CN1824135A - Medicinal preparation for treating cardio and cerebral vascular disease and its preparation method and quality control method - Google Patents
Medicinal preparation for treating cardio and cerebral vascular disease and its preparation method and quality control method Download PDFInfo
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- CN1824135A CN1824135A CN 200610000651 CN200610000651A CN1824135A CN 1824135 A CN1824135 A CN 1824135A CN 200610000651 CN200610000651 CN 200610000651 CN 200610000651 A CN200610000651 A CN 200610000651A CN 1824135 A CN1824135 A CN 1824135A
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- ZAVXXBAIPSQJGS-UHFFFAOYSA-B tetracalcium;tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O.[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O.[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O ZAVXXBAIPSQJGS-UHFFFAOYSA-B 0.000 description 1
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Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
A Chinese medicine for treating cardiovascular and cerebrovascular diseases is prepared from swordleaf dragon tree. Its preparing process and quality control method are also disclosed.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation and preparation thereof, particularly relate to the Chinese medicine preparation of being processed into through extraction with Dracaena cochinchinensis.
Background technology:
Background of the present invention derives from the relevant document record to Sanguis Draxonis, Guangxi Sanguis Draxonis and Dracaena cochinchinensis.
Sanguis Draxonis and Dracaena cochinchinensis mainly contain flavones ingredient, and other contains a small amount of glycoside, terpenoid and sterols composition; Pharmacological research shows that Guangxi Sanguis Draxonis has tangible antithrombotic, increases fibrinolytic and improves effects such as hemorheology, and wherein flavones ingredient is the main effective ingredient of blood circulation promoting and blood stasis dispelling; Many tame hospitals are used for the treatment of cerebral thrombosis, coronary heart disease, diabetes hyperlipidemia better curative effect.The present invention has carried out resource, chemical constituent and the pharmacological research of system to Dracaena cochinchinensis, finds that Dracaena cochinchinensis extract has obvious suppression platelet aggregation, anti-myocardial ischemia and improves effect such as hemorheology.And then the effective site of Dracaena cochinchinensis furtherd investigate, be intended to develop the new drug of the treatment cardiovascular and cerebrovascular disease of efficient, low toxicity.
Cardiovascular and cerebrovascular disease ranks first in the constituent ratio of cause of death of China, and wherein coronary heart disease rises to the eighties to present first by the 4th of the fifties in cardiovascular diseases's precedence.Therefore, seek, exploitation is treated safely and effectively and is prevented the medicine of coronary heart disease is one of great problem.So this project is based oneself upon local resources, develops a kind of cardiovascular and cerebrovascular vessel medication of determined curative effect.
The Dracaena cochinchinensis plant resources is abundant, is widely distributed in Yunnan and south Guangxi, and cultivation easily, and deeply developing for it provides good material base.
Summary of the invention:
The invention provides a kind of Chinese medicine preparation, said preparation is a raw material with the medicinal part of liliaceous plant Dracaena cochinchinensis, is prepared into through extraction step.
Preparation of the present invention, wherein the medicinal part of Dracaena cochinchinensis is selected from, the root of Dracaena cochinchinensis, stem, resiniferous wood, resin, preferably resiniferous wood.
The present invention also comprises with formulation preparation of the present invention and prevents and/or treats application in the medicine of cardiovascular and cerebrovascular disease.
The present invention also comprises the preparation method of preparation of the present invention, it is characterized in that, and through following steps,
A. the medicinal part of Dracaena cochinchinensis is pulverized,
B. water or alkali organic solvent are extracted,
C. reclaim solvent, extracting solution is regulated pH value to acid, filter,
D. precipitation adds water washing to neutral, and drying adds organic solvent extraction,
E. reclaim organic solvent, extracting solution concentrates, drying, pulverize active constituents of medicine;
F. the active constituents of medicine that makes with step e is a raw material, makes preparation according to a conventional method.
