CN1650917A

CN1650917A - Medicine for treating arrhythmia and its preparation method

Info

Publication number: CN1650917A
Application number: CN 200410036428
Authority: CN
Inventors: 林慧娟
Original assignee: Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Current assignee: Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Priority date: 2004-12-01
Filing date: 2004-12-01
Publication date: 2005-08-10
Anticipated expiration: 2024-12-01
Also published as: CN100479842C

Abstract

A Chinese medicine for treating arrhythmia is prepared from 11 Chinese-medicinal materials including Chinese angelica root, white peony root, ginseng, liquorice root, etc. Its advantages are high curative effect and no toxic by-effect.

Description

Treat ARR medicine and preparation method thereof

Affiliated technical field

The invention belongs to the Chinese medicine preparation in the field of medicaments, particularly be the ARR medicine of treatment that cardiovascular and cerebrovascular disease is had special efficacy.

Background technology

Coronary heart disease is because coronary atherosclerosis causes coronary stricture, obstruction or spasm, makes cardiac muscle can not get enough blood and oxygen, causes myocardial cell to wear out, be obstructed and the dead and heart disease that causes of large tracts of land.Along with work, social pressure anxiety, it is irregular to live, evidence of coronary heart diseases increases day by day, and the rejuvenation of being tending towards is arranged, arrhythmia (ventricular presystole) be in the cardiovascular system sickness rate than a higher class illness, often cause that hemodynamics changes, having a strong impact on patient's quality of life, even threat to life.Therefore, in recent years, modern medicine has dropped into huge human and material resources to the control of arrhythmia (ventricular presystole), though obtained bigger achievement, treatments such as wound property radio-frequency (RF) ablation is arranged, and patient is difficult for accepting; The drug effect performance of modern antiarrhythmic drug is subjected to the restriction of multiple complicated factors such as the cause of disease, electrophysiological mechanism, arrhythmia type, and the medicine that has has been taken arrhythogenic side effect for a long time.

Summary of the invention

The purpose of this invention is to provide a kind ofly to hyperactivity of fire caused by deficiency of YIN, malaise type cardiopalmus particularly has the ARR medicine of treatment of special efficacy to arrhythmia.

The objective of the invention is to realize, specify as follows by following scheme:

The ARR medicine of a kind of treatment, it is formulated by weight by following raw material of Chinese medicine:

Radix Rehmanniae 10-45 part Radix Angelicae Sinensis 9-30 part Radix Paeoniae Alba 9-23 part Rhizoma Anemarrhenae 9-22 part

Rhizoma Coptidis 6-14 part Radix Scutellariae 6-14 part Radix Ginseng 6-9 part Semen Ziziphi Spinosae 10-45 part

Semen Platycladi 9-23 part Fluoritum 9-45 part Radix Glycyrrhizae 3-9 part.

The ARR medicine of above-mentioned treatment, it is formulated by weight by following raw material of Chinese medicine:

Radix Rehmanniae 10-30 part Radix Angelicae Sinensis 9-30 part Radix Paeoniae Alba 9-25 part Rhizoma Anemarrhenae 9-15 part

Rhizoma Coptidis 6-9 part Radix Scutellariae 6-9 part Radix Ginseng 6-9 part Semen Ziziphi Spinosae 10-30 part

Semen Platycladi 9-15 part Fluoritum 9-30 part Radix Glycyrrhizae 3-9 part.

Radix Rehmanniae 20-30 part Radix Angelicae Sinensis 15-30 part Radix Paeoniae Alba 15-25 part Rhizoma Anemarrhenae 9-15 part

Rhizoma Coptidis 6-9 part Radix Scutellariae 6-9 part Radix Ginseng 6-9 part Semen Ziziphi Spinosae 15-30 part

Semen Platycladi 9-15 part Fluoritum 15-30 part Radix Glycyrrhizae 3-9 part.

The ARR medicine production technological process of a kind of above-mentioned treatment is as follows: get Rhizoma Coptidis, Radix Ginseng～pulverizing～ethanol extraction～filtration～recovery ethanol～concentrate～vacuum drying～I that gets dry extract, and standby; Other gets Radix Angelicae Sinensis extraction volatile oil and stays part standby; 8 flavor medicines of remainders such as another part volatile oil and medicinal residues thereof and Radix Rehmanniae mix and decoct～refilter～concentrate～precipitate with ethanol～filtration～recovery ethanol～concentrated～vacuum drying～make dried cream II; Again the above-mentioned standby cream I, standby part Radix Angelicae Sinensis of making extracted volatile oil and dried cream II mixing～powder and become fine powder～again after packing, packing, check, promptly become the qualified medicine of the present invention.

The concrete production method of the ARR medicine of above-mentioned treatment is:

1. at first should get all the needed crude drug of respectively distinguishing the flavor of of said preparation ready, and should clear up, roguing, standby;

2. get Rhizoma Coptidis, the people participates in the 30-80% alcohol reflux at least 1 time, solvent consumption 7-15 doubly, reflux, extract, is 1-5h,, filter, merging filtrate reclaims ethanol, and is concentrated into the extractum that relative density is 1.15-1.35, vacuum drying, I gets dry extract;

3. get Radix Angelicae Sinensis and extract volatile oil with steam distillation, extraction time is 1-8h, and it is standby to take out a part of volatile oil; All the other 8 flavor medical materials such as another part volatile oil and medicinal residues thereof and Radix Rehmanniae, Fluoritum decoct with water 1 time at least, and amount of water is 8-20 times, and decocting time is 2-8h, filter, merging filtrate is evaporated to the extractum that relative density is 1.05-1.25, adds ethanol and is 50-75% to containing the alcohol amount, leave standstill 12-24h, filter, reclaim ethanol, be concentrated into the extractum that relative density is 1.25-1.35, vacuum drying, II gets dry extract;

4. dried cream I and dried cream II are merged, be ground into fine powder, add right amount of auxiliary materials, spray into Radix Angelicae Sinensis volatile oil, mix homogeneously, promptly encapsulated.

The traditional Chinese medical science thinks that coronary heart disease is because qi depression to blood stasis causes, Chinese patent medicine kind on the market is a lot, as compound Salviae Miltiorrhizae, Radix Salviae Miltiorrhizae drop pill, arklemin, the heart can relax, mostly heart nourishing etc. is strengthening the body resistance, blood circulation promoting and blood stasis dispelling, promoting the circulation of QI to relieve pain, lack prescription preferably for the interior-heat caused by deficiency of YIN person, treat ARR medicine and remedied this deficiency.Ventricular presystole belongs to motherland's medical science " cardiopalmus " and reaches categories such as " palpitation with a distress feelings ".Motherland's medical science has deep understanding and detailed argumentation to the etiology and pathogenesis of cardiopalmus, and has also accumulated rich experience at drug treatment.Chinese medicine is from organic conception, and dialectical opinion is controlled the ventricular presystole tool and had great advantage: not only effectively improve the body symptom, and, treat from the cause of disease at all, simultaneously, take for a long time and have no side effect.

Introduce the property of medicine of the medicine of respectively distinguishing the flavor of below:

The Radix Rehmanniae: sweet, bitter, cold, go into the heart, liver, kidney channel, be used for nourishing YIN to lower pathogenic fire, cooling blood for hemostasis.

Radix Angelicae Sinensis: sweet, hot, warm, go into the heart, liver, spleen channel, promoting blood circulation to remove blood stasis, tonifying blood and regulating menstruation.

The Radix Paeoniae Alba: bitter, acid, be slightly cold, go into Liver Channel, the yin fluid astringing that nourishes blood, easing the affected liver to relieve pain.

The Rhizoma Anemarrhenae: bitter, cold, go into lung, stomach, kidney channel, resolving heat and reducing pathogenic fire, nourshing Yin and drynsessmoistening prescription.

Rhizoma Coptidis: bitter, cold, go into kidney, urinary bladder channel, clearing away heat-damp and promoting diuresis, nourishing YIN to lower pathogenic fire.

Radix Scutellariae: bitter, cold, go into the heart, lung, gallbladder, large and small intestinal warp, lung heat clearing pathogenic fire purging, clearing away heat to cure dysentery.

Radix Ginseng: sweet, bitter, tepor, go into spleen, lung meridian, strongly invigorating primordial QI, tonifying the lung spleen invigorating, promoting the production of body fluid to quench thirst.

Semen Ziziphi Spinosae: sweet, sour, flat, go into the heart, spleen, liver, gallbladder meridian, tranquilizing by nourishing the heart, tonifying YIN arresting sweating.

Semen Platycladi: sweet, flat, go into the heart, liver, kidney channel, tranquilizing by nourishing the heart, tonifying YIN arresting sweating.

Fluoritum: salty, cold, go into the heart, Liver Channel, mind tranquilizing and the heart calming, pathogenic fire reducing tonifying YIN.

Radix Glycyrrhizae; Sweet, flat, go into 12 warps, invigorating the spleen and replenishing QI, eliminating fire and detoxication, relieving spasm to stop pain.

Effect of the present invention is very good, and nourishing YIN and benefiting blood, pathogenic fire purging are calmed the nerves.Cure mainly the deficiency of YIN-blood hyperactivity of fire and disturb diseases such as the shortness of breath and palpitation due to the heart, vexed insomnia, dysphoria with feverish sensation in the chest palms and soles, dizziness and tinnitus, soreness of the waist and knees, be adapted to tachyarrhythmia and belong to and go up the disease person.

Description of drawings

Further the present invention is explained by accompanying drawing

Fig. 1 is technological process of production figure of the present invention

Among Fig. 1: Rhizoma Coptidis, Radix Ginseng by pulverizer at first powder become coarse powder, use 30%～80% alcohol reflux at least once then, molten coal consumption is 7～15 times, reflux extracting time is 1～5 hour, then multiple extraction liquid is merged, filter, after reclaiming ethanol, its filtrate is concentrated into relative density and is 1.15～1.35 extractum, pass through vacuum drying then, obtain dried cream I;

Get Radix Angelicae Sinensis and extract volatile oil with steam distillation, extraction time is 1～8 hour; All the other eight medical materials such as the medicinal residues of Radix Angelicae Sinensis and Radix Rehmanniae, Fluoritum decoct with water at least once, and amount of water is 8～20 times, and decocting time is 2～8 hours, filter then, to decoct filtrate and merge, and be evaporated to relative density and be 1.05～1.25 extractum, adding ethanol again is 50～75% to containing the alcohol amount, left standstill 24 hours, filter, reclaim ethanol, and to be concentrated into relative density be 1.25～1.35 extractum, carry out vacuum drying again, obtain dried cream II;

Above-mentioned dried cream I that obtains and dried cream II are merged, and mixed powder becomes fine powder, sprays into Radix Angelicae Sinensis volatile oil, and mix homogeneously carries out packing, packing, check, is the preparation of the ARR medicine of treatment of the present invention.

The specific embodiment

Example 1, the ARR medicine of above-mentioned treatment, it is formulated by weight by following raw material of Chinese medicine:

Radix Rehmanniae (life) 450g, Radix Angelicae Sinensis 300g, Radix Paeoniae Alba 225g, Rhizoma Anemarrhenae 225g, Rhizoma Coptidis 135g, Radix Scutellariae 135g, Radix Ginseng 90g, Semen Ziziphi Spinosae (stir-fry) 450g, Semen Platycladi 225g, Fluoritum 450g, Radix Glycyrrhizae 90g.

Example 2, the ARR medicine of above-mentioned treatment, it is formulated by weight by following raw material of Chinese medicine:

Radix Rehmanniae (life) 300g, Radix Angelicae Sinensis 200g, Radix Paeoniae Alba 125g, Rhizoma Anemarrhenae 125g, Rhizoma Coptidis 100g, Radix Scutellariae 100g, Radix Ginseng 80g, Semen Ziziphi Spinosae (stir-fry) 300g, Semen Platycladi 125g, Fluoritum 300g, Radix Glycyrrhizae 60g.

Example 3, the ARR medicine of above-mentioned treatment, it is formulated by weight by following raw material of Chinese medicine:

Radix Rehmanniae (life) 200g, Radix Angelicae Sinensis 100g, Radix Paeoniae Alba 100g, Rhizoma Anemarrhenae 100g, Rhizoma Coptidis 80g, Radix Scutellariae 80g, Radix Ginseng 70g, Semen Ziziphi Spinosae (stir-fry) 200g, Semen Platycladi 125g, Fluoritum 150g, Radix Glycyrrhizae 40g.

