Traditional Chinese medicine composition for treating epilepsy as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating epilepsy and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition is prepared from the following medicinal raw materials in parts by mass: 6-18 parts of radix bupleuri, 10-20 parts of dragon bone, 10-20 parts of nacre mother of pearl, 3-9 parts of arisaema cum bile, 6-18 parts of bighead atractylodes rhizome, 6-18 parts of cassia twig, 5-15 parts of rhizoma zingiberis, 5-15 parts of rhizoma pinelliae preparata, 5-15 parts of cynanchum otophyllum, 1-5 parts of rhizoma typhonii, 5-15 parts of fried stiff silkworm, 6-18 parts of rhizoma acori graminei and 6-18 parts of vinegar radix curcumae. , 3-9 parts of wine-treated rhubarb, 6-18 parts of ginger-treated officinal magnolia bark, 1-5 parts of scorpion and 3-9 parts of honey-fried licorice root. The invention further discloses a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition has the beneficial effects that the traditional Chinese medicine composition is mainly used for reconciling Shaoyang and relieving dizziness and treating epilepsy, also has the effects of inducing resuscitation, reducing phlegm and dredging collaterals, and can improve the physique of epilepsy patients, care healthy qi and reduce the incidence frequency; the traditional Chinese medicine composition has extremely high safety, can cooperate with western medicine treatment while giving consideration to the self curative effect, exerts the curative effect of 1 + 1 > 2, and is suitable for most epilepsy patients.

Description

Technical Field

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

[0002] Epilepsy is a chronic brain disorder characterized by recurrent seizures caused by abnormal discharges of neurons in the brain. It has a wide range of impacts and diverse causes, affecting people of all ages. It is one of the most common neurological disorders. Seizures are recurrent and transient, and can be caused by a variety of factors, including brain damage, tumors, genetic and metabolic diseases. In modern medicine, epilepsy is classified as a type of epilepsy in Traditional Chinese Medicine (TCM), also known as "epilepsy syndrome" or "epilepsy." It was first recorded in the Yellow Emperor's Classic of Internal Medicine. The Tang Dynasty physician Sun Simiao first coined the term "epilepsy" in his "Prescriptions for Emergencies," a term still used today. Physicians throughout history have exploratory theories on epilepsy, including treatment based on phlegm, shock, and fire. As stated in the Clinical Guide to Medical Cases: Epilepsy, "Epilepsy may be caused by fright, dietary irregularities, or shock in the mother's womb, leading to imbalanced internal organs and prolonged dysfunction. Once contact with accumulated phlegm occurs, the cold qi and internal wind are generated, causing sudden and violent reversal of qi that cannot be stopped until the qi returns to normal." Generally speaking, epilepsy is caused by congenital factors, head trauma, dietary irregularities, frightened qi stagnation, phlegm and qi entanglement, and excessive fatigue, which lead to imbalanced internal qi, disordered qi flow, internal wind and yang, and phlegm obscuring the clear orifices. Therefore, treatment should be tailored to the severity of the symptoms. During an attack, the key is to treat the symptoms, using a combination of methods to harmonize the Shaoyang meridians and extinguish wind and calm epilepsy. During the remission period and for those who have not recovered after prolonged treatment, supplementary methods include soothing the liver and regulating qi, strengthening the spleen and nourishing blood, and nourishing the liver and kidneys.

[0003] Although advances in medical care have improved understanding and diagnosis of epilepsy, its incidence remains high. According to statistics, approximately 70% of epilepsy patients are adequately controlled with antiepileptic drugs, while the remaining 20%-30% develop drug resistance. Commonly used drugs, such as carbamazepine and sodium valproate, have side effects and resistance, and long-term use may adversely affect organs beyond the nervous system. Currently, surgical resection of the epileptogenic zone is the primary treatment option for intractable epilepsy, but some patients are not suitable for surgery, and the procedure itself carries certain risks. Neuromodulatory technologies are also available to improve epilepsy symptoms. However, the efficacy of neuromodulatory technologies, such as transcranial magnetic stimulation and vagus nerve stimulation, can vary greatly among individuals, resulting in unsatisfactory results for some patients and the development of long-term dependence. Therefore, the search for safer and more effective treatments is a pressing issue for the medical community. Traditional Chinese medicine, as a current clinical treatment option, offers multiple advantages, including multiple targets, minimal adverse effects, and the ability to enhance efficacy when used in combination with Western medicine.

[0004] In view of this, the inventor conducted in-depth research on this demand, and thus came up with this case. Summary of the Invention

[0005] To overcome the side effects and drug resistance of traditional and new anti-epileptic drugs during treatment, as well as the problem of interactions affecting the efficacy of multiple drugs taken by patients to control their condition, the present invention provides a traditional Chinese medicine composition for treating epilepsy, its preparation method, and application.

[0006] In order to achieve the purpose of the above invention, the technical solution adopted by the present invention is:

[0007] A traditional Chinese medicine composition for treating epilepsy comprises the following medicinal raw materials in parts by weight: 6-18 parts of bupleurum, 10-20 parts of dragon bones, 10-20 parts of mother-of-pearl, 3-9 parts of arisaema, 6-18 parts of atractylodes macrocephala, 6-18 parts of cassia twig, 5-15 parts of dried ginger, 5-15 parts of pinellia ternata, 5-15 parts of ginseng, 1-5 parts of white aconite root, 5-15 parts of stir-fried bombyx batryticatus, 6-18 parts of calamus, 6-18 parts of vinegar-curcuma, 3-9 parts of wine-brewed rhubarb, 6-18 parts of magnolia bark, 1-5 parts of scorpion, and 3-9 parts of roasted liquorice.

