CN103893571A - Medicinal composition for treating hypertension and application thereof - Google Patents
Medicinal composition for treating hypertension and application thereof Download PDFInfo
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- CN103893571A CN103893571A CN201410082362.XA CN201410082362A CN103893571A CN 103893571 A CN103893571 A CN 103893571A CN 201410082362 A CN201410082362 A CN 201410082362A CN 103893571 A CN103893571 A CN 103893571A
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Abstract
The invention relates to the technical field of traditional Chinese medicines, and particularly discloses a medicinal composition for treating hypertension and an application thereof. The medicinal composition comprises the following components by weight: 80-200g of red-rooted salvia root extract, 50-120g of tall gastrodia tuber extract, 40-200g of eucommia ulmoides leaf extract, 100-500g of natural dispersing agent and 10-50g of natural suspending agent. Through synergistic effect among various Chinese medicinal extracts, the medicinal value of each extract is increased, the dose of each Chinese medicinal extract for achieving the same medicinal effect is reduced, and the defects of a large number of taking forms, large dosage, slow response, gastrointestinal tract discomfort and the like in the conventional oral antihypertensive Chinese medicinal composition are overcome. Meanwhile, a special production process is adopted, and pure natural extracts such as the dispersing agent are taken as medicinal adjuvants, so that the mouthfeel of the medicine is improved. Compared with other products of the same type, the medicinal composition has the advantages of no bitterness and convenience in taking, and the compliance of patients is improved.
Description
Technical field
The present invention relates to technical field of traditional Chinese medicine pharmacy, particularly relate to one for antihypertensive, have Chinese medicine extraction medicine composition and the application thereof of blood fat reducing and adjusting cardiac function, anti-cardiac-cerebral ischemia effect simultaneously concurrently.
Background technology
Hypertension is a kind of take arterial pressure rising as feature, can be functional with heart, blood vessel, brain and kidney and other organs or the systemic disease of organic change, it have essential hypertension and secondary hypertension point, be a kind of commonly encountered diseases and frequently-occurring disease.Essential hypertension is called again hypertension, is the independence disease take hypertension as main clinical manifestation etiology undetermined, accounts for the more than 90% of hypertensive patient.Secondary hypertension is called again symptomatic hypertension, clear and definite in the hypertensive cause of disease of this apoplexy due to endogenous wind, is one of performance of certain disease.This sick general onset is slow, patient is often asymptomatic in early days, or only there are symptoms such as dizziness, headache, cardiopalmus, tinnitus, independently disease of one outwardly, malpractice is actually an important risk factor that causes the heart, cerebrovascular and nephropathy, if will pathological changes become these common hypertension complications such as more serious apoplexy, myocardial infarction and renal failure.
At present to hypertensive chemotherapy for adopting ACEI hypotensor thing etc. to be classified as a line antihypertensive drugs by World Health Organization (WHO) and China's " Treatment Guidelines for Hypertension ", but there is serious side effect, as after taking, occur zest dry cough, can be with dry pharynx, itching throat, uncomfortable in chest, night and flat sleeping postemphasis, or there is the untoward reaction such as erythra, pruritus, dysgeusia, albuminuria, granulocytopenia.No matter conventional Macrocyclolactone lactone kind medicine is oral or intravenously administrable, prolonged application or dosage are excessive and to cause that hepatic injury, Auditory nerve impairment cause deaf etc.Western medicine not only has very large side effect in treatment, and has larger dependency, needs long-term taking, and the most important is that blood pressure lowering is unstable, in the process of taking medicine, blood pressure can be fluctuated, can not dispel old complaint, once drug withdrawal, blood pressure bounce-back amplitude is large, has increased the weight of patient body burden.
