CN103007427A - Slow-releasing controlling intrauterine drug releaser and preparation method thereof - Google Patents
Slow-releasing controlling intrauterine drug releaser and preparation method thereof Download PDFInfo
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- CN103007427A CN103007427A CN2011102822948A CN201110282294A CN103007427A CN 103007427 A CN103007427 A CN 103007427A CN 2011102822948 A CN2011102822948 A CN 2011102822948A CN 201110282294 A CN201110282294 A CN 201110282294A CN 103007427 A CN103007427 A CN 103007427A
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Abstract
The invention relates to a slow-releasing controlling intrauterine drug releaser which is characterized by comprising a bracket, a drug-containing layer and a release-controlling layer. The invention also relates to a preparation method for the slow-releasing controlling intrauterine drug releaser. The slow-releasing controlling intrauterine drug releaser provided by the invention can accurately control the trace drug-releasing dosage.
Description
(1) technical field
The present invention relates in utero medicine-feeder of slow controlled release, the invention still further relates to the preparation method of described medicament release device.
(2) background technology
Intrauterine device (IUD) is used one of wider contraceptive device, the IUD that wherein discharges progestogen originates in the seventies, because such IUD plays dual parts machinery contraception and progestogen contraception in uterus, and the low dosage progestogen can alleviate the symptoms such as hemorrhage and pain that cause because of IUD, therefore have than Inrrt IUD and lower pregnancy rate and the side effect of Copper IUD.
Methylvinyl-polysiloxane (silicone rubber) is a class hydrophobicity non-biodegradation polymer, and biocompatibility is better, is widely used in body and is implanted in shaping and the controlled release drug delivery system.But discharge third generation progestogen such as gestodene (gestodene) as preparation, promise medroxyprogesterone (Normegestodene), gestrinone (R-2323), the triketone desogestrel, desogestrel (De80 goestral), norgestrienone (Norgestrienon), demegestone (Demegestone), promegestone (Promegestone), dydrogesterone (Isopregneone), trimegestone (Trimegestone), drospirenone (Drospirenone) etc.Answer its biological activity high, effective dose is very low, and these medicines are higher at middle silicone rubber permeability, just limited the application of these medicines.The present invention is that the lower macromolecular material of permeability is made the in utero outer controlled release pipe of medicine-feeder, to reach the release dosage of accurate control trace.
Mode by administration in the uterine cavity, the focus that treatment is local and the disease of whole body, be widely used clinically, also there are in the market some formulation products using, as oral contraceptive, injection-type Contraceptive, etc., but take a broad view of curative effect and the use of these formulation products, will find in its curative effect and use all in the presence of column defects:
1. oral drugs are at the first pass effect of liver, and dosage is large, and drug bioavailability is low, and side reaction is large, and the curative effect of medicine is fully played.
2. be difficult to continue, constant effective dose administration.Need be administered once above every day.Giving needs the patient of long-term prescription to bring difficulty.
The outer controlled release pipe of the in utero medicine-feeder of the macromolecular material of experiment confirm making has ethylene-vinyl acetate copolymer (EVA), polyethylene (PE) and polyester (PET) etc., it has changed the permeability of these specific medication in release-controlled film of having given an example, the requirement of the release mode that satisfied in utero medicine-feeder is micro-, long-term, constant.And adopt hot irradiation to make the controlled release layer of contraction adhere well to described medicated layer to have changed outward in the past in the preparation process because these macromolecular materials can't expand in solvent, that is to say and critically to be attached to the tubulose medicated layer of internal layer, affected the form of degree of accuracy, stability and the outward appearance of drug release.
Described technical field is sought after adopting domestic existing plant equipment, the vagina administration apparatus of using with the method producer of mold pressing, injection moulding, expressing technique, thus reduce cost and reach the release dosage of accurate control trace, long-term, efficient, effective, easy administration purpose.
(3) summary of the invention
An object of the present invention is to provide processing technology simple, can be for long term administration and the accurate slow controlled release medicine-feeder in utero of the release dosage of control trace.
A further object of the present invention provides the in utero preparation method of medicine-feeder of described slow controlled release.