[0008] Preferably, the medicinal raw materials are included in the following parts by mass: 8-16 parts of bupleurum, 12-18 parts of dragon bones, 12-18 parts of mother-of-pearl, 4-8 parts of arisaema, 8-16 parts of white atractylodes, 8-16 parts of cinnamon twigs, 7-13 parts of dried ginger, 7-13 parts of pinellia, 7-13 parts of ginseng, 1-4 parts of white aconite, 7-13 parts of fried silkworm pupa, 8-16 parts of calamus, 8-16 parts of vinegar turmeric, 4-8 parts of wine rhubarb, 8-16 parts of ginger magnolia bark, 1-4 parts of scorpion, and 4-8 parts of roasted licorice.

[0009] Preferably, the medicinal raw materials are included in the following parts by mass: 10-14 parts of bupleurum, 14-16 parts of dragon bones, 14-16 parts of mother-of-pearl, 5-7 parts of arisaema, 10-14 parts of white atractylodes, 10-14 parts of cinnamon twigs, 9-11 parts of dried ginger, 9-11 parts of pinellia, 9-11 parts of ginseng, 2-4 parts of white aconite, 9-11 parts of fried silkworm pupa, 10-14 parts of calamus, 10-14 parts of vinegar turmeric, 5-7 parts of wine rhubarb, 10-14 parts of ginger magnolia bark, 2-4 parts of scorpion, and 5-7 parts of roasted licorice.

[0010] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition for treating epilepsy in preparing medicine for treating epilepsy.

[0011] The present invention also provides a medicine for treating epilepsy, comprising the above-mentioned traditional Chinese medicine composition for treating epilepsy and pharmaceutically acceptable excipients.

[0012] Preferably, the dosage form of the drug is granules, pills, capsules, Chinese herbal decoctions, decoctions, tablets, teas, suspensions, powders or oral solutions.

[0013] Preferably, the drug is a granule, and its preparation method is as follows:

[0014] Step 1: Weigh the raw materials according to the weight ratio, select, dry, cut, crush and mix evenly;

[0015] Step 2: adding water to cover the raw material drug by 3-5 cm and soaking for 30-50 minutes, then boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the residue by 2-4 cm, boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to remove the residue, and obtaining a second filtrate;

[0016] Step 3: Combine the first filtrate and the second filtrate, place the combined filtrate in a vacuum dryer, and dry at a temperature of 40-60° C. and a pressure of 5-6 kPa until the weight no longer decreases, thereby obtaining granules.

[0017] Preferably, the drug is a pill, and its preparation method is as follows:

[0018] Step 1: Weigh the raw materials according to the weight ratio, select, dry, cut, crush and mix evenly;

[0019] Step 2: adding water to cover the raw material drug by 3-5 cm and soaking for 30-50 minutes, then boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the residue by 2-4 cm, boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to remove the residue, and obtaining a second filtrate;

[0020] Step 3: Combine the first filtrate and the second filtrate, place the combined filtrate in a vacuum dryer, and dry at a temperature of 40-60° C. and a pressure of 5-6 kPa until the weight no longer decreases, thereby obtaining dry particles;

[0021] Step 4: Mix water or honey with the dry medicine evenly, adjust it to a suitable humidity and viscosity so that it is neither too sticky nor too loose, and then add it to a pill-making machine to obtain water pills or honey pills through mechanical extrusion or rolling.

[0022] Preferably, the drug is a capsule, and its preparation method is as follows:

[0023] Step 1: weigh the raw materials according to the weight ratio, select, dry, cut, crush, sieve and mix evenly;

[0024] Step 2: adding water to cover the raw material drug by 3-5 cm and soaking for 30-50 minutes, then boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the residue by 2-4 cm, boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to remove the residue, and obtaining a second filtrate;

[0025] Step 3: Combine the first filtrate and the second filtrate and concentrate them, add an appropriate amount of solvent (such as ethanol, etc., for adjusting the properties and stability of the drug solution) and excipients (such as starch, dextrin, etc., for improving the taste and formability of the drug), mix them evenly, place them in a granulator for granulation, dry the obtained granules, sieve them, and fill them into capsule shells to obtain capsules.

[0026] The beneficial effects produced by the technical solution of the present invention are as follows:

[0027] The above-mentioned traditional Chinese medicine composition uses bupleurum, dragon bone, and pearl mother as the main herbs, primarily to harmonize the Shaoyang meridian, relieve depression and calm the mind, and extinguish wind and suppress yang. Cinnamon twig, bombyx batryticatus, pinellia, Arisaema cinerea, calamus gramineus, white aconite root, and scorpion as the auxiliary herbs, which dispel phlegm and dredge the meridians, open the orifices and invigorate the mind, and enhance the efficacy of calming the liver and suppressing yang. Dry ginger, Magnolia officinalis, Panax chinensis, and Atractylodes macrocephala are used as auxiliary herbs to warm the middle and strengthen the spleen, eliminate dampness and promote qi circulation. Rhubarb and turmeric are used as guiding herbs to clear heat and reduce turbidity, and roasted licorice harmonizes the other herbs. The entire formula, when used together, works to harmonize the Shaoyang meridian, extinguish wind and calm epilepsy, while simultaneously dispelling pathological factors such as phlegm and dampness, stagnant heat, and other factors in the patient's body, improving the patient's constitution, holistically controlling clinical symptoms, and enhancing the patient's quality of life.

