CN104258315A - Traditional Chinese medicine preparation for treating epilepsy and preparation method thereof - Google Patents

Abstract

The invention provides a traditional Chinese medicine preparation for treating epilepsy and a preparation method thereof, and belongs to the technical field of medicines. The traditional Chinese medicine preparation is prepared from 18 traditional Chinese medicinal materials such as bamboo juice, gastrodia elata, sanguisuge, bile arisaema, lumbricus, scorpion, radix curcumae, pericarpium citri reticulatae, poria cocos, periostracum cicada, radix angelicae pubescentis, poria with hostwood, salvia miltiorrhiza, dwarf lilyturf root, polygala tenuifolia, rhizoma acori Talarinowii, frankincense and liquorice by adopting a modern pharmacy technology. The traditional Chinese medicine preparation has an obvious curative effect in treating epilepsy and is simple and convenient in preparation technology, strong in universality and easy to popularize and apply.

Description

A kind of Chinese medicine preparation for the treatment of epilepsy and preparation method thereof

Technical field

The present invention relates to technical field of Chinese medicine, be specifically related to a kind of Chinese medicine preparation for the treatment of epilepsy and preparation method thereof.

Technical background

Epilepsy is chronic recurrent of short duration brain function imbalance syndrome.Cause repeatedly epilepsy outbreak for feature with brain neuron paradoxical discharge.Epilepsy is one of nervous system common disease, and prevalence is only second to apoplexy.The sickness rate of epilepsy is relevant with the age.Within it is generally acknowledged 1 years old, prevalence is the highest, is secondly to reduce gradually for 1 ~ 10 years old later.The ratio of China men and women is 1.15: 1-1.7: 1.Race's prevalence no significant difference.

Current doctor trained in Western medicine can select antiepileptic according to seizures types clinically, once find the medicine and dosage that can control completely to show effect, just should apply incessantly.Generally after outbreak controls completely, should continue again to take 3 ~ 5 years as having no adverse reaction, can drug withdrawal be considered.Many opinions use a kind of medicine at present, after confirmation form medicine Endodontic failure, can add with the 2nd kind of medicine.

Therapeutic effect is often very undesirable, and side effect is also very large.

The traditional Chinese medical science thinks that epilepsy syndrome is many by suddenly taking fright, and natural endowment is not enough, and the factors such as tumbling down shock, cause wind-phlegm impatency, and heart deficiency of the kidney is empty, stagnation of QI-blood, causes epilepsy, therefore, medication always not from relieving convulsion, relieve dizziness, high fever, infantile convulsions, epilepsy, etc., eliminating phlegm, pleasant, all methods of blood stasis dispelling.Ancient Chinese medicine doctor is paid attention to controlling (especially be many with phlegm-fire and expectorant heat) from expectorant opinion, such as, " cure the five types of epilepsy that reflects at all times " and point out: " husband epilepsy person has five etc.. be all mental confusion due to phlegm control must not divide five, all suitable dissipating phlegm and regulating QIs, relieve inflammation or internal heat suppressing the hyperactive liver ".And for example " Zhang Shi doctor logical epilepsy " says: " the main expectorant of Dan Xi and heat with star, partly, a kind of reed mentioned in ancient books, are linked as master ".In the modern times, activating blood and removing stasis Method is usually used in epilepsy syndrome, obtains good therapeutic effect.In addition, flat lowering the adverse flow of QI, adjustment internal organs, meridians, all methods of QI and blood function are all selected at the different times of disease.Specimen deficiency and excess must be distinguished, the order of importance and emergency when facing card.During frequent outbreak, to take stopgap measures, dissipating phlegm and regulating QI emphatically, relieving dizziness, high fever, infantile convulsions, epilepsy, etc. has one's ideas straightened out determines epilepsy.Attach most importance to effect a permanent cure at ordinary times, suitable invigorating the spleen for dissipating phlegm, liver and kidney tonifying; Tranquilizing by nourishing the heart, and be aided with spirit of taking good care of oneself, be careful in one's diet, daily life, work.Epilepsy syndrome needs long-term medicine to control, when avoiding refusing to eat of upseting one's stomach.

The traditional Chinese medical science is to the pathogenic analysis of epilepsy, outer frightened, strongly fragrant, wind, expectorant, heat, the stasis of blood, empty seven ends, in conjunction with clinical manifestation, be generally divided in wind-phlegm impatency (or liver-wind expectorant is turbid), phlegm-fire more and contain the type such as (or liver-fire expectorant heat), insufficiency of the spleen phlegm-damp, brain virtual loss (or hepatic and renal YIN deficiency), stasis blocking venation (or obstruction of the orifices by blood stasis) and opinion is controlled.

(1) wind-phlegm impatency: method for the treatment of: subduing wind syndrom by clearing away phlegm, has one's ideas straightened out and determines epilepsy.

(2) contain in phlegm-fire: method for the treatment of: purging liver-fire, waking up the patient from unconsciousness by dissipating phlegm.

