CN103169786A - Pulse-invigorating capsule for treating carotid artery atherosclerosis as well as preventing and treating ischemic cerebral apoplexy - Google Patents
Pulse-invigorating capsule for treating carotid artery atherosclerosis as well as preventing and treating ischemic cerebral apoplexy Download PDFInfo
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Abstract
The invention provides a pulse-invigorating capsule for treating carotid artery atherosclerosis as well as preventing and treating ischemic cerebral apoplexy, which is composed of red sage root, coptis, root of kudzu vine and pseudo-ginseng with weight percentage of 50-55%: 15-20%: 15-20%: 5-10%. The pulse-invigorating capsule for treating carotid artery atherosclerosis as well as preventing and treating ischemic cerebral apoplexy has the characteristics of multiple targets and multiple approaches, and has integration and regulation effects with multiple targets on atherosclerotic plaque. The pulse-invigorating capsule can inhibit the formation of neointima through antithrombosis, anti inflammatory, endothelial cells injury restoration, lipid lowering, microcirculation improvement, blood vessel smooth muscle cell propagation inhibition and the like, the antiatherosclerosis effect can be performed, and the pulse-invigorating capsule can promote the restoration of tissue of the operation blood vessel wound, can prevent several phases of a restenosis process at an early stage after a CEA operation, and the several phases comprise a thrombus formation phase, an inflammation reaction phase, an endothelial restoration phase, a blood vessel smooth muscle propagation phase, a matrix formation phase and the like.
Description
Technical field
The present invention relates to a kind of Chinese medicine for the treatment of carotid arterial atherosclerosis and the courageous and upright apoplexy of control iron deficiency, is a kind of pulse invigorating capsule for the treatment of carotid arterial atherosclerosis control ischemia apoplexy.
Background technology
Apoplexy is harm humans life and healthy commonly encountered diseases and frequently-occurring disease, has the advantages that sickness rate is high, mortality rate is high, disability rate is high, relapse rate is high, occupies the 3rd of mankind's cause of death and first of the reason of disabling.About 2,000,000 people of the annual new patient of China, deadly surpass 1,500,000 people, approximately 75% disable in the survivor, in 5 years, relapse rate is up to 41%, and the existing patient in the whole nation is 6,000,000-7,000,000 people.Wherein, hemorrhagic accounts for 29.3%, and ischemic accounts for 62.4%, and the unknown accounts for 8.3%, and annual health care expenditures are more than 20,000,000,000 yuans.About 830,000 people of the annual new patient of the U.S., 15% is hemorrhagic, and 85% is ischemic, approximately have 170,000 people dead, in ischemic, 20% is thrombosis, and 65% is due to atherosclerosis plaque forming, annual about 2,000,000 people need Medicare, and annual direct medical cost is more than 5,000,000,000 dollars.Nearly 20%-30% is by due to carotid artery stenosis in ischemia apoplexy.Apoplexy causes great misery not only for patient's body and mind, and brings huge spirit and financial burden for society and family.
At present, Therapeutic Method for carotid artery stenosis mainly comprises internal medicine treatment, Endarterectomy (Carotid Endarterectomy, CEA) and the carotid artery intracavity stent implant (Carotid Angioplasty and Stenting, CAS) etc., in recent years extensive multicenter randomized control clinical trial result of study has a far reaching influence to the secondary prevention of cerebrovascular.The nineties, American-European countries has established CEA " goldstandard " status as Carotid Stenosis by large-scale clinical researches such as NASCET, ACAS and ECST.Chinese scholars is all thought through system evaluation: the patient's Drug therapy for carotid artery stenosis 〉=50% can not reduce apoplexy incidence rate and mortality rate effectively, and CEA and CAS are the measures of effectively treating, but the patient who only has about 10%-15% is not suitable for accepting CEA, patient's discomfort of 10%-15% is fit to do CAS, the patient of all the other 70%-80% two kinds of methods is fit to, and carry out evaluation and selection according to patient's comprehensive condition.
But CEA and CAS postoperative restenosis problem are very serious, and be especially outstanding at atherosclerotic stenosis patient CEA postoperative 6-12 month.Due to, restenosis problems affect late result is again the final result of the dependent event of series of complex, and pathomechanism is also not fully aware of, and the aspirin that uses at present and stanin fat-reducing medicament etc. are attempted to change or are controlled this process and still be unsatisfied with.So research CEA postoperative restenosis is one of current problem in the urgent need to address.
