A pharmaceutical composition for treating pediatric epilepsy and its use

Abstract

The present invention belongs to the field of medical technology, and specifically relates to a pharmaceutical composition for treating epilepsy and its use. The pharmaceutical composition comprises pachymic acid and rhynchophylline. Pharmacological experiments have shown that the pharmaceutical composition of the present invention has a synergistic protective effect on neurons in a neuronal epilepsy cell model, and has no toxic side effects, and has good clinical application prospects. The natural product monomers used in the pharmaceutical composition of the present invention are widely available and can be produced by mature methods, making the pharmaceutical composition of the present invention convenient for industrial large-scale production. In addition, by adding a pharmaceutically acceptable carrier, the pharmaceutical composition of the present invention is made into a conventional oral preparation, so that the drug treatment is stable, the efficacy of the drug is improved, and it is easy to take.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology, and specifically relates to a pharmaceutical composition for treating epilepsy (especially pediatric epilepsy) and its use. Background Art

[0002] Epilepsy, commonly known as "epilepsy", is a brain disease caused by a variety of causes. Its pathogenesis is that the brain has a short-term dysfunction due to sudden abnormal discharges of brain neurons. The clinical manifestations are characterized by paroxysmal, transient, repetitive and stereotyped. Due to the different starting sites, scopes and transmission methods of abnormal discharges, the clinical manifestations of epileptic seizures are complex and diverse, and can be manifested as paroxysmal movement, sensation, autonomic nerves, consciousness and mental disorders or both. There are many types of this disease, and patients mainly show limb twitching, changes in consciousness, special behaviors, etc. If not treated in time, long-term continuation of this state can easily lead to irreversible damage to the patient's central nervous system, seriously affecting the patient's quality of life. The causes of epilepsy are complex and diverse, including genetic factors, brain diseases, trauma, etc. According to the causes of epilepsy, it can be divided into primary and secondary epilepsy; according to the type of epileptic seizure, it can be divided into generalized tonic-clonic seizures, partial seizures, absence seizures, etc.

[0003] The incidence of epilepsy is bimodal, with the highest incidence in children and the elderly. 66% of epilepsy patients develop the disease before the age of 30. Studies have shown that the high incidence of epilepsy in children is mainly due to birth trauma, neonatal asphyxia, congenital malformations and other reasons.

[0004] At present, there is no drug or treatment method that can completely and effectively treat epilepsy. Anti-epileptic drugs used in clinical practice are divided into traditional drugs and new drugs. Traditional anti-epileptic drugs include phenobarbital, carbamazepine, phenytoin sodium, and sodium valproate; new anti-epileptic drugs include Trileptin (oxcarbazepine), Lamictal (lamotrigine), and Keppra (levetiracetam). Levetiracetam is the most widely used new anti-epileptic drug in clinical practice, but in clinical application, it is inconvenient to carry and take, the dosage is large, the cost is high, and the effect is not satisfactory.

[0005] In recent years, the efficacy of traditional Chinese medicine in treating various types of epilepsy has been continuously confirmed, and its position in the comprehensive treatment model of epilepsy has become increasingly important. Various studies on the treatment of epilepsy with traditional Chinese medicine have also been carried out extensively and in depth, and the mechanism of Chinese medicine has gradually been revealed. Traditional Chinese medicine decoctions are heavy and may irritate the gastrointestinal tract, and are inconvenient to carry, resulting in poor compliance with medication and making it difficult for patients to persist in long-term use. At the same time, due to the large number of traditional Chinese medicine flavors in traditional Chinese medicine prescriptions, their costs and safety risks are high, which is not conducive to effective quality control and large-scale production.

[0006] In view of this, it is imperative to use modern pharmacological research methods to conduct in-depth research and screening of the active monomer components of natural products in classic Chinese medicines for treating epilepsy, and then develop drugs for treating epilepsy with good efficacy, few side effects and easy use. Summary of the invention

[0007] The purpose of the present invention is to provide a safe, effective, convenient and economical pharmaceutical composition for epilepsy patients, and to provide a new idea for the clinical treatment of epilepsy (especially pediatric epilepsy) and the modernization of traditional Chinese medicine.

[0008] Specifically, the present invention is realized through the following technical solutions:

[0009] In a first aspect, the present invention provides a pharmaceutical composition for treating epilepsy, the pharmaceutical composition comprising pachymic acid and rhynchophylline.

