CN106038701A - Application of Flos Buddlejae and extract thereof in preparation of cardiac tumor disease treatment medicines - Google Patents

Application of Flos Buddlejae and extract thereof in preparation of cardiac tumor disease treatment medicines Download PDF

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CN106038701A
CN106038701A CN201610650497.0A CN201610650497A CN106038701A CN 106038701 A CN106038701 A CN 106038701A CN 201610650497 A CN201610650497 A CN 201610650497A CN 106038701 A CN106038701 A CN 106038701A
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flos buddlejae
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温先敏
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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)
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    • A—HUMAN NECESSITIES
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    • A61K2236/30—Extraction of the material
    • 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
    • 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
    • A61K2236/35—Extraction with lipophilic solvents, e.g. Hexane or petrol ether
    • A—HUMAN NECESSITIES
    • 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 the technical field of traditional Chinese medicines, and concretely relates to an application of a natural plant medicine material and/or extract thereof in the preparation of heart disease treatment medicines, and relates to an application of Flos Buddlejae and/or extract thereof in the preparation of cardiac tumor disease treatment medicines. The Flos Buddlejae is buds, inflorescences or total plants of Loganiaceae plant Flos Buddlejae, the extract is obtained through crushing the Flos Buddlejae and carrying out room temperature extraction, heating refluxing or supercritical extraction, and a solvent used for extraction is a liquid formed by mixing water with ethanol according to an arbitrary ratio, or a liquid formed by mixing ether, petroleum ether, chloroform and ethyl acetate according to an arbitrary ratio, or liquid CO2. The Flos Buddlejae and/or the extract thereof can be individually used as a main active component to prepare medicinal preparations, and also can be used as a main active component together with other components in order to prepare the medicinal preparations.

Description

Flos Buddlejae and extract thereof treat the application of the medicine of cardiac tumor disease as preparation
Technical field
The invention belongs to technical field of 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, scope is wide, frequency of disease development is high and hazardness is big the most gradually with morbidity for heart disease Become the underlying cause of death of urban and rural residents of China, the most accounted for the 35% of total death toll, be the first of harm China national health Big killer.Heart disease is many at present treats with operation and Western medicine, big yet with western medicine heart disease side effect, often causes Many untoward reaction, cause the organ damage such as the liver to patient, kidney, intestinal, stomach very big, in the case, are attempted to find one Individual more particularly suitable method, and Chinese medicine oneself advantage the most just, Chinese medicine heart disease is not only to patient's Heart has one's own knack, and other internal organs are also had conditioning, health-care effect.
Flos Buddlejae Buddleja officinalis Maxim. is loganiaceae plant, contained " Chinese Pharmacopoeia " 2010 editions Function with cure mainly as " heat clearing away nourishing the liver, improving acuity of vision and removing nebula.For conjunctival congestion and swelling pain, many tear photophobia, nebula of looking unfamiliar film, hepatasthenia dim eyesight, depending on thing dusk Flower.”
Flos Buddlejae is all used by history tree and the medicinal ancient books and records of each ethnic groups as " nourishing the liver to improve visual acuity " medicine, especially as " ophthalmology panacea " uses.Before this, have many should in Flos Buddlejae medicine in terms of preparing ophthalmology and liver Patent application and document report, but Flos Buddlejae treatment cardiac disease there is no document report.
Summary of the invention
It is an object of the invention to provide a kind of Flos Buddlejae and/or its extract new opplication in pharmaceutical field.
The present invention relates to the application in cardiopathic medicine is treated in preparation of Flos Buddlejae and/or its extract.
The present invention relates to the application in the medicine of preparation treatment coronary heart disease of Flos Buddlejae and/or its extract.
The present invention relates to the application in the medicine of preparation treatment rheumatic heart disease of Flos Buddlejae and/or its extract.
The present invention relates to the application in the medicine of preparation treatment hypertensive heart disease of Flos Buddlejae and/or its extract.
The present invention relates to the application in the medicine of preparation treatment pulmonary heart disease of Flos Buddlejae and/or its extract.
The present invention relates to the application in myocardiac medicine is treated in preparation of Flos Buddlejae and/or its extract.
