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

Abstract

The invention provides a traditional Chinese medicine composition for treating epilepsy as well as a preparation method and application thereof, and belongs to the technical field of biological medicines. The traditional Chinese medicine composition for treating epilepsy provided by the invention comprises the following raw materials in parts by weight: 5-15 parts of rhizoma acori graminei, 3-10 parts of earthworm, 5-15 parts of codonopsis pilosula, 3-10 parts of schisandra chinensis, 3-10 parts of scutellaria baicalensis, 5-15 parts of gastrodia elata, 5-15 parts of radix bupleuri, 5-15 parts of dragon bone and 5-15 parts of poria cocos. The traditional Chinese medicine composition provided by the invention aims at epilepsy, achieves the purpose of treating epilepsy through the effects of calming liver wind, breaking phlegm, dispersing blood stasis, tonifying kidney and treating epilepsy on the basis of the treatment thought of traditional Chinese medicine that disease treatment must be essential and deep understanding of disease mechanisms, and reduces possible side effects and recurrence risks at the same time. The traditional Chinese medicine composition provided by the invention has the effects of treating epilepsy, inducing resuscitation and replenishing essence and marrow, and has the advantages of good curative effect and small side effect when being used for treating epilepsy.

Description

Technical Field

[0001] This invention belongs to the field of biomedical technology, specifically relating to a traditional Chinese medicine composition for treating epilepsy, its preparation method, and its application. Background Technology

[0002] Epilepsy is one of the top ten medical problems worldwide, and it is the second most intractable neurological disease after cerebrovascular diseases. Due to the complex pathogenesis of epilepsy, there is currently no effective cure, and the side effects and adverse reactions of antiepileptic drugs are often difficult for some patients to tolerate. Therefore, researching safe, effective, and low-side-effect antiepileptic drugs or new therapies is of significant clinical importance.

[0003] Western medicine believes that epilepsy is caused by a disorder of local neural networks and mainly uses drugs such as phenytoin sodium, phenobarbital, lamotrigine, and levetiracetam for treatment. Although the clinical efficacy is certain, there are many side effects, such as gingival hyperplasia, increased hair growth, high teratogenicity, hyperactivity, poor concentration, poor patient tolerance, and drug resistance with long-term use. Traditional Chinese medicine classifies epilepsy under the categories of "epilepsy" or "epilepsy syndrome," with symptoms such as: sudden collapse, unconsciousness, limb spasms and contractures, vocalizations, frothing at the mouth, restlessness, absence seizures, or slurred speech, cold extremities, limb convulsions, hand and foot twitching, forgetfulness, insomnia, and weakness in the lower back and knees; red tongue with a white or greasy white coating, and a wiry and thready or wiry and slippery pulse. Traditional Chinese medicine (TCM) believes that epilepsy is caused by dysfunction of the meridians, leading to loss of mental control. It is mainly caused by pathological factors such as wind, qi, fire, phlegm, and blood stasis, which disrupt the body's qi flow and cause loss of control of the spirit. The disease is located in the brain and is closely related to the liver, spleen, and kidneys. However, there is currently a lack of a TCM formula with clearly defined efficacy for treating epilepsy. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition that can effectively treat epilepsy, with good therapeutic effect, few side effects, and significant effects in improving patient symptoms, prolonging the epileptic seizure cycle and reducing seizure time.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine composition for treating epilepsy, comprising the following raw materials in parts by weight: 5-15 parts of Acorus tatarinowii, 3-10 parts of Pheretima aspergillum, 5-15 parts of Codonopsis pilosula, 3-10 parts of Schisandra chinensis, 3-10 parts of Scutellaria baicalensis, 5-15 parts of Gastrodia elata, 5-15 parts of Bupleurum chinense, 5-15 parts of fossilized bone, and 5-15 parts of Poria cocos.

