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

Abstract

The invention 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, and the traditional Chinese medicine composition is composed of clove, fructus amomi, cinnamon, radix paeoniae alba and honey-fried licorice root. The traditional Chinese medicine composition can effectively relieve or even cure the tourette syndrome of children, and is simple in components, low in toxic and side effects on children, convenient to use and easy to accept by children.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition, a traditional Chinese medicine patch, a preparation method and an application thereof. Background Art

[0002] Tourette syndrome is a neuropsychiatric disorder characterized by involuntary muscle twitches or vocal tics. It is more common in preschool and school-age children, with a significantly higher incidence in males than in females. Typical symptoms include motor tics such as blinking, frowning, nodding, shaking the head, shrugging, and kicking, as well as vocal tics such as coughing and throat clearing. Symptoms often worsen during times of emotional stress, and are alleviated or disappear during concentration or sleep. Symptom clusters may shift as the disease progresses. Some children also experience problems such as inattention, hyperactivity, or mood disorders.

[0003] At present, the treatment options for pediatric tics include Western medicine and traditional Chinese medicine. Among them, Western medicine mainly uses drug therapy and psycho-behavioral therapy. Drug therapy is mainly based on antipsychotic drugs, such as dopamine receptor antagonists (haloperidol, pimozide), selective norepinephrine reuptake inhibitors (sertraline) and α2 adrenergic receptor agonists (clonidine). For those with comorbid attention deficit, central nervous system excitatory inhibitors such as atomoxetine can be used in combination. Psychological-behavioral therapy uses psychological intervention as the basic therapy, and children with mild symptoms improve their symptoms through cognitive behavioral therapy, habit reversal training, etc. Treatment emphasizes the cooperation between family and school, and reduces children's anxiety through education and guidance, and environmental adjustments, and enhances their confidence in treatment. In addition, Western medicine also includes physical therapies such as transcranial magnetic stimulation as auxiliary means. Some cases require the combination of neurotransmitter regulating drugs (such as risperidone) or short-term use of benzodiazepines Drugs that improve sleep rhythm.

[0004] Traditional Chinese Medicine (TCM) primarily utilizes internal and external therapies. Internal therapies are centered around syndrome differentiation and treatment. For example, for spleen deficiency and liver hyperactivity, laxatives are often used to soothe the liver and regulate spleen qi. For spleen deficiency and phlegm accumulation, Shiwei Wendan Decoction is used to invigorate the spleen and resolve phlegm. For kidney yang deficiency, Jinkui Shenqi Pills are used to warm and tonify kidney yang. In addition, Chinese patent medicines such as Chudongning Granules and Xifengning Decoction are also widely used. External therapies include acupuncture, massage, and auricular acupressure. Acupuncture often targets acupoints such as Baihui and Shenmen to regulate qi and blood; massage relieves muscle tension through spinal massage and kneading; and auricular acupressure combines magnetic beads to stimulate specific acupoints. TCM also advocates for the integration of internal and external therapies, such as combining Chinese medicine with spinal massage or magnetic auricular acupressure to enhance efficacy.

[0005] In the prior art, there are also traditional Chinese medicine preparations for pediatric tics. For example, Chinese patent application CN202410766176.1 proposes a pediatric tics patch, which is made of 5-15 parts of Xanthium sibiricum, 5-15 parts of Magnolia officinalis, 5-15 parts of Coptis chinensis, 5-15 parts of Chrysanthemum, 5-15 parts of Gastrodia elata, 5-15 parts of Uncaria rhynchophylla, 5-15 parts of Papaya, 5-15 parts of Lycopodiella truncatum, 5-15 parts of Acorus calamus, 8-12 parts of Pinellia ternata, 5-15 parts of Curcuma aromatica, 8-12 parts of Cicada slough, 8-12 parts of Bombyx batryticatus, 8-12 parts of Scrophularia ningpoensis, 8-12 parts of Isatis indigotica, 8-12 parts of Scorpio, 8-12 parts of Scolopendra subspinipes, 8-12 parts of White Peony Root and 8-12 parts of Licorice. Chinese patent application CN202311761760.X proposes a traditional Chinese medicine acupoint application formula for treating tic disorders, which includes the following ingredients: 10-20g of Rehmannia root, 5-15g of Poria cocos, 3-8g of Schisandra chinensis, 10-20g of papaya, 5-20g of Achyranthes bidentata, 8-12g of Lycium barbarum, 7-13g of Cuscuta seed, 8-13g of Eucommia bark, 8-12g of Gastrodia elata, 2-12g of White Peony root, 5-15g of Jujube, 1-5g of Dry Ginger, 2-7g of Preserved Licorice root, 3-8g of Uncaria rhynchophylla, and 2-10g of Chinese Angelica sinensis. Although the above traditional Chinese medicines can alleviate tic disorders in children to a certain extent, their complex composition can easily cause significant side effects in children.

