CN108403882A - A kind of red sage root composition and preparation method thereof for treating coronary heart disease - Google Patents
A kind of red sage root composition and preparation method thereof for treating coronary heart disease Download PDFInfo
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Abstract
The invention belongs to the field of Chinese medicines, provide a kind of Chinese medicine composition and preparation method thereof containing Radix Salviae Miltiorrhizae, specifically include following components in parts by weight：500 800 parts of Radix Salviae Miltiorrhizae, 120 300 parts of schefflera arboricola, 5 20 parts of grass-leaved sweetflag, the present invention passes through to each component extraction purification in composition, and add the solubility that cyclodextrin ensures liposoluble constituent, it adds suitable auxiliary material and corresponding preparation is prepared, and further said preparation active ingredient is defined, be conducive to drug quality control.Mutually collaboration plays a role between composition each component provided by the invention, substantially increases the effect for the treatment of coronary heart disease.
Description
Technical field
The present invention relates to a kind of Chinese medicine compositions and preparation method thereof, and in particular to a kind of Radix Salviae Miltiorrhizae combination for treating coronary heart disease
Object and preparation method thereof.
Background technology
Coronary atherosclerotic heart disease (CHD), abbreviation coronary heart disease refer to since atherosis occurs for coronary artery
Caused arteries luminal stenosis entirely shuts, and leads to myocardial ischemia, anoxic or heart disease caused by necrosis.Coronary disease
Disease, which is atherosclerosis, leads to most common type in organ lesion, and seriously endangers the common of people's health now
Disease, frequently-occurring disease.Data show that since 40 years old, often increase by 10 years old, the illness rate of coronary heart disease increases by 1 times, male 50 years old, female
Property 60 years old after, coronary sclerosis development it is rapider, same myocardial infarction danger increase also with the increase at age.
Developed country's incidence is higher, and morbidity in recent years is in rejuvenation trend, and the incidence in China also rises, has become at present year by year
Threaten one of the principal disease of human health.
Coronary disease and angina pectoris is so that angiemphraxis or/and coronary artery function is sexually revised (convulsion by coronary atherosclerosis
Contraction), lead to heart disease caused by myocardial ischemia-anoxemia, is one of coronary heart disease common type, seriously threatens in the world
Public health health.
With the development of modern science and technology, people also have made some progress the diagnosis and prevention of coronary heart disease, such as exist
In terms of inspection, by routine electrocardiogram, load ECG inspection, update to Holter, ultrasonic cardiography check that art, coronary artery are made
Shadow, the application of electron beam ct machine, biochemical analysis and cardiac determination method are also being continuously improved, and are provided for early diagnosis good
Means；The foundation etc. of foundation, bypass operation of coronary artery in terms of prevention including CCV；Drug treatment, in expansion coronary artery
On the basis of, there is the application of calcium ion antagonist, beta-blocker, thrombolytic drug, is provided for treatment coronary heart disease more
Kind means.
However clinical practice shows that simple western medicine treatment is only palliative, especially side effects of pharmaceutical drugs keep patient difficult
To receive and take for a long time.With the raising of economic level, contemporary mankind is not in simple the effect of requiring drug, for drug
Safety requirements is increasingly strong, generally wishes the Chinese medicine treatment of natural nuisance-free, good to be provided for the development of traditional Chinese medicine
Opportunity.In traditional Chinese medical science field, coronary disease and angina pectoris belongs to obstruction of qi in the chest scope, refers to suffocating pain over the chest, very then chest pain radiating to the back, failing to sleep due to dyspnea
For a kind of disease of cardinal symptom, the state of an illness it is lighter it is only uncomfortable in chest such as stop up, breathe and owe sense freely, the state of an illness compared with severe one can pain such as
Thorn such as burns, such as twists, and more severe patient can chest pain radiating to the back, backache radiating to the heart.
Radix Salviae Miltiorrhizae is labiate, has promoting blood circulation, inducing meastruation to relieve menalgia, relieving restlessness that clears away heart-fire, cool blood to disappear carbuncle.It is usually used in the obstruction of qi in the chest heart
Bitterly, gastral cavity abdomen hypochondriac pain , lumps in the chest and abdomen, hot numbness pain, dysphoria and insomnia, irregular menstruation, dysmenorrhoea Amenorrhea, sore Ulcers swelling and pain.It is in the treatment heart
It is tanshinone and root of red-rooted salvia phenolic acid, Ke Yizeng to have notable curative effect, main active in terms of cranial vascular disease, especially coronary heart disease
Add coronary blood flow, promote Doppler flow mapping, improve Myocardial Microcirculation, without increasing ventricle effect and myocardial oxygen consumption, increases hat
Arteries and veins blood flow.In recent years, people increase the research of Treated with Radix Salviae Miltiorrhizae coronary heart disease, achieve certain achievement, have multiple kinds
For clinic, oral drugs have Fufang Danshen Pian, compound danshen dripping pills etc., and main component is Radix Salviae Miltiorrhizae, Radix Notoginseng and borneol, wherein
Compound danshen dripping pills are rapid extensively and applied to clinic due to its good effect, effect.
In addition to this, also numerous to be compounded with Radix Salviae Miltiorrhizae, it is combined as the Chinese medicine composition for the treatment of coronary heart disease.Patent
CN100556445C is disclosed with Radix Salviae Miltiorrhizae, Snakegourd Fruit, Radix Curcumae are good, grass-leaved sweetflag combination, has obtained a kind of having the wide chest of qi-regulating, changing turbid solution
Strongly fragrant, eliminating blood stasis and smoothing collaterals Chinese medicine compositions, can be applied to Treating Patients of Angina Pectoris.
Patent application CN105212504A discloses Radix Salviae Miltiorrhizae, safflower, Rhizoma Chuanxiong, radix paeoniae rubra, dalbergia wood combination with promoting blood circulation and removing blood stasis, logical
The effect of network analgesic, can be used for administering coronary heart disease.
But active ingredient is indefinite in the above patented composition, is unfavorable for drug treatment control.
Tianjin Tian Shili pharmaceutical Co. Ltds have applied a series of using Radix Salviae Miltiorrhizae as the Chinese traditional medicine composition of the treatment coronary heart disease of core
Object, the combination as in patent CN1778344B being the treatment coronary heart disease that Radix Salviae Miltiorrhizae, Radix Notoginseng, dalbergia heartwood oil or storax combination are prepared
Object；The Chinese medicine dripping pills that patent CN1778334B is prepared using Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong and borneol as raw material have treatment coronary disease and angina pectoris
Curative effect.But two patents are prepared using ultrafiltration technology, complex process, cost of manufacture greatly improves.
Invention content
Based on the defect of the above-mentioned prior art, the present invention provides a kind of red sage root composition, passes through rational proportion Radix Salviae Miltiorrhizae, seven leaves
The proportioning of lotus and grass-leaved sweetflag, the collaboration for giving full play to three act on, and are defined to the content of active ingredient therein, obtain
Reasonable, definite ingredients, significant effect, the low treatment coronary heart disease of side effect the Chinese medicine composition to a kind of component.
