CN102579846B - Chinese patent medicament wind-calming and pain-relieving granules for treating migraine and preparation method thereof - Google Patents

Chinese patent medicament wind-calming and pain-relieving granules for treating migraine and preparation method thereof Download PDF

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CN102579846B
CN102579846B CN 201210061770 CN201210061770A CN102579846B CN 102579846 B CN102579846 B CN 102579846B CN 201210061770 CN201210061770 CN 201210061770 CN 201210061770 A CN201210061770 A CN 201210061770A CN 102579846 B CN102579846 B CN 102579846B
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radix angelicae
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CN102579846A (en
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李浪辉
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GUANGXI STRONGLIFE PHARMACEUTICAL GROUP CO Ltd
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GUANGXI STRONGLIFE PHARMACEUTICAL GROUP CO Ltd
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Abstract

The invention provides Chinese patent medicament wind-calming and pain-relieving granules for treating migraine and a preparation method thereof. The granules are prepared by finishing Chinese angelica, hemlock parsley, white peony root, gastrodia elata, dahurian angelica root, paniculate swallowwort root, corydalis tuber and rhizoma cyperi. In the prescription, the Chinese angelica, the hemlock parsley, the dahurian angelica root and the corydalis tuber are common Chinese medicaments for treating migraine, and years of application prove that the granules have an excellent curative effect. The whole prescription of the granules has effects of activating blood, removing wind and relieving pains. The wind-calming and pain-relieving granules are suitable for patients with stubborn migraine, and have the characteristics of convenience for administration, reasonable administration route, high bioavailability, stable product quality and the like. The preparation method is easy and practical.