The ARR medicine production method of above-mentioned treatment embodiment:

2. get Rhizoma Coptidis 135g, Radix Ginseng 90g, add 75% alcohol reflux secondary, 7 times of amounts for the first time, 5 times of amounts for the second time, reflux, extract, is 3 hours, filters, and merging filtrate reclaims ethanol, and to be concentrated into relative density be 1.30 extractum, vacuum drying, I gets dry extract;

3. get Radix Angelicae Sinensis 300g and extract volatile oil with steam distillation, extraction time is 8h, its medicinal residues and Radix Rehmanniae (life) 450g, Fluoritum 450g, Radix Paeoniae Alba 225g, Rhizoma Anemarrhenae 225g, Radix Scutellariae 135g, Semen Ziziphi Spinosae (stir-fry) 450g, Semen Platycladi 225g, Radix Glycyrrhizae 90g, decoct with water 1 time, amount of water is 20 times, decocting time is 8h, filters merging filtrate, be evaporated to relative density and be 1.25 extractum, adding ethanol is 75% to containing the alcohol amount, leaves standstill 24h, filters, reclaim ethanol, be concentrated into relative density and be 1.35 extractum, vacuum drying, II gets dry extract;

4. dried cream I and dried cream II are merged, be ground into fine powder, add right amount of auxiliary materials, mix homogeneously sprays into Radix Angelicae Sinensis volatile oil, and mix homogeneously is promptly encapsulated; This product is a capsule, and it is encapsulated that promptly dry extract becomes 60 order fine powders, and inventory of this product is 100 times of said ratio, goes out about 100,000 of finished capsule product.

In order to guarantee to treat the quality of ARR drug medication, adopt orthogonal test, find out that intuitively optimum extraction condition is 14 times of water gagings, extract secondary, extraction time is 5 hours, and alcohol precipitation concentration is 60%, and the dried cream content of extraction is the highest.(auspicious see attached)

In order to confirm that the present invention treats the reliability of ARR medicine, made animal acute toxicity test, test shows: treat ARR drug suspension for white mice ig, dose has reached 40g.kg ^-1The clinical consumption of this product is each 4, every day 3 times, and daily dose 5.4g in body weight for humans 60kg, is about 0.1g.kg ^-1Body weight; Continuous observation is 7 days behind the medicine, and mice is movable normal, does not have death and poisoning.Dislocation is put to death the part zootomy and is checked that main organs there is no abnormal change, calculate the suitable people's consumption of mice maximum tolerated dose thus 444.4 times, shows that this medicine clinical practice is safety and low toxicity.

The present invention treats ARR medicine and has made long-term toxicity test for animals again; Studies show that: give rat with 75.30 and 7.5 multiple doses for the treatment of ARR clinical drug consumption; Continuously monthlyly do not see that the toxicity variation of outward appearance, body weight gain, hemogram, hepatic and renal function and main organs tissue appears in animal half after ig administration 3 months and the drug withdrawal, prove that this poison of drug is very low, clinical long-term oral application is safe.(above-mentioned acute and chronic toxicity test auspicious see attached).

(arrhythmia: ventricular premature contraction) the II clinical trial phase is summed up and is finished by No.1 Hospital Attached to He'nan Traditional Chinese Medical College's Vasculocardiology Deparment to treat ARR Drug therapy cardiopalmus.Multicenter, stratified random double-blind trial method are adopted in test.The II clinical trial phase adopts random stratified double blinding clinical trial, is finished by 3 tame clinical trial units.Selection meets includes case standard 200 examples in, and conclusion is: the cardiopalmus therapeutic effect of syndrome: test group and matched group clinical symptoms curative effect relatively have notable difference, and the test group curative effect is better than matched group, and test group shows more rate: 69.00%, and total effective rate: 92.00%; The premature beat curative effect: test group and matched group premature beat curative effect relatively have notable difference.The test group curative effect is better than matched group.Test group shows more rate: 56.00%, and total effective rate: 89.00%; Total effects: test group and matched group total effects relatively have notable difference, and the test group curative effect is better than matched group, and test group shows more rate: 54.00%, and total effective rate: 89.00%.(auspicious see attached)

By material beneath technique scheme is made and to be further specified

Heart disease Yiganning capsule treatment cardiopalmus (arrhythmia: ventricular premature contraction) sum up by the II clinical trial phase

The unit of accepting: No.1 Hospital Attached to He'nan Traditional Chinese Medical College's Vasculocardiology Deparment

Test objective

Objective evaluation heart disease Yiganning capsule is treated the curative effect and the safety of cardiopalmus (arrhythmia ventricular premature contraction): do contrasting the double blinding multiple center trial at random with the WENXIN KELI agent, relatively the therapeutic value of heart disease Yiganning capsule; Determine indication by clinical trial; Find out therapeutic regimen, recommend clinical medicine dose, every day administration number of times; There are why not very reaction and danger to make objective evaluation to heart disease Yiganning capsule, and the method for control is provided.

Preface

Heart disease Yiganning capsule is Chinese medicine three kind new medicines of the common treatment cardiopalmus of developing (arrhythmia ventricular premature contraction) of Hospital Attached to Shandong Chinese Medical Univ. and Shen, Weihai prestige Pharmaceutical limited company, through ZL-58 number " Clinical Researches of New Drugs official written reply " file approval of Ministry of Public Health bureau of drug administration (1999), specifying No.1 Hospital Attached to He'nan Traditional Chinese Medical College, Affiliated Hospital of Heilongjiang University of Chinese Medicine and Hospital Affiliated to Shandong Medical College by Ministry of Public Health bureau of drug administration is clinical trial unit.Three tame hospitals from the _ year _ moon _ day to _ year _ moon _ day this medicine has been carried out the II clinical trial phase, to investigate its clinical efficacy and safety.Now the result is reported as follows:

Case is selected

One, diagnostic criteria

(1) traditional Chinese medical science cardiopalmus diagnostic criteria (working out) with reference to " new Chinese medicine clinical research guideline "

1. clinical manifestation

Primary symptom: consciously sharply beat in the heart, be panic-stricken, can not be autonomous.Double disease: shortness of breath and fatigue, spiritlessness and too weak to speak etc.

2. pulse condition: short, knot, generation.

3. look state of an illness difference, cardiopalmus can be paroxysm, a few days 1 time, or several on the 1st, or be the persistence outbreak.

(2) cardiopalmus deficiency of YIN-blood, hyperactivity of fire are disturbed the heart and are demonstrate,proved dialectical standard (working out with reference to opening Bai Yu chief editor " Chinese Internal Medicine " Shanghai science tech publishing house front page in 1985)

Main symptom: cardiopalmus, breathe hard dysphoria with feverish sensation in the chest palms and soles, red tongue with a little fluid, irregularly rapid pulse, knot, generation.

Inferior card: dizziness and tinnitus, soreness of the waist and knees, vexed insomnia, xerostomia.

1. cardiopalmus syndrome differential diagnosis: the main symptom or time one of the card of holding concurrently are promptly diagnosable.

2. tcm symptom weight classification:

Cardiopalmus:

Do not have (0): asymptomatic.

Gently (3): can be competent at general daily routines, be had palpitation but ass work is moving slightly; Cardiopalmus takes place once in a while;

In (6): cardiopalmus is promptly felt in general daily routines; Cardiopalmus happens occasionally;

Heavy (9): promptly feel cardiopalmus than the physical exertion that daily routines are light; Cardiopalmus often takes place.

Breathe hard:

Do not have (0): asymptomatic.Gently (2): breathe hard after the activity; In (4): movingly slightly promptly breathe hard; Heavy (6): promptly breathe hard usually.

Vexed insomnia:

Do not have (0): asymptomatic.

Gently (1): vexed to cause sleep unreal or easily wake up;

In (2): vexed influence sleep is less than 6 hours;

Heavy (3): vexed influence sleep is less than 4 hours.

Dizziness and tinnitus: do not have (0): asymptomatic.Gently (1): take place once in a while; In (2): often take place; Heavy (3): often take place, do not alleviate.

Soreness of the waist and knees: do not have (0): asymptomatic.Gently (1): the waist knee joint is miserable, passive getting; In (2): soreness of the waist and knees, initiatively say;

Heavy (3): soreness of the waist and knees continues endlessly.

Dysphoria with feverish sensation in the chest palms and soles: do not have (0): asymptomatic.Gently (1): the heating of brothers' heart; In (2): brothers' desire is revealed outside the clothing, the time and vexed;

Heavy (3): brothers desire to hold cold thing then relaxes, vexed not peaceful.

Xerostomia: do not have (0): asymptomatic.Gently (1): the random thoughts xerostomia, drinking-water then takes a turn for the better slightly; In (2): frequent xerostomia, drinking-water then takes a turn for the better;

Heavy (3): frequent xerostomia, drinking-water is peace slightly, stops then unbearably.

Body of the tongue: normal (0); Red tongue with a little fluid (2).Pulse condition: normal pulse (0); Short, knot, generation (3).

(3) Western medicine diagnose standard (working out) with reference to " new Chinese medicine clinical research guideline "

1. electrocardio illustrates ventricular presystole.Diagnosis (with reference to high medical college teaching material " internal medicine ").

2. the order of severity classification of ventricular presystole (as if with reference to yellow chief editor: " clinical electrocardiography " People's Health Publisher, January in 1998 the 5th edition)

0 grade: no ventricular premature contraction.

The I level: accidental ventricular premature contraction＜30 time/h or per minute are less than 1 time.

The II level: the ventricular premature contraction that takes place frequently (＞6 times/min or＞30 times/h).

III level: polyphyly ventricular premature contraction.

The IVA level: paired ventricular premature contraction occurs repeatedly: 1. two premature beats of running fire (chamber early in pairs), 2. three above chambers of running fire morning (short battle array chamber speed).

IVB level: the ventricular premature contraction of bunchiness (three or three above ventricular premature contractions occur repeatedly).

The V level: chamber R ripple early drops on the T ripple of previous hole excitement (Ront).

3. etiological diagnosis

1. coronary heart disease (with reference to International Society of Cardiology and association and World Health Organization's clinical name standardization associating special topic group report " name of ischemic heart desease and diagnostic criteria ")

2. viral myocarditis (the adult diseases viral myocarditis diagnosis reference standard, Ministry of Public Health bureau of drug administration " new Chinese medicine clinical research guideline " 1993 first phases that propose with reference to nineteen ninety-five whole nation myocarditis, cardiomyopathy symposium).

3. etiology unknown (comprising the special property and functional of sending out) cardiopalmus.

Two, test case standard

(1) includes the case standard in

1. meet diagnostic criteria of traditional Chinese medical science cardiopalmus and deficiency of YIN-blood, hyperactivity of fire is disturbed the patient that the heart is demonstrate,proved dialectical standard;

2. meet Western medicine diagnose and be the patient that I level, II level ventricular premature contraction, the cause of disease belong to coronary heart disease, viral myocarditis convalescent period and agnogenio (comprising the special property and functional of sending out).

To possessing above two persons simultaneously, include the test case in.

(2) get rid of the case standard

1. the age is at under-18s or over-65s, gestation or women breast-feeding their children, allergic constitution person.

2. merge serious primary disease such as cerebrovascular, lung, liver, kidney and hemopoietic system and severe cardiac dysfunction person, the psychotic.

3. coronary heart disease is than severe, severe angina pectoris and acute myocardial infarction concurrent premature beat of acute stage, in, the patient of premature beat due to heavy increased in acute viral myocarditis and the other diseases.

4. the ventricular presystole classification belongs to III, IV, V level and Ventricular Rate and is lower than 60 times/minute patient.

5. simple room, simple nodal extrasystole, supraventricular tachycardia, atrial fibrillation, atrial flutter and ventricular tachycardia patient.

6. the viewing duration patient of other antiarrhythmic drug that can not stop using.

(3) reject the case standard:

1. patient withdraws from 2 weeks in test, does not finish regulation course of treatment, can't judge curative effect or untoward reaction person.

2. patient dependence is poor, not by the EXPERIMENTAL DESIGN pill taker.

3. data is not congruent affects the treatment or safety judgement person.It is for future reference that above-mentioned rejecting case should write down retention.

Test method

One, multicenter, stratified random double-blind trial method are adopted in test.

The II clinical trial phase adopts random stratified double blinding clinical trial, is finished by 3 tame clinical trial units.Selection meets includes case standard 200 examples in, is divided into two classes by the arrhythmia classification: I level, II level, the ratio of its case be, respectively accounts for 30%, 70% of case sum, i.e. I level 60 examples, II level 140 examples, and every class is according to the ratio grouping of random table in 1: 1.

Two, blind method requirement.

To meeting Chinese and western medicine diagnostic criteria and Chinese medical discrimination standard, and through including in, the case of exclusion standard screening, the grouping of employing random method, control by the clinical trial responsible department, by the establishment of the random table on NDST software random assortment card, if three bags of methods of blind employing envelope, will be big, in, give each clinical trial hospital after the little envelope sealing, the sequencing that the clinical research personnel study by qualified experimenter, open big envelope card taking for carrying into execution a plan, envelope carries into execution a plan for the case that comes off in opening, and when serious adverse reaction rescue in time occurring, opens little envelope and is broken blind scheme.Grouping by the card regulation carries into execution a plan.