Preparation method of the present invention can be following method specifically, gets Dracaena cochinchinensis, is ground into coarse powder, add 25～75% alcohol reflux secondaries that contain 0.2 ‰～0.7 ‰ sodium hydroxide, add 4～14 times of amounts at every turn, each 0.5～2 hour, filter, filtrate merges, and reclaims ethanol, to there not being the alcohol flavor, put coldly, adding 5～20% hydrochloric acid, to regulate pH value be 1～3, placed 6～18 hours, filter, precipitation adds water washing to neutral, and drying is ground into coarse powder, add ethyl acetate reflux, extract, secondary, add 3～12 times of amounts at every turn, each 0.5～2 hour, filter, filtrate merges, reclaiming ethyl acetate and being evaporated to relative density is 1.1～1.6 thick paste under 80 ℃, dry below 85 ℃, pulverizes, sieve, get medicated powder; The medicated powder that above-mentioned steps obtains is the extract that contains pharmaceutically active substance, presses pharmaceutical dosage form and adds adjuvant, makes preparation.
Chinese medicine preparation of the present invention has blood circulation promoting and blood stasis dispelling, the effect of coronary circulation-promoting pain-relieving.Can be used for obstruction of qi in the chest and cardialgia, heart blood silt, disease is seen ambition pain, as thorn as strand, fixes and does not move, very then chest pain radiating to the back, or pain draws the shoulder back of the body,, loses heart dim complexion, cyanotic lips often with chest distress and palpitation symptoms.Purplish tongue, or ecchymosis is arranged, the Sublingual venation is livid purple, small and stringy pulse or carefully puckery; Angina pectoris sees that above-mentioned disease person also is suitable for it, can also be applicable to the cerebrovascular disease of blood stasis type, as apoplexy, headache, dizzy etc.The present invention is preferred for the treatment of the cardiovascular disease of blood stasis pattern of syndrome and uses.
The Dracaena cochinchinensis extract made from method of the present invention is the active component extract of pharmaceutical preparation of the present invention, wherein contain Flavonoid substances, through the assay to Flavonoid substances, total phenol content is greater than 30%, and preferred index is that total phenol content is greater than 50%.
Use Dracaena cochinchinensis medicinal part 5000g can make active component extract 50～1250g,
Above Dracaena cochinchinensis medicinal part 500g calculates with crude drug, this dosage can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, 1000 bags of granules, oral liquid 1000 peace bottles etc., also can make big packing as granule, as 100～500 bags, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
Above dosage can be made into the preparation of 50～1000 taking doses, as tablet, makes 1000, and each taking dose can be 1～20, can take altogether 50～1000 times.As granule, make 125 bags, take 1～2 bag at every turn, can take altogether 62.5～125 times.
Chinese medicine preparation of the present invention is by Dracaena cochinchinensis being processed through extraction or other modes, being made pharmaceutically active substance, subsequently, is pharmaceutically active substance with this material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine, also can obtain by other modes, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, extracting method can take that supersound extraction, microwave extraction, supercritical are carried, macroporous resin extraction etc., these active substances can be the materials of extractum form, can be that dry extract also can be a fluid extract, according to the different needs of preparation, make different concentration.Use suitable solvent during extraction, these solvents can be selected from, water, ethanol, methanol, propanol, acetone, butanone, ethyl acetate, n-butyl alcohol etc., the alkalization of solution can be used sodium hydroxide, potassium hydroxide, ammonia, sodium carbonate, sodium bicarbonate etc., and the scope of pH value is 7～14.
Active substance extract in the pharmaceutical preparation of the present invention, its shared percentage by weight in preparation can be 0.1～99.9%, all the other are the medicine acceptable carrier.Pharmaceutical preparation of the present invention exists with unit dosage form, and described unit dosage form is meant the unit of preparation, as every of tablet, capsular every capsules, every of injection etc., in the unit dose, the amount that contains active substance is 50～1250mg, preferably 150～800mg.
Pharmaceutical preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, capsule, oral liquid, syrup, granule, pill, powder, unguentum, sublimed preparation, suspensoid, injection, suppository, cream, spray, drop pill, patch, slow releasing preparation, controlled release preparation etc.
Pharmaceutical preparation of the present invention, the preparation of its oral administration can contain excipient commonly used, such as binding agent, filler, diluent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet in case of necessity.
The filler that is suitable for comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, polyvinylpyrrolidone and starch derivatives, for example sodium starch glycollate.Suitable lubricant comprises, for example magnesium stearate.The acceptable wetting agent of appropriate drug comprises sodium lauryl sulphate.
