CN106074834B - Application of qi-tonifying and blood-activating medicine in preparation of chronic arrhythmia relieving medicine - Google Patents
Application of qi-tonifying and blood-activating medicine in preparation of chronic arrhythmia relieving medicine Download PDFInfo
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- CN106074834B CN106074834B CN201610466308.4A CN201610466308A CN106074834B CN 106074834 B CN106074834 B CN 106074834B CN 201610466308 A CN201610466308 A CN 201610466308A CN 106074834 B CN106074834 B CN 106074834B
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Abstract
The invention discloses an application of a medicament for tonifying qi and activating blood circulation in preparing a medicament for relieving chronic arrhythmia. The qi-tonifying and blood-activating medicament comprises the following raw material medicaments: 100-150 parts of astragalus mongholicus, 80-120 parts of codonopsis pilosula, 60-100 parts of salvia miltiorrhiza, 60-100 parts of kudzuvine root, 60-100 parts of epimedium, 60-100 parts of hawthorn, 40-80 parts of rehmannia, 40-80 parts of angelica sinensis, 40-80 parts of coptis chinensis, 40-80 parts of vinegar rhizoma corydalis, 40-80 parts of lucid ganoderma, 20-30 parts of ginseng and 20-30 parts of honey-fried licorice root. Pharmacodynamic test researches find that the medicament for tonifying qi and activating blood has definite vasodilation effect and also has obvious clearing effect on nitrogen free radicals, hydroxyl free radicals and nitroxide free radicals. The medicament can improve the calm heart rate, the total 24-hour heart rate, the fastest heart rate, the slowest heart rate and the average heart rate of a patient with bradyarrhythmia, and random contrast research shows that the embodiment 1 of the invention has positive curative effect on the bradyarrhythmia.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicine application, and particularly relates to application of a qi-tonifying and blood-activating medicine in preparation of a chronic arrhythmia-relieving medicine.
Background
Arrhythmia (arrhythmia) is caused by abnormal sinus node activation or activation arising outside the sinus node, and slow conduction, blockage or conduction through abnormal pathways, i.e., the origin of cardiac activity and/or conduction disorder, results in abnormal frequency and/or rhythm of the heart beat. The types of arrhythmias include sinus tachycardia, sinus bradyarrhythmia, sinus asystole, sinus block, sick sinus syndrome, etc., and the different types of arrhythmias vary in treatment regimens, such as medication.
Bradyarrhythmia is one of common diseases in cardiovascular system diseases, mainly comprises sinus bradycardia, atrioventricular block and sick sinus Syndrome, is mainly characterized by lasting slow pulse and accompanied by palpitation, chest distress, short breath, hypodynamia, dizziness and the like, and severe patients can have the symptoms of syncope, heart failure, cardiogenic shock and Alos Syndrome (ASS, Adams-Stokes Syndrome) attack and even death. Activation of the normal heart originates in the sinoatrial node (which is the normal pacing point), and if activation of the sinoatrial node does not occur regularly at the normal frequency or does not conduct outward normally, a sinoatrial node dysfunction occurs: therefore, heart rate is reduced, stroke volume is reduced, blood supply is insufficient, and heart and brain ischemia is caused. Modern medicine makes active studies on the pathogenesis and treatment method of the heart disease, and the vast majority of patients need drug treatment and the few patients need artificial cardiac pacing treatment. The modern western medicine uses aminophylline, isoproterenol, atropine, ephedrine and other medicines and is provided with a pacemaker, the clinical curative effect is obvious, but the medicines have side effects and poor patient compliance, so the traditional Chinese medicine is not suitable for long-term use. Pacing therapy has not been widespread due to high technical and equipment requirements and high price. The disease with mild symptoms and slow disease progression is not the first choice.
The invention discloses a medicament with the functions of tonifying qi and activating blood, which has the functions of strengthening body resistance and consolidating foundation, tonifying qi and activating blood, and promoting blood circulation to stop pain, and is mainly used for treating qi deficiency and blood stasis type coronary heart disease, coronary heart disease angina, myocardial infarction, combined hyperlipidemia, hyperglycemia and other symptoms, and has the patent number of 20101021256.8.
The invention further researches the pharmacodynamic action of the medicament for treating the chronic arrhythmia on the basis of the invention patents.
Disclosure of Invention
The invention aims to provide application of a medicament for tonifying qi and activating blood circulation in preparing a medicament for treating chronic arrhythmia.
The technical scheme of the invention is as follows:
the medicine of the invention comprises the following raw medicines: the method comprises the following specific steps:
the medicine of the invention comprises the following raw medicines:
100-150 parts of astragalus mongholicus, 80-120 parts of codonopsis pilosula, 60-100 parts of salvia miltiorrhiza, 60-100 parts of kudzuvine root, 60-100 parts of epimedium, 60-100 parts of hawthorn, 40-80 parts of rehmannia, 40-80 parts of angelica sinensis, 40-80 parts of coptis chinensis, 40-80 parts of vinegar corydalis tuber, 40-80 parts of lucid ganoderma, 20-30 parts of ginseng and 20-30 parts of honey-fried licorice root.
Preferably, the raw material medicaments of the medicament comprise:
120 parts of astragalus membranaceus, 100 parts of codonopsis pilosula, 80 parts of salvia miltiorrhiza, 80 parts of kudzu roots, 80 parts of epimedium, 80 parts of hawthorn, 60 parts of rehmannia, 60 parts of angelica sinensis, 60 parts of coptis chinensis, 60 parts of vinegar rhizoma corydalis, 60 parts of lucid ganoderma, 25 parts of ginseng and 25 parts of honey-fried licorice roots.
Or 140 parts of astragalus, 90 parts of codonopsis pilosula, 70 parts of salvia miltiorrhiza, 90 parts of kudzuvine root, 90 parts of epimedium, 70 parts of hawthorn, 50 parts of rehmannia, 70 parts of angelica, 70 parts of coptis chinensis, 50 parts of vinegar rhizoma corydalis, 50 parts of lucid ganoderma, 28 parts of ginseng and 28 parts of honey-fried licorice root.