The present invention relates to the application in the medicine of preparation treatment cardiac tumor of Flos Buddlejae and/or its extract.
The present invention relates to the application in the medicine of preparation treatment vascular lesion of Flos Buddlejae and/or its extract.
Flos Buddlejae of the present invention is loganiaceae plant Flos Buddlejae alabastrum, inflorescence or its Herb, and described extract is Flos Buddlejae pulverize after in room temperature extraction or be heated to reflux or extract obtained in supercritical extraction, extract and used Solvent is the liquid that water is the most miscible with ethanol；Or ether, petroleum ether, chloroform, ethyl acetate etc. are organic molten The liquid that agent is the most miscible；Or liquid CO2。
Flos Buddlejae of the present invention and/or its extract can make pharmaceutical preparation separately as main active, Pharmaceutical preparation can also be made collectively as main active with other composition.
Pharmaceutical dosage form of the present invention includes the medicinal thing of the different way of administration such as various oral, injection, tract, percutaneous 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 crude drug composition.
The invention provides the new opplication of Flos Buddlejae 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 tumor, the Comprehensive Treatment of vascular lesion.Pharmaceutical preparation made by the present invention shows without bright through animal experiment and clinical trial Aobvious untoward reaction and toxic and side effects, can provide safe and efficient treatment cardiopathic natural drug new product for patient.
Drug safety of the present invention is tested:
One, 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: Flos Buddlejae capsule (preparation method is shown in embodiment 2, lower same) is famous in Pharmaceutical by Yunnan to be had Limit company provides, specification 0.5g/ grain.Take 40 Flos Buddlejae capsules and remove capsule shell, pour out medicated powder, in mortar, grind 5min After be gradually added into 2% sodium carboxymethyl cellulose, join for pasty state suspension, thickness, end level is 40%, for Flos Buddlejae 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 mouse toxicity reaction in a week with dead Die situation, fail to measure capsule gavage LD50 value, therefore select mtd test.
Choose 20 health qualified cleaning grade Kunming mouses, male and female half and half, by gavage in capsule suspension 24h, be administered Capacity is 0.2ml/10g body weight, the most freely drinks water and looks for food, and observes one week, record mice appetite, body weight, position, breathing, The situations such as righting reflex.
1.3 result of the test
Mouse stomach capsule suspension is none example death in 1 week, takes food and change without exception of drinking water, as shown in table 1.
Result after table 1 mouse gavaging Flos Buddlejae capsule
In observing 7 days, take medicine dead mouse and the generation of obvious abnormal phenomena.Put to death through cervical dislocation and dissect every animal also 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, for human body dose 666 times, have no that toxicity occurs.
Pharmacodynamics test of the present invention:
Two, mist Air Bladder pseudosciaenae seu Acipenser capsule anti-experimental character Atherosclerosis
1 materials and methods
1.1 reagent and medicine cholesterol, cholate are purchased from Tianjin Yong great chemical reagents corporation；Adeps Sus domestica is made by oneself；Yolk powder with Whole milk powder market is bought；Normal feedstuff is provided by Kunming Medical University's Experimental Animal Center.Malonaldehyde (MDA) and superoxides Dismutase (SOD) detection kit: Nanjing poly-power biomedical engineering institute.Rabbit anti-Mus ICAM-1 (ICAM- 1) antibody, peroxidase (HRP) labelling goat anti-rabbit igg, instant SABC (peroxidase) immunohistochemical kit and DAB Nitrite ion (Wuhan Boster Biological Technology Co., Ltd.).Flos Buddlejae capsule is developed by Yunnan Mingyang Pharmaceutical Co., Ltd..
1.2 instrument 5804R low temperature supercentrifuges (eppendorf company of Germany)；UV-2401 spectrophotometer (Japan Shimadzu)；AMS-18A automatic clinical chemistry analyzer (Zhangjiakou Ao Pusen development in science and technology company limited)；Olympus CH30 optics Microscope.
