CN106668183A - Pharmaceutical composition for treating epilepsy and preparation method thereof - Google Patents

Pharmaceutical composition for treating epilepsy and preparation method thereof Download PDF

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CN106668183A
CN106668183A CN201611134460.9A CN201611134460A CN106668183A CN 106668183 A CN106668183 A CN 106668183A CN 201611134460 A CN201611134460 A CN 201611134460A CN 106668183 A CN106668183 A CN 106668183A
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不公告发明人
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Jinan Haoyu Qingtian Medicine Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
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    • A61K35/612Crustaceans, e.g. crabs, lobsters, shrimps, krill or crayfish; Barnacles
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/55Liquid-liquid separation; Phase separation

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Abstract

The invention discloses a pharmaceutical composition for treating epilepsy and a preparation method thereof. The pharmaceutical composition disclosed by the invention is proportioned by taking king crab's gallbladder, pinkflower ecdysanthera roots and leaves, sunset abelmoschus flowers, piper sarmentosum roxb, polyglycerol-10 laurate and 3-methyl capraldehyde as raw material medicines, can be prepared into various forms according to a conventional preparation process, and is remarkable in curative effect for treating epilepsy.

Description

Pharmaceutical composition for the treatment of epilepsy and preparation method thereof
Technical field
The invention belongs to technical field of Chinese medicines, more particularly to a kind of treat pharmaceutical composition of epilepsy and preparation method thereof.
Background technology
Epilepsy (eplepsy) is a kind of of short duration central nervous system function by caused by cerebral neuron paradoxical discharge The not normal chronic brain diseasess being characterized, with occurring suddenly, recurrent exerbation the characteristics of, equivalent to the epilepsy disease of motherland's medical science, epilepsy Disease has " epilepsy syndrome ", the title of " epilepsy " again.So far, the medicine of significantly more efficient treatment epilepsy is not yet found.
Fel Tachyplei tridentati:For the gallbladder of king crab section animal Tachypleus tridentatus.Take gallbladder after catching and killing, using fresh herb or dry in the shade.【Nature and flavor】Bitter in the mouth;It is cold in nature.【Return Jing】Lung;Large intestine channel.【Indication】Wind dispelling insecticide.Main leprosy;Scabies.【Take passages】《Chinese book on Chinese herbal medicine》.
Radix Seu Folium Ecdysantherae Roseae:For root, the leaf of apocynaceae plant acid leaf glue rattan.Whole year can adopt.Take root to dry.Ye Duolin is used Shi Caixin fresh goods.【Original shape state】For woody climber, up to 10m.Herb tool breast, peel of stem dark brown, without obvious hole skin.Leaf opposite; The long 1-2cm of petiole;Blade papery, oblong, long 3-7cm, wide 1-4cm, without hair, blade back is by white lead on two sides;Lateral vein is per side 4-6 Bar.Basidixed cyme, coniform, majority of blossoming is loose to launch, and spends little, 5 numbers, pink;Calyx lobes oval;Corolla Nearly urniform;Stamen is born in tube base portion, and filigree is short, flower pesticide lanceolar, base portion tool ear;Floral disc ring-type, around ovary; Ovary is constituted by 2 pieces from raw carpel, and by pubescence, style is thread, and stigma tip 2 splits.2 pieces of Follicle radish, diverges in line, outer fruit Skin has obvious speckle.Seed Long Circle, tip tool thin,tough silk matter kind hair.The month at florescence 4-12, January fruiting period July to next year.【Chemical composition】 The aerial partss of this product contain sour leaf glue rattan triterpene ester(D-friedours-14-en-11a, 12a-epoxy-33-yl palmitate).【Nature and flavor】Acid;It is mild-natured.【Return through】Liver Channel.【Indication】Heat-clearing and toxic substances removing;Dampness removingization is stagnant;Promoting blood circulation and detumescence.Main pharynx Larynx swells and ache;Stomatitis;Enteritis;Chronic nephritiss;Dyspepsia distension;Carbuncle sore tumefacting virus;Rheumatic arthralgia;Treating swelling and pain by traumatic injury.【Take passages】《China is originally Grass》.
