CN105497417A

CN105497417A - Traditional Chinese medicine preparation for treating epilepsy as well as preparation method and application of traditional Chinese medicine preparation

Info

Publication number: CN105497417A
Application number: CN201510981924.9A
Authority: CN
Inventors: 刘可
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-12-22
Filing date: 2015-12-22
Publication date: 2016-04-20

Abstract

The invention discloses a traditional Chinese medicine preparation for treating epilepsy as well as a preparation method and an application of the traditional Chinese medicine preparation. The traditional Chinese medicine preparation for treating epilepsy comprises raw materials in parts by weight as follows: centipedes, vinegar processed Chinese thorowax roots, pinellia tuber, herbs of asiatic striga, motherwort fruits, 5-15 parts of Boor's mustard herbs, pittosporumlike nothapodytes, Japanese raspberry roots, septemlobate kalopanax, rhizoma dioscoreae septemlobae, bottle gourd peel, perfoliote knotweed herbs and szechuan lovage rhizomes. During preparation, a sweetening agent, an antioxidant and a preservative are added, wherein the sweetening agent is cane sugar, xylitol, stevioside or acesulfame-K, the antioxidant is butylated hydroxytoluene, butylated hydroxyanisole or tert-butylhydroquinone. The raw materials perform a synergistic function, has the functions of fast efficacy, definite curative effect, high safety and simple pharmacy and can effectively relieve coughs, eliminate phlegm and prevent asthma; the preparation process is simple and environment-friendly; the traditional Chinese medicine preparation can effectively relieve symptoms such as visual hallucination, dizziness, coma, restlessness and the like caused by epilepsy, does not have toxic or side effects and provides a new selection for clinically relieving various symptoms caused by epilepsy.

Description

A kind of Chinese medicine preparation for the treatment of epilepsy and its production and use

Technical field

The present invention relates to medical applications technical field, specifically a kind of Chinese medicine preparation for the treatment of epilepsy and its production and use.

Background technology

Epilepsy, it is commonly called as " sheep is insane crazy ", just on the books in the Huangdi's Internal Classics before in two thousand 2 hundred.People are not strange to this disease, usually by popular being called " convulsion " of people.Epilepsy is the electric discharge of cerebral neuron paroxysmal abnormality, causes a kind of chronic disease of of short duration cerebral disorder.And epilepsy refers to that abnormal and excessive supersynchronousization of brain neuron is discharged the clinical picture caused.Neuron position in the brain due to paradoxical discharge is different and have diversified performance, can be Yun Dong ﹑ Gan Jue ﹑ spirit or autonomic nerve, with or without the change of consciousness and vigilance degree.To the really asymptomatic clinically and person that only occurs paradoxical discharge on electroencephalogram (EEG), be not called epilepsy.Because epilepsy is the illness of brain, neuron (as nervi trigeminus unit or the spinal cord anterior horn neurons) exception at other positions of health and over-discharge do not belong to epilepsy.

During human body rest, the discharge frequency of a cerebral cortex pyramidal cell generally remains between 1-10 time/s, and in epileptic focus, the discharge frequency of one group of pathological neuronal can up to hundreds of times per second.The reignition of epilepsy stove cell mass high frequency, the neuron that its aixs cylinder is contacted directly produces larger postsynaptic potential, thus produce propagation continuously, until inhibitory action (comprises the activity of inhibitory nerve cell around epilepsy, glial cell is to the recovery of excitatory substance, and the participation of the outer dampening mechanism of focus) outbreak is stopped.Various forms is caused to show effect due to route of transmission and scope difference.Epilepsy sexual activity may only involve the cerebral cortex in a region and no longer spread, and causes simple partial seizure; Excited front central authorities return or postcentral gyrus by electric discharge after increasing of extracellular potassium ion and be transmitted to contiguous neuron, cause jacksonian epilepsy; Epilepsy sexual activity often propagates into thalamus and formatio reticularis mesencephali by cerebral cortex by Descending Projections fiber, causes loss of consciousness, then spreads whole cerebral cortex by dispersivity thalamus projection system, produces the generalized tonic-clonic seizure of secondary.

The common tendency of epilepsy can be the photis of the special sense, olfactory hallucination, dizzy, the numb limbs and tense tendons of general sensory, electrical sensation.This is one of symptom of common epilepsy disease.About half patient has tendency, refers to the various experience occurred in a flash before loss of consciousness.The patient after stopping that twitching enters lethargy, comatose state, and then regain consciousness gradually, some patients is spiritedness dystropy in clear-headed process, shows as struggle, refuses to resist, restlessness.

Motherland's medical science the pathogenic factor of epilepsy is divided into congenital reason and the day after tomorrow reason two class.Congenital reason mainly anemia of pregnant woman is lost in taking good care of and fetal hypoplasia.Reason will be divided into exogenous with endogenous two class the day after tomorrow.Exogenous comprise in maternal infuries, craniocerebral trauma, scaring, temperature accumulate, parasitosis in brain, food stagnation, expectorant heat, the stasis of blood are stagnant.Endogenous is the chronic infantile convulsion due to dysfunction of the spleen caused by insufficiency of the spleen chronic diarrhea mainly, gradates as disease.

Current treatment epilepsy takes Western medicine more, but Western medicine is to effect a radical cure on the one hand, also has a lot of side effect on the one hand in addition, as drug dependence is strong, produces spirit depressing, emotional responses imbalance, has IQ, dysnoesia etc., have very large injury to patient.And traditional Chinese medical science Chinese herbal medicine oneself by universally acknowledged be the treasure-house of indispensable human medical's preciousness.The means of Chinese medicine are adopted to treat epileptic condition, it is a channel extremely leaved for development, this is because Chinese medicine have mild in medicine property and, the feature such as applied widely, therefore as the effect having it original in epilepsy therapy, although also there is the Chinese medicine of corresponding treatment epilepsy at present, prescription is complicated, medical expense is high.

