CN1634110A - Injectio of hawthorn leaf total flavone and its preparing process - Google Patents
Injectio of hawthorn leaf total flavone and its preparing process Download PDFInfo
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- CN1634110A CN1634110A CN 200410086714 CN200410086714A CN1634110A CN 1634110 A CN1634110 A CN 1634110A CN 200410086714 CN200410086714 CN 200410086714 CN 200410086714 A CN200410086714 A CN 200410086714A CN 1634110 A CN1634110 A CN 1634110A
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Abstract
The present invention belongs to the medicine technology field, specifically relates to an injection adopting hawthorn leaves flavonoids as essential component and exhibiting remarkable curative effects for coronary heart diseases, angina pectoris as well as cerebral apoplexy, and method for making same. The hawthorn leaves flavonoids prepared according to ht extracting process in accordance with the present invention has a content of 80-99.9%, wherein the content of vitexin rhamnoside is 10-50% and the content of the vitexin glucoside is 3-30%.
Description
Technical field
The invention belongs to medical technical field, being specifically related to a kind of is main component with the Folium Crataegi total flavones, and coronary heart disease, angina pectoris and apoplexy are had injection of significant curative effect and preparation method thereof.
Background technology
Contain abundant flavonoids in the Folium Crataegi; main component has vitexin rhamnopyranoside, vitexin glycoside, hyperin etc.; has pharmacologically active widely; be mainly: vasodilator; increase coronary flow, anti-myocardial ischemia, anti-cerebral ischemia and protection cerebral tissue are removed local congestion state.Be mainly used in diseases such as depressed blood stasis, chest distress, coronary heart disease, angina pectoris, coronary insufficiency clinically.
Listing at present with the Folium Crataegi total flavones be that functional component treatment coronary heart disease, anginal pharmaceutical preparation have the Yixintong sheet, the capsule of feeling at ease, multiple heart sheet etc., the performance of oral formulations curative effect is slow, and coronary heart disease, angina pectoris belong to clinical acute disease, rapid onset, need first aid medicine, injection is best dosage form.Because Folium Crataegi total flavones is made aqueous injection certain degree of difficulty is arranged on technology, so never relevant product comes out.We finally succeed in developing through having researched and solved an a series of difficult problem.Effect experiment proof Injectio of hawthorn leaf total flavone has blood circulation promoting and blood stasis dispelling, the easypro network of regulating the flow of vital energy, and the function of the logical heart arteries and veins of a surname can increase coronary flow, dilating coronary blood vessel, and treatment coronary heart disease, angina pectoris are had significant curative effect.Experimental result shows: the PH scope is an optimum PH value range at 6.0-7.5 in the injection, and compares more than the PH7.5, and not only the preparation color is more shallow, and active component is more stable.
Through retrieval, extraction process of the present invention and application number are that 03120841X is that the preparation process that main functional component is made has similarity by Folium Crataegi extract for one kind, technology of the present invention is improved this technology, directly adopted the polyamide chromatography of certain specification to separate, best process conditions have been found out, saved macroporous resin, improved yield, production cost reduces greatly.Effect experiment proves that the total flavones drug effect of preparation is definite, meets the prescription of injection.
Summary of the invention
The present invention relates to a kind of have coronary heart disease, angina pectoris are had Injectio of hawthorn leaf total flavone of significant curative effect and preparation method thereof.It is characterized in that: the Folium Crataegi total flavones content that is used to prepare injection is 80-99.9%, and wherein vitexin rhamnopyranoside content is 10-50%, and vitexin glycoside content is 3-30%.Wherein injection comprises aqueous injection, infusion solution, injectable powder and lyophilized injectable powder.
Preparation Folium Crataegi total flavones aqueous injection, with Folium Crataegi total flavones, be dissolved in an amount of water for injection, add the injection water soluble adjuvant of metering, the active carbon that adds 0.1-0.5% is removed thermal source, regulate PH to 6.0-7.5, after the microporous filter membrane ultrafiltration, replenish water for injection to ormal weight, fill is in ampoule bottle or in the infusion bottle, sealing by fusing/roll lid, through after the assay was approved, packing promptly.Per ampoule Folium Crataegi total flavones content is 3.0-50.0mg/ml; Specification is 2ml, 5ml.Folium Crataegi total flavones content is 0.5-10.0mg/ml in the infusion solution, and specification is 50ml, 100ml, 150ml and 200ml.