Summary of the invention
The technical problem to be solved in the present invention is: a kind of pulse invigorating capsule for the treatment of carotid arterial atherosclerosis control ischemia apoplexy is provided, and promoting blood circulation and detoxication, speckle removing is promoted blood circulation, and is used for the premonitory apoplexy symptom due to carotid arterial atherosclerosis, and card belongs to blood stasis pyretic toxicity person.
Summary of the invention of the present invention is: the pulse invigorating capsule for the treatment of carotid arterial atherosclerosis control ischemia apoplexy is comprised of Radix Salviae Miltiorrhizae, Rhizoma Coptidis, Radix Puerariae, Radix Notoginseng 4 flavor Chinese medicines, and in formula, the percentage by weight of each composition is Radix Salviae Miltiorrhizae: Rhizoma Coptidis: Radix Puerariae: Radix Notoginseng powder=50%-55%: 15%-20%: 15%-20%: 5%-10%; In formula, each composition optimum weight percentage ratio is Radix Salviae Miltiorrhizae: Rhizoma Coptidis: Radix Puerariae: Radix Notoginseng powder=55%: 20%: 15%: 10%.
One. the Chinese medicine ingredients content of respectively distinguishing the flavor of in this formula:
Radix Salviae Miltiorrhizae: main active, liposoluble constituent mainly contain Tanshinone I, Tanshinone I I A, cryptotanshinone, dihydrotanshinone I etc.Water soluble ingredient mainly contains danshensu, salvianolic acid A, B, C, D, E, F etc.Contain in addition other compositions such as flavonoid, triterpenes, sterols.
Rhizoma Coptidis: main component is the alkaloids such as berberine (7%-9%), berberine, 13-methyl-.psi.-coptisine., palmatine, jateorhizine, and containing phenolic compound has magnoline, ferulic acid etc.
Radix Puerariae: its main component has multiple isoflavone, as daidzin, daidzein, puerarin etc., Radix Puerariae glycoside A, B, C, and triterpenes, 7 kinds of novel oleanane type alcohol compounds mainly naming with Pueraria lobota soap alcohol A, B, C, alkaloid etc.
Radix Notoginseng: its Main Ingredients and Appearance has the active ingredients such as Radix Notoginseng total arasaponins (8.19%-29.4%), Radix Notoginseng propylhomoserin, Radix Notoginseng flavone (A, B), volatile oil, aminoacid, saccharide.
Two. the production technology of preparation:
In order to screen optimum extraction, purification condition, by orthogonal experiment, to extraction time, amount of water, extraction time carry out 3 levels to be investigated, and the concentration when refining during to the density of concentrated solution, ethanol precipitation is carried out 2 levels and investigated.
1. pulverizing flour extraction investigates
Take the full side 900g in pulse invigorating capsule side for the treatment of carotid arterial atherosclerosis control ischemia apoplexy, be divided into 3 parts, every part of 300g, drying is pulverized, and crosses 100 mesh sieves, weighed powder outlet quantity, weighed flour extraction.
The flour extraction of the pulse invigorating capsule side of table 1 treatment carotid arterial atherosclerosis control ischemia apoplexy
2. medical material water absorption rate experiment
According to the prescription ratio, take Radix Salviae Miltiorrhizae, Rhizoma Coptidis, Radix Puerariae, Radix Notoginseng powder, add a certain amount of water that gets, soak, until all saturating hearts of medical material leach unabsorbed aqueous solution, trying to achieve the medical material water absorption rate is 17.
Water absorption rate=(medical material weight in wet base-medical material dry weight)/medical material dry weight * 100%.
3. water extraction process experiment
Select amount of water, decocting time, the decoction number of times is principal element.Reciprocal action is ignored in the experiment of Three factors-levels, is designed to L9 (3
4) orthogonal experiment.
Table 2 decocting process condition orthogonal test factor level table
9. number take Radix Salviae Miltiorrhizae, Rhizoma Coptidis, Radix Puerariae, Radix Notoginseng powder by formula proportion, totally 9 parts, weave at random 1.～, press L9 (3
4) orthogonal table arrangement test, extracting solution filters, standardize solution.