Summary of the invention

The object of the present invention is to provide a kind of Chinese medicine preparation for the treatment of epilepsy and its production and use.

For achieving the above object, the invention provides following technical scheme:

Treat a Chinese medicine preparation for epilepsy, be made up of the following raw material according to weight portion: Scolopendra 50-70 part, Radix Bupleuri (processed with vinegar) 30-40 part, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 20-30 part, Herba Strigae Asiaticae 20-30 part, Fructus Leonuri 10-20 part, Herba Thlaspis 5-15 part, Cortex Nothapodytis Radicis 5-15 part, Radix Rubi Parvifolii 8-12 part, Kalopanax septemlobum 8-12 part, Mian Rhizoma Dioscoreae Septemlobae 5-10 part, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 5-10 part, Herba Polygoni cymosi 3-7 part, Rhizoma Chuanxiong 3-7 part.

As the present invention's further scheme: the Chinese medicine preparation of described treatment epilepsy, be made up of the following raw material according to weight portion: Scolopendra 55-65 part, Radix Bupleuri (processed with vinegar) 32-38 part, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 22-28 part, Herba Strigae Asiaticae 22-28 part, Fructus Leonuri 12-18 part, Herba Thlaspis 8-12 part, Cortex Nothapodytis Radicis 8-12 part, Radix Rubi Parvifolii 9-11 part, Kalopanax septemlobum 9-11 part, Mian Rhizoma Dioscoreae Septemlobae 6-9 part, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 6-9 part, Herba Polygoni cymosi 4-6 part, Rhizoma Chuanxiong 4-6 part.

As the present invention's further scheme: the Chinese medicine preparation of described treatment epilepsy, be made up of the following raw material according to weight portion: Scolopendra 60 parts, Radix Bupleuri (processed with vinegar) 35 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 25 parts, Herba Strigae Asiaticae 25 parts, Fructus Leonuri 15 parts of, Herba Thlaspiss 10 parts, Cortex Nothapodytis Radicis 10 parts, Radix Rubi Parvifolii 10 parts, Kalopanax septemlobum 10 parts, Mian Rhizoma Dioscoreae Septemlobae 8 parts, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 8 parts, Herba Polygoni cymosi 5 parts, Rhizoma Chuanxiong 5 parts.

The preparation method of the Chinese medicine preparation of described treatment epilepsy, concrete steps are as follows:

(1) each raw material is taken according to weight portion;

(2) Scolopendra, Radix Bupleuri (processed with vinegar), Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Herba Strigae Asiaticae, Fructus Leonuri He Herba Thlaspis are crushed to 80-100 order, join after mix homogeneously and extract in still, then to extracting the water adding 800-1000 part in still, close and extract still, be heated to 110-130 DEG C, pressure is 0.3-0.6MPa, keep 8-10min, Temperature fall, to room temperature, after centrifugalize, obtains extracting solution;

(3) being condensed into by the extracting solution obtained 60 DEG C of survey relative densities is the clear paste of 1.25, and adding ethanol to making containing amount of alcohol is 60%, stirs evenly, and leaves standstill, and filters, gets filtrate recycling ethanol, be condensed into the extractum containing solid weight 67%, obtain extractum A;

(4) Cortex Nothapodytis Radicis, Radix Rubi Parvifolii, Kalopanax septemlobum, Mian Rhizoma Dioscoreae Septemlobae, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae), Herba Polygoni cymosi and Rhizoma Chuanxiong power are broken into 100-120 order, use soak by water secondary, each water consumption is the 5-7 times amount of medical material weight, each decoction 2-4h, filter, filtrate is condensed into and surveys relative density at 60 DEG C is the clear paste of 1.25, and adding ethanol to making containing amount of alcohol is 60%, stir evenly, leave standstill, filter, get filtrate recycling ethanol, be condensed into the extractum containing solid weight 67%, obtain extractum B;

(5) extractum A described in and described extractum B are according to volume ratio 1:1, and merge mixing, add 20-30 part sweeting agent, 5-10 part antioxidant and 1-2 part antiseptic, stock solution embedding, irradiation sterilization, packed products, makes oral liquid, to obtain final product.

As the present invention's further scheme: described sweeting agent is sucrose, xylitol, stevioside or acesulfame potassium.

As the present invention's further scheme: described antioxidant is dibenzylatiooluene, BHA or tertiarybutylhydroquinone.

As the present invention's further scheme: the application of described Chinese medicine preparation in preparation treatment antiepileptic.

Compared with prior art, the invention has the beneficial effects as follows:

In the present invention, each crude drug synergism plays and has the high and medication of rapid-action, determined curative effect, safety and simply act on, can effectively antitussive, eliminate the phlegm, relieving asthma, preparation technology is simple, environmentally friendly, effectively can alleviate the symptoms such as photis that epilepsy causes, dizzy, stupor and restlessness, do not have toxic and side effects, the various symptoms caused for clinical pre-alleviation epilepsy provide a newly selection.

Detailed description of the invention

Be described in more detail below in conjunction with the technical scheme of detailed description of the invention to this patent.

Embodiment 1

Treat a Chinese medicine preparation for epilepsy, be made up of the following raw material according to weight portion: Scolopendra 50 parts, Radix Bupleuri (processed with vinegar) 30 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 20 parts, Herba Strigae Asiaticae 20 parts, Fructus Leonuri 10 parts of, Herba Thlaspiss 5 parts, Cortex Nothapodytis Radicis 5 parts, Radix Rubi Parvifolii 8 parts, Kalopanax septemlobum 8 parts, Mian Rhizoma Dioscoreae Septemlobae 5 parts, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 5 parts, Herba Polygoni cymosi 3 parts, Rhizoma Chuanxiong 3 parts.