Description

A kind of migrainous Chinese patent medicine endogenous wind stopping pain relieving granule and preparation method thereof for the treatment of
One, technical field:
The present invention relates to a kind of Chinese patent medicine particles and preparation method thereof, particularly a kind of migrainous Chinese patent medicine endogenous wind stopping pain relieving granule and preparation method thereof for the treatment of.
Two, background technology:
Migraine is a kind of common disease of nervous system, and in population, this sick sickness rate is 5%.The women is slightly more than the male.Migraine is the unstable headache that adds that the temporary change of some humoral substance causes of a kind of ictal head section's vasomotoricity.Still not fully aware of to migrainous pathogenesis at present, but migraine affects people's orthobiosis and work.
The migrainous medicine for the treatment of has the products such as ZHENGTIAN WAN, Toutongning capsule for headache, blood-nourishing and brain-refreshing granules, ibuprofen class now.Treat in the world at present migraine and there is no any special measures and medicine.
Three, summary of the invention:
Purpose of the present invention, be a kind of compatibility of invention proper, have invigorate blood circulation, dispel the wind, analgesic effect and can give full play to the migrainous Chinese patent medicine endogenous wind stopping for the treatment of pain relieving granule of drug effect and preparation method thereof.
The present invention treats migrainous Chinese patent medicine endogenous wind stopping pain relieving granule, mainly be by Radix Angelicae Sinensis 266-400g, Rhizoma Chuanxiong 214-320g, Radix Paeoniae Alba 266-400g, Rhizoma Gastrodiae 160-240g, Radix Angelicae Dahuricae 266-400g, Radix Cynanchi Paniculati 214-320g, Rhizoma Corydalis 266-400g, Rhizoma Cyperi 214-320g, make the 800-1200g granule through polish; The key step of its preparation is:
(1) it is for subsequent use Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Radix Cynanchi Paniculati, the Rhizoma Cyperi five tastes to be extracted volatile oil with vapor distillation, and the aqueous solution after the distillation in addition device is collected;
(2) Radix Paeoniae Alba, Rhizoma Gastrodiae, Rhizoma Corydalis three flavors add an amount of heating and refluxing extraction secondary of 60% alcoholic solution, and each 3 hours, merge extractive liquid,, for subsequent use;
(3) medicinal residues of (2) and the medicinal residues after (1) distillation are merged, decoct with water secondary, 10 times of water for the first time, 8 times of water for the second time, each 1.5 hours, filter, aqueous solution after the distillation of filtrate and (1) merges, and relative density is 1.10~1.13 clear paste when being concentrated into 80 ℃, adds ethanol and makes and contain the alcohol amount to 60%, left standstill 24 hours, get supernatant and filter, filtrate merges with the reflux extracting liquid of (2), Recycled ethanol and when being concentrated into 80 ℃ relative density be 1.38~1.40 thick paste, drying is ground into fine powder;
(4) get in addition beta-schardinger dextrin-, add 12.5 times of water gagings, heating makes dissolving, is cooled to 40 ℃, make saturated aqueous solution, the volatile oil of getting (1) adds a small amount of dehydrated alcohol dilution, is added drop-wise in the beta-schardinger dextrin-saturated aqueous solution by 1: 100, makes inclusion complex, leave standstill, filter, drying, for subsequent use;
(5) get the dried cream fine powder of (3), add the capacity dextrin, granulate with 90% appropriate amount of ethanol, drying adds the inclusion complex that (4) make, and mixing namely gets the migrainous Chinese patent medicine endogenous wind stopping pain relieving granule for the treatment of.
The optimum weight of each main component is during preparation 1000g granule: Radix Angelicae Sinensis 333g, Rhizoma Chuanxiong 267g, Radix Paeoniae Alba 333g, Rhizoma Gastrodiae 200g, Radix Angelicae Dahuricae 333g, Radix Cynanchi Paniculati 267g, Rhizoma Corydalis 333g, Rhizoma Cyperi 267g.
We adopt the Chinese medicine of nourishing blood for calming endogenous wind, promoting blood circulation to remove obstruction in the collateral according to the medication characteristics of Chinese medicine, make migraine " stagnation of QI and blood may bring about pain " replacement " general rule is not bitterly ", reach the migrainous purpose of radical cure.Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Rhizoma Corydalis are treatment wind syndrome of head headache conventional Chinese medicines in the side, through using for many years, migraine are had good efficacy.Full side have invigorate blood circulation, dispel the wind, the effect of pain relieving.Prolonged patient of not healing is applicable to have a headache.
Endogenous wind stopping pain relieving granule result of study is as follows:
1, pharmacodynamic study
