CN102626428B - Ginkgo leaf extract osmotic pump controlled-release preparation and preparation method thereof - Google Patents
Ginkgo leaf extract osmotic pump controlled-release preparation and preparation method thereof Download PDFInfo
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- CN102626428B CN102626428B CN201210108641.XA CN201210108641A CN102626428B CN 102626428 B CN102626428 B CN 102626428B CN 201210108641 A CN201210108641 A CN 201210108641A CN 102626428 B CN102626428 B CN 102626428B
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Abstract
The invention relates to a ginkgo leaf extract, in particular to a ginkgo leaf extract osmotic pump controlled-release preparation and a preparation method thereof. In the preparation, a membrane controlled-release technology is adopted, the ginkgo extract is prepared into a single-chamber osmotic pump tablet, a semipermeable membrane polymer is used for coating outside, and the top of one end is provided with a medicament releasing hole. The coating semipermeable membrane is permeable for water molecules, and is impermeable for medicaments. After the tablet is contacted with a body fluid in a gastrointestinal tract, water molecules enter a tablet core through the semipermeable membrane, a medicament is dissolved into a saturated solution, an intramembrane solution is turned into a hypertonic solution through a permeation enhancer, so that the medicament saturated solution can be pumped out from the medicament releasing small hole at a constant speed, the medicament releasing speed is not influenced by the pH value of the gastrointestinal tract, and the influence on individual differences is small. Moreover, the in-vivo release of the medicament is basically accordant with a zero-order releasing process, i.e., the medicament is released at a constant speed or a speed which is approximate to a constant speed, the blood concentration can be kept in an effective concentration range constantly for a long time, side effect is small, and the safety is high.
Description
Technical field
The present invention relates to a kind of Folium Ginkgo extract, be specifically related to a kind of Folium Ginkgo extract controlled releasing penetrant pump and preparation method thereof, belong to pharmaceutical preparations technology field.
Background technology
Folium Ginkgo, has another name called Folium Ginkgo, is the leaf of Ginkgoaceae plant Ginkgo biloba.According to < < Treatise on Dietetic Therapy > >, record, Folium Ginkgo can be used for the diseases such as severe palpitation, cough and asthma due to lung deficiency.Folium Ginkgo extract is the extract of Folium Ginkgo through being processed into.Chinese Pharmacopoeia 2010 editions has recorded 5 relevant kinds that comprise Folium Ginkgo.Studies confirm that, Folium Ginkgo extract mainly has control cerebral infarction; Treatment disordered brain function; Control Alzheimer; Improve the diseases such as intermittent claudication that arteriosclerosis causes; The effects such as treatment diabetes, control glaucoma and antiinflammatory, antiallergic, shock.Therefore ginkgo leaf extract preparation is widely used in the clinical treatment of Neurology Department and the heart, cerebrovascular various diseases.At present, China is that gone on the market has injection, tablet (Li Chongming etc. with gingko leaf preparation that researching and developing, CN:1528350,2004), capsule, micropill (Rhizoma Picrorhizae etc., China Dispensary magazine, 2009), drop pill (Ge Yuebin etc., CHINA JOURNAL OF CHINESE MATERIA MEDICA, 2003), granule, oral liquid, liposome etc.These preparations have defect in various degree, as injection is used inconvenience, also easily produce the problem of safety aspect; Tablet, capsule, granule have dissolution and the problem such as bioavailability is low; The less stable of oral liquid, and store and all inconvenience of transportation; Soft capsule and drop pill have aging problem; The poor stability of liposome and burst drug release problem.
Slow releasing preparation can solve the problem (only needing every day to take medicine once) that above-mentioned ordinary preparation need to frequently be taken medicine, and reduces to a certain extent side effect.Domestic existing ginkgo biloba extract sustained-release pellet and preparation method thereof (Pei Yuanying, CN:101259150,2008), composition containing ginkgo leaf extract slow/controlled release pellet composition and preparation method thereof (Wang Guangji, CN:101375869,2009) the multiple slow releasing preparation patent application such as.But, because slow releasing preparation is non-constant speed release medicine lentamente, the emission and absorption speed of medicine is also subject to the impact of the factors such as the interior gastro-intestinal Fluid of patient body, be difficult to control and expect, therefore its blood drug level still may have larger fluctuation, have certain unstability, its effective persistent period and side effect size also vary with each individual, and individual variation is larger.