The present invention provides a kind of red sage root composition for treating coronary heart disease, in parts by weight comprising 500-800 parts red
Ginseng, 120-300 portions of schefflera arboricolas, 5-20 parts of grass-leaved sweetflags.
Further, the composition in parts by weight, including 600-700 parts of Radix Salviae Miltiorrhizaes, 150-200 portions of schefflera arboricolas,
10-15 parts of grass-leaved sweetflags.
Further, the composition in parts by weight, including 650 parts of Radix Salviae Miltiorrhizaes, 180 portions of schefflera arboricolas, 12 parts of stones
Calamus.
Further, composition score meter by weight further includes 50 portions of cortex albiziaes.
The present invention also provides a kind of Chinese medicine preparations containing red sage root composition, by above-mentioned red sage root composition and pharmaceutically may be used
Receive auxiliary material composition.
Further, Tanshinone I I in the preparationAMass percentage 0.10%-0.50%, tanshin polyphenolic acid B quality percentage
Content 3.0-5.0%, total saposins mass percentage 0.20%-0.40%, volatile oil mass percentage 0.02%-
0.05%.
Further, Tanshinone I I in the preparationAMass percentage 0.20%-0.40%, tanshin polyphenolic acid B quality hundred
Divide content 3.5%-4.0%, total saposins mass percentage 0.25%-0.35%, volatile oil mass percentage 0.03%-
0.04%.
Further, the pharmaceutically acceptable auxiliary material includes hydroxypropyl-β-cyclodextrin.
Further, the Chinese medicine preparation agent includes granule, tablet, capsule, pill.
Invention further provides a kind of preparation methods of red sage root composition preparation, include the following steps：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, ethyl alcohol impregnates, flash extracter extraction, concentration, concentrate mistake
HPD100 macroporous resin columns are washed through washing, ethyl alcohol successively, after collecting eluent concentration, hydroxypropyl-β-cyclodextrin are added, grinds
Radix Salviae Miltiorrhizae extractum inclusion compound is obtained after mill, drying；
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, after EtOH Sonicate assisted extraction, Soxhlet extractor reflux leaching
It carries, filtrate is concentrated and dried to obtain schefflera arboricola medicinal extract, and medicinal extract uses petroleum ether, dichloromethane, ethyl acetate, positive fourth successively after being diluted with water
Alcohol extracts, and silicagel column, methylene chloride-methanol 100 are crossed after n-butyl alcohol extract is concentrated:0~0:100 gradient elutions, are received respectively
Collect fraction, differentiates through TLC and similar compositions are merged, are concentrated, obtain schefflera arboricola fraction extract；
(3) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Extraction obtains Essential Oil of Acorus tatarinowii liquid, and hydroxypropyl is added
Group-beta-cyclodextrin is ground, and obtains Essential Oil of Acorus tatarinowii inclusion compound；
(4) extraction of cortex albiziae：Cortex albiziae adds alcohol reflux to extract through petroleum ether degreasing, and filtrate is concentrated and dried to obtain silk tree
Skin medicinal extract uses petroleum ether, dichloromethane, ethyl acetate, extracting n-butyl alcohol, butanol extraction liquid concentration successively after medicinal extract dissolving
Afterwards, oxidized aluminium column elution, ethanol elution, eluent are concentrated and dried up to silktree albizia bark extract.(5) Radix Salviae Miltiorrhizae extractum inclusion compound,
Schefflera arboricola fraction extract and Essential Oil of Acorus tatarinowii inclusion compound are crushed, are uniformly mixed, and suitable excipients are added, normal according to Chinese medicine preparation
Rule method is prepared to obtain the final product；Or Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola fraction extract, Essential Oil of Acorus tatarinowii inclusion compound and cortex albiziae carry
It takes object to crush, be uniformly mixed, suitable excipients is added, are prepared according to Chinese medicine preparation conventional method to obtain the final product.
Further, the preparation method of the red sage root composition preparation, includes the following steps：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, 10-30min, room temperature are impregnated with 10-15 times of 70%-80% ethyl alcohol
Under, flash extracter extracts 3-10min, 5-20min is stood after extraction, twice, merging filtrate concentrates, concentrate mistake for extraction
HPD100 macroporous resin columns are washed with 2-3 times of cylinder ponding, 25% ethyl alcohol, 50% ethyl alcohol, 75% ethyl alcohol and 100% ethyl alcohol successively
It washs, for 2-3 times of column volume per hour, after collecting eluent concentration, hydroxypropyl-β-cyclodextrin is added in elution flow rate, be fully ground,
Radix Salviae Miltiorrhizae extractum inclusion compound is obtained after drying.
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, add 8-12 times of 70%-80% EtOH Sonicate assisted extractions 50-
60min, 50-60 DEG C of reflux extraction 3-4h, are extracted 2-3 times, 3500-4000r/min centrifuges 10-20min, merging filtrate, concentration
Dry schefflera arboricola medicinal extract, medicinal extract be diluted with water after successively with the petroleum ether of 10-20 times of volume, dichloromethane, ethyl acetate, just
Butanol, before immunoassay crosses silica gel (200-300 mesh) column, methylene chloride-methanol 100 after n-butyl alcohol extract is concentrated:0、100:25、
100:50、100:100、50:100、25:100、0:100 gradient elutions, collect fraction respectively, differentiate through TLC and close component
And measure the highest part of selection total saponin content and concentrated, obtain schefflera arboricola fraction extract.
(3) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Flow velocity 2-3L/h extracts pressure 5.0-7.0MPa, carries
It takes 40-50 DEG C of temperature, constant temperature and pressure to extract 1.5-3h, obtains Essential Oil of Acorus tatarinowii liquid, hydroxypropyl-β-cyclodextrin is added, fully
Grinding, obtains Essential Oil of Acorus tatarinowii inclusion compound.
(4) extraction of cortex albiziae：For cortex albiziae through 5-10 times of petroleum ether, 60-70 DEG C is heated at reflux degreasing, adds 8-12 times of 70-
80% ethyl alcohol, in 50-60 DEG C of reflux extraction, filtrate is concentrated and dried to obtain cortex albiziae medicinal extract, successively with 10-20 times of body after medicinal extract dissolving
Product petroleum ether, dichloromethane, ethyl acetate, extracting n-butyl alcohol, after butanol extraction liquid concentration, oxidized aluminium column elution, 55-
65% ethanol elution, eluent are concentrated and dried up to silktree albizia bark extract.
(5) Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola medicinal extract and Essential Oil of Acorus tatarinowii inclusion compound are crushed, are uniformly mixed, and are added and are closed
Suitable auxiliary material, prepares according to Chinese medicine preparation conventional method to obtain the final product；Or Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola fraction extract, grass-leaved sweetflag
Volatile oil clathrate compound and silktree albizia bark extract are crushed, are uniformly mixed, and suitable excipients are added, and are prepared according to Chinese medicine preparation conventional method
To obtain the final product.
