CN1559498A - Ginkgo leaf extract and bimidamo oral compound medicine and its preparation method - Google Patents
Ginkgo leaf extract and bimidamo oral compound medicine and its preparation method Download PDFInfo
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- CN1559498A CN1559498A CNA2004100121549A CN200410012154A CN1559498A CN 1559498 A CN1559498 A CN 1559498A CN A2004100121549 A CNA2004100121549 A CN A2004100121549A CN 200410012154 A CN200410012154 A CN 200410012154A CN 1559498 A CN1559498 A CN 1559498A
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- folium ginkgo
- dipyridamole
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Abstract
A medicine for treating and curing coronary heart disease and thrombosis is prepared from the extract of gingko leaf and dipyridamole.
Description
Technical field
The present invention relates to the medicine-Folium Ginkgo extract of a kind of treatment and prevention coronary heart disease, thrombotic disease and dipyridamole compound medicine and preparation method thereof.
Background technology
Folium Ginkgo, but only limits in the prescription or single proved recipe among the people of Chinese medicine as medicinal existing more than 5000 year history in China.With modern scientific method Folium Ginkgo is discovered that the most important effective ingredient of Folium Ginkgo is bilobalide and flavonol.Bilobalide has the effect of opposing platelet activating factor, can improve blood circulation.Flavonol then has the function of eliminating free radical, except the use of doing of blood vessel dilating is arranged, also can prevent arteriosclerosis.Find that also Folium Ginkgo extract is influential to human memory's basic neural tuple, can improve memory, treat dizzy, tinnitus and cerebrovascular disease, effect is very remarkable.
But up to now, oral Folium Ginkgo extract mostly is the single medicinal material preparation, be difficult to bring into play better the effect of symptomatic treatment, the Folium Ginkgo extract of commercially available clinical use and dipyridamole compound medicine then are little aqueous injection (5 milliliters and 10 milliliters of two kinds of specifications), reason such as stable not good enough because of the Folium Ginkgo extract effective ingredient, there are problems such as quality is stable inadequately, reduce under cover very big clinical drug safety hidden danger at the easy variable color of lay up period, appearance precipitation and content." a kind of Folium Ginkgo extract and dipyridamole compound medicine and preparation method thereof " that the inventor invents before this (application number: 03137926.5) successfully solved the security hidden trouble of this compound medicine injection.The oral formulations that the present invention finds Folium Ginkgo extract and dipyridamole composition of medicine has effect same aspect treatment and prevention coronary heart disease, the thrombotic disease, but because of not being vein or drug administration by injection, clinical safety is better, and taking convenience has more advantage aspect prophylactic treatment.
Summary of the invention
The present invention be directed to existing Folium Ginkgo extract single medicinal material preparation and be difficult to better bring into play the effect of symptomatic treatment, commercially available Folium Ginkgo extract and dipyridamole compound medicine only have little liquid drugs injection dosage form, the quality instability, has safety of clinical administration hidden danger, use inconvenient, the defective that affects the treatment provides a kind of good stability, safe and effective, the Folium Ginkgo extract of taking convenience and the oral administered dosage form of dipyridamole compound medicine, to bring into play the advantage of such chemoprophylaxis treatment coronary heart disease, thrombotic disease better.Pharmaceutical dosage form of the present invention is the peroral dosage forms such as the tablet that contains Folium Ginkgo effective ingredient and dipyridamole, capsule, soft capsule, drop pill, granule, dispersible tablet, powder, oral cavity disintegration tablet, oral solution and syrup of oral administration, every (grain, bag etc. basic dosage unit) contain 1.5 milligrams to 30.0 milligrams of 4 milligrams to 50 milligrams of Semen Ginkgo total flavones and dipyridamoles, and all the other can be the various adjuvants on the pharmaceutics.
Clinical proof already, the Ginkgo total flavones among the present invention in the Folium Ginkgo extract has dilating coronary blood vessel, cerebrovascular, improves symptom and memory function that cerebral ischemia produces.Dipyridamole anticoagulant, high concentration (50 mcg/ml) can suppress platelet and discharge.The two is in conjunction with can be used for prevention and treatment coronary heart disease, thrombotic disease.The present invention has overcome the weakness that Folium Ginkgo extract and dipyridamole compound medicine injection can only drug administration by injection, and under the prerequisite that has good clinical efficacy equally, strengthened drug safety greatly, taking convenience is flexible, can bring into play the prophylactic treatment effect of this medicine two compositions better.Taking dose is that each dose is equivalent to 3.6 milligrams to 200 milligrams of 9 milligrams to 1000 milligrams of Ginkgo total flavones and dipyridamoles, every day 1 to 4 time.Existing dosage form is easy to use, good effect.
