CN1463984A - Medicinal collagen material and its making process - Google Patents
Medicinal collagen material and its making process Download PDFInfo
- Publication number
- CN1463984A CN1463984A CN 02121227 CN02121227A CN1463984A CN 1463984 A CN1463984 A CN 1463984A CN 02121227 CN02121227 CN 02121227 CN 02121227 A CN02121227 A CN 02121227A CN 1463984 A CN1463984 A CN 1463984A
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- China
- Prior art keywords
- collagen material
- manufacturing process
- medicinal
- under
- medicinal collagen
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Links
- 102000008186 Collagen Human genes 0.000 title claims abstract description 26
- 108010035532 Collagen Proteins 0.000 title claims abstract description 26
- 229920001436 collagen Polymers 0.000 title claims abstract description 24
- 238000000034 method Methods 0.000 title claims abstract description 16
- 239000000463 material Substances 0.000 title claims abstract description 13
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims abstract description 6
- SQDAZGGFXASXDW-UHFFFAOYSA-N 5-bromo-2-(trifluoromethoxy)pyridine Chemical compound FC(F)(F)OC1=CC=C(Br)C=N1 SQDAZGGFXASXDW-UHFFFAOYSA-N 0.000 claims abstract description 4
- 229920001287 Chondroitin sulfate Polymers 0.000 claims abstract description 4
- 229940059329 chondroitin sulfate Drugs 0.000 claims abstract description 4
- 238000004132 cross linking Methods 0.000 claims abstract 2
- 238000004519 manufacturing process Methods 0.000 claims description 9
- 230000001954 sterilising effect Effects 0.000 claims description 7
- 238000001035 drying Methods 0.000 claims description 5
- 238000003756 stirring Methods 0.000 claims description 4
- 241001465754 Metazoa Species 0.000 claims description 3
- 108091005804 Peptidases Proteins 0.000 claims description 3
- 239000004365 Protease Substances 0.000 claims description 3
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 claims description 3
- 238000004140 cleaning Methods 0.000 claims description 3
- 210000002808 connective tissue Anatomy 0.000 claims description 3
- 238000005538 encapsulation Methods 0.000 claims description 3
- 239000012535 impurity Substances 0.000 claims description 3
- 150000003839 salts Chemical class 0.000 claims description 3
- 238000010306 acid treatment Methods 0.000 claims description 2
- 238000000746 purification Methods 0.000 claims description 2
- 239000002994 raw material Substances 0.000 claims description 2
- 238000007493 shaping process Methods 0.000 claims description 2
- 230000018044 dehydration Effects 0.000 claims 1
- 238000006297 dehydration reaction Methods 0.000 claims 1
- 238000003958 fumigation Methods 0.000 claims 1
- 210000001951 dura mater Anatomy 0.000 abstract description 3
- 210000000578 peripheral nerve Anatomy 0.000 abstract description 3
- 230000002490 cerebral effect Effects 0.000 abstract description 2
- 238000001291 vacuum drying Methods 0.000 abstract 1
- 230000015556 catabolic process Effects 0.000 description 4
- 238000006731 degradation reaction Methods 0.000 description 4
- 241001448725 Endorchis Species 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 230000015572 biosynthetic process Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 102000012422 Collagen Type I Human genes 0.000 description 1
- 108010022452 Collagen Type I Proteins 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 208000031737 Tissue Adhesions Diseases 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 230000002924 anti-infective effect Effects 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 210000001175 cerebrospinal fluid Anatomy 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 238000004388 gamma ray sterilization Methods 0.000 description 1
- 230000023597 hemostasis Effects 0.000 description 1
- 206010020718 hyperplasia Diseases 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 210000002435 tendon Anatomy 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Landscapes
- Materials For Medical Uses (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
The medical collagen material is made through the processes of chondroitin sulfate crosslinking, high temperature vacuum drying and ethylene oxide. Is has stable molecule structure and better anti-seepage and anti-stick performance, and is used in repairing cerebral dura mater, spinal dura mater and peripheral nerve.
Description
Technical field
The present invention relates to a kind of medicinal collagen material and manufacturing process thereof, be particularly useful for medicinal collagen material and manufacturing process thereof that cerebral dura mater repairing, endorchis and peripheral nerve are repaired.
Technical background
In rising trend based on the goods research and the clinical application of collagen protein at medical field in recent years, particularly the collagen protein medical article with film or sponge form has obtained significant development.The preparation of these type of medical collagen goods at present prolong substantially in order to animal connective tissue particularly the ox tendon be raw material, obtain through processes such as removal of impurities, cleaning, acid-alkali treatment and salt processing, protease hydrolyzed, chemically crosslinked, cryodrying, shaping encapsulation, γShe Xianmiejun sterilizations, the main body of product is a type i collagen albumen.The range of application of currently available products is limited to protecting wound surface, hemostasis, anti-infective substantially, and principal indication is that burn, wound, internal organs are hemorrhage or the like.Because its molecular structure of medical collagen goods with above-mentioned traditional method preparation is stable inadequately, anti-leakage is poor, and degradation time is short in tissue, therefore can't be applied to such product performance are had some field of requirements at the higher level.