Further, the weight ratio of step (1) Radix Salviae Miltiorrhizae and hydroxypropyl-β-cyclodextrin is 100 in the preparation method:2-
5。
Further, the weight ratio of step (3) grass-leaved sweetflag and hydroxypropyl-β-cyclodextrin is 100 in the preparation method:
2-5。
The present invention also provides application of the above-mentioned red sage root composition on preparing treatment medicaments for coronary disease.
Preferably, application of the red sage root composition on preparing the angina drug that treatment coronary heart disease causes.
Beneficial effects of the present invention are：
(1) in red sage root composition provided by the invention, Radix Salviae Miltiorrhizae has promoting blood circulation, inducing meastruation to relieve menalgia effect；Schefflera arboricola has
There is the effect of wind-expelling pain-stopping, activating blood circulation and reducing swelling；Grass-leaved sweetflag has slit phlegm of having one's ideas straightened out, inducing resuscitation intelligence development.Mutually collaboration plays work between each component
With, there is significantly treatment coronary heart disease, especially treat anginal effect, and cortex albiziae has promoting blood circulation, stagnation resolvation, Xie Yu, analgesic
And other effects, further enhance the effect of composition treatment coronary heart disease.
(2) present invention is to active constituent Tanshinone I I in preparationA, tanshin polyphenolic acid B, total saposins, volatile oil content carry out
It clearly limits, ensure that the safety of clinical application, easily controllable product quality.
(3) present invention process is extracted for active constituent, detaches, is purified, and tanshinone in Chinese medicine preparation is prepared
IIA, tanshin polyphenolic acid B, total saposins and volatile oil purity higher, be conducive to it and play a role, especially headed by oleanolic acid
Triterpene saponins and the volatile oil based on beta-Asarone have the effect of good expansion artery blood vessel, between four kinds of active constituents
In the presence of the effect mutually cooperateed with, the effect of composition treats coronary heart disease is significantly increased.
(4) extraction process of the present invention is simple, hydroxypropyl-β-cyclodextrin is added respectively to Salvia root P.E and grass-leaved sweetflag essential oil
It is included, increases the dissolubility of shipwreck melt into, while improving the slow releasing function of drug, considerably increase active ingredient medicine
The performance of effect.
Specific implementation mode
1 red sage root composition of embodiment and its preparation
In parts by weight, it is made of 650 parts of Radix Salviae Miltiorrhizae, 180 parts of schefflera arboricola, 12 parts of grass-leaved sweetflag.
Compound Danshen Root process for producing granula：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, 20min, at room temperature, homogenate extraction are impregnated with 12 times of 75% ethyl alcohol
Device extracts 5min, and 10min is stood after extraction, and twice, merging filtrate concentrates, and concentrate crosses HPD100 macroporous resin columns for extraction, according to
Secondary to be washed with 2 times of cylinder ponding, 25% ethyl alcohol, 50% ethyl alcohol, 75% ethyl alcohol and 100% ethyl alcohol, elution flow rate is 3 times of column volumes
Per hour, collect eluent concentration after, be added 19.5 parts of hydroxypropyl-β-cyclodextrins, be fully ground, dry after Radix Salviae Miltiorrhizae extractum packet
Close object；
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, add 10 times of 75% EtOH Sonicate assisted extraction 55min, 55 DEG C
Reflux extraction 3.5h, extract 2 times, 4000r/min centrifuge 10min, merging filtrate, be concentrated and dried schefflera arboricola medicinal extract, medicinal extract add
Successively with the petroleum ether of 10 times of volumes, dichloromethane, ethyl acetate, extracting n-butyl alcohol after water dilution, n-butyl alcohol extract is through dense
Silica gel (200-300 mesh) column, methylene chloride-methanol 100 are crossed after contracting:0、100:25、100:50、100:100、50:100、25:
100、0:100 gradient elutions, collect fraction respectively, differentiate through TLC and merge component, measure and choose total saponin content highest
Part concentrated, obtain schefflera arboricola fraction extract；
(3) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Flow velocity 2.5L/h extracts pressure 6.0MPa, extraction temperature
45 DEG C of degree, constant temperature and pressure extract 2h, obtain Essential Oil of Acorus tatarinowii liquid, and 0.36 part of hydroxypropyl-β-cyclodextrin is added, is fully ground,
Obtain Essential Oil of Acorus tatarinowii inclusion compound；
(4) Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola fraction extract and Essential Oil of Acorus tatarinowii inclusion compound are crushed, are uniformly mixed,
Suitable excipients are added, are prepared according to Chinese herbal granules conventional method to obtain the final product.
2 red sage root composition of embodiment and its preparation
In parts by weight, it is made of 600 parts of Radix Salviae Miltiorrhizae, 200 parts of schefflera arboricola, 15 parts of grass-leaved sweetflag.
Compound Danshen Root tablet preparation method：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, 30min, at room temperature, homogenate extraction are impregnated with 10 times of 80% ethyl alcohol
Device extracts 3min, and 20min is stood after extraction, and twice, merging filtrate concentrates, and concentrate crosses HPD100 macroporous resin columns for extraction, according to
Secondary to be washed with 3 times of cylinder ponding, 25% ethyl alcohol, 50% ethyl alcohol, 75% ethyl alcohol and 100% ethyl alcohol, elution flow rate is 2 times of column volumes
Per hour, collect eluent concentration after, be added 30 parts of hydroxypropyl-β-cyclodextrins, be fully ground, dry after Radix Salviae Miltiorrhizae extractum inclusion
Object；
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, add 8 times of 70% EtOH Sonicate assisted extraction 50min, 50 DEG C
Reflux extraction 4h, extract 2 times, 4000r/min centrifuge 10min, merging filtrate, be concentrated and dried schefflera arboricola medicinal extract, medicinal extract add water
Successively with the petroleum ether of 20 times of volumes, dichloromethane, ethyl acetate, extracting n-butyl alcohol after dilution, n-butyl alcohol extract is concentrated
Silica gel (200-300 mesh) column, methylene chloride-methanol 100 are crossed afterwards:0、100:25、100:50、100:100、50:100、25:100、
0:100 gradient elutions, collect fraction respectively, differentiate through TLC and merge component, measure and choose the highest portion of total saponin content
Divide and concentrated, obtains schefflera arboricola fraction extract；
(3) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Flow velocity 2L/h extracts pressure 5.0MPa, Extracting temperature
40 DEG C, constant temperature and pressure extracts 3h, obtains Essential Oil of Acorus tatarinowii liquid, and 0.75 part of hydroxypropyl-β-cyclodextrin is added, is fully ground, obtains
Essential Oil of Acorus tatarinowii inclusion compound；
(4) Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola fraction extract and Essential Oil of Acorus tatarinowii inclusion compound are crushed, are uniformly mixed,
Suitable excipients are added, tabletting to obtain the final product.
3 red sage root composition of embodiment and its preparation
In parts by weight, it is made of 500 parts of Radix Salviae Miltiorrhizae, 150 parts of schefflera arboricola, 5 parts of grass-leaved sweetflag.
