The invention provides a kind of determined curative effect, safe ready, little, the cheap pure traditional Chinese compound medicine of side effect.
Therefore, the purpose of this invention is to provide a kind of compound Chinese medicinal preparation for the treatment of coronary heart disease;
Another object of the present invention has provided a kind of preparation method for the treatment of the compound Chinese medicinal preparation of coronary heart disease;
Another object of the present invention has provided a kind of purposes that prevents and/or treats coronary heart disease or anginal medicine with the compound Chinese medicinal preparation preparation.
The invention provides a kind of Chinese medicine preparation of new treatment coronary heart disease, said preparation is made by the Chinese medicine of following weight proportion: Radix Astragali 85-342 part Radix Salviae Miltiorrhizae 46-186 part Radix Ginseng 22-90 part Poria 31-124 part Radix Notoginseng 45-180 part Hirudo 46-186 part Flos Carthami 31-124 part Rhizoma Chuanxiong 31-124 part Fructus Crataegi 46-186 part Pollen Typhae 31-124 part Radix Polygoni Multiflori Preparata 31-124 part Radix Puerariae 46-186 part Radix Scutellariae 31-124 part Radix Scrophulariae 31-124 part Radix Glycyrrhizae 45-180 part
Said preparation is preferably made by the Chinese medicine of following weight proportion: Radix Astragali 128-228 part Radix Salviae Miltiorrhizae 69-124 part Radix Ginseng 33-60 part Poria 46-82 part Radix Notoginseng 66-118 part Hirudo 69-124 part Flos Carthami 46-82 part Rhizoma Chuanxiong 46-82 part Fructus Crataegi 69-124 part Pollen Typhae 46-82 part Radix Polygoni Multiflori Preparata 46-82 part Radix Puerariae 69-124 part Radix Scutellariae 46-82 part Radix Scrophulariae 46-82 part Radix Glycyrrhizae 66-118 part
Said preparation is most preferably made by the Chinese medicine of following weight proportion: 89 parts in 62 portions of Radix Glycyrrhizaes of 62 portions of Radix Scrophulariaes of 93 parts of Radix Scutellariaes of 62 parts of Radix Puerariaes of 62 parts of Radix Polygoni Multiflori Preparata of 93 parts of Pollen Typhaes of 62 portions of Fructus Crataegis of 62 parts of Rhizoma Chuanxiongs of 93 parts of Flos Carthamis of 89 portions of Hirudos of 62 portions of Radix Notoginseng of 45 parts of Poria of 93 parts of Radix Ginsengs of 171 parts of Radix Salviae Miltiorrhizaes of the Radix Astragali
Chinese medicine preparation of the present invention prepares by the following method:
Ten five kinds of Chinese medicine are arranged in the above-mentioned Chinese medicine composition, and Radix Ginseng, Radix Notoginseng, that Hirudo powder is broken into fine powder is standby, and Radix Salviae Miltiorrhizae adds 60% ethanol 600ml and refluxes twice, and each 1.5 hours, filter, merging filtrate device is in addition preserved, the medicinal residues usefulness of purchasing in addition; Rhizoma Chuanxiong is soaked after 2 hours and to be extracted volatile oil about 6 hours, carry to the greatest extent till, after volatile oil adds an amount of dissolve with ethanol, the airtight preservation of device in addition, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong medicinal residues all the other 10 flavor medicines altogether decoct with water 3 times, each 1.5 hours, filter, merging filtrate is concentrated into relative density and is about 1.15 (60 ℃), add ethanol and make the alcohol amount about 60% that contains, stir, placed 24 hours, filter, merge with the Radix Salviae Miltiorrhizae backflow, reclaim ethanol, and to be condensed into relative density be 1.35 (60 ℃) extractum, add Radix Ginseng, Radix Notoginseng, the Hirudo fine powder, mixing, 60 ℃ of oven dry are ground into fine powder, evenly spray into volatile oil ethanol liquid, moistening 1 hour obtains active constituents of medicine, and this active constituents of medicine can be made any pharmaceutically useful preparation by the ordinary preparation technology.