Summary of the invention
The purpose of this invention is to provide a kind of medicinal collagen material and manufacturing process thereof, this medicinal collagen material has than stable molecular structure, anti-leakage is good, degradation time is long, can be used for all kinds of medical operatings that endocranium, endorchis, peripheral nerve reparation etc. are had relatively high expectations to preventing tissue liquid seepage, preventing tissue adhesion.
Embodiment
Specific embodiments of the present invention is as follows:
1. by traditional method animal connective tissue is carried out removal of impurities, cleaning, acid treatment, alkaline purification, salt processing, protease hydrolyzed, obtain the homogenate of medical collagen work in-process, because described traditional method is application known technology for many years, therefore be not further described at this.
2. the homogenate of acquired medical collagen work in-process is placed in the agitator, after stirring 30～180 minutes under 2～15 ℃ of temperature, drip chondroitin sulfate, concentration ratio is 0.2～0.5%, and the time is 10～60 minutes, continues then to stir 30～180 minutes.
3. above-mentioned medical collagen work in-process are put into special shaped device, place in the frozen vacuum dryer vacuum tightness 200～900 millitorrs, under ℃ condition of temperature-55～-35 freezing 1～2 hour, naturally slowly be warming up to 0～20 ℃ then in machine, dewatering time is 12～16 hours.
4. with above-mentioned medical collagen work in-process cutting encapsulation through processed, insert in the high-temperature drier, drying treatment is 12～72 hours under 90～140 ℃ of temperature.
5. dried finished product are carried out ethylene oxide sterilization processes in sterilization in the fumigator, temperature is 45～55 ℃, 3～4 hours time, leaves standstill under the ventilated environment and reaches sterilising effect more than 7 days and protect collagen structure to greatest extent.
The present invention compares with existing medical collagen goods and production technology and has the following advantages:
1. owing to adopt chondroitin sulfate crosslinked, so that the collagen molecules chain structure after the restructuring is stable, The hyperplasia of degradation cycle and cell and creeping is grown into synchronously.
2. do not expand after wetting, non-leakage, can prevent the cerebrospinal fluid seepage effectively when being used for endocranium, endorchis reparation.
3. being capped formation one effective separating layer between tissue and the outer surrounding structure, reduce or avoid the formation of adhesion.
4. the employing of ethylene oxide sterilizing method can be protected the collagen molecules structure effectively, has avoided the destruction of gamma ray sterilization to protein molecular, has delayed degradation speed.
5. can obtain the space as required targetedly by the control to technological process is that the medicinal collagen material of 20～150 μ m is to satisfy the corrective surgery requirement.
Claims (4)
1. medicinal collagen material and manufacturing process thereof, it is characterized in that with the animal connective tissue being raw material, that makes through removal of impurities, cleaning, acid treatment, alkaline purification, salt processing, protease hydrolyzed, crosslinked, cryogenic vacuum dehydration shaping, high temperature drying, ethylene oxide sterilizing has required spongy, film like or a sheath piped medicinal collagen material, and hole is 20～150 μ m.
2. it is characterized in that according to described medicinal collagen material of claim 1 and manufacturing process thereof: described cross-linking method is for to place the homogenate of medical collagen work in-process in the agitator, after stirring 30～180 minutes under 2～15 ℃ of temperature, drip chondroitin sulfate, concentration ratio is 0.2～0.5%, time is 10～60 minutes, continues then to stir 30～180 minutes.
3. it is characterized in that according to described medicinal collagen material of claim 1 and manufacturing process thereof: described high temperature drying method is drying treatment 12～72 hours under 90～140 ℃ of temperature.
