CN102145050A - Application of traditional Chinese medicine composition for preparing drugs for preventing and treating post percutaneous coronary intervention (PCI) no-reflow - Google Patents

Abstract

The invention discloses application of a traditional Chinese medicine composition for preparing drugs for preventing and treating acute myocardial infarction post percutaneous coronary intervention (PCI) no-reflow, wherein the traditional Chinese medicine composition of the invention comprises ginseng, leech, centipede, scorpio, ground beeltle, cicada slough, root of common peony, borneol and the like, and has effects of tonifying qi, invigorating the circulation of blood, eliminating blood stasis and dredging collateral. The clinical study shows that the traditional Chinese medicine composition in the invention can treat and prevent the acute myocardial infarction post PCI no-reflow.

Description

A kind of Chinese medicine composition does not have application in the medicine of stream at preparation control PCI postoperative again

Technical field

The present invention relates to a kind of new purposes of Chinese medicine composition, particularly, the present invention relates to a kind of Chinese medicine composition does not have application in the medicine of stream at preparation prevention and treatment acute myocardial infarction PCI postoperative again, belongs to the Chinese medicine application.

Background technology

Acute myocardial infarction (Acute Myocardial Infarction, AMI) morbidity is dangerous, the case fatality rate height, mainly be because due to the acute thrombotic obturation of coronary artery of supply cardiac muscle, thereby to its carry out arteria coronaria again extensively treating treat and to comprise that thrombolytic or emergency treatment arteria coronaria get involved (PCI, balloon expandable+Stent) is primary treatment measure, with the perfusion again that recovers coronary blood flow and cardiac muscular tissue [Gersh BJ, Optimalmanagement of acute myocardial infarction at the down of the next millennium.Am Heart J.1999; 138 (2pt2): 188-202.].Since the percutaneous puncture radial artery carried out coronary artery sacculus plasty and stent endoprosthesis success first, later trans-radial approach carries out the superiority of percutaneous coronary intervention (PCI) to be familiar with by increasing heart intervention doctor gradually.Through clinical practice for many years, the success rate that the trans-radial approach carries out PCI greatly improves, and becomes the first-selected approach that interventional therapy is carried out at many hearts center, and has obtained the approval of extensive patients.But Ito uses myocardium acoustic contrast (MCE) to discover, after the logical again recovery blood of AMI arteria coronaria supplies, cardiac muscular tissue pours into and not exclusively even do not have a perfusion more again, be called (no-reflow phenomenon) [the Ito H that do not have again flow phenomenon, MaruyamaA, Iwakura K, et al.Clinical implications of the ' no-reflow ' phenomenon:apredictor of complications and left ventricular remodeling in perfused anteriorwall myocardial infarction.Circulation.1996; 93:223-228.].Do not have again stream usually with relevant [the Ito H of increase of severe complications such as extensive and serious cardiac damage, progressive left chamber expansion and congestive heart failure, Tomooka T, Sakai N, et al.Lack of myocardial perfusionimmediately after successful thrombolysis:a predictor of poor recovery of leftventricular function in anterior myocardial infarction.Circulation.1992; 85:1699-1705.], become the current AMI reperfusion as treatment epoch can not realize the main cause and the biggest obstacle of " cardiac muscle pours into effectively again ", also be a great problem of the international painstaking effort of current puzzlement area within a jurisdiction.

