CN105412278A - Medicine composition, preparation method thereof, preparation and application - Google Patents
Medicine composition, preparation method thereof, preparation and application Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/734—Crataegus (hawthorn)
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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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- 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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/537—Salvia (sage)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
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Abstract
The invention discloses a medicine composition, a preparation method thereof, preparation and application. The medicine composition consists of radix notoginsengs, Yunnan fallopia multiflora, salvia miltiorrhiza and hawthorns, wherein the weight ratio is (0.5-1.5):( 0.5-1.5):(0.5-1.5):(0.5-1.5). The preparation method comprises the working procedures of preprocessing, coarse grinding, superfine grinding and mixing. The preparation is powder, tablets, granules, capsules, dripping pills or honey pills prepared by adding pharmaceutically acceptable auxiliary materials into the medicine composition. The medicine composition is applied to preparation of medicines for lowering blood pressure and blood fat. The medicine composition is prepared through mixing according to precisely set composition, achieves the effect of lowering blood pressure and blood fat according to physical and chemical properties of the raw medicines and compatibility of contained active ingredients and has the advantages of being high in bioavailability, fast in active ingredient dissolution, good in medicine absorption effect and small in side effect.
Description
Technical field
The invention belongs to Chinese drug preparation technique field, be specifically related to a kind of pharmaceutical composition and preparation method thereof, preparation and application.
Background technology
Hyperlipemia refers to that blood lipid level is too high, directly can cause the disease of some serious harm healths, as atherosclerosis, coronary heart disease, pancreatitis etc.Hyperlipemia can be divided into constitutional and Secondary cases two class.Constitutional is relevant with heredity with congenital, due to single-gene defect or polygenes defect, make the receptor of the transhipment of participation lipoprotein and metabolism, enzyme or apolipoprotein caused by abnormal, or cause due to environmental factors (diet, nutrition, medicine) with by unknown mechanism.Secondary cases is multiple is born in metabolic disorder disease (diabetes, hypertension, myxedema, hypothyroidism, obesity, hepatorenal disease, adrenal cortex function are hyperfunction), or with other factor age, sex, season, drink, smoking, diet, physical exertion, psychentonia, emotional activity etc. be relevant.The clinical manifestation of hyperlipemia is the xanthoma of lipid caused by intradermal deposition and the arteriosclerosis of lipid caused by blood vessel endothelium deposition mainly.Although hyperlipemia can cause xanthoma, its incidence rate is also not bery high; And atherosclerotic generation and development are a kind of slowly progressive processes.Therefore under normal conditions, most of patients non-evident sympton and abnormal sign.Many people raise owing to just finding that there is blood plasma lipoprotein level when other reasons carries out blood biochemical inspection.
Hypertension, is divided into two classes clinically: essential hypertension and secondary hypertension, and hypertensive symptom varies with each individual.Early stage possibility is asymptomatic or symptom is not obvious, blood pressure only can occur after fatigue, psychentonia, anxious state of mind and raise, and recover normal after rest.Along with the course of disease extends, blood pressure significantly continues to raise, and there will be various symptom gradually.Now be called as benign hypertension.Benign hypertension common clinical symptoms has headache, dizziness, absent minded, hypomnesis, numb limbs and tense tendons, nocturia increase, cardiopalmus, uncomfortable in chest, weak etc.Even there will be severe headache, vomiting, cardiopalmus, the symptom such as dizzy when blood pressure is elevated to a certain degree suddenly, time serious, obnubilation, tic can occur.This just belongs to accelerated hypertension and hypertension critical illness, how infringement and the pathological changes of the organs such as the serious heart, brain, kidney can occur in a short time, as apoplexy, heart infarction, renal failure etc.Symptom there is no consistent relation with the level that blood pressure raises.
The medicine preventing from treating hyperlipemia is at present main have Statins and resinae mainly with reducing serum total cholesterol and LDL-C.The special class of shellfish and nicotinic acid class is had based on the medicine reducing serum triacylglycerol.Antihypertensive drugs kind: 1. diuretic.2. beta-blocker.3. calcium channel blocker.4. angiotensin converting enzyme inhibitor.5. angiotensin-ii receptor blocker.Most of can separately or conbined usage thiazide diuretic, beta-blocker etc. without complication or complication patient.Treatment should from low dose, progressively ascending-dose.When clinical practice uses, patient's cardiovascular risk factors situation, target organ damage, Complication, efficacy of antihypertensive treatment, untoward reaction etc., all can affect the selection of depressor.2 grades of hyperpietics just can adopt two kinds of antihypertensive drugs therapeutic alliances when starting.All there is sizable side effect and need Long-term taking medicine in said medicine, therefore, the blood fat reducing Altace Ramipril developing a kind of side effect little is very important.
Summary of the invention
The first object of the present invention is to provide a kind of pharmaceutical composition; Second object is the preparation method providing described pharmaceutical composition; 3rd object is the preparation providing described pharmaceutical composition; 4th object is the application providing described pharmaceutical composition.
The first object of the present invention is achieved in that described pharmaceutical composition is made up of Radix Notoginseng, Yunnan Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae and Fructus Crataegi, and weight ratio is 0.5 ~ 1.5:0.5 ~ 1.5:0.5 ~ 1.5:0.5 ~ 1.5.
The second object of the present invention is achieved in that and comprises pretreatment, coarse pulverization, micronizing and mixture operation, specifically comprises:
A, pretreatment: the foreign material in each raw material are rejected, through selected, cleaning, dry in the sun, to be dried to moisture content≤3% for subsequent use;
B, coarse pulverization: raw material Radix Notoginseng, Yunnan Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae and Fructus Crataegi are pulverized with Roughpulverizer respectively, crosses 80 ~ 140 mesh sieves for subsequent use;
C, micronizing: the micropowders each raw material after coarse pulverization being obtained respectively each raw material through micronizing;
D, mixture: each raw material micropowders mixture is evenly obtained object by formulation ratio.
The third object of the present invention is achieved in that in described pharmaceutical composition that adding pharmaceutically acceptable adjuvant makes powder, tablet, granule, capsule, drop pill or honey pill agent.
The fourth object of the present invention is achieved in that described pharmaceutical composition is preparing the application in hypertension and hyperlipemia medicine.
In prescription of the present invention, Radix Notoginseng has dissipating blood stasis hemostasis, and effect of reducing swelling and alleviating pain can improve the state of blood stasis retardance.Radix Notoginseng total arasaponins has the effect of invigorating blood circulation, and can expand cardiovascular, increases coronary flow, inhibition thrombosis, antiplatelet aggregation, and can dissolve established thrombosis, having additional nutrients property myocardial flow.Yunnan Radix Polygoni Multiflori Preparata has effect of invigorating the liver and kidney, and the lipid metabolism approach of liver is recovered, and accelerates the toxicant metabolism in body; Promote that cholesterol is transformed into bile acid and discharges from intestinal.Radix Salviae Miltiorrhizae can make aorta atheromatous plaque formation area obviously reduce, serum total cholesterol, triglyceride, all decreases to some degree.The synthesis of danshensu energy T suppression cell endogenous cholesterol, prevents blood fat from rising.The triterpenes contained in Fructus Crataegi and flavones ingredient have the effect of significant blood vessel dilating and blood pressure lowering, often eat Fructus Crataegi and also have the function strengthening cardiac muscle, arrhythmia, adjustment blood pressure and cholesterol.Three medicines share, and can effectively prevent and treat the disease such as hypertension, hyperlipidemia.
Pharmaceutical composition of the present invention is made according to the prescription mixture of accurately setting, carry out according to former medicine reason, chemical property and contained active component the efficacy effect that compatibility reaches reducing blood pressure and blood fat, and have that bioavailability is high, active component stripping is fast, drug absorption is effective and the feature that side effect is little.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is further illustrated, but limited the present invention never in any form, and any conversion done based on training centre of the present invention or replacement, all belong to protection scope of the present invention.
Pharmaceutical composition of the present invention, is made up of Radix Notoginseng, Yunnan Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae and Fructus Crataegi, and weight ratio is 0.5 ~ 1.5:0.5 ~ 1.5:0.5 ~ 1.5:0.5 ~ 1.5.
Described pharmaceutical composition is made up of Radix Notoginseng, Yunnan Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae and Fructus Crataegi, and weight ratio is 1:1:1:1.
The preparation method of pharmaceutical composition of the present invention, comprises pretreatment, coarse pulverization, micronizing and mixture operation, specifically comprises:
A, pretreatment: the foreign material in each raw material are rejected, through selected, cleaning, dry in the sun, to be dried to moisture content≤3% for subsequent use;
B, coarse pulverization: raw material Radix Notoginseng, Yunnan Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae and Fructus Crataegi are pulverized with Roughpulverizer respectively, crosses 80 ~ 140 mesh sieves for subsequent use;
C, micronizing: the micropowders each raw material after coarse pulverization being obtained respectively each raw material through micronizing;
D, mixture: each raw material micropowders mixture is evenly obtained object by formulation ratio.
The particle diameter of described micropowders is 6 ~ 12 μm.
The preparation of pharmaceutical composition of the present invention is add pharmaceutically acceptable adjuvant in described pharmaceutical composition to make powder, tablet, granule, capsule, drop pill or honey pill agent.
The described pharmaceutical composition that is applied as of pharmaceutical composition of the present invention is preparing the application in hypertension and hyperlipemia medicine.
Described pharmaceutical composition instructions of taking is that sooner or later respectively once taking dose is 2g/ time.
With specific embodiment, the present invention will be further described below:
Embodiment 1
---the preparation method of described pharmaceutical composition
A, pretreatment: get Radix Notoginseng 50kg, Radix Salviae Miltiorrhizae 50kg, Fructus Crataegi 50kg, be placed in the silt etc. that SUS304 rustless steel XSG-600 type circulating water washer utilizes the rolling friction removing medical material of Water spray and the cleaning of general water and medical material respectively, drum speed is 12rpm, after medical material foreign material are wherein rejected, choose, cut into slices again, Radix Notoginseng after section is placed in baking oven sterilizing, sterilization time is set as 5min, sterilising temp is 75 DEG C, Radix Salviae Miltiorrhizae after section is placed in baking oven sterilizing, sterilization time is set as 10min, sterilising temp is 70 DEG C, Fructus Crataegi after section is placed in baking oven sterilizing, sterilization time is set as 10min, sterilising temp is 70 DEG C, then by Radix Notoginseng, Radix Salviae Miltiorrhizae, Fructus Crataegi is placed in RXH type hot air circular drying machine respectively, be dried to moisture content≤3% for subsequent use.
Semen sojae atricolor 1kg is added the water of 3 times of weight, boil 4.5h after soaking 7h, filter, second time adds the water of 2 times of weight, continues to boil 3.5h, and filter, merging filtrate, boils 2.5h again by filtrate.Then Radix Polygoni Multiflori 10kg is cut into the thin slice of 2 ~ 4cm, mix with 2.5kg decoction of black soybean, repeat to steam 9 times, each 8 hours, until the saturating heart, then by the Radix Polygoni Multiflori pieces after steaming, Mel, yellow wine according to the weight ratio mix homogeneously of 10:0.5:0.5, Mel, Chinese liquor are inhaled thoroughly by the Radix Polygoni Multiflori pieces after steaming, and are dried to moisture content≤3% for subsequent use at 65 DEG C.
B, coarse pulverization: Radix Notoginseng, Radix Salviae Miltiorrhizae, Fructus Crataegi, Yunnan Radix Polygoni Multiflori Preparata Circoplex classified grinding machine are pulverized, Radix Notoginseng, Radix Salviae Miltiorrhizae, Fructus Crataegi, that Yunnan Radix Polygoni Multiflori Preparata coarse powder crosses 80 mesh sieves is for subsequent use, microorganism detection is carried out in Radix Notoginseng, Radix Salviae Miltiorrhizae, Fructus Crataegi, the sampling of Yunnan Radix Polygoni Multiflori Preparata coarse powder, and the Radix Notoginseng after qualified, Radix Salviae Miltiorrhizae, Fructus Crataegi, Yunnan Radix Polygoni Multiflori Preparata coarse powder carry out micronizing.
C, micronizing: the Radix Notoginseng after Micro biological Tests is qualified, Radix Salviae Miltiorrhizae, Fructus Crataegi, Radix Polygoni Multiflori Preparata coarse powder WFM100 type ultra micro vibromill in Yunnan is pulverized, working condition is set as: grinding media is bar-shaped, grinding media diameter is 0.3mm, grinding media pack completeness is 50%, Radix Notoginseng inventory is 11kg, grinding time is 5h, Radix Salviae Miltiorrhizae inventory is 9kg, grinding time is 30min, Fructus Crataegi inventory is 12kg, grinding time is 30min, Yunnan Radix Polygoni Multiflori Preparata dosage is 11kg, grinding time is 5h, Radix Notoginseng after pulverizing, Radix Salviae Miltiorrhizae, Fructus Crataegi, in the Radix Polygoni Multiflori Preparata micropowders of Yunnan, particle diameter is the fine powder ratio of 6 ~ 12um is 92%.After micropowders is crossed 200 mesh sieves, the micropowders having crossed sieve is placed in rustless steel CBS series drawer type permanent-magnetic iron expeller and removes individual metal class material.
