CN105832788A - Drug composition for treating cardiovascular and cerebrovascular diseases - Google Patents
Drug composition for treating cardiovascular and cerebrovascular diseases Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K31/201—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having one or two double bonds, e.g. oleic, linoleic acids
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- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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Abstract
The invention relates to a drug composition for treating cardiovascular and cerebrovascular diseases .The drug composition for treating cardiovascular and cerebrovascular diseases is prepared from, by weight, 24-60 parts of nervonic acid, 48-90 parts of panax notoginseng saponins and 10-38 parts of breviscapine .The three active ingredients are combined in a particular proportion for usage, have an unexpected therapeutic effect on the aspect of treatment of the heart and cerebral vessels compared with one or two single ingredient and have no toxic or side effect .In addition, when the drug composition is prepared into dropping pills, the effect is optimum .Especially, when a preferable formula of the drug composition is adopted, namely matrix auxiliary materials in the dropping pills are used as mixed matrix auxiliary materials based on the 10:3 weight ratio of xylitol to lactose, and a plasticizer auxiliary material is Arabic gum, the prepared dropping pills are round, regular, uniform in size, consistent in color and luster and free of adhesion phenomena .
Description
Technical field
The present invention relates to drug world, relate in particular to a kind of pharmaceutical composition for treating cardiovascular and cerebrovascular disease.
Technical background
According to China's Epidemiological study, in recent years, the M & M of cardiovascular and cerebrovascular disease is the most in rising trend.
China is part proportioning of total dead population because cardiovascular and cerebrovascular disease died accounts for, and is risen to calendar year 2001 by the 12.07% of nineteen fifty-seven
42.6%, 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 stays
Deformity, can't take care of oneself, and causes serious burden to relatives and society.Cardiovascular and cerebrovascular disease Ye Shi western countries crowd death
Main cause.Speculating according to current existing epidemiologic data, advancing of disease trend is: to the year two thousand twenty, human diseases is dead
To there is great change because putting in order, but coronary heart disease and apoplexy will be first and seconds of mankind's cause of the death.Arrive 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 moneys
Material absolutely proves, cardiovascular and cerebrovascular disease is not only the principal disease of harm human health, especially the mankind at present and in following 20 years
Lethal, that disable " number one killer ".
In the medicine of cardiovascular and cerebrovascular disease, the application of Chinese medicine and western medicine emphasizes particularly on different fields, and Chinese medicine is with little excellent of its side effect
Gesture also takes up the bigger market share.Such as: the Yiqi Huoxue Recipe being made up of Radix Ginseng, Radix Codonopsis, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Flos Carthami [wishes dimension
Peak, Shandong College of Traditional Chinese Medicine's journal, 1994,18 (5)]；Added Radix Salviae Miltiorrhizae by SHENGMAI YIN, Radix Ginseng, Radix Notoginseng, Flos Carthami, Rhizoma Corydalis, Fructus Crataegi form
Red stilbene SHENGMAI YIN, [Chen Yuchun, the bright traditional Chinese medical science, 1999,14 (5)]；It is made up of Radix Ginseng, Radix Codonopsis, Radix Ophiopogonis, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Lignum Dalbergiae Odoriferae
Coronary heart disease substantially square [Wang Jinrong etc., Liaoning Journal of Traditional Chinese Medicine, 2001,28 (8)]；By Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Radix Ginseng, Radix Notoginseng, Rhizoma Chuanxiong,
The Shuxintongmai sheet [Wang Xiue etc., Shandong journal of Chinese medicine, 1997,16 (8)] of Radix Angelicae Sinensis composition；Etc..But above clinical prescription and
Chinese patent medicine all has certain weak point, or relatively QI invigorating, or relatively activates yang, or relatively invigorates blood circulation, and is pushed away the most comprehensively
Extensively.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 treating cardiovascular and cerebrovascular disease particularly coronary heart disease utilizing new technology development new is vast medicine work
The target that person makes great efforts.