[0010] As an optional mode, in the above-mentioned pharmaceutical composition, the pharmaceutical composition consists of pachymic acid and rhynchophylline.

[0011] As an optional manner, in the above pharmaceutical composition, the weight ratio of the pachymic acid to the rhynchophylline is in the range of 1-100:1-100.

[0012] As an optional manner, in the above pharmaceutical composition, the weight ratio of the pachymic acid to the rhynchophylline is in the range of 1-50:1-50.

[0013] As an optional manner, in the above pharmaceutical composition, the weight ratio of the pachymic acid to the rhynchophylline is in the range of 1-10:1-10.

[0014] As an optional manner, in the above pharmaceutical composition, the weight ratio of the pachymic acid to the rhynchophylline is in the range of 1:10-100.

[0015] As an optional method, in the above-mentioned pharmaceutical composition, the combined use of pachymic acid and rhynchophylline has a significant synergistic effect and can significantly enhance the effect of the pharmaceutical composition in treating epilepsy.

[0016] Those skilled in the art can anticipate that the two natural product monomer components of pachymic acid and rhynchophylline, the active ingredients used in the pharmaceutical composition of the present invention, can be extracted and separated from traditional Chinese medicines containing the above-mentioned active ingredients by a biological purification method, or can be directly purchased from commercially available products.

[0017] In addition, those skilled in the art can anticipate that the two natural product monomer components, pachymic acid and rhynchophylline, used in the pharmaceutical composition of the present invention can also be administered sequentially, concomitantly or simultaneously in different pharmaceutical preparations.

[0018] In a second aspect, the present invention provides a pharmaceutical preparation for treating epilepsy, wherein the pharmaceutical preparation comprises the pharmaceutical composition described in the first aspect, and a pharmaceutically acceptable carrier or excipient.

[0019] As an optional mode, in the above-mentioned pharmaceutical preparation, the pharmaceutical preparation is an oral dosage form.

[0020] As an optional mode, in the above-mentioned pharmaceutical preparation, the oral dosage form is a capsule, a tablet, a granule or an oral liquid, preferably a tablet or a capsule.

[0021] The pharmaceutically acceptable carrier or excipient refers to a conventional drug carrier in the field of pharmaceutical preparations, selected from one or more of fillers, binders, disintegrants, lubricants, suspending agents, wetting agents, pigments, flavoring agents, solvents, and surfactants.

[0022] The filler of the present invention includes but is not limited to starch, microcrystalline cellulose, sucrose, dextrin, lactose, powdered sugar, glucose, etc.; the lubricant includes but is not limited to magnesium stearate, stearic acid, sodium chloride, sodium oleate, sodium lauryl sulfate, poloxamer, etc.; the binder includes but is not limited to water, ethanol, starch slurry, syrup, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, sodium alginate, polyvinyl pyrrolidone, etc.; the disintegrant includes but is not limited to starch effervescent mixture, i.e. sodium bicarbonate and citric acid, tartaric acid, low-substituted hydroxypropyl cellulose, etc.; the suspending agent includes but is not limited to polysaccharides such as acacia gum, agar, alginic acid, cellulose ether and carboxymethyl chitosan, etc.; the solvent includes but is not limited to water, a balanced salt solution, etc.

[0023] The above-mentioned various dosage forms can be prepared according to conventional processes in the field of pharmaceutical preparations.

[0024] In a third aspect, the present invention provides use of the pharmaceutical composition described in the first aspect in preparing a drug for treating epilepsy.

[0025] As an optional mode, in the above use, the epilepsy is childhood epilepsy.

[0026] As an alternative, in the above use, the epilepsy is partial epilepsy, generalized epilepsy, absence epilepsy, myoclonic epilepsy or reflex epilepsy.

[0027] It should be understood that within the scope of the present invention, the above-mentioned technical features of the present invention and the technical features specifically described below (such as embodiments) can be combined with each other to form a new or preferred technical solution. Due to space limitations, they will not be described one by one here.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] (1) Based on the classical Chinese medicinal materials for the clinical treatment of epilepsy, the present invention selects two natural product monomers through a large number of pharmacological experimental screenings, and combines them in a specific ratio to prepare a pharmaceutical composition capable of treating epilepsy, providing a new idea for the modernization of traditional Chinese medicine.