In the Traditional Chinese Medicine of China, generally hypertension is belonged to the disease categories such as " dizzy ", " headache ", " liver-yang ", " liver-wind ", " apoplexy ", be mainly manifested in the aspects such as type of deficiency of YIN leading to hyper activity of YANG, liver-wind stirring up internally, deficiency of both YIN and YANG, deficiency of spleen-YANG and kidneyYANG, stagnation of phlegm-damp in middle-JIAO, blood-stasis internal-depression.Mainly treat with the medicine such as suppressing the hyperactive liver and subsiding YANG, blood circulation promoting and blood stasis dispelling.But be mainly and utilize the formula of pure Chinese medicine to treat in existing disclosed technology, in prescription, generally contain kinds of traditional Chinese medicines material, adopt the method decocting to take, although there is certain curative effect, but exist, onset is slow, mechanism of action is indefinite, therapeutic effect is not obvious, it is poor that taste hardship, patient comply with, and indivedual patients have the defects such as gastrointestinal upset.
Summary of the invention
The object of the invention is the side effect producing in order to overcome western medicine hypertension, make up the deficiency and the defect that in existing Chinese prescription, exist, provide that the one mechanism for the treatment of is clear and definite, good patient compliance, mouthfeel be good, evident in efficacy, the precisely compositions of the Chinese medicine extract of lowering and stabilizing blood pressure, said composition can also regulate cardiac function, the symptoms such as the cardiac-cerebral ischemia that hypertension is caused play good therapeutic effect, in the hypertensive cardiac-cerebral ischemia being caused by hypertension, the anginal complication of curing for the treatment of, real effect that has played treating both the principal and secondary aspects of a disease simultaneously.
Another object of the present invention is to provide the application of a kind of pharmaceutical composition in preparation treatment hypertension drug.
To achieve these goals, the present invention is achieved by following aspect:
A kind of pharmaceutical composition, the component that contains following weight: Radix Salviae Miltiorrhizae extract 80 ~ 200g, Rhizoma Gastrodiae extract 50 ~ 120g, Folium Eucommiae extract 40 ~ 200g, natural dispersant 100 ~ 500g, natural suspending agent 10 ~ 50g.
Wherein, the water solubility extract that Radix Salviae Miltiorrhizae extract is ZANGDANSHEN.Concrete preparation method is: by ZANGDANSHEN medical material, pulverize extracting in water after sieving; Extracting solution is carried out after precipitate with ethanol processing, filter, concentrated alcohol liquid; By the pH regulator to 1.0 of alcohol liquid ~ 4.0, remove by filter precipitation, get supernatant; By polydextran gel resin, supernatant is carried out after purification, after water and alcohol eluting, collect alcohol washing liquid respectively, concentrated; Concentrated solution under the condition of pH6.0 ~ 11.0, heat treated 2 ~ 6 hours at the temperature of 65 ℃ ~ 100 ℃; Regulation system pH to 3.0 ~ 5.0, concentrate drying makes.
Wherein, Rhizoma Gastrodiae extract is ZANGTIANMA alcohol extract, after dry ZANGTIANMA is cleaned, process by microwave method or ultrasonic method within 8 ~ 10 minutes, carry out fragmentation, the defibrination that adds water, centrifugalize obtains supernatant; Supernatant is through macroporous adsorbent resin, adds after 80% alcohol reflux defat except albumen, and upper water liquid dialysis 24h removes after organic solvent and small-molecule substance concentrated, add water with absolute ethanol washing 5 ~ 10 times after, vacuum lyophilization makes.
Wherein, Folium Eucommiae extract is alcohol extract, and the alcoholic solution by fresh Folium Eucommiae take volume fraction as 85% is as solvent, and the ratio of Folium Eucommiae and solvent is 1:4(g/mL), 60 ℃ of supersound extraction 30-60min, vacuum filtration obtains filtrate; The extract that filtrate is made to Folium Eucommiae by carbon dioxide supercritical fluid extraction method, vacuum lyophilization makes.
Natural dispersant is one or more the compositions containing in walnut oil, olive oil, perilla oil, Radix Oenotherae erythrosepalae oil, Oleum Vitis viniferae, Fructrs Hippophae seed oil, Semen Maydis oil, Cortex Eucommiae bar oil.
Natural suspending agent is the mixture of natural oil wax or Cera Flava and soybean phospholipid, and its ratio is (calculating by weight) natural oil wax or Cera Flava: soybean phospholipid=1:5 ~ 3:1.