The dry extract preparation: precision measures above-mentioned each extracting solution 100mL, is placed in respectively the evaporating dish of constant weight, and water bath method, residue take out in 105 ℃ of dry 3h, are placed in exsiccator and place 30min, and the calculating of weighing the results are shown in Table 3.
Table 3 water extraction Orthogonal experiment results
Profile error is A as can be seen from the above table
1B
1C
3, namely best amount of water is 10 times of water, and best decocting time is 120min, and best decoction number of times is 1 time.
4 assays
With the Tanshinone I I in monarch drug Radix Salviae Miltiorrhizae and Rhizoma Coptidis in the side
AFor investigating index, adopt thin layer chromatography scanning to carry out assay with berberine.
4.1 tanshinone ⅡA assay:
Take octadecyl silane as filler; Take methanol-water (75: 25) as mobile phase; The detection wavelength is 270nm.Number of theoretical plate is pressed Tanshinone I I
AThe peak calculates should be not less than 2000.Approximately 0.3g of this product powder (crossing sieve No. three) is got in the preparation of reference substance solution, and is accurately weighed, puts in tool plug conical flask, and precision adds methanol 50ml, weighed weight, reflux 1 hour in weighed weight, is supplied the weight of less loss with methanol, shake up, filter, get filtrate, and get final product.Precision is drawn reference substance solution and each 5 μ l of need testing solution respectively, and the injection liquid chromatography is measured, and be get final product.This product contains Tanshinone I I
A(C
19H
18O
3) must not be less than 0.20%.
4.2 content of berberine is measured:
Get approximately 0.1g of this product powder, accurately weighed, put in the 100ml measuring bottle, add approximately 95ml of hydrochloric acid-methanol (1: 100), added 15 minutes in 60 ℃ of water-baths, take out, supersound process 30 minutes, room temperature are placed and are spent the night, add methanol and put scale, shake up, filter, filtrate is as need testing solution.Separately get the berberine reference substance appropriate, accurately weighed, add methanol and make the solution that every 1ml contains 0.04mg, in contrast product solution.Test according to thin layer chromatography, draw need testing solution 1 μ l, reference substance solution 1 μ l and 3 μ l, the cross point is on same silica gel g thin-layer plate, take benzene-ethyl acetate-isopropyl alcohol-methanol-water (6: 3: 1.5: 1.5: 0.3) as developing solvent, another groove adds isopyknic strong ammonia solution, about pre-equilibration 15 minutes, be expanded to 8cm, take out, volatilize, carry out fluorescent scanning according to thin layer chromatography, excitation wavelength is λ=366nm, measure the integrated value of test sample and reference substance fluorescence intensity, calculate, and get final product.This product contains berberine with berberine hydrochloride (C
20H
18ClNO
4).
5. preparations shaping engineer testing
5.1 the fill material mobility is investigated
For guaranteeing the stability of content uniformity, require granule to have good mobility.Investigate mobility angle of repose by measuring.Filling medicine angle of repose is 66.2 °, and filler particles angle of repose is 33.1 °.Known by experiment, filler particles satisfies and fills requirement less than 40 ° of good fluidities.
5.2 supplementary product kind is selected
Adjuvant is selected to consider to improve hygroscopicity, according to the knowhow of having grasped, can select starch, Pulvis Talci etc.In the pulse invigorating capsule for the treatment of carotid arterial atherosclerosis control ischemia apoplexy, because the mobility of medical material dry extract is better, therefore do not add any adjuvant in the capsule preparation process.
5.3 mixing of materials and method of granulating are investigated
Because of easily moisture absorption, get damp, therefore adopt swing granulation, three-dimensional hybrid.Three-dimensional mixer, oscillating granulator correlation technique parameter and preparation become the agent process conditions to see Table 4.
Table 4 preparation process condition table
5.4 preparations shaping technique lab scale test
Investigate content uniformity and the disintegration of capsule, carry out 2 tests, all feed intake with 300 capsules recipe quantities at every turn.The results are shown in Table 5.
Table 5 preparations shaping technique lab scale result of the test
Conclusion: from above twice interpretation, the average loading amount of medicated powder, content uniformity, disintegration are all qualified, illustrate that medicated powder is fit to direct filled capsules, determines that this preparations shaping technique is reasonable.