Or 110 parts of astragalus, 110 parts of codonopsis pilosula, 90 parts of salvia miltiorrhiza, 70 parts of kudzuvine root, 70 parts of epimedium, 90 parts of hawthorn, 70 parts of rehmannia, 50 parts of angelica, 50 parts of coptis chinensis, 70 parts of vinegar corydalis tuber, 70 parts of lucid ganoderma, 22 parts of ginseng and 22 parts of honey-fried licorice root.
Or 120 parts of astragalus membranaceus, 100 parts of codonopsis pilosula, 80 parts of salvia miltiorrhiza, 80 parts of kudzu root, 80 parts of epimedium, 80 parts of hawthorn, 60 parts of rehmannia, 60 parts of angelica sinensis, 60 parts of coptis chinensis, 60 parts of vinegar rhizoma corydalis, 60 parts of lucid ganoderma, 25 parts of ginseng and 25 parts of honey-fried licorice root.
Or 140 parts of astragalus membranaceus, 90 parts of codonopsis pilosula, 70 parts of salvia miltiorrhiza, 90 parts of kudzu root, 90 parts of epimedium, 70 parts of hawthorn, 50 parts of rehmannia, 70 parts of angelica sinensis, 70 parts of coptis chinensis, 50 parts of vinegar rhizoma corydalis, 50 parts of lucid ganoderma, 28 parts of ginseng and 28 parts of honey-fried licorice root.
Or 110 parts of astragalus, 110 parts of codonopsis pilosula, 90 parts of salvia miltiorrhiza, 70 parts of kudzuvine root, 70 parts of epimedium, 90 parts of hawthorn, 70 parts of rehmannia, 50 parts of angelica, 50 parts of coptis chinensis, 70 parts of vinegar corydalis tuber, 70 parts of lucid ganoderma, 22 parts of ginseng and 22 parts of honey-fried licorice root.
Or 120 parts of astragalus, 100 parts of codonopsis pilosula, 80 parts of salvia miltiorrhiza, 80 parts of kudzu root, 80 parts of epimedium, 80 parts of hawthorn, 60 parts of rehmannia, 60 parts of angelica, 60 parts of coptis chinensis, 60 parts of vinegar rhizoma corydalis, 60 parts of lucid ganoderma, 25 parts of ginseng and 25 parts of honey-fried licorice root.
The raw materials are taken, added with conventional auxiliary materials and prepared into clinically acceptable tablets, granules, pills, capsules, dripping pills, soft capsules, sustained release agents, oral liquid preparations or freeze-dried powder injections according to a conventional process.
The preparation method of the medicine comprises the following steps:
taking ginseng, coptis chinensis, rhizoma corydalis processed with vinegar, hawthorn and half of astragalus root in the raw materials, crushing the ginseng, the coptis chinensis, the rhizoma corydalis processed with vinegar and the hawthorn into fine powder, adding water into the other eight raw materials and the rest of the astragalus root, decocting the rest eight raw materials and the rest of the astragalus root for 1 to 3 times, each time lasts for 1 to 3 hours, merging decoction, filtering, concentrating the filtrate until the relative density is 1.05 to 1.15 at 90 to 95 ℃, cooling, adding one time of ethanol to precipitate, taking supernatant, recovering the ethanol, concentrating the supernatant to obtain clear paste with the relative density of 1.15 to 1.25 at 90 to 95 ℃, mixing the clear paste with the medicinal powder, and preparing tablets, granules, pills, capsules, dripping pills, soft capsules, sustained release agents, oral liquid preparations or.
The preparation method of the medicament preferably comprises the following steps:
taking ginseng, coptis chinensis, rhizoma corydalis processed with vinegar, hawthorn and half of astragalus root in the raw materials, crushing the ginseng, the coptis chinensis, the rhizoma corydalis processed with vinegar and the hawthorn into fine powder, adding water into the other eight raw materials and the rest of the astragalus root, decocting the mixture for 2 times, decocting for 2 hours for the first time and 1.5 hours for the second time, merging decoction, filtering, concentrating filtrate until the relative density is 1.06-1.12 at 90 ℃, cooling, adding ethanol for one time to precipitate, taking supernatant, recovering ethanol, concentrating the supernatant to clear paste with the relative density of 1.20-1.22 at 90 ℃, mixing the clear paste with the medicinal powder, and preparing tablets, granules, pills, capsules, dropping pills, soft capsules, sustained release agents, oral liquid preparations or freeze-dried powder injections.
The preparation method of the dripping pill in the pharmaceutical preparation comprises the following steps:
taking the raw materials, soaking in 8-12 times of water for 40-80 minutes, boiling for 1-3 hours, taking out the liquid medicine, adding 6-10 times of water into the residue, decocting for 70-110 minutes, mixing the two liquid medicines, and filtering; passing the medicinal liquid through treated JD-1(WLD) macroporous adsorbent resin column with the resin amount 1-3 times of the weight of the raw materials, controlling the adsorption flow rate at 2-4ml/min, washing the resin column with water until the effluent is clear, eluting with 60-90% ethanol 2-4 times of the weight of the resin, collecting the eluate, washing with 1-2 times of water, mixing the eluates, recovering ethanol, concentrating to relative density of 1.05-1.20, spray drying to obtain extract spray dried medicinal powder, and adding conventional adjuvants to obtain dripping pill.
The preparation method of the dripping pill in the pharmaceutical preparation preferably comprises the following steps:
taking the raw materials, soaking in 10 weight times of water for 60 minutes, boiling for 2 hours, taking out the liquid medicine, adding 8 weight times of water into the decoction dregs, decocting for 90 minutes, combining the secondary liquid medicines, and filtering; passing the medicinal liquid through treated JD-1(WLD) macroporous adsorbent resin column with the resin amount 1.5 times of the weight of the raw materials, controlling the adsorption flow rate at 2-4ml/min, washing the resin column with water until the effluent is clear, eluting with 70% ethanol with the resin amount 3 times of the weight of the effluent, collecting the eluate, washing with 1.5 times of water, mixing the eluates, recovering ethanol, concentrating to relative density of 1.08-1.15, spray drying to obtain extract spray dried medicinal powder, and adding conventional adjuvants to obtain dripping pill.
Wherein, the spray drying condition in the preparation method is controlled as follows: the feeding speed is 35-40ml/min, and the atomization speed is as follows: 25000-: 130 ℃ and 160 ℃, and the air outlet temperature: 70-80 ℃.