[0006] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: mixing and pulverizing Acorus tatarinowii, Codonopsis pilosula, Schisandra chinensis, Scutellaria baicalensis and Bupleurum chinense to obtain mixture 1; mixing mixture 1 with water for water extraction; concentrating the extract to obtain concentrate 1; mixing and pulverizing Pheretima aspergillum, Gastrodia elata, fossilized bone and Poria cocos to obtain mixture 2; mixing mixture 2 with water for water extraction; concentrating the extract to obtain concentrate 2; mixing concentrate 1 and concentrate 2 to obtain the traditional Chinese medicine composition.

[0007] Preferably, the pulverization process involves pulverizing the material and then passing it through a 20-mesh sieve.

[0008] Preferably, the mass ratio of mixture 1 to water is 1:6~12.

[0009] Preferably, the mass ratio of mixture 2 to water is 1:6~12.

[0010] Preferably, the water extraction temperature is 100℃, the water extraction is performed 2 to 3 times, and the extraction time for each extraction is 1 to 2 hours.

[0011] Preferably, the concentration is carried out to a solid content of 10% to 12%.

[0012] Preferably, the concentration method is vacuum concentration.

[0013] Preferably, the temperature of the vacuum concentration is 60℃~80℃, and the pressure of the vacuum concentration is 0.06Mpa~0.08Mpa.

[0014] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition or the above-mentioned preparation method in the preparation of products for treating epilepsy.

[0015] The beneficial effects of this invention are: The traditional Chinese medicine composition provided by this invention targets epilepsy. Based on the TCM principle of "treating the root cause of disease" and a deep understanding of the disease mechanism, it achieves the goal of treating epilepsy by calming the liver and extinguishing wind, resolving phlegm and removing blood stasis, and tonifying the kidneys and stabilizing epilepsy, while reducing possible side effects and the risk of recurrence. The core efficacy of the TCM composition of this invention lies in addressing both the root cause and the symptoms, treating both the etiology and alleviating symptoms. Clinical studies of over 100 epilepsy patients have shown significant effects in improving patient symptoms, prolonging the epileptic seizure cycle, and reducing seizure duration; it also significantly improves patients' bowel difficulties and mood swings such as depression. The TCM composition provided by this invention has the effects of stabilizing epilepsy, opening the orifices, and replenishing essence and marrow. It has the advantages of good efficacy and few side effects in treating epilepsy and is widely loved by patients. Attached Figure Description

[0016] Figure 1 The results show the gender distribution of patients (n=100). Figure 2It is the result of the distribution of the proportion of patient age. Detailed implementation mode

[0017] The present invention provides a traditional Chinese medicine composition for treating epilepsy, comprising the following raw materials in parts by weight: 5-15 parts of Acorus tatarinowii, 3-10 parts of Pheretima, 5-15 parts of Codonopsis pilosula, 3-10 parts of Schisandra chinensis, 3-10 parts of Scutellaria baicalensis, 5-15 parts of Gastrodia elata, 5-15 parts of Bupleurum chinense, 5-15 parts of Os Draconis and 5-15 parts of Poria cocos.

[0018] The present invention has no special limitation on the specific sources of the above raw materials, and conventional commercially available products in the art can be used. In the present invention, the dosage of Acorus tatarinowii is preferably 7-13 parts, more preferably 9-11 parts; the dosage of Pheretima is preferably 5-8 parts, more preferably 6-7 parts; the dosage of Codonopsis pilosula is preferably 7-13 parts, more preferably 9-11 parts; the dosage of Schisandra chinensis is preferably 4-8 parts, more preferably 5-6 parts; the dosage of Scutellaria baicalensis is preferably 4-8 parts, more preferably 6-7 parts; the dosage of Gastrodia elata is preferably 7-12 parts, more preferably 9-10 parts; the dosage of Bupleurum chinense is preferably 7-13 parts, more preferably 9-11 parts; the dosage of Os Draconis is preferably 7-13 parts, more preferably 9-11 parts; the dosage of Poria cocos is preferably 7-13 parts, more preferably 9-10 parts.

