CN101342314A - Traditional Chinese medicine for treating cardiovascular disease, preparation method and uses thereof - Google Patents
Traditional Chinese medicine for treating cardiovascular disease, preparation method and uses thereof Download PDFInfo
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Abstract
The present invention relates to the field of natural medicine, in particular to a Chinese herbal compound medicine which is used for treating cardiovascular disease and particularly coronary heart disease. The compound medicine is characterized by comprising the ingredients of the following weight portions: 20 to 50 portions of rhizoma polygonati, 6 to 20 portions of angelica, 5 to 20 portions of leaf of fructus trichosanthis, 2 to 12 portions of notoginseng, and 3 to 15 portions of rhizoma nardostachyos. The present invention also discloses a preparation method of the compound medicine and medical purposes thereof.
Description
Technical field
The present invention relates to natural medicine field, be specifically related to a kind of particularly traditional Chinese compound medicine of coronary heart disease of cardiovascular disease for the treatment of, the invention also discloses its preparation method and medical application.
Background technology
Along with improving constantly of rapid development of national economy and living standards of the people, cardiovascular disease has become the harm world and one of China's national health and lethal principal disease, and its sickness rate is the trend that rises year by year, and wherein coronary heart disease is more remarkable.Therefore how to prevent and treat coronary heart disease effectively and become an interior important scientific research task of world today's scope.The western medical treatment method of coronary heart disease is more, comprise medicine, intervention and operation etc., though its indication is respectively arranged, but there are toxic and side effects, untoward reaction, wound treatment is arranged, cost an arm and a leg and non-etiological treatment or the like reason, up to the present, still seeking new breakthrough, particularly aspect the medicine of Primary Care.The traditional Chinese medical science belongs to thoracic obstruction category with coronary heart disease, clinical with Danzhong or left chest feel oppressed, pain is main performance; The cause of disease is main relevant with factors such as worn with age, internal injury caused by excess of seven emotions, rich and fatty diet, exopathogen invasion and attack, work and rest mistake degree, internal organs pathological changes; Sick position is at the heart, and is relevant with liver,spleen,kidney three dirty functional disorders again; Pathology character is deficiency in origin and excess in superficiality, and deficiency in origin then is a heart spleen caused by liver and kidney deficiency, functional disorder, and mark is blood stasis, stagnation of phlegm, the stagnation of QI, cold coagulation actually, stagnated chest-YANG, stagnating heart meridian; Basic pathogenesis is the yin and yang qi and blood disorder of the heart, and blockage of the cardiac vessels is not smooth; In the generation evolution of disease, the empty earlier real person in back is arranged, also have because of real to cause empty person, but mostly clinical manifestation is simulataneous insufficiency and excessive, or based on excess syndrome, or based on deficiency syndrome.Chinese medicine has accumulated rich practice experience and has obtained certain curative effect the diagnosis and treatment of coronary heart disease, but still needs further to strengthen research, particularly aspect new drug development.
Summary of the invention
The invention discloses a kind of traditional Chinese compound medicine for the treatment of cardiovascular disease, it is made by Rhizoma Polygonati, Radix Angelicae Sinensis, Pericarpium Trichosanthis, Radix Notoginseng and five kinds of Chinese crude drugs of Radix Et Rhizoma Nardostachyos.
Traditional Chinese compound medicine of the present invention is through clinical verification for many years, to cardiovascular disease particularly coronary heart disease certain curative effect is arranged, can obviously improve the performance of clinical symptoms and ischemic electrocardiogram, and, have no adverse reaction in clinical practice safety; In addition, lipid metabolism, blood viscosity lowering and the antiplatelet aggregation effect of adjusting still arranged.