(3) insufficiency of the spleen phlegm-damp: method for the treatment of: invigorating the spleen to clear away damp pathogen, reduces phlegm and determines epilepsy.

(4) brain virtual loss: method for the treatment of: nourish essence and blood, liver and kidney tonifying.

(5) stasis blocking venation: method for the treatment of: blood circulation promoting and blood stasis dispelling, dredging collateral determines epilepsy.

All types can interlock cross-reference above, and its apoplexy, expectorant, the stasis of blood, void are the most common.Activating blood and removing stasis Method, except for except wound blood stasis, the prolonged illness folder stasis of blood, still can coordinate for other various, because epilepsy all belongs to resembling of wind symptom, can according to the theory of " control wind and first control blood, blood wind is from going out ", and coordinating relieves dizziness, high fever, infantile convulsions, epilepsy, etc. determines epilepsy agent, and often effect is better.

The present invention, according to above-mentioned dialectical theory, takes into account various typing, in conjunction with clinical practice, repeatedly gropes practice, and a final invention Chinese prescription, has shown good therapeutic effect to the treatment of epilepsy.

Summary of the invention

The technical problem to be solved in the present invention is to provide a kind of Chinese medicine epilepsy being had to better therapeutic effect, and present invention, is made into that universality is strong, drug effect is significantly stablized, be easy to carry about with one the Chinese medicine preparation taken.

The present invention is from the dialectical of the traditional Chinese medical science to epilepsy, in conjunction with feature ill at present, sum up Conventional wisdom, again compatibility medical material, obtain one has very significant therapeutic effect Chinese prescription to epilepsy, and utilize modern pharmaceutical technology, ensure its curative effect basis on be made into the Chinese medicine finished product preparation being easy to carry about with one and taking, and its preparation technology's cost low, easy and simple to handle, be easy to apply.Chinese prescription in inventive solution is made up of the Chinese crude drug of following weight portion:

Succus Bambusae 45-60 part, Rhizoma Gastrodiae 15-24 part, Hirudo 6-11 part, Arisaema Cum Bile 16-26 part, Pheretima 5-14 part, Scorpio 6-12 part, Radix Curcumae 11-18 part, Pericarpium Citri Reticulatae 11-22 part, Poria 17-26 part, Periostracum Cicadae 10-19 part, Radix Angelicae Pubescentis 10-17 part, Poria cum Radix Pini 17-28 part, Radix Salviae Miltiorrhizae 15-25 part, Radix Ophiopogonis 10-18 part, Radix Polygalae 12-19 part, Rhizoma Acori Graminei 6-11 part, Olibanum 6-11 part, Radix Glycyrrhizae 9-16 part.

Sum up the weight of 3 effect optimums in clinical practice:

Proportioning 1: Succus Bambusae 53 parts, 18 parts, Rhizoma Gastrodiae, Hirudo 7 parts, Arisaema Cum Bile 22 parts, Pheretima 11 parts, Scorpio 10 parts, Radix Curcumae 15 parts, Pericarpium Citri Reticulatae 16 parts, 21 parts, Poria, Periostracum Cicadae 14 parts, Radix Angelicae Pubescentis 14 parts, Poria cum Radix Pini 21 parts, Radix Salviae Miltiorrhizae 20 parts, Radix Ophiopogonis 14 parts, Radix Polygalae 15 parts, Rhizoma Acori Graminei 9 parts, Olibanum 8 parts, 12 parts, Radix Glycyrrhizae.

Proportioning 2: Succus Bambusae 55 parts, 20 parts, Rhizoma Gastrodiae, Hirudo 8 parts, Arisaema Cum Bile 21 parts, Pheretima 12 parts, Scorpio 10 parts, Radix Curcumae 13 parts, Pericarpium Citri Reticulatae 18 parts, 20 parts, Poria, Periostracum Cicadae 16 parts, Radix Angelicae Pubescentis 13 parts, Poria cum Radix Pini 22 parts, Radix Salviae Miltiorrhizae 21 parts, Radix Ophiopogonis 16 parts, Radix Polygalae 13 parts, Rhizoma Acori Graminei 10 parts, Olibanum 7 parts, 13 parts, Radix Glycyrrhizae.

Proportioning 3: Succus Bambusae 51 parts, 21 parts, Rhizoma Gastrodiae, Hirudo 9 parts, Arisaema Cum Bile 23 parts, Pheretima 10 parts, Scorpio 9 parts, Radix Curcumae 14 parts, Pericarpium Citri Reticulatae 18 parts, 23 parts, Poria, Periostracum Cicadae 14 parts, Radix Angelicae Pubescentis 13 parts, Poria cum Radix Pini 23 parts, Radix Salviae Miltiorrhizae 22 parts, Radix Ophiopogonis 13 parts, Radix Polygalae 17 parts, Rhizoma Acori Graminei 8 parts, Olibanum 9 parts, 13 parts, Radix Glycyrrhizae.

