CN101053607A - Blood-nourishing and cephalocathartic micropills and its preparation technology - Google Patents
Blood-nourishing and cephalocathartic micropills and its preparation technology Download PDFInfo
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- CN101053607A CN101053607A CN 200610072314 CN200610072314A CN101053607A CN 101053607 A CN101053607 A CN 101053607A CN 200610072314 CN200610072314 CN 200610072314 CN 200610072314 A CN200610072314 A CN 200610072314A CN 101053607 A CN101053607 A CN 101053607A
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Abstract
The invention relates to a micro-pill preparation and its producing craft, especially a micro-pill for tonifying blood and clearing liver heat and its producing craft. The material drug is produced according to following weight shares: angelica 250-420; ligusticus wallichii franchet 280-40; Paeonia lactiflora pallas 200-380; ripe radix rehmanniae 200-400; gambir plant 580-750; suberect spatholobus stem 550-780; brunella vulgaris linne 600-720; cassia seed 500-750; nacre 560-750; corydalis tuber 200-420; manchurian wildginger 30-100. The invention has a good resolvability, a smart curative effect, a stable medicine releasing, a high bio-availability, a small local thrill, a beautiful pill appearance, a small moisture absorption, and a good feeling for patients, further it is easy to transport, store and carry.
Description
Technical field
The present invention relates to a kind of pellet preparations and preparation technology thereof, particularly relate to a kind of blood-nourishing and cephalocathartic micropills and preparation technology thereof.
Background technology
The blood-nourishing and brain-refreshing granules that existing market is sold is the national standard WS of National Drug Administration
3-258 (Z-036)-2001 (z) are made up of eight flavor medicines such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Rehmanniae Preparata, have the meninges of improvement microcirculation, and the cerebral blood flow increasing amount is improved blood supply insufficiency of brain, alleviating vascular spasm, pain relieving.Be mainly used in the dizziness that causes of treatment chronic insufficient cerebral blood supply clinically, have a headache, stagger, symptoms such as susceptible to lose temper due to restlessness, insomnia and dreamful sleep.
The blood-nourishing and brain-refreshing granules prescription is as follows: Radix Angelicae Sinensis 338g, Rhizoma Chuanxiong 338g, Radix Paeoniae Alba 270.3g, Radix Rehmanniae Preparata 270.3g, Ramulus Uncariae Cum Uncis 675.7g, Caulis Spatholobi 675.7g, Spica Prunellae 675.7g, Semen Cassiae 675.7g, Margarita order 675.7g, Rhizoma Corydalis 338g, Herba Asari 67.3g.Blood-nourishing and brain-refreshing granules preparation technology is as follows: Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis add 70% ethanol, reflux 2 hours, and backflow device is in addition preserved; Medicinal residues and the Six-elements such as all the other Radix Rehmanniae Preparata except that Ramulus Uncariae Cum Uncis decoct with water three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis, collecting decoction, being evaporated to relative density is 1.09～1.13 (55 ℃), adds ethanol and makes and contain alcohol amount and reach 65%, leaves standstill 24 hours, filter, filtrate and above-mentioned backflow merge, and decompression recycling ethanol also is concentrated into relative density 1.10～1.20 (55 ℃), adds an amount of steviosin, mixing, with an amount of dextrin is adjuvant, with spraying legal system granule, drying, make 1000g, promptly.
The granule ubiquity mouthfeel of Chinese medicine is not so good, and the easy moisture absorption of granule is softening, and caking goes mouldy, and poor stability makes troubles for packing, transportation and storage etc.
Summary of the invention
Problem and shortage such as the not so good and easy moisture absorption of mouthfeel at above-mentioned blood-nourishing and brain-refreshing granules existence is softening, caking goes mouldy the invention provides a kind of blood-nourishing and cephalocathartic micropills, and the preparation technology of this micropill are provided.
Technical scheme of the present invention is as follows:
The invention provides a kind of blood-nourishing and cephalocathartic micropills, make by following bulk drugs:
Radix Angelicae Sinensis 250-420;
Rhizoma Chuanxiong 280-400;
Radix Paeoniae Alba 200-380;
Radix Rehmanniae Preparata 200-400;
Ramulus Uncariae Cum Uncis 580-750;
Caulis Spatholobi 550-780;
Spica Prunellae 600-720;
Semen Cassiae 500-750;
Concha Margaritifera 560-750;
Rhizoma Corydalis 200-420;
Herba Asari 30-100.
As prioritization scheme, blood-nourishing and cephalocathartic micropills provided by the present invention, the starch that also comprises the 100-500 weight portion is as adjuvant.
As prioritization scheme, blood-nourishing and cephalocathartic micropills provided by the present invention is made by following bulk drugs:
Radix Angelicae Sinensis 300-360;
Rhizoma Chuanxiong 300-360;
Radix Paeoniae Alba 220-320;
Radix Rehmanniae Preparata 220-320;
Ramulus Uncariae Cum Uncis 600-720;
Caulis Spatholobi 600-720;
Spica Prunellae 600-720;
Semen Cassiae 600-720;
Concha Margaritifera 600-720;
Rhizoma Corydalis 320-420;
Herba Asari 40-80.
The present invention also provides the preparation method of above-mentioned blood-nourishing and cephalocathartic micropills, comprises the following steps:
1) get Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis with 70% alcohol reflux of 6～12 times of amounts 2 hours, the reflux extracting liquid usefulness of purchasing in addition, medicinal residues keep standby;
2) medicinal residues with step 1) mix with Radix Rehmanniae Preparata, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Herba Asari, adding the decocting that 6-14 doubly measures boils two to three times, each 1 hour, when decocting, last adds Ramulus Uncariae Cum Uncis, collecting decoction, filter, the clear paste that is concentrated into relative density and is 1.0～1.2 (55 ℃) is standby;
3) in step 2) clear paste add ethanol and make and contain the alcohol amount and reach 65%, left standstill 24 hours, filter, the reflux extracting liquid of filtrate and step 1) merges, recovery ethanol and to be concentrated into the thick paste of relative density 1.10～1.35 (55 ℃) standby;
4) with the thick paste vacuum drying of step 3), pulverize, add the appropriate amount of starch mixing,, make micropill with 60～95% ethanol system soft materials.
As prioritization scheme, the preparation method of described blood-nourishing and cephalocathartic micropills comprises the following steps:
1) get Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis 70% ethanol with 8 times of amounts, reflux, extract, 2 hours, backflow is standby, and medicinal residues keep standby;
2) medicinal residues and Radix Rehmanniae Preparata, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, the Herba Asari with step 1) decocts with water three times, each amount of water is respectively 10,8,6 times of amounts, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis, collecting decoction, filter, the clear paste that is concentrated into relative density and is 1.0～1.2 (55 ℃) is standby;
3) in step 2) clear paste in add ethanol and make and contain the alcohol amount and reach 65%, left standstill 24 hours, filter, the backflow merging of filtrate and step 1), the thick paste of simmer down to relative density 1.10～1.35 (55 ℃) is standby;
4) with the thick paste vacuum drying of step 3), pulverize the back and add the appropriate amount of starch mixing, with 85% ethanol system soft material, make micropill.