Flos abelmoschi manihot:For malvaceae plant Abelmoschus manihot (L.) Medic or the flower of bristle Abelmoschus manihot (L.) Medic.The 7-10 months, in addition to reserving seed for planting, pluck in batches Alabastrum, dries.【Original shape state】1. Abelmoschus manihot (L.) Medic is annual or perennial herb, high 1-2m.Dredge by long bristle.Leaf alternate;Petiole is long 6-18cm, dredges by long bristle;Stipule lanceolar, long l-1.5cm.Leaf palmate 5-9 drastic crack, diameter 15-30cm, the long round shape of sliver is draped over one's shoulders Aciculiform, long 8-18cm, wide 1-6cm, two sides is dredged by long bristle, and edge has thick crenation.Hua Dan is born in an end axil;Squamella 4- 5, ovum shape lanceolar, long 15-25mm, wide 4-5mm are dredged by long bristle;Calyx spathe shape, 5 split, nearly full edge, longer than squamella, By pubescence, come off during fruit;Hua great, faint yellow, inner face base portion purple, diameter about 12cm;Stamen column length 1.5-2cm, the nearly nothing of flower pesticide Handle;Stigma atropurpureuss, spoon-shaped dish type.Capsule ovate-elliptic, long 4-5cm, diameter 2.5-3cm, by bristle.Seed is most, kidney Shape, the striped constituted by pubescence is a plurality of.The month at florescence 8-10.2. this mutation and upper kind are distinguished as:Plant is all close long by yellow Bristle.【Chemical composition】Flos abelmoschi manihot -3- Flos Robiniae Pseudoacaciae the glucosides of element containing bark(quercetin-3-robinobioside), Quercetin- 3- glycosides(quercetin-3-glucoside), hyperin(hyperin), ampelopsin(myricetin)And Quercetin (quercetin).【Nature and flavor】It is sweet;It is pungent;It is cool in nature.【Return through】The heart;Kidney;Bladder warp.【Indication】Inducing diuresis for treating stranguria syndrome;Promoting blood circulation;Hemostasis; Subduing swelling and detoxicating.Main stranguria;Spit blood;Epistaxis;Metrorrhagia;Placenta retention;Carbuncle sore tumefacting virus;Burn due to hot liquid or fire.【Take passages】《Chinese book on Chinese herbal medicine》.
Clam beach wormwood:Piperaceae Fructus Piperiss platymiscium vacation beach wormwood Piper sarmentosum Roxb., are entered with Herb, root, leaf or fruit Medicine.Herb, root can be adopted at any time;Leaf and fruit autumn gather, and dry.【Nature and flavor】It is pungent, temperature.【Indication】Warming spleen and stomach for dispelling cold, wind-dispelling profit It is wet, reducing swelling and alleviating pain.For stomach coldness of the intestines pain, cough due to wind and cold, edema, malaria, toothache, rheumatic ostalgia, traumatic injury.【Take passages】《Entirely State's Chinese herbal medicine compilation》.
Natrulon H-10 laurate(Polyglyceryl-10 Laurate):Molecular formula:C42H84O22,Molecular weight: C42H84O22, CAS accession number:34406-66-1.
3- methyl decanals(3-Methyldecanal):Molecular formula:C11H22O,Molecular weight:170.29, CAS accession number: 77772-07-7.Density:0.819g/cm3(Value of calculation).Boiling point:222.45°C at 760 mmHg(Value of calculation).Flash-point: 81.765°C(Value of calculation).
The chemical constitution of 2 crude drug:
Natrulon H-10 laurate(Polyglyceryl-10 Laurate)3- methyl decanals(3-Methyldecanal).
The content of the invention
The purpose of the present invention is to overcome the shortcomings of background technology, there is provided a kind of pharmaceutical composition of effectively treatment epilepsy and its Preparation method.