D, mixture: by Radix Notoginseng micropowders 50 parts by weight, Fructus Crataegi micropowders 50 parts, Radix Salviae Miltiorrhizae micropowders 50 parts, Yunnan Radix Polygoni Multiflori Preparata micropowders 50 parts mixing, be placed in EYH-1000A type two-dimensional motion mixer mix and blend, rotation number is 8rpm, shake number is 6rpm, mixing time is 30min, after mixture is even, in pharmaceutical composition, particle diameter is the fine powder ratio of 4 ~ 14um is 92%.
Embodiment 2
Pharmaceutical composition pack prepared by Example 1 becomes powder.
Embodiment 3
Pharmaceutical composition prepared by Example 1 adds pharmaceutically acceptable adjuvant and makes tablet.
Embodiment 4
Pharmaceutical composition prepared by Example 1 adds pharmaceutically acceptable adjuvant and makes capsule.
Embodiment 5
Pharmaceutical composition prepared by Example 1 adds pharmaceutically acceptable adjuvant and makes granule.
Embodiment 6
Pharmaceutical composition prepared by Example 1 adds pharmaceutically acceptable adjuvant and makes drop pill.
Embodiment 7
Pharmaceutical composition prepared by Example 1 adds pharmaceutically acceptable adjuvant and makes honey pill agent.
Embodiment 8
---decompression lipid-lowering effect pharmacological evaluation
One, experiment material:
(1) experimental drug and reagent: embodiment 1 prepare pharmaceutical composition of the present invention, Radix Notoginseng powder, Yunnan Radix Polygoni Multiflori Preparata powder, Radix Salviae Miltiorrhizae powder, Fructus Crataegi powder, by weight Radix Notoginseng powder, Yunnan Radix Polygoni Multiflori Preparata powder, Radix Salviae Miltiorrhizae powder, Fructus Crataegi powder pharmaceutical composition, compound hypoensive sheet, normal saline, normal diet, high lipid food, cholesterol, the methylthiouracil of 2:1:1:1,1:2:1:1,1:1:2:1,1:1:1:2 mixture.Wherein, Radix Notoginseng powder, Yunnan Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae powder and Fructus Crataegi powder are prepared with quality inspection according to the quality standard of " Yunnan Province's prepared slices of Chinese crude drugs standard " (cloud YPBZ-0194-2013 cloud YPBZ-0197-2013) defined.Compound hypoensive sheet purchased from Beijing Double-Crane Modern Medicine Technologies Limited Liability Company, sterile NaCl-peptone buffer agent purchased from the good Medical Devices Co., Ltd. of Shanghai luck tendency, normal diet is supplied by animal housing of biology department of Yunnan University, high lipid food is prepared voluntarily (forms percentage rate: cholesterol 2%, Adeps Sus domestica 10%, methylthiouracil 0.2%, normal diet 87.8%), angiotensin
(Ang
) radioimmunoassay kit, atrial natriuretic peptide put exempt from medicine box, Endothelin puts and exempts from medicine box: Jun You PLA General Hospital Science and Technology Development Center puts and exempts from institute and produce.
(2) experimental subject: spontaneous hypertensive rat, body weight 20 ± 2g, is provided by Beijing Vital River Experimental Animals Technology Co., Ltd., the quality certification number: SCXK(capital) 2002-0003; Kunming kind male white mice, body weight 20 ± 2g, is provided by Test Animal Centre, Academy of Military Medical Sciences, P.L.A, quality certification SCXK(army) 2007-004.
(3) experimental facilities: aluminum pot, Stainless steel basin, electric furnace, water-bath, electronic balance, baking oven, analytical balance, zip lock bag, weighing botle, sieve, white mouse inspection box and active box, stopwatch, disposable syringe, beaker, triangular flask.Above-mentioned experimental facilities is laboratory apparatus & equipment in common use.