Though it is unclear fully that generation does not have the mechanism of flow phenomenon again, yet it is because the blood capillary level is stopped up, due to can not pouring at all.Concrete mechanism comprises [Reffelmann T, Kloner RA.The " no-reflow " phenomenon:basic science and clinical correlatesHeart.2002Feb such as blood capillary spasm, microthrombusis, thromboembolism, structural deterioration and reperfusion injury, platelet activation and inflammatory cell infiltration; 87 (2): 162-8.].In recent years, the measure of stream mainly contains at not having again behind the above-mentioned mechanism prevention AMI reperfusion as treatment in the world: (1) uses distal protection device, thrombosis and speckle rotary-cut and sucking-off technology in the AMI emergency PCI, the blood capillary thromboembolism [8-10] after the guard key arteria coronaria is logical again; (2) use platelet II b/IIIa receptor antagonist abciximab (Reopro) or for Luo Fei speckle (Tilofiban) [Montalescot G, Barragan P, Wittenberg O, et al.Plateletglycoprotein IIb/IIIa inhibitionwith coronary steting for acute myocardialinfarction.N Engl J Med.2001; 344:1895-1903.], prevent microvascular thrombosis and thromboembolism by antiplatelet; And (3) use vasodilation such as calcium antagonist, adenosine (Adenosine) and KATP channel opener nicorandil (nicorandil) [Ito H, Taniyama Y, Iwakura K, etal.Intravenous nicorandil can preserve microvascular integrity and myocardialviability in patients with reperfused anterior wall myocardial infarction.J AmColl Cardiol.1999; 33:654-60.], keypoint control blood capillary spasm.Though these measures demonstrate certain curative effect, breakthrough is not arranged all.And we find in the research to pig AMI re-perfusion model, as the index that can reflect microvascular endothelial 26S Proteasome Structure and Function integrity, (β, γ-catenin), its expression have a significant dependency [17-18] with what AMI poured into that the back do not have stream again again for blood vessel endothelium cadherin (VE-cadherin), β and γ catenin.Still to imagine the damage of microvessel structure and functional completeness or destroy may be to produce not have the core mechanism of stream again, do not have the key of stream again and protect microvascular 26S Proteasome Structure and Function integrity to be only control.Yet correlational study is few in the world, also untappedly so far goes out the specific medicament that myocardium microvessel structure and functional completeness is had protective effect.

The present invention is the improvement invention of carrying out on the basis of No. 01131203.3 and No. 200410048292.2 patent, quotes in full the content of this two patent documents record at this.Unexposed this Chinese medicine composition of above-mentioned two patents does not have application in the medicine of stream at prevention and treatment acute myocardial infarction PCI postoperative again.

Summary of the invention

The object of the invention provides a kind of Chinese medicine composition does not have application in the medicine of stream at preparation prevention and treatment acute myocardial infarction PCI postoperative again, and described Chinese medicine composition is made by following bulk drugs:

Radix Ginseng 3-10 Hirudo 3-11 Eupolyphaga Seu Steleophaga 5-10 Olibanum (system) 1-5 Radix Paeoniae Rubra 3-9 Lignum Dalbergiae Odoriferae 1-5

Lignum Santali Albi 1-5 Scorpio 3-9 Periostracum Cicadae 3-12 Scolopendra 1-3 Borneolum Syntheticum 1-7 Semen Ziziphi Spinosae (stir-fry) 3-10;

Preferably, this Chinese medicine composition is made by following bulk drugs:

Radix Ginseng 6 Hirudo 10 Eupolyphaga Seu Steleophagas, 7 Olibanums (system) 2 Radix Paeoniae Rubra 5 Lignum Dalbergiae Odoriferaes 2

Lignum Santali Albi 2 Scorpios 7 Periostracum Cicadaes 7 Scolopendra 1 Borneolum Syntheticum, 5 Semen Ziziphi Spinosaes (stir-fry) 5;

Or:

Radix Ginseng 10 Hirudo 8 Eupolyphaga Seu Steleophagas, 7 Olibanums (system) 2 Radix Paeoniae Rubra 5 Lignum Dalbergiae Odoriferaes 2

Lignum Santali Albi 2 Scorpios 9 Periostracum Cicadaes 7 Scolopendra 1 Borneolum Syntheticum, 5 Semen Ziziphi Spinosaes (stir-fry) 5;

Or:

Radix Ginseng 6 Hirudo 11 Eupolyphaga Seu Steleophagas, 7 Olibanums (system) 2 Radix Paeoniae Rubra 5 Lignum Dalbergiae Odoriferaes 2

Lignum Santali Albi 2 Scorpios 3 Periostracum Cicadaes 7 Scolopendra 1 Borneolum Syntheticum, 5 Semen Ziziphi Spinosaes (stir-fry) 5;

More preferably, the active component of above-mentioned Chinese medicine composition is made up of following ingredients:

The a mean diameter is less than Scorpio, Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga, Periostracum Cicadae and the Olibanum (processed) medicated powder of 100 μ m;

B Borneolum Syntheticum medicated powder;

The volatile oil that c is extracted by Lignum Dalbergiae Odoriferae and Lignum Santali Albi;

The alcohol-extracted extract of the alcohol extract of d Radix Ginseng after after concentrating with ethanol extraction;

The water extracted immersing paste that is condensed into behind the water extract after the Lignum Dalbergiae Odoriferae behind the e extraction composition c and water extract, Radix Paeoniae Rubra and the Semen Ziziphi Spinosae (parched) of Lignum Santali Albi medicinal residues decoct with water and the water extract filtration of the medicine residues of Radix Ginseng after the extraction ingredient d, the mixing.

