The objective of the invention is at the existing defective of state of the art, by excavating the Chinese patent medicine that is exclusively used in the treatment angina pectoris that the abundant Chinese medicine resource of motherland provides a kind of prescription science, curative effect height and human body is had no side effect.
The preparation scheme of Chinese patent medicine of the present invention is according to the traditional Chinese medical science analytics of angina pectoris etiology and pathology to be controlled the relevant pharmacological experiment of thought and modern medicine basis to obtain.The traditional Chinese medical science thinks that the etiology and pathology of angina pectoris mostly is " imbalance of YIN and YANG, mechanism of qi be contrary to cause disorderly that the painstaking effort stasis of blood stagnates, blockage of the cardiac vessels, stagnation of QI and blood may bring about pain ".Interior warp " a Ling Shu Miraculous Pivot or Divine Axis five pathogenic factors piece of writing " has saying of " evil in the heart, then sick in pain "; " opinion when element is asked the internal organs method " points out " heart patient, chest pain, discomfort and fullness in the hypochondrium, pain over the hypochondrium, pain between breast back of the body omoplate, pain in the medial sides of both arms." " Ling Shu Miraculous Pivot or Divine Axis faint disease a piece of writing " say: " precordial pain with cold limbs ... pain is moved the pain benefit very in the heart." " angina pectoris, bluish colour of the limbs extending up to the elbows and knees, very pained, onset of disease in the morning and dying in the evening, onset of disease in the evening and dying in the next morning." also claim in " Medical Treasures of the Golden Chamber obstruction of qi in the chest and cardialgia lose heart abnormal pulse card control ": " and the thoracic obstruction for sick, dyspnea and expectoration, the pain over the chest and back is losed heart." " thoracic obstruction must not crouch chest pain radiating to the back " etc.These are all very similar to the clinical manifestation of angina pectoris, and visible stagnation of heart-blood is the main morbidity base reason of this disease.The traditional Chinese medical science is thought " heart governing blood and vessels ", and " heart master yang-energy " is so pained pathogeny and deficiency of heart-QI relation are most close.A little less than the motive incentive force, stagnation of heart-blood and cause painedly, this just need be aided with the method that invigorates vital energy and reinforce the heart and treat based on the blood circulation and channel invigorating pain relieving.Chinese patent medicine of the present invention promptly is on pathological analysis and clinical practice basis to this disease, dialectically combine with differential diagnosis of diseases, at patient's disease and by develop acquisition to motherland's Chinese medicine resource is in addition selected, medicine material in the side is made up of Rhizoma Corydalis, siphonostegia chinensis, Rhizoma Drynariae, Radix Ginseng, have fabulous blood circulation and channel invigorating pain relieving, the cardiac stimulant effect of QI invigorating warming YANG, aspect angina pectoris class treatment of conditions, significant effect is being arranged.
The weight proportion of forming each herbal medicine raw material of Chinese patent medicine of the present invention is: 100~2000 unit of weights of Rhizoma Corydalis (vinegar system), 150~1800 unit of weights of siphonostegia chinensis, 200~2500 unit of weights of Rhizoma Drynariae, 50~1000 unit of weights of Radix Ginseng.
Prescription analysis:
Rhizoma Corydalis, is gone into the pain relieving of conscience spleen channel blood-activating and qi-promoting at arduous temperature.Invigorate blood circulation is that blood stasis dispelling is with promoting blood circulation; Circulation of qi promoting is to help blood capable, and is also capable with the capable then blood of gas.Blood stasis also can cause functional activity of QI being not smooth and the stagnation of QI has the merit of killing two birds with one stone with Rhizoma Corydalis." so stasis in the gas is all pains about specially controlling all over the body for Rhizoma Corydalis, the stagnation of QI in the energy promoting the circulation of blood for the Compendium of Material Medica cloud.With among, simply fantastic." " Thunder God concoct opinion " also have saying of " pained desire being dead, and speed is looked for Rhizoma Corydalis ".So with Rhizoma Corydalis is monarch drug.
Siphonostegia chinensis, bitter temperature is gone into heart channel, and its effect is that removing blood stasis stimulates the menstrual flow, eliminating stasis to stop pain." Japan hanako materia medica " says that it " controls cardiac and abdominal pain ", and " it is former that book on Chinese herbal medicine is asked " says that it " controls motive pain ", and " book on Chinese herbal medicine converges " claims that also it is " the celestial agent of removing blood stasis ... specially go into blood system ... specially treat mass formed by blood stasis ".So with the siphonostegia chinensis is ministerial drug, the main disease of the principal drug assistance treatment obstruction of collaterals by blood stasis thoracic obstruction.
Radix Ginseng, the sweetness and bitterness temperature is gone into heart spleen channel.Strongly invigorating primordial QI, the beneficial motive, tranquilizing mind.With the deficiency of reinforcing the heart gas, and treatment time card.Motive foot, blood vessels just are able to normal operation, do not stagnate and do not stay, and make blood stasis be difficult to produce.So also be ministerial drug.
Rhizoma Drynariae, bitter temperature is also gone into heart channel, promoting blood circulation and stopping pain, " Katyuan book on Chinese herbal medicine " claims its " main removing blood stasis ", because of it has the effect of promoting blood circulation and stopping pain, but principal drug assistance is treated main disease, so this medicine is helped for it.
Above-mentioned four medicines, monarch drug Rhizoma Corydalis promoting blood circulation, removing blood stasis and relieving pain has the merit of circulation of qi promoting the most again for; Ministerial drug siphonostegia chinensis promoting blood circulation and stopping pain power is strong, borrows the bitter temperature of Radix Ginseng to go into heart channel, strongly invigorating primordial QI again; The kidney warming pain relieving of invigorating blood circulation of adjuvant drug Rhizoma Drynariae.Three medicines are bitter using warming therapy product, but the hardship the turbid descending, temperature can be driven YIN-cold, the turbid YIN pathogen of reducing phlegm, in case the heresy of YIN-cold stagnates, all medicines are all gone into heart channel.By the organic composition and the cooperation of this four medicine, the merit that play the blood circulation and channel invigorating pain relieving altogether, invigorates vital energy and reinforce the heart.
Actual product dosage form of the present invention can be the various one-tenth pharmaceutically dosage forms that comprise capsule, tablet, granule etc.
Clinical observation and curative effect
In the development process of Chinese patent medicine of the present invention, for the clinical efficacy of this medicine of objective evaluation treatment angina pectoris and to the safety of human body, the applicant had once carried out the II clinical trial phase according to Ministry of Public Health bureau of drug administration (98) ZL-038 certification, during clinical treatment and observe case 301 examples altogether.
One, case is selected: include in test case person be have the angina pectoris primary symptom, diagnosis is clear and definite, meet the traditional Chinese medical science " stagnation of heart-blood hold concurrently insufficiency of heart-QI " the dialectical and above angina pectoris person that shows effect weekly twice, patient age is between 18~70 years old.
Two, medicining mode: oral, every day 3 times, day dose 3~5g is a course of treatment around taking continuously, and stopping using in the course of treatment, other treats the medicine and the method for this disease.
Three, observation index:
1, safety observation:
A) general physical examination project (comprising the untoward reaction performance that may occur);
B) blood, urinate just routine test;
C) electrocardiogram, liver function (ALT), renal function (Bun, Cr).
2, health giving quality observation:
A) variation of tcm symptom, tongue, arteries and veins is observed;
B) angina pectoris attacks time, number of times, degree, persistent period;
C) Electrocardioscopy;
D) specific heart isozyme, blood fat monitoring;
E) blood examination;
F) cardiac inspection;
G) exercise ECG inspection;
H) vectorcardiogram inspection;
I) dynamic ecg recordings examination;
J) table thought-read electrograph is checked.
Four, curative effect determinate standard
1, symptom criterion of therapeutical effect (with reference to therapy of combining Chinese and Western medicine angina pectoris in 1979 and arrhythmia forum " angina pectoris and ECG curative effect evaluation criteria "):
A) produce effects: pain symptom disappears or basic the disappearance;
B) effective: pain attack times, degree and persistent period have obviously and alleviate;
C) invalid: symptom is preceding identical with treatment substantially;
D) increase the weight of: pain attack times, degree and persistent period increase the weight of to some extent.
2, ECG curative effect evaluation criteria (with reference to therapy of combining Chinese and Western medicine angina pectoris in 1979 and arrhythmia forum " angina pectoris and ECG curative effect evaluation criteria "):
A) produce effects: electrocardiogram returns to " roughly normal " (i.e. " normal range ") or reaches " normal ECG ";
B) effective: the reduction of S-T section, more than the treatment back rise 0.05mV, but do not reach normal level, (reaching 25% above person) shoals at the negative T wave that mainly leads; Or the T ripple becomes uprightly chamber or intraventricular block improver by smooth;
C) invalid: electrocardiogram is preceding identical with treatment substantially;
D) increase the weight of: the S-T section reduces more than the 0.05mV before the treatment, and negative T wave is deepened (reaching 25% above person) mainly leading; Or treatment T ripple flattens smoothly, and smooth T ripple becomes to be inverted, and ectopic cardiac rhythm, atrioventricular block or intraventricular block occur.
Five, therapeutic outcome:
Above experimental observation group 301 routine cases are after taking Chinese patent drugs for treatment of the present invention, and obvious effective rate is 52.16%, total effective rate 93.02%.Make discovery from observation in the process of the test, this medicine all has in various degree improve (P<0.05) to cardiac function, hemorheology, does not find obvious adverse reaction after the patient takes.