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CN1283303C - Medicine composition for ischemia apoplexy - Google Patents

Medicine composition for ischemia apoplexy Download PDF

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Publication number
CN1283303C
CN1283303C CNB021535159A CN02153515A CN1283303C CN 1283303 C CN1283303 C CN 1283303C CN B021535159 A CNB021535159 A CN B021535159A CN 02153515 A CN02153515 A CN 02153515A CN 1283303 C CN1283303 C CN 1283303C
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CN
China
Prior art keywords
radix
medicine composition
pharmaceutical composition
fel ursi
rhizoma
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CNB021535159A
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CN1504221A (en
Inventor
范吉平
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Shandong Wohua Pharmaceuticals Co ltd
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Tiantaiyuan Medical Tech Dev Co Ltd Beijing
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Abstract

The present invention discloses a medicine composition for ischemia apoplexy and a preparation method thereof. The medicine composition for ischemia apoplexy uses bear gall powder, notoginseng, gastrodia tubers, red sage roots, tabasheer and wine treated rhubarb as raw materials. According to the different characteristics of the traditional Chinese medicines, the medicine composition for ischemia apoplexy is prepared through pulverization, solvent extraction, concentration, uniform mixing, etc. The present invention has the advantages of peculiar pharmaceutical formulation and manufacturing method and obviously therapeutic effect.