[0019] The traditional Chinese medicine composition provided by the present invention is made from Acorus tatarinowii, Pheretima, Codonopsis pilosula, Schisandra chinensis, Scutellaria baicalensis, Gastrodia elata, Bupleurum chinense, Os Draconis and Poria cocos, and has the effects of calming the liver and suppressing hyperactive yang, resolving phlegm and removing stasis, and tonifying the kidney and stopping epilepsy. The relationship of monarch, minister, assistant and envoy of the traditional Chinese medicine composition of the present invention is as follows: Monarch drug: Gastrodia elata, sweet, flat; belonging to the liver meridian; treating dizziness and dark eyes, headache due to wind pathogen, limb numbness, hemiplegia, speech impediment, infantile epilepsy with convulsion; mainly treating headache due to wind pathogen, dizziness, dizziness with deficiency and rotation, epilepsy with strong spasm, limb contracture, speech disorder, all kinds of stroke, wind-phlegm. Pheretima is used for high fever with coma, epilepsy with convulsion, arthralgia, limb numbness, hemiplegia, cough and asthma due to lung heat, oliguria and edema, hypertension; and also treating epilepsy and throat obstruction. The two together are monarch drugs, treating to suppress liver yang and dredge wind collaterals.

[0020] Minister drug: Os Draconis is a drug for absorbing floating yang, and Poria cocos can activate the pivot of the lesser yang triple energizer, that is, it can dredge the heart mechanism; Os Draconis and Poria cocos can remove the frightened phlegm in the liver and gallbladder. All the drugs can harmonize the liver and gallbladder, coordinate the upper and lower, suppress yang and extinguish wind, use cold and warm drugs together, combine attack and supplementation, and guide according to the situation, so that the stagnant mechanism can be smooth, the rampant situation can be softened, and the effect of calming epilepsy can be achieved. Codonopsis pilosula mainly soothes the nerves; Schisandra chinensis is a genuine medicinal material in Jilin Province; Schisandra chinensis is warm in nature and sour in taste, and can enter the lung, heart, liver and kidney meridians. Its main functions are to replenish qi and astringe, nourish the heart and soothe the nerves, tonify the kidney and astringe essence, nourish yin and soothe the liver. Tonifying qi and tonifying the yin and yang of the kidney complement each other.

[0021] Adjuvant herbs: Adjuvant herbs are used to simultaneously "resolve phlegm" and "open the orifices." Acorus tatarinowii (Shi Chang Pu) opens the orifices, resolves phlegm, and refreshes the mind and improves intelligence. Scutellaria baicalensis (Huang Qin), a heat-clearing herb, has neuroprotective and anticonvulsant effects and is used to treat epilepsy and other diseases.

[0022] Guiding herb: Bupleurum is used as the guiding herb to promote Yang.

[0023] The composition provided by this invention has the effects of calming the liver and extinguishing wind, resolving phlegm and removing blood stasis, tonifying the kidney and stabilizing epilepsy. It is mainly used to treat epilepsy characterized by sudden collapse, unconsciousness, limb spasms and contractures, vocalizations, frothing at the mouth, restlessness, absent seizures, slurred speech, cold extremities, limb convulsions, hand and foot twitching, forgetfulness, insomnia, and weakness in the lower back and knees. The tongue is red with a white or greasy white coating, and the pulse is wiry and thready or wiry and slippery.

[0024] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: mixing and pulverizing Acorus tatarinowii, Codonopsis pilosula, Schisandra chinensis, Scutellaria baicalensis and Bupleurum chinense to obtain mixture 1; mixing mixture 1 with water for water extraction; concentrating the extract to obtain concentrate 1; mixing and pulverizing Pheretima aspergillum, Gastrodia elata, fossilized bone and Poria cocos to obtain mixture 2; mixing mixture 2 with water for water extraction; concentrating the extract to obtain concentrate 2; mixing concentrate 1 and concentrate 2 to obtain the traditional Chinese medicine composition.

[0025] This invention does not specifically limit the pulverization method; conventional pulverization methods in the art are acceptable. In this invention, the pulverization is preferably performed by passing the pulverized material through a 20-mesh sieve. In this invention, the mass ratio of mixture 1 to water is preferably 1:6~12, more preferably 1:8~10; the mass ratio of mixture 2 to water is preferably 1:6~12, more preferably 1:8~10. In this invention, the water extraction temperature is preferably 100℃, the number of water extractions is preferably 2~3 times, and the extraction time for each extraction is preferably 1~2 hours, more preferably 1.2~1.8 hours. In this invention, the concentration is preferably concentrated to a solid content of 10%~12%, more preferably to a solid content of 11%; the concentration method is preferably vacuum concentration, the vacuum concentration temperature is preferably 60℃~80℃, more preferably 65℃~75℃, and the vacuum concentration pressure is preferably 0.06Mpa~0.08Mpa, more preferably 0.07Mpa.

[0026] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition or the above-mentioned preparation method in the preparation of products for treating epilepsy.

[0027] The technical solution proposed in this invention can, on the one hand, promote the formation of standardized diagnostic and treatment guidelines for epilepsy using traditional Chinese medicine, and on the other hand, enable the development of traditional Chinese medicine granules with epilepsy-treating functions, which can meet market demand and meet the current need for treatment of epilepsy with clear efficacy and few side effects. The application of the traditional Chinese medicine composition provided by this invention is highly targeted, gradual, and effective in treatment, not only significantly improving symptoms but also having few toxic side effects and adverse reactions. Therefore, this invention is of great significance for the treatment of epilepsy.

[0028] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0029] Unless otherwise specified, the following embodiments are all conventional methods.

[0030] Unless otherwise specified, all materials and reagents used in the following examples are commercially available.

[0031] Example 1 A traditional Chinese medicine composition for treating epilepsy is made from the following raw materials in parts by weight: 9 parts of Acorus tatarinowii, 9 parts of Codonopsis pilosula, 5 parts of Schisandra chinensis, 6 parts of Scutellaria baicalensis, 9 parts of Bupleurum chinense, 6 parts of Pheretima aspergillum, 9 parts of Gastrodia elata, 9 parts of fossilized bone, and 9 parts of Poria cocos.

[0032] The preparation method is as follows: Mix Acorus tatarinowii, Codonopsis pilosula, Schisandra chinensis, Scutellaria baicalensis, and Bupleurum chinense, pulverize them, and pass them through a 20-mesh sieve to obtain mixture 1. Add water equal to 8 times the weight of mixture 1 and extract at 100℃ for 1.5 hours, repeating the extraction 3 times (when repeating the extraction, the extract obtained from the previous extraction needs to be filtered out, and then water equal to 8 times the weight of mixture 1 is added for extraction again). Concentrate the extract obtained from the 3 extractions under reduced pressure at 70℃ and 0.08 MPa until the solid content is 12% to obtain concentrate 1, which is then cooled to room temperature for use.

[0033] Earthworm, gastrodia, dragon bone, and poria cocos were mixed, pulverized, and passed through a 20-mesh sieve to obtain mixture 2. Water equal to 8 times the weight of mixture 2 was added and extracted at 100℃ for 1.5 hours. The extraction was repeated 3 times (when repeating the extraction, the extract obtained from the previous extraction should be filtered out, and then water equal to 8 times the weight of mixture 1 should be added for extraction). The extract obtained from the 3 extractions was concentrated under reduced pressure at 70℃ and 0.08 MPa until the solid content was 12% to obtain concentrate 2. The concentrate was cooled to room temperature for later use.

[0034] Concentrate 1 and Concentrate 2 are mixed to obtain a traditional Chinese medicine composition.

