The objective of the invention is to problem, by excavating the abundant Chinese medicine resource of motherland, for the clinical treatment essential hypotension provides a kind of natural safely and effectively treatment Chinese patent medicine at the state of the art existence.
The research and development scheme of medicine of the present invention is the analytics of the dizzy card class of void etiology and pathology is controlled thought and to obtain in conjunction with modern medicine pharmacological experiment basis according to motherland's traditional medicine.The traditional Chinese medical science thinks that essential hypotension is main relevant with body void, the traditional Chinese medical science and Gui Zhiwei " empty dizzy card " scope.Described in Shanghai science and technology publishing house 1989 version " practical Chinese Internal Medicine ": " pathological change of deficiency syndrome; be lowly or too to suppress parasympathetic nervous; make the vascular tone abnormal ascending; myocardial function is low; inadequate circulatory blood volume, so that blood pressure reduces with function of nervous system, pulse pressure difference dwindles; and basal metabolism descends, living matter basis deficiency is a feature." emphasized the relation of deficient syndrome and hypopiesi thus.About " deficient syndrome ", as far back as " interior warp " epoch.Motherland's medical science has just formed more complete understanding, the also a lot of argumentation of ancient Chinese medicine doctor subsequently." element ask beautiful machine really hide opinion " descended a very generalized definition once for " void ": " lack of vital essence resulting in deficiency syndrome ", and point out: " thready pulse, cold skin, gas are few, diarrhea and polyuria, anorexia, and this calls deficiency syndrome of five ZANG-organs ".In treatment, " element ask three ones nine opinion " proposes " deficiency syndrome should be treated by tonifying method ", and " element ask the most pure virginity will discuss greatly " also proposed the Therapeutic Principle of " diseases caused by over-strain should be treated by warming ", " disease due to consumption should be treated by warming-tonifying ".Difficult Classic further proposes the method for treatment of deficient disease on the basis of " interior warp " theory: " decrease its gas of its lung person benefit; Decreasing its heart person transfers its battalion to defend; Decrease its spleen person and transfer its diet, harmonizing the cool with warmth of the body; It is slow wherein to decrease its liver person; Decrease its essence of its kidney person benefit." for causing dizzy person because of empty, motherland's medical science also has special topic to discuss, and is said as Jing-Yue Complete Works, dizzy " and former disease by deficiency of vital energy person is arranged, be that clearing heat in QI system can not rise, or hyperhidrosis YANG-depletion and causing, work as ascending YANG and invigorating QI; Blood deficiency person is arranged, be because of exhaustion of blood too much, YANG unable to attach to somewhere and right, when tonifying YIN is enriched blood, the disease of this neither foot also." illustrate that deficiency of both QI and blood is to cause a dizzy major reason.Comprehensive above the record as seen, the appearance of assertive evidence is owing to the deficiency of vital energy and the hyperamization stasis of blood, the rule of treatment is when benefiting QI for activating blood circulation, warming YANG YIN nourishing.In view of the above, designer spy of the present invention chooses some drug effects and concentrates and be easy to the raw material of Chinese medicine side of being prepared into for absorption of human body, medicine in the side is made up of meter ten herbal medicines that comprise Radix Ginseng Rubra, Radix Rehmanniae Preparata, Fructus Aurantii Immaturus, Herba Ephedrae, Ramulus Cinnamomi, Radix Ophiopogonis, Caulis Trachelospermi, Herba Agrimoniae, Colla Corii Asini, Rhizoma Gastrodiae, to promote blood circulation with invigorating the kidney and spleen, blood-activating and qi-promoting be aim to the prescription of Gou Chenging thus, aspect the treatment of essential hypotension, have fabulous effect, thereby significantly reducing or eliminate of the threat of this disease health of people.
The proportioning value that constitutes each raw material components of Chinese patent medicine of the present invention is: 10~1200 unit of weights of Radix Ginseng Rubra, 20~1500 unit of weights of Radix Rehmanniae Preparata, 20~2000 unit of weights of Fructus Aurantii Immaturus, 10~1500 unit of weights of Herba Ephedrae, 30~3000 unit of weights of Ramulus Cinnamomi, Radix Ophiopogonis 20~1500 unit of weights, 20~4000 unit of weights of Caulis Trachelospermi, 20~4000 unit of weights of Herba Agrimoniae, 2~100 unit of weights of Colla Corii Asini, 4~150 unit of weights of Rhizoma Gastrodiae.