The general ratio compatibility routinely of the consumption of Rhizoma Polygonati and other drug in the routine clinical prescription.The inventor discovers that in Chinese medicine of the five flavours material of the present invention was formed, it is good especially that the consumption of Rhizoma Polygonati accounts for compound medicine gross weight 20~50% o'clock drug effect, and promptly other a few flavor Chinese crude drug consumptions of the amount ratio of Rhizoma Polygonati want big, and proportion compatibility is:
3~15 parts of 20~50 parts of Rhizoma Polygonatis, 6~20 parts of Radix Angelicae Sinensis, 5~20 parts of Pericarpium Trichosanthiss, 2~12 parts of Radix Notoginseng and Radix Et Rhizoma Nardostachyos.
Preferred weight ratio is: 9~15 parts of 25~40 parts of Rhizoma Polygonatis, 9~15 parts of Radix Angelicae Sinensis, 9~15 parts of Pericarpium Trichosanthiss, 3~6 parts of Radix Notoginseng and Radix Et Rhizoma Nardostachyos.
Traditional Chinese compound medicine preparation method of the present invention is simple, can take after can directly will the Chinese medicine of the five flavours material decocting by traditional method, and in order to obtain better efficacy and to be more conducive to be prepared into the modern medicines dosage form, more preferably preparation method is as follows for the above-mentioned prescription of the present invention:
1, after Radix Et Rhizoma Nardostachyos and Radix Angelicae Sinensis mix, use vapor distillation, collect volatilization liquid, medicinal residues are standby;
2, the Rhizoma Polygonati water decocts, and filters, and filtrate concentrates, and medicinal residues are standby;
3, will the medicinal residues in above-mentioned 1,2 steps with the side in other medicines merge the back alcohol dipping, reflux, extract, again, backflow concentrating under reduced pressure;
4, concentrate in 2,3 steps and the volatilization liquid in 1 step are merged, promptly.
Be preferably 6~15 times of medical material weight with the amount of vapor distillation time institute water in the above-mentioned preparation method.
Above-mentioned concentration of ethanol is preferred 50%~70%, is weight percentage.
Can obtain the medicine of liquid by above-mentioned preparation method,, then can add pharmaceutic adjuvant mixing back refabrication and become solid dosage formss such as tablet, capsule, micropill if be prepared into solid preparation.For fear of the instability of volatile ingredient, this method with volatile oil (in preparation preparation process, the liquid second distillation that will volatilize, volatile oil, the reuse dissolve with ethanol) earlier and behind the beta-cyclodextrin inclusion compound, the concentrate with extract merges again.
Traditional Chinese compound medicine of the present invention is by Chinese crude drug crude drug weight, and clinical using dosage can be 20~30g/ days, also can depart from this dosage range according to the difference of the pharmaceutical dosage form of disease severity or preparation.
Below be traditional Chinese compound medicine part clinical trial situation of the present invention:
(1) test method
1, grouping
The prescription of test group 1 is: 30 parts of Rhizoma Polygonatis, 10 parts of Radix Angelicae Sinensis, 12 parts of Pericarpium Trichosanthiss, 10 parts of 5 parts of Radix Notoginseng and Radix Et Rhizoma Nardostachyos.
The prescription of test group 2 is: 25 parts of Rhizoma Polygonatis, 9 parts of Radix Angelicae Sinensis, 10 parts of Pericarpium Trichosanthiss, 9 parts of 3 parts of Radix Notoginseng and Radix Et Rhizoma Nardostachyos.
The prescription of test group 3 is: 10 parts of Rhizoma Polygonatis, 12 parts of Radix Angelicae Sinensis, 15 parts of Pericarpium Trichosanthiss, 9 parts of 3 parts of Radix Notoginseng and Radix Et Rhizoma Nardostachyos.
Used dosage is counted 18g/ day by Chinese crude drug crude drug weight, makes tablet, and 4 slices/time, 3 times/day.
Matched group is selected XINKESHU PIAN (Baoding herbal pharmaceutical responsibility company limited) for use: 4 slices/time, and 3 times/day.