Pharmacodynamic study shows that endogenous wind stopping pain relieving granule has the reaction of the mouse writhing of inhibition, improves the mice hot plate threshold of pain and the rat radiant heat threshold of pain, and prompting this product has analgesic activity; Endogenous wind stopping pain relieving granule has the mice of improvement meninges microcirculation, rat brain regional blood flow and improves the rat whole blood viscosity, and prompting this product has the microcirculation of improvement; (Plasma Prostaglandin E is penetrated, improved to β-EP) and neuropeptide tyrosine (NPY) generation to improve 5-hydroxy tryptamine (5-HT) in the mouse brain, beta-endorphin 2(PGE 2) level, the analgesic activity of prompting this product may be relevant with neurotransmitter in the brain.
Migrainous pathogenesis is illustrated so far not yet fully, and research finds that entocranial artery shrinks, cerebral blood flow descends, and is the main pathological manifestations of migraine aura phase.This test observe emphatically endogenous wind stopping pain relieving granule analgesic activity, its to the shadow of cerebrovascular, cerebral blood flow and neurotransmitter metabolism to.
Result of study shows that this product can suppress the mouse writhing reaction, improve the mice hot plate threshold of pain and the rat radiant heat threshold of pain; Improve mice meninges microcirculation, rat brain regional blood flow and reduce the rat whole blood viscosity; Increase 5-HT, β-EP and reduction NPY level in the mouse brain, improve blood plasma PGE 2Level.Prompting this product has analgesia, improves the effect of neurotransmitter in brain microcirculation and the adjusting brain, can be used for migraine.
2, long term toxicity test
Test period: the long term toxicity test administration time is 6 months.To the rat oral gavage administration, continuous 6 months, the general status of rat was good with 70.2g, 35.1g and 17.55g medical material/kg/d for endogenous wind stopping pain relieving granule, and body weight gain is normal; Hematological examination, blood biochemical are learned and are checked and organ coefficient inspection, administration group and matched group no significant difference meaning.The histopathologic examination of main organs has no the obvious pathological change that causes because of drug toxicity.Above results suggest endogenous wind stopping pain relieving granule should be safe by using dosage, approach and the course for the treatment of of clinical plan usefulness.
3, stability test
The test of endogenous wind stopping pain relieving granule primary stability and accelerated stability were examined three months continuously, and the direct packaging material that contact with medicine have been observed to the impact of stability of drug products, the character of three batch samples, discriminating, inspection, assay are all up to specification, limit test of microbe is up to specification, and namely result of the test is up to specification.Show this product under clinical application product terms of packing, primary stability test and accelerated stability test prompting this product are stable in two years.
The present invention treat the full side of migrainous Chinese patent medicine endogenous wind stopping pain relieving granule have invigorate blood circulation, dispel the wind, the effect of pain relieving.Prolonged patient of not healing is applicable to have a headache.And preparation method is simple and easy to do, and medication is convenient, route of administration is reasonable, bioavailability is high, constant product quality.
Four, the specific embodiment:
Embodiment 1
Main component: Radix Angelicae Sinensis 333g, Rhizoma Chuanxiong 267g, Radix Paeoniae Alba 333g, Rhizoma Gastrodiae 200g, Radix Angelicae Dahuricae 333g, Radix Cynanchi Paniculati 267g, Rhizoma Corydalis 333g, Rhizoma Cyperi 267g.
(1) it is for subsequent use Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Radix Cynanchi Paniculati, the Rhizoma Cyperi five tastes to be extracted volatile oil with vapor distillation, and the aqueous solution after the distillation in addition device is collected;
(2) three flavors such as the Radix Paeoniae Alba, Rhizoma Gastrodiae, Rhizoma Corydalis add an amount of heating and refluxing extraction secondary of 60% alcoholic solution, and each 3 hours, merge extractive liquid,, for subsequent use;
(3) medicinal residues of (2) and the medicinal residues after (1) distillation are merged, decoct with water secondary, 10 times of water for the first time, 8 times of water for the second time, each 1.5 hours, filter, aqueous solution after filtrate and the above-mentioned distillation merges, and relative density is 1.10~1.13 clear paste when being concentrated into 80 ℃, adds ethanol and makes and contain the alcohol amount to 60%, left standstill 24 hours, get supernatant and filter, filtrate merges with the reflux extracting liquid of (2), Recycled ethanol and when being concentrated into 80 ℃ relative density be 1.38~1.40 thick paste, drying is ground into fine powder;