Also some are had sporadicly to report additionally, have treatment cardiovascular and cerebrovascular disease about some biological active constituents from natural medicines,
" progress of nervonic acid ", Gong's honey etc. " China's apiculture ", volume 62 the 40-53 page, in documents in 2011, introduce nervonic acid
Source can be animal, plant even chemistry or biosynthesis, in terms of pharmacology, discloses its prevention and treatment encephalopathy, resists
Tumor, effect to multiple sclerosis, and blood lipid-reducing blood sugar-decreasing and the effect to cardiovascular system diseases；In Chinese patent application
Disclosing in 03114658.9 and Acer Truncatum Buge kind seed extract is prepared as soft capsule and fatty acid, it is applicable to the old cancerous and the heart
Cerebrovascular disease；But no matter be periodical literature or patent documentation, it is applied in cardiovascular and cerebrovascular disease not provide about it
Any concrete data, more do not account for coordinating it with the medicine of other the most suitable treatment cardiovascular and cerebrovascular disease, with
Phase reaches the purpose of actual application.
At present, Chinese patent 200710077979.2 discloses a kind of medicine for treating cardiovascular and cerebrovascular vessel, wherein contains
The Radix Astragali, Radix Puerariae, breviscapine etc., wherein the content of breviscapine is trace, and it is at neurologic impairment evaluation, blood fat and improving etc.
Aspect has certain effect；Chinese patent 200610014243.6 discloses a kind of combination containing erigeron breviscapus for treating cardiovascular diseases
Thing and preparation thereof, wherein comprise Radix Notoginseng, Herba Erigerontis, Radix Salviae Miltiorrhizae etc. in raw material, result shows, it damages at Ischemic/reperfused Myocardium
The protection aspect of wound has certain effect；But the application is it has been found that these prior art controlling at cardiovascular system diseases
Therapeutic effect is not notable, and technology develops over nearly 10 years, obtains significant curative effect the most clinically；
Further, applicant finds in concrete research, single nervonic acid, and Radix Notoginseng disclosed in prior art
Although each have the fragmentary report at treatment cardiovascular system diseases with Herba Erigerontis, exist yet with these components itself
Various defects or deficiency, effect inconspicuous in actual medicinal application；Surprisingly, it has been found that when by this three
After kind component combines with specific ratio, it is compared each single dose and has unforeseeable effect in terms for the treatment of cardiovascular system diseases
Really.
Summary of the invention
An object of the present invention is to overcome the deficiencies in the prior art, it is provided that a kind of medicine for treating cardiovascular and cerebrovascular vessel
Compositions, it is characterised in that described pharmaceutical composition comprises the raw material of following weight portion: nervonic acid 24-60, Radix Notoginseng total arasaponins
48-90, breviscapine 10-38.
Preferably, described pharmaceutical composition comprises the raw material of following weight portion: nervonic acid 32-55, Radix Notoginseng total arasaponins 56-
70, breviscapine 15-30.
It is highly preferred that described pharmaceutical composition comprises the raw material of following weight portion: nervonic acid 40, Radix Notoginseng total arasaponins 65, lamp
Small cup florigen 20.
Further, the invention still further relates to a kind of drug combination preparation for treating cardiovascular and cerebrovascular vessel, said preparation is by upper
State acceptable adjuvant on pharmaceutical composition and one or more pharmaceuticss to make.
Said preparation can be prepared as drop pill, capsule, soft capsule, granule or tablet.
Preferably, described preparation is drop pill；Further, the composition of described drop pill be the effective ingredient by 1-5 weight portion,
The substrate adjuvant of 1-20 weight portion and the plasticizer auxiliary material combination of 1-10 form:
Described substrate adjuvant is selected from Polyethylene Glycol, monosaccharide, oligosaccharide, polysaccharide, sugar ester, sugar alcohol, fruit acid, higher fatty acids
One or more in derivant, high fatty alcohol, polyhydric alcohol, carbamide or polyethylene oxide derivant；
Described plasticizer adjuvant selected from starch and derivant thereof, cellulose and its derivates, arabic gum, dextran,
Chitin, sesbania gum, carrageenan, Ficus elastica, Furcellaran, tragakanta, carrageenin, tamarind gum, pectin, xanthan gum, sea
One or more in alginic acid and salt, dextrin, cyclodextrin, agar or lactose.