[0028] This prescription, based on the common pathogenesis of epilepsy, primarily harmonizes the Shaoyang meridian, extinguishes wind, and calms epilepsy. It also awakens the mind, resolves phlegm, and dredges the meridians. It can improve the patient's constitution, maintain vital energy, and reduce the frequency of seizures. It is highly safe, maintains its own efficacy, and can synergize with Western medication, achieving a 1+1 greater than 2 therapeutic effect, making it suitable for most epilepsy patients. Experimental studies have shown that glycyrrhetinic acid, stigmasterol, quercetin, baicalin, kaempferol, and saikosaponin a, found in bupleurum, dragon bone, and mother-of-pearl, exert anti-epileptic effects by improving the expression of inhibitor of apoptosis protein (XIAP), inhibiting apoptosis and anticonvulsant effects, reducing inflammatory factors, and providing neuroprotective effects. Furthermore, this prescription is available in multiple dosage forms, ensuring efficacy while allowing patients to choose the appropriate dosage form based on their individual needs. This provides convenience for diverse populations and enhances medication compliance. DETAILED DESCRIPTION

[0029] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all the embodiments. Therefore, the following detailed description of the embodiments provided by the present invention is not intended to limit the scope of the invention claimed for protection, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0030] This embodiment fully analyzes the side effects and drug resistance of traditional and new anti-epileptic drugs during treatment, as well as the effects of interactions between patients taking multiple drugs to control their condition, and other related issues. The present invention provides a traditional Chinese medicine composition for treating epilepsy, a preparation method, and use thereof. Specific embodiments are as follows:

[0031] A traditional Chinese medicine composition for treating epilepsy comprises the following medicinal raw materials in parts by weight: 6-18 parts of bupleurum, 10-20 parts of dragon bones, 10-20 parts of mother-of-pearl, 3-9 parts of arisaema, 6-18 parts of atractylodes macrocephala, 6-18 parts of cassia twig, 5-15 parts of dried ginger, 5-15 parts of pinellia ternata, 5-15 parts of ginseng, 1-5 parts of white aconite root, 5-15 parts of stir-fried bombyx batryticatus, 6-18 parts of calamus, 6-18 parts of vinegar-curcuma, 3-9 parts of wine-brewed rhubarb, 6-18 parts of magnolia bark, 1-5 parts of scorpion, and 3-9 parts of roasted liquorice.

[0032] As a preferred embodiment, the invention comprises the following medicinal raw materials in parts by weight: 8-16 parts of bupleurum, 12-18 parts of dragon bones, 12-18 parts of mother-of-pearl, 4-8 parts of arisaema, 8-16 parts of white atractylodes, 8-16 parts of cinnamon twig, 7-13 parts of dried ginger, 7-13 parts of pinellia, 7-13 parts of ginseng, 1-4 parts of white aconite, 7-13 parts of fried silkworm, 8-16 parts of calamus, 8-16 parts of vinegar turmeric, 4-8 parts of wine rhubarb, 8-16 parts of ginger magnolia bark, 1-4 parts of scorpion, and 4-8 parts of roasted licorice.

[0033] As a preferred embodiment, the invention comprises the following medicinal raw materials in parts by weight: 10-14 parts of bupleurum, 14-16 parts of dragon bone, 14-16 parts of mother of pearl, 5-7 parts of arisaema, 10-14 parts of white atractylodes, 10-14 parts of cinnamon twig, 9-11 parts of dried ginger, 9-11 parts of pinellia, 9-11 parts of ginseng, 2-4 parts of white aconite, 9-11 parts of fried silkworm, 10-14 parts of calamus, 10-14 parts of vinegar turmeric, 5-7 parts of wine rhubarb, 10-14 parts of ginger magnolia bark, 2-4 parts of scorpion, and 5-7 parts of roasted licorice.

[0034] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition for treating epilepsy in preparing medicine for treating epilepsy.

[0035] The present invention also provides a medicine for treating epilepsy, comprising the above-mentioned traditional Chinese medicine composition for treating epilepsy and pharmaceutically acceptable excipients.

[0036] As a preferred embodiment, the dosage form of the drug is granules, pills, capsules, Chinese medicine decoctions, decoctions, tablets, teas, suspensions, powders or oral liquids.

[0037] As a preferred embodiment, the drug is a granule, and its preparation method is as follows:

[0038] Step 1: Weigh the raw materials according to the weight ratio, select, dry, cut, crush and mix evenly;

[0039] Step 2: adding water to cover the raw material drug by 3-5 cm and soaking for 30-50 minutes, then boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the residue by 2-4 cm, boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to remove the residue, and obtaining a second filtrate;

[0040] Step 3: Combine the first filtrate and the second filtrate, place the combined filtrate in a vacuum dryer, and dry at a temperature of 40-60° C. and a pressure of 5-6 kPa until the weight no longer decreases, thereby obtaining granules.

[0041] As a preferred embodiment, the drug is a pill, and its preparation method is as follows:

[0042] Step 1: Weigh the raw materials according to the weight ratio, select, dry, cut, crush and mix evenly;

[0043] Step 2: adding water to cover the raw material drug by 3-5 cm and soaking for 30-50 minutes, then boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the residue by 2-4 cm, boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to remove the residue, and obtaining a second filtrate;

[0044] Step 3: Combine the first filtrate and the second filtrate, place the combined filtrate in a vacuum dryer, and dry at a temperature of 40-60° C. and a pressure of 5-6 kPa until the weight no longer decreases, thereby obtaining dry particles;

[0045] Step 4: Mix water or honey with the dry medicine evenly, adjust to appropriate humidity and viscosity, and then add them to a pill-making machine to obtain water pills or honey pills through mechanical extrusion or rolling.