[0035] Example 2 A traditional Chinese medicine composition for treating epilepsy is made from the following raw materials in parts by weight: 5 parts of Acorus tatarinowii, 5 parts of Codonopsis pilosula, 3 parts of Schisandra chinensis, 3 parts of Scutellaria baicalensis, 5 parts of Bupleurum chinense, 3 parts of Pheretima aspergillum, 5 parts of Gastrodia elata, 5 parts of fossilized bone, and 5 parts of Poria cocos.

[0036] The preparation method is the same as in Example 1.

[0037] Example 3 A traditional Chinese medicine composition for treating epilepsy is made from the following raw materials in parts by weight: 15 parts of Acorus tatarinowii, 15 parts of Codonopsis pilosula, 10 parts of Schisandra chinensis, 10 parts of Scutellaria baicalensis, 10 parts of Bupleurum chinense, 10 parts of Pheretima aspergillum, 15 parts of Gastrodia elata, 15 parts of fossilized bone, and 10 parts of Poria cocos.

[0038] The preparation method is the same as in Example 1.

[0039] Example 4 The difference from Example 1 lies in the preparation method, which is shown below; all other aspects are the same as in Example 1: Mix Acorus tatarinowii, Codonopsis pilosula, Schisandra chinensis, Scutellaria baicalensis, and Bupleurum chinense, pulverize them, and pass them through a 20-mesh sieve to obtain mixture 1. Add water at 12 times the weight of mixture 1 and extract at 100℃ for 1 hour, and extract twice (when repeating the extraction, the extract obtained from the previous extraction needs to be filtered out, and then water at 12 times the weight of mixture 1 is added for extraction again). Concentrate the extracts obtained from the two extractions under reduced pressure at 80℃ and 0.06 MPa until the solid content is 10% to obtain concentrate 1, and cool it to room temperature for later use.

[0040] Earthworm, gastrodia, dragon bone, and poria cocos were mixed, pulverized, and passed through a 20-mesh sieve to obtain mixture 2. Water of 12 times the weight of mixture 2 was added and extracted at 100°C for 1 hour. The extraction was repeated twice (when repeating the extraction, the extract obtained from the previous extraction should be filtered out, and then water of 12 times the weight of mixture 1 should be added for extraction). The extracts obtained from the two extractions were concentrated under reduced pressure at 80°C and 0.06 MPa until the solid content was 10% to obtain concentrate 2. The concentrate was cooled to room temperature for later use.

[0041] Concentrate 1 and Concentrate 2 are mixed to obtain a traditional Chinese medicine composition.

[0042] Example 5 A traditional Chinese medicine composition for treating epilepsy is made from the following raw materials in parts by weight: 15 parts of Acorus tatarinowii, 15 parts of Codonopsis pilosula, 10 parts of Schisandra chinensis, 10 parts of Scutellaria baicalensis, 15 parts of Bupleurum chinense, 10 parts of Pheretima aspergillum, 15 parts of Gastrodia elata, 15 parts of fossilized bone, and 15 parts of Poria cocos.

[0043] The preparation method is as follows: Mix Acorus tatarinowii, Codonopsis pilosula, Schisandra chinensis, Scutellaria baicalensis, and Bupleurum chinense, pulverize them, and pass them through a 20-mesh sieve to obtain mixture 1. Add water equal to 6 times the weight of mixture 1 and extract at 100℃ for 2 hours, repeating the extraction 3 times (when repeating the extraction, the extract obtained from the previous extraction needs to be filtered out, and then water equal to 6 times the weight of mixture 1 is added for extraction again). Concentrate the extract obtained from the 3 extractions under reduced pressure at 70℃ and 0.07 MPa until the solid content is 11% to obtain concentrate 1, which is then cooled to room temperature for use.