Summary of the invention
The object of the invention is, for overcoming above-mentioned the deficiencies in the prior art part, provides a kind of Folium Ginkgo extract controlled releasing penetrant pump and preparation method thereof.Said preparation is usingd Folium Ginkgo extract as medicine, it comprises label, the coating membrane of Folium Ginkgo extract, and be equipped with small delivery aperture in label one or both sides, by adopting film controlled-release technology, Folium Ginkgo extract is made to elementary osmotic pump tablet, coating is carried out with semipermeable membrane polymer in outside, and then at one end a drug release hole is opened at top.Coating semipermeable membrane water permeable molecule, but can not osmotic drug.After tablet contacts with body fluid in gastrointestinal tract, hydrone enters label by semipermeable membrane, make medicine dissolution become saturated solution, short penetrating agent makes solution in film become hyperosmotic solution, thereby impel medicine saturated solution to pump with constant speed from small delivery aperture, its drug release rate is not subject to the impact of gastrointestinal tract pH value, thereby the impact of individual variation is less.Said preparation forms rationally, can reach good controlled-release effect, effectively the persistent period is long, only need to take medicine once every day, side effect is little, the impact of individual variation is little, safety good, patient dependence is good.And osmotic pump type controlled release preparation is to take osmotic pressure as the drug-supplying system of powered medicine with the release of zero level speed, and rate of releasing drug is not subject to gastrointestinal tract variable factor as the impact in wriggling, pH, gastric emptying time etc., be ideal a kind of in controlled release formulations for oral administration up to now.
The present invention realizes with following technical scheme: a kind of Folium Ginkgo extract controlled releasing penetrant pump, it is characterized in that: said preparation is usingd Folium Ginkgo extract as medicine, it comprises label, the coating membrane of Folium Ginkgo extract, and is provided with small delivery aperture in label one side; The component of described label and percentage by weight are:
Folium Ginkgo extract 15%-80%
Short penetrating agent 20%-85%
Filler 5%-50%
Binding agent 1%-15%
Disintegrating agent 1%-15%
Lubricant 0.1%-10%
Described semi-transparent coating membrane w/v is:
Semipermeable membrane coating macromolecular material 2%-20%(w/v, mg/ml)
Plasticizer 2%-25%(w/v, mg/ml)
Lubricant 0.1%-30%(w/v, mg/ml)
Film coating weightening finish is the heavy 2%-10% of sheet.
The penetrating agent of described label is that inorganic salts, low molecular sugar class or other have the material of short osmotically active; Described inorganic salts is sodium chloride, potassium chloride, magnesium sulfate, magnesium chloride, potassium sulfate, sodium sulfate; Described low molecular sugar class is sucrose, d-mannitol, sorbitol; Other described short osmo active substance is polyvidone, sodium carboxymethyl cellulose, polyethylene glycols, carbamide, Magnesium succinate, tartaric acid, tween.
The filler of described label is pharmaceutic adjuvant, as lactose, pregelatinized Starch, microcrystalline Cellulose, starch, Icing Sugar, dextrin, mannitol.
The binding agent of described label is mixed solution, polyvidone, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, the methylcellulose of water, water or alcohol.
The disintegrating agent of described label is carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose or polyvinylpolypyrrolidone.
The lubricant of described label is the pharmaceutically useful adjuvant with lubrication, comprises magnesium stearate, stearic acid, Pulvis Talci, micropowder silica gel, hydrogenated vegetable oil, sodium lauryl sulphate, polyethylene glycols.
The material of described coating membrane is polyolefin, polyester, cellulose esters or Eudragit(acrylic resin), be specially cellulose acetate, ethyl cellulose, polrvinyl chloride, Merlon, polyvinyl alcohol, polyvinyl acetate and ethylene, acrylic polymers, coating materials is coating weightening finish 2%-10% in accordance with regulations.
In described coating membrane, plasticizer is triethyl citrate, triglyceride, phthalic acid ester, PEG-4000, PEG-4000, glyceride, succinate, benzoate, phosphate ester, adipic acid ester, tartrate.