Description

The pharmaceutical composition of treatment cerebral infarction
The present invention relates to treat the pharmaceutical composition of cerebral infarction, the pharmaceutical composition of acute cerebral ischemic stroke and convalescent care specifically the invention still further relates to the preparation method of this medicine.
Apoplexy sickness rate height, case fatality rate height, disability rate height, treatment difficulty.According to the relevent statistics, in China, the sickness rate of apoplexy has risen to 109.74/10 ten thousand, and prevalence is 245.58/10 ten thousand, and annual newfound stroke patient is about 1,320,000 people, about 3,000,000 people of number of patients.Mortality rate is 30~40%, and existent has 50~60% to leave sequela after being ill, mainly shows as obstacle of limb movement, aphasis, dysnoesia, has a strong impact on patient's ability to work and quality of life.This brings heavy burden not only for society and family, also brings very big misery to the patient.
Western medical treatment cerebral infarction means are limited in the market, lack the specific treatment medicine:
-still unsatisfactory as brain-protection drugs clinical efficacies such as excitatory amino acid receptor antagonists, free radical scavengers.
-early stage thrombolytic therapy is owing to the treatment time window, and the restriction of bringing out negative factors such as cerebral hemorrhage, has influenced the performance of its curative effect, and at present still can't be as conventional therapy at clinical application.
The objective of the invention is to develop with strong points, good effect, easy to use, safe, be suitable for acute cerebral ischemic stroke and convalescent new Chinese medicine.
Pharmaceutical composition of the present invention is mainly made by following component: (consumption is a weight portion)
Fel Ursi powder 0.3-10 Radix Notoginseng 4-130 Rhizoma Gastrodiae 20-640
Concretio Silicea Bambusae 10-385 Radix Salviae Miltiorrhizae 17-575 Radix Et Rhizoma Rhei (processed with wine) 7-255
The formula optimization weight portion ratio range of pharmaceutical composition of the present invention is:
Fel Ursi powder 0.5-2.5 Radix Notoginseng 6-32 Rhizoma Gastrodiae 32-160
Concretio Silicea Bambusae 20-200 Radix Salviae Miltiorrhizae 28-144 Radix Et Rhizoma Rhei (processed with wine) 12-64
Most preferably weight (part) proportioning of pharmaceutical composition of the present invention is:
Fel Ursi powder 1.3 Radix Notoginseng 16.7 Rhizoma Gastrodiaes 83.3
Concretio Silicea Bambusae 50 Radix Salviae Miltiorrhizaes, 75 Radix Et Rhizoma Rhei (processed with wine) 33.3
The present invention is the Chinese medicine expert for many years on the basis of apoplexy clinical experience, is guidance with the therapeutics thought of " heresy is gone to then Zhengan County ", is that principle of treatment plan side forms with eleminating phlegm and freeing channels, detoxifcation purging FU-organs.The Fel Ursi bitter in the mouth is cold in nature in the side, goes into liver, gallbladder, spleen, stomach warp.The suppressing the hyperactive liver that clears away heart-fire, " it is former that book on Chinese herbal medicine is asked " record Fel Ursi " is controlled blood-retention ", with being monarch drug, dispels the turbid poison of blood stagnant in cerebral venation syndrome.The Rhizoma Gastrodiae sweet in the mouth is flat, goes into Liver Channel, and with being ministerial drug, relieving dizziness, high fever, infantile convulsions, epilepsy, etc. and reduce phlegm, the clear sharp head, shared with Fel Ursi, help its removing toxic substances turbid merit of dispelling.Radix Notoginseng, sweet and slightly bitter taste, warm in nature, go into liver, stomach warp, blood circulation promoting and blood stasis dispelling, the analgesic therapy of invigorating blood circulation, with Rhizoma Gastrodiae be ministerial drug altogether, endogenous wind-evil caused by sthenic liver-energy) reduces phlegm, and helps eliminating evilization of Fel Ursi turbid, and turbid pathogen speed is gone, the venation of brain gets freely.The Concretio Silicea Bambusae sweet in the mouth, cold in nature, go into the heart, liver, gallbladder meridian.Removing heat-phlegm, the arresting convulsion that clears away heart-fire, with wind-phlegm fan in controlling, phlegm-accumulating vertigo helps the Fel Ursi Rhizoma Gastrodiae turbid power of dispelling of reducing phlegm.The Radix Salviae Miltiorrhizae bitter in the mouth, slightly warm in nature is gone into the heart, Liver Channel, blood circulation promoting and blood stasis dispelling, calming heart and tranquilizing mind, the power that helps the Radix Notoginseng blood stasis dispelling to promote blood circulation.The Radix et Rhizoma Rhei (stir-fried with wine) bitter in the mouth is cold in nature, goes into liver, stomach, large intestine channel, the poison that purges heat, and clots absorbing blood, expectorant is real, " Japan hanako materia medica " " logical all gas of a surname, blood circulation regulating, sharp joint ".All medicines and usefulness are changed turbid poison, promoting blood circulation, and it is wet to eliminate the phlegm, and puts out liver-wind, and merit is eliminating evil.Symptomatic treatment in acute condition, the gesture on the wind from the northwest being apt to impair the small intestine expectorant blood stasis, so that the brain arteries and veins is logical again, the brain key is recovered lost eyesight, all diseases of apoplexy must subtract.
Pharmaceutical composition of the present invention adopts routine techniques, adds conventional adjuvant or excipient, preferably make to be fit to oral dosage form, for example, granule, capsule, tablet and watered pill; Drug regimen of the present invention is preferably made injection, ointment, spray.
Its pharmacological tests of pharmaceutical composition provided by the present invention is:
(1) pharmacodynamic study:
Mainly study under the rat cerebral ischemia situation, this pharmaceutical composition is to the influence of indexs such as its nervous symptoms, time-to-live and cerebral infarction district vascular permeability, platelet aggregation time, thrombus formation time.
The result shows, the big-and-middle small dose group of this pharmaceutical composition (6g crude drug/kg, 3g crude drug/kg, 1.5g crude drug/kg) all have following effect:
