CN110856691A - Implant diolame device - Google Patents

Implant diolame device Download PDF

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Publication number
CN110856691A
CN110856691A CN201810963227.4A CN201810963227A CN110856691A CN 110856691 A CN110856691 A CN 110856691A CN 201810963227 A CN201810963227 A CN 201810963227A CN 110856691 A CN110856691 A CN 110856691A
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China
Prior art keywords
tablet
pipeline
implant
push rod
coating
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CN201810963227.4A
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CN110856691B (en
Inventor
尹述贵
王实强
贾少微
张涛
刘庆哲
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Shenzhen Good Health Health Industry Co Ltd
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Shenzhen Good Health Health Industry Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/005Coating of tablets or the like

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention provides an implant film-coating device, which comprises a film arranging machine, a film pushing machine, a film coating pool, a tablet pipeline, a tablet conveying device, a collecting device and an automatic control device, wherein the film pushing machine is arranged on the film arranging machine; the film arranging machine is connected with the film pushing machine, and the film coating pool is arc-shaped; the coating pool is filled with a coating liquid; the entrance of tablet pipeline with the tablet pusher is connected, the export of tablet pipeline with collection device connects, tablet conveyor is used for carrying the implant tablet in the tablet pipeline, collection device is connected with automatic control device, and automatic control device is used for controlling collection device horizontal migration. The implant enveloping device provided by the invention is simple in structure and convenient to operate, and is suitable for large-scale production.

Description

Implant diolame device
Technical Field
The invention relates to a medicine coating device, in particular to an implant coating device.
Background
In the research of sustained release implant, the selection of biodegradable material is crucial, polylactic acid is a polymer with excellent biocompatibility and degradability, the final product of in vivo metabolism is water and carbon dioxide, the intermediate product lactic acid is also the normal sugar metabolite in vivo, can not be accumulated in organs any more, and is a medical adjuvant approved by FDA. In order to ensure the compatibility of the medicine, the implant coating is prepared by adopting the material which is the same as or similar to the sustained-release matrix as far as possible, but the viscosity of the polylactic acid is very high, the coated implants are mutually adhered, the coating yield is damaged, and the coating operation is not suitable. For example, chinese patent CN200610152903.7 discloses a long-acting sustained release preparation of naltrexone, which uses polylactic acid to coat naltrexone microspheres, and chinese patent CN201110457641.6 discloses a long-acting naltrexone implant, which also uses DL-polylactic acid to coat the compressed naltrexone microspheres. However, as mentioned above, the polylactic acid has too high viscosity, and the coated microspheres or tablets may be adhered to and broken by the surface of the coating film when they are placed on a tray during approaching or drying, which may affect the release stability of the drug.
The current research and published literature technologies are laboratory-level preparation processes, and large-scale production cannot be carried out, wherein a plurality of influence factors and obtained conditions for investigation and screening cannot be applied to large-scale production, because the active ingredients wrapped by the microspheres are different, the modes of adding the internal phase emulsion into the external phase solution are different, the components of the solutions are different, the optimal preparation process conditions are changed difficultly to be predicted due to the fact that the adopted specific auxiliary materials are different in components, and research needs to be carried out again to obtain the sustained-release microspheres with ideal sustained-release effect and treatment effect.
The Chinese invention patent (a slow release fertilizer coating device: 201810333180.3) discloses a slow release fertilizer coating device, which comprises a supporting device and a coating mechanism arranged on the supporting device; the film coating mechanism comprises a film coating cylinder and a feeding hopper fixed at the upper end of the film coating cylinder; a screen is fixed on the inner surface of the peripheral side of the coating cylinder, and a discharge notch is formed at the joint of the screen and the side wall of the coating cylinder; the surface of the side wall of the coating cylinder is provided with a circular through hole matched with the liquid spraying pipe, and the liquid spraying pipe penetrates through the side wall of the coating cylinder through the circular through hole; and a heating pipe is fixed on the inner surface of the peripheral side of the coating cylinder. Although the coating device of the patent is simple, the coating device of the patent uses a liquid spraying pipe for coating, the incomplete coating and the uneven coating are caused, and the coated slow release fertilizer has thick bags, thin bags and poor uniformity, so that the slow release performance is uneven, and the cost is increased.
