CN106138210A - Butterflybush flower and the application of the medicine as preparation treatment hypertensive cardiopathy for the extract thereof - Google Patents

Butterflybush flower and the application of the medicine as preparation treatment hypertensive cardiopathy for the extract thereof Download PDF

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CN106138210A
CN106138210A CN201610648732.0A CN201610648732A CN106138210A CN 106138210 A CN106138210 A CN 106138210A CN 201610648732 A CN201610648732 A CN 201610648732A CN 106138210 A CN106138210 A CN 106138210A
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温先敏
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The invention belongs to technical field of traditional Chinese medicines, be specifically related to the application in the cardiopathic medicine of preparation treatment of a kind of natural plant crude drugs and/or its extract.The present invention relates to the application in the medicine of preparation treatment hypertensive cardiopathy of butterflybush flower and/or its extract.Butterflybush flower of the present invention is loganiaceae plant butterflybush flower bud, inflorescence or its complete stool, described extract is to extract in room temperature after butterflybush flower is pulverized or be heated to reflux or the extract obtained in supercritical extract, and extracting used solvent is the water liquid miscible in any proportion with ethanol；Or the organic solvent liquid miscible in any proportion such as ether, petroleum ether, chloroform, ethyl acetate；Or liquid CO2.Butterflybush flower of the present invention and/or its extract can make pharmaceutical preparation separately as main active, it is also possible to make pharmaceutical preparation with other compositions collectively as main active.

Description

Butterflybush flower and extract thereof are as the medicine of preparation treatment hypertensive cardiopathy Application
Technical field
The invention belongs to technical field of traditional Chinese medicines, be specifically related to a kind of natural plant crude drugs and/or its extract is controlled in preparation Treat the new opplication in cardiopathic medicine.
Technical background
Since eighties of last century nineties, heart disease is wide with the scope of falling ill, frequency of disease development is high and harmfulness is big gradually Become the underlying cause of death of urban and rural residents of China, accounted for the 35% of total death toll at present, be the first of harm China national health Big killer.Current heart disease is many treats with operation and Western medicine, big yet with western medicine heart disease side effect, often causes Many bad reactions, cause the organ damage such as the liver to patient, kidney, intestines, stomach very big, in the case, are attempted to find one Individual more particularly suitable method, and the traditional Chinese medicine advantage of oneself just in this respect, Chinese medicine heart disease is not only to patient's Heart has one's own knack, and also has conditioning, health-care effect to other internal organs.
Butterflybush flower Buddleja officinalis Maxim. is loganiaceae plant, contained " Chinese Pharmacopoeia " 2010 editions Function with cure mainly as " heat-clearing nourishing the liver, removing nebula.For red eye, swell pain, many tear photophobia, screen of looking unfamiliar film, hepatasthenia dim eyesight, depending on thing dusk Flower.”
Butterflybush flower is all used by the medicinal ancient books and records of history tree and each ethnic group as " nourishing the liver to improve visual acuity " medicine, especially as " ophthalmology panacea " uses.Before this, have many should in medicine in terms of preparing ophthalmology and liver for the butterflybush flower Patent application and document report, but butterflybush flower treatment cardiac disease there is no document report.
Content of the invention
It is an object of the invention to provide a kind of butterflybush flower and/or new opplication in pharmaceutical field for its extract.
The present invention relates to the application in the cardiopathic medicine of preparation treatment of butterflybush flower and/or its extract.
The present invention relates to the application in the medicine of preparation treatment coronary heart disease of butterflybush flower and/or its extract.
The present invention relates to the application in the medicine of preparation treatment rheumatic heart disease of butterflybush flower and/or its extract.
The present invention relates to the application in the medicine of preparation treatment hypertensive cardiopathy of butterflybush flower and/or its extract.
The present invention relates to the application in the medicine of preparation treatment cor pulmonale of butterflybush flower and/or its extract.
The present invention relates to the application in the myocardiac medicine of preparation treatment of butterflybush flower and/or its extract.
The present invention relates to the application in the medicine of preparation treatment cardiac tumor of butterflybush flower and/or its extract.
The present invention relates to the application in the medicine of preparation treatment vascular lesion of butterflybush flower and/or its extract.
Butterflybush flower of the present invention is loganiaceae plant butterflybush flower bud, inflorescence or its complete stool, and described extract is Extracting in room temperature after butterflybush flower pulverizing or being heated to reflux or the extract obtained in supercritical extract, extraction is used Solvent is the water liquid miscible in any proportion with ethanol；Or ether, petroleum ether, chloroform, ethyl acetate etc. are organic molten Agent liquid miscible in any proportion；Or liquid CO2。
Butterflybush flower of the present invention and/or its extract can make pharmaceutical preparation separately as main active, Also pharmaceutical preparation can be made with other compositions collectively as main active.
