Traditional Chinese medicine composition, traditional Chinese medicine patch, preparation method and application

Abstract

The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition, a traditional Chinese medicine patch, a preparation method and application. The traditional Chinese medicine composition is composed of the following raw medicinal materials: clove, amomum villosum, cassia bark, radix paeoniae alba and prepared licorice. The application can effectively relieve or even cure pediatric tic, and has simple drug components, low toxicity and side effects on children, and convenient medication mode, and is easy to be accepted by children.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a traditional Chinese medicine composition, a traditional Chinese medicine patch, a preparation method and application. Background Technology

[0002] Childhood tic disorder is a neuropsychiatric disorder characterized by involuntary muscle tics or vocal tics. It is most common in preschool and school-aged children, with a significantly higher incidence in males than females. Typical symptoms include motor tics such as blinking, eyebrow raising, head nodding, head shaking, shoulder shrugging, and leg kicking, as well as vocal tics such as coughing and throat clearing. Symptoms often worsen during emotional stress and lessen or disappear during concentration or sleep, and may shift symptom clusters as the disease progresses. Some children also experience problems such as inattention, hyperactivity, or mood disorders.

[0003] Currently, treatment options for childhood tic disorders include Western medicine and traditional Chinese medicine. Western medicine primarily employs medication and psychotherapy. Medication mainly consists of antipsychotics, such as dopamine receptor antagonists (haloperidol, piracetam), selective norepinephrine reuptake inhibitors (sertraline), and α2-adrenergic receptor agonists (clonidine). For those with comorbid attention deficit, central nervous system depressants such as atomoxetine may be used in combination. Psychotherapy uses psychological intervention as its foundation. Mild cases improve symptoms through cognitive behavioral therapy and habit reversal training. Treatment emphasizes cooperation between family and school, reducing anxiety and enhancing confidence through education, guidance, and environmental adjustments. Additionally, Western medicine includes physical therapies such as transcranial magnetic stimulation as adjunctive treatments. Some cases require the use of neurotransmitter modulators (such as risperidone) or short-term benzodiazepines. These drugs improve sleep rhythm.

[0004] Traditional Chinese medicine (TCM) treatment primarily employs internal and external therapies. Internal therapies are centered on syndrome differentiation and treatment based on syndrome differentiation. For example, for spleen deficiency with liver hyperactivity, a common treatment is a formula for relieving pain and promoting liver qi and spleen function; for spleen deficiency with phlegm accumulation, the Ten-Ingredient Warming Gallbladder Decoction is used to strengthen the spleen and resolve phlegm; and for kidney yang deficiency, the Golden Chamber Kidney Qi Pill is used to warm and tonify kidney yang. In addition, prepared Chinese medicines such as Choudongning Granules and Xifengning Decoction are also widely used. External therapies include acupuncture, massage, and auricular acupressure. Acupuncture often selects acupoints such as Baihui and Shenmen to regulate qi and blood; massage relieves muscle tension through spinal manipulation and kneading; and auricular acupressure combines magnetic bead stimulation of specific acupoints. TCM also advocates combined internal and external treatments, such as combining Chinese herbal medicine with spinal manipulation or magnetic bead auricular acupressure to enhance efficacy.

[0005] In the existing technology, there are also traditional Chinese medicine preparations for childhood tic disorders. For example, Chinese patent application CN202410766176.1 proposes a pediatric tic disorder plaster, which is made from the following ingredients by weight: 5-15 parts of Xanthium sibiricum, 5-15 parts of Magnolia biondii, 5-15 parts of Coptis chinensis, 5-15 parts of Chrysanthemum morifolium, 5-15 parts of Gastrodia elata, 5-15 parts of Uncaria rhynchophylla, 5-15 parts of Chaenomeles speciosa, 5-15 parts of Lycopodium clavatum, 5-15 parts of Acorus tatarinowii, 8-12 parts of Pinellia ternata, 5-15 parts of Curcuma longa, 8-12 parts of Cicadae periostracum, 8-12 parts of Bombyx mori, 8-12 parts of Scrophularia ningpoensis, 8-12 parts of Isatis indigotica, 8-12 parts of Buthus martensii, 8-12 parts of Scolopendra subspinipes, 8-12 parts of Paeonia lactiflora, and 8-12 parts of Glycyrrhiza uralensis. Chinese patent application CN202311761760.X discloses a traditional Chinese medicine acupoint patch formula for treating tic disorders, which includes the following ingredients: 10-20g of Rehmannia glutinosa (processed), 5-15g of Poria cocos, 3-8g of Schisandra chinensis, 10-20g of Chaenomeles speciosa, 5-20g of Achyranthes bidentata, 8-12g of Lycium barbarum, 7-13g of Cuscuta chinensis, 8-13g of Eucommia ulmoides, 8-12g of Gastrodia elata, 2-12g of Paeonia lactiflora, 5-15g of Ziziphus jujuba, 1-5g of Zingiber officinale (dried), 2-7g of Glycyrrhiza uralensis (processed), 3-8g of Uncaria rhynchophylla, and 2-10g of Angelica sinensis. While these traditional Chinese medicines can alleviate tic disorders in children to some extent, their complex composition makes them prone to causing significant side effects in children.