Can fill by mixing, the method that tabletting etc. are commonly used prepares solid oral composition.Mix repeatedly active substance is distributed in those compositionss of a large amount of filleies of whole use.
The form of oral liquid for example can be aqueous or oily suspensions, solution, Emulsion, syrup or mixture, perhaps can be a kind of available water before use or other suitable composite dry products of carrier.This liquid preparation can contain conventional additive, such as suspending agent, for example sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl-cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenation edible fat, emulsifying agent, for example lecithin, anhydro sorbitol-oleate or arabic gum; Non-aqueous carrier (they can comprise edible oil), for example almond oil, fractionated coconut oil, such as oily ester, propylene glycol or the ethanol of the ester of glycerol; Antiseptic, for example para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if desired, can contain conventional flavouring agent or coloring agent.
For injection, the liquid unit dosage forms of preparation contains active substance of the present invention and sterile carrier.According to carrier and concentration, this chemical compound can be suspended or dissolving.The preparation of solution is normally by being dissolved in active substance in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, sealing then.For example a kind of local anesthetic of adjuvant, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.
Pharmaceutical preparation of the present invention, when being prepared into medicament, optionally add suitable medicine acceptable carrier, described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, the EDTA disodium, EDTA calcium sodium, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Preparation of the present invention is determined usage and dosage according to patient's situation in use, but obeys every day 1～4 time, each 1～20 dose, as: 1～20 or sheet.
Pharmaceutical preparation sample reserved sample observing method of the present invention, under simulation listing terms of packing, put under room temperature and the natural conditions and place a year and a half, by clinical research quality standard inspection, except that check in this month, first trimester check in every month once, check once that later on the result shows that every index all meets the quality standard regulation every half a year, and with do not see significant change in 0 month, tentatively show constant product quality.
The present invention also provides the method for quality control of preparation of the present invention, it is the internal soundness of the Chinese patent medicine of raw material that this method can be used for controlling with it simultaneously, the quality of pharmaceutical preparatioies such as the tablet of producing as above-mentioned method, capsule, injection, granule, drop pill, paster, pill.The method of quality control of pharmaceutical preparation of the present invention may further comprise the steps:
A. differentiate:
B. check:
C. assay:
Wherein differentiate the following method that adopts:
(1) gets the about 0.5g of tablet or capsule, add chloroform 10ml, jolting 10 minutes filters, and filtrate is as need testing solution, other gets lourerin A and lourerin B reference substance, chlorination is copied into the solution that every 1ml contains 0.25mg, and product solution is tested according to the thin layer chromatography of an appendix VIB regulation of Chinese Pharmacopoeia version in 2000 in contrast, draw each 4 μ l of above-mentioned two kinds of solution, put respectively in same be the silica gel G F of binding agent with the sodium carboxymethyl cellulose
254On the lamellae, be that oil ether-ester acetoacetic ester-acetone of 8: 3: 1 is developing solvent, launch, take out, dry, put under the ultra-violet lamp (254nm) and inspect with ratio, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
(2) get the about 5mg of tablet or capsule, add methanol 1ml and make dissolving, as need testing solution, other gets 7, and 4 '-dihydroxyflavone reference substance adds methanol and makes the solution that every 1ml contains 0.1mg, in contrast product solution.Thin layer chromatography test according to an appendix VIB regulation of Chinese Pharmacopoeia version in 2000, draw each 4 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with ratio is that 8: 1 chloroform-methanol is developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;
Wherein check the following method that adopts:
(1) loss on drying: get tablet or capsule 1.0g, be dried to constant weight, subtract weight loss and must not cross 5.0% (an appendix IX of Chinese Pharmacopoeia version in 2000 G) at 105 ℃;
(2) residue on ignition is got tablet or capsule 1.0g, checks in accordance with the law and leaves over (an appendix IX of Chinese Pharmacopoeia version in 2000 J) residue and must not cross 3.0%;
(3) heavy metal is got the residue of leaving under the residue on ignition item, checks to contain (an appendix IX of Chinese Pharmacopoeia version in 2000 E second method) heavy metal and must not cross 20/1000000ths in accordance with the law;
Wherein assay adopts following method:
For total phenols, the method for assay is:
(1) 7, the preparation precision of 4 '-dihydroxyflavone standard curve takes by weighing and is dried to 7 of constant weight, and 4 '-dihydroxyflavone reference substance 10mg puts in the 25ml measuring bottle, with dissolve with methanol and be diluted to scale, shakes up, and makes storing solution.Get storing solution 2ml, put in the 25ml measuring bottle, with dissolve with methanol and be diluted to scale, shake up, compare product solution.Precision is measured 0ml respectively, 1.0ml, and 1.5ml, 2.0ml, 2.5ml, 3.0ml puts in the 25ml measuring bottle, adds dehydrated alcohol 5.0ml respectively, 4.0ml, 3.5ml, 3.0ml, 2.5ml and 2.0ml.Add 0.1%～1% sodium dodecyl sulfate solution 2ml, 0.1%～2% potassium ferricyanide solution 1ml, 0.1%～2% ferric chloride 1ml more respectively successively, shake up, to dark place placement 2～10min, the hydrochloric acid that adds 0.1M is settled to scale, places 20～35min again to the dark place.According to the spectrophotography of an appendix V of Chinese Pharmacopoeia version in 2000 B regulation, be blank with No. 0 sample, measure trap at 780 ± 5nm place, with the trap vertical coordinate, concentration is abscissa, the drawing standard curve;
(2) measure precision and take by weighing tablet or capsule 10mg, put in the 25ml measuring bottle, add anhydrous alcohol solution and be diluted to scale, filter, get subsequent filtrate 1ml, put in the 25ml measuring bottle, add anhydrous alcohol solution and be diluted to scale, shake up, as need testing solution, the accurate absorption for trial target solution 5ml, put in the 25ml measuring bottle, according to method under the standard curve preparation,, measure from " add successively 0.1%～1% sodium dodecyl sulfate solution 2ml " in accordance with the law, read weight from standard curve, calculate, promptly
This product is pressed dry product and is calculated, and contains total phenols with 7,4 '-dihydroxyflavone (C
15H
10O
3) calculate, must not be less than 50%; For lourerin A and lourerin B, the method for assay is:
(1) measures according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D);
(2) test of chromatographic condition and system suitability is a filler with octadecylsilane chemically bonded silica; Acetonitrile-glacial acetic acid solution (1 → 95) (33.5: 66.5) is a mobile phase; The detection wavelength is 280nm.Number of theoretical plate calculates by lourerin A and lourerin B peak should be not less than 3000;
(3) it is an amount of to the lourerin A and the lourerin B reference substance of constant weight that the preparation precision of reference substance solution takes by weighing 80 ℃ of following drying under reduced pressure, adds methanol respectively and make the solution that every 1ml contains 0.01mg, in contrast product solution;
(4) the about 40mg of this product is got in the preparation of need testing solution, and accurate the title decides, and adds 0.35% sodium hydroxide solution 25ml, slight fever makes dissolving, puts coldly, extracts 3 times with the ethyl acetate jolting, each 20ml merges ethyl acetate extraction liquid, water 25ml washing, divide and to get ethyl acetate extraction liquid, be evaporated to driedly, residue adds methanol makes dissolving in right amount, and be transferred in the 25ml measuring bottle, add methanol and be diluted to scale, filter, get subsequent filtrate as need testing solution;
(5) accurate respectively reference substance solution and each the 20 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly;
The every 1g of this product contains lourerin A (C
17H
18O
4), must not be less than 3.0mg; Contain lourerin B (C
18H
20O
5), must not be less than 4.0mg.
Below by effect experiment beneficial effect of the present invention is described, used medicine is the pharmaceutical preparation of the embodiment of the invention 1, this experiment in be called the blood vessels health.
Pharmacodynamic experiment:
1, dog myocardial ischemia experimental result shows: blood vessels health 120mg/kg, 60mg/kg, 30mg/kg can obviously reduce the Δ N-ST and the Δ ∑-ST level (P＜0.05, P＜0.01) of myocardial infarction due to the dog coronary artery ligation through duodenal administration; Can obviously reduce CPK in the serum, LD, LDH, MDA release, enhance SOD activity (P＜0.05, P＜0.01); Obviously dwindle myocardial infarct size (P＜0.05, P＜0.01).Press (DAP), mean arterial pressure (MAP) to influence all not remarkable (P＞0.05) to systolic arterial pressure (SAP), the auterial diastole of myocardial ischemia dog.The blood vessels health high dose group that gives duodenum can suppress the heart rate of quickening, with model group comparing difference remarkable (P＜0.05).Prompting blood vessels health can obviously alleviate degree of myocardial ischemia.