The used Folium Ginkgo extract with the dipyridamole compatibility of the present invention can be to extract from the Folium Ginkgo medical material, also can be mixing active ingredients thing, Ginkgo total flavones or Folium Ginkgo extract such as direct Ginkgo total flavones of buying from market and bilobalide.
When the present invention prepares peroral dosage forms such as tablet, capsule, soft capsule, drop pill, granule, dispersible tablet, powder, oral cavity disintegration tablet, oral solution and syrup, what adopt is the prior art and the equipment of these dosage forms of preparation, need not specific (special) requirements, be suitable for large-scale production, so be easy to promote.
The present invention makes raw material as using Folium Ginkgo, extraction scheme can for: getting Folium Ginkgo, is that 5～20 times alcohol-water (ratio is 1: 1～5) solution soaking of Folium Ginkgo is spent the night with its weight, after reflux, extract, twice, extracting solution merge, concentrate thick paste, drying gets dry extract, and pulverizes the powder that gets dry extract.Be used to prepare above-mentioned various oral formulations.As use the mixture of the pure product of commercially available ginkgetin or pure product of ginkgetin and the pure product of bilobalide to be raw material, can directly press the common prepared of above-mentioned preparation.
The specific embodiment
Embodiment 1: the Folium Ginkgo extracting method
Get Folium Ginkgo 5kg, spend the night reflux, extract, twice, 9 hours for the first time with 30kg alcohol-water (1: 1) solution soaking, 7 hours for the second time, after extracting solution merges, filter press, resin bed (the strong acid anion resin on average mixes with the highly basic cationic resin) decontamination, after being concentrated into nothing alcohol flavor, continue to concentrate thick paste, drying gets dry extract, and pulverizes the powder that gets dry extract.
Embodiment 2: preparation tablets
The supplementary material consumption
Folium Ginkgo extract (conversion is Ginkgo total flavones) 10.0g
Dipyridamole 4g
Lactose 60.4g
Starch 26.0g
Carboxymethyl starch sodium 2.7g
Magnesium stearate 0.9g
10% starch slurry is an amount of
Make 1000
Technology: (1) principal agent and adjuvant pulverize separately, principal agent is crossed 120 mesh sieves, and adjuvant is crossed 100 mesh sieves, and is standby.(2) principal agent that accurately takes by weighing recipe quantity mixes with the equivalent dilution method of progressively increasing with the part lactose, crosses 100 mesh sieves three times, gets female powder.(3) remainder lactose, starch and Nei Jia part disintegrating agent mix homogeneously are crossed 80 mesh sieves three times, get the adjuvant mixture.(4) female powder and adjuvant mixture mixing are crossed 80 mesh sieves three times, and it is an amount of to add 10% starch slurry, makes soft material, cross 18 mesh sieves and granulate, 50～60 ℃ of dryings three hours.(5) 16 mesh sieve granulate add Extra Section disintegrating agent, magnesium stearate, mixing.(6) tabletting.
Embodiment 3: the capsule preparation
The supplementary material consumption
Folium Ginkgo extract (conversion is Ginkgo total flavones) 20.0g
Dipyridamole 8g
Pregelatinized Starch 12g
Microcrystalline Cellulose 25g
2%HPMC (50cp) is an amount of
Make 1000
Dipyridamole is pulverized, and 60 ℃ of dry backs are standby, Folium Ginkgo extract, microcrystalline Cellulose and pregelatinized Starch pulverize separately, and 60 ℃ of dryings are crossed 100 mesh sieves, take by weighing by recipe quantity, and fully mixing is crossed 80 mesh sieves and is mixed 3 times; Dipyridamole is added down in the said mixture with the equivalent incremental method, add the abundant mixing of fashionable mistake 80 mesh sieves 3 times at every turn; Add 2% hypromellose and make soft material in right amount; Cross 55 ℃ of oven dry of 30 mesh sieves granulation; 20 mesh sieve granulate; Survey intermediate content; The dress capsule.
Embodiment 4: the syrup preparation
The supplementary material consumption
Folium Ginkgo extract (conversion is Ginkgo total flavones) 2.5g
Dipyridamole 1.0g
Cycloheptaamylose 10.0g
Sodium benzoate 2.5g
Citric acid 0.3g
95% ethanol 5ml
Citrua paradiai essence 1ml
Sucrose 650g
Purified water adds to 1000ml
Full dose 1000ml.