In the prior art, there is also a technique for coating by spraying a coating solution, for example, chinese patent document CN107638295A discloses a fluidized bed bottom-spraying coating device, in which particles move spirally in a guide cylinder and are coated by spraying a coating solution. However, this method is not suitable for coating materials having high viscosity such as polylactic acid.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides the implant coating device which is simple in structure and convenient to operate, and avoids the problem that the prior art can only carry out coating preparation of the implant in a laboratory and cannot carry out large-scale production.
In order to solve the technical problem, the invention adopts the technical scheme that the implant film coating device comprises a film arranging machine, a film pushing machine, a film coating pool, a tablet pipeline, a tablet conveying device, a collecting device and an automatic control system; the film arranging machine is connected with the film pushing machine, and the film coating pool is arc-shaped; the coating pool is filled with a coating liquid; the inlet of the tablet pipeline is connected with the tablet pushing machine, the outlet of the tablet pipeline is connected with the collecting device, the tablet conveying device is used for conveying the implant tablets in the tablet pipeline, and the collecting device is a special vessel which is highly anti-sticking.
Preferably, the collecting device is made of stainless steel with teflon (polytetrafluoroethylene) attached to the surface, the collecting device is a flat plate placed horizontally, and the collecting device is connected with an automatic control device which is used for controlling the collecting device to move on the horizontal plane.
Preferably, the tablet conduits include a first tablet conduit, a second tablet conduit, a third tablet conduit; the first tablet pipeline, the second tablet pipeline and the third tablet pipeline are all hard pipes, the hard pipes are made of stainless steel pipes, the first tablet pipeline, the second tablet pipeline and the third tablet pipeline are of an integrated structure, and the first tablet pipeline, the second tablet pipeline and the third tablet pipeline are sequentially connected;
the inlet of the first tablet pipeline is connected with the tablet pushing machine, and the outlet of the third tablet pipeline extends into the collecting device.
Preferably, the first tablet pipelines are arranged in parallel, the inlet of each first tablet pipeline is connected with the tablet pushing machine, and the outlet of each first tablet pipeline is connected with the inlet of each second tablet pipeline; the second tablet pipeline is arc-shaped and is attached to the inside of the film coating pool, and the third tablet pipeline is obliquely arranged.
Preferably, the third tablet conduit is arranged at an angle of 10-15 °.
Preferably, the bottom end of the second tablet pipeline is attached to the inner side of the coating pool, and the second tablet pipeline is soaked in the coating liquid.
Preferably, the second tablet conduit is provided with meshes, and the density of the meshes is at least 100/30 cm; the diameter of the mesh is 2 mm.
Preferably, the pipe diameter of the second tablet pipeline is gradually reduced from the inlet to the outlet, the pipe diameter inlet of the second tablet pipeline is 0.5-1.5mm larger than the pipe diameter inlet of the second tablet pipeline, and the pipe diameter of the outlet of the second tablet pipeline is 1.5-2mm larger than the diameter of the implant tablet.
Preferably, the second tablet conduit and the third tablet conduit are respectively provided with a first push rod track and a second push rod track; the first push rod track and the second push rod track are both openings with the width of 2 mm.
The tablet conveying device comprises a first driving device, a rotating push rod, a second driving device and a translation push rod, and the first driving device is arranged at the position of the circle center of the coating pool; a second driving device is arranged at the upper end of the third tablet pipeline; the first driving device and the second driving device are both electrically connected with the automatic control device;
one end of the rotary push rod is connected with the first driving device, and the other end of the rotary push rod extends into the second tablet pipeline through the first push rod track;
one end of the translation push rod is connected with the second driving device, and the other end of the translation push rod extends into the third tablet pipeline through the second push rod rail.
