CN103961429B - Traditional Chinese medicine composition having effects of moving qi and invigorating blood circulation and preparation method thereof - Google Patents

Abstract

The invention provides a traditional Chinese medicine composition having effects of moving qi and invigorating blood circulation and a preparation method thereof. The traditional Chinese medicine composition comprises, by weight, 50-500 parts of fructus choerospondiatis, 100-700 parts of red sage root, 50-500 parts of mulberry, 10-100 parts of safflower and 50-500 parts of haw. The traditional Chinese medicine composition has stable clinical curative effects on thoracic obstruction (coronary heart disease-caused angina) and qi stagnation and blood stasis, can improve symptoms such as chest distress and palpitaition of patients, can improve an electrocardiogram and blood fat of patients suffering from coronary heart disease-caused angina to different degrees, and can reduce nitrate-type drug dependence of patients.

Description

A kind of Chinese medicine composition with promoting flow of QI and blood effect and preparation method thereof

Technical field

The present invention relates to a kind of Chinese medicine composition and preparation method thereof is and in particular to a kind of have in promoting flow of QI and blood effect Drug composition and preparation method thereof, belongs to field of medicaments.

Background technology

Coronary heart disease full name coronary atherosclerotic heart disease, the traditional Chinese medical science claims " thoracic obstruction ", is cardiovascular system commonly encountered diseases, many Morbidity, current China sickness rate steeply rises, age of onset rejuvenation increasingly, and the myocardial infarction caused by coronary heart disease has become current Invisible killer.Caused by coronary heart disease leads to different degrees of myocardial ischemia, ischemia mainly due to coronary atherosclerosiies.In Doctor thinks, the pathogenesis of coronary heart disease is that heart arteries and veins is obstructed, how because blood stasis, expectorant are turbid, the stagnation of QI and cause, be long-term visceral dysfunction again Result.

The medicament categories being applied to coronary heart disease treatment at present are a lot, and most of Western medicine cannot play the effect effected a permanent cure.It is controlled Treatment approach is many to be improved myocardial oxygen delivery and is reduced myocardial oxygen consumption with the medicine using coronary dilating and decreased heart rate, thus mitigation symptoms, one Denier is discontinued and will reply the original state of an illness.And Chinese medicine is definite with its stable curative effect, the advantage that has no toxic side effect is in treatment coronary heart disease Aspect is played a greater and greater role.

Content of the invention

First purpose of the present invention is to provide a kind of Chinese medicine composition with promoting flow of QI and blood effect；

Second purpose of the present invention is to provide the preparation method of this Chinese medicine composition；

The 3rd purpose of the present invention is to provide application in preparation treatment medicaments for coronary disease for this Chinese medicine composition.

The 4th purpose of the present invention is to provide application in preparing blood lipid-lowering medicine for this Chinese medicine composition.

The purpose of the present invention is achieved by the following technical solution:

A kind of Chinese medicine composition with promoting flow of QI and blood effect, the crude drug of this Chinese medicine composition consists of:

Fructus Choerospondiatis 50-500 weight portion, Radix Salviae Miltiorrhizae 100-700 weight portion, Fructus Mori 50-500 weight portion, Flos Carthami 10-100 weight portion, Fructus Crataegi 50-500 weight portion；

Further, its crude drug consists of:

Fructus Choerospondiatis 100-450 weight portion, Radix Salviae Miltiorrhizae 150-600 weight portion, Fructus Mori 100-450 weight portion, Flos Carthami 15-80 weight Part, Fructus Crataegi 100-450 weight portion；

Further, its crude drug consists of:

Fructus Choerospondiatis 120-400 weight portion, Radix Salviae Miltiorrhizae 180-500 weight portion, Fructus Mori 120-400 weight portion, Flos Carthami 20-70 weight Part, Fructus Crataegi 120-400 weight portion；

Further, its crude drug consists of:

Fructus Choerospondiatis 150-350 weight portion, Radix Salviae Miltiorrhizae 200-400 weight portion, Fructus Mori 150-350 weight portion, Flos Carthami 30-65 weight Part, Fructus Crataegi 150-350 weight portion；

Further, its crude drug consists of:

Fructus Choerospondiatis 180-300 weight portion, Radix Salviae Miltiorrhizae 250-350 weight portion, Fructus Mori 180-300 weight portion, Flos Carthami 40-55 weight Part, Fructus Crataegi 180-300 weight portion；

Further, its crude drug consists of:

Fructus Choerospondiatis 200 weight portion, Radix Salviae Miltiorrhizae 300 weight portion, Fructus Mori 200 weight portion, Flos Carthami 50 weight portion, Fructus Crataegi 200 weight portion；

Or, Fructus Choerospondiatis 180 weight portion, Radix Salviae Miltiorrhizae 350 weight portion, Fructus Mori 180 weight portion, Flos Carthami 55 weight portion, Fructus Crataegi 180 weight Part；

Or, Fructus Choerospondiatis 300 weight portion, Radix Salviae Miltiorrhizae 250 weight portion, Fructus Mori 300 weight portion, Flos Carthami 40 weight portion, Fructus Crataegi 300 weight Part.

