CN101926783B - Drug slow control releaser and preparation method thereof - Google Patents
Drug slow control releaser and preparation method thereof Download PDFInfo
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- CN101926783B CN101926783B CN2010102682350A CN201010268235A CN101926783B CN 101926783 B CN101926783 B CN 101926783B CN 2010102682350 A CN2010102682350 A CN 2010102682350A CN 201010268235 A CN201010268235 A CN 201010268235A CN 101926783 B CN101926783 B CN 101926783B
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Abstract
The invention discloses a drug slow control releaser which comprises a drug controlled-release membrane, wherein a base material of the drug controlled-release membrane is a pharmaceutically acceptable first type polymer material, the drug controlled-release membrane comprises porogen molecules dispersed in the first type polymer material, the drug controlled-release membrane is a drug controlled-release capsule which can form a pore structure on the wall in vivo, and a drug-containing core containing a pharmaceutical effective dose of drug which can be uniformly distributed in a pharmaceutically acceptable second type polymer material and carry out drug administration in vivo is closed in the drug controlled-release capsule. The drug controlled-release membrane has good permeability, and the solid drug-containing core can be quickly and quantitatively placed into the hollow capsule prepared by the release membrane. Tissue fluid can enter into the drug slow control releaser after the drug slow control releaser is implanted into an organism, thereby leading the drug in the drug core to dissolve out rapidly, controlling the release speed of the drug by the drug controlled-release membrane, leading the drug to be released slowly for a long time and absorbed by the organism, and achieving the purpose of long-term drug delivery.
Description
Technical field
The present invention relates to a kind of drug slow control releaser and method for preparing, more particularly, the present invention relates to medicine is packed into the polymeric material is in the capsule pipe of base material, obtains drug slow control releaser.
Background technology
The treatment of some diseases needs long-term low dose of administration, therefore needs single administration and the long-term treatment preparation that keeps of effect.In addition, in order to reach the purpose of long-term antifertility, also need long lasting contraceptive medicament preparation.At present, for small-sized, hypomegetic medicine bag, not only manual being difficult to the medicated powder medicine bag of directly packing into fast, quantitatively, the existing mechanical loading method can't solve also that compact capsule is quantitatively canned, the problem of sealing medicated powder.
Summary of the invention
To above-mentioned prior art; The present invention provides a kind of drug slow control releaser; Can solve in the capsule of small-sized, microminiature drug slow control releaser fast, accurately, the technical problem of quantitatively canned and sealing medicine; Adopt the release-controlling medicinal capsule that is dispersed with the porogen molecule in the cyst wall simultaneously, can not influence the slow sustained release of medicine.
In order to solve the problems of the technologies described above; The technical scheme that drug slow control releaser of the present invention is achieved is: comprise pharmaceutical controlled-release membrane; Said pharmaceutical controlled-release membrane has permeability to moisture, medicine; The base material of said pharmaceutical controlled-release membrane is pharmaceutically acceptable first kind of polymeric material; Said pharmaceutical controlled-release membrane comprises the porogen molecule that is dispersed in said first kind of polymeric material; This pharmaceutical controlled-release membrane be for can forming the release-controlling medicinal capsule of pore structure on the wall in vivo, but said release-controlling medicinal capsule inner sealing has the drug-containing core of the medicine that contains the subcutaneous administration that is distributed in the pharmaceutically effective dose in pharmaceutically acceptable second kind of polymeric material equably or intrauterine administration.
Drug slow control releaser of the present invention; Wherein, said first kind of polymeric material and said second kind of polymeric material are any in polylactic acid, polylactide, polylactic acid-hydroxide acetic acid, polylactide Acetic acid, hydroxy-, bimol. cyclic ester, polycaprolactone, poly hydroxybutyric acid, polyurethane and the silicone rubber; Said first kind of polymeric material can be identical or different with said second kind of polymeric material.The shape of said release-controlling medicinal capsule be tubulose, lamellar and spherical in any be suitable for the shape of subcutaneous heeling-in in human body or the animal body.Said medicine is a contraceptive, or acts on immune medicine, or acts on the medicine of neuroendocrine system.Said contraceptive is a levonorgestrel.The effective dose pharmaceutically of said medicine be said drug-containing core weight 50% to 80%.The length of said release-controlling medicinal capsule is that 1cm to 3cm, its internal diameter are that 1-2.5mm, wall thickness are 0.1-0.3mm; The length of said drug-containing core is 1cm to 3cm, and the diameter of cross section is 1-3mm.