Above-mentioned each group was 1 course of treatment with 4 weeks of taking medicine all, observed for 1 course of treatment.
Illustrate: in secular clinical treatment, the inventor attempted the different proportioning of this Chinese medicine of the five flavours material, after a large amount of statistical datas is just determined the only ratio range of Chinese medicine of the five flavours material among the present invention, test group 3 is not within the scope of the present invention one group of data of choosing of inventor just.The preparation method of test group 1~3 is identical, and used dosage is also identical, following clinical statistics data as seen, test group 3 curative effects are obviously not as test group 1 and test group 2.
2, observation index
Safety observation: the general data inspection before and after the treatment, blood, urine, stool routine inspection, the heart, liver, kidney function test.
Health giving quality observation: angina pectoris: the risk factor of angina pectoris attacks, the number of times of the size of physical exertion, degree, pain, degree, persistent period, the consumption of nitroglycerin preparation etc. and related symptoms.Write down weekly 1 time.Relevant sign: comprise heart rate, the rhythm of the heart, blood pressure, pulse, body of the tongue, tongue fur, pulse condition etc.Relevant physico-chemical examination: blood fat, hemorheology, electrocardiogram, exercise test etc.
3, efficacy assessment standard
The main project of efficacy determination is that angina pectoris, electrocardiogram, nitroglycerin stop lapse rate.The standard reference Ministry of Public Health was worked out the curative effect determinate standard in the issue " the new Chinese medicine treatment thoracic obstruction (angina pectoris) clinical research guideline " in 2002.
4, statistical procedures
Statistical method: clinical data and data are imported computer after inspection and verification, and measurement data is with mean ± standard deviation (X ± SD represents), with many prescriptions difference analysis or t check.
(2) result
1, clinical total effects: the clinical efficacy after four groups of treatments is all remarkable, and test group 1 and test group 2 obvious effective rates are better than matched group, and test group 3 is lower than matched group.
The clinical total effects of table 1 relatively
Group | The example number | Produce effects example (%) | Effectively routine (%) | Invalid example (%) | Increase the weight of example (%) | Total effective rate (%) |
Test group 1 | 30 | 10 | 16 | 4 | 0 | 86.67 |
Test group 2 | 28 | 9 | 15 | 4 | 0 | 85.71 |
Test group 3 | 26 | 4 | 12 | 10 | 0 | 61.54 |
Matched group | 26 | 7 | 14 | 5 | 0 | 80.77 |
2, curative effect to treat angina pectoris: the angina pectoris after four groups of treatments all obviously improves, test group 1 and test group 2 angina pectoris total effective rates are respectively 93.33% and 92.86%, and the matched group total effective rate is 84.62%, and test group 3 total effective rates are minimum, be 73.08%, see Table 2.
The anginal curative effect of table 2 relatively
Group | The example number | Produce effects example (%) | Effectively routine (%) | Invalid example (%) | Increase the weight of example (%) | Total effective rate (%) |
Test group 1 | 30 | 16 | 12 | 2 | 0 | 93.33 |
Test group 2 | 28 | 15 | 11 | 2 | 0 | 92.86 |
Test group 3 | 26 | 10 | 9 | 7 | 0 | 73.08 |
Matched group | 26 | 12 | 10 | 4 | 0 | 84.62 |
3, ECG curative effect: four groups of ECG curative effect all have improvement, but it is obviously different to improve effect, and test group 1 and 2 effects are better than test group 3 and matched group, the results are shown in Table 3.
The Electrocardiographic curative effect of table 3 relatively
Group | The example number | Produce effects example (%) | Effectively routine (%) | Invalid example (%) | Increase the weight of example (%) | Total effective rate (%) |
Test group 1 | 30 | 3 | 11 | 16 | 0 | 46.67 |
Test group 2 | 28 | 3 | 10 | 17 | 0 | 46.43 |
Test group 3 | 26 | 1 | 7 | 19 | 0 | 30.77 |
Matched group | 26 | 2 | 7 | 17 | 0 | 34.62 |
4, nitroglycerin subtract the situation of stopping: each use of organizing nitroglycerin all has obviously to subtract and stops, but test group 1 and 2 obviously is better than test group 3 and matched group, sees Table 4.
Table 4 nitroglycerin stops lapse rate relatively
Group | The example number | Produce effects example (%) | Effectively routine (%) | Invalid example (%) | Increase the weight of example (%) | Total effective rate (%) |
Test group 1 | 21 | 11 | 7 | 4 | 0 | 85.71 |
Test group 2 | 20 | 10 | 7 | 3 | 0 | 85.00 |
Test group 3 | 15 | 4 | 6 | 5 | 0 | 66.67 |
Matched group | 17 | 6 | 7 | 4 | 0 | 76.47 |
5, to hemorheological influence: whole blood viscosity, fibronectin, plasma viscosity decline all have significant difference before and after each group treatment, see Table 5.
Hemorheology is learned index and is changed relatively (X ± SD) before and after table 5 treatment
Annotate: self compares before and after the treatment
*P<0.05, self compares before and after the treatment
*P<0.01, treatment back treatment group 1 and 2 and matched group between Δ P<0.05 relatively.
6, to the influence of blood fat: each organizes cholesterol, triglyceride, and notable difference is all arranged before and after the treatment; And the HDL of test group 1 and 2 has obvious rising, and statistical significance is all arranged.Compare with matched group, test group 1 and 2 is aspect TG, HDL, and treatment back test group is better than matched group, and significant difference is arranged, and sees Table 6.
Blood Lipid comparison before and after table 6 treatment (X ± SD)
Annotate: self compares before and after the treatment
*P<0.05, self compares before and after the treatment
*P<0.01, treatment back treatment group 1 and 2 and matched group between Δ P<0.05 relatively.
7, safety indexes: before and after four groups of routine blood tests, routine urinalysis, GPT, BuN, the Cr medication, through X2 check there are no significant difference P>0.05; WBC, Hgb, Cr, GPT, four groups of treatments of BuN anteroposterior diameter t check P all>0.05 no significance difference.
See Table 7.
The change of relevant safety indexes before and after the table 7 liang group treatment (with the directly long-pending rate method of Fisher)
(3) conclusion
Above-mentioned clinical test results shows that test group 3 curative effects obviously not as test group 1 and test group 2, illustrate that the present invention is with 25~30 parts of Rhizoma Polygonatis, 10~12 parts of Radix Angelicae Sinensis, 9~12 parts of Pericarpium Trichosanthiss, 3~6 parts of Radix Notoginseng and 9~15 parts of compatibilities of Radix Et Rhizoma Nardostachyos are good effect not only, and the no side reaction of safety.
The specific embodiment
(multiple that relates among the embodiment all is times of weight)
Embodiment 1
Rhizoma Polygonati 250g, Radix Angelicae Sinensis 60g, Pericarpium Trichosanthis 50g, Radix Notoginseng 20g, Radix Et Rhizoma Nardostachyos 60g.
Preparation method: get Radix Et Rhizoma Nardostachyos, Radix Angelicae Sinensis, add 12 times of amounts of water, vapor distillation extracted volatilization liquid 2 hours, collected the about 200ml of volatilization liquid, and device is deposited in addition; Medicinal residues decoct with water twice with Rhizoma Polygonati, Radix Notoginseng, Pericarpium Trichosanthis, add 10 times of weight of water at every turn, filter, and filtrate is concentrated into 700ml; In concentrated solution, add volatilization liquid, add water to 1000ml, packing, sterilization, packing, promptly.
Embodiment 2
Rhizoma Polygonati 300g, Radix Angelicae Sinensis 100g, Pericarpium Trichosanthis 100g, Radix Notoginseng 50g, Radix Et Rhizoma Nardostachyos 100g.
Preparation method: 1, get Radix Et Rhizoma Nardostachyos, Radix Angelicae Sinensis, add 10 times of amounts of water, vapor distillation extracted volatilization liquid 2 hours, collected volatilization liquid, and device is deposited and cold preservation in addition, and medicinal residues are standby;
2, get Rhizoma Polygonati and add 8 times of amount decoctions twice of water, each 1 hour, merging filtrate, filtrate is concentrated into other device of about 1.20 (the 80 ℃ of surveys) of relative density back and deposits standby; Medicinal residues are standby;
3, the medicinal residues that obtain added 70% alcohol dipping after 2 hours Radix Notoginseng, Pericarpium Trichosanthis and the first two step, reflux, extract, 2 times, and each 1 hour, filter, merge backflow, ethanol is reclaimed in pressurization, and continues to be concentrated into about 1.20 (the 80 ℃ of surveys) of relative density.
4, the thick paste that the second and the 3rd step was obtained merges vacuum drying;
5, the volatilization liquid that obtains in 1 step is carried out second distillation, divide and get volatile oil, use the 50ml ethanol dilution, use the 40g beta-cyclodextrin inclusion compound, cold preservation 24 hours filters, and the filter cake oven drying at low temperature is standby;
6, the dry thing of the 4th step gained is mixed with the Benexate Hydrochloride of 5 step gained, be ground into fine powder, add the dextrin mixing, granulate, drying promptly gets granule.
Embodiment 3
Rhizoma Polygonati 35g, Radix Angelicae Sinensis 10g, Pericarpium Trichosanthis 12g, Radix Notoginseng 5g, Radix Et Rhizoma Nardostachyos 10g.
Preparation method is with embodiment 1.
Embodiment 4
Rhizoma Polygonati 250g, Radix Angelicae Sinensis 100g, Pericarpium Trichosanthis 100g, Radix Notoginseng 30g, Radix Et Rhizoma Nardostachyos 120g.
Preparation method: 1, get Radix Et Rhizoma Nardostachyos, Radix Angelicae Sinensis, add 10 times of amounts of water, vapor distillation extracted volatilization liquid 2 hours, collected volatilization liquid, and device is deposited and cold preservation in addition, and medicinal residues are standby;
2, get Rhizoma Polygonati and add 8 times of amount decoctions twice of water, each 1 hour, merging filtrate, filtrate is concentrated into other device of about 1.20 (the 80 ℃ of surveys) of relative density back and deposits standby; Medicinal residues are standby;
3, the medicinal residues that obtain added 70% alcohol dipping after 2 hours Radix Notoginseng, Pericarpium Trichosanthis and the first two step, reflux, extract, 2 times, and each 1 hour, filter, merge backflow, ethanol is reclaimed in pressurization, and continues to be concentrated into about 1.20 (the 80 ℃ of surveys) of relative density.
4, the thick paste that the second and the 3rd step was obtained merges vacuum drying;
5, the volatilization liquid that 1 step is obtained carries out second distillation, divides and gets volatile oil, uses the 50ml ethanol dilution, uses the 40g beta-cyclodextrin inclusion compound, and cold preservation 24 hours filters, and the filter cake oven drying at low temperature is standby;
6, the dry thing of the 4th step gained is mixed with the Benexate Hydrochloride of 5 step gained, be ground into fine powder, add starch 20g, mixing is granulated, and drying is sieved.
7. in above-mentioned granule, add Pulvis Talci 3g, tabletting.
8. get Ah crust's glycosides 3g, add water 20ml dissolving, put coating in the automatic coating machine, promptly get coated tablet.
Embodiment 5
Rhizoma Polygonati 300g, Radix Angelicae Sinensis 100g, Pericarpium Trichosanthis 120g, Radix Notoginseng 50g, Radix Et Rhizoma Nardostachyos 100g.