The trial drug code table of random digit harmony in the exterior correspondence is preserved portion separately by group leader unit and bidding person.

Three, test case quantity

Case 200 examples are established in this research altogether, test group 100 examples wherein, matched group 100 examples.Inpatient is no less than 1/3 of total routine number,

Clinic case should strict control patient compliance sexual factor.Concrete enforcement seen attached list:

Subordinate list 1 double blinding allocation table (example)

Unit	Test group	Matched group	Add up to
Unit	Test group	Matched group	Add up to	No.1 Hospital Attached to He'nan Traditional Chinese Medical College	????35	????35	????70
Affiliated Hospital of Heilongjiang University of Chinese Medicine	????35	????35	????70		????35	????35	????70
	????35	????35	????70	Hospital Affiliated to Shandong Medical College	????30	????30	????60
Add up to	????100	????100	????200	Hospital Affiliated to Shandong Medical College	????30	????30	????60

Subordinate list 2 200 routine case allocation tables (example)

Unit	Test group	Matched group	Add up to
Unit	Test group	Matched group	Add up to	No.1 Hospital Attached to He'nan Traditional Chinese Medical College	????35	????35	??70
Affiliated Hospital of Heilongjiang University of Chinese Medicine	????35	????35	??70		????35	????35	??70
	????35	????35	??70	Hospital Affiliated to Shandong Medical College	????30	????30	??60
Add up to	????100	????100	????200	Hospital Affiliated to Shandong Medical College	????30	????30	??60

Four, the contrast medicine selects for use

The contrast medicine intends selecting for use the WENXIN KELI agent.

Illustrate: the WENXIN KELI agent is the arrhythmia Chinese patent medicine that the Ministry of Public Health approval is produced, function supplementing QI and nourishing YIN, the multiple arteries and veins of throbbing with fear surely, blood circulation promoting and blood stasis dispelling.Cure mainly hold concurrently palpitation and uneasiness due to the heart arteries and veins stasis of blood resistance of deficiency of both QI and YIN, shortness of breath and fatigue, dizzy vexed, feeling of oppression and pain in the chest.The ventricular premature contraction, artrial premature beat etc. that are applicable to arrhythmia belong to above-mentioned card marquis person.Because of at present domesticly still not having, cure mainly, be suitable for aspects and the identical Chinese patent medicine of heart disease Yiganning capsule such as disease, dosage form in function, though and the WENXIN KELI agent is different with heart disease Yiganning capsule dosage form, function, cure mainly approximately, suitable disease is identical, so select this medicine medicine in contrast for use.

Five, the enforcement of blind method

Because curative heart disease Yiganning capsule is different at aspects such as dosage form, outward appearance, colors with the agent of contrast medicine WENXIN KELI, so double-dummy technique is adopted in this research double blinding, promptly make two kinds of placebo, a kind of is the starch granules agent, makes its outward appearance, shape, color etc. consistent with the agent of contrast medicine WENXIN KELI; A kind of is the starch capsule, makes its outward appearance, shape, color etc. consistent with curative heart disease Yiganning capsule.Each patient all takes two kinds of medicines, that is: heart disease Yiganning capsule+WENXIN KELI placebo, or the WENXIN KELI+peaceful placebo of heart disease.

Six, take off blind condition.

Double blinding take off blind must be after the II clinical trial phase be all finished, and carry out statistical procedures, responsible department by clinical trial is taken off blind according to random number, in particular cases, when conditions of patients urgent variation or serious allergy takes place or serious adverse reaction takes place, should open little envelope and break blind.

Seven, administrated method and dosage

Test and withdraw other antiarrhythmic Chinese and western drugs the last week.

(1) test group

Heart disease Yiganning capsule (), oral, each 5, every day 3 times, one after each meal.

WENXIN KELI placebo (), oral, each 1 bag (9g), every day 3 times, one after each meal

(2) matched group

WENXIN KELI (), oral, each 1 bag (9g), every day 3 times, one after each meal.

The peaceful placebo of heart disease (), oral, each 5, every day 3 times, one after each meal.

Above test drug provides by Weihai Shen Wei pharmaceutcal corporation, Ltd.

Eight, the course of treatment

Test group and matched group are a course of treatment with 4 weeks of taking medicine all, promptly finish to observe.

Nine, clinical trial points for attention

(1) conscientiously fill in the observation form, before treatment, in and finish after, by observe show in listed content and time, conscientiously check, fill in, write down its result item by item, the space must not changed.The state of an illness person of changing should check at any time, and record at any time is in order to accurate reflection curative effect.

(2) the reference inspection list must be complete before and after the treatment invest the observation table after.

(3) clinical trial observation table uses pen or signature pen to fill in without exception

(4) homogeneity and the tightness for guaranteeing to study, when the problem that does not relate to as yet as this programme need solve, or serious adverse reaction appears in the process of the test, should notify at once and bid to host the unit and the unit of taking the lead, study and define unified solution and in time notify other relevant personnel to consult and carry out, in order to avoid cause confusion, disturb the science of this research.

(5) data of result of the test and data belong to secret, the announcement of data, deliver the agreement that should obtain development person.

Ten, the quality control of clinical trial and quality assurance

(1) testing program enforcement is followed in strictness

1. participate in clinical trial investigator and should have the above professional titles of attending doctor, the clinical trial director should have the above academic title of associate chief physician.

2. to give training research worker before the clinical trial, make it fully grasp, understand clinical trial protocol, to guarantee the enforcement of scheme.

3. all case all need be made explanation, and all cases that can carry out therapeutic evaluation are by the level Four standard evaluation, and the case that can not estimate should explain the situation.

4. observation should be consistent with writing time.

5. all indexs (symptom, sign, lab testing) all need have self front and back record.

6. the observed result of clinical trial should be examined, and to guarantee data reliability, guarantees that every conclusion derives from initial data.

(2) laboratory and clinical evaluation adopt standard operating procedure and quality control standard.

(3) guarantee experimenter's compliance.The medical personnel that participate in test should observe patient in person, take medicine in accordance with regulations, objectively reduce the probability that patient does not comply with.

(4) hold regularly the clinical trial coordination committee, in time research and solve the relevant issues in the test, to guarantee carrying out smoothly of clinical trial.

(5) establish the supervisor, accurate with the rights and interests and the test data sheet that guarantee experimenter in the clinical trial with report data, the assurance scheme follow the standardized administration of clinical trial medicine.

11, end test processing:

(1) clinical observation table should be completed, and the date of dated drug withdrawal and reason, as carrying out the evaluation of related item by the requirement of off-test when (the 4th week).

(2) if any the patient of drug withdrawal and mistake visit, should replenish new case.

(3) duration of test sb.'s illness took a turn for the worse the incident of might causing danger must be ended test, and be adopted the Chinese and western medicine measure to handle, and surpasses for 2 weeks as test, should handle as invalid case.

(4) patient requires to end clinical trial, should add up curative effect but surpassed test 2 all persons.

(5) can not tolerate because of drug anaphylaxis or untoward reaction patient, judge according to the doctor and can end test, and should in time be treated, get well, not list in and observe the case statistics, estimate but should count in the untoward reaction case until it.But surpassed test 2 all persons and should add up curative effect.

(6) researcher to conscientiously write down reason that test ends, with the relation of test: 1. withdraw from automatically and (can not adhere to the therapist person that 2. serious adverse reaction thes occur.3. serious other diseases person appears in the process of the test.4. severity of symptoms must the person of taking urgent measure.Treatment evaluation when researcher answers itemized record to end test.

Observation index

One, safety observation

(1) general health check-up project.

(2) blood, urine, just routine test.Treat and forward and backwardly respectively look into once.

(3) heart, liver, kidney function test.Treat and forward and backwardly respectively look into once.

(4) untoward reaction.

Two, health giving quality observation

(1) variation of clinical card marquis and tongue, pulse condition

The syndrome of disturbing the heart, malaise card with cardiopalmus deficiency of YIN-blood, hyperactivity of fire is as observation index, judged by the symptom standard of keeping the score and keeps the score, and every each symptom of routine case sum of keeping the score is this card marquis total mark value.

(2) ARR observation: include case in and preceding 1 week withdraw other antiarrhythmic drugs in treatment.24 hr Ambulatory EKG Monitoring are respectively looked into 1 time after preceding 3 days of treatment and treatment, observe heart rate, ST, T, premature beat number of times and premature beat and have or not regularly outbreak tendency, regularly send out the author if having, and writing time, regularly carry out cardiac monitoring or oscillography during treatment.

(3) cardiac monitoring (oscillography): after patient's rest half an hour, regularly cardiac monitoring (oscillography) is 30 minutes, record premature beat number of times, and Continuous Observation was 3 days before and after outpatient service and inpatient treated, viewing duration inpatient cardiac monitoring weekly (oscillography) 2 times.The observation of 24 hr Ambulatory EKG Monitoring, cardiac monitoring (oscillography) changes and curative effect in order to classification, ST, the T that judges premature beat.Routine electrocardiogram is before treatment, and in treatment the 1st, 2,3,4 weeks of back, each writes down 1 time.

(4) signs such as treatment anteroposterior view measuring blood pressure, heart rate, the rhythm of the heart change.

(5) color doppler ultrasonography kinetocardiogram: before and after treatment, respectively look into 1 time indexs such as observation EF, SV, CO.Observe 35 pairs, finish by a tame hospital.

Three, Fan Ying observation:

Should strictly observe patient, note various contingent untoward reaction or the toxic and side effects of failing to reckon with, analyze reason, judge, and tracing study and record, the statistics incidence rate of adverse reaction

(1) classification: observe the symptoms, sign, lab testing (electrocardiogram, ambulatory electrocardiogram, blood, routine urinalysis, hepatic and renal function etc.).

(2) performance, time of origin, degree (slightly, moderate, severe), persistent period, extinction time, processing process and the commentaries on classics of observing untoward reaction advised.At any time itemized record.

The relation of (three) judgement, analysis and trial drug: relevant certainly, may be relevant, may have nothing to do, certainly irrelevant, can not judge.

(4) reporting system:

As serious adverse reaction takes place will take immediate steps, protection experimenter safety, and bid to host unit and clinical trial responsible department on the same day or earlier than the 2nd Days report, and in time notify relevant test unit.

Efficacy evaluation

One, curative effect determinate standard (working out) with reference to " new Chinese medicine clinical research guideline "

(1) cardiopalmus syndrome of hyperactivity of fire due to deficiency of YIN card marquis curative effect

1. recovery from illness: treatment back symptom all disappears.

2. produce effects: treatment back symptom integral value reduces 〉=2/3.

3. effective: treatment back symptom integral value reduces between 2/3～1/3.

4. invalid: treatment back symptom integral value is not as good as 1/3.Individual event symptom efficacy determination also adopts this method.

(2) premature beat curative effect (working out) with reference to " new Chinese medicine clinical research guideline "

1. clinical cure: premature beat complete obiteration.

2. produce effects: electrocardiographic oscillogram observation or dynamic ecg recordings examination premature beat reduce more than 80%.

3. effective: electrocardiographic oscillogram observation or dynamic ecg recordings examination premature beat number of times reduce more than 50% before the treatment.

4. invalid: electrocardiographic oscillogram observation or dynamic ecg recordings examination premature beat reduce less than 50% or no change or increase the weight of.

(3) total effects (working out) with reference to " new Chinese medicine clinical research guideline "

1. clinical recovery: symptom all disappears, and it is normal that electrocardiographic oscillogram observation or dynamic ecg recordings examination recover.

2. produce effects: treatment back cardiopalmus transference cure or obviously improve, integrated value reduces 〉=2/3; Electrocardiographic oscillogram observation or dynamic ecg recordings examination premature beat reduce more than 80%.

3. effective: treatment back symptom integral value reduces between 2/3～1/3; Electrocardiographic oscillogram observation or dynamic ecg recordings examination premature beat number of times reduce more than 50% before the treatment.

4. invalid: treatment back symptom integral value is not as good as 1/3; Electrocardiographic oscillogram observation or dynamic ecg recordings examination premature beat reduce less than 50% or no change or increase the weight of.

Two, safety evaluatio standard

(1) safety: have no adverse reaction.

(2) mild adverse effects: need not drug withdrawal, can die away.

(3) moderate untoward reaction: need not drug withdrawal, but need in time to handle.

(4) severe untoward reaction: need drug withdrawal, and in time handle.

Date processing and statistical analysis

One, test finishes, and Total Test case data gathers, checks and accepts, and makes data summary table and logins.

Two, the input microcomputer is set up the data base, carries out statistical disposition with the SAS statistical procedure.