The technique effect that the present invention realized is as follows:
Blood-nourishing and cephalocathartic micropills provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, the bioavailability height, and local irritation is little, and the pill outward appearance is neat and artistic, the patient is glad to take, and hygroscopicity is little, transports, stores, carries etc. all more convenient.Blood-nourishing and cephalocathartic micropills adopts starch to replace steviosin in preparations shaping to be adjuvant, can to reduce production costs in addition, and blood-nourishing and cephalocathartic micropills and blood-nourishing and brain-refreshing granules have equal pharmacologic action, has the suppressing the hyperactive liver of nourishing blood, the paulownia network of invigorating blood circulation.Be used for due to the blood deficiency and excessive liver-YANG headache, stagger, susceptible to lose temper due to restlessness, insomnia and dreamful sleep etc.
The specific embodiment
The present invention is described further below in conjunction with embodiment, and embodiment only means never that for indicative it limits the scope of the invention by any way.
Embodiment 1:
The component that the prescription that blood-nourishing and cephalocathartic micropills that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Angelicae Sinensis 338;
Rhizoma Chuanxiong 338;
The Radix Paeoniae Alba 270.3;
Radix Rehmanniae Preparata 270.3;
Ramulus Uncariae Cum Uncis 675.7;
Caulis Spatholobi 675.7;
Spica Prunellae 675.7;
Semen Cassiae 675.7;
Concha Margaritifera 675.7;
Rhizoma Corydalis 338;
Herba Asari 67.3;
Starch 385.
The preparation method of blood-nourishing and cephalocathartic micropills that present embodiment provides is as follows:
1) get Radix Angelicae Sinensis 338g, Rhizoma Chuanxiong 338g, Radix Paeoniae Alba 270.3g, Rhizoma Corydalis 338g, with 6 times of amount 70% ethanol, reflux 2 hours, backflow device is in addition preserved, and medicinal residues are standby;
2) with the medicinal residues of step 1) and Radix Rehmanniae Preparata 270.3g, Caulis Spatholobi 675.7g, Spica Prunellae 675.7g, Semen Cassiae 675.7g, Concha Margaritifera 675.7g, Herba Asari 67.3g, adding 8 times of water gagings decocts three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis 675.7g, collecting decoction, filter, the clear paste that is evaporated to relative density and is 1.1 (55 ℃) is standby;
3) with step 2) clear paste add ethanol and make and contain alcohol amount and reach 65%, left standstill 24 hours, filter the backflow merging of filtrate and step 1), decompression recycling ethanol and to be concentrated into relative density be that the thick paste of 1.35 (55 ℃) is standby;
4) with the thick paste vacuum drying of step 3), pulverize, add the appropriate amount of starch mixing, with 60% ethanol system soft material, pill, packing, promptly.
GUSHUKANG micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 58%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Blood-nourishing and cephalocathartic micropills is treated migrainous clinical observation result:
This group is chosen 23 routine patients, male 8 examples, women 15 examples.Selected patient's period in a medicine diet cheese, chocolate and red wine etc. may bring out migrainous food, give the MAR card simultaneously, the regulation administrated method is distinguished the flavor of each 1～2 bag, every day 3 times is oral, period in a medicine record headache attack degree, headache situation of change and simultaneous phenomenon situation, and the untoward reaction after taking medicine etc., after taking medicine continuously 3 months the MAR card is returned.
Efficacy assessment standard: produce effects: the back headache symptom of taking medicine is not reaccessed, or seizure frequency significantly reduces, and degree alleviates.Effectively: the back times of headache of taking medicine reduces, and degree alleviates.Invalid: headache and related symptoms are with before treating.
Efficacy result: this is organized among the 23 routine patients, produce effects 15 examples; Effective 6 examples; Invalid 2 examples.
Blood-nourishing and cephalocathartic micropills is to MCAO rat model function of nervous system protection mechanism result of study:
Select purebred rat of 22 monthly ages for use, adopt line bolt method to block middle cerebral artery and bring out cerebral ischemic model, the treatment group is given the blood-nourishing and brain-refreshing pill for curing, and matched group and sham operated rats are then given the equivalent normal saline and irritated stomach.
The result: the treatment group can significantly alleviate model mouse neurologic defect symptom, improves blocking-up side E Ding district electroencephalogram wave amplitude and reduces and frequency deceleration; Cerebral morphology is observed and is found, the increment of ischemic region spider cell is obvious, and neuron only slightly reduces than matched group.Cerebral blood flow also is significantly improved, and GSH, GSH-PX level raise in the blood, and the MDA level is then suppressed and reduces.
Conclusion: the blood-nourishing and brain-refreshing ball is many-sided to the protection mechanism of cerebral ischemia, and strengthens the spider cell activity, neuroprotective unit ischemic lesions, and improving the damage of cerebral blood flow and free radical resisting is one of main mechanism of its treatment ischemia injury.
Blood-nourishing and cephalocathartic micropills is inquired into the result to renal hypertension rat model hypotensive effect and mechanism thereof:
Adopt 7 age in week male Wistar rat, duplicate the renal hypertension model with improved Goldblatt2 kidney 2 folder methods after, be divided into 4 groups: model group, the high, medium and low dosage group of blood-nourishing and brain-refreshing, every day, gastric infusion was 1 time, normal group and sham operated rats gavage the equivalent distilled water.Measure rat arteria caudalis systolic pressure respectively at the 1st, 2,4 weekends.Get blood after 4 weeks, detect blood ALD and the AngII of cardiac muscular tissue concentration.
The result: gavaging blood-nourishing and brain-refreshing continuously and can obviously reduce the RHR systolic pressure after 4 weeks, and can reduce plasma A LD and myocardium Ang II concentration, is remarkable with the high dose group.Point out this medicine can reduce the RHR blood pressure, but blood pressure lowering mechanism may be relevant with its antagonism RAS system.
Blood-nourishing and cephalocathartic micropills treatment acute cerebral infarction clinical observation result:
The 162 routine acute cerebral infarction patients that will meet diagnosis are divided into treatment A group (n=54), treatment B group (you=55), matched group (n=53) at random.Treatment A group adds on the basis of conventional Comprehensive Treatment uses the blood-nourishing and brain-refreshing ball, and each 1 bag, one day 3 times; Treatment B organizes the first and second blood-nourishing and brain-refreshing balls, and each 2 bags, one day 3 times; Matched group adds on the basis of conventional Comprehensive Treatment uses DELE CHONGJI, and each 1 bag one day 3 times, was for 2 weeks the course of treatment.Measure serum superoxide dismutases (SOD) and malonaldehyde (MDA) before and after the treatment, D-dimer (D-D), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) level are observed clinical efficacy simultaneously.
The result: treatment A group, B group are respectively 79.6%, 92.7%, 56.6% with the matched group total effective rate.Treatment A group finishes back MDA, D-D in the course of treatment, TNF-α, IL-6 descend to some extent, and SOD then raises to some extent.It is more obvious that treatment B organizes each index improvement, and each index of matched group changes little.
Conclusion: blood-nourishing and brain-refreshing pill for curing acute cerebral infarction determined curative effect, and curative effect increases along with the increase of dosage.