4. it is characterized in that according to described medicinal collagen material of claim 1 and manufacturing process thereof: described ethylene oxide sterilizing method for after the drying and the finished product that finish of encapsulation placed in the Sterilizers under 45～55 ℃ of temperature epoxyethane fumigation 3～4 hours, left standstill under the ventilated environment 7 days.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02121227 CN1253473C (en) | 2002-06-10 | 2002-06-10 | Medicinal collagen material and its making process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02121227 CN1253473C (en) | 2002-06-10 | 2002-06-10 | Medicinal collagen material and its making process |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1463984A true CN1463984A (en) | 2003-12-31 |
| CN1253473C CN1253473C (en) | 2006-04-26 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 02121227 Expired - Lifetime CN1253473C (en) | 2002-06-10 | 2002-06-10 | Medicinal collagen material and its making process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1253473C (en) |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006066483A1 (en) * | 2004-12-24 | 2006-06-29 | Haiying Yu | Adhesion preventing biologic film for tendon ligament and its application |
| CN101099874B (en) * | 2006-07-04 | 2010-08-25 | 孙雨龙 | Biological coupling material and its preparing method |
| CN102078641A (en) * | 2011-01-07 | 2011-06-01 | 北京天新福医疗器材有限公司 | Method for preparing anti-adhesive membrane for tendon ligaments |
| CN101332134B (en) * | 2008-07-15 | 2012-01-11 | 许和平 | Preparation and use of I -type collagen artificial tendon, ligaments |
| CN101579247B (en) * | 2009-06-23 | 2012-02-29 | 许和平 | I-type collagen peripheral nerve sheath keeping the peculiar triple helical structure of collagen, preparation method and applications thereof |
| CN101569765B (en) * | 2009-06-23 | 2012-12-05 | 许和平 | I-type medical collagen material keeping original specific triple helix structure of collagen, product and application thereof |
| CN101015709B (en) * | 2005-09-29 | 2013-06-12 | 科德曼及舒特莱夫公司 | Dural graft and method of preparing the same |
| CN103393482A (en) * | 2013-08-14 | 2013-11-20 | 北京瑞健高科生物科技有限公司 | Breast implant support device based on periplast material and preparation method thereof |
| CN103897211A (en) * | 2012-12-26 | 2014-07-02 | 天津市赛宁生物工程技术有限公司 | Elastic cerebral dura mater |
-
2002
- 2002-06-10 CN CN 02121227 patent/CN1253473C/en not_active Expired - Lifetime
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006066483A1 (en) * | 2004-12-24 | 2006-06-29 | Haiying Yu | Adhesion preventing biologic film for tendon ligament and its application |
| CN100366303C (en) * | 2004-12-24 | 2008-02-06 | 于海鹰 | Preparation and application of anti blocking biomembrane for tendon and ligament |
| CN101015709B (en) * | 2005-09-29 | 2013-06-12 | 科德曼及舒特莱夫公司 | Dural graft and method of preparing the same |
| CN101099874B (en) * | 2006-07-04 | 2010-08-25 | 孙雨龙 | Biological coupling material and its preparing method |
| CN101332134B (en) * | 2008-07-15 | 2012-01-11 | 许和平 | Preparation and use of I -type collagen artificial tendon, ligaments |
| CN101579247B (en) * | 2009-06-23 | 2012-02-29 | 许和平 | I-type collagen peripheral nerve sheath keeping the peculiar triple helical structure of collagen, preparation method and applications thereof |
| CN101569765B (en) * | 2009-06-23 | 2012-12-05 | 许和平 | I-type medical collagen material keeping original specific triple helix structure of collagen, product and application thereof |
| CN102078641A (en) * | 2011-01-07 | 2011-06-01 | 北京天新福医疗器材有限公司 | Method for preparing anti-adhesive membrane for tendon ligaments |
| CN103897211A (en) * | 2012-12-26 | 2014-07-02 | 天津市赛宁生物工程技术有限公司 | Elastic cerebral dura mater |
| CN103393482A (en) * | 2013-08-14 | 2013-11-20 | 北京瑞健高科生物科技有限公司 | Breast implant support device based on periplast material and preparation method thereof |
| CN103393482B (en) * | 2013-08-14 | 2016-04-06 | 北京瑞健高科生物科技有限公司 | A kind of mammary prostheses supporting device based on tissue matrix material and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1253473C (en) | 2006-04-26 |
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| C06 | Publication | ||
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| ASS | Succession or assignment of patent right |
Owner name: YU HAIYING; XU HEPING Free format text: FORMER OWNER: YU HAIYING Effective date: 20081031 |
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| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20081031 Address after: No. 100028, building three, building 15, left hospital, Beijing, Chaoyang District, China Co-patentee after: Xu Heping Patentee after: Yu Haiying Address before: No. 100028, building three, building 15, left hospital, Beijing, Chaoyang District, China Patentee before: Yu Haiying |
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Granted publication date: 20060426 |
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Addressee: Yu Haiying Document name: Notice of expiration and termination of patent right |
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Addressee: Beijing Huaxia Botong Patent Agency Document name: Notice of invalidation request for oral hearing (patent holder) |
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Addressee: Liu Jun Document name: Notice of Review Status for Invalidation Cases |
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Addressee: Beijing Huaxia Botong Patent Agency Document name: Notice of invalidation and closure of case |