Chinese medicine composition of the present invention can be prepared as follows:

Take five tastes crude drug in proportion, the organic solvent extraction dissolve each other with water or with aqueous phase；

Further, the described organic solvent dissolving each other with aqueous phase is selected from one or more of methanol, ethanol, acetone；More The more preferably ethanol of 30-80%；It is still more preferably the ethanol of 40-60%；It is still more preferably 50% ethanol；

Extracting method used includes decocting in extraction, reflux, extract, soak extraction, supersound extraction or seepage pressure effects Plant or several ways.

Pharmaceutical composition of the present invention also can adopt: takes five tastes crude drug in proportion, using decoction and alcohol sedimentation technique preparation；Wherein institute Stating alcohol precipitation concentration is 30-80%；

Further, described alcohol precipitation concentration is 40-60%；Further described alcohol precipitation concentration is 50%.

Also can be purified, refined after in above-mentioned preparation method, crude drug is extracted, such as cross macroporous resin column；And press further Conventional preparation process makes the acceptable any conventional formulation of pharmaceuticss, including granule, tablet, capsule, drop pill, oral liquid, Suspension, emulsion, injection.

For making above-mentioned dosage form be capable of, pharmaceutically acceptable adjuvant need to be added when preparing these dosage forms, for example: filling Agent, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctivess, preservative, substrate etc..Filler includes: starch, pre- Gelling starch, Lactose, Mannitol, chitin, Microcrystalline Cellulose, sucrose etc.；Disintegrating agent includes: starch, Pregelatinized Starch, crystallite Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.； Lubricant includes: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.；Suspending agent includes: polyvinylpyrrolidine Ketone, Microcrystalline Cellulose, sucrose, agar, hydroxypropyl methyl cellulose etc.；Binding agent includes: starch slurry, Polyvinylpyrrolidone, Hydroxypropyl methyl cellulose etc.；Sweeting agent includes: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.；Correctivess bag Include: sweeting agent and various essence；Preservative includes: parabenses, benzoic acid, sodium benzoate, sorbic acid and its esters, benzene prick bromine Ammonium, acetic acid chloroethene are fixed, eucalyptus oil etc.；Substrate includes: peg6000, peg4000, insect wax etc..In so that above-mentioned dosage form is capable of Medicine pharmaceuticss, need to add pharmaceutically acceptable other adjuvant (Fan Biting " pharmacy of Chinese materia medica ", Shanghai section when preparing these dosage forms Learn the adjuvant that in publishing house's December in 1997 the 1st edition, each dosage form is recorded).

In addition to Chinese medicine composition of the present invention is in the form of fed intake with Fructus Choerospondiatis, Radix Salviae Miltiorrhizae, Fructus Mori, Flos Carthami, Fructus Crataegi crude drug, Can also be in the form of being fed intake with Fructus Choerospondiatis, Radix Salviae Miltiorrhizae, Fructus Mori, Flos Carthami and Fructus Crataegi extract (effective site), therefore the present invention enters One step disclose a kind of have promoting flow of QI and blood effect Chinese medicine composition:

A kind of Chinese medicine composition with promoting flow of QI and blood effect, the raw material of this Chinese medicine composition consists of:

Fructus Choerospondiatis extract 50-500 weight portion, Radix Salviae Miltiorrhizae extract 100-700 weight portion, Fructus Mori extract 50-500 weight Part, Flos Carthami extract 10-100 weight portion, Fructus Crataegi extract 50-500 weight portion；

Further, its crude drug consists of:

Fructus Choerospondiatis extract 100-450 weight portion, Radix Salviae Miltiorrhizae extract 150-600 weight portion, Fructus Mori extract 100-450 weight Part, Flos Carthami extract 15-80 weight portion, Fructus Crataegi extract 100-450 weight portion；

Further, its crude drug consists of:

Fructus Choerospondiatis extract 120-400 weight portion, Radix Salviae Miltiorrhizae extract 180-500 weight portion, Fructus Mori extract 120-400 weight Part, Flos Carthami extract 20-70 weight portion, Fructus Crataegi extract 120-400 weight portion；