Embodiment 2:
The component that the prescription that blood-nourishing and cephalocathartic micropills that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Angelicae Sinensis 250;
Rhizoma Chuanxiong 400;
The Radix Paeoniae Alba 200;
Radix Rehmanniae Preparata 400;
Ramulus Uncariae Cum Uncis 580;
Caulis Spatholobi 780;
Spica Prunellae 600;
Semen Cassiae 750;
Concha Margaritifera 560;
Rhizoma Corydalis 420;
Herba Asari 30;
The preparation method of blood-nourishing and cephalocathartic micropills that present embodiment provides is as follows:
1) get Radix Angelicae Sinensis 250g, Rhizoma Chuanxiong 400g, Radix Paeoniae Alba 200.3g, Rhizoma Corydalis 420g, with 8 times of amount 70% ethanol, reflux 2 hours, backflow device is in addition preserved, and medicinal residues are standby;
2) with the medicinal residues of step 1) and Radix Rehmanniae Preparata 400g, Caulis Spatholobi 780g, Spica Prunellae 600g, Semen Cassiae 750g, Concha Margaritifera 560g, Herba Asari 30g, adding 6 times of water gagings decocts three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis 580g, collecting decoction, filter, the clear paste that is evaporated to relative density and is 1.0 (55 ℃) is standby;
3) with step 2) clear paste add ethanol and make and contain alcohol amount and reach 65%, left standstill 24 hours, filter the backflow merging of filtrate and step 1), decompression recycling ethanol and to be concentrated into relative density be that the thick paste of 1.10 (55 ℃) is standby;
4) with the thick paste vacuum drying of step 3), pulverize, add 100g starch mixing, with 60% ethanol system soft material, pill, packing, promptly.
GUSHUKANG micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 58%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Blood-nourishing and cephalocathartic micropills is treated migrainous clinical observation result:
This group is chosen 21 routine patients, male 6 examples, women 15 examples.Selected patient's period in a medicine diet cheese, chocolate and red wine etc. may bring out migrainous food, give the MAR card simultaneously, the regulation administrated method is distinguished the flavor of each 1～2 bag, every day 3 times is oral, period in a medicine record headache attack degree, headache situation of change and simultaneous phenomenon situation, and the untoward reaction after taking medicine etc., after taking medicine continuously 3 months the MAR card is returned.
Efficacy assessment standard: produce effects: the back headache symptom of taking medicine is not reaccessed, or seizure frequency significantly reduces, and degree alleviates.Effectively: the back times of headache of taking medicine reduces, and degree alleviates.Invalid: headache and related symptoms are with before treating.
Efficacy result: this is organized among the 21 routine patients, and produce effects 12 examples account for 57.1%; Effective 6 examples account for 28.6%; Invalid 3 examples account for 14.3%.Total effective rate 85.7%.
Blood-nourishing and cephalocathartic micropills is to MCAO rat model function of nervous system protection mechanism result of study:
Select purebred rat of 22 monthly ages for use, adopt line bolt method to block middle cerebral artery and bring out cerebral ischemic model, the treatment group is given the blood-nourishing and brain-refreshing pill for curing, and matched group and sham operated rats are then given the equivalent normal saline and irritated stomach.
The result: the treatment group can significantly alleviate model mouse neurologic defect symptom, improves blocking-up side E Ding district electroencephalogram wave amplitude and reduces and frequency deceleration; Cerebral morphology is observed and is found, the increment of ischemic region spider cell is obvious, and neuron only slightly reduces than matched group.Cerebral blood flow also is significantly improved, and GSH, GSH-PX level raise in the blood, and the MDA level is then suppressed and reduces.
Conclusion: the blood-nourishing and brain-refreshing ball is many-sided to the protection mechanism of cerebral ischemia, and strengthens the spider cell activity, neuroprotective unit ischemic lesions, and improving the damage of cerebral blood flow and free radical resisting is one of main mechanism of its treatment ischemia injury.
Blood-nourishing and cephalocathartic micropills is inquired into the result to renal hypertension rat model hypotensive effect and mechanism thereof:
Adopt 7 age in week male Wistar rat, duplicate the renal hypertension model with improved Goldblatt2 kidney 2 folder methods after, be divided into 4 groups: model group, the high, medium and low dosage group of blood-nourishing and brain-refreshing, every day, gastric infusion was 1 time, normal group and sham operated rats gavage the equivalent distilled water.Measure rat arteria caudalis systolic pressure respectively at the 1st, 2,4 weekends.Get blood after 4 weeks, detect blood ALD and the Ang II of cardiac muscular tissue concentration.
The result: gavaging blood-nourishing and brain-refreshing continuously and can obviously reduce the RHR systolic pressure after 4 weeks, and can reduce plasma A LD and myocardium AngII concentration, is remarkable with the high dose group.Point out this medicine can reduce the RHR blood pressure, but blood pressure lowering mechanism may be relevant with its antagonism RAS system.
Blood-nourishing and cephalocathartic micropills treatment acute cerebral infarction clinical observation result:
The 162 routine acute cerebral infarction patients that will meet diagnosis are divided into treatment A group (n=54), treatment B group (you=55), matched group (n=53) at random.Treatment A group adds on the basis of conventional Comprehensive Treatment uses the blood-nourishing and brain-refreshing ball, and each 1 bag, one day 3 times; Treatment B organizes the first and second blood-nourishing and brain-refreshing balls, and each 2 bags, one day 3 times; Matched group adds on the basis of conventional Comprehensive Treatment uses DELE CHONGJI, and each 1 bag one day 3 times, was for 2 weeks the course of treatment.Measure serum superoxide dismutases (SOD) and malonaldehyde (MDA) before and after the treatment, D-dimer (D-D), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) level are observed clinical efficacy simultaneously.
The result: treatment A group, B group are respectively 78.2%, 93.6%, 56.6% with the matched group total effective rate.Treatment A group finishes back MDA, D-D in the course of treatment, TNF-α, IL-6 descend to some extent, and SOD then raises to some extent.It is more obvious that treatment B organizes each index improvement, and each index of matched group changes little.
Conclusion: blood-nourishing and brain-refreshing pill for curing acute cerebral infarction determined curative effect, and curative effect increases along with the increase of dosage.
Embodiment 3:
The component that the prescription that blood-nourishing and cephalocathartic micropills that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Angelicae Sinensis 420;
Rhizoma Chuanxiong 280;
The Radix Paeoniae Alba 380;
Radix Rehmanniae Preparata 200;
Ramulus Uncariae Cum Uncis 750;
Caulis Spatholobi 550;
Spica Prunellae 720;
Semen Cassiae 500;
Concha Margaritifera 750;
Rhizoma Corydalis 200;
Herba Asari 100;
Starch 100.
