CN1174017A - Production method of artificial vitreous body - Google Patents
Production method of artificial vitreous body Download PDFInfo
- Publication number
- CN1174017A CN1174017A CN 97108943 CN97108943A CN1174017A CN 1174017 A CN1174017 A CN 1174017A CN 97108943 CN97108943 CN 97108943 CN 97108943 A CN97108943 A CN 97108943A CN 1174017 A CN1174017 A CN 1174017A
- Authority
- CN
- China
- Prior art keywords
- polyvinylpyrrolidone
- vinylpyrrolidone
- packed
- normal saline
- ampoule
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000004519 manufacturing process Methods 0.000 title claims description 5
- 210000004127 vitreous body Anatomy 0.000 title abstract description 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 12
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 12
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 12
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims abstract description 9
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 9
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000003708 ampul Substances 0.000 claims abstract description 7
- GUTLYIVDDKVIGB-OUBTZVSYSA-N Cobalt-60 Chemical compound [60Co] GUTLYIVDDKVIGB-OUBTZVSYSA-N 0.000 claims abstract description 4
- 229910052786 argon Inorganic materials 0.000 claims abstract description 4
- 238000000034 method Methods 0.000 claims description 5
- 230000008961 swelling Effects 0.000 claims description 5
- 230000001954 sterilising effect Effects 0.000 claims description 4
- 238000004659 sterilization and disinfection Methods 0.000 claims description 4
- 238000006392 deoxygenation reaction Methods 0.000 claims description 3
- 238000004821 distillation Methods 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 230000004927 fusion Effects 0.000 claims description 3
- 239000000126 substance Substances 0.000 claims description 3
- 239000000463 material Substances 0.000 abstract description 4
- 230000002163 immunogen Effects 0.000 abstract 1
- 238000000746 purification Methods 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
- 239000004372 Polyvinyl alcohol Substances 0.000 description 4
- 239000000017 hydrogel Substances 0.000 description 4
- 229920002451 polyvinyl alcohol Polymers 0.000 description 4
- 206010061218 Inflammation Diseases 0.000 description 2
- 229910018503 SF6 Inorganic materials 0.000 description 2
- 230000002016 colloidosmotic effect Effects 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 230000005847 immunogenicity Effects 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 230000004410 intraocular pressure Effects 0.000 description 2
- QYSGYZVSCZSLHT-UHFFFAOYSA-N octafluoropropane Chemical compound FC(F)(F)C(F)(F)C(F)(F)F QYSGYZVSCZSLHT-UHFFFAOYSA-N 0.000 description 2
- 230000003204 osmotic effect Effects 0.000 description 2
- SFZCNBIFKDRMGX-UHFFFAOYSA-N sulfur hexafluoride Chemical compound FS(F)(F)(F)(F)F SFZCNBIFKDRMGX-UHFFFAOYSA-N 0.000 description 2
- 229960000909 sulfur hexafluoride Drugs 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 206010030113 Oedema Diseases 0.000 description 1
- 206010038848 Retinal detachment Diseases 0.000 description 1
- 208000034700 Vitreous opacities Diseases 0.000 description 1
- 210000001742 aqueous humor Anatomy 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 238000005138 cryopreservation Methods 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 210000000871 endothelium corneal Anatomy 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 229960004065 perflutren Drugs 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 210000001525 retina Anatomy 0.000 description 1
- 230000004264 retinal detachment Effects 0.000 description 1
- 229920002545 silicone oil Polymers 0.000 description 1
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- TXEYQDLBPFQVAA-UHFFFAOYSA-N tetrafluoromethane Chemical compound FC(F)(F)F TXEYQDLBPFQVAA-UHFFFAOYSA-N 0.000 description 1
- 239000003190 viscoelastic substance Substances 0.000 description 1
Landscapes
- Materials For Medical Uses (AREA)
- Medicinal Preparation (AREA)
Abstract
Vinylpyrrolidone is distilled for purification and compounded with normal saline into vinylpyrrolidone solution, which is filtered, disinfected, packed in ampoule, deoxidized by introducing argon, sealed through molting, and irradiated with cobalt-60 rays to polymerize into polyvinylpyrrolidone. Polyvinylpyrrolidone is mixed with 1-2.5% normal saline and swelled in water bath of 85 deg. c under bacteria-free condition, and completely swelled and tested polyvinylpyrrolidone is packed in ampoules. Artificial vitreous body produced based on the present invention is used in clinical application and it has excellent biological compatibility, wide material source, low cost and no immunogen problem.
Description
The present invention relates to a kind of artificial vitreous's manufacture method.
Along with carrying out of vitrectomy and surgery of retinal detachment with universal gradually, more and more need a kind of good vitreous substitute, be used for filling glass body cavity after the vitrectomy, the vitreous body of displacement pathological changes, carry out ophthalmic simultaneously and fill, help the reattachment of retina that breaks away from.Ophthalmic industry is to the existing last 100 years history of the research of vitreous substitute, successively used air, sulfur hexafluoride (SF6), perfluoropropane (C3F8), hyaluronate sodium, silicone oil and perfluorocarbon etc., all have to be difficult to the defective that overcomes separately, can not become the vitreous body that forever rests on ophthalmic.