2, the cardiac hemodynamics of dogs result of the test shows: blood vessels health 120mg/kg, 60mg/kg, 30mg/kg and negative control group are relatively to dog blood pressure (SAP, DAP, MAP), heart rate there was no significant difference (P＞0.05).Can obviously increase coronary flow, cardiac output, stroke volume, cardiac index, SI (P＜0.05, P＜0.01), reduce Peripheral resistance.
3, blood vessels health 360mg/kg, 180mg/kg, three dosage of 90mg/kg have obvious protective effect (P＜0.01, P＜0.05) to the rat heart muscle ischemia phenomenon due to the pituitrin.
4, blood vessels health 720mg/kg, 360mg/kg, continuous 7 days gastric infusions of three dosage of 180mg/kg can obviously prolong the death time (P＜0.01) of closing the myocardial ischemia that the mice trachea causes because of folder.
5, blood vessels health 360mg/kg, 180mg/kg, three dosage of 90mg/kg have a significant effect to the hemorheology of syndrome of blood stasis rat model, can significantly reduce whole blood and plasma viscosity, anticoagulant (P＜0.01, P＜0.05).
Toxicological experiment:
1, acute toxicity test in mice
This product is through LD
50Prerun shows that this product can't obtain the LD of mice
50Value, maximum dosage-feeding is measured with maximum drug level 0.5g/ml, maximum administration volume 0.8ml/20g, gastric infusion secondary.Observed 14 days continuously after the administration, as a result mice none is only dead, movable normal after the administration, do not find mice on the feed, aspects such as breathing, heart rate, chroma of hair unusual.Show that blood vessels health maximum dosage-feeding is 40g/kg, be 1333.33 times (clinical plan dosage are 0.03g/kg) of clinical plan with dosage.
2, rat long term toxicity test
This product 2.00g/kg, 1.00g/kg, 0.5g/kg crude drug (being equivalent to clinical plan 66.7 times, 33.3 times, 16.67 times) with dosage, gastric infusion, administration every day 1 time, administration is 6 days weekly, and administration is 6 months altogether.Get 10,20,10 rats in every group of 3 months, 6 months and convalescent period after administration, male and female half and half are carried out system and are detected.Observe general performance, food consumption, the body weight change of rat; Measure animal hematology index, blood biochemical index.Result of the test shows, blood vessels health high dose (2.00g/kg crude drug) 6 months leukocyte and lymphocyte, middle dosage (1.00g/kg crude drug) convalescent period platelet, low dosage (0.5g/kg crude drug) convalescent period lymphocyte has been compared notable difference (P＜0.05) with corresponding time point matched group, 3 months total protein of this medicine high dose, the aspartic acid aminotransferase, middle 3 months albumin of dosage, 3 months total protein of low dosage has been compared notable difference (P＜0.05 with corresponding time point matched group, P＜0.01), but these numerical value still in normal range.In addition, hematology and blood biochemical are learned its remainder values and are compared equal no significant difference (P＞0.05) with corresponding time point matched group.System becomes celestial, and 12 kinds of organ indexs and 18 kinds of internal organs histopathology are detected.The result does not find the toxic and side effects relevant with taking this medicine.