The preparation method of blood-nourishing and cephalocathartic micropills that present embodiment provides is as follows:
The preparation method of blood-nourishing and cephalocathartic micropills that present embodiment provides is as follows:
1) get Radix Angelicae Sinensis 420g, Rhizoma Chuanxiong 280g, Radix Paeoniae Alba 380g, Rhizoma Corydalis 200g, with 12 times of amount 70% ethanol, reflux 2 hours, backflow device is in addition preserved, and medicinal residues are standby;
2) with the medicinal residues of step 1) and Radix Rehmanniae Preparata 200g, Caulis Spatholobi 550g, Spica Prunellae 720g, Semen Cassiae 500g, Concha Margaritifera 750g, Herba Asari 100g, adding 8 times of water gagings decocts three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis 750g, collecting decoction, filter, the clear paste that is evaporated to relative density and is 1.1 (55 ℃) is standby;
3) with step 2) clear paste add ethanol and make and contain alcohol amount and reach 65%, left standstill 24 hours, filter the backflow merging of filtrate and step 1), decompression recycling ethanol and to be concentrated into relative density be that the thick paste of 1.35 (55 ℃) is standby;
4) with the thick paste vacuum drying of step 3), pulverize, add 500g starch mixing, with 85% ethanol system soft material, pill, packing, promptly.
GUSHUKANG micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 58%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Blood-nourishing and cephalocathartic micropills is treated migrainous clinical observation result:
This group is chosen 28 routine patients, male 12 examples, women 16 examples.Selected patient's period in a medicine diet cheese, chocolate and red wine etc. may bring out migrainous food, give the MAR card simultaneously, the regulation administrated method is distinguished the flavor of each 1～2 bag, every day 3 times is oral, period in a medicine record headache attack degree, headache situation of change and simultaneous phenomenon situation, and the untoward reaction after taking medicine etc., after taking medicine continuously 3 months the MAR card is returned.
Efficacy assessment standard: produce effects: the back headache symptom of taking medicine is not reaccessed, or seizure frequency significantly reduces, and degree alleviates.Effectively: the back times of headache of taking medicine reduces, and degree alleviates.Invalid: headache and related symptoms are with before treating.
Efficacy result: this is organized among the 28 routine patients, produce effects 19 examples; Effective 6 examples; Invalid 3 examples.
Blood-nourishing and cephalocathartic micropills is to MCAO rat model function of nervous system protection mechanism result of study:
Select purebred rat of 22 monthly ages for use, adopt line bolt method to block middle cerebral artery and bring out cerebral ischemic model, the treatment group is given the blood-nourishing and brain-refreshing pill for curing, and matched group and sham operated rats are then given the equivalent normal saline and irritated stomach.
The result: the treatment group can significantly alleviate model mouse neurologic defect symptom, improves blocking-up side E Ding district electroencephalogram wave amplitude and reduces and frequency deceleration; Cerebral morphology is observed and is found, the increment of ischemic region spider cell is obvious, and neuron only slightly reduces than matched group.Cerebral blood flow also is significantly improved, and GSH, GSH-PX level raise in the blood, and the MDA level is then suppressed and reduces.
Conclusion: the blood-nourishing and brain-refreshing ball is many-sided to the protection mechanism of cerebral ischemia, and strengthens the spider cell activity, neuroprotective unit ischemic lesions, and improving the damage of cerebral blood flow and free radical resisting is one of main mechanism of its treatment ischemia injury.
Blood-nourishing and cephalocathartic micropills is inquired into the result to renal hypertension rat model hypotensive effect and mechanism thereof:
Adopt 7 age in week male Wistar rat, duplicate the renal hypertension model with improved Goldblatt2 kidney 2 folder methods after, be divided into 4 groups: model group, the high, medium and low dosage group of blood-nourishing and brain-refreshing, every day, gastric infusion was 1 time, normal group and sham operated rats gavage the equivalent distilled water.Measure rat arteria caudalis systolic pressure respectively at the 1st, 2,4 weekends.Get blood after 4 weeks, detect blood ALD and the Ang II of cardiac muscular tissue concentration.
The result: gavaging blood-nourishing and brain-refreshing continuously and can obviously reduce the RHR systolic pressure after 4 weeks, and can reduce plasma A LD and myocardium Ang II concentration, is remarkable with the high dose group.Point out this medicine can reduce the RHR blood pressure, but blood pressure lowering mechanism may be relevant with its antagonism RAS system.
Blood-nourishing and cephalocathartic micropills treatment acute cerebral infarction clinical observation result:
The 162 routine acute cerebral infarction patients that will meet diagnosis are divided into treatment A group (n=54), treatment B group (you=55), matched group (n=53) at random.Treatment A group adds on the basis of conventional Comprehensive Treatment uses the blood-nourishing and brain-refreshing ball, and each 1 bag, one day 3 times; Treatment B organizes the first and second blood-nourishing and brain-refreshing balls, and each 2 bags, one day 3 times; Matched group adds on the basis of conventional Comprehensive Treatment uses DELE CHONGJI, and each 1 bag one day 3 times, was for 2 weeks the course of treatment.Measure serum superoxide dismutases (SOD) and malonaldehyde (MDA) before and after the treatment, D-dimer (D-D), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) level are observed clinical efficacy simultaneously.The result: treatment A group, B group are respectively 80.6%, 91.7%, 56.6% with the matched group total effective rate.Treatment A group finishes back MDA, D-D in the course of treatment, TNF-α, IL-6 descend to some extent, and SOD then raises to some extent.It is more obvious that treatment B organizes each index improvement, and each index of matched group changes little.
Conclusion: blood-nourishing and brain-refreshing pill for curing acute cerebral infarction determined curative effect, and curative effect increases along with the increase of dosage.
Embodiment 4:
The component that the prescription that blood-nourishing and cephalocathartic micropills that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Angelicae Sinensis 320;
Rhizoma Chuanxiong 320;
The Radix Paeoniae Alba 300;
Radix Rehmanniae Preparata 300;
Ramulus Uncariae Cum Uncis 660;
Caulis Spatholobi 680;
Spica Prunellae 680;
Semen Cassiae 680;
Concha Margaritifera 680;
Rhizoma Corydalis 320;
Herba Asari 50;
The preparation method of blood-nourishing and cephalocathartic micropills that present embodiment provides is as follows:
The preparation method of blood-nourishing and cephalocathartic micropills that present embodiment provides is as follows:
1) get Radix Angelicae Sinensis 320g, Rhizoma Chuanxiong 320g, Radix Paeoniae Alba 300g, Rhizoma Corydalis 320g, with 8 times of amount 70% ethanol, reflux 2 hours, backflow device is in addition preserved, and medicinal residues are standby;
2) with the medicinal residues of step 1) and Radix Rehmanniae Preparata 300g, Caulis Spatholobi 680g, Spica Prunellae 680g, Semen Cassiae 680g, Concha Margaritifera 680g, Herba Asari 50g, adding 14 times of water gagings decocts three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis 660g, collecting decoction, filter, the clear paste that is evaporated to relative density and is 1.1.2 (55 ℃) is standby;
3) with step 2) clear paste add ethanol and make and contain alcohol amount and reach 65%, left standstill 24 hours, filter the backflow merging of filtrate and step 1), decompression recycling ethanol and to be concentrated into relative density be that the thick paste of 1.35 (55 ℃) is standby;
4) with the thick paste vacuum drying of step 3), pulverize, add the appropriate amount of starch mixing, with 95% ethanol system soft material, pill, packing, promptly.
