A traditional Chinese medicine composition for treating epilepsy

Abstract

This invention provides a traditional Chinese medicine composition for treating epilepsy, comprising Gastrodia elata, Fritillaria thunbergii, Bombyx mori, Magnetite, Bambusa textilis, Acanthopanax senticosus, and white pepper. This traditional Chinese medicine composition has sedative, orifice-opening, anticonvulsant, and anti-twitching effects on epilepsy patients, effectively inhibiting epileptic seizures.

Description

Technical Field

[0001] This application relates to a traditional Chinese medicine composition for treating epilepsy, belonging to the field of traditional Chinese medicine technology. Background Technology

[0002] Epilepsy is a chronic, recurrent, and transient syndrome of brain dysfunction, characterized by abnormal electrical discharges in the brain, resulting in abnormalities in motor, sensory, consciousness, mental state, behavior, and autonomic nervous system functions. Epilepsy is one of the most common neurological diseases, with an annual incidence rate of 50–70 per 100,000, or a prevalence of 5‰. Epidemiological studies in China have found a lifetime prevalence of 7‰, with a prevalence of 5.4‰ among patients with active epilepsy who have had seizures within the past 5 years. Epilepsy has become the second most common neurological disease after stroke.

[0003] Currently, the main treatment for epilepsy involves various antiepileptic drugs. 75% of epilepsy patients can control their seizures with first-line antiepileptic drugs, while 25% suffer from drug-resistant epilepsy. Most antiepileptic drugs have adverse effects such as liver damage, skin rash, bone marrow damage, mental illness, and drowsiness. Regular monitoring of blood drug concentrations is necessary, leading to poor clinical adherence and impacting patients' quality of life. Summary of the Invention

[0004] To address the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for treating epilepsy and its application in the preparation of drugs for treating epilepsy.

[0005] As one aspect of the present invention, the present invention provides a traditional Chinese medicine composition for treating epilepsy, the traditional Chinese medicine composition being made from Gastrodia elata, Fritillaria thunbergii, Bombyx mori, Magnetite, Bambusa textilis, Acanthopanax senticosus, and white pepper.

[0006] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 5-32 parts by weight of Gastrodia elata, 5-30 parts by weight of Fritillaria thunbergii, 5-30 parts by weight of Bombyx mori, 8-45 parts by weight of Magnetite, 3-18 parts by weight of Bambusa textilis, 12-60 parts by weight of Acanthopanax senticosus, and 1-5 parts by weight of white pepper.

[0007] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 7-28 parts by weight of Gastrodia elata, 7-24 parts by weight of Fritillaria thunbergii, 7-24 parts by weight of Bombyx mori, 10-40 parts by weight of Magnetite, 3-15 parts by weight of Bambusa textilis, 15-55 parts by weight of Acanthopanax senticosus, and 1-4 parts by weight of white pepper.

[0008] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 9-21 parts by weight of Gastrodia elata, 9-18 parts by weight of Fritillaria thunbergii, 9-18 parts by weight of Bombyx mori, 12-36 parts by weight of Magnetite, 4-12 parts by weight of Bambusa textilis, 17-48 parts by weight of Acanthopanax senticosus, and 1.2-3.6 parts by weight of white pepper.

[0009] Most preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10 parts by weight of Gastrodia elata, 10 parts by weight of Fritillaria thunbergii, 10 parts by weight of Bombyx mori, 15 parts by weight of Magnetite, 5 parts by weight of Bambusa textilis, 20 parts by weight of Acanthopanax senticosus, and 1.5 parts by weight of white pepper.

[0010] Alternatively, 15 parts by weight of Gastrodia elata, 15 parts by weight of Fritillaria thunbergii, 15 parts by weight of Bombyx mori, 30 parts by weight of Magnetite, 10 parts by weight of Bambusa textilis, 30 parts by weight of Acanthopanax senticosus, and 2 parts by weight of white pepper.