In more than forming, weight is calculated with crude drug, if be unit with the gram, this composition can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, 1000 bags of granules, oral liquid 1000 peace bottles etc., also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form, as if being unit with the gram, can be made into the preparation of 50-1000 taking dose, as tablet, make 1000, each taking dose can be the 1-20 sheet, can take 50-1000 time altogether.As granule, make 125 bags, take the 1-2 bag at every turn, can take 62.5-125 time altogether.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, and for especial patient, the proportioning of can corresponding adjustment forming increases or reduce being no more than 100%.
Single medicinal material, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.This substituting do not change essence of the present invention, still belongs to protection scope of the present invention.
Chinese medicine preparation of the present invention, can add the medicine acceptable carrier when being prepared into medicament, described medicine acceptable carrier can be: starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preparation of the present invention, peroral dosage form preferably, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc., preferably capsule, granule.
Preparation of the present invention is determined usage and dosage according to patient's situation in use, but obeys every day three times, each 1-20 agent, as: 1-20 bag or grain or sheet.
Chinese medicine preparation of the present invention, one of treatment blood stasis due to qi deficiency of using angina pectoris, disease is seen stabbing pain over the chest or dull pain, localized pain, shortness of breath and palpitation, fatigue and weakness, spontaneous perspiration, light red tongue is dark or ecchymosis is arranged, and irregularly intermittent and regularly intermittent pulse or string are puckery.This is sick really for because of void causes the stasis of blood, and because of the stasis of blood is had a pain, but preparation benefiting heart-QI of the present invention and the heart-yang that shakes are to control " deficiency in origin ", blood circulation promoting and blood stasis dispelling is with can blood vessels and control " mark is real ".Heresy just two turns round and look at, treating both the principal and the secondary aspects of a disease at the same time, and two arrogate to oneself its merit.
Benefiting QI for activating blood circulation ruling by law angina pectoris has reliable experiment and clinical foundation.Dongzhimen Hospital of Chinese Traditional Medicine College's utilization QI invigorating prescription is treated 54 routine angina pectoris patients, and the multinomial parameters of left ventricular function of result obviously is improved, shorten as PEP, and the LVET significant prolongation, PEP/LVET descends
[7]The Fuwai Hospital finds that QI invigorating side's (SHENGMAI SAN) to chamber, patients with coronary heart disease left side compliance, increases and stroke volume, and all there is certain effect cardiac output and reduction myocardial oxygen consumption aspect.Dongzhimen institute of hospital finds that also the benefiting QI for activating blood circulation prescription is more evident in efficacy with QI invigorating ruling by law treatment angina pectoris than single.And someone finds that resistance and supplementing qi medicine can suppress the activity of fibrinolysin, and blood circulation promoting medicine has the raising plasmin activity; Xiyuan hospital studies show that, the resistance and supplementing qi medicine Radix Astragali can make euglobulin lysis time prolong, and fibrin stabilizing factor is active to be improved, and resistance and supplementing qi medicines such as the prompting Radix Astragali have blood coagulation enhancing effect, therefore angina pectoris sees that deficiency of vital energy disease person is arranged, and utilization QI invigorating method should be same with realistic meaning is then more arranged with activating blood circulation method.Modern pharmacological research also confirms.Medicines such as the Radix Astragali, Radix Ginseng, Salvia miltiorrhiza and Panax notoginseng, Radix Puerariae have the cardiac function of improvement in the Chinese medicine composition of the present invention, improve the coronary disease blood flow, reduction myocardial oxygen consumption etc. are to the therapeutical effect of angina pectoris, the ability (with reference to " Chinese medicine voluminous dictionary ", the Shanghai People's Press in January, 1977 front page) that also has health invigorating and body resist the disease.These are one of main formula foundation of the present invention, also are the clinical bases that obtains remarkable curative effect.