GUSHUKANG micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 58%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Blood-nourishing and cephalocathartic micropills is treated migrainous clinical observation result:
This group is chosen 21 routine patients, male 6 examples, women 15 examples.Selected patient's period in a medicine diet cheese, chocolate and red wine etc. may bring out migrainous food, give the MAR card simultaneously, the regulation administrated method is distinguished the flavor of each 1～2 bag, every day 3 times is oral, period in a medicine record headache attack degree, headache situation of change and simultaneous phenomenon situation, and the untoward reaction after taking medicine etc., after taking medicine continuously 3 months the MAR card is returned.
Efficacy assessment standard: produce effects: the back headache symptom of taking medicine is not reaccessed, or seizure frequency significantly reduces, and degree alleviates.Effectively: the back times of headache of taking medicine reduces, and degree alleviates.Invalid: headache and related symptoms are with before treating.
Efficacy result: this is organized among the 21 routine patients, and produce effects 12 examples account for 57.1%; Effective 6 examples account for 28.6%; Invalid 3 examples account for 14.3%.Total effective rate 85.7%.
Blood-nourishing and cephalocathartic micropills is to MCAO rat model function of nervous system protection mechanism result of study:
Select purebred rat of 22 monthly ages for use, adopt line bolt method to block middle cerebral artery and bring out cerebral ischemic model, the treatment group is given the blood-nourishing and brain-refreshing pill for curing, and matched group and sham operated rats are then given the equivalent normal saline and irritated stomach.
The result: the treatment group can significantly alleviate model mouse neurologic defect symptom, improves blocking-up side E Ding district electroencephalogram wave amplitude and reduces and frequency deceleration; Cerebral morphology is observed and is found, the increment of ischemic region spider cell is obvious, and neuron only slightly reduces than matched group.Cerebral blood flow also is significantly improved, and GSH, GSH-PX level raise in the blood, and the MDA level is then suppressed and reduces.
Conclusion: the blood-nourishing and brain-refreshing ball is many-sided to the protection mechanism of cerebral ischemia, and strengthens the spider cell activity, neuroprotective unit ischemic lesions, and improving the damage of cerebral blood flow and free radical resisting is one of main mechanism of its treatment ischemia injury.
Blood-nourishing and cephalocathartic micropills is inquired into the result to renal hypertension rat model hypotensive effect and mechanism thereof:
Adopt 7 age in week male Wistar rat, duplicate the renal hypertension model with improved Goldblatt2 kidney 2 folder methods after, be divided into 4 groups: model group, the high, medium and low dosage group of blood-nourishing and brain-refreshing, every day, gastric infusion was 1 time, normal group and sham operated rats gavage the equivalent distilled water.Measure rat arteria caudalis systolic pressure respectively at the 1st, 2,4 weekends.Get blood after 4 weeks, detect blood ALD and the Ang II of cardiac muscular tissue concentration.
The result: gavaging blood-nourishing and brain-refreshing continuously and can obviously reduce the RHR systolic pressure after 4 weeks, and can reduce plasma A LD and myocardium Ang II concentration, is remarkable with the high dose group.Point out this medicine can reduce the RHR blood pressure, but blood pressure lowering mechanism may be relevant with its antagonism RAS system.
Blood-nourishing and cephalocathartic micropills treatment acute cerebral infarction clinical observation result:
The 162 routine acute cerebral infarction patients that will meet diagnosis are divided into treatment A group (n=54), treatment B group (you=55), matched group (n=53) at random.Treatment A group adds on the basis of conventional Comprehensive Treatment uses the blood-nourishing and brain-refreshing ball, and each 1 bag, one day 3 times; Treatment B organizes the first and second blood-nourishing and brain-refreshing balls, and each 2 bags, one day 3 times; Matched group adds on the basis of conventional Comprehensive Treatment uses DELE CHONGJI, and each 1 bag one day 3 times, was for 2 weeks the course of treatment.Measure serum superoxide dismutases (SOD) and malonaldehyde (MDA) before and after the treatment, D-dimer (D-D), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) level are observed clinical efficacy simultaneously.The result: treatment A group, B group are respectively 79.6%, 92.7%, 56.6% with the matched group total effective rate.Treatment A group finishes back MDA, D-D in the course of treatment, TNF-α, IL-6 descend to some extent, and SOD then raises to some extent.It is more obvious that treatment B organizes each index improvement, and each index of matched group changes little.
Conclusion: blood-nourishing and brain-refreshing pill for curing acute cerebral infarction determined curative effect, and curative effect increases along with the increase of dosage.
Embodiment 5:
The component that the prescription that blood-nourishing and cephalocathartic micropills that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Angelicae Sinensis 300;
Rhizoma Chuanxiong 360;
The Radix Paeoniae Alba 220;
Radix Rehmanniae Preparata 320;
Ramulus Uncariae Cum Uncis 600;
Caulis Spatholobi 720;
Spica Prunellae 600;
Semen Cassiae 720;
Concha Margaritifera 600;
Rhizoma Corydalis 420;
Herba Asari 40.
The preparation method of blood-nourishing and cephalocathartic micropills that present embodiment provides is as follows:
1) get Radix Angelicae Sinensis 300g, Rhizoma Chuanxiong 360g, Radix Paeoniae Alba 220g, Rhizoma Corydalis 420g, with 8 times of amount 70% ethanol, reflux 2 hours, backflow device is in addition preserved, and medicinal residues are standby;
2) with the medicinal residues of step 1) and Radix Rehmanniae Preparata 320g, Caulis Spatholobi 720g, Spica Prunellae 600g, Semen Cassiae 720g, Concha Margaritifera 600g, Herba Asari 40g, adding 8 times of water gagings decocts three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis 600g, collecting decoction, filter, the clear paste that is evaporated to relative density and is 1.1 (55 ℃) is standby;
3) with step 2) clear paste add ethanol and make and contain alcohol amount and reach 65%, left standstill 24 hours, filter the backflow merging of filtrate and step 1), decompression recycling ethanol and to be concentrated into relative density be that the thick paste of 1.35 (55 ℃) is standby;
4) with the thick paste vacuum drying of step 3), pulverize, add the appropriate amount of starch mixing, with 60% ethanol system soft material, pill, packing, promptly.
GUSHUKANG micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 58%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Blood-nourishing and cephalocathartic micropills is treated migrainous clinical observation result:
This group is chosen 26 routine patients, male 11 examples, women 15 examples.Selected patient's period in a medicine diet cheese, chocolate and red wine etc. may bring out migrainous food, give the MAR card simultaneously, the regulation administrated method is distinguished the flavor of each 1～2 bag, every day 3 times is oral, period in a medicine record headache attack degree, headache situation of change and simultaneous phenomenon situation, and the untoward reaction after taking medicine etc., after taking medicine continuously 3 months the MAR card is returned.
Efficacy assessment standard: produce effects: the back headache symptom of taking medicine is not reaccessed, or seizure frequency significantly reduces, and degree alleviates.Effectively: the back times of headache of taking medicine reduces, and degree alleviates.Invalid: headache and related symptoms are with before treating.
Efficacy result: this is organized among the 26 routine patients, produce effects 19 examples; Effective 6 examples; Invalid 1 example.