The preparation technology of Chinese medicine preparation of the present invention is following steps:

Step 1, go joint to rive Hsinchu, put fire upper roasting, collect the juice that two ends ooze, filter, be Succus Bambusae, for subsequent use;

Step 2, truncated by Scorpio, Radix Ophiopogonis, Radix Polygalae remove the heart, for subsequent use; Poria, Poria cum Radix Pini's (removing wood) are steamed 1-2 hour respectively, dries, for subsequent use; Radix Salviae Miltiorrhizae, Pheretima, Hirudo are pulverized respectively, steams 1-2 hour with the ethanol of 50-65%, dry, for subsequent use;

Step 3, the Scorpio handled well, Radix Ophiopogonis, Radix Polygalae, Poria, Poria cum Radix Pini, Radix Salviae Miltiorrhizae, Pheretima, Hirudo and Rhizoma Gastrodiae, Arisaema Cum Bile, Radix Curcumae, Pericarpium Citri Reticulatae, Periostracum Cicadae, Radix Angelicae Pubescentis, Rhizoma Acori Graminei, Olibanum, Radix Glycyrrhizae are dried pulverizing respectively, levigate, cross 100 mesh sieves, obtain fine powder, mix homogeneously, is Chinese medicine mixed powder;

Step 4, Succus Bambusae to be added in Chinese medicine mixed powder in proportion, to stir, dry, levigate, be raw material of Chinese medicine powder;

Step 5, by raw material of Chinese medicine powder add adjuvant make the finished dosage forms such as capsule, tablet or honeyed pill.

The source of the present invention's Chinese crude drug used, meridian distribution of property and flavor and function cure mainly:

Succus Bambusae: the Succus Bambusae flowed out through heating for grass phyllostachys nigra (lodd.ex lindl.) munro var.henonis (miff.) spapf et rendle.Sweet in the mouth, cool in nature; To dispel hot eliminating phlegm.

Rhizoma Gastrodiae: this product is the dry tuber of orchid Rhizoma Gastrodiae.Sweet in the mouth, property is put down; Return Liver Channel; Suppressing the hyperactive liver to relieve the wind syndrome relieving convulsion.

Hirudo: this product is the dry body of Hirudinidae animal whitmania, Hirudo or Folium Salicis Babylonicae Hirudo.Salty in the mouth, hardship, property is put down; Return Liver Channel; Removing blood stasis, removing blood stasis, stimulates the menstrual flow.

Arisaema Cum Bile: this product is that the fine powder of Rhizoma Arisaematis (processed) and cattle, sheep or Fel Sus domestica process from strand, or forms through fermentation processing for Arisaema Cum Bile fine powder and cattle, sheep or Fel Sus domestica.Bitter in the mouth, micro-pungent, cool in nature; Return lung, liver, spleen channel; Removing heat-phlegm, dispelling wind and relieving convulsion.

Pheretima: this product is the dry body of Ju Yin section animal Pheretima aspergillum, popular Pheretimatschiliensis, power simulation or the blind Pheretimatschiliensis of comb.Salty in the mouth, cold in nature; Return liver, spleen, urinary bladder channel; Heat clearing away is calmed the frightened, and dredging collateral, relievings asthma, diuresis.

Scorpio: this product is the dry body of Buthidae animal Scorpio.Acrid in the mouth, property is put down; Return Liver Channel; Endogenous wind stopping spasmolytic, dispersing pathogen accumulation, removing obstruction in the collateral to relieve pain.

Radix Curcumae: this product is the dried root of zingiberaceous plant RADIX CURCUMAE, Rhizoma Curcumae Longae, Guangxi zedoary or Rhizoma Curcumae.Acrid in the mouth, hardship, cold in nature; Return liver, the heart, lung meridian; Regulating qi to disperse stagnation, heart fire-clearing upset-relieving, promoting the function of the gallbladder to alleviate jaundice.

Pericarpium Citri Reticulatae: be the mature peel of rutaceae orange and variety thereof.Bitter in the mouth, pungent, warm in nature; Return lung, spleen channel; Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.

Poria: this product is the dry sclerotia of On Polyporaceae Poria.Sweet in the mouth, light, property is put down; GUIXIN, spleen, kidney channel; Eliminating dampness and diuresis, invigorating the spleen and regulating the stomach, mind tranquilizing and the heart calming.

Periostracum Cicadae: exuviae shell when this product is the larva emergence of cicada Cryptotympana atrata Fabr..Sweet in the mouth, cold in nature; Return lung, Liver Channel; Loose wind heat extraction, sore-throat relieving, rash, nebula removing, spasmolytic.

Radix Angelicae Pubescentis: this product is the dry root of samphire Angelica pubescens.Acrid in the mouth, hardship, slightly warm in nature; Return kidney, urinary bladder channel; Expelling wind and removing dampness, numbness relieving and pain relieving.

Poria cum Radix Pini: in the middle of poria cocos sclerotium, (Poria) entertains the part of Radix Pini massonianae or fine core person.Sweet in the mouth, property are flat; Mind tranquilizing and the heart calming.