(1) each raw material is taken according to weight portion;

(2) Scolopendra, Radix Bupleuri (processed with vinegar), Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Herba Strigae Asiaticae, Fructus Leonuri He Herba Thlaspis are crushed to 80 orders, join after mix homogeneously and extract in still, then to extracting in still the water adding 800 parts, close and extract still, be heated to 110 DEG C, pressure is 0.3MPa, keep 8min, Temperature fall, to room temperature, after centrifugalize, obtains extracting solution;

(4) Cortex Nothapodytis Radicis, Radix Rubi Parvifolii, Kalopanax septemlobum, Mian Rhizoma Dioscoreae Septemlobae, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae), Herba Polygoni cymosi and Rhizoma Chuanxiong power are broken into 100 orders, use soak by water secondary, each water consumption is 5 times amount of medical material weight, each decoction 2h, filter, filtrate is condensed into and surveys relative density at 60 DEG C is the clear paste of 1.25, and adding ethanol to making containing amount of alcohol is 60%, stir evenly, leave standstill, filter, get filtrate recycling ethanol, be condensed into the extractum containing solid weight 67%, obtain extractum B;

(5) extractum A described in and described extractum B, according to volume ratio 1:1, merge mixing, add 20 portions of sucrose, 5 parts of dibenzylatiooluene and 1 portion of antiseptic, stock solution embedding, irradiation sterilization, packed products, makes oral liquid, to obtain final product.

Usage and dosage: half an hour is oral after meal.A 20ml, 3 times on the one two months is a course for the treatment of.

Embodiment 2

Treat a Chinese medicine preparation for epilepsy, be made up of the following raw material according to weight portion: Scolopendra 55 parts, Radix Bupleuri (processed with vinegar) 32 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 22 parts, Herba Strigae Asiaticae 22 parts, Fructus Leonuri 12 parts of, Herba Thlaspiss 8 parts, Cortex Nothapodytis Radicis 8 parts, Radix Rubi Parvifolii 9 parts, Kalopanax septemlobum 9 parts, Mian Rhizoma Dioscoreae Septemlobae 6 parts, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 6 parts, Herba Polygoni cymosi 4 parts, Rhizoma Chuanxiong 4 parts.

(1) each raw material is taken according to weight portion;

(2) Scolopendra, Radix Bupleuri (processed with vinegar), Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Herba Strigae Asiaticae, Fructus Leonuri He Herba Thlaspis are crushed to 85 orders, join after mix homogeneously and extract in still, then to extracting in still the water adding 850 parts, close and extract still, be heated to 115 DEG C, pressure is 0.4MPa, keep 8.5min, Temperature fall, to room temperature, after centrifugalize, obtains extracting solution;

(4) Cortex Nothapodytis Radicis, Radix Rubi Parvifolii, Kalopanax septemlobum, Mian Rhizoma Dioscoreae Septemlobae, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae), Herba Polygoni cymosi and Rhizoma Chuanxiong power are broken into 105 orders, use soak by water secondary, each water consumption is 5.5 times amount of medical material weight, each decoction 2.5h, filter, filtrate is condensed into and surveys relative density at 60 DEG C is the clear paste of 1.25, and adding ethanol to making containing amount of alcohol is 60%, stir evenly, leave standstill, filter, get filtrate recycling ethanol, be condensed into the extractum containing solid weight 67%, obtain extractum B;

(5) extractum A described in and described extractum B are according to volume ratio 1:1, and merge mixing, add 22 parts of xylitol honey, 6 parts of BHAs and 1.2 portions of antiseptic, stock solution embedding, irradiation sterilization, packed products, makes oral liquid, to obtain final product.

Embodiment 3

Treat a Chinese medicine preparation for epilepsy, be made up of the following raw material according to weight portion: Scolopendra 60 parts, Radix Bupleuri (processed with vinegar) 35 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 25 parts, Herba Strigae Asiaticae 25 parts, Fructus Leonuri 15 parts of, Herba Thlaspiss 10 parts, Cortex Nothapodytis Radicis 10 parts, Radix Rubi Parvifolii 10 parts, Kalopanax septemlobum 10 parts, Mian Rhizoma Dioscoreae Septemlobae 8 parts, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 8 parts, Herba Polygoni cymosi 5 parts, Rhizoma Chuanxiong 5 parts.

(1) each raw material is taken according to weight portion;

(2) Scolopendra, Radix Bupleuri (processed with vinegar), Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Herba Strigae Asiaticae, Fructus Leonuri He Herba Thlaspis are crushed to 90 orders, join after mix homogeneously and extract in still, then to extracting in still the water adding 900 parts, close and extract still, be heated to 120 DEG C, pressure is 0.45MPa, keep 9min, Temperature fall, to room temperature, after centrifugalize, obtains extracting solution;

(4) Cortex Nothapodytis Radicis, Radix Rubi Parvifolii, Kalopanax septemlobum, Mian Rhizoma Dioscoreae Septemlobae, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae), Herba Polygoni cymosi and Rhizoma Chuanxiong power are broken into 110 orders, use soak by water secondary, each water consumption is 6 times amount of medical material weight, each decoction 3h, filter, filtrate is condensed into and surveys relative density at 60 DEG C is the clear paste of 1.25, and adding ethanol to making containing amount of alcohol is 60%, stir evenly, leave standstill, filter, get filtrate recycling ethanol, be condensed into the extractum containing solid weight 67%, obtain extractum B;

(5) extractum A described in and described extractum B are according to volume ratio 1:1, and merge mixing, add 25 parts of steviosides, 8 parts of tertiarybutylhydroquinonees and 1.5 portions of antiseptic, stock solution embedding, irradiation sterilization, packed products, makes oral liquid, to obtain final product.

