CN1799650B - Method for preparing biodegradable drug-carried high molecular material stent - Google Patents
Method for preparing biodegradable drug-carried high molecular material stent Download PDFInfo
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- CN1799650B CN1799650B CN 200510104766 CN200510104766A CN1799650B CN 1799650 B CN1799650 B CN 1799650B CN 200510104766 CN200510104766 CN 200510104766 CN 200510104766 A CN200510104766 A CN 200510104766A CN 1799650 B CN1799650 B CN 1799650B
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Abstract
The invention relates to a method for preparing a biodegradable cradle carrying medical high molecular material, with the technique program comprising: (1) mixing the degradable high molecular polylactic acid and polycaprolactone or polylactide according to the percentage by weight (100%: 0%)-(0%:100%); (2) adding anti-stenosis medicine of arsenic trioxide into the mixture above, making the mole volume concentration of the medicine be 0.001%-10%; (3)extrusion by melting with helical rotor or double screw, preparing the tubular goods with spinning board; (4) immersing the tubular goods in the carboxylated sulfation chitose solution with the mass volume concentration of 0.1%-20%, getting out and drying; (5) etching the tubular goods with cutting machine to net structure; (6) immersing in dimethy ketone solution for three to five times; (7) assembling the cradle with preassembling machine, making the cradle be adhesive to the saccule; (8) when the saccule expands, the shape of the openedcradle is high molecular cradle. The high molecular material used in this invention comprises polylactic acid, polylactide, and polycaprolactone, which is biodegradable. The partial low release of the medicine added in the cradle can act for a long time, the carboxylated sulfation chitose possesses good anticoagulant property, and by immersing the cradle in the high molecular cradle to realize different acting time by different medicine.
Description
Technical field
The present invention relates to a kind of preparation method of biodegradable drug-carried high molecular material stent, belong to technical field of bioengineering.
Background technology
Through the conduit interventional therapy is one of the most frequently used treatment means of vascular obstruction disease, and especially percutaneous puncture transluminal coronary angioplasty art (PTCA) is the very effective Therapeutic Method of coronary occlusion disease.The metal rack of present clinical use is a kind of foreign body to human body, and human body has rejection to it, and reaction and restenosis cause inflammation; And metal rack also can cause damage to ductus arteriosus wall, makes us that its secular safety is had doubt.Another problem of metal rack is to implant once more in position, or causes the implant surgery difficulty in its downstream to increase.Usually, when the patient falls ill again, have to adopt the heart bypass or claim bypass surgery.The degradable high polymer material support has better biocompatibility, and finally degradation in vivo disappears, and avoids the The Long-term Effect to human body.Macromolecular material can carry slow releasing pharmaceutical by means such as blend, spraying, absorption, scion graftings easily, reaches the purpose of anti-hemostasis-coagulation and restenosis.This support also can be used for his position of human body, is used to guarantee the unobstructed of various pipelines, and as urethra, bile duct etc.Tamai H etc. has reported that on the CIRCULATION magazine (CIRCULATION 102 (4): 399-404 JUL 25 2000), this is the report that the degradable macromolecule support is applied to human body for the first time for experimental result in the polylactic acid bracket implant into body six months.In order better to prevent restenosis, research worker is explored the various methods that prevent restenosis always.Commonly used have radiation method, gene therapy, a medicament slow release method etc.Datta A etc. thank to build at patent EP Li Wen great waves and described a kind of band medicine degradable macromolecule support among the 0561-A2, and are two-layer inside and outside being divided into, and can carry different medicines, to regulate the slow release speed of medicine.The medicine of common anti-restenosis has taxol etc.The preparation of support is first filamentation, and is Wrapping formed again.Canesh R. makes the polylactic acid film forming with the method for spraying, and then is rolled into silk, but this silk is thick excessively, can not satisfy the demand (ASAIO Journal, M584,1994) of implant into body.L.Fambri etc. have obtained acid fiber by polylactic with melt spinning, but have serious signs of degradation, cause polymer molecular weight about 2/3 (Polymer Vol.38 NO.1 pp79-85,1997) that descend.Before this, L.Fambri etc. must be the fiber of polylactic acid with dry spinning, signs of degradation is also not serious, but there is the very poor problem of operability, be difficult to obtain long even filament (Journal of materials science:materials in medicine 679-683,5,1994), and be not easy to pore-creating on fiber.