The method for preparing the said medicine slow control releaser; Comprise: (1) prepares said drug-containing core; Select one of following dual mode for use: getting and accounting for the drug-containing core gross weight is that 50% to 80% medicine and surplus are second kind of polymeric material; After the fusion method mixing, in mould, be pressed into the uniform solid drug-containing core of character; Or getting and accounting for the drug-containing core gross weight is that 50% to 80% medicine and surplus are second kind of polymeric material, and after mixing through solvent method, spray-dried method or solvent evaporated method form granule, in mould, are pressed into the uniform solid drug-containing core of character; (2) said pharmaceutical controlled-release membrane is processed into hollow capsule pipe; Length cutting capsule pipe according to drug-containing core; End sealing with the capsule pipe; (3) insert said drug-containing core in the said capsule pipe and seal described capsule Guan Weiyi capsule, promptly be assembled into described drug slow control releaser; Above-mentioned steps (1), step (2) and step (3) are consecutive steps or are respectively independent step.
Compared with prior art, the invention has the beneficial effects as follows:
The medicine of the effective dose in the Chinese medicine slow control releaser of the present invention is to form solid drug-containing core in the polymeric material by being evenly distributed in; The effect of medicated core is in order to make the medicine molding; Be convenient to incapsulate, the contained medicine of medicated core runs into and gets into capsular moisture and should dissolve as early as possible and discharge, and is convenient to further be discharged into outside the capsule; The effect of pharmaceutical controlled-release membrane is restriction, control drug release speed, reaches the purpose of slow release medicine.Can solve in the shell of small-sized, microminiature drug slow control releaser fast, accurately, the technical problem of canned and sealing medicine quantitatively; Simultaneously; Because the shell of releaser adopts the release-controlling medicinal capsule that is dispersed with the porogen molecule in the cyst wall, can not influence the slow sustained release of medicine.
Description of drawings
Fig. 1-the 1st, the capsular simplified schematic diagram of drug slow control releaser hollow core of the present invention;
Fig. 1-2 is the simplified schematic diagram of drug-containing core in the drug slow control releaser of the present invention;
Fig. 1-the 3rd, the simplified schematic diagram of drug slow control releaser of the present invention;
Fig. 2 is the curve of the constant drug releasing rate of drug slow control releaser of the present invention.
Among the figure: 1---drug-containing core, 2---release-controlling medicinal capsule, 3---the pore molecule, 4---hole, 5---Capsules.
The specific embodiment
Below in conjunction with the accompanying drawing and the specific embodiment the present invention is done to describe in further detail.
Shown in Fig. 1-1, Fig. 1-2 and Fig. 1-3; Drug slow control releaser of the present invention comprises pharmaceutical controlled-release membrane; The base material of said pharmaceutical controlled-release membrane is pharmaceutically acceptable first kind of polymeric material; Said pharmaceutical controlled-release membrane comprises the porogen molecule 3 that is dispersed in said first kind of polymeric material; This pharmaceutical controlled-release membrane be for can forming the release-controlling medicinal capsule 2 of pore structure on the wall in vivo, but said release-controlling medicinal capsule 2 inner sealings have the drug-containing core 1 of the medicine that contains the subcutaneous administration that is distributed in the pharmaceutically effective dose in pharmaceutically acceptable second kind of polymeric material equably or intrauterine administration.
Drug slow control releaser of the present invention; Wherein, said first kind of polymeric material and said second kind of polymeric material are any in polylactic acid, polylactide, polylactic acid-hydroxide acetic acid, polylactide Acetic acid, hydroxy-, bimol. cyclic ester, polycaprolactone, poly hydroxybutyric acid, polyurethane and the silicone rubber; Said first kind of polymeric material can be identical or different with said second kind of polymeric material, particularly preferably is polycaprolactone and polyurethane, silicone rubber, and they are easy to process film forming, and drug permeability is good.Polycaprolactone can slowly be degraded in vivo, prepares drug slow control releaser with it, can keep in vivo more than 2 years, and after drug release finishes, can be voluntarily by body degraded, absorption, the taking-up of need not performing the operation.Polyurethane, silicone rubber are non-degradable material, can keep in vivo more than 5 years, and it is long to keep pharmaceutical release time, but after drug release finishes, can not degraded, absorb by body, need operation to take out.
