CN104306437B - A kind of for Chinese medicinal granular formulation treating cardiovascular disease and preparation method thereof - Google Patents
A kind of for Chinese medicinal granular formulation treating cardiovascular disease and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a kind of for Chinese medicinal granular formulation treating cardiovascular disease and preparation method thereof, belong to the field of Chinese medicines.The Chinese medicinal granular formulation of the present invention is made up of Chinese medicine extract and adjuvant.The weight ratio of described Chinese medicine extract and adjuvant is 10:0.8～1.5；Described Chinese medicine extract by weight portion is: Radix Salviae Miltiorrhizae 30 parts, Radix Notoginseng 10 parts and Radix Et Caulis Acanthopanacis Senticosi 20 parts are made, and described adjuvant is the hydroxypropyl methyl cellulose of the pregelatinized Starch of 1～5 weight portion, the HP-β-CD of 5～10 weight portions, the Aspartame of 0.5 weight portion and 1～5 weight portion.
Description
Technical field
The present invention relates to a kind of for Chinese medicinal granular formulation treating cardiovascular disease and preparation method thereof, belong to the field of Chinese medicines.
Background technology
According to China's Epidemiological study, no matter in rural area or city over nearly 50 years, the M & M of cardiovascular and cerebrovascular disease is all in rising trend.50-60 age China population cause of death cardiovascular disease and cerebrovascular occupy the five or six respectively, then rise to the two or three respectively after 1970, and cardiovascular and cerebrovascular disease died has accounted for whole disease causes of the death first.China is part proportioning of total dead population because cardiovascular and cerebrovascular disease died accounts for, risen to the 42.6% of calendar year 2001 by the 12.07% of nineteen fifty-seven, person reaches 2,000,000 to die from cardiovascular and cerebrovascular disease every year, though separately there being some patients to survive through rescue, but majority leaves deformity, can't take care of oneself, cause serious burden to relatives and society.Cardiovascular and cerebrovascular disease Ye Shi western countries crowd's main causes of death.Speculating according to current existing epidemiologic data, advancing of disease trend is: to the year two thousand twenty, and the human diseases cause of the death puts in order will great change, but coronary heart disease and apoplexy will be first and seconds of mankind's cause of the death.Till that time, estimation whole world coronary heart disease death number will increase to 11,000,000 from the 6300000 of nineteen ninety；Apoplexy increases to 7,700,000 from 4,400,000.In 30 years, blood circulation Disease structure will increase 59.6%, and coronary heart disease and apoplexy increase 74.6% and 75% respectively.These data absolutely prove, cardiovascular and cerebrovascular disease is not only the principal disease of harm human health, especially at present and in following 20 years, the mankind are lethal, " number one killer " disabled.
In the medicine of cardiovascular and cerebrovascular disease, the application of Chinese medicine and western medicine emphasizes particularly on different fields, and Chinese medicine also takes up the bigger market share with the advantage that its side effect is little.Such as: the Yiqi Huoxue Recipe that is made up of Radix Ginseng, Radix Codonopsis, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Flos Carthami [Zhu Weifeng, Shandong College of Traditional Chinese Medicine's journal, 1994,18 (5)]；Added Radix Salviae Miltiorrhizae by SHENGMAI YIN, red stilbene SHENGMAI YIN that Radix Ginseng, Radix Notoginseng, Flos Carthami, Rhizoma Corydalis, Fructus Crataegi form, [Chen Yuchun, the bright traditional Chinese medical science, 1999,14 (5)]；The coronary heart disease being made up of Radix Ginseng, Radix Codonopsis, Radix Ophiopogonis, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Lignum Dalbergiae Odoriferae substantially square [Wang Jinrong etc., Liaoning Journal of Traditional Chinese Medicine, 2001,28 (8)]；The Shuxintongmai sheet that is made up of Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Radix Ginseng, Radix Notoginseng, Rhizoma Chuanxiong, Radix Angelicae Sinensis [Wang Xiue etc., Shandong journal of Chinese medicine, 1997,16 (8)]；Etc..But above clinical prescription and Chinese patent medicine all have certain weak point, or are partial to QI invigorating, or relatively activate yang, or relatively invigorate blood circulation, and are popularized in an all-round way clinically.And dosage form mostly is traditional conventional tablet, capsule etc., production technology is more backward, and active constituent content is low, without quality control standard, therefore, the Chinese medicine utilizing the new treatment cardiovascular disease particularly coronary heart disease of new technology development is the target that numerous medical personal make great efforts.