The present invention adopts the following technical scheme that realization:
The composition and weight portion for making the crude drug of the pharmaceutical composition of the treatment epilepsy be:
Fel Tachyplei tridentati 2250-2350g Radix Seu Folium Ecdysantherae Roseae 8550-8650g Flos abelmoschi manihot 4525-4625g clams beach wormwood 3125- 3225g Natrulon H-10 laurate 103-113g 3- 66-76g of methyl decanal.
The pharmaceutical composition for the treatment of epilepsy is preferably used in, is made up of the crude drug of following weight portion:
Fel Tachyplei tridentati 2300g Radix Seu Folium Ecdysantherae Roseae 8600g Flos abelmoschi manihot 4575g clam beach wormwood 3175g Natrulon H-10 laurate 108g 3- methyl decanal 71g.
A kind of pharmaceutical composition for treating epilepsy, it is characterised in that pharmaceutical composition can adopt the conventional method of galenic pharmacy Prepare piece agent or capsule or drop pill.
A kind of pharmaceutical composition for treating epilepsy, it is characterised in that the treatment that pharmaceutical composition is constituted with chemical drugs or Chinese medicine AED.
A kind of preparation method of the pharmaceutical composition for treating epilepsy, it is characterised in that prepare as follows:
The composition and weight portion of crude drug be:Fel Tachyplei tridentati 2250-2350g Radix Seu Folium Ecdysantherae Roseae 8550-8650g Flos abelmoschi manihots 4525-4625g clam beach wormwood 3125-3225g Natrulon H-10 laurate 103-113g 3- 66-76g of methyl decanal;
Preparation method:
(1)Fel Tachyplei tridentati, Radix Seu Folium Ecdysantherae Roseae, Flos abelmoschi manihot, clam beach wormwood, Natrulon H-10 laurate, the 3- methyl last of the ten Heavenly stems are taken by crude drug proportioning Aldehyde, mixes, and with the ethanol of weight percent concentration 23% as solvent, extracts in 38 DEG C of warm macerating, and extraction time is 10 times, is carried every time The time is taken for 27 hours, each solvent load is 44 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A Ethanol is reclaimed, relative density 1.10 is concentrated into, is filtered, medicinal liquid is first washed with water by LSA-40 macroporous adsorptive resins, then is used The ethanol solution eluting LSA-40 macroporous adsorptive resins of weight percent concentration 51%, collect the ethanol of weight percent concentration 51% and wash De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 3 times, carries every time The time is taken for 1.1 hours, each solvent load is 13 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.13 is concentrated into, is filtered, medicinal liquid is first washed with water by DM11 macroporous adsorptive resins, then uses weight The ethanol solution eluting DM11 macroporous adsorptive resins of percent concentration 63%, collect the ethanol elution of weight percent concentration 63%, Ethanol is reclaimed, concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Preferred a kind of preparation method of the pharmaceutical composition for treating epilepsy, it is characterised in that prepare as follows:
The composition and weight portion of crude drug be:Fel Tachyplei tridentati 2300g Radix Seu Folium Ecdysantherae Roseae 8600g Flos abelmoschi manihot 4575g clam beach wormwood 3175g Natrulon H-10 laurate 108g 3- methyl decanal 71g;
Preparation method:
(1)Fel Tachyplei tridentati, Radix Seu Folium Ecdysantherae Roseae, Flos abelmoschi manihot, clam beach wormwood, Natrulon H-10 laurate, the 3- methyl last of the ten Heavenly stems are taken by crude drug proportioning Aldehyde, mixes, and with the ethanol of weight percent concentration 23% as solvent, extracts in 38 DEG C of warm macerating, and extraction time is 10 times, is carried every time The time is taken for 27 hours, each solvent load is 44 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A Ethanol is reclaimed, relative density 1.10 is concentrated into, is filtered, medicinal liquid is first washed with water by LSA-40 macroporous adsorptive resins, then is used The ethanol solution eluting LSA-40 macroporous adsorptive resins of weight percent concentration 51%, collect the ethanol of weight percent concentration 51% and wash De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 3 times, carries every time The time is taken for 1.1 hours, each solvent load is 13 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.13 is concentrated into, is filtered, medicinal liquid is first washed with water by DM11 macroporous adsorptive resins, then uses weight The ethanol solution eluting DM11 macroporous adsorptive resins of percent concentration 63%, collect the ethanol elution of weight percent concentration 63%, Ethanol is reclaimed, concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
A kind of preparation method of the pharmaceutical composition for treating epilepsy, it is characterised in that pharmaceutical composition can adopt galenic pharmacy Conventional method prepare piece agent or capsule or drop pill.