[0030] (2) Pharmacological experiments have shown that the pharmaceutical composition of the present invention has a synergistic protective effect on neurons in a neuronal epilepsy cell model, has no toxic side effects, and has good clinical application prospects.

[0031] (3) The natural product monomers used in the pharmaceutical composition of the present invention are widely available and can be produced by mature methods, making the pharmaceutical composition of the present invention convenient for industrial large-scale production. In addition, by adding a pharmaceutically acceptable carrier, the pharmaceutical composition of the present invention is made into a conventional oral preparation, which makes the drug treatment stable, improves the efficacy of the drug, and is easy to take. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 : Representative microscopic photographs of neuronal cell morphology.

[0033] Figure 2 : Representative microscopic photos of neuronal cell identification results.

[0034] Figure 3 :Pachymic acid (PA, Figure 3 A) and rhynchophylline (Rhy, Figure 3 B) The results of the cytotoxic concentration exploration experiment.

[0035] Figure 4 :Western Blot was used to detect the expression changes of epileptic neuron-related proteins P-gp and Bax.

[0036] Figure 5 :The effects of Pachycolic acid (PA) and Rhynchophylline (Rhy) on cell activity in a cell epilepsy model.

[0037] Figure 6 :Western Blot was used to detect the effects of pachymic acid and rhynchophylline on the expression changes of neuronal cell-related proteins.

[0038] Figure 7 :Effects of Pachymic Acid and Rhynchophylline on Reactive Oxygen Species (ROS) in Neuronal Cells Figure 7 A) and MDA( Figure 7 B) The impact of content.

[0039] Figure 8 :Effects of Pachymic Acid and Rhynchophylline on TNF-α( Figure 8 A) and IL-1β ( Figure 8B) The effect of content. DETAILED DESCRIPTION

[0040] The present invention will be further described with reference to specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the scope of the present invention.

[0041] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0042] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples are commercially available products unless otherwise specified.

[0043] Unless otherwise specified, all percentages and parts in the present invention are percentages and parts by weight.

[0044] Example

[0045] 1. Experimental purpose:

[0046] An in vitro epilepsy cell model was constructed and the protective effects of pachymic acid and rhynchophylline on neuronal cells were studied.

[0047] 2. Experimental methods:

[0048] 2.1 Isolation and culture of hippocampal neurons

[0049] (1) Take newborn mice that are 24 hours old and immerse them in alcohol for 10 minutes for disinfection;

[0050] (2) Remove the brain by decapitation and place it in a glass dish containing pre-cooled D-Hanks buffer, and remove the bilateral hippocampi;

[0051] (3) Cut the hippocampal tissue into small pieces of about 1 mm x 1 mm x 1 mm, transfer them to a sterile centrifuge tube, add 5 volumes of 0.125% trypsin digestion solution, place in a 37°C constant temperature water tank for water bath digestion for 20 min, and gently mix the digestion solution every 5 min;

[0052] (4) After digestion, complete medium (DMEM + 10% serum + double antibody + 2% B27) was added to terminate the digestion, and the cells were gently pipetted 20-30 times and centrifuged at 1000 r / min for 5 min;

[0053] (5) Discard the supernatant, add 10 mL of complete medium to resuspend, filter through a 200-mesh sieve, take out 100 μL of cell suspension, add 20 μL of trypan blue staining for counting;

[0054] (6) According to the counting results, adjust the cell density to 1x10 6 / mL, inoculated into a well plate pre-coated with 0.01% poly-lysine;

[0055] (7) After the cells were cultured in a cell culture incubator at 37°C and 5% CO2 for 10 h, the medium was replaced with serum-free culture medium;

[0056] (8) After 48 h of in vitro culture, Ara-C working solution was added to inhibit excessive proliferation of non-neuronal cells and aspirated after 24 h. Subsequently, half of the solution was replaced every 3 days and culture was continued for 10 days. When the neuronal cells were mature, they could be used for subsequent experiments.

[0057] (9) Preparation method of main reagents

[0058] Preparation of inoculation solution: According to the volume ratio of fetal bovine serum to DMEM culture medium of 1:10, add 1% volume fraction of double antibody storage solution (penicillin + streptomycin) under sterile conditions.

[0059] Preparation of neuronal cell maintenance culture medium (serum-free culture medium): Neurobasal; 2% B-27; 1% 0.5mmol / L L-glutamine; 1% penicillin-streptomycin. Prepare 3 hours before changing the medium and place at 4°C for use.

