CN100496481C - Medicinal composition for treating cardio-cerebral-vascular disease and its preparing method - Google Patents
Medicinal composition for treating cardio-cerebral-vascular disease and its preparing method Download PDFInfo
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- CN100496481C CN100496481C CNB200610026793XA CN200610026793A CN100496481C CN 100496481 C CN100496481 C CN 100496481C CN B200610026793X A CNB200610026793X A CN B200610026793XA CN 200610026793 A CN200610026793 A CN 200610026793A CN 100496481 C CN100496481 C CN 100496481C
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Abstract
The present invention relates to a medicine composition for curing angiocardiopathy and cerebrovascular diseases. It is characterized by that the weight ratio of hydroxycarthamus uranidin A and ferulaic acid is 1:0.5-1:5. The invented medicine composition and medicinal auxiliary material can be made into various oral preparations, such as tablet, capsule, dripping pills, oral liquior and injection, etc.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof, belong to the pharmaceutical technology field.
Background technology
In recent years, the cardiovascular and cerebrovascular disease health problem that become international.The World Health Organization's report in 2000, it is main cause that the whole world is died from apoplexy and myocardial infarction, the death toll that cardiovascular and cerebrovascular disease causes reaches 1,700 ten thousand, accounts for 1/3rd of all former cause deaths.In China, along with the raising of living standards of the people, the change of life style and the quickening of rhythm of life, the death toll of China's cardiovascular and cerebrovascular disease has accounted for 1/3 of total death toll.China dies from more than 300 ten thousand people that have of cardiovascular and cerebrovascular disease every year, and the ill people who survives 75% disability to some extent, 4% is heavy residual.The cardiovascular and cerebrovascular disease M ﹠ M is in rising trend in the world wide, becomes to threaten human life and healthy " No.1 killer ".The traditional Chinese medicine and pharmacy of China is with its determined curative effect, and the advantage that toxic and side effects is little is used for the treatment of cardiovascular and cerebrovascular disease clinically, has brought into play distinctive effect.Chinese medicine needs modernization, needs determined curative effect, and active ingredient is clear and definite, the content height, quality controllable, taking dose is little, toxic and side effects little Chinese medicine preparation.
Flos Carthami has the effect of promoting blood circulation to restore menstrual flow, blood stasis removing pain relieving in China cultivation and the medication history in existing more than 2100 year, is traditional blood-activating stasis-removing kind Chinese medicine.Flos Carthami mainly contains effective ingredient such as Carthamus yellow, carthamin, safflower red pigment.S-A Hydroxysafflor yellow A (hydroxysafflor yellow A) is the chemical compound with single chalcone glycoside structure, and molecular formula is C
27H
32O
16, be the most effective water soluble ingredient of Flos Carthami pharmacological effect, can suppress platelet aggregation and release that platelet activating factor brings out, can suppress combining of platelet activating factor and platelet receptor competitively, pharmacology and clinical research show for many years both at home and abroad: this composition has coronary artery dilator, anoxia enduring, improve the myocardial blood supply, bring high blood pressure down, blood vessel dilating improves the organ blood supply, anticoagulation, suppress thrombosis, blood fat reducing, multiple pharmacological effect such as antiinflammatory.Be used for the treatment of cardiovascular and cerebrovascular diseases such as coronary heart disease, angina pectoris, ischemia apoplexy.Ferulic acid (English Ferulic acid by name) is the effective ingredient that extracts from plurality of Chinese such as Radix Angelicae Sinensis, Rhizoma Chuanxiong, clinically its sodium salts of using more, claim that (molecular formula is C to sodium ferulate for English Sodium Ferulate by name, chemistry 3-methoxyl group by name-4-Hydroxycinnamic Acid sodium
10H
9O
4Na), have antiplatelet aggregation, suppress the platelet 5-hydroxy tryptamine and discharge, suppress the generation of the plain A2 of platelet thrombus (TXA2), strengthen pharmacological actions such as prostaglandin activity.In human body, have effects such as antithrombotic, anti-inflammatory and antalgic, antioxidation, free radical resisting.Clinical treatment coronary heart disease, cerebrovascular, vasculitis and the diseases such as leukocyte and thrombocytopenia of being mainly used in.