Blood-nourishing and cephalocathartic micropills is to MCAO rat model function of nervous system protection mechanism result of study:
Select purebred rat of 22 monthly ages for use, adopt line bolt method to block middle cerebral artery and bring out cerebral ischemic model, the treatment group is given the blood-nourishing and brain-refreshing pill for curing, and matched group and sham operated rats are then given the equivalent normal saline and irritated stomach.
The result: the treatment group can significantly alleviate model mouse neurologic defect symptom, improves blocking-up side E Ding district electroencephalogram wave amplitude and reduces and frequency deceleration; Cerebral morphology is observed and is found, the increment of ischemic region spider cell is obvious, and neuron only slightly reduces than matched group.Cerebral blood flow also is significantly improved, and GSH, GSH-PX level raise in the blood, and the MDA level is then suppressed and reduces.
Conclusion: the blood-nourishing and brain-refreshing ball is many-sided to the protection mechanism of cerebral ischemia, and strengthens the spider cell activity, neuroprotective unit ischemic lesions, and improving the damage of cerebral blood flow and free radical resisting is one of main mechanism of its treatment ischemia injury.
Blood-nourishing and cephalocathartic micropills is inquired into the result to renal hypertension rat model hypotensive effect and mechanism thereof:
Adopt 7 age in week male Wistar rat, duplicate the renal hypertension model with improved Goldblatt2 kidney 2 folder methods after, be divided into 4 groups: model group, the high, medium and low dosage group of blood-nourishing and brain-refreshing, every day, gastric infusion was 1 time, normal group and sham operated rats gavage the equivalent distilled water.Measure rat arteria caudalis systolic pressure respectively at the 1st, 2,4 weekends.Get blood after 4 weeks, detect blood ALD and the Ang II of cardiac muscular tissue concentration.
The result: gavaging blood-nourishing and brain-refreshing continuously and can obviously reduce the RHR systolic pressure after 4 weeks, and can reduce plasma A LD and myocardium Ang II concentration, is remarkable with the high dose group.Point out this medicine can reduce the RHR blood pressure, but blood pressure lowering mechanism may be relevant with its antagonism RAS system.
Blood-nourishing and cephalocathartic micropills treatment acute cerebral infarction clinical observation result:
The 162 routine acute cerebral infarction patients that will meet diagnosis are divided into treatment A group (n=54), treatment B group (you=55), matched group (n=53) at random.Treatment A group adds on the basis of conventional Comprehensive Treatment uses the blood-nourishing and brain-refreshing ball, and each 1 bag, one day 3 times; Treatment B organizes the first and second blood-nourishing and brain-refreshing balls, and each 2 bags, one day 3 times; Matched group adds on the basis of conventional Comprehensive Treatment uses DELE CHONGJI, and each 1 bag one day 3 times, was for 2 weeks the course of treatment.Measure serum superoxide dismutases (SOD) and malonaldehyde (MDA) before and after the treatment, D-dimer (D-D), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) level are observed clinical efficacy simultaneously.
The result: treatment A group, B group are respectively 79.6%, 92.7%, 56.6% with the matched group total effective rate.Treatment A group finishes back MDA, D-D in the course of treatment, TNF-α, IL-6 descend to some extent, and SOD then raises to some extent.It is more obvious that treatment B organizes each index improvement, and each index of matched group changes little.
Conclusion: blood-nourishing and brain-refreshing pill for curing acute cerebral infarction determined curative effect, and curative effect increases along with the increase of dosage.
Embodiment 6:
The component that the prescription that blood-nourishing and cephalocathartic micropills that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Angelicae Sinensis 360;
Rhizoma Chuanxiong 300;
The Radix Paeoniae Alba 320;
Radix Rehmanniae Preparata 220;
Ramulus Uncariae Cum Uncis 720;
Caulis Spatholobi 600;
Spica Prunellae 720;
Semen Cassiae 600;
Concha Margaritifera 720;
Rhizoma Corydalis 320;
Herba Asari 80.
The preparation method of blood-nourishing and cephalocathartic micropills that present embodiment provides is as follows:
1) get Radix Angelicae Sinensis 360g, Rhizoma Chuanxiong 300g, Radix Paeoniae Alba 320g, Rhizoma Corydalis 320g, with 6 times of amount 70% ethanol, reflux 2 hours, backflow device is in addition preserved, and medicinal residues are standby;
2) with the medicinal residues of step 1) and Radix Rehmanniae Preparata 220g, Caulis Spatholobi 600g, Spica Prunellae 720g, Semen Cassiae 600g, Concha Margaritifera 720g, Herba Asari 80g, adding 8 times of water gagings decocts three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis 720g, collecting decoction, filter, the clear paste that is evaporated to relative density and is 1.1 (55 ℃) is standby;
3) with step 2) clear paste add ethanol and make and contain alcohol amount and reach 65%, left standstill 24 hours, filter the backflow merging of filtrate and step 1), decompression recycling ethanol and to be concentrated into relative density be that the thick paste of 1.35 (55 ℃) is standby;
4) with the thick paste vacuum drying of step 3), pulverize, add the appropriate amount of starch mixing, with 60% ethanol system soft material, pill, packing, promptly.
GUSHUKANG micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 58%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Blood-nourishing and cephalocathartic micropills is treated migrainous clinical observation result:
This group is chosen 23 routine patients, male 8 examples, women 15 examples.Selected patient's period in a medicine diet cheese, chocolate and red wine etc. may bring out migrainous food, give the MAR card simultaneously, the regulation administrated method is distinguished the flavor of each 1～2 bag, every day 3 times is oral, period in a medicine record headache attack degree, headache situation of change and simultaneous phenomenon situation, and the untoward reaction after taking medicine etc., after taking medicine continuously 3 months the MAR card is returned.
Efficacy assessment standard: produce effects: the back headache symptom of taking medicine is not reaccessed, or seizure frequency significantly reduces, and degree alleviates.Effectively: the back times of headache of taking medicine reduces, and degree alleviates.Invalid: headache and related symptoms are with before treating.
Efficacy result: this is organized among the 23 routine patients, produce effects 15 examples; Effective 6 examples; Invalid 2 examples.
Blood-nourishing and cephalocathartic micropills is to MCAO rat model function of nervous system protection mechanism result of study:
Select purebred rat of 22 monthly ages for use, adopt line bolt method to block middle cerebral artery and bring out cerebral ischemic model, the treatment group is given the blood-nourishing and brain-refreshing pill for curing, and matched group and sham operated rats are then given the equivalent normal saline and irritated stomach.
The result: the treatment group can significantly alleviate model mouse neurologic defect symptom, improves blocking-up side E Ding district electroencephalogram wave amplitude and reduces and frequency deceleration; Cerebral morphology is observed and is found, the increment of ischemic region spider cell is obvious, and neuron only slightly reduces than matched group.Cerebral blood flow also is significantly improved, and GSH, GSH-PX level raise in the blood, and the MDA level is then suppressed and reduces.
Conclusion: the blood-nourishing and brain-refreshing ball is many-sided to the protection mechanism of cerebral ischemia, and strengthens the spider cell activity, neuroprotective unit ischemic lesions, and improving the damage of cerebral blood flow and free radical resisting is one of main mechanism of its treatment ischemia injury.