The shape of said release-controlling medicinal capsule 2 be tubulose, lamellar and spherical in any be suitable for the shape of subcutaneous heeling-in in human body or the animal body, such as cylinder, annular solid, spheroid etc.The length of said release-controlling medicinal capsule 2 is that 1cm to 3cm, its internal diameter are 1 to 2.5mm, wall thickness is 0.1 to 0.3mm; The length of said drug-containing core is 1cm to 3cm, and the diameter of cross section is 1 to 2mm.
Said medicine is a contraceptive, or acts on immune medicine, or acts on the medicine of neuroendocrine system.Said contraceptive is a levonorgestrel etc.The effective dose pharmaceutically of said medicine be said drug-containing core weight 50% to 80%.But among the present invention indication pharmaceutically the implication of the medicine of the subcutaneous administration of effective dose be: discharge dose every day and should reach effective dose, for example levonorgestrel should discharge 46 micrograms in subcutaneous every day, just can reach the effect of contraception.Pharmaceutically but the implication of the medicine of the intrauterine administration of effective dose is: discharge dose every day and should reach effective dose, for example levonorgestrel should discharge the 15-20 microgram in uterus every day, just can reach the effect of contraception.
Prepare the method for said medicine slow control releaser, comprising:
(1) prepares said drug-containing core; Select one of following dual mode for use: getting and accounting for the drug-containing core gross weight is that 50% to 80% medicine and surplus are second kind of polymeric material; After mixing through fusion method, be processed into needed solid shape such as the uniform cylinder of character, annular solid, spheroid with the thermoforming process of thermoplastic well known in the prior art.Or,
Getting and accounting for the drug-containing core gross weight is that 50% to 80% medicine and surplus are second kind of polymeric material; After the solvent method mixing; Spray-dried or solvent evaporated method forms medicine and the blended granule of carrier material; Thermoforming process with thermoplastic well known in the prior art is processed into needed solid shape such as cylinder, annular solid, spheroid, and Fig. 1-2 shows cylindrical drug-containing core.
(2) said pharmaceutical controlled-release membrane is processed into Capsules 5, shown in Fig. 1-1; Length cutting capsule 5 according to drug-containing core; End sealing with capsule 5;
(3) said drug-containing core 2 being inserted in the said capsule 5 and seals described capsule 5 is a capsule 2, is assembled into described drug slow control releaser, shown in Fig. 1-3; Above-mentioned steps (1), step (2) and step (3) are consecutive steps or are respectively independent step.
After drug slow control releaser was implanted in the body, the porogen molecule 3 on the capsule wall can be overflowed from first kind of polymeric material, and on the origin-location of cyst wall, formed hole 4; Shown in Fig. 1-3; Tissue fluid can get into drug slow control releaser through the numerous holes on the capsule 24, and with the quick stripping of the medicine in the medicated core, the rate of release of medicine is controlled by pharmaceutical controlled-release membrane; Making that medicine is long-term slowly discharges and is absorbed by body, reaches the purpose of long term administration.
But among the present invention indication pharmaceutically the implication of the medicine of the subcutaneous administration of effective dose be: discharge dose every day and should reach effective dose, for example levonorgestrel should discharge 46 micrograms in subcutaneous every day, just can reach the effect of contraception.If 1 levonorgestrel slow release body underdosage can heeling-in 2.
Pharmaceutically but the implication of the medicine of the intrauterine administration of effective dose is: discharge dose every day and should reach effective dose, for example levonorgestrel should discharge the 15-20 microgram in uterus every day, just can reach the effect of contraception.
Embodiment 1: prepare the drug release body that contains levonorgestrel (LNG) with polycaprolactone capsule pipe
The preferred embodiment of drug-containing core is among the present invention; Said drug-containing core is to be made up of the levonorgestrel that is distributed in equably in polycaprolactone; Wherein: said levonorgestrel account for said drug-containing core weight 65%, promptly get the levonorgestrel of 400g and the polycaprolactone of 200g.
Certainly; The content of component can also be in the drug-containing core: said levonorgestrel account for said drug-containing core gross weight 70%; Or 75%; Or 80%, surplus is as in polylactic acid, polylactide, polylactic acid-hydroxide acetic acid, polylactide Acetic acid, hydroxy-, bimol. cyclic ester, polycaprolactone, poly hydroxybutyric acid, polyurethane and the silicone rubber in second kind of polymeric material of drug-containing core carrier any.Thereby, can assembly go out to contain the drug-containing core that levonorgestrel (medicine) and above-mentioned various polymerization material are formed.