3, Beagle dog long term toxicity test
This product 1.8g/kg, 0.9g/kg, 0.45g/kg crude drug (being equivalent to clinical plan 60 times, 30 times, 15 times) with dosage, gastric infusion (ig), once a day, administration is 6 days weekly, and 6 months and convalescent period (8 months) are measured animal behind 3 months, administration behind 1.5 months, administration before administration, after the administration electrocardiogram, hematological indices, blood biochemical are learned index and routine urinalysis index, and before administration, reaching the general performance of observing animal in the administration process, consumption and body weight change eaten in record.3 months, 6 months, convalescent period are carried out system to 2,4,2 animals respectively for every group and are become celestial after administration, calculate 12 kinds of organ indexs, and 23 kinds of internal organs are carried out histopathology detect.The result shows, blood vessels health high dose is (P＜0.05) in administration premonocyte absolute value apparently higher than matched group, lymphocyte percentage is starkly lower than matched group (P＜0.05), 1.5 months mononuclear cell absolute values of administration are apparently higher than matched group (P＜0.05), and hematocrit value is starkly lower than matched group (P＜0.05); Neutrophilic granulocyte is apparently higher than matched group (P＜0.05) before administration for middle dosage, and erythrocyte is starkly lower than matched group (P＜0.05), and hemoglobin and hematocrit value are starkly lower than matched group (P＜0.01); Low dosage in administration proleukocyte and neutrophilic granulocyte apparently higher than matched group (P＜0.05, P＜0.01), mononuclear cell is starkly lower than matched group (P＜0.05), erythrocyte is starkly lower than matched group (P＜0.05), hemoglobin and hematocrit value are starkly lower than matched group (P＜0.01), 6 months lymphocyte percentage of administration are apparently higher than matched group (P＜0.05), and convalescent period, erythrocyte was apparently higher than matched group (P＜0.05).Blood biochemical is learned the index testing result and is shown, carbamide and creatinine are apparently higher than matched group (P＜0.05, P＜0.01) before administration for high dose group, and 1.5 months globulin of administration are starkly lower than matched group (P＜0.05); In dosage group total bilirubin before administration be starkly lower than matched group (P＜0.05), convalescent period total protein, carbamide and globulin apparently higher than matched group (P＜0.05); 3 valley third transaminases of low dosage are apparently higher than matched group (P＜0.05), and 6 valley third transaminases are starkly lower than matched group (P＜0.05).But above these numerical value are all within normal range.In addition, this medicine is learned all not have obviously to general performance, body weight change, other hematological indices, electrocardiogram index, every routine urinalysis index, other blood biochemicals indexs, organ index and 23 organs and tissues of being tried dog influences.
The specific embodiment:
Further specify the present invention by the following examples.
Embodiment 1
The preparation of active substance extract:
Get Dracaena cochinchinensis resiniferous wood 500g, be ground into coarse powder, add the 70% alcohol reflux secondary that contains 0.5 ‰ sodium hydroxide, add 8 times of amounts at every turn, each 1 hour, filter, filtrate merges, and reclaims ethanol, to there not being the alcohol flavor, put coldly, adding 10% hydrochloric acid, to regulate pH value be 2, placed 10 hours, filter, precipitation adds water washing to neutral, drying, be ground into coarse powder, add ethyl acetate reflux, extract, secondary, add 8 times of amounts at every turn, each 1 hour, filter, filtrate merges, and reclaims ethyl acetate and is evaporated to the thick paste that relative density is 1.1～1.6 (80 ℃), dry below 85 ℃, pulverize, sieve, promptly.
Embodiment 2
The preparation of capsule
The fine powder that method for making: embodiment 1 obtains is the pharmaceutically active substance extract, presses pharmaceutical dosage form and adds adjuvant, make 1000 of capsules,
Embodiment 3
The preparation of tablet
The fine powder that method for making: embodiment 1 obtains is the pharmaceutically active substance extract, presses pharmaceutical dosage form and adds adjuvant, makes 1000 in tablet.
Embodiment 4
The preparation of granule
The fine powder that method for making: embodiment 1 obtains is the pharmaceutically active substance extract, presses pharmaceutical dosage form and adds adjuvant, makes 250 bags of electuaries.
Embodiment 5: the preparation of oral liquid
The fine powder that method for making: embodiment 1 obtains is the pharmaceutically active substance extract, presses pharmaceutical dosage form and adds adjuvant, makes 1000 of oral liquids.
Embodiment 6: the preparation of pill:
The fine powder that method for making: embodiment 1 obtains is the pharmaceutically active substance extract, presses pharmaceutical dosage form and adds adjuvant, makes pill 1000 balls.