The medicine of existing clinically at present hydroxyl carthamin yellow A-containing respectively and sodium ferulate (or ferulic acid) is used for the treatment of cardiovascular and cerebrovascular diseases such as coronary heart disease, angina pectoris and apoplexy.But because cardiovascular and cerebrovascular disease belongs to multifactor complexity disease, the single medicine pharmacological action of composition is comprehensive inadequately, and clinical comprehensive therapeutic effect is not ideal enough.
Summary of the invention
The purpose of this invention is to provide a kind of pharmacological action cooperative compensating that contains, effective ingredient is clear and definite, the content height, and rapid-action, quality controllable, taking dose is little, pharmaceutical composition of the treatment cardiovascular and cerebrovascular disease of determined curative effect and preparation method thereof.
For realizing above purpose, technical scheme of the present invention provides a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease, it is characterized in that, weight ratio by S-A Hydroxysafflor yellow A and sodium ferulate or ferulic acid is that 1:0.5-1:5 compatibility is formed, and makes tablet, capsule, drop pill, injection and freeze-dried powder.
A kind of preparation of drug combination method for the treatment of cardiovascular and cerebrovascular disease, it comprises the following steps:
A) by weight take by weighing respectively S-A Hydroxysafflor yellow A and sodium ferulate or ferulic acid mix, pulverize mixed material;
B) in the mixed material of step a), adding is the medical starch of 1:1-1:4 with the mixed material weight ratio, the sodium carboxymethyl cellulose of 1:0.1-1:0.8, and the magnesium stearate of 1:0.01-1:0.1, mix homogeneously, tabletting promptly gets tablet;
C) in the mixed material of step a), adding is the medical starch of 1:1-1:2 with the mixed material weight ratio, the lactose of 1:0.2-1:1,1:0.1 the sodium carboxymethyl cellulose of-1:0.8, the magnesium stearate of 1:0.01-1:0.1, mix homogeneously, record capsule, promptly get capsule;
D) in the mixed material of step a), add drop pill substrate polyethylene glycol 6000 by weight 1:1-1:5, heating and melting, temperature is 80-95 ℃, stirs, and moves into the drop pill machine, is that coolant drips system with the simethicone, promptly gets drop pill;
E) in the mixed material of step a), the sodium chloride that adds total preparation amount 0.9%g/v, the water for injection that adds total preparation amount 30%-80%v/v, regulate PH to 7.0-8.0 with 35-45% sodium hydroxide solution, stirring makes abundant dissolving, adds water for injection to preparation amount, with filtering with microporous membrane, packing promptly gets injection;
F) in the mixed material of step a), the mannitol that adds total preparation amount 0.1%-5% (g/v) adds total preparation amount 30%-80%v/v water for injection, regulates PH to 7.0-8.0 with the 35-45% sodium hydroxide solution, stirring makes abundant dissolving, add water for injection to preparation amount, with filtering with microporous membrane, filtrate is sub-packed in the cillin bottle, vacuum lyophilization, gland, the envelope aluminium lid promptly gets the injection freeze-dried powder.
The object of the invention provides a kind of pharmaceutical composition of being made up of S-A Hydroxysafflor yellow A and sodium ferulate (or ferulic acid), two kinds of effective ingredient that contain the pharmacological action cooperative compensating, pharmacological action is comprehensive, clinical comprehensive therapeutic effect is good, the active constituent content height, rapid-action, quality controllable, taking dose is little, determined curative effect.Animal experiment shows that this pharmaceutical composition obviously is better than single S-A Hydroxysafflor yellow A and single sodium ferulate (or ferulic acid) to the multinomial pharmacodynamics index of angina pectoris and apoplexy animal model, and side effect is little.On this basis, the present invention also will further provide with its peroral dosage form that is used for the treatment of angina pectoris and ischemia apoplexy and injection type as effective medicinal ingredient.