The invention also discloses that to contain above-mentioned Chinese medicine composition be capsule, tablet, granule, powder, oral liquid or pill as the pharmaceutical preparation of active component.

In the Chinese medicine composition of the present invention, as the latin name of the crude drug of active component and processing method thereof from " Chinese medicine voluminous dictionary " (in July, 1977, front page, Shanghai science tech publishing house) and " Chinese pharmacopoeia (version in 2005, Chemical Industry Press).

Chinese medicine composition of the present invention can also be routinely extraction and preparation process, for example, the preparation technology of Fan Biting " pharmacy of Chinese materia medica " (Shanghai Science Press 1997 December the 1st edition) record, make the acceptable any conventional dosage form of pharmaceutics, for example capsule, tablet, granule, powder, oral liquid or pill etc.

In the application of the present invention, described Chinese medicine composition is capsule, tablet, granule, powder, oral liquid or pill, for above-mentioned dosage form can be realized, need when these dosage forms of preparation, to add the pharmacy acceptable auxiliary, for example: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, fixed, the Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods of acetic acid chloroethene; Substrate comprises: PEG6000, PEG4000, insect wax etc.

Capsule of the present invention is preferably made by following preparation method: five kinds of Chinese medicine such as the Hirudo of said ratio, Scorpio, Periostracum Cicadae, Eupolyphaga Seu Steleophaga, Scolopendra cleaned, and oven drying at low temperature, standby; Lignum Santali Albi, Lignum Dalbergiae Odoriferae extract volatile oil, and medicinal residues and aqueous solution are standby; Radix Ginseng extracts secondary with 70% alcohol heating reflux, and 3 hours for the first time, 2 hours for the second time, merge extractive liquid, reclaimed ethanol to there not being the alcohol flavor; The medicinal residues of medicine residues of Radix Ginseng and Lignum Santali Albi, Lignum Dalbergiae Odoriferae merge with aqueous solution, add Radix Paeoniae Rubra, Semen Ziziphi Spinosae (stir-fry), decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.20-1.25 (60 ℃), add above-mentioned panaxynol extract, mixing, cold drying is ground into fine powder; The five tastes such as Olibanum (system) and Hirudo are ground into fine powder altogether; The Borneolum Syntheticum porphyrize, with above-mentioned fine powder facing-up, mixing sprays into volatile oil respectively, and mixing incapsulates, promptly.

Perhaps, capsule of the present invention is preferably made by following preparation method:

A) weight ratio of crude drug is: Radix Ginseng 3-10 part, Hirudo 3-11 part, Eupolyphaga Seu Steleophaga 5-10 part, Olibanum (processed) 1-5 part, Radix Paeoniae Rubra 3-9 part, Lignum Dalbergiae Odoriferae 1-5 part, Lignum Santali Albi 1-5 part, Scorpio 3-9 part, Periostracum Cicadae 3-12 part, Scolopendra 1-3 part, Borneolum Syntheticum 1-7 part, Semen Ziziphi Spinosae (parched) 3-10 part;

B) pulverizing medicinal materials technology:

Scorpio, Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga and five kinds of worm medicines of Periostracum Cicadae are prepared burden by prescription through the Olibanum (processed) that cleans, washes after handling the back and cleaning the process of preparing Chinese medicine, pulverized by pulverizer, the medicated powder fineness reaches more than 80 orders; Medicated powder behind the coarse powder carries out micronizing through various superfine communication techniques, makes the medicated powder mean diameter less than 100 μ m; Medical material to be pulverized is prepared burden after the cleaning, drying sterilization;

C) extract concentrated and drying process:

Reuse water extraction behind Lignum Dalbergiae Odoriferae and the Lignum Santali Albi elder generation extracting in water volatile oil, Radix Paeoniae Rubra and Semen Ziziphi Spinosae decoct with water, after the water extract filters, extractum to be condensed into; Radix Ginseng with ethanol extraction after, reuse water extraction, alcohol extract are condensed into alcohol-extracted extract after reclaiming ethanol, the water extract filter with all water extract mixings after be condensed into the water extracted immersing paste;

D) preparation process:

In Fluidbedgranulatingdrier, add the superfine powder flour, again the step c) gained is extracted extractum and spray into granulation; The granule made through granulate, is added the Borneolum Syntheticum fine powder, spray into the volatile oil that extracts by Lignum Dalbergiae Odoriferae and Lignum Santali Albi, by the capsule filler filling, make capsule behind the mixing.