Obviously alleviate the nervous symptoms after the focal cerebral ischemia in rats, reduce the cerebral infarction scope;
Obviously improve pathological change such as cerebrovascular permeability and brain water content increase due to the cerebral ischemia;
Obviously increase the dog cerebral blood flow, reduce cerebral vascular resistance, arteriotony and heart rate;
Platelet aggregation rate when obviously reducing focal cerebral ischemia in rats;
Obviously delay the animal thrombus formation time;
Obviously suppress rat suppository and form, alleviate the weight in wet base of artery-vein bypass thrombosis;
Obviously prolong the time-to-live of mice under the normal pressure resistant anoxia condition, increase mice normal pressure resistant anoxia ability;
Dehisce the time of breathing after obviously prolonging the mice broken end.
(2) anxious, long poison experiment:
1. anxious poison test: 48 mice fasting are after 12 hours, gastric infusion is three times in 24 hours, dosage is 60 gram crude drugs/kg/ time, accumulated dose was 180 gram crude drug/kg/ days, continuously observed mice 7 after the administration, index no abnormality seen such as general state, hair color, body weight, diet, activity and do not have death.
As calculated, this pharmaceutical composition mouse stomach maximum tolerated dose was 180 gram crude drug/kg/ days, was equivalent to 414.5 times of people's consumption.
2. long term toxication: laboratory observation this pharmaceutical composition continuous irrigation stomach 180 days body weight to rat, hematological indices, serum biochemistries learn index and main organs coefficient and histological influence.
Experimental result:
1. during administration, it is all normal that each organizes the behavior of rat outward appearance, body weight, food-intake; When routine blood test, blood coagulation all in the normal variation scope, biochemical indicator: comprise that liver function renal function etc. compared with corresponding matched group in 90 days, 180 days after administration, all in the normal variation scope, do not see notable difference.
2. the histoorgan organ index in administration two weeks after 90,180 days and after the drug withdrawal, outward appearance are observed and be there is no obvious pathologic and change.
The above results shows, this pharmaceutical composition 30g crude drug/kg, 15g crude drug/kg and 7.5g crude drug/kg successive administration no overt toxicity reaction in 6 months.
Embodiment 1: capsule
Prescription:
Fel Ursi powder 13g Radix Notoginseng 167g Rhizoma Gastrodiae 833g
Concretio Silicea Bambusae 500g Radix Salviae Miltiorrhizae 750g Radix Et Rhizoma Rhei (processed with wine) 333g
Production method: above Six-element, Fel Ursi powder are ground into fine powder I.Rhizoma Gastrodiae, Radix Notoginseng, Radix Et Rhizoma Rhei (processed with wine) add 8 times of amount 75% alcohol heating reflux at every turn and extract 4 times, and each 40 minutes, filter, merging filtrate reclaims ethanol, and medicinal liquid is concentrated into the thick paste II for future that relative density is 1.30~1.35 (60 ℃); Radix Salviae Miltiorrhizae, Concretio Silicea Bambusae decoct with water 3 times, each 1 hour, amount of water is 8,6,6 times, filter, merging filtrate, filtrate decompression is concentrated into the thick paste II I that relative density is 1.30~1.35 (60 ℃), the thick paste that extracts with Rhizoma Gastrodiae, Radix Notoginseng, Radix Et Rhizoma Rhei merges, mixing, drying under reduced pressure, dried cream powder is broken into fine powder.Fel Ursi powder 12.5g, dried cream powder 279.5g and dextrin 108g mixing, drying is sieved, and incapsulates, promptly.
Embodiment 2: granule
Press example 1 described proportioning and technology with Fel Ursi powder I, Rhizoma Gastrodiae, Radix Notoginseng, Radix Et Rhizoma Rhei thick paste II, Radix Salviae Miltiorrhizae, Concretio Silicea Bambusae thick paste II I and an amount of dextrin mix homogeneously, granule is sterilized, made to alcohol granulation, at cold drying.
Embodiment 3: tablet
Press example 1 described proportioning and technology with Fel Ursi powder I, Rhizoma Gastrodiae, Radix Notoginseng, Radix Et Rhizoma Rhei thick paste II, Radix Salviae Miltiorrhizae, Concretio Silicea Bambusae thick paste II I and an amount of dextrin mix homogeneously, alcohol granulation, drying, compacting are in blocks.
Embodiment 4: the watered pill
By example 1 described proportioning and technology Fel Ursi powder I, Rhizoma Gastrodiae, Radix Notoginseng, Radix Et Rhizoma Rhei thick paste II, Radix Salviae Miltiorrhizae, Concretio Silicea Bambusae thick paste II I and water are placed mixing in general ball pot or other container, make wet-milling, pressed No. two sieve series to become granule, again granule is put into the spin friction of general ball pot, wound goes corner angle circular, makes the watered pill.
Embodiment 5: injection
Press example 1 described proportioning and technology Rhizoma Gastrodiae, Radix Notoginseng, Radix Et Rhizoma Rhei thick paste II are mixed with Radix Salviae Miltiorrhizae, Concretio Silicea Bambusae thick paste II I, pulverize behind the drying under reduced pressure, add solvent and make its dissolving; Fel Ursi powder I adds solvent makes its dissolving.Then two parts solution is mixed, add solvent to 1000ml, regulate pH value, filtration, perfusion, sealing by fusing, sterilization, quality inspection are promptly.
Embodiment 6: ointment
By example 1 described proportioning and technology Fel Ursi powder I, Rhizoma Gastrodiae, Radix Notoginseng, Radix Et Rhizoma Rhei thick paste II, Radix Salviae Miltiorrhizae, Concretio Silicea Bambusae thick paste II I and an amount of dextrin mix homogeneously are ground to no granular sensation, gradation adds with in the substrate (as vaseline, tween 80, Polyethylene Glycol etc.) of melting, the limit edged is stirred to condensation, makes ointment.
Embodiment 7: spray
Press example 1 described proportioning and technology with Fel Ursi powder I, Rhizoma Gastrodiae, Radix Notoginseng, Radix Et Rhizoma Rhei thick paste II, Radix Salviae Miltiorrhizae, Concretio Silicea Bambusae thick paste II I and an amount of dextrin and suspending agent (as Arlacel-85) mixing after, being ground to particle diameter through colloid mill is that the following person of 5um accounts for more than 90%, add propellant (as dichlorodifluoromethane, noble gas etc.), press while stirring and irritate in molten device, make spray.