[0046] As a preferred embodiment, the drug is a capsule, and its preparation method is as follows:

[0047] Step 1: weigh the raw materials according to the weight ratio, select, dry, cut, crush, sieve and mix evenly;

[0048] Step 2: adding water to cover the raw material drug by 3-5 cm and soaking for 30-50 minutes, then boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to obtain a first filtrate; then adding water to cover the residue by 2-4 cm, boiling over high heat, then switching to low heat and continuing to decoct for 50-70 minutes, filtering through a Chinese medicine sieve to remove the residue, and obtaining a second filtrate;

[0049] Step 3: Combine the first filtrate and the second filtrate and concentrate them, add appropriate amount of solvent and auxiliary materials and mix them evenly, place them in a granulator for granulation, dry the obtained granules, sieve them and fill them into capsule shells to obtain capsules.

[0050] The present invention is further described in detail below in conjunction with specific embodiments:

[0051] Example 1

[0052] A Chinese medicine composition for treating epilepsy, comprising the following Chinese medicine ingredients in parts by mass: 6 parts of bupleurum, 10 parts of dragon bone, 10 parts of mother-of-pearl, 3 parts of arisaema, 6 parts of atractylodes, 6 parts of cinnamon twig, 5 parts of dried ginger, 5 parts of pinellia tuber, 5 parts of ginseng, 1 part of white aconite root, 5 parts of fried silkworm, 6 parts of calamus, 6 parts of vinegared turmeric, 3 parts of wine-soaked rhubarb, 6 parts of ginger magnolia bark, 1 part of scorpion, and 3 parts of roasted liquorice. This embodiment 1 also provides a method for preparing a drug for treating epilepsy, and the preparation method is as follows:

[0053] Step 1: Weigh the raw materials according to the weight ratio, select, dry, cut, crush and mix evenly;

[0054] Step 2: add water to cover the raw material drug by 5 cm and soak for 40 minutes, then boil over high heat, then continue to decoct for 60 minutes over low heat, and filter through a Chinese medicine sieve to obtain a first filtrate; then add water to cover the slag by 3 cm, boil over high heat, then continue to decoct for 60 minutes over low heat, and filter through a Chinese medicine sieve to remove the slag to obtain a second filtrate;

[0055] Step 3: Combine the first filtrate and the second filtrate, place the combined filtrate in a vacuum dryer, and dry at a temperature of 60° C. and a pressure of 6 kPa until the weight no longer decreases to obtain granules.

[0056] Example 2

[0057] A traditional Chinese medicine composition for treating epilepsy is prepared by grabbing the following traditional Chinese medicine formula ingredients in parts by weight: 8 parts of bupleurum, 12 parts of dragon bone, 12 parts of mother-of-pearl, 4 parts of Arisaema cinerea, 8 parts of Atractylodes macrocephala, 8 parts of cinnamon twig, 7 parts of dried ginger, 7 parts of Pinellia ternata, 7 parts of Panax notoginseng, 1 part of white aconite root, 7 parts of fried silkworm pupa, 8 parts of Acorus calamus, 8 parts of vinegared turmeric, 4 parts of wine-brewed rhubarb, 8 parts of ginger magnolia bark, 1 part of scorpion, and 4 parts of roasted liquorice. The preparation method of the medicament for treating epilepsy in this embodiment 2 is the same as that in embodiment 1.

[0058] Example 3

[0059] A Chinese medicine composition for treating epilepsy is prepared by grabbing the following Chinese medicine formula ingredients in parts by weight: 10 parts of bupleurum, 14 parts of dragon bone, 14 parts of pearl shell, 5 parts of arisaema, 10 parts of atractylodes, 10 parts of cinnamon twig, 9 parts of dried ginger, 9 parts of pinellia, 9 parts of ginseng, 2 parts of white aconite, 9 parts of fried silkworm, 10 parts of calamus, 10 parts of vinegar turmeric, 5 parts of wine rhubarb, 10 parts of ginger magnolia bark, 2 parts of scorpion, and 5 parts of roasted liquorice. The preparation method of the drug for treating epilepsy in this Example 3 is the same as that in Example 1.

[0060] Example 4

[0061] A Chinese medicine composition for treating epilepsy is prepared by grabbing the following Chinese medicine formula ingredients in parts by weight: 12 parts of bupleurum, 15 parts of dragon bone, 15 parts of mother-of-pearl, 6 parts of Arisaema cinerea, 12 parts of Atractylodes macrocephala, 12 parts of cinnamon twig, 10 parts of dried ginger, 10 parts of Pinellia ternata, 10 parts of Panax notoginseng, 3 parts of white aconite root, 10 parts of stir-fried Bombyx batryticatus, 12 parts of Acorus calamus, 12 parts of vinegar-curcuma, 6 parts of wine-fermented rhubarb, 12 parts of ginger magnolia bark, 3 parts of scorpion, and 6 parts of roasted liquorice. The preparation method of the medicament for treating epilepsy in this Example 4 is the same as that in Example 1.

[0062] Example 5

[0063] A Chinese medicine composition for treating epilepsy, comprising the following raw materials by weight: 14 parts of bupleurum, 16 parts of dragon bone, 16 parts of pearl shell, 7 parts of arisaema, 14 parts of atractylodes, 14 parts of cinnamon twig, 11 parts of dried ginger, 11 parts of pinellia, 11 parts of ginseng, 4 parts of white aconite, 11 parts of fried bombyx batryticatus, 14 parts of calamus, 14 parts of vinegared turmeric, 7 parts of wine-boiled rhubarb, 14 parts of ginger magnolia bark, 4 parts of scorpion, and 7 parts of roasted liquorice. The preparation method of the medicament for treating epilepsy in Example 5 is the same as that in Example 1.