Embodiment 4

Treat a Chinese medicine preparation for epilepsy, be made up of the following raw material according to weight portion: Scolopendra 65 parts, Radix Bupleuri (processed with vinegar) 38 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 28 parts, Herba Strigae Asiaticae 28 parts, Fructus Leonuri 18 parts of, Herba Thlaspiss 12 parts, Cortex Nothapodytis Radicis 12 parts, Radix Rubi Parvifolii 11 parts, Kalopanax septemlobum 11 parts, Mian Rhizoma Dioscoreae Septemlobae 9 parts, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 9 parts, Herba Polygoni cymosi 6 parts, Rhizoma Chuanxiong 6 parts.

(1) each raw material is taken according to weight portion;

(2) Scolopendra, Radix Bupleuri (processed with vinegar), Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Herba Strigae Asiaticae, Fructus Leonuri He Herba Thlaspis are crushed to 95 orders, join after mix homogeneously and extract in still, then to extracting in still the water adding 950 parts, close and extract still, be heated to 125 DEG C, pressure is 0.5MPa, keep 9.5min, Temperature fall, to room temperature, after centrifugalize, obtains extracting solution;

(4) Cortex Nothapodytis Radicis, Radix Rubi Parvifolii, Kalopanax septemlobum, Mian Rhizoma Dioscoreae Septemlobae, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae), Herba Polygoni cymosi and Rhizoma Chuanxiong power are broken into 115 orders, use soak by water secondary, each water consumption is 6.5 times amount of medical material weight, each decoction 3.5h, filter, filtrate is condensed into and surveys relative density at 60 DEG C is the clear paste of 1.25, and adding ethanol to making containing amount of alcohol is 60%, stir evenly, leave standstill, filter, get filtrate recycling ethanol, be condensed into the extractum containing solid weight 67%, obtain extractum B;

(5) extractum A described in and described extractum B are according to volume ratio 1:1, and merge mixing, add 28 parts of acesulfame potassiums, 9 parts of dibenzylatiooluene and 1.8 portions of antiseptic, stock solution embedding, irradiation sterilization, packed products, makes oral liquid, to obtain final product.

Embodiment 5

Treat a Chinese medicine preparation for epilepsy, be made up of the following raw material according to weight portion: Scolopendra 70 parts, Radix Bupleuri (processed with vinegar) 40 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 30 parts, Herba Strigae Asiaticae 30 parts, Fructus Leonuri 20 parts of, Herba Thlaspiss 15 parts, Cortex Nothapodytis Radicis 15 parts, Radix Rubi Parvifolii 12 parts, Kalopanax septemlobum 12 parts, Mian Rhizoma Dioscoreae Septemlobae 10 parts, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 10 parts, Herba Polygoni cymosi 7 parts, Rhizoma Chuanxiong 7 parts.

(1) each raw material is taken according to weight portion;

(2) Scolopendra, Radix Bupleuri (processed with vinegar), Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Herba Strigae Asiaticae, Fructus Leonuri He Herba Thlaspis are crushed to 100 orders, join after mix homogeneously and extract in still, then to extracting in still the water adding 1000 parts, close and extract still, be heated to 130 DEG C, pressure is 0.6MPa, keep 10min, Temperature fall, to room temperature, after centrifugalize, obtains extracting solution;

(4) Cortex Nothapodytis Radicis, Radix Rubi Parvifolii, Kalopanax septemlobum, Mian Rhizoma Dioscoreae Septemlobae, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae), Herba Polygoni cymosi and Rhizoma Chuanxiong power are broken into 120 orders, use soak by water secondary, each water consumption is 7 times amount of medical material weight, each decoction 4h, filter, filtrate is condensed into and surveys relative density at 60 DEG C is the clear paste of 1.25, and adding ethanol to making containing amount of alcohol is 60%, stir evenly, leave standstill, filter, get filtrate recycling ethanol, be condensed into the extractum containing solid weight 67%, obtain extractum B;

(5) extractum A described in and described extractum B are according to volume ratio 1:1, and merge mixing, add 30 portions of sucrose, 10 parts of BHAs and 2 portions of antiseptic, stock solution embedding, irradiation sterilization, packed products, makes oral liquid, to obtain final product.

Comparative example 1

Treat a Chinese medicine preparation for epilepsy, be made up of the following raw material according to weight portion: Scolopendra 55 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 22 parts, Herba Strigae Asiaticae 22 parts, Fructus Leonuri 12 parts of, Herba Thlaspiss 8 parts, Cortex Nothapodytis Radicis 8 parts, Radix Rubi Parvifolii 9 parts, Kalopanax septemlobum 9 parts, Mian Rhizoma Dioscoreae Septemlobae 6 parts, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 6 parts, Herba Polygoni cymosi 4 parts, Rhizoma Chuanxiong 4 parts.

(1) each raw material is taken according to weight portion;

(2) Scolopendra, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Herba Strigae Asiaticae, Fructus Leonuri He Herba Thlaspis are crushed to 85 orders, join after mix homogeneously and extract in still, then to extracting in still the water adding 850 parts, close and extract still, be heated to 115 DEG C, pressure is 0.4MPa, keep 8.5min, Temperature fall, to room temperature, after centrifugalize, obtains extracting solution;

Comparative example 2

Treat a Chinese medicine preparation for epilepsy, be made up of the following raw material according to weight portion: Scolopendra 65 parts, Radix Bupleuri (processed with vinegar) 38 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 28 parts, Herba Strigae Asiaticae 28 parts, Fructus Leonuri 18 parts of, Herba Thlaspiss 12 parts, Radix Rubi Parvifolii 11 parts, Kalopanax septemlobum 11 parts, Mian Rhizoma Dioscoreae Septemlobae 9 parts, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 9 parts, Herba Polygoni cymosi 6 parts, Rhizoma Chuanxiong 6 parts.