[0011] Alternatively, use 20 parts by weight of Gastrodia elata, 12 parts by weight of Fritillaria thunbergii, 12 parts by weight of Bombyx mori, 20 parts by weight of magnetite, 9 parts by weight of Bambusa textilis, 45 parts by weight of Acanthopanax senticosus, and 3 parts by weight of white pepper.

[0012] The traditional Chinese medicine composition described in this invention can be a composition formed by mixing various raw materials after pulverizing them, or it can be an extract obtained by mixing or extracting various raw materials individually, or an effective part obtained by further refining and purifying the extract, or it can be a conventional dosage form made by adding pharmaceutically acceptable excipients to the extract / effective part.

[0013] The extraction methods include decoction extraction, reflux extraction, maceration extraction, ultrasonic extraction, percolation extraction, and microwave extraction; the purification methods include water extraction and alcohol precipitation, alkali dissolution and acid precipitation, and various column chromatography purification methods, such as macroporous resin columns, silica gel columns, gel columns, and reversed-phase columns; the conventional dosage forms include, but are not limited to, injections, capsules, tablets, granules, gels, sustained-release preparations, oral liquids, pellets, or nano-preparations; the pharmaceutically acceptable excipients include: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices. Fillers include: starch, pregelatinized starch, lactose, mannitol, chitosan, microcrystalline cellulose, sucrose, etc.; disintegrants include: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, croscarmellose, low-substituted hydroxypropyl cellulose, croscarmellose sodium, etc.; lubricants include: magnesium stearate, sodium lauryl sulfate, talc, silica, etc.; suspending agents include: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include: starch paste, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.

[0014] As another aspect of the present invention, the traditional Chinese medicine composition of the present invention may also use an extract of the raw material as a raw material. Therefore, the present invention further provides a traditional Chinese medicine composition for treating epilepsy, the traditional Chinese medicine composition being made from the following raw materials:

[0015] Gastrodia elata extract 5-32 parts by weight, Fritillaria thunbergii extract 5-30 parts by weight, Bombyx mori extract 5-30 parts by weight, Magnetite extract 8-45 parts by weight, Bambusa textilis extract 3-18 parts by weight, Acanthopanax senticosus extract 12-60 parts by weight, and Piper nigrum extract 1-5 parts by weight.

[0016] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 7-28 parts by weight of Gastrodia elata extract, 7-24 parts by weight of Fritillaria thunbergii extract, 7-24 parts by weight of Bombyx mori extract, 10-40 parts by weight of magnetite extract, 3-15 parts by weight of Bambusa textilis extract, 15-55 parts by weight of Acanthopanax senticosus extract, and 1-4 parts by weight of white pepper extract.

[0017] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 9-21 parts by weight of Gastrodia elata extract, 9-18 parts by weight of Fritillaria thunbergii extract, 9-18 parts by weight of Bombyx mori extract, 12-36 parts by weight of magnetite extract, 4-12 parts by weight of Bambusa textilis extract, 17-48 parts by weight of Acanthopanax senticosus extract, and 1.2-3.6 parts by weight of white pepper extract.

[0018] Most preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10 parts by weight of Gastrodia elata extract, 10 parts by weight of Fritillaria thunbergii extract, 10 parts by weight of Bombyx mori extract, 15 parts by weight of magnetite extract, 5 parts by weight of Bambusa textilis extract, 20 parts by weight of Acanthopanax senticosus extract, and 1.5 parts by weight of white pepper extract.

[0019] Alternatively, 15 parts by weight of Gastrodia elata extract, 15 parts by weight of Fritillaria thunbergii extract, 15 parts by weight of Bombyx mori extract, 30 parts by weight of magnetite extract, 10 parts by weight of Bambusa textilis extract, 30 parts by weight of Acanthopanax senticosus extract, and 2 parts by weight of white pepper extract.

[0020] Alternatively, 20 parts by weight of Gastrodia elata extract, 12 parts by weight of Fritillaria thunbergii extract, 12 parts by weight of Bombyx mori extract, 20 parts by weight of magnetite extract, 9 parts by weight of Bambusa textilis extract, 45 parts by weight of Acanthopanax senticosus extract, and 3 parts by weight of white pepper extract.