Three, statistical processing methods: measurement data adopts the t check; The significance test of rate adopts X ²Check; Clinical scale relatively

Adopt the Ridit check; The sxemiquantitative data adopts rank test; Relevant linear correlation or the rectilinear regression of adopting of variable; If there are heterogencity in the test group and the matched group state of an illness, then adopt relatively t check of layering.

Four, analysis is ended, the rejecting case is total reaches curative effects.

Physical data

One, case source:

Observe case totally 200 examples, comprise several 95 examples of inpatient, account for 47.50%, several 105 examples of outpatient account for 52.50%, test group 100 examples wherein, matched group 100 examples.Case source distribution situation sees Table 1.

Table 1 case source distribution situation (example)

The inpatient The outpatient Add up to

Group

n????％?????????n?????％????????N????％

Test group 54 54.00 46 46.00 100 100.00

Matched group 41 41.00 59 59.00 100 100.00

Add up to 95 47.50 105 52.50 200 100.00

Compare X between group ²=3.39, P＞0.05.Aspect, two groups of case sources no significant difference has comparability.

Two, sex:

200 examples are observed in the case, male's 111 examples, and women's 89 examples, the sex distribution situation sees Table 2.

Table 2 patient sex distribution situation (example)

The male The women Add up to

Group men and women's ratio

n????％????????????n????％????????????????????N????％

Test group 54 54.00 46 46.00 1.17: 1 100 100.00

Matched group 57 57.00 43 43.00 1.33: 1 100 100.00

Add up to 111 55.50 89 44.50 1.25: 1 200 100.00

Compare X between group ²=0.18, P＞0.05.Two groups of sex distribution aspect no significant differences have comparability.

Three, the age:

In the observed case, test group age reckling 19 years old, the maximum 65 years old, 49.81 years old mean age, person's 69 examples account for 69.00% more than 45 years old; Matched group age reckling 18 years old, the maximum 65 years old, 48.73 years old mean age, person's 67 examples account for 67.00% more than 45 years old.The age structure situation sees Table 3.

Table 3 patient age constitutes situation (example)

Group 18 years old- 25 years old- 35 years old- 45 years old- 55 years old- Add up toMean age

Other n % n % n % n % n % N % (X ± S)

1

Try 23 49.81 ±

Test 6 6.0 7 7.0 18 18.0 23 46 46.0 100 0

Group .0 12.88

0

1

To 1 26 48.73 ±

According to 6 6.0 10 17 17.0 26 41 41.0 100 0

Organize 0 .0 12.83

0

1

1??????????????????????????24

Close

12???6.0????????8.5???35???17.5??49?????????87???43.5????200???0?????-

Meter

7??????????????????????????.5

0

Compare u=0.59, P＞0.05 between group.No significant difference is compared in two groups of age structures, has comparability.

Four, the course of disease

In the observed case, the test group course of disease is the shortest 0.5 year, and is the longest 8 years, average 2.37 years; The shortest course of disease of matched group 0.2 year, the longest 15 years, average 2.48 years.Patient's course of disease distribution situation sees Table 4.

Table 4 patient course of disease distribution situation (example)

Group ＜1 year 1 year- 3 years- Add up toAverage course of disease

Other n % n % n % N % (X ± S)

Test 13.0 47.0 40.0 2.37 ±

13??????????????47?????????????40??????????????100???100

Organize 000 1.67

Contrast 13.0 56.0 31.0 2.48 ±

13??????????????56?????????????31??????????????100???100

Organize 000 2.51

Close 13.0 10 51.5 35.5

26?????????????????????????????71??????????????200???100????-

Count 0300

Compare u=0.37, P＞0.05 between group.Two groups of patient's course of disease distribution no significant differences have comparability.

Five, the cause of disease:

In 200 routine patients, patients with coronary heart disease 115 examples account for 57.50%.Two groups of cause of disease distribution situations see table 5 for details.

Table 5 patient cause of disease distribution situation (example)

Coronary heart disease Myocarditis Agnogenio

Group

n??????％??????????n??????％??????????n?????％

Test group 59 59.00 22 22.00 19 19.00

Matched group 56 56.00 26 26.00 18 18.00

Add up to 115 57.50 48 24.00 37 18.50

Compare X between group ²=0.44, P＞0.05.Two groups of patient's cause of disease distribution no significant differences have comparability.

Six, the chamber classification early before two groups of patient treatments of classification early constitutes situation, sees Table 6.

The classification early of table 6 chamber constitutes situation (example)

The I level The II level Add up to

Group

n?????％????????n??????％???????????N?????％

Test group 33 33.00 67 67.00 100 100

Matched group 33 33.00 67 67.00 100 100

Add up to 66 33.00 134 67.00 200 100

Relatively, two groups of chamber classifications early constitute zero difference, have comparability between group.

Seven, clinical symptoms

Clinical symptoms light and heavy degree distribution situation before two groups of patient treatments sees Table 7.

Table 7 clinical symptoms light and heavy degree distribution situation (example)

The symptom group does not have the light middle meter U value P value that overlaps

Test group 0 26 49 25 100

Cardiopalmus NS NS

Matched group 0 26 49 25 100

Test group 0 51 43 6 100

Breathe hard 1.04＞0.05

Matched group 0 46 42 12 100

Test group 21 29 41 19 100

Vexed insomnia 1.21＞0.05

Matched group 22 40 30 8 100

Test group 34 31 27 8 100

Dizziness and tinnitus 0.42＞0.05

Matched group 31 40 26 3 100

Test group 46 29 18 7 100

Soreness of the waist and knees 1.02＞0.05

Matched group 37 34 25 4 100

Test group 0 57 33 10 100

Dysphoria with feverish sensation in the chest palms and soles 0.43＞0.05

Matched group 0 53 38 9 100

Test group 32 31 31 6 100

Xerostomia 0.64＞0.05

Matched group 32 39 23 6 100

Two groups of clinical symptoms light and heavy degree distribution situations relatively all do not have explicitly difference.

Eight, body of the tongue

Body of the tongue distribution situation before two groups of patient treatments sees Table 8.

Body of the tongue distribution situation (example) before table 8 treatment

Normally Red tongue with a little fluid Add up to

Group

n????％??????n?????％????????N????％

Test group 00 100 100 100 100

Matched group 00 100 100 100 100

Add up to 00 200 100 200 100

Two groups relatively, and two groups of body of the tongue distribution zero differences have comparability.

Nine, pulse condition

Pulse condition distribution situation before two groups of patient treatments sees Table 9.

Pulse condition distribution situation (example) before table 9 treatment

Normal pulse Short, knot, generation Add up to

Group

n????％?????n??????％???????N?????％

Test group 00 100 100 100 100

Matched group 00 100 100 100 100

Add up to 00 200 100 200 100

Two groups relatively, and two groups of pulse condition distribution zero differences have comparability.

Ten, sign

Sign distribution situation before two groups of patient treatments sees table 10 for details.

Sign distribution situation before table 10 treatment (X ± S)

Sign test group (n=100) matched group (n=100) u value

SBP(mmHg)????????128.04±13.26?????????128.98±14.17??????0.48

DBP(mmHg)????????79.97±7.33???????????80.96±7.49????????0.95

HR (inferior/minute) 77.05 ± 12.20 76.15 ± 8.57 0.60

Premature beat (inferior/minute) 6.51 ± 5.80 7.31 ± 6.73 0.90

Two groups relatively, and systolic pressure, diastolic pressure, resting heart rate and premature beat no significant difference (P＞0.05) have comparability.

11, ambulatory electrocardiogram

Two groups of preceding 24 hr Ambulatory EKG Monitoring distribution situations of patient treatment see table 11 for details.

The preceding 24 hr Ambulatory EKG Monitoring distribution situations of table 11 treatment (X ± S)

Sign test group (n=91) matched group (n=90) u value

2680.21±????????????????????????????3175.19±

Premature beat sum (inferior/24h) 0.69

4876.71???????????????4832.40

Two groups relatively, and 24H premature beat sum no significant difference (P＞0.05) has comparability.

12, cardiac monitoring

Electrocardio monitored record premature beat sum before two groups of patient treatments (inferior/30 minute) distribution situation sees table 12 for details.

Electrocardio monitored record premature beat sum distribution situation before table 12 treatment (X ± S)

Sign test group (n=100) matched group (n=100) u value

First day 70.49 ± 111.10 71.01 ± 99.36 0.04

Second day 65.98 ± 108.45 69.45 ± 96.59 0.24

The 3rd day 66.75 ± 111.33 68.23 ± 95.19 0.10

Treat preceding average 67.74 ± 109.82 69.56 ± 96.71 0.12

Two groups relatively, and cardiac monitoring electrographic recording premature beat sum no significant difference (P＞0.05) has comparability before the treatment.

Therapeutic outcome

One, cardiopalmus disease curative effect

(1) the clinical symptoms curative effect sees Table 13

Table 13 clinical symptoms curative effect relatively

Group Recovery from illness produce effects enabledisable shows more rate total effective rate

N

Other n % n % n % n % n % n %

Examination

Test 100 16 16.00 53 53.00 23 23.00 8 8.00 69 69.00 92 92.00

Group

Right

According to 100 12 12.00 32 32.00 45 45.00 11 11.00 44 44.00 89 89.00

Group

Close

200????28???14.00????85???42.50???68???34.00???19???9.50???113??56.50???181??90.50

Meter

Compare u=2.95, P＜0.01 between group.

Test group and matched group clinical symptoms curative effect relatively have notable difference.The test group curative effect is better than matched group.

(2) cardiopalmus mild symptoms weight classification curative effect table 14

Table 14 cardiopalmus mild symptoms weight classification curative effect relatively

Classification group example number (n) treatment back (X ± S) compare between group

Test group 26 0.46 ± 1.10

2.21

Slight matched group 26 1.27 ± 1.51

P＜0.05

Add up to 52

Test group 49 1.65 ± 1.63

0.89

Moderate matched group 49 1.96 ± 1.79

P＞0.05

Add up to 98

Test group 25 2.16 ± 1.84

2.97

Severe matched group 25 3.96 ± 2.41

P＜0.01

Add up to 50

Cardiopalmus mild symptoms weight classification curative effect is compared for two groups, and test group has been compared notable difference to curative effect light, severe cardiopalmus symptom with matched group; To the curative effect of moderate cardiopalmus symptom, two groups are compared no significant difference.

(3) clinical symptoms integration curative effect table 15

Table 15 clinical symptoms integration curative effect relatively

Before the treatment After the treatmentFront and back are than ratio between group

The symptom group

N X ± S X ± S is (u) (u)

Test group 100 5.97 ± 2.15 1.47 ± 1.68 16.49

Cardiopalmus 2.98

Matched group 100 5.97 ± 2.15 2.28 ± 2.14 12.16 P＜0.01

Test group 100 3.10 ± 1.22 0.86 ± 1.11 13.58

Breathe hard 2.13

Matched group 100 3.32 ± 1.37 1.22 ± 1.27 11.24 P＜0.05

Vexed

Test group 79 1.75 ± 0.65 0.59 ± 0.67 11.05 0.09

Insomnia

P＞0.05

Matched group 78 1.59 ± 0.67 0.58 ± 0.67 9.47

Test group 66 1.65 ± 0.69 0.61 ± 0.68 8.72

Dizzy 1.91

Tinnitus

Matched group 69 1.46 ± 0.58 0.41 ± 0.52 11.19 P＞0.05

Test group 54 1.59 ± 0.71 0.63 ± 0.68 7.18

Waist knee joint 1.39

Aching and limp

Matched group 63 1.52 ± 0.62 0.46 ± 0.64 9.44 P＞0.05

Test group 100 1.53 ± 0.67 0.40 ± 0.57 12.85

Five hearts 1.35

Dysphoria with smothery sensation

Matched group 100 1.56 ± 0.66 0.51 ± 0.58 11.95 P＞0.05

Test group 68 1.63 ± 0.64 0.68 ± 0.72 8.13

Xerostomia 0.94

Matched group 68 1.51 ± 0.66 0.57 ± 0.65 8.37 P＞0.05

Two groups to the effect that all has clear improvement of all symptoms, P＜0.01; The two groups of symptom integral in treatment back compare,

Test group is better than matched group to the curative effect of cardiopalmus, the symptom of breathing hard, and to the curative effect of other symptom, compares no significant difference for two groups.

Two, body of the tongue, pulse condition and sign situation of change

(1) body of the tongue situation of change table 16

Table 16 body of the tongue situation of change relatively

Compare (u) between group example number X ± S group

Test group 100 0.64 ± 0.94

Matched group 100 0.51 ± 0.89 1.00

Total 200-

The two groups of body of the tongue situations of change in treatment back are no significant difference relatively, P＞0.05.

(2) pulse condition situation of change

Table 17 pulse condition situation of change relatively

Compare (u) between group example number X ± S group

Test group 100 0.96 ± 1.41

Matched group 100 1.32 ± 1.50 1.75

Total 200-

The two groups of pulse condition situations of change in treatment back are no significant difference relatively, P＞0.05.

(3) the changes in heart rate information slip 18

Table 18 changes in heart rate situation relatively

Before the treatment After the treatmentFront and back relatively

Compare between the group group (u)

n???????X±S????????????X±S????????????(u)

Test group 100 77.05 ± 12.20 73.68 ± 10.98 2.05

Matched group 100 76.15 ± 8.57 73.52 ± 8.07 2.03 0.12

Total 200---

The two groups of hearts rate in treatment back all have to a certain degree decline, but still in normal range, relatively there is notable difference front and back, P＜0.05; Compare no significant difference, P＞0.05 between group.

(4) the blood pressure information slip 19,20

Table 19 blood pressure situation is (systolic pressure SBP) relatively

Before the treatment After the treatmentFront and back are than comparing between group

Group

N X ± S X ± S than (u) (u)

128.04±

Test group 100 123.35 ± 9.58 2.87

13.26

128.98±?????????????124.48±??????????????????????????0.70

Matched group 100 2.34

14.17?????????12.99

Total 200---

The two groups of systolic pressures in treatment back all have to a certain degree decline, but still in normal range,

Relatively there are notable difference, P＜0.05～0.01 in front and back; Compare no significant difference, P＞0.05 between group

Table 20 blood pressure situation is (diastolic pressure DBP) relatively

Before the treatment After the treatmentCompare between the comparable group of front and back

Group

n??????X±S????????X±S??????????(u)????????????(u)

79.97±

Test group 100 77.41 ± 6.02 2.69

7.33

80.96±?????????????????????????????????????????????????????????????0.63

Matched group 100 77.99 ± 7.03 2.89

7.49

Total 200---

The two groups of diastolic pressures in treatment back all have to a certain degree decline, but still in normal range, relatively there is notable difference front and back, P＜0.01;

Compare no significant difference, P＞0.05 between group

Three, premature beat curative effect

(1) premature beat curative effect table 21

Table 21 premature beat curative effect relatively

Group Recovery from illness Produce effects Effectively Invalid Show more rate Total effective rate

N

Other n % n % n % n % n % n %

Examination

Test 100 8 8.00 48 48.00 33 33.00 11 11.00 56 56.00 89 89.00

Group

Right

According to 100 6 6.00 31 31.00 43 43.00 20 20.00 37 37.00 80 80.00

Group

Close

200????14???7.00???79???39.50???76???38.00???31???15.50???93???46.50???169??84.50

Meter

Compare between group, u=2.67, P＜0.01, test group and matched group premature beat curative effect relatively have notable difference.The test group curative effect is better than matched group.

(2) per minute premature beat frequency table 22

Table 22 per minute premature beat number of times relatively

Group

n??????X±S??????????X±S??????????(u)??????????(u)

Test group 100 6.51 ± 5.80 1.21 ± 1.81 8.72

Matched group 100 7.31 ± 6.73 2.01 ± 2.54 7.37 2.57

Total 200---

The two groups of per minute premature beats in treatment back time number average obviously reduces, and relatively there is notable difference front and back, P＜0.01,

Notable difference is more also arranged between group, P＜0.01, the test group curative effect is better than matched group.

(3) the total numerical table 23 of cardiac monitoring record premature beat

The total comparison of table 23 cardiac monitoring record premature beat (X ± S)

Before the treatment Treat 4 weeks of backCompare between the comparable group of front and back

Group

n????????X±S????????X±S??????????(u)??????????(u)

Test group 100 67.74 ± 109.82 15.21 ± 31.70 4.59

Matched group 100 69.56 ± 96.71 27.44 ± 49.89 3.87 2.07

Total 200---

Two groups of treatment back total number averages of cardiac monitoring record premature beat have obvious decline, and more all there is notable difference front and back, P＜0.01;

Notable difference is more also arranged between group, P＜0.05, the test group curative effect is better than matched group.

(4) 24 hr Ambulatory EKG Monitoring situation of change tables 24

The comparison of table 24 24 hr Ambulatory EKG Monitoring situations of change (X ± S)

Compare between the comparable group of front and back

After treating before the N treatment

(u)???????????(u)

2680.21±

Test

91?????????????????????580.41±944.63?????????4.03

Group

4876.71

Premature beat sum (inferior 2.79

/24h)

3175.19±???????????????1682.03±

Contrast

90????????????????????????????????????????????2.35

Group

4832.40?????????3622.76

24 hr Ambulatory EKG Monitoring situations of change relatively relatively have notable difference, P＜0.05～0.01 before and after two groups of treatments;

Notable difference is relatively arranged between group, P＜0.01, the test group curative effect is better than matched group.

Four, total effects table 25

Table 25 total effects relatively

N

Other n % n % n % n % n % n %

Examination

Test 100 7 7.00 47 47.00 35 35.00 11 11.00 54 54.00 89 89.00

Group

Right

According to 100 6 6.00 29 29.00 45 45.00 20 20.00 35 35.00 80 80.00

Group

Close

200?????13???6.50?????76???38.00????80???40.00????31????15.50????89???44.50???169???84.50

Meter

Compare u=2.64, P＜0.01 between group.

Test group and matched group total effects relatively have notable difference.The test group curative effect is better than matched group.

Five, the relation of the cause of disease and curative effect

(1) relation table 26,27 of the cause of disease and clinical symptoms curative effect

The relation of table 26 cause of disease and clinical symptoms curative effect is (test group) relatively

Cause of disease example number faces control produce effects enabledisable Ridit value standard error 95% fiducial limit

Coronary heart disease 59 11 29 15 4 0.51 0.08 0.43～0.58

Myocarditis 22 3 13 33 0.49 0.12 0.37～0.62

Agnogenio 19 2 11 51 0.48 0.13 0.35～0.61

Add up to 100 16 53 23 8 0.50--

The comparison of the cause of disease of test group and clinical symptoms therapeutic effect relationship, no significant difference.

The relation of table 27 cause of disease and clinical symptoms curative effect is (matched group) relatively

Coronary heart disease 56 7 19 22 8 0.50 0.07 0.42～0.58

Myocarditis 26 48 12 2 0.53 0.11 0.41～0.64

Agnogenio 18 15 11 1 0.46 0.14 0.32～0.59

Add up to 100 12 32 45 11 0.50--

The comparison of the cause of disease of matched group and clinical symptoms therapeutic effect relationship, no significant difference.

(2) relation table 28,29 of the cause of disease and premature beat curative effect

The relation of table 28 cause of disease and premature beat curative effect is (test group) relatively

Coronary heart disease 59 5 30 18 6 0.52 0.08 0.44～0.59

Myocarditis 22 2884 0.45 0.12 0.32～0.57

Agnogenio 19 1 10 71 0.51 0.13 0.38～0.65

Add up to 100 8 48 33 11 0.50--

The comparison of the cause of disease of test group and premature beat therapeutic effect relationship, no significant difference.

The relation of table 29 cause of disease and premature beat curative effect is (matched group) relatively

Coronary heart disease 56 4 17 21 14 0.49 0.08 0.41～0.57

Myocarditis 26 17 15 3 0.50 0.11 0.39～0.61

Agnogenio 18 1773 0.54 0.14 0.40～0.67

Add up to 100 6 31 43 20 0.50--

The comparison of the cause of disease of matched group and premature beat therapeutic effect relationship, no significant difference.

(3) relation table 30,31 of the cause of disease and total effects

The relation of table 30 cause of disease and total effects is (test group) relatively

Coronary heart disease 59 4 30 19 6 0.52 0.08 0.44～0.59

Myocarditis 22 2884 0.45 0.12 0.33～0.58

Agnogenio 19 1981 0.50 0.13 0.37～0.64

Add up to 100 7 47 35 11 0.50--

The comparison of the cause of disease of test group and total effects relation, no significant difference.

The relation of table 31 cause of disease and total effects is (matched group) relatively

Coronary heart disease 56 4 15 23 14 0.48 0.08 0.41～0.56

Myocarditis 26 17 15 3 0.51 0.11 0.39～0.62

Agnogenio 18 1773 0.55 0.14 0.41～0.68

Add up to 100 6 29 45 20 0.50--

The comparison of the cause of disease of matched group and total effects relation, no significant difference.

Six, the relation of chamber classification early and curative effect

(1) relation table 32,33 of chamber classification early and clinical symptoms curative effect

The relation of classification early of table 32 chamber and clinical symptoms curative effect is (test group) relatively

Chamber classification early example number faces control produce effects enabledisable Ridit value standard error 95% fiducial limit

I level 33 7 18 71 0.55 0.10 0.45～0.65

II level 67 9 35 16 7 0.48 0.07 0.40～0.55

Add up to 100 16 53 23 8 0.50--

The comparison of classification early of the chamber of test group and clinical symptoms therapeutic effect relationship, no significant difference.

The relation of classification early of table 33 chamber and clinical symptoms curative effect is (matched group) relatively

I level 33 5 11 14 3 0.53 0.10 0.43～0.63

II level 67 7 21 31 8 0.49 0.07 0.42～0.56

Add up to 100 12 32 45 11 0.50--

The comparison of classification early of the chamber of matched group and clinical symptoms therapeutic effect relationship, no significant difference.

(2) relation table 34,35 of chamber classification early and premature beat curative effect

The relation of classification early of table 34 chamber and premature beat curative effect is (test group) relatively

I level 33 4 16 11 2 0.54 0.10 0.44～0.64

II level 67 4 32 22 9 0.48 0.07 0.41～0.55

Add up to 100 8 48 33 11 0.50--

The comparison of classification early of the chamber of test group and premature beat therapeutic effect relationship, no significant difference.

The relation of classification early of table 35 chamber and premature beat curative effect is (matched group) relatively

I level 33 4 12 12 5 0.58 0.07 0.50～0.65

II level 67 2 19 31 15 0.47 0.07 0.39～0.54

Add up to 100 6 31 43 20 0.50--

The comparison of classification early of the chamber of matched group and premature beat therapeutic effect relationship, no significant difference.

(3) relation table 36,37 of chamber classification early and total effects

The relation of classification early of table 36 chamber and total effects is (test group) relatively

I level 33 3 16 12 2 0.53 0.10 0.43～0.63

II level 67 4 31 23 9 0.48 0.07 0.41～0.56

Add up to 100 7 47 35 11 0.50--

The comparison of classification early of the chamber of test group and total effects relation, no significant difference.

The relation of classification early of table 37 chamber and total effects is (matched group) relatively

I level 33 4 11 13 5 0.57 0.10 0.47～0.67

II level 67 2 18 32 15 0.47 0.07 0.39～0.54

Add up to 100 6 29 45 20 0.50--

The comparison of classification early of the chamber of matched group and total effects relation, no significant difference.

Seven, each tame curative effect relatively

(1) comparison sheet 38,39 of each tame clinical symptoms curative effect

(remarks: 1. No.1 Hospital Attached to He'nan Traditional Chinese Medical College is called for short: " the Henan traditional Chinese medical science ", 2. Affiliated Hospital of Heilongjiang University of Chinese Medicine is called for short: " Longjiang traditional Chinese medical science ", 3. Hospital Affiliated to Shandong Medical College is called for short: " Shandong medical university ".Below herewith.)

The relation of each tame clinical symptoms curative effect of table 38 is (test group) relatively

The Henan traditional Chinese medical science 35 5 17 10 3 0.47 0.09 0.37～0.57

Longjiang traditional Chinese medical science 35 5 20 82 0.51 0.09 0.41～0.60

Shandong medical university 30 6 16 53 0.53 0.11 0.42～0.63

Add up to 100 16 53 23 8 0.50--

The relation of each tame clinical symptoms curative effect of test group compares, and no significant difference has concordance.

The relation of each tame clinical symptoms curative effect of table 39 is (matched group) relatively

The Henan traditional Chinese medical science 35 46 20 5 0.43 0.09 0.33～0.53

Longjiang traditional Chinese medical science 35 48 21 2 0.48 0.09 0.38～0.57

Shandong medical university 30 4 18 44 0.61 0.11 0.50～0.72

Add up to 100 12 32 45 11 0.50--

The relation of each tame clinical symptoms curative effect of matched group compares, and no significant difference has concordance.

(2) comparison sheet 40,41 of each tame premature beat curative effect

The relation of each tame premature beat curative effect of table 40 is (test group) relatively

The Henan traditional Chinese medical science 35 3 18 10 4 0.52 0.09 0.42～0.61

Longjiang traditional Chinese medical science 35 3 17 12 3 0.51 0.09 0.41～0.61

Shandong medical university 30 2 13 11 4 0.47 0.11 0.36～0.57

Add up to 100 8 48 33 11 0.50--

The relation of each tame premature beat curative effect of test group compares, and no significant difference has concordance.

The relation of each tame premature beat curative effect of table 41 is (matched group) relatively

The Henan traditional Chinese medical science 35 29 19 5 0.49 0.09 0.39～0.59

Longjiang traditional Chinese medical science 35 28 17 8 0.46 0.09 0.36～0.56

Shandong medical university 30 2 14 77 0.55 0.11 0.45～0.66

Add up to 100 6 31 43 20 0.50--

The relation of each tame premature beat curative effect of matched group compares, and no significant difference has concordance.

(3) comparison sheet 42,43 of each tame total effects

The relation of each tame total effects of table 42 is (test group) relatively

The Henan traditional Chinese medical science 35 2 18 11 4 0.51 0.09 0.41～0.61

Longjiang traditional Chinese medical science 35 3 16 13 3 0.51 0.09 0.41～0.61

Shandong medical university 30 2 13 11 4 0.48 0.11 0.37～0.58

Add up to 100 7 47 35 11 0.50--

The relation of each tame total effects of test group compares, and no significant difference has concordance.

The relation of each tame total effects of table 43 is (matched group) relatively

The Henan traditional Chinese medical science 35 28 20 5 0.49 0.09 0.39～0.59

Longjiang traditional Chinese medical science 35 27 18 8 0.46 0.09 0.36～0.55

Shandong medical university 30 2 14 77 0.56 0.11 0.45～0.66

Add up to 100 6 29 45 20 0.50--

The relation of each tame total effects of matched group compares, and no significant difference has concordance.

Untoward reaction and safety indexes detect

One, untoward reaction table 44

Table 44 untoward reaction evaluation table

Experiment processing and medication take place to continue to disappear in the journey symptom

Numbering

Degree time sign time time check is through relation

-??????-???????-???????-??????-???????-???????-???????-

Untoward reaction does not take place in viewing duration.

Two, reject case and do not have the rejecting case.

Three, safety indexes detects table 45

Table 45 safety indexes testing result

Test group (100 example) Matched group (100 example)

Unusually it is unusual normally to control the back after controlling after normally controlling after controlling

Control preceding normal 100 0 100 0

Routine blood test

Control preceding unusual 0000

The front and back comparison----

Control preceding normal 100 0 100 0

Routine urinalysis

Control preceding unusual 0000

The front and back comparison----

Control preceding normal 100 0 100 0

Stool routine examination

Control preceding unusual 0000

The front and back comparison----

GPT controls preceding normal 100 0 98 0

Control preceding unusual 0011

The front and back comparison----

Control preceding normal 100 0 100 0

BUN

Control preceding unusual 0000

The front and back comparison----

Control preceding normal 100 0 100 0

Cr

Control preceding unusual 0000

The front and back comparison----

The safety indexes testing result, zero difference relatively before and after test group and the matched group self illustrates that this medicine takes safety.

Conclusion

One, cardiopalmus therapeutic effect of syndrome

1. test group and matched group clinical symptoms curative effect relatively have notable difference.The test group curative effect is better than matched group.Test group shows more rate: 69.00%, and total effective rate: 92.00%.Matched group shows more rate: 44.00%, and total effective rate: 89.00%.

2. cardiopalmus mild symptoms weight classification curative effect is compared for two groups, and test group has been compared notable difference to curative effect light, severe cardiopalmus symptom with matched group; To the curative effect of moderate cardiopalmus symptom, two groups are compared no significant difference.

3. two groups to the effect that all has clear improvement of all symptoms, P＜0.01; The two groups of symptom integral in treatment back compare, and test group is better than matched group to the curative effect of cardiopalmus, the symptom of breathing hard, and to the curative effect of other symptom, compares no significant difference for two groups.

Two, body of the tongue, pulse condition and sign situation of change

1. the two groups of body of the tongues in treatment back, pulse condition situation of change compare no significant difference, P＞0.05.

2. treatment back two groups of hearts rate, blood pressures all have to a certain degree decline, but still in normal range,

Relatively there are notable difference, P＜0.05～0.01 in front and back; Compare no significant difference, P＞0.05 between group.

Three, premature beat curative effect

1. test group and matched group premature beat curative effect relatively have notable difference.The test group curative effect is better than matched group.Test group shows more rate: 56.00%, and total effective rate: 89.00%.Matched group shows more rate: 37.00%, and total effective rate: 80.00%.

2. treatment back two groups of per minute premature beats time number average obviously reduces, and relatively there is notable difference front and back, P＜0.01,

3. two groups of treatment back total number averages of cardiac monitoring record premature beat have obvious decline, and more all there is notable difference front and back, P＜0.01; Notable difference is more also arranged between group, P＜0.05, the test group curative effect is better than matched group.

4. 24 hr Ambulatory EKG Monitoring situations of change relatively relatively have notable difference, P＜0.05～0.01 before and after two groups of treatments; Notable difference is relatively arranged between group, P＜0.01, the test group curative effect is better than matched group.

Four, total effects

Test group and matched group total effects relatively have notable difference.The test group curative effect is better than matched group.Test group shows more rate: 54.00%, and total effective rate: 89.00%.Matched group shows more rate: 35.00%, and total effective rate: 80.00%.

Five, the relation of the cause of disease, chamber classification early and curative effect

Classification early of the cause of disease, chamber and curative effect concern no significant difference, have concordance.

Six, each tame curative effect relatively

Each tame clinical symptoms curative effect, premature beat curative effect and total effects compare, and no significant difference has concordance.

Seven, untoward reaction and safety indexes detect

Untoward reaction does not take place in viewing duration.The safety indexes testing result, zero difference relatively before and after test group and the matched group self illustrates that this medicine takes safety.

Eight, reject case

Viewing duration does not have the rejecting case.

Discuss

Ventricular presystole is that sickness rate often causes that than a higher class illness hemodynamics changes in the cardiovascular system, is having a strong impact on patient's quality of life, even threat to life.Because of than, in recent years, modern medicine has dropped into huge human and material resources to the control of ventricular presystole, though obtained bigger achievement, treatments such as wound property radio-frequency (RF) ablation is arranged, patient is difficult for accepting; The drug effect performance of modern antiarrhythmic drug is subjected to the restriction of multiple complicated factors such as the cause of disease, electrophysiological mechanism, arrhythmia type, and the medicine that has has been taken arrhythogenic side effect for a long time.

Ventricular presystole belongs to motherland's medical science " cardiopalmus " and reaches categories such as " palpitation with a distress feelings ".Motherland's medical science has deep understanding and detailed argumentation to the etiology and pathogenesis of cardiopalmus, and has also accumulated rich experience at drug treatment.Chinese medicine is from organic conception, and dialectical opinion is controlled the ventricular presystole tool and had great advantage: not only effectively improve the body symptom, and, treat from the cause of disease at all, simultaneously, take for a long time and have no side effect.

One, deficiency of YIN-blood, hyperactivity of fire are disturbed the main pathomechanism that the heart is a cardiopalmus (ventricular presystole).

Ventricular presystole belongs to the traditional Chinese medical science " cardiopalmus ", " palpitation with a distress feeling " reaches diseases such as " irregularly intermittent and regularly intermittent pulse ".Ancient Chinese medicine doctor is recognized deficiency of YIN-blood in the long term medical practice, hyperactivity of fire is disturbed the main pathomechanism that the heart is a cardiopalmus.

Forefathers recognize the substantial connection of deficiency of YIN-blood and cardiopalmus, palpitation with a distress feeling already in clinical practice." the turbid palpitation with a distress feeling source and course of miscellaneous diseases source and course rhinoceros " indicates the pathological change of palpitation with a distress feeling: " palpitation with a distress feeling, the deficiency of heart-blood disease is also ... painstaking effort are withered away, the manner fall, then hollow in the heart, disgruntled shaking is much troubled, and always does, name is said palpitation with a distress feeling " [1]; Zhu Danxi then more emphasizes " palpitation with a distress feeling person's blood deficiency, when palpitation with a distress feeling did not have, the insufficiency of blood person was many " [2].Cloudy blood homology, blood deficiency must reach in the moon." the Jing Yue's complete work palpitation with a distress feeling is terrified " piece of writing is then set forth the deficiency of YIN and is caused the pathogenesis of throbbing with fear: " disease of palpitation with a distress feeling, vibration is built in ambition, and alarmed fearing gets Ning Zheshi also when no.This card covers the deficiency of YIN in following for the people of deficiency of YIN strain has it ..., vibrate by umbilicus next in what is deep in one's heart in last then floating regret, empty little person is moving also little, and void very person is moving also very ".And emphasize " sun system the moon, the heart is kidney originally, peaceful person does not have and can't help down on all " [3].Palpitation with fear " source arises from deficiency of kidney-YIN, can not rise, so that heart-fire can not descend " [4] is also thought at aloof from politics and material pursuits bulging peak.

Ancient times, the scholar also recognized not only deficiency of YIN-blood, and lack of preservation of spirit is done to throb with fear in the heart, and deficiency of heart-blood, and kidney water is not good, and deficiency-fire stirring up is upset the mind, also can aggravate (or send out for) palpitation with fear.Record in " element is asked arcane truth source sick formula fire class ": " water declines hyperactivity of fire and disturbs moving also of fire, so ambition is restless, and the palpitation with a distress feeling of meaning "; Clear Wu Cheng does not say in " not occupying the forgetful susceptible to fear sleeplessness of collection palpitation with a distress feeling ": " the cardiopalmus body is thin for cloudy gas interior-deficiency, deficiency-fire stirring up " [5]; Above-mentioned argumentation is the etiology and pathogenesis of cardiopalmus (ventricular arrhythmia) for understanding " deficiency of YIN-blood, asthenic fire is disturbed the heart ", and the side's of sending medication, has directive significance.

Ancient Chinese medicine doctor has rich experience to the treatment of cardiopalmus, palpitation with a distress feeling.Zhang Zhongjing treatise on Febrile Diseases note in Han dynasty has: " SHAO YIN syndrome ... vexation must not crouch, Chinese goldthread colla corii asini decoction master it ".Rhizoma Coptidis, the relieving restlessness of Radix Scutellariae pathogenic fire reducing in the side, Ovum Gallus domesticus Flavus, the Radix Paeoniae Alba, Colla Corii Asini nourish cloudy blood, and the clinical cardiopalmus that is used for cloudy blood hyperactivity of fire is vexed fabulous curative effect.All family sides book is throbbed with fear in " interior warp " opinion, on the basis of Zhong Jing prescription, extensively gather again, makes it to become increasingly abundant.Liu's interchannel is emphasized " palpitation with a distress feeling of palpitating from nervousness, all hot within do ", and to belong to kidney water Kidney-Yin deficient more, and heart-fire Yang Renei is vehement, advocates the agent " make its god keep blood honor and heal " [6] of " fire decline the road of level side for effecting a permanent cure, medication is many from cold and cool, with Radix Angelicae Sinensis Radix Gentianae ball class " the system fire that nourishes blood; " Prescriptions for Universal Relief " then declared " deficiency of heart-blood " and is the reason of trouble, and upright beneficial flourish soup " is specially mended true blood "; Group two should be controlled " discordance between water(the kidney)and fire(the heart), in ear tinnitus of deficiency type, forgetful palpitation with a distress feeling, the vertigo " [7] by folk prescription; Li Dongyuan then brings into play " the blood fire second of the three ten-day periods of the hot season on the diaphragm ", gets Cinnabar Sedative Pill " floating on town's YIN-fire " [8], side's Cinnabaris tranquillization with heavy prescription.The straight eliminating heart-fire of Rhizoma Coptidis, Radix Angelicae Sinensis, the Radix Rehmanniae, Poria, Radix Polygalae replenishing blood for nourishing heart, for deficiency of YIN-blood, asthenic fire is disturbed the palpitation with fear insomnia of the heart, and diseases such as irritability with mental disarrangement are whenever used every effect; Bright formula " the Cheng Shi doctor draws a bow to the full and collects ancient " Chinese medicine is with medicines such as Semen Platycladi, Plumula Nelumbinis, gardenia florida, Radix Ginseng, Radix Polygalae, Poria cum Radix Pini, Semen Ziziphi Spinosae, Radix Glycyrrhizae Preparata and Rhizoma Coptidis phase 5, and the prescription heart-nourishing pill clears away heart-fire and presses down fire, and taste blood is allayed excitement, and tonifying deficiency is treated palpitation with a distress feeling [9].Point out in " the Jing Yue's complete work palpitation with a distress feeling is terrified ": " if losing fire, contains in water, the thirsty and peaceful person of palpitation with a distress feeling palpitation with fear of irritated heat, Yiyin Decoction is fried in shallow oil or added and subtracted to two the moon "; Two the moon are fried in shallow oil by the Radix Rehmanniae, Radix Ophiopogonis, Semen Ziziphi Spinosae, Radix Scrophulariae, Poria cum Radix Pini, Caulis Akebiae, Rhizoma Coptidis, Radix Glycyrrhizae and are formed, and play the merit [3] that nourishing YIN to lower pathogenic fire is calmed the nerves altogether.

Two, made progress the modern age of motherland's therapeutic treatment ventricular presystole

Modern medicine has accumulated many experiences at aspects such as treatment tachyarrhythmias.Treat tachyarrhythmias such as premature beat, supraventricular tachycardia, atrial fibrillation, Dou Su with ginseng mattress soup (Radix Sophorae Flavescentis, Herba Artemisiae Scopariae, Radix Ginseng, succinum) as woods peaceful [10], total effective rate is 82.35%; Wang Kequan [11] intends defibrillation soup (Radix Salviae Miltiorrhizae, Radix Sophorae Flavescentis, Radix Glycyrrhizae Preparata, Semen Platycladi, Radix Notoginseng, Rhizoma Chuanxiong, Fructus Schisandrae Chinensis) treatment atrial fibrillation 40 examples certainly, and wherein the room rate of electrocardiogram per minute more than 400 times transfers normal cardiac rate at short notice to before the 32 example treatments; It is basis side that Sun Qifeng etc. [12] fry in shallow oil (Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Adenophorae (Radix Glehniae), Semen Ziziphi Spinosae (parched), Concha Margaritifera, Semen Platycladi, Os Draconis etc.) to hold back the heart, with the card plus-minus, and treatment tachycardia, premature beat and atrial fibrillation 164 examples, total effective rate 84.75%; Bringing up that essay [13] calms the nerves with clearing away heat and nourishing YIN to tachyarrhythmia is method of treatment, selects medicines such as Radix Sophorae Flavescentis, Rhizoma Coptidis, the Radix Rehmanniae, Radix Ophiopogonis, Radix Scrophulariae, Semen Ziziphi Spinosae (parched), Semen Platycladi for use, and effective percentage reaches 82.5%; Jin Yaotang [14] thinks that blood stasis due to qi deficiency is the pathomechanism of tachyarrhythmia, from intending flat rule mixture (Radix Astragali, Radix Salviae Miltiorrhizae, Radix Sophorae Flavescentis, Radix Puerariae, Radix Stephaniae Tetrandrae) is observation group, with the mexiletine sheet is matched group, result of study shows, flat rule mixture does not relatively have significant difference to ventricular arrhythmia and mexiletine group, but supraventricular arrhythmia then is better than the mexiletine group; Report such as Zhou Yuping [15] metancenter electuary treatment Qi deficiency blood stasis type tachyarrhythmia, clinical primary symptom total effective rate 93.58%, electrocardiogram total effective rate 90.2%, the clinical total effective rate 88.0% of the oral amiodarone of matched group, electrocardiogram total effective rate 84.0%, learn by statistics and handle, the metancenter electuary is better than amiodarone (P＜0.05); Xiang Conggui etc. [16] treat type of deficiency of both QI and YIN tachyarrhythmia 86 examples, total effective rate 88.4% with steady arteries and veins soup (Radix Pseudostellariae, the Radix Astragali, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Rehmanniae, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Colla Corii Asini, Carapax et Plastrum Testudinis, Radix Glycyrrhizae).

Three, heart disease Yiganning capsule prescription foundation

The invaluable experience of human therapy cardiopalmus before professor Lin Huijuan of Hospital Attached to Shandong Chinese Medical Univ. uses for reference, conscientiously sum up clinical practice for many years, think that " deficiency of YIN-blood; hyperactivity of fire is disturbed the heart " is the main pathogenesis of cardiopalmus (ventricular presystole), sick position is the card of deficiency in origin and excess in superficiality at the heart, kidney, and at the pathogenesis of " hyperactivity of fire caused by deficiency of YIN ", in conjunction with the clinical exploration in 30 years, change the sanction prescription, the utilization modern crafts process heart disease Yiganning capsule; Carried out the clinical and experimentation of system as Shandong Province Department of Public Health emphasis problem in 1993 ~ 1996 years.Observe by 160 routine clinical cases, prove cardiopalmus (ventricular presystole) evident in efficacyly, effective percentage 88.4% does not have and delays to conduct and other toxic and side effects clinical practice safety.Through expert testimony, this problem reaches leading domestic level, and obtains 1996 annual Shandong Province scientific and technological progress third prizes.

Four, the theory of Chinese medical science basis of heart disease Yiganning capsule prescription

According to its cardinal symptom and unusual pulse condition, premature beat can be under the jurisdiction of " cardiopalmus " of motherland's medical science, the category that " palpitation with a distress feeling " reaches " intermittent pulse ".We's card is few for cloudy anemia, and asthenic fire is disturbed the heart.So see the palpitation with fear palpitation with a distress feeling, vertigo and tinnitus, soreness of waist asthenia, cards such as dysphoria with feverish sensation in the chest palms and soles.The major function of the heart is a controlling blood and vessel, and house mind's will is for guaranteeing the normal performance of these two big functions, than the equilibrium relation that must coordinate the heart-yin heart-yang.Heart-yang agitate blood in vascular, to move and escort the mind in outside, make the unlikely dissipation of the heart-yin, mind quietness is in interior; The heart-yin abundance then blood vessels must be filled, and heart-yang biochemistry is active, and is foster to some extent in the mind, promptly so-called " sun makes also pudendum, cloudy keeping also at interior sun ".When the imbalance of this balancing, cross with insufficiency of heart-YIN, heart-yang and to contain when being principal contradiction, the cardiopalmus that deficiency of YIN-blood, hyperactivity of fire are disturbed the heart, malaise just can take place, this is the basic pathologic basis that primary disease takes place.Heart-fire comes down to the deficiency of painstaking effort.Heart storing spirit, keep in the manner rely the heart-yin with moisten it, heart-yang to be to protect it, heart-fire is prosperous excessively, heart-Yin deficiency then do not have in the mind support, not having institute outward protects, the variation of mind aspects such as vexed insomnia, forgetful dreaminess can appear on the one hand, on the other hand because of mental derangement, the heart is become homeless and is supported and occur fearing in the heart and diseases such as moving cardiopalmus, palpitation with a distress feeling; As " element asks arcane truth former sick formula " what is called: " frightened for disease be heart gas must not its just, moving and be pathogenic fire person also ".Also emphasize in " Standards of Diagnosis and Treatment ": " ont yet from also, modern its cloudy inclination that loses is in sun at heart for the gas of negative and positive, and sun is also at random with air bearing, so spirit is stared blankly laden with anxiety " [17].Blood is capable with gas, and gas carries with blood, and blood is the material base that gas is rely and generated, and with the passing of time the deficiency of YIN-blood of the heart certainly will cause the deficiency of the motive, so show as disease such as breathe hard, uncomfortable in chest.Heart-yang descends in kidney, to control kidney water, helps on the kidney yin in the heart, with the Ji heart-fire; Cloudy blood homology, insufficiency of blood must reach cloudy.If deficiency of kidney yin, the not good fire of water, deficiency-fire stirring up is upset the mind, also can do to throb with fear." element is asked the former sick formula fire of arcane truth class " point out " water decline hyperactivity of fire and disturb fire moving also, so ambition is restless, the palpitation with a distress feeling of meaning ", the deficiency of YIN is in descending, soreness of the waist and knees, sun are disturbed in last, then vertigo and tinnitus.Feverish sensation in the palms and soles, red tongue, thready and rapid pulse or the knot generation, be levying of hyperactivity of fire caused by deficiency of YIN.

In a word, to disturb the main pathogenesis of heart type cardiopalmus be the unusual of heart governing blood and vessels due to the imbalance of YIN and YANG and heart storing spirit function for deficiency of YIN-blood, hyperactivity of fire.Analysis based on above pathogenesis, will and hold on to " deficiency of YIN, hyperactivity of fire, the mind " these three basic links during treatment, therefore, its Therapeutic Principle should be " nourishing YIN and benefiting blood, pathogenic fire purging is calmed the nerves ", and purpose must be answered cloudy blood, heart-fire gets clearly, god returns to some extent, and the heart is foster to some extent, and the relation of " YIN and YANG in a relative equilibrium " is recovered.

Five, the Fang Yi of heart disease Yiganning capsule prescription analyzes

Monarch drug: the Radix Rehmanniae, Radix Angelicae Sinensis.Reuse the Radix Rehmanniae in the side and grow cloudy blood, clearing away heat and promoting production of body fluid, Compendium of Material Medica is carried the Radix Rehmanniae and is " product on the tonifying YIN blood " [18], " book on Chinese herbal medicine meets the source " thinks " cloudy little excess of YANG, the phase heated is strong, takes advantage of cloudy position; day by day decoct, the disease of hyperactivity of fire caused by deficiency of YIN should Radix Rehmanniae be moved back sun with YIN nourishing " [19]; Chinese angelica blood supplementing nourishes heart." Radix Angelicae Sinensis ... specially can enrich blood ", " blood deficiency blood depletion such as; the cloudy card that loses void that divides all should be used it " [20], Radix Angelicae Sinensis is warm in nature, blood system there is cold person for suitable, recognize in the ancient medicine clinical practice that this medicine also can be used for the blood deficiency interior-heat, as " curing mainly secret formula " said " though warm in nature, and blood deficiency have heat also available it; because of its can hemopoietic be YIN nourishing, the moon can be brought down a fever also " [20]; The Radix Rehmanniae, Radix Angelicae Sinensis two medicines are harmonious, and nourishing YIN blood, kidney nourishing water, clearing away heart-fire are monarch drug altogether.

Ministerial drug: Rhizoma Coptidis, Radix Scutellariae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba.The clear eliminating heart-fire of Rhizoma Coptidis, " Treatise on Febrile Disease with Notes " point out that they also can " catharsis heart purgation deficiency-heat " [21]; The Radix Scutellariae bitter cold, " pearl sac " calls it: " Radix Scutellariae gas tremble with fear bitter in the mouth, bitter in taste acting on the heart, cold prevailing over heat, eliminating heart-fire " [18] are said in " remove sun have a surplus, the cool heart reduces phlegm and internal heat " [22], Compendium of Material Medica, and Shennong's Herbal is put down in writing " fire of the clear part of the body cavity above the diaphragm housing the heart and lungs of withered person " [23]; A kind of reed mentioned in ancient books connects mutually 5, burning hot decline, and heat goes that then blood is peaceful; The flexible profit of Rhizoma Anemarrhenae bitter cold matter, clearing away heat-fire, nourshing Yin and drynsessmoistening prescription, " Japan hanako materia medica " carries this product " spasmolytic of feeling at ease is throbbed with fear " [24]; Radix Paeoniae Alba picric acid, be slightly cold, " medicine justice " say " Radix Paeoniae Alba little bitter can nourishing YIN, slightly acid can restrain " [20], " Treatise on Febrile Disease with Notes " thought just because of " the acid receipts of Radix Paeoniae are held back body fluid and beneficial honor " [21]; Medicine-feeding four flavors are ministerial drug altogether, the usefulness of principal drug assistance nourishing yin and purging fire.

Adjuvant drug: Radix Ginseng, Fluoritum, Semen Platycladi, Semen Ziziphi Spinosae.Deficiency of YIN-blood, hyperactivity of fire is disturbed the heart, all causes deficiency of heart-QI, malaise.So use the Radix Ginseng tonifying QI to produce body fluid, the arresting convulsion of calming the nerves, Shennong's Herbal is said: " Radix Ginseng master tonifying five ZANG-organs, peace spirit is decided soul, spasmolytic is throbbed with fear " [23]; The sweet temperature of Fluoritum is gone into heart channel, and " book on Chinese herbal medicine is new again " carried it and " felt at ease to compose oneself, nourish blood and dry " [25], and it is warm in nature and mend, the strong motive, and it is the most suitable that the palpitation with fear palpitation with a distress feeling of deficiency of heart-QI is used, and 5 is the beneficial motive altogether mutually with Radix Ginseng, the usefulness of tranquilizing mind; Radix Ginseng, Fluoritum are stated from [26] among the general medicine of Song Wanghuai latent Holy Benevolent Prescriptions treatment palpitation with fear; Semen Platycladi is gone into the heart, kidney, Compendium of Material Medica [18] stomach its " gas that nourishes heart, the profit kidney dry, Fructus Alpiniae Oxyphyllae is allayed excitement "; The sweet acidity of Semen Ziziphi Spinosae is flat, and sweet benefit is received in acid, the tonifying YIN that nourishes heart, and " book on Chinese herbal medicine remittance speech " carries its " astringing QI is calmed the nerves " [27]; Four medicines match, and assist the monarch and his subjects, and tonifying YIN nourishes blood, and the QI invigorating mind calming is adjuvant drug altogether.

Messenger drug: the Radix Glycyrrhizae sweet in the mouth is gone into 12 warps, the energy coordinating the actions of various ingredients in a prescription, and the efficacy of a drug can reach heart arteries and veins in the side of drawing, so be messenger drug.