A kind of preparation method of the pharmaceutical composition for treating epilepsy, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine Composition treatment AED.
Specific embodiment
Embodiment 1:Pharmaceutical composition for the treatment of epilepsy and preparation method thereof
Treatment epilepsy pharmaceutical composition crude drug composition and weight portion be:2300g Radix Seu Folium Ecdysantherae Roseae 8600g is yellow for Fel Tachyplei tridentati Flos althaeae roseae 4575g clam beach wormwood 3175g Natrulon H-10 laurate 108g 3- methyl decanal 71g;
Preparation method:
(1)Fel Tachyplei tridentati, Radix Seu Folium Ecdysantherae Roseae, Flos abelmoschi manihot, clam beach wormwood, Natrulon H-10 laurate, the 3- methyl last of the ten Heavenly stems are taken by crude drug proportioning Aldehyde, mixes, and with the ethanol of weight percent concentration 23% as solvent, extracts in 38 DEG C of warm macerating, and extraction time is 10 times, is carried every time The time is taken for 27 hours, each solvent load is 44 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A Ethanol is reclaimed, relative density 1.10 is concentrated into, is filtered, medicinal liquid is first washed with water by LSA-40 macroporous adsorptive resins, then is used The ethanol solution eluting LSA-40 macroporous adsorptive resins of weight percent concentration 51%, collect the ethanol of weight percent concentration 51% and wash De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 3 times, carries every time The time is taken for 1.1 hours, each solvent load is 13 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.13 is concentrated into, is filtered, medicinal liquid is first washed with water by DM11 macroporous adsorptive resins, then uses weight The ethanol solution eluting DM11 macroporous adsorptive resins of percent concentration 63%, collect the ethanol elution of weight percent concentration 63%, Ethanol is reclaimed, concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 2:Pharmaceutical composition for the treatment of epilepsy and preparation method thereof
Treatment epilepsy pharmaceutical composition crude drug composition and weight portion be:2250g Radix Seu Folium Ecdysantherae Roseae 8650g is yellow for Fel Tachyplei tridentati Flos althaeae roseae 4525g clam beach wormwood 3225g Natrulon H-10 laurate 103g 3- methyl decanal 76g;
Preparation method:
(1)Fel Tachyplei tridentati, Radix Seu Folium Ecdysantherae Roseae, Flos abelmoschi manihot, clam beach wormwood, Natrulon H-10 laurate, the 3- methyl last of the ten Heavenly stems are taken by crude drug proportioning Aldehyde, mixes, and with the ethanol of weight percent concentration 23% as solvent, extracts in 38 DEG C of warm macerating, and extraction time is 10 times, is carried every time The time is taken for 27 hours, each solvent load is 44 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A Ethanol is reclaimed, relative density 1.10 is concentrated into, is filtered, medicinal liquid is first washed with water by LSA-40 macroporous adsorptive resins, then is used The ethanol solution eluting LSA-40 macroporous adsorptive resins of weight percent concentration 51%, collect the ethanol of weight percent concentration 51% and wash De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 3 times, carries every time The time is taken for 1.1 hours, each solvent load is 13 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.13 is concentrated into, is filtered, medicinal liquid is first washed with water by DM11 macroporous adsorptive resins, then uses weight The ethanol solution eluting DM11 macroporous adsorptive resins of percent concentration 63%, collect the ethanol elution of weight percent concentration 63%, Ethanol is reclaimed, concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 3:Pharmaceutical composition for the treatment of epilepsy and preparation method thereof