[0021] The above-mentioned extracts may be aqueous extracts of the active pharmaceutical ingredients, or organic solvent extracts, or refined products obtained by further refining and purification processes of aqueous extracts / organic solvent extracts.

[0022] The organic solvent is selected from one or more of methanol, 20-95% ethanol solution, and acetone;

[0023] The extraction methods used to prepare the above extracts include any one of reflux extraction, maceration extraction, ultrasonic extraction or percolation extraction, or a combination of different extraction methods.

[0024] As another aspect of the present invention, the present invention also provides the use of the traditional Chinese medicine composition in the preparation of a medicament for treating epilepsy.

[0025] The beneficial effects of the traditional Chinese medicine composition of this invention:

[0026] This invention utilizes a combination of Gastrodia elata, Fritillaria thunbergii, Bombyx mori, Magnetite, Bambusa textilis, Acanthopanax senticosus, and white pepper to treat epilepsy patients, providing sedation, clearing the mind, anticonvulsant, and stopping seizures, effectively suppressing epileptic seizures.

[0027] The formulation principle of the herbal composition of this invention: Epilepsy is often caused by liver wind carrying phlegm, which ascends to the brain, causing mental confusion and muscle stiffness. The *Neijing* states that all dizziness and vertigo are related to the liver. Therefore, the chief ingredient in this formula is *Gastrodia elata*, which is sweet and neutral in nature, specifically entering the liver meridian. It can calm the liver and extinguish wind, making it a key medicine for treating wind-related ailments. Once liver wind is extinguished, upward gaze, frothing at the mouth, and convulsions of the hands and feet will naturally cease. Internal liver wind also originates from kidney deficiency, where water fails to nourish wood. Extinguishing wind requires nourishing kidney water. The kidneys govern bones and store marrow, and the brain is the sea of ​​marrow. Insufficient kidney water leads to malnourishment of the brain marrow. Therefore, the treatment of epilepsy must tonify the kidneys and strengthen the brain, addressing the root cause. Acanthopanax senticosus, with its pungent, slightly bitter, and warm properties, enters both the spleen and kidney meridians. It can strengthen the spleen and tonify the kidneys, and its greatest value lies in replenishing essence and marrow, nourishing the brain and calming the mind, thus treating the root cause. This prevents epilepsy, dizziness, and vertigo, and restores a cheerful mood. The spleen is the source of phlegm; when the spleen is deficient, phlegm is produced. Wind and phlegm combine and obstruct the orifices. Bambusa textilis, with its sweet and cold properties, enters the heart and liver meridians. It possesses a clearing and transforming quality, clearing away all kinds of phlegm, thus treating the symptoms. This naturally cures the rattling in the throat. Both of these are used as assistant herbs. Bombyx mori, with its pungent, salty, and neutral properties, enters the liver to unblock the meridians, calm wind, and stop epilepsy. Magnetite, with its salty and cold properties, enters the kidneys. Its heavy and calming properties help to subdue the liver and suppress yang, thus assisting Gastrodia elata in calming the liver and calming wind. Fritillaria thunbergii, with its bitter and cold properties, clears heat, resolves phlegm, and disperses nodules, thus assisting Bambusa textilis in clearing heat and eliminating phlegm. These three herbs are used as adjuvant herbs. White pepper, with its pungent and warming properties, can warm and resolve cold phlegm, and its penetrating nature can clear phlegm from the orifices. Its warming nature also counteracts the coldness of other herbs like fritillaria thunbergii, bamboo shavings, and magnetite, making the entire formula mild and gentle on the spleen and stomach. The combined effects of these herbs are to soothe the liver and strengthen the spleen, extinguish wind and resolve phlegm, and calm the mind and relieve epilepsy. This formula is suitable for epilepsy with wind-phlegm disturbance. Symptoms include sudden loss of consciousness, upward gaze, frothing at the mouth, convulsions of the hands and feet, rattling sounds in the throat, and recovery after a short time. Before the attack, there is often dizziness, lightheadedness, chest tightness, fatigue, excessive phlegm, and mood swings. The tongue is pale red with a white, greasy coating, and the pulse is slippery.