In a word, this side is from traditional Chinese medical science organic conception, and compatibility is rigorous, and monarch is various, complements each other, altogether the agent of calming the nerves for nourishing YIN and benefiting blood, pathogenic fire purging.

Six, the Pharmacodynamic test of active extract research conclusion of heart disease Yiganning capsule

1. show that with the scale-model investigation of experiment tachyarrhythmia the peaceful ig administration of heart disease has following effect:

(1) makes chloroform bring out mice ventricle flutter rate and obviously reduce, illustrate that this medicine has protective effect to ventricular fibrillation.

(2) making aconitine bring out rat ventricular institute expense increases, and illustrates that this medicine has tangible antagonism to rat ventricular premature contraction, ventricular tachycardia and the ventricular fibrillation that aconitine brought out.

(3) make chloroform-epinephrine bring out rabbit arrhythmia time of occurrence and prolong, the persistent period shortens, and illustrates that this medicine has antagonism to chloroform-epinephrine brings out the rabbit arrhythmia.

(4) bidirectional tachycardia that barium chloride is brought out transfers the shortening of normal sinus rhythm time to, shows that this medicine can resist the arrhythmia that barium chloride brings out.

(5) the ventricular premature contraction number of times that the ligation rat coronary artery is brought out reduces, and illustrates that this medicine has certain therapeutical effect to the caused arrhythmia of myocardial ischemia.

2. mice calmness, hypnosis experimental study are shown: this medicine can reduce spontaneous activity in mice, prolongs the length of one's sleep of pentobarbital sodium.

Illustrate that this medical instrument has the effect of tranquillizing and allaying excitement.This is relevant with the Cure for insomnia dreaminess.

3. experimental study shows to the domesticated dog hemodynamics: this medicine has inhibitory action to myocardial contractility, i.e. negativity muscular strength and negative chronotropic action, and this is also relevant with the treatment tachyarrhythmia.

Seven, the animal acute toxicity of heart disease Yiganning capsule and long term toxicity test research conclusion

Acute toxicity testing shows: give the peaceful suspension of white mice ig heart disease, dose has reached the 40g/kg body weight.This product clinical application amount is 4/time, and 3 times/day, daily dose 5.4g in body weight for humans 60kg, is about the 0.1g/kg body weight.Calculate the suitable people's consumption of mice maximum tolerated dose thus 444.4 times, show this medicine clinical practice safety and low toxicity.

Long term toxicity test studies show that: 75,30 and 7.5 multiple doses with the peaceful clinical consumption of heart disease are given rat, continuously monthlyly do not see that the toxicity variation of outward appearance, body weight gain, hemogram, hepatic and renal function and main organs tissue appears in animal half after ig administration 3 months and the drug withdrawal, prove that this poison of drug is very low, clinical long-term oral application is safe.

Five. untoward reaction and safety

Clinical practice heart disease Yiganning capsule is observed and is shown, does not find obvious adverse reaction at viewing duration, blood, urine, just conventional, hepatic and renal function no significant change before and after medication.Heart disease Yiganning capsule is evident in efficacy to ventricular premature contraction, and is safe and reliable, has no side effect, and for the Chinese medicine ventricular premature contraction has been opened up a new treatment approach, is worth applying clinically.

In a word, more than explanation heart disease Yiganning capsule not only meets deficiency of YIN-blood, hyperactivity of fire is disturbed the pathological characteristic of heart type cardiopalmus, and the basis of modern pharmacological research is arranged, and therefore is the comparatively ideal Chinese medicine compound of treatment ventricular presystole.

List of references

1. the turbid Shanghai of Shen Jin huge legendary turtle miscellaneous diseases source and course rhinoceros Shanghai science tech publishing house.

2. Zhu Zhenheng danxi's experiential therapy Shanghai Shanghai science tech publishing house.

3. Zhang Jingyue Jing Yue's complete work Shanghai Shanghai science tech publishing house.

4. the typesetting and printing of 22 years integrated seals of Shanghai books of tame heart method letter out thread publishing house is cured originally in high drum peak.

5. Wu Cheng does not occupy school bulletins such as collecting clear Cheng Zhi cloud originally.

6. Liu's interchannel Yellow Emperor, a legendary ruler element is asked Xuanming Lun Fang, Clear Synopsis on Recipes Nanjing Wu in 13 years bright Wanli year the carving copy of remonstrating with.

7. Prescriptions for Universal Relief Beijing people health publishing house such as Zhu Di.

8. wound is distinguished Wu Mian school edition in the wall of Lee east

9. formula Cheng Shi doctor draws a bow to the full and collects ancient bright edition

10. woods is rather joined mattress soup treatment tachyarrhythmia clinical observation Fujian Chinese medicine 1993. (5): 15

11. Wang Ke power defibrillation soup is treated quick type atrial fibrillation 40 examples.Jilin Chinese medicine 1989. (1): 14

12. clinical observation Liaoning Journal of Traditional Chinese Medicine 1992. (3): 25 of application " holding back the heart fries in shallow oil " such as Sun Qi phoenix treatment tachyarrhythmia

13. bring up the bitter yellow Zengye Tang treatment of the essay tachyarrhythmia Sichuan traditional Chinese medical science 1989. (9): 19

14. clinical observation Hunan College of Traditional Chinese Medicine journal 1990. (3): 132 of the flat rule of gold credit hall mixture treatment tachyarrhythmia

15. the clinical research Journal of Traditional Chinese Medicine 1993. (8): 477 of metancenter electuaries such as all beautiful duckweeds treatment Qi deficiency blood stasis type tachyarrhythmia

16. to treating type of deficiency of both QI and YIN tachyarrhythmia 86 routine Liaoning Journals of Traditional Chinese Medicine 1994. (10): 462 from steady arteries and veins soup such as your grade

17. the bright Wang Kentang Standards of Diagnosis and Treatment

18. bright Li Shizhen (1518-1593 A.D.) Compendium of Materia Medica

19. opening the fine jade book on Chinese herbal medicine clearly meets former

20. quote medical college Chinese medicine voluminous dictionary Shanghai, Jiangsu Shanghai Science Press

21. golden Cheng Wuji Treatise on Febrile Disease with Notes

22. golden Zhang Yuansu pearl sac

23. Western Han Dynastry anonymous person Sheng Nong's herbal classic

24. Shangzhi's an ancient unit of weight is collected the school Japan hanako materia medica

25. clear leaf small peak book on Chinese herbal medicine is new again

26. Song Wang Huai conceals Taiping Royal Prescriptions

27. converging, the unconcerned book on Chinese herbal medicine of Ming Ni Zhu says

Clinical trial unit: No.1 Hospital Attached to He'nan Traditional Chinese Medical College, Affiliated Hospital of Heilongjiang University of Chinese Medicine, Hospital Affiliated to Shandong Medical College; Clinical observation director: king nine lotus academic titles: professor, chief physician's post: Vasculocardiology Deparment director; Clinical observation participant: king nine lotus academic titles: chief physician, No.1 Hospital Attached to He'nan Traditional Chinese Medical College; Hospital Attached to Shandong Chinese Medical Univ., Lin Huijuan teaches the chief physician

Calendar year 2001 December

Test responsible department: No.1 Hospital Attached to He'nan Traditional Chinese Medical College, test director: Wang Jiulian, academic title: professor, chief physician, post: Vasculocardiology Deparment director phone: 0371-6212355; Test participant: No.1 Hospital Attached to He'nan Traditional Chinese Medical College; Affiliated Hospital of Heilongjiang University of Chinese Medicine; Hospital Affiliated to Shandong Medical College;

Surveillant: Weihai Shen Wei pharmaceutcal corporation, Ltd;

Raw data is preserved: No.1 Hospital Attached to He'nan Traditional Chinese Medical College national drug clinical research base,

Weihai Shen Wei pharmaceutcal corporation, Ltd

Main researcher or cooperating research person signature and bidding person's medical science director signature

The test exercise question:

The test report author: Sun Tian good fortune Yuan Zhi space: I have read this report, according to my understanding, and confirmed this part report accurate description process of the test and result.

Researcher: Wang Jiulian signature: Wang Jiulian

The relevant personnel: Wang Jiulian, Wei Ming, Sun Tianfu, Yuan Zhiyu.Date: calendar year 2001 December

Claims

1, the ARR medicine of a kind of treatment, it is characterized in that it be by following raw material of Chinese medicine by weight formulated capsule: Radix Rehmanniae 10-45 part, Radix Angelicae Sinensis 9-30 part, Radix Paeoniae Alba 9-23 part, Rhizoma Anemarrhenae 9-22 part, Rhizoma Coptidis 6-14 part, Radix Scutellariae 6-14 part, Radix Ginseng 6-9 part, Semen Ziziphi Spinosae 10-45 part, Semen Platycladi 9-23 part, Fluoritum 9-45 part, Radix Glycyrrhizae 3-9 part.

2,, it is characterized in that it is formulated by weight by following raw material of Chinese medicine: Radix Rehmanniae 10-30 part, Radix Angelicae Sinensis 9-30 part, Radix Paeoniae Alba 9-25 part, Rhizoma Anemarrhenae 9-15 part, Rhizoma Coptidis 6-9 part, Radix Scutellariae 6-9 part, Radix Ginseng 6-9 part, Semen Ziziphi Spinosae 10-30 part, Semen Platycladi 9-15 part, Fluoritum 9-30 part, Radix Glycyrrhizae 3-9 part according to the ARR medicine of the described treatment of claim 1.

3,, it is characterized in that it is formulated by weight by following raw material of Chinese medicine: Radix Rehmanniae 20-30 part, Radix Angelicae Sinensis 15-30 part, Radix Paeoniae Alba 15-25 part, Rhizoma Anemarrhenae 9-15 part, Rhizoma Coptidis 6-9 part, Radix Scutellariae 6-9 part, Radix Ginseng 6-9 part, Semen Ziziphi Spinosae 15-30 part, Semen Platycladi 9-15 part, Fluoritum 15-30 part, Radix Glycyrrhizae 3-9 part according to the ARR medicine of the described treatment of claim 1.

4,, it is characterized in that it is formulated by weight by following raw material of Chinese medicine: Radix Rehmanniae (life) 450g, Radix Angelicae Sinensis 300g, Radix Paeoniae Alba 225g, Rhizoma Anemarrhenae 225g, Rhizoma Coptidis 135g, Radix Scutellariae 135g, Radix Ginseng 90g, Semen Ziziphi Spinosae (stir-fry) 450g, Semen Platycladi 225g, Fluoritum 450g, Radix Glycyrrhizae 90g according to the ARR medicine of the described treatment of claim 1.

5, the ARR medicine production technological process of a kind of above-mentioned treatment is as follows: get Rhizoma Coptidis, Radix Ginseng～pulverizing～ethanol extraction～filtration～recovery ethanol～concentrate～vacuum drying～I that gets dry extract, and standby; Other gets Radix Angelicae Sinensis extraction volatile oil and stays part standby; 8 flavor medicines of remainders such as another part volatile oil and medicinal residues thereof and Radix Rehmanniae mix and decoct～refilter～concentrate～precipitate with ethanol～filtration～recovery ethanol～concentrated～vacuum drying～make dried cream II; Again the above-mentioned standby cream I, standby part Radix Angelicae Sinensis of making extracted volatile oil and dried cream II mixing～powder and become fine powder～again after packing, packing, check, promptly become the qualified medicine of the present invention.

6, aforesaid right requires the concrete production method of the ARR medicine of 5 described treatments to be:

2. get Rhizoma Coptidis, the people participates in the 30-80% alcohol reflux at least 1 time, solvent consumption 7-15 doubly, reflux, extract, is 1-5h, filters, merging filtrate reclaims ethanol, and is concentrated into the extractum that relative density is 1.15-1.35, vacuum drying, I gets dry extract;

3. get Radix Angelicae Sinensis and extract volatile oil with steam distillation, extraction time is 1-8h, and all the other 8 flavor medical materials such as medicinal residues and Radix Rehmanniae, Fluoritum decoct with water 1 time at least, amount of water is 8-20 times, and decocting time is 2-8h, filters, merging filtrate is evaporated to the extractum that relative density is 1.05-1.25, adds ethanol and is 50-75% to containing the alcohol amount, leave standstill 12-24h, filter, reclaim ethanol, be concentrated into the extractum that relative density is 1.25-1.35, vacuum drying, II gets dry extract;

7, according to the ARR medicine production method of the described treatment of claim 5, used Radix Rehmanniae is used crude drug.

8, according to the ARR medicine production method of the described treatment of claim 5, the raw material of Semen Ziziphi Spinosae after wherein with parch.

9, according to claim 1, the ARR medicine of 6 described treatments and production method thereof, can produce multiple peroral dosage form.