A preparation method for Folium Ginkgo extract controlled releasing penetrant pump as claimed in claim 1, is characterized in that: comprise the steps:
(1) by metering formulation selection Core formulation, Folium Ginkgo extract, filler, short penetrating agent and binding agent are sieved, abundant mix homogeneously, with ethanol and water mixed solution 90:10, volume ratio soft material processed, 20 orders are granulated, and 40 ℃ of-60 ℃ of drying baker are dry, 18 mesh sieve granulate, add lubricant and are pressed into label;
(2) by each components dissolved of coating membrane (Sulisi coating solution is directly used) in solvent, label is placed in and in coating pan or fluid bed, carries out coating, increase weight to 2%-10% to coating, coated tablet is dry in drying baker, coating membrane is solidified;
(3) use machine drilling or laser-beam drilling machine in a side of label, to prepare the aperture of one or two diameter 0.1-1.0 mm.
Advantage of the present invention is: said preparation adopts film controlled-release technology, and Folium Ginkgo extract is made to elementary osmotic pump tablet, and coating is carried out with semipermeable membrane polymer in outside, and then at one end a drug release hole is opened at top.Coating semipermeable membrane water permeable molecule, but can not osmotic drug.After tablet contacts with body fluid in gastrointestinal tract, hydrone enters label by semipermeable membrane, make medicine dissolution become saturated solution, short penetrating agent makes solution in film become hyperosmotic solution, thereby impel medicine saturated solution to pump with constant speed from small delivery aperture, its drug release rate is not subject to the impact of gastrointestinal tract pH value, thereby the impact of individual variation is less.And medicine release in vivo meets zero level dispose procedure substantially, with constant speed or approach constant release, blood drug level can maintain within the scope of valid density for a long time more consistently, blood drug level is steady, fluctuates less, can avoid occurring peak valley phenomenon, side effect is little, and safety is good.Effective persistent period is long, can reduce administration number of times, only need every day to take medicine once, and taking convenience, thus improve patient's compliance.
Accompanying drawing explanation
Fig. 1 is Folium Ginkgo extract osmotic pump controlled release tablet embodiment of the present invention 1 medicine (total flavol glycosides: Quercetin+kaempferide+isorhamnetin) release curve chart;
Fig. 2 is Folium Ginkgo extract osmotic pump controlled release tablet embodiment of the present invention 2 medicines (total flavol glycosides: Quercetin+kaempferide+isorhamnetin) release curve chart;
Fig. 3 is Folium Ginkgo extract osmotic pump controlled release tablet embodiment of the present invention 3 medicines (total flavol glycosides: Quercetin+kaempferide+isorhamnetin) release curve chart;
Fig. 4 is Folium Ginkgo extract osmotic pump controlled release tablet embodiment of the present invention 4 medicines (total flavol glycosides: Quercetin+kaempferide+isorhamnetin) release curve chart.
The specific embodiment
Below in conjunction with embodiment, to the present invention's further instruction in addition, but following embodiment does not limit the interest field of this patent.
Embodiment 1,
Core formulation:
Folium Ginkgo extract 120g
Lactose 200g
Sodium chloride 50g
Mannitol 50g
Polyvinylpolypyrrolidone 15g
2% hydroxypropyl methylcellulose aqueous solution 40g
Magnesium stearate 6g
Coating membrane prescription:
Cellulose acetate 60g
PEG-4000 15g
Coating weightening finish 3%
Preparation: the medicine of recipe quantity and lactose, sodium chloride, mannitol, polyvinylpolypyrrolidone are distinguished to grinding and sieving, after mix homogeneously, with hydroxypropyl methylcellulose aqueous solution soft material processed, 20 mesh sieves are granulated, 40 ± 5 ℃ dry, 18 mesh sieve granulate, dry granule adds magnesium stearate lubricant, be pressed into label, cellulose acetate and plasticizer PEG-4000 are dissolved in the mixed solvent of acetone, chloroform, label is placed in to coating pan, carry out coating, after coating, coated tablet is dry in drying baker, coating membrane is solidified.Then in coated tablet one side, with laser or mechanical means, prepare the small delivery aperture that an aperture is 0.4mm and obtain Folium Ginkgo extract osmotic pump type controlled release tablets.