[0060] Preparation of Cytarabine Solution:

[0061] Ara-C stock solution: weigh 0.01 g of Ara-C and dissolve it in 25 mL of deionized water to make a 1.4 mmol / L stock solution. Filter through a 0.22 μm positive pressure filter and store in a -20°C refrigerator.

[0062] Ara-C working solution: Ara-C stock solution and serum-free culture medium are prepared at a volume ratio of 1:3 to a solution with a concentration of 100μg / mL. When used, dilute the culture medium to 100μg / mL Ara-C at a volume ratio of 40:1, that is, the working concentration of Ara-C is 2.5μg / mL.

[0063] 2.2 Cell identification

[0064] (1) Neuronal cells were seeded on a 24-well plate coated with 0.01% poly-lysine, and after 7 days of isolation and culture as described above, neuronal cells were identified by immunofluorescence, using the identification indicators βIII Tubulin and NeuN;

[0065] (2) Fix cells with 4% paraformaldehyde for 20 min and wash with PBS three times, 5 min each time;

[0066] (3) 0.1% TritonX-100 treatment for 15 min, followed by PBS washing three times, 5 min each time;

[0067] (4) 3% H2O2 treatment for 10 min, followed by PBS washing three times, 5 min each time;

[0068] (5) 5% BSA blocking for 30 min;

[0069] (6) Dilute the primary antibody 1:200 in PBS, incubate overnight at 4°C, and wash three times with PBS, 5 min each time;

[0070] (7) Dilute the secondary antibody with PBS at 1:200, incubate at 37°C for 2 h, and wash with PBS three times, 5 min each time;

[0071] (8) DAPI staining of nuclei, washing with PBS three times, 5 min each time;

[0072] (9) Observation under fluorescence microscope;

[0073] 2.3 Experimental study on cytotoxic concentration of pachymic acid (PA) and rhynchophylline (Rhy)

[0074] (1) Neuronal cells were inoculated in 96-well plates and cultured for 10 days. The control group was replaced with normal culture medium, and the experimental group was replaced with culture medium containing drugs at different final concentrations (the pachymic acid group was replaced with culture medium containing 0.5, 1, 5, 10, 20, 50, 100, 200, and 500 μM pachymic acid, and the rhynchophylline group was replaced with culture medium containing 1, 5, 10, 20, 50, 100, 200, 500, and 1000 μM rhynchophylline);

[0075] (2) Continue culturing for 48 h, with triplicate wells in each group;

[0076] (3) After 48 h of treatment, 10 μL / well of CCK-8 reaction solution was added to each well inoculated with cells, and the wells without cells were used as blank wells (culture medium + reaction solution). After incubation for an appropriate time, the absorbance at 450 nm was measured on a microplate reader;

[0077] 2.4 Establishment of neuronal epilepsy cell model

[0078] (1) The hippocampal neurons seeded into 6-well plates and cultured for 10 days were divided into a control group and a model group, with 3 parallel wells in each group;

[0079] (2) The control group was cultured with normal cell extracellular fluid for 3 hours and then restored to the maintenance medium. The model group was cultured with magnesium-free extracellular fluid for 3 hours and then restored to the maintenance medium for another 48 hours.

[0080] (3) After 48 h of treatment, the cell pellets were collected;

[0081] (4) Western Blot was used to detect the expression changes of P-gp protein and Bax protein in epileptic neuron cells, and each sample was loaded in triplicate.

[0082] 2.5CCK8 detection of the effects of pachymic acid and rhynchophylline on cell activity in epilepsy models

[0083] (1) Hippocampal neurons seeded into 96-well plates and cultured for 10 days were divided into a control group, a model group, a PA group with three concentrations (1, 5, and 10 μM), a Rhy group with three concentrations (10, 50, and 100 μM), and a PA and Rhy combination drug group with three corresponding concentrations, with three replicates in each group.

[0084] (2) The control group was cultured with normal cell extracellular fluid for 3 hours and then restored to maintenance medium. The model group was cultured with magnesium-free extracellular fluid for 3 hours and then restored to maintenance medium. The drug group was cultured with magnesium-free extracellular fluid for 3 hours and then added with medium containing PA and Rhy in each well and continued to culture for 48 hours.