Preferably, the composition of described drop pill is by the effective ingredient of 1 weight portion, the substrate adjuvant of 8 weight portions and 2 weight portions
Plasticizer auxiliary material combination.
Preferably, the substrate adjuvant in described drop pill be xylitol and lactose auxiliary with the mixed-matrix that weight ratio is 10: 3
Material, plasticizer adjuvant is arabic gum.
The conventional method that the preparation of described drop pill uses this area to prepare drop pill prepares.
Further, the invention still further relates to aforementioned pharmaceutical compositions application in preparation treatment cardiovascular medicament.
Further, the invention still further relates to aforementioned pharmaceutical compositions preparation answering in preparation treatment cardiovascular medicament
With.
About above-mentioned active component nervonic acid, Radix Notoginseng total arasaponins and the source of breviscapine:
Nervonic acid can be to extract from plant, such as, extract from the plant such as Acer Truncatum Buge, malania oleifera and obtain, it is also possible to be logical
Cross other method, such as, obtained by the method such as chemosynthesis, biosynthesis；It can also be commercially available prod.
Preferably, preparation is extracted in described nervonic acid from Malania Oleifera Oil, specifically includes following steps:
(1) slightly extract: in Malania Oleifera Oil, add the ethanol of 2-5 times amount 70-100%, stir into homogeneous solution, to described
Adding sodium hydroxide or the potassium hydroxide solution of the 20-40% of Malania Oleifera Oil quality 1-3 times amount in solution, heated and stirred is to saponification
Reaction completely, filters, acidification of filtrate to pH3-4, stands, and the solidification of collection upper strata is saponified, is washed to neutrality, drips moisture to the greatest extent,
Nervonic acid crude product；
(2) crystallization: take described nervonic acid crude product, carry out following crystallization operation:
The dehydrated alcohol of 3.8～4.2 times amount and the mixing that volume ratio is 1: 1 of acetone is added in described nervonic acid crude product
Solution, 60～70 DEG C are heated to reflux making dissolving, filter, and collect filtrate and in-5～-10 DEG C of standing, centrifugal, collect and crystallize；Described
Crystallization operation obtains nervonic acid primary crystal；
(3) recrystallization: repeat crystallization operation in step (2) 2-7 time, in crystallizing to gained, nervonic acid monomer contains
Amount is not less than 85%, to obtain final product.
The term that Radix Notoginseng total arasaponins is known in the art, can use any conventional method to prepare, as long as quality meets 2010
" Radix Notoginseng total arasaponins " quality standard that version Chinese Pharmacopoeia one records, it is also possible to be commercially available prod.
Preferably, the preparation method of described Radix Notoginseng total arasaponins is:
Pseudo-ginseng is ground into coarse powder, with 12-20 times amount 50-90% alcohol reflux 2-4 time, each 1-3 hour,
Extracting solution merges after filtering, and decompression recycling ethanol obtains extract, adds pseudo-ginseng quality 0.5-that feeds intake in described extract
The water of 2 times amount, filters, and on filtrate, the absorption of AB-8 macroporous adsorptive resins, is washed to effluent substantially colorless, then uses 50-
80% ethanol elution, gained eluent crosses chromatography neutral alumina column and decolours remove impurity, decompression recycling ethanol, vacuum drying,
Radix Notoginseng total arasaponins, after inspection meets version Chinese Pharmacopoeia Radix Notoginseng total arasaponins quality standard in 2010, to obtain final product.
It is highly preferred that the preparation method of described Radix Notoginseng total arasaponins is: pseudo-ginseng is ground into coarse powder, by 16 times amount 70%
Alcohol reflux 3 times, each 2 hours, extracting solution merged after filtering, and decompression recycling ethanol obtains extract, to described extract
Middle addition feeds intake the water of pseudo-ginseng quality 1 times amount, filters, AB-8 macroporous adsorptive resins absorption filtrate on, is washed to outflow
Liquid is substantially colorless, then uses 75% ethanol elution, gained eluent to cross chromatography neutral alumina column and decolours remove impurity, recovered under reduced pressure
Ethanol, vacuum drying, obtain Radix Notoginseng total arasaponins, after inspection meets version Chinese Pharmacopoeia Radix Notoginseng total arasaponins quality standard in 2010, to obtain final product.
