academic performance is significantly improved, and the hyperactivity index is less than 1.1;

[0065] Marked effect: After treatment, the SNAP-IV score decreases by ≥ 60%, the adaptability and social function basically return to normal, the academic performance is significantly improved, and the hyperactivity index is less than 1.5;

[0066] Effective: After treatment, the SNAP-IV score decreased by ≥35%, the adaptability, social function, and academic performance all improved, but not stably. The index decreased, but the hyperactivity index was still greater than 1.5;

[0067] Ineffective: Did not meet the above criteria.

[0068] (2) Criteria for judging the curative effect of traditional Chinese medicine syndromes

[0069] Refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)" formulated by the Ministry of Health in 2002 [9] . Judged as clinically cured, markedly effective, effective, and ineffective.

[0070] Clinically cured: All traditional Chinese medicine symptoms and signs disappeared, and the cumulative syndrome score decreased by ≥90%;

[0071] Markedly effective: The cumulative syndrome score decreased by ≥70% - 90%;

[0072] Effective: The cumulative syndrome score decreased by ≥30% - 70%;

[0073] Ineffective: The cumulative syndrome score decreased by less than 30%.

[0074] (3) Statistical methods

[0075] SPSS 25.0 software was used for statistical analysis. Measurement data were described by mean ± standard deviation for statistical description. For those conforming to the normal distribution, independent sample t-tests were used to compare the differences between groups. For the comparison of between-group and within-group differences at different time points, repeated measures analysis of variance and simple effect analysis were used; for those not conforming to the normal distribution, the median (25th percentile, 75th percentile) [P50(P25, P75)] was used for statistical description, and the Mann-Whitney U rank sum test was used for between-group comparison; for repeated measurement data, generalized estimating equations were used for analysis. Count data were described by frequency (constituent ratio), rate, and percentage. For the comparison between groups of binary or multi-class unordered variables, the X 2 test was used, and correlation analysis was used for related data; for unordered count data, the X 2 test was used for between-group and within-group comparison; for single-item ordered categorical data, the Mann-Whitney U rank sum test was used for between-group comparison, and the Wilcoxon test was used for within-group comparison; for repeated measurement categorical data, generalized estimating equations were used. P < 0.05 was considered statistically significant.

[0076] 5. Experimental results

[0077] 1) General information

[0078] There were no statistically significant differences in the baseline data of the two groups of children in terms of gender, age, height, weight, etc. (P>0.05), ensuring the comparability of the two groups after treatment.

[0079] 2) The comparison of the efficacy of Western medicine and traditional Chinese medicine for attention deficit hyperactivity disorder in the two groups is shown in Table 1-2, and there was no significant difference in the efficacy between the two groups.

[0080] 3) The comparison of the SNAP-IV scale scores of the two groups of children is shown in Table 3-5. Both groups could improve the scores of attention deficit, hyperactivity-impulsivity, and oppositional defiant behavior in children. The efficacy of the traditional Chinese medicine group was comparable to that of the Western medicine group (P<0.05).

[0081] 4) The comparison of the Conners scale scores of the two groups is shown in Table 7. Both groups could improve the scores of conduct problems, psychosomatic disorders, anxiety, hyperactivity index, learning problems, impulsive hyperactivity, and total score. With the extension of the treatment time, the traditional Chinese medicine group was more significant in improving the scores of conduct problems, psychosomatic disorders, anxiety, and hyperactivity index (P<0.05).

[0082] 5) The comparison of the WEISS scale scores of the two groups is shown in Table 8. Both groups could improve the scores of each dimension before and after treatment, and the long-term effect of the traditional Chinese medicine group was more significant than that of the Western medicine group (P<0.05).

[0083] 6) The comparison of the traditional Chinese medicine syndrome scores of the two groups is shown in Table 9. The scores of the main symptoms of traditional Chinese medicine in both groups of children decreased with the delay of treatment time. After 12 weeks of treatment, in terms of the scores of distraction, timidity and fearfulness, poor memory, and learning difficulties, the traditional Chinese medicine group was lower than the Western medicine group, and the efficacy was more significant (P<0.05). In terms of the secondary symptoms of traditional Chinese medicine, the improvement of the traditional Chinese medicine group was better than that of the Western medicine group (both P<0.05).