The experimental data of to sum up doing, best preparation production technology is:
In the pulse invigorating capsule for the treatment of carotid arterial atherosclerosis control ischemia apoplexy, the percentage by weight of each composition is Radix Salviae Miltiorrhizae: Rhizoma Coptidis: Radix Puerariae: Radix Notoginseng powder=50%-55%: 15%-20%: 15%-20%: 5%-10%; 4 flavor Chinese medicines in formula respectively according to respectively the distinguish the flavor of concocting method of Chinese medicine of Pharmacopoeia of the People's Republic of China version First in 2010, are purified, the processing such as the process of preparing Chinese medicine.Cold drying 2 hours is with standby.Wherein be ground into fine powder after Radix Salviae Miltiorrhizae, Rhizoma Coptidis, Radix Puerariae 3 flavor Chinese medicine mixings, cross 100 mesh sieves, standby.The Radix Notoginseng mixing dries and is ground into middle powder, crosses 80 mesh sieves, and is by the weighing of equivalent incremental method mixing, standby with above-mentioned 3 flavor medicines.
With above-mentioned four flavor Chinese medicines, add 10 times of water, decocting time is 120 minutes, decocting number of times is 1 time, obtains filtrate, is placed in the evaporating dish of constant weight, water bath method, residue takes out in 105 ℃ of dryings 3 hours, is placed in exsiccator and places 30 minutes, makes dry extract.
Above-mentioned dry powder is mixed with dry extract, adopt and to shake formula granulator, granulate, semi-automatic capsule-filling agent is during filling incapsulates, the radiation sterilization of packing, 60C0 machine, after the assay was approved and get final product.
This formula respectively distinguish the flavor of effect and the tcm theory of Chinese medicine:
Radix Salviae Miltiorrhizae: bitter in the mouth, cold nature, GUIXIN, Liver Channel have the effect of stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow.Wherein tanshinone ⅡA, danshensu, salvianolic acid etc. have the effect of antiplatelet aggregation, and Radix Salviae Miltiorrhizae can obviously reduce blood plasma triacylglycerol and low density lipoprotein, LDL, and can reduce the area of atheromatous plaque and the cholesterol level of arterial wall.Radix Salviae Miltiorrhizae also has the use of doing of certain blood vessel dilating, also can improve rheological property of blood, microcirculation etc.
Rhizoma Coptidis: bitter in the mouth, cold in nature, GUIXIN, spleen, stomach, liver, gallbladder, large intestine channel have heat clearing and damp drying, eliminating fire and detoxication effect.The platelet aggregation that its Berberine is induced ADP, arachidonic acid, collagen etc. has difference
The inhibitory action of degree, and berberine can lower serum cholesterol.
Radix Puerariae: sweet in the mouth, suffering, cool in nature, return spleen, stomach warp, have the effect of antiplatelet aggregation, blood fat reducing.Wherein puerarin can suppress the platelet aggregation that adenosine diphosphate (ADP), 5-hydroxy tryptamine are induced, and puerarin can also obviously lower the T-CHOL in serum.
Radix Notoginseng: sweet in the mouth, little hardship, warm in nature.Return liver, stomach warp.Has the dissipating blood stasis hemostasis, the effect of subduing swelling and relieving pain.Radix Notoginseng has blood fat reducing, prevents arteriosclerotic effect, and Radix Notoginseng total arasaponins wherein can obviously suppress low density lipoprotein, LDL to the effect of vascular smooth muscle, can prevent the formation of endarterium speckle and atherosclerotic generation, development.