Embodiment 2,
Core formulation:
Folium Ginkgo extract 1200g
Lactose 120g
Microcrystalline Cellulose 80g
Cross-linking sodium carboxymethyl cellulose 48g
Potassium chloride 500g
Sucrose 500g
10% polyvinylpyrrolidone water liquid 300g
Micropowder silica gel 30g
Coating membrane prescription:
Cellulose acetate 600g
PEG-4000 150g
Tributyl citrate 180ml
Coating weightening finish 6%
Preparation: the medicine of recipe quantity and lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, potassium chloride, sucrose are distinguished to grinding and sieving, after mix homogeneously, add binding agent soft material processed, 20 mesh sieves are granulated, 40 ± 5 ℃ dry, 18 mesh sieve granulate, dry granule adds lubricant micropowder silica gel and is pressed into label, cellulose acetate and plasticizer PEG-4000 are dissolved in the mixed solvent of acetone, chloroform, label is placed in to coating pan, carry out coating, after coating, coated tablet is dry in drying baker, coating membrane is solidified.Then in coated tablet one side, with laser or mechanical means, prepare the small delivery aperture that an aperture is 0.6mm and obtain Folium Ginkgo extract osmotic pump type controlled release tablets.
Embodiment 3,
Core formulation:
Folium Ginkgo extract 240g
Lactose 120g
Pregelatinized Starch 60g
Low-substituted hydroxypropyl cellulose 21g
Sodium chloride 120g
Sucrose 130g
2% sodium carboxymethyl cellulose water liquid 75g
Magnesium stearate 21g
Coating membrane prescription:
Ethyl cellulose 240g
Dibutyl phthalate 40ml
Coating weightening finish 10%
Preparation: the medicine of recipe quantity and lactose, pregelatinized Starch, low-substituted hydroxypropyl cellulose, potassium chloride, sucrose are distinguished to grinding and sieving, after mix homogeneously, add binding agent soft material processed, 20 mesh sieves are granulated, 40 ± 5 ℃ dry, 18 mesh sieve granulate, dry granule adds magnesium stearate lubricant and is pressed into label, ethyl cellulose and plasticizer phthalic acid dibutyl ester are dissolved in the mixed solvent of second alcohol and water, label is placed in to coating pan, carry out coating, after coating, coated tablet is dry in drying baker, coating membrane is solidified.Then at coated tablet one side roof part, with laser or mechanical means, prepare the small delivery aperture that an aperture is 0.5mm and obtain Folium Ginkgo extract osmotic pump type controlled release tablets.
Embodiment 4,
Core formulation:
Folium Ginkgo extract 200g
Lactose 75g
Microcrystalline Cellulose 25g
Polyvinylpolypyrrolidone 16g
Sodium chloride 150g
Mannitol 50g
2% hypromellose water liquid 60g
Micropowder silica gel 9g
Coating membrane prescription:
" Surelease " coating solution 200g
Coating weightening finish 8%
Preparation: the medicine of recipe quantity and lactose, microcrystalline Cellulose, polyvinylpolypyrrolidone, potassium chloride, mannitol are pulverized respectively to rear sieving later, after mix homogeneously, add binding agent soft material processed, 20 mesh sieves are granulated, and 40 ± 5 ℃ dry, 18 mesh sieve granulate, dry granule adds lubricant micropowder silica gel and is pressed into label, and label is placed in to coating pan, with " Surelease " coating solution, carries out coating, after coating, coated tablet is dry in drying baker, coating membrane is solidified.Then in coated tablet one side, with laser or mechanical means, prepare the small delivery aperture that an aperture is 0.9mm and obtain Folium Ginkgo extract osmotic pump type controlled release tablets.