[0085] (3) After 48 h of treatment, 10 μL of CCK-8 reaction solution was added to each well inoculated with cells, and the wells without cells were used as blank wells (culture medium + reaction solution). After incubation for an appropriate time, the absorbance at 450 nm was measured on a microplate reader.

[0086] 2.6 Cell treatment

[0087] (1) Hippocampal neurons seeded into 6-well plates and cultured for 10 days were divided into control group (Control), model group (Model); model + pachymic acid group (5 μmol / L PA); model + rhynchophylline group (50 μmol / L Rhy); model + pachymic acid + rhynchophylline group (5 μmol / LPA + 50 μmol / L Rhy);

[0088] (2) The control group was cultured with normal cell extracellular fluid for 3 hours and then restored to maintenance medium. The model group was cultured with magnesium-free extracellular fluid for 3 hours and then restored to maintenance medium for 48 hours; the model + pachymic acid group was cultured with magnesium-free extracellular fluid for 3 hours and then replaced with culture medium containing 5μM PA; the model + rhynchophylline group was cultured with magnesium-free extracellular fluid for 3 hours and then replaced with culture medium containing 50μM Rhy; the model + pachymic acid + rhynchophylline group was cultured with magnesium-free extracellular fluid for 3 hours and then replaced with culture medium containing 5μM PA + 50μM Rhy and then continued to culture for 48 hours;

[0089] (3) After 48 h of treatment, the cell pellet and supernatant were collected for testing.

[0090] 2.7 Other experimental methods

[0091] Western Blot, reactive oxygen species (ROS), lipid oxidation (MDA) and ELISA were all performed using conventional methods in the art.

[0092] 3. Data Processing and Statistical Analysis Methods

[0093] The data were expressed as mean ± standard deviation, and the results were analyzed using SPSS17.0 statistical software. One-way analysis of variance was used for comparison among multiple groups, and t-test was used for comparison between two groups. P < 0.05 indicated statistically significant differences.

[0094] 4. Experimental Results

[0095] 4.1 Observation of neuronal cell morphology

[0096] The primary hippocampal neurons that have just been inoculated are round or oval, suspended, small and translucent. They begin to adhere to the wall after 2 hours of culture and are basically attached to the wall after 24 hours. After 3-5 days of culture, the cell processes increase, elongate and thicken, and the cell bodies are plump. After 7-10 days, the neuron cell bodies are plump, with obvious halos around them, more and longer processes, and they migrate close to each other, starting to form colony-like neurons, which are suitable for related research. Representative microscope photos of neuronal cell morphology are shown below. Figure 1 shown.

[0097] 4.2 Neuronal cell identification

[0098] Immunofluorescence results showed that βIII Tubulin and NeuN were positively expressed, and they were identified as neuronal cells. Figure 2 shown.

[0099] 4.3 Exploration of cytotoxic concentrations of Pachycolic acid (PA) and Rhynchophylline (Rhy)

[0100] The CCK8 results showed that pachymic acid below 10 μM and rhynchophylline below 100 μM had no significant cytotoxicity. Figure 3 A and Figure 3 As shown in B.

[0101] In subsequent experiments, three PA groups with different concentrations (1, 5, and 10 μM), three Rhy groups with different concentrations (10, 50, and 100 μM), and three PA and Rhy combination drug groups with corresponding concentrations (1 μM PA+100 μM Rhy, 2 μM PA+20 μM Rhy, 5 μM PA+50 μM Rhy, and 10 μM PA+100 μM Rhy) were selected for formal experiments.

[0102] 4.4 Establishment of neuronal epilepsy cell model

[0103] Western Blot was used to detect the expression changes of epileptic neuron-related proteins P-gp and Bax. The results showed that after induction with magnesium-free extracellular fluid, the expression of P-gp and Bax proteins increased significantly, and the difference was statistically significant (P < 0.05). Figure 4 4.5 Effects of Pachymarine (PA) and Rhynchophylline (Rhy) on the cell activity of epilepsy model CCK8 results showed that Pachymarine and Rhynchophylline had a protective effect on neuronal cell damage induced by magnesium-free extracellular fluid, which was concentration gradient dependent. The Pachymarine and Rhynchophylline compound drug group had a synergistic neuronal protective effect within a certain concentration range. The results are shown in Figure 5 shown.