Pharmaceutical composition of the present invention, effective medicinal ingredient S-A Hydroxysafflor yellow A wherein is orange-yellow powder, and flavor is slightly pained, and nothing is smelt, and is soluble in water, is soluble in methanol, slightly is dissolved in ethanol, the atomic acetone that is dissolved in.This composition can directly adopt the pure product of S-A Hydroxysafflor yellow A monomer, also can be substituted existing commercial goods by the plant extract that contains S-A Hydroxysafflor yellow A content 〉=70% that extraction separation obtains in the medical material such as natural drug Flos Carthami.
Pharmaceutical composition of the present invention, wherein effective medicinal ingredient sodium ferulate or ferulic acid, the two can be by the mode of full chemosynthesis, or obtain by the approach of other related compound through chemical improvement and/or modification, the pure product of monomer that also can adopt natural medicinal raw material Radix Angelicae Sinensis, Rhizoma Chuanxiong etc. to obtain through extraction separation, can also substitute existing commercial goods by the plant extract of sodium ferulate or ferulaic acid content 〉=70%.
Advantage of the present invention is that active ingredient is clear and definite, the content height, and rapid-action, quality controllable, taking dose is little, determined curative effect.
The specific embodiment
The invention will be further described below in conjunction with embodiment.
Auxiliary adding ingredients such as corresponding pharmaceutic adjuvant of acceptable or carrier also by corresponding pharmaceutical methods processing, can become corresponding oral drug preparation and injection medicine preparation in pharmaceutical composition of the present invention and the medicine.As tablet, capsule, drop pill, granule, oral liquid, injection, slow releasing preparation, controlled release preparation.Oral formulations contain commonly used can received auxiliary adding ingredient, as binding agent, filler, diluent, disintegrating agent, lubricant, flavoring agent etc., can carry out coating to tablet, drop pill etc. in case of necessity.With ejection preparation in can received solvent for injection, auxiliary adding ingredients commonly used such as buffer agent, additives, handle by corresponding common process method, make injection, injection freeze-dried powder, infusion preparation.
The specific embodiment of form is further described foregoing of the present invention again by the following examples, but is not limited to the scope of following examples.All under technological thought of the present invention inspires, various modifications, replacement and change with ordinary skill knowledge and process are made include in the present invention.
Embodiment 1:
Get S-A Hydroxysafflor yellow A 30g, sodium ferulate 30g, supplementary product starch 80g, sodium carboxymethyl cellulose 20g, magnesium stearate 3g respectively, mix homogeneously is granulated, and is pressed into 1000, promptly gets oral tablet.
Embodiment 2:
Get S-A Hydroxysafflor yellow A 10g, sodium ferulate 30g, starch 70g, lactose 10g, carboxymethyl cellulose 5g, magnesium stearate 2g respectively, mix homogeneously, 1000 in dress glue capsule promptly gets oral capsule.
Embodiment 3:
Get S-A Hydroxysafflor yellow A 5g, sodium ferulate 20g respectively, mix, pulverize, cross 100 mesh sieves, add polyethylene glycol 6000 substrate 50g, heating and melting, temperature is 80-90 ℃, stirs, move into the drop pill machine, with the simethicone is that coolant drips system, makes 1000 of drop pill, promptly gets the oral administration dripping pill agent.
Embodiment 4:
Get S-A Hydroxysafflor yellow A 2g, sodium ferulate 10g, sodium chloride 9g respectively, add water for injection 800ml, regulate PH to 7.0-8.0 with 40% sodium hydroxide solution, stirring makes abundant dissolving, adds water for injection to 1000ml, with filtering with microporous membrane, packing, every 5ml promptly gets injection.