The pulse invigorating capsule for the treatment of carotid arterial atherosclerosis control ischemia apoplexy is by Radix Salviae Miltiorrhizae, Rhizoma Coptidis, Radix Puerariae, Radix Notoginseng 4 flavor Chinese medicines, forms according to monarch, minister, the principles of formulating prescriptions compatibility helping, make, and wherein Radix Salviae Miltiorrhizae, Rhizoma Coptidis monarch drug, the Radix Puerariae ministerial drug, Radix Notoginseng is adjuvant drug.Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, Rhizoma Coptidis heat-clearing and toxic substances removing, Radix Salviae Miltiorrhizae are one of atherosclerotic Chinese medicine of modal clinical treatment, and Rhizoma Coptidis has the antiatherogenic effect of many target spots.The pulse invigorating capsule side for the treatment of carotid arterial atherosclerosis control ischemia apoplexy has multicomponent, many target spots, multipath characteristics, atheromatous plaque is formed the integration with many target spots regulate effect.the pharmaceutical research that Radix Salviae Miltiorrhizae is relevant to Rhizoma Coptidis shows: main vivo effect composition has tanshinone ⅡA, salvianolic acid B, danshensu, protocatechualdehyde, berberine, ferulic acid etc., pass through antithrombotic, antiinflammatory, repair endothelial cell damage, blood fat reducing, improve microcirculation, suppress the formation of the inhibition new intimas such as vascular smooth muscle cell proliferation, bring into play antiatherogenic effect, all has simultaneously the effect that the operation vascular wound is promoted tissue repair, can prevent several stages of the early stage restenosis process of CEA postoperative, comprise thrombosis, inflammatory reaction, endothelium is repaired, vascular smooth muscle cell proliferation, the stages such as substrate formation.
Advantage of the present invention is: the pulse invigorating capsule for the treatment of carotid arterial atherosclerosis control ischemia apoplexy has multicomponent, many target spots, multipath characteristics, atheromatous plaque is formed the integration with many target spots regulate effect.It by antithrombotic, antiinflammatory, reparation endothelial cell damage, blood fat reducing, improve microcirculation, suppress the formation that vascular smooth muscle cell proliferation etc. suppresses new intimas, bring into play antiatherogenic effect, all has simultaneously the effect that the operation vascular wound is promoted tissue repair, can prevent several stages of the early stage restenosis process of CEA postoperative, comprise the stages such as thrombosis, inflammatory reaction, endothelium reparation, vascular smooth muscle cell proliferation, substrate formation.
The specific embodiment
At first will treat each composition that the carotid arterial atherosclerosis chemoprevention controls in the pulse invigorating capsule formula of ischemia apoplexy and be by weight percentage Radix Salviae Miltiorrhizae: Rhizoma Coptidis: Radix Puerariae: Radix Notoginseng powder=55%: 20%: 15%: 10% ratio feeding.
4 flavor Chinese medicines in the pulse invigorating capsule formula for the treatment of carotid arterial atherosclerosis control ischemia apoplexy respectively according to respectively the distinguish the flavor of concocting method of Chinese medicine of Pharmacopoeia of the People's Republic of China version First in 2010, are purified, the processing such as the process of preparing Chinese medicine.Cold drying 2 hours is with standby.Wherein be ground into fine powder after Radix Salviae Miltiorrhizae, Rhizoma Coptidis, Radix Puerariae 3 flavor Chinese medicine mixings, cross 100 mesh sieves, standby.The Radix Notoginseng mixing dries and is ground into middle powder, crosses 80 mesh sieves, and is by the weighing of equivalent incremental method mixing, standby with above-mentioned 3 flavor medicines.
With above-mentioned four flavor Chinese medicines, add 10 times of water, decocting time is 120 minutes, decocting number of times is 1 time, obtains filtrate, is placed in the evaporating dish of constant weight, water bath method, residue takes out in 105 ℃ of dryings 3 hours, is placed in exsiccator and places 30 minutes, makes dry extract.
Above-mentioned dry powder is mixed with dry extract, adopt and to shake formula granulator, granulate, semi-automatic capsule-filling agent is during filling incapsulates, the radiation sterilization of packing, 60C0 machine, after the assay was approved and get final product.
Claims (2)
1. treat the pulse invigorating capsule that carotid arterial atherosclerosis is prevented and treated ischemia apoplexy for one kind, it is characterized in that: it is comprised of Radix Salviae Miltiorrhizae, Rhizoma Coptidis, Radix Puerariae, Radix Notoginseng 4 flavor Chinese medicines, and in formula, the percentage by weight of each composition is Radix Salviae Miltiorrhizae: Rhizoma Coptidis: Radix Puerariae: Radix Notoginseng powder=50%-55%: 15%-20%: 15%-20%: 5%-10%.
2. a kind of pulse invigorating capsule for the treatment of carotid arterial atherosclerosis control ischemia apoplexy according to claim 1, it is characterized in that: in formula, the optimum weight percentage ratio of each composition is Radix Salviae Miltiorrhizae: Rhizoma Coptidis: Radix Puerariae: Radix Notoginseng powder=55%: 20%: 15%: 10%.
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Application publication date: 20130626 |