In addition, also comprise pharmaceutically acceptable carrier auxiliary material, be prepared into medical dosage form or functional health product.
Medical dosage form is conventional tablet, slow releasing tablet, capsule, drop pill, dry suspension, powder, granule, Orally taken emulsion.
Wherein, the preparation method of slow releasing tablet is: pharmaceutical composition oven drying at low temperature as above is made after dried powder and lactose, hydrogel matrix, diluent, mix lubricant, make through direct compression process; Wherein hydrogel matrix comprises hydroxypropyl cellulose or hydroxypropyl emthylcellulose, and diluent is one or more mixture in arginine, glutamic acid, glutamine, alanine, and lubricant is magnesium stearate.
Wherein, the preparation method of capsule is: by pharmaceutical composition mix homogeneously as above, using natural gelatin as capsule shells, glycerol makes as coloring agent as plasticizer, titanium dioxide and cocoa element.
Wherein, the preparation method of drop pill is: pharmaceutical composition as above and water solublity Basic compose are comprised to Polyethylene Glycol, sodium stearate, poloxamer, monostearate are that carrier or its both or both above mixture are mixed homogeneously, be heated to 60 ~ 70 ℃, stir melting; Adding correctives, mix, is that bowing of 1 millimeter or 2 millimeters drops in medicinal liquid in the liquid paraffin or methyl-silicone oil of-10 ℃ with diameter, solidify after 30 ~ 40 minutes, then through filtering, washing, dry, packing both.
Two of object of the present invention is to provide aforementioned pharmaceutical compositions in the particularly application in essential hypertension medicine of preparation hypertension.
Three of object of the present invention is to provide aforementioned pharmaceutical compositions, in the application of preparing in essential hypertension medicine.
Four of object of the present invention is to provide aforementioned pharmaceutical compositions, in preparation with the application in the medicine of the hypertension of hyperlipidemia.
Five of object of the present invention is to provide aforementioned pharmaceutical compositions, in preparation with the application in the medicine of the hypertension of hyperglycemia.
Six of object of the present invention is to provide aforementioned pharmaceutical compositions, in preparation with the application in the medicine of the hypertension of hyperlipidemia, hyperglycemia.
Seven of object of the present invention is to provide aforementioned pharmaceutical compositions, regulates the application in cardiac function, anti-cardiac-cerebral ischemia medicine in preparation in preparation.
Compared with prior art, the present invention has following beneficial effect:
1. medicament sources of the present invention is natural, and the side effect producing can avoid Western medicine long-term taking time and dependency solve the Liver and kidney visceral organ injury that long-term taking Western medicine causes; The effective ingredient of medicine of the present invention is clear and definite, and adopting the extract of genuine medicinal materials is effective ingredient, has solved that kind in Chinese medicine material prescription is numerous, dosage is large, taste is pained, decoction is inconvenient, poor reproducibility, problem that patient's compliance is low.
2. medicine of the present invention has (1) targeting, rapid-action, suitable with Western medicine, there is after accurate blood pressure lowering, voltage stabilizing, drug withdrawal the blood pressure rising that do not rebound, there is the effect of special " bidirectional pressure regulating " simultaneously, not only can reduce high pressure, too low blood pressure can also be adjusted to normal level;
(2) treating both the principal and secondary aspects of a disease, treats from pathology, can fundamentally cure particularly essential hypertension of hypertension; Remove cerebral vasospasm, vessel softening, removes Lipid Plaque, steadily blood pressure lowering increases the supply of brain blood oxygen simultaneously, solves pressure reduction excessive, high drops, the difficult problem that low pressure also declines, simultaneously scalable has the syndrome such as angina pectoris, cardiac insufficiency that cardiac-cerebral ischemia that hypertension causes causes.
(3) safety is good, and long-term taking has no adverse reaction, the liver and the kidney tonifying, improve renal function, remove harmful substance in free radical and body, repair damaged cell, delay the internal organs agings such as Liver and kidney, solve the too fast too urgent and cerebral blood supply insufficiency symptom such as dizziness that causes of blood pressure drops.