[0006] In view of this, the present invention is hereby proposed. Summary of the Invention

[0007] In order to overcome the shortcomings of the existing technology, the present invention addresses the characteristics of existing traditional Chinese medicine compositions for treating childhood tic disorders being complex in composition and having significant side effects on children. It proposes a traditional Chinese medicine composition, traditional Chinese medicine patch, preparation method and application that can effectively prevent and / or treat childhood tic disorders, with simple composition and few toxic side effects.

[0008] The first aspect of the present invention provides a traditional Chinese medicine composition, which is composed of the following raw materials: clove, amomum villosum, cinnamon, white peony root, and prepared licorice root.

[0009] The detailed pharmacological effects of each of the above components are as follows:

[0010] Clove: pungent in flavor and warm in nature, it enters the spleen, stomach, lung, and kidney meridians. It has the effects of warming the middle jiao and relieving nausea, tonifying the kidneys and assisting yang. It is used for spleen and stomach deficiency-cold, hiccups and vomiting, poor appetite and diarrhea, cold pain in the heart and abdomen, and kidney deficiency-induced impotence.

[0011] Amomum villosum: pungent in taste and warm in nature, it enters the spleen, stomach, and kidney meridians; it has the effects of resolving dampness and stimulating appetite, warming the spleen and stopping diarrhea, regulating qi and calming the fetus. It is used for dampness and turbidity obstructing the middle jiao, epigastric fullness and lack of appetite, spleen and stomach deficiency and cold, vomiting and diarrhea, morning sickness, and threatened abortion.

[0012] Cinnamon: It has a pungent and sweet taste, and is very hot in nature. It enters the kidney, spleen, heart, and liver meridians. It has the effects of tonifying fire and assisting yang, guiding fire back to its source, dispelling cold and relieving pain, and warming and unblocking the meridians. It is used for impotence and cold uterus, cold pain in the lower back and knees, shortness of breath due to kidney deficiency, upward floating of deficient yang, dizziness and red eyes, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, abdominal pain due to cold hernia, dysmenorrhea and amenorrhea.

[0013] White peony root: bitter and sour in taste, slightly cold in nature, and enters the liver and spleen meridians. It nourishes blood and regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain, and calms liver yang. It is used for blood deficiency and chlorosis, irregular menstruation, spontaneous sweating, night sweats, hypochondriac pain, abdominal pain, limb spasms, headache and dizziness.

[0014] Prepared licorice root: It is sweet in taste and neutral in nature; it enters the heart, lung, and spleen meridians, and has the effects and functions of invigorating qi and replenishing the middle jiao, moistening the lungs and relieving cough, clearing heat and detoxifying, relieving spasms and pain, and harmonizing the properties of other herbs.

[0015] In summary, it can be seen that the traditional Chinese medicine composition of the present invention has sufficient theoretical support at the level of modern pharmacological research, and the traditional Chinese medicine composition of the present invention has good therapeutic and / or preventive effects on childhood tic disorders.

[0016] The formula of the traditional Chinese medicine composition of the present invention is as follows:

[0017] Traditional Chinese medicine (TCM) considers the causes of childhood tic disorders to be complex, potentially involving both genetic and environmental factors. Genetic factors may lead to an imbalance in constitution, making individuals more susceptible to external influences; environmental factors such as prolonged mental stress and fright may cause emotional imbalances, thereby triggering tic symptoms. TCM summarizes the pathogenesis as internal stirring of liver wind and deficiency of spleen and kidney yang, considering emotional factors to be one of the important causes of tic disorders.

[0018] It is evident that the etiology and pathogenesis of childhood tic disorders are closely related. The traditional Chinese medicine composition of this invention comprehensively and dialectically addresses childhood tic disorders. Through the rational combination of principal, assistant, adjuvant, and guide herbs, it adopts the treatment principle of warming the kidneys and strengthening the spleen, calming the liver and extinguishing wind, and alleviates symptoms by adjusting the functions of the internal organs and the circulation of qi and blood.

[0019] Since Yang energy is the master of the human body, and its deficiency leads to various diseases, the formulation of the herbal composition and herbal patch in this application is based on the principle of warming the Yang of the spleen and kidneys, supplemented by soothing the liver and calming wind to achieve the therapeutic purpose. Clove and cinnamon are the principal herbs to warm and tonify kidney Yang, Amomum villosum is the assistant herb to invigorate the spleen and stimulate appetite, and white peony root and prepared licorice root are used as adjuvant and guiding herbs to achieve the effect of supporting the earth and suppressing the wood. At the same time, the combination of white peony root and licorice root can relieve all smooth muscle spasms, so that the herbal composition of this application has the effects of warming the kidneys and strengthening the spleen, soothing the liver and stopping spasms, and can effectively treat and / or prevent childhood tic disorders.

[0020] Optionally, the traditional Chinese medicine composition consists of the following raw materials in parts by weight: clove 0.5-2 parts by weight, amomum villosum 0.5-2 parts by weight, cinnamon 0.5-2 parts by weight, white peony root 1.5-6 parts by weight, and prepared licorice root 1.5-6 parts by weight, wherein the amount of each of the clove, amomum villosum, and cinnamon is less than the amount of each of the white peony root and prepared licorice root.

[0021] The large dosage of white peony root and prepared licorice root in this formula is because they were used in the *Shanghan Lun* (Treatise on Cold Damage) to treat "leg cramps," and are still used in modern medicine to treat all smooth muscle spasms. Therefore, white peony root and prepared licorice root can be used as specific antispasmodics. The principle of treating tics is to relieve muscle spasms, hence the maximum dosage of these two herbs, following the *Shanghan Lun* formula and using equal proportions. Clove and cinnamon are used as the principal herbs, following the principle of warming the kidneys and strengthening the spleen, taking into account the characteristics of children's constitution: a pure yang constitution, prone to generating heat. These two herbs are warming; excessive dosage can easily amplify heat, leading to symptoms of extreme heat generating wind, which is detrimental to relieving spasms. Insufficient dosage will not achieve the effect of warming and tonifying kidney yang, nor will it fulfill its dominant role as the principal herbs. As an assistant herb, Amomum villosum assists the principal herb in strengthening the spleen. Its dosage should be less than or equal to that of the principal herb. Considering the rationality of the total amount of medicine applied to acupoints and the exploration of clinical experience, the above ratio of raw materials is the most reasonable.

[0022] Optionally, the traditional Chinese medicine composition consists of the following raw materials in parts by weight: clove 0.8-1.2 parts by weight, amomum villosum 0.8-1.2 parts by weight, cinnamon 0.8-1.2 parts by weight, white peony root 2.4-3.6 parts by weight, and prepared licorice root 2.4-3.6 parts by weight.

[0023] Optionally, the traditional Chinese medicine composition consists of the following raw materials in parts by weight: clove 0.8-1 parts by weight, amomum villosum 0.8-1 parts by weight, cinnamon 0.8-1 parts by weight, white peony root 2.4-3 parts by weight, and prepared licorice root 2.4-3 parts by weight.

[0024] Optionally, the traditional Chinese medicine composition consists of the following raw materials in parts by weight: 1 part clove, 1 part amomum villosum, 1 part cinnamon, 3 parts white peony root, and 3 parts prepared licorice root.

[0025] The traditional Chinese medicine composition of this invention can be made into powder, ointment, or patch. During use, the ointment can be applied directly to the Dazhui (GV14) and Feishu (BL23) acupoints, or the powder can be made into a medicated pack and applied to the Shenque (CV8) acupoint. Alternatively, the patch can be applied directly to the Shenque acupoint. In practical applications, the dosage form can be flexibly selected based on a comprehensive consideration of the method of administration, application location, and efficacy.

[0026] A second aspect of the present invention provides a traditional Chinese medicine patch, wherein the traditional Chinese medicine preparation includes a carrier and the traditional Chinese medicine composition proposed in the first aspect of the present invention.

[0027] Optionally, the carrier shown may include nonwoven fabric, gauze, adhesive tape, adhesive plaster, or medical rubber.

[0028] Optionally, the herbal patch includes excipients, including rice wine. The ratio of the herbal composition to the rice wine is, for example, 1:1 to 2.

[0029] A third aspect of this invention provides a method for preparing a traditional Chinese medicine patch, wherein the preparation method is applied to the traditional Chinese medicine patch proposed in the second aspect of this invention, and the preparation method includes:

[0030] Weigh each raw material separately according to its weight and mix them together;

[0031] After pulverizing each raw material, pass it through a 40-100 mesh sieve, preferably through an 80 mesh sieve, to obtain a powdered mixture of traditional Chinese medicines;

[0032] Add excipients to a mixture of powdered Chinese medicine to prepare a dressing.