(1) each raw material is taken according to weight portion;

(4) Radix Rubi Parvifolii, Kalopanax septemlobum, Mian Rhizoma Dioscoreae Septemlobae, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae), Herba Polygoni cymosi and Rhizoma Chuanxiong power are broken into 115 orders, use soak by water secondary, each water consumption is 6.5 times amount of medical material weight, each decoction 3.5h, filter, filtrate is condensed into and surveys relative density at 60 DEG C is the clear paste of 1.25, and adding ethanol to making containing amount of alcohol is 60%, stir evenly, leave standstill, filter, get filtrate recycling ethanol, be condensed into the extractum containing solid weight 67%, obtain extractum B;

Embodiment 6

Clinical trial

(1) subjects: adopt the present invention to treat 250 examples altogether, wherein man 130 example, female 120 example; The oldest person 50 years old, age reckling 18 years old;

(2) diagnostic criteria:

1) Diagnosis of Epilepsy standard: 1. recurrent exerbation, can spontaneous remission; 2. Acute onset, through giving treatment to many can recovery, if with the passing of time take place frequently, then can the concurrent disease such as forgetful, dull-witted; 3. disease often has premonitory symptom before sending out, and morbidity can have inducement; 4. EEG is abnormal.

2) epilepsy classification diagnostic criteria: 1. YANG epilepsy: soldier so holds down, syncope, extremity strong convulsion contracture is sound in mouth, spits out white foams, dysphoria, upward adverse flow of QI raucous breath, and rale is filtered, halitosis dry stool; Red tongue or dark red, yellow and greasy fur, stringy and rolling pulse; 2. epilepsy of YIN type: soldier so falls forward, syncope, slobbering, and tic of the limbs is unable, wriggling of the limbs, and extremity are not warm, enuresis and encopresis; Pale tongue, few tongue, thready and weak pulse.

3) syndrome diagnostic criterion: 1. scorching on wind-fire, close in expectorant heat: soldier so flutters dusk, tic of the limbs is strong, or roars, upward adverse flow of QI raucous breath, manic uneasiness, constipation dark coloured urine; Red tongue with yellowish and greasy fur, slippery and rapid pulse; 2. pneumatic stagnation of phlegm, turbid pathogen is violated: soldier so fall forward by dusk, order eyeball looked, spits out white foams, tetany, gurgling with sputum; Body of the tongue is light red, and tongue is greasy in vain, rolling pulse; 3. stop in blood stasis, clear key is obstructed: send out then soldier and so flutter clonic convulsion tic dusk, face cyanotic lips; Purplish tongue or have petechia, stringy pulse or puckery; 4. deficiency of both the heart and spleen, wind syndrome caused by deficiency is more dynamic: epilepsy does not heal for a long time, and soldier so flutters dusk, coma, and pale complexion, spits out white foams, and tic of the limbs is unable, and locked mouth order closes, enuresis and encopresis; Pale tongue, tongue is white, deep and weak pulse; 5. nephrons is not enough, and endogenous wind border is incited; Soldier so fall forward by dusk, extremity cold of the limbs, and limb is jerked unable, wriggling of the limbs; Deep red tongue, few tongue or no fur, stringy and thready pulse.

4) epilepsy staging scale: 1. stage of attack: coma, tic of the limbs, stiffness of the nape and back etc. belong to the outbreak stage; 2. the catabasis: paresthesia epilepsy is alleviated, and mind turns clear.

(3) Therapeutic Method: by man 130 example, the routine patient of female 120 is equally divided into five groups, often group man 26 example, female 24 example, one group, two groups and three groups are test group, one group, two groups and three components do not take the Chinese medicine preparation of the treatment epilepsy of the present invention that embodiment 1-embodiment 3 prepares, four groups and five groups is matched group, four groups and the five groups Chinese medicine preparation taken comparative example 1 and comparative example 2 respectively and prepare, usage and dosage: half an hour is oral after meal.A 20ml, 3 times on the one two months is a course for the treatment of.After taking 3 courses for the treatment of continuously, add up the therapeutic outcome of five groups, observe the untoward reaction that treatments period patient occurs simultaneously.

(4) standard is treated:

Cure: sings and symptoms disappears or substantially disappears;

Effective: sings and symptoms major part takes a turn for the better;

Effective: a sings and symptoms part takes a turn for the better;

Invalid: sings and symptoms is all not improved.

(5) therapeutic outcome: how to take effect after 5 days after taking medicine in the routine case of patient 250,2-3 the course for the treatment of cures; Wherein cure 95 examples, effective 66 examples, effective 48 examples, invalid 41 examples, total effective rate reaches 83.67%, and therapeutic outcome is as shown in table 1:

Table 1: clinical trial therapeutic outcome

As shown in Table 1, the average effectiveness level adopting the Chinese medicine preparation for the treatment of epilepsy of the present invention to carry out treating reaches 96%, and the effective percentage of the pharmaceutical composition adopting comparative example to prepare only has 65%, therefore, between medicine of the present invention, there is synergistic function, add the effective percentage of Chinese medicine preparation.

Model case:

(1) grandson, man, 48 years old, because " meningioma " operation of opening cranium 2 years, left limb paroxysmal was twitched, and twitch the about 3-30 minute that at every turn shows effect.Time medical, left limb and bicker have twitch, Consciousness, and on the right side of EEG (electrocardiogram) examination, frontal lobe has abnormal epilepsy spike.Oral " valproic acid that " 1 year, effect is deteriorated gradually.Be diagnosed as focal seizure, by the dosage of regulation, take three courses for the treatment of of Chinese medicine of the present invention, shape disappears completely, and electroencephalogram check epilepsy spike disappears.

(2) Zheng, female, 37 years old, emotional at ordinary times, angry.Because occur that tic of the limbs repeatedly after quarreling with people, during outbreak, eyes are stared, and shout strangely, sustainable several minutes, check that right epilepsy sample discharges during electroencephalogram outbreak.Pulse condition stringy and rapid pulse time medical, red tongue, few tongue.By the dosage of regulation, after taking a course for the treatment of of medicine of the present invention, symptom alleviates, and consolidates and takes transference cure after two courses for the treatment of, follow up a case by regular visits to and do not recur for 2 years.

(3) Wang, man, 18 years old, student, patient is interrupted extremity and repeatedly twitches, sleep because pressure is excessive middle generation confusion, companion's tic of the limbs, closes order, and mouth is spat saliva, allophone in mouth, lip pastiness, spontaneous remission after continuing a few minutes, dizzy weak after alleviating, once took multi-medicament, without positive effect.Be diagnosed as epilepsy.After taking two courses for the treatment of of Chinese medicine oral liquid of the present invention, the symptom such as tic of the limbs, palpitation and short breath is obviously alleviated, and continues to take two courses for the treatment of, and laboratory indexes is all normal, and physical recovery is healthy.Follow up a case by regular visits to and do not recur so far.

(4) Shen, man, 27 years old, falls ill, faints suddenly during outbreak, tic of the limbs, spit out white foams for 19 years old.Within 5-7 minute, revive, absentminded after reviving, head has an intense pain.January about 4 times time serious.Once section hospital's unsatisfactory curative effect was tossed about in bed.Took the Chinese medicine oral liquid that the embodiment of the present invention 2 provides before 3 years, during three courses for the treatment of, symptom alleviates, and attack times reduces.With taking again 6 courses for the treatment of, transference cure.Follow up a case by regular visits to one year over without outbreak.

(5) season, female, 50 years old, because being accidentally rolled down from stair, whole body was twitched afterwards, obnubilation, incontinence of urination and defecation, and electroencephalogram has spike to occur, after take three courses for the treatment of of Chinese medicine of the present invention after, recovery from illness, 2 years so far without recurring.

The present invention is the good effect that has in treatment epilepsy, below by animal efficacy data in addition further instruction:

Pharmacological toxicity is tested

One, the animal acute toxicity experiment of Chinese medicine preparation of the present invention

1. test material:

(1) animal mouse NIH kind male and female half and half, body weight 20-22g.

(2) test medicine: the oral liquid prepared by the embodiment of the present invention 3, is diluted with distilled water into suspension.

2. test method and result:

Mice maximum tolerance determination: get healthy mice 32, male and female half and half, divided three groups within 24 hours, and only, gross weight 1.8ml, is equivalent to crude drug in whole 4.0g to each 0.6ml/ of gavage intestinal, i.e. 100g crude drug/kg/d, is equivalent to 857 times of clinical 65 kilograms of people.After mice administration routinely feedstuff within 12 days, have no animal dead and do not go out, existing toxic reaction.Therefore prove, medicine of the present invention has no side effect, and clinical practice is safe and reliable.

Two, the long-term toxicity test for animals of pharmaceutical composition of the present invention

1. experiment material and method:

(1) test medicine: the oral liquid prepared by the embodiment of the present invention 2.

(2) laboratory animal: healthy rat Wistar, body weight 110-130g, 140 male and female half and half, by sex and body weight random packet, four groups, often organize 35.First group, second group and three components do not take test medicine, and dosage is respectively 9.6/kg/d, 6.4/kg/d, 3.2/kg/d.4th group contrasts to the distilled water of respective volume amount, the equal gavage enteral administration of rat, often organizes and be once used in conjunction 6 months, puts to death half, and all death in 12 days is observed in remaining 1/2 drug withdrawal.

2. test index:

(1) general status comprises body weight, diet, emotion, movable energy.

(2) hemogram checking: red blood cell count(RBC), numeration of leukocyte, platelet count, hemogram etc., quantitative hemoglobin counts.

(3) biochemical analysis, serum albumin quantitatively, cholesterol, blood sugar quantitative.

(4) pathologic diagnosis: get half animal after experimental result and weigh, sacrificed by decapitation, gets blood, solution is treated others for earnest simultaneously, liver, kidney, lung, brain, spleen, gastrointestinal, bladder, adrenal gland do pathologic diagnosis.

3. Skin Irritation Test: above-mentioned three groups of medication Cavia porcellus trunk unhairing districts, having no local skin has edema, hyperemia, erythema, petechia and ulcer.Medication group and control animals chroma of hair, ingest, the matched group no significant difference such as extremity are movable, blood biochemistry checking, medication group and matched group are all in normal range.Histopathologic examination, tests each group of heart, liver, kidney and local skin and is showed no obvious pathological changes.Prompting, Chinese medicine preparation long-term prescription of the present invention is showed no obvious toxic action to local skin and whole body important organ.Result of the test shows: Chinese medicine preparation experiment safety of the present invention.

4. cumulative toxicity experiment:

Traditional Chinese medicine preparation capsule agent of the present invention presses 7.69,19.18 and 43.21g crude drug/kg continuous use 15 weeks (1.0ml/100g body weight to mice, every day 2 times) and drug withdrawal after 3 weeks, result shows: the index such as hair, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat of Chinese medicine preparation of the present invention to rat all has no significant effect, internal organs naked eyes do not find that difference change and histological indications show, medication 15 weeks and drug withdrawal are after 3 weeks, and each internal organs of rat are all without obviously changing.Illustrate that Chinese medicine preparation oral capsule of the present invention is little to toxicity after rat long-term prescription, also there is no difference reaction after drug withdrawal, application safety.