Chinese medicine preparation of the present invention has good effect by clinical verification: angina pectoris (chest pain) symptom curative effect
Observing case curative effect to treat angina pectoris treatment group and matched group comparing difference has the significance meaning, and prompting curative curative effect is better than contrasting medicine: see Table 1
Table 1 liang group case angina pectoris symptom curative effect relatively
| Group | The example number | Produce effects (%) | Effectively (%) | Invalid (%) | Increase the weight of | Total effective rate |
| The open group of treatment group matched group | 108 100 200 | 65(60.19)△ 46(46.00) 123(61.50) | 34(31.48) 36(36.00) 66(33.00) | 9(8.33) 18(18.00) 11(5.50) | 0 0 0 | 91.67% 82.00% 94.50% |
Control: right: μ=2.172 P<0.05 * X
2=4.295, P<0.05; △ X
2=4.198, P<0.05.Observe the case ECG curative effect
3 weeks compared with 6 weeks on the same group: there is the highly significant meaning in 3 weeks of total effective rate treatment group with 6 all comparing differences, and matched group difference does not have the significance meaning.Do not have the significance meaning with course of therapy group and matched group comparison 3 all differences, 6 all differences have the significance meaning, and the treatment group is described, and curative effect is more obvious along with the growth of medicine time: see Table 2
Table 2 is observed the case ECG curative effect
| Group | The example number | All numbers | Multiple normal | Produce effects | Effectively | Invalid | Increase the weight of | Obvious effective rate | Total effective rate |
| The open group of treatment group matched group | 108 100 200 | 3 6 3 6 3 6 | 0 10 0 3 1 11 | 17 23 13 15 9 34 | 30 36 26 31 54 75 | 57 35 59 48 128 74 | 4 4 2 3 8 6 | 15.74 30.56△ 13.00 18.00 5.00 22.50 | 43.52% 63.89%**# 39.00% 49.00% 32.00% 60.00% |
Compare before and after self: * * P<0.05, compare #P<0.05 △ between group and control: to P<0.05; Control: right: 3 all μ=0.493, P>0.05
6 all μ=2.332, P<0.05.
Observe case tcm syndrome curative effect
Than total effective rate treatment group and matched group comparing difference the significance meaning is arranged, the prompting curative is better than contrasting medicine aspect the tcm syndrome improving; See Table 3
Table 3 tcm syndrome curative effect relatively
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | Increase the weight of | Total obvious effective rate | Total effective rate |
| The open group of treatment group matched group | 108 100 200 | 14 15 23 | 41 25 88 | 43 41 75 | 10 19 14 | 0 0 0 | 50.93% 40.00% 55.51% | 90.74% 81.00% 93.00% |
Control: right: X
2=4.106, P<0.05.
Blood fat, hemorheology situation of change
The Blood Lipid situation:
Treat preceding two groups of dyslipidemia cases, before and after treatment back blood fat situation of change treatment group and the matched group self significant differences or significant difference are arranged more all, illustrate that two medicines all have the effect of certain blood lipid regulation.But comparing difference does not have the significance meaning between group: see Table 4,5,6.
Table 4 PC ANOMALOUS VARIATIONS situation (mmol/L)
| Group | Routine number raises before controlling | X ± S before the treatment | Treatment back X ± S | Front and back are (t value) relatively |
| The open group of treatment group matched group | 49 40 100 | 6.355±0.995 6.238±0.782 6.276±0.777 | 5.729±1.069 5.512±0.922 5.689±1.017 | 5.497** 4.246** 6.438** |
* P<0.01 is controlled: right: t value 0.507, P>0.05
Table 5 T part ANOMALOUS VARIATIONS situation
| Group | Routine number raises before controlling | X ± S before the treatment | Treatment back X ± S | Front and back are (t value) relatively |
| The open group of treatment group matched group | 55 42 116 | 2.307±0.946 2.605±1.583 2.382±1.326 | 1.926±1.126 2.086±1.249 1.921±1.008 | 2.406* 2.577* 5.608** |
* P<0.05 * * P<0.01; Control: right: t value 0.545, P>0.05
Table 6 HDL-C ANOMALOUS VARIATIONS situation
| Group |
Routine number raises before controlling |
X ± S before the treatment |
Treatment back X ± S |
Front and back are (t value) relatively |
| The open group of treatment group matched group |
47 38 82 |
0.924±0.160 0.918±0.120 0.830±0.277 |
1.154±0.322 1.062±0.237 1.038±0.588 |
4.859** 3.111** 3.530** |
* P<0.01; Control: right: t value 1.360, P>0.05
The hemorheology situation of change
Comparing (except that the matched group packed cell volume) difference before and after treatment group and the matched group all has the significance meaning, illustrates that two medicines all have the effect that improves hemorheological property, the lower significance meaning of having cut between group, and the prompting curative is better than contrasting medicine, sees Table 7.