Further, its crude drug consists of:

Fructus Choerospondiatis extract 150-350 weight portion, Radix Salviae Miltiorrhizae extract 200-400 weight portion, Fructus Mori extract 150-350 weight Part, Flos Carthami extract 30-65 weight portion, Fructus Crataegi extract 150-350 weight portion；

Further, its crude drug consists of:

Fructus Choerospondiatis extract 180-300 weight portion, Radix Salviae Miltiorrhizae extract 250-350 weight portion, Fructus Mori extract 180-300 weight Part, Flos Carthami extract 40-55 weight portion, Fructus Crataegi extract 180-300 weight portion；

Further, its crude drug consists of:

Fructus Choerospondiatis extract 200 weight portion, Radix Salviae Miltiorrhizae extract 300 weight portion, Fructus Mori extract 200 weight portion, Flos Carthami extract Thing 50 weight portion, Fructus Crataegi extract 200 weight portion；

Or, Fructus Choerospondiatis extract 180 weight portion, Radix Salviae Miltiorrhizae extract 350 weight portion, Fructus Mori extract 180 weight portion, Flos Carthami carry Take thing 55 weight portion, Fructus Crataegi extract 180 weight portion；

Or, Fructus Choerospondiatis extract 300 weight portion, Radix Salviae Miltiorrhizae extract 250 weight portion, Fructus Mori extract 300 weight portion, Flos Carthami carry Take thing 40 weight portion, Fructus Crataegi extract 300 weight portion.

Fructus Choerospondiatis extract of the present invention, Radix Salviae Miltiorrhizae extract, Fructus Mori extract, Flos Carthami extract, Fructus Crataegi extract are respectively For Fructus Choerospondiatis, Radix Salviae Miltiorrhizae, Fructus Mori, Flos Carthami, the water extract of Fructus Crataegi or the extractive with organic solvent dissolving each other with aqueous phase；Or, being respectively wide The extract that Fructus Jujubae, Radix Salviae Miltiorrhizae, Fructus Mori, Flos Carthami, Fructus Crataegi obtain after water extract-alcohol precipitation process.

Further, any one in methanol, ethanol, acetone of the described organic solvent dissolving each other with aqueous phase；Enter one Step is preferably the ethanol that concentration is 30%-80%；It is the ethanol of 40%-60% still more preferably for concentration；

Extracting method used can be decocted in extraction, reflux, extract, soak extraction, supersound extraction or seepage pressure effects Any one mode, or the combination of Different Extraction Method.

Further, described alcohol precipitation concentration is 30-80%；More preferably alcohol precipitation concentration 40-60%；Still more preferably Alcohol precipitation concentration is 50%.

Decoction and alcohol sedimentation technique of the present invention means in Chinese medicine water extracting liquid, adds ethanol to make to reach the alcohol content of regulation (i.e. alcohol precipitation concentration), some compositions dissolubility in alcoholic solution reduces precipitation precipitation, filtration, takes ethanol solution, reclaims ethanol and obtains Extract, makes Aqueous extracts be able to refined method.

Clinical research shows, the clinical obvious effective rate of traditional Chinese medicine composition for treating angina pectoris of the present invention is 35.43%, always Effective percentage is 73.84%；26.36% and 65.45% is respectively to electrocardiogram Evaluation of Synthetic Effect of Holistic result obvious effective rate and total effective rate； Therapeutic evaluation result obvious effective rate to the pained symptom of angina pectoriss is 67.55%, and total effective rate is 75.50%；Nitrate esters are disabled Rate is 27.80%, and always stopping lapse rate is 63.41%.Chinese medicine composition therefore of the present invention to treatment the thoracic obstruction (angina pectoris) and its Syndrome of qi stagnation and blood stasis all has relatively stable clinical efficacy, can improve uncomfortable in chest, the cardiopalmus symptom of patient and angina pectoris are suffered from Person's electrocardiogram, blood fat have different degrees of improvement effect, and can effectively reduce the dependence to nitrate esters medicine for the patient.

Experimental example 1

1. clinical data

This is tested as multi-center clinical trial, by Hunan Inst of Traditional Chinese Medicine Affiliated Hospital, Hospital No.1 of Traditional Chinese Medicine, Affiliated Hospital of Hunan University of Traditional Chinese Medicine second, Zhuzhou City Hospital of Traditional Chinese Medicine complete jointly.Include case 406 altogether.Treatment group enters group 304 Example, completes 302, comes off 2, and matched group enters group 102, completes 100, comes off 2.Two groups of experimenter (treatment group and right According to group) before treatment in main demographic data such as age, sex, nationality, height, body weight, case source and state of an illness data as sick The aspect group differences all not statistically significant (p ＞ 0.05) such as journey, disease, syndrome and state of an illness indexing, two groups of experimenter's distributing equilibriums, There is preferable comparability.