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

[0007] In order to overcome the deficiencies in the above-mentioned prior art, the present invention aims at the characteristics that the existing traditional Chinese medicine compositions for treating tic disorder in children have complex ingredients and large side effects on children, and proposes a traditional Chinese medicine composition, a traditional Chinese medicine patch, a preparation method and an application that can effectively prevent and / or treat tic disorder in children, with simple ingredients and small toxic and side effects.

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

[0009] The detailed pharmacology of the above components are as follows:

[0010] Clove: Pungent and warm in nature, it enters the spleen, stomach, lung, and kidney meridians. It warms the middle and lowers adverse reactions, tonifies the kidneys, and boosts yang. It is used for spleen and stomach deficiency and cold, hiccups and vomiting, loss of appetite, vomiting, diarrhea, cold pain in the heart and abdomen, and impotence due to kidney deficiency.

[0011] Amomum villosum: Pungent in flavor and warm in nature, it enters the spleen, stomach, and kidney meridians. It has the effects of eliminating dampness and stimulating appetite, warming the spleen and stopping diarrhea, regulating qi and stabilizing pregnancy. It is used for dampness and turbidity blocking the middle part of the body, abdominal distension without hunger, spleen and stomach deficiency and cold, vomiting and diarrhea, nausea and vomiting during pregnancy, and fetal movement disorder.

[0012] Cinnamon bark: Pungent, sweet, and highly warming, it enters the kidney, spleen, heart, and liver meridians. It replenishes fire and yang, guides fire back to its source, dispels cold and relieves pain, and warms and unclogs the meridians. It is used for impotence, cold uterus, cold pain in the waist and knees, asthma due to kidney deficiency, floating yang deficiency, dizziness and red eyes, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency-cold, abdominal pain due to cold hernia, and dysmenorrhea and amenorrhea.

[0013] White Peony Root: Bitter and sour in flavor, slightly cold in nature, 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 sallow complexion due to blood deficiency, irregular menstruation, spontaneous sweating, night sweats, flank pain, abdominal pain, cramps in the limbs, headache and dizziness.

[0014] Roasted licorice root: sweet in taste, neutral in nature; enters the heart, lung and spleen meridians, and has the effects and functions of invigorating qi and tonifying the middle, moistening the lungs and relieving cough, clearing away heat and detoxifying, relieving pain, and harmonizing the properties of medicines.

[0015] In summary, it can be seen that the Chinese medicine composition of the present invention also has sufficient theoretical support in modern pharmacological research, and the Chinese medicine composition of the present invention has a good therapeutic and / or preventive effect on pediatric tics.

[0016] The prescription of the Chinese medicine composition of the present invention is explained as follows:

[0017] Traditional Chinese Medicine (TCM) believes the etiology of pediatric tics is complex, potentially involving both genetic and environmental factors. Genetic factors can lead to a skewed constitution, making it susceptible to external influences. Environmental factors, such as chronic stress and shock, can contribute to emotional imbalances, which in turn can trigger tics. TCM categorizes the etiology and pathogenesis as internalized liver wind and spleen and kidney yang deficiency, considering emotional factors a key contributor to tics.

[0018] It can be seen that the etiology and pathogenesis of tic syndrome in children are closely related. The Chinese medicine composition of the present invention comprehensively and dialectically analyzes tic syndrome in children. Through the reasonable combination of monarch, minister, assistant and guiding ingredients, it takes warming the kidney and strengthening the spleen, calming the liver and extinguishing wind as the treatment principles, and alleviates symptoms by adjusting the functions of the internal organs and the circulation of qi and blood.