The term that breviscapine is also known in the art, can use any conventional method to prepare, as long as quality meets 2010
" breviscapine " quality standard that version Chinese Pharmacopoeia one records, it is also possible to be commercially available prod.
Preferably, the preparation method of described breviscapine is:
(1) to be heated to boiling treated water in add Herba Erigerontis, be heated to boiling and keep seething with excitement one section time
Between, obtain breviscapine leachate；
(2) put in sedimentation tank after breviscapine leachate being filtered and this solution is kept heating；At sedimentation tank thermosol
Adding hydrochloric acid in liquid, regulation pH value, to 1.5-2.5, stands to precipitation completely, to obtain precipitate；
(3) by described drying precipitate, breviscapine product is obtained；
Wherein, described treated water processes through following steps: 500kg water is heated to boiling；To boiling
Water in add reducing agent 50g, Ovum Gallus domesticus album 200g, Sal 500g, sucrose 500g and carry out processing for the first time, described reducing agent is anti-
Bad hematic acid；In the water through processing for the first time, add sodium hydroxide (NaOH) solution, regulate pH to 8.5-9.5, carry out second
Secondary process；The water processed through second time is heated to boiling.
Medicine for treatment cardiovascular and cerebrovascular disease has carried out numerous studies the most both at home and abroad, and also reporting many may have
The medicine of effect, but the actual therapeutic effect of these medicines unsatisfactory.Surprisingly, inventor finds, nervonic acid, three
Seven total saponins and breviscapine three are applied in combination with specific ratio, in terms for the treatment of cardiovascular and cerebrovascular disease, compare independent one
Kind or two kinds there is beyond thought therapeutic effect, and without any side effects.
Cardiovascular and cerebrovascular disease described in the application such as coronary heart diseases and angina pectoris, myocardial infarction, arrhythmia, ischemic brain
Disease, cerebral thrombosis, cerebral embolism, cerebral hemorrhage and sequela thereof, vascular dementia；The most various arterial occlusion of peripheral circulation disorders disease
Microcirculation disturbance that disease, vasculitis, diabetes cause, intractable neck week syndrome, vertebro-basilar artery insufficiency and other lack
Blood and with the application in the treatment of the diseases such as the disease of microcirculation disturbance, high blood viscosity or the medicine of prevention.
Additionally, applicant the most also finds, when described medicament is prepared as drop pill, its best results；Particularly
When use the substrate adjuvant in the application optimization formula, i.e. drop pill be xylitol and lactose be the mixed-matrix of 10: 3 with weight ratio
Adjuvant, when plasticizer adjuvant is arabic gum, obtained drop pill rounding, size is uniform, color and luster is consistent, without adhesion phenomenon.
Detailed description of the invention
One, preparation embodiment
Preparation embodiment 1
Weigh according to the following formulation, the Chinese medicine dripping pills of preventing and treating cardiovascular and cerebrovascular disease of the present invention can be prepared.
Effective ingredient is nervonic acid 40g, Radix Notoginseng total arasaponins 65g, breviscapine 20g；
Substrate include xylitol and lactose with 10: 3 mixed-matrix adjuvant 1000g；
Plasticizer adjuvant: arabic gum 250g.
Weighing effective ingredient and adjuvant according to aforementioned proportion respectively, and be sufficiently mixed, hybrid mode is ultrasonic mixing
Method；Use Electric heating, mixed material is added to molten condition, stirs；Described molten mixture is inserted pill dripping machine
In funnel, being incubated, temperature controls at 75 DEG C；Selecting sizeable drip nozzle, with suitable speed, molten mixture instills
In condensing agent, condensing agent is vegetable oil, and temperature is-5 DEG C；Treat that molten mixture shrinks molding at condensing agent, take out, remove surface
Condensing agent, is dried and i.e. can be made into medicament composition dropping pills of the present invention.