2. diagnostic criteria

Adopt based on disease, the mode that disease, card combine, selection of clinical Western medicine diagnose is angina pectoris, tcm diagnosis For the qi stagnation and blood stasis type thoracic obstruction experimenter as the object of observation.

2.1 tcm diagnosis and CM syndrome differentiation criterion: with reference to " new Chinese medicine guideline of clinical investigations new Chinese medicine treats coronary disease The anginal guideline of clinical investigations of disease " (trying) and related content formulation.

2.1.1 thoracic obstruction tcm diagnosis standard: 1. suffocating pain over the chest, or even chest pain radiating to the back；2. the lighter only feels disadvantage gas uncomfortable in chest, breathing Not smooth；3. Electrocardioscopy has ischemic change or exercise test positive.

2.1.2 syndrome of qi stagnation and blood stasis CM syndrome differentiation criterion:

Primary symptom: chest pain；

Secondary disease: uncomfortable in chest, fullness and distention in the chest and hypochondrium, cardiopalmus, words are purple dark, hesitant pulse.

Above primary symptom, and referring to secondary disease 1 and/or more than, in conjunction with tongue arteries and veins can dialectical for syndrome of qi stagnation and blood stasis.

2.2 Western medicine diagnostic criterias: with reference to International Society of Cardiology and association and World Health Organization's clinical name standardization Joint special topic group report " name of ischemic heart desease and diagnostic criteria " related content is worked out.

Stable type angina pectoris: it is characterized in that being induced by motion or other situations of increasing myocardial oxygen consumption Show effect in a short time, after rest or sublingual administration nitroglycerin, pain often can rapidly disappear.The course of disease was stablized more than 1 month.

2.3 severity Scaling standards: with reference to Angina Pectoris from Coronary Artery Disease with Therapy of Combination of TCM with Western Medicines in 1979 and arrhythmia forum " angina pectoris and ECG curative effect evaluation criteria " is formulated.

Slight: there are more typically angina pectoris attacks, each last for several minutes, at least show effect 2-3 time weekly, or the 1- that shows effect daily 3 times, but pain does not weigh, and sometimes needs to take nitroglycerin.

Moderate: there are repeatedly more typically angina pectoris attacks, each persistent period several minutes to 10 minutes daily, pain is heavier, Generally require buccal nitroglycerin.

Severe: there is classical angina outbreak for several times daily, thus impact activities of daily living (for example defecate, wear the clothes), The outbreak persistent period is longer every time, needs multiple buccal nitroglycerin.

Meet the above-mentioned traditional Chinese medical science thoracic obstruction, syndrome of qi stagnation and blood stasis, doctor trained in Western medicine coronary heart disease stable type angina pectoris diagnostic criteria is (if simultaneous Have other illnesss it is necessary to above-mentioned disease be medical reason and first diagnosis), and angina pectoriss show effect weekly 1 time and more than, every time The outbreak persistent period includes this experiment 3 minutes and above case.

3 therapeutic schemes

3.1 medicine

By reagent: oral liquid (by the preparation of embodiment 1 method) of the present invention.

Comparison medicine: TONGMAI KOUFUYE.Produced by Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd., specification: 10ml/ props up；Mouthful Clothes, a 10ml, 3 times a day.

3.2 Therapeutic Method

Treatment group: oral liquid of the present invention, a 10ml, 3 times a day, it is administered orally.

Matched group: TONGMAI KOUFUYE, a 10ml, 3 times a day, it is administered orally.

Two groups all with 4 weeks for 1 course for the treatment of.

4 observation index and efficacy determination

4.1 health giving qualities are observed

4.1.1 the thoracic obstruction (angina pectoris) curative effect observation index: with reference to " in new Chinese medicine guideline of clinical investigations The guideline of clinical investigations of medicine Drugs in Therapy angina pectoris " dependent observation index selects to formulate in (trying).

1. angina pectoriss related symptoms sign (see Table 1): attack times, degree, persistent period, characteristic of pain, nitrate esters Dose etc..

Table 1 angina pectoriss related symptoms sign

2. angina pectoris and its syndrome of qi stagnation and blood stasis correlation disease levy and Chinese medicine tongue arteries and veins change, classification score standard be shown in Table 2.

Table 2 angina pectoris and its syndrome of qi stagnation and blood stasis correlation disease levy classification and score standard

3. Electrocardioscopy.

4. lipid examination.

