CN101161298A - A technique for preparing absorbable gelatin sponge particle suppository with glutin as raw material - Google Patents
A technique for preparing absorbable gelatin sponge particle suppository with glutin as raw material Download PDFInfo
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- CN101161298A CN101161298A CNA2007101569344A CN200710156934A CN101161298A CN 101161298 A CN101161298 A CN 101161298A CN A2007101569344 A CNA2007101569344 A CN A2007101569344A CN 200710156934 A CN200710156934 A CN 200710156934A CN 101161298 A CN101161298 A CN 101161298A
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Abstract
The present invention provides a technique for preparing the gelfoam particle suppository which uses the glutin as the raw material, and the invention comprises the steps of: dissolving the glutin to the water, stirring to uniform at the water-bath condition when the formaldehyde solution is added, and the white porous spongy product is produced after freezing; defreezing the white porous spongy product, removing the water and formaldehyde after washing, and the gelfoam is obtained; crushing the gelfoam after freezing and the gelfoam particle is obtained; defreezing the gelfoam particle and placing the gelfoam particle to the water to do sifting after dewatering, and drying after sifting; disinfecting the dried gelfoam particle after sifting and the gelfoam particle suppository is obtained. The cost of the method in the invention is low and the invention easily causes that the residual quantity of the formaldehyde reaches the clinical using standard.
Description
Technical field
The present invention relates to the interventional medicine field, refer to that particularly a kind of is the technology of feedstock production absorbable gelatin sponge particle suppository with the gelatin
Background technology
Interventional medicine is the 3rd clinical medicine subject of running neck and neck with internal medicine, surgery that recent two decades grows up.Along with the development of modern medicine image technology, the scope of interventional therapy is more and more wider.Interventional medicine is by various flexibly image technologies and computer post-processing technologies from strength to strength clearly, comprehensive analysis focus, and the treatment of specific aim guided bone, not needing to operate on just can be accurately, and slight illness is wiped out by efficient Wicresoft.Interventional medicine develops into today, has differentiated specializations such as tumor gets involved, neural intervention, cardiac catheter intervention, vascular surgery intervention, non-blood vessel intervention and has got involved subject.
It is medical image instrument guiding by means of fine definition that tumor gets involved, and through little otch conduit is inserted the tumor locus of body, again by the blood oxygen of feeding artery perfusion antitumor drug or blocking-up tumor tissues, makes tumor lack atrophy behind the blood oxygen, reaches therapeutic purposes.
The key technology that tumor gets involved is the embolism agent of granule that is used to block tumor tissues blood oxygen, and particulate size has material impact to therapeutic effect.The foam beads of import costs an arm and a leg.
Chinese patent 200410017046.0 discloses a kind of preparation technology of absorbable gelatin sponge particle suppository, may further comprise the steps: absorbable gelatin sponge is pulverized dried; Be specially earlier and under-10 ℃～-30 ℃ temperature gelfoam carried out the lyophilizing processing, the freezing time more than half an hour, is carried out pulverization process at least then in pulverizer, then carry out dried at drying baker; Crossing packs into behind the sieve classification carries out the packing gland and handles in the cillin bottle of cleaning and sterilizing.Raw material is expensive among the preparation technology of this patent disclosure, and the residual quantity of formaldehyde is difficult for reaching clinical criteria.
Summary of the invention
The invention provides a kind of with low cost be the technology of feedstock production absorbable gelatin sponge particle suppository with the gelatin.
A kind of is the technology of feedstock production absorbable gelatin sponge particle suppository with the gelatin, may further comprise the steps:
(1) gelatin is soluble in water, add formalin under the water bath condition and stir, make white porous spongy product after freezing.
Wherein gelatin is soluble in water may further comprise the steps:
A. gelatin is added in the entry, leave standstill swelling to gelatin particle and be pellucidity;
B. under 20～50 ℃ of water bath condition, the solution that step (a) is prepared carries out stirring and dissolving, is pellucidity until solution.
Bath temperature is 20～50 ℃.
The concentration 1-15% of formalin (weight), the formalin addition is 30-60ml.
Cryogenic temperature is-50～-10 ℃, cooling time 5-50h.
(2) white porous spongy product is thawed, remove water and formaldehyde after the washing, make gelfoam.