(4) get in addition beta-schardinger dextrin-, add 12.5 times of water gagings, heating makes dissolving, is cooled to 40 ℃, make saturated aqueous solution, the volatile oil of getting (1) adds a small amount of dehydrated alcohol dilution, is added drop-wise in the beta-schardinger dextrin-saturated aqueous solution by 1: 100, makes inclusion complex, leave standstill, filter, drying, for subsequent use;
(5) get the dried cream fine powder of (3), add the capacity dextrin, granulate with 90% appropriate amount of ethanol, drying adds the inclusion complex that (4) make, and mixing namely gets 1000g and treats migrainous Chinese patent medicine endogenous wind stopping pain relieving granule.
Embodiment 2
Main component: Radix Angelicae Sinensis 266g, Rhizoma Chuanxiong 214g, Radix Paeoniae Alba 266g, Rhizoma Gastrodiae 160g, Radix Angelicae Dahuricae 266g, Radix Cynanchi Paniculati 214g, Rhizoma Corydalis 266g, Rhizoma Cyperi 214g.
(1) it is for subsequent use Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Radix Cynanchi Paniculati, the Rhizoma Cyperi five tastes to be extracted volatile oil with vapor distillation, and the aqueous solution after the distillation in addition device is collected;
(2) Radix Paeoniae Alba, Rhizoma Gastrodiae, Rhizoma Corydalis three flavors add an amount of heating and refluxing extraction secondary of 60% alcoholic solution, and each 3 hours, merge extractive liquid,, for subsequent use;
(3) medicinal residues of (2) and the medicinal residues after (1) distillation are merged, decoct with water secondary, 10 times of water for the first time, 8 times of water for the second time, each 1.5 hours, filter, aqueous solution after filtrate and the above-mentioned distillation merges, and relative density is 1.10~1.13 clear paste when being concentrated into 80 ℃, adds ethanol and makes and contain the alcohol amount to 60%, left standstill 24 hours, get supernatant and filter, filtrate merges with the reflux extracting liquid of (2), Recycled ethanol and when being concentrated into 80 ℃ relative density be 1.38~1.40 thick paste, drying is ground into fine powder;
(4) get in addition beta-schardinger dextrin-, add 12.5 times of water gagings, heating makes dissolving, is cooled to 40 ℃, make saturated aqueous solution, the volatile oil of getting (1) adds a small amount of dehydrated alcohol dilution, is added drop-wise in the beta-schardinger dextrin-saturated aqueous solution by 1: 100, makes inclusion complex, leave standstill, filter, drying, for subsequent use;
(5) get the dried cream fine powder of (3), add the capacity dextrin, granulate with 90% appropriate amount of ethanol, drying adds the inclusion complex that (4) make, and mixing namely gets 800g and treats migrainous Chinese patent medicine endogenous wind stopping pain relieving granule.
Embodiment 3
Main component: Radix Angelicae Sinensis 400g, Rhizoma Chuanxiong 320g, Radix Paeoniae Alba 400g, Rhizoma Gastrodiae 240g, Radix Angelicae Dahuricae 400g, Radix Cynanchi Paniculati 320g, Rhizoma Corydalis 400g, Rhizoma Cyperi 320g.
(1) it is for subsequent use Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Radix Cynanchi Paniculati, the Rhizoma Cyperi five tastes to be extracted volatile oil with vapor distillation, and the aqueous solution after the distillation in addition device is collected;
(2) Radix Paeoniae Alba, Rhizoma Gastrodiae, Rhizoma Corydalis three flavors add an amount of heating and refluxing extraction secondary of 60% alcoholic solution, and each 3 hours, merge extractive liquid,, for subsequent use;
(3) medicinal residues of (2) and the medicinal residues after (1) distillation are merged, decoct with water secondary, 10 times of water for the first time, 8 times of water for the second time, each 1.5 hours, filter, aqueous solution after filtrate and the above-mentioned distillation merges, and relative density is 1.10~1.13 clear paste when being concentrated into 80 ℃, adds ethanol and makes and contain the alcohol amount to 60%, left standstill 24 hours, get supernatant and filter, filtrate merges with the reflux extracting liquid of (2), Recycled ethanol and when being concentrated into 80 ℃ relative density be 1.38~1.40 thick paste, drying is ground into fine powder;
(4) get in addition beta-schardinger dextrin-, add 12.5 times of water gagings, heating makes dissolving, is cooled to 40 ℃, make saturated aqueous solution, the volatile oil of getting (1) adds a small amount of dehydrated alcohol dilution, is added drop-wise in the beta-schardinger dextrin-saturated aqueous solution by 1: 100, makes inclusion complex, leave standstill, filter, drying, for subsequent use;
(5) get the dried cream fine powder of (3), add the capacity dextrin, granulate with 90% appropriate amount of ethanol, drying adds the inclusion complex that (4) make, and mixing namely gets 1200g and treats migrainous Chinese patent medicine endogenous wind stopping pain relieving granule.
During suitability for industrialized production, can be by the proportioning expanding production.