Compound capsule of red sage root preparation method：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, 25min, at room temperature, homogenate extraction are impregnated with 15 times of 75% ethyl alcohol
Device extracts 8min, and 5min is stood after extraction, and twice, merging filtrate concentrates, and concentrate crosses HPD100 macroporous resin columns for extraction, according to
Secondary to be washed with 2 times of cylinder ponding, 25% ethyl alcohol, 50% ethyl alcohol, 75% ethyl alcohol and 100% ethyl alcohol, elution flow rate is 2 times of column volumes
Per hour, collect eluent concentration after, be added 10 parts of hydroxypropyl-β-cyclodextrins, be fully ground, dry after Radix Salviae Miltiorrhizae extractum inclusion
Object；
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, add 10 times of 80% EtOH Sonicate assisted extraction 60min, 55 DEG C
Reflux extraction 4h, extract 3 times, 3500r/min centrifuge 20min, merging filtrate, be concentrated and dried schefflera arboricola medicinal extract, medicinal extract add water
Successively with the petroleum ether of 12 times of volumes, dichloromethane, ethyl acetate, extracting n-butyl alcohol after dilution, n-butyl alcohol extract is concentrated
Silica gel (200-300 mesh) column, methylene chloride-methanol 100 are crossed afterwards:0、100:25、100:50、100:100、50:100、25:100、
0:100 gradient elutions, collect fraction respectively, differentiate through TLC and merge component, measure and choose the highest portion of total saponin content
Divide and concentrated, obtains schefflera arboricola fraction extract；
(3) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Flow velocity 3L/h extracts pressure 6.0MPa, Extracting temperature
45 DEG C, constant temperature and pressure extracts 1.5h, obtains Essential Oil of Acorus tatarinowii liquid, and 0.25 part of hydroxypropyl-β-cyclodextrin is added, is fully ground,
Obtain Essential Oil of Acorus tatarinowii inclusion compound；
(4) Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola fraction extract and Essential Oil of Acorus tatarinowii inclusion compound are crushed, are uniformly mixed,
Be added suitable excipients, granulation be filled into capsule shells to get.
4 red sage root composition of embodiment and its preparation
In parts by weight, it is made of 700 parts of Radix Salviae Miltiorrhizae, 300 parts of schefflera arboricola, 20 parts of grass-leaved sweetflag.
Compound Danshen Root preparation method of granules：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, 10min, at room temperature, homogenate extraction are impregnated with 12 times of 70% ethyl alcohol
Device extracts 10min, and 15min is stood after extraction, and twice, merging filtrate concentrates, and concentrate crosses HPD100 macroporous resin columns for extraction,
It is washed successively with 2.5 times of cylinder ponding, 25% ethyl alcohol, 50% ethyl alcohol, 75% ethyl alcohol and 100% ethyl alcohol, elution flow rate is 3 times of columns
Volume per hour, collect eluent concentration after, be added 28 parts of hydroxypropyl-β-cyclodextrins, be fully ground, dry after Radix Salviae Miltiorrhizae extractum
Inclusion compound；
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, add 12 times of 75% EtOH Sonicate assisted extraction 60min, 60 DEG C
Reflux extraction 3h, extract 2 times, 3500r/min centrifuge 20min, merging filtrate, be concentrated and dried schefflera arboricola medicinal extract, medicinal extract add water
Successively with the petroleum ether of 15 times of volumes, dichloromethane, ethyl acetate, extracting n-butyl alcohol after dilution, n-butyl alcohol extract is concentrated
Silica gel (200-300 mesh) column, methylene chloride-methanol 100 are crossed afterwards:0、100:25、100:50、100:100、50:100、25:100、
0:100 gradient elutions, collect fraction respectively, differentiate through TLC and merge component, measure and choose the highest portion of total saponin content
Divide and concentrated, obtains schefflera arboricola fraction extract；
(3) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Flow velocity 2.5L/h extracts pressure 7.0MPa, extraction temperature
50 DEG C of degree, constant temperature and pressure extract 2.5h, obtain Essential Oil of Acorus tatarinowii liquid, and 0.4 part of hydroxypropyl-β-cyclodextrin is added, is fully ground,
Obtain Essential Oil of Acorus tatarinowii inclusion compound；
(4) Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola fraction extract and Essential Oil of Acorus tatarinowii inclusion compound are crushed, are uniformly mixed,
Suitable excipients are added, fluidized bed prilling is up to granular preparation.
5 red sage root composition of embodiment and its preparation
In parts by weight, it is made of 800 parts of Radix Salviae Miltiorrhizae, 120 parts of schefflera arboricola, 10 parts of grass-leaved sweetflag.
Compound Danshen Root tablet preparation method：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, 15min, at room temperature, homogenate extraction are impregnated with 15 times of 75% ethyl alcohol
Device extracts 10min, and 15min is stood after extraction, and twice, merging filtrate concentrates, and concentrate crosses HPD100 macroporous resin columns for extraction,
It is washed successively with 3 times of cylinder ponding, 25% ethyl alcohol, 50% ethyl alcohol, 75% ethyl alcohol and 100% ethyl alcohol, elution flow rate is 3 times of cylinders
Product per hour, collect eluent concentration after, be added 30 parts of hydroxypropyl-β-cyclodextrins, be fully ground, dry after Radix Salviae Miltiorrhizae extractum packet
Close object；
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, add 10 times of 75% EtOH Sonicate assisted extraction 60min, 60 DEG C
Reflux extraction 3h, extract 2 times, 3500r/min centrifuge 20min, merging filtrate, be concentrated and dried schefflera arboricola medicinal extract, medicinal extract add water
Successively with the petroleum ether of 10 times of volumes, dichloromethane, ethyl acetate, extracting n-butyl alcohol after dilution, n-butyl alcohol extract is concentrated
Silica gel (200-300 mesh) column, methylene chloride-methanol 100 are crossed afterwards:0、100:25、100:50、100:100、50:100、25:100、
0:100 gradient elutions, collect fraction respectively, differentiate through TLC and merge component, measure and choose the highest portion of total saponin content
Divide and concentrated, obtains schefflera arboricola fraction extract；
(3) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Flow velocity 2.5L/h extracts pressure 6.0MPa, extraction temperature
45 DEG C of degree, constant temperature and pressure extract 2.5h, obtain Essential Oil of Acorus tatarinowii liquid, and 0.5 part of hydroxypropyl-β-cyclodextrin is added, is fully ground,
Obtain Essential Oil of Acorus tatarinowii inclusion compound；
(4) Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola fraction extract and Essential Oil of Acorus tatarinowii inclusion compound are crushed, are uniformly mixed,
It is sent out according to Chinese medicinal tablet routine side, it is tabletted.
6 red sage root composition of embodiment and its preparation
In parts by weight, it is made of 650 parts of Radix Salviae Miltiorrhizae, 180 parts of schefflera arboricola, 12 parts of grass-leaved sweetflag, 50 parts of cortex albiziae.