[0064] Example 6

[0065] A Chinese medicine composition for treating epilepsy, comprising the following raw materials by weight: 16 parts of bupleurum, 18 parts of dragon bone, 18 parts of pearl shell, 8 parts of arisaema, 16 parts of atractylodes macrocephala, 16 parts of cinnamon twig, 13 parts of dried ginger, 13 parts of pinellia tuber, 13 parts of ginseng, 4 parts of white aconite root, 13 parts of fried bombyx batryticatus, 16 parts of calamus, 16 parts of vinegared turmeric, 8 parts of wine-brewed rhubarb, 16 parts of ginger magnolia bark, 4 parts of scorpion, and 8 parts of roasted liquorice. The preparation method of the medicament for treating epilepsy in Example 6 is the same as that in Example 1.

[0066] Example 7

[0067] A Chinese medicine composition for treating epilepsy, comprising the following raw materials by weight: 18 parts of bupleurum, 20 parts of dragon bone, 20 parts of mother-of-pearl, 9 parts of arisaema, 18 parts of atractylodes, 18 parts of cinnamon twig, 15 parts of dried ginger, 15 parts of pinellia tuber, 15 parts of ginseng, 5 parts of white aconite root, 15 parts of fried bombyx batryticatus, 18 parts of calamus, 18 parts of vinegared turmeric, 9 parts of wine-soaked rhubarb, 18 parts of ginger magnolia bark, 5 parts of scorpion, and 9 parts of roasted liquorice. The preparation method of the medicament for treating epilepsy in Example 7 is the same as that in Example 1.

[0068] In order to verify its efficacy, the present application uses the drug prepared in preferred embodiment 4 to conduct clinical research on the efficacy of the present invention on epilepsy patients:

[0069] 1. Source of cases

[0070] The cases included in this study were all patients who visited the outpatient department of encephalopathy at the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from 2022 to 2024. A total of more than 120 epilepsy patients were admitted for clinical observation and research. All patients met the epilepsy diagnostic criteria established by the Anti-Epilepsy Association in 2021. Among them, a total of 120 patients who met the diagnostic criteria and inclusion criteria for epilepsy patients were randomly screened.

[0071] 2. Diagnostic criteria

[0072] 2.1 Western medicine diagnostic criteria

[0073] A definitive diagnosis requires at least one of the following conditions to be met, as outlined in the 2017 ILAE Clinical Diagnosis and Treatment Guidelines for Epilepsy:

[0074] (1) ≥2 unprovoked (or reflex) seizures, with the interval between the two seizures greater than 24 hours;

[0075] (2) After one unprovoked (or reflex) seizure, the risk of recurrence (within 10 years) is equivalent to the risk of recurrence after two unprovoked (reflex) seizures (at least 60%);

[0076] ① Previous brain injury (Grade A)

[0077] ② EEG shows epileptiform abnormalities (Grade B)

[0078] ③Cranial imaging suggests epileptogenic lesions (Grade B)

[0079] ④The first attack is a nocturnal attack (Grade B)

[0080] (3) Diagnosis of certain epilepsy syndromes.

[0081] 2.2 Traditional Chinese Medicine Diagnostic Criteria

[0082] This study developed diagnostic criteria for triple-burner obstruction syndrome based on the diagnostic criteria for epilepsy in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes 2012 Edition," the Technical Guidelines for Clinical Research Trials of Epilepsy Drugs issued by the Center for Drug Evaluation (CDE), and the "New Century (Second Edition) National Higher Traditional Chinese Medicine Colleges and Universities Planning Textbook: Traditional Chinese Medicine Internal Medicine."

[0083] Main symptoms: sudden fainting, stiffness of the neck and back, convulsions of the limbs, saliva spitting from the mouth, phlegm in the throat, or just staring with the eyes, no response to calls, or drooping head, limp limbs; partial seizures can be seen in various forms, such as local convulsions of the mouth, eyes, hands, etc. without sudden fainting, or hallucinations, vomiting, sweating, or speech disorders, or unconscious movements, etc.; all of the above have an acute onset, and the patient is like a normal person after waking up, and the seizures recur repeatedly.

[0084] Secondary syndrome: often accompanied by dizziness, headache, dry mouth, irritability, chest tightness, abdominal distension, loss of appetite, insomnia and other symptoms. There is often a family history of this disease, and it is often triggered by fear, fatigue, and excessive emotions.

[0085] Tongue and pulse: The tongue is dark red, the tongue coating is white or yellow, and the pulse is stringy, slippery and rapid or moist and thin.

[0086] Patients with corresponding main symptoms + secondary symptoms and identical or similar tongue and pulse patterns meet the inclusion criteria of this trial.

[0087] 3. Inclusion and exclusion criteria

[0088] 3.1 Inclusion criteria:

[0089] (1) Clinical manifestations are consistent with the characteristics of epilepsy: ① The patient experiences recurrent epileptic seizures, which are manifested as sudden, short-lived, and stereotyped clinical symptoms, such as loss of consciousness, limb convulsions, and paresthesias; ② The seizures are characterized by sudden onset and cessation, and the patient can usually recover to the state before the seizure.

[0090] (2) Abnormal electroencephalogram (EEG): ① The EEG shows epileptic-like discharges, such as spike waves, sharp waves, and spike-slow complex waves; ② The EEG during the seizure period may capture abnormal brain electrical activity during the seizure.

[0091] (3) Neuroimaging support (if applicable): ① For some epilepsy patients, brain CT or brain MRI may reveal abnormal brain structures, such as brain tumors, vascular malformations, etc.; ② These imaging abnormalities are consistent with the patient's epileptic seizure symptoms.

[0092] (4) Comply with the classification of epilepsy syndromes: ① According to the ILAE classification criteria for epilepsy and epilepsy syndromes, the patient may be classified as having a specific epilepsy syndrome, such as benign childhood epilepsy, juvenile myoclonic epilepsy, etc.

[0093] (5) Willingness to accept anti-epileptic treatment: ① The patient and his / her family understand and accept the diagnosis of epilepsy and are willing to cooperate with the doctor for anti-epileptic treatment.

[0094] 3.2 Rejection criteria:

[0095] (1) Non-epileptic seizures: ① The patient's symptoms do not conform to the characteristics of an epileptic seizure, such as prolonged seizure duration and lack of stereotypy; ② The electroencephalogram does not show epileptic-like discharges.

[0096] (2) Other neurological diseases: ① The patient suffers from other neurological diseases, such as stroke, brain trauma, encephalitis, etc., which may cause symptoms similar to epilepsy; ② Neuroimaging examinations show brain lesions unrelated to epilepsy.

[0097] (3) Unable to cooperate with treatment: ① The patient or his / her family is unwilling to accept anti-epileptic treatment, or is unable to follow the doctor's advice for treatment and follow-up.

[0098] (4) Serious complications or contraindications: ① Patients with serious complications or contraindications, such as severe liver and kidney dysfunction, blood system diseases, etc., may not be suitable for anti-epileptic treatment.

[0099] 4. Observation indicators

[0100] Epilepsy patients' quality of life assessment scale, number of epileptic seizures per month.

[0101] 5. Data Analysis

[0102] Statistical analysis was performed using SPSS 25.0. Measurement data were expressed as mean ± standard deviation. Normally distributed data were analyzed using the t-test (for homogeneous variances) or the adjusted t-test (for unequal variances). Non-normally distributed data were analyzed using nonparametric tests, with the Wilcoxon test used for comparisons between groups. P < 0.05 was considered statistically significant.

[0103] 6. Research Plan

[0104] A total of 120 patients who met the diagnostic criteria were randomly divided into a treatment group (60 cases) and a control group (60 cases).

[0105] (1) Control group: Conventional treatment with basic anti-epileptic drugs. If the patient has taken anti-epileptic drugs in the past and the symptoms are under stable control, continue to take them; if the patient has not taken relevant basic anti-epileptic drugs in the past or the symptoms are under unstable control, the medication is based on the patient's own situation and the epilepsy diagnosis and treatment guidelines. For example, for simple seizures, oxcarbazepine 300 mg is given once in the morning and evening, with a maximum dose not exceeding 2400 mg / day; for absence seizures, magnesium valproate 250 mg is given once in the morning and evening, with a maximum dose not exceeding 1500 mg / day; the dosage of the drug is increased or decreased according to the clinical condition, and combined medication is used until the condition stabilizes.

[0106] (2) Treatment group: The same basic anti-epileptic drugs as the control group were used plus the granules prepared in Example 4 of the present application for 3 weeks, followed by regular administration of pills.

[0107] 7. Scoring Indicators

[0108] The QOLIE-31 score consists of 31 items, covering overall health, energy and fatigue, emotional well-being, seizure concern, cognitive function, social function, medication effects, Chinese cultural adjustment, and a total score. Each item corresponds to several questions. The t-values ​​for each item and the total t-value were used to calculate the average t-values ​​for each item before and after treatment for the control and treatment groups, respectively. A higher t-value indicates better quality of life. Scoring method: Each raw value = the sum of all values ​​ / the number of items in that item; the raw values ​​of each item multiplied by their corresponding weights are added together to equal the total score. The values ​​for each item and the total score are then calculated from the table.

[0109] 8. Research Results

[0110] Table 1 Comparison of clinical efficacy and quality of life between the two groups of patients ( ±s)

[0111] Grouping n Number of epileptic seizures per month (before treatment) Number of seizures per month (after treatment) QOLIE-31 score (before treatment) QOLIE-31 score (after treatment) Total incidence of adverse reactions Treatment group 60 2.65±0.52 <![CDATA[0.57±0.12 ab ]]> 52.28±4.23 71.02±8.10 1.41% control group 60 2.63±0.51 <![CDATA[1.24±0.25 a ]]> 52.36±4.24 63.33±6.33 7.04% P P>0.05 P<0.05 P>0.05

[0112] Note: Compared with the group before treatment, a is P < 0.05; compared with the control group after treatment, b is P < 0.05

[0113] Table 1 is a comparison table of the efficacy of the treatment group and the control group before and after treatment. It can be seen from Table 1 that the combination of this prescription treatment can effectively reduce the number of seizures, improve the QOLIE-31 score of epilepsy patients, and improve the quality of life. In addition, the incidence of adverse reactions in subjects during the clinical trial was significantly reduced, which can effectively reduce the side effects and drug resistance of epilepsy patients during the treatment process, indicating that this prescription is relatively safe and well tolerated.