Pharmaceutical dosage form of the present invention includes various oral, injection, the medicinal thing of cavity, the different way of administration such as percutaneously Preparation.Can be raw material of the present invention make through common process with corresponding pharmaceutic adjuvant capsule, tablet, granule, ball Agent, externally-applied liniment, spray, injection etc., it is also possible to be the compound preparation of raw material of the present invention and other Chinese medicines composition.
The invention provides the new opplication of butterflybush flower and/or its extract, provide new crude drug for disease treatment Thing plant.Present invention is mainly used for coronary heart disease, rheumatic heart disease, hypertensive cerebral heart, pulmonary heart, cardiomyopathy, the heart Dirty tumour, the complex treatment of vascular lesion.Pharmaceutical preparation made by the present invention shows without bright through animal experiment and clinical testing Aobvious bad reaction and toxic and side effect, can provide safe and efficient treatment cardiopathic natural drug new product for patient.
Drug safety of the present invention is tested:
First, acute toxicity test
1 materials and methods
1.1.1 animal: healthy qualified cleaning grade Kunming mouse 40, body weight 18～22g, male and female half and half, is cured by Kunming University of section experimental animal center provides.
1.1.2 test medicine and preparation thereof: butterflybush flower capsule (preparation method is shown in embodiment 2, lower same) is famous in medicine company by Yunnan to be had Limit company provides, specification 0.5g/ grain.Take 40 butterflybush flower capsules and remove capsule shell, pour out medicinal powder, in mortar, grind 5min After be gradually added into 2% sodium carboxymethylcellulose, join for pasty state suspension, thickness, end level is 40%, is butterflybush flower capsule Maximum concentration.
1.2 test method
With reference to " study of tcm new drug guide " (pharmacy, pharmacology, toxicology), in the laboratory of room temperature 22 DEG C, repeatedly Prerun mouse gavaging capsule 40g/kg (capsule suspension Cmax and heap(ed) capacity), observes one week mouse toxicity and reacts and dead Die situation, fail to measure capsule gavage LD50 value, therefore select mtd test.
Choose the qualified cleaning grade Kunming mouse of 20 health, male and female half and half, by gavage in capsule suspension 24h, be administered Capacity is 0.2ml/10g body weight, then freely drinks water and looks for food, and observes one week, record mouse appetite, body weight, position, breathing, The situations such as righting reflex.
1.3 result of the test
None example death in 1 week of mouse stomach capsule suspension, takes food and change without exception of drinking water, as shown in table 1.
Result after table 1 mouse gavaging butterflybush flower capsule
In observing 7 days, take medicine dead mouse and the generation of obvious anomaly.Put to death through cervical dislocation and dissect every animal simultaneously Compare with normal mouse, under bore hole, the discovery without exception such as the heart, liver, spleen, lung, kidney, brain.
This result of the test, mouse gavaging capsule Cmax and maximum volume, i.e. 40g/kg body weight, is human body dose 666 times, have no that toxicity occurs.
Pharmacodynamics test of the present invention:
2nd, mist flower Capsules On Anti experimental atherosclerosis effect
1 materials and methods
1.1 reagent and medicine cholesterol, cholate are purchased from Tianjin Yong great chemical reagents corporation；Lard is made by oneself；Yolk powder with Whole milk powder market is bought；Basal feed is provided by Kunming Medical University's Experimental Animal Center.MDA (MDA) and superoxides Mutase (SOD) detection kit: Nanjing Ju Li biomedical engineering research institute.Rabbit anti-mouse ICAM-1 (ICAM- 1) antibody, peroxidase (HRP) mark goat anti-rabbit igg, instant SABC (peroxidase) immunohistochemical kit and DAB Nitrite ion (Wuhan Boster Biological Technology Co., Ltd.).Butterflybush flower capsule is developed by Yunnan Mingyang Pharmaceutical Co., Ltd..
1.2 instrument 5804R low temperature ultracentrifuges (eppendorf company of Germany)；UV-2401 spectrophotometer (Japan Shimadzu)；AMS-18A automatic clinical chemistry analyzer (Zhangjiakou Ao Pusen development in science and technology Co., Ltd)；Olympus CH30 optics Microscope.