[0044] Earthworm, gastrodia, dragon bone, and poria cocos were mixed, pulverized, and passed through a 20-mesh sieve to obtain mixture 2. Water of 6 times the weight of mixture 2 was added and extracted at 100°C for 2 hours. The extraction was repeated 3 times (when repeating the extraction, the extract obtained from the previous extraction should be filtered out, and then water of 6 times the weight of mixture 1 should be added for extraction). The extract obtained from the 3 extractions was concentrated under reduced pressure at 70°C and 0.07 MPa until the solid content was 11% to obtain concentrate 2. The concentrate was cooled to room temperature for later use.

[0045] Concentrate 1 and Concentrate 2 are mixed to obtain a traditional Chinese medicine composition.

[0046] Comparative Example 1 A traditional Chinese medicine composition is made from the following raw materials in parts by weight: 16 parts of Gastrodia elata, 12 parts of Pheretima aspergillum, 16 parts of fossilized bone, and 16 parts of Poria cocos.

[0047] The preparation method is as follows: Gastrodia elata, earthworm, dragon bone, and Poria cocos were mixed, pulverized, and passed through a 20-mesh sieve to obtain a mixture. Water equal to 8 times the weight of the mixture was added and extracted at 100°C for 1.5 hours. This extraction was repeated 3 times (for repeated extractions, the extract obtained from the previous extraction should be filtered out, and then water equal to 8 times the weight of the mixture should be added for extraction). The extract obtained from the 3 extractions was concentrated under reduced pressure at 70°C and 0.08 MPa until the solid content was 12%, and then cooled to room temperature to obtain the final product.

[0048] Comparative Example 2 A traditional Chinese medicine composition is made from the following raw materials in parts by weight: 16 parts of Acorus tatarinowii, 16 parts of Codonopsis pilosula, 12 parts of Schisandra chinensis, 12 parts of Scutellaria baicalensis, and 16 parts of Bupleurum chinense.

[0049] The preparation method is as follows: Mix Acorus tatarinowii, Codonopsis pilosula, Schisandra chinensis, Scutellaria baicalensis, and Bupleurum chinense, pulverize them, and pass them through a 20-mesh sieve to obtain a mixture. Add water equal to 6 times the weight of the mixture and extract at 100°C for 1 hour. Repeat the extraction 3 times (when repeating the extraction, filter out the extract obtained from the previous extraction and add water equal to 6 times the weight of the mixture 1 for extraction). Concentrate the extract obtained from the 3 extractions under reduced pressure at 70°C and 0.08 MPa until the solid content is 12%, and then cool to room temperature to obtain the final product.

[0050] Comparative Example 3 A traditional Chinese medicine composition is made from the following raw materials in parts by weight: 16 parts of Gastrodia elata, 12 parts of Pheretima aspergillum, 16 parts of fossilized bone, 16 parts of Poria cocos, 16 parts of Codonopsis pilosula, and 12 parts of Schisandra chinensis.

[0051] The preparation method is as follows: Gastrodia elata, earthworm, dragon bone, Poria cocos, Codonopsis pilosula, and Schisandra chinensis were mixed and pulverized to obtain a mixture. Water equal to 8 times the weight of the mixture was added and extracted at 100°C for 1 hour. The extraction was repeated twice (when repeating the extraction, the extract obtained from the previous extraction should be filtered out, and then water equal to 8 times the weight of the mixture should be added for extraction). The extract obtained from the two extractions was concentrated under reduced pressure at 60°C and 0.08 MPa until the solid content was 12%, and then cooled to room temperature to obtain the final product.

[0052] Comparative Example 4 A traditional Chinese medicine composition is made from the following raw materials in parts by weight: 16 parts Codonopsis pilosula, 16 parts dragon bone, and 16 parts Poria cocos.

[0053] The preparation method is as follows: Codonopsis pilosula, dragon bone, and Poria cocos were mixed and pulverized to obtain a mixture. Water equal to 8 times the weight of the mixture was added and extracted at 100°C for 1 hour. The extraction was repeated twice (when repeating the extraction, the extract obtained from the previous extraction should be filtered out, and then water equal to 8 times the weight of the mixture should be added for extraction). The extract obtained from the two extractions was concentrated under reduced pressure at 60°C and 0.08 MPa until the solid content was 12%, and then cooled to room temperature to obtain the final product.