Two, experimental technique:
(1) blood pressure lowering experiment
Get the close spontaneous hypertensive rat of pressure value 88, adapt to 1 week in fixed environment after, use blood pressure measuring instrument to measure often group white mouse systolic pressure and be worth as before medicine.88 Hypertensive Rats are divided into 11 groups at random: i.e. Radix Notoginseng powder group, Yunnan Radix Polygoni Multiflori Preparata powder group, Radix Salviae Miltiorrhizae powder group, Fructus Crataegi powder group, pharmaceutical composition group of the present invention, the Radix Notoginseng powder of Different Weight ratio: Yunnan Radix Polygoni Multiflori Preparata powder: Radix Salviae Miltiorrhizae powder: Fructus Crataegi powder pharmaceutical composition (2:1:1:1,1:2:1:1,1:1:2:1,1:1:1:2) group, compound hypoensive group and matched group.Adopt the administration of gavage mode, Radix Notoginseng powder group, Yunnan Radix Polygoni Multiflori Preparata powder group, Radix Salviae Miltiorrhizae powder group, Fructus Crataegi powder group, pharmaceutical composition group of the present invention, the Radix Notoginseng powder of Different Weight ratio: Yunnan Radix Polygoni Multiflori Preparata powder: Radix Salviae Miltiorrhizae powder: Fructus Crataegi powder pharmaceutical composition (2:1:1:1, 1:2:1:1, 1:1:2:1, 1:1:1:2) dosage of group and compound hypoensive group is 60mg/kg, matched group gives the normal saline of equivalent (60mg/kg), every day 1 time, totally 20 days, to measure before administration with blood pressure measuring instrument and 1d after administration, 4d, 8d, 11d, 15d, 18d, 1d after 21d and drug withdrawal, the each composition of medicine of 2d is on the impact of original hypertensive rat systolic pressure.Each measurement 4h after morning dose carries out (this time point animal blood pressure value of display that predicts the outcome is down to lower and locates steady statue).Experimental result data average X ± SD represents, compare between group and carry out data statistic analysis with independent samples t-test, experimental result is in table 1.
(2) lipid-lowering test
After healthy white mouse adaptability feeds 1 week, feed with high lipid food (cholesterol 2%, Adeps Sus domestica 10%, methylthiouracil 0.2%, normal diet 87.8%), make hyperlipemia model, after three weeks, fasting 12h, detect fasting plasma lipid, confirm that hyperlipemia model is successful, and press serum TC level by except too high or too low animal, all the other animals are divided into 11 groups at random, that is: pharmaceutical composition group of the present invention, Radix Notoginseng powder group, Yunnan Radix Polygoni Multiflori Preparata powder group, Radix Salviae Miltiorrhizae powder group, Fructus Crataegi powder group, the Radix Notoginseng powder of Different Weight ratio: Yunnan Radix Polygoni Multiflori Preparata powder: Radix Salviae Miltiorrhizae powder: Fructus Crataegi powder pharmaceutical composition (2:1:1:1, 1:2:1:1, 1:1:2:1, 1:1:1:2) group, compound hypoensive group, matched group.Often organize 8 white mouse.Adopt the administration of gavage mode, Radix Notoginseng powder group, Yunnan Radix Polygoni Multiflori Preparata powder group, Radix Salviae Miltiorrhizae powder group, Fructus Crataegi powder group, pharmaceutical composition group of the present invention, the Radix Notoginseng powder of Different Weight ratio: Yunnan Radix Polygoni Multiflori Preparata powder: Radix Salviae Miltiorrhizae powder: the dosage of Fructus Crataegi powder pharmaceutical composition (2:1:1:1,1:2:1:1,1:1:2:1,1:1:1:2) group and compound hypoensive group is 60mg/kg, matched group gives the normal saline of equivalent (60mg/kg), once a day, after 5 days, mice broken end gets the every blood lipids index of hematometry.Experimental result is in table 2.
Table 1 each pharmaceutical composition group blood pressure lowering result of the test
| Group | Dosage | Value before medicine | 1d | 4d | 8d | 11d |
| Contrast | 60 | 32.8±0.7 | 32.9±0.9 | 32.7±0.7 | 32.8±0.9 | 33.1±0.8 |
| Drug regimen group (1:1:1:1) of the present invention | 60 | 32.8±0.8 | 31.1±0.8＊＊ | 30.9±0.8＊＊ | 30.8±0.9＊＊ | 30.8±0.9＊＊ |
| Drug regimen group (2:1:1:1) | 60 | 32.8±0.7 | 32.1±1.6 | 31.7±1.6 | 31.7±1.3＊ | 32.1±1.5 |
| Drug regimen group (1:2:1:1) | 60 | 32.8±0.7 | 32.4±1.7 | 31.6±1.5 | 30.9±1.0＊＊ | 31.1±1.2＊ |
| Drug regimen group (1:1:2:1) | 60 | 32.8±0.7 | 32.9±0.9 | 32.8±0.7 | 31.6±0.9＊ | 33.0±0.8 |
| Drug regimen group (1:1:1:2) | 60 | 32.8±0.8 | 32.3±0.4 | 31.3±0.9＊ | 32.5±0.8 | 32.1±0.7 |
| Radix Notoginseng powder group | 60 | 32.8±0.8 | 31.9±0.9 | 31.9±0.8 | 31.5±0.7＊ | 31.5±0.8 |
| Yunnan Radix Polygoni Multiflori Preparata group | 60 | 32.8±0.8 | 32.0±1.3 | 31.9±1.1 | 31.9±1.5 | 32.0±1.5 |
| Radix Salviae Miltiorrhizae powder group | 60 | 32.8±0.7 | 32.5±1.6 | 32.3±0.7 | 32.3±1.6 | 31.7±1.7 |
| Fructus Crataegi powder group | 60 | 32.8±0.7 | 32.4±1.3 | 32.1±1.2 | 32.4±1.1 | 32.5±1.1 |
| Compound hypoensive group | 60 | 32.8±0.7 | 32.3±0.4 | 30.1±1.1＊＊ | 31.3±0.9＊ | 32.5±0.8 |
| Group | Dosage | 15d | 18d | 21d | Drug withdrawal 1d | Drug withdrawal 2d |
| Contrast | 60 | 32.9±0.4 | 33.1±0.8 | 32.9±0.8 | 32.9±0.8 | 32.8±1.2 |
| Drug regimen group (1:1:1:1) of the present invention | 60 | 30.9±1.1＊＊ | 30.9±0.9＊＊ | 30.8±0.8＊＊ | 32.7±1.5 | 33.2±1.5 |
| Drug regimen group (2:1:1:1) | 60 | 32.1±1.3 | 31.9±1.3＊ | 31.9±1.1＊ | 33.2±1.5 | 33.7±0.8 |
| Drug regimen group (1:2:1:1) | 60 | 31.2±1.1＊ | 32.5±2.1 | 33.5±1.7 | 33.2±1.5 | 33.1±1.7 |
| Drug regimen group (1:1:2:1) | 60 | 32.8±1.0 | 31.5±0.9＊ | 31.9±0.8＊＊ | 33.2±0.8 | 32.8±0.8 |
| Drug regimen group (1:1:1:2) | 60 | 32.1±0.8 | 32.0±0.9 | 31.1±1.1＊ | 32.3±0.8 | 32.5±0.9 |
| Radix Notoginseng powder group | 60 | 31.5±0.6＊ | 31.7±0.8 | 32.3±1.2 | 32.5±0.7 | 32.1±0.8 |
| Yunnan Radix Polygoni Multiflori Preparata group | 60 | 31.9±1.6 | 32.0±1.3＊ | 32.0±1.7 | 32.5±1.5 | 32.9±1.6 |
| Radix Salviae Miltiorrhizae powder group | 60 | 31.9±2.0 | 32.1±1.7 | 32.0±1.7 | 32.8±1.3 | 32.9±1.5 |
| Fructus Crataegi powder group | 60 | 32.8±0.8 | 32.8±0.9 | 31.9±1.3＊ | 32.7±1.2 | 32.4±0.8 |
| Compound hypoensive group | 60 | 32.4±0.7 | 30.8±1.1＊＊ | 32.3±0.5 | 33.1±0.6 | 32.8±0.7 |
As seen from Table 1, compared with matched group, pharmaceutical composition of the present invention (1:1:1:1), (2:1:1:1), (1:2:1:1), (1:1:2:1) (1:1:1:2) organize compound hypoensive group 1d, 4d upon administration, 8d, 11d, 15d, 18d, 21d, the systolic pressure of original hypertensive rat all has reduction in various degree, and wherein, pharmaceutical composition group (1:1:1:1) effect of the present invention is the most remarkable.
Table 2 medicine is on the impact of Serum TC, TG
| Group | N | TC（mmol/L） | TG（mmol/L） |
| Matched group | 10 | 3.19±0.43 | 0.98±0.39 |
| Model group | 10 | 6.53±1.24＊＊ | 7.48±1.91＊＊ 5 --> |
| Pharmaceutical composition (1:1:1:1) | 10 | 4.89±0.72△△ | 3.90±0.66△△ |
| Pharmaceutical composition (2:1:1:1) | 10 | 6.00±1.10 | 4.72±0.56 |
| Pharmaceutical composition (1:2:1:1) | 10 | 5.53±0.70 | 5.35±2.22△ |
| Pharmaceutical composition (1:1:2:1) | 10 | 5.91±1.00 | 4.72±0.56 |
| Pharmaceutical composition (1:1:1:2) | 10 | 5.29±0.91△ | 5.29±1.50△ |
| Radix Notoginseng powder group | 10 | 5.65±0.80 | 4.73±0.57 |
| Yunnan Radix Polygoni Multiflori Preparata group | 10 | 5.85±0.78 | 5.29±1.51△ |
| Radix Salviae Miltiorrhizae powder group | 10 | 5.29±0.91△ | 5.35±2.22△ |
| Fructus Crataegi powder group | 10 | 5.54±0.70 | 4.73±0.55 |
| Compound hypoensive group | 10 | 5.53±0.71 | 4.73±0.56 |
Note: model group compares with matched group:
*p<0.05,
*p<0.01; Pharmaceutical composition compares with model group:
△p<0.05,
△ △p<0.01.
Table 2 shows, and model control group serum TC, TG and matched group comparing difference have statistical significance (P<0.01), and modeling success is described.As seen from table, pharmaceutical composition group (1:1:1:1) of the present invention, pharmaceutical composition (1:1:1:2), pharmaceutical composition (1:2:1:1), pharmaceutical composition (1:1:1:2) Yunnan Radix Polygoni Multiflori Preparata group, Radix Salviae Miltiorrhizae powder group Serum TC, TG content reduce all in various degree, and wherein pharmaceutical composition group (1:1:1:1) effect of the present invention is the most remarkable.
Toxicity test
After administration 2h, mice is quiet, movable minimizing; 7h after administration, mice behavioral activity recovers normal.After 24h, mice behavioral activity is all normal.Continuous Observation 7d, mouse survival state, dietary amount, amount of drinking water, body weight all without obviously changing, without animal dead, illustrate pharmaceutical composition avirulence of the present invention and untoward reaction, use safety.
Claims (7)
1. a pharmaceutical composition, it is characterized in that described pharmaceutical composition is made up of Radix Notoginseng, Yunnan Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae and Fructus Crataegi, weight ratio is 0.5 ~ 1.5:0.5 ~ 1.5:0.5 ~ 1.5:0.5 ~ 1.5.
2. pharmaceutical composition according to claim 1, it is characterized in that described pharmaceutical composition is made up of Radix Notoginseng, Yunnan Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae and Fructus Crataegi, weight ratio is 1:1:1:1.
3. a preparation method for pharmaceutical composition according to claim 1, is characterized in that comprising pretreatment, coarse pulverization, micronizing and mixture operation, specifically comprises:
A, pretreatment: the foreign material in each raw material are rejected, through selected, cleaning, dry in the sun, to be dried to moisture content≤3% for subsequent use;
B, coarse pulverization: raw material Radix Notoginseng, Yunnan Radix Polygoni Multiflori Preparata, Radix Salviae Miltiorrhizae and Fructus Crataegi are pulverized with Roughpulverizer respectively, crosses 80 ~ 140 mesh sieves for subsequent use;
C, micronizing: the micropowders each raw material after coarse pulverization being obtained respectively each raw material through micronizing;
D, mixture: each raw material micropowders mixture is evenly obtained object by formulation ratio.
4. the preparation method of pharmaceutical composition according to claim 3, is characterized in that the particle diameter of described micropowders is 6 ~ 12 μm.
5. a preparation for the pharmaceutical composition described in claim 1 or 2, is characterized in that adding pharmaceutically acceptable adjuvant in described pharmaceutical composition makes powder, tablet, granule, capsule, drop pill or honey pill agent.
6. an application for the pharmaceutical composition described in claim 1 or 2, is characterized in that described pharmaceutical composition is preparing the application in hypertension and hyperlipemia medicine.
7. the application of pharmaceutical composition according to claim 6, is characterized in that described pharmaceutical composition instructions of taking is that sooner or later respectively once taking dose is 2g/ time.
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