CN103055122A - Medicine for preventing restenosis after intracoronary stent implantation and preparation method thereof - Google Patents

Medicine for preventing restenosis after intracoronary stent implantation and preparation method thereof Download PDF

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CN103055122A
CN103055122A CN2012105884353A CN201210588435A CN103055122A CN 103055122 A CN103055122 A CN 103055122A CN 2012105884353 A CN2012105884353 A CN 2012105884353A CN 201210588435 A CN201210588435 A CN 201210588435A CN 103055122 A CN103055122 A CN 103055122A
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CN103055122B (en
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张新元
张淑霞
王强
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张新元
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Abstract

The invention discloses a medicine for preventing restenosis after the intracoronary stent implantation, which is characterized by comprising the components in parts by mass as follows: 200-250 parts of astragalus mongholicus, 35-50 parts of ginseng, 65-85 parts of radix ophiopogonis, 220-245 parts of salvia miltiorrhiza, 65-90 parts of lignum dalbergiae odoriferae, 100-130 parts of fructus aurantii, 100-125 parts of ligusticum wallichii, 105-130 parts of poria cocos, 65-90 parts of processed rhizoma pinelliae, 105-135 parts of trichosanthes kirilowii maxim, 85-105 parts of allium macrostemon, 105-138 parts of pericarpium citri reticulatae and 60-85 parts of liquorice. Compared with the prior art, the medicine can prevent a restenosis phenomenon after the intracoronary stent implantation, effectively relieve angina, and prevent and treat in-stent restenosis.

Description

Medicine of restenosis and preparation method thereof behind the prevention percutaneous transluminal coronary stent implantation
Technical field
The invention belongs to field of medicaments, be specially a kind of prevent restenosis behind the percutaneous transluminal coronary stent implantation medicine and preparation method thereof.
Background technology
Along with the generally raising of people's living standard, the sickness rate of coronary atherosclerotic heart disease (CHD) raises year by year, has become in recent years the first killer of harm humans health.Percutaneous tranluminal coronary angioplasty (PTCA) is one of best means of coronary blood transport reconstruction, is the breakthrough of coronary heart disease treatment, and its appearance is a milestone of coronary heart disease treatment, has the advantages such as wound is little, determined curative effect.Vascular Restenosis after Balloom (RS) and in-stent restenosis (ISR) incidence rate have had a strong impact on late result still up to 10%~50%.
The medicine that is used at present the ISR prevention is a lot, and usually adopting two anti-methods is aspirin chlorination pyrrole Gray scheme, has prevented to a certain extent ISR, but causes simultaneously some patients were peptic ulcer or the serious complication such as hemorrhage.
Chinese medicine has certain preventive and therapeutic effect to in-stent restenosis.Chinese medicine thinks that treatment of instent restenosis and advanced thrombus form the category that still belongs to the traditional Chinese medical science " thoracic obstruction ", " angina pectoris ".
Summary of the invention
In order to overcome above-mentioned technical problem, the invention provides a kind of prevent restenosis behind the percutaneous transluminal coronary stent implantation medicine and preparation method thereof, compared with prior art, can effectively prevent the phenomenon of restenosis behind the percutaneous transluminal coronary stent implantation, and can be at effectively allevating angina pectoris and control ISR.
For achieving the above object, the technical solution adopted in the present invention is as follows:
A kind of medicine that prevents restenosis behind the percutaneous transluminal coronary stent implantation is characterized in that: by the composition ingredients of following mass component: Radix Astragali 200-250, Radix Ginseng 35-50, Radix Ophiopogonis 65-85, Radix Salviae Miltiorrhizae 220-245, Lignum Dalbergiae Odoriferae 65-90, Fructus Aurantii 100-130, Rhizoma Chuanxiong 100-125, Poria 105-130, Rhizoma Pinelliae Preparata 65-90, Fructus Trichosanthis 105-135, Bulbus Allii Macrostemonis 85-105, Pericarpium Citri Reticulatae 105-138, Radix Glycyrrhizae 60-85.
Above-mentioned, by the ingredients of following mass component: Radix Astragali 230-240, Radix Ginseng 40-45, Radix Ophiopogonis 70-80, Radix Salviae Miltiorrhizae 230-235, Lignum Dalbergiae Odoriferae 75-80, Fructus Aurantii 110-120, Rhizoma Chuanxiong 110-120, Poria 110-120, Rhizoma Pinelliae Preparata 75-80, Fructus Trichosanthis 110-120, Bulbus Allii Macrostemonis 90-95, Pericarpium Citri Reticulatae 110-120, Radix Glycyrrhizae 75-80.
Further, described medicine is by the ingredients of following mass parts: the Radix Astragali 232, Radix Ginseng 46, Radix Ophiopogonis 77, Radix Salviae Miltiorrhizae 232, Lignum Dalbergiae Odoriferae 77, Fructus Aurantii 116, Rhizoma Chuanxiong 116, Poria 116, Rhizoma Pinelliae Preparata 77, Fructus Trichosanthis 116, Bulbus Allii Macrostemonis 93, Pericarpium Citri Reticulatae 116, Radix Glycyrrhizae 77.
Further, Radix Ginseng, Poria two flavors are ground into fine powder, residue ten adds simply water and filters, decocts, and merging filtrate is condensed into the thick paste shape, with above-mentioned fine powder and auxiliary materials and mixing, granulates, and drying incapsulates.
Further, described decoction is secondary, each 2 hours.
Further, described adjuvant is medical dextrin, the about 30:1 of the ratio of blending.
Pharmacology of the present invention is as follows:
The Radix Astragali: be the root of leguminous herbaceous plant's Radix Astagali, Radix Astragali, have the effects such as invigorating QI to consolidate the body surface resistance, diuretic detumescent, expelling pus and toxin by strengthening QI, granulation promoting.
Radix Ginseng: to the effect of cardiovascular system
A. to the effect of cardiac function: Radix Ginseng the heart of many animals is all had suppress after excited first, excited in a small amount, a large amount of effects that suppress.It is similar to cardiotonic glycoside to action of the heart, can improve myocardial contraction.Heavy dose then weakens contractility and decreased heart rate.Experiment shows: the alcohol extract of Radix Ginseng Rubra and infusion can make it shrink and strengthen isolated frog heart, stop at last systole; To dog, rabbit, the cat heart in place, it is shunk strengthen decreased heart rate.These effects mainly are due to the direct excited cardiac muscle.Acute circulatory failure (heart rate is slow, mental and physical efforts are weak) is occured the animal massive blood loss, and Radix Ginseng can make the heart beating amplitude unusually strengthen, and heart rate significantly speeds.The ginsenoside has the rat ventricular effect that stronger anti-barium chloride brings out, and the tachycardia that produces is had stronger role of correcting, can make the rhythm of the heart return to normal level.There is report to point out, the Experimental Arrhythmia that Herba Herminii or Radix Ginseng Saponin can cause antiadrenergic drug.The ginsenoside contains the measurer dual regulation to cAMP in the myocardial cell and cGMP, so keep the factor that the balance of cAMP and cGMP also is antagonism cardiac arrhythmia under stress state.Stem and leaf of Radix Ginseng total saponins has protective effect to the experimental sinus node function damage of rabbit.
B. to the effect of cardiac muscle: Radix Ginseng has protective effect to cardiac muscle.The ginsenoside can reduce mice brain and myocardium lactic acid content in the severe depletion of oxygen situation, content of cAMP in the time of recovering anoxia/cGMP ratio, and the effect that has protection heart muscle capillary endotheliocyte and alleviate mitochondrial injury.From the Saponin that extract at the positions such as Stem and leaf of Radix Ginseng, reed head, fruit and main root, the rat heart muscle that the p-isopropyl epinephrine causes is downright bad, and obvious myocardium protecting action is all arranged, and disease damage is alleviated, and especially act as good with the Herba Herminii saponin.The different extract fractions of Radix ginseng Saponin is equipped with similar action effect to gains in depth of comprehension.Ginseng rhizoma saponin can promote that the DNA of myocardial cell is synthetic, and the myocardial cell that lacks sugared anoxia-induced apoptosis cultivation is had certain protective effect.Research thinks, Radix Ginseng total saponins resists myocardial ischemia and the mechanism of reperfusion injury, is to promote cardiac muscle to generate and discharge prostaglandin, suppresses the generation of thromboxane A2, and by antioxidant radical and lipoid peroxidization resistant and protecting myocardial cell.
C. to the effect of blood vessel: Radix Ginseng it is generally acknowledged that to the effect of blood vessel it is vasodilator, but low dose of the contraction also arranged, heavy dose of expansion or shrink first the report of expanding afterwards.Radix Ginseng shows difference to the effect of blood vessel because of blood vessel kind difference or fuselage state.Radix Ginseng has contraction to rabbit ear blood vessel and rat hindlimb blood vessel.But whole animal coronary artery, cerebrovascular, optical fundus blood vessel there is dilating effect.The total Saponin of intravenous injection can reduce dog hind leg blood vessel and cerebral vascular resistance, but can increase the kidney of rats vascular resistance.Ginsenoside Rg1, Re also are dilating effect to the dog blood vessel, and it is very weak that effect is respectively the effect of 1/20 and 1/50, Rc, Rb2 of papaverine, and Rb1 is invalid.Radix Ginseng affects the effective ingredient of vascular function and studies show that of mechanism of action: ginsenoside Rb1 and R0 are nonselective to the dilating effect of blood vessel, and the only vasoconstriction that causes of selectivity antagonism Ca++ of Rg1, its mechanism of action still remains further research.Someone thinks that Radix Ginseng may be the reason of Radix Ginseng two-ways regulation blood pressure to the different regulating action of blood vessel under different classes of, the different physiological statuss.
D. to the effect of blood pressure: most data shows: animal is at normal or hypertension state, and Radix Ginseng has the effect that reduces blood pressure, but the report of the hypertension of making is also arranged.Radix Ginseng is to the blood pressure of anesthetized animal, and low dose is boosted, heavy dose of blood pressure lowering.Therapeutic dose has no significant effect patient's blood pressure.The boosting of Radix Ginseng may shrink relevant with kidney, spleen volume-diminished, visceral vessel.Blood pressure lowering then is owing to discharge due to the histamine.Anesthetized dog has tachylaxis to the hypotensive effect of Radix Ginseng.Ginsenoside Rb1, Rb2, Rc, Rd, Re, Rf have the two-way function that descends behind the first microlitre to blood pressure, and be the strongest with Rg1, and Rb1 boosts when heavy dose of.But its effect on blood pressure is not subjected to the impact of atropine, diphenhydramine, phenol azoles quinoline and propranolol.Radix Ginseng ether extract 40mg/kg intravenous injection can make the slight dog decreased heart rate of anaesthetizing of halothane, and central venous pressure reduces.It should be noted that: intravenous injection Radix Ginseng extractum can make that breathing stops, the cat of blood pressure drops, reflection complete obiteration recovers from moribund condition.
It is generally acknowledged that the mechanism of Radix Ginseng hypotensive effect is: Radix Ginseng has the effect of the choline of plan; The of short duration hypotensive effect that the Radix Ginseng Rubra ether extract begins to occur, relevant with histamine release, the lasting hypotensive effect that then occurs belongs to other reasons; Radix Ginseng can cause that Ca++ reduces in the blood vessel, its hypotensive effect be Radix Ginseng to the result of vascular smooth muscle effect, the ginsenoside Rb1 has lasting hypotensive effect; Because excision animal brain or with the hypotensive effect that all can eliminate Radix Ginseng behind the ganglionic block agents, the hypotensive effect of old friend's ginseng may have the participation of nervus centralis and reflex mechanism.
Radix Ophiopogonis: nature,taste and action: sweet, little hardship, cold, Yin-nourishing and body fluid promoting, nourishing the lung to arrest cough, relieving restlessness clears away heart-fire.Cure mainly consumption of body fluid caused by febrile disease, vexed, thirsty, dry pharynx lung-heat, cough, pulmonary tuberculosis.
Radix Salviae Miltiorrhizae has another name called Radix Salviae Miltiorrhizae, Radix Salviae Miltiorrhizae, Arisaema balansae Engl. etc.Be the dicotyledon Labiatae, dry root and rhizome.Main product in Anhui, the ground such as Henan, Shaanxi.Effect: promoting blood flow to regulate menstruation, stasis-dispelling and pain-killing, removing heat from blood eliminating carbuncle, the relieving restlessness that clears away heart-fire, nourishing blood to tranquillize the mind.
Lignum Dalbergiae Odoriferae: promoting flow of QI and blood, pain relieving, hemostasis.
Fructus Aurantii: dispelling the stagnated QI, row expectorant, removing food stagnancy.Control chest and diaphragm expectorant and stagnate, the feeling of stuffiness in chest, the side of body is swollen, food stagnation, eructation, vomiting.
Rhizoma Chuanxiong; Acrid in the mouth, warm in nature.Return liver, gallbladder, pericardium channel.
Poria; Sweet in the mouth, light, property are flat, be used as medicine have promoting diuresis to eliminate damp pathogen, the function of strengthening the spleen stomach function regulating, mind tranquilizing and the heart calming.Modern medicine study: Poria energy enhancing human body immunity function, pachyman has obvious antitumor and protects the liver dirty effect.
The Rhizoma Pinelliae: suffering, temperature.Poisonous.Return spleen, stomach, lung meridian.Drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass; The externally used detumescence pain relieving.
Fructus Trichosanthis: fruit contains Saponin, organic acid, fatty wet goods.Sweet in the mouth, cold in nature.Have that lung moistening is eliminated the phlegm, the effect of promoting the circulation of QI the chest stuffiness relieving.The treatment cough with ropy sputum is uncomfortable in chestly had a pain.The Fructus Trichosanthis preparation is controlled angina pectoris certain curative effect.
Bulbus Allii Macrostemonis: activating YANG and eliminating stagnation, circulation of qi promoting intestinal stasis relieving.The thorough back of the body of obstruction of qi in the chest and cardialgia; Breast gastral cavity painful abdominal mass is vexed; The cough with asthma abundant expectoration; Epigastric pain; Weigh after letting out dysentery; Leucorrhea; The furuncle carbuncle.
Pericarpium Citri Reticulatae: the appetizing drying dampness to eliminate phlegm of regulating the flow of vital energy is controlled the spleen-stomach disease.
Radix Glycyrrhizae: function cures mainly heat-clearing and toxic substances removing, expelling phlegm for arresting cough, gastral cavity abdomen etc.
Monarch drug: Radix Ginseng strongly invigorating primordial QI, the prosperous handsome blood of gas, blood circulation depending on qi flow; The Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, coronary circulation-promoting pain-relieving; The Fructus Trichosanthis dissipating phlegm and resolving masses, the chest stuffiness relieving is regulated the flow of vital energy; The three is harmonious, and plays altogether replenishing qi and promoting blood flow, phlegm reduction of blood circulation promoting, the merit of coronary circulation-promoting pain-relieving.
Ministerial drug: Radix Astragali QI invigorating is activated yang, the Rhizoma Chuanxiong blood-activating and qi-promoting, and Rhizoma Pinelliae drying dampness to eliminate phlegm, the Poria invigorating the spleen to clear away damp pathogen cooperates monarch drug to help pectoral qi, the loose expectorant stasis of blood, Tong Xinmai is except arthralgia pain.
Adjuvant drug: the hot temperature of Lignum Dalbergiae Odoriferae is kind loose, and promoting flow of QI and blood is good at pain relieving; Fructus Aurantii promoting the circulation of QI to alleviate the stagnation in middle-JIAO, Pericarpium Citri Reticulatae are regulated the flow of vital energy and are eliminated the phlegm, and the two is harmonious expectorant is disappeared with gas, tonify without causing stagnation; The pain relieving of Bulbus Allii Macrostemonis the chest stuffiness relieving, temperature is logical sliding sharp, and it is turbid that hardship is let out expectorant, activating YANG and eliminating stagnation, the circulation of qi promoting intestinal stasis relieving, the expectorant of the YIN-cold of faling apart is turbid sluggish, declares in the heart yang-energy with the chest stuffiness relieving; Radix Ophiopogonis in addition, the YIN nourishing soft pulse, holding concurrently can righting, makes hotly loosely not rob blood, and warm-dryness syndrome is not just hindered.
Make medicine: the Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription.
Make a general survey of full side, logical benefit is taken into account, and strongly invigorating primordial QI is hot loose warm logical, qi and blood circulation promotion, and Tong Xinmai, the expectorant stasis of blood, except arthralgia pain, tonify without causing stagnation, logical treating both the principal and secondary aspects of a disease brings out the best in each other and loose, the good recipe of reducing phlegm for supplementing qi and invigorating vasculum in fact.
This medicine can not only improve the malaise symptoms such as coronary artery bracket postoperative patient person feeling of oppression and pain in the chest, the Effective Raise patients ' life quality, and also curative effect has been confirmed in clinical practice, and ISR has definite curative effect to control.
Innovation: 1. embodied the compatibility of medicines in a prescription, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs and the modern pharmacology of the traditional Chinese medical science and mutually combining of achievement in research.2, beneficial heart capsule for freeing collateral vessels is pure Chinese medicinal preparation, safety non-toxic, and curative effect is reliable, taking convenience.3, there is no at present the medicine of special control ISR both at home and abroad, it is blank both at home and abroad that this medicine can be filled up this field.4, can obtain good Social benefit and economic benefit, wide DEVELOPMENT PROSPECT is arranged.Benefit more patient.
Full side is totally ten three flavor Chinese medicines, and letter is not and numerous, and prescription is careful, and compatibility is rigorous.Radix Ginseng sweet in the mouth in the side, little hardship, property is flat, strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, invigorating the spleen to benefit the lung, the promoting the production of body fluid and inducing sedation of the mind Fructus Alpiniae Oxyphyllae, " Mingyi Bielu " meaning cure mainly the intestinal cold in the stomach, trusted subordinate's drum pain, feeling of fullness and discomfort in the hypochondrium, cholera is told contrary, in the accent, the promoting blood circulation of only quenching one's thirst, broken hard amassing makes us not forgetting." property of medicine opinion ": main five hide QI-insufficiency, and five kinds of strain and seven kinds of impairment is deficient, thin and weakly tell contraryly, and lower food ends the cholera unhappiness sound of vomiting of vomitting, and the tonifying five ZANG-organs six internal organs are kept god among the guarantor.The Radix Ginseng strongly invigorating primordial QI, the prosperous handsome blood of gas, blood circulation depending on qi flow; Radix Salviae Miltiorrhizae bitter in the mouth, cold nature, effect stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, nourishing blood to tranquillize the mind, Shennong's Herbal are called it " can control trusted subordinate's pathogen, “ Po Disorder is except abdominal mass ", and Jing-Yue Complete Works is said its energy nourshing blood and promoting blood circulation, tissue regeneration promoting blood, row stagnated blood; The Fructus Trichosanthis sweet in the mouth, bitter in the mouth, cold in nature, the function clearing away heat and eliminating phlegm, relieving stuffiness of the chest by dispersing aggregation of pathogens, loosening bowel to relieve constipation, Compendium of Material Medica is said: sweet trembling with fear do not violated gastric qi, can fall the fire of the part of the body cavity above the diaphragm housing the heart and lungs, and mental disorder is descended also.Radix Ginseng, Radix Salviae Miltiorrhizae, Fructus Trichosanthis are monarch drug altogether, and the three is harmonious, and play altogether replenishing qi and promoting blood flow, phlegm reduction of blood circulation promoting, the merit of the analgesic therapy of promoting blood circulation.
Radix Astragali sweet in the mouth is warm in nature in the side, returns the warp of spleen lung, and the inclined to one side invigorating QI to consolidate the body surface resistance of merit can prevent exopathogen invasion body surface, Guo Wenqin meaning " ginseng, stilbene are called the hat of all resistance and supplementing qi medicines ", and the power of the Radix Astragali, Radix Ginseng two medicine compatibility QI invigorating is rich; The Rhizoma Chuanxiong acrid in the mouth, warm in nature, be good at blood-activating and qi-promoting, wind-expelling pain-stopping, " herbal lease making " is called gas medicine in the blood, yang invigorating dissipating depression of QI ... the up head, the descending sea of blood, and blood gas.Rhizoma Chuanxiong closes Radix Salviae Miltiorrhizae and enriches blood and invigorate blood circulation and do not stagnate; The Rhizoma Pinelliae is drying dampness to eliminate phlegm, and stopping nausea and vomiting by lowering the adverse flow of QI, the good medicine of dissolving lump and resolving mass, the Rhizoma Pinelliae close the Fructus Trichosanthis excellent compatibility of sending down the abnormal ascending QI that eliminates the phlegm, and control the thoracic obstruction with Gualou Xiebai Banxia Tang such as Zhong Jing, and the little sunken chest soup of epigastric fullness is all with the Rhizoma Pinelliae, Fructus Trichosanthis collocation; Poria sweet in the mouth, light, property is put down, and energy promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming, Shennong's Herbal carry its energy " the main breast side of body is against gas, and melancholy is angerd, and frightened heresy is probably throbbed with fear, and ties bitterly cold and heat, stuffy sensation with restlessness under the heart ... clothes of a specified duration are pacified soul and reposed ".The Radix Astragali, Rhizoma Chuanxiong, the Rhizoma Pinelliae, Poria are ministerial drug altogether, close monarch drug and strengthen the merit that benefiting QI for activating blood circulation eliminates the phlegm.
The hot temperature of Lignum Dalbergiae Odoriferae is kind loose, and promoting flow of QI and blood is good at pain relieving; Fructus Aurantii promoting the circulation of QI to alleviate the stagnation in middle-JIAO, Pericarpium Citri Reticulatae are regulated the flow of vital energy and are eliminated the phlegm, and the two is harmonious expectorant is disappeared with gas, tonify without causing stagnation; The pain relieving of Bulbus Allii Macrostemonis the chest stuffiness relieving, temperature is logical sliding sharp, and it is turbid that hardship is let out expectorant, activating YANG and eliminating stagnation, the circulation of qi promoting intestinal stasis relieving, the expectorant of the YIN-cold of faling apart is turbid sluggish, declares in the heart yang-energy with the chest stuffiness relieving; Radix Ophiopogonis in addition, the YIN nourishing soft pulse, holding concurrently can righting, makes hotly loosely not rob blood, and warm-dryness syndrome is not just being hindered, and is altogether adjuvant drug in the side.The Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription is for making medicine.
Make a general survey of full side, logical benefit is taken into account, and strongly invigorating primordial QI is hot loose warm logical, qi and blood circulation promotion, and Tong Xinmai, the expectorant stasis of blood, except arthralgia pain, tonify without causing stagnation, logical treating both the principal and secondary aspects of a disease brings out the best in each other and loose, the good recipe of reducing phlegm for supplementing qi and invigorating vasculum in fact.
The Radix Ginseng strongly invigorating primordial QI, handsome blood and going.Modern pharmacological research is thought: the Saponin energy blood vessel dilating in the Radix Ginseng, and microcirculation is improved, prevent blood coagulation, promote fibrinolysis, erythrocytic aggregation there is inhibition, improve the flowability of blood.Can increase the nonspecific resistance of body, to various harmful factors, all can increase the resistance of body such as physics, biological harmful effect.To the effect of cardiovascular system, have the adjusting heart body, blood vessel dilating is adjusted blood pressure and the effect of antibody gram.Radix Salviae Miltiorrhizae has another name called Radix Salviae Miltiorrhizae, Radix Salviae Miltiorrhizae, Arisaema balansae Engl. etc., kind blood circulation promoting and blood stasis dispelling, stasis-dispelling and pain-killing, dispersing swelling and dissipating binds, removing heat from blood eliminating carbuncle; Modern medicine finds that Radix Salviae Miltiorrhizae contains a lot of compositions, wherein TANSHINONES, danshensu, succinic acid, vitamin E, Radix Scutellariae young pilose antler, daucosterol etc. confirm through zoopery, can stop the reduction of fibrinolytic in the atherogenesis process, delay and stop atherosclerotic formation.Red sage formulation is the main medicine of state's internal therapy coronary heart disease, has obvious function of resisting myocardial ischemia, can act on multiple prothrombin factor and anticoagulant, activation fibrinolytic and anticoagulant cause it to reach the curative effect of anti-microthrombusis; Also can promote the reparation of vascular endothelial cell, coronary artery blood flow is increased, reduce myocardial oxygen consumption; Can find out that treatment group TXA2 level significantly is lower than matched group from this research, difference has statistical significance (P<0.05); Also have in addition blood fat reducing, prevent and treat atherosclerotic effect.Fructus Trichosanthis energy removing heat-phlegm, promoting the circulation of QI dissipating depression of QI, the sharp diaphragm of the chest stuffiness relieving, relieving restlessness resolving depression, clearing away phlegm eliminating stagnation.Experiment shows that suitably the Fructus Trichosanthis of dosage can make the guinea pig isolated heart contractility strengthen to some extent, and the Pericarpium Trichosanthis dilate coronary effect is relevant with its contained Alkaloid, and its total amino acids may have phlegm-dispelling functions rather than dilate coronary effect.
The Radix Astragali not only has coronary artery dilator, improve myocardial blood flow and myocardial metabolism and dwindle the effect of infarct size, can also strengthen myocardial contraction and improve left heart function.Have obvious antifatigue effect, enhancing body anoxia enduring and stress ability can promote the metabolism of body.The Radix Astragali can also affect blood pressure, reduces blood viscosity and improve unusual hemorheology index.Rhizoma Chuanxiong: hot, warm, return liver, gallbladder, pericardium channel, main effect is blood-activating and qi-promoting, wind-expelling pain-stopping.Modern pharmacology studies confirm that Rhizoma Chuanxiong has inhibition vascular smooth muscle cell proliferation, reduces platelet adhesion reaction, gathering, prevents thrombosis, the effects such as protection vascular endothelial cell; Also has the effect of control coronary artery bracket restenosis after vascular intervention.Rhizoma Chuanxiong water extraction liquid and alkaloid thereof can be expanded crown and blood vessel, increase coronary flow, improve the myocardial ischemia situation.Anesthetized dog is quiet push away ligustrazine after, arteria coronaria and cerebral blood flow increase, arteria coronaria, cerebrovascular and Peripheral resistance reduce.Poria: sweet, light, flat, GUIXIN, lung, spleen, stomach warp, function promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.The reports such as Kang Shi are reused Poria and are treated 55 routine cardiac edemas, and obvious diuresis is arranged.Effect to cardiovascular system is mainly manifested in the enhancing myocardial contraction, and the Poria aqueous extract also has hypotensive activity.The Rhizoma Pinelliae: hot, warm, poisonous, return spleen, stomach, lung meridian, main effect is drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass.The Rhizoma Pinelliae has obvious antiarrhythmic effect, and its decoct has antagonism to dog ventricular tachycardia and ventricular premature contraction.The Rhizoma Pinelliae also has significant effect for reducing blood fat, can reduce rat TC, LDL-C and TC/TG, LDL-C/HDL-C ratio, stops or delays the formation of hyperlipemia, and hyperlipemia is had certain therapeutical effect.In addition, the Rhizoma Pinelliae also has the heart rate of inhibition and of short duration hypotensive effect.
The main effect of Lignum Dalbergiae Odoriferae is promoting flow of QI and blood, pain relieving, hemostasis.Wang Hongbo etc. studies show that Lignum Dalbergiae Odoriferae oil can significantly recover the ST field offset degree of Rat Ecg, obviously improve the acute myocardial ischemia that is brought out by element on the isopropyl kidney, and have remarkable effect aspect anti-platelet aggregation.Lignum Dalbergiae Odoriferae reduces the effect of matter I type between myocardial cell/III collagen type ratio in addition, improves the remodeling ventricle of myocardial infarction prognosis.Radix Ophiopogonis is sweet cold clear and rich, the heat of the kind lung that clears away heart-fire and yin nourishing relieving restlessness.Radix Ophiopogonis polysaccharide can be protected cardiac muscle, has simultaneously to suppress the free radical that myocardial ischemia causes and generate the effect that increases and remove oxygen-derived free radicals.Xu Desheng etc. experimental results show that the S-T section that Radix Ophiopogonis, but active polysaccharide antagonism pituitrin caused and raise, the ST section that raises behind the rat coronary ligation is obviously reduced, reduce simultaneously CK and the rising of inhibition serum lactate dehydrogenase (SLD) (LDH) content in the animal serum, superoxide dismutase (SOD) reduction and malonaldehyde (MDA) increase that myocardial ischemia is caused have certain inhibitory action.The Bulbus Allii Macrostemonis acrid in the mouth is bitter, returns lung, stomach, large intestine channel, and main effect is activating YANG and eliminating stagnation, the circulation of qi promoting intestinal stasis relieving, and the energy anticoagulant, coronary artery dilator reduces oxygen consumption, arrhythmia, cholesterol reducing and antioxidation.Bulbus Allii Macrostemonis and composition thereof have inhibitory action to the platelet aggregation of inducing, and its active component is that N-is to coumaric acyl tyramine, the anti-feruloyltyramine of N-, adenosine.The Fructus Aurantii warming middle-JIAO is regulated the flow of vital energy, clearing heat in QI system raises up, promoting flow of QI and blood, pain relieving.N-methyltyramine contained in the Fructus Aurantii can increase coronary flow and renal blood flow, can significantly reduce myocardial oxygen consumption, and obvious diuresis is arranged.Contained Neosynephrine is epinephrine a-receptor agonist in the Fructus Aurantii, and the heart beta-receptor is also had certain excitation, and vasoconstrictive is arranged, and produces the hypertensive effect that rises.The Pericarpium Citri Reticulatae drying dampness to eliminate phlegm can help Fructus Trichosanthis to reduce phlegm, again can circulation of qi promoting, and the capable then blood of gas, gasification is wet eliminating the phlegm then, the eliminate the phlegm power of blood stasis dispelling of enhancing.Pericarpium Citri Reticulatae can improve hemorheological property, reduces blood viscosity, antiplatelet aggregation, and the main component hesperidin of Pericarpium Citri Reticulatae can strengthen myocardial contraction, and cardiac output is increased.Extrasomatic rabbit heart perfusion experiment shows that the Pericarpium Citri Reticulatae decoct still can coronary artery dilator.
More than all medicines for pathogenesis, compatibility is rigorous, share to reach blood circulation promoting and blood stasis dispelling, activating QI to eliminate phlegm heat clearing away, holds concurrently with QI invigorating, warming YANG, collateral dredging the effect for the treatment of both the principal and secondary aspects of a disease.This prescription is in fact that anticoagulant, anti-fibre and antiplatelet aggregation are organically combined, can alleviate behind the early stage stenting body to the inflammatory reaction of coronary artery bracket, obviously improve the relation of vascular endothelial injury and Platelet Activation, PCI postoperative patients with coronary heart disease immunologic hypofunction state is regulated, thereby reached the purpose that reduces restenosis.This Chinese patent medicine not only can effectively improve the malaise symptoms such as coronary artery bracket postoperative patient person feeling of oppression and pain in the chest, the Effective Raise patients ' life quality, and also curative effect has been confirmed in clinical practice, to the obvious effect that has of prevention ISR.
Describe below in conjunction with the specific embodiment.
The specific embodiment
 
Figure 2012105884353100002DEST_PATH_IMAGE002
My institute accepts patients with coronary heart disease 605 examples year January in January, 2007 to 2012 altogether for medical treatment, and from safety with guarantee the angle of sample size, the patient who selects wherein intracoronary stening success totally 363 examples studies.
All patients all meet " percutaneous coronary intervention (pci) guide " treatment indication that angiocardiology branch of Chinese Medical Association formulated in 2002.Carried out coronary stenting, and the standard that hits pay dirk.And coronarography confirms that coronary artery has significantly narrow (>50%) within behind the percutaneous transluminal coronary stent implantation 6 months.
Method: select immediately eligible personnel's 350 examples, and be divided at random treatment group 280 example and matched group 70 examples.The conventional Aspirin sheet of matched group 100mg(Bayer A.G produces), every day 1 time, clopidogrel sheet 75mg (Plavix) (Hangzhou Sai Nuofei-Sheng Delabao people's livelihood pharmaceutical Co. Ltd produces), every day 1 time, treatment group is divided into four groups and add on the basis of matched group and to make capsule in the institute by oneself according to embodiment 1-4.Be 6 months two groups of courses for the treatment of.
Result: observe 6 months coronary angiography restenosis rate of postoperative, late period internal diameter numerical value, on the impact of serological index, electrocardiogram, clinical symptoms.Above difference all has statistical significance (P<0.05).Adverse reaction rate difference not statistically significant (P>0.05) during two groups of medications.
1. health giving quality index:
Before and after the stenting and postoperative 6 months, look into respectively two groups of Coronary Artery in patients radiography situations, the electrocardiogram ST-T changes, serum enzyme index, angina pectoris attacks number of times and persistent period.
Figure 2012105884353100002DEST_PATH_IMAGE004
 
Result of study
Untoward reaction during the medication such as digestive tract reaction, dermoreaction, leukopenia etc., concurrent sudden cardiac death, myocardial infarction, heart failure have or not death.
1. the check coronary angiography is relatively:
1.1 6 months capable coronary angiographies (CAG) of postoperative: treatment group obtains all greater than matched group at pathological changes minimum diameter, internal diameter acquisition in late period, clean internal diameter, and the narrow percentage ratio of pathological changes, late period internal diameter lose, late period internal diameter lose index all less than matched group, difference has statistical significance (P<0.05).
1.2 restenosis rate: the restenosis for the treatment of group is 6 examples, and restenosis rate is 8. 57%, and the restenosis of matched group is 22 examples, and restenosis rate is 27.5%, and treatment group significantly is lower than matched group, and difference has statistical significance (P<0.05).
2. the electrocardiogram ST-T changes: two groups of patients' ST section reduction 〉=0.05mV or ST section are obviously raised and are that mo(u)ld top half and T ripple are low flat dorsad, and two-phase or measurement have pathologic all obviously to reduce, and the matched group routine number that descends is more, and difference has statistical significance (P<0.05).
3. serum enzyme index contrast:
3.1 η b, η p, HCT, RFC, IR, VAI, TFL, DI all have remarkable reduction behind two groups of patient treatments, the treatment group fall is larger, and difference has statistical significance (P<0.05).
3.2 two groups of patients' TC, TG, LDL-C all obviously descend, HDL-C significantly raises, and the TC for the treatment of group, LDL-C fall are larger, illustrate that the improvement for the treatment of group patient TC, LDL-C obviously is better than matched group, and difference has statistical significance (P<0.05).
3.3 two groups of patients' IL-8, super quick CRP level all obviously descend, the treatment group fall is larger, and two groups of patients' TXA2 level obviously descends, and the treatment group fall is larger; The PGI2 level has remarkable rising, and treatment group rising amplitude is larger, and above difference has statistical significance (P<0.05).
4. clinical symptoms relatively: two groups of patients' weekly angina pectoris attacks number of times and each persistent period obviously reduce, and the treatment group fall is larger, and difference has statistical significance (P<0.05).
5. adverse effect: mainly contain that digestive tract reaction is felt sick, allergic rash and leukopenia, all disappear after the anti symptom treatment.The treatment group adverse reaction rate is 7.5%, and the matched group adverse reaction rate is 10.0%, difference not statistically significant P>0.05), two groups all without death.
Conclusion
Coronary artery bracket postoperative restenosis ISR patient belongs to the syndrome performance of traditional Chinese medical science blood stasis due to qi deficiency phlegm retention more, benefit heart capsule for freeing collateral vessels compatibility rigorous and scientific, can invigorating the spleen and replenishing QI, blood circulation promoting and blood stasis dispelling, can also reduce phlegm and promote blood circulation, can significantly improve coronary artery bracket postoperative patient person's blood stasis due to qi deficiency stagnation of phlegm state, alleviate that body improves body's immunity to the inflammatory reaction of coronary artery bracket behind the early stage stenting, reduce the incidence rate of postoperative restenosis, and without obvious adverse reaction.Digestive tract reaction, allergic rash and leukopenia that individual patient occurs, all very fast disappearances after the anti symptom treatment.This medicine is effective and safe to prevention ISR.

Claims (6)

1. medicine that prevents restenosis behind the percutaneous transluminal coronary stent implantation is characterized in that: by the composition ingredients of following mass component: Radix Astragali 200-250, Radix Ginseng 35-50, Radix Ophiopogonis 65-85, Radix Salviae Miltiorrhizae 220-245, Lignum Dalbergiae Odoriferae 65-90, Fructus Aurantii 100-130, Rhizoma Chuanxiong 100-125, Poria 105-130, Rhizoma Pinelliae Preparata 65-90, Fructus Trichosanthis 105-135, Bulbus Allii Macrostemonis 85-105, Pericarpium Citri Reticulatae 105-138, Radix Glycyrrhizae 60-85.
2. the medicine of restenosis behind the prevention percutaneous transluminal coronary stent implantation according to claim 1 is characterized in that: by the ingredients of following mass component: Radix Astragali 230-240, Radix Ginseng 40-45, Radix Ophiopogonis 70-80, Radix Salviae Miltiorrhizae 230-235, Lignum Dalbergiae Odoriferae 75-80, Fructus Aurantii 110-120, Rhizoma Chuanxiong 110-120, Poria 110-120, Rhizoma Pinelliae Preparata 75-80, Fructus Trichosanthis 110-120, Bulbus Allii Macrostemonis 90-95, Pericarpium Citri Reticulatae 110-120, Radix Glycyrrhizae 75-80.
3. the medicine of restenosis behind the prevention percutaneous transluminal coronary stent implantation according to claim 1 and 2 is characterized in that: described medicine is by the ingredients of following mass parts: the Radix Astragali 232, Radix Ginseng 46, Radix Ophiopogonis 77, Radix Salviae Miltiorrhizae 232, Lignum Dalbergiae Odoriferae 77, Fructus Aurantii 116, Rhizoma Chuanxiong 116, Poria 116, Rhizoma Pinelliae Preparata 77, Fructus Trichosanthis 116, Bulbus Allii Macrostemonis 93, Pericarpium Citri Reticulatae 116, Radix Glycyrrhizae 77.
One kind prepare claim require restenosis behind the 1-3 any one prevention percutaneous transluminal coronary stent implantation the method for medicine, it is characterized in that: Radix Ginseng, Poria two flavors are ground into fine powder, residue ten adds simply water and filters, decocts, merging filtrate, be condensed into the thick paste shape, with above-mentioned fine powder and auxiliary materials and mixing, granulate, drying incapsulates.
Behind the preparation according to claim 4 prevention percutaneous transluminal coronary stent implantation restenosis the method for medicine, it is characterized in that: described decoction is secondary, each 2 hours.
6. the method for the medicine of restenosis behind the preparation according to claim 4 prevention percutaneous transluminal coronary stent implantation, it is characterized in that: described adjuvant is medical dextrin, the ratio 30:1 of blending.
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105641083A (en) * 2016-02-25 2016-06-08 吕煜 Traditional Chinese medicine composition for preventing and treating restenosis after coronary stenting
CN106860920A (en) * 2017-02-20 2017-06-20 吉林大学 PLA coronary artery bracket preparation method

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CN1334121A (en) * 2001-08-31 2002-02-06 石家庄以岭药业有限公司 Medicinal composition for restoring cardiac collaterals and its application

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1334121A (en) * 2001-08-31 2002-02-06 石家庄以岭药业有限公司 Medicinal composition for restoring cardiac collaterals and its application

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105641083A (en) * 2016-02-25 2016-06-08 吕煜 Traditional Chinese medicine composition for preventing and treating restenosis after coronary stenting
CN106860920A (en) * 2017-02-20 2017-06-20 吉林大学 PLA coronary artery bracket preparation method

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