[0114] Typical cases:

[0115] Case 1:

[0116] Patient Yan Moumou, male, 35 years old, first visited the hospital on March 5, 2022, with the main complaint: repeated loss of consciousness and limb convulsions for one month after stopping anti-epileptic drugs. More than a month ago, after stopping oxcarbazepine, the patient developed paroxysmal loss of consciousness, convulsions of the limbs, and upward gaze. There was no strange cry from the mouth, incontinence of feces and bladder, etc., which lasted for several minutes and resolved on its own. After waking up, he did not complain of other discomfort. He is now taking Depakine at a reduced dose, but his condition is not well controlled. He has had three major seizures in one month. His appetite, sleep, and bowel movements are normal. His tongue is pale red, with a greasy white tongue coating and a deep and thin pulse. Western medicine diagnosis: epilepsy; Chinese medicine diagnosis: epilepsy, the syndrome is triple burner obstruction, and the treatment is: reconciling Shaoyang, extinguishing wind and calming epilepsy. He took 30 doses of the Chinese medicine decoction prepared in Example 4 of this application, decocted in water, one dose per day, morning and evening; 1 tablet of oxcarbazepine in the morning and evening, 1 tablet of Depakine in the morning and evening. On April 7, 2022, the patient had two attacks this month, manifested as: unconsciousness, convulsions on the right limbs, lasting 2 to 3 minutes, mild degree, short time, appetite, sleep and bowel movements as usual, pale red tongue, thin white fur, and deep and thin pulse; the patient had significant efficacy after taking the medicine. In order to further reduce the dosage, facilitate taking, and maintain the efficacy, the decoction prepared by Example 4 of this application was changed to pills, which were taken regularly without follow-up. From May 2022 to October 2024, the patient had intermittent follow-up visits. There was no attack in the past two years. He now took 1 tablet of sodium valproate in the morning and evening, and took pills regularly. His tongue was dark red, his fur was thin white, and his pulse was stringy and smooth.

[0117] Note: Phlegm plays a primary role in the pathogenesis of epilepsy. Traditional Chinese Medicine believes that "epileptic seizures occur without phlegm" and that "all diseases are caused by phlegm." The "Danxi Heart Method" states, "Nothing is more than phlegm blocking the mind and obstructing the heart." These findings indicate that epilepsy is related to phlegm. Shaoyang epilepsy is closely related to phlegm. Frequent epileptic seizures can be attributed to the presence of stubborn phlegm, which blocks the triple energizer, stagnates the qi flow, and obscures the clear orifices. Patients experience symptoms such as loss of consciousness, upward gaze, and limb twitching. This is due to the reversal of the yang qi of the Shaoyang liver and gallbladder, resulting in disharmony in the vital organs, disturbing the clear orifices, and obscuring the mind. This is a case of yang epilepsy. Treatment should be with a Shaoyang-harmonic slow-acting agent. The Huotan Dingxian formula is selected to regulate the Shaoyang vital organs, harmonize the Shaoyang meridian, and clear the triple energizer. It is supplemented with Quanxie and Jiangcan to calm the liver and extinguish wind, and Baifuzi, Nanxing, and Shichangpu to dry dampness, resolve phlegm, and awaken the mind. After taking the decoction, the five internal organs recovered and the pulse became gentle, so the medicine was changed to pills to consolidate the therapeutic effect.

[0118] Case 2:

[0119] Patient Mei, male, 23 years old, first visited the hospital on August 31, 2024. Chief complaint: epilepsy for 13 years. The patient had brain damage at birth and is currently taking two tablets of oxcarbazepine and levetiracetam in the morning and evening. His intelligence is acceptable, but his academic performance is slightly poor. Recently, he has had frequent seizures, dizziness and discomfort, but no loss of consciousness, no limb symptoms, and the symptoms last for 10 minutes. His appetite is good, and his sleep and bowel movements are normal. His tongue is dark red, with a thin white fur and a stringy pulse. Western medicine diagnosis: epilepsy; Traditional Chinese Medicine diagnosis: epilepsy - obstruction of the triple burner, treated with reconciling the Shaoyang meridians, extinguishing wind and calming epilepsy. He took 14 doses of the Chinese medicine decoction prepared in Example 4 of this application, decocted in water, 1 dose per day, taken in 2 doses. Regular follow-up visits from September 21, 2024 to October 15, 2024: During the medication period, there were no seizures, general fatigue and excessive sleepiness were reduced, appetite was good, bowel movements were normal, dry mouth and bitter taste, pale tongue, greasy white fur, and a deep and fine pulse. The patient has been taking Chinese medicine for two months with good results and no recurrence of the disease. According to the patient's condition control, the dosage of Western medicine can be gradually reduced and Chinese medicine can be changed to pills for maintenance treatment.

[0120] Note: The patient was born with a brain injury, with blood stasis and phlegm obstructing the brain orifices. "Suwen: Zhizhen Yao Da Lun" states: "All wind-induced dizziness and vertigo are attributed to the liver." Combined with the tongue and pulse, this indicates liver and gallbladder qi stagnation, with liver yang rising up to disturb the clear orifices and obscure the mind. Therefore, the prescription is modified from Chaihu Jia Longgu Muli Decoction, taking Xiao Chaihu Decoction but removing licorice to harmonize the liver and gallbladder and resolve the Shaoyang meridian. Cinnamon twigs are added to calm the upward surge of qi. Red lead in the formula is toxic, so prolonged use may lead to lead poisoning, so it has been omitted and replaced with other herbs. Dragon bone and pearl mother-of-pearl calm the liver and soothe the soul, and are essential herbs for absorbing floating yang. These two ingredients, aided by Pinellia ternata, can dissipate liver and gallbladder phlegm. Rhubarb purges internal heat. Green ginseng and roasted licorice root invigorate qi and nourish the heart. Pearl mother-of-pearl and stir-fried silkworm calm the liver, extinguish wind, and calm epilepsy. Atractylodes macrocephala and Magnolia officinalis invigorate the spleen, eliminate dampness, and promote qi circulation.