Radix Salviae Miltiorrhizae: this product is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae.Bitter in the mouth, cold nature; GUIXIN, Liver Channel; Stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.

Radix Ophiopogonis: this product is the dried root of liliaceous plant Radix Ophiopogonis (dwarf lilyturf).Sweet in the mouth, micro-hardship, cold nature; GUIXIN, lung, stomach warp; YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire.

Radix Polygalae: this product is the dry root of milk wort Radix Polygalae or ovum leaf Radix Polygalae.Bitter in the mouth, pungent, warm in nature; GUIXIN, kidney, lung meridian; To calm the nerves Fructus Alpiniae Oxyphyllae, eliminate the phlegm, detumescence.

Rhizoma Acori Graminei: this product is the dry rhizome of acorus gramineus araceae plant.Acrid in the mouth, hardship, warm in nature; GUIXIN, stomach warp; Removing dampness is whetted the appetite, eliminating phlegm of having one's ideas straightened out, refreshment Fructus Alpiniae Oxyphyllae.

Olibanum: Burseraceae Boswellia carterii platymiscium Boswellia carterii, medicine glue XIANGSHU and wild Boswellia carterii etc., is used as medicine with the oleo-gum-resin that its trunk skin zone wound oozes out.Acrid in the mouth is bitter, warm in nature; Enter the heart, liver, spleen channel; Regulating qi and activating blood, analgesic therapy, chases after poison.

Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.

The prescription analysis of Chinese medicine of the present invention:

Chinese prescription of the present invention is with Succus Bambusae, Rhizoma Gastrodiae, Arisaema Cum Bile, Poria, Poria cum Radix Pini for monarch drug, hot eliminating phlegm of dispelling, suppressing the hyperactive liver relieving convulsion, dispelling wind and relieving convulsion, mind tranquilizing and the heart calming; With Hirudo, Pheretima, Scorpio, Periostracum Cicadae for ministerial drug, removing blood stasis, endogenous wind stopping dredging collateral, loose wind heat extraction; With Radix Curcumae, Pericarpium Citri Reticulatae, Radix Salviae Miltiorrhizae, Radix Ophiopogonis for adjuvant drug, regulating qi to disperse stagnation, drying dampness to eliminate phlegm, promoting blood circulation to restore menstrual flow, lung moistening clear away heart-fire; With Radix Angelicae Pubescentis, Radix Polygalae, Rhizoma Acori Graminei, Olibanum for making medicine, expelling wind and removing dampness, Fructus Alpiniae Oxyphyllae of calming the nerves, eliminating phlegm of having one's ideas straightened out, analgesic therapy chase after poison; With Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, all medicine of monarch coordinates, complement each other can subduing wind syndrom by clearing away phlegm, invigorating the spleen to clear away damp pathogen, reduce phlegm and determine epilepsy, blood nourishing acupuncture-stimulating, thus significant therapeutic effect is shown to epilepsy.

Compared with prior art, Chinese medicine preparation treating both the principal and secondary aspects of a disease of the present invention, good effect, stable curative effect, individual variation little, have no side effect; And make the simple process of preparation, be easy to apply.

detailed description of the invention:

Embodiment 1

Step 1, go joint to rive Hsinchu, put fire upper roasting, collect the juice that two ends ooze, filter, be Succus Bambusae, for subsequent use;

Step 2, truncated by Scorpio, Radix Ophiopogonis, Radix Polygalae remove the heart, for subsequent use; Poria, Poria cum Radix Pini's (removing wood) are steamed 1.5 hours respectively, dries, for subsequent use; Radix Salviae Miltiorrhizae, Pheretima, Hirudo are pulverized respectively, the ethanol with 60% steams 1.5 hours, dries, for subsequent use;

Step 3, by the Scorpio 600g handled well, Radix Ophiopogonis 1000g, Radix Polygalae 1200g, Poria 1700g, Poria cum Radix Pini 1700g, Radix Salviae Miltiorrhizae 1500g, Pheretima 500g, Hirudo 600g and Rhizoma Gastrodiae 1500g, Arisaema Cum Bile 1600g, Radix Curcumae 1100g, Pericarpium Citri Reticulatae 1100g, Periostracum Cicadae 1000g, Radix Angelicae Pubescentis 1000g, Rhizoma Acori Graminei 600g, Olibanum 600g, Radix Glycyrrhizae 900g dry pulverizing respectively, levigate, cross 100 mesh sieves, obtain fine powder, mix homogeneously, is Chinese medicine mixed powder;

Step 4, Succus Bambusae 4500g to be added in Chinese medicine mixed powder, to stir, dry, levigate, be raw material of Chinese medicine powder;

Step 5, by raw material of Chinese medicine powder add adjuvant make capsule, crude drug content is about 0.3g crude drug/capsules.