Blood-nourishing and cephalocathartic micropills is inquired into the result to renal hypertension rat model hypotensive effect and mechanism thereof:
Adopt 7 age in week male Wistar rat, duplicate the renal hypertension model with improved Goldblatt2 kidney 2 folder methods after, be divided into 4 groups: model group, the high, medium and low dosage group of blood-nourishing and brain-refreshing, every day, gastric infusion was 1 time, normal group and sham operated rats gavage the equivalent distilled water.Measure rat arteria caudalis systolic pressure respectively at the 1st, 2,4 weekends.Get blood after 4 weeks, detect blood ALD and the Ang II of cardiac muscular tissue concentration.
The result: gavaging blood-nourishing and brain-refreshing continuously and can obviously reduce the RHR systolic pressure after 4 weeks, and can reduce plasma A LD and myocardium Ang II concentration, is remarkable with the high dose group.Point out this medicine can reduce the RHR blood pressure, but blood pressure lowering mechanism may be relevant with its antagonism RAS system.
Blood-nourishing and cephalocathartic micropills treatment acute cerebral infarction clinical observation result:
The 162 routine acute cerebral infarction patients that will meet diagnosis are divided into treatment A group (n=54), treatment B group (you=55), matched group (n=53) at random.Treatment A group adds on the basis of conventional Comprehensive Treatment uses the blood-nourishing and brain-refreshing ball, and each 1 bag, one day 3 times; Treatment B organizes the first and second blood-nourishing and brain-refreshing balls, and each 2 bags, one day 3 times; Matched group adds on the basis of conventional Comprehensive Treatment uses DELE CHONGJI, and each 1 bag one day 3 times, was for 2 weeks the course of treatment.Measure serum superoxide dismutases (SOD) and malonaldehyde (MDA) before and after the treatment, D-dimer (D-D), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) level are observed clinical efficacy simultaneously.
The result: treatment A group, B group are respectively 78.6%, 93.7%, 56.6% with the matched group total effective rate.Treatment A group finishes back MDA, D-D in the course of treatment, TNF-α, IL-6 descend to some extent, and SOD then raises to some extent.It is more obvious that treatment B organizes each index improvement, and each index of matched group changes little.
Conclusion: blood-nourishing and brain-refreshing pill for curing acute cerebral infarction determined curative effect, and curative effect increases along with the increase of dosage.
Embodiment 7:
The component that the prescription that blood-nourishing and cephalocathartic micropills that present embodiment provides adopts comprises and the weight portion of each component are as follows:
Radix Angelicae Sinensis 300;
Rhizoma Chuanxiong 300;
The Radix Paeoniae Alba 320;
Radix Rehmanniae Preparata 320;
Ramulus Uncariae Cum Uncis 600;
Caulis Spatholobi 720;
Spica Prunellae 600;
Semen Cassiae 720;
Concha Margaritifera 600;
Rhizoma Corydalis 320;
Herba Asari 80.
The preparation method of blood-nourishing and cephalocathartic micropills that present embodiment provides is as follows:
1) get Radix Angelicae Sinensis 300g, Rhizoma Chuanxiong 300g, Radix Paeoniae Alba 320g, Rhizoma Corydalis 320g, with 10 times of amount 70% ethanol, reflux 2 hours, backflow device is in addition preserved, and medicinal residues are standby;
2) with the medicinal residues of step 1) and Radix Rehmanniae Preparata 320g, Caulis Spatholobi 720g, Spica Prunellae 600g, Semen Cassiae 720g, Concha Margaritifera 600g, Herba Asari 80g, adding 8 times of water gagings decocts three times, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis 600g, collecting decoction, filter, the clear paste that is evaporated to relative density and is 1.1 (55 ℃) is standby;
3) with step 2) clear paste add ethanol and make and contain alcohol amount and reach 65%, left standstill 24 hours, filter the backflow merging of filtrate and step 1), decompression recycling ethanol and to be concentrated into relative density be that the thick paste of 1.35 (55 ℃) is standby;
4) with the thick paste vacuum drying of step 3), pulverize, add the appropriate amount of starch mixing, with 60% ethanol system soft material, pill, packing, promptly.
GUSHUKANG micropill provided by the present invention, pill diameter＜0.05mm, the disintegrate melting is excellent, and the curative effect performance is fast, and release is stable, about 60 minutes of disintegration time, the bioavailability height, local irritation is little.The pill outward appearance is neat and artistic, and the patient is glad to take, and the critical relative humidity of micropill is 58%, and hygroscopicity is little, transports, stores, carries etc. all more convenient.
Blood-nourishing and cephalocathartic micropills is treated migrainous clinical observation result:
This group is chosen 20 routine patients, male 8 examples, women 12 examples.Selected patient's period in a medicine diet cheese, chocolate and red wine etc. may bring out migrainous food, give the MAR card simultaneously, the regulation administrated method is distinguished the flavor of each 1～2 bag, every day 3 times is oral, period in a medicine record headache attack degree, headache situation of change and simultaneous phenomenon situation, and the untoward reaction after taking medicine etc., after taking medicine continuously 3 months the MAR card is returned.
Efficacy assessment standard: produce effects: the back headache symptom of taking medicine is not reaccessed, or seizure frequency significantly reduces, and degree alleviates.Effectively: the back times of headache of taking medicine reduces, and degree alleviates.Invalid: headache and related symptoms are with before treating.
Efficacy result: this is organized among the 20 routine patients, produce effects 12 examples; Effective 6 examples; Invalid 2 examples.
Blood-nourishing and cephalocathartic micropills is to MCAO rat model function of nervous system protection mechanism result of study:
Select purebred rat of 22 monthly ages for use, adopt line bolt method to block middle cerebral artery and bring out cerebral ischemic model, the treatment group is given the blood-nourishing and brain-refreshing pill for curing, and matched group and sham operated rats are then given the equivalent normal saline and irritated stomach.
The result: the treatment group can significantly alleviate model mouse neurologic defect symptom, improves blocking-up side E Ding district electroencephalogram wave amplitude and reduces and frequency deceleration; Cerebral morphology is observed and is found, the increment of ischemic region spider cell is obvious, and neuron only slightly reduces than matched group.Cerebral blood flow also is significantly improved, and GSH, GSH-PX level raise in the blood, and the MDA level is then suppressed and reduces.
Conclusion: the blood-nourishing and brain-refreshing ball is many-sided to the protection mechanism of cerebral ischemia, and strengthens the spider cell activity, neuroprotective unit ischemic lesions, and improving the damage of cerebral blood flow and free radical resisting is one of main mechanism of its treatment ischemia injury.
Blood-nourishing and cephalocathartic micropills is inquired into the result to renal hypertension rat model hypotensive effect and mechanism thereof:
Adopt 7 age in week male Wistar rat, duplicate the renal hypertension model with improved Goldblatt2 kidney 2 folder methods after, be divided into 4 groups: model group, the high, medium and low dosage group of blood-nourishing and brain-refreshing, every day, gastric infusion was 1 time, normal group and sham operated rats gavage the equivalent distilled water.Measure rat arteria caudalis systolic pressure respectively at the 1st, 2,4 weekends.Get blood after 4 weeks, detect blood ALD and the Ang II of cardiac muscular tissue concentration.