1.3 packet and healthy SD rat 30 of drawing materials, ♂, body weight (205 ± 20) g, purchased from Kunming Medical University's laboratory animal Center.Rat is randomly divided into and organizes 3 groups: matched group, model group and Chinese drug-treated group, often group 10.Matched group feeding with standard feed, Model group and mist flower Capsules group are fed with high lipid food (1% cholesterol, 0.1% cholate, 10% Adeps Sus domestica, 5% yolk powder, 5% complete Fat milk powder, 78.9% normal feedstuff), mist flower Capsules group feed while high lipid food, give Flos Buddlejae capsule.Each group is all Freely drinking water, acute execution after feeding 8 weeks continuously, abdominal vein takes blood, centrifuging and taking serum, and 20 DEG C of refrigerators are placed, and rat is rapid Opening breast and take out aorta 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 (LDL-C), height Density lipoprotein (HDL-C).The operation of test kit description is pressed in serum MDA level and SOD determination of activity.
1.5 light microscopic histology are drawn materials with thoracic aorta intersection at rat aorta bow, and 10% neutral formalin is fixed, Paraffin embedding, preparation cross section paraffin section, thickness about 4 microns, HE dyes, om observation.
1.6 aorta tube wall ICMA-1 detection ventral aortas shear one section of blood vessel of about 0.6cm, and 10% neutral formalin is solid Fixed, remaining blood vessel is used for extracting albumen, 75% ethanol dehydration, paraffin embedding cross-sectional slice, thick 4 microns, takes 1 every 4 , 5 slice, thin pieces of every part of vascular specimen.SABC immunohistochemical method detection 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 dropping reagent SABC after 20min, PBS wash.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 Comparison, the cell membrane of positive cell and Cytoplasm are dyed yellowish-brown, are pointed out and have ICMA-1 to express.Choose cell distribution the highest 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 specimen takes the meansigma methods of its 4 slice, thin pieces, draws ICMA-1 positive cell expression rate
1.7 aortic blood tube wall ICMA-1 expressing quantity Detection and Extraction albumen, carry out SDS-poly-third by protein extract Acrylamide gel electrophoresis, then transferring film, 5% defatted milk powder 37 DEG C closes 1h, 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) labelling 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 matched group, mist Air Bladder pseudosciaenae seu Acipenser capsule Atherosclerosis (AS) rat TC and LDL-C level can be significantly reduced, and TG and HDL-C is affected inconspicuous (being shown in Table 2).
Table 2 serum TC, TG, LDL-C and HDL-C level
Compare with matched 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-derived free radicals indexs of correlation apparently higher than matched group, and SOD live Property the most substantially reduce, mist Air Bladder pseudosciaenae seu Acipenser capsule can reduce MDA level, improves SOD activity (being shown in Table 3).
Table 3 serum MDA level and SOD activity
Compare with matched 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 shows Micro-Microscopic observation, the complete smooth not damaged of control rats arterial wall endothelium, smooth muscle marshalling；Model group rats arterial wall Endotheliocytic swelling, part endothelial denudation, smooth muscle arrangement disorder, form of diverse, part smooth muscle has propagation, and inwardly Layer migrates, and endothelial cell adhesion has mononuclear cell, inner membrance to have monocyte infiltration, and macrophage be can be observed；Mist Air Bladder pseudosciaenae seu Acipenser Capsule group endothelium ratio is more complete, has no endothelial denudation, and smooth muscle arrangement the most relatively model group is neat, and the rare mononuclear cell of endothelium soaks Profit.
The impact on rat aorta ICMA-1 expression of the 2.4 mist Air Bladder pseudosciaenae seu Acipenser capsules
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 aorta Endotheliocyte core smooth muscle cell ICMA-1 is that strong positive is expressed, and mist flower Capsules group can significantly reduce it and express.
2.4.2 Western blot result control rats aorta does not detects obvious ICMA-1 albumen, model group rats Aorta ICMA-1 expressing quantity substantially increases, and mist flower Capsules group then can significantly lower the table of aorta ICMA-1 Reach.
3 conclusions
Mist Air Bladder pseudosciaenae seu Acipenser capsule can significantly reduce AS rat TC, LDL-C and MDA level, significantly improves SOD activity, hence it is evident that lower Aorta ICMA-1 protein expression；Pathological examination also shows that mist Air Bladder pseudosciaenae seu Acipenser capsule has protective effect to aortic tunica intima, shows fan Flos Buddlejae capsule has and alleviates atherosclerosis, prevents and treats the effect of coronary heart disease.