[0019] Because yang energy is the primary organ of the human body, a deficiency can lead to a myriad of illnesses. Therefore, the formulation strategy of the present Chinese medicine composition and patch is to warm the yang energy of the spleen and kidneys while softening the liver and calming wind to achieve the therapeutic purpose. Cloves and cinnamon serve as the main ingredients to warm and tonify kidney yang, while amomum villosum serves as the secondary ingredient to invigorate the spleen and stimulate appetite. White peony root and roasted licorice serve as adjuvants and guiding ingredients, working together to achieve the effects of supporting earth and suppressing wood. Simultaneously, the white peony root and licorice combination can relieve all smooth muscle spasms, resulting in the present Chinese medicine composition having the effects of warming the kidneys and strengthening the spleen, soothing the liver and relieving spasms, and effectively treating and / or preventing pediatric tics.

[0020] Optionally, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 0.5-2 parts by weight of cloves, 0.5-2 parts by weight of Amomum villosum, 0.5-2 parts by weight of cinnamon, 1.5-6 parts by weight of white peony root and 1.5-6 parts by weight of pre-cured licorice, and the respective amounts of cloves, Amomum villosum and cinnamon are less than the respective amounts of white peony root and pre-cured licorice.

[0021] The dominant dosages of white peony and roasted licorice in this prescription stem from their use in the Treatise on Febrile Diseases to treat "leg cramps." They are still used today to treat all smooth muscle spasms, making them suitable for specific antispasmodic applications. The principle of treating tics is to relieve muscle spasms, so these two herbs are used in the largest amounts, adhering to the Treatise on Febrile Diseases and using equal proportions. Cloves and cinnamon are used as monarch herbs, adhering to the principle of warming the kidneys and strengthening the spleen, taking into account the characteristics of children's constitution: a purely yang body prone to heat transformation. These two herbs tend to be warming, and excessive dosages can promote heat, potentially leading to the generation of wind from extreme heat, which in turn hinders spasm relief. Using too small a dosage will not achieve the desired warming and tonifying effect on the kidney yang, nor will it play a dominant role as monarch herbs. As a minister drug, Amomum villosum assists the monarch drug in strengthening the spleen-strengthening effect. Its dosage should be less than or equal to the ratio of the monarch drug. Combined with the rationality of the total amount of medication used in acupoint application and the exploration of clinical experience, it is most reasonable to adopt the above ratios for each raw material drug.

[0022] Optionally, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 0.8-1.2 parts by weight of cloves, 0.8-1.2 parts by weight of Amomum villosum, 0.8-1.2 parts by weight of cinnamon bark, 2.4-3.6 parts by weight of white peony root and 2.4-3.6 parts by weight of pre-cured liquorice root.

[0023] Optionally, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 0.8-1 parts by weight of cloves, 0.8-1 parts by weight of Amomum villosum, 0.8-1 parts by weight of cinnamon bark, 2.4-3 parts by weight of white peony root and 2.4-3 parts by weight of pre-cured liquorice root.

[0024] Optionally, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 1 part by weight of cloves, 1 part by weight of Amomum villosum, 1 part by weight of cinnamon bark, 3 parts by weight of white peony root and 3 parts by weight of prepared liquorice root.

[0025] The Chinese medicine composition of the present invention can be prepared into a powder, ointment, or patch. During use, the ointment can be applied directly to the Dazhui and Feishu acupoints, or the powder can be prepared into a medicine bag and applied to the Shenque acupoint. The patch can also be applied directly to the Shenque acupoint. In actual use, the Chinese medicine dosage form can be flexibly selected based on a comprehensive consideration of the method of administration, the location of administration, and the efficacy.

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

[0027] Optionally, the carrier includes non-woven fabric, gauze, adhesive tape, adhesive plaster or medical rubber.

[0028] Optionally, the Chinese medicine patch includes an auxiliary material, and the auxiliary material includes yellow rice wine. The ratio of the Chinese medicine composition to the yellow rice wine is, for example, 1:1-2.

[0029] The third aspect of the present invention provides a method for preparing a Chinese medicine patch, which is applied to the Chinese medicine patch proposed in the second aspect of the present invention, and the preparation method comprises:

[0030] Weigh each raw material drug according to weight and mix them;

[0031] After grinding each raw material drug, pass through a 40-100 mesh sieve, preferably through an 80 mesh sieve, to obtain a powdered Chinese medicine mixture;

[0032] Adding auxiliary materials to the powdered Chinese medicine mixture to prepare a dressing;

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

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

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

[0036] Dosage method: External acupoint application, apply to Shenque point.

[0037] The fourth aspect of the present invention provides use of the traditional Chinese medicine composition proposed in the first aspect of the present invention or the traditional Chinese medicine patch proposed in the second aspect of the present invention in the preparation of a medicament, wherein the medicament is used to prevent and / or treat symptoms of tic disorder in children, wherein the symptoms include motor tics and / or vocal tics, wherein the motor tics include at least one of blinking, frowning, nodding, shaking the head, shrugging, and kicking, and the vocal tics include coughing and / or throat clearing.

[0038] Compared with the prior art, the present invention has the following beneficial effects:

[0039] The Chinese medicine composition and the Chinese medicine patch of the present invention have good therapeutic effects on pediatric tics, have simple and reasonable formulas, small toxic and side effects, safe and reliable therapeutic effects, convenient medication methods, and are easily accepted by children. DETAILED DESCRIPTION

[0040] The present invention is further illustrated below by describing specific implementation methods, but this is not intended to limit the present invention. Those skilled in the art can make various modifications or improvements based on the basic ideas of the present invention, but as long as they do not deviate from the basic ideas of the present invention, they are all within the scope of the present invention.

[0041] Example

[0042] Example 1

[0043] 1 part by weight of cloves, 1 part by weight of Amomum villosum, 1 part by weight of cinnamon bark, 3 parts by weight of white peony root, and 3 parts by weight of prepared licorice root were weighed and mixed, and the mixed Chinese medicinal materials were then ground and sieved through an 80-mesh sieve to obtain a powdered Chinese medicinal mixture. Yellow rice wine was added to the powdered Chinese medicinal mixture to prepare a dressing, and the dressing was placed on a non-woven fabric to prepare a Chinese medicinal patch.

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

[0045] Table 1: Chinese medicine formula and screening conditions

[0046]

[0047]

[0048] Test example

[0049] This test example is a clinical study on the use of the Chinese medicine patch prepared from the Chinese medicine composition of Example 1 in the treatment of tic disorder in children.

[0050] 1. Case selection:

[0051] A total of 80 children with Tourette syndrome were randomly selected from Beijing Huimin Children's Hospital of Traditional Chinese Medicine. 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] Children with tics were scored for motor tics and vocal tics using the Yale Global Tic Severity Scale (YGTSS). The severity of the tics was determined based on the combined motor and vocal tics scores. The evaluation criteria are shown in Table 2.

[0054] Table 2: Scoring criteria for tic severity in the Yale Comprehensive Tic Severity Scale

[0055]

[0056]

[0057]

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

[0059] 3. Medical record grouping

[0060] According to the above evaluation criteria, 40 cases of mild tics, 32 cases of moderate tics, and 8 cases of severe tics were detected. The control group and the experimental group were divided into groups based on the same number of men and women, the same average age, the same main symptoms, and similar severity.

[0061] Twenty patients with mild tics, 16 patients with moderate tics, and four patients with severe tics were enrolled in the experimental group and the control group, respectively. Data from two weeks of treatment were collected and compared. The experimental group used a Chinese medicine patch prepared from the Chinese medicine composition of Example 1 to treat pediatric tics, while the control group used a clonidine transdermal patch, which is commonly used in clinical treatment of tics and whose main ingredient is an adrenaline α receptor agonist.

[0062] 4. Medication process: The experimental group adopted the Chinese medicine patch of the present embodiment to be attached to the Shenque acupoint, and applied it continuously for 2 weeks, one patch per day, and 2 hours at a time. The control group adopted the clonidine transdermal patch to be attached to the back under the shoulder blade, one patch per week, and continuously applied for 2 weeks.

[0063] 5. Experimental results statistics

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

[0065] Specifically, a score difference percentage of less than 20% is considered ineffective: there is no obvious improvement in clinical symptoms and signs, or even worsens; a score difference percentage of 20%-50% is considered effective: both clinical symptoms and signs have improved; a score difference percentage of 50%-80% is considered markedly effective: both clinical symptoms and signs have significantly improved; a score difference percentage greater than 80% is considered cured: both clinical symptoms and signs have disappeared or have basically disappeared.