[0033] The dressing is placed on a carrier to obtain a patch. In practical applications, the dressing can be prepared into a medicated ball, then pressed into a cake shape, and finally the cake-shaped dressing is placed on a carrier to obtain a patch.

[0034] An optional method of using the herbal patch of the present invention is as follows:

[0035] Treatment course: Apply the patch continuously for two weeks, one patch per day, for two hours each time;

[0036] Administration method: External application to acupoints, applied to the Shenque acupoint.

[0037] The fourth aspect of this invention provides the application of the traditional Chinese medicine composition proposed in the first aspect of this invention or the traditional Chinese medicine patch proposed in the second aspect of this invention in the preparation of a medicine, the medicine being used to prevent and / or treat symptoms of childhood tic disorders, the symptoms including motor tics and / or vocal tics, the motor tics including at least one of blinking, eyebrow raising, head nodding, head shaking, shoulder shrugging, and leg kicking, the vocal tics including coughing and / or throat clearing.

[0038] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0039] The traditional Chinese medicine composition and herbal patch of the present invention have a good therapeutic effect on childhood tic disorders. The formula is simple and reasonable, with few toxic side effects, safe and reliable efficacy, convenient administration, and easy acceptance by children. Detailed Implementation

[0040] The present invention will be further described below through specific embodiments, but this is not a limitation of the present invention. Those skilled in the art can make various modifications or improvements based on the basic idea of ​​the present invention, but as long as they do not depart from the basic idea of ​​the present invention, they are all within the scope of the present invention.

[0041] Example

[0042] Example 1

[0043] Weigh out 1 part by weight of cloves, 1 part by weight of cardamom, 1 part by weight of cinnamon, 3 parts by weight of white peony root, and 3 parts by weight of prepared licorice root, and mix them together. Then grind the mixed Chinese medicinal materials into powder and pass them through an 80-mesh sieve to obtain a powdered Chinese medicinal mixture. Add rice wine to the powdered Chinese medicinal mixture and prepare it into a dressing. Finally, place the dressing on non-woven fabric to obtain a Chinese medicinal patch.

[0044] Examples 2-14: Traditional Chinese medicine patches were prepared according to the formulation and sieving process in Table 1, following the preparation method in Example 1.

[0045] Table 1: Traditional Chinese Medicine Formulas and Sieving Conditions

[0046]

[0047]

[0048] Test case

[0049] This experimental example is a clinical study of the application of a traditional Chinese medicine patch made from the herbal composition of Example 1 in the treatment of childhood tic disorders.

[0050] 1. Case selection:

[0051] Eighty children with Tourette syndrome were randomly selected from Beijing Huimin Traditional Chinese Medicine Children's Hospital. The average age of the children was 5 years and 11 months, and the male-to-female ratio was 1:1.

[0052] 2. Tic symptom score

[0053] The Yale Comprehensive Tic Severity Scale (YGTSS) was used to score children with Tourette syndrome for both motor and vocal tics. The severity of the syndrome was then determined by the total score for both motor and vocal tics. The evaluation criteria are shown in Table 2.

[0054] Table 2: Scoring Criteria for Tourette Syndrome Severity on the Yale Comprehensive Tic Severity Scale

[0055]

[0056]

[0057]

[0058] The Yale Comprehensive Tic Severity Scale (YGTSS) is a commonly used tool for assessing the severity of Tourette syndrome. Its total score ranges from 0 to 50. Generally, a score of 0-15 indicates mild tics, 16-30 indicates moderate tics, and 31-50 indicates severe tics.

[0059] 3. Medical record grouping

[0060] Based on the above evaluation criteria, 40 cases of mild tics, 32 cases of moderate tics, and 8 cases of severe tics were identified. The control group and the experimental group were mainly divided according to the following criteria: an equal number of males and females, equal average age, similar main symptoms, and similar severity.

[0061] Twenty patients with mild tics, 16 with moderate tics, and 4 with severe tics were selected for each of the experimental and control groups. Data were collected and compared over two weeks of treatment. Specifically, the experimental group received a traditional Chinese medicine patch made from the herbal composition described in Example 1 to treat childhood tic disorders, while the control group received a transdermal patch of clonidine, a commonly used clinical treatment for tic disorders, whose main component is an adrenaline α-receptor agonist.