Compound Danshen Root process for producing granula：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, 20min, at room temperature, homogenate extraction are impregnated with 12 times of 75% ethyl alcohol
Device extracts 5min, and 10min is stood after extraction, and twice, merging filtrate concentrates, and concentrate crosses HPD100 macroporous resin columns for extraction, according to
Secondary to be washed with 2 times of cylinder ponding, 25% ethyl alcohol, 50% ethyl alcohol, 75% ethyl alcohol and 100% ethyl alcohol, elution flow rate is 3 times of column volumes
Per hour, collect eluent concentration after, be added 19.5 parts of hydroxypropyl-β-cyclodextrins, be fully ground, dry after Radix Salviae Miltiorrhizae extractum packet
Close object；
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, add 10 times of 75% EtOH Sonicate assisted extraction 55min, 55 DEG C
Reflux extraction 3.5h, extract 2 times, 4000r/min centrifuge 10min, merging filtrate, be concentrated and dried schefflera arboricola medicinal extract, medicinal extract add
Successively with the petroleum ether of 10 times of volumes, dichloromethane, ethyl acetate, extracting n-butyl alcohol after water dilution, n-butyl alcohol extract is through dense
Silica gel (200-300 mesh) column, methylene chloride-methanol 100 are crossed after contracting:0、100:25、100:50、100:100、50:100、25:
100、0:100 gradient elutions, collect fraction respectively, differentiate through TLC and merge component, measure and choose total saponin content highest
Part concentrated, obtain schefflera arboricola fraction extract；
(3) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Flow velocity 2.5L/h extracts pressure 6.0MPa, extraction temperature
45 DEG C of degree, constant temperature and pressure extract 2h, obtain Essential Oil of Acorus tatarinowii liquid, and 0.36 part of hydroxypropyl-β-cyclodextrin is added, is fully ground,
Obtain Essential Oil of Acorus tatarinowii inclusion compound；
(4) extraction of cortex albiziae：For cortex albiziae through 8 times of petroleum ethers, 65 DEG C are heated at reflux degreasing, add 10 times of 75% ethyl alcohol, in
55 DEG C of reflux extractions, filtrate is concentrated and dried to obtain cortex albiziae medicinal extract, successively with 15 times of volume petroleum ethers, dichloromethanes after medicinal extract dissolving
Alkane, ethyl acetate, extracting n-butyl alcohol, after butanol extraction liquid concentration, oxidized aluminium column elution, 60% ethanol elution, eluent
It is concentrated and dried up to silktree albizia bark extract；
(5) Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola fraction extract, Essential Oil of Acorus tatarinowii inclusion compound and silktree albizia bark extract powder
It is broken, uniformly mixed, suitable excipients are added, are prepared according to Chinese herbal granules conventional method to obtain the final product.
Red sage root composition and its preparation of the comparative example 1 without schefflera arboricola
In parts by weight, it is made of 650 parts of Radix Salviae Miltiorrhizae, 12 parts of grass-leaved sweetflag.
Compound red sage root preparation preparation method：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, 20min, at room temperature, homogenate extraction are impregnated with 12 times of 75% ethyl alcohol
Device extracts 5min, and 10min is stood after extraction, and twice, merging filtrate concentrates, and concentrate crosses HPD100 macroporous resin columns for extraction, according to
Secondary to be washed with 2 times of cylinder ponding, 25% ethyl alcohol, 50% ethyl alcohol, 75% ethyl alcohol and 100% ethyl alcohol, elution flow rate is 3 times of column volumes
Per hour, collect eluent concentration after, be added 19.5 parts of hydroxypropyl-β-cyclodextrins, be fully ground, dry after Radix Salviae Miltiorrhizae extractum packet
Close object；
(2) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Flow velocity 2.5L/h extracts pressure 6.0MPa, extraction temperature
45 DEG C of degree, constant temperature and pressure extract 2h, obtain Essential Oil of Acorus tatarinowii liquid, and 0.36 part of hydroxypropyl-β-cyclodextrin is added, is fully ground,
Obtain Essential Oil of Acorus tatarinowii inclusion compound；
(3) Radix Salviae Miltiorrhizae extractum inclusion compound and Essential Oil of Acorus tatarinowii inclusion compound are crushed, are uniformly mixed, and suitable excipients are added, according to
Chinese herbal granules conventional method is prepared to obtain the final product.
Red sage root composition and its preparation of the comparative example 2 without grass-leaved sweetflag
In parts by weight, it is made of 650 parts of Radix Salviae Miltiorrhizae, 180 parts of schefflera arboricola.
Compound Danshen Root process for producing granula：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, 20min, at room temperature, homogenate extraction are impregnated with 12 times of 75% ethyl alcohol
Device extracts 5min, and 10min is stood after extraction, and twice, merging filtrate concentrates, and concentrate crosses HPD100 macroporous resin columns for extraction, according to
Secondary to be washed with 2 times of cylinder ponding, 25% ethyl alcohol, 50% ethyl alcohol, 75% ethyl alcohol and 100% ethyl alcohol, elution flow rate is 3 times of column volumes
Per hour, collect eluent concentration after, be added 19.5 parts of hydroxypropyl-β-cyclodextrins, be fully ground, dry after Radix Salviae Miltiorrhizae extractum packet
Close object；
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, add 10 times of 75% EtOH Sonicate assisted extraction 55min, 55 DEG C
Reflux extraction 3.5h, extract 2 times, 4000r/min centrifuge 10min, merging filtrate, be concentrated and dried schefflera arboricola medicinal extract, medicinal extract add
Successively with the petroleum ether of 10 times of volumes, dichloromethane, ethyl acetate, extracting n-butyl alcohol after water dilution, n-butyl alcohol extract is through dense
Silica gel (200-300 mesh) column, methylene chloride-methanol 100 are crossed after contracting:0、100:25、100:50、100:100、50:100、25:
100、0:100 gradient elutions, collect fraction respectively, differentiate through TLC and merge component, measure and choose total saponin content highest
Part concentrated, obtain schefflera arboricola fraction extract；
(3) Radix Salviae Miltiorrhizae extractum inclusion compound and seven schefflera arboricola fraction extracts are crushed, are uniformly mixed, and suitable excipients are added, according to
Chinese herbal granules conventional method is prepared to obtain the final product.
Red sage root composition and its preparation of hydroxypropyl-β-cyclodextrin preparation is not used in comparative example 3
In parts by weight, it is made of 650 parts of Radix Salviae Miltiorrhizae, 180 parts of schefflera arboricola, 12 parts of grass-leaved sweetflag.