Perhaps, capsule of the present invention is preferably made by following preparation method:

A) weight ratio of crude drug is: Radix Ginseng 3-10 part, Hirudo 3-11 part, Eupolyphaga Seu Steleophaga 5-10 part, Olibanum (system) 1-5 part, Radix Paeoniae Rubra 3-9 part, Lignum Dalbergiae Odoriferae 1-5 part, Lignum Santali Albi 1-5 part, Scorpio 3-9 part, Periostracum Cicadae 3-12 part, Scolopendra 1-3 part, Borneolum Syntheticum 1-7 part, Semen Ziziphi Spinosae (parched) 3-10 part;

B) pulverizing medicinal materials technology:

Scorpio, Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga and five kinds of worm medicines of Periostracum Cicadae are prepared burden by prescription through the Olibanum (processed) that cleans, washes after handling the back and cleaning the process of preparing Chinese medicine, pulverized by pulverizer, the medicated powder fineness reaches more than 80 orders; Medicated powder behind the coarse powder carries out micronizing through various superfine communication techniques, makes the medicated powder mean diameter less than 100 μ m; Medical material to be pulverized is prepared burden after the cleaning, drying sterilization;

C) extract concentrated and drying process:

Reuse water extraction behind Lignum Dalbergiae Odoriferae and the Lignum Santali Albi elder generation extracting in water volatile oil, Radix Paeoniae Rubra and Semen Ziziphi Spinosae decoct with water, after the water extract filters, extractum to be condensed into; Radix Ginseng with ethanol extraction after, reuse water extraction, alcohol extract are condensed into alcohol-extracted extract after reclaiming ethanol, the water extract filter with all water extract mixings after be condensed into the water extracted immersing paste, extractum directly is spray dried to spray powder;

D) preparation process:

The superfine powder flour is added in the Fluidbedgranulatingdrier with step c) gained spray drying powder, sprays solvent again and make granule; The granule made through granulate, is added the Borneolum Syntheticum fine powder, spray into the volatile oil that extracts by Lignum Dalbergiae Odoriferae and Lignum Santali Albi, by the capsule filler filling, make capsule behind the mixing.

The consumption of pharmaceutical composition of the present invention is converted to the weight of raw medicinal material, is each 0.8-3 gram, and take 2-4 every day, is preferably each 1.11-2.22 and restrains, and takes every day three times.

The specific embodiment

Embodiment 1:

A) the crude drug prescription is:

Radix Ginseng 39.6g Hirudo 72.6g Eupolyphaga Seu Steleophaga 46.2g Olibanum (system) 13.2g

Radix Paeoniae Rubra 33g Lignum Dalbergiae Odoriferae 13.2g Lignum Santali Albi 13.2g Scorpio 19.8g

Periostracum Cicadae 46.2g Scolopendra 6.6g Borneolum Syntheticum 33g Semen Ziziphi Spinosae (stir-fry) 33g;

B) pulverizing medicinal materials technology:

Scorpio, Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga and five kinds of worm medicines of Periostracum Cicadae are prepared burden by prescription through the Olibanum (processed) that cleans, washes after handling the back and cleaning the process of preparing Chinese medicine, pulverized by pulverizer, the medicated powder fineness reaches more than 80 orders; Medicated powder behind the coarse powder carries out micronizing through various superfine communication techniques, makes the medicated powder mean diameter less than 30-40 μ m; Medical material to be pulverized is prepared burden after the cleaning, drying sterilization;

C) extract concentrated and drying process:

Reuse water extraction behind Lignum Dalbergiae Odoriferae and the Lignum Santali Albi elder generation extracting in water volatile oil, Radix Paeoniae Rubra and Semen Ziziphi Spinosae add suitable quantity of water and decoct secondary, and each 3 hours, merge the water extract, after the filtration, extractum to be condensed into; Radix Ginseng is with an amount of 70% ethanol extraction secondary, each 3 hours, merge extractive liquid,, reclaim ethanol to there not being the alcohol flavor, the reuse water extraction, it is 0.9～1.1 (60 ℃) alcohol-extracted extract that alcohol extract is condensed into relative density, is concentrated into the clear paste that relative density is 0.9～1.1 (60 ℃) behind the filtration of water extract and above-mentioned all water extract mixings, standby;

D) preparation process:

In Fluidbedgranulatingdrier, add the superfine powder flour, again the step c) gained is extracted extractum and spray into granulation; The granule made through granulate, is added the Borneolum Syntheticum fine powder, spray into the volatile oil that extracts by Lignum Dalbergiae Odoriferae and Lignum Santali Albi, by the capsule filler filling, make 1000 capsules behind the mixing.