Preferably, the rotating push rod and the translation push rod are both made of steel materials with Teflon attached to the outer sides, and the diameters of the rotating push rod and the translation push rod are both 1.5 mm.
Preferably, the coating solution is a PLA solution, and the concentration of the PLA solution is 5-9%.
Preferably, the time for the implant tablet to pass through the coating solution in the second tablet channel is 15-40 s;
the temperature of the coating liquid in the coating process is controlled to be 33-40 ℃.
The invention provides a treatment process of an implant in an implant enveloping device, which comprises the following steps: the tablet discharging machine discharges the implant tablets into the tablet pushing machine, the tablet pushing machine pushes the implant tablets into the tablet pipeline, the implant tablets enter the second tablet pipeline along the first tablet pipeline, the time of the implant tablets in the second tablet pipeline is controlled to be 15-50 s, preferably 30s, through the first driving device and the rotary push rod, and the temperature of the coating process is controlled to be 33-40 ℃, preferably 37 ℃; after the coating in the second tablet pipeline is finished, the third tablet pipeline is entered, and the implant tablets are pushed into the collecting device through the second driving device and the translation push rod to be collected.
Compared with the prior art, the invention has the following beneficial effects:
(1) according to the invention, PLA with high viscosity can be uniformly wrapped on the surface of the implant through a special coating device, so that the problem of incomplete coating caused by mutual adhesion is effectively avoided, and the problem of incomplete coating when PLA is used as a coating liquid in the prior art is solved.
(2) The diameters of the tablet pipeline (particularly the second tablet pipeline) and the implant tablet in the coating device are important, the difference between the diameter of the outlet of the second tablet pipeline and the diameter of the implant tablet provided by the invention is 1.5-2mm, the consistency of the coating thickness of the implant tablet can be effectively ensured, and the problem of uneven coating quality is avoided.
(3) The invention provides the coating device for the implant for the first time, which has the advantages of simple structure and convenient operation, and avoids the problem that the prior art can only carry out coating preparation on the implant in a laboratory and cannot carry out large-scale production.
(4) The pipe diameter of the second tablet pipeline provided by the invention is gradually reduced from the inlet to the outlet, so that the integrity of the envelope is ensured, and the thickness of the implant tablet can be uniform.
(5) The integrity, uniformity, thickness and coating speed of the coating device provided by the invention are related to the aperture of the second tablet pipeline, the concentration of the coating liquid and the elapsed time in the coating liquid, and the three are affected together, so that the coating is prevented from being too slow, and the coating liquid is easy to permeate inwards to damage the microspheres and the framework;
(6) the coating device for the implant provided by the invention can realize one coating, one coating and no adhesion, control temperature and control temperature, ensures that the coating difference of each implant tablet is very small, and the release degree difference of each tablet is less than 3% in a release degree test.
(7) The first driving device and the rotary push rod provided by the invention can control the soaking and enveloping time of each implant tablet in the enveloping solution, so as to control the enveloping thickness of each tablet, and when the time of the implant tablet passing through the enveloping solution is 30s, the enveloping thickness is proper and the integrity is good.
(8) The collecting device in the coating device provided by the invention is a high-adhesion-resistant vessel, is made of steel with Teflon attached to the surface, can move, and can prevent falling implant tablets from repeatedly falling into a space position and being stuck together.
Drawings
FIG. 1 is a schematic structural view of an encapsulation device for an implant according to the present invention;
the specific meanings of the symbols in the drawings are as follows:
1: arranging a sheet machine; 2: pushing the sheet machine; 3: a coating pool; 4: coating liquid; 5: a collection device; 6: a first tablet conduit; 7: a second tablet conduit; 8: a third tablet conduit; 9: a first driving device; 10: a second driving device; 11: rotating the push rod; 12: the push rod is translated.
Detailed Description
The following detailed description of embodiments of the invention refers to the accompanying drawings.