Summary of the invention
Purpose of the present invention is exactly the defective that exists at prior art, and a kind of preparation method of more safe and effective biodegradable drug-carried high molecular material stent is provided.
Its technical scheme comprises:
Method one
(1), degradable macromolecule polylactic acid (PLLA) and the polycaprolactone (PCL) with tool certain molecular weight (intrinsic viscosity 0.5-9.0dl/g) is that fully mix (100%: 0%)-(0%: 100%) by mass percentage;
(2), at said mixture, add anti-restenosis medicaments arsenic trioxide, making medicine molal volume concentration is 0.001%-10% (mol/ml);
(3), with the mixture of above-mentioned preparation, through single screw rod or twin screw melt extrusion equipment, melt extrude, and make tubing (internal diameter 0.1mm-45mm, external diameter 0.4mm-50mm) by spinneret;
(4), with different-diameter, it is that the aqueous solution of carboxylated Sulfation chitosan of 0.1%-20% (g/ml) or the anticoagulation solution of Low molecular heparin sodium water solution and acetone (volume ratio) preparation in 1: 1 soak that the tubing of certain-length is put into the quality volumetric concentration, and taking-up is dried; The also available spraying of solution is joined by institute, and tubing is carried out face coat;
(5), laser cutting machine presses the graphic design software design configuration, computer control is etched into network structure with tubing down.
(6), support that etching is good, in acetone soln, soak 3-5 time, each soak time 10 seconds is to a few minutes;
(7), support assembling adopts pre-installation, and the sacculus of support and evacuation is heated (55-65 ℃) simultaneously, and support and sacculus are applied torsion along the tangent to periphery direction, and support is sticked on the sacculus.
(8), behind the balloon expandable, the form polymeric stent of stent open.
Method two
(1), degradable macromolecule polylactic acid (PLLA) and the polycaprolactone (PCL) with tool certain molecular weight (intrinsic viscosity 0.5-9.0dl/g) is that fully mix (100%: 0%)-(0%: 100%) by mass percentage;
(2), at said mixture, add anti-restenosis medicaments arsenic trioxide, make medicine molal volume concentration 0.001%-10% (mol/ml);
(3), with the mixture of above-mentioned preparation, through single screw rod or twin screw melt extrusion equipment, melt extrude, and make tubing (internal diameter 0.1mm-45mm, external diameter 0.4mm-50mm) by special spinneret;
(4), laser cutting machine presses the graphic design software design configuration, computer control is etched into network structure with tubing down;
(5), to put into the quality volumetric concentration be the aqueous solution of carboxylated Sulfation chitosan of 0.1%-20% (g/ml) or Low molecular heparin sodium water solution and acetone soaks by the anticoagulation solution of 1: 1 (volume ratio) preparation with the tubing of different-diameter, length, taking-up is dried; The also available spraying of solution is joined by institute, and tubing is carried out face coat;
(6), support that etching is good, in acetone soln, soak 3-5 time, each soak time 10 seconds is to a few minutes;
(7), support assembling adopts pre-installation, and the sacculus of support and evacuation is heated (55-65 ℃) simultaneously, and support and sacculus are applied torsion along the tangent to periphery direction, and support is sticked on the sacculus.
(8), behind the balloon expandable, the form polymeric stent of stent open.
The used macromolecular material of the present invention comprises polylactic acid (PLLA) and polylactide (PGA), and these materials all are the high-molecular biologic degradation materials that can be used for human body through the medical practice proof.PLLA has good hardness strength character, adds the elasticity that a certain amount of PCL or PGA then can improve support, so use PLLA and the mixture of PCL or the mixture of PLLA or PGA in the skeleton of support.If add medicine in support, along with high molecular degraded, medicine just can be released in the blood.The local sustained release of this medicine both can be brought into play long curative effect, saved repeatedly external injection, also can make medicine that the side effect of other parts of health is dropped to minimum.In order to control the speed of medicament slow release, can add at rack surface and be coated with the medicine controlled-release coating.Carboxylated Sulfation chitosan and low molecular sodium heparin have good anticoagulation function, infiltrate in the polymeric stent by infusion method or spraying, by control solution concentration, soak time, can reach different drug treating times.
The specific embodiment
Embodiment 1
(1), degradable macromolecule polylactic acid and the polycaprolactone with the tool certain molecular weight is fully mixing in 80%: 20% by mass percentage;
(2), at said mixture, add anti-restenosis medicaments arsenic trioxide, make medicine molal volume concentration 0.05%mol/ml;
(3), with the mixture of above-mentioned preparation, through single screw rod melt extrusion equipment, melt extrude, and make tubing (internal diameter 0.1mm-45mm, external diameter 0.4mm-50mm) by spinneret;
(4), the tubing of different-diameter can cut into different length as required;
(5), PROSTENT 1 laser cutting machine presses AlphaCAM (LICOM) graphic design software design configuration, computer control is etched into the network structure form with tubing down;
(6), support that etching is good, putting into the quality volumetric concentration is that the aqueous solution of the carboxylated Sulfation chitosan of 0.1%-20% (g/ml) soaks, and takes out airing;
(7), support that etching is good, in acetone soln, soak 3-5 time, each soak time 10 seconds is to a few minutes;
(8), support assembling adopts metal rack to install in advance, and the sacculus of support and evacuation is heated (60 ℃) simultaneously, and support and sacculus are applied torsion along the tangent to periphery direction, and support is sticked on the sacculus.
(9), behind the balloon expandable, stent open forms polymeric stent.
Embodiment 2
(1), degradable macromolecule polylactic acid (PLLA) and the polylactide (PGA) with tool certain molecular weight (intrinsic viscosity 0.5-9.0dl/g) is fully mixing in 70%: 30% by mass percentage;
(2), at said mixture, add anti-restenosis medicaments arsenic trioxide, make medicine molal volume concentration 0.001%-10% (mol/ml);
(3), with the mixture of above-mentioned preparation, through twin screw melt extrusion equipment, melt extrude, and make tubing (internal diameter 0.1mm-45mm, external diameter 0.4mm-50mm) by special spinneret;
(4), the tubing of different-diameter can cut into different length as required;
(5), PROSTENT 1 laser cutting machine presses AlphaCAM (LICOM) graphic design software design configuration, computer control is etched into the network structure form with tubing down;
(6), be the Low molecular heparin sodium water solution of 0.1%-20% (g/ml) and the anticoagulation spray solution of acetone (volume ratio) preparation in 1: 1 with the network structure of different-diameter, length with the quality volumetric concentration, the tubing network structure is carried out face coat;
(7), support that etching is good, in acetone soln, soak 3-5 time, each soak time 10 seconds is to a few minutes;
(8), support assembling adopts metal rack to install in advance, and the sacculus of support and evacuation is heated (55 ℃) simultaneously, and support and sacculus are applied torsion along the tangent to periphery direction, and support is sticked on the sacculus.
(9), behind the balloon expandable, the form polymeric stent of stent open.
Claims (6)
1. the preparation method of a biodegradable drug-carried high molecular material stent is characterized in that according to the following step:
(1), degradable macromolecule polylactic acid and the polycaprolactone with intrinsic viscosity 0.5-9.0dl/g is that fully mix (100%: 0%)-(0%: 100%) by mass percentage;
(2), in said mixture, add arsenic trioxide, making arsenic trioxide molal volume concentration is 0.001%-10%mol/ml;
(3), with the mixture of above-mentioned preparation, melt extrude, and make internal diameter 0.1mm-45mm, the tubing of external diameter 0.4mm-50mm by spinneret;
(4), with different-diameter, it is that the aqueous solution of carboxylated Sulfation chitosan of 0.1%-20%g/ml or the anticoagulation solution of Low molecular heparin sodium water solution and acetone preparation in 1: 1 by volume soak that the tubing of certain-length is put into the quality volumetric concentration, and taking-up is dried;
(5), cutting machine is etched into the network structure support with tubing;
(6), support that etching is good, in acetone soln, soak 3-5 time, each soak time 10 seconds is to a few minutes;
(7), support assembling adopts pre-installation, to 55-65 ℃ of the sacculus heating of support and evacuation, simultaneously, support and sacculus applied torsion along the tangent to periphery direction, and support is sticked on the sacculus;
(8), behind the balloon expandable, stent open forms.
2. the preparation method of a biodegradable drug-carried high molecular material stent is characterized in that according to the following step:
(1), degradable macromolecule polylactic acid and the polycaprolactone with intrinsic viscosity 0.5-9.0dl/g is that fully mix (100%: 0%)-(0%: 100%) by mass percentage;
(2), in said mixture, add arsenic trioxide, making arsenic trioxide molal volume concentration is 0.001%-10%mol/ml;
(3), with the mixture of above-mentioned preparation, melt extrude, and make internal diameter 0.1mm-45mm, the tubing of external diameter 0.4mm-50mm by spinneret;
(4), cutting machine is etched into the network structure support with tubing;
(5), with different-diameter, it is that the aqueous solution of carboxylated Sulfation chitosan of 0.1%-20%g/ml or the anticoagulation solution of Low molecular heparin sodium water solution and acetone preparation in 1: 1 by volume soak that the tubing of certain-length is put into the quality volumetric concentration, and taking-up is dried;
(6), support that etching is good, in acetone soln, soak 3-5 time, each soak time 10 seconds is to a few minutes;
(7), support assembling adopts pre-installation, to 55-65 ℃ of the sacculus heating of support and evacuation, simultaneously, support and sacculus applied torsion along the tangent to periphery direction, and support is sticked on the sacculus;
(8), behind the balloon expandable, stent open forms.
3. the preparation method of a biodegradable drug-carried high molecular material stent is characterized in that according to the following step:
(1), degradable macromolecule polylactic acid and the polycaprolactone with intrinsic viscosity 0.5-9.0dl/g is fully mixing in 80%: 20% by mass percentage;
(2), in said mixture, add arsenic trioxide, making arsenic trioxide molal volume concentration is 0.05%mol/ml;
(3), with the mixture of above-mentioned preparation, melt extrude, and make internal diameter 0.1mm-45mm, the tubing of external diameter 0.4mm-50mm by spinneret;
(4), the tubing of different-diameter can cut into different length as required;
(5), press AlphaCAM graphic design software design configuration, computer control time is etched into the network structure form with tubing with the PROSTENT1 laser cutting machine;
(6), support that etching is good, putting into the quality volumetric concentration is that the aqueous solution of the carboxylated Sulfation chitosan of 0.1%-20% (g/ml) soaks, taking-up is dried;
(7), support that etching is good, in acetone soln, soak 3-5 time, each soak time 10 seconds is to a few minutes;
(8), support assembling adopts metal rack to install in advance, and the sacculus of support and evacuation is heated 60 ℃, simultaneously, support and sacculus applied torsion along the tangent to periphery direction, and support is sticked on the sacculus.
(9), behind the balloon expandable, stent open forms polymeric stent.
4. the preparation method of a biodegradable drug-carried high molecular material stent is characterized in that according to the following step:
(1), degradable macromolecule polylactic acid and the polylactide with intrinsic viscosity 0.5-9.0dl/g is fully mixing in 70%: 30% by mass percentage;
(2), in said mixture, add arsenic trioxide, make arsenic trioxide molal volume concentration 0.001%-10%mol/ml;
(3), with the mixture of above-mentioned preparation, through twin screw melt extrusion equipment, melt extrude, and make internal diameter 0.1mm-45mm, the tubing of external diameter 0.4mm-50mm by special spinneret;
(4), the tubing of different-diameter can cut into different length as required;
(5), press AlphaCAM graphic design software design configuration, computer control time is etched into the network structure form with tubing with PROSTENT 1 laser cutting machine;
(6), be the Low molecular heparin sodium water solution of 0.1%-20%g/ml and the anticoagulation spray solution of acetone volume ratio preparation in 1: 1 with the network structure of different-diameter, length with the quality volumetric concentration, the tubing network structure is carried out face coat;
(7), support that etching is good, in acetone soln, soak 3-5 time, each soak time 10 seconds is to a few minutes;
(8), support assembling adopts metal rack to install in advance, and the sacculus of support and evacuation is heated 55 ℃, simultaneously, support and sacculus applied torsion along the tangent to periphery direction, and support is sticked on the sacculus.
(9), behind the balloon expandable, the form polymeric stent of stent open.
5. the preparation method of biodegradable drug-carried high molecular material stent according to claim 1 and 2 is characterized in that the anticoagulation solution with preparation, with spraying on the tubing or be etched into cancellated support and carry out face coat.
6. according to the preparation method of one of claim 1-4 described biodegradable drug-carried high molecular material stent, it is characterized in that described to melt extrude be to adopt single screw rod or twin screw melt extrusion equipment to melt extrude.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20120302954A1 (en) * | 2011-05-25 | 2012-11-29 | Zhao Jonathon Z | Expandable devices coated with a paclitaxel composition |
| US10349939B2 (en) * | 2015-03-25 | 2019-07-16 | Ethicon Llc | Method of applying a buttress to a surgical stapler |
| WO2019136593A1 (en) * | 2018-01-09 | 2019-07-18 | 上海微特生物技术有限公司 | Degradable vascular stent capable of avoiding late restenosis |
| CN111803719A (en) * | 2020-05-28 | 2020-10-23 | 广州新诚生物科技有限公司 | Preparation method of degradable balloon and balloon prepared by using preparation method |
| CN113975593A (en) * | 2021-09-16 | 2022-01-28 | 上海市普陀区中心医院 | Kedalong medicine balloon and preparation method thereof |
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| US5670161A (en) * | 1996-05-28 | 1997-09-23 | Healy; Kevin E. | Biodegradable stent |
| CN2383533Y (en) * | 1999-06-09 | 2000-06-21 | 安泰科技股份有限公司 | Medical saccule blood vessel dilating internal supporter |
| CN1346249A (en) * | 1999-02-09 | 2002-04-24 | 爱德华兹生命科学公司 | Laser cutting of fabric grafts |
| CN1355005A (en) * | 2001-12-13 | 2002-06-26 | 华东理工大学 | Medicine eluted cardiovascular frame and its preparing process |
| CN1367023A (en) * | 2002-03-08 | 2002-09-04 | 清华大学 | Preparation method of biodegradable medicine composite macromolecular scaffold material |
| CN1644184A (en) * | 2005-01-14 | 2005-07-27 | 大连理工大学 | Medicinal coating production for vascular stand and electrostatic spraying apparatus |
| CN1657023A (en) * | 2005-01-31 | 2005-08-24 | 上海市第一人民医院 | Arsenic trioxide control release elution stent |
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2005
- 2005-12-30 CN CN 200510104766 patent/CN1799650B/en active Active
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5670161A (en) * | 1996-05-28 | 1997-09-23 | Healy; Kevin E. | Biodegradable stent |
| CN1346249A (en) * | 1999-02-09 | 2002-04-24 | 爱德华兹生命科学公司 | Laser cutting of fabric grafts |
| CN2383533Y (en) * | 1999-06-09 | 2000-06-21 | 安泰科技股份有限公司 | Medical saccule blood vessel dilating internal supporter |
| CN1355005A (en) * | 2001-12-13 | 2002-06-26 | 华东理工大学 | Medicine eluted cardiovascular frame and its preparing process |
| CN1367023A (en) * | 2002-03-08 | 2002-09-04 | 清华大学 | Preparation method of biodegradable medicine composite macromolecular scaffold material |
| CN1644184A (en) * | 2005-01-14 | 2005-07-27 | 大连理工大学 | Medicinal coating production for vascular stand and electrostatic spraying apparatus |
| CN1657023A (en) * | 2005-01-31 | 2005-08-24 | 上海市第一人民医院 | Arsenic trioxide control release elution stent |
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