Amount of drug of the present invention for each 2-4 grain, is taken three times every day.

Embodiment 2

A) the crude drug prescription is:

Radix Ginseng 66g Hirudo 52.8g Eupolyphaga Seu Steleophaga 46.2g Olibanum (system) 13.2g

Radix Paeoniae Rubra 33g Lignum Dalbergiae Odoriferae 13.2g Lignum Santali Albi 13.2g Scorpio 59.4g

Periostracum Cicadae 46.2g Scolopendra 6.6g Borneolum Syntheticum 33g Semen Ziziphi Spinosae (stir-fry) 33g

B) pulverizing medicinal materials technology:

Scorpio, Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga and five kinds of worm medicines of Periostracum Cicadae are prepared burden by prescription through the Olibanum (processed) that cleans, washes after handling the back and cleaning the process of preparing Chinese medicine, pulverized by pulverizer, the medicated powder fineness reaches more than 80 orders; Medicated powder behind the coarse powder carries out micronizing through various superfine communication techniques, makes the medicated powder mean diameter less than 70-90 μ m; Medical material to be pulverized is prepared burden after the cleaning, drying sterilization;

C) extract concentrated and drying process:

Reuse water extraction behind Lignum Dalbergiae Odoriferae and the Lignum Santali Albi elder generation extracting in water volatile oil, Radix Paeoniae Rubra and Semen Ziziphi Spinosae add suitable quantity of water and decoct secondary, and each 3 hours, merge the water extract, after the filtration, extractum to be condensed into; Radix Ginseng is with an amount of 70% ethanol extraction secondary, each 3 hours, merge extractive liquid,, reclaim ethanol to there not being the alcohol flavor, the reuse water extraction, alcohol extract is condensed into relative density and is determined as 1.0～1.05 alcohol-extracted extracts at 60 ℃, the water extract filter with above-mentioned all water extract mixings after be concentrated into 60 ℃ to measure relative densities be 1.0～1.1 clear paste, standby;

D) preparation process:

In Fluidbedgranulatingdrier, add the superfine powder flour, again the step c) gained is extracted extractum and spray into granulation; The granule made through granulate, is added the Borneolum Syntheticum fine powder, spray into the volatile oil that is extracted by Lignum Dalbergiae Odoriferae and Lignum Santali Albi, preparation process is pressed into 1000 routinely.

Amount of drug of the present invention for each 2-4 sheet, is taken three times every day.

Embodiment 3: the preparation of pill

A) the crude drug prescription is:

Radix Ginseng 39.6g Hirudo 66g Eupolyphaga Seu Steleophaga 46.2g Olibanum (system) 13.2g

Radix Paeoniae Rubra 33g Lignum Dalbergiae Odoriferae 13.2g Lignum Santali Albi 13.2g Scorpio 46.2g

Periostracum Cicadae 46.2g Scolopendra 6.6g Borneolum Syntheticum 33g Semen Ziziphi Spinosae (stir-fry) 33g

B) pulverizing medicinal materials technology:

Scorpio, Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga and five kinds of worm medicines of Periostracum Cicadae are prepared burden by prescription through the Olibanum (processed) that cleans, washes after handling the back and cleaning the process of preparing Chinese medicine, pulverized by pulverizer, the medicated powder fineness reaches more than 80 orders; Medicated powder behind the coarse powder carries out micronizing through various superfine communication techniques, makes medicated powder mean diameter 10-20 μ m; Medical material to be pulverized is prepared burden after the cleaning, drying sterilization;

C) extract concentrated and drying process:

Reuse water extraction behind Lignum Dalbergiae Odoriferae and the Lignum Santali Albi elder generation extracting in water volatile oil, Radix Paeoniae Rubra and Semen Ziziphi Spinosae add suitable quantity of water and decoct secondary, and each 3 hours, merge the water extract, after the filtration, extractum to be condensed into; Radix Ginseng is with an amount of 70% ethanol extraction secondary, each 3 hours, merge extractive liquid,, reclaim ethanol to there not being the alcohol flavor, the reuse water extraction, alcohol extract is condensed into 60 ℃, and to measure relative densities be 0.9～1.0 alcohol-extracted extract, the water extract filter with above-mentioned all water extract mixings after be concentrated into 60 ℃ to measure relative densities be 1.0～1.1 clear paste, standby;

D) preparation process:

Preparation process is made 1000 pills routinely.