[0084] During this clinical research process, 5 children in the Western medicine group had gastrointestinal discomfort, and no other children had adverse reactions such as allergic reactions, liver and kidney function damage, gastrointestinal discomfort, and rash.

[0085] Table 1. Comparison of the disease efficacy of the two groups of children [n(%)]

[0086]

[0087] Table 2. Comparison of the efficacy of traditional Chinese medicine in the two groups of children [n(%)]

[0088]

[0089] Table 3. Comparison of the attention deficit scores of the SNAP-IV scale in the two groups of children before and after treatment

[0090]

[0091] Table 4. Comparison of the hyperactivity-impulsivity scores of the SNAP-IV scale in the two groups of children before and after treatment

[0092]

[0093] Table 5. Comparison of oppositional defiant scores on the SNAP-IV scale in two groups of children before and after treatment

[0094]

[0095] Table 6. Comparison of total scores on the SNAP-IV scale in two groups of children before and after treatment

[0096]

[0097] Table 7. Comparison of scores on the Conners scale in two groups of children before and after treatment

[0098]

[0099] Table 8. Comparison of scores on each dimension of the WEISS scale at different times in two groups of children

[0100]

[0101] Table 9. Comparison of traditional Chinese medicine syndrome scores at different times in two groups of children [n(%)]

[0102]

[0103]

[0104] Table 10. Comparison of traditional Chinese medicine syndrome scores at different times in two groups of children [n(%)]

[0105]

[0106]

[0107] In summary, the traditional Chinese medicine composition of the present invention has a slower onset in the treatment of attention deficit hyperactivity disorder in children than methylphenidate hydrochloride sustained release tablets, but its effect is comparable after 12 weeks of use. Moreover, traditional Chinese medicine is superior to western medicine in improving mental distraction, anxiety, psychosomatic disorders, timidity and fear, poor memory, learning difficulties, spontaneous sweating and night sweating, appetite, sleep, etc. in children with ADHD, and has no obvious adverse reactions and higher safety.

Claims

1. A traditional Chinese medicine composition for treating attention deficit hyperactivity disorder in children, characterized in that , The traditional Chinese medicine composition is prepared from the following raw materials by weight: 15 - 20 parts of raw fossil fragments of dragon bone, 15 - 20 parts of raw oyster shell, 6 - 9 parts of prepared rehmannia root, 6 - 9 parts of tortoise plastron, 6 - 9 parts of acorus tatarinowii, 6 - 9 parts of prepared polygala root, 6 - 9 parts of semen pini, 9 - 15 parts of poria with hostwood, 15 - 20 parts of wheat, 6 - 9 parts of angelica sinensis, 3 - 6 parts of schizandra chinensis, 6 - 9 parts of dwarf lilyturf tuber, 6 - 9 parts of asparagus root, 15 - 20 parts of magnetite, 15 - 20 parts of Chinese yam.

2. The traditional Chinese medicine composition for treating attention deficit hyperactivity disorder in children according to claim 1, wherein, , The parts by weight of the raw materials are respectively: 15 parts of raw fossil fragments of dragon bone, 15 parts of raw oyster shell, 6 parts of prepared rehmannia root, 6 parts of tortoise plastron, 6 parts of acorus tatarinowii, 6 parts of prepared polygala root, 6 parts of semen pini, 9 parts of poria with hostwood, 15 parts of wheat, 6 parts of angelica sinensis, 3 parts of schizandra chinensis, 6 parts of dwarf lilyturf tuber, 6 parts of asparagus root, 15 parts of magnetite, 15 parts of Chinese yam.

3. The traditional Chinese medicine composition for treating attention deficit hyperactivity disorder in children according to claim 1 or 2, characterized in that , The traditional Chinese medicine composition is mixed with pharmaceutically acceptable pharmaceutical excipients to prepare tablets, pills, granules or ointments.

4. Use of the traditional Chinese medicine composition according to claim 1 or 2 or 3 in the preparation of a medicament for treating attention deficit hyperactivity disorder in children.

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