Table 7 hemorheology situation of change
| Project | Group | The example number | Before the treatment | After the treatment | Front and back relatively |
| Overall height is cut the low plasma viscosity packed cell volume of cutting of blood viscosity | The open group of the open group for the treatment of group control group treatment group control group open group treatment group control group treatment group control group | 67 65 200 67 65 200 67 65 200 32 65 | 5.914±0.817 6.009±0.841 5.722±1.157 12.340±3.691 12.084±3.844 11.813±4.559 1.937±0.327 1.925±0.288 1.876±0.407 48.125±4.956 49.633±4.731 | 5.235±0.712 5.473±0.928 5.165±1.129 9.866±2.525 10.468±3.105 10.620±4.073 1.829±0.202 1.847±0.242 1.738±0.375 46.594±5.254 47.967±7.005 | 6.562** 4.125** 8.125** 11.421**# 5.962** 4.349** 3.898** 2.445* 8.244** 2.248* 1.284 |
| |
Open group |
200 |
46.657±6.989 |
43.866±4.803 |
6.864** |
#P<0.05 relatively between * P>0.05 * * P<0.01 group relatively before and after self
The clinical sign situation of change
Heart rate more all has the significance meaning before and after the situation of change treatment group of blood pressure and the matched group self, points out two medicines that the effect that reduces heart rate and blood pressure is all arranged: to see Table 8
The situation of change of table 8 heart rate blood pressure
| Project | Group | The example number | Before the treatment (X ± S) | The treatment back (X ± S) | Front and back relatively |
| Heart rate blood systolic pressure is pressed diastolic pressure | The open group of the open group of the open group for the treatment of group control group treatment group control group treatment group control group | 108 100 200 108 100 200 108 100 200 | 83.574±37.702 80.880±12.071 80.135±14.521 18.308±3.254 18.227±3.138 18.901±2.384 11.119±1.696 11.163±1.351 11.217±1.635 | 75.870±9.509 76.590±9.309 74.980±9.810 17.411±2.491 16.958±2.295 17.949±1.803 10.677±1.245 10.503±1.126 10.484±1.076 | 2.219* 4.564** 7.337** 4.736** 6.003** 9.708** 3.426** 6.324** 7.701** |
**P<0.01 *P>0.05
The specific embodiment:
Further specify the present invention by the following examples, it should be understood that embodiments of the invention are to be used to illustrate the present invention rather than limitation of the present invention.Simple modifications or replacement that essence according to the present invention is carried out the preparation method of compound Chinese medicinal preparation of the present invention and/or preparation of the present invention all belong to the scope of protection of present invention.
Embodiment 1: capsular preparation
89 parts of 62 portions of Radix Notoginseng of 45 parts of Poria of 93 parts of Radix Ginsengs of 171 parts of Radix Salviae Miltiorrhizaes of the Radix Astragali
62 parts of 93 parts of Pollen Typhaes of 62 portions of Fructus Crataegis of 62 parts of Rhizoma Chuanxiongs of 93 parts of Flos Carthamis of Hirudo
89 parts in 62 portions of Radix Glycyrrhizaes of 62 portions of Radix Scrophulariaes of 93 parts of Radix Scutellariaes of 62 parts of Radix Puerariaes of Radix Polygoni Multiflori Preparata
Ten five kinds of Chinese medicine are arranged in the above-mentioned Chinese medicine composition, are that Chinese crude drug is got by unit in the gram, and with Radix Ginseng, Radix Notoginseng, that Hirudo powder is broken into fine powder is standby, Radix Salviae Miltiorrhizae adds 60% ethanol 600ml and refluxes twice, each 1.5 hours, filter, and merging filtrate device is in addition preserved, the medicinal residues usefulness of purchasing in addition; Rhizoma Chuanxiong is soaked after 2 hours and to be extracted volatile oil about 6 hours, carry to the greatest extent till, after volatile oil adds an amount of dissolve with ethanol, the airtight preservation of device in addition, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong medicinal residues all the other 10 flavor medicines altogether decoct with water 3 times, each 1.5 hours, filter merging filtrate, be concentrated into relative density and be about 1.15 (60 ℃), add ethanol and make the alcohol amount of containing about 60%, stir, placed 24 hours, and filtered, merge with the Radix Salviae Miltiorrhizae backflow, reclaim ethanol, and to be condensed into relative density be 1.35 (60 ℃) extractum, add Radix Ginseng, Radix Notoginseng, the Hirudo fine powder, mixing, 60 ℃ of oven dry are ground into fine powder, evenly spray into volatile oil ethanol liquid, moistening 1 hour, encapsulated, promptly.Make 1000 altogether.