Three ginseng electuaries, are made up of Radix Salviae Miltiorrhizae, Radix Et Caulis Acanthopanacis Senticosi and Radix Notoginseng, and the weight proportion between three is followed successively by 25:1:1.Radix Et Caulis Acanthopanacis Senticosi has another name called " Radix Acanthopanacis Senticosi ", and Radix Notoginseng has another name called " Radix Notoginseng ", and the two is with monarch drug Radix Salviae Miltiorrhizae prescription, adds suitable amount of sucrose and dextrin is gained the name three ginseng grains in Chinese medicine extract.It is clinically used for coronary heart diseases and angina pectoris, apoplexy sequela etc..Clinical practice more than 30 year, determined curative effect.But it has preparation technology and falls behind, quality is uncontrollable, the shortcoming that supplementary product consumption is relatively big and preparation stability is bad, and the proportioning about three ginseng Chinese medicine compositions is unreasonable, can not give full play to three taste Chinese medicines synergism in treatment cardiovascular disease in three ginsengs.
Summary of the invention
An object of the present invention is in that to overcome the deficiencies in the prior art, it is provided that a kind of Chinese medicinal granular formulation treating cardiovascular disease.
The Chinese medicinal granular formulation of the present invention is made up of Chinese medicine extract and adjuvant.The weight ratio of described Chinese medicine extract and adjuvant is 10:0.8～1.5；Described Chinese medicine extract by weight portion is: Radix Salviae Miltiorrhizae 30 parts, Radix Notoginseng 10 parts and Radix Et Caulis Acanthopanacis Senticosi 20 parts are made, and described adjuvant is the hydroxypropyl methyl cellulose of the pregelatinized Starch of 1～5 weight portion, the HP-β-CD of 5～10 weight portions, the Aspartame of 0.5 weight portion and 1～5 weight portion.
Further carry out in scheme in the present invention, the weight ratio of described Chinese medicine extract and adjuvant is preferably 10:1, and the weight portion of described adjuvant is preferably the hydroxypropyl methyl cellulose of the pregelatinized Starch of 3 weight portions, the HP-β-CD of 8 weight portions, the Aspartame of 0.5 weight portion and 2 weight portions.
It is a further object to provide a kind of method preparing described Chinese medicinal granular formulation, specifically comprise the following steps that
(1) red rooted salvia of corresponding weight portion is taken, the alcohol reflux with the 90% of 8 times amount 1.5 hours, extracts 2 times, filters, concentrating under reduced pressure, obtain tanshinol extracted extract；By the filtering residue soak by water 1 hour with 8 times amount, extract 2 times, filter, concentrating under reduced pressure, obtain Salvia miltiorrhiza Bge water extracted extract；
(2) take Radix Et Caulis Acanthopanacis Senticosi and the Radix Notoginseng of corresponding weight portion, extract 2 hours with 75% alcohol heating reflux, extract 2 times, filter, concentrating under reduced pressure, obtain the alcohol-extracted extract of Radix Et Caulis Acanthopanacis Senticosi and Radix Notoginseng,
(3) extractum in step 1 and 2 is merged, drying under reduced pressure, mix and obtain described Chinese medicine extract；
(4) Chinese medicine extract obtained in step 3 adds the auxiliary materials and mixing of corresponding weight portion, makes soft material with 60% ethanol as wetting agent, granulate, dry, to obtain final product.
Three traditional ginseng electuaries are optimized by the present invention by lot of experiments research, greatly improve drug effect；There is great clinical value, give certain enlightenment effect to the synergism improving Chinese medicine compound.In addition, the present invention gropes to obtain the preferred plan of ratio of adjuvant and consumption by lot of experiments research, adopt above-mentioned adjuvant can overcome the hygroscopic problem of extractum, and improve the stability of three ginseng grains greatly, and content of active component in granule is stable, difference is little；Ensure that the stability of the homogeneity of compound medicine and content uniformity.