The objective of the invention is to realize by following design:
A kind of slow controlled release is medicine-feeder in utero, it comprises support, medicated layer and controlled release layer, described medicated layer and controlled release layer are coated on the described support successively, the cross sectional shape of described support is T-shape or " r " type, described medicated layer is 20 by ratio of weight and number: 70-80: 30 medicine and the mixture of medical grade silicon rubber consist of, described medical grade silicon rubber is selected from HTV (high temperature vulcanized or heat cure, molecular weight 30～1,000,000), RTV-2 (double component room temperature vulcanization, molecular weight 0.74～110,000), RTV-1 is (single-component room temperature vulcanized, molecular weight 0.74～110,000) or LTV (baking, molecular weight 400～20000), Dow corning SiLastic-382 medical grade silicone rubber, Q7 medical grade silicone rubber series, implant level MDX series, the ethylene methacrylic radical siloxane of medical grade; Described controlled release layer is made of the macromolecule memory material, and described macromolecule memory material is selected from ethylene-vinyl acetate copolymer, polyethylene or the polyester of cross-linked form.
In one embodiment, described medicated layer is tubulose, and its internal diameter is the 1-3 millimeter, and thickness is the 0.2-2 millimeter, and external diameter is the 2-4 millimeter.
In another embodiment, described controlled release pipe layer is tubulose, and its internal diameter is the 1-3.5 millimeter, and thickness is the 0.2-3 millimeter, and external diameter is the 2-5 millimeter.
The material of described support can be selected from the medical material of the composite of polypropylene, polyethylene, polyurethane, polypropylene and composite polyethylene material or rubber and plastics.
When described support cross sectional shape was T-shape, it comprised that a trailing arm 1a and a transverse arm 1b diameter are 1.2-1.7mm, and length is that the described trailing arm 1a of 25-45mm is cylindrical, and diameter is 1.2-2mm, highly is 25-50mm.
When described support was " r " type, it comprised a trailing arm 1a and two forearm 1b and 1b ', and described trailing arm 1a is cylindrical, diameter is 1.2-1.7mm, highly is 25-50mm, and described forearm 1b and 1b ' are circular arc, diameter is 2-4mm, and length is 25-50mm.
In general, the ethylene-vinyl acetate copolymer of cross-linked form (the content 20-45% of vinyl acetate VA), polyethylene (low-density) or polyester (fibre strength is the 5-6 gram/dawn) can be buied by commercially available; Also can by making linear ethylene-acetate ethylene copolymer, polyethylene or polyester change over network structure behind the radiation effects through radioactive sources such as electron accelerators, form ethylene-vinyl acetate copolymer, polyethylene or the polyester of described cross-linked form.
In one embodiment, the ethylene-vinyl acetate copolymer of described cross-linked form, polyethylene or polyester shrink under 80-105 ℃ heat radiation, and its radial shrinkage ratio is 50%-80%.
Employed medicine can be selected from gestodene, promise medroxyprogesterone, gestrinone, triketone desogestrel, desogestrel, norgestrienone, demegestone, promegestone, dydrogesterone, trimegestone or drospirenone among the present invention.
The present invention relates to the in utero preparation method of medicine-feeder of slow controlled release on the other hand, comprising:
The medical material that (a) will be selected from the composite of polypropylene, polyethylene, rustless steel, silicone rubber, polyurethane, polypropylene and composite polyethylene material or rubber and plastics carries out mold pressing or injection moulding, obtains T-shape or " r " type support;
(b) with the methylvinyl-polysiloxane of medicine and medical grade with 20: 70-80: 30 part by weight evenly is mixed to get mixture, then puts into mould and carries out hot pressing, sulfuration, forms the tubulose medicated layer;
(c) the tubulose medicated layer that step (b) is obtained is inserted in the trailing arm middle-end of the support that step (a) obtains; Or
The mixture that (c ') obtains step (b) injects the trailing arm middle-end of support by injection molded;
(d) the cylindrical controlled release pipe that comprises the macromolecule memory material of intercepting external diameter 2-7mm, internal diameter 1-3mm, long 10-55mm, described macromolecule memory material is selected from ethylene-vinyl acetate copolymer, polyethylene or the polyester of cross-linked form;
(e) the cylindrical controlled release layer that step (d) is obtained is inserted in the product outside with medicated layer that step (c) or (c ') obtain, and hot irradiation adhere well to outside the described medicated layer described controlled release layer.