The conditions for spray drying in the above preparation method are preferably controlled as follows: feed rate 37ml/min, atomization rate: 30000rpm, inlet air temperature: 145-147 ℃, air outlet temperature: 71-76 ℃.
Wherein, after the extract is obtained in the preparation method, the preparation method of the dripping pill can also comprise the following steps:
weighing polyethylene glycol-4000, performing water bath at 60-90 deg.C until swelling completely, adding the above extract spray dried medicinal powder at a ratio of medicinal powder to polyethylene glycol-4000 of 1: 2-6, stirring at 80-90 deg.C to completely dissolve and disperse the medicinal powder in polyethylene glycol-4000; moving the mixture into a pill dropping machine, keeping the dropping distance and the dropping temperature, and adjusting the dropping parameters as follows: oil bath temperature: 80-90 ℃, temperature of liquid medicine: 75-85 ℃, temperature of drip plate: 85-90 ℃, refrigeration temperature: 10-15 ℃, tube orifice temperature: 35-40 ℃, the caliber of the dripper is as follows: 3mm/5mm, dropping speed: 1 drop/1 second-1 drop/7 seconds; the liquid drops are dropped into dimethyl silicon oil or liquid paraffin as condensing agent by regulating the switch at proper speed, the medicine drops are condensed and contracted into dripping pills, the dripping pills are collected, the oil is removed by centrifugation at the rotation speed of 1000-.
After the extract is obtained by the preparation method, the preparation method of the dripping pill can also preferably comprise the following steps:
weighing polyethylene glycol-4000, bathing in water at 80-85 deg.C until swelling completely, adding the above extract spray dried medicinal powder at a ratio of medicinal powder to polyethylene glycol-4000 of 1: 4, stirring at 85 deg.C under heat preservation to completely dissolve and disperse the medicinal powder in polyethylene glycol-4000; moving the mixture into a pill dropping machine, keeping the dropping distance and the dropping temperature, and adjusting the dropping parameters as follows: oil bath temperature: 85 ℃, temperature of liquid medicine: 80 ℃, drip plate temperature: 87 ℃, refrigeration temperature: 12 ℃, tube orifice temperature: the caliber of the dripper is as follows at 37 ℃: 3mm/5mm, dropping speed: 1 drop/2 sec-1 drop/5 sec; the liquid drops are dropped into dimethyl silicon oil or liquid paraffin as condensing agent by adjusting a switch at a proper speed, the liquid drops are condensed and contracted into dripping pills, the dripping pills are collected, the dripping pills are centrifugally deoiled at a rotating speed of 1500-.
Preferably: the type distribution of the bradyarrhythmia in the application is as follows: sinus bradycardia and/or degree II atrioventricular block and/or degree III atrioventricular block and/or sick sinus syndrome.
The treatment of the bradyarrhythmia refers to the improvement of the calm heart rate and/or the total 24-hour heart beat and/or the fastest heart rate and/or the slowest heart rate and/or the average heart rate of a patient with the bradyarrhythmia.
The invention has the beneficial effects that:
clinical trial researches show that the medicine has obvious treatment effect on bradyarrhythmia of sinus bradycardia, II-degree atrioventricular block, III-degree atrioventricular block and sick sinus syndrome, can improve calm heart rate, 24-hour total heart rate, fastest heart rate, slowest heart rate and average heart rate of patients with bradyarrhythmia, and random contrast researches show that the medicine has a positive curative effect on bradyarrhythmia, can cure or improve clinical symptoms of patients, improves the survival quality of patients, and does not find serious adverse reactions in safety observation.
Detailed Description
Example 1
The medicine tablet for treating the chronic arrhythmia is prepared from the following raw material medicines in parts by weight:
the preparation method of the medicine tablet comprises the following steps: taking ginseng, coptis chinensis, rhizoma corydalis processed with vinegar, hawthorn and half of astragalus root in the raw materials, crushing the ginseng, the coptis chinensis, the rhizoma corydalis processed with vinegar and the hawthorn into fine powder, adding water into the other eight raw materials and the rest of the astragalus root, decocting the mixture for 2 times, decocting for 2 hours for the first time and 1.5 hours for the second time, merging decoction, filtering, concentrating the filtrate until the relative density is 1.06-1.12 at 90 ℃, cooling, adding one time of ethanol to precipitate, taking supernatant, recovering ethanol, concentrating the filtrate to clear paste with the relative density of 1.20-1.22 at 90 ℃, mixing the clear paste with the medicinal powder, preparing into granules, drying, pressing into 1000 tablets (small tablets), coating sugar or film-coated tablets or pressing into 500 tablets (large tablets), and coating film-coated to obtain the traditional. The tablet is 0.3g per tablet, and is taken 3 times a day, 4-6 tablets once; the tablet of the large tablet weighs 0.6g, and is taken 3 times a day, 2-3 tablets once. For treating sinus bradycardia, and/or degree II atrioventricular block, and/or degree III atrioventricular block, and/or sick sinus syndrome, improving the calm heart rate and/or the 24-hour total heart beat and/or the fastest heart rate and/or the slowest heart rate and/or the average heart rate of patients with bradyarrhythmia.
Example 2
The medicine capsule for treating the chronic arrhythmia is prepared from the following raw material medicines in parts by weight:
the preparation method of the medicine capsule comprises the following steps: pulverizing Ginseng radix, Coptidis rhizoma, rhizoma corydalis, fructus crataegi and half amount of radix astragali into fine powder, decocting the other eight materials and the rest radix astragali with water for 2 times, 2 hr for the first time and 1.5 hr for the second time, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.06-1.12 at 90 deg.C, cooling, precipitating with ethanol, collecting supernatant, recovering ethanol, concentrating to fluid extract with relative density of 1.20-1.22 at 90 deg.C, mixing with the above medicinal powder, and making into capsule. For treating sinus bradycardia, and/or degree II atrioventricular block, and/or degree III atrioventricular block, and/or sick sinus syndrome, improving the calm heart rate and/or the 24-hour total heart beat and/or the fastest heart rate and/or the slowest heart rate and/or the average heart rate of patients with bradyarrhythmia.
Example 3
The medicinal granules for treating the chronic arrhythmia are prepared from the following raw material medicines in parts by weight:
the preparation method of the medicine granules comprises the following steps: pulverizing Ginseng radix, Coptidis rhizoma, rhizoma corydalis, fructus crataegi and half amount of radix astragali into fine powder, decocting the other eight materials and the rest radix astragali with water for 2 times, 2 hr for the first time and 1.5 hr for the second time, mixing decoctions, filtering, concentrating the filtrate to relative density of 1.06-1.12 at 90 deg.C, cooling, precipitating with ethanol, collecting supernatant, recovering ethanol, concentrating to fluid extract with relative density of 1.20-1.22 at 90 deg.C, mixing with the above medicinal powder, and making into granule. For treating sinus bradycardia, and/or degree II atrioventricular block, and/or degree III atrioventricular block, and/or sick sinus syndrome, improving the calm heart rate and/or the 24-hour total heart beat and/or the fastest heart rate and/or the slowest heart rate and/or the average heart rate of patients with bradyarrhythmia.
Example 4
The medicinal pill for treating the chronic arrhythmia is prepared from the following raw material medicines in parts by weight:
the preparation method of the medicine pill comprises the following steps: mixing the above raw materials, adding conventional adjuvants, and making into pill according to conventional process. For treating sinus bradycardia, and/or degree II atrioventricular block, and/or degree III atrioventricular block, and/or sick sinus syndrome, improving the calm heart rate and/or the 24-hour total heart beat and/or the fastest heart rate and/or the slowest heart rate and/or the average heart rate of patients with bradyarrhythmia.
Example 5
The medicine oral liquid for treating the chronic arrhythmia is prepared from the following raw material medicines in parts by weight:
the preparation method of the medicine oral liquid comprises the following steps: the raw materials are taken, added with conventional auxiliary materials and prepared into oral liquid according to a conventional process. For treating sinus bradycardia, and/or degree II atrioventricular block, and/or degree III atrioventricular block, and/or sick sinus syndrome, improving the calm heart rate and/or the 24-hour total heart beat and/or the fastest heart rate and/or the slowest heart rate and/or the average heart rate of patients with bradyarrhythmia.
Example 6
The medicine injection for treating the chronic arrhythmia is prepared from the following raw material medicines in parts by weight:
the preparation method of the medicine injection comprises the following steps: the raw materials are taken, added with conventional auxiliary materials and prepared into injection according to the conventional process. For treating sinus bradycardia, and/or degree II atrioventricular block, and/or degree III atrioventricular block, and/or sick sinus syndrome, improving the calm heart rate and/or the 24-hour total heart beat and/or the fastest heart rate and/or the slowest heart rate and/or the average heart rate of patients with bradyarrhythmia.
Example 7
The medicinal dripping pill for treating the chronic arrhythmia is prepared from the following raw material medicaments in part by weight:
the preparation method of the medicine dripping pill comprises the following steps:
taking the raw materials, soaking in 10 weight times of water for 60 minutes, boiling for 2 hours, taking out the liquid medicine, adding 8 weight times of water into the decoction dregs, decocting for 90 minutes, combining the secondary liquid medicines, and filtering; passing the medicinal liquid through treated JD-1(WLD) macroporous adsorbent resin column with resin amount 1.5 times of the weight of the raw materials, controlling adsorption flow rate at 2-4ml/min, washing the resin column with water until the effluent is clear, eluting with 70% ethanol 3 times of the weight of the resin, collecting the eluate, washing with 1.5 times of water, mixing the eluates, recovering ethanol, concentrating to relative density of 1.08-1.15, spray drying to obtain extract spray dried medicinal powder, adding conventional adjuvants to obtain dripping pill with weight of 49-52 mg/pill, orally administering 10 pills once, and 3 times a day. For treating sinus bradycardia, and/or degree II atrioventricular block, and/or degree III atrioventricular block, and/or sick sinus syndrome, improving the calm heart rate and/or the 24-hour total heart beat and/or the fastest heart rate and/or the slowest heart rate and/or the average heart rate of patients with bradyarrhythmia.
Clinical trial
The applicant developed a clinical study of the tablet of example 1 of the present invention for treating bradyarrhythmia from month 1 to month 12 in 2012, and observed the clinical efficacy of the drug of example 1 of the present invention for treating bradyarrhythmia.
1. Case selection
1.1 diagnostic criteria
1.1.1 Western diagnostic standards
The medicine is prepared according to the relevant regulations of Western medicine internal sciences and cardiology on sinus bradycardia, atrioventricular block and sick sinus syndrome.
Sinus bradycardia with a rate of 40-60 beats/minute is often accompanied by sinus arrhythmia. Significant sinus bradycardia can produce an escape.
(1) Atrioventricular block
1) Degree II atrioventricular block: type I: the venture type, the P-R interval of the ventricular leakage wave front is gradually prolonged, the R-R interval is gradually shortened, and the ventricular leakage is stopped once ventricular beat after the P wave. n type: after one or several ventricular beats at fixed P-R intervals, a ventricular leak occurs suddenly. The atrioventricular block does not show a gradual extension of the P-R interval before the P-wave, which may be normal or extended, often with a conduction ratio of 2:1, 3:2, 4:3, etc.
2) Degree III atrioventricular block: the P wave is independent of the QRS wave group; the atrial rate is faster than the ventricular rate, and the atrial rhythm may be sinus or ectopic; the QRS time limit may be normal or extended.
(2) Sick Sinus Syndrome (SSS)
According to the electrocardiogram expression, the diagnosis can be confirmed according to one of the following four items (except the influence of drugs, nerve or metabolic dysfunction and the like):
1) sinus bradycardia is less than or equal to 40 times/min and lasts for more than or equal to 1 min;
2) second degree type II sinus block;
3) sinus arrest >3.0 s;
4) sinus bradycardia with transient atrial fibrillation, atrial flutter, supraventricular tachycardia, sinus beat recovery time at the end of onset > 2S.
Wherein any one of 1-3 is satisfied, and the diagnosis is simple sick sinus type; (ii) satisfies any one of items 1 to 3 + item 4, and is diagnosed as slow-fast syndrome type; any one of claims 1-4 with atrioventricular or intra-atrial or bundle branch block, diagnosed as a double node lesion or a holo-conduction system lesion. Dynamic electrocardiogram, namely continuously monitored 24h electrocardiogram, and positive standard: 24h total heart beat <8 ten thousand times, average <50 times/min; the heart rate change is small, the lowest is <35 times/min at night, the highest is <90 times/min, and the duration is greater than 1 min; frequent sinus arrest, frequent atrioventricular block of more than two degrees; bradycardia, ventricular escape rhythms. E.g. 24h total heart beats <8 million times, but >90 times/min after activity, is considered to be associated with vagal tone. When SSS is diagnosed, the 24h total heart beat and average heart rate criteria are not suitable for patients with chronic and fast syndrome. Slow-fast syndrome electrocardiographic manifestation: based on slow arrhythmia such as sinus bradycardia, sinus arrest, sinus block and the like, the atrial tachyarrhythmia which is most common is accompanied by paroxysmal atrial fibrillation, and when the tachyarrhythmia is terminated, the slow arrhythmia (such as sinus bradycardia or sinus arrest) can be accompanied.
1.1.2 differentiation Standard of traditional Chinese medicine for the syndrome of deficiency of Heart and Kidney Yang, coagulation of Yin Cold, blood stasis
Is formulated according to the relevant regulations of the diagnosis and treatment standards of the traditional Chinese medicine diseases, the clinical research guiding principles of new traditional Chinese medicines and the diagnosis and treatment effect standards of the traditional Chinese medicine diseases.
(1) Palpitation, chest distress;
(2) the secondary symptoms are as follows: shortness of breath, hypodynamia, dizziness, tinnitus, aversion to cold, cold limbs, pale complexion, and purple lips; tongue and pulse: the tongue is dark red or has ecchymosis or pale and swollen; the tongue coating is white and slippery; deep, thready and slow, or deep, astringent and slow, or intermittent.
And (3) dialectical standards: the 2 main symptoms plus 3 secondary symptoms or tongue pulse conditions can be diagnosed.
1.2 grading scoring standard of Chinese medicine symptom
Made by referring to the guideline of clinical research on treating senile diseases by using new medicines (traditional Chinese medicines).
1.3 inclusion criteria
(1) Age between 18 and 70 years, voluntarily receiving clinical observations.
(2) The traditional Chinese medicine composition meets the diagnosis standard of chronic arrhythmia of western medicine, is diagnosed as slow pulse in traditional Chinese medicine, and is distinguished as patients with heart-kidney yang deficiency, yin cold coagulation and blood vessel weakness obstruction.
(3) The patients who have taken the antiarrhythmic drugs stop taking the drugs for more than 2 weeks.
(4) Volunteer participants.
1.4 exclusion criteria
(1) Those who do not meet the syndrome differentiation standard of traditional Chinese medicine and the diagnosis standard of Western medicine.
(2) The syndrome is confirmed to be slow-fast by examination.
(3) Subjects <18 years or >70 years old, pregnant or lactating women, allergic constitution and those allergic to the drug.
(4) Severe hypertension, cardiovascular and cerebrovascular diseases, liver, kidney, hemopoietic system, etc.
(5) The heart failure is in the patients taking digitalis.
(6) Sinus node impulse formation and conduction disorder caused by drug, nerve and metabolic dysfunction.
(7) Subjects with a mental disorder.
1.5 criteria for discontinuation and withdrawal of clinical trials
(1) The physician participating in the clinical trial carefully recorded the reasons for the discontinuation of the trial and how it relates to the trial, including the assessment at the time of discontinuation, and the following patients who were able to discontinue the trial: those who cannot adhere to the treatment; those with severe adverse reactions; serious other complications occur during the test; the symptoms worsen, and emergency measures must be taken.
(2) The reason for the subject who withdraws from the test is clearly recorded in the middle of the test, and the evaluation index at the time of termination is recorded in detail. The following cases are included: the subject proposes to exit the trial; the subject does not come to the hospital for a follow-up visit on time, and should ask for reasons and investigate the passage of things by telephone, letter, etc.
(3) The principle of case elimination is as follows: naturally detaching during observation; the medicine is effective when being taken, but the subject can not judge the curative effect because other similar medicines are taken to accelerate the curative effect; the drugs should be taken out after two weeks or other drugs are not used, and should not be removed according to the treatment of ineffectiveness.
1.6. Statistical principle
(1) The patients with adverse reactions should be listed for adverse reaction statistics;
(2) patients who fall off by themselves after half ineffective treatment period should be listed as treatment statistics;
(3) patients who take other antiarrhythmic drugs after half-ineffective treatment period should be listed for the statistics of curative effect;
(4) the patients with the effect after a treatment course is not taken as the abscission case;
(5) the course of treatment is effective, but the entire course of treatment cannot be completed, and the case of missed visits is not listed as a statistics of efficacy, but how many such cases of abscission should be accounted for in the summary.
2 Observation and treatment methods
2.1 grouping method of experiments
The selected cases were randomly divided into 40 cases in the treatment group and 40 cases in the control group according to age, sex, course of disease, symptoms, and the like.
2.2 methods of treatment
(1) Treatment groups: the drug of the invention (prepared as in example 1) was administered orally 3 times daily, 3 tablets each time.
(2) Control group: xinbao pill for oral administration, prepared by pharmaceutical research of Guangdong province, 60 mg/pill. Is prepared from datura flower, ginseng, pilose antler, cinnamon bark, prepared aconite root, notoginseng, borneol, musk, toad venom, etc. Has effects in exciting sinoatrial node, improving cardiac function, and relieving myocardial ischemia. Is suitable for patients with bradycardia, sick sinus syndrome, chronic heart failure, angina pectoris, etc., 3 pills each time, 3 times daily.
(3) The course of treatment is as follows: the treatment course is 6 weeks for both groups. Other drugs and measures affecting heart rate are not used during treatment.
2.3 Observation index
The following indexes are all detected by the unified equipment of the second hospital affiliated to Jilin university.
2.3.1 Observation of therapeutic Effect
(1) Changes in clinical symptoms: the total 7 signs of the common symptoms of sinus bradycardia are observed, inquired and recorded item by item before treatment and at the 1 st, 2 nd, 3 th, 4 th, 5 th and 6 th weeks respectively, the score is judged according to the symptom score standard, and the sum of the symptom scores of each case is the total integral value of the symptom of the case.
(2) Measuring the calm heart rate by electrocardiogram: no physical activity was measured 30 minutes before the morning at 10-11 am. The conventional 12-lead electrocardiograph in the electrocardio-chamber of the hospital is adopted to observe and record the heart rate change, and the conventional one-time examination is carried out every week.
(3) 24-hour dynamic electrocardiogram: recording under daily activities, adopting electrocardio-ventricular dynamic electrocardiogram analysis of our hospital, carrying out examination once before and after treatment, and comparing the changes of the slowest heart rate, the fastest heart rate, the average heart rate and the total heart rate in 24 hours before and after treatment.
2.3.2 Security Observation
(1) Routine examination of blood, urine and feces, and one examination before and after treatment;
(2) liver function and kidney function examination, and examination is performed once before and after treatment;
(3) adverse reactions may occur.
3 clinical data
3.1 sources of cases
80 bradyarrhythmia patients with complete data collected from 11 months to 12 months in 2012 were randomly divided into 40 treatment groups in the treatment group of example 1 and 40 heart-treasure pill control groups in the invention, and all the patients were from the outpatients and inpatients of the department of cardiology in the second hospital affiliated to the Jilin university. The treated group and the control group have no significant difference in case source (P > 0.05). (see Table 1)
TABLE 1 comparison of the sources of two groups of cases
Note: two groups of cases were from the source, meridian X2Inspection, P>0.05。
3.2 sex distribution
The sex profiles of the two groups of cases are shown in Table 2, the ratio between men and women is 1.2:1, and the sex profiles of the two groups are not different (P > 0.05).
TABLE 2 gender comparison of two groups of cases
Note: sex distribution of two groups of cases, meridian X2Inspection, P>0.05。
3.3 age distribution
The age distribution of the two groups of cases is shown in Table 3, wherein the treated group is 28 years old for the youngest age, 69 years old for the youngest age, and 53.23 + -11.00 years old for the average age; the control group had a minimum age of 30 years, a maximum age of 65 years, and a mean age of 52.29 + -10.15 years. There was no significant difference in mean age and age group distribution for the two groups (P > 0.05).
TABLE 3 age distribution comparison of two groups of cases
Note: age distribution in two groups, channel X2Inspection, P>0.05, mean age by t test, P>0.05.
3.4 working Properties
The distribution of the working properties of the two groups of cases is shown in table 4, and the brain workers are slightly higher than the physical workers in terms of working properties, and the brain workers: the ratio of the manual workers is about 1.3:1, and the distribution of the manual workers are not significantly different (P > 0.05).
Table 4 comparison of working properties of two groups of cases
Note: two sets of working property distributions are shown by X2Inspection, P>0.05
3.5 distribution of bradyarrhythmia types
The distribution of bradyarrhythmia types in the two groups of cases is shown in Table 5, and the treated group has no significant difference (P >0.05) with the control group and is comparable.
TABLE 5 distribution of bradyarrhythmia types in two groups of cases
Note: two groups of bradyarrhythmias distribution types, X2Inspection, P>0.05.
3.6 symptom distribution
The main symptoms before treatment are graded according to scores of light degree, medium degree and heavy degree as shown in table 6, and the positive rate and the grade distribution condition of the two groups of symptoms have no significant difference (P > 0.05).
TABLE 6 comparison of the pre-treatment chief complaints for the two groups of cases
Note: the number of positive cases and grade distribution of two groups of symptoms are analyzed by Ridid, and P is greater than 0.05.
4 criteria for efficacy assessment
4.1 Electrocardiogram curative effect
Refer to the standard formulation of the national traditional Chinese medicine administration 'guidelines for clinical research of new Chinese medicines' in 1995.
(1) And (3) healing: the average heart rate is more than 60 times/min after 24 hours;
(2) the effect is shown: the average heart rate or the lowest heart rate is increased for 24 hours or the visit heart rate is more than or equal to 10 times/min;
(3) the method has the following advantages: the average heart rate or the lowest heart rate is increased for 24 hours or the visit heart rate is more than or equal to 5 times/min;
(4) and (4) invalidation: the effective standard is not reached.
4.2 Standard of Total therapeutic Effect of Chinese medicine
The total curative effect of the traditional Chinese medicine is judged according to the integral curative effect index, wherein the curative effect index (n) is (integration before treatment and integration after treatment)/integration before treatment multiplied by 100 percent.
(1) And (3) curing: clinical symptom, sign score improvement > 95%;
(2) the effect is shown: the clinical symptoms and sign integral are improved by 60 to 95 percent;
(3) the method has the following advantages: the clinical symptoms and sign integral are improved by 30 to 60 percent;
(4) and (4) invalidation: clinical symptoms, signs score improvement 30%.
4.3 Standard of treatment Effect of Single symptom of traditional Chinese medicine
(1) The effect is shown: the original symptoms disappear, or the symptoms are improved to more than grade 2;
(2) the method has the following advantages: symptom improvement grade 1 without disappearance;
(3) and (4) invalidation: no change in symptoms.
5 evaluation of safety
(1) Level 1: safe and has no adverse reaction;
(2) and 2, stage: is safe, if adverse reaction exists, the medicine can be continuously taken without any treatment;
(3) and 3, level: has safety problem and moderate adverse reaction, and can be continuously used after treatment;
(4)4, level: the test was discontinued due to adverse reactions.
6 statistical method
Data to
Indicating, the grade data is checked by Riddit, the count data is X2And (4) checking, namely, checking the metering data by using t, and analyzing by using SPSS 13.0 software.
7 results of the study
7.1 clinical symptom Change before and after treatment
7.1.1 Total therapeutic Effect of Chinese medicine symptoms
As shown in table 7, the significant efficiency of treating the traditional Chinese medicine symptoms is 47.5%, the effective rate is 42.5%, and the total effective rate is 90.00%; the control group has the significant efficiency of 40.0 percent, the effective rate of 35.0 percent and the total effective rate of 75.0 percent, and the two groups have significant difference (P <0.05) through comparative analysis, which indicates that the symptom curative effect of the treatment group is better than that of the control group.
TABLE 7 comparison of the overall therapeutic effects of the two groups of clinical TCM symptoms
Note: by Ridit analysis, P is < 0.05.
7.1.2 comparison of curative effects of single symptom of traditional Chinese medicine
As shown in Table 8, the treated group had improved symptoms to different degrees after single treatment, compared with the control group, the treated group had no obvious difference between the three groups of short breath, fatigue, aversion to cold, cold limbs and pale complexion (P >0.05), and the treated group had better curative effects on other symptoms such as palpitation, chest distress, dizziness, tinnitus and cyanosis of lips than the control group (P < 0.05).
TABLE 8 comparison of the curative effects of the individual symptoms in two groups of cases
Note: through the Ridit analysis, the product is obtained,*P<0.05，**comparison between groups P>0.05。
7.1.3 comparison of the curative effects of two groups of electrocardiograms
As shown in table 9, the total effective rate of the treatment group electrocardiogram is 87.50%; the total effective rate of the control group is 85.00 percent, and the two groups have no significant difference (P is more than 0.05) through comparative analysis, which indicates that the electrocardiogram curative effect of the treatment group is similar to that of the control group.
TABLE 9 comparison of the curative effects of two groups of electrocardiograms
Note: ridit analysis showed P >0.05.
7.1.4 quiet Heart Rate increase amplitude comparison
As shown in Table 10, when the resting heart rate increase amplitudes of the two groups of patients are compared, the resting heart rate of the patients in the treatment group is increased similarly to that of the control group when 6W is taken, and the increase values of the two groups have no significant difference (P > 0.05).
TABLE 10 comparison of quiet Heart Rate increase values during two groups of treatments: (
Times/minutes)
Note: comparison of P >0.05 between the two groups by t-test
7.1.5 effects on dynamic electrocardiogram (dECG)
As shown in Table 11, there was no significant difference in the average rate of dECG, the slowest rate of dECG, the fastest rate of dECG, and 24 hours total heart rate for the two pre-treatment comparisons (P > 0.05). The average heart rate of dECG, the slowest heart rate of dECG, the fastest heart rate of dECG and the total heart rate of dECG24 hours of patients in the treatment group are obviously improved before and after the patients take the medicine (P is less than 0.001). The indexes of the control group also show different degrees of significant difference (P < 0.001). Comparative analysis after two groups of treatments showed similar efficacy of dECG average heart rate, dECG slowest heart rate, dECG fastest heart rate, and dECG24 hours total heart beat improvement compared to control group taking inventive example 1 and inventive example 1 pieces (P > 0.05).
TABLE 11 results of measurement of indices before and after treatment of two groups of patients
Note: by t-test, comparison of two groups before treatment####P>0.05; the post-treatment and pre-treatment comparisons for each group,*P<0.05，**P<0.01，***P<0.001，****P>0.05; comparison after treatment of two groups, P>0.05。
Example 1 of the invention the significant efficiency of example 1 of the invention in treating bradyarrhythmia is 47.5%, and the total effective rate is 90.00%; the significant efficiency of the control group is 40.0%, the total effective rate is 75.00%, and through Ridit analysis, the two groups have significant difference (P < 0.05); and the main symptoms of the treatment group such as palpitation, chest distress, short breath and hypodynamia, dizziness and tinnitus and the total effective rate of the lip-rounding pliers are all over 90 percent, and the qi removing, short breath and hypodynamia and the like are all obviously superior to those of the control group (P is less than 0.05).
The symptom improvement is the result of the balance and coordination of qi and blood of the organism, the functions of the viscera and the yin and yang of the organism, the curative effect of the symptoms of the treatment group is obviously better than that of the control group, and the advantages of the treatment based on syndrome differentiation in traditional Chinese medicine in the diagnosis and treatment of the bradyarrhythmia are shown. Because the symptoms reflect the essence of visceral dysfunction and qi and blood dysfunction of the bradyarrhythmia, the improvement of the symptoms has practical significance in a certain sense compared with the simple improvement of the heart rate, improves the life quality of patients while improving the heart rate, and is the main advantage of treating the bradyarrhythmia by using the traditional Chinese medicine.
In addition, the research can objectively and comprehensively reflect the change of the 24-hour cardiac rhythm of the patient with the bradyarrhythmia in the drug treatment period by using 24-hour dynamic electrocardiogram monitoring to evaluate the curative effect. The study data shows that the average heart rate of dECG, the total heart rate of dECG24 hours, the fastest heart rate of dECG and the slowest heart rate of dECG before and after the patients in the treatment group take the medicine are all obviously improved (P is less than 0.001). Comparative analysis of the two groups after treatment showed that the dECG average heart rate, of the patients taking inventive example 1 and inventive example 1,
The improvement of the fastest heart rate of dECG, the slowest heart rate of dECG and the total heart rate of dECG24 hours is similar to the curative effect of the control group (P > 0.05). Compared with the increase amplitude of the calm heart rate, the calm heart rate of the patients taking the 6W treatment group rises similarly compared with the control group, and the increase values of the two groups have no significant difference (P > 0.05). Example 1 of the invention the example 1 of the invention increased heart rate in the treatment group similarly to the control group.
Although the present invention has been described with reference to the specific embodiments, it should be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention.
Claims (8)
1. The application of a medicament for tonifying qi and activating blood circulation in preparing a medicament for treating bradyarrhythmia comprises the following raw material medicaments: 100-150 parts of astragalus mongholicus, 80-120 parts of codonopsis pilosula, 60-100 parts of salvia miltiorrhiza, 60-100 parts of kudzuvine root, 60-100 parts of epimedium, 60-100 parts of hawthorn, 40-80 parts of rehmannia, 40-80 parts of angelica sinensis, 40-80 parts of coptis chinensis, 40-80 parts of vinegar rhizoma corydalis, 40-80 parts of lucid ganoderma, 20-30 parts of ginseng and 20-30 parts of honey-fried licorice root;
the bradyarrhythmia is: sinus bradycardia and/or degree II atrioventricular block and/or degree III atrioventricular block and/or sick sinus syndrome;
the treatment of the bradyarrhythmia is to increase the calm heart rate and/or the total 24-hour heart beat and/or the fastest heart rate and/or the slowest heart rate and/or the average heart rate of a patient with the bradyarrhythmia.
2. The application of the qi-tonifying and blood-circulation-promoting medicine in preparing the medicine for treating the bradyarrhythmia according to claim 1, wherein the qi-tonifying and blood-circulation-promoting medicine comprises the following raw material medicines: 120 parts of astragalus membranaceus, 100 parts of codonopsis pilosula, 80 parts of salvia miltiorrhiza, 80 parts of kudzu roots, 80 parts of epimedium, 80 parts of hawthorn, 60 parts of rehmannia, 60 parts of angelica sinensis, 60 parts of coptis chinensis, 60 parts of vinegar rhizoma corydalis, 60 parts of lucid ganoderma, 25 parts of ginseng and 25 parts of honey-fried licorice roots.
3. The application of the qi-tonifying and blood-circulation-promoting medicine in preparing the medicine for treating the bradyarrhythmia according to claim 1, wherein the qi-tonifying and blood-circulation-promoting medicine comprises the following raw material medicines: 140 parts of astragalus membranaceus, 90 parts of codonopsis pilosula, 70 parts of salvia miltiorrhiza, 90 parts of kudzu roots, 90 parts of epimedium, 70 parts of hawthorn, 50 parts of rehmannia, 70 parts of angelica sinensis, 70 parts of coptis chinensis, 50 parts of vinegar rhizoma corydalis, 50 parts of lucid ganoderma, 28 parts of ginseng and 28 parts of honey-fried licorice roots.
4. The application of the qi-tonifying and blood-circulation-promoting medicine in preparing the medicine for treating the bradyarrhythmia according to claim 1, wherein the qi-tonifying and blood-circulation-promoting medicine comprises the following raw material medicines: 110 parts of astragalus, 110 parts of codonopsis pilosula, 90 parts of salvia miltiorrhiza, 70 parts of kudzuvine root, 70 parts of epimedium, 90 parts of hawthorn, 70 parts of rehmannia, 50 parts of angelica, 50 parts of coptis chinensis, 70 parts of vinegar rhizoma corydalis, 70 parts of lucid ganoderma, 22 parts of ginseng and 22 parts of honey-fried licorice root.
5. The application of the qi-tonifying and blood-circulation-promoting medicine in preparing the medicine for treating the bradyarrhythmia as claimed in claim 1, wherein the preparation method of the qi-tonifying and blood-circulation-promoting medicine comprises the following steps: taking ginseng, coptis chinensis, rhizoma corydalis processed with vinegar, hawthorn and half of astragalus root in the raw materials, crushing the ginseng, the coptis chinensis, the rhizoma corydalis processed with vinegar and the hawthorn into fine powder, adding water into the other eight raw materials and the rest of the astragalus root, decocting the rest eight raw materials and the rest of the astragalus root for 1 to 3 times, each time lasts for 1 to 3 hours, merging decoction, filtering, concentrating the filtrate until the relative density is 1.05 to 1.15 at 90 to 95 ℃, cooling, adding one time of ethanol to precipitate, taking supernatant, recovering the ethanol, concentrating the supernatant to obtain clear paste with the relative density of 1.15 to 1.25 at 90 to 95 ℃, mixing the clear paste with the medicinal powder, and preparing tablets, granules, pills, capsules, dripping pills, soft capsules, sustained release agents, oral liquid preparations or.
6. The application of the qi-tonifying and blood-circulation-promoting medicine in preparing the medicine for treating the bradyarrhythmia as claimed in claim 1, wherein the preparation method of the qi-tonifying and blood-circulation-promoting medicine comprises the following steps: taking ginseng, coptis chinensis, rhizoma corydalis processed with vinegar, hawthorn and half of astragalus root in the raw materials, crushing the ginseng, the coptis chinensis, the rhizoma corydalis processed with vinegar and the hawthorn into fine powder, adding water into the other eight raw materials and the rest of the astragalus root, decocting the mixture for 2 times, decocting for 2 hours for the first time and 1.5 hours for the second time, merging decoction, filtering, concentrating filtrate until the relative density is 1.06-1.12 at 90 ℃, cooling, adding ethanol for one time to precipitate, taking supernatant, recovering ethanol, concentrating the supernatant to clear paste with the relative density of 1.20-1.22 at 90 ℃, mixing the clear paste with the medicinal powder, and preparing tablets, granules, pills, capsules, dropping pills, soft capsules, sustained release agents, oral liquid preparations or freeze-dried powder injections.
7. The application of the qi-tonifying and blood-circulation-promoting medicine in preparing the medicine for treating the bradyarrhythmia as claimed in claim 1, wherein the preparation method of the qi-tonifying and blood-circulation-promoting medicine comprises the following steps: taking the raw materials, soaking in 8-12 times of water for 40-80 minutes, boiling for 1-3 hours, taking out the liquid medicine, adding 6-10 times of water into the residue, decocting for 70-110 minutes, mixing the two liquid medicines, and filtering; passing the medicinal liquid through treated JD-1(WLD) macroporous adsorbent resin column with the resin amount 1-3 times of the weight of the raw materials, controlling the adsorption flow rate at 2-4mL/min, washing the resin column with water until the effluent is clear, eluting with 60-90% ethanol 2-4 times of the weight of the resin, collecting the eluate, washing with 1-2 times of water, mixing the eluates, recovering ethanol, concentrating to relative density of 1.05-1.20, spray drying to obtain extract spray dried medicinal powder, and adding conventional adjuvants to obtain dripping pill.
8. The application of the qi-tonifying and blood-circulation-promoting medicine in preparing the medicine for treating the bradyarrhythmia as claimed in claim 1, wherein the preparation method of the qi-tonifying and blood-circulation-promoting medicine comprises the following steps: taking the raw materials, soaking in 10 weight times of water for 60 minutes, boiling for 2 hours, taking out the liquid medicine, adding 8 weight times of water into the decoction dregs, decocting for 90 minutes, combining the secondary liquid medicines, and filtering; passing the medicinal liquid through treated JD-1(WLD) macroporous adsorbent resin column with the resin amount 1.5 times of the weight of the raw materials, controlling the adsorption flow rate at 2-4mL/min, washing the resin column with water until the effluent is clear, eluting with 70% ethanol with the resin amount 3 times of the weight of the effluent, collecting the eluate, washing with 1.5 times of water, mixing the eluates, recovering ethanol, concentrating to relative density of 1.08-1.15, spray drying to obtain extract spray dried medicinal powder, and adding conventional adjuvants to obtain dripping pill.
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