The size that is applicable to the cylindrical drug-containing core of human body intrauterine heeling-in is length 2cm, the cylinder drug-containing core of the diameter 2mm of its cross section.
Levonorgestrel (LNG) is provided by Zizhu Pharmaceutical Co., Ltd., Beijing; It is 99100283.0 that the method for preparing of polycaprolactone capsule pipe can adopt the patent No.; Name is called disclosed technical scheme in " release-controlling medicinal capsule that can form hole on the wall in vivo ", repeats no more at this.Can make internal diameter according to this technical scheme is that 2.5mm, wall thickness are the polycaprolactone capsule 5 of 0.15mm.
Preparation drug-containing core: 400 milligrams of levonorgestrels are dissolved in 15 milliliters of dichloromethane process the levonorgestrel dichloromethane solution; 200 milligrams of polycaprolactones are dissolved in 15 milliliters of dichloromethane and process the polycaprolactone dichloromethane solution.The levonorgestrel dichloromethane solution is mixed with the polycaprolactone dichloromethane solution, form levonorgestrel-polycaprolactone dichloromethane solution.Levonorgestrel-polycaprolactone dichloromethane solution impouring does not adhere to gathering in the tetrafluoro mould of any material, behind the volatilization dichloromethane, in mould, forms the medicine film of levonorgestrel and polycaprolactone mix homogeneously; From mould, take out the medicine film; Shred and form tiny sheet material, sheet material is put into cylindrical die, pressurization, heating and melting; Cooling back shape is grown into 2 centimetres, the cylindrical drug-containing core that diameter is 2 millimeters.The drug-containing core that above-mentioned employing solvent technology makes is easy to put into fast, quantitatively the hollow capsule of being processed by the medicine controlled releasing release film.
Above-mentioned polycaprolactone capsule 5 one ends are added heat-seal, and the other end inserts above-mentioned drug-containing core, and heated sealant is processed the cylindrical drug release body that contains levonorgestrel (LNG) then.
Above-mentioned drug-containing core method for preparing is applicable to laboratory sample preparation in a small amount.Above-mentioned levonorgestrel-polycaprolactone dichloromethane solution can prepare levonorgestrel-polycaprolactone granule in enormous quantities through spray drying or solvent evaporated method process, and then is processed into needed solid shape through the thermoforming process of known thermoplastic.
Medicine sustained release body of the present invention can be through in the conventional means implant into body.
Embodiment 2: the vitro drug release to the drug release body that contains levonorgestrel (LNG) carries out is tested
The drug release body that contains levonorgestrel (LNG) that makes among the embodiment 1 is put into the 100ml distilled water, in 37 ± 2 ℃ constant temperature shaking table, keep 130 rev/mins agitation speed, change release liquid at regular intervals.Measure the levonorgestrel concentration that discharges in the liquid with HPLC, it is said that the chromatographic determination condition is pressed document, can calculate average drug releasing rate every day according to measuring the result.The drug-containing core that makes among the embodiment 1 calculates average drug releasing rate every day as contrast with quadrat method mensuration.
As shown in Figure 2, said drug-containing core discharged medicine speed at external preceding 6 days and forms a peak, and rate of release increases gradually subsequently.Said drug release body reaches certain level at external preceding 3 days drug releasing rates, and drug release is kept constant rate of release basically and can be kept more than 6 months subsequently.
As stated, medicine is processed drug-containing core makes medicine put into medicine bag more easily than powder, and the medicine in the drug-containing core is easy to discharge; Controlled release membrane of medicament has played the effect of constant drug releasing rate.
Utilize drug slow control releaser of the present invention can be used in the long-acting antifertility drug intrauterine device of preparation,, therefore, do not receive the restriction of intrauterine device structure basically because the overall dimensions of drug slow control releaser of the present invention is less.
Although invention has been described for top combination figure; But the present invention is not limited to the above-mentioned specific embodiment, and the above-mentioned specific embodiment only is schematically, rather than restrictive; Those of ordinary skill in the art is under enlightenment of the present invention; Under the situation that does not break away from aim of the present invention, can also make a lot of distortion, these all belong within the protection of the present invention.