Compound Danshen Root process for producing granula：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, 20min, at room temperature, homogenate extraction are impregnated with 12 times of 75% ethyl alcohol
Device extracts 5min, and 10min is stood after extraction, and twice, merging filtrate, concentration, concentrate cross HPD100 macroporous resin columns for extraction, according to
Secondary to be washed with 2 times of cylinder ponding, 25% ethyl alcohol, 50% ethyl alcohol, 75% ethyl alcohol and 100% ethyl alcohol, elution flow rate is 3 times of column volumes
Per hour, after collecting eluent concentration, Radix Salviae Miltiorrhizae extractum is obtained after dry；
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, add 10 times of 75% EtOH Sonicate assisted extraction 55min, 55 DEG C
Reflux extraction 3.5h, extract 2 times, 4000r/min centrifuge 10min, merging filtrate, be concentrated and dried schefflera arboricola medicinal extract, medicinal extract add
Successively with the petroleum ether of 10 times of volumes, dichloromethane, ethyl acetate, extracting n-butyl alcohol after water dilution, n-butyl alcohol extract is through dense
Silica gel (200-300 mesh) column, methylene chloride-methanol 100 are crossed after contracting:0、100:25、100:50、100:100、50:100、25:
100、0:100 gradient elutions, collect fraction respectively, differentiate through TLC and merge component, measure and choose total saponin content highest
Part concentrated, obtain schefflera arboricola fraction extract；
(3) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Flow velocity 2.5L/h extracts pressure 6.0MPa, extraction temperature
45 DEG C of degree, constant temperature and pressure extract 2h, obtain Essential Oil of Acorus tatarinowii liquid, Essential Oil of Acorus tatarinowii liquid；
(4) after Radix Salviae Miltiorrhizae extractum and schefflera arboricola fraction extract are crushed, are sufficiently mixed, Essential Oil of Acorus tatarinowii is sprayed into, is added and closes
Suitable auxiliary material, prepares according to Chinese herbal granules conventional method to obtain the final product.
The unreasonable red sage root composition of 4 constituent content of comparative example and its preparation
In parts by weight, it is made of 400 parts of Radix Salviae Miltiorrhizae, 100 parts of schefflera arboricola, 30 parts of grass-leaved sweetflag.
Compound Danshen Root process for producing granula：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, 20min, at room temperature, homogenate extraction are impregnated with 12 times of 75% ethyl alcohol
Device extracts 5min, and 10min is stood after extraction, and twice, merging filtrate concentrates, and concentrate crosses HPD100 macroporous resin columns for extraction, according to
Secondary to be washed with 2 times of cylinder ponding, 25% ethyl alcohol, 50% ethyl alcohol, 75% ethyl alcohol and 100% ethyl alcohol, elution flow rate is 3 times of column volumes
Per hour, collect eluent concentration after, be added 19.5 parts of hydroxypropyl-β-cyclodextrins, be fully ground, dry after Radix Salviae Miltiorrhizae extractum packet
Close object；
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, add 10 times of 75% EtOH Sonicate assisted extraction 55min, 55 DEG C
Reflux extraction 3.5h, extract 2 times, 4000r/min centrifuge 10min, merging filtrate, be concentrated and dried schefflera arboricola medicinal extract, medicinal extract add
Successively with the petroleum ether of 10 times of volumes, dichloromethane, ethyl acetate, extracting n-butyl alcohol after water dilution, n-butyl alcohol extract is through dense
Silica gel (200-300 mesh) column, methylene chloride-methanol 100 are crossed after contracting:0、100:25、100:50、100:100、50:100、25:
100、0:100 gradient elutions, collect fraction respectively, differentiate through TLC and merge component, measure and choose total saponin content highest
Part concentrated, obtain schefflera arboricola fraction extract；
(3) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Flow velocity 2.5L/h extracts pressure 6.0MPa, extraction temperature
45 DEG C of degree, constant temperature and pressure extract 2h, obtain Essential Oil of Acorus tatarinowii liquid, and 0.36 part of hydroxypropyl-β-cyclodextrin is added, is fully ground,
Obtain Essential Oil of Acorus tatarinowii inclusion compound；
(4) Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola fraction extract and Essential Oil of Acorus tatarinowii inclusion compound are crushed, are uniformly mixed,
Suitable excipients are added, are prepared according to Chinese herbal granules conventional method to obtain the final product.
6 red sage root composition pharmacodynamic study of embodiment
Therapeutic effect of 6.1 red sage root compositions to myocardial ischemia in rats
6.1.1 grouping and administering mode
Rat adaptable fed after a week, is divided into 10 groups immediately, every group 5, half male and half female, respectively blank group, model
Group, 1 group of embodiment, 2 groups of embodiment, 6 groups of embodiment, comparative example 1-4 groups, commercially available Composite Salvia Dropping Pill group, are daily 0.18g/
Kg is administered, and Composite Salvia Dropping Pill group is converted into rat daily administration dosage (3 balls/kg), and every sublingual vein is to posterior pituitary
Element causes Model of Acute Myocardial Ischemia by per kg body weight 4U sublingual veins injection of pituitrin (3U/ml).
6.1.2 myocardial infarction and ischemia model
Blank group and model group gavage distilled water, administration group difference gavage each group drug, totally 7 days, after the 7th day is administered 1h,
10% chloral hydrate anesthesia is injected intraperitoneally, lies on the back and is fixed on operating table, posterior pituitary is injected by per kg body weight 4U sublingual veins
Plain (3U/ml) causes Model of Acute Myocardial Ischemia, and after modeling 20min, abdominal aortic blood is placed in and promotees solidifying vacuum blood collection tube
In, 4 DEG C, 3500r/min centrifuges 10min, and separation serum centrifuges to obtain serum.Creatine kinase (CK) in serum is detected using biochemical process
With the content of lactic dehydrogenase (LDH).
6.1.3 experimental result
Table 1 resists myocardial ischemia drug effect result
| Group | N | Dosage | CK(U/L) | LDH(U/L) |
| Blank group | 5 | - | 1296.37±147.32a | 702.33±78.51a |
| Model group | 5 | - | 3217.22±156.41b | 1546.78±101.30b |
| Embodiment 1 | 5 | 0.18g/kg | 1754.21±112.21c | 894.25±54.33c |
| Embodiment 2 | 5 | 0.18g/kg | 1875.14±143.52c | 954.12±96.30c |
| Embodiment 6 | 5 | 0.18g/kg | 1731.31±134.21c | 880.35±58.36c |
| Comparative example 1 | 5 | 0.18g/kg | 2514.67±175.65d | 1314.22±54.21d |
| Comparative example 2 | 5 | 0.18g/kg | 2344.14±153.20d | 1296.45±68.54d |
| Comparative example 3 | 5 | 0.18g/kg | 2314.55±110.01d | 1302.54±78.31d |
| Comparative example 4 | 5 | 0.18g/kg | 2001.30±98.54e | 1143.02±104.38e |
| Commercially available compound danshen dripping pills | 5 | 3 balls/kg | 2115.67±145.32e | 1042.1±121.11e |
Note：Being represented between different letters in same row in table has significant difference.
As shown in Table 1, model group has significant difference with blank group, illustrates modeling success.The CK of embodiment 1,2 and 6
With LDH values there is significant difference compared with comparative example 1-4 and commercially available compound danshen dripping pills, can significantly reduce and make myocardium lack
CK the and LDH values of blood rat illustrate that red sage root composition provided by the invention has the function of preferably treating myocardial ischemia.Combination
Lack the effect of ratio between any type component or adjustment component can all influence composition in object.