Embodiment 2: the preparation of tablet
89 parts of 62 portions of Radix Notoginseng of 45 parts of Poria of 93 parts of Radix Ginsengs of 171 parts of Radix Salviae Miltiorrhizaes of the Radix Astragali
62 parts of 93 parts of Pollen Typhaes of 62 portions of Fructus Crataegis of 62 parts of Rhizoma Chuanxiongs of 93 parts of Flos Carthamis of Hirudo
89 parts in 62 portions of Radix Glycyrrhizaes of 62 portions of Radix Scrophulariaes of 93 parts of Radix Scutellariaes of 62 parts of Radix Puerariaes of Radix Polygoni Multiflori Preparata
Ten five kinds of Chinese medicine are arranged in the above-mentioned Chinese medicine composition, are that Chinese crude drug is got by unit in the gram, and with Radix Ginseng, Radix Notoginseng, that Hirudo powder is broken into fine powder is standby, Radix Salviae Miltiorrhizae adds 60% ethanol 600ml and refluxes twice, each 1.5 hours, filter, and merging filtrate device is in addition preserved, the medicinal residues usefulness of purchasing in addition; Rhizoma Chuanxiong is soaked after 2 hours and to be extracted volatile oil about 6 hours, carry to the greatest extent till, after volatile oil adds an amount of dissolve with ethanol, the airtight preservation of device in addition, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong medicinal residues all the other 10 flavor medicines altogether decoct with water 3 times, each 1.5 hours, filter merging filtrate, be concentrated into relative density and be about 1.15 (60 ℃), add ethanol and make the alcohol amount of containing about 60%, stir, placed 24 hours, and filtered, merge with the Radix Salviae Miltiorrhizae backflow, reclaim ethanol, and to be condensed into relative density be 1.35 (60 ℃) extractum, adds Radix Ginseng, Radix Notoginseng, the Hirudo fine powder, mixing, 60 ℃ of oven dry are ground into fine powder, evenly spray into volatile oil ethanol liquid, moistening 1 hour, add suitable amount of adhesive, lubricant, mix homogeneously, tabletting is made 1000.
Embodiment 3: the preparation of granule
89 parts of 62 portions of Radix Notoginseng of 45 parts of Poria of 93 parts of Radix Ginsengs of 171 parts of Radix Salviae Miltiorrhizaes of the Radix Astragali
62 parts of 93 parts of Pollen Typhaes of 62 portions of Fructus Crataegis of 62 parts of Rhizoma Chuanxiongs of 93 parts of Flos Carthamis of Hirudo
89 parts in 62 portions of Radix Glycyrrhizaes of 62 portions of Radix Scrophulariaes of 93 parts of Radix Scutellariaes of 62 parts of Radix Puerariaes of Radix Polygoni Multiflori Preparata
Ten five kinds of Chinese medicine are arranged in the above-mentioned Chinese medicine composition, are that Chinese crude drug is got by unit in the gram, and with Radix Ginseng, Radix Notoginseng, that Hirudo powder is broken into fine powder is standby, Radix Salviae Miltiorrhizae adds 60% ethanol 600ml and refluxes twice, each 1.5 hours, filter, and merging filtrate device is in addition preserved, the medicinal residues usefulness of purchasing in addition; Rhizoma Chuanxiong is soaked after 2 hours and to be extracted volatile oil about 6 hours, carry to the greatest extent till, after volatile oil adds an amount of dissolve with ethanol, the airtight preservation of device in addition, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong medicinal residues all the other 10 flavor medicines altogether decoct with water 3 times, each 1.5 hours, filter merging filtrate, be concentrated into relative density and be about 1.15 (60 ℃), add ethanol and make the alcohol amount of containing about 60%, stir, placed 24 hours, filter, merge, reclaim ethanol with the Radix Salviae Miltiorrhizae backflow, and to be condensed into relative density be 1.35 (60 ℃) extractum, add Radix Ginseng, Radix Notoginseng, the Hirudo fine powder, mixing, 60 ℃ of oven dry, be ground into fine powder, evenly spray into volatile oil ethanol liquid, moistening 1 hour, add an amount of sucrose, mix homogeneously in the packaging bag of packing into, is adorned 125 bags.