Embodiment 2

Step 1, go joint to rive Hsinchu, put fire upper roasting, collect the juice that two ends ooze, filter, be Succus Bambusae, for subsequent use;

Step 2, truncated by Scorpio, Radix Ophiopogonis, Radix Polygalae remove the heart, for subsequent use; Poria, Poria cum Radix Pini's (removing wood) are steamed 1.5 hours respectively, dries, for subsequent use; Radix Salviae Miltiorrhizae, Pheretima, Hirudo are pulverized respectively, the ethanol with 60% steams 1.5 hours, dries, for subsequent use;

Step 3, by the Scorpio 1200g handled well, Radix Ophiopogonis 1800g, Radix Polygalae 1900g, Poria 2600g, Poria cum Radix Pini 2800g, Radix Salviae Miltiorrhizae 2500g, Pheretima 1400g, Hirudo 1100g and Rhizoma Gastrodiae 2400g, Arisaema Cum Bile 2600g, Radix Curcumae 1800g, Pericarpium Citri Reticulatae 2200g, Periostracum Cicadae 1900g, Radix Angelicae Pubescentis 1700g, Rhizoma Acori Graminei 1100g, Olibanum 1100g, Radix Glycyrrhizae 1600g dry pulverizing respectively, levigate, cross 100 mesh sieves, obtain fine powder, mix homogeneously, is Chinese medicine mixed powder;

Step 4, Succus Bambusae 6000g to be added in Chinese medicine mixed powder, to stir, dry, levigate, be raw material of Chinese medicine powder;

Step 5, by raw material of Chinese medicine powder add adjuvant make capsule, crude drug content is about 0.3g crude drug/capsules.

Embodiment 3

Step 1, go joint to rive Hsinchu, put fire upper roasting, collect the juice that two ends ooze, filter, be Succus Bambusae, for subsequent use;

Step 2, truncated by Scorpio, Radix Ophiopogonis, Radix Polygalae remove the heart, for subsequent use; Poria, Poria cum Radix Pini's (removing wood) are steamed 1.5 hours respectively, dries, for subsequent use; Radix Salviae Miltiorrhizae, Pheretima, Hirudo are pulverized respectively, the ethanol with 60% steams 1.5 hours, dries, for subsequent use;

Step 3, by the Scorpio 1000g handled well, Radix Ophiopogonis 1400g, Radix Polygalae 1500g, Poria 2100g, Poria cum Radix Pini 2100g, Radix Salviae Miltiorrhizae 2000g, Pheretima 1100g, Hirudo 700g and Rhizoma Gastrodiae 1800g, Arisaema Cum Bile 2200g, Radix Curcumae 1500g, Pericarpium Citri Reticulatae 1600g, Periostracum Cicadae 1400g, Radix Angelicae Pubescentis 1400g, Rhizoma Acori Graminei 900g, Olibanum 800g, Radix Glycyrrhizae 1200g dry pulverizing respectively, levigate, cross 100 mesh sieves, obtain fine powder, mix homogeneously, is Chinese medicine mixed powder;

Step 4, Succus Bambusae 5300g to be added in Chinese medicine mixed powder, to stir, dry, levigate, be raw material of Chinese medicine powder;

Step 5, by raw material of Chinese medicine powder add adjuvant make capsule, crude drug content is about 0.3g crude drug/capsules.

Embodiment 4

Step 1, go joint to rive Hsinchu, put fire upper roasting, collect the juice that two ends ooze, filter, be Succus Bambusae, for subsequent use;

Step 2, truncated by Scorpio, Radix Ophiopogonis, Radix Polygalae remove the heart, for subsequent use; Poria, Poria cum Radix Pini's (removing wood) are steamed 1.5 hours respectively, dries, for subsequent use; Radix Salviae Miltiorrhizae, Pheretima, Hirudo are pulverized respectively, the ethanol with 60% steams 1.5 hours, dries, for subsequent use;

Step 3, by the Scorpio 1000g handled well, Radix Ophiopogonis 1600g, Radix Polygalae 1300g, Poria 2000g, Poria cum Radix Pini 2200g, Radix Salviae Miltiorrhizae 2100g, Pheretima 1200g, Hirudo 800g and Rhizoma Gastrodiae 2000g, Arisaema Cum Bile 2100g, Radix Curcumae 1300g, Pericarpium Citri Reticulatae 1800g, Periostracum Cicadae 1600g, Radix Angelicae Pubescentis 1300g, Rhizoma Acori Graminei 1000g, Olibanum 700g, Radix Glycyrrhizae 1300g dry pulverizing respectively, levigate, cross 100 mesh sieves, obtain fine powder, mix homogeneously, is Chinese medicine mixed powder;

Step 4, Succus Bambusae 5500g to be added in Chinese medicine mixed powder, to stir, dry, levigate, be raw material of Chinese medicine powder;

Step 5, by raw material of Chinese medicine powder add adjuvant make capsule, crude drug content is about 0.3g crude drug/capsules.