(4) take natural dispersant and natural suspending agent as pharmaceutic adjuvant, make the effective ingredient mix homogeneously of Chinese medicine extract, be convenient to preparation, the defect that solved the extract thickness that exists in Chinese medicine preparation modernization, in bulk, is difficult for disperseing the various preparations of preparation.
(5) between simple, the different batches product of preparation technology, mass discrepancy is little, uniform in quality stable, has good producing feasibility and using value.
In published document, there is no the present composition and the report take natural dispersant and natural suspensoid as the preparation method of pharmaceutic adjuvant thereof.In published document, there is no the accurate blood pressure lowering of the present composition, regulate the application aspect blood fat, blood glucose, cardiac function and anti-blood cerebral ischemia.
The specific embodiment
Further describe the present invention below in conjunction with specific embodiment.Unless stated otherwise, reagent, the equipment that the present invention adopts is the conventional reagent of the art and equipment.
The preparation of the water solubility extract of ZANGDANSHEN: by genuine medicinal materials ZANGDANSHEN, pulverize extracting in water after sieving; Extracting solution is carried out after precipitate with ethanol processing, filter, concentrated alcohol liquid; By the pH regulator to 2.0 of alcohol liquid, remove by filter precipitation, get supernatant; By polydextran gel resin, supernatant is carried out after purification, respectively, after water and alcohol eluting 5 times, collect alcohol washing liquid, concentrated; Concentrated solution, under the condition of pH8.0, is processed 1 hour at the temperature of 65 ℃, is warming up to 80 ℃ and processes 2 hours, then be warming up at the temperature of 100 ℃ heat treated 1 hour; Regulation system pH to 4.0, concentrate drying makes.
The preparation method of ZANGTIANMA alcohol extract is: after dry genuine medicinal materials ZANGTIANMA is cleaned, process by microwave method or ultrasonic method within 8 ~ 10 minutes, carry out fragmentation, the defibrination that adds water, centrifugalize obtains supernatant; Supernatant is through macroporous adsorbent resin, adds after 80% alcohol reflux defat except albumen, and upper water liquid dialysis 24h removes after organic solvent and small-molecule substance concentrated, add water with absolute ethanol washing 5 ~ 10 times after, vacuum lyophilization makes.
The preparation method of Folium Eucommiae alcohol extract is: the alcoholic solution by fresh Folium Eucommiae take volume fraction as 85% is as solvent, and the ratio of Folium Eucommiae and solvent is 1:4(g/mL), 60 ℃ of supersound extraction 30-60min, vacuum filtration obtains filtrate; The extract that filtrate is made to Folium Eucommiae by carbon dioxide supercritical fluid extraction method, vacuum lyophilization makes.
embodiment 1 tablet
Get the above-mentioned ZANGDANSHEN dry extract 100g preparing, ZANGTIANMA dry extract 70g, Folium Eucommiae dry extract 60g and be dispersed in 200g Semen Maydis oil low-temperature vacuum drying at 30 ℃, add 50g lactose, 50g mannitol, 100g Oligomeric maltose, 0.2g steviosin mixed pelletization, dry granulate to add 4g magnesium stearate to mix after being ground into 200 object fine powders; Tabletting makes 1000 tablet preparations.
embodiment 2 dry suspension
Get the above-mentioned ZANGDANSHEN dry extract 150g preparing, ZANGTIANMA dry extract 60g, Folium Eucommiae dry extract 100g are dispersed in 150g olive oil and mix, after adding the mixture of 15g Cera Flava and 15 soybean phospholipids to stir, oven drying at low temperature makes dried powder, inserts in mixer and mixs homogeneously with 100g hydroxypropyl emthylcellulose, 200g microcrystalline Cellulose, 200g sucrose; Granulate; With 50% ethanol 20ml soft material processed, granulate with 20 order nylon wires; Dry, granulate is packaged into 1000 bags of dry suspension preparations.