Influence of 6.2 red sage root compositions to rat myocardium block range
6.2.1 grouping and administering mode
Wistar rats are randomly divided into 9 groups, and 0.9% physiological saline of 8ml, embodiment 1,2,6, comparative example is administered in model group
1-4 and commercially available Composite Salvia Dropping Pill group.It is administered daily for 0.18g/kg, Composite Salvia Dropping Pill group is converted into rat daily administration
Dosage (3 balls/kg), gastric infusion.
6.2.2 the foundation of rat myocardium block model
Animal amobarbital intraperitoneal injection of anesthesia (45mg/kg) is faced upward position and is fixed.Trachea cannula makees 2cm's on the left of breastbone
The 3rd, the 4th costal cartilage is cut in longitudinal incision, nearly breastbone side, after opening thoracic cavity, connection breathing apparatus (force tolerance 2ml/100g, 50
Secondary/min).Pericardium is cut off, exposure heart, coronary artery left front battle array branch root threading is in case ligation, the record standard II lead hearts
Electrograph is stablized 10 minutes, following coronary artery occlusion left anterior descending branch, and thoracic cavity is closed.Animal throat secretion is sucked out with syringe, makes animal
Restore autonomous respiration.After following coronary artery occlusion 15min, gastric infusion.Hole coronary artery is tied after 4 hours, heart is won, is ligaturing
It is 5 horizontal below line, chlorination nitro is carried out because of slightly blue (N-BT) dyeing of nitrogen, and calculating myocardium infarct plug area area accounts for ventricle and surface of heart
Long-pending percentage
6.2.3 experimental result
Influence of 2 red sage root composition of table to Rat Experimental myocardial infarct size
Note：Being represented between different letters in same row in table has significant difference.
As shown in Table 2, compared with model group, myocardial infarction area is substantially reduced after each group drug therapy, and embodiment 6 is imitated
Fruit is best, and myocardial infarction area is substantially less than the red sage root composition and commercially available compound danshen dripping pills that comparative example 1-4 is provided, explanation
Red sage root composition each component collaboration provided by the invention plays a role, and significantly reduces the range of myocardial infarction, controls coronary heart disease
Treatment has remarkable result.
Protective effect of 6.3 red sage root compositions to SD isolated rat heart reperfusion injuries
6.3.1 experiment packet and administering mode
SD rats are divided into 10 groups.Blank group：With oxygen-containing K-H liquid continuous perfusion 120min；Model group：It is filled with oxygen-containing K-H liquid
After flowing 15min, stop filling 25min, then restore oxygen-containing K-H liquid perfusion 60min；Embodiment 1,2,6, comparative example 1-4 is according to 0.18g/
Kg is administered and commercially available Composite Salvia Dropping Pill group is administered according to 3 balls/kg, and administering mode is：Contained with different when restoring perfusion
Medicine perfusion liquid perfusion, and continue entire refilling process.
6.3.2 experimental method
Chest is opened rapidly after rat abdominal cavity anesthesia, gently lifts heart, cuts superior and inferior vena cava, pulmonary artery, aorta and the heart
Tissue around dirty, rapidly takes out heart together with one section of aorta, and aortic root retains the length of about 0.5-1cm, the standby heart
Dirty intubation is used.It is immediately moved into 4 DEG C of oxygen-containing K-H liquid (K-H liquid ingredients (g/L)：NaCl 6.9g、KCl 0.35g、CaCl2 0.28g、
Anhydrous MgSO4 0.14g、KH2PO4 0.16g、NaHCO32.09g, Glu 2.08g adjust pH value 7.4) in, gently squeeze heart
So that intraventricular residual blood is discharged, cleans heart remained blood, hang on Langendorff perfusion devices, by heart master
Artery ascending branch is connected on the casing of perfusion, and is ligatured and fixed with cotton thread.It is carried out immediately with oxygen-containing K-H liquid, constant temperature (37 ± 0.5) DEG C
Perfusion；Perfusion pressure 70mm mercury column, flow velocity (11.5 ± 0.5) ml/min.In atrium sinistrum, side wall cuts an osculum, and small latex water pocket is led to
It crosses atrioventricular orifice and is inserted into left ventricle.It is full of ultra-pure water in latex water pocket and the conduit being connected, the other end of conduit passes through T joint
Pressure transducer thoroughly removes internal size bubble.The water of intra-ventricle water pocket is adjusted by finely tuning injector makes ventricle relax
It opens end pressure and maintains 4-6mmHg ranges.Left indoor pressure is tested again after stablizing 30min.Each minute heart is recorded with graduated cylinder
Coronary flow；Pressure transducer signal inputs multitrack recording system by bridge amplifier, carries out real time signal aquisition and place
Reason.
Each group record stops after filling preceding and filling again since 10min, every coronary flow (CBF), the left ventricle of 10min
Diastolic pressure (LVEDP), left indoor pressure maximum climbing speed (+dp/dtmax) and left indoor pressure maximum fall off rate (- dp/dtmax),
N=8.
6.3.3 experimental result
Influence of 3 red sage root composition of table to isolated rat heart Reperfu- sion 60min haemodynamics
Note：Being represented between different letters in same row in table has significant difference.
As shown in Table 3, compared with the control group, when model group ischemia-reperfusion 60min, CBF, LVEDP ,+dp/dtmax、-
dp/dtmaxSignificant difference is all had, illustrates Reperfusion injury wound model modeling success.Compared with model group, each administration group is every
Index has clear improvement, and the red sage root composition that wherein embodiment 6 provides mitigates isolated rat heart ischemical reperfusion injury
Best results can inhibit coronary flow caused by ischemia-reperfusion to reduce, left room diastolic pressure rises, raising speed in left indoor pressure maximum
Rate declines, left indoor pressure maximum fall off rate declines.Prompt red sage root composition provided by the invention that can be obviously improved coronary blood flow
Amount, systolic and diastolic function, the cardioprotection ischemical reperfusion injury for improving isolated heart aortic diastolic function and damaged myocardium.And this
It is indispensable to invent the red sage root composition three's component provided, by reasonably matching the therapeutic effect for reaching best.
The clinical therapeutic efficacy of 7 red sage root composition of embodiment
7.1 experimental design：
Using multicenter, random, Double-blind double-dummy test method, selects the age in 45-70 Sui men and women patient, accord with
The case for closing coronary disease and angina pectoris diagnosis CM syndrome differentiation criterion is observation object, and the evaluation compound Danshen Root capsulae enterosolubilis treatment coronary heart disease heart twists
The clinical drug effect of pain.
Treatment and medication：Subject is probabilistically assigned into after test group or control group, receives 4 weeks drug therapies.It controls
Treatment group takes orally the red sage root composition granule of the embodiment of the present invention 1 and 6 respectively, and 3 times a day, 1 packet, bfore meals every time；Control
The red sage root composition granule of group 1-4 difference oral contrast examples 1-4,3 times a day, 1 packet, bfore meals every time.Positive controls,
Commercially available compound danshen dripping pills are taken, 3 times a day, 10 ball, bfore meals every time.