Embodiment 5

Step 1, go joint to rive Hsinchu, put fire upper roasting, collect the juice that two ends ooze, filter, be Succus Bambusae, for subsequent use;

Step 2, truncated by Scorpio, Radix Ophiopogonis, Radix Polygalae remove the heart, for subsequent use; Poria, Poria cum Radix Pini's (removing wood) are steamed 1.5 hours respectively, dries, for subsequent use; Radix Salviae Miltiorrhizae, Pheretima, Hirudo are pulverized respectively, the ethanol with 60% steams 1.5 hours, dries, for subsequent use;

Step 3, by the Scorpio 900g handled well, Radix Ophiopogonis 1300g, Radix Polygalae 1700g, Poria 2300g, Poria cum Radix Pini 2300g, Radix Salviae Miltiorrhizae 2200g, Pheretima 1000g, Hirudo 900g and Rhizoma Gastrodiae 2100g, Arisaema Cum Bile 2300g, Radix Curcumae 1400g, Pericarpium Citri Reticulatae 1800g, Periostracum Cicadae 1400g, Radix Angelicae Pubescentis 1300g, Rhizoma Acori Graminei 800g, Olibanum 900g, Radix Glycyrrhizae 1300g dry pulverizing respectively, levigate, cross 100 mesh sieves, obtain fine powder, mix homogeneously, is Chinese medicine mixed powder;

Step 4, Succus Bambusae 5100g to be added in Chinese medicine mixed powder, to stir, dry, levigate, be raw material of Chinese medicine powder;

Step 5, by raw material of Chinese medicine powder add adjuvant make capsule, crude drug content is about 0.3g crude drug/capsules.

Embodiment 6

The animal toxicity test of Chinese medicine capsules of the present invention

(1) acute toxicity test

1, test drug: Chinese medicine capsules obtained by the embodiment of the present invention 1, takes apart capsule, is modulated into pasty state by purified water.Test animal used: regular grade NIH mice, body weight 22g ± 5g, male and female half and half, female mice is all without pregnant.

2, result of the test:

Application mice carries out acute toxicity testing and shows: mouse stomach Chinese medicine of the present invention, under 693.3g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 hours recovers normal, Continuous Observation 7 days after administration, none is dead for mice, and overall health of patients, diet, takes the photograph water, urine and body weight and increase all normal.Result of the test shows: the maximum dosage-feeding of mouse stomach Chinese medicine of the present invention is 693.3g crude drug/kg/d(LD ₅₀> 693.3g crude drug/kg).Chinese medicine preparation clinical application every day total amount of the present invention is 0.15g crude drug/kg/d; By weighing machine, the dosis tolerata of mouse stomach Chinese medicine preparation of the present invention is 4622 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.

(2) long term toxicity test

1, test material:

(1), animal: select adult healthy SD rat 180, original body mass 220 ± 13g, male and female half and half, female rats is all without pregnant.

(2), medicine: embodiment of the present invention 1-5 gained Chinese medicinal capsule, take capsule apart, add purified water and be modulated into scattered paste shape, per weight dosage is by 20 times of calculating (clinical application amount foundation Pharmacopoeia of the People's Republic of China version in 2010) of clinical application amount.

2, test method

(1) 180 SD rats are divided into 6 groups, often organize 30, male and female half and half.Experimental animal male and female sub-cage rearing, 5, every cage, quantitative feeding (every cage 1200-1500g/ week), normal feedstuff is experimental mouse full-valence pellet feed, freely drinks water.Experimental temperature (22 ± 2) DEG C, humidity 60%-80%.The natural lighting light and shade cycle.After SD rat is bought, under this laboratory rearing condition, adapt to 2 weeks, observe general behavior performance.Test pre-test animal ingestion amount, selects qualified rat.

(2) medication

With 5 kinds of capsules obtained by embodiment, to wherein 5 groups of SD rat oral gavages administration, every day 2 times, each volume is 0.2ml/10g body weight, successive administration 26 weeks.Remaining one group is matched group, by same method gavage normal saline.Experimental animal is weighed weekly 1 time, according to body weight change adjustment dosage.24h after administration in the 13rd week, often organize execution 10, male and female half and half, observe and detect indices; Remaining continuation administration was observed to 26 weeks, and 24h after last 1 administration, often organizes and put to death 10 again, male and female half and half, observe and detect indices; Remaining 10 are carried out 8 week convalescent period and observe.

(3) test item and the time

General inspection: the general status observing animal every day, as the mental status, dynamic response, behavioral activity, the change of dietary amount, defecation situation, eyes and duct secretions, hair color, cleannes etc.Body weight change situation and food ration measure weekly 1 time.

Hematological examination: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) and detect following index respectively: packed cell volume (HCT), red blood cell count(RBC) (RBC), content of hemoglobin (HGB), numeration of leukocyte (WBC), lymphocyte comparative counting (LY), platelet count (PLT), neutrophilic granulocyte comparative counting (NE), mononuclear cell comparative counting (Mon) and clotting time (CT).