embodiment 3 soft capsules
Get the above-mentioned ZANGDANSHEN dry extract 90g preparing, ZANGTIANMA dry extract 80g, Folium Eucommiae dry extract 120g are dispersed in 50g perilla oil and 50g olive oil and mix, add 7g Cera Flava and 13g soybean phospholipid that the main component in mixture is evenly suspended in the content of capsule, capsule skin using the natural gelatin of 140g as soft capsule, 56g glycerol as plasticizer, 0.16g titanium dioxide and 0.04g can cocoa element as coloring agent, be dispersed in and in 126g purified water, make 1000 soft capsules.
embodiment 4 Orally taken emulsions
Get the above-mentioned ZANGDANSHEN dry extract 180g preparing, ZANGTIANMA dry extract 90g, Folium Eucommiae dry extract 70g, be dispersed in 200g Semen Maydis oil and 100g Radix Oenotherae erythrosepalae oil and mix, add 10g oil wax and 20g soybean phospholipid, heating for dissolving becomes oil phase; The hydroxypropyl cellulose of getting 50g glycerol, 2g vitamin E, 0.5g sodium citrate, the low replacement of 50g forms water to sterile water for injection; Oil phase is slowly added in intensively stirred water liquid, and strong agitation forms colostrum,, under the pressure of 10000psi, homogenizes 8 to 10 times with high pressure homogenizer, and the granularity of prepared lipomul is less than 2 microns, and the scope of mean diameter is 20-500 nanometer.
embodiment 5 slow releasing tablet
Get the above-mentioned ZANGDANSHEN dry extract 120g preparing, ZANGTIANMA dry extract 120g, Folium Eucommiae dry extract 80g are dispersed in 200g Semen Maydis oil and 200g Oleum Vitis viniferae and mix, oven drying at low temperature makes 1000 slow releasing tablets with 60g lactose, 100g hydroxypropyl emthylcellulose, 20g arginine, 10g magnesium stearate through direct powder compression after making dried powder.
embodiment 6 drop pill
Get the above-mentioned ZANGDANSHEN dry extract 150g preparing, ZANGTIANMA dry extract 100g, Folium Eucommiae dry extract 150g are dispersed in 300g perilla oil and 200g Semen Maydis oil and mix, add 25g Cera Flava and 25g soybean phospholipid to make the even suspendible of main component in mixture, join mix homogeneously in 525g water solublity Basic compose Polyethylene Glycol, be heated to 60 ~ 70 ℃, stir melting; Add correctives, mix, with drop pill, medicinal liquid is dropped in the liquid paraffin of-10 ℃, solidify after 30 ~ 40 minutes, filter, washing, dry, pack and get final product.
comparative example 1
The patent No. is 201310498899.X, denomination of invention is that the patent that a kind of guarantor with raising immunity, hypolipemic function builds food and preparation method thereof discloses a kind of Chinese medicine composition, and it comprises the component of following weight fraction: 15 ~ 35% Radix Panacis Quinquefolii extracts (available Cortex Eucommiae extract substitutes), 15 ~ 35% Radix Notoginseng extracts, 5 ~ 25% Radix Salviae Miltiorrhizae extracts, 5 ~ 25% Rhizoma Gastrodiae extracts and 10 ~ 30% Fructus Hippophae extracts.The formula preparation capsule preparations of disclosed embodiment 1 to specifications.
test example
Experiment material
Medicine: adopt pharmaceutical composition embodiment 1 of the present invention the write out a prescription suspensoid and the tablet that make;
Animal: Wistar rat is provided by experimental animal center, Guangzhou; Spontaneously hypertensive rat model is provided by Shanghai Research Institute of Hypertension;
Instrument: SY-1 type rat blood pressure analyzer, MRB-III type computer rat blood pressure cardiotachometer.