Embodiment 5:
Get S-A Hydroxysafflor yellow A 20g, sodium ferulate 20g, mannitol 20g respectively, add water for injection 400ml, regulate PH to 7.0-8.0, stir and make abundant dissolving with 40% sodium hydroxide solution, add water for injection to 1000ml, with filtering with microporous membrane, filtrate is sub-packed in the cillin bottle, every bottle of 1ml, vacuum lyophilization, gland, the envelope aluminium lid promptly gets the injection freeze-dried powder.
Embodiment 6:
Get S-A Hydroxysafflor yellow A content respectively and be 72% Flos Carthami extract 40g, sodium ferulate content are 70% Radix Angelicae Sinensis extract 150g, carboxymethyl cellulose 50g, magnesium stearate 4g, mix homogeneously, 1000 in dress glue capsule promptly gets oral capsule.
With S-A Hydroxysafflor yellow A and sodium ferulate weight ratio is that 1:2 makes test specimen, carries out following pharmacological toxicology test.
One, acute toxicity test
Get 20 of Kunming mouses, once irritating the stomach maximum dosage-feeding is 6.90g/kg (being equivalent to intend clinical every day about 300 times of recommended dose).Observed 7 days continuously, do not see animal dead.The outward appearance of animal, behavioral activity, the mental status, defecation, breathing, nose, eye, oral secretion etc. there is no unusually, dissect naked eyes during off-test and do not see the obvious pathological change of internal organs, show that pharmaceutical composition of the present invention does not have overt toxicity.
Two, pharmacological testing
With S-A Hydroxysafflor yellow A of the present invention and sodium ferulate weight ratio is that 1:2 makes test specimen, carry out pharmacodynamics test to the multinomial pharmacodynamics index of angina pectoris and ischemia apoplexy animal model, and with single S-A Hydroxysafflor yellow A and single sodium ferulate in contrast sample compare test, with proof pharmaceutical composition of the present invention in the effect aspect the treatment cardiovascular and cerebrovascular disease.
Test of the influence of 1. pharmaceutical compositions of the present invention to the experimental rat cerebral ischemia
Get 60 of Wistar kind male rats, be divided into 6 groups at random: sham operated rats (normal saline), cerebral ischemic model matched group (normal saline), S-A Hydroxysafflor yellow A group (50mg/kg), sodium ferulate group (100mg/kg), pharmaceutical composition low dose group (S-A Hydroxysafflor yellow A 15mg/kg+ sodium ferulate 30mg/kg), pharmaceutical composition high dose group (S-A Hydroxysafflor yellow A 30mg/kg+ sodium ferulate 60mg/kg), 10 every group.Gastric infusion, once a day, continuous 7 days.After the last administration 1 hour, with 24% chloral hydrate (350mg/kg, ip) anesthesia, the cervical region median incision separates and ligation bilateral neck common carotid artery forms acute imperfection cerebral ischemia, break end fast behind the 3h and get brain, it is heavy to take by weighing full cutaneous horn, puts drying baker and is dried to constant weight for interior 105 ℃, calculates brain water content.
Table 1 medicine group is to the influence of the experimental rat cerebral ischemia brain water yield (χ ± SD)
Annotate: compare with model group
*P＜0.05,
*P＜0.01; Compare Δ P＜0.05, Δ Δ P＜0.01 with sham operated rats.
From the experimental result of table 1 as can be seen, pharmaceutical composition group of the present invention causes cerebral edema to the rat bilateral ligation significant inhibitory effect, obviously is better than single S-A Hydroxysafflor yellow A group or single sodium ferulate group.