Blood parameters check: after administration the 13rd, 26 week and drug withdrawal recovery the end of term (the 34th week) detect following index respectively: alanine aminotransferase (ALT), alkali phosphatase (AST), Lomefloxacin aspartate injection (AST), total bilirubin (TB), albumin (ALB), gross protein (TP), blood glucose (GLU), blood urea nitrogen (BUN), T-CHOL (TC), creatinine (Crea), uric acid (UA), blood sodium (Na ⁺), blood potassium (K ⁺), blood calcium (Ca ⁺) and β ₂-microglobulin.

Urinate biochemical and urine routine: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) each survey 1 time.Animal metabolism cage list cage is raised and is collected 24h urine, overnight fasting before test, detects urine bilirubin (BIL), glucose (GLU), ketoboidies (KET), protein, pH value, urobilinogen (URO), urine is occulted blood (BLO), nitrite (NIT), proportion and leukocyte (WBC); Quantitative determination of radioimmunoassay urine β ₂-MG(renal tubular function obstacle sensitive indicator).

System postmortem and histopathologic examination: macroscopy is carried out to each internal organs, the organs such as heart, liver, lungs, kidney, spleen, brain, adrenal gland, thymus, thyroid, pancreas, uterus, ovary, testis, prostate are taken out and weighs, calculate organ coefficient (organ weights/body weight).With light microscopic, histological examination is carried out to above-mentioned internal organs and spinal cord, thymus, bladder, bone marrow (breastbone), duodenum, stomach, ileum, pancreas, hypophysis cerebri, optic nerve, lymph node, coton and rectal etc.

3, result of the test

The all rats of overview all do not show any abnormal conditions; Hematological examination, blood parameters inspection, urinate biochemical, urine routine, system postmortem and histopathologic examination, indices, compared with control animals, does not all have obvious difference.Therefore, Chinese medicine oral liquid of the present invention to SD rat without any toxic action, in view of 20 times of ratios of its behaviour dose, so can infer that to take be safe to this oral liquid for patient.

The clinical trial of embodiment 7, Chinese medicinal capsule of the present invention

1, experimenter's data

Experimenter all from the epileptic that the People's Hospital of certain city the 4th accepted for medical treatment year February in March, 2010 to 2014, therefrom filter out be applicable to doing clinical trial patient 156 example, wherein man 68 example, age 19-62 year, female 88 example, age 17-65 year.

2, divide into groups

Experimenter is divided into 4 groups, often organizes 39 examples, wherein man 17 example, female 22 example; Be numbered matched group, example 3 groups, example 4 groups, example 5 groups respectively.

3, medication is tested

(1) medicine is contrasted: levetiracetam tablet, specification: 0.5g/ sheet, authentication code: H20110410, manufacturing enterprise: UCB Pharma S.A..

(2) investigational agent: the embodiment of the present invention 3, embodiment 4, capsule obtained by embodiment 5, specification: amount to crude drug amount and be about 0.9g crude drug/capsules.

4, testing program

The oral levetiracetam tablet of matched group, each 0.5g, every day 2 times; Example 3, example 4, example 5 groups be the oral embodiment of the present invention 3, embodiment 4, capsule obtained by embodiment 5 respectively, each 5, every day 2 times.Within 4 weeks, be a course for the treatment of, treat 4 courses for the treatment of continuously.In medication process, the treatment such as itemized record patient, untoward reaction, physical recovery situation, medication impression situation.

5, evaluation criterion

(1) cure: epilepsy syndromes disappears completely, and make a definite diagnosis through doctor and return to one's perfect health.

(2) effective: epilepsy syndromes has improvement in various degree or alleviation.

(3) invalid: epilepsy is without any improvement, even more serious.

(4) untoward reaction: because of uncomfortable caused by drug administration or cause former disease other symptoms concurrent.

6, logging and analysis

(1) untoward reaction record: matched group has 21 routine patients to occur untoward reaction in various degree, main manifestations has drowsiness, emotional lability, diarrhoea, loss of appetite, dizzy, diplopia, erythra etc.Wherein there are 2 routine patients to occur serious untoward reaction, have to exit clinical trial.The all patients of test group 3 group all none routine untoward reaction.

(2) result of the test statistical computation:

After test all being carried out by the scheme designed, analysis of statistical results in table 1, wherein matched group come off two example, complete 37 example, test group does not have case to come off.

Table 1 analysis of statistical results table

7, conclusion (of pressure testing)

As can be seen from statistical result, investigational agent has significant technical advantage compared with contrast medicine, is mainly manifested in: the untoward reaction of contrast medicine is serious, up to over half, and has occurred 2 routine serious adverse reactions, none routine untoward reaction of investigational agent; The average cure rate (23.9%) of investigational agent is 4.4 times of matched group; The average total effective rate (86.3%) of investigational agent is higher than matched group 34.9 percentage points.Therefore, Chinese medicine preparation of the present invention, relative to prior art, has and treats advantage very significantly, and technical advantage clearly, present invention obtains beat all technological achievement.