The Chinese patent medicine of making according to the said medicine raw material has demonstrated fully the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs thought of motherland's medical science about " treatment must aim at the pathogenesis of disease ", " original is former clearly ".The outstanding QI invigorating Yin-nourishing drug of enriching blood of using in the side as Radix Ginseng Rubra, Radix Rehmanniae Preparata, Colla Corii Asini, Radix Ophiopogonis, adds the warming the meridian medicine that boosts of promoting blood circulation, simultaneously as Ramulus Cinnamomi, Herba Ephedrae, Fructus Aurantii Immaturus, Herba Agrimoniae, Caulis Trachelospermi.Its epheday intermedia is the logical medicine of traditional blood circulation promoting and blood stasis dispelling temperature, and Shennong's Herbal record Herba Ephedrae has " broken disease heavily fortified point gathers " effect, and " Waike Zhengzhi Quansheng Ji, Life-saving Manual of Diagnosis and Treatment of External Diseases " thinks the hot temperature of Herba Ephedrae, and suffering can be dispersed, and blood gets Wen Zehang, and points out that Herba Ephedrae gets then collateral dredging and not delivering of Radix Rehmanniae Preparata.According to modern medicine study, Radix Ginseng Rubra, Fructus Aurantii Immaturus, Herba Agrimoniae all have demulcent boosting again, and the use in conjunction boosting is particularly remarkable, add Ramulus Cinnamomi, Herba Ephedrae, Caulis Trachelospermi and then can make its boosting stable and lasting.Fructus Aurantii Immaturus promptly is being considered to have dispelling the stagnated QI, diffusing painful abdominal mass, removing food stagnancy effect traditionally, and animal body test in chamber finds that also it has arteries and veins boosting (referring to " Chinese medicine voluminous dictionary " volume two, 1509 pages) significantly and rapidly again by experiment in recent years.Herba Agrimoniae proves that traditionally as hemorrhage it also has the strengthening heart and boosting pressure effect in research in recent years, so " modern practical Chinese medicine " thinks that Herba Agrimoniae " is the agent of robustness astringing to arrest bleeding, has cardiotonic concurrently ".Radix Rehmanniae can make increased blood pressure, and diuresis is arranged, and also has cardiotonic simultaneously.Rhizoma Gastrodiae has calmness, analgesic effect, adds in the prescription with Rhizoma Gastrodiae to improve dizziness, the cardio palmus shape that hypotension causes.Make a general survey of full side and form, merit is at supplementing QI and nourishing YIN, strengthening spleen, tonifying kidney, warming YANG and promoting blood circulation, can treat the empty dizzy card that having a dizzy spell due to the essential hypotension deficiency of both QI and YIN, palpitation and amnesia, extremity asthenia, tinnitus are fainted effectively.
Actual product of the present invention is the various form of Chinese drug made from the conventional preparation technology of Chinese medicine that comprise capsule, tablet, granule etc.
Clinical observation and curative effect
In development process of the present invention, for the clinical efficacy of this pharmaceutical preparation of objective evaluation treatment essential hypotension and to the safety of human body, the applicant has been once according to the ZL of National Drug Administration (1998)~No. 91 certification has carried out clinical trial, during clinical treatment and observe case 270 examples altogether.
One, case is selected:
1, Western medicine diagnose standard: with reference to formulations such as The World Health Organization's required standard and " diagnostics " (higher medical universities and colleges teaching material the 4th edition, People's Health Publisher 1997) hypopiesi diagnostic criterias.
(1) medical history and body constitution: family history is generally arranged, and body constitution is relatively poor, is asthenic type more;
(2) blood pressure long-time (more than 3 months) is below 90/60mmHg;
(3) clinical main performance: have a dizzy spell, cardiopalmus, breathe hard, weak, forgetful etc.;
(4) there is not obvious cardiovascular and cerebrovascular disease on inspection.
2, Chinese medical discrimination: reach " syndrome of deficiency of QI " chapters and sections and draft with relevant academic monograph with reference to " (new Chinese medicine clinical guidance principle " " dizzy ".
Syndrome of deficiency of both qi and yin: have a dizzy spell, spiritlessness and weakness, xerostomia few Tianjin, cardiopalmus, breathe hard, insomnia forgetfulness, red tongue or light red, few tongue or tongue are white, deep-slow pulse or deep and slow unable.
3, include test case standard in: have the essential hypotension history, the age met Chinese and western medicine diagnosis, Chinese medical discrimination standard person simultaneously between 18~65 years old.
Two, Therapeutic Method: oral this Chinese patent medicine capsule, 3 times on the one, day dosage 2~3g, serve on 4 weeks be a course of treatment.The treatment viewing duration is if diastolic pressure<50mmHg systolic pressure<75mmHg appears, in patient, occur simultaneously that 1. mind is indifferent or irritated, 2. skin is clammy, pale complexion, when 3. the periphery weak and faint pulse maybe can not touch, can adopt other treatment measure to this patient, and with this case as rejecting case; And above symptoms appear in test 2 week backs, should adopt other treatment measure, simultaneously with it as invalid case.