The influence of 2. pairs of experimental rat myocardial damages of test
Get 60 of Wistar kind male rats, be divided into 6 groups at random: sham operated rats (normal saline), model control group (normal saline), S-A Hydroxysafflor yellow A group (50mg/kg), sodium ferulate group (100mg/kg), pharmaceutical composition low dose group (S-A Hydroxysafflor yellow A 15mg/kg+ sodium ferulate 30mg/kg), pharmaceutical composition high dose group (S-A Hydroxysafflor yellow A 30mg/kg+ sodium ferulate 60mg/kg), 10 every group.Gastric infusion, once a day, for three days on end.After the last administration 1 hour, with pentobarbital anesthesia, tracheal intubation, artificial respiration.In between the 2nd～3 rib, open breast,, cause occlusive arteria coronaria district myocardial infarction apart from coronary artery outlet 5mm place's ligation left anterior descending coronary artery.Behind 4h, use the electromagnetic flowmeter determination coronary artery blood flow, open breast then and take out heart,, cut off atrium and each trunk, the ventricular weight of weighing along coronary sulcus with normal saline flushing remainder blood.Ventricular muscles is cut into the thick myocardium sheet of 0.1cm, puts in the NBT dyeing liquor, dyeing is 10 minutes in 37 ℃ of waters bath with thermostatic control, and infarct is not painted, and non-infarct is dyed by NBT and is blueness.Cut off the nonstandard infarct cardiac muscle that each myocardium sheet is colored, undyed infarcted myocardium is weighed, calculate the percentage rate that infarct accounts for the ventricle gross weight.The results are shown in Table 2.
Table 2 pharmaceutical composition is to the influence of experimental rat myocardial damage (χ ± SD)
Annotate: compare with model control group
*P＜0.05,
*P＜0.01; Compare Δ P＜0.05, Δ Δ P＜0.01 with Sham-operated control group.
By experimental result as can be known, the myocardial ischemia situation that pharmaceutical composition of the present invention causes coronary occlusion,
Can significantly increase coronary flow, and obviously reduce myocardial infarction area weight, obviously be better than single S-A Hydroxysafflor yellow A group or single sodium ferulate group.
Test the influence that 3. pairs of experimental rat thrombus in vivo form
Get 50 random packet of Wistar rat, be respectively matched group (normal saline), S-A Hydroxysafflor yellow A group (50mg/kg), sodium ferulate group (100mg/kg), pharmaceutical composition low dose group (S-A Hydroxysafflor yellow A 15mg/kg+ sodium ferulate 30mg/kg), pharmaceutical composition high dose group (S-A Hydroxysafflor yellow A 30mg/kg+ sodium ferulate 60mg/kg), 10 every group.Gastric infusion, after 1 hour, lumbar injection pentobarbital sodium 45mg/kg anesthesia cutting one side common carotid artery, form on the analyzer at experimental thrombus in vivo, with 2mA galvanism blood vessel wall 7min, by temperature sensor monitors blood vessel surface variations in temperature, record thrombus formation time, result of the test sees Table 3 simultaneously
The thrombotic influence of table 3 pair rat experiment (χ ± SD)
Annotate: compare with the normal saline matched group:
*P＜0.05;
*P＜0.01
By table 3 as seen, pharmaceutical composition of the present invention can significantly delay the formation of animal thrombosis, thrombus formation time illustrates that than S-A Hydroxysafflor yellow A group and the equal significant prolongation of sodium ferulate group the antithrombotic pharmacology effect of pharmaceutical composition of the present invention is better than single S-A Hydroxysafflor yellow A and single sodium ferulate.
Test 4. antiplatelet aggregative activities
With 50 random packet of Wistar rat, matched group (normal saline), S-A Hydroxysafflor yellow A group (50mg/kg), sodium ferulate group (100mg/kg), pharmaceutical composition low dose group (S-A Hydroxysafflor yellow A 15mg/kg+ sodium ferulate 30mg/kg), pharmaceutical composition high dose group (S-A Hydroxysafflor yellow A 30mg/kg+ sodium ferulate 60mg/kg), 10 every group.Gastric infusion, once a day, successive administration 3 days, after the last administration 1 hour, blood was got in docking, anticoagulant adopts 3.8% sodium citrate, with blood with the 1:9 mixed.Well-established law prepares platelet rich plasma (PRP) and platelet poor plasma (PPP).Concentration so that PPP regulates PRP makes each PRP concentration identical.PRP after the preheating, is added AA (arachidonic acid) 10ul (0.5mmol/L) respectively in 37 ℃ temperature chamber, cause platelet aggregation, rating model matched group and each medicine group are to the accumulative influence of AA induced platelet.