[0062] 4. Medication Procedure: The experimental group received the herbal patch described in this embodiment applied to the Shenque acupoint for two consecutive weeks, one patch per day, for two hours each time. The control group received clonidine transdermal patches applied to the back under the scapula, one patch per week for two consecutive weeks.

[0063] 5. Statistical analysis of experimental results

[0064] Based on the Yale Comprehensive Tic Severity Scale (YGTSS), the percentage difference in scores before and after treatment for the same child was calculated. The percentage difference in scores before and after treatment is the percentage of the total score before and after treatment. The larger the percentage difference in scores, the more significant the therapeutic effect.

[0065] Specifically, a score difference of less than 20% indicates ineffectiveness: clinical symptoms and signs show no significant improvement or even worsen; a score difference of 20%-50% indicates effectiveness: clinical symptoms and signs improve; a score difference of 50%-80% indicates significant effectiveness: clinical symptoms and signs improve significantly; and a score difference of more than 80% indicates recovery: clinical symptoms and signs disappear or essentially disappear.

[0066] The final experimental results are shown in Table 3.

[0067] Table 3: Experimental Results

[0068]

[0069] The experimental results show that the overall effective rate of the experimental group in treating childhood tic disorders was 20% higher than that of the control group, especially in terms of effectiveness and cure. This indicates that the experimental group showed significant improvement compared to the control group in these two criteria. Therefore, the tic symptoms of the vast majority of children in the experimental group were effectively relieved, and no significant adverse reactions were observed during the treatment. The experimental group demonstrated a more significant therapeutic effect on childhood tic disorders compared to the control group.

[0070] 6. Case Analysis:

[0071] The patient, a 5-year-old boy, presented with frequent blinking and grimacing movements induced by strained parental relationships, persisting for over three months. Psychological counseling had little effect, and the parents refused Western medicine treatment, thus seeking traditional Chinese medicine. The child's current symptoms included: a state of tension, restless sleep with vivid dreams and easy startling, poor appetite, loose stools, and cold hands and feet. Examination revealed a pale, swollen tongue with red edges and a wiry pulse. The diagnosis was spleen and kidney yang deficiency combined with liver stagnation. After psychological communication with the parents and child, external herbal patch therapy was initiated. Following two weeks of external application of the herbal patch, a follow-up visit revealed a significant reduction in both symptoms, indicating satisfactory efficacy and meeting the criteria for effectiveness. The above treatment will continue to be administered to observe future results.

[0072] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for the prevention and / or treatment of childhood tic disorders, characterized in that, The raw materials of the traditional Chinese medicine composition are: clove 0.8-1.2 parts by weight, amomum villosum 0.8-1.2 parts by weight, cinnamon 0.8-1.2 parts by weight, white peony root 2.4-3.6 parts by weight, and prepared licorice root 2.4-3.6 parts by weight.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials of the traditional Chinese medicine composition are: clove 0.8-1 parts by weight, amomum villosum 0.8-1 parts by weight, cinnamon 0.8-1 parts by weight, white peony root 2.4-3 parts by weight, and prepared licorice root 2.4-3 parts by weight.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The raw materials of the traditional Chinese medicine composition are: 1 part by weight of clove, 1 part by weight of cardamom, 1 part by weight of cinnamon, 3 parts by weight of white peony root and 3 parts by weight of prepared licorice root.

4. A traditional Chinese medicine patch, characterized in that, The herbal patch includes a carrier and the herbal composition as described in any one of claims 1-3.

5. The traditional Chinese medicine patch according to claim 4, characterized in that, The carrier may include non-woven fabric, gauze, adhesive tape, adhesive plaster, or medical rubber.

6. The traditional Chinese medicine patch according to claim 5, characterized in that, The herbal patch includes excipients, including rice wine.

7. A method for preparing a traditional Chinese medicine patch, characterized in that, The preparation method is applied to the traditional Chinese medicine patch according to any one of claims 5 or 6, and the preparation method includes: Weigh each raw material separately according to its weight and mix them together; After pulverizing each raw material, pass it through a 40-100 mesh sieve to obtain a powdered mixture of traditional Chinese medicines; Add excipients to a mixture of powdered Chinese medicine to prepare a dressing. The dressing is placed on a carrier to form a patch.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-3 or the traditional Chinese medicine patch according to any one of claims 4-6 in the preparation of a drug, characterized in that, The drug is used to prevent and / or treat symptoms of childhood tic disorders, including motor tics and / or vocal tics, wherein the motor tics include at least one of blinking, eyebrow raising, head nodding, head shaking, shoulder shrugging, and leg kicking, and the vocal tics include coughing and / or throat clearing.

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