Referring to fig. 1, fig. 1 is a schematic structural view of an encapsulation device for an implant according to the present invention.
An implant coating device comprises a tablet arranging machine 1, a tablet pushing machine 2, a coating pool 3, a tablet pipeline, a tablet conveying device, a collecting device 5 and an automatic control system; the film arranging machine 1 is connected with a film pushing machine 2, the film pushing machine 2 is positioned at one end of a film coating pool 3, and the film coating pool 3 is arc-shaped; coating liquid 4 is filled in the coating pool 3; the inlet of the tablet pipeline is connected with the tablet pushing machine 2, the outlet of the tablet pipeline is connected with the collecting device 5, and the tablet conveying device is used for conveying the implant tablets in the tablet pipeline.
The collecting device 5 provided by the invention is a flat plate which is horizontally placed, the collecting device 5 is connected with an automatic control device, the automatic control device is used for controlling the collecting device to horizontally move, the collecting device 5 is made of stainless steel materials with Teflon attached on the surface, and the collecting device 5 is movable and highly anti-sticking, so that falling implant tablets can be prevented from repeatedly falling to a spatial position, and the implant tablets are prevented from being stuck together.
The implant film-coating device provided by the invention also comprises a micro motor, the film pushing machine 2 is electrically connected with the micro motor, a pushing piece is arranged in the film pushing machine 2 and is electrically connected with the automatic control device, and the automatic control device is used for controlling the micro motor to drive the pushing piece to push the implant tablet to move.
The tablet tube provided in the present invention includes a first tablet tube 6, a second tablet tube 7, and a third tablet tube 8; the first tablet pipeline 6, the second tablet pipeline 7 and the third tablet pipeline 8 are all hard pipes made of stainless steel, the first tablet pipeline 6, the second tablet pipeline 7 and the third tablet pipeline 8 are of an integrated structure, and the first tablet pipeline 6, the second tablet pipeline 7 and the third tablet pipeline 8 are sequentially connected; the inlet of the first tablet conduit 6 is connected to the tablet pusher 2 and the outlet of the third tablet conduit 8 is connected to the collecting device 5. The third tablet conduit is inclined at an angle of 8 degrees, which is 10-15 degrees.
The first tablet pipeline 6 is arranged in parallel, the inlet of the first tablet pipeline 6 is connected with the tablet pushing machine, and the outlet of the first tablet pipeline 6 is connected with the inlet of the second tablet pipeline 7; the second tablet pipeline 7 is arranged in an arc shape, is attached to the coating tank 3, and the third tablet pipeline 8 is obliquely arranged.
The bottom end of the second tablet pipeline 7 provided by the invention is attached to the inner side of the coating tank 3, and the second tablet pipeline 7 is soaked in the coating liquid 4. The length of the second tablet pipeline 7 provided by the invention is 30cm, the second tablet pipeline 7 is provided with dense meshes, and the density of the meshes is at least 100/30 cm; the diameter of the mesh is 2 mm.
The pipe diameter of the second tablet pipeline 7 is gradually smaller from the inlet to the outlet, and the difference between the pipe diameter of the outlet of the second tablet pipeline 7 and the diameter of the implant tablet is 1.5-2 mm. When the pipe diameter inlet of the second tablet pipeline 7 is 0.9mm larger than the outlet, and the pipe diameter outlet of the second tablet pipeline 7 is 1.5mm larger than the diameter of the implant tablet, the thickness and the integrity of the coating film are better.
The second tablet pipeline 7 and the third tablet pipeline 8 provided by the invention are respectively provided with a first push rod track and a second push rod track; first push rod track and 11 looks adaptations of rotatory push rod, first push rod track are the opening that the width is 2mm, and rotatory push rod 11 diameter is 1.5mm, and second push rod track and translation push rod 12 looks adaptations, second push rod track are the opening that the width is 2mm, and translation push rod 12 diameter is 1.5 mm.