Before above main related symptoms are treated with sign, start medication latter 1 week, start medication latter 2 weeks, start medication latter 3 weeks And each observed and recorded is once (to start medication latter 4 weeks) after treating.

4.2 Effect Evaluation indexs

4.2.1 leading indicator:

1. tcm syndrome curative effect

2. Angina

3. cardinal symptom curative effect

4. ECG curative effect

5. nitrate esters subtract the rate of stopping

4.2.2 other indexs:

1. TCM symptom score

2. before and after related symptoms treatment, changed in stages, disease mitigate and Disappearance Scenarios

3. change before and after lipid therapy

4.3 Effect Evaluation methods

4.3.1 leading indicator therapeutic evaluation: two groups of curative effects are compared, and compare two groups of total effective rate and always effective Rate.

4.3.2 secondary index therapeutic evaluation:

1. TCM syndrome integration: symptom integral mean ± standard deviation and mean are described, and when different to each group Between and integration dynamic change be described.

2. related symptoms: the situation of change to constituting ratio in related symptoms analysis group and before and after treating between group: different before convection potential Chang Zheyong mean ± standard deviation and mean are described, and each group different time and integration dynamic change are described.

3. blood fat: mean ± standard deviation and mean are described, and to group in and group between situation of change be compared.

4.4 Effect Evaluation standards

Angina pectoris related diseases, card curative effect determinate standard: with reference to " new Chinese medicine guideline of clinical investigations Chinese medicine The guideline of clinical investigations of Drugs in Therapy angina pectoris " curative effect determinate standard is worked out in (trying).

4.4.1 tcm syndrome curative effect determinate standard: curative effect percent=[before (integrating after integration-treatment before treatment)/treatment Integration] × 100%.

Effective: clinical symptoms, sign are obviously improved, syndrome integral reduces >=70%.

Effective: clinical symptoms, sign all take a favorable turn, syndrome integral reduces >=30%.

Invalid: clinical symptoms, sign are not improved, even increasing, syndrome integral reduces ＜ 30%.

Increase: clinical symptoms, sign all have and increase.

4.4.2 Angina synthetic determination standard:

Effective: the cardinal symptom such as angina pectoriss disappears or reaches effective standard, electrocardiogram recovers to normal ECG or reaches big Cause normal (i.e. electrocardiogram normal range).

Effective: the cardinal symptom such as angina pectoriss mitigates or reach effective standard, electrocardiogram improvement reaches effective standard.

Invalid: the cardinal symptom such as angina pectoriss is not improved before relatively being tested with electrocardiogram.

Increase: the cardinal symptom such as angina pectoriss is increased before relatively being tested with electrocardiogram.

When comprehensive therapeutic effect judges, if the cardinal symptom curative effect such as angina pectoriss is inconsistent with ECG curative effect, should be to treat Imitating relatively low result is comprehensive therapeutic effect.

4.4.3 cardinal symptom curative effect judging standard:

Slight: effective: symptom disappears or basic disappearance.

Effective: panic attacks number of times, degree and duration have obvious mitigation.

Invalid: symptom is basic identical with before treatment.

Increase: panic attacks number of times, degree and duration have increased (or reaching " moderate ", the standard of " severe ").

Moderate: effective: symptom disappears or basic disappearance.

Effective: symptom mitigation is to the standard of " slight ".

Invalid: symptom is basic identical with before treatment.

Increase: panic attacks number of times, degree and duration have increased (or reaching the standard of " severe ").

Severe: effective: symptom substantially disappears or is relieved to the standard of " slight ".

Effective: symptom mitigation is to the standard of " moderate ".

Invalid: symptom is basic identical with before treatment.

Increase: panic attacks number of times, degree and duration have increased.

4.4.4 ECG curative effect evaluation criteria:

Effective: electrocardiogram recovers to " substantially normal " i.e. " normal range " or reaches " normal ECG ".

Effective: the reduction of s-t section, with more than rise 0.05mv after treating, but do not reach normal level, in inversion of mainly leading T ripple shoals (reaching more than 25% person)；Or t ripple is changed into upright from flat, chamber or intraventricular block improver.

Invalid: electrocardiogram is basic identical with before treatment.

Increase: s-t section reduces more than 0.05mv before relatively treating, and is inverted t ripple intensification (reaching more than 25%) mainly leading, or Upright t ripple becomes flat, and flat t ripple becomes to be inverted, and ectopic cardiac rhythm, atrioventricular block or intraventricular block.

4.4.5 nitrate esters subtract the rate of stopping: work out with reference to national " Angina evaluation criteria ".

Disable: after treatment, disable nitrate esters completely.