[0054] Experimental Example 1 Two hundred adult SD rats (half male and half female), weighing 200±20g, were used. The rats were acclimatized for one week prior to the experiment, during which they were fed pelleted feed and had free access to water.

[0055] (1) Modeling The rats were injected intraperitoneally with a sub-dose of pentylenetetrazol (PTZ) (35 mg / kg) every other day and observed for 1 hour. The rats were assessed for epileptic seizures according to the Racine grading criteria shown in Table 1.

[0056] Table 1 Racine Grading Standards

[0057] Three or more grade V seizures during the modeling process were considered a successful model. If a rat experienced persistent grade V seizures, it was given 0.2 ml of 10% chloral hydrate to alleviate the seizures. The modeling period was 29 days, with 15 intraperitoneal injections of PTZ. Rats that did not meet the seizure grade requirements or that had died were discarded.

[0058] (2) Grouping and administration Ninety adult epileptic rats were randomly divided into nine groups of ten each: epilepsy model group, perampanel group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, and Comparative Example 4 group. Each group of rats was labeled with picric acid solution.

[0059] Seven groups of animals, including Example 1, Example 2, Example 3, Comparative Example 1, Comparative Example 2, Comparative Example 3 and Comparative Example 4, were administered 6 g / kg daily. -1 The dosages were administered by gavage once in Examples 1-3 and Comparative Examples 1-4. The perampanel group was administered 8 mg / kg solution by gavage daily, while the epilepsy model group was given the same volume of physiological saline, for a total of 9 weeks.

[0060] (3) Specimen collection From the start of modeling, the rats' epileptic seizures were observed and recorded daily using imaging equipment.

[0061] (4) Observation indicators The epileptic seizure situation includes the seizure grade associated with the seizure and the seizure latency period.

[0062] Based on the Racine grading criteria shown in Table 1, the epileptic seizure behavior of the model rats within 30 minutes after PTZ injection was observed and recorded, and the data from the last day before treatment and after treatment were compared. The results are shown in Tables 2 and 3.

[0063] Table 2. Seizure levels before and after drug intervention.

[0064] Table 3. Latency period of epileptic seizures after drug intervention ( ±S)

[0065] As shown in Table 2, before drug intervention, there was no significant difference in the seizure severity among the model group, positive control group, and rats in Examples 1-3 and Comparative Examples 1-4. After gavage treatment, compared with the epilepsy model group, the seizure severity of rats in Examples 1-3 was significantly reduced. Comparative Examples 1-4 also showed a reduction in seizure severity, but the effect was relatively weaker.

[0066] As shown in Table 3, after intervention with the experimental drugs, compared with the epilepsy model group, the latency period of epileptic seizures in rats in Examples 1-3 was significantly prolonged. Comparative Examples 1-4 also showed a prolonged latency period of epileptic seizures in rats, but the effect was relatively weak.

[0067] Experimental Example 2 Clinical observations over 20 years have shown that the traditional Chinese medicine composition provided by this invention has significant therapeutic effects on epilepsy. The following is a statistical summary of 100 clinical cases from the medical records of the Affiliated Hospital of Changchun University of Traditional Chinese Medicine, compiled from January 1, 2021 to August 1, 2025: Clinical medical record collection details: Distribution by year is shown in Table 4; patient gender distribution is shown in... Figure 1 As shown; patient age statistics are as follows. Figure 2 As shown; Table 4. Clinical medical record collection status

[0068] Table 5 shows the circumstances under which the traditional Chinese medicine composition obtained in Example 1 is exempt from toxicological research data; moreover, the traditional Chinese medicine composition provided by this invention does not contain any of the eighteen incompatibilities or nineteen taboos. The dosage of the medicinal ingredients in the prescription does not exceed the limits specified in the drug standards, as detailed in Table 6. This indicates that all the medicinal ingredients in the traditional Chinese medicine composition of this invention comply with the regulations of the Chinese Pharmacopoeia and have good safety.