Amount of drug of the present invention for each 2-4 grain, is taken three times every day.

For illustrating Chinese medicine composition of the present invention acute myocardial infarction PCI postoperative there are not the prevention and the therapeutical effect of stream again, carried out following clinical trial proving its curative effect with the capsule that makes by the foregoing description 1 method (to call medicine of the present invention in the following text), but it can not constitute any restriction to scope of the present invention.

Experimental example 1:

1 data and method

1.1 be subjected to the reagent thing

Medicine superfine powder capsule of the present invention: press embodiment 1 crude drug prescription and preparation technology preparation.

1.2 physical data

All cases all are selected from the patient that the section of ST first that mound outer cardiovascular diseases hospital in Beijing accepts for medical treatment is raised AMI and accepted the emergency treatment interventional therapy.The patient is divided into drug test group of the present invention (medicament capsule of the present invention+PCI art+conventional Western medicine group) 108 examples at random, matched group (placebo+PCI art+conventional Western medicine group) 111 examples.Raise aspect comparing difference not statistically significants (P＞0.05) such as amplitude in age, sex, blood pressure, history of past illness (angina pectoris, arrhythmia), Killip classification, ST section for two groups, have comparability.Coronary angiography is estimated before the PCI art effect assessment art and immediate postoperative TIMI blood flow classification difference not statistically significant (P＞0.05), shows two groups of baseline equilibriums of arteria coronaria myocardial revascularization, has comparability.

1.3 case is selected

Inclusion criteria: the sex patient in (1) age 18-75 year; (2) myocardial ischemia symptom 〉=30 minute; (3) outbreak of infarction chest pain is in 12 hours; (4) the ST section is at two or more limb leads rising 〉=0.Lmv; The ST section is at two or more precordial leadses rising 〉=0.2mv; (5) the Killip classification belongs to I-III level person; (6) be ready to accept remedial PCI person behind emergency PCI or the thrombolytic; (7) this research of voluntary participation, and signed Informed Consent Form.

Exclusion standard: (1) age is less than 18 years old or greater than 75 years old; (2) clear and definite old myocardial infarction medical history is arranged; (3) accepted emergency treatment thromboembolism treatment and be reluctant row coronary angiography evaluation and remedial PCI person; (4) the cardio-pulmonary resuscitation person of wound, long-time (greater than 20 minutes) is arranged; (5) clear and definite mechanical complication, cardiogenic shock or unmanageable malignant arrhythmia are arranged; (6) serious liver, renal insufficiency person; (7) gastrointestinal tract and urogenital system bleeder are arranged in all around; (8) still have the active hemorrhage or the known hemorrhage body constitution (comprising menstrual phase) at any position at present; (9) seriously hemostasis and coagulation disorders, or using the anticoagulant medicine (as warfarin) of therapeutic dose; (10) allergic constitution or to this research ingredient allergy sufferers is arranged; (11) gestation or women breast-feeding their children; (12) previous month interior patient who participates in other Chinese medicine clinical researches of morbidity; (13) suspicious dissection of aorta person; (14) other breathing, digestion, blood, infection, immunity, endocrine, neural spirit, tumor disease with clinical meaning maybe may cause the disease of grave danger to the patient.

The standard that gives up the study of: (1) takes place and the clearly relevant anaphylaxis of research medicine, as hyperpyrexia, erythra etc.; (2) take place and the clearly relevant abnormal bleeding of research medicine; (3) other ill symptoms or sign, abnormal examination result, researcher is judged the situation that must stop research; (4) listed accompanying diseases in the exclusion standard takes place; (5) gestation takes place in the women during research; (6) substantial deviation research approach; (7) answer the patient to require to stop continuing research.

1.4 Therapeutic Method

Selected patient is at signature informed consent postscript, by at random, double blinding, placebo method be divided into medication therapy groups of the present invention and placebo group.Medicine of the present invention (ultra micro powder) or placebo give 8 of loading before patient row emergency PCI, with aspirin and clopidogrel decoction being taken at a draught together, played conventional every day 3 times on the 2nd day, each 4.Follow-up period is 6 months.