Reduce: after treatment, nitrate esters consumption reduces more than 50%.

Constant: after treatment, nitrate esters consumption no changes.

Dosage: after treatment, nitrate esters consumption increases.

5 statistical analysiss

5.1 statistical analysis technique

1. metering type index: using mean ± standard deviation, the confidence interval of mean, maximum, minima, median to inspection Measured value carries out statistics description, and between group and before and after treatment and in front and back difference is more conform with normality and homogeneity of variance employing t inspection Test, do not meet homogeneity of variance person using correction t inspection；Person adopts median to detect not to meet normality.Analysis baseline and center Covariance analysis is adopted during effect.

2. attribute index: ordered categorization data adopts order to close inspection, and unordered group data adopts Chi-square statistic.In investigation Cmh is adopted to detect during the impact of heart effect.

The meaning judgement of 5.2 statistical analysiss and the format design of statistical table:

1. statistical analysiss meaning judge: all using two-sided test, p value will be considered to be examined less than or equal to 0.05 The difference tested has statistical significance.Hereinafter owning (p) is parametric test, and (n) is non parametric testss.

2. the format design of statistical table: statistical table is used uniformly across three line tables.Table content specifically includes that title, group Not, detection project, number of cases, statistical parameter (mean, standard deviation, maximum, minima, median, or composition ratio, percentage rate), Statistic (t value, x2 value, z value etc.), statistical result (p value).

6 results

6.1 curative effect of disease evaluations

The results are shown in Table 3-9.

Table 3 oral liquid of the present invention is to angina pectoris curative effect of disease overall merit (example, %)

Table 4 oral liquid of the present invention is to angina pectoris chest pain symptom curative effect overall merit (example, %)

Table 5 oral liquid clinical trial ECG curative effect overall merit (example, %) of the present invention

Table 6 oral liquid clinical trial nitrate esters of the present invention subtract and stop rate curative effect overall merit (example, %)

Change before and after the treatment of table 7 oral liquid experimenter's integration of illness of the present invention

The main disease of table 8 oral liquid clinical trial experimenter of the present invention is classified before and after levying treatment

Change before and after table 9 oral liquid clinical trial lipid therapy of the present invention

From above analysis result, the obvious effective rate of oral liquid treatment angina pectoris of the present invention is 35.43%, always has Efficiency is 73.84%, and matched group is respectively 39%, 74%；Angina pectoris chest pain symptom is improved with obvious effective rate is 67.55%, always Effective percentage is 75.50%, and matched group is respectively 61%, 74%；The obvious effective rate that electrocardiogram is improved with curative effect is 26.36%, total effective rate For 65.45%, matched group is respectively 23.61%, 68.06%；Discontinuation rate to Patients With Angina Pectoris nitrate esters medicine is 27.80%, Always stopping lapse rate is 63.41%, and matched group is respectively 26.58%, 64.56%.Oral liquid of the present invention is all no united with matched group comparing difference Meaning (p ＞ 0.05) learned by meter.

After treatment, the disease integration of two groups of cases is all decreased significantly with comparing before treatment, but between the group of integration, comparing difference is equal Not statistically significant (p ＞ 0.05).Two groups all can be improved blood fat, can effectively reduce serum total cholesterol and triglyceride, treatment Difference statistically significant (p ＜ 0.05) in front and back

6.2 therapeutic effect of syndrome evaluations

The results are shown in Table 10-12.

Table 10 oral liquid clinical trial tcm syndrome curative effect overall merit (example, %) of the present invention

Table 11 oral liquid clinical trial experimenter's syndrome of qi stagnation and blood stasis of the present invention integrates

The main disease of table 12 oral liquid clinical trial experimenter of the present invention is classified before and after levying treatment

From above analysis result, the obvious effective rate of oral liquid treatment angina pectoris syndrome of qi stagnation and blood stasis of the present invention is 49.01%, total effective rate is 86.75%, and matched group is respectively 42%, 73%.Oral liquid group of the present invention and matched group comparing difference have Statistical significance (p ＜ 0.05).After treatment, the syndrome integral of two groups of cases is all decreased significantly with comparing before treatment, between the group of integration Comparing difference statistically significant (p ＜ 0.05).

Specific embodiment

Embodiment 1 oral liquid

Prescription crude drug forms: Fructus Choerospondiatis 200g, Radix Salviae Miltiorrhizae 300g, Fructus Mori 200g, Flos Carthami 50g, Fructus Crataegi 200g；

Take the crude drug of recipe quantity, add water to cook 2 times, 2 hours for the first time, second 1.5 hours, collecting decoction, filtration, Filtrate is concentrated into relative density and is 1.10-1.12(50 DEG C), plus ethanol, to alcohol content to 50%, stands, filtration, filtrate reclaims second Alcohol is to no alcohol taste, and is concentrated into relative density for 1.15-1.20(60 DEG C), add Mel 200g, potassium sorbate 2.5g, filter, Adjust ph to 3.5-5.5, make about 1000ml, fill, sterilizing, obtain final product oral liquid.