1.3 packets and healthy SD rat 30 of drawing materials, ♂, body weight (205 ± 20) g, dynamic purchased from Kunming Medical University's experiment Thing center.Rat is randomly divided into and organizes 3 groups: control group, model group and Chinese drug-treated group, often organize 10.Control group feeding is raised with standard Material, model group and mist flower Capsules group feed with high lipid food (1% cholesterol, 0.1% cholate, 10% lard, 5% yolk powder, 5% whole milk powder, 78.9% basal feed), mist flower Capsules group gives butterflybush flower capsule while feeding with high lipid food.Respectively Group is all freely drunk water, acute execution after feeding 8 weeks continuously, and abdominal vein takes blood, centrifuging and taking serum, and 20 DEG C of refrigerators are placed, rat Opening rapidly chest and taking out sustainer chest and abdomen section blood vessel, remove surrounding tissue, 70 DEG C of refrigerators keep, standby.
1.4 Biochemical Indexes measure serum cholesterol (TC), triacylglycerol (TG), low-density lipoprotein (LDL-C), HDL (HDL-C).The operation of kit specification is pressed in serum MDA level and SOD determination of activity.
1.5 light microscopic histology is drawn materials with aorta pectoralis intersection at rat aorta bow, 10% neutral formalin is solid Fixed, FFPE, preparation cross section paraffin section, thickness about 4 microns, HE dyes, om observation.
1.6 sustainer tube wall ICMA-1 detection abdominal aorta shearing one section of blood vessel of about 0.6cm, 10% neutral formalin is solid Fixed, remaining blood vessel is used for extracting albumen, 75% ethanol dehydration, FFPE cross-sectional slice, thick 4 microns, takes 1 every 4 , 5 slice, thin pieces of every part of vascular specimen.SABC immunohistochemical method detects ICMA-1:3%H2O2Room temperature closes min, with fire extinguishing Endogenous enzyme, after boiling water bath is repaired, normal three sheep blood serum room temperatures are closed and are blocked non-specific binding, rabbit anti-rat ICMA-1 antibody (1:100) 37 DEG C of 1h, biotinylation three goat anti-rabbit igg 37 DEG C hatches 20min, PBS wash after dropping reagent SABC.DAB develops the color, Soviet Union Lignin is slightly redyed, dehydration, transparent, and mounting, microscope are observed, to be not added with the section of rabbit anti-rat ICMA-1 antibody as feminine gender Compareing, the cell membrane of positive cell and cytoplasm dye yellowish-brown, and prompting has ICMA-1 to express.Choose cell distribution high uniformly Times visual field, as observation area, by positive cell number under mirror compared with total cell number, obtains the expression rate of positive cell, every part of blood Pipe sample takes the mean value of its 4 slice, thin pieces, draws ICMA-1 positive cell expression rate
Protein extract is carried out SDS-poly-third by 1.7 aortic blood tube wall ICMA-1 expressing quantity Detection and Extraction albumen Acrylamide gel electrophoresis, then transferring film, 1h closed by 5% skimmed milk power 37 DEG C, after TBS washes film, first resists with rabbit anti-rat ICMA-1 4 DEG C of reaction overnight of body (1:100), then react 1h, T-TBS with peroxidase (HRP) mark goat anti-rabbit igg (1:200) 37 DEG C Washing film, DAB develops the color, and analyzes.
The 1.8 all experimental datas of statistical procedures use SPSS11.5 software kit statistical analysis.
2 results
The comparison model group Serum TC of 2.1 blood fat, TG and LDL-C level are apparently higher than control group, mist flower capsule Atherosclerotic (AS) rat TC and LDL-C level can be significantly reduced, and inconspicuous (being shown in Table 2) is affected on TG and HDL-C.
Table 2 serum TC, TG, LDL-C and HDL-C level
Compare with control group,cP ＜ 0.05,bP ＜ 0.01；Compare with model groupcfP ＜ 0.01.
The comparison model group rat blood serum MDA level of 2.2 oxygen radical indexs of correlation apparently higher than control group, and SOD Activity then substantially reduces, and mist flower capsule can reduce MDA level, improves SOD activity (being shown in Table 3).
Table 3 serum MDA level and SOD activity
Compare with control group,cP ＜ 0.05,bP ＜ 0.01；Compare with model groupcfP ＜ 0.01.
The change naked-eye observation 3 treated animal aortic tunica intima no significant difference of 2.3 aorta wall tectologies, optics Basis of microscopic observation, the complete smooth not damaged of control rats arterial wall endothelium, smooth muscle marshalling；Model group rats artery Wall endotheliocytic swelling, part endothelial denudation, smooth muscle arrangement disorder, form of diverse, part smooth muscle has propagation, and to Internal layer migrates, and endothelial cell adhesion has monocyte, and inner membrance has monocyte infiltration, and macrophage can be observed；Mist flower Capsules group endothelium ratio is more complete, has no endothelial denudation, and smooth muscle arrangement is also neat compared with model group, the rare monocyte of endothelium Infiltration.