The tablet conveying device provided by the invention comprises a first driving device 9, a rotating push rod 11, a second driving device 10 and a translation push rod 12, wherein the first driving device 9 is arranged at the position of the circle center of the coating tank 3; the upper end of the third tablet pipeline 7 is provided with a second driving device 10; the first driving device 9 and the second driving device 10 are both electrically connected with the automatic control device;
one end of a rotary push rod 11 is connected with the first driving device 9, and the other end of the rotary push rod extends into the second tablet pipeline 7 through a first push rod track; one end of the translational push rod 12 is connected with the second driving device 10, and the other end thereof extends into the third tablet track 8 through the second push rod track. The rotating push rod 11 and the translation push rod 12 are both made of steel materials with teflon attached to the outer sides, wherein teflon is actually made of polytetrafluoroethylene.
The coating liquid 4 provided by the invention is a PLA solution, the molecular weight of PLA (polylactic acid) in the coating liquid 4 is 5-7 ten thousand, and the concentration of the PLA solution is 5-9%.
EXAMPLE 1 naltrexone implant encapsulation procedure
(1) Dissolving polylactic acid with the molecular weight of 6 ten thousand in dichloromethane to form 6% of coating liquid, and placing the coating liquid in a coating pool for later use;
(2) and pushing the naltrexone implant tablet into the first tablet pipeline through the tablet pushing machine, then entering the second tablet pipeline, and moving the implant tablet from the inlet to the outlet of the second tablet pipeline through the first driving device to carry out capsule coating, wherein the capsule coating time is 30s, and the temperature is 37 ℃.
Wherein the mesh density on the second tablet pipeline is 100/30 cm; the diameter of the mesh is 2mm, the diameter of the inlet of the second tablet pipeline is 0.9mm larger than that of the outlet of the second tablet pipeline, and the diameter of the outlet of the second tablet pipeline is 1.5mm larger than that of the naltrexone implant tablet.
The naltrexone implant tablet obtained by the coating device has the film thickness of 0.002-0.003mm and the coating integrity of 100 percent.
The above-described series of detailed descriptions are merely specific to possible embodiments of the present invention, and they are not intended to limit the scope of the present invention, and various changes made without departing from the gist of the present invention within the knowledge of those skilled in the art are included in the scope of the present invention.

Claims (10)

1. An implant film coating device is characterized by comprising a film arranging machine, a film pushing machine, a film coating pool, a tablet pipeline, a tablet conveying device, a collecting device and an automatic control system; the film arranging machine is connected with the film pushing machine, and the film coating pool is arc-shaped; the coating pool is filled with a coating liquid; the inlet of the tablet pipeline is connected with the tablet pushing machine, the outlet of the tablet pipeline is connected with the collecting device, and the tablet conveying device is used for conveying the implant tablets in the tablet pipeline.
2. The implant encapsulation device according to claim 1, wherein the collecting device is a flat plate horizontally placed, the collecting device is connected with an automatic control device, the automatic control device is used for controlling the horizontal movement of the collecting device, and the collecting device is made of stainless steel with Teflon attached on the surface.
3. The implant capsule device of claim 1, wherein said tablet conduit comprises a first tablet conduit, a second tablet conduit, a third tablet conduit; the first tablet pipeline, the second tablet pipeline and the third tablet pipeline are all stainless steel pipes, the first tablet pipeline, the second tablet pipeline and the third tablet pipeline are of an integrated structure, and the first tablet pipeline, the second tablet pipeline and the third tablet pipeline are sequentially connected;
the inlet of the first tablet pipeline is connected with the tablet pushing machine, and the outlet of the third tablet pipeline extends into the collecting device.
4. The implant encapsulation device of claim 3, wherein the second tablet conduit is provided with a first pushrod track and the third tablet conduit is provided with a second pushrod track; the first push rod track and the second push rod track are both openings with the width of 2 mm.
5. The implant encapsulation device according to claim 3, wherein the bottom end of the second tablet conduit is attached to the inner side of the encapsulation pool, and the second tablet conduit is immersed in the encapsulation liquid; the second tablet pipeline is provided with meshes, and the density of the meshes is at least 100/30 cm; the diameter of the mesh is 2 mm.
6. The implant enveloping apparatus of claim 3, wherein the second tablet conduit has a pipe diameter gradually decreasing from the inlet to the outlet, the pipe diameter inlet of the second tablet conduit is 0.5 to 1.5mm larger than the outlet, and the pipe diameter outlet of the second tablet conduit is 1.5 to 2mm larger than the diameter of the implant tablet.
7. The implant encapsulation device according to claim 4, wherein the tablet delivery device comprises a first driving device, a rotating push rod, a second driving device and a translation push rod, and the first driving device is arranged at the position of the center of the circle of the encapsulation pool; a second driving device is arranged at the upper end of the third tablet pipeline;
the first driving device and the second driving device are both electrically connected with the automatic control device;
one end of the rotary push rod is connected with the first driving device, and the other end of the rotary push rod extends into the second tablet pipeline through the first push rod track;
one end of the translation push rod is connected with the second driving device, and the other end of the translation push rod extends into the third tablet pipeline through the second push rod rail.
8. The implant encapsulation device according to claim 7, wherein the rotary push rod and the translational push rod are made of steel with Teflon attached on the surface, and the diameters of the rotary push rod and the translational push rod are both 1.5 mm.
9. The implant capsule device according to claim 1, wherein the coating solution is a PLA solution having a concentration of 5-9%.
10. The implant encapsulation device of claim 2, wherein the time for the implant tablet to pass through the encapsulation fluid in the second tablet channel is 15-40 seconds;
the temperature of the coating liquid in the coating process is controlled to be 33-40 ℃.
CN201810963227.4A 2018-08-22 2018-08-22 Implant coating device Active CN110856691B (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115518048A (en) * 2022-09-28 2022-12-27 深圳善康医药科技股份有限公司 Compound sustained-release implant of naltrexone and risperidone, preparation method and application thereof

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Publication number Priority date Publication date Assignee Title
KR20090114188A (en) * 2008-04-29 2009-11-03 (주)크레템 Dispenser of free shape type tablet for medicine packing apparatus and tablet dispensing method thereof
CN101766537A (en) * 2010-02-26 2010-07-07 罗彦凤 Dry-method coating machine
JP5830618B1 (en) * 2015-01-30 2015-12-09 大原薬品工業株式会社 Method for producing multilayer film coated tablets for laser printing
CN107792417A (en) * 2017-10-24 2018-03-13 福州法莫优科机械科技有限公司 Full-automatic building material distributing tablet sub-packaging device and its method for filling
CN209596217U (en) * 2018-08-22 2019-11-08 深圳善康医疗健康产业有限公司 A kind of implant coating device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20090114188A (en) * 2008-04-29 2009-11-03 (주)크레템 Dispenser of free shape type tablet for medicine packing apparatus and tablet dispensing method thereof
CN101766537A (en) * 2010-02-26 2010-07-07 罗彦凤 Dry-method coating machine
JP5830618B1 (en) * 2015-01-30 2015-12-09 大原薬品工業株式会社 Method for producing multilayer film coated tablets for laser printing
CN107792417A (en) * 2017-10-24 2018-03-13 福州法莫优科机械科技有限公司 Full-automatic building material distributing tablet sub-packaging device and its method for filling
CN209596217U (en) * 2018-08-22 2019-11-08 深圳善康医疗健康产业有限公司 A kind of implant coating device

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115518048A (en) * 2022-09-28 2022-12-27 深圳善康医药科技股份有限公司 Compound sustained-release implant of naltrexone and risperidone, preparation method and application thereof
CN115518048B (en) * 2022-09-28 2023-11-07 深圳善康医药科技股份有限公司 Naltrexone and risperidone compound sustained-release implant, preparation method and application thereof

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