Preparation embodiment 2
In addition to effective ingredient nervonic acid, Radix Notoginseng total arasaponins, breviscapine all use the method for the present invention and prepare, remaining is with real
Execute example:
The preparation of nervonic acid:
(1) slightly extract: in Malania Oleifera Oil, add the ethanol of 3 times amount 80%, stir into homogeneous solution, in described solution
The sodium hydroxide of the 30% of addition Malania Oleifera Oil quality 2 times amount or potassium hydroxide solution, heated and stirred to saponification is complete, filter
Cross, acidification of filtrate to pH3-4, stand, collect upper strata and solidify saponified, be washed to neutrality, drip moisture to the greatest extent, obtain neural acid crude；
(2) crystallization: take described nervonic acid crude product, carry out following crystallization operation:
The dehydrated alcohol of 4 times amount and the mixed solution that volume ratio is 1: 1 of acetone is added in described nervonic acid crude product, 60
～70 DEG C be heated to reflux making dissolving, filter, collect filtrate and in-5～-10 DEG C of standing, centrifugal, collect and crystallize；Described crystallization behaviour
Make to obtain nervonic acid primary crystal；
(3) recrystallization: repeat crystallization operation in step (2) 2-7 time, in crystallizing to gained, nervonic acid monomer contains
Amount is not less than 85%, to obtain final product；
The preparation of Radix Notoginseng total arasaponins:
Pseudo-ginseng is ground into coarse powder, and with 16 times amount 70% alcohol reflux 3 times, each 2 hours, extracting solution filtered
Rear merging, decompression recycling ethanol, obtain extract, in described extract, add the water of pseudo-ginseng quality 1 times amount that feeds intake, filter
Crossing, on filtrate, the absorption of AB-8 macroporous adsorptive resins, is washed to effluent substantially colorless, then uses 75% ethanol elution, gained
Eluent is crossed chromatography neutral alumina column and is decoloured remove impurity, decompression recycling ethanol, and vacuum drying obtains Radix Notoginseng total arasaponins, check character
After closing version Chinese Pharmacopoeia Radix Notoginseng total arasaponins quality standard in 2010, to obtain final product；
The preparation of breviscapine:
(1) to be heated to boiling treated water in add Herba Erigerontis, be heated to boiling and keep seething with excitement one section time
Between, obtain breviscapine leachate；
(2) put in sedimentation tank after breviscapine leachate being filtered and this solution is kept heating；At sedimentation tank thermosol
Adding hydrochloric acid in liquid, regulation pH value, to 1.5-2.5, stands to precipitation completely, to obtain precipitate；
(3) by described drying precipitate, breviscapine product is obtained.
Preparation embodiment 3
Except nervonic acid is 24g, Radix Notoginseng total arasaponins 48g, outside breviscapine 10g, remaining is with preparation embodiment 1.
Preparation embodiment 4
Except nervonic acid is 60g, Radix Notoginseng total arasaponins 90g, outside breviscapine 38g, remaining is with preparation embodiment 1.
Preparation embodiment 5
Except substrate adjuvant be xylitol and lactose be in addition to 5: 5 with weight ratio, remaining is with preparation embodiment 1.
Preparation embodiment 6
In addition to substrate adjuvant is xylitol, remaining is with preparation embodiment 1.
Preparation embodiment 7
In addition to substrate adjuvant is lactose, remaining is with preparation embodiment 1.
Preparation embodiment 8:
Except the substrate adjuvant in drop pill is in addition to polyethylene glycol 6000, remaining is with preparation embodiment 1.
Comparative example 1
In addition to effective ingredient is nervonic acid 125g, remaining is with preparation embodiment 1；
Comparative example 2
In addition to effective ingredient is Radix Notoginseng total arasaponins 125g, remaining is with preparation embodiment 1；
Comparative example 3
In addition to effective ingredient is breviscapine 125g, remaining is with preparation embodiment 1；
Comparative example 4
Except effective ingredient be nervonic acid 55g, in addition to Radix Notoginseng total arasaponins 70g, remaining is with preparation embodiment 1；
Comparative example 5
Except effective ingredient is Radix Notoginseng total arasaponins 80g, outside breviscapine 45g, remaining is with preparation embodiment 1；
Comparative example 6
Except effective ingredient be nervonic acid 80g, in addition to breviscapine 45g, remaining is with preparation embodiment 1；
Comparative example 7
Except effective ingredient is nervonic acid 20g, Radix Notoginseng total arasaponins 43g, outside breviscapine 5g, remaining is with preparation embodiment 1；
Comparative example 8
Except effective ingredient is nervonic acid 70g, Radix Notoginseng total arasaponins 95g, outside breviscapine 45g, remaining is with preparation embodiment 1.