One, the impact on clear-headed antioxidant type rat blood pressure: Wistar rat, body weight 150～200g, male and female all have, and under lumbar injection pentobarbital sodium 30mg/kg anesthesia, separate left renal artery, clamp narrow renal artery with the silver brain clip of internal diameter 0.2mm, and right kidney does not touch.SY-1 type rat blood pressure analyzer is surveyed right hind systolic arterial pressure under rat waking state.Within postoperative 5 weeks, blood pressure is than the preoperative 0.27kPa that increases, be greater than 16.0kPa person and be confirmed to be antioxidant type rat, every group 5, the gastric infusion embodiment of the present invention 1 tablet 0.75g/kgd × 14d making that writes out a prescription, matched group is given the calcium antagonist nifedipine with same volume, result of the test is: the 16.9 ± 0.5kPa of trial drug group blood pressure before by administration is down to 11.3 ± 0.6kPa, blood pressure drops 37.2%, compared with chemical medicine matched group nifedipine administration group (being down to 12 ± 0.5kPa), hypotensive effect is suitable, hypotensive effect is remarkable, drawdown curve is steady, being down to normal arterial pressure before administration no longer continues to decline after quite.
Two, the impact on clear-headed spontaneous hypertensive rat (SHR) blood pressure:
42 of SHR rats, body weight 145～190g, female, be divided into 4 groups, MRB-III type computer rat blood pressure cardiotachometer is measured waking state lower tail systolic arterial pressure, before each pressure measurement, animal is in 40 ℃ of incubator preheating 10～15min, each tie-in 2 times, and getting its mean is a pressure value.Result: after the dry suspension gavage 0.94g/kg that described in a gavage embodiment of the present invention 2, prescription is made, when 1h, blood pressure significantly declines; When 3h, blood pressure is down to minimum, has respectively 25.0 ± 0.5kPa to be down to 18.7 ± 0.5kPa, blood pressure drops 25.6%, and 24h blood pressure drops 6.8%, antihypertensive effect is better than matched group captopril.The compounds of this invention can reduce blood pressure dose dependent, and medication is without clear and definite drug resistance repeatedly, and on heart rate, without impact, after captopril administration, the phenomenon of the tachycardias of a property crossed appears in rat heart rate.
Three. Treatment of Hypertension when hypertension merges cerebrovascular
Normal brain blood flow all can keep normal range in the time of mean blood pressure 7.98～19.9kPa, has good self-regulation ability.Hypertensive patient's self-regulation ability declines, and cerebral blood flow reduces, and while there is cerebrovascular accident, regulating power almost disappears, and convalescent period recovers gradually, but is starkly lower than normal person, also lower than the hypertensive patient without cerebrovascular complication.The present composition can improve the blood flow of heart and brain in reducing Hypertension, and hypertensive patient's life quality of cerebrovascular complication is improved greatly.
The impact of the soft capsule that described in the embodiment of the present invention 3, prescription is made on mouse brain exponential sum brain capillary permeability: to NIH white mice, 18～22g, 60, be divided at random 6 groups, every group 10, male and female half and half, the respectively following medicine of gavage (1) cerebral ischemic model group (distilled water); (2) soft capsule that described in the embodiment of the present invention 3, prescription is made, dosage is 30mg/kg, successive administration 12 days, last administration 1 hour, animal lumbar injection pentobarbital sodium 50mg/kg, separates bilateral common carotid arteries, introduce two-wire ligation and cause tentative cerebral ischemic model, 3 hours broken ends of ligation carotid artery are got brain, claim cutaneous horn weight, calculate cerebral index.Result shows: the present composition can make ligation common carotid artery cause cerebral blood supply insufficiency and cause the cerebral anoxia animals survived time obviously to extend, and can reduce the infringement of hypoxic-ischemic to cerebral tissue, alleviates the pathological changes such as cerebrovascular permeability increases due to cerebral ischemia.
Four, the fat-reducing effect of the present composition and comparative example 1:
SD rat, 250～300g, 50, be divided at random 5 groups, 10 every group, male and female half and half, wherein 1 group as a control group, all the other 4 groups as medicine group.Except matched group, all feed with high lipid food (high lipid food formula: 10% yolk powder for all the other 4 groups, 5% large oil, 0.5% gallbladder salt, 0.2% cholesterol, 84.3% normal feedstuff, processed by the Chinese medical courses in general institute special feedstuff processing of animal center group), wherein, in medicine group, have 2 groups oral to the soft capsule (6.0g/kg) made of prescription described in the embodiment of the present invention 4, remain 2 groups of medicine groups oral to pharmaceutical composition (6.0g/kg) described in comparative example 1, matched group is given and equal-volume distilled water, once a day, continuous 15 days, 60min after last administration, get tail blood, measure the serum triglycerides (TG) of matched group and each administration group rat by Hitachi's automatic clinical chemistry analyzer 7060 types, serum total cholesterol (TC), whole blood viscosity erythrocyte electrophoretic time.Result is as shown in the table.