Detailed description of the invention
The detailed description present invention further below.It is pointed out that following description is only the illustration to claimed technical scheme, the not any restriction to these technical schemes.The content that protection scope of the present invention is recorded with appended claims is as the criterion.
The preparation of embodiment 1 Chinese medicine extract
(1) red rooted salvia of 30kg is taken, the alcohol reflux with the 90% of 8 times amount 1.5 hours, extracts 2 times, filters, concentrating under reduced pressure, obtain tanshinol extracted extract；By the filtering residue soak by water 1 hour with 8 times amount, extract 2 times, filter, concentrating under reduced pressure, obtain Salvia miltiorrhiza Bge water extracted extract；
(2) take Radix Et Caulis Acanthopanacis Senticosi and the 10kg Radix Notoginseng of 20kg, extract 2 hours with 75% alcohol heating reflux, extract 2 times, filter, concentrating under reduced pressure, obtain the alcohol-extracted extract of Radix Et Caulis Acanthopanacis Senticosi and Radix Notoginseng,
(3) extractum in step 1 and 2 is merged, drying under reduced pressure, mix and obtain described Chinese medicine extract 758.6g.
The preparation of embodiment 2-4 Chinese medicine granules
In the Chinese medicine extract obtained, add the auxiliary materials and mixing of corresponding weight portion, make soft material with 60% ethanol as wetting agent, granulate, dry, to obtain final product；Described Chinese medicine extract and ratio of adjuvant and adjuvant particular make-up are referring to following table:
Test example 1
(1) duplication of animal cardiac muscle ischemia model and medication
Male SD rat, body weight 250 ± 50g, often group 10.Sham operated rats: gavage the aqueous solution of equivalent；Model group: gavage the aqueous solution of equivalent；Each treated animal all gives test medicine (5ml/kg) by body weight gavage.Every day 1 time, altogether administration 7 times.It is administered latter 30 minutes at last, 1% pentobarbital sodium intraperitoneal injection of anesthesia, rat is faced upward position and is fixed on self-control Mus plate.Chest cropping, preserved skin, be embedded in left lower extremity by ECG electrode pin and right upper extremity be subcutaneous, cuts off the 4th rib in left side, by vascular forceps along the 4th rib blunt separation Intercostal muscle 3cm length, opens thoracic cavity, struts rib, heart is extruded thoracic cavity.2mm place ophthalmology pin 6-0 silk thread threading below left auricle, depth of needle is about 1-1.5mm, wide about 2-3mm, together with great cardiac vein following coronary artery occlusion left anterior descending branch (sham operated rats threading not ligation).After ligation, heart is put back to rapidly thoracic cavity.Electrocardiogram display ST section greatly drives up or during abnormality Q wave;Namely acute myocardial ischemia modeling success is shown.Sew up rapidly thoracic wall, stop artificial respiration, remove respiratory secretions, sew up and close trachea, put to death after 24h.The ligation 10min ECG ST section person of being not changed in eliminates.
The mensuration of myocardial ischemia infarct size percentage ratio: postoperative 24h, postanesthetic rat is opened thoracic cavity, take off rapidly heart, put-20 DEG C of freezing 20min, below ligature, left ventricle is cut into the 4-5 sheet that thickness is 2mm, put in 1%TTC solution, dye 15min when 37 DEG C of water-baths, lucifuges, infarcted region not painted (white), and redness is dyed in non-infarcted region, 1% paraformaldehyde fixes 12h, according to formula 1 Image-J (NIH) computed in software Infarct area percentage ratio.Myocardial infarction area percentage ratio (S) %=Infarct area/left ventricle gross area × 100%.
Left room hemodynamic index measures: postoperative 24h, is again anaesthetized by rats by intraperitoneal injection 1% pentobarbital sodium (50mg/kg), then intravenous injection heparin whole body anticoagulant, and physiograph detection cardiac hemodynamic parameter is applied in operation after separating right common carotid artery.Intubate to left ventricular recording pressure curve, record left room maximum collapse (+) and diastole (-) speed (± dp/dtmax).