Specification: every dress 10ml.

Usage and consumption: oral a, 10ml, 3 times a day.

Embodiment 2 tablet

Prescription crude drug forms: Fructus Choerospondiatis 180g, Radix Salviae Miltiorrhizae 450g, Fructus Mori 180g, Flos Carthami 60g, Fructus Crataegi 180g；

Take the crude drug of recipe quantity, plus 5 times amount, 60% alcohol reflux 2 times, 1.5 hours every time；United extraction liquid, filter Cross, reclaim ethanol and be concentrated into relative density for 1.15-1.20(60 DEG C)；Drying under reduced pressure, is ground into fine powder, adds conventional auxiliary Material, mixes；Dry-pressing is pelletized, and tabletting obtains final product.

Embodiment 3 capsule

Prescription crude drug forms: Fructus Choerospondiatis 300g, Radix Salviae Miltiorrhizae 250g, Fructus Mori 300g, Flos Carthami 40g, Fructus Crataegi 300g；Take recipe quantity Crude drug, plus 10 times amount methanol supersound extraction 3 times, first time 40min, the 2nd, 3 each 20min, united extraction liquid, filtration, subtract Pressure be concentrated into relative density be 1.15-1.20(60 DEG C) thick paste；Take thick paste drying under reduced pressure, be ground into fine powder, add conventional auxiliary Material, mixes；Dry-pressing is pelletized, and loads capsule, obtains final product.

Embodiment 4 granule

Prescription crude drug forms: Fructus Choerospondiatis 150g, Radix Salviae Miltiorrhizae 400g, Fructus Mori 150g, Flos Carthami 70g, Fructus Crataegi 150g；Take recipe quantity Crude drug, soaks 30min, adds 8 times amount decoctings to boil three times, 1.5 hours every time, filters, merging filtrate, be concentrated into relatively Density is 1.10-1.12(50 DEG C)；By macroporous resin, first with 5 times amount water elutions, eluent is abandoned or adopted, then is washed with adding 50% ethanol De-, collect eluent, decompression recycling ethanol is to no alcohol taste；Less than 80 DEG C drying under reduced pressure, are ground into fine powder, add adjuvant, mix； Dry-pressing is pelletized, and obtains final product.

Embodiment 5 oral liquid

Prescription crude drug forms: Fructus Choerospondiatis 300g, Radix Salviae Miltiorrhizae 200g, Fructus Mori 350g, Flos Carthami 30g, Fructus Crataegi 250g；

Take recipe quantity crude drug, add water to cook 2 times, 1.5 hours every time, collecting decoction, filtration, filtrate is concentrated into relatively close Spend for 1.10-1.12(50 DEG C), plus ethanol, to alcohol content to 70%, stands, filtration, filtrate recycling ethanol is to no alcohol taste, and concentrates It is 1.15-1.20(60 DEG C to relative density), add adjuvant, make oral liquid.

Embodiment 6 drop pill

Prescription crude drug forms: Fructus Choerospondiatis 180g, Radix Salviae Miltiorrhizae 400g, Fructus Mori 100g, Flos Carthami 80g, Fructus Crataegi 200g；

Take the crude drug of recipe quantity, add 8 times amount water retting 6h, percolation 24h, flow velocity 2l/h.Collect percolate, be centrifuged, Upper macroporous adsorptive resins, first wash with water, then use 40% ethanol elution, collect ethanol elution, and filtrate concentrates, and adds system On medicine, acceptable adjuvant makes drop pill according to the routine techniquess of this area preparation.

Embodiment 7

Prescription crude drug forms: Fructus Choerospondiatis extract 200g, Radix Salviae Miltiorrhizae extract 300g, Fructus Mori extract 200g, Flos Carthami extract Thing 50g, Fructus Crataegi extract 200g；

Described Fructus Choerospondiatis extract, Radix Salviae Miltiorrhizae extract, Fructus Mori extract, Flos Carthami extract, Fructus Crataegi extract be respectively Fructus Choerospondiatis, The extract that Radix Salviae Miltiorrhizae, Fructus Mori, Flos Carthami, Fructus Crataegi prepare through 60% alcohol reflux.Said extracted thing is pulverized as fine powder, Mix, add customary adjuvant to make granule.