(4) description of drawings
Fig. 1 is the sectional view of T-shape support.
Fig. 2 a is the cross-sectional view that is coated on the medicated layer on the support.
Fig. 2 b is the longitudinal section that is coated on the medicated layer on the support.
Fig. 3 is the sectional view of " r " support.
Fig. 4 a is the cross-sectional view of controlled release layer pipe.
Fig. 4 b is the longitudinal section of controlled release layer pipe.
Fig. 5 a is the T-shape support schematic diagram with medicated layer.
Fig. 5 b is " r " type support schematic diagram with medicated layer.
Fig. 6 a is with the slow controlled release of " r " type support schematic diagram of medicine-feeder in utero.
Fig. 6 b is with the slow controlled release of the T-shape support schematic diagram of medicine-feeder in utero.
Fig. 7 is the in utero release curve of medicine-feeder under two kinds of different macromolecular material controlled releases of gestodene.
(5) specific embodiment
Below in conjunction with accompanying drawing, the present invention is done further detailed elaboration.
After the present invention is macromolecular material that permeabilitys such as ethylene-vinyl acetate copolymer (EVA), polyethylene (PE) or polyester (PET) is the lower radiation effects through radioactive sources such as electron accelerators, make its common linear structure change over network structure, formed the crosslinked of described macromolecular material, these materials will possess unique " memory effect " after crosslinked, and the material of expansion, cooling and shaping can again shrink after being heated and return to the original form.Claim again polymer shape memory material.
Term used herein " memory effect ", just refer to that the crystallizations such as radiant crosslinked polyethylene or amorphous polymeric materials are heated to fusing point when above, although crystal grain fusing, but flow regime does not appear, and has the elasticity of rubber one class, if make polyethylene dilating this moment, then still can keep expansion state behind the cooling and shaping, if this expansion polyethylene is reheated crystalline melting temperature, original form that this polymeric material meeting " memory " plays it when not expanding is also again shunk and is recovered former state, thus claim polymer shape memory material ".The radial shrinkage ratio of shrink-down material can reach 50%-80%.
Referring to Fig. 1, described support cross sectional shape is T-shape, and it comprises trailing arm 1a and transverse arm 1b, and its diameter is 1.2-1.7mm, and length is 25-45mm, and described trailing arm 1a is cylindrical, and diameter is 1.2-2mm, highly is 25-50mm.
Referring to Fig. 2 a and 2b, described medicated layer is tubulose, and it has shown the medicated layer that is coated on the support, and wherein medicated layer length H is the length of energy covered stent, preferably 10-30 millimeter, more preferably 15-25 millimeter., its internal diameter (A3-B3) is the 1-3 millimeter, and thickness (C3-D3) is the 0.2-2 millimeter, and external diameter (E3-F3) is the 2-4 millimeter.
Referring to Fig. 3, when described support was " r " type, it comprised trailing arm 1a and two forearm 1b and 1b ', described trailing arm 1a is cylindrical, and diameter is 1.2-1.7mm, highly is 25-50mm, described forearm 1b and 1b ' are circular arc, and diameter is 2-4mm, and length is 25-50mm.
Referring to Fig. 4 a and 4b, described controlled release pipe layer is tubulose, and its internal diameter (A2-B2) is the 1-3.5 millimeter, and thickness (C2-D2) is the 0.2-3 millimeter, and external diameter (E2-F2) is the 2-5 millimeter.
Described controlled release pipe can be cylindrical controlled release layer.In one embodiment, adopt injection moulding or extrude ethylene-vinyl acetate copolymer, polyethylene or the polyester formation controlled release cylinder controlled release pipe that makes cross-linked form, its external diameter 2-7mm, internal diameter 1-3mm, long 10-55mm; The ethylene-vinyl acetate copolymer of described cross-linked form, polyethylene or polyester can commercially availablely be buied, for example available from Changchun thermoplastic material limited company.Perhaps, can be from the commercially available cylindrical controlled release pipe of buying ethylene-vinyl acetate copolymer, polyethylene or the polyester of the cross-linked form with shape memory effect.