Two, effect example
(1) experiment to the protective effect that Ischemic/reperfused Myocardium damages
1. animal model: Wistar strain male rat, open chest anesthetized, maintain and breathe, in left auricle and pulmonary conus
Between around left coronary artery, and ligature.
2. method: rat is randomly divided into 4 groups: 1. sham operated rats (sham-operated control), normal saline fills
Stomach, 1ml/ days, totally 4 days；2. myocardial ischemia-reperfusion group (M-IR), gavage method is ibid；Medicine group the most of the present invention is (by above-mentioned system
The drop pill that the method for standby embodiment and comparative example is prepared), with the consumption of 2g crude drug/kg/ days, gavage method is ibid.
Sham operated rats does not ligatures；Other group is Reperfu-sion after ligaturing 1 hour.Left coronary artery is again ligatured, note in ventricle before animal is put to death
Take out after entering her the Wen orchid of 1%, rinse with PBS, freeze 1 hour.After removing excess tissue, dye 30 minutes in 1%TTC
(37℃).With weight method calculating myocardium ischemia hazardous area (her Wen Lan Weiran district), infarcted region (TTC Wei Ran district).
3. the result of variations of myocardial infarct size
As can be seen here, in terms of myocardial infarction, sham-operation has no that myocardial infarction phenomenon, myocardial ischemia fill for 1 hour again for 7 hours
Note after 6 hours myocardial infarction obvious, medicine of the present invention can be obviously reduced the myocardial infarct size of myocardial reperfusion rat, display this
Invention medicine has good protective effect to the change of ischemic myocardial cells Reperfu-sion myocardium cell necrosis；Particularly compare list
Solely or two kinds of active component, even comparing three kinds of active component embodiment not within the scope of the application, the application is equal
There is good effect；Additionally, use the specific preparation method of the application to prepare the system of nervonic acid, Radix Notoginseng total arasaponins, breviscapine
It is the most excellent that standby embodiment 2 compares preparation embodiment 1；In terms of preparation, also can bring more excellent effect when using specific adjuvant.
(2) clinical efficacy
Clinical observation on the therapeutic effect test below by way of the medicine obtained by above-mentioned preparation embodiment is expanded on further this
The beneficial effect of bright described medicine.
1. case selection
The patient of this test all meets " the atherosclerotic blood that nineteen ninety-five the 4th, whole nation cerebrovascular meeting is formulated
Bolt cerebral infarction " diagnostic criteria, and make a definite diagnosis through brain CT.Get rid of cerebral ischemia and transient ischemic attack.Wherein treatment group 40 example,
Matched group 30 example.Treatment group age 45～72 years old, average 65 years old, merge hyperlipidemia 31 example；Matched group age 49～71 years old, flat
Equal 60 years old, merge hyperlipidemia 23 example.
2. diagnostic criteria
With reference to " new Chinese medicine guideline of clinical investigations " " guideline of clinical investigations of new Chinese medicine treatment apoplexy "
And " Chinese Internal Medicine " draft diagnostic criteria.Eligibility enters test, is divided into treatment group and matched group by random method.Warp
Statistical analysis treatment group and matched group case overview are similar, have comparability.
3. Therapeutic Method
All use regular western medicine expectant treatment, lie up, close observation vital sign patient and head CT change and limb
Body motion conditions.Substantially cerebral edema patient is with 20% mannitol rapid intravenous drop, hyperpietic is given blood pressure lowering, makes blood pressure
Controlling at 140/90mmHg. and control to infect, maintain water-electrolyte balance, expanding blood volume etc. is treated, and selects after stable disease
Require mental skill the treatment such as multiple element, enteric coated aspirin.Treatment group adds with this prescription capsule on the basis of above-mentioned treatment, each 3, often
Day 3 times, 21d is a course for the treatment of.
4. curative effect determinate standard
By department of neurology association of China, clinical neurologic deficit of stroke patients degree standards of grading, carry out clinical neural
Functional impairment degree and the scoring of viability situation, carry out clinical efficacy scoring simultaneously.
It is almost recovered: neurological deficits score reduces 91-100%, and disability degree is 0 grade；
Effective: neurological deficits score reduces 46-90, and disability degree is 1-3 level；
Effective: neurological deficits score reduces 18-45%；
Invalid: neurological deficits score reduces less than 17% or increases；
5. observed result
Clinical efficacy comparison before and after 5.1 treatments
| Group | Number of cases | It is almost recovered | Effective | Effectively | Invalid | Total effective rate |
| Preparation embodiment 1 | 50 | 10 | 25 | 10 | 5 | 90% |
| Preparation embodiment 2 | 50 | 10 | 24 | 12 | 4 | 92% |
| Preparation embodiment 3 | 50 | 8 | 24 | 10 | 8 | 84% |
| Preparation embodiment 4 | 50 | 9 | 25 | 9 | 7 | 86% |
| Preparation embodiment 5 | 50 | 9 | 25 | 10 | 6 | 88% |
| Preparation embodiment 6 | 50 | 8 | 24 | 8 | 10 | 80% |
| Preparation embodiment 7 | 50 | 9 | 23 | 8 | 10 | 80% |
| Preparation embodiment 8 | 50 | 5 | 24 | 8 | 13 | 74% |
| Comparative example 1 | 50 | 4 | 20 | 6 | 20 | 60% |
| Comparative example 2 | 50 | 5 | 21 | 5 | 19 | 62% |
| Comparative example 3 | 50 | 4 | 21 | 5 | 20 | 60% |
| Comparative example 4 | 50 | 5 | 25 | 4 | 16 | 68% |
| Comparative example 5 | 50 | 6 | 25 | 4 | 15 | 70% |
| Comparative example 6 | 50 | 5 | 24 | 5 | 16 | 68% |
| Comparative example 7 | 50 | 8 | 25 | 6 | 11 | 78% |
| Comparative example 8 | 50 | 8 | 24 | 7 | 11 | 78% |
As seen from the above table, the total effective rate of medicine of the present invention is significantly greater than with one or both active component, even
When the amount ranges of three kinds of active component is outside the application scope, its effect is also far below embodiments herein, same,
In terms of preparation, also can bring more excellent effect when using specific adjuvant.Additionally, use the specific preparation method of the application
It is the most excellent that preparation embodiment 1 is compared in preparation nervonic acid, Radix Notoginseng total arasaponins, the preparation embodiment 2 of breviscapine；
A kind of pharmaceutical composition for treating cardiovascular and cerebrovascular vessel of the present invention is described by concrete example,
Those skilled in the art can use for reference present invention, and the link such as suitable feed change, process conditions realizes other mesh corresponding
, its relevant change is all without departing from present disclosure, and all similar replacements and change come for those skilled in the art
Say and be apparent from, be considered as being included within the scope of the present invention.
Claims (10)
1. the pharmaceutical composition being used for treating cardiovascular and cerebrovascular vessel, it is characterised in that described pharmaceutical composition comprises following weight
The raw material of part: nervonic acid 24-60, Radix Notoginseng total arasaponins 48-90, breviscapine 10-38.
Pharmaceutical composition the most according to claim 1, it is characterised in that described pharmaceutical composition comprises following weight portion
Raw material: nervonic acid 32-55, Radix Notoginseng total arasaponins 56-70, breviscapine 15-30.
Pharmaceutical composition the most according to claim 1, it is characterised in that described pharmaceutical composition comprises following weight portion
Raw material: nervonic acid 40, Radix Notoginseng total arasaponins 65, breviscapine 20.
4., for treating a drug combination preparation for cardiovascular and cerebrovascular vessel, said preparation is by the arbitrary described medicine of claims 1 to 3
In compositions and one or more pharmaceuticss, acceptable adjuvant is made.
Drug combination preparation the most according to claim 4, it is characterised in that said preparation be drop pill, capsule, soft capsule,
Granule, tablet.