Preparation Folium Crataegi total flavones injectable powder, Folium Crataegi total flavones is dissolved in an amount of water for injection, adds the pharmaceutic adjuvant of metering, the active carbon that adds 0.1-0.5% is removed thermal source, adjusting PH is 6.0-7.5, after the microporous filter membrane ultrafiltration, vacuum or spray drying, aseptic subpackaged in cillin bottle, every bottle contains Folium Crataegi total flavones 10-200mg, roll lid, through after the assay was approved, packing promptly.
Preparation Folium Crataegi total flavones lyophilized injectable powder, Folium Crataegi total flavones is dissolved in an amount of water for injection, add the pharmaceutic adjuvant of metering, the active carbon that adds 0.1-0.5% is removed thermal source, and adjusting PH is 6.0-7.5, after the microporous filter membrane ultrafiltration, be sub-packed in the ampoule, per ampoule contains Folium Crataegi total flavones 10-200mg, sealing by fusing after lyophilization, after the assay was approved, packing promptly.
Be used to prepare the aqueous injection and the injectable powder of Folium Crataegi total flavones, pharmaceutic adjuvant wherein is meant antioxidant, comprises in sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, the vitamin C one or both.
Be used to prepare the lyophilized injectable powder of Folium Crataegi total flavones, pharmaceutic adjuvant wherein is meant the lyophilized powder proppant, comprises in the following adjuvant one or both: lactose, mannitol, inositol, glucosan, glycine.
Folium Crataegi total flavones preparation method of extract of the present invention is as follows:
Get Folium Crataegi, add the Diluted Alcohol warm macerating that 10-16 doubly measures and extract each 1-5 hour three times, filter, merging filtrate, concentrating under reduced pressure, being concentrated into does not have the alcohol flavor, it is an amount of to add water, cold preservation 24-48 hour, draw supernatant, lower floor filters, filtrate and supernatant merge, with water saturated n-butyl alcohol equimultiple extraction three times, merge and reclaim n-butyl alcohol to doing, go up polyamide resin column with suitable quantity of water dissolving back, begin to receive when being eluted to the reaction of hydrochloric acid-magnesium powder with distilled water, and use the Diluted Alcohol eluting simultaneously instead, collect ethanol elution, to hydrochloric acid-magnesium powder reaction negative, reclaim ethanol to doing, promptly get Folium Crataegi total flavones of the present invention.
The assay method of general flavone content among the present invention:
1, the preparation of reference substance solution
Precision takes by weighing at the vitexin rhamnopyranoside reference substance 200mg of 120 ℃ of drying under reduced pressure to constant weight, puts in the 100ml measuring bottle, adds methanol 70ml, and slight fever makes dissolving to the water-bath, puts coldly, adds methanol to scale, shakes up.The accurate 10ml that draws puts in the 100ml measuring bottle, adds water to scale, shakes up, and promptly gets (containing vitexin rhamnopyranoside 0.2mg among every 1ml).
2, the preparation of standard curve
Precision is measured reference substance solution 0ml, 1.0ml, 2.0ml, 3.0ml, 4.0ml, 5.0ml and 6.0ml, puts respectively in the 25ml measuring bottle, respectively adds water to 6ml, add 5% sodium nitrite solution 1ml, make mixing, placed 6 minutes, add 10% aluminum nitrate solution 1ml, shake up, placed 6 minutes, hydro-oxidation sodium solution 10ml adds water to scale again, shakes up, placing 15 minutes, and measured trap according to spectrophotography at the wavelength place of 280nm, is vertical coordinate with the trap, concentration is abscissa, the drawing standard curve.
3, algoscopy
The about 1g of Folium Crataegi total flavones powder in 60 ℃ of dryings 6 hours, accurately claims surely, puts in the apparatus,Soxhlet's, and the 120ml that adds diethyl ether, reflux is to extracting liquid colourless, puts coldly, discards ether solution.Add methanol 90ml again, reflux is to extracting liquid colourless, and in the dislocation 100ml measuring bottle, with a small amount of washing container of methanol, washing liquid is incorporated in the measuring bottle, adds methanol to scale, shakes up.Precision is measured 10ml, puts in the 100ml measuring bottle, adds water to scale, shakes up.Precision is measured 3ml, puts in the 25ml measuring bottle, and the method under the sighting target directrix curve preparation is measured trap from " adding water to 6ml " in accordance with the law, from the weight (μ g) that standard curve is read vitexin rhamnopyranoside the need testing solution, calculates, promptly.
Embodiment 1
Preparation Folium Crataegi total flavones aqueous injection and infusion solution.
The Folium Crataegi total flavones 2kg that will make with preparation method of the present invention is dissolved in the 100L water for injection, is made into 20mg/ml, regulates PH to 7.0.After the microporous filter membrane ultrafiltration, replenish water for injection to ormal weight, fill is in ampoule bottle or in the infusion bottle, and sealing by fusing/roll lid through after the assay was approved, is packed promptly.
The method that provides in the by specification is measured, and the result gets: the concentration of Folium Crataegi total flavones is 9.7-10.2mg/ml in the injection per ampoule; Specification is 2ml, 5ml.The concentration of Folium Crataegi total flavones is 1.0-1.2mg/ml in the infusion solution, and specification is 50ml, 100ml, 150ml and 200ml.
Embodiment 2
Preparation Folium Crataegi total flavones injectable powder.
To be dissolved in an amount of 100L water for injection with the Folium Crataegi total flavones 2kg that preparation method of the present invention makes, the pharmaceutic adjuvant that adds metering, regulating PH is 7.0, after the microporous filter membrane ultrafiltration, vacuum or spray drying get the Folium Crataegi total flavones aseptic powder, and be aseptic subpackaged in cillin bottle, make every bottle and contain two specifications of Folium Crataegi total flavones aseptic powder 50mg, 100mg, roll lid, through after the assay was approved, packing promptly.
Embodiment 3
Preparation Folium Crataegi total flavones lyophilized injectable powder.
The Folium Crataegi total flavones 2kg that will make with preparation method of the present invention is dissolved in the 100L water for injection, is made into the solution of 20mg/ml, regulates PH to 7.0.After the microporous filter membrane ultrafiltration, be sub-packed in 5ml, the 10ml ampoule, sealing by fusing after lyophilization, after the assay was approved, packing is promptly.Get per ampoule respectively and contain Folium Crataegi total flavones 50mg, 100mg.
Embodiment 4
The preparation method of Folium Crataegi total flavones of the present invention is as follows:
Get Folium Crataegi 1kg, add 50 ℃ of warm macerating of 40% Diluted Alcohol and extract each 3 hours three times, filter, merging filtrate, concentrating under reduced pressure, being concentrated into does not have the alcohol flavor, add water to 2kg, supernatant is drawn in cold preservation 48 hours, and lower floor filters, filtrate and supernatant merge, with water saturated n-butyl alcohol equimultiple extraction three times, merge and reclaim n-butyl alcohol to doing, with going up polyamide resin column behind the 2000ml water dissolution, use earlier the distilled water eluting, begin to receive when the reaction of hydrochloric acid-magnesium powder is arranged, and use 40% Diluted Alcohol eluting simultaneously instead, collect ethanol elution, to hydrochloric acid-magnesium powder reaction negative, reclaim ethanol to doing, promptly get extract 210g of the present invention, testing result shows that Folium Crataegi total flavones content is 85%, the content of the main component vitexin rhamnopyranoside in the total flavones is 25%, and the content of vitexin glycoside is 10%.
The relevant pharmacodynamic experiment of Injectio of hawthorn leaf total flavone of the present invention:
Because the injection described in the present invention all is to be made by the Folium Crataegi total flavones of quality standard of the same race, therefore can carry out effect experiment with haw leaf general flavone material.
Experiment one, Folium Crataegi total flavones are to the influence of dog coronary flow
Experiment material
1. laboratory animal: 36 of healthy adult dogs, male and female dual-purpose, body weight 17.50 ± 1.77kg.
2. experiment medicine: Folium Crataegi total flavones 50mg/ props up, 0.9% sodium chloride injection.
Experiment is divided into 4 groups of (1) blank groups, normal saline 1ml/kg; (2) Folium Crataegi total flavones 5mg/kg dosage group; (3) Folium Crataegi total flavones 10mg/kg dosage group; (4) Folium Crataegi total flavones 20mg/kg dosage group.N=12 before each administration group 60min, n=6 behind the 90min.
The experiment medicine is mixed with same volume (50ml) with normal saline, and the computer micro-injection pump feeds reagent with the speed of 5ml/min through femoral vein.