The invention will be further elaborated based on embodiment for the below
Embodiment 1
The in utero medicine-feeder that contains the gestodene
(1) take by weighing LTV (liquid state adds shaping) silicone rubber 2g, gestodene 2g, each is an amount of for platinum catalyst and active hydrogen cross-linking agent, puts into grinding tool and is pressed into medicated layer cylindraceous by mould, external diameter 2.5mm, internal diameter 1.5mm, long 20mm.
(2) get polyethylene IUD plasticity " r " type support and put into dehydrated alcohol and soak and to drain in one hour, for subsequent use.
(3) the cylindric medicated layer that step (1) is obtained is enclosed within the trailing arm middle-end of the polyethylene IUD plasticity support that step (2) processed.
(4) intercepting external diameter 3.5mm, internal diameter 3mm, the cylindrical controlled release pipe of the polyethylene with shape memory effect of long 20mm is (available from the good plastic in Wal, Wujiang company, ProductName: the controlled release pipe is extruded in the ethylene-vinyl acetate copolymer pyrocondensation), be inserted in the medicated layer outside of the product that above-mentioned steps (3) obtains, with hot-air radiation Celsius 80 ℃ on the controlled release pipe, make it recover shape memory, closely be attached at outside the medicated layer, form the dual control medicine-releasing system of compound depot and speed release-controlled film.
Embodiment 2 contains the in utero medicine-feeder of norgestrienone
(1) with norgestrienone and medical grade LS-4100 addition-type silicon rubber 1: 1 after evenly mixing on the rubber mixing machine, put into grinding tool and be pressed into cylindric medicated layer by mould, external diameter 3mm, internal diameter 1.5mm, long 20mm.
(2) get polyethylene IUD plasticity " r " type support and put into dehydrated alcohol and soak and to drain in one hour, for subsequent use.
(3) the cylindric medicated layer that step (1) is obtained is enclosed within the trailing arm middle-end of the IUD plasticity support of processing in the step (2).
(4) intercepting external diameter 3.5mm, internal diameter 3.2mm, the cylindrical controlled release pipe of the polyethylene with shape memory effect (PE) of long 25mm is (available from the good plastic in Wal, Wujiang company, the controlled release pipe is extruded in ProductName polyethylene (PE) pyrocondensation), be inserted in the medicated layer outside of the product that above-mentioned steps (3) obtains, with hot-air radiation Celsius 105 ℃ on the controlled release pipe, make it recover shape memory, closely be attached at outside the medicated layer, form the dual control medicine-releasing system of compound depot and speed release-controlled film.
Embodiment 3 contains the in utero medicine-feeder of triketone desogestrel
(1) triketone desogestrel 2 grams and medical grade LS-4100 addition-type silicon rubber 4 are restrained after evenly mixing on the rubber mixing machine, be pressed into cylindric by mould, hot-press vulcanization becomes medicated layer, its pastille bed thickness 0.6mm, internal diameter are that 1.5mm, external diameter are 2.7mm, then deburring intercepts the cylindric medicated layer that long 1.7cm weighs 85mg.
(2) the garden tubbiness medicated layer that step (1) is obtained is placed in the upper of IUD " r " type support trailing arm.
(3) the intercepting internal diameter is that 3mm, external diameter are 3.2mm, the cylindrical controlled release pipe of the polyester with shape memory effect (PET) of long 2cm is (available from the good plastic in Wal, Wujiang company, ProductName: the controlled release pipe is extruded in polyester (PU) pyrocondensation, be inserted in the medicated layer outside of the product that above-mentioned steps (3) obtains, with hot-air radiation Celsius 100 ℃ on the controlled release pipe, make it recover shape memory, closely be attached at outside the medicated layer, form the dual control medicine-releasing system of compound depot and speed release-controlled film.
Embodiment 4
The in utero medicine-feeder that contains the gestodene
(1) take by weighing LTV (liquid state adds shaping) silicone rubber 2g, gestodene 2g, each is an amount of for platinum catalyst and active hydrogen cross-linking agent, puts into grinding tool and is pressed into medicated layer cylindraceous by mould, external diameter 2.5mm, internal diameter 1.5mm, long 20mm.
(2) get polyethylene IUD plasticity " r " type support and put into dehydrated alcohol and soak and to drain in one hour, for subsequent use.
(3) the cylindric medicated layer that step (1) is obtained is enclosed within the trailing arm middle-end of the polyethylene IUD plasticity support that step (2) processed.
(4) intercepting external diameter 3.5mm, internal diameter 3mm, the cylindrical controlled release pipe of the polyethylene with shape memory effect of long 20mm is (available from the good plastic in Wal, Wujiang company, ProductName: the controlled release pipe is extruded in the ethylene-vinyl acetate copolymer pyrocondensation, be inserted in the medicated layer outside of the product that above-mentioned steps (3) obtains, with hot-air radiation Celsius 80 ℃ on the controlled release pipe, make it recover shape memory, closely be attached at outside the medicated layer, form the dual control medicine-releasing system of compound depot and speed release-controlled film.
The comparative example 1
The in utero medicine-feeder that contains the gestodene
(1) take by weighing LTV (liquid state adds shaping) silicone rubber 2g, gestodene 2g, each is an amount of for platinum catalyst and active hydrogen cross-linking agent, puts into grinding tool and is pressed into medicated layer cylindraceous by mould, external diameter 2.5mm, internal diameter 1.5mm, long 20mm.
(2) get polyethylene IUD plasticity " r " type support and put into dehydrated alcohol and soak and to drain in one hour, for subsequent use.
(3) the cylindric medicated layer that step (1) is obtained is enclosed within the trailing arm middle-end of the polyethylene IUD plasticity support that step (2) processed.
(4) intercepting external diameter 3.5mm, internal diameter 3mm, the silicone rubber controlled release pipe of long 20mm (this making in laboratory extrude controlled release, outside the medicated layer of being inserted in the product that above-mentioned steps (3) obtains after the petroleum ether swelling, after it volatilizees.Make it recover shape memory, closely be attached at outside the medicated layer, form the dual control medicine-releasing system of compound depot and speed release-controlled film.
Dissolution test 1
To the gestodene's of embodiment 4 and comparative example 1 preparation in utero medicine-feeder extracorporeal releasing test radially.
Instrument: 1, HPLC Shimadzu LC-10AT
2, constant temperature water bath shaker
Method:
Getting one of nylon filament will be by the hanging of test sample (embodiment 4 and comparative example's 1 product) in the white wide mouthed bottle of 125ml, placing the 20ml distilled water is medium, design temperature is 37 ℃, 60 beats/mins of oscillation rate, after the continuous oscillation 24 hours, take out underproof in utero medicine-feeder.
With C-18-250mn analytical column (Shimadzu), setting HPLC testing conditions is: wavelength 240nm, sensitivity 0.01AUFS, flow velocity 1ml/ minute, sample size 25 μ l, time to peak 6.78 minutes.
Get standard substance 0.22 μ g/ml, sample introduction 25 μ l record about AREA:18152, compile ID and show to get gestodene's content among the 20ml.
Get test sample 50 μ l every day, measure its of burst size every day, draw to get external release curve, see Fig. 7.
The result shows: the pastille that makes with the inventive method is medicine-feeder in utero, has basically reached tablets in vitro curve long-term, stable state; Two kinds of different materials burst sizes differ more than 10 times, and EVA thermoplastic controlled release pipe release behavior is more stable.
Claims (10)
1. slow controlled release medicine-feeder in utero, it comprises support, medicated layer and controlled release layer, described medicated layer and controlled release layer are coated on the described support successively, the cross sectional shape of described support is T-shape or " r " type, it is characterized in that, described medicated layer is 20 by ratio of weight and number: 70-80: the methyl ethylene mixture of siloxanes of 30 medicine and medical grade consists of, described controlled release layer is made of the macromolecule memory material, and described macromolecule memory material is selected from ethylene-vinyl acetate copolymer, polyethylene or the polyester of cross-linked form.
2. slow controlled release according to claim 1 medicine-feeder in utero is characterized in that, described medicated layer is tubulose, and its internal diameter (A3-B3) is the 1-3 millimeter, and thickness (C3-D3) is the 0.2-2 millimeter, and external diameter (E3-F3) is the 2-4 millimeter.