Drug combination preparation the most according to claim 5, it is characterised in that said preparation is drop pill, the one-tenth of described drop pill
Point it is that the plasticizer auxiliary material combination of the effective ingredient by 1-5 weight portion, the substrate adjuvant of 1-20 weight portion and 1-10 forms:
Described substrate adjuvant derives selected from Polyethylene Glycol, monosaccharide, oligosaccharide, polysaccharide, sugar ester, sugar alcohol, fruit acid, higher fatty acids
One or more in thing, high fatty alcohol, polyhydric alcohol, carbamide or polyethylene oxide derivant；
Described plasticizer adjuvant is selected from starch and derivant, cellulose and its derivates, arabic gum, dextran, carapace
Element, sesbania gum, carrageenan, Ficus elastica, Furcellaran, tragakanta, carrageenin, tamarind gum, pectin, xanthan gum, alginic acid
And one or more in salt, dextrin, cyclodextrin, agar or lactose.
Drug combination preparation the most according to claim 6, it is characterised in that the composition of described drop pill is by 1 weight portion
Effective ingredient, the substrate adjuvant of 8 weight portions and the plasticizer auxiliary material combination of 2 weight portions.
Drug combination preparation the most according to claim 6, it is characterised in that the substrate adjuvant in described drop pill is xylose
Alcohol and lactose are arabic gum with the mixed-matrix adjuvant that weight ratio is 10: 3, plasticizer adjuvant.
9. preparing, according to the arbitrary described pharmaceutical composition of claims 1 to 3, the application treated in cardiovascular medicament.
10. according to the arbitrary described drug combination preparation of claim 5 to 8 answering in preparation treatment cardiovascular medicament
With.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610273149.6A CN105832788A (en) | 2016-04-27 | 2016-04-27 | Drug composition for treating cardiovascular and cerebrovascular diseases |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610273149.6A CN105832788A (en) | 2016-04-27 | 2016-04-27 | Drug composition for treating cardiovascular and cerebrovascular diseases |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106581109A (en) * | 2017-02-28 | 2017-04-26 | 王沛 | Cerebral thrombosis treating pharmaceutical composition |
| CN107441130A (en) * | 2017-08-04 | 2017-12-08 | 杨宇明 | A kind of composition of the anti-Alzheimer disease of effective extract containing malania oleifera and its application |
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| CN1522705A (en) * | 2003-02-20 | 2004-08-25 | 深圳市清华源兴生物医药科技有限公司 | Pharmaceutical for treating cardiovascular and cerebrovascular disease |
| CN101084957A (en) * | 2006-06-08 | 2007-12-12 | 天津天士力制药股份有限公司 | Composition containing notoginseng and rhus taishanensis for treating cardiovascular diseases and preparation thereof |
| CN101167813A (en) * | 2007-10-22 | 2008-04-30 | 贵州古特药业有限公司 | Medicine for treating cardiovascular and cerebrovascular diseases and preparation method thereof |
| CN103156898A (en) * | 2013-04-12 | 2013-06-19 | 云南天秀植物科技开发有限公司 | Compound preparation of nervonic acid and panax notoginseng total saponins and preparation method of compound preparation |
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| CN1522705A (en) * | 2003-02-20 | 2004-08-25 | 深圳市清华源兴生物医药科技有限公司 | Pharmaceutical for treating cardiovascular and cerebrovascular disease |
| CN101084957A (en) * | 2006-06-08 | 2007-12-12 | 天津天士力制药股份有限公司 | Composition containing notoginseng and rhus taishanensis for treating cardiovascular diseases and preparation thereof |
| CN101167813A (en) * | 2007-10-22 | 2008-04-30 | 贵州古特药业有限公司 | Medicine for treating cardiovascular and cerebrovascular diseases and preparation method thereof |
| CN103156898A (en) * | 2013-04-12 | 2013-06-19 | 云南天秀植物科技开发有限公司 | Compound preparation of nervonic acid and panax notoginseng total saponins and preparation method of compound preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106581109A (en) * | 2017-02-28 | 2017-04-26 | 王沛 | Cerebral thrombosis treating pharmaceutical composition |
| CN107441130A (en) * | 2017-08-04 | 2017-12-08 | 杨宇明 | A kind of composition of the anti-Alzheimer disease of effective extract containing malania oleifera and its application |
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