Pharmacological experiment:

1. materials and methods:

(1) reagent:

Sodium phenobarbital: Lik-Sang pharmacy head factory in Tianjin is produced; Penicillin: Harbin Pharmaceutical General Factory produces; Urethane: Harbin Pharmaceutical General Factory produces; LIVZON CHANGLE: Zhuhai Livzon Pharmaceutical Factory, Livzon Group is produced; R2 aminobutyric acid: Tianjin Hongqiao Reagent Company produces.

(2) Chinese drug preparation of the present invention: prepare by above-mentioned oral liquor, by the oral liquid for preparing and sterilized water according to 1: 8 ratio wiring solution-forming, be placed in aseptic bottle and seal, preserve 200g/L crude drug amounts for 4 DEG C, before administration, rewarming is to 25-30 DEG C.

(3) animal grouping and epilepsy model preparation:

Wistar adult rat 72, body weight 180-220g, male and female half and half, are provided by Hefei City's animal center.Be divided into Normal group (ZC), treatment by Chinese herbs group of the present invention (NM), normality treatment by Chinese herbs group (CT), epilepsy treatment group (KD), LIVZON CHANGLE treatment group (LZ) and natural recovering group (ZR) after adapting to this room environmental at random, often organize 12.Except Normal group, all the other are respectively organized rat and all make epilepsy model with penicillin 6,000,000 U/kg lumbar injection.

(4) medication:

ZC:2ml normal saline gavage, every day 2 times, continuous 7d.

NM:2ml Chinese medicine gavage of the present invention, every day 2 times, continuous 7d.

CT:2ml normality Chinese medicine gavage, every day 2 times, continuous 7d.

KD:2ml sodium phenobarbital gavage (4.2/kg), every day 2 times, continuous 7d.

LZ:2ml LIVZON CHANGLE solution gavage, every day 2 times, continuous 7d.

(5) intestinal microbial population detects:

1) collection of specimens takes experimental rat cecal content 0.1g with dilution is aseptic, and be placed in and be equipped with in the sterile vials of bead, add 0.9ml diluent, vibrate 15min on agitator, and cecal content is homogenized.Then 10 times of serial dilutions are carried out to 10-8.

2) culture medium and dilution selection BS (Medium of Bifidobacterium): 10-4,10-6,10-8.

(6) r2 aminobutyric acid (GABA) assay is with after urethane (5ml/kg) anesthesia of 20%, cut off rat scalp and skull, peel off parietal bone of head, with sterilization shears, whole cerebral tissue is taken out, blood is sucked with filter paper, cut temporo district cerebral tissue fast, insert cryopreservation tube, be placed in-70 DEG C of refrigerators and save backup.Get cerebral tissue to weigh on electronic balance, add phosphate buffer (0.1mol/L, pH7.2) by 1:10, broken in miniature refiner, in 4 DEG C of refrigerated centrifuges, the centrifugal 20min of 15000g/min gets supernatant.The high performance liquid chromatography set up by CHEN etc. detects.Computational methods: be marked with peak area quantification outward.Formula is as follows: GABA concentration=(A sample/A mark) × standard concentration × standard substance sampling amount × population of samples amasss/sample volume × example weight, unit μm ol/g.

(7) statistical analysis technique experimental data average ± standard deviation (x ± s) represents, statistical procedures method is the variance analysis of Group Design, through the process of SPSS statistical software.

2. result:

(1) each treatment group and natural recovering group bacillus bifidus detection by quantitative, the results are shown in Table 2.

The each treatment group of table 2 and natural recovering group bacillus bifidus detection by quantitative result (logN/g, x ± s)

Note: compare with ZR, * P<0.001.

(2) each treatment group bacillus bifidus detection by quantitative result significance compares, in table 3.

Table 3 each treatment group bacillus bifidus detection by quantitative result significance compares

Relatively	1h	3d	7d
				NM/CT	P＞0.05	P＞0.05	P＜0.05
NM/LZ	P＞0.05	P＞0.05	P＜0.001
				CT/LZ	P＞0.05	P＞0.05	P＞0.05
NM/KD	P＜0.05	P＜0.05	P＜0.05
				KD/LZ	P＜0.05	P＜0.05	P＜0.05
CT/KD	P＜0.05	P＜0.05	P＜0.05

As can be seen from table 2 and table 3, each treatment group is through continuing the treatment of 7d, epilepsy treatment group bacillus bifidus bacterium amount no significant difference (P>0.05) compared with natural recovering group, illustrates that epilepsy treatment group can not improve bacillus bifidus bacterium amount, and counter making it declines.Other each treatment groups all increase considerably, and compared with natural recovering group, difference has significance (P<0.05, P<0.01 or P<0.001).Though natural recovering group bacterium amount has increase, obviously not as each treatment group is recovered rapidly.Treatment by Chinese herbs group bacillus bifidus of the present invention grows steadily, within 7th day, normal level is returned in treatment, its bacterium amount is in the normal state on treatment by Chinese herbs group and LIVZON CHANGLE treatment group, and difference has significance (P<0.05 or P<0.001).Illustrate that Chinese medicine of the present invention effect when adjusting dysbacteriosis is more remarkable.

(3) Normal group and natural recovering group rat cerebral tissue GABA content testing result are in table 4.As known from Table 4, after rat modeling, in brain, GABA content obviously reduces, and has significance with Normal group comparing difference, and after modeling is described, in rat brain, inhibitory neurotransmitter reduces, and in prompting brain, GABA content is relevant with the outbreak of epilepsy.