1.5 observation index

1.5.1 18 lead electrocardiogram

Before selected patient accepted interventional therapy, 1,2,6,12,24 hours each time points of PCI postoperative carry out 18 lead electrocardiogram inspections.Recorded heart rate, PR interval, QT interval changes, the ST section falls amplitude, T ripple, Q ripple situation of change after rise.

1.5.2 radioisotope scanning

Observed patient PCI postoperative 7 days and the 180 days 17 damaged scope indexes of sections heart muscle perfusion.

1.5.3 myocardium acoustic contrast (MCE)

The 7th day and myocardium acoustic contrast video picture in the 180th day behind the observation PCI are estimated cardiac muscular tissue and are not had rheologyization again.

1.5.4 cardiac ultrasonic

Selected patient is accepted behind the interventional therapy to carry out 2DE in 48-72 hour, the 90th day and 180 days to be checked and graphical analysis.Survey the also 2DE image of record standard long axis of left ventricle, minor axis and apex of the heart tangent plane, with the variation of chambers of the heart size, contractile function and locular wall segmentation movement behind the understanding myocardial infarction re-perfusion.

1.6 efficacy determination index

1.6.1 main evaluation index

AMI emergency PCI postoperative does not have rheologyization again

Evaluation methodology: the relevant ST section of leading falls amplitude after rise shown in the electrocardiogram

The damaged scope index of cardiac muscle 17 sections heart muscle perfusions of nucleic perfusion scanning

Myocardium acoustic contrast cardiac muscular tissue blood perfusion value (hospital with good conditionsi carries out)

1.6.2 less important evaluation index

6 months changes of cardiac function

Evaluation methodology: the scoring of 16 sections locular wall abnormal motion sections shown in cardiac ultrasonic index

1.7 statistical procedures

1.7.1 descriptive analysis

Enumeration data adopts constituent ratio to describe, and measurement data adopts mean, standard deviation, median, the 25th and the 75th quantile to describe.

1.7.2 the baseline demography is analyzed

Relatively adopt chi-square criterion or the accurate probabilistic method of Fisher between the enumeration data group; Relatively adopt t check in groups between the measurement data group of normal distribution; Relatively adopt the Wilcoxon rank test between the measurement data group of nonnormal distribution.

1.7.3 efficacy analysis

Relatively adopt paired t-test in the measurement data group of normal distribution, relatively adopt t check in groups between group; The Wilcoxon rank test is relatively adopted in relatively symbolization rank test in the measurement data group of nonnormal distribution between group.

1.7.4 safety evaluatio

Describe in detail the concrete manifestation respectively organize whole adverse events that case occurs and with the relation of medicine.

All statistical analysiss will carry out under 0.05 significance level.The typing software that data management is used is EPI DATA 3.0, and statistical analysis software is 9.13.

2 results

ECG ST section changes in the 24h: postoperative 24h ST section is raised amplitude (mv), postoperative 6h, 12h, the relative baseline of 24h ST section fall amplitude after rise, the relative baseline falling of 24h ST section rate (%), falling rate fully (%) and nothing flow incidence rate (%) again, test group all is better than matched group (P＜0.05, P＜0.01), sees Table 1-5.

The ST section of table 1 different time points is raised amplitude (mV)

The ST section of the relative baseline of table 2 different time points falls amplitude (mV) situation of change after rise

Falling amplitude: before treating back-treatment

The relative baseline ST of table 3 different time points section falling rate (%)

Falling rate=(before treating back-treatment)/before treating * 100

Table 4 different time points relative baseline ST section falling rate fully (%)

The ST section falls amplitude＞75% after rise and is defined as falling fully

The nothing of table 5 different time points flows that a situation arises relatively (%) again

Do not have and flow criterion again; 1h, 2h≤50%, 12h, 24h≤75%

Radioisotope scanning: postoperative 7 days and the 180 days 17 damaged scope index of sections heart muscle perfusion test group are better than matched group (P＜0.05), see Table 6.

The damaged scope index of table 6 different time points radioisotope scanning 17 sections heart muscle perfusions

Myocardium acoustic contrast: 7 days myocardium blood perfusion value test group of postoperative and matched group zero difference (P＞0.05), 180 days test group of postoperative see Table 7 apparently higher than matched group (P＜0.05).

Table 7 different time points myocardium acoustic contrast myocardial blood flow perfusion value changes

Cardiac ultrasonic: the postoperative unusual sections scoring of sections ventricular wall motion in 180 days 16 index test group is better than matched group, sees Table 8; 90 days relative postoperative 48-72h scoring index variation test group with 180 days of postoperative all are better than matched group (P＜0.05, P＜0.01), see Table 9.