The impact of 2.4 mist flower Capsule in Rats sustainer ICMA-1 expressions
2.4.1 SABC is dyed yellowish-brown by SABC sections observation, positive cell cell membrane and cytoplasm, is had ICMA-1 expresses.Control rats aortic endothelial cell core smooth muscle cell has trace ICMA-1, model group rats sustainer Endothelial cell core smooth muscle cell ICMA-1 is that strong positive is expressed, and mist flower Capsules group can significantly reduce it and express.
2.4.2Western blot result control rats sustainer does not detects obvious ICMA-1 albumen, model group rats Sustainer ICMA-1 expressing quantity substantially increases, and mist flower Capsules group then can significantly lower the table of sustainer ICMA-1 Reach.
3 conclusions
Mist flower capsule can significantly reduce AS rat TC, LDL-C and MDA level, significantly improves SOD activity, hence it is evident that lower Sustainer ICMA-1 protein expression；Pathological examination also shows that mist flower capsule has protective effect to aortic tunica intima, shows fan Cover flower capsule and there is mitigation atherosclerosis, prevent and treat the effect of coronary heart disease.
3rd, the research that SHR rat blood pressure and left ventricular hypertrophy are affected by mist flower capsule
1 materials and methods
1.1 animal used as test spontaneous hypertensive rats (SHR) 50, are purchased from Chinese Academy of Sciences's Shanghai Experimental Animal Center, male Property, 11 week old, body weight (260 ± 18) g, sub-cage rearing, 2, every cage, room temperature (23 ± 2) DEG C, relative humidity (60 ± 5) %, from Drunk water by feed.
1.2 instruments and reagent RBP-1B type Hypertensive Rats measuring cell, Beijing China-Japan Friendship Hospital produces；UV-2401 Spectrophotometer (Japan's Shimadzu)；5804R low temperature ultracentrifuge (eppendorf company of Germany).Mist flower capsule is by Yunnan It is famous in pharmaceutcal corporation, Ltd's self-control；Enalapril is commercially available.Remaining reagent is that commercially available analysis is pure.
1.3 method
Whole rats are randomly divided into 5 groups by 1.3.1 animal packet and administration, often organize 10.Blank group gavages every day Drinking water；Mist flower capsule high, medium and low dosage group gavages mist by 400mg/kg, 800mg/kg, 1200mg/kg every day respectively Flower capsule；Enalapril group gavages enalapril by 20mg/kg every day.Every rat is pressed 10ml/kg and is administered or feedwater, surveys weekly Measure a body weight, and adjust dosage, administration time 8 weeks according to body weight.
1.3.2 observation index and assay method blood pressure determination: the blood pressure of the 4th, 8 weeks mensuration rats before experiment and after experiment Value, measurement 3 times continuously, average every time.Weighing rat body weight (BW) after last is administered, measuring blood pressure, sacrificed by decapitation is moved Thing, takes out rapidly heart, removes big blood vessel residue and connective tissue, cut off atrium along sexual intercourse ring, cut off right ventricle along interventricular septum, Reservations room interval, left compartment muscle, with normal saline flushing blood stains, weigh after blotting with filter paper, record left ventricular mass (LVW), Calculate the ratio (LVMI) of left ventricular mass and body weight.
The 1.4 all experimental datas of statistical procedures use SPSS11.5 software kit statistical analysis.
2 results
The impact of rat blood pressure is administered 4 weeks, after 8 weeks by 2.1, enalapril group and dosage group blood pressure high, middle with test before It is relatively remarkably decreased (P ＜ 0.05), and with blank group, low dose group compares significant difference (P ＜ 0.05), enalapril group With dosage group comparing difference not statistically significant (P ＞ 0.05) high, middle；Between blank group, low dose group, comparing difference is without statistics Meaning (P ＞ 0.05).The results are shown in Table 4.
The change of rat treatment anteroposterior contraction pressure respectively organized by table 4
Compare with before experiment, * P < 0.05；Compare with blank, low dose group,P<0.05。
2.2 on Cardiac Function in Rat affect enalapril group and dosage group high, middle compares with blank group, LVMI refers to Number declines notable (P ＜ 0.05), low dose group LVMI and blank group comparing difference not statistically significant (P ＞ 0.05)；High Dosage group and enalapril group LVMI index comparing difference statistically significant (P ＜ 0.05), the results are shown in Table 5.