Treatment epilepsy pharmaceutical composition crude drug composition and weight portion be:2350g Radix Seu Folium Ecdysantherae Roseae 8550g is yellow for Fel Tachyplei tridentati Flos althaeae roseae 4625g clam beach wormwood 3125g Natrulon H-10 laurate 113g 3- methyl decanal 66g;
Preparation method:
(1)Fel Tachyplei tridentati, Radix Seu Folium Ecdysantherae Roseae, Flos abelmoschi manihot, clam beach wormwood, Natrulon H-10 laurate, the 3- methyl last of the ten Heavenly stems are taken by crude drug proportioning Aldehyde, mixes, and with the ethanol of weight percent concentration 23% as solvent, extracts in 38 DEG C of warm macerating, and extraction time is 10 times, is carried every time The time is taken for 27 hours, each solvent load is 44 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A Ethanol is reclaimed, relative density 1.10 is concentrated into, is filtered, medicinal liquid is first washed with water by LSA-40 macroporous adsorptive resins, then is used The ethanol solution eluting LSA-40 macroporous adsorptive resins of weight percent concentration 51%, collect the ethanol of weight percent concentration 51% and wash De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 3 times, carries every time The time is taken for 1.1 hours, each solvent load is 13 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.13 is concentrated into, is filtered, medicinal liquid is first washed with water by DM11 macroporous adsorptive resins, then uses weight The ethanol solution eluting DM11 macroporous adsorptive resins of percent concentration 63%, collect the ethanol elution of weight percent concentration 63%, Ethanol is reclaimed, concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
Embodiment 4:The preparation of tablet
The pharmaceutical composition 308g of Example 1, adds starch 102g, mixes, and granulation is dried, plus Microcrystalline Cellulose 34g, Hard Fat Sour magnesium 4g, mixes, and is pressed into 1000, obtains final product medicinal composition tablets.
Embodiment 5:The preparation of capsule
The pharmaceutical composition 311g of Example 2, adds starch 81g, mixes, and granulation is dried, granulate, adds appropriate magnesium stearate, Mix, encapsulated 1000, obtain final product medicament composition capsule.
Embodiment 6:The preparation of drop pill
Weigh (80 DEG C) heating of polyethylene glycol 6000 193g water-baths and boil molten, add the pharmaceutical composition 14g of embodiment 3, fully stir Mix uniform, with liquid paraffin as coolant, put glass tubing(4*80cm)In, chilling temperature is 5 DEG C, and drip internal-and external diameter is 6.0/ 2.0 (mm/mm), drip is 2.5cm away from liquid level, and drop speed, as optimum condition, with cotton the cold of drop pill surface is blotted with per point 57 drops Solidifying agent, obtains final product medicament composition dropping pills.
Embodiment 7:The pharmaceutical composition for the treatment of epilepsy
Treatment epilepsy pharmaceutical composition crude drug composition and weight portion be:
Fel Tachyplei tridentati 4350g Radix Seu Folium Ecdysantherae Roseae 4550g Natrulon H-10 laurate 58g 3- methyl decanal 78g.
Embodiment 8:The pharmaceutical composition for the treatment of epilepsy
Treatment epilepsy pharmaceutical composition crude drug composition and weight portion be:
Fel Tachyplei tridentati 4300g Radix Seu Folium Ecdysantherae Roseae 4600g Natrulon H-10 laurate 53g 3- methyl decanal 83g.
Embodiment 9:The pharmaceutical composition for the treatment of epilepsy
Treatment epilepsy pharmaceutical composition crude drug composition and weight portion be:
Fel Tachyplei tridentati 4400g Radix Seu Folium Ecdysantherae Roseae 4500g Natrulon H-10 laurate 63g 3- methyl decanal 73g.