The unusual sections scoring of ultrasonic cardiography Figure 16 sections ventricular wall motion of table 8 different time points index

The unusual sections scoring of ultrasonic cardiography Figure 16 sections ventricular wall motion of table 9 different time points index variation

Safety evaluatio: 6 example and 4 routine adverse events respectively take place in test group and matched group.

3 conclusions

This result of study shows, on routine of western medicine treatment basis, adds with medicine of the present invention and can obviously promote acute myocardial infarction to get involved that ECG ST section falls after rise in the patient 24 hours, reduces myocardium no resurgent; Improve early stage and the perfusion of late cardiac microcirculation blood flow, obviously myocardial blood flow perfusion value; Prolonged application is significantly improved cardiac systolic function, prolonged application safety.

Claims (6)

1. a Chinese medicine composition does not have application in the medicine of stream at preparation prevention and treatment acute myocardial infarction PCI postoperative again, it is characterized in that this Chinese medicine composition is made by following bulk drugs:

Radix Ginseng 3-10 Hirudo 3-11 Eupolyphaga Seu Steleophaga 5-10 Olibanum (system) 1-5 Radix Paeoniae Rubra 3-9 Lignum Dalbergiae Odoriferae 1-5

Lignum Santali Albi 1-5 Scorpio 3-9 Periostracum Cicadae 3-12 Scolopendra 1-3 Borneolum Syntheticum 1-7 Semen Ziziphi Spinosae (stir-fry) 3-10.

2. application as claimed in claim 1 is characterized in that, this Chinese medicine composition is made by following bulk drugs:

Radix Ginseng 6 Hirudo 10 Eupolyphaga Seu Steleophagas, 7 Olibanums (system) 2 Radix Paeoniae Rubra 5 Lignum Dalbergiae Odoriferaes 2

Lignum Santali Albi 2 Scorpios 7 Periostracum Cicadaes 7 Scolopendra 1 Borneolum Syntheticum, 5 Semen Ziziphi Spinosaes (stir-fry) 5.

3. application as claimed in claim 1 is characterized in that, this Chinese medicine composition is made by following bulk drugs:

Radix Ginseng 10 Hirudo 8 Eupolyphaga Seu Steleophagas, 7 Olibanums (system) 2 Radix Paeoniae Rubra 5 Lignum Dalbergiae Odoriferaes 2

Lignum Santali Albi 2 Scorpios 9 Periostracum Cicadaes 7 Scolopendra 1 Borneolum Syntheticum, 5 Semen Ziziphi Spinosaes (stir-fry) 5.

4. application as claimed in claim 1 is characterized in that, this Chinese medicine composition is made by following bulk drugs:

Radix Ginseng 6 Hirudo 11 Eupolyphaga Seu Steleophagas, 7 Olibanums (system) 2 Radix Paeoniae Rubra 5 Lignum Dalbergiae Odoriferaes 2

Lignum Santali Albi 2 Scorpios 3 Periostracum Cicadaes 7 Scolopendra 1 Borneolum Syntheticum, 5 Semen Ziziphi Spinosaes (stir-fry) 5.

5. as each described application among the claim 1-4, it is characterized in that the active component of described Chinese medicine composition is made up of following ingredients:

The a mean diameter is less than Scorpio, Hirudo, Scolopendra, Eupolyphaga Seu Steleophaga, Periostracum Cicadae and Olibanum (system) medicated powder of 100 μ m;

B Borneolum Syntheticum medicated powder;

The volatile oil that c is extracted by Lignum Dalbergiae Odoriferae and Lignum Santali Albi;

The alcohol-extracted extract of the alcohol extract of d Radix Ginseng after after concentrating with ethanol extraction;

The water extracted immersing paste that is condensed into behind the water extract after the Lignum Dalbergiae Odoriferae behind the e extraction composition c and water extract, Radix Paeoniae Rubra and the Semen Ziziphi Spinosae (stir-fry) of Lignum Santali Albi medicinal residues decoct with water and the water extract filtration of the medicine residues of Radix Ginseng after the extraction ingredient d, the mixing.

6. as each described application among the claim 1-4, it is characterized in that this Chinese medicine composition is capsule, tablet, granule, powder, oral liquid or pill as the pharmaceutical preparation of active component.