Wherein dehydration of washing back and formaldehyde may further comprise the steps:
A. the platinum sponge shape product after will thawing tentatively washs the back dehydration;
B. the porous spongy product after will dewatering is cut into small pieces, and cleans the back dehydration once more.
(3) the freezing back of gelfoam is pulverized, make absorbable gelatin sponge particle.
(4) absorbable gelatin sponge particle is thawed, insert in the water and sieve, the screening after drying.
After thawing, absorbable gelatin sponge particle added entry after, carry out processed, further remove formaldehyde.
Wherein dry is lyophilizing.
(5) with exsiccant absorbable gelatin sponge particle screening back sterilization, make absorbable gelatin sponge particle suppository.
Wherein sterilization is the co-60 radiation sterilization, and radiation dose 5-25K, radiated time are 10-60h.
Provided by the invention is the technology of feedstock production absorbable gelatin sponge particle suppository with the gelatin, and the gelatin raw material is easy to get, and is with low cost, and removes processing through formaldehyde, and the residual quantity of formaldehyde easily reaches clinical use standard, has a extensive future.
The specific embodiment
Embodiment 1
(1) gets the gelatin raw material 28g of 250ps, place the 500ml beaker, add 350ml water for injection, stir 1min, leave standstill swelling 1h then, all be pellucidity until gelatin particle;
(2) under 20 ℃ of water bath condition, above-mentioned gelatin solution is carried out stirring and dissolving, be transparence until solution;
(3) the clear gelatin solution after will dissolving is transferred in the 2000ml beaker, place 20 ℃ water-bath to heat, stir with electric blender, under the low or first gear stirring condition, add concentration while stirring and be 1% formalin 60ml, cover plastic paper, when foam to be had occurs, the blender rotating speed is heightened to high-grade speed (2000 rev/mins), stirred 15min, just stop to stir when making gelatin solution be the foam of uniform and smooth (the about 1600ml of volume), and rapidly solution is transferred in the refrigerator-freezer, cooling time is 5h, and cryogenic temperature is-50 ℃, until the porous spongy that is white in color.
(4) take out freezing white porous spongy product, and be not higher than 50 ℃ water for injection with temperature and thaw, the precipitate below remove the back that thaws is got the upper strata foam product.
(5) foam product that takes out is carried out hand washing 10 times, utilize the high speed dewatering machine thoroughly to dewater then, dewatering time is 1min (repeating 29 times), foam product behind the previous cleaning is cut into small pieces, artificial cleaning is placed in the dewaterer dewaters, dewatering time 2min (repeating 29 times) to remove most formaldehyde in the sponge, makes the free formaldehyde content of product meet the standard of every 100mg≤50ug; To wash good product then and be loaded on again in the etui, add the injection water till soaking gelatin sponge blocks, box will be transferred to below-10 ℃ freezing in the refrigerator-freezer.
(6) freezing good gelatin sponge blocks is pulverized with pulverizer, the goods that crush are packed in the box, it is standby to inject water for injection.
(7) absorbable gelatin sponge particle that crushes is put into the 5000ml beaker, inject 30 ℃ of water for injection 5000ml, put into 20 ℃ of water-baths and stir with electric blender, time 2h places the nylon mesh cloth bag then, with the dewaterer 5min that dewaters; Again change water for injection, after the repetitive operation 3 times, place the container that water for injection is housed to sieve absorbable gelatin sponge particle, sieve with 10 orders-14 order-18 order-26 order-32 order-50 order-100 order respectively.Wherein 10 orders, 14 orders, 18 orders are minimum sieves more than 5 times, 26 orders, 32 orders, 50 orders are minimum sieves more than 8 times.When sieving, every replacing should change water for injection.100 orders are minimum to sieve more than 15 times, should not have substantially when sieving for the last time and can cross granule.After sieving at every turn, remove granule and obtain the granule of each specification.
(8) will sieve good granule and add water for injection, fully mixing makes particle suspending in water, changes the lyophilizing dish over to and inserts freeze dryer and carry out evacuation, when products temperature reaches 30 ℃, continues to take out getting final product dry screen more than the lyophilizing 3h.