Technology: get the recipe quantity cycloheptaamylose and add in the purified water of total amount 1/5, heating makes dissolving; Get the recipe quantity dipyridamole and add in the ethanol, stir and make dissolving, add in the above-mentioned solution, with adding with being stirred to dissolving fully with thread; Get the recipe quantity Folium Ginkgo extract, sucrose adds total amount 3/5 purified water, heating makes is dissolved into syrup, when being cooled to 60 ℃, above-mentioned solution is added, with adding with stirring, when being cooled to below 40 ℃, add benzoic acid solution, citric acid soln and Citrua paradiai essence, add purified water, stir to full dose, filter, promptly.
Embodiment 5: the oral administration solution preparation
The supplementary material consumption
Folium Ginkgo extract (conversion is Ginkgo total flavones) 10.0g
Dipyridamole 4g
Propylene glycol 1500ml
Glycerol 2500g
Sorbitol 2500g
Saccharin sodium 1.0g
Propanoic acid 10ml
Acetic acid-sodium-acetate buffer 1600ml
Distilled water is lived and is measured
Full dose 10000ml (1000).
Technology: get an amount of distilled water, add sorbitol earlier, heating makes dissolving, and is cold slightly, adds other adjuvant and crude drug, stirs and makes dissolving, and adding distil water is to full dose.Filter with the G4 sintered glass funnel.The filling machine fill is jumped a queue and is rolled lid, sterilizes 30 minutes for 115.5 ℃, examines qualified back packing entirely, promptly.
Embodiment 6: the dispersible tablet preparation
The supplementary material consumption
Ginkgo total flavones 20.0g
Dipyridamole 8.0g
Mannitol 35.0g
10% polyvinylpyrrolidone (80% ethanol) solution 150ml
Crospolyvinylpyrrolidone 10.0g
Aspartame 2.0g
Micropowder silica gel 2.0g
Magnesium stearate 2.6g
Cross-linking sodium carboxymethyl cellulose 10.0g
Make 1000
Technology: take by weighing polyvinylpyrrolidone by recipe quantity, make 10% solution (1) with 80% ethanol; Take by weighing cross-linking sodium carboxymethyl cellulose, aspartame, micropowder silica gel and the magnesium stearate mix homogeneously (2) of crossing 100 mesh sieves respectively by prescription; Take by weighing Ginkgo total flavones, dipyridamole, mannitol and crospolyvinylpyrrolidone, the mixing of crossing 100 mesh sieves by recipe quantity, cross 80 mesh sieves twice, add (1), 18 mesh sieves are granulated, 60 ± 5 ℃ of oven dry, 20 mesh sieve granulate; Add (2) fully mixing; Tabletting; After the assay was approved, packing.
Embodiment 6: the oral cavity disintegration tablet preparation
Glucose 30g, compressibility sorbitol 10g, mannitol 20g, sucrose 20g, sodium bicarbonate 10g, citric acid 9.9g, saccharin sodium 0.05g, aspartame 0.05g be totally eight kinds of adjuvant 100g, with principal agent Ginkgo total flavones 10g, bilobalide 2g and dipyridamole 4g mix homogeneously, add wetting agent and make soft material, sieve, oven dry, granulate, tabletting behind the adding lubricant, make 1000
Embodiment 7: the oral cavity disintegration tablet preparation
Principal agent Ginkgo total flavones 20g, bilobalide 4g and dipyridamole 8g are suspended in the hydroxyethyl-cellulose 7.5g aqueous solution, form solution A, press the prescription in the adjuvant 1, then 2.5g gelatin, 0.5g spice, 64.5g mannitol and 25g sucrose mixed dissolution, form solution B, it is mixed that the formation solution A is added solution B, and add the suitable quantity of water dilution, and abundant mixing, join sharp freezing in the mould, be put into evacuation in the freeze dryer, ice sublimes up into material bone dry, press seal, packing.
Embodiment 8: the drop pill preparation
Folium Ginkgo extract (conversion is Ginkgo total flavones) 10.0g
Dipyridamole 4g
Sodium stearate 100g
Insect wax 25g
Water 40g
Each supplementary material beyond dewatering is added in flask, shakes up, shake up again after adding water, will fill in flask with the rubber closure of reflux condensing tube after, jolting constantly also is heated to about 100 ℃ and makes whole fusions, a glue ball.Be coolant with 2% aqueous sulfuric acid when dripping system.Ooze by the dropper mouth when making medicinal liquid remain on 65 ℃.Because this ball proportion is less than 2% aqueous sulfuric acid, for this reason, during drop pill, melt liquid is splashed in the coolant by the bottom of coolant, and every dropper per minute oozes 200 drop pill approximately.Ball is oozed by the drip place and floats, the cooling of limit rising edge, and drop pill can be pulled out with strainer, is dipped in the acid solution of removing attachment removal in the cold water, inserts in the dish of absorbent paper again, makes rolling, after the water mark on pill surface is removed in suction, promptly.
Embodiment 9: the drop pill preparation
Folium Ginkgo extract (conversion is Ginkgo total flavones) 20.0g
Dipyridamole 8g
Polyethylene glycol 6000 90g
Taking polyethylene glycol 6000 is heated to 135 ℃ in oil bath.Add Folium Ginkgo extract and dipyridamole, constantly be stirred to moltenly entirely, (135 ℃) filter while hot, put in the liquid containing bottle, drip system when making it remain on 135 ℃.The drip internal diameter 9.0mm of rustless steel dropper, external diameter 9.8mm.Drip in the outside with the speed of 80 of per minutes and to form drop pill in the refrigerative liquid paraffin condensed fluid that contains 43% kerosene with frozen water.Ball is taken out the back wash several with flush away kerosene flavor, inhale with writing paper made from bamboo and remove adherent liquid paraffin with liquid paraffin.
Embodiment 10: preparation tablets
Folium Ginkgo extract (conversion is Ginkgo total flavones) 30.0g
Dipyridamole 12g
Sodium carboxymethyl cellulose 10g
Microcrystalline Cellulose 40g
Starch 10g
3.0% hydroxypropyl emthylcellulose E50 aqueous solution is an amount of
Magnesium stearate 0.5%
Make 1000
Technology: conventional method prepares this product, takes by weighing principal agent and microcrystalline Cellulose, starch, low-substituted hydroxypropyl cellulose by prescription, crosses 100 mesh sieves, and mixing is with 3%HPMC
E50Aqueous solution system soft material, 24 mesh sieve granulate; 50-60 ℃ of aeration-drying to moisture is about reuse 24 mesh sieve granulate behind the content 2-%, adds the magnesium stearate mixing, measures drug content, determines that sheet is heavy, tabletting.
Embodiment 11: the buccal tablet preparation
Ginkgo total flavones 10.0g
Bilobalide 2.0g
Dipyridamole 4g
Mannitol 53.4g
Lactose 13.0g
Citric acid 1.6g
Hypromellose (K15M) 1.0g
Cyclamate 3.0g
Carboxymethyl starch sodium 4.0g
Magnesium stearate 0.3g
Make 1000
1), supplementary material crosses 100 mesh sieves respectively through after the assay was approved technology:.2), take by weighing supplementary material by recipe quantity.3), with mannitol, citric acid, carboxylic third methylcellulose, cyclamate, lactose by the equivalent mixing method mix homogeneously that progressively increases, make the soft material of doing wet appropriateness with 70% ethanol moistening, cross 30 eye mesh screen system wet granulars, in 60～70 ℃ of forced air dryings 4 hours, cross 100 order net granulate, as blank granule.4), with Ginkgo total flavones, bilobalide and dipyridamole mixing and with blank granule, magnesium stearate mixing (mixing in the sub-mixer about 2 hours).5), measure the percentage composition (%) of principal agent in the particle powder.6), determine that according to the content of principal agent in the granule sheet is heavy.7), according to sheet reselection procedure drift, adjustment sheet is heavy, adjusts the pressure tabletting, promptly.
Embodiment 12: soft capsule preparation
Folium Ginkgo extract (conversion is Ginkgo total flavones) 25.0g
Dipyridamole 10g
PEG400 400g
Make 1000
Folium Ginkgo extract and dipyridamole with recipe quantity mixes with the PEG400 of 1/6 amount earlier, pulverizes with colloid mill, adds the PEG400 miscible (also available ball mill grinding 3 hours) of surplus then.It is standby that other joins gelatin solution (100 parts in gelatin, 55 parts of glycerol, 120 parts in water).Under the condition of 28 ± 2 ℃ of room temperatures, relative humidity 40%, medicinal liquid and gelatin press capsule machine-processed with rotation automatically, 28 ± 2 ℃, during relative humidity 40% with dry 20 hours of capsule, get product.
Embodiment 13: preparation tablets
Folium Ginkgo extract (conversion is Ginkgo total flavones) 25.0g
Dipyridamole 10g
Lactose 50g
Carboxymethyl starch sodium 70g
Microcrystalline Cellulose 85g
Starch 90g
Magnesium stearate 3g
5%K30 is an amount of
Make 1000.
Principal agent, starch, lactose, microcrystalline Cellulose, carboxymethyl starch sodium are crossed 100 mesh sieves, mixing respectively.Add the 5%PVP alcoholic solution, the system soft material, 18 mesh sieves are granulated, 60 ℃ of oven dry, 16 mesh sieve granulate add the magnesium stearate mixing, make semi-finished product, after the assay was approved tabletting.
Embodiment 14: Ginkgo total flavones content is measured with the following method among the present invention:
Measure according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2000).
Chromatographic condition and system suitability experiment are filler with octadecylsilane chemically bonded silica; With 0.4% phosphoric acid solution-methanol (50: 50) is mobile phase; Flow velocity is 1.2ml/min; Detect wavelength 360nm.Number of theoretical plate calculates by the Quercetin peak should be not less than 1500, repeats 5 relative standard deviations of sample introduction (RSD) and should be not more than 2.0%.
Reference substance solution prepares precision and takes by weighing the about 12mg of Quercetin reference substance, puts in the 200ml measuring bottle, adds methanol and is diluted to scale, shakes up.
Need testing solution prepares precision, and to measure this product an amount of, adds sulfuric acid solution (5 → 100) 15ml, adds methanol 20ml, put in the water-bath and to reflux 4 hours, put coldly, move in the 100ml measuring bottle, add washed with methanol and, shake up, filter through filter membrane (aperture must not greater than 0.45 μ m) to scale.
The algoscopy precision is measured reference substance solution and each 20 μ l of need testing solution, inject high performance liquid chromatograph respectively, the record chromatogram, Zui Da three peaks wherein, be followed successively by Quercetin (Q), nimbecetin (K), isorhamnetin (I) by retention time, calculate Q, K, I with external standard method, be calculated as follows content of total flavone:
Q×2.50+K×2.59+I×2.44
Embodiment 15: treatment cerebral thrombus forming patient's observation of curative effect
Typical cerebral infarction clinical manifestation patient 30 examples that Acute onset is arranged, male 20 examples, women 10 examples.37 years old to 69 years old age, 60.60 ± 8.73 years old mean age.Be through Grade III Class A hospital and be diagnosed as the cerebral thrombus patient.Take ginkgo bilobate extract extract and dipyridamole soft capsule (pressing the preparation of embodiment 12 methods), every day 3 times, each 2 examples were taken in 1.5 hours after meal, in 4 weeks of the course of treatment, treated 3 courses of treatment.After treatment finished, clinical symptom disappearance was made clinical assay to Grade III Class A hospital, and it is normal that hemorheology index recovers, and the head ischemic focus disappears substantially.
Claims (4)
1, the combination drug of a kind of Folium Ginkgo extract and dipyridamole is characterized in that said medicament is the peroral dosage forms such as the tablet that contains Folium Ginkgo effective ingredient and dipyridamole, capsule, soft capsule, drop pill, granule, dispersible tablet, powder, oral cavity disintegration tablet, oral solution and syrup of oral administration.
2, Folium Ginkgo extract according to claim 1 and dipyridamole combination drug, it is characterized in that every of said peroral dosage form (basic dosage unit such as grain, bag) contains 1.5 milligrams to 30.0 milligrams of 4 milligrams to 50 milligrams of Semen Ginkgo total flavones and dipyridamoles, all the other can be the various adjuvants on the pharmaceutics, also can comprise other effective ingredient of Folium Ginkgo.
3, Folium Ginkgo extract according to claim 1 and 2 and dipyridamole compound medicine, it is characterized in that used Folium Ginkgo extract with the dipyridamole compatibility can extract from the Folium Ginkgo medical material, also can be directly with mixing active ingredients thing, Ginkgo total flavones or Folium Ginkgo extract such as existing Ginkgo total flavones and bilobalides.
4, Folium Ginkgo extract according to claim 1 and dipyridamole combination drug, the taking dose that it is characterized in that oral formulations is that each dose is equivalent to 3.6 milligrams to 200 milligrams of 9 milligrams to 1000 milligrams of Ginkgo total flavones and dipyridamoles, every day 1 to 4 time, be used for prevention and treatment coronary heart disease, thrombotic disease.
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| CNA2004100121549A CN1559498A (en) | 2004-02-23 | 2004-02-23 | Ginkgo leaf extract and bimidamo oral compound medicine and its preparation method |
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| CNA2004100121549A CN1559498A (en) | 2004-02-23 | 2004-02-23 | Ginkgo leaf extract and bimidamo oral compound medicine and its preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939357B (en) * | 2005-09-27 | 2010-12-15 | 博安兄弟制药（中国）有限公司 | Preparation of Ginkgo Damo injection |
-
2004
- 2004-02-23 CN CNA2004100121549A patent/CN1559498A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939357B (en) * | 2005-09-27 | 2010-12-15 | 博安兄弟制药（中国）有限公司 | Preparation of Ginkgo Damo injection |
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