Three, the research that SHR rat blood pressure and left ventricular hypertrophy are affected by mist Air Bladder pseudosciaenae seu Acipenser capsule
1 materials and methods
1.1 laboratory animal spontaneous hypertensive rats (SHR) 50, 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 supercentrifuge (eppendorf company of Germany).Mist Air Bladder pseudosciaenae seu Acipenser capsule is by Yunnan It is famous in pharmaceutcal corporation, Ltd's self-control；Enalapril is commercially available.Remaining reagent is commercially available analytical pure.
1.3 method
1.3.1 whole rats are randomly divided into 5 groups by animal packet and administration, often group 10.Blank group gavages every day Drinking water；Mist Air Bladder pseudosciaenae seu Acipenser capsule high, medium and low dosage group gavages mist by 400mg/kg, 800mg/kg, 1200mg/kg every day respectively Air Bladder pseudosciaenae seu Acipenser 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: experiment before and experiment after the 4th, 8 weeks mensuration rat blood pressure Value, measures 3 times the most continuously, averages.Weighing rat body weight (BW) after last is administered, measure blood pressure, sacrificed by decapitation is moved Thing, takes out rapidly heart, removes big blood vessel residue and connective tissue, cuts off atrium along sexual life 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 Relatively it is 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；Blank between group, low dose group comparing difference 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 index Decline notable (P ＜ 0.05), low dose group LVMI and blank group comparing difference not statistically significant (P ＞ 0.05)；High agent Amount group and enalapril group LVMI index comparing difference statistically significant (P ＜ 0.05), the results are shown in Table 5.
The change of cardiac function after rat is treated respectively organized by table 5
* P < 0.05 is compared with blank group；Compare with enalapril groupP<0.05。
3 conclusions
Mist Air Bladder pseudosciaenae seu Acipenser capsule can effectively reduce and control SHR rat blood pressure, alleviates and reverses SHR Left Ventricular Hypertrophy in Rats, carrying Show that mist Air Bladder pseudosciaenae seu Acipenser capsule has good therapeutic effect to hypertensive heart disease.
Four, mist Air Bladder pseudosciaenae seu Acipenser capsule is to the pharmacological action of Rabbit Lung cardiopathia caused by ferric chloride
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, purchased from Kunming Medical University Experimental Animal Center.
1.2 instruments are produced by Baiyunshan Pharmaceutics Stock-sharing Co., Ltd., Guangzhou City with reagent acetylspiramycin；Aminophylline is by mountain East Pharmacy stock Co., Ltd of Xinhua produces；Mist Air Bladder pseudosciaenae seu Acipenser capsule is made by oneself by Yunnan Mingyang Pharmaceutical Co., Ltd.；Olympus CH30 Optical microscope.
1.3 methods take rabbit 30, divide 5 groups, blank group, model group, positive controls acetylspiramycin (0.15g/kg, oral)+aminophylline (0.02g/kg, oral), mist Air Bladder pseudosciaenae seu Acipenser 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 of 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 acetylspiramycin (0.15g/kg, oral)+aminophylline (0.02g/kg, oral) gavage；Mist Air Bladder pseudosciaenae seu Acipenser 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, 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, under mobility Fall, there is rapid breathing in most rabbit, and after particularly dosage strengthens, animal breath frequency is accelerated, and kicks, drowsiness, can after about 1h Recovering normal, body weight increases slow compared with blank group.
After 2.2 survival condition terminate to experiment, administration group relatively model group animal dis motility rate is high, is shown in Table 6.
The impact on pulmonary heart disease Rabbits Models survival condition of the table 6 mist Air Bladder pseudosciaenae seu Acipenser capsule
* P < 0.05, * * P P < 0.01 is compared 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 the most visible The heart, lung and thoracic cavity adhesion, lungs edge has edema due to disorder of QI, lung surface to have hemorrhage；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 Air Bladder pseudosciaenae seu Acipenser capsule dosage group high, middle relatively mould Type group mild symptoms, table 7 between the heart, lung index of correlation.
The impact on pulmonary heart disease Rabbits Models organ index of the table 7 mist Air Bladder pseudosciaenae seu Acipenser capsule
* P < 0.05 is compared with model group.