Experimental example 1:The experimental study for the treatment of epilepsy
1. all 80 patients of clinical data are selected from December, 2014-2015 year December LINYI PEOPLE'S HOSPITAL encephalopathy section Outpatient service, diagnosis meets what Ministry of Health of the People's Republic of China developed and published for 1993《New Chinese medicine clinical research is instructed former Then》In the guideline of clinical investigations of epilepsy syndrome " new Chinese medicine treat " diagnostic criteria.Wherein male 45, women 25 Example, the ratio of men and women is 1.8:1;Age is minimum 10 years old, maximum 48 years old, 24 years old mean age;The course of disease is most short 6 months, most long 11 years, Average course of disease 6.4 years.
2. Therapeutic Method gives the oral pharmaceutical composition(The pharmaceutical composition lot number 20140912 of embodiment 1), every time 1.5g, 2 times a day.Divide and take for 2 times sooner or later, be within 3 months 1 course for the treatment of, treat 3 courses for the treatment of, patient is before treatment and the course for the treatment of terminates Check electroencephalogram in 1 week afterwards.
3. criterion of therapeutical effect is developed and published for 1993 with reference to Ministry of Health of the People's Republic of China《New Chinese medicine clinic is ground Study carefully guideline》In the guideline of clinical investigations of epilepsy syndrome " new Chinese medicine treat " with regard to epilepsy curative effect judging standard.Recovery from illness: Outbreak is controlled more than 3 years completely, and electroencephalogram recovers normal;It is effective:Seizure frequency reduces more than 75%, or between the front outbreak for the treatment of Compare every the time, prolongation does not show effect for more than 1 year, electroencephalogram change is clearly better;Effectively:Seizure frequency subtracts 50%~and 75%, or send out Make symptom substantially to mitigate, decreased duration more than 1/2, electroencephalogram change take a favorable turn;It is invalid:Seizure frequency, degree, outbreak disease Shape, electroencephalogram without improvement or deteriorates.
4. therapeutic outcome clinical efficacy is taken medicine 3 months:Recovery from illness 38, accounts for 47.5%;Effective 12, account for 15%;Effective 23 Example, accounts for 28.75%;Invalid 7, account for 8.75%.Medication 6 months:Recovery from illness 42, accounts for 52.5%;Effective 15, account for 18.75%;Effectively 17, account for 21.25%;Invalid 6, account for 7.5%.Medication 9 months:Recovery from illness 45, accounts for 56.25%;Effective 16, account for 20%;Effectively 15, account for 18.75%;Invalid 4, account for 5%.Total effective rate is 95%.
5. electroencephalogram change is shown in Table 1 before and after electroencephalogram change medication, and data adopt x2Inspection carries out statistical procedures. Compare with electroencephalogram before medication within 3 months after medication, it is as a result not statistically significant;Compare with electroencephalogram before medication within 6 months after medication, As a result it is variant;Compare with electroencephalogram before medication within 9 months after medication, as a result there is significant difference.It is right after illustrating medication 9 months The abnormal change effect is significant of patient's electroencephalogram.
Electroencephalogram changes before and after table 1 is taken medicine
Before and after medication n Normally It is abnormal
Before medication 80 9(11.25) 71(88.75)
After medication 3 months 80 21(26.25) 59(73.75)
After medication 6 months 80 34(42.5)* 46(57.5)*
After medication 9 months 80 45(56.25)** 35(43.75)**
Note:Compare with before medication, * P<O.05, * * P<O.01.