Three, observation index:
1, blood pressure classification method: blood pressure determination is divided into 3 grades.
Slightly: systolic pressure<90mmHg,>85mmHg and/or diastolic pressure<60mmHg,>55mmHg;
Moderate: systolic pressure≤85mmHg, 〉=81mmHg and/or diastolic pressure≤55mmHg, 〉=51mmHg;
Severe: systolic pressure≤80mmHg and/or diastolic pressure≤50mmHg.
2, tcm clinical practice syndrome and scoring system
State of an illness weight classification scoring system
Symptom and sign | 0 minute | 2 minutes | 5 minutes | 8 minutes |
Have a dizzy spell | Do not have | Conscious have obvious dizziness and have dizzy, but do not have self or scenery rocks and sense of rotation, or simple head is dizzy heavy and do not influence activity | Conscious dizziness, dizzy and have the rolling of self or scenery dynamic, or simple dizziness and influence activity | Conscious having had a dizzy spell self rocked or sense of rotation or dizzy merely with scenery, is difficult to competent at a job |
Cardiopalmus | Do not have | After being arranged every day, 2~3 activities feel cardiopalmus, continue about 5~10 minutes, the back of having a rest disappears | Inertia had cardiopalmus on the 1st 2~3 times, about 10~20 minutes of persistent period | Cardiopalmus more than 3 times on the one, the persistent period was difficult to competent at a job greater than 20 minutes |
Breathe hard | Do not have | Arranged at 21~30 minutes 1~2 the persistence of sensation time of breathing hard behind the general activity every day | 2~3 senses of breathing hard are arranged, 31~40 minutes persistent period in one day | Feel more than 3 times in one day and breathing hard, the persistent period is more than 41 minutes |
Spiritlessness and weakness | Do not have | The general activity aftersensation is very tired | Every day, inertia also felt tired, but still can work | Every day, inertia also felt tired, and can not adhere to work |
Insomnia forgetfulness | Do not have | Sleep is awakened often or is slept and unstable, morning wakes up too early, but does not influence work, and idol is forgotten things | Do not have enough sleep and still can adhere to work in 4 hours, often forget things but do not influence work | Lie awake all night, forgetful obviously, difficult competent at a job |
The few Tianjin of xerostomia | Do not have | Red lip, idol have xerostomia to feel yearningly | Lip is red and dried, xerostomia is thirsty obviously, but can stand | Lip is dark red dry and cracked, and thirsty being difficult to of xerostomia stands |
Picture of the tongue | Light red thin coating | Light red tongue lacks tongue (1 minute) in vain | The few tongue (2 minutes) of red tongue | Red and uncoated tongue (3 minutes) |
Pulse condition | Gentle strong | Deep pulse (1 minute) | Deep-slow pulse (2 minutes) | Deep and slow unable (3 minutes) |
Slightly: symptom integral≤14 minute;
Moderate: symptom integral is 15~20 minutes;
Severe: symptom integral was greater than 20 minutes.
Four, curative effect determinate standard
1, blood pressure recovers curative effect determinate standard
(1), clinic control: treatment back blood pressure recovers normal, systolic pressure rising 〉=20mmHg, diastolic pressure rising 〉=20mmHg.
(2), produce effects: treatment back blood pressure recovers normally substantially, systolic pressure rising<20mmHg, 〉=10mmHg, diastolic pressure rising 〉=5mmHg.
(3), effectively: treatment back blood pressure improves before the treatment, but does not recover normal, systolic pressure rising<10mmHg, 〉=5mmHg, diastolic pressure rising 〉=3mmHg,<5mmHg.
(4), invalid: blood pressure does not have improvement before and after the treatment.
2, Chinese medical discrimination curative effect determinate standard
(1), clinic control: the syndrome integration reduces 〉=90%.
(2), produce effects: syndrome integration minimizing<90%, 〉=60%.
(3), effective: syndrome integration minimizing<60%, 〉=30%.
(4), the syndrome integration reduces<30%.
Five, therapeutic outcome: experimental observation group 270 routine cases are after taking this Drug therapy, and blood pressure recovers efficacy determination: clinic control 94 examples, and produce effects 105 examples, it is 73.7% that control shows rate, total effective rate is 91.9%; The tcm syndrome efficacy determination: clinic control 86 examples, produce effects 108 examples, it is 71.9% that control shows rate, total effective rate is 91.5%.In the process of the test, do not find that this medicine has obvious adverse reaction.