2.4 light microscopic pathological examination results display model groups have 4 rabbit myocytes granular degeneration, interstitial congestion occur； It is scorching that lungs occur filling the air interstitial, accidental small artery endotheliocytic swelling, and intercellular is every broadening, and limit office alveolar wall thickens, and has scorching thin Born of the same parents infiltrate congestion；In positive control and mist Air Bladder pseudosciaenae seu Acipenser capsule, dosage group is respectively arranged with 2 rabbit lungs slight pathological changes of appearance, cardiac muscle nothing Substantially pathological change；Mist Air Bladder pseudosciaenae seu Acipenser capsule high dose group lungs and cardiac muscle are all without obvious pathological change.Model group and each administration group man Rabbit thyroid, adrenal gland, spleen all convert without 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 cardiopathia that ferric chloride is induced by mist Air Bladder pseudosciaenae seu Acipenser capsule has improves symptom, alleviates the positive role of the state of an illness.
Clinical data:
Five, mist flower capsule for treating unstable angina pectoris observation of curative effect
Coronary heart disease unstable angina (UA) refers between stable angina pectoris and acute myocardial infarction (AMI) Group anginal syndrome when participating in the cintest.
1 data and method
1.1 physical data 68 example patients all meet International Society of Cardiology and WHO clinical name standardization associating special topic report Accuse " name of ischemic heart desease and diagnostic criteria ", discharge acute myocardial infarction, serious hepatic and renal function injure.68 example patients with Machine is divided into 2 groups, matched group 32 example, wherein male 19 example, women 13 example, age 40～72 years old；Treatment group 36 example, wherein male 22 Example, women 14 example, age 40～74 years old.Two groups in sides such as sex, age, Clinical types, the course of disease, Electrocardiogram Feature, complication Face, difference not statistically significant.
1.2 Therapeutic Method matched groups are administered orally Tab. Isosorbidi Dinitratis: each 5 10mg of sublingual administration, three times a day；Treatment The oral mist Air Bladder pseudosciaenae seu Acipenser capsule of group, each 3, 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 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 normally Or the most normally meet with the next item up or two for effective；Effective: angina pectoris attacks number of times, degree and duration substantially subtract Gently, reduce ST section more than 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 groups angina pectoris, ECG curative effect are shown in Table 8, table 9
Table 8 curative effect to treat angina pectoris compares
Two groups of obvious effective rates, total effective rate comparing differences statistically significant (P < 0.05).
Table 9 ECG curative effect compares
Two groups of obvious effective rates, total effective rate comparing differences statistically significant (P < 0.05)
2.2 untoward reaction two groups are the most all without obvious adverse reaction.
Six, 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 left over of acute rheumatic valvulitis Disease, we achieve satisfied effect by mist flower capsule for treating rheumatic heart disease, are now summarized as follows by clinical data.
1 data and method
The 1.1 all patients of physical data are after checking, according to the chronic rheumatic heart disease of Ministry of Public Health formulation in 1992 Diagnostic criteria is diagnosed as rheumatic heart.72 example rheumatic heart diseases are divided into 2 groups, matched group 32 example, wherein, male 14 example, female Property 18 examples, age 34～61 years old, mitral lesion person 18 example, aortic valve disease person 16 example, having 2 examples is that two valves are the most sick Become；Treatment group 40 example, wherein male 17 example, women 23 example, age 35～61 years old, mitral lesion person 22 example, aortic disease Change person 20 example, having 2 examples is two equal pathological changes of valve.All patients are without the serious congruent disease of Liver and kidney function, and patient is in property Not, there are comparability, P ＞ 0.05 in age, the course of disease.
1.2 Therapeutic Method matched group oral hydrochloride amiodarone sheets, loading: usual one day 600mg (3), maintenance dose: One day 100～400mg can be given according to individual reaction.Treatment group is administered orally mist Air Bladder pseudosciaenae seu Acipenser capsule, each 3, three times a day, and two groups of treatments Cheng Junwei 4 months.
1.3 observation index check Cardiac Function of Patients
1.4 efficacy determinations are effective: movable unrestricted, general activity is without any discomfort；It is effective: physical exertion is the most restricted, Discomfort occurs during general physical exertion；Minor effect: physical exertion is the most restricted, slight physical exertion has a strong impact on life；Invalid: Can not orthobiosis, 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, respiratory tract infection, thromboembolism, acataposis 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 cardiac function, result It is shown in Table 10.