Table 1 each group rat blood serum triglyceride TG level (X ± S)
Table 2 each group rat blood serum T-CHOL TC level (X ± S)
The each group of table 3 rat whole blood viscosity meansigma methods, the comparison of erythrocyte electrophoretic time meansigma methods
From table 1,2,3 results, described in medicine and comparative example 1, pharmaceutical composition all can significantly reduce hyperlipidemia rats whole blood viscosity and serum triglycerides described in the embodiment of the present invention 4, serum total cholesterol, and erythrocyte electrophoretic time is had no significant effect.And compared with pharmaceutical composition described in comparative example, the compositions that the present invention only contains Radix Salviae Miltiorrhizae extract, Rhizoma Gastrodiae extract and Folium Eucommiae extract, except can blood fat reducing, also has blood pressure reduction effect; In addition, the lipid-lowering effect of embodiment 4 is better than comparative example 1; The effect of the reduction blood viscosity of embodiment 4 is significantly better than comparative example 1.
Five, clinical efficacy
In the 490 routine clinical experiments that carry out in the clinical experiment base of specifying in national Yao Jian department, clinical trial medicine is the tablet that in embodiment 1, prescription makes, and result is that obvious effective rate 82%, total effective rate are up to 94%.
Country's clinical verification base clinical evaluation standard is: more than effective diastolic pressure decline 10mmHg, and reach normal range; Though diastolic pressure is not down to normally, declined 20mmHg or more than; Systolic pressure decline 40mmHg or more than; Possesses wherein one.Effectively diastolic pressure declines not as good as 10mmHg, but has reached normal range; Front decline 10～19mmHg is treated in diastole, but does not reach normal range; More than systolic pressure is treated front decline 30mmHg; Possesses wherein one.
Claims (10)
1. a pharmaceutical composition, is characterized in that, the component that contains following weight: Radix Salviae Miltiorrhizae extract 80 ~ 200g, Rhizoma Gastrodiae extract 50 ~ 120g, Folium Eucommiae extract 40 ~ 200g, natural dispersant 100 ~ 500g, natural suspending agent 10 ~ 50g.
2. pharmaceutical composition according to claim 1, is characterized in that, the water solubility extract that described Radix Salviae Miltiorrhizae extract is ZANGDANSHEN; Described Rhizoma Gastrodiae extract is ZANGTIANMA alcohol extract; Described Folium Eucommiae extract is the alcohol extract of Folium Eucommiae.
3. pharmaceutical composition according to claim 2, is characterized in that, the preparation method of the water solubility extract of ZANGDANSHEN is: by ZANGDANSHEN medical material, pulverize extracting in water after sieving; Extracting solution is carried out after precipitate with ethanol processing, filter, concentrated alcohol liquid; By the pH regulator to 1.0 of alcohol liquid ~ 4.0, remove by filter precipitation, get supernatant; By polydextran gel resin, supernatant is carried out after purification, after water and alcohol eluting, collect alcohol washing liquid respectively, concentrated; Concentrated solution under the condition of pH6.0 ~ 11.0, heat treated 2 ~ 6 hours at the temperature of 65 ℃ ~ 100 ℃; Regulation system pH to 3.0 ~ 5.0, concentrate drying makes.
4. pharmaceutical composition according to claim 2, it is characterized in that, the preparation method of described ZANGTIANMA alcohol extract is: after dry ZANGTIANMA is cleaned, process by microwave method or ultrasonic method within 8 ~ 10 minutes, carry out fragmentation, the defibrination that adds water, centrifugalize obtains supernatant; Supernatant is through macroporous adsorbent resin, adds after 80% alcohol reflux defat except albumen, and upper water liquid dialysis 24h removes after organic solvent and small-molecule substance concentrated, add water with absolute ethanol washing 5 ~ 10 times after, vacuum lyophilization makes.