[0028] Clinical studies have shown that the herbal composition of this invention can effectively reduce the frequency of epileptic seizures. After 6 weeks of treatment, compared with the control group of herbal analogs, the frequency of epileptic seizures in the herbal composition group of this invention was reduced by 36.1%, and the epilepsy score was reduced by 1.7 points, demonstrating a significant therapeutic effect on epilepsy. Detailed Implementation

[0029] The present invention is further described below through specific embodiments, but the present invention is not limited to the following embodiments. Modifications, combinations, or substitutions made to the present invention within the scope of the present invention or without departing from the content, spirit, and scope of the present invention will be obvious to those skilled in the art and are included within the scope of the present invention.

[0030] Example 1

[0031] Formula: Gastrodia elata 10g, Fritillaria thunbergii 10g, Bombyx mori 10g, Magnetite 15g, Bambusa textilis 5g, Acanthopanax senticosus 20g, White pepper 1.5g.

[0032] Take the raw materials according to the specified proportions, crush them, and process them into granules using conventional methods.

[0033] Example 2

[0034] Formula: Gastrodia elata 15g, Fritillaria thunbergii 15g, Bombyx mori 15g, Magnetite 30g, Bambusa textilis 10g, Acanthopanax senticosus 30g, White pepper 2g.

[0035] Take the raw materials according to the specified proportions, crush them, and make them into capsules according to conventional pharmaceutical processes.

[0036] Example 3

[0037] Formula: Gastrodia elata 20g, Fritillaria thunbergii 12g, Bombyx mori 12g, Magnetite 20g, Bambusa textilis 9g, Acanthopanax senticosus 45g, and white pepper 3g.

[0038] Take the raw materials according to the specified proportions, pulverize them, and make them into tablets according to conventional pharmaceutical processes.

[0039] Example 4

[0040] Formula: Gastrodia elata 12g, Fritillaria thunbergii 16g, Bombyx mori 11g, Magnetite 25g, Bambusa textilis 7g, Acanthopanax senticosus 42g, and white pepper 1.2g.

[0041] Take the raw materials according to the specified proportions, crush them, and make them into pills according to conventional pharmaceutical processes.

[0042] Example 5

[0043] Formula: Gastrodia elata 18g, Fritillaria thunbergii 11g, Bombyx mori 17g, Magnetite 18g, Bambusa textilis 11g, Acanthopanax senticosus 25g, and white pepper 3.4g.

[0044] Take each raw material according to the proportion, decoct in water to extract, and then use the decoction to make an oral liquid according to conventional preparation process.

[0045] Example 6

[0046] Formula: Gastrodia elata 8g, Fritillaria thunbergii 22g, Bombyx mori 8g, Magnetite 38g, Bambusa textilis 4g, Acanthopanax senticosus 52g, and white pepper 1g.

[0047] Take each raw material according to the proportion, decoct in water to extract, and then process the decoction into granules according to conventional pharmaceutical processes.

[0048] Example 7

[0049] Formula: Gastrodia elata 26g, Fritillaria thunbergii 8g, Bombyx mori 22g, Magnetite 11g, Bambusa textilis 14g, Acanthopanax senticosus 16g, and white pepper 4g.

[0050] Take each raw material according to the proportion, add 75% ethanol and reflux to extract, and make capsules from the extract according to conventional pharmaceutical processes.

[0051] Example 8

[0052] Formula: Gastrodia elata 6g, Fritillaria thunbergii 28g, Bombyx mori 6g, Magnetite 43g, Bambusa textilis 3g, Acanthopanax senticosus 58g, and white pepper 1.2g.

[0053] Take each raw material according to the proportion, add 75% ethanol for reflux extraction, and make tablets from the extract according to conventional pharmaceutical processes.

[0054] Example 9

[0055] Formula: Gastrodia elata 30g, Fritillaria thunbergii 6g, Bombyx mori 27g, Magnetite 9g, Bambusa textilis 17g, Acanthopanax senticosus 13g, and white pepper 4.5g.