Experimental example 2:Model case
Appoint XX, male, 30 years old, epileptic, outbreak perplexed him 5 years, and outbreak every time is all entirely ignorant of, and unintentionally touches Rope, rubs hands, and makes clicks.If that is just more frightful for grand mal, the latter point that falls down to the ground during outbreak occurrences in human life are not saved, and slobbering, whole body is taken out Jerk, or even also gatism.On October 26th, 2015 starts to give the oral pharmaceutical composition(The pharmaceutical composition of embodiment 1 Lot number 20140912), each 1.5g, 2 times a day.Divide and take for 2 times sooner or later, be within 3 months 1 course for the treatment of, after 3 courses for the treatment of of treatment, appoint The state of an illness number of times that has obvious improvement, petit mal considerably reduce, symptom during outbreak is also mitigated.Continue to take again 1 course for the treatment of of medicine, patient never reaccessed, and goes to hospital to do 24 h Ambulatory ElectroencephalogramIn inspections and also all goes well, epilepsy Shape is wholly absent, and he is now spiritual also quite full.
Zhao XX, man, 28 years old, epileptic, sudden loss of consciousness during morbidity fell down to the ground, head layback, because diaphragm spasm goes out Now roar, tic of the limbs is spat out white foams, purplish complexion, turn on two, sometimes with gatism, to showing effect after outbreak Cheng Buneng recalls, and overall pain is weak.On November 1st, 2015 starts to give the oral pharmaceutical composition(The drug regimen of embodiment 1 Thing lot number 20140912), each 1.5g, 2 times a day.Divide and take for 2 times sooner or later, be within 3 months 1 course for the treatment of, after 3 courses for the treatment of of treatment, The number of times that the state of an illness of Zhao has obvious improvement, outbreak is considerably reduced, and symptom during outbreak is also mitigated.Continue to take again 1 course for the treatment of of medicine, patient never reaccessed, and goes to hospital to do 24 h Ambulatory ElectroencephalogramIn inspections and also all goes well, epilepsy Shape is wholly absent.

Claims (8)

1. a kind of pharmaceutical composition for treating epilepsy, it is characterised in that make the composition and weight of the crude drug of the pharmaceutical composition Part it is:
Fel Tachyplei tridentati 2250-2350g Radix Seu Folium Ecdysantherae Roseae 8550-8650g Flos abelmoschi manihot 4525-4625g clams beach wormwood 3125- 3225g Natrulon H-10 laurate 103-113g 3- 66-76g of methyl decanal.
2. a kind of pharmaceutical composition for treating epilepsy according to claim 1, it is characterised in that make the pharmaceutical composition The composition and weight portion of crude drug be:
Fel Tachyplei tridentati 2300g Radix Seu Folium Ecdysantherae Roseae 8600g Flos abelmoschi manihot 4575g clam beach wormwood 3175g Natrulon H-10 laurate 108g 3- methyl decanal 71g.
3. a kind of pharmaceutical composition for treating epilepsy according to claim 1, it is characterised in that pharmaceutical composition can be adopted The conventional method of galenic pharmacy prepares piece agent or capsule or drop pill.
4. a kind of pharmaceutical composition for treating epilepsy according to claim 1, it is characterised in that pharmaceutical composition and chemical drugs Or the treatment AED of Chinese medicine composition.