[0069] Table 5 explains the exemptions from toxicology studies.

[0070] Table 6 shows that the dosage of medicinal ingredients in the prescription does not exceed the limits specified in the drug standards.

[0071] Analysis of combined medication or concomitant treatment: medication was administered according to the routine guidelines for the diagnosis and treatment of epilepsy (2023 revised edition).

[0072] Treatment course statistical analysis: All medication records were treated for 15 days as one course of treatment. Clinical prescription: Gastrodia elata 9g, Pheretima aspergillum 6g, Os draconis 9g, Codonopsis pilosula 9g, Poria cocos 9g, Acorus tatarinowii 9g, Schisandra chinensis 5g, Bupleurum chinense 9g and Scutellaria baicalensis 6g were the daily dosage, twice a day, decocted in water and taken orally.

[0073] Therapeutic effect evaluation: Among 100 patients with epileptic symptoms, 79% reported an overall improvement in their condition (n=79), 21% reported stable symptoms (n=21), and no adverse reactions were reported, as shown in Table 7.

[0074] Table 7 Statistical results of 100 epilepsy patients

[0075] The efficacy was evaluated for the following four symptoms: delayed interictal period; shortened seizure duration; improvement of post-epileptic depression and anxiety; and improvement of insomnia. Results showed that 67% of patients experienced prolonged interictal period (n=67); 70% experienced shortened seizure duration (n=70); 61% experienced reduced post-epileptic depression and anxiety (n=61); and 70% experienced reduced insomnia symptoms (n=70).

[0076] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating epilepsy, characterized in that, The ingredients include the following ingredients by weight: 5-15 parts of Acorus tatarinowii, 3-10 parts of Pheretima aspergillum, 5-15 parts of Codonopsis pilosula, 3-10 parts of Schisandra chinensis, 3-10 parts of Scutellaria baicalensis, 5-15 parts of Gastrodia elata, 5-15 parts of Bupleurum chinense, 5-15 parts of fossilized bone, and 5-15 parts of Poria cocos.

2. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, The process includes the following steps: Acorus tatarinowii, Codonopsis pilosula, Schisandra chinensis, Scutellaria baicalensis, and Bupleurum chinense are mixed and pulverized to obtain mixture 1. Mixture 1 is then mixed with water for water extraction, and the extract is concentrated to obtain concentrate 1. Pheretima aspergillum, Gastrodia elata, fossilized bone, and Poria cocos are mixed and pulverized to obtain mixture 2. Mixture 2 is then mixed with water for water extraction, and the extract is concentrated to obtain concentrate 2. Concentrate 1 and concentrate 2 are then mixed to obtain a traditional Chinese medicine composition.

3. The preparation method according to claim 2, characterized in that, The pulverization process involves pulverizing the material and then passing it through a 20-mesh sieve.

4. The preparation method according to claim 2, characterized in that, The mass ratio of mixture 1 to water is 1:6~12.

5. The preparation method according to claim 2, characterized in that, The mass ratio of mixture 2 to water is 1:6~12.

6. The preparation method according to claim 2, characterized in that, The water extraction temperature is 100℃, the water extraction is performed 2 to 3 times, and the extraction time for each extraction is 1 to 2 hours.

7. The preparation method according to claim 2, characterized in that, The concentration is to concentrate the product to a solids content of 10% to 12%.

8. The preparation method according to claim 2, characterized in that, The concentration method is vacuum concentration.

9. The preparation method according to claim 8, characterized in that, The temperature for vacuum concentration is 60℃~80℃, and the pressure for vacuum concentration is 0.06Mpa~0.08Mpa.

10. The use of the traditional Chinese medicine composition of claim 1 or the preparation method of any one of claims 2 to 9 in the preparation of a product for treating epilepsy.