[0056] Take each raw material according to the proportion, add 75% ethanol and reflux to extract, and make the extract into pills according to conventional preparation process.

[0057] Example 10

[0058] Formula: 10g Gastrodia elata extract, 10g Fritillaria thunbergii extract, 10g Bombyx mori extract, 15g Magnetite extract, 5g Bambusa textilis extract, 20g Acanthopanax senticosus extract, and 1.5g Piper nigrum extract.

[0059] Example 11

[0060] Formula: 15g Gastrodia elata extract, 15g Fritillaria thunbergii extract, 15g Bombyx mori extract, 30g Magnetite extract, 10g Bambusa textilis extract, 30g Acanthopanax senticosus extract, and 2g Piper nigrum extract.

[0061] Example 12

[0062] Formula: 20g Gastrodia elata extract, 12g Fritillaria thunbergii extract, 12g Bombyx mori extract, 20g Magnetite extract, 9g Bambusa textilis extract, 45g Acanthopanax senticosus extract, and 3g Piper nigrum extract.

[0063] Example 13

[0064] Formula: Gastrodia elata extract 12g, Fritillaria thunbergii extract 16g, Bombyx mori extract 11g, Magnetite extract 25g, Bambusa textilis extract 7g, Acanthopanax senticosus extract 42g, and Piper nigrum extract 1.2g.

[0065] Example 14

[0066] Formula: Gastrodia elata extract 18g, Fritillaria thunbergii extract 11g, Bombyx mori extract 17g, Magnetite extract 18g, Bambusa textilis extract 11g, Acanthopanax senticosus extract 25g, Piper nigrum extract 3.4g.

[0067] Example 15

[0068] Formula: Gastrodia elata extract 8g, Fritillaria thunbergii extract 22g, Bombyx mori extract 8g, Magnetite extract 38g, Bambusa textilis extract 4g, Acanthopanax senticosus extract 52g, and white pepper extract 1g.

[0069] Example 16

[0070] Formula: Gastrodia elata extract 26g, Fritillaria thunbergii extract 8g, Bombyx mori extract 22g, Magnetite extract 11g, Bambusa textilis extract 14g, Acanthopanax senticosus extract 16g, and Piper nigrum extract 4g.

[0071] Example 17

[0072] Formula: Gastrodia elata extract 6g, Fritillaria thunbergii extract 28g, Bombyx mori extract 6g, Magnetite extract 43g, Bambusa textilis extract 3g, Acanthopanax senticosus extract 58g, and Piper nigrum extract 1.2g.

[0073] Example 18

[0074] Formula: Gastrodia elata extract 30g, Fritillaria thunbergii extract 6g, Bombyx mori extract 27g, Magnetite extract 9g, Bambusa textilis extract 17g, Acanthopanax senticosus extract 13g, and Piper nigrum extract 4.5g.

[0075] The extracts described in Examples 10-18 above are aqueous extracts of each of the active pharmaceutical ingredients. The extracts are combined according to the formulation amounts and prepared into conventional oral dosage forms such as tablets, capsules, or granules using conventional pharmaceutical processes.

[0076] Example 19 Formulation Screening Experiment

[0077] Formula A: Gastrodia elata 15g, Fritillaria thunbergii 15g, Bombyx mori 15g, Magnetite 30g, Bambusa textilis 10g, Acanthopanax senticosus 30g, White pepper 2g (Traditional Chinese medicine composition of this invention);

[0078] Formula B: Fritillaria thunbergii 15g, Bombyx batryticatus 15g, Magnetitum 30g, Bambusae Concretio Silicea 10g, Acanthopanax Senticosus 30g, white pepper 2g (the monarch drug Gastrodia elata is removed from the traditional Chinese medicine composition of the present invention);

[0079] Formula C: Gastrodia elata 15g, Fritillaria thunbergii 15g, Bombyx batryticatus 15g, Magnetitum 30g, Caulis Bambusae in Taenia 10g, Rehmanniae Radix Praeparata 20g, white pepper 2g (the ministerial drugs Bambusae Concretio Silicea and Acanthopanax Senticosus are replaced in the traditional Chinese medicine composition of the present invention);

[0080] For each of the above formulas, take each raw material according to the proportion, pulverize, and prepare granules by a conventional process.

