CN102657671A - Troxerutin and ligustrazine combined preparation and application thereof - Google Patents
Troxerutin and ligustrazine combined preparation and application thereof Download PDFInfo
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Abstract
The invention belongs to fields of medicinal preparation and application of the medicinal preparation. A troxerutin and ligustrazine combined preparation is characterized in that the oral preparation or injection is prevented from troxerutin and ligustrazine in a weight ratio of 500:40. The troxerutin and ligustrazine combined preparation is used for treating coronary disease, angina pectoris, hyperviscosity, fundus arteriosclerosis ischemic blindness, impaired vision and cerebral infarction and preventing cardiovascular events. The troxerutin and ligustrazine combined preparation disclosed by the invention has the beneficial effects that the two drugs are combined and the single dose of the troxerutin therein is increased by more than one time so as to be convenient for the large dose taking. Proved by clinic, the combination of large dose of the troxerutin and the ligustrazine plays roles of which the single drug cannot play; roles of the two drugs are complementary; the dose is increased, the curative effect is improved and an unexpected role of treating ischemic diseases is played; good treatment effects on the angina pectoris, the hyperviscosity, the fundus arteriosclerosis ischemic blindness, the impaired vision, the cerebral infarction and the like are provided; and acute myocardial infarction and the cerebral infarction can be prevented from happening through taking the combination disclosed by the invention for a long term.
Description
Technical field
The invention belongs to pharmaceutical preparation and application thereof.
Background technology
Troxerutin, another name: troxerutin, troxerutin.Chemistry is called 3 ', 4 ', 7-three [0-(2-ethoxy)-5 flavonols-3]-rutin, molecular formula C
33H
42O
19, molecular weight: 742.68.
The pharmacological action of troxerutin: can suppress hematoblastic coagulation; The thrombotic effect that prevents is arranged. the blood vessel injury that can cause medmain, Kallidin I simultaneously; Increase capillary resistance; Reduce capillary permeability, can prevent the edema that vascular permeability raises and causes. the acute ischemic brain injury there is significant protective effect.The semi-synthetic chromocor compound that this strain rutin is processed through hydroxyethylation has the erythrocyte of inhibition and platelet aggregation effect, prevents thrombosis, can increase the content of oxygen in the blood simultaneously, and microcirculation improvement promotes neovascularity to generate to promote side Zhi Xunhuan.It has protective effect to endotheliocyte, and effects such as radioresistance damage, anti-inflammatory, antiallergic, antiulcer are arranged.
At present troxerutin be usually used in treating ischemic cerebrovascular, thrombophlebitis, central serous chorioretinopathy, vascular permeability increase due to edema etc.
Dosage form and specification: tablet: 60mg/ sheet.Injection: 100mg/2ml; 100ml: troxerutin 0.4g and sodium chloride 0.9g; 250ml: troxerutin 0.32g and sodium chloride 2.25g; 250ml: troxerutin 0.48g and sodium chloride 2.25g.
Conventional usage and dosage: intramuscular injection: a 60 ~ 150mg, 2 times on the one.20 was 1 course of treatment, 3 ~ 7 days at interval per course of treatment.Intravenous drip: a 240 ~ 480mg, 1 time on the one (instiling with 5～10% glucose injections or low molecular dextran injection dilution back) was 1 course of treatment or follows the doctor's advice in 20 days.
Because the low price of troxerutin preparation, and not remarkable at therapeutic effect under predose, withdraw from the market gradually.
Ligustrazine, another name: tetramethylpyazine.Molecular formula C
8H
12N
2, molecular weight 136.20.
The pharmacological action of ligustrazine: have pair antiadrenergic drug and potassium chloride to cause the effect that the stripped tremulous pulse of rabbit shrinks.Coronary flow be can obviously increase, arterial pressure and arteria coronaria resistance reduced.Can pass through blood brain barrier, the quiet notes of rabbit can be observed the mesentery microcirculation blood flow velocity and the open number of blood capillary increases, so the microcirculatory effect of enhancement is arranged.Can suppress the inductive rabbit extracorporeal platelet aggregation of ADP, when 1mg/ml, its suppression ratio can reach 94.3%.During rat intravenous injection 60mg/kg, vein shunt thrombosis is had inhibitory action, to the then unrestraint effect of thrombosis that is caused by blood coagulation in the rabbit auricular vein, therefore, ligustrazine possibly stop the formation of arterial thrombus through anticoagulant.The antiplatelet function of TMPZ suppresses Ca++ mobilization in the cell through inducing; Strengthen cAMP in the cell through suppressing phosphodiesterase activity; The exposure of the GP IIb/IIIa that reduces simultaneously at activated platelet surface. at CPB; TMPZ has the complete and quantity of hematoblastic form of maintenance and acting under the high shear stress of function; Platelet thrombus forms and is considered to by von Willebrand factor (vWF) and platelet receptor Protein G P Iba and GP IIb/IIIa, the generation that interacts.TMPZ performance antiplatelet effect possibly be through suppressing the platelet thrombus forming process of vWF-mediation.In addition, detecting P-selectin surface expression and microgranule through quantitative flow cytometer discharges and can be suppressed by TMPZ.TMP has direct vasodilative effect, the effect that can block TMP to the special blocker of the K passage of SKCa (small conductance calcium-activated potassium channel) or KATP (ATP-sensitive potassium channel).In addition, the inductive vasodilation of TMP can be reversed by the sGC inhibitor.Similar with the K channel blocker.The expansion of results suggest TMP induction of vascular is relevant with the KATP channel opener with SKCa.Be used for obliterative vascular disease, cerebral thrombosis, vasculitis, coronary heart disease, angina pectoris.
Ligustrazine, the chemical name 2 is that the Chinese medicine Rhizoma Chuanxiong forms through separating to purify.The hot temperature of Rhizoma Chuanxiong is walked to scurry, and blood-activating and qi-promoting is walked and do not kept, and is gas medicine in the blood.Modern pharmacological research, ligustrazine have the blood vessel dilating blood pressure lowering, and free radical is removed in the oxidation of lipotropism matter, prevents effects such as reperfusion injury.The clinical ischemic cerebrovascular that is used for deficiency of vital energy blood paralysis, the tired arthralgia due to stagnation of blood resistance of wind-phlegm venation more.
Ligustrazine Phosphate pill single dose 50mg; Oral one time 1～2.Ligustrazine injection single dose 40mg/2ml, 1～2 of usual amounts.Although ligustrazine is used as the treatment of the ischemic heart, cerebrovascular disease, clinical effectiveness can not show a candle to Radix Salviae Miltiorrhizae or other Chinese medicine preparation, so seldom use.
Unstable angina pectoris is sucked or quiet notes nitroglycerin still can not alleviation person, and this is the problem that the intracardiac doctor of section need solve.In addition, the infusion nitroglycerin needs lucifuge, and dripping fast per minute can not surpass 10, and too fast meeting causes blood pressure drops, makes troubles for nurse and patient.The cardiovascular Coronary Artery Bypass pulsation frame intervene operation of coming of age has solved the angina pectoris attacks that causes because of arteria coronaria severe stenosis or obstruction; But operation has traumatic and risk; And surgery cost is higher, much need not perform the operation or certain reason to be reluctant that the patient who performs the operation hopes that still Drug therapy solves ailing.
Summary of the invention
The present invention is intended to overcome the defective and the deficiency of prior art; The medicine and the application process thereof of a kind of troxerutin and ligustrazine combination preparation are provided, in order to solve coronary heart disease unstable angina and other the serious ischemic diseases that the infusion nitroglycerin all can not be alleviated.
Troxerutin and ligustrazine combination preparation (abbreviation compositions) is characterized in that, oral formulations or injection that troxerutin and ligustrazine are processed with the weight ratio of 500:40.
Described oral formulations is that single dose contains troxerutin 0.5g; The tablet of ligustrazine 40mg.
Described oral formulations is that single dose contains troxerutin 0.25g; The tablet of ligustrazine 20mg.
Described injection is the intravenous injection that contains 1g troxerutin and 80mg ligustrazine in the 250ml normal saline.
The application of said troxerutin and ligustrazine combination preparation is used to treat angina pectoris, high blood viscosity, the blind and visual deterioration of ocular fundus arteriosclerosis ischemic, the prevention of cerebral infarction and cardiovascular and cerebrovascular vessel incident.
Compared with prior art, the invention has the beneficial effects as follows: because two medicines share, and wherein the single dose of troxerutin adds and is twice abovely, is convenient to large dose oral administration.Clinical proof, heavy dose of troxerutin and ligustrazine are share the effect that single drug does not have of playing.The two share action compensating; Dosage increases, and curative effect improves, and the treatment ischemic diseases plays beyond thought effect.To angina pectoris, high blood viscosity, the blind and visual deterioration of ocular fundus arteriosclerosis ischemic, cerebral infarction etc. have excellent curative.But take the generation of present composition prophylaxis of acute myocardial infarction and cerebral infarction for a long time.
The specific embodiment
Embodiment 1:
Inventory:
Technology: with troxerutin, ligustrazine, starch, Icing Sugar mix homogeneously, make wetting agent with ethanol and process soft material, cut into granule; 14 eye mesh screens pendulum grain, 60 degree are dry, add magnesium stearate; Cross 14 eye mesh screen granulate, mixing is pressed into single dose and contains troxerutin 0.5g; The tablet of ligustrazine 40mg.
Embodiment 2:
Inventory:
Technology: with troxerutin, ligustrazine, starch, Icing Sugar mix homogeneously, make wetting agent with ethanol and process soft material, cut into granule; 14 eye mesh screens pendulum grain, 60 degree are dry, add magnesium stearate; Cross 14 eye mesh screen granulate, mixing is pressed into single dose and contains troxerutin 0.25g; The tablet of ligustrazine 20mg.
Embodiment 3:
Single dose: troxerutin 100g;
Ligustrazine 8g;
Sodium chloride 225g;
Distilled water adds to 25000ml.
Technology: according to conventional method above-mentioned raw materials is added in the water for injection, stir, fully dissolving; Add activated carbon adsorption, coarse filtration, fine straining, the 250ml intravenous fluid that contains 1g troxerutin and 80mg ligustrazine is processed in fill, the heating and pressurizing sterilization.
Clinical observation one: the present composition is observed the treatment of coronary heart disease unstable angina:
1. patient selection: be the inpatient, have typical chest pain and electrocardiogram ischemia to change, be diagnosed as coronary heart disease unstable angina.Amount to 186 examples.Wherein, male 121 examples, women 65 examples, minimal ages 48 years old, maximum 76 years old.
2. method: at random patient is divided into two groups; 95 examples are organized in treatment, wherein, and male 59 examples, women 36 examples, minimal ages 50 years old, maximum 76 years old.Employing contains troxerutin 1g, ligustrazine 80mg, and 2 of the 250ml injections of sodium chloride 2.25g, intravenous drip was once a day observed 7 days.Matched group 91 examples, wherein, male 62 examples, women 29 examples, minimal ages 48 years old, maximum 73 years old.Adopt nitroglycerin 2mg to add lucifuge intravenous drip among the normal saline 250ml, once a day, observed 7 days.
3. observation index: 1. clinic control: angina pectoris disappears; 2. produce effects: angina pectoris obviously alleviates, and attack times reduces; 3. effective: angina pectoris alleviates slightly, and attack times reduces; 4. invalid, the angina pectoris no change.(seeing table 1)
Table 1 compositions is observed the treatment of unstable angina pectoris
4, brief summary: treatment group treatment unstable angina pectoris total effective rate 100%, and be mainly to account for 97.9% with the clinic control, the matched group clinic control accounts for 71.4%, invalidly accounts for 11%, total effective rate 89%, both have significant difference P＜0.01 by the therapeutic effect statistics.And the 10 routine patients that fail to respond to any medical treatment of matched group nitroglycerin, used combination treatment instead 4 days, angina pectoris disappears all.The curative effect that present composition treatment unstable angina pectoris is described is superior to nitroglycerin.
Clinical observation two: the present composition is observed the treatment of high blood viscosity:
1. all be the outpatient, amount to 82 examples, male 49 examples, women 33 examples, 39～72 years old age.Be judged to be high blood viscosity through complete check of hemorheology.
2. method: at random patient is divided into two groups, 41 examples are organized in treatment, male 24 examples, women 17 examples, the oral troxerutin 0.5g that contains, 2 in the tablet of ligustrazine 40mg; Bid; Matched group 41 examples, male 25 examples, women 16 examples, oral aspirin 100mg Qd; All be 30 days the course of treatment.Period in a medicine stop using diuretic, blood-activating and stasis-dissolving presscription.
3. observation index: check complete of hemorheology before and after the treatment respectively, observe lowly cut, height is cut, plasma viscosity and erythrocyte aggregation index.(seeing table 2～4)
Table 2 WBV (meansigma methods)
Table 3 plasma viscosity (meansigma methods)
Table 4 erythrocyte aggregation index (meansigma methods)
4. brief summary: aspirin is the medicine of internationally recognized control cardiovascular and cerebrovascular disease, through suppressing the effect of Cycloxygenase-1, transforms to thromboxane thereby suppress arachidonic acid, reduces the generation of thromboxane, finally reduces platelet aggregation and anti-tampon.Therefore influence the gathering of blood rbc and viscosity is reduced, and plasma viscosity is not had influence.The treatment group has obvious reduction effect to erythrocyte aggregation index, and with aspirin contrast, both statistics no significant differences, but result of laboratory test is better than matched group slightly.Explain that the treatment group also has antiplatelet aggregative activity, and contrast all there is significant difference before and after WBV and the plasma viscosity treatment, explains that the treatment group has the blood viscosity of reduction, dilute blood effect.
Clinical observation three: the present composition is to the Electrocardiographic influence of coronary heart disease and myocardial ischemia:
1. all be to be in hospital or the outpatient amounts to 205 examples.Wherein, male 113 examples, women 92 examples; 45～76 years old age.Patient mainly with uncomfortable in chest, feel suffocated, cardiopalmus goes to a doctor, and is diagnosed as coronary heart disease and myocardial ischemia through electrocardiogram.
2. method is divided into two groups with patient at random.112 examples are organized in treatment, adopt to contain troxerutin 1g, ligustrazine 80mg, 2 of the 250ml injections of sodium chloride 2.25g, intravenous drip, Qd, 14 days courses of treatment.Matched group 93 examples adopt FUFANG DANSHEN ZHUSHEYE 16ml to add normal saline 250ml iv drip, Qd, 14 days courses of treatment.
3. S-T, the T of observation index electrocardiogram after treatment changes.1. recover normal, recover normal ECG, 2. produce effects, S-T, T have bigger recovery, and be 3. effective, and S-T, T have slight recovery, and be 4. invalid, S-T, T no change or increase the weight of.(seeing table 5)
The Electrocardiographic variation of table 5 combination treatment coronary heart disease and myocardial ischemia
4, brief summary: FUFANG DANSHEN ZHUSHEYE is the Chinese medicine preparation of well treating coronary heart disease and myocardial ischemia, has the effect that blood circulation promoting and blood stasis dispelling etc. improves myocardial ischemia, and compositions and compound Salviae Miltiorrhizae are relatively; It is stronger that the former improves the effect of myocardial ischemia, because reduction in ST segment depression, the T ripple hangs down flat or is inverted is the diagnosis sign of reflecting myocardium infringement and ischemia; So increasing of coronary blood supply explained in the improvement of ST, T, also just improved the damage that myocardial ischemia and ischemia cause to cardiac muscle, from observing table analysis treatment group the total effective rate that improves of ECG ST-T is accounted for 95.5%; Electrocardiogram recovers normally to account for 37.5% fully, produce effects 42.8%, and matched group total effective rate 77.4%; Electrocardiogram recovers normally to account for 18.3% fully, produce effects 31.2%, and invalidly account for 22.6%; The two contrast of statistics has significant difference; P＜0.01 explains that compositions has good coronary blood flow increasing, improves the myocardial ischemia effect, so the ischemic electrocardiogram improves more obvious.
Clinical observation four: the present composition is to the blind treatment of ocular fundus arteriosclerosis ischemic
1. it is blind that patient is diagnosed as ischemic, and totally 7 examples adopt combination treatment, male 5 examples, and women 2 examples, at 51～72 years old age, medical history 1～3 year has diabetic history 5 examples, and wherein 2 examples are accompanied the dried adacryas of eye, and 3 examples have light sensation.
2. method: adopt to contain troxerutin 1g, ligustrazine 80mg, 2 of the 250ml injections of sodium chloride 2.25g, intravenous drip, Qd treats that patient all recovers lost eyesight after 14 days, has an eyesight test between 0.3～0.6, and 2 example eyes are done patients and have been flowed out tear simultaneously.
3. brief summary: the visual deterioration that arteriosclerosis optical fundus ischemia causes and blind more common; Special diabetes patient falls ill more; Up to the present also not effective especially drug treatment reads up the literature; 7 routine patients all recover lost eyesight after with the present composition, have removed blind hardship, have explained that said composition has to improve the optical fundus ischemia well, increase the optical fundus blood flow, promote the effect of vision restoration.
Clinical observation five: the present composition is observed the treatment of cerebral infarction sequela
1. patient all is the cerebral department discharged patient, in the course of disease 2 years, half body moving obstacle is in various degree arranged all, and part patient accompanies aphasis or dysphagia, and patient amounts to 94 examples, wherein, and male 56 examples, women 38 examples, 41～75 years old age.
2. method: all patients take in internal medicine ward, are divided into 2 groups at random.48 examples are organized in treatment, wherein male 29 examples, and women 19 examples at 46～75 years old age, adopt to contain troxerutin 1g, ligustrazine 80mg, 2 of the 250ml injections of sodium chloride 2.25g, intravenous drip, Qd, 14 days courses of treatment.Matched group 46 examples, wherein male 27 examples, women 19 examples at 41～73 years old age, adopt Herba Erigerontis 40ml and vinpocetine 20mg to add normal saline 250ml respectively, intravenous drip, Qd, 14 days courses of treatment.
3. observation index: 1. produce effects, can stand or walk down, upper limb can be movable, language or swallow and have clear improvement or take a turn for the better fully, 2. effective, upper and lower extremities can be praised, and activity makes moderate progress, and language or swallowed improvement is 3. invalid, treatment back no change.(seeing table 6)
Table 6 compositions is observed the treatment of cerebral infarction sequela
4. brief summary: matched group, hemiplegia produce effects 6.5%, total effective 58.7%; Aphasia produce effects 7.1%, dysphagia produce effects 33.3%, and treatment group; Hemiplegia produce effects 35.4%, total effective 87.5%, aphasia, dysphagia produce effects are respectively 37.5%, 55.6%; Two groups of statistics contrast there were significant differences P＜0.01 explain that the treatment group has good therapeutic effect to cerebral infarction sequela, the recovery of functions such as promotion hemiplegia and aphasia.
Clinical observation six: the present composition is observed the long-term prophylactic treatment of coronary heart disease unstable angina
1. patient all is that clinical observation one treatment group was treated and the coronary heart disease unstable angina patient that obtains clinic control 93 examples totally, wherein, and male 57 examples; Woman's 36 examples, minimal ages 50 years old, maximum 76 years old; 8 examples are through coronary angiography, and coronary stenosis reaches between 75～90% respectively.
2. method: at random patient is divided into two groups, 46 examples are organized in treatment, male 30 examples; Woman's 16 examples, 50～76 years old age is earlier with the oral troxerutin 0.5g that contains; 2 Bid treatments of the tablet of ligustrazine 40mg were used the oral troxerutin 0.5g that contains instead, 1 Bid of the tablet of ligustrazine 40mg after one month; Matched group 47 examples, male 27 examples, women 20 examples, 51～71 years old age, oral aspirin 100mg and metoprolol 12.5mgQd, while and the glad health 20mg of southern Shandong and gingko leaf dispersible tablet 0.3gTid share.All patient's prophylactic treatment was observed 2 years.
3. observation index: whether angina pectoris generation and frequency are converted into myocardial infarction.
4, brief summary: acute myocardial infarction takes place in matched group 2 examples, wherein sick back death in 3 days of an example; Other has angina pectoris to recur 9 examples; Myocardial infarction takes place in none example of treatment group, but 3 routine recurrent angina are arranged, and two groups of contrasts of statistics there were significant differences P＜0.05 explain that the compositions long-term prescription has the effect that reduces the angina pectoris recurrence and prevent myocardial infarction.
Clinical observation seven present compositions are observed cerebral infarction patient's long-term prophylactic treatment
1, patient is the cerebral infarction disorder of limb ' s activity, back patient totally 43 examples of leaving hospital, wherein male 30 examples, women 13 examples, 54～73 years old age.
2, method: at random patient is divided into two groups, 22 examples are organized in treatment, wherein male 15 examples, women 7 examples, 55～73 years old age.The oral troxerutin 0.5g that contains, two in the tablet of ligustrazine 40mg; One day twice; Change the oral troxerutin 0.5g that contains after 2 months into, tablet a slice of ligustrazine 40mg, a twice-daily; Matched group 21 examples, wherein male 15 examples, women 6 examples, 54～69 years old age.3 Tid of oral aspirin 100mg Qd and XUESHUANXINMAINING and YIKAI 240 Tid of unit; All patient is 2 years.
3, observation index: prevention at a specified future date and therapeutic effect mainly comprise: the limb activity capacity variation has or not cerebral infarction to take place.The state of an illness lapses to variation, refers to that sb.'s illness took a favorable turn or deterioration.
4, brief summary: cerebral infarction disorder of limb ' s activity patient, 19 examples are organized in treatment has improvement in various degree, and wherein 8 examples can be stood or walk, the acute cerebral infarction of 3 example recurrences; Matched group 10 examples have in various degree to be improved, and does not have 1 example and stands or walk, and 9 example recurrence acute cerebral infarction are in hospital once more, and 2 example nothings are improved.Two groups of contrast statistics there were significant differences P＜0.01 explain that the treatment group still has good therapeutic effect at a specified future date to cerebral infarction sequela, has also reduced relapse rate.
Claims (5)
1. troxerutin and ligustrazine combination preparation is characterized in that, oral formulations or injection that troxerutin and ligustrazine are processed with the weight ratio of 500:40.
2. troxerutin according to claim 1 and ligustrazine combination preparation is characterized in that, described oral formulations is that single dose contains troxerutin 0.5g; The tablet of ligustrazine 40mg.
3. troxerutin according to claim 1 and ligustrazine combination preparation is characterized in that, described oral formulations is that single dose contains troxerutin 0.25g; The tablet of ligustrazine 20mg.
4. troxerutin according to claim 1 and ligustrazine combination preparation is characterized in that, described injection is the intravenous injection that contains 1g troxerutin and 80mg ligustrazine in the 250ml normal saline.
5. the application of described troxerutin of claim 1 and ligustrazine combination preparation is used to treat angina pectoris, high blood viscosity, the blind and visual deterioration of ocular fundus arteriosclerosis ischemic, the prevention of cerebral infarction and cardiovascular and cerebrovascular vessel incident.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1969897A (en) * | 2005-11-23 | 2007-05-30 | 北京奇源益德药物研究所 | Pharmaceutical composition for treating cardiovascular and cerebrovascular diseases, preparation process and quality control method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1969897A (en) * | 2005-11-23 | 2007-05-30 | 北京奇源益德药物研究所 | Pharmaceutical composition for treating cardiovascular and cerebrovascular diseases, preparation process and quality control method thereof |
Non-Patent Citations (4)
| Title |
|---|
| 《中国乡村医药》 20011031 连建共 川芎嗪、曲克芦丁治疗脑梗死疗效观察 第8卷, 第10期 * |
| 孟德俊: "维脑路通与川芎嗪联合治疗脑梗死32例", 《滨州医学院学报》, vol. 23, no. 05, 31 December 2000 (2000-12-31) * |
| 李纪元: "川芎嗪、曲克芦丁治疗脑梗死98例疗效观察", 《基层医学论坛》, vol. 10, no. 05, 31 December 2006 (2006-12-31) * |
| 连建共: "川芎嗪、曲克芦丁治疗脑梗死疗效观察", 《中国乡村医药》, vol. 8, no. 10, 31 October 2001 (2001-10-31) * |
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Application publication date: 20120912 |