[0104] To demonstrate the systemic protective effects of pachymic acid (PA) and rhynchophylline (Rhy) on neuronal cell damage in a cell epilepsy model, the inventors Figure 5 The original experimental data corresponding to the experimental results in the paper were used to calculate the synergistic effect of Pachycolic acid and Rhynchophylline in the ratio of 1:10, 1:50 and 1:100 using Jin Zhengjun's synergistic index formula.

[0105] The synergy index is determined by the Kim Jong-gwan q value method, and the q value is obtained by the following formula: q = P A+B / (P A +P B -P A ×P B ). Where P A , P B and P A+B These are the improvement ratios of neuron protection in drug group A, drug group B, and the combination of the two drugs. q<1 indicates that the two drugs produce an antagonistic effect after combination; q>1 indicates that the two drugs produce a synergistic effect after combination; q=1 indicates that the two drugs produce an additive effect after combination. Among them, the improvement ratio = (cell viability of the drug group - cell viability of the model group) / (cell viability of the blank group - cell viability of the model group).

[0106] The specific results are shown in Table 1 below. The experimental results show that under the three calculated ratios, the combination of Pachycolic acid and Rhynchophylline showed significant synergistic effects.

[0107] Table 1: Synergistic effect of Pachycolic acid and Rhynchophylline in combination at ratios of 1:10, 1:50 and 1:100

[0108]

[0109] 4.6P-gp protein and Bax protein

[0110] Western Blot was used to detect the changes in the expression of neuronal cell-related proteins induced by magnesium-free extracellular fluid, pachymic acid and rhynchophylline. The detection indicators were: P-gp protein and Bax protein; the results showed (see Figure 6 ), compared with the control group, the expression of P-gp protein and Bax protein in the model group induced by magnesium-free extracellular fluid was significantly increased, and the difference was statistically significant (P < 0.05); compared with the model group, the expression of P-gp protein and Bax protein in the pachymic acid and rhynchophylline and their combination group was decreased, and the difference was statistically significant (P < 0.05).

[0111] 4.7 Reactive oxygen species and lipid oxidation

[0112] The results of the determination of ROS and MDA contents showed (see Figure 7 ), compared with the control group, the expression of reactive oxygen species and the content of metabolite MDA in the model group induced by magnesium-free extracellular fluid increased, and the difference was statistically significant (P < 0.05); the application of pachymic acid and rhynchophylline and their combined application group improved the level of reactive oxygen species and reduced the content of MDA; the difference was statistically significant (P < 0.05), suggesting that pachymic acid and rhynchophylline may play a protective role in neuronal cells through antioxidant effect.

[0113] 4.8 TNF-α and IL-1β

[0114] The results of the determination of the contents of reactive oxygen species TNF-α and IL-1β showed (see Figure 8 ), compared with the control group, the levels of inflammatory factors TNF-α and IL-1β in the model group induced by magnesium-free extracellular fluid increased, while the levels of TNF-α and IL-1β in the pachymic acid and rhynchophylline and their combination groups were lower than those in the model group, and the differences were statistically significant (P<0.05), suggesting that pachymic acid and rhynchophylline may play a protective role in neuronal cells through anti-inflammatory effects.

[0115] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A pharmaceutical composition for treating epilepsy, characterized in that: The pharmaceutical composition consists of pachymic acid and rhynchophylline, and the ratio of the pachymic acid to the rhynchophylline is 1 μmol / L:10 μmol / L, 1 μmol / L:50 μmol / L or 1 μmol / L:100 μmol / L.

2. A pharmaceutical preparation for treating epilepsy, characterized in that: The pharmaceutical preparation comprises the pharmaceutical composition according to claim 1 and a pharmaceutically acceptable carrier or excipient.

3. The pharmaceutical preparation according to claim 2, characterized in that: The pharmaceutical preparation is an oral dosage form.

4. The pharmaceutical preparation according to claim 3, characterized in that: The oral dosage form is capsule, tablet, granule or oral liquid.

5. Use of the pharmaceutical composition according to claim 1 in preparing a drug for treating epilepsy.

6. The use according to claim 5, characterized in that: The epilepsy is childhood epilepsy.

7. The use according to claim 5, characterized in that: The epilepsy is partial epilepsy or generalized epilepsy.

8. The use according to claim 5, characterized in that: The epilepsy is absence epilepsy, myoclonic epilepsy or reflex epilepsy.

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