Claims (6)

1. treat a Chinese medicine preparation for epilepsy, it is characterized in that being made up of the raw material of following weight portion: Succus Bambusae 45-60 part, Rhizoma Gastrodiae 15-24 part, Hirudo 6-11 part, Arisaema Cum Bile 16-26 part, Pheretima 5-14 part, Scorpio 6-12 part, Radix Curcumae 11-18 part, Pericarpium Citri Reticulatae 11-22 part, Poria 17-26 part, Periostracum Cicadae 10-19 part, Radix Angelicae Pubescentis 10-17 part, Poria cum Radix Pini 17-28 part, Radix Salviae Miltiorrhizae 15-25 part, Radix Ophiopogonis 10-18 part, Radix Polygalae 12-19 part, Rhizoma Acori Graminei 6-11 part, Olibanum 6-11 part, Radix Glycyrrhizae 9-16 part.

2. treat the Chinese medicine preparation of epilepsy as claimed in claim 1, it is characterized in that being made up of the raw material of following weight portion: Succus Bambusae 53 parts, 18 parts, Rhizoma Gastrodiae, Hirudo 7 parts, Arisaema Cum Bile 22 parts, Pheretima 11 parts, Scorpio 10 parts, Radix Curcumae 15 parts, Pericarpium Citri Reticulatae 16 parts, 21 parts, Poria, Periostracum Cicadae 14 parts, Radix Angelicae Pubescentis 14 parts, Poria cum Radix Pini 21 parts, Radix Salviae Miltiorrhizae 20 parts, Radix Ophiopogonis 14 parts, Radix Polygalae 15 parts, Rhizoma Acori Graminei 9 parts, Olibanum 8 parts, 12 parts, Radix Glycyrrhizae.

3. treat the Chinese medicine preparation of epilepsy as claimed in claim 1, it is characterized in that being made up of the raw material of following weight portion: Succus Bambusae 55 parts, 20 parts, Rhizoma Gastrodiae, Hirudo 8 parts, Arisaema Cum Bile 21 parts, Pheretima 12 parts, Scorpio 10 parts, Radix Curcumae 13 parts, Pericarpium Citri Reticulatae 18 parts, 20 parts, Poria, Periostracum Cicadae 16 parts, Radix Angelicae Pubescentis 13 parts, Poria cum Radix Pini 22 parts, Radix Salviae Miltiorrhizae 21 parts, Radix Ophiopogonis 16 parts, Radix Polygalae 13 parts, Rhizoma Acori Graminei 10 parts, Olibanum 7 parts, 13 parts, Radix Glycyrrhizae.

4. treat the Chinese medicine preparation of epilepsy as claimed in claim 1, it is characterized in that being made up of the raw material of following weight portion: Succus Bambusae 51 parts, 21 parts, Rhizoma Gastrodiae, Hirudo 9 parts, Arisaema Cum Bile 23 parts, Pheretima 10 parts, Scorpio 9 parts, Radix Curcumae 14 parts, Pericarpium Citri Reticulatae 18 parts, 23 parts, Poria, Periostracum Cicadae 14 parts, Radix Angelicae Pubescentis 13 parts, Poria cum Radix Pini 23 parts, Radix Salviae Miltiorrhizae 22 parts, Radix Ophiopogonis 13 parts, Radix Polygalae 17 parts, Rhizoma Acori Graminei 8 parts, Olibanum 9 parts, 13 parts, Radix Glycyrrhizae.

5. prepare as arbitrary in claim 1-4 as described in the method for Chinese medicine preparation for the treatment of epilepsy, it is characterized in that comprising the following steps:

Step 1, go joint to rive Hsinchu, put fire upper roasting, collect the juice that two ends ooze, filter, be Succus Bambusae, for subsequent use;

Step 2, truncated by Scorpio, Radix Ophiopogonis, Radix Polygalae remove the heart, for subsequent use; Poria, Poria cum Radix Pini's (removing wood) are steamed 1-2 hour respectively, dries, for subsequent use; Radix Salviae Miltiorrhizae, Pheretima, Hirudo are pulverized respectively, steams 1-2 hour with the ethanol of 50-65%, dry, for subsequent use;

Step 3, the Scorpio handled well, Radix Ophiopogonis, Radix Polygalae, Poria, Poria cum Radix Pini, Radix Salviae Miltiorrhizae, Pheretima, Hirudo and Rhizoma Gastrodiae, Arisaema Cum Bile, Radix Curcumae, Pericarpium Citri Reticulatae, Periostracum Cicadae, Radix Angelicae Pubescentis, Rhizoma Acori Graminei, Olibanum, Radix Glycyrrhizae are dried pulverizing respectively, levigate, cross 100 mesh sieves, obtain fine powder, mix homogeneously, is Chinese medicine mixed powder;

Step 4, Succus Bambusae to be added in Chinese medicine mixed powder in proportion, to stir, dry, levigate, be raw material of Chinese medicine powder;

Step 5, by raw material of Chinese medicine powder add adjuvant make finished product preparation.

6. as described in as arbitrary in claim 1-4, the Chinese medicine preparation for the treatment of epilepsy, is characterized in that: described Chinese medicine can make capsule, tablet or honeyed pill.