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

[0067] Table 3: Experimental results

[0068]

[0069] The above experimental results show that the overall efficacy of the experimental group in treating pediatric tics was 20% higher than that of the control group. In particular, the experimental group showed significant improvement in the two criteria of effectiveness and cure. This shows that the tic symptoms of the vast majority of children in the experimental group were effectively alleviated, and no obvious adverse reactions were found during the treatment. The experimental group had a more significant effect on pediatric tics than the control group.

[0070] 6. Case analysis:

[0071] The child, a 5-year-old boy, had frequent blinking and grinning movements caused by the unharmonious relationship between the parents. This lasted for more than 3 months. The psychological counseling effect was very small, and the parents refused Western medicine treatment and sought treatment with a Chinese medicine program. The following is the result: the child was in a state of tension, had many dreams and was easily startled, had a poor appetite, loose stools, and cold hands and feet. The tongue was found to be fat and pale, with red edges and a stringy pulse. The syndrome was diagnosed as spleen-kidney yang deficiency with liver depression. After psychological communication with the parent and child, an external application therapy was taken. The Chinese medicine patch of the present embodiment was applied externally for 2 weeks, and the above two symptoms were significantly reduced, with satisfactory efficacy, reaching an effective standard. The above treatment was continued to be used to observe the aftereffects.

[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 aforementioned embodiments, those skilled in the art will be able to modify the technical solutions described in the aforementioned embodiments or substitute equivalents for some of the technical features. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition, characterized in that The traditional Chinese medicine composition consists of the following raw materials: clove, amomum villosum, cinnamon bark, white peony root and roasted liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 0.5-2 parts by weight of cloves, 0.5-2 parts by weight of Amomum villosum, 0.5-2 parts by weight of cinnamon bark, 1.5-6 parts by weight of white peony root and 1.5-6 parts by weight of prepared liquorice root, and the respective amounts of cloves, Amomum villosum and cinnamon bark are less than the respective amounts of white peony root and prepared liquorice root.

3. The Chinese medicine composition according to claim 2, characterized in that The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 0.8-1.2 parts by weight of cloves, 0.8-1.2 parts by weight of Amomum villosum, 0.8-1.2 parts by weight of cinnamon bark, 2.4-3.6 parts by weight of white peony root and 2.4-3.6 parts by weight of pre-cured liquorice root.

4. The Chinese medicine composition according to claim 2, characterized in that The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 0.8-1 parts by weight of cloves, 0.8-1 parts by weight of Amomum villosum, 0.8-1 parts by weight of cinnamon bark, 2.4-3 parts by weight of white peony root and 2.4-3 parts by weight of prepared liquorice root.

5. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 1 part by weight of cloves, 1 part by weight of Amomum villosum, 1 part by weight of cinnamon bark, 3 parts by weight of white peony root and 3 parts by weight of prepared liquorice root.

6. A Chinese medicine patch, characterized in that: The traditional Chinese medicine preparation comprises a carrier and the traditional Chinese medicine composition according to any one of claims 1 to 5.

7. The Chinese medicine patch according to claim 6, characterized in that The carrier includes non-woven fabric, gauze, adhesive tape, adhesive plaster or medical rubber.

8. The Chinese medicine patch according to claim 6, characterized in that The Chinese medicine patch comprises auxiliary materials, and the auxiliary materials include yellow rice wine.

9. A method for preparing a Chinese medicine patch, characterized in that: The preparation method is applied to the traditional Chinese medicine patch according to claim 7 or 8, and the preparation method comprises: Weigh each raw material drug according to weight and mix them; The raw materials are crushed and passed through a 40-100 mesh sieve to obtain a powdered Chinese medicine mixture; Adding auxiliary materials to the powdered Chinese medicine mixture to prepare a dressing; The dressing is placed on a carrier to prepare a patch.

10. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine patch according to claims 6 to 8 in preparing medicines, characterized in that: The drug is used to prevent and / or treat symptoms of tic disorder in children, which include motor tics and / or vocal tics, wherein the motor tics include at least one of blinking, frowning, nodding, shaking the head, shrugging, and kicking, and the vocal tics include coughing and / or throat clearing.

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