The seventies, Japan scholar Shan Neiai makes and has introduced 7% polyvinyl alcohol (PVA) solution, make the PVA hydrogel through crosslinking with radiation, swelling and carry out the vitreous substitute experiment, domestic scholars is also used with quadrat method and is made the PVA hydrogel and carried out zoopery, though Chinese scholars is proceeded this research 20 years nearly, but all find to have in various degree post-operation inflammatory reaction, intraocular pressure to raise respectively and vitreous opacity etc., still rest on animal experiment stage and fail to be applied to clinical.
The object of the present invention is to provide a kind of artificial vitreous's manufacture method, made artificial vitreous can be used for clinical, and its physicochemical property is stable, does not have the immunogenicity problem, excellent biological compatibility is arranged, and material source is extensive, and is cheap.
The present invention be achieved in that with purity greater than 99% vinylpyrrolidone distillation purifying after, be made into 5～15% vinylpyrrolidone solution with normal saline, the funnel filtration sterilization is sub-packed in ampoule, feeds the argon deoxygenation, fusion envelope bottle; With cobalt-60 irradiation [close rate 10～100 rads/minute (rd/min), accumulated dose 0.1～0.5 Megarad (Mrads)], make vinylpyrrolidone aggregate into polyvinylpyrrolidone; The polyvinylpyrrolidone of gained is added normal saline molten bloated in 85 ℃ of water-baths under the aseptic condition by 1～2.5% concentration, after the complete swelling, its physical and chemical index is detected, as meet the requirements, then be sub-packed in the ampoule.
Below in conjunction with embodiment the present invention is described in detail.
With vinylpyrrolidone (NVP, purity 99.9%), behind the distillation purifying, be made into 10% NVP solution with normal saline (NS), No. 5 funnel filtration sterilizations, the ampoule of packing 10ml feeds the argon deoxygenation, fusion envelope bottle; With cobalt-60 irradiation (close rate 40rd/min, accumulated dose 0.2Mrads), make NVP aggregate into polyvinylpyrrolidone (PVP); The PVP of gained by 2% concentration add NS under the aseptic condition in 85 ℃ of water-baths swelling, after the complete swelling, its physical and chemical index is detected, as meets the requirements, it is stand-by then to be sub-packed in the 1ml ampoule.
The invention is not restricted to above-mentioned described embodiment.
With the PVP hydrogel that the present invention makes, its pH is 7.35～7.45, total osmotic pressure 250～320mosm (milliosmolarity), and colloid osmotic pressure is 5～10cmH
2O (colloid osmotic pressure is close with organizing), viscosity is a kind of good visco-elastic material greater than 2000cs (can control), simultaneously, its pH and osmotic pressure and tissue and aqueous humor are close, can not cause edema, dehydration or other infringement of tissue; Inflammatory reaction is light behind the intraocular lens implants, can not cause that intraocular pressure raises, and does not damage corneal endothelium; In addition, the PVP hydrogel is the polymer chemistry material of synthetic, does not have the immunogenicity problem; Simultaneously, material source is extensive, and preparation is simple, and is cheap, and room temperature is stable down, can autoclave sterilization, need not cryopreservation.
Claims (1)
1. an artificial vitreous manufacture method, it is characterized in that with purity greater than 99% vinylpyrrolidone distillation purifying after, be made into 5～15% vinylpyrrolidone solution with normal saline, the funnel filtration sterilization, be sub-packed in ampoule, feed the argon deoxygenation, fusion envelope bottle; With cobalt-60 irradiation [close rate 10～100 rads/minute (rd/min), accumulated dose 0.1～0.5 Megarad (Mrads)], make vinylpyrrolidone aggregate into polyvinylpyrrolidone; The polyvinylpyrrolidone of gained is added normal saline molten bloated in 85 ℃ of water-baths under the aseptic condition by 1～2.5% concentration, after the complete swelling, its physical and chemical index is detected, as meet the requirements, then be sub-packed in the ampoule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 97108943 CN1174017A (en) | 1997-06-11 | 1997-06-11 | Production method of artificial vitreous body |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 97108943 CN1174017A (en) | 1997-06-11 | 1997-06-11 | Production method of artificial vitreous body |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1174017A true CN1174017A (en) | 1998-02-25 |
Family
ID=5170775
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 97108943 Pending CN1174017A (en) | 1997-06-11 | 1997-06-11 | Production method of artificial vitreous body |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1174017A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2009304462B2 (en) * | 2008-10-15 | 2011-09-29 | Guangzhou Vesber Biotechnology Co., Ltd. | Manufacturing method of foldable artificial vitreous body and mould thereof |
-
1997
- 1997-06-11 CN CN 97108943 patent/CN1174017A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2009304462B2 (en) * | 2008-10-15 | 2011-09-29 | Guangzhou Vesber Biotechnology Co., Ltd. | Manufacturing method of foldable artificial vitreous body and mould thereof |
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| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |