CN106491958A - Compound Chinese medicinal preparation for the treatment of coronary disease and angina pectoris and preparation method thereof - Google Patents

Compound Chinese medicinal preparation for the treatment of coronary disease and angina pectoris and preparation method thereof Download PDF

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CN106491958A
CN106491958A CN201510567546.XA CN201510567546A CN106491958A CN 106491958 A CN106491958 A CN 106491958A CN 201510567546 A CN201510567546 A CN 201510567546A CN 106491958 A CN106491958 A CN 106491958A
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chinese medicinal
angina pectoris
medicinal preparation
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CN106491958B (en
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徐燕
严世芸
黄敏华
姚成增
刘永明
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Shuguang Hospital Affiliated to Shanghai University of TCM
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Abstract

The present invention relates to the field of Chinese medicines, discloses a kind of compound Chinese medicinal preparation for treating coronary disease and angina pectoris, it is made up of the Chinese medicine material medicine of following weight portion:1~3 part of pseudo-ginseng, 1~3 part of dalbergia wood, 1~3 part of the root of Chinese wild ginger, 3~10 parts of the Radix Astragali, 1~3 part of Ligusticum wallichii, 1~5 part of cassia twig, 1~2 part of leech, sealwort 2-6 parts.The invention further relates to the preparation method of the compound Chinese medicinal preparation:The Chinese medicine material for taking above-mentioned weight portion carries out boiling water and brews, with conventional method of Chinese medicinal, the regular dosage form of the compound Chinese medicinal preparation of preparation cost invention.The invention provides a kind of compound Chinese medicinal preparation for treating coronary disease and angina pectoris, can efficiently reduce artery sclerosis and effectively can regulate and control inflammatory factor again, coronary disease and angina pectoris can be preferably treated, taking convenience, dose are few, and long-term taking has no toxic side effect.

Description

Compound Chinese medicinal preparation for the treatment of coronary disease and angina pectoris and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, more particularly to a kind of compound Chinese medicinal preparation for treating coronary disease and angina pectoris And preparation method thereof.
Background technology
Coronary atherosclerotic heart disease (coronary heart disease, referred to as " CHD ") letter Win worry, is to sexually revise to cause coronary artery luminal stenosis or close as coronary artery generation is atherosis Plug, the heart disease for causing respective regions cardiac muscle hypoxic-ischemic even necrosis occur and causing.Coronary heart disease is faced Bed symptom is not only relevant with coronary artery blockage or narrow degree, more ceases with the unstability of atheromatous plaque Manner of breathing is closed.Relevant coronary heart disease Crack cause, " endothelial injuries reaction hypothesis " people the most are received, i.e., Various main hazards are damaged to arterial endothelial cell, artery endothelium, inner film injury are made inflammation- Fibroproliferative reacts and causes artery atherosclerotic pathology occur.Pass through some cells in recent years and divide The biological research of son, find arterial lumen narrow be not cause as patch is unstable merely inflammatory because Sub- level increases, but inflammatory factor level increases patch can be caused unstable, due to inflammatory factor all the time Formation, the development of coronary atherosclerosis is participated in, the activity of inflammatory factor is therefore effectively reduced, right It is very important even to avoid acute adverse events in prevention and cure of cardiovascular disease.
With the development of modern medicine, the treatment of coronary disease and angina pectoris obtains further specification, but quite Some cases are dissatisfied through doctor trained in Western medicine medical treatment effect, and PCI, CABG ( Referred to as off pump coronary artery bypass) etc. also have the risk and limitation of itself, while it is original coronal dynamic all to eliminate which Arteries and veins pathology, therefore traditional Chinese medicine has its important value and potential advantages to the preventing and treating of this disease.From its clinical onset table From the point of view of now, belong to China's traditional Chinese medicine and pharmacy " obstruction of qi in the chest ", the category of " pained ".Seen with regard to its clinical manifestation earliest In《The Yellow Emperor's Canon of Internal Medicine》, have in book " evil the heart, then sick pained ", " angina pectoris, bluish colour of the limbs extending up to the elbows and knees, Pained very, onset of disease in the morning and dying in the evening, onset of disease in the evening and dying in the next morning." record.However, not providing yet on the market at present a kind of The compound Chinese medicinal preparation of coronary disease and angina pectoris is effectively treated.
Content of the invention
It is an object of the invention to provide, there is provided a kind of safe and effective, price appropriateness and Western medicine joint clothes With the compound Chinese medicinal preparation of the treatment coronary disease and angina pectoris that can be heightened the effect of a treatment, artery can be efficiently reduced hard Change and can effectively regulate and control inflammatory factor again.
Another object of the present invention is to the compound Chinese medicinal preparation of above-mentioned treatment coronary disease and angina pectoris is provided Preparation method.
For solving above-mentioned technical problem, embodiments of the present invention treat coronary disease and angina pectoris there is provided one kind Compound Chinese medicinal preparation, be made up of the Chinese medicine material medicine of following weight portion:1~3 part of pseudo-ginseng, dalbergia wood 1~ 3 parts, 1~3 part of the root of Chinese wild ginger, 3~10 parts of the Radix Astragali, 1~3 part of Ligusticum wallichii, 1~5 part of cassia twig, leech 1~ 2 parts, sealwort 2-6 parts.
The present invention also provides the compound Chinese medicinal preparation of above-mentioned treatment coronary disease and angina pectoris, comprises the steps of:
(1) each Chinese medicine material of following weight portion is weighed:1~3 part of pseudo-ginseng, 1~3 part of dalbergia wood, thin Pungent 1~3 part, 3~10 parts of the Radix Astragali, 1~3 part of Ligusticum wallichii, 1~5 part of cassia twig, 1~2 part of leech, Sealwort 2-6 parts.
(2) each Chinese medicine material for weighing is mixed;
(3) the mixed Chinese medicine material is brewed with boiling water;
(4) with conventional method of Chinese medicinal, the conventional agent of the compound Chinese medicinal preparation of preparation cost invention Type.
The compound Chinese medicinal preparation of the present invention is multiple relative to the existing Chinese medicine for treating coronary disease and angina pectoris Square preparation, in the selection of raw material flavour of a drug:Reuse the Radix Astragali, the big gas for mending the whole body, righting with eliminating evil, just Contain heresy side to move back, and act yang-energy, invigorating the heart-YANG can be risen;Pseudo-ginseng, dalbergia wood work(arrogate to oneself promoting blood circulation and removing blood stasis, the heart arteries and veins stasis of blood of dispelling Hinder and pain relieving;5 with the root of Chinese wild ginger, pungent scattered sensible, coronary circulation-promoting pain-relieving etc..Complete square compatibility 5 is rigorous, and the few power of medicine is special, Strengthening vital QI to eliminate pathogenic factors, inrigorating qi and promoting blood circulation, the effect of stagnation resolvation analgesic therapy are played altogether.Accordingly, it is capable to coronary disease and angina pectoris are treated preferably, Taking convenience, dose are few, and long-term taking has no toxic side effect.
In terms of drug action, first, preclinical research is (as prospective randomized clinical is studied or disease Example control clinical research) find on the basis of western medicine plus effectively can not only be reduced with invention formulation Patients with coronary heart disease angina pectoris attacks number of times, and can also significantly improve Treating Patients of Angina Pectoris oxidation should Sharp state, has good therapeutic action to Treating Patients of Angina Pectoris.
Secondly, the present invention is further advanced by clinical testing and shows, the compound Chinese medicinal preparation treatment of the present invention Angina is definite, has no the toxic and side effect of drug-induced in clinical testing, is treatment coronary disease The anginal safe and effective medicine of disease.We detect patient's by prospective contrast case research Carotid intimal medial thickness (IMT), AAi (ABI) and the heart-ankle vascular index (CAVI), And before and after being treated by enzyme-linked immunosorbent assay (ELISA) method detection invention formulation in serum Inflammatory factor, it was demonstrated that invention formulation is combined with Western medicine so that artery sclerosis again energy can be efficiently reduced Effectively regulate and control inflammatory factor.
In addition, bulk drug involved in the present invention is natural Chinese medicinal herb, Chinese Pharmacopoeia is 2000 One recorded Chinese medicine of version, and meet pharmacopoeial quality requirement.Draw materials easily, prepare simplicity, medicine source is wide, Low cost.
Specific embodiment
For making the object, technical solutions and advantages of the present invention clearer, below by each reality to the present invention The mode of applying is explained in detail.However, it will be understood by those skilled in the art that in the present invention In each embodiment, in order that reader more fully understands the application and proposes many ins and outs.But, Even if there is no these ins and outs and many variations based on following embodiment and modification, it is also possible to real The each claim of existing the application technical scheme required for protection.
Coronary disease and angina pectoris belong to the category of the traditional Chinese medical science " chest impediment and cardialgia " disease, with regard to its earliest medication guide " worry preferably eats Chinese onion ", it can be seen that coronary disease and angina pectoris are exactly a kind of common emergency and severe disease in ancient times, and Have accumulated corresponding Couple herbs.Behind《Synopsis Golden Chamber》In, Zhang Zhongjing proposes " chest first The name of disease of numbness ", and think that its interpretation of the cause, onset and process of an illness is " weak pulse at YANG and stringy pulse at YIN ", inheriting《The Yellow Emperor's Canon of Internal Medicine》To coronary heart disease The warp such as " Gualou Xiebai Baijiu Tang ", " Gualou Xiebai Banxia Tang " is proposed on anginal Couple herbs Allusion quotation prescription.In the middle of the succession of later age, the understanding to coronary disease and angina pectoris is also more and more comprehensive, it is believed that lead The reason for causing coronary disease and angina pectoris has that turbid hemostasis, phlegm, fever and chills, inernal injuries caused by seven emotions, eating and drinking without temperance etc. are many to be recognized Know.Modern Chinese medicine generally believes that the basic pathogenesis of coronary disease and angina pectoris is " asthenia in origin and asthenia in superficiality ", and this void is with the heart Gas virtual loss, based on deficiency of heart-blood, mark actually with blood stasis, phlegm turbid based on.
Embodiments of the present invention are related to a kind of compound Chinese medicinal preparation for treating coronary disease and angina pectoris, the treatment The compound Chinese medicinal preparation of coronary disease and angina pectoris is made up of the Chinese medicine material medicine of following weight portion:Pseudo-ginseng 1~3 Part, 1~3 part of dalbergia wood, 1~3 part of the root of Chinese wild ginger, 3~10 parts of the Radix Astragali, 1~3 part of Ligusticum wallichii, cassia twig 1~ 5 parts, 1~2 part of leech, sealwort 2-6 parts.
Such as, 1.5~3 parts of pseudo-ginseng, 1.5~2.5 parts of dalbergia wood, 1.5~3 parts of the root of Chinese wild ginger, the Radix Astragali 5~10 Part, 1.5~3 parts of Ligusticum wallichii, 2.5~5 parts of cassia twig, 1~1.5 part of leech, sealwort 2.5-5 parts.
The preparation method of the compound Chinese medicinal preparation of the present invention is expanded on further below by way of embodiment is prepared.
Embodiment 1 prepares the compound Chinese medicinal preparation granule of the present invention
(1) each Chinese medicine material of following weight portion is weighed:1~3 part of pseudo-ginseng, 1~3 part of dalbergia wood, the root of Chinese wild ginger 1~ 3 parts, 3~10 parts of the Radix Astragali, 1~3 part of Ligusticum wallichii, 1~5 part of cassia twig, 1~2 part of leech, sealwort 2-6 parts;
(2) each Chinese medicine material for weighing is mixed;
(3) the mixed Chinese medicine material is brewed with boiling water;
(4) with conventional method of Chinese medicinal, the regular dosage form of the compound Chinese medicinal preparation of preparation cost invention.
More preferably, in the step (1), can weigh 1.5~3 parts of pseudo-ginseng, 1.5~2.5 parts of dalbergia wood, 1.5~3 parts of the root of Chinese wild ginger, 5~10 parts of the Radix Astragali, 1.5~3 parts of Ligusticum wallichii, 2.5~5 parts of cassia twig, leech 1~ 1.5 parts, sealwort 2.5-5 parts.In the step (3), entered using the boiling water of 150CC~200CC Brew described in row.
Below by way of the beneficial effect that test example illustrates compound Chinese medicinal preparation of the present invention.
The Clinical criteria Changeement test of 1 invention formulation of test example
1. case selection method
Test case is that Shuguang Hospital's internal medicine special outpatient clinic and ward are recruited and closed The Treating Patients of Angina Pectoris of lattice.
1.1 inclusive criteria:
(1) diagnosis of the traditional Chinese medical science obstruction of qi in the chest, card category syndrome of blood stasis due to qi deficiency person are met;(2) meet doctor trained in Western medicine coronary heart disease steady Sizing angina diagnostic criteria person;(3) between age 18-75 year, male or female;(4) voluntarily join Plus this test, and sign " Informed Consent Form ".
1.2 exclusion standard:
(1) merge the patient of the serious protopathy such as cardiovascular and cerebrovascular, liver, hemopoietic system;(2) merge There are diabetes severe complication, hypertension severe complication;(3) concurrent infection, electrolyte disturbance etc. be simultaneously Send out disease person;(4) insane is associated with;(5) gestation and women breast-feeding their children;(6) researcher thinks Because other reasonses are not suitable for participating in this clinical testing person.
2. research and design method
Experimental design:Studied using random packet method.By SAS statistical softwares PROCPLNA Procedure statement, produce meet inclusive criteria research object received process (investigational agent and comparison medicine) with Machine arranges (i.e. random coded table), by 1:1 ratio be assigned at random treatment group (Western medicine group+in Medicine group) and control group (Western medicine group).The personnel that randomizing scheme is not involved in clinical testing by seminar are special Management.
Sample content:According to the actual conditions that this is studied, intend carrying out small sample clinical research, treatment group 30 patients each with control group.
3. treatment method
All research objects for meeting inclusive criteria are with reference to cardiovascular disease branch of Chinese Medical Association in 2007 With regard to《Chronic stable angina Clinics and Practices guide》Give western medicine routine treatment, including nitrate Class, beta receptor antagonist, calcium channel blocker, Bayaspirin Enteric-coated, ACE Inhibitor etc..
Control group gives western medicine routine treatment.
Treatment group patient give on the basis of western medicine routine treatment plus with invention formulation (containing pseudo-ginseng, dalbergia wood, The root of Chinese wild ginger, the Radix Astragali, Ligusticum wallichii, cassia twig, leech, sealwort etc.), using single herbal concentrate-granule (from Shanghai Attached SHUGUANG HOSPITAL Chinese medicine pharmacy of university of TCM, purchased from Tianjiang Pharmaceutical Industry Co., Ltd., Jiangyin), drink after brewing With.For example, weigh 1.5~3 parts of pseudo-ginseng (every part weight be 1 gram~2 grams), 1.5~2.5 parts of dalbergia wood, 1.5~3 parts of the root of Chinese wild ginger, 5~10 parts of the Radix Astragali, 1.5~3 parts of Ligusticum wallichii, 2.5~5 parts of cassia twig, leech 1~ 1.5 parts, sealwort 2.5-5 parts.Described brewing is carried out using the boiling water of 150CC~200CC;Using The boiling water of 150CC~200CC is brewed, and makes the regular dosage form of compound Chinese medicinal preparation.
Administrated method:Half bag/time, drinks after brewing by 2 times/day.The course for the treatment of is 3 months.
4. observation item and method
The course for the treatment of and follow-up:Two groups of patients are before treatment, treatment March and follow-up March carry out security Index (routine blood test, routine urinalysis, hepatic and renal function, blood fat, blood sugar, glycosylated hemoglobin, Color Sonography, ECG) check with responsiveness index (AVI, ABI, IMT, pulse pressure).Inspection according to safety indexes Survey, without 1 because test is exited in bad reaction in terms of security, not relevant with trial drug yet Bad reaction occurs.
At present, clinically we can judge subtracting for arterial elasticity by detecting CAVI and ABI Move back or carotid intimal medial thickness (IMT) observation patients with coronary heart disease in treatment curative effect.This is because: CAVI good examination effects for artery sclerosis has, but coronary heart disease can not be detected, more cannot be anti- Reflect the extent of disease of coronary heart disease;ABI values can reflect the degree of Coronary Artery Lesions well, and ABI values are lower, Coronary artery involved is heavier, but can not reflect the scope of pathology, also has research to think ABI to coronary artery two And above person's predicting function is more apparent but specific poor for Single vessel disease.Normal reference value is: RCAVI < 9.0, LCAVI8.2 ± 0.7, ABI scopes are 0.9~1.3.In addition, atherosclerotic early stage Occur that endarterium is thickened, and middle film is the position that endarterium thickens earliest generation in arteria carotis, because This by ultrasonic measurement carotid intimal medial thickness (IMT) can in the degree of early stage clear and definite artery sclerosis, And for the morbidity of coronary heart disease also has very strong predictive ability, therefore IMT is referred to as the independence of coronary heart disease Predictive factor, the morbidity of prediction coronary heart disease that can not only be very strong, and the order of severity for coronary heart disease There is great relevance.IMT>1.0mm is to thicken, IMT>1.2mm is considered as has patch to be formed.
5. statistical method
Statistical analysis:It is analyzed using SPSS13.0 statistical analysis softwares, enumeration data is using composition Than description, measurement data using mean ± standard deviation describe, Non-Gaussian Distribution data adopt median, hundred Quantile is described.The measurement data of normal distribution adopts independent samples t-test, the measurement data of Non-Gaussian Distribution Use Nonparametric Analysis.The baseline of two groups of symptom integrals and rate compares, treat after compare, treat before and after difference Group between more adopt independent samples t-test;Compare before and after in group and adopt paired t-test.Treat between two groups Effect is constituted the difference of ratio and adopts the comparison of Chi-square Test, rate to be analyzed using Ridit, and P < 0.05 are have statistics Learn difference.
6. result
Arterial function is checked:Pulse pressure, CAVI and ABI are checked.
Observation result is as follows:
The change of 1 two groups of patient's items arterial function indexs of table is compared
Above-mentioned data display, after medication, invention formulation show clearly than Western medicine become apparent from reducing left, The effect of RCCA (IMT), after invention formulation March is taken, follow-up March (take system Agent June) occur afterwards, L-ABI also (takes preparation 6 taking invention formulation March, follow-up March Month), the obvious (p lower than Western medicine group ABI value of the L-ABI of Chinese medicine group<0.05), coronary artery involved is described Lighter than Western medicine group.
The antiinflammatory action development test of 2 invention formulation of test example
The contents such as case selection method, research and design method, treatment method, statistical method are with embodiment 1.
1. observation item and method:
The course for the treatment of and follow-up:Two groups of patients are before treatment, treatment March and follow-up March carry out security Index and responsiveness index checking (detect angiogenic factor and the inflammation in serum using ELISA method The factor).
Serum sample collection:Two groups of patients take empty stomach ulnar vein blood 4ml, 3000r min respectively at early morning- 1Centrifugation 10min, it is standby that -70 DEG C of Refrigerator stores put by separation serum.
Detection method:Super quick CRP (hs-CRP), IL-18, TNF-α, MMP-9, PPAR γ, NF-kB, Using ELISA (enzyme linked immunoassay) detection method.
2. observation result is as follows:
2 every blood vessel of table and the mean value of inflammatory factor
Above-mentioned data display, invention formulation is on the basis of Western medicine is drunk and Western medicine has equal work( Effect, TNF-α, IL-18, NF- κ B (ng/ml) can occur bright after invention formulation and pure Western medicine is taken Concentration in aobvious serum declines, and in follow-up March (taking preparation June) MMP-9, PPAR- γ afterwards Concentration ratio Western medicine is significantly increased.
The impact that 3 of the invention two groups of different therapeutic modalities of test example change to each index
Case selection method, research and design method, therapeutic scheme, observation item is with contents such as methods with real Apply example 1 and embodiment 2.
1. statistical method:
Statistical analysis:Group is packet variable, if P<0.05 shows that the difference between each group has statistics Learn meaning;Time is time variable, if P<0.05 shows that the difference between different time has statistics to anticipate Justice;Group*time is interaction, and between two groups, whether each index variation over time has system Meaning learned by meter, and this is most important result, P<0.05 shows that the change between two groups is variant, that is, treat Mode is had an impact to index.
2. observation result is as follows:
Between 3 two groups of cases of table, the otherness of each index change compares
Above-mentioned data display, left and right arteria carotis communis (IMT), R-ABI and L-ABI, pulse pressure, with And the change between the two groups of IL-18, MMP9, PPAR- γ, NF- κ B indexs has obvious difference, That is between invention formulation loading Western medicine and the treatment of simple western medicine, it will be apparent that two groups different to control Treat has different impacts to These parameters.
It will be understood by those skilled in the art that the respective embodiments described above are to realize that the present invention's is concrete Embodiment, and in actual applications, can to which, various changes can be made in the form and details, and not inclined From the spirit and scope of the present invention.

Claims (6)

1. a kind of compound Chinese medicinal preparation for treating coronary disease and angina pectoris, it is characterised in that by following weight portion Chinese medicine material medicine make:1~3 part of pseudo-ginseng, 1~3 part of dalbergia wood, 1~3 part of the root of Chinese wild ginger, the Radix Astragali 3~ 10 parts, 1~3 part of Ligusticum wallichii, 1~5 part of cassia twig, 1~2 part of leech, sealwort 2-6 parts.
2. according to claim 1 treatment coronary disease and angina pectoris compound Chinese medicinal preparation, its feature It is, is made up of the Chinese medicine material medicine of following weight portion:
1.5~3 parts of pseudo-ginseng, 1.5~2.5 parts of dalbergia wood, 1.5~3 parts of the root of Chinese wild ginger, 5~10 parts of the Radix Astragali, river 1.5~3 parts of rhizome of chuanxiong, 2.5~5 parts of cassia twig, 1~1.5 part of leech, sealwort 2.5-5 parts.
3. a kind of preparation method of the compound Chinese medicinal preparation for treating coronary disease and angina pectoris, it is characterised in that bag Contain following steps:
(1) each Chinese medicine material of following weight portion is weighed:1~3 part of pseudo-ginseng, 1~3 part of dalbergia wood, thin Pungent 1~3 part, 3~10 parts of the Radix Astragali, 1~3 part of Ligusticum wallichii, 1~5 part of cassia twig, 1~2 part of leech, Sealwort 2-6 parts.
(2) each Chinese medicine material for weighing is mixed;
(3) the mixed Chinese medicine material is brewed with boiling water;
(4) with conventional method of Chinese medicinal, the conventional agent of the compound Chinese medicinal preparation of preparation cost invention Type.
4. according to claim 3 treatment coronary disease and angina pectoris compound Chinese medicinal preparation preparation side Method, it is characterised in that in the step (1), weighs 1.5~3 parts of pseudo-ginseng, dalbergia wood 1.5~2.5 Part, 1.5~3 parts of the root of Chinese wild ginger, 5~10 parts of the Radix Astragali, 1.5~3 parts of Ligusticum wallichii, 2.5~5 parts of cassia twig, leech 1~1.5 part, sealwort 2.5-5 parts.
5. according to claim 3 treatment coronary disease and angina pectoris compound Chinese medicinal preparation preparation side Method, it is characterised in that in the step (3), carries out institute using the boiling water of 150CC~200CC State and brew;Wherein, every part of weight is 1 gram~2 grams.
6. according to claim 3 treatment coronary disease and angina pectoris compound Chinese medicinal preparation preparation side Method, it is characterised in that described regular dosage form is granule, decoction.
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