Claims (3)

1. pharmaceutical composition for the treatment of cerebral infarction, the raw materials of effective components medicine that it is characterized in that making medicine are formed:
Fel Ursi powder 0.5-2.5 Radix Notoginseng 6-32 Rhizoma Gastrodiae 32-160
Concretio Silicea Bambusae 20-200 Radix Salviae Miltiorrhizae 28-144 Radix Et Rhizoma Rhei 12-64.
2. pharmaceutical composition according to claim 1 is characterized in that the raw materials of effective components medicine composition of making medicine is by weight:
Fel Ursi powder 1.3 Radix Notoginseng 16.7 Rhizoma Gastrodiaes 83.3
Concretio Silicea Bambusae 50 Radix Salviae Miltiorrhizaes 75 Radix Et Rhizoma Rhei 33.3.
3. pharmaceutical composition according to claim 1 is characterized in that it being capsule, granule, tablet, watered pill, injection, ointment, spray.
CNB021535159A 2002-12-02 2002-12-02 Medicine composition for ischemia apoplexy Expired - Lifetime CN1283303C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CNB021535159A CN1283303C (en) 2002-12-02 2002-12-02 Medicine composition for ischemia apoplexy

Publications (2)

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CN1504221A CN1504221A (en) 2004-06-16
CN1283303C true CN1283303C (en) 2006-11-08

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Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108938672B (en) * 2018-09-27 2020-09-01 延边大学 Traditional Chinese medicine composition and traditional Chinese medicine preparation for rehabilitation treatment of ischemic cerebral apoplexy

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Owner name: WOHUA MEDICINE SCIENCE AND TECHNOLOGY CO., LTD., S

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Address after: 261205, 519, Liyuan street, hi tech Development Zone, Shandong, Weifang

Patentee after: SHANDONG WOHUA PHARMACEUTICALS CO.,LTD.

Address before: 100038, Beijing, Haidian District, 8 North honeycomb building, block A, 7 floor

Patentee before: Beijing Tiantaiyuan Medicine Technology Development Ltd.

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Granted publication date: 20061108