Table 4 antiplatelet aggregative activity (χ ± SD)
Annotate: compare with matched group:
*P＜0.05;
*P＜0.01
By table 4 experimental result as seen, pharmaceutical composition group of the present invention is anticoagulant significantly, and maximum agglutination rate and gathering suppression ratio all significantly are better than single S-A Hydroxysafflor yellow A group and single sodium ferulate group.The platelet aggregation inhibitor reason effect that pharmaceutical composition of the present invention is described is better than single S-A Hydroxysafflor yellow A and single sodium ferulate.
Claims (4)
1. a pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease is characterized in that, is that 1:0.5-1:5 compatibility is formed by the weight ratio of S-A Hydroxysafflor yellow A and sodium ferulate or ferulic acid, makes tablet, capsule, drop pill, injection and freeze-dried powder.
2. a kind of preparation of drug combination method for the treatment of cardiovascular and cerebrovascular disease according to claim 1, it comprises the following steps:
A) by weight take by weighing respectively S-A Hydroxysafflor yellow A and sodium ferulate or ferulic acid mix, pulverize mixed material;
B) in the mixed material of step a), adding is the medical starch of 1:1-1:4 with the mixed material weight ratio, the sodium carboxymethyl cellulose of 1:0.1-1:0.8, and the magnesium stearate of 1:0.01-1:0.1, mix homogeneously, tabletting promptly gets tablet;
C) in the mixed material of step a), adding is the medical starch of 1:1-1:2 with the mixed material weight ratio, the lactose of 1:0.2-1:1,1:0.1 the sodium carboxymethyl cellulose of-1:0.8, the magnesium stearate of 1:0.01-1:0.1, mix homogeneously, record capsule, promptly get capsule;
D) in the mixed material of step a), add drop pill substrate polyethylene glycol 6000 by weight 1:1-1:5, heating and melting, temperature is 80-95 ℃, stirs, and moves into the drop pill machine, is that coolant drips system with the simethicone, promptly gets drop pill;
E) in the mixed material of step a), the sodium chloride that adds total preparation amount 0.9%g/v, the water for injection that adds total preparation amount 30%-80%v/v, regulate PH to 7.0-8.0 with 35-45% sodium hydroxide solution, stirring makes abundant dissolving, adds water for injection to preparation amount, with filtering with microporous membrane, packing promptly gets injection;
F) in the mixed material of step a), the mannitol that adds total preparation amount 0.1%-5%g/v adds the water for injection of total preparation amount 30%-80%v/v, regulates PH to 7.0-8.0 with 35-45% sodium hydroxide solution, stirring makes abundant dissolving, add water for injection to preparation amount, with filtering with microporous membrane, filtrate is sub-packed in the cillin bottle, vacuum lyophilization, gland, the envelope aluminium lid promptly gets the injection freeze-dried powder.
3. a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease according to claim 1 is characterized in that, S-A Hydroxysafflor yellow A is wherein substituted by the plant extract of S-A Hydroxysafflor yellow A content 〉=70%.
4. a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease according to claim 1 is characterized in that, sodium ferulate wherein or ferulic acid are substituted by the plant extract or the synthetic product of sodium ferulate or ferulaic acid content 〉=70%.
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| CN103127197B (en) * | 2013-03-21 | 2015-02-18 | 悦康药业集团有限公司 | Preparation method of freeze-drying preparation for safflower yellow injection |
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