(2) concrete outcome is as follows:
In all test examples, in order to the effect of the present invention is described, spy arranges four comparative examples, specific as follows:
Comparative example 1: Radix Salviae Miltiorrhizae: Radix Notoginseng: the weight proportion of Radix Et Caulis Acanthopanacis Senticosi is 30:5:15, and preparation method is with embodiment 1；
Comparative example 2: Radix Salviae Miltiorrhizae: Radix Notoginseng: the weight proportion of Radix Et Caulis Acanthopanacis Senticosi is 30:25:30, and preparation method is with embodiment 1；
Comparative example 3: referring to the embodiment 2 in patent CN101085008A；Radix Salviae Miltiorrhizae: Radix Notoginseng: the weight proportion of Radix Et Caulis Acanthopanacis Senticosi is 20:2:3；
Comparative example 4: referring to three ginseng electuaries, Radix Salviae Miltiorrhizae: Radix Notoginseng: the weight proportion of Radix Et Caulis Acanthopanacis Senticosi is 25:1:1 in " Heilongjiang Provincial Hospital's preparation specification "；
Myocardial ischemia infarct size:
* or * * be medicine group compared with model group, T check P < 0.05 or 0.01, T inspection P < 0.05 or 0.01.
Left room hemodynamic index:
* or * * be medicine group compared with model group, T check P < 0.05 or 0.01, T inspection P < 0.05 or 0.01.
The test example 2 impact on rat myocardial cell
(1) rat myocardial cell primary culture method: take out the SD neonatal rat 25 in raw 24h, after heart all takes out, rejecting blood clotting and the fibrous tissue of heart periphery, Digestive system (0.125% pancreatin+0.05% II Collagenase Type) digests, and collects cell, it is filtered to remove and does not digest tissue, it is inoculated in culture bottle, puts in cell culture incubator (37 DEG C, 95%O2+5%CO2) and cultivate, fibrocyte, purification myocardial cell is removed with differential attachment method.After 2h, the not yet adherent cell suspension of sucking-off blows even, adjusts density and implants (every hole 500 μ l) in 24 orifice plates to 1 × 10-6, makes cell be uniformly distributed, and adds Brdu to 0.1mmol/L, 24h and changes liquid once, and every 3-4d changes liquid once later.The regularly situation of observation of cell growth under inverted microscope, after cultivating 48h, random packet is tested.
Cell is inoculated in 24 orifice plates with the density of 1 × 106/ml, every hole 500 μ l.37 DEG C, 5%CO2 saturated humidity when cultivate.After primary myocardial cell culture 72h, Normal group and model group are normally cultivated with 500 μ lDMEM culture fluid, each administration group adds the DMEM culture fluid containing 10% medicinal liquid, after hatching 6h, rinsing 2 times with ice-cold PBS, model group and the every hole of administration group add 500 μ l through Tyrode liquid saturated for 95%N2-5%O2, then culture plate is put into a hermetic container, continuing to pass to hermetic container after mixing gas (95%N2-5%O2) 30min, put into incubator anoxia 12h, simulation is at body ischemia model.Normal group adds cultivation 12h in Tyrode liquid 500 μ l, the CO2 incubator containing 10g/L glucose after cleaning old culture medium.
Every hole adds final concentration of 0.5mg/mlMTT serum-free DMEM culture fluid 500 μ l and cultivates 4h, then incline supernatant, adds the DMSO of 500 μ l, jolting 10min, the absorbance (OD570nm) at 570nm place is measured, for quantitative cell survival rate by full-automatic microplate reader.
200 μ l culture supernatant are drawn in the every hole of culture plate after processing, illustrates according to LDH detection kit, detect LDH activity.
(2) concrete outcome is as follows:
The impact on the rat myocardial cell of Anoxia of each single medicinal material, by Radix Salviae Miltiorrhizae extract for Radix Salviae Miltiorrhizae alcohol extraction and the water extracted immersing paste being mixed and get final product, the extract of two taste medicines is extracted and obtained to Radix Et Caulis Acanthopanacis Senticosi and Radix Notoginseng respectively, and the preparation method of each extract is with embodiment 1.
Cell survival rate (MTT) and LDH activity:
Test example 3 stability test
Investigate correlated samples stability according to the stability guideline of 2010 editions two annex of Chinese Pharmacopoeia, investigated respectively, place the medicine stability of 60 days under 25 DEG C and relative humidity 75% condition.HPLC method is adopted to measure the content of syringoside, tanshinone ⅡA and salvianolic acid B in granule.
It addition, be the superiority embodying granule of the present invention, ad hoc fixed following comparative example:
Comparative example 1: without any adjuvant, other are with embodiment 2；
Comparative example 2: adjuvant is hydroxypropyl methyl cellulose, consumption and other are with embodiment 3；
Comparative example 3: Chinese medicine extract and supplementary product consumption are than for 10:2, and other are with embodiment 3；
The weight ratio of 4: four kinds of adjuvants of comparative example is 1:1:0.1:0.5, and other are with embodiment 3；
The weight ratio of 5: four kinds of adjuvants of comparative example is 1:6:0.5:2, and other are with embodiment 3；
Each group Effective Component of Chinese Medicine content (n=10) after placing 60 days under 25 DEG C and relative humidity 75% condition
It addition, sample after taking above-mentioned test, requiring to carry out detection disintegration with reference to 2010 editions annex XIIA of Chinese Pharmacopoeia, result is as follows:
Place 60 days under 25 DEG C and relative humidity 75% condition
Embodiment 5
Adopt fixed funnel method (Xi Nianzhu edits " pharmaceutics " third edition) to measure the angle of repose of granule before sample fill, and measure the granularity qualification rate of sample.Granularity qualification rate=[weight of conforming particle/(weight of the weight+adjuvant of dry extract)] X100%；Conforming particle standard can pass through a sieve can not pass through the granule of No. four sieves.
Result is as follows:
Present invention merely illustrates some claimed specific embodiments; technical characteristic described in one of them or more technical scheme can be combined with arbitrary one or more technical schemes; the technical scheme that these are combined and obtain is also in the application protection domain, technical scheme that is combined just as these and that obtain specifically has been recorded in the disclosure of invention.
Claims (3)
1. the Chinese medicinal granule treating cardiovascular disease, it is characterised in that be made up of Chinese medicine extract and adjuvant；The weight ratio of described Chinese medicine extract and adjuvant is 10:1；Described Chinese medicine extract by weight portion is: Radix Salviae Miltiorrhizae 30 parts, Radix Notoginseng 10 parts and Radix Et Caulis Acanthopanacis Senticosi 20 parts are made, and described adjuvant is the hydroxypropyl methyl cellulose of the pregelatinized Starch of 3 weight portions, the HP-β-CD of 8 weight portions, the Aspartame of 0.5 weight portion and 2 weight portions.
2. the preparation method of Chinese medicinal granule described in a claim 1, it is characterised in that: specifically comprise the following steps that
(1) take the red rooted salvia of corresponding weight portion, with the alcohol reflux 1.5 hours of the 70%-95% of 6-10 times amount, extract 2 times, filter, concentrating under reduced pressure, obtain tanshinol extracted extract；By the filtering residue soak by water 1 hour with 6-10 times amount, extract 2 times, filter, concentrating under reduced pressure, obtain Salvia miltiorrhiza Bge water extracted extract；
(2) take Radix Et Caulis Acanthopanacis Senticosi and the Radix Notoginseng of corresponding weight portion, extract 2 hours with 70-90% alcohol heating reflux, extract 2 times, filter, concentrating under reduced pressure, obtain the alcohol-extracted extract of Radix Et Caulis Acanthopanacis Senticosi and Radix Notoginseng；
(3) extractum in step 1 and 2 is merged, drying under reduced pressure, mix and obtain described Chinese medicine extract；
(4) Chinese medicine extract obtained in step 3 adds the auxiliary materials and mixing of corresponding weight portion, makes soft material with 60% ethanol as wetting agent, granulate, dry, to obtain final product.
3. the application in preparation treatment cardiovascular disease medicine of the Chinese medicinal granule described in a claim 1.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101085008A (en) * | 2006-06-08 | 2007-12-12 | 天津天士力制药股份有限公司 | Composition containing acanthopanax root for treating cardiovascular diseases and its preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101085008A (en) * | 2006-06-08 | 2007-12-12 | 天津天士力制药股份有限公司 | Composition containing acanthopanax root for treating cardiovascular diseases and its preparation |
Non-Patent Citations (1)
| Title |
|---|
| 中医药治疗心血管疾病循证医学研究进展;袁兆明;《辽宁中医药大学学报》;20110131;第13卷(第1期);16-18 * |
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