Preparation method: 1, get Radix Et Rhizoma Nardostachyos, Radix Angelicae Sinensis, add 10 times of amounts of water, vapor distillation extracted volatilization liquid 2 hours, collected volatilization liquid, and device is deposited and cold preservation in addition, and medicinal residues are standby;
2, get Rhizoma Polygonati and add 8 times of amount decoctions twice of water, each 1 hour, merging filtrate, filtrate is concentrated into other device of about 1.20 (the 80 ℃ of surveys) of relative density back and deposits standby; Medicinal residues are standby;
3, the medicinal residues that obtain added 70% alcohol dipping after 2 hours Radix Notoginseng, Pericarpium Trichosanthis and the first two step, reflux, extract, 2 times, and each 1 hour, filter, merge backflow, ethanol is reclaimed in pressurization, and continues to be concentrated into about 1.20 (the 80 ℃ of surveys) of relative density.
4, the thick paste that the second and the 3rd step was obtained merges vacuum drying;
5, the volatilization liquid that 1 step is obtained carries out second distillation, divides and gets volatile oil, uses the 50ml ethanol dilution, uses the 40g beta-cyclodextrin inclusion compound, and cold preservation 24 hours filters, and the filter cake oven drying at low temperature is standby;
6, the dry thing of the 4th step gained is mixed with the Benexate Hydrochloride of 5 step gained, be ground into fine powder, add 15g starch, mixing is granulated, and is encapsulated, promptly.
Claims (9)
1, a kind of Chinese medicine for the treatment of cardiovascular disease is characterized in that being made by the Chinese crude drug of following weight ratio:
3~15 parts of 20~50 parts of Rhizoma Polygonatis, 6~20 parts of Radix Angelicae Sinensis, 5~20 parts of Pericarpium Trichosanthiss, 2~12 parts of Radix Notoginseng and Radix Et Rhizoma Nardostachyos.
2, the Chinese medicine of claim 1 is characterized in that being made by the Chinese crude drug of following weight ratio:
9~15 parts of 25~40 parts of Rhizoma Polygonatis, 9~15 parts of Radix Angelicae Sinensis, 9~15 parts of Pericarpium Trichosanthiss, 3~6 parts of Radix Notoginseng and Radix Et Rhizoma Nardostachyos.
3, claim 1 or 2 preparation method of Chinese medicine comprise:
A, Radix Et Rhizoma Nardostachyos and Radix Angelicae Sinensis are used vapor distillation after mixing, and collect volatilization liquid, and medicinal residues are standby;
B, Rhizoma Polygonati water decoct, and filter, and filtrate concentrates, and medicinal residues are standby;
C, will the medicinal residues in above-mentioned a, the b step with the side in other medicines merge the back alcohol dipping, reflux, extract, again, backflow concentrating under reduced pressure;
D, the concentrate in concentrate in the c step and the b step and the volatilization liquid in a step are merged, promptly.
4, the preparation method of claim 3, wherein the amount of vapor distillation time institute water is 6~15 times of medical material weight in a step.
5, the preparation method of claim 3, wherein concentration of ethanol is 50%~70% in the c step, is weight percentage.
6, the preparation method of claim 3, wherein in the d step, volatilization liquid through distillation after, divide and get volatile oil, add dissolve with ethanol again, and with behind the cyclodextrin inclusion compound, again with the c step in concentrate merge.
7, the preparation method of claim 3 comprises that also merging thing and pharmaceutic adjuvant that the d step is obtained are mixed and made into various pharmaceutical preparatioies.
8, claim 1 or 2 Chinese medicine are used to prepare the purposes for the treatment of medicaments for coronary disease.
9, claim 1 or 2 Chinese medicine are used to prepare the purposes of the medicine for the treatment of angina pectoris, hyperlipemia or high blood viscosity.
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CN111513155B (en) * | 2020-05-21 | 2022-11-08 | 云南中医药大学 | Composition for preventing and treating lipid metabolism disorder |
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