Claims (6)
1. drug slow control releaser; Comprise pharmaceutical controlled-release membrane; Said pharmaceutical controlled-release membrane has permeability to moisture, medicine; It is characterized in that: the base material of said pharmaceutical controlled-release membrane is a polycaprolactone, and said pharmaceutical controlled-release membrane comprises the porogen molecule that is dispersed in the said base material, and this pharmaceutical controlled-release membrane is for can form the release-controlling medicinal capsule of pore structure on the wall in vivo; Said release-controlling medicinal capsule is the polycaprolactone capsule, but said polycaprolactone capsule inner sealing has the drug-containing core of the levonorgestrel that contains the intrauterine administration that is distributed in the pharmaceutically effective dose in pharmaceutically acceptable polymeric material equably; Said polymeric material is any in polylactic acid, polylactide, polylactic acid-hydroxide acetic acid, polylactide Acetic acid, hydroxy-, bimol. cyclic ester, polycaprolactone, poly hydroxybutyric acid, polyurethane and the silicone rubber; The effective dose pharmaceutically of said levonorgestrel be said drug-containing core weight 50% to 80%.
2. according to the said drug slow control releaser of claim 1, wherein, the shape of said release-controlling medicinal capsule be tubulose, lamellar and spherical in any be suitable for the shape of human body or animal in-vivo embed.
3. according to the said drug slow control releaser of claim 1, wherein, the length of said release-controlling medicinal capsule is that 1cm to 3cm, its internal diameter are that 1-2.5mm, wall thickness are 0.1-0.3mm.
4. according to the said drug slow control releaser of claim 1, wherein, the length of said drug-containing core is 1cm to 3cm, and the diameter of cross section is 1-2mm.
5. one kind prepares the method for drug slow control releaser according to claim 1, it is characterized in that, comprising:
(1) prepare said drug-containing core, select one of following dual mode for use:
Getting and accounting for the drug-containing core gross weight is that 50% to 80% levonorgestrel and surplus are any polymeric material that is selected from polylactic acid, polylactide, polylactic acid-hydroxide acetic acid, polylactide Acetic acid, hydroxy-, bimol. cyclic ester, polycaprolactone, poly hydroxybutyric acid, polyurethane and the silicone rubber; After the fusion method mixing, in mould, be pressed into the uniform solid drug-containing core of character;
Getting and accounting for the drug-containing core gross weight is that 50% to 80% medicine and surplus are any polymeric material that is selected from polylactic acid, polylactide, polylactic acid-hydroxide acetic acid, polylactide Acetic acid, hydroxy-, bimol. cyclic ester, polycaprolactone, poly hydroxybutyric acid, polyurethane and the silicone rubber; After the solvent method mixing; Spray drying or solvent evaporated method form granule, in mould, are pressed into the uniform solid drug-containing core of character;
(2) said pharmaceutical controlled-release membrane is processed into hollow capsule pipe; Length cutting capsule pipe according to drug-containing core; End sealing with the capsule pipe;
(3) insert said drug-containing core in the said capsule pipe and seal described capsule Guan Weiyi capsule, promptly be assembled into described drug slow control releaser;
Above-mentioned steps (1), step (2) and step (3) are consecutive steps or are respectively independent step.
6. according to the method for preparing of the said drug slow control releaser of claim 5, wherein, said drug-containing core is long 2cm, the cylinder of diameter 2mm; Said capsular length is that 2.5cm, internal diameter are that 2.5mm, wall thickness are 0.15mm.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2010102682350A CN101926783B (en) | 2010-08-31 | 2010-08-31 | Drug slow control releaser and preparation method thereof |
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| CN2010102682350A CN101926783B (en) | 2010-08-31 | 2010-08-31 | Drug slow control releaser and preparation method thereof |
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| CN101926783A CN101926783A (en) | 2010-12-29 |
| CN101926783B true CN101926783B (en) | 2012-07-11 |
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| CN102743329B (en) * | 2012-04-26 | 2014-05-14 | 辽宁省计划生育科学研究院 | Intrauterine sustained control release drug delivery system and preparation method thereof |
| CN102743328B (en) * | 2012-04-26 | 2014-09-24 | 辽宁省计划生育科学研究院 | Intrauterine sustained control release drug delivery system adopting biodegradation material, and preparation method thereof |
| CN104001260A (en) * | 2014-06-10 | 2014-08-27 | 中国医学科学院生物医学工程研究所 | Intrauterine drug releaser capable of improving release speed of drug |
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| CN1101185C (en) * | 1999-01-28 | 2003-02-12 | 中国医学科学院生物医学工程研究所 | Release-controlling medicinal capsule able to form on-wall porous structure in body |
| CN1864689A (en) * | 2005-05-20 | 2006-11-22 | 中国医学科学院生物医学工程研究所 | Subcutaneous implant of mifespristone and use thereof in treatment of endometriosis |
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