Table 10 heart function recovery situation
Two groups of total effective rate comparing differences 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 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: Flos Buddlejae tablet
Formula: Flos Buddlejae 1000 parts, starch 3 parts, lactose 20 parts, carboxymethyl starch sodium 15 parts, Pulvis Talci 4 parts.
Preparation method: take Flos Buddlejae 800 parts, presses decocting method with drinking water and extracts secondary, and each 1 hour, collecting decoction (or took close Flos Buddlejae, is ground into coarse powder, soaks secondary with the aquiferous ethanol of variable concentrations in 40 DEG C, each 6～8 hours, merges immersion, reclaim Ethanol), concentrate decocting liquid and become thick paste, dry, pulverize into fine powder in 55 DEG C～65 DEG C standby.Separately take Flos Buddlejae 200 parts, directly pulverize Become fine powder, with aforementioned Flos Buddlejae extract fine powder, lactose, carboxymethyl starch sodium mixing, make adhesive with starch slurry, make Grain, is dried, and adds Pulvis Talci mixing, tabletting and get final product.
Embodiment 2: Flos Buddlejae capsule
Formula: Flos Buddlejae 1000 parts, starch 100 parts.
Preparation method: take Flos Buddlejae 800 parts, presses decocting method with drinking water or (aquiferous ethanol) and extracts secondary, each 1 hour, close And decocting liquid (or take Flos Buddlejae, it is ground into coarse powder, soaks secondary with the aquiferous ethanol of variable concentrations, each 6～8 hours, 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 Flos Buddlejae 200 parts, It is directly ground to fine powder, mixes with starch with aforementioned Flos Buddlejae extract fine powder, load capsule.
Embodiment 3: Flos Buddlejae capsule
Formula: Flos Buddlejae 1000 parts, starch 100 parts.
Preparation method: take Flos Buddlejae 700 parts, be ground into coarse powder, extracts secondary by ethyl acetate room temperature, 48 hours for the first time, and the Secondary 40 hours, merges immersion, reclaims ethyl acetate, and extract is standby.Separately take Flos Buddlejae 300 parts, be directly ground to fine powder, with Aforementioned Flos Buddlejae extract mix homogeneously, dry, pulverize into fine powder in 60 DEG C～70 DEG C, mixes with starch, loads capsule and get final product.
Embodiment 4: Flos Buddlejae granule
Formula: Flos Buddlejae 1000 parts, Icing Sugar 200 parts, 10 parts of dextrin, lactose 20 parts.
Preparation method: take Flos Buddlejae, is ground into coarse powder, 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 lixiviating solution, recycling design, extract addition Icing Sugar, dextrin, lactose stir, and make Granule, is dried, subpackage and get final product.
Embodiment 5: Flos Buddlejae pill
Formula: Flos Buddlejae 1000 parts, refined honey 110 parts.
Preparation method: take Flos Buddlejae 800 parts, choose, wash, dry, pulverize into fine powder in 60-65 DEG C, loads extraction kettle, gets rid of All gas impurity in still, 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, blood pressure lowering from extraction kettle top, and extract separates out；Separately take Flos Buddlejae 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: Flos Buddlejae liniment
Formula: Flos Buddlejae 1000 parts, glycerol 200 parts.
Preparation method: take Flos Buddlejae 1000 parts, with deionized water press decocting method extract secondary, each 1 hour, collecting decoction, dense It is reduced to relative density 1.1～1.2, adds qdx ethanol, stirring, stand, filter, filtrate recycling ethanol (or take Flos Buddlejae coarse powder, Soak secondary with the aquiferous ethanol of variable concentrations in 40 DEG C, each 6～8 hours, merge immersion, reclaim ethanol), cold preservation 24 is little Time, filtering, filtrate glycerol adding mixes, subpackage and get final product.
Embodiment 7: Flos Buddlejae spray
Formula: Flos Buddlejae 1000 parts, ethyl hydroxybenzoate 3 parts.
Preparation method: take Flos Buddlejae Herb 1000 parts, presses decocting method with distilled water and extracts secondary, each 1 hour, merge decocting Liquid, is concentrated into relative density 1.1～1.2, adds qdx ethanol, stir evenly, and stands, and filters, filtrate recycling ethanol (or take Flos Buddlejae Coarse powder, soaks secondary with the aquiferous ethanol of variable concentrations in 40 DEG C, each 6～8 hours, merges immersion, reclaim ethanol), cold preservation 24 hours.Filter, add ethyl hydroxybenzoate and distilled water is appropriate, mixing, fill, to obtain final product.
Embodiment 8: Flos Buddlejae injection
Formula: Flos Buddlejae 1000 parts, benzyl alcohol 10ml, 8 parts of sodium chloride.
Preparation method: take Flos Buddlejae 1000 parts, presses decocting method with distilled water and extracts secondary, each 1 hour, merge decocting liquid, dense It is reduced to relative density 1.1～1.2, adds qdx ethanol, stirring, cold preservation, precipitation, filter, filtrate recycling ethanol, be concentrated into relatively Density 1.05～1.06 (or take Flos Buddlejae coarse powder, and soak secondaries with the aquiferous ethanol of variable concentrations in 40 DEG C, each 4～6 is little Time, merge immersion, reclaim ethanol and be also concentrated into relative density 1.05～1.06), then add ethanol to alcohol content and reach 80%, cold preservation, Filtering, filtrate recycling ethanol, to without alcohol taste, adds benzyl alcohol and sodium chloride, stirring and dissolving, injects water to 1000ml, use G4 Sintered glass funnel filters, embedding in the ampoule of 2ml, 100 DEG C of sterilizings 30 minutes and get final product.
Embodiment 9: compound preparation 1
Formula: Flos Buddlejae 350 parts, Radix Rubiae Yunnanensis 150 parts, Radix Notoginseng 240 parts, Radix Salviae Miltiorrhizae 260 parts.
Preparation method: Radix Notoginseng powder is broken into coarse powder, according to fluid extract and the percolation under extractum item, uses 70% ethanol as solvent, Carrying out percolation, diacolation liquid recycling ethanol after impregnating 24 hours, be concentrated into relative density 1.0～1.1 (60 DEG C), medicinal residues are standby.Separately take Flos Buddlejae, Radix Rubiae Yunnanensis, Radix Salviae Miltiorrhizae and Radix Notoginseng medicinal residues, add drinking water and extract secondary by decocting method, each 1 hour, collecting decoction (or take Flos Buddlejae, Radix Rubiae Yunnanensis, Radix Salviae Miltiorrhizae powder are broken into coarse powder and the mixing of Radix Notoginseng medicinal residues, carry in 40 DEG C of warm macerating with the aquiferous ethanol of variable concentrations Take secondary, each 6～8 hours, merge immersion, 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: Flos Buddlejae 550 parts, Radix Salviae Miltiorrhizae 390 parts, 60 parts of Flos Carthami.
Preparation method: above 3 tastes, it is standby that Flos Carthami powder is broken into fine powder, Flos Buddlejae, Radix Salviae Miltiorrhizae, adds drinking water and extracts secondary by decocting method, Each 1 hour, and collecting decoction (or take Flos Buddlejae, Radix Salviae Miltiorrhizae coarse powder, soak secondary with the aquiferous ethanol of variable concentrations in 40 DEG C, often Secondary 6～8 hours, merge immersion, reclaim ethanol), concentrate decocting liquid and become thick paste, dry, pulverize into fine powder in 55 DEG C～65 DEG C, with red Flower fine powder and appropriate amount of auxiliary materials mixing, 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 for the purpose limited.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. Flos Buddlejae and/or the application in the medicine of preparation treatment cardiac tumor disease of its extract, described close illiteracy Flower is loganiaceae plant Flos Buddlejae alabastrum, inflorescence or its Herb, described extract be Flos Buddlejae pulverize after room temperature extraction or Person is heated to reflux or extract obtained in supercritical extraction, extract the solvent used be water with ethanol in any proportion Miscible liquid；Or the liquid that ether, petroleum ether, chloroform, ethyl acetate organic solvent are the most miscible；Or Person is liquid CO2。
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