[0121] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating epilepsy, characterized in that: The invention comprises the following medicinal raw materials in parts by weight: 6-18 parts of bupleurum, 10-20 parts of dragon bones, 10-20 parts of mother-of-pearl, 3-9 parts of arisaema, 6-18 parts of atractylodes, 6-18 parts of cinnamon twigs, 5-15 parts of dried ginger, 5-15 parts of pinellia, 5-15 parts of ginseng, 1-5 parts of white aconite, 5-15 parts of stir-fried silkworm, 6-18 parts of calamus, 6-18 parts of vinegared turmeric, 3-9 parts of wine-soaked rhubarb, 6-18 parts of ginger magnolia bark, 1-5 parts of scorpion, and 3-9 parts of roasted liquorice.

2. The Chinese medicine composition for treating epilepsy according to claim 1, characterized in that: The invention comprises the following medicinal raw materials in parts by weight: 8-16 parts of bupleurum, 12-18 parts of dragon bones, 12-18 parts of mother-of-pearl, 4-8 parts of arisaema, 8-16 parts of atractylodes, 8-16 parts of cinnamon twig, 7-13 parts of dried ginger, 7-13 parts of pinellia, 7-13 parts of ginseng, 1-4 parts of white aconite, 7-13 parts of stir-fried silkworm, 8-16 parts of calamus, 8-16 parts of vinegar turmeric, 4-8 parts of wine rhubarb, 8-16 parts of ginger magnolia bark, 1-4 parts of scorpion, and 4-8 parts of roasted liquorice.

3. The Chinese medicine composition for treating epilepsy according to claim 1, characterized in that: The invention includes the following medicinal raw materials in parts by weight: 10-14 parts of bupleurum, 14-16 parts of dragon bones, 14-16 parts of mother-of-pearl, 5-7 parts of arisaema, 10-14 parts of white atractylodes, 10-14 parts of cinnamon twig, 9-11 parts of dried ginger, 9-11 parts of pinellia, 9-11 parts of ginseng, 2-4 parts of white aconite, 9-11 parts of stir-fried silkworm, 10-14 parts of calamus, 10-14 parts of vinegar turmeric, 5-7 parts of wine rhubarb, 10-14 parts of magnolia bark, 2-4 parts of scorpion, and 5-7 parts of roasted liquorice.

4. Use of the traditional Chinese medicine composition for treating epilepsy according to any one of claims 1 to 3 in the preparation of a drug for treating epilepsy.

5. A drug for treating epilepsy, characterized in that: The invention comprises the traditional Chinese medicine composition for treating epilepsy according to any one of claims 1 to 3 and pharmaceutically acceptable excipients.

6. The drug for treating epilepsy according to claim 5, characterized in that: The dosage form of the medicine is granules, pills, capsules, Chinese medicine decoctions, decoctions, tablets, teas, suspensions, powders or oral liquids.

7. The method for preparing the drug for treating epilepsy according to claim 5 or 6, characterized in that: The medicine is a granule, and its preparation method is as follows: Step 1: Weigh the raw materials according to the weight ratio, select, dry, cut, crush and mix evenly; Step 2: adding water to cover the raw material drug and fully soaking it, then boiling it over high heat, then decocting it over a low heat for 50 to 70 minutes, and filtering to obtain a first filtrate; then adding water to cover the drug residue, boiling it over high heat, then decocting it over a low heat for 50 to 70 minutes, filtering to remove the drug residue, and obtaining a second filtrate; Step 3: Combine the first filtrate and the second filtrate, place the combined filtrate in a vacuum dryer, and dry at a temperature of 40-60° C. and a pressure of 5-6 kPa until the weight no longer decreases, thereby obtaining granules.

8. The method for preparing the drug for treating epilepsy according to claim 5 or 6, characterized in that: The medicine is a pill, and its preparation method is as follows: Step 1: Weigh the raw materials according to the weight ratio, select, dry, cut, crush and mix evenly; Step 2: adding water to cover the raw material drug and fully soaking it, then boiling it over high heat, then decocting it over a low heat for 50 to 70 minutes, and filtering to obtain a first filtrate; then adding water to cover the drug residue, boiling it over high heat, then decocting it over a low heat for 50 to 70 minutes, filtering to remove the drug residue, and obtaining a second filtrate; Step 3: Combine the first filtrate and the second filtrate, place the combined filtrate in a vacuum dryer, and dry at a temperature of 40-60° C. and a pressure of 5-6 kPa until the weight no longer decreases, thereby obtaining dry particles; Step 4: Mix water or honey with the dry medicine evenly, then add them into a pill making machine, and obtain water pills or honey pills by mechanical extrusion or rolling.

9. The method for preparing the drug for treating epilepsy according to claim 5 or 6, characterized in that: The medicine is a capsule, and its preparation method is as follows: Step 1: weigh the raw materials according to the weight ratio, select, dry, cut, crush, sieve and mix evenly; Step 2: adding water to cover the raw material drug and fully soaking it, then boiling it over high heat, then decocting it over a low heat for 50 to 70 minutes, and filtering to obtain a first filtrate; then adding water to cover the drug residue, boiling it over high heat, then decocting it over a low heat for 50 to 70 minutes, filtering to remove the drug residue, and obtaining a second filtrate; Step 3: Combine the first filtrate and the second filtrate and concentrate them, add appropriate amount of solvent and auxiliary materials and mix them evenly, place them in a granulator for granulation, dry the obtained granules, sieve them and fill them into capsule shells to obtain capsules.