The change of heart function after rat is treated respectively organized by table 5
Compare * P < 0.05 with blank group；Compare with enalapril groupP<0.05。
3 conclusions
Mist flower capsule can effectively reduce and control SHR rat blood pressure, mitigates and reverses SHR Left Ventricular Hypertrophy in Rats, carrying Show that mist flower capsule has good therapeutic effect to hypertensive heart disease.
4th, the mist flower pharmacological action to Rabbit Lung worry caused by ferric trichloride for the capsule
1 materials and methods
1.1 experimental animal Japan large ear rabbits 30, male and female half and half, body weight 2.2～3.5kg, it is purchased from Kunming Medical University Experimental Animal Center.
1.2 instruments are produced by Baiyunshan Pharmaceutics Stock-sharing Co., Ltd., Guangzhou City with reagent acetyl spiramycin；Aminophylline is by mountain East Pharmacy stock Co., Ltd of Xinhua produces；Mist flower capsule is made by oneself by Yunnan Mingyang Pharmaceutical Co., Ltd.；Olympus CH30 Light microscope.
1.3 methods take rabbit 30, divide 5 groups, blank group, model group, positive controls acetyl spiramycin (0.15g/kg, oral)+aminophylline (0.02g/kg, oral), mist flower capsule dosage group high, middle (1.2g/kg, 0.8g/kg). In addition to blank group, the liquor ferri trichloridi of remaining various auricular vein all simultaneously injection 1% 45 days.First 4 weeks 2 times/week, 0.5ml/ time；The injection next day later, 1ml/ time, totally four times；Then 1.5ml/ only, injects 2 times；2.0ml/ only, injects 1 time；? Rear difference one 2.5ml, 2.5ml, 3.0ml, 4.0ml/ only continuously injection 4 days (45 days, 19 times altogether, 25ml).In injection trichlorine Changing the same day of ferrous solution, blank group, model group are with distilled water gavage 50ml/ only；Positive controls is with acetyl spiramycin (0.15g/kg, oral)+aminophylline (0.02g/kg, oral) gavage；Mist spends capsule senior middle school dosage component not with 1.2g/kg, 0.8g/kg gavage.Put to death animal after 45th day gastric infusion 4h, win thyroid gland, spleen, the heart, lung, adrenal gland do pathology under light microscopic Check, and satisfactory, lung weight, measure heart path length in length and breadth, and pulmonic ring is long.
2 results
After 2.1 sign rabbit injection liquor ferri trichloridis, fur is all not as good as blank group rabbit gloss, mobility Declining, being short of breath occur in most rabbit, and after particularly dosage strengthens, animal breath frequency is accelerated, and kicks, addicted to sleeping, and about 1h rear Can recover normal, body weight increases slow compared with blank group.
After 2.2 survival condition terminate to experiment, administration group is high compared with model group animal dis motility rate, is shown in Table 6.
The flower impact on pulmonary heart disease Rabbits Models survival condition for the capsule of table 6 mist
Compare * P < 0.05, * * P P < 0.01 with model group.
Post mortem at 2.3 internal organs gross examination of skeletal muscle animals, naked eyes are visible in addition to blank group, and all animals are all visible The heart, lung and thoracic cavity adhesion, there is wind-puff at lungs edge, and there is bleeding on lung surface；Cardiac contour expands, full, sub-circular, longitudinal and transverse demeter Difference reduces, and heart size increases；Pulmonic ring expands.Above-mentioned performance positive control and mist flower capsule dosage group high, middle are compared with mould Type group mild symptoms, table 7 between the heart, lung index of correlation.
The flower impact on pulmonary heart disease Rabbits Models organ index for the capsule of table 7 mist
Compare * P < 0.05 with model group.
2.4 light microscopic pathological examination results display model groups have 4 rabbit myocytes granular degeneration, interstitial extravasated blood occur； It is scorching that interstitial occur diffusing in lungs, accidental parteriole endotheliocytic swelling, and intercellular is every broadening, and limit office alveolar wall thickens, and has scorching thin Born of the same parents infiltrate extravasated blood；In positive control and mist flower capsule, dosage group is respectively arranged with 2 rabbit lungs and slight pathological change, cardiac muscle nothing occurs Obvious pathological change；Mist flower capsule in high dose group lungs and cardiac muscle are all without obvious pathological change.Model group and each administration group man Rabbit thyroid gland, adrenal gland, spleen are all without the conversion of obvious pathology.Illustrate that the pathological change of the mist flower each internal organs of Capsule on Rabbit has relatively Strong protective effect.
3 conclusions
The Rabbit Lung worry that ferric trichloride is induced by mist flower capsule has improves symptom, alleviates the positive role of the state of an illness.