Claims (4)
1. a Folium Ginkgo extract osmotic pump controlled release tablet, is characterized in that, it is the medicament of making by following raw material and step:
(1) prepare pastille label: get Folium Ginkgo extract, filler, disintegrating agent, binding agent and short penetrating agent mix homogeneously, add binder aqueous solution and make soft material, 20 mesh sieves are granulated, 40 ± 5 ℃ are dry, 18 mesh sieve granulate, and dry granule adds lubricant and is pressed into label; Described supplementary material and proportioning are: Folium Ginkgo extract 120 weight portions, filler lactose 200 weight portions, short penetrating agent sodium chloride 50 weight portions, mannitol 50 weight portions, disintegrating agent polyvinylpolypyrrolidone 15 weight portions, hypromellose aqueous solution 40 weight portions of binding agent 2%, magnesium stearate lubricant 6 weight portions;
(2) prepare semipermeable membrane coating solution and coated tablet: semipermeable membrane coating material cellulose acetate and plasticizer are scattered in the mixed solvent of acetone and chloroform and make semipermeable membrane coating solution; The pastille label that step (1) is made is placed in coating pan and carries out coating, then coated tablet is placed in to drying baker dry, to coating weightening finish 3%, coating membrane is solidified, and obtains coated tablet; Described supplementary material and proportioning are: semipermeable membrane coating material cellulose acetate 60 weight portions, and plasticizer Macrogol 4000 is 15 weight portions, coating weightening finish is 3%;
(3) punching: use machinery or laser-beam drilling machine to make a call in a side of coated tablet the aperture that a diameter is 0.4mm, make osmotic pump controlled release tablet.
2. a Folium Ginkgo extract osmotic pump controlled release tablet, is characterized in that, it is the medicament of making by following raw material and step:
(1) prepare pastille label: get Folium Ginkgo extract, filler, disintegrating agent, binding agent and short penetrating agent mix homogeneously, add binder aqueous solution and make soft material, 20 mesh sieves are granulated, 40 ± 5 ℃ are dry, 18 mesh sieve granulate, and dry granule adds lubricant and is pressed into label; Described in step (1), supplementary material and proportioning are: Folium Ginkgo extract 1200 weight portions, filler lactose 120 weight portions, microcrystalline Cellulose 80 weight portions, short penetrating agent potassium chloride 500 weight portions, sucrose 500 weight portions, polyvinylpyrrolidone aqueous solution 300 weight portions of binding agent 10%, disintegrating agent cross-linking sodium carboxymethyl cellulose 48 weight portions, lubricant micropowder silica gel 30 weight portions;
(2) prepare semipermeable membrane coating solution and coated tablet: semipermeable membrane coating material cellulose acetate and plasticizer are scattered in the mixed solvent of acetone and chloroform and make semipermeable membrane coating solution; The pastille label that step (1) is made is placed in coating pan and carries out coating, then coated tablet is placed in to drying baker dry, to coating weightening finish 6%, coating membrane is solidified, and obtains coated tablet; Supplementary material described in step 2 and proportioning are: semipermeable membrane coating material cellulose acetate 600 weight portions, plasticizer polyethylene glycol 6000 is 105 weight portions, plasticizer tirbutyl citrate 180 parts by volume, it is the relation of ml/g that the unit of above-mentioned parts by volume and weight portion closes; Coating weightening finish is 6%;
(3) punching: use machinery or laser-beam drilling machine to make a call in a side of coated tablet the aperture that a diameter is 0.6mm, make osmotic pump controlled release tablet.
3. a Folium Ginkgo extract osmotic pump controlled release tablet, is characterized in that, it is the medicament of making by following raw material and step:
(1) prepare pastille label: get Folium Ginkgo extract, filler, disintegrating agent, binding agent and short penetrating agent mix homogeneously, add binder aqueous solution and make soft material, 20 mesh sieves are granulated, 40 ± 5 ℃ are dry, 18 mesh sieve granulate, and dry granule adds lubricant and is pressed into label; Described supplementary material and proportioning are: Folium Ginkgo extract 240 weight portions, filler lactose 120 weight portions, filler pregelatinized Starch 60 weight portions, short penetrating agent sodium chloride 120 weight portions, sucrose 130 weight portions, disintegrating agent low-substituted hydroxypropyl cellulose 21 weight portions, sodium carboxymethyl cellulose solution 75 weight portions of binding agent 2%, magnesium stearate lubricant 21 weight portions;
(2) prepare semipermeable membrane coating solution and coated tablet: semipermeable membrane coating material ethyl cellulose 240 weight portions are scattered in the mixed solvent of water and ethanol, add plasticizer phthalic acid dibutyl ester, obtain semipermeable membrane coating solution; The label that step (1) is made is placed in coating pan and carries out coating, to coating weightening finish 10%, then coated tablet is placed in to drying baker dry, and coating membrane is solidified, and obtains coated tablet; Described supplementary material and proportioning are: semipermeable membrane coating material ethyl cellulose 240 weight portions, and plasticizer phthalic acid dibutyl ester 40 parts by volume, it is the relation of ml/g that the unit of above-mentioned parts by volume and weight portion closes; Coating weightening finish is 10%;
(3) punching: use machinery or laser-beam drilling machine to make a call in a side of coated tablet the aperture that a diameter is 0.5mm, make osmotic pump controlled release tablet.