Experimental technique
Laboratory animal pentobarbital sodium (30mg/kg) intravenous anesthesia, tracheal intubation connects the phrenoton.Execute left side the 4th intercostal thoracotomy, expose heart, cut off pericardium, make the pericardium bed, separate LCA and aortic root, place the electromagnetic flowmeter probe, measure coronary flow.Operation finishes, treat that observed index is stable after, value before the record medicine feeds institute's reagent thing.And in behind the medicine at once, behind the medicine 10,30,60,90min writes down and measure the influence of each administration group to dog coronary flow (ml/100gmin-1).Every observation index and derivation parameter are carried out statistical procedures, carry out administration with the measured values of different observing times before and after self relatively, its change percentage rate organize between relatively, judge its significance with the t check.
Table 1: each administration group is to the influence of dog coronary flow (ml/100gmin-1) (X ± SD)
| Group | Dosage/kg | Before the ischemia (normal value) | (value before the medicine) rate of change (100%) behind the ischemia | Behind the medicine at once | Minute | |||
| ????10 | ????30 | ?????60 | ????90 | |||||
| Normal saline | ???1ml | ????89.2±54.7 | ???110.1±56.8 | ??99.4± ????61.9 | ???89.3± ??????53.5 | ???90.9± ??????55.1 | ????91.7± ????????57.8 | ???92.6± ??????52.0 |
| Folium Crataegi total flavones | ???20m ???g | ????78.8±33.1 | ???81.5±30.5 | ??103.1 ??±34.2 | ???105.8 ???±39.9 | ???109.3 ???±46.6 | ????118.1 ????±40.6 | ???131.0 ???±42.1 |
| Folium Crataegi total flavones | ???10m ???g | ????80.5±31.2 | ???91.2±41.1 | ??100.8 ??±53.8 | ???102.8 ???±50.7 | ???104.1 ???±43.3 | ????109.0 ????±57.7 | ???117.7 ???±50.8 |
| Folium Crataegi total flavones | ???5mg | ????90.5±46.1 | ???93.7±50.7 | ??98.3± ????50.7 | ???100.3 ???±57.1 | ???103.9 ???±57.2 | ????105±5 ????8.1 | ???109.2 ???±61.6 |
Experimental result shows that Folium Crataegi total flavones can obviously increase coronary flow, and dilating coronary blood vessel reduces coronary resistance, improves the blood supply oxygen supply of cardiac muscle, and can reduce total peripheral resistance, cardiovascular system is played adjust and the improvement effect.
Experiment two, Folium Crataegi total flavones are to the influence of myocardial infarction due to the ischemia-reperfusion
Experiment material
1. laboratory animal: 32 of Wistar kind rats, male, body weight 250~270g.
2. experiment medicine: Folium Crataegi total flavones 50mg/ props up, 0.9% sodium chloride injection.
Experimental technique
Animal is divided into 4 groups at random: model group (normal saline), Folium Crataegi total flavones 20,10,5mg/kg group.Medicine is diluted to desired concn with normal saline, and the administration volume is 3ml/kg, and route of administration is a vein.
Animal faces upward the position and fixes with pentobarbital sodium intraperitoneal anesthesia (45mg/kg), and electrocardiograph leads with standard I I and monitors the animal electrocardiogram; Tracheostomize inserts tracheal intubation, connects respirator practice artificial respiration (32 times/minute, breathed ratio 1: 3); Open breast, disconnected 3-5 rib is opened pericardium, exposes heart, in left anterior descending coronary artery root threading (No. 0 stitching thread), is equipped with ligation and uses; Separate left femoral vein, be equipped with administrable; Stablize 10min behind the threading, recessed pipe of plastics and blood vessel is arranged side by side, and ligation (no ST section and T ripple changer eliminate) feeds and is subjected to the reagent thing; Behind the 40min, cut off ligature, fall limb before making and realize perfusion again along groove; Sew up thoracic wall, recover autonomous respiration.
After the reperfusion injury 2 hours, abdominal aortic blood, 5 of the following crosscuts of heart ligature, N-BT dyeing, adopt multi-media color pathology picture and text analytical systems (MPIAS-500) fixedly to get image distance, observe the myocardial infarction degree from measuring normal myocardium and infarcted myocardium area; The result carries out statistical procedures (t check).