Table 4ZC and ZR rat cerebral tissue GABA content testing result (μm ol/g, x ± s)

Group	GABA content
		ZC	3.12±0.84
ZR	2.35±0.38
		P value	P＜0.05

(4) each treatment group and natural recovering group rat cerebral tissue GABA content detect, and the results are shown in Table 5.Found out by table 5, after each treatment group rat oral gavage 7d, in epilepsy treatment group brain, GABA content is compared with natural recovering group, no significant difference (P>0.05).In other each treatment group brains, GABA content is all higher than natural recovering group, and difference has significance (P<0.05, P<0.01).Treatment by Chinese herbs group GABA content of the present invention is the highest, is better than normality Chinese medicine and LIVZON CHANGLE treatment group.

The each treatment group of table 5 and natural recovering group rat cerebral tissue GABA content testing result (μm ol/g, x ± s)

Group	GABA content
		NM	4.08±0.21
LZ	3.52±0.68
		CT	3.29±0.23
KA	2.15±0.19
		ZR	2.18±0.37

Note: compare with ZR, * * P<0.01, * P<0.05.

Experiment makes epilepsy model with rats by intraperitoneal injection penicillin 6,000,000 U/kg, and intestinal bifidobacteria bacterium amount obviously declines (P<0.01).Apply Chinese medicine of the present invention continue 7d treatment after, intestinal bifidobacteria bacterium amount obviously rises, and has pole significance (P<0.01) with natural recovering group comparing difference.Previously research shows, normality Chinese medicine, as prebiotics, has the effect of obviously fostering normal intestinal flora growth.This subject study shows, Chinese drug-treated group intestine in rats bacillus bifidus bacterium amount of the present invention is significantly higher than normality Chinese medicine and LIVZON CHANGLE treatment group (P<0.01, P<0.05).In brain, r2 aminobutyric acid (GABA) content is all higher than matched group (P<0.05, P<0.01), show that Chinese drug-treated group of the present invention is better than normality Chinese medicine and LIVZON CHANGLE treatment group thus, there is good antiepileptic action.Traditional antiepileptic has obvious side effect, not only destroys normal intestinal flora, and body's immunity is declined, and too increases the negative damage of body while disease therapy.And treatment by Chinese herbs epileptics of the present invention is by fostering normal flora growth, enhancing human body immunity function, improves inhibitory neurotransmitter GABA content in brain, reaches the object for the treatment of both the principal and secondary aspects of a disease.

Above the better embodiment of this patent is explained in detail, but this patent is not limited to above-mentioned embodiment, in the ken that one skilled in the relevant art possesses, various change can also be made under the prerequisite not departing from this patent aim.

Claims

1. treat the Chinese medicine preparation of epilepsy for one kind, it is characterized in that, be made up of the following raw material according to weight portion: Scolopendra 50-70 part, Radix Bupleuri (processed with vinegar) 30-40 part, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 20-30 part, Herba Strigae Asiaticae 20-30 part, Fructus Leonuri 10-20 part, Herba Thlaspis 5-15 part, Cortex Nothapodytis Radicis 5-15 part, Radix Rubi Parvifolii 8-12 part, Kalopanax septemlobum 8-12 part, Mian Rhizoma Dioscoreae Septemlobae 5-10 part, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 5-10 part, Herba Polygoni cymosi 3-7 part, Rhizoma Chuanxiong 3-7 part.

2. the Chinese medicine preparation for the treatment of epilepsy according to claim 1, it is characterized in that, be made up of the following raw material according to weight portion: Scolopendra 55-65 part, Radix Bupleuri (processed with vinegar) 32-38 part, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 22-28 part, Herba Strigae Asiaticae 22-28 part, Fructus Leonuri 12-18 part, Herba Thlaspis 8-12 part, Cortex Nothapodytis Radicis 8-12 part, Radix Rubi Parvifolii 9-11 part, Kalopanax septemlobum 9-11 part, Mian Rhizoma Dioscoreae Septemlobae 6-9 part, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 6-9 part, Herba Polygoni cymosi 4-6 part, Rhizoma Chuanxiong 4-6 part.

3. according to the Chinese medicine preparation of the arbitrary described treatment epilepsy of claim 1-2, it is characterized in that, be made up of the following raw material according to weight portion: Scolopendra 60 parts, Radix Bupleuri (processed with vinegar) 35 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 25 parts, Herba Strigae Asiaticae 25 parts, Fructus Leonuri 15 parts of, Herba Thlaspiss 10 parts, Cortex Nothapodytis Radicis 10 parts, Radix Rubi Parvifolii 10 parts, Kalopanax septemlobum 10 parts, Mian Rhizoma Dioscoreae Septemlobae 8 parts, Pericarpium Lagenariae (pericarpium Lagenariae sicerariae) 8 parts, Herba Polygoni cymosi 5 parts, Rhizoma Chuanxiong 5 parts.

4. a preparation method for the Chinese medicine preparation of the treatment epilepsy as described in as arbitrary in claim 1-2, it is characterized in that, concrete steps are as follows:

(1) each raw material is taken according to weight portion;

5. the preparation method of the Chinese medicine preparation for the treatment of epilepsy according to claim 4, is characterized in that, described sweeting agent is sucrose, xylitol, stevioside or acesulfame potassium.

6. the preparation method of the Chinese medicine preparation for the treatment of epilepsy according to claim 4, is characterized in that, described antioxidant is dibenzylatiooluene, BHA or tertiarybutylhydroquinone.

7. one kind as arbitrary in claim 1-2 as described in Chinese medicine preparation preparation treatment AED in application.