4. a Folium Ginkgo extract osmotic pump controlled release tablet, is characterized in that, it is the medicament of making by following raw material and step:
(1) prepare pastille label: get Folium Ginkgo extract, filler, disintegrating agent, binding agent and short penetrating agent mix homogeneously, add binder aqueous solution and make soft material, 20 mesh sieves are granulated, 40 ± 5 ℃ dry, and 18 mesh sieve granulate, add lubricant and be pressed into label; Described supplementary material and proportioning are: Folium Ginkgo extract 200 weight portions, filler lactose 75 weight portions, filler microcrystalline Cellulose 25 weight portions, short penetrating agent sodium chloride 150 weight portions, mannitol 50 weight portions, disintegrating agent polyvinylpolypyrrolidone 16 weight portions, hypromellose aqueous solution 60 weight portions of binding agent 2%, lubricant micropowder silica gel 9 weight portions;
(2) prepare semipermeable membrane coating solution and coated tablet: the label that step (1) is made is placed in coating pan, with " Surelease " coating solution, carry out coating, to coating weightening finish 8%, then coated tablet is placed in to drying baker dry, coating membrane is solidified; Described supplementary material and proportioning are: " Surelease " coating solution 200 weight portions, and coating weightening finish is 8%;
(3) punching: use machinery or laser-beam drilling machine to make a call in a side of coated tablet the aperture that a diameter is 0.9mm, make osmotic pump controlled release tablet.
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| CN201210108641.XA CN102626428B (en) | 2012-04-15 | 2012-04-15 | Ginkgo leaf extract osmotic pump controlled-release preparation and preparation method thereof |
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Families Citing this family (6)
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| CN102871982B (en) * | 2012-10-16 | 2014-09-10 | 中国科学院上海药物研究所 | Medicine osmotic pump preparation |
| CN103599099B (en) * | 2013-11-18 | 2015-12-30 | 沈阳药科大学 | Bilobalide bi-layer osmotic pump control tablet and preparation method |
| CN103599086B (en) * | 2013-11-19 | 2016-02-03 | 沈阳药科大学 | Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet and preparation method |
| CN103690672B (en) * | 2013-12-31 | 2016-08-31 | 贵阳新天药业股份有限公司 | For treating controlled release preparation of anovulatory dysfunctional uterine hemorrhage that women's ovary dysfunction causes and preparation method thereof |
| CN104001041A (en) * | 2014-05-22 | 2014-08-27 | 乔岭梅 | Traditional Chinese medicine for treating cerebral infarction |
| CN106860836A (en) * | 2017-02-24 | 2017-06-20 | 贵州神奇药业有限公司 | A kind of pharmaceutical controlled release formulation for treating diabetes and its complication and preparation method thereof |
Citations (1)
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| CN101612171A (en) * | 2008-06-27 | 2009-12-30 | 武汉爱民制药有限公司 | Ginkgo biloba extract sustained-release pellet and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101612171A (en) * | 2008-06-27 | 2009-12-30 | 武汉爱民制药有限公司 | Ginkgo biloba extract sustained-release pellet and preparation method thereof |
Non-Patent Citations (1)
| Title |
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| 王效山、王键主编.《制药工艺学》.《制药工艺学》.北京科学技术出版社,2003,350－352页. * |
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