Experimental result sees the following form:
Table 2. Folium Crataegi total flavones is to the influence of myocardial infarction degree
| Grouping | Dosage/kg | Number of animals | Normal myocardium area mm2 | Infarcted myocardium area mm2 | Infarct weight g | Infarct accounts for ventricle % | Infarct accounts for heart % |
| Model group | ??8 | ???333.2±42.3 | ???102.7±13.1 | ??0.259±0.032 | ???31.7±4.3 | ???25.3±4.7 | |
| Folium Crataegi total flavones | ?20mg | ??8 | ???323.2±16.0 | ???69.8±16.99 | ??0.171±0.022 | ???18.5±5.0 | ???16.5±4.2 |
| Folium Crataegi total flavones | ?10mg | ??8 | ???339.6±24.2 | ???73.9±16.0 | ??0.189±0.031 | ???22.7±4.1 | ???19.2±3.3 |
| Folium Crataegi total flavones | ?5mg | ??8 | ???347.5±26.3 | ???75.4±12.1 | ??0.210±0.021 | ???23.6±4.7 | ???21.2±2.3 |
Compare P<0.05, P<0.01. with model group
Experimental result confirms that Folium Crataegi total flavones 20mg/kg, 10mg/ml and 5mg/kg group infarct size reduce, and the plug district accounts for ventricle and heart percentage ratio reduces, and with model group significant difference (P<0.01) is arranged relatively; The 20mg/kg group also can obviously alleviate infarct weight, with model group significant difference (P<0.01) is arranged relatively.
Experiment three, Folium Crataegi total flavones are to the protective effect of focal cerebral ischemia in rats and to the protective effect of mice global brain ischemia
Experiment purpose:
Folium Crataegi total flavones is to SOD, the MDA of experimental limitation rats with cerebral ischemia with to the life span of experimental global brain ischemia mice.
Laboratory animal: Wistar rat, kunming mice.
Experimental technique:
48 rats, male, body weight 300-350g is divided into 6 groups at random by body weight, and 8 every group, i.e. sham operated rats, model group, positive drug group, heavy dose of group, middle dosage group, small dose group.The positive drug group gives lumbar injection Folium Ginkgo 0.15ml/100g, and large, medium and small dosage group gives lumbar injection respectively and is subjected to reagent 20mg/kg, 10mg/kg, 5mg/kg, and sham operated rats and model group give the normal saline of equivalent, successive administration 5 days.After after the last administration 30 minutes, model group, positive group, large, medium and small dosage group are separated branch's arteria pterygopalatina of right carotid and external carotid artery and internal carotid artery and respectively at the initial position ligation blood vessel of tremulous pulse under 20% chloral hydrate anesthesia.The common carotid artery proximal part closes with miniature bulldog clamp folder, distal end is with suture pull-up gently, on common carotid artery, cut a little otch, the nylon wire that one end is heated into round bead shape (0.3mm) inserts osculum, cerebral arteries is again toward pulling back about 2mm promptly to the middle cerebral artery mouth before slowly being pushed into, be about 17mm (the aortic bifurcation place is counted inside and outside neck) fixedly nylon wire rod of suture ligation, take off bulldog clamp, operation finishes.And sham operated rats except that bolt line not its in the same.Get 4 milliliters of blood after 4 hours centrifugal 8 minutes, draw serum, survey SOD, MDA content in the serum with 1000rpm.
The statistical procedures of the whole experimental datas of statistical procedures method all adopts the t method of inspection to carry out significance test, and the result subtracts standard deviation (x ± S) expression with mean.
Experimental result:
Folium Crataegi total flavones to the life span of global brain ischemia mice obviously prolong, SOD raises, MDA content obviously reduces, and prove that the Folium Crataegi total flavones with prepared of the present invention has prolongation apoplexy patient's life span and has the effect of protecting cerebral tissue.
Table 3 Folium Crataegi total flavones to the influence of the life span of global brain ischemia mice, SOD, MDA content (x ± S, n=10)
Group life span SOD MDA
Blank group 335.46 ± 61.63 95.96 ± 32.50
Sham operated rats 338.21 ± 25.02 87.02 ± 19.06
Model group 112.30 ± 32.74 235.89 111.39
△114.56 ± 37.72
△
Folium Ginkgo group 120.21 ± 42.30
△315.57 ± 52.89 93.68 ± 25.92
Heavy dose of group 150.65 ± 38.37
△356.95 ± 93.06
△61.21 ± 22.62
△
Middle dosage group 130.65 ± 30.97
△337.06 ± 57.23
△70.91 ± 16.30
△
Small dose group 119.21 ± 25.80 296.39 ± 110.28 96.32 ± 40.35
Compare with the blank group
△P<0.05
The optimum PH value range screening experiment result of injection of the present invention:
Investigate relatively both stability, condition: 40 ℃ of temperature, relative humidity 75% with the accelerated stability experimental technique, three months time, every other month sampling Detection once, optimum PH value range is 6.0-7.5, the color is too dark for injection, is unfavorable for the inspection of orange lightness.The results are shown in following table:
| ????PH | 0 month | 1 month | 2 months | 3 months |
| ????6.0 | Yellow, clear and bright | Yellow, clear and bright | Yellow, clear and bright | Yellow, a small amount of muddy |
| ????7.0 | Deep yellow, clear and bright | Deep yellow, clear and bright | Deep yellow, clear and bright | Deep yellow, clear and bright |
| ????7.5 | Light brown, clear and bright | Light brown, clear and bright | Light brown, clear and bright | Light brown, clear and bright |
| ????8.0 | Dark brown red, clear and bright | Dark brown red, clear and bright | Dark brown red, clear and bright | Dark brown red, clear and bright |
Remarks: the chemical name of vitexin rhamnopyranoside and vitexin glycoside among the present invention:
Vitexin rhamnopyranoside is: 5,7, and 4`-trihydroxyflavone-8-C-β-D-glucosyl group (1 → 2)-β-D-rhamnoside
The vitexin glycoside is: 5,7, and 4`-trihydroxyflavone-8-C-β-D-glucosyl group (1 → 4)-β-D-glycoside
Claims (8)
1, a kind of have Injectio of hawthorn leaf total flavone of significant curative effect and preparation method thereof to coronary heart disease, angina pectoris, the Folium Crataegi total flavones content that it is characterized in that being used to preparing injection is 80-99.9%, the content of the main component vitexin rhamnopyranoside in the total flavones is 10-50%, and the content of vitexin glycoside is 3-30%.
2, injection according to claim 1 comprises aqueous injection, injectable powder, infusion solution.
3, injection according to claim 1 is made up of as active component and pharmaceutic adjuvant Folium Crataegi total flavones.
4, aqueous injection according to claim 2 is made up of Folium Crataegi total flavones and water for injection and pharmaceutic adjuvant, it is characterized in that: with Folium Crataegi total flavones, be dissolved in an amount of water for injection, add the injection water soluble adjuvant of metering, the active carbon that adds 0.1-0.5% is removed pyrogen, regulates PH to 6.0-7.5, after the microporous filter membrane ultrafiltration, replenish water for injection to ormal weight, fill is in ampoule bottle or in the infusion bottle, sealing by fusing/roll lid, through after the assay was approved, packing promptly; The content of Folium Crataegi total flavones is 3.0-50.0mg/ml in the injection; Specification is 2ml, 5ml; Infusion solution contains Folium Crataegi total flavones 0.5-10.0mg/ml, and specification is 50ml, 100ml, 150ml and 200ml.
5, injectable powder according to claim 2 is made up of Folium Crataegi total flavones and water for injection dissolubility pharmaceutic adjuvant, it is characterized in that: Folium Crataegi total flavones is dissolved in an amount of water for injection, the pharmaceutic adjuvant that adds metering, the active carbon that adds 0.1-0.5% is removed pyrogen, and adjusting PH is 6.0-7.5, after the microporous filter membrane ultrafiltration, vacuum or spray drying, aseptic subpackaged in cillin bottle, every bottle contains Folium Crataegi total flavones 10-200mg, rolls lid, through after the assay was approved, packing promptly.
6, injectable powder according to claim 2, form by Folium Crataegi total flavones and water for injection dissolubility pharmaceutic adjuvant, it is characterized in that: Folium Crataegi total flavones is dissolved in an amount of water for injection, adds the pharmaceutic adjuvant of metering, adjusting PH is 6.0-7.5, after the microporous filter membrane ultrafiltration, be sub-packed in the ampoule, Folium Crataegi total flavones content is 10-200mg in the per ampoule, sealing by fusing after lyophilization, after the assay was approved, packing promptly.
7, according to claim 4 or 5 described Injectio of hawthorn leaf total flavone, pharmaceutic adjuvant wherein is meant antioxidant, comprises in sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, the vitamin C one or both.
8, Injectio of hawthorn leaf total flavone according to claim 6, pharmaceutic adjuvant wherein is meant the lyophilized powder proppant, comprises in the following adjuvant one or both: lactose, mannitol, inositol, glucosan, glycine.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101849956A (en) * | 2010-05-27 | 2010-10-06 | 辽宁中医药大学 | Vitexin-2"-O-rhamnoside as raw material injection and preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101849956A (en) * | 2010-05-27 | 2010-10-06 | 辽宁中医药大学 | Vitexin-2"-O-rhamnoside as raw material injection and preparation method |
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