5. a kind of preparation method of the pharmaceutical composition for treating epilepsy, it is characterised in that prepare as follows:
The composition and weight portion of crude drug be:Fel Tachyplei tridentati 2250-2350g Radix Seu Folium Ecdysantherae Roseae 8550-8650g Flos abelmoschi manihots 4525-4625g clam beach wormwood 3125-3225g Natrulon H-10 laurate 103-113g 3- 66-76g of methyl decanal;
Preparation method:
(1)Fel Tachyplei tridentati, Radix Seu Folium Ecdysantherae Roseae, Flos abelmoschi manihot, clam beach wormwood, Natrulon H-10 laurate, the 3- methyl last of the ten Heavenly stems are taken by crude drug proportioning Aldehyde, mixes, and with the ethanol of weight percent concentration 23% as solvent, extracts in 38 DEG C of warm macerating, and extraction time is 10 times, is carried every time The time is taken for 27 hours, each solvent load is 44 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A Ethanol is reclaimed, relative density 1.10 is concentrated into, is filtered, medicinal liquid is first washed with water by LSA-40 macroporous adsorptive resins, then is used The ethanol solution eluting LSA-40 macroporous adsorptive resins of weight percent concentration 51%, collect the ethanol of weight percent concentration 51% and wash De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 3 times, carries every time The time is taken for 1.1 hours, each solvent load is 13 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.13 is concentrated into, is filtered, medicinal liquid is first washed with water by DM11 macroporous adsorptive resins, then uses weight The ethanol solution eluting DM11 macroporous adsorptive resins of percent concentration 63%, collect the ethanol elution of weight percent concentration 63%, Ethanol is reclaimed, concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
6. a kind of preparation method of the pharmaceutical composition for treating epilepsy according to claim 5, it is characterised in that by following step It is rapid to prepare:
The composition and weight portion of crude drug be:Fel Tachyplei tridentati 2300g Radix Seu Folium Ecdysantherae Roseae 8600g Flos abelmoschi manihot 4575g clam beach wormwood 3175g Natrulon H-10 laurate 108g 3- methyl decanal 71g;
Preparation method:
(1)Fel Tachyplei tridentati, Radix Seu Folium Ecdysantherae Roseae, Flos abelmoschi manihot, clam beach wormwood, Natrulon H-10 laurate, the 3- methyl last of the ten Heavenly stems are taken by crude drug proportioning Aldehyde, mixes, and with the ethanol of weight percent concentration 23% as solvent, extracts in 38 DEG C of warm macerating, and extraction time is 10 times, is carried every time The time is taken for 27 hours, each solvent load is 44 times of crude drug gross weight, filters, and obtains medicinal residues A and extracting solution A, extracting solution A Ethanol is reclaimed, relative density 1.10 is concentrated into, is filtered, medicinal liquid is first washed with water by LSA-40 macroporous adsorptive resins, then is used The ethanol solution eluting LSA-40 macroporous adsorptive resins of weight percent concentration 51%, collect the ethanol of weight percent concentration 51% and wash De- liquid, reclaims ethanol, and concentrate drying obtains final product extract A;
(2)Take step(1)Medicinal residues A, with the ethanol of weight percent concentration 51% as solvent, heating and refluxing extraction 3 times, carries every time The time is taken for 1.1 hours, each solvent load is 13 times of medicinal residues A weight, filters, obtain medicinal residues B and extracting solution B, extracting solution B is returned Ethanol is received, relative density 1.13 is concentrated into, is filtered, medicinal liquid is first washed with water by DM11 macroporous adsorptive resins, then uses weight The ethanol solution eluting DM11 macroporous adsorptive resins of percent concentration 63%, collect the ethanol elution of weight percent concentration 63%, Ethanol is reclaimed, concentrate drying obtains final product extract B;
(3)Extract A and extract B are mixed, pharmaceutical composition is obtained final product.
7. a kind of preparation method of the pharmaceutical composition for treating epilepsy according to claim 5, it is characterised in that drug regimen Thing can adopt the conventional method of galenic pharmacy to prepare piece agent or capsule or drop pill.
8. a kind of preparation method of the pharmaceutical composition for treating epilepsy according to claim 5, it is characterised in that drug regimen Thing and chemical drugs or Chinese medicine composition treatment AED.
CN201611134460.9A 2016-12-10 2016-12-10 Pharmaceutical composition for treating epilepsy and preparation method thereof Withdrawn CN106668183A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105477071A (en) * 2016-01-25 2016-04-13 济南星懿医药技术有限公司 Medicine composition for treating encephalanalosis and preparation method thereof
CN105535075A (en) * 2016-01-25 2016-05-04 济南星懿医药技术有限公司 Medicine composition for treating encephalatrophy

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105477071A (en) * 2016-01-25 2016-04-13 济南星懿医药技术有限公司 Medicine composition for treating encephalanalosis and preparation method thereof
CN105535075A (en) * 2016-01-25 2016-05-04 济南星懿医药技术有限公司 Medicine composition for treating encephalatrophy

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Application publication date: 20170517