7.2 evaluation index：
It is effective：The cardinal symptoms such as angina pectoris disappear or reach effective standard, and electrocardiogram restores to normal ECG or reaches
Substantially normal (i.e. normal range (NR) electrocardiogram)；
Effectively：The cardinal symptoms such as angina pectoris mitigate or reach effective standard, and electrocardiogram improvement reaches effective standard；
In vain：For the cardinal symptoms such as angina pectoris without improvement, electrocardiogram is substantially identical as before treatment.
It, should be with if both the cardinal symptoms such as angina pectoris curative effect and ECG curative effect are inconsistent when comprehensive therapeutic effect judges
The low result of curative effect is comprehensive therapeutic effect.
7.3 comprehensive therapeutic effect
4 each group red sage root composition comprehensive therapeutic effect of table compares
Note：Being represented between different letters in same row in table has significant difference.
As seen from the above table, red sage root composition provided by the invention can effectively improve the angina pectoris symptom of patients with coronary heart disease, show
It writes and is better than comparative example 1-4 and commercially available compound danshen dripping pills.
Influence of 7.4 red sage root compositions to nitroglycerin service condition
Influence result of 5 red sage root composition of table to nitroglycerin service condition
Note：Rate of descent=(nitroglycerin need not be used before number-treatment of nitroglycerin need not be used after treatment
Number) case load × 100% using nitroglycerin is needed before/treatment
Being represented between different letters in same row in table has significant difference.
As seen from the above table, use of the patient to nitroglycerin can be reduced using red sage root composition provided by the invention, subtracted
The toxic side effect of few drug.
7.5 safety evaluatio
Treat it is forward and backward carry out general vital sign (body temperature, breathing, pulse, blood pressure), blood, urine, stool routine (+occult blood) and
Liver (ALT, AST), the measurement of renal function (BUN, Cr) and ECG examination, observe during entire medication and are likely to occur not
Good reaction, especially digestive tract reaction.There is abnormal number after recording 4 weeks, as a result referring to table 6.
Influence of 6 red sage root composition of table to patient with angina pectoris Safety Evaluation Index
As shown in Table 6, red sage root composition provided by the invention has no adverse effects to Treating Patients of Angina Pectoris, does not disappear
Change road adverse reaction.
Above-mentioned detailed description is illustrating for one of them possible embodiments of the present invention, the embodiment not to
The scope of the claims of the present invention is limited, all equivalence enforcements or change without departing from carried out by the present invention are intended to be limited solely by the technology of the present invention
In the range of scheme.
Claims (10)
1. a kind of red sage root composition for treating coronary heart disease, which is characterized in that the composition includes the Chinese medicine group of following weight parts
Point：500-800 parts of Radix Salviae Miltiorrhizae, 120-300 parts of schefflera arboricola, 5-20 parts of grass-leaved sweetflag.
2. the red sage root composition for the treatment of coronary heart disease according to claim 1, which is characterized in that the composition includes following
The traditional Chinese medicinal components of parts by weight：600-700 parts of Radix Salviae Miltiorrhizae, 150-200 parts of schefflera arboricola, 10-15 parts of grass-leaved sweetflag.
3. the red sage root composition for the treatment of coronary heart disease according to claim 2, which is characterized in that the composition includes following
The traditional Chinese medicinal components of parts by weight：650 parts of Radix Salviae Miltiorrhizae, 180 parts of schefflera arboricola, 12 parts of grass-leaved sweetflag.
4. the red sage root composition for the treatment of coronary heart disease according to claim 1, which is characterized in that the composition further includes closing
Joyous 50 parts of skin.
5. a kind of Chinese medicine preparation containing red sage root composition, which is characterized in that the pharmaceutical preparation is described in claim any one of 1-4
Composition and pharmaceutically acceptable auxiliary material composition.
6. Chinese medicine preparation according to claim 5, which is characterized in that the mass percentage of tanshinone is in the preparation
0.10%-0.50%, tanshin polyphenolic acid B mass percentage are 3%-5%, and total saposins mass percentage is 0.20%-0.40%,
Volatile oil mass percent is 0.02%-0.05%.
7. Chinese medicine preparation according to claim 6, which is characterized in that the pharmaceutically acceptable auxiliary material includes hydroxypropyl-
Beta-cyclodextrin.
8. Chinese medicine preparation according to claim 7, which is characterized in that the Chinese medicine preparation dosage form include granule, tablet,
Capsule, pill.
9. the preparation method of claim 5-8 any one of them composite preparations, which is characterized in that include the following steps：
(1) extraction of Radix Salviae Miltiorrhizae：After Radix Salviae Miltiorrhizae drying and crushing, ethyl alcohol impregnates, and flash extracter extraction, concentration, concentrate cross HPD100
After collecting eluent concentration, hydroxypropyl-β-cyclodextrin, grinding, drying is added successively through washing, ethyl alcohol washing in macroporous resin column
Radix Salviae Miltiorrhizae extractum inclusion compound is obtained afterwards；
(2) extraction of schefflera arboricola：After schefflera arboricola drying and crushing, after EtOH Sonicate assisted extraction, Soxhlet extractor reflux extraction, filter
Liquid is concentrated and dried to obtain schefflera arboricola medicinal extract, and medicinal extract uses petroleum ether, dichloromethane, ethyl acetate, n-butanol extraction successively after being diluted with water
It takes, silicagel column, methylene chloride-methanol 100 is crossed after n-butyl alcohol extract is concentrated:0~0:100 gradient elutions are collected evaporate respectively
Point, differentiate through TLC and similar compositions are merged, are concentrated, obtains schefflera arboricola fraction extract；
(3) extraction of grass-leaved sweetflag：Grass-leaved sweetflag crushes, supercritical CO2Extraction obtains Essential Oil of Acorus tatarinowii liquid, and hydroxy propyl-Beta-is added
Cyclodextrin is included, and Essential Oil of Acorus tatarinowii inclusion compound is obtained；
(4) extraction of cortex albiziae：Cortex albiziae adds alcohol reflux to extract through petroleum ether degreasing, and filtrate is concentrated and dried to obtain cortex albiziae leaching
Cream uses petroleum ether, dichloromethane, ethyl acetate, extracting n-butyl alcohol successively after medicinal extract dissolving, after butanol extraction liquid concentration, warp
Alumina column elutes, ethanol elution, and eluent is concentrated and dried up to silktree albizia bark extract；
(5) Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola fraction extract and Essential Oil of Acorus tatarinowii inclusion compound are crushed, are uniformly mixed, and are added
Suitable excipients are prepared according to Chinese medicine preparation conventional method to obtain the final product；Or Radix Salviae Miltiorrhizae extractum inclusion compound, schefflera arboricola fraction extract, stone Chang
Pu volatile oil clathrate compound and silktree albizia bark extract are crushed, are uniformly mixed, and suitable excipients are added, according to Chinese medicine preparation conventional method system
For to obtain the final product.
10. application of any one of the claim 1-4 compositions on preparing treatment medicaments for coronary disease.
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