5. pharmaceutical composition according to claim 2, it is characterized in that, the preparation method of the alcohol extract of described Folium Eucommiae is: the alcoholic solution by fresh Folium Eucommiae take volume fraction as 85% is as solvent, the ratio of Folium Eucommiae and solvent is 1:4(g/mL), 60 ℃ of supersound extraction 30-60min, vacuum filtration obtains filtrate; The extract that filtrate is made to Folium Eucommiae by carbon dioxide supercritical fluid extraction method, vacuum lyophilization makes.
6. pharmaceutical composition according to claim 1, is characterized in that, described natural dispersant is one or more in walnut oil, olive oil, perilla oil, Radix Oenotherae erythrosepalae oil, Oleum Vitis viniferae, Fructrs Hippophae seed oil, Semen Maydis oil or Cortex Eucommiae bar oil.
7. pharmaceutical composition according to claim 1, is characterized in that, described natural suspending agent is the mixture of natural oil wax or Cera Flava and soybean phospholipid, and its ratio is (calculating by weight) natural oil wax or Cera Flava: soybean phospholipid=1:5 ~ 3:1.
8. pharmaceutical composition according to claim 1, is characterized in that, also comprises pharmaceutically acceptable carrier auxiliary material, is prepared into medical dosage form or functional health product; Described medical dosage form is conventional tablet, slow releasing tablet, capsule, drop pill, dry suspension, powder, granule, Orally taken emulsion.
9. the pharmaceutical composition described in claim 1 to 8 any one is in the application of preparing in Hypertension medicine.
10. the application of pharmaceutical composition in preparation treatment hypertension drug according to claim 9, it is characterized in that, described Hypertension medicine is treatment essential hypertension medicine, with the hypertension disease medicament of hyperlipidemia, with the hypertension disease medicament of hyperglycemia, with the hypertension disease medicament of hyperlipidemia, hyperglycemia or regulate cardiac function, anti-cardiac-cerebral ischemia medicine.
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| CN106540097A (en) * | 2016-11-29 | 2017-03-29 | 新乡医学院 | A kind of Chinese medicine composition for treating atherosclerosiss hypertension and its application |
| CN107898936A (en) * | 2017-12-12 | 2018-04-13 | 吴祥玉 | Chinese medicine sustained release tablets and preparation method thereof |
| CN108578584A (en) * | 2018-05-25 | 2018-09-28 | 西安华森医药生物工程有限公司 | A kind of sieve fiber crops capsule and preparation method thereof with auxiliary function for lowering blood pressure |
| CN110755393A (en) * | 2019-12-01 | 2020-02-07 | 江苏黄河药业股份有限公司 | Lisinopril drop and preparation method thereof |
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| CN105106434A (en) * | 2015-09-24 | 2015-12-02 | 上海春芝堂生物制品有限公司 | Wolfberry fruit and American ginseng soft capsules and preparation method thereof |
| CN106540097A (en) * | 2016-11-29 | 2017-03-29 | 新乡医学院 | A kind of Chinese medicine composition for treating atherosclerosiss hypertension and its application |
| CN107898936A (en) * | 2017-12-12 | 2018-04-13 | 吴祥玉 | Chinese medicine sustained release tablets and preparation method thereof |
| CN108578584A (en) * | 2018-05-25 | 2018-09-28 | 西安华森医药生物工程有限公司 | A kind of sieve fiber crops capsule and preparation method thereof with auxiliary function for lowering blood pressure |
| CN110755393A (en) * | 2019-12-01 | 2020-02-07 | 江苏黄河药业股份有限公司 | Lisinopril drop and preparation method thereof |
| CN113499397A (en) * | 2021-09-02 | 2021-10-15 | 北京贡源本草生物科技有限公司 | Composition for treating coronary heart disease and preparation method thereof |
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