Clinical data:
5th, mist flower capsule for treating unstable angina observation of curative effect
Coronary heart disease unstable angina (UA) refers between stable angina pectoris and acute myocardial infarction AMI (AMI) Group anginal syndrome when participating in the cintest.
1 data and method
1.1 physical data 68 case patients all meet International Society of Cardiology and WHO clinical name standardization associating special topic report Accuse " name of ischemic heart disease and diagnostic criteria ", discharge acute myocardial infarction AMI, serious liver and kidney dysfunction.68 case patients with Machine is divided into 2 groups, control group 32 case, the wherein male sex 19 case, women 13 case, 40～72 years old age；Treatment group 36 case, the wherein male sex 22 Example, women 14 case, 40～74 years old age.Two groups in sides such as sex, age, Clinical types, the course of disease, Electrocardiogram Feature, complication Face, difference not statistically significant.
1.2 treatment method control groups are administered orally Tab. Isosorbidi Dinitratis: sublingual administration 5 10mg every time, three times a day；Treatment Group oral mist flower capsule, 3 every time, three times a day, two groups of courses for the treatment of are 30 days.
1.3 observation index observe angina pectoris attacks situation and ECG Change before and after two groups of patient's treatments.
1.4 efficacy determinations are effective: angina pectoris transference cure or substantially disappear within a course for the treatment of, and electrocardiogram recovers to just Often or substantially normally meet with the next item up or two be effective；Effective: angina pectoris attacks number of times, degree and duration substantially subtract Gently, reduce more than ST section rise 0.05mV or negative T wave and shoal that to reach more than 25% or T ripple from smooth becoming be uprightly effective；Nothing Effect: symptom is without improving, and electrocardiogram is front with treatment essentially identical for invalid.
2 results
2.1 liang of group angina pectoris, ECG curative effects are shown in Table the 8th, table 9
Table 8 curative effect to treat angina pectoris compares
Two groups of obvious effective rates, total effective rate comparing differences are statistically significant (P < 0.05).
Table 9 ECG curative effect compares
Two groups of obvious effective rates, total effective rate comparing differences are statistically significant (P < 0.05)
2.2 bad reactions two groups are over the course for the treatment of all without obvious adverse reaction.
6th, mist flower capsule for treating rheumatic heart disease observation of curative effect
Rheumatic heart disease is modal one in heart disease, is the chronic valvular that acute rheumatic valvulitis is left over Disease, we achieve satisfied effect by mist flower capsule for treating rheumatic heart disease, are now summarized as follows clinical data.
1 data and method
The 1.1 all patients of physical data after checking, the chronic rheumatic heart disease formulated according to the Ministry of Public Health in 1992 Diagnostic criteria is diagnosed as rheumatic heart.72 case rheumatic heart diseases are divided into 2 groups, control group 32 case, wherein, the male sex 14 case, female Property 18 cases, 34～61 years old age, mitral lesion person 18 case, aortic valve disease person 16 case, there are 2 cases to be that two valves are all sick Become；Treatment group 40 case, the wherein male sex 17 case, women 23 case, 35～61 years old age, mitral lesion person 22 case, aortic disease Change person 20 case, has 2 cases to be the equal pathology of two valves.All patients are without the not congruent disease of serious Liver and kidney function, and patient is in property Not, the age, have comparativity, P ＞ 0.05 in the course of disease.
1.2 treatment method control group oral hydrochloride amiodarone pieces, load: usual one day 600mg (3), maintenance dose: 100～400mg on the one can be given according to individual reaction.Treatment group be administered orally mist flower capsule, 3 every time, three times a day, two groups of treatments Cheng Junwei 4 months.
1.3 observation index check Cardiac Function of Patients
1.4 efficacy determinations are effective: activity is unrestricted, and general activity is without any discomfort；It is effective: physical exertion is slightly restricted, Discomfort occurs during general physical exertion；Minor effect: physical exertion is substantially restricted, slight physical exertion has a strong impact on life；Invalid: Can not normal life, symptom is without any improvement.Total effective rate=(total case-Ineffective Cases)/total case × 100%.All trouble All there is the one or many in the complication such as heart failure, arrhythmia cordis, respiratory tract infection, embolism, dyscatabrosis before treating in person Kind, formulate the standard of curative effect evaluation for treatment infectious-related complication: 0～1 complication is effective for treatment；2～3 complication occur for controlling Treat effectively；More than 3 complication occur for failing to respond to any medical treatment.Total coincidence=(total case-effective case)/total case × 100%.
2 results
2.1 liang of group two groups of patients of Cardiac Function of Patients recovery situation, through treatment, follow up a case by regular visits to after 4 months check heart function, result It is shown in Table 10.
Table 10 heart function recovery situation
Two groups of total effective rate comparing differences are statistically significant (P < 0.05).