Claims (4)
1. preparation method for the treatment of the Chinese medicine preparation of cardiovascular and cerebrovascular disease, described preparation is by containing active component extract and the medicine acceptable auxiliary is formed, the described active component extract that contains is that medicinal part by the liliaceous plant Dracaena cochinchinensis is a raw material, be prepared into through extraction step, wherein the medicinal part of Dracaena cochinchinensis is selected from, the root of Dracaena cochinchinensis, stem, resiniferous wood or resin, described preparation is a tablet, capsule, oral liquid, syrup, granule, pill, powder, unguentum, sublimed preparation, suspensoid, injection, suppository, cream, spray, drop pill, patch, slow releasing preparation or controlled release preparation, it is characterized in that, through following steps
A. the medicinal part of Dracaena cochinchinensis is pulverized,
B. water or alkali organic solvent are extracted,
C. reclaim solvent, extracting solution is regulated pH value to acid, filter,
D. precipitation adds water washing to neutral, and drying adds organic solvent extraction,
E. reclaim organic solvent, extracting solution concentrates, drying, pulverize active constituents of medicine;
F. the active constituents of medicine that makes with step e is a raw material, makes preparation according to a conventional method.
2, according to the preparation method of claim 1, the organic solvent among the described step b is selected from, ethanol, acetone, methanol, n-butyl alcohol, ethyl acetate, and described extraction is selected from, lixiviate, supersound extraction, microwave extraction, supercritical extraction.
According to the preparation method of claim 1, it is characterized in that 3, the alkali organic solvent among the described step b is 25～75% ethanol of 0.2 ‰～0.7 ‰ sodium hydroxide, the accent PH among the described step c is that to regulate pH value with 5～20% hydrochloric acid be 1～3 to acidity; Organic solvent in the steps d is an ethyl acetate.
4, according to the preparation method of claim 1, it is characterized in that,
Pulverizing among the step a is to be ground into coarse powder;
It is to add 25～75% alcohol reflux secondaries that contain 0.2 ‰～0.7 ‰ sodium hydroxide that alkali organic solvent among the step b is extracted, and adds 4～14 times of amounts at every turn, each 0.5～2 hour, filter, and filtrate merges;
Reclaim solvent among the step c, extracting solution is regulated pH value to acid, and filtration is to reclaim ethanol, to there not being the alcohol flavor, puts coldly, and adding 5～20% hydrochloric acid, to regulate pH value be 1～3, placed filtration 6～18 hours;
Precipitation in the steps d adds water washing to neutral, drying, and adding organic solvent extraction is that precipitation adds water washing to neutral, drying is ground into coarse powder, adds ethyl acetate reflux, extract, secondary, adds 3～12 times of amounts at every turn, and each 0.5～2 hour, filter, filtrate merges;
Recovery organic solvent among the step e, extracting solution concentrate, and drying is pulverized to such an extent that active constituents of medicine is that to reclaim ethyl acetate and be evaporated to relative density be 1.1～1.6 thick paste under 80 ℃, and is dry below 85 ℃, pulverizes, sieve, medicated powder;
The active constituents of medicine that makes with step e among the step f is a raw material, and making preparation according to a conventional method is to be that raw material adding excipient substance is made pharmaceutical preparation with medicated powder.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102872303A (en) * | 2012-10-31 | 2013-01-16 | 贾国平 | Resina draconis application paster as well as preparation and detection methods |
| CN104998022A (en) * | 2015-07-04 | 2015-10-28 | 昆药集团股份有限公司 | Dragon's blood tree leaf extract product, and preparation method, pharmaceutical composition, preparation, and applications thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN86108273A (en) * | 1986-12-15 | 1988-07-06 | 广西壮族自治区林业科学研究所 | The preparation method of Sanguis Draxonis |
| CN1235581C (en) * | 2002-09-12 | 2006-01-11 | 江苏康缘药业股份有限公司 | Method for preparing Sanguis Draxonis flavoniod formulation and its quality controlling method |
-
2004
- 2004-08-31 CN CNB2006100006516A patent/CN100391513C/en not_active Expired - Lifetime
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102872303A (en) * | 2012-10-31 | 2013-01-16 | 贾国平 | Resina draconis application paster as well as preparation and detection methods |
| CN104998022A (en) * | 2015-07-04 | 2015-10-28 | 昆药集团股份有限公司 | Dragon's blood tree leaf extract product, and preparation method, pharmaceutical composition, preparation, and applications thereof |
| CN104998022B (en) * | 2015-07-04 | 2018-03-13 | 昆药集团股份有限公司 | A kind of dragon's blood leaf extract and preparation method thereof, its pharmaceutical composition, preparation and application |
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