The result: gavaging blood-nourishing and brain-refreshing continuously and can obviously reduce the RHR systolic pressure after 4 weeks, and can reduce plasma A LD and myocardium Ang II concentration, is remarkable with the high dose group.Point out this medicine can reduce the RHR blood pressure, but blood pressure lowering mechanism may be relevant with its antagonism RAS system.
Blood-nourishing and cephalocathartic micropills treatment acute cerebral infarction clinical observation result:
The 162 routine acute cerebral infarction patients that will meet diagnosis are divided into treatment A group (n=54), treatment B group (you=55), matched group (n=53) at random.Treatment A group adds on the basis of conventional Comprehensive Treatment uses the blood-nourishing and brain-refreshing ball, and each 1 bag, one day 3 times; Treatment B organizes the first and second blood-nourishing and brain-refreshing balls, and each 2 bags, one day 3 times; Matched group adds on the basis of conventional Comprehensive Treatment uses DELE CHONGJI, and each 1 bag one day 3 times, was for 2 weeks the course of treatment.Measure serum superoxide dismutases (SOD) and malonaldehyde (MDA) before and after the treatment, D-dimer (D-D), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) level are observed clinical efficacy simultaneously.
The result: treatment A group, B group are respectively 80.2%, 93.7%, 56.6% with the matched group total effective rate.Treatment A group finishes back MDA, D-D in the course of treatment, TNF-α, IL-6 descend to some extent, and SOD then raises to some extent.It is more obvious that treatment B organizes each index improvement, and each index of matched group changes little.
Conclusion: blood-nourishing and brain-refreshing pill for curing acute cerebral infarction determined curative effect, and curative effect increases along with the increase of dosage.
Claims (5)
1. blood-nourishing and cephalocathartic micropills is characterized in that being made by following bulk drugs:
Radix Angelicae Sinensis 250-420;
Rhizoma Chuanxiong 280-400;
Radix Paeoniae Alba 200-380;
Radix Rehmanniae Preparata 200-400;
Ramulus Uncariae Cum Uncis 580-750;
Caulis Spatholobi 550-780;
Spica Prunellae 600-720;
Semen Cassiae 500-750;
Concha Margaritifera 560-750;
Rhizoma Corydalis 200-420;
Herba Asari 30-100.
2. blood-nourishing and cephalocathartic micropills according to claim 1 is characterized in that also comprising the starch of 100-500 weight portion.
3. blood-nourishing and cephalocathartic micropills according to claim 2 is characterized in that being made by following bulk drugs:
Radix Angelicae Sinensis 300-360;
Rhizoma Chuanxiong 300-360;
Radix Paeoniae Alba 220-320;
Radix Rehmanniae Preparata 220-320;
Ramulus Uncariae Cum Uncis 600-720;
Caulis Spatholobi 600-720;
Spica Prunellae 600-720;
Semen Cassiae 600-720;
Concha Margaritifera 600-720;
Rhizoma Corydalis 320-420;
Herba Asari 40-80.
4. as the preparation technology of blood-nourishing and cephalocathartic micropills as described in as described in the claim 1-3 any, it is characterized in that comprising the following steps:
1) get Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis with 70% alcohol reflux of 6～12 times of amounts 2 hours, the reflux extracting liquid usefulness of purchasing in addition, medicinal residues keep standby;
2) medicinal residues with step 1) mix with Radix Rehmanniae Preparata, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, Herba Asari, add the decocting that 6-14 doubly measures and boil each 1 hour two to three times, when decocting, last adds Ramulus Uncariae Cum Uncis, collecting decoction filters, and it is standby to be concentrated into relative density and to be 1.0～1.2 clear paste;
3) in step 2) clear paste add ethanol and make and contain the alcohol amount and reach 65%, left standstill 24 hours, filter, the reflux extracting liquid of filtrate and step 1) merges, recovery ethanol and to be concentrated into the thick paste of relative density 1.10～1.35 standby;
4) with the thick paste vacuum drying of step 3), pulverize, add the appropriate amount of starch mixing,, make micropill with 60～95% ethanol system soft materials.
5. according to the preparation method of the described blood-nourishing and cephalocathartic micropills of claim 4, it is characterized in that comprising the following steps:
1) get Radix Angelicae Sinensis, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Rhizoma Corydalis 70% ethanol with 8 times of amounts, reflux, extract, 2 hours, backflow is standby, and medicinal residues keep standby;
2) medicinal residues and Radix Rehmanniae Preparata, Caulis Spatholobi, Spica Prunellae, Semen Cassiae, Concha Margaritifera, the Herba Asari with step 1) decocts with water three times, each amount of water is respectively 10,8,6 times of amounts, each 1 hour, when decocting for the third time, add Ramulus Uncariae Cum Uncis, collecting decoction, filter, it is standby to be concentrated into relative density and to be 1.0～1.2 clear paste;
3) in step 2) clear paste in add ethanol and make and contain the alcohol amount and reach 65%, left standstill 24 hours, filter, the backflow merging of filtrate and step 1), the thick paste of simmer down to relative density 1.10～1.35 is standby;
4) with the thick paste vacuum drying of step 3), pulverize the back and add the appropriate amount of starch mixing, with 85% ethanol system soft material, make micropill.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103285143A (en) * | 2008-03-13 | 2013-09-11 | 天士力制药集团股份有限公司 | Preventive effects of blood-nourishing and brain-refreshing granules on edema around cerebral blood vessels |
| WO2014094632A1 (en) * | 2012-12-21 | 2014-06-26 | 天士力制药集团股份有限公司 | Pharmaceutical composition for treating headache, and preparation method thereof |
| CN104587237A (en) * | 2014-12-19 | 2015-05-06 | 刘瑞英 | Traditional Chinese medicine composition for treating chronic brain blood supply shortage |
-
2006
- 2006-04-12 CN CN 200610072314 patent/CN101053607A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103285143A (en) * | 2008-03-13 | 2013-09-11 | 天士力制药集团股份有限公司 | Preventive effects of blood-nourishing and brain-refreshing granules on edema around cerebral blood vessels |
| CN103285143B (en) * | 2008-03-13 | 2016-01-27 | 天士力制药集团股份有限公司 | Blood-nourishing and brain-refreshing granules is to the preventive effect of cerebrovascular peripheral edema |
| WO2014094632A1 (en) * | 2012-12-21 | 2014-06-26 | 天士力制药集团股份有限公司 | Pharmaceutical composition for treating headache, and preparation method thereof |
| US9795648B2 (en) | 2012-12-21 | 2017-10-24 | Tasly Pharmaceutical Group Co., Ltd. | Pharmaceutical composition for treating headache, and preparation method thereof |
| EA030048B1 (en) * | 2012-12-21 | 2018-06-29 | Тасли Фармасьютикал Груп Ко., Лтд. | Pharmaceutical composition for treating headache, traumatic cranial nerve syndrome, dizziness and vertigo, vexation and irritability, insomnia and/or dreaminess and preparation method thereof |
| CN104587237A (en) * | 2014-12-19 | 2015-05-06 | 刘瑞英 | Traditional Chinese medicine composition for treating chronic brain blood supply shortage |
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