2.2 complication results were treated after 4 months, for rheumatic heart disease complication follow-up observation and add up, knot Fruit is shown in Table 11.
Table 11 complication result
Two groups of total coincidence comparing differences are statistically significant (P < 0.05).
Detailed description of the invention
The present invention prepares embodiment by following medicine and carrys out detailed explanation and describe the present invention, but, the present invention is not It is limited to these embodiments.
Embodiment 1: butterflybush flower tablet
Formula: butterflybush flower 1000 parts, starch 3 parts, lactose 20 parts, sodium carboxymethyl starch 15 parts, talcum powder 4 parts.
Preparation method: take butterflybush flower 800 parts, presses decocting method with drinking water and extracts secondary, and 1 hour every time, collecting decoction (or took close Cover flower, be ground into meal, soak secondary with the hydrous ethanol of variable concentrations in 40 DEG C, 6～8 hours every time, merge immersion liquid, reclaim Ethanol), concentrate decocting liquid and become thick paste, dry, pulverize into fine powder in 55 DEG C～65 DEG C standby.Separately take butterflybush flower 200 parts, directly pulverize Become fine powder, mix with aforementioned Flos Buddlejae extract fine powder, lactose, sodium carboxymethyl starch, make binder with starch slurry, make Grain, is dried, and adds talcum powder and mixes, compressing tablet and get final product.
Embodiment 2: butterflybush flower capsule
Formula: butterflybush flower 1000 parts, starch 100 parts.
Preparation method: take butterflybush flower 800 parts, presses decocting method with drinking water or (hydrous ethanol) and extracts secondary, 1 hour every time, close And decocting liquid (or take butterflybush flower, it is ground into meal, soak secondary with the hydrous ethanol of variable concentrations, 6～8 hours every time, merge leaching Liquid, reclaims ethanol), concentrate decocting liquid and become thick paste, dry, pulverize into fine powder in 55 DEG C～65 DEG C standby.Separately take butterflybush flower 200 parts, It is directly ground to fine powder, mixes with starch with aforementioned Flos Buddlejae extract fine powder, load capsule.
Embodiment 3: butterflybush flower capsule
Formula: butterflybush flower 1000 parts, starch 100 parts.
Preparation method: take butterflybush flower 700 parts, be ground into meal, extracts secondary by ethyl acetate room temperature, 48 hours for the first time, and the Secondary 40 hours, merges immersion liquid, reclaims ethyl acetate, and extract is standby.Separately take butterflybush flower 300 parts, be directly ground to fine powder, with Aforementioned Flos Buddlejae extract mixes, and dry, pulverize into fine powder in 60 DEG C～70 DEG C, mixes with starch, loads capsule and get final product.
Embodiment 4: butterflybush flower granule
Formula: butterflybush flower 1000 parts, Icing Sugar 200 parts, 10 parts of dextrin, lactose 20 parts.
Preparation method: take butterflybush flower, is ground into meal, extracts secondary by petroleum ether and ether mixed liquor (3 1) room temperature, for the first time 40 hours, 35 hours for the second time, merging leaching liquor, recycling design, extract adds Icing Sugar, dextrin, lactose to stir, and makes Particle, is dried, dispenses and get final product.
Embodiment 5: butterflybush flower pill
Formula: butterflybush flower 1000 parts, refined honey 110 parts.
Preparation method: take butterflybush flower 800 parts, selection, washing, dry, pulverize into fine powder in 60-65 DEG C, load extraction kettle, get rid of All gas impurity in kettle, then by supercritical fluid CO2(temperature 31.05 DEG C, pressure 7.39MP) injects extraction kettle, extraction, High pressure CO dissolved with extract2Gas flows into separating still, step-down from extraction kettle top, and extract separates out；Separately take butterflybush flower 200 Part, it is ground into fine powder, mixes with extract, add refined honey appropriate with water, general ball, make water-honeyed pill, to obtain final product.
Embodiment 6: butterflybush flower liniment
Formula: butterflybush flower 1000 parts, glycerine 200 parts.
Preparation method: take butterflybush flower 1000 parts, with deionized water press decocting method extract secondary, 1 hour every time, collecting decoction, dense It is reduced to relative density 1.1～1.2, add qdx ethanol, stirring, stand, filter, filtrate recycling ethanol (or take butterflybush flower meal, Soak secondary with the hydrous ethanol of variable concentrations in 40 DEG C, 6～8 hours every time, merge immersion liquid, reclaim ethanol), refrigeration 24 is little When, filtering, filtrate glycerol adding mixes, and dispenses and get final product.