(9) dry screen must carry out in ten thousand grades of districts, humidity must be controlled at more than 55% in the district, the granule of each specification after the lyophilizing is crossed 10 orders-14 order-18 order-26 order-32 order-50 order-100 mesh sieve respectively carry out primary dcreening operation, the gained granule is pressed the separately independent placement of different size, each format diameter qualification rate is advisable with 50-60%, removes with ST504A ion aluminium bar when producing a large amount of static when screening.
Fine screen: the goods after will sieving, press the particle diameter method of inspection, detect each diameter respectively greater than repeatedly sieving with granule less than this specification, until each format diameter qualification rate meet 〉=80% standard till.
(10) the sieve granule of 7 following specifications obtaining: 50-100 μ m, 150-350 μ m, 350-560 μ m, 560-710 μ m, 710-1000 μ m, 1000-1400 μ m, 1400-2000 μ m.Divided to install in the cillin bottle of sterilization in ten thousand grades of districts, every bottled amount is answered 〉=100mg, and the product that branch installs is gland at once.
(11) open the freeze dryer evacuation, when the vacuum of indication during less than 10Pa, keep 3min after, carry out tamponade.Gland is operated in 100,000 grades of districts and carries out.Different size is distinguished with the different colours bottle cap.
(12) gland is good goods carry out radiation sterilization with cobalt 60, and exposure dose is 5k, time 60h.
Embodiment 2
(1) gets the gelatin raw material 28g of 250ps, place the 500ml beaker, add 350ml water for injection, stir 1min, leave standstill swelling 1h then, all be pellucidity until gelatin particle;
(2) under 50 ℃ of water bath condition, above-mentioned gelatin solution is carried out stirring and dissolving, be transparence until solution;
(3) the clear gelatin solution after will dissolving is transferred in the 2000ml beaker, place 50 ℃ water-bath to heat, stir with electric blender, under the low or first gear stirring condition, add concentration while stirring and be 15% formalin 30ml, cover plastic paper, when foam to be had occurs, the blender rotating speed is heightened to high-grade speed (2000 rev/mins), stirred 15min, just stop to stir when making gelatin solution be the foam of uniform and smooth (the about 1600ml of volume), and rapidly solution is transferred in the refrigerator-freezer, cooling time is 50h, and cryogenic temperature is-5 ℃, until the porous spongy that is white in color.
(4) take out freezing white porous spongy product, and be not higher than 50 ℃ water for injection with temperature and thaw, the precipitate below remove the back that thaws is got the upper strata foam product.
(5) foam product that takes out is carried out hand washing 10 times, utilize the high speed dewatering machine thoroughly to dewater then, dewatering time is 1min (repeating 29 times), foam product behind the previous cleaning is cut into small pieces, artificial cleaning is placed in the dewaterer dewaters, dewatering time 2min (repeating 29 times) to remove most formaldehyde in the sponge, makes the free formaldehyde content of product meet the standard of every 100mg≤50 μ g; To wash good product then and be loaded on again in the etui, add the injection water till soaking gelatin sponge blocks, box will be transferred to below-10 ℃ freezing in the refrigerator-freezer.
(6) freezing good gelatin sponge blocks is pulverized with pulverizer, the goods that crush are packed in the box, it is standby to inject water for injection.
(7) absorbable gelatin sponge particle that crushes is put into the 5000ml beaker, inject 60 ℃ of water for injection 5000ml, put into 50 ℃ of water-baths and stir with electric blender, time 20min places the nylon mesh cloth bag then, with the dewaterer 5min that dewaters; Again change water for injection, after the repetitive operation 3 times, place the container that water for injection is housed to sieve absorbable gelatin sponge particle, sieve with 10 orders-14 order-18 order-26 order-32 order-50 order-100 order respectively.Wherein 10 orders, 14 orders, 18 orders are minimum sieves more than 5 times, 26 orders, 32 orders, 50 orders are minimum sieves more than 8 times.When sieving, every replacing should change water for injection.100 orders are minimum to sieve more than 15 times, should not have substantially when sieving for the last time and can cross granule.After sieving at every turn, remove granule and obtain the granule of each specification.
(8) will sieve good granule and add water for injection, fully mixing makes particle suspending in water, changes the lyophilizing dish over to and inserts freeze dryer and carry out evacuation, when products temperature reaches 30 ℃, continues to take out getting final product dry screen more than the lyophilizing 3h.
(9) