A kind of Chinese medicinal capsule agent and method for making thereof that can be used for treating the apoplexy and the thoracic obstruction
Content of the present invention belongs to the preparing technical field of pharmaceuticals, relates to a kind of pure Chinese medicinal preparation that can be used for treating the apoplexy (being cerebral hemorrhage, cerebral thrombosis, cerebral embolism of Western medicine diagnose etc.) and the thoracic obstruction (coronary heart disease, angina pectoris etc.) and preparation method thereof.
The apoplexy and the thoracic obstruction two diseases of Chinese medicine definition belong to cerebrovascular disease and cardiovascular disease, and they all are clinically important commonly encountered diseases and frequently-occurring disease.Apoplexy is many under energy and blood of human body interior-deficiency situation, or because of the overstrain internal injury or because of being worried angry or eating savoury and tobacco and wine etc. and bring out because of having a liking for, and shows as unexpected confused servant, hemiplegia, facial hemiparalysis, in silence or symptom such as stuttering puckery, the hemianesthesia of speech.The pathogenesis of the thoracic obstruction or because of cold blood stasis or because of phlegm stagnation in collateral or because of qi depression to blood stasis or because of blood stasis due to qi deficiency shows as breast breast portion painful abdominal mass plug, cardiopalmus, uncomfortable in chest, chest pain, symptom such as breathe hard.Morbidity is anxious because apoplexy and thoracic obstruction class cardiovascular and cerebrovascular disease have, the state of an illness is heavy, it is fast to change, can repeatedly fall ill and characteristics such as case fatality rate height, particularly old people healthy of human body health in serious harm, bring very white elephant per capita to society, family and patient are individual, thereby this class disease also is the heat subject that medical circle is concentrated concern and research in recent years always.
At present, doctor trained in Western medicine clinical treatment cardiovascular and cerebrovascular disease mainly is the therapeutic alliance that relies on multiple medicine, as adopt vasodilation, depressor etc., though curative effect is very fast, but human body all there are the untoward reaction and the side effect of certain degree, and its emphasis is the acute stage at disease, for patient after acute stage recovery and the treatment of sequela also lack safe and effective medicine; And the traditional Chinese medical science is treated the medicine of apoplexy and thoracic obstruction class at present generally based on benefiting QI for activating blood circulation class medicine, as ZHONGFENG HUICHUN WAN, Danshen heart-benefiting capsule etc., but in clinical practice, also still exist medication not comprehensively, problem such as curative effect is unstable and cure rate is low.
The objective of the invention is at the existing defective of state of the art, by excavate the abundant Chinese medicine resource of motherland provide a kind of prescription science, easy to prepare, curative effect is high and the pure Chinese medicine capsule preparation that is exclusively used in the treatment apoplexy and the thoracic obstruction that human body is had no side effect, and provides a kind of preparation method of producing this Chinese medicinal capsule preparation that is exclusively used in simultaneously.
The preparation scheme of medicine of the present invention comes from motherland's medical science about traditional determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs thoughts such as " treating different diseases with the same therapeutic principle ", " treating both the principal and secondary aspects of a disease ", " treatment must aim at the pathogenesis of disease ", it be the designer according to clinical practice for many years and take in concurrently on the theoretical and experiment basis of a large amount of at all times pharmacy by concentrated sum up to develop obtain.Though the sick position of apoplexy, the thoracic obstruction is different with clinical manifestation, etiology and pathogenesis has points of resemblance, and its common pathogenesis is blood stasis due to qi deficiency, venation block, excessive rising of liver-YANG, obstruction of collateral caused by windphlegm.The apoplexy and the thoracic obstruction all often betided after the middle age, also mainly were because come to one's autumn, and healthy energy day by day void declines, and it is capable unable to promote blood, and blood operation is slow and stagnate gradually and the stasis of blood hinders in arteries and veins.According to understanding to above-mentioned etiology and pathogenesis, designer of the present invention has proposed the Therapeutic Principle of " the brain heart is ruled together ", and more selected drug effects are concentrated and are easy to the raw material of Chinese medicine prescription that absorbs for people body-centered brain internal organs and are prepared into capsule, medicine in the side is by comprising the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Semen Persicae, Flos Carthami, Olibanum, Myrrha, Caulis Spatholobi, Radix Achyranthis Bidentatae, Ramulus Cinnamomi, Ramulus Mori, Pheretima, Scorpio, Hirudo is formed in interior meter ten six medicaments, full side has benefiting QI for activating blood circulation, the effect of disperse blood stasis and dredge collateral, aspect the treatment of apoplexy and thoracic obstruction disease, particularly aspect the treatment of this two diseases convalescent period and sequela stage, has fabulous effect, the blood stasis due to qi deficiency sign is fundamentally improved, thereby significantly reduced or eliminate of the threat of this type of disease health of people.
The proportioning value that constitutes each raw material components of capsule medicine of the present invention is: 20~80 unit of weights of the Radix Astragali, 10~60 unit of weights of Radix Salviae Miltiorrhizae, 8~50 unit of weights of Radix Angelicae Sinensis, 10~100 unit of weights of Radix Paeoniae Rubra, 10~55 unit of weights of Rhizoma Chuanxiong, 10~40 unit of weights of Semen Persicae, 5~35 unit of weights of Flos Carthami, 5~30 unit of weights of Olibanum, 5~35 unit of weights of Myrrha, 10~40 unit of weights of Caulis Spatholobi, 10~40 unit of weights of Radix Achyranthis Bidentatae, 5~30 unit of weights of Ramulus Cinnamomi, 10~50 unit of weights of Ramulus Mori, 5~60 unit of weights of Pheretima, 5~40 unit of weights of Scorpio, 10~50 unit of weights of Hirudo.
According to above-mentioned raw materials make prescription demonstrated fully the card opinion of facing that the promptly logical card of motherland medical science treating different diseases with the same therapeutic principle is ruled together, pathogenesis is identical, method of treatment is identical and controlled principle.Reuse the Radix Astragali in the side, tonifying Qi and lifting yang, capable stagnant, the strongly invigorating primordial QI of hemopoietic, " herbal classic is met former " cloud: " Radix Astragali ... though the property temperature compensation, and can lead to blood circulation regulating, popular meridians stagnate also can hinder in stopping up." vigour is filled contain by QI invigorating and reach the capable merit of the capable then blood of gas; Radix Salviae Miltiorrhizae function blood circulation promoting and blood stasis dispelling, removing heat from blood detumescence, clearing away heart-fire for tranquillization, Compendium of Material Medica is said it and " is invigorated blood circulation, leads to percardium." " book on Chinese herbal medicine converges and says " cloud: " Radix Salviae Miltiorrhizae is apt to control blood system, goes to stagnate tissue regeneration promoting, regulating menstruation along the feeling pulse medicine also." Radix Astragali and Radix Salviae Miltiorrhizae, one can stagnate by the QI invigorating row, and one can stimulate the menstrual flow by blood stasis dispelling, and two medicines share, and are monarch drug altogether, and the merit of benefiting QI for activating blood circulation, disperse blood stasis and dredge collateral is arranged.The Radix Angelicae Sinensis function is enriched blood and is invigorated blood circulation, menstruction regulating and pain relieving; Radix Paeoniae Rubra function eliminating stasis to stop pain, removing heat from blood detumescence; The Rhizoma Chuanxiong merit is apt to blood-activating and qi-promoting, wind-expelling pain-stopping; Radix Angelicae Sinensis, Radix Paeoniae Rubra all can promoting blood circulation to remove blood stasis, and the two and the same usefulness of Rhizoma Chuanxiong that can blood-activating and qi-promoting can reach the effect of blood circulation depending on qi flow, and auxiliary monarch drug activating blood circulation to dissipate blood stasis and dredge the collateral is ministerial drug altogether.Semen Persicae, Flos Carthami all are apt to promoting blood circulation to disperse blood clots and relieves pain, and Olibanum, Myrrha can be invigorated blood circulation, and also the circulation of qi promoting of double energy is diffusing stagnant in analgesic therapy, and four medicines share, and help the effect that the principal drug assistance ministerial drug is brought into play blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain.Radix Achyranthis Bidentatae can blood circulation promoting and blood stasis dispelling, conducting blood to flow downwards, but liver and kidney tonifying, bone and muscle strengthening again, its benefaction lower limb; Ramulus Cinnamomi, Ramulus Mori the meridian dredging, sharp joint, the benefaction upper limb; The Caulis Spatholobi promoting the circulation of blood is enriched blood, relaxing muscles and tendons and activating QI and blood in the collateral, and this four medicine all has stronger promoting blood circulation to remove obstruction in the collateral effect, has the justice of the through sick institute of priming concurrently, and in the row benefit is arranged, and is eliminating evil and do not hinder healthy energy, also makes for assistant in the side, and assistant helps its medicine to bring into play the effect of activating blood circulation to dissipate blood stasis and dredge the collateral.Pheretima has the effect of clearing heat for calming endogenous wind, current meridians, Scorpio endogenous wind stopping relieving convulsion, removing obstruction in the collateral to relieve pain, and the Hirudo merit is apt to removing blood stasis, this sentences three flavor worm medicines and makes as Fang Zhongzuo, is to get insects can search the effect of picking the heresy in the network, and network stimulates the menstrual flow, the justice that inducting the medicines into affected channel is arranged again, the through sick institute of all medicines venation in can the side of drawing, in addition, the insects flavour of a drug become, its with the side in blood circulation promoting medicine with the justice that then has Xin Chengtong to use, lid Xin Zetong, becoming can hard masses softening and resolving, makes that the blood network stasis of blood stagnates capablely, QI movement being in harmonious way, vital QI recovered after pathogens eliminated.All medicines share in the full side, can play the merit of benefiting QI for activating blood circulation, disperse blood stasis and dredge collateral altogether, examine because of opinion is controlled, method is upright with card, and Fang Congfa goes out, certificate cube is arranged.
The preparation method of capsule of the present invention is as described below: at first get Pheretima, Scorpio two flavors in the raw material side, mixed powder is broken into fine powder; Then all the other 14 flavor raw material mixed powders are broken into fine powder; With two kinds of fine powders facing-up mix homogeneously again, incapsulate every heavily about 0.4g of capsule at last.
Clinical observation and curative effect
One, the clinical observation and the curative effect that are used for the treatment of apoplexy:
Clinical this medicine of use is observed stroke in convalescent stage (6 week of apoplexy morbidity back) case 244 examples, and patient age is between 18~70 years old.
1, clinical symptoms: dizziness headache, one's ears rang and spots danced before one's eyes, dysphonia, facial hemiparalysis, hemiplegia, numb limbs and tense tendons, soft unable, the stiff contracture of limb.
2, medicining mode: oral capsule every day 3 times, each 4 is a course of treatment all around.
3, efficacy determination method (integration method): with reference to the integration method of Ministry of Public Health bureau of drug administration 1989 " new drug (Chinese medicine) clinical research guideline ", symptom that all actives are said note 4 minutes (+++), the symptom of getting, symptom are significantly or continue to occur 3 minutes (++) of note, heavy or be interrupted and 2 minutes (+) of note occur when light during symptom, mild symptoms or 1 minute (±) of appearance note once in a while, asymptomatic note 0 minute (-) has any one and should remember 6 fens in inspection or the pulse-taking.
4, efficacy determination: curative effect is divided recovery from illness, produce effects, effective and invalid four kinds, with inquiring, inspection, the pulse-taking integrated value of summation for this patient's card of keeping the score.All treatments back symptom all disappearance person is recovery from illness; It is produce effects that treatment back symptom integral value descends greater than 2/3; Treatment back symptom integral value descends, and the person is effective between 2/3 to 1/3; It is invalid that treatment back symptom integral value descends not as good as 1/3.
5, therapeutic outcome: this organizes 244 routine cases after treatment, 12 examples of fully recovering, and produce effects 106 examples, effective 105 examples, invalid 21 examples, total effective rate is 91.39%, does not find obvious adverse reaction in the observation process.
Two, the clinical observation and the curative effect that are used for the treatment of chest-rheumatism:
Clinical this medicine of use is observed the thoracic obstruction (coronary heart disease) case 100 examples, and patient age is between 18~70 years old.
1, clinical symptoms: suffocating pain over the chest even chest pain radiating to the back, cardiopalmus, breathe hard, weak, have a dizzy spell, tiredness with no desire to speak, dimly pale tongue or ecchymosis is arranged or Sublingual venation blood stasis is purple dark or tongue body is huge, tongue fur is white, deep-thready pulse or disease such as thin and delicate.
2, medicining mode: oral capsule every day 3 times, each 4 is a course of treatment all around.Inactive other angina drug before the treatment, can only contain nitroglycerine tablets during angina pectoris attacks, in the clinical trial process, if carrying out property of patient's angina pectoris increases the weight of or when critical situation such as acute myocardial infarction, severe cardiac functional defect and severe arrhythmia occurring, can treat by combination of Chinese and Western medicine principle, and as rejecting the case statistics.
3, efficacy assessment standard: efficacy assessment standard mainly is the improvement situation according to angina pectoris, electrocardiogram, tcm syndrome, formulates 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 ".
(1), angina pectoris symptom criterion of therapeutical effect:
A, slight: produce effects: chest pain disappears or basic the disappearance;
Effectively: the chest pain outbreak obviously alleviates;
Invalid: the chest pain symptom does not have improvement;
Increase the weight of: the chest pain outbreak increases the weight of, and reaches " moderate " above standard.
B, moderate: produce effects: chest pain disappears or basic the disappearance;
Effectively: chest pain alleviates one-level, reaches slight standard;
Invalid: the chest pain symptom does not have improvement;
Increase the weight of: the chest pain sx reaches " than severe " above standard.
C, than severe: produce effects: chest pain disappears or is relieved to " slightly " standard;
Effectively: chest pain is relieved to the moderate standard;
Invalid: the chest pain symptom is preceding identical with treatment;
Increase the weight of: chest pain outbreak increases the weight of or reaches " severe " standard.
(2), ECG curative effect evaluation criteria:
Produce effects: electrocardiogram returns to " roughly normal " or reaches " normal ECG ";
Effectively: the S-T section reduces, and more than the treatment back rise 0.05mv, but does not reach normal level, and shoal at the negative T wave that mainly leads (reaching 25% above person), or the T ripple is upright by smooth change;
Invalid: as to be as good as before electrocardiogram and the treatment;
Increase the weight of: treatment back S-T section reduces and increases the weight of, and the T ripple is deepened or the T ripple is inverted by smooth change.
(3), the tcm syndrome total effects is judged:
Judge the tcm syndrome total effects according to integration method
Produce effects: n 〉=70%;
Effectively: 70%>n 〉=30%;
Invalid: n<30%.
4, therapeutic outcome: this organizes 100 routine cases after treatment, and curative effect to treat angina pectoris is observed produce effects 53 examples, effective 36 examples, invalid 11 examples, 0 example that increases the weight of, and total effective rate is 89%; ECG curative effect is observed produce effects 16 examples, effective 35 examples, invalid 49 examples, 0 example that increases the weight of, and total effective rate is 51%; Tcm syndrome observation of curative effect produce effects 41 examples, effective 51 examples, invalid 8 examples, total effective rate is 92%, does not find obvious adverse reaction in the observation process.