Embodiment 8

Prescription raw material forms: Fructus Choerospondiatis extract 180g, Radix Salviae Miltiorrhizae extract 400g, Fructus Mori extract 350g, Flos Carthami extract 60g, Fructus Crataegi extract 100g；

Described Fructus Choerospondiatis extract, Radix Salviae Miltiorrhizae extract, Fructus Mori extract, Flos Carthami extract, Fructus Crataegi extract be respectively Fructus Choerospondiatis, Radix Salviae Miltiorrhizae, Fructus Mori, Flos Carthami, Fructus Crataegi boil the extract preparing through decocting.Said extracted thing is pulverized as fine powder, mixing, addition Customary adjuvant makes tablet.

Embodiment 9

Prescription raw material forms: Fructus Choerospondiatis extract 180g, Radix Salviae Miltiorrhizae extract 450g, Fructus Mori extract 180g, Flos Carthami extract 60g, Fructus Crataegi extract 180g；

Described Fructus Choerospondiatis extract, Radix Salviae Miltiorrhizae extract, Fructus Mori extract, Flos Carthami extract, Fructus Crataegi extract be respectively Fructus Choerospondiatis, Radix Salviae Miltiorrhizae, Fructus Mori, Flos Carthami, Fructus Crataegi extract, through acetone reflux, the extract preparing.Said extracted thing is pulverized as fine powder, mixes Even, add customary adjuvant to make capsule.

Claims (8)

1. a kind of Chinese medicine composition with promoting flow of QI and blood effect is it is characterised in that the crude drug of this Chinese medicine composition consists of:

Fructus Choerospondiatis 180-300 weight portion, Radix Salviae Miltiorrhizae 250-350 weight portion, Fructus Mori 180-300 weight portion, Flos Carthami 40-55 weight portion, mountain Short, bristly hair or beard 180-300 weight portion.

2. Chinese medicine composition as claimed in claim 1 is it is characterised in that the crude drug of this Chinese medicine composition consists of:

Fructus Choerospondiatis 200 weight portion, Radix Salviae Miltiorrhizae 300 weight portion, Fructus Mori 200 weight portion, Flos Carthami 50 weight portion, Fructus Crataegi 200 weight portion；

Or, Fructus Choerospondiatis 180 weight portion, Radix Salviae Miltiorrhizae 350 weight portion, Fructus Mori 180 weight portion, Flos Carthami 55 weight portion, Fructus Crataegi 180 weight portion；

Or, Fructus Choerospondiatis 300 weight portion, Radix Salviae Miltiorrhizae 250 weight portion, Fructus Mori 300 weight portion, Flos Carthami 40 weight portion, Fructus Crataegi 300 weight portion.

3. a kind of Chinese medicine composition with promoting flow of QI and blood effect, the raw material of this Chinese medicine composition consists of:

Fructus Choerospondiatis extract 200 weight portion, Radix Salviae Miltiorrhizae extract 300 weight portion, Fructus Mori extract 200 weight portion, Flos Carthami extract 50 Weight portion, Fructus Crataegi extract 200 weight portion；

Or, Fructus Choerospondiatis extract 180 weight portion, Radix Salviae Miltiorrhizae extract 350 weight portion, Fructus Mori extract 180 weight portion, Flos Carthami extract 55 weight portions, Fructus Crataegi extract 180 weight portion；

Or, Fructus Choerospondiatis extract 300 weight portion, Radix Salviae Miltiorrhizae extract 250 weight portion, Fructus Mori extract 300 weight portion, Flos Carthami extract 40 weight portions, Fructus Crataegi extract 300 weight portion.

4. the preparation method of Chinese medicine composition as claimed in claim 1 or 2 is it is characterised in that the method includes:

Take five tastes crude drug in proportion, the organic solvent extraction dissolve each other with water or with aqueous phase；

Or, taking five tastes crude drug in proportion, using decoction and alcohol sedimentation technique preparation；During wherein said precipitate with ethanol, the concentration of alcohol is 30- 80%.

5. preparation method as claimed in claim 4 is it is characterised in that the described organic solvent dissolving each other with aqueous phase is selected from methanol, second One or more of alcohol, acetone；Extracting method used include decoct extraction, reflux, extract, soak extraction, supersound extraction or One or more of seepage pressure effects mode.

6. preparation method as claimed in claim 4 is it is characterised in that described alcohol precipitation concentration is 40-60%.

7. application in preparation treatment medicaments for coronary disease for the described Chinese medicine composition as arbitrary in claims 1 to 3.

8. described Chinese medicine composition as arbitrary in claims 1 to 3 is preparing the application in blood lipid-lowering medicine.