Claims (2)

1. treat migrainous Chinese patent medicine endogenous wind stopping pain relieving granule for one kind, it is characterized in that it mainly is by Radix Angelicae Sinensis 266-400g, Rhizoma Chuanxiong 214-320g, Radix Paeoniae Alba 266-400g, Rhizoma Gastrodiae 160-240g, Radix Angelicae Dahuricae 266-400g, Radix Cynanchi Paniculati 214-320g, Rhizoma Corydalis 266-400g, Rhizoma Cyperi 214-320g, makes the 800-1200g granule through polish; The key step of its preparation is:
(1) use water vapour distillation volatile oil for subsequent use Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Angelicae Dahuricae, Radix Cynanchi Paniculati, the Rhizoma Cyperi five tastes, the aqueous solution after the distillation in addition device is collected;
(2) Radix Paeoniae Alba, Rhizoma Gastrodiae, Rhizoma Corydalis three flavors add an amount of heating and refluxing extraction secondary of 60% alcoholic solution, and each 3 hours, merge extractive liquid,, for subsequent use;
(3) medicinal residues of (2) and the medicinal residues after (1) distillation are merged, decoct with water secondary, 10 times of water for the first time, 8 times of water for the second time, each 1.5 hours, filter, aqueous solution after the distillation of filtrate and (1) merges, and relative density is 1.10~1.13 clear paste when being concentrated into 80 ℃, adds ethanol and makes and contain the alcohol amount to 60%, left standstill 24 hours, get supernatant and filter, filtrate merges with the reflux extracting liquid of (2), Recycled ethanol and when being concentrated into 80 ℃ relative density be 1.38~1.40 thick paste, drying is ground into fine powder;
(4) get in addition beta-schardinger dextrin-, add 12.5 times of water gagings, heating makes dissolving, is cooled to 40 ℃, make saturated aqueous solution, the volatile oil of getting (1) adds a small amount of dehydrated alcohol dilution, is added drop-wise in the beta-schardinger dextrin-saturated aqueous solution by 1: 100, makes inclusion complex, leave standstill, filter, drying, for subsequent use;
(5) get the dried cream fine powder of (3), add the capacity dextrin, granulate with 90% appropriate amount of ethanol, drying adds the inclusion complex that (4) make, and mixing namely gets the migrainous Chinese patent medicine endogenous wind stopping pain relieving granule for the treatment of.
2. the migrainous Chinese patent medicine endogenous wind stopping for the treatment of according to claim 1 pain relieving granule, each predominant quantity is when it is characterized in that preparing the 1000g granule: Radix Angelicae Sinensis 333g, Rhizoma Chuanxiong 267g, Radix Paeoniae Alba 333g, Rhizoma Gastrodiae 200g, Radix Angelicae Dahuricae 333g, Radix Cynanchi Paniculati 267g, Rhizoma Corydalis 333g, Rhizoma Cyperi 267g.
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CN105343409A (en) * 2014-08-21 2016-02-24 李新民 Formula for treating migraine
CN104491759B (en) * 2015-01-15 2017-12-19 张士红 A kind of Chinese medicine composition for treating antimigraine and preparation method thereof
CN104740183A (en) * 2015-04-18 2015-07-01 青岛辰达生物科技有限公司 Pharmaceutical composition for treating migraine
CN105535511A (en) * 2016-02-01 2016-05-04 胶州市人民中医医院 Stomach harmonizing and pain relieving granule and preparation method thereof

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CN1943689A (en) * 2005-10-08 2007-04-11 刘国飞 A Chinese traditional medicinal composition for treatment of wind-heat type common cold and its preparation method
CN1943708A (en) * 2005-10-08 2007-04-11 刘国飞 A Chinese traditional medicinal composition and its preparation method
CN101167817B (en) * 2007-10-20 2011-12-07 刘衍 Traditional Chinese medicine for treating migraine

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