Embodiment 7: butterflybush flower spray
Formula: butterflybush flower 1000 parts, ethylparaben 3 parts.
Preparation method: take butterflybush flower complete stool 1000 parts, presses decocting method with distilled water and extracts secondary, 1 hour every time, merge decocting Liquid, is concentrated into relative density 1.1～1.2, adds qdx ethanol, stirs evenly, and stands, and filters, filtrate recycling ethanol (or take butterflybush flower Meal, soaks secondary with the hydrous ethanol of variable concentrations in 40 DEG C, 6～8 hours every time, merges immersion liquid, reclaim ethanol), refrigeration 24 hours.Filter, add ethylparaben and distilled water appropriate, mix, filling, to obtain final product.
Embodiment 8: butterflybush flower injection
Formula: butterflybush flower 1000 parts, phenmethylol 10ml, 8 parts of sodium chloride.
Preparation method: take butterflybush flower 1000 parts, presses decocting method with distilled water and extracts secondary, 1 hour every time, merge decocting liquid, dense It is reduced to relative density 1.1～1.2, add qdx ethanol, stirring, refrigeration, precipitation, filter, filtrate recycling ethanol, be concentrated into relatively Density 1.05～1.06 (or take butterflybush flower meal, and soak secondaries with the hydrous ethanol of variable concentrations in 40 DEG C, 4～6 is little every time When, merge immersion liquid, reclaim ethanol and be simultaneously concentrated into relative density 1.05～1.06), then add ethanol to alcohol content and reach 80%, refrigeration, Filtering, filtrate recycling ethanol, to without alcohol taste, adds phenmethylol and sodium chloride, stirring and dissolving, injects water to 1000ml, use G4 Sintered glass funnel filters, and embedding is in the ampoule of 2ml, and 100 DEG C sterilize 30 minutes and get final product.
Embodiment 9: compound preparation 1
Formula: butterflybush flower 350 parts, little red ginseng 150 parts, pseudo-ginseng 240 parts, the red sage root 260 parts.
Preparation method: Radix Notoginseng powder is broken into meal, according to liquid extract and the percolation under extract item, uses 70% ethanol as solvent, Carrying out diacolation, diacolation liquid recycling ethanol after impregnating 24 hours, being concentrated into relative density 1.0～1.1 (60 DEG C), the dregs of a decoction are standby.Separately take Butterflybush flower, little red ginseng, the red sage root and the pseudo-ginseng dregs of a decoction, extract secondary with drinking water by decocting method, and 1 hour every time, collecting decoction (or took Butterflybush flower, little red ginseng, danshen powder are broken into meal and the mixing of the pseudo-ginseng dregs of a decoction, with the hydrous ethanol of variable concentrations in 40 DEG C of temperature extractions Take secondary, 6～8 hours every time, merge immersion liquid, reclaim ethanol), decocting liquid is merged with liquid of filtering and is condensed into thick paste, in 55 DEG C～ 65 DEG C dry, pulverize into fine powder, mix with appropriate amount of auxiliary materials, load capsule and get final product.
Embodiment 10: compound preparation 2
Formula: butterflybush flower 550 parts, the red sage root 390 parts, 60 parts of safflower.
Preparation method: above 3 tastes, it is standby that safflower is ground into fine powder, butterflybush flower, the red sage root, extracts secondary with drinking water by decocting method, 1 hour every time, and collecting decoction (or take butterflybush flower, red sage root meal, soak secondary with the hydrous ethanol of variable concentrations in 40 DEG C, often Secondary 6～8 hours, merge immersion liquid, reclaim ethanol), concentrate decocting liquid and become thick paste, dry, pulverize into fine powder in 55 DEG C～65 DEG C, and red Flower fine powder and appropriate amount of auxiliary materials mix, and load capsule, to obtain final product.
Above description is the general description of the present invention.According to circumstances or be actually needed, can carry out form change and etc. The replacement of value, although use specific term herein, but these terms are intended to describe, rather than the purpose in order to limit.Ability The present invention can be made various changes or modifications by field technique personnel, and these equivalent form of values fall within the application claims equally Within book limited range.

Claims (1)

1. butterflybush flower and/or an application in the medicine of preparation treatment hypertensive cardiopathy for its extract, described is close Covering flower is loganiaceae plant butterflybush flower bud, inflorescence or its complete stool, and described extract is in room temperature extraction after butterflybush flower is pulverized Or be heated to reflux or the extract obtained in supercritical extract, extract used solvent be water with ethanol with any ratio The miscible liquid of example；Or the liquid that ether, petroleum ether, chloroform, ethyl acetate organic solvent are miscible in any proportion； Or liquid CO2。
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