3. the slow controlled release of human according to claim 1 medicine-feeder in utero is characterized in that, the material of described support is selected from the medical material of the composite of polypropylene, polyethylene, polyurethane, polypropylene and composite polyethylene material or rubber and plastics.
4. slow controlled release according to claim 1 and 2 medicine-feeder in utero, it is characterized in that, when described support cross sectional shape is T-shape, it comprises that a trailing arm (1a) and a transverse arm (1b) diameter are 1.2-1.7mm, length is 25-45mm, described trailing arm (1a) is cylindrical, and diameter is 1.2-2mm, highly is 25-50mm;
When described support is " r " type, it comprises a trailing arm (1a) and two forearms (1b) and (1b '), described trailing arm (1a) is cylindrical, diameter is 1.2-1.7mm, highly be 25-50mm, described forearm (1b) and (1b ') are circular arc, and diameter is 2-4mm, and length is 25-50mm.
5. slow controlled release according to claim 1 and 2 medicine-feeder in utero, it is characterized in that, by making linear ethylene-acetate ethylene copolymer, polyethylene or polyester change over network structure after the radioactive source radiation, form ethylene-vinyl acetate copolymer, polyethylene or the polyester of described cross-linked form.
6. slow controlled release according to claim 1 medicine-feeder in utero is characterized in that, the ethylene-vinyl acetate copolymer of described cross-linked form, polyethylene or polyester shrink under 80-105 ℃ heat radiation, and its radial shrinkage ratio is 50%-80%.
7. slow controlled release according to claim 1 medicine-feeder in utero, it is characterized in that, described medicine is selected from gestodene, promise medroxyprogesterone, gestrinone, triketone desogestrel, desogestrel, norgestrienone, demegestone, promegestone, dydrogesterone, trimegestone or drospirenone.
8. such as the arbitrary described slow controlled release of the claim 1-7 preparation method of medicine-feeder in utero, comprising:
The medical material that (a) will be selected from the composite of polypropylene, polyethylene, polyurethane, polypropylene and composite polyethylene material or rubber and plastics carries out mold pressing or injection moulding, obtains T-shape or " r " type support;
(b) with the methylvinyl-polysiloxane of medicine and medical grade with 20: 70-80: 30 part by weight evenly is mixed to get mixture, then puts into mould and carries out hot pressing, sulfuration, forms the tubulose medicated layer;
(c) the tubulose medicated layer that step (b) is obtained is inserted in the trailing arm middle-end of the support that step (a) obtains; Or
The mixture that (c ') obtains step (b) injects the trailing arm middle-end of support by injection molded;
(d) the cylindrical controlled release pipe that comprises the macromolecule memory material of intercepting external diameter 2-7mm, internal diameter 1-3mm, long 10-55mm, described macromolecule memory material is selected from ethylene-vinyl acetate copolymer, polyethylene or the polyester of cross-linked form;
(e) the cylindrical controlled release layer that step (d) is obtained is inserted in the product outside with medicated layer that step (c) or (c ') obtain, and hot irradiation adhere well to outside the described medicated layer described controlled release layer.
9. method according to claim 8 is characterized in that, described hot irradiation temperature is 80-105 ℃.
10. method according to claim 9, wherein said hot irradiation carries out with hot-air.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2019200694A1 (en) * | 2018-04-19 | 2019-10-24 | 易浦润（上海）生物技术有限公司 | Elastic membrane having function of reactivating endometrium basal layer in uterine cavity and preparation method for elastic membrane |
| CN110624137A (en) * | 2019-10-28 | 2019-12-31 | 易浦润（上海）生物技术有限公司 | Uterine stent |
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| WO2019200694A1 (en) * | 2018-04-19 | 2019-10-24 | 易浦润（上海）生物技术有限公司 | Elastic membrane having function of reactivating endometrium basal layer in uterine cavity and preparation method for elastic membrane |
| CN110624137A (en) * | 2019-10-28 | 2019-12-31 | 易浦润（上海）生物技术有限公司 | Uterine stent |
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| Publication number | Publication date |
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| CN103007427B (en) | 2016-01-20 |
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