[0081] From May 2021 to January 2022, 60 epilepsy patients were observed in the Third Affiliated Hospital of Beijing University of Chinese Medicine, randomly divided into three groups with 20 cases in each group. They were treated with formula A, B and C respectively, for a total of 4 weeks of treatment. The curative effect of epilepsy was evaluated by using the epilepsy curative effect evaluation standard and epilepsy scoring scale, and the therapeutic effect on epilepsy was observed.

[0082] The therapeutic effect was evaluated according to the frequency of epileptic seizures, and there was a significant difference in seizure frequency after 4 weeks of treatment. The effective rate of group formula A at the 4th week was 73.2%, that of group formula B at the 4th week was 41.8%, and that of group formula C at the 4th week was 50.3%. The difference among the three groups was statistically significant (P<0.05), and the curative effect was in the order of group A > group C > group B.

[0083] The therapeutic effect was evaluated according to the epilepsy scoring scale. After 4 weeks of treatment, the epilepsy score of group formula A was 5.6±1.4 points, that of group formula B was 7.1±1.1 points, and that of group formula C was 6.3±1.2 points. The difference among the three groups was statistically significant (P<0.05), and the score was in the order of group A < group C < group B.

[0084] The research results show that the curative effect of group A is significantly better than that of groups B and C. This indicates that the compatibility of the traditional Chinese medicine composition of the present invention is optimal. When the monarch drug Gastrodia elata is removed or the ministerial drugs Bambusae Concretio Silicea and Acanthopanax Senticosus are replaced with other drugs, the compatibility of the original formula is broken, resulting in a significant reduction in the anti-epileptic effect of the formula. It can be seen that the compatibility of the present invention, which "takes Gastrodia elata as the monarch, Bambusae Concretio Silicea and Acanthopanax Senticosus as the ministers, Fritillaria thunbergii, Bombyx batryticatus and Magnetitum as the assistants, and white pepper as the guide", is a specific choice to achieve the anti-epileptic effect of the present invention, which cannot be achieved by other compatibility relationships.

[0085] Example 20 Clinical effect experiment

[0086] From March 2022 to March 2023, 68 patients with epilepsy were observed at the Third Affiliated Hospital of Beijing University of Chinese Medicine. A randomized, double-blind, parallel-controlled clinical design was used. Epilepsy patients meeting the inclusion criteria were randomly assigned to two groups: the herbal composition group (prepared as granules according to Example 1) and the control group (herbal imitation agent). Treatment lasted for 4 weeks. At weeks 0, 1, 2, 4, and 6, the efficacy and safety were evaluated using epilepsy efficacy evaluation criteria, epilepsy scoring, and electroencephalography (EEG).

[0087] I. Research Plan

[0088] 1. Diagnostic criteria and basis

[0089] 1.1 Diagnostic criteria for epilepsy

[0090] Refer to the classification scheme for epileptic seizures recommended by the International League Against Epilepsy (ILAE) Classification and Nomenclature Committee (1981) and the Classification Criteria for Epilepsy and Epilepsy Syndromes.

[0091] 1.4 Traditional Chinese Medicine Diagnostic Criteria: Refer to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine in 1994.

[0092] 2. Inclusion criteria:

[0093] ① Meets the diagnostic criteria for epilepsy in both traditional Chinese and Western medicine;

[0094] ② The patient and their guardian must give their consent and sign an informed consent form.

[0095] Exclusion criteria:

[0096] Those who do not meet the above diagnostic and inclusion criteria, or who have not taken medication as prescribed;

[0097] It is complicated by serious primary diseases of the cardiovascular, liver, kidney and hematological systems;

[0098] Mental disorders caused by chronic subdural hematoma and other organic brain diseases; patients with severe neurological deficits, such as aphasia and agnosia;

[0099] Women who are breastfeeding, pregnant, or planning to become pregnant;

[0100] Patients with known hypersensitivity to any of the known components of this preparation;

[0101] Any applicant meeting any of the above criteria will be excluded.

[0102] Exclusion criteria

[0103] Those who were mistakenly included after being selected but did not meet the diagnostic criteria;

[0104] Those whose symptoms worsen and require emergency measures;

[0105] Those who experience severe side effects or adverse reactions;

[0106] Those who cannot adhere to treatment;

[0107] Automatic withdrawal from the trial or loss to follow-up;

[0108] Those who add other similar Chinese herbal medicines or prepared Chinese medicines.

[0109] 3. Administration method

[0110] Weeks 0-6 (0-42 days):

[0111] The herbal composition of this invention is to be taken in the morning and evening, respectively, as a granule of the herbal composition of this invention.

[0112] Control group: Administered traditional Chinese medicine granules twice daily, morning and evening;

[0113] 4. Observation content, efficacy evaluation indicators and detection methods

[0114] 4.1 Main efficacy indicator: Epilepsy efficacy evaluation criteria (epilepsy seizure frequency).

[0115] Control: No seizures, seizure frequency reduced by 100%;

[0116] Significant effect: seizure frequency reduced by more than 75%;

[0117] Effective: Reduces seizure frequency by 50%–75%;

[0118] Ineffective: Seizure frequency reduced by less than 50%;

[0119] Worsening: Increased frequency of attacks.

[0120] 4.2 Secondary efficacy indicators: Epilepsy score.

[0121] 5. Safety Evaluation

[0122] Safety assessment includes vital signs, physical examination, Treatment Emergent Symptom Scale (TESS), complete blood count, urinalysis, blood biochemistry and electrocardiogram (ECG). Adverse events and serious adverse events will be recorded as other safety and tolerability indicators.

[0123] 6 Statistical Methods

[0124] Descriptive statistical methods were used for data analysis. Quantitative data were described using the number of observations, mean, standard deviation, mode, maximum, and minimum values; categorical data were described using the number of observations, frequency, and percentage. All statistical tests were two-tailed tests, and a p-value less than or equal to 0.05 was considered statistically significant. SPSS 18.0 statistical software was used.

[0125] II. Research Results

[0126] 1. General situation

[0127] This study included 68 participants, with 5 dropping out and 3 excluded. Dropout was due to loss to follow-up, and there was no statistically significant difference between the two groups. Exclusion was due to patients self-medicating with other prohibited drugs. A total of 60 participants completed the clinical observation, including 29 males and 31 females. The group receiving the herbal composition of this invention consisted of 31 participants, while the control group consisted of 29 participants.

[0128] 2. Main therapeutic indicators

[0129] 2.1 Improvement in the frequency of epileptic seizures

[0130] The efficacy of the treatment was evaluated based on the frequency of epileptic seizures. There were no significant differences between the two groups at weeks 1 and 2 of treatment. Significant differences in seizure frequency were observed at weeks 4 and 6. The effective rate of the herbal composition group at week 4 was 71.5%, significantly higher than the 35.3% in the control group (P<0.05). At the end of week 6, the average total effective rate of the herbal composition group was 81.2%, significantly higher than the 45.1% in the control group (P<0.01).

[0131] 2.2 Comparison of Epilepsy Scores

[0132] The efficacy of the treatment was evaluated based on the epilepsy score. At week 4, the epilepsy score of the herbal composition group was 6.2±1.3, while that of the control group was 7.3±2.4 (P<0.05). At the end of week 6, the epilepsy score of the herbal composition group was 5.8±1.8, significantly lower than that of the control group (7.5±2.7) (P<0.01).

[0133] 2.3 Safety and side effect evaluation

[0134] No abnormalities were found in blood routine, liver and kidney function, electrocardiogram and other related indicators in any of the enrolled patients before and after treatment in this study.

[0135] III. Research Conclusions

[0136] The results of this study show that the traditional Chinese medicine composition of the present invention exhibits the following advantages:

[0137] (1) Effectively reduced the frequency of epileptic seizures: After 6 weeks of treatment, the frequency of epileptic seizures in the herbal composition group of the present invention was reduced by 36.1% and the epilepsy score was reduced by 1.7 points compared with the control group of herbal analogs.

[0138] (2) Few side effects: No side effects or safety events were found in the Chinese herbal composition of the present invention during the treatment period.

Claims

1. A traditional Chinese medicine composition for treating epilepsy, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Gastrodia elata 5-32 parts by weight, Fritillaria thunbergii 5-30 parts by weight, Bombyx mori 5-30 parts by weight, Magnetite 8-45 parts by weight, Bambusa textilis 3-18 parts by weight, Acanthopanax senticosus 12-60 parts by weight, and white pepper 1-5 parts by weight.

2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Gastrodia elata 7-28 parts by weight, Fritillaria thunbergii 7-24 parts by weight, Bombyx mori 7-24 parts by weight, Magnetite 10-40 parts by weight, Bambusa textilis 3-15 parts by weight, Acanthopanax senticosus 15-55 parts by weight, and white pepper 1-4 parts by weight.

3. The traditional Chinese medicine composition as described in claim 2, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Gastrodia elata 9-21 parts by weight, Fritillaria thunbergii 9-18 parts by weight, Bombyx mori 9-18 parts by weight, Magnetite 12-36 parts by weight, Bambusa textilis 4-12 parts by weight, Acanthopanax senticosus 17-48 parts by weight, and white pepper 1.2-3.6 parts by weight.

4. The traditional Chinese medicine composition as described in claim 3, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10 parts of Gastrodia elata, 10 parts of Fritillaria thunbergii, 10 parts of Bombyx mori, 15 parts of Magnetite, 5 parts of Bambusa textilis, 20 parts of Acanthopanax senticosus, and 1.5 parts of white pepper. Alternatively, 15 parts by weight of Gastrodia elata, 15 parts by weight of Fritillaria thunbergii, 15 parts by weight of Bombyx mori, 30 parts by weight of Magnetite, 10 parts by weight of Bambusa textilis, 30 parts by weight of Acanthopanax senticosus, and 2 parts by weight of white pepper. Alternatively, use 20 parts by weight of Gastrodia elata, 12 parts by weight of Fritillaria thunbergii, 12 parts by weight of Bombyx mori, 20 parts by weight of magnetite, 9 parts by weight of Bambusa textilis, 45 parts by weight of Acanthopanax senticosus, and 3 parts by weight of white pepper.

5. The traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The traditional Chinese medicine composition is a composition formed by mixing various raw materials after pulverizing them, or an extract obtained by mixing or extracting various raw materials separately, or an effective part obtained by further refining and purifying the extract, or a conventional dosage form made by adding pharmaceutically acceptable excipients to the extract / effective part.

6. A traditional Chinese medicine composition for treating epilepsy, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Gastrodia elata extract 5-32 parts by weight, Fritillaria thunbergii extract 5-30 parts by weight, Bombyx mori extract 5-30 parts by weight, Magnetite extract 8-45 parts by weight, Bambusa textilis extract 3-18 parts by weight, Acanthopanax senticosus extract 12-60 parts by weight, and Piper nigrum extract 1-5 parts by weight.

7. The traditional Chinese medicine composition according to claim 6, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 7-28 parts by weight of Gastrodia elata extract, 7-24 parts by weight of Fritillaria thunbergii extract, 7-24 parts by weight of Bombyx mori extract, 10-40 parts by weight of magnetite extract, 3-15 parts by weight of Bambusa textilis extract, 15-55 parts by weight of Acanthopanax senticosus extract, and 1-4 parts by weight of white pepper extract.

8. The traditional Chinese medicine composition according to claim 7, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 10 parts by weight of Gastrodia elata extract, 10 parts by weight of Fritillaria thunbergii extract, 10 parts by weight of Bombyx mori extract, 15 parts by weight of magnetite extract, 5 parts by weight of Bambusa textilis extract, 20 parts by weight of Acanthopanax senticosus extract, and 1.5 parts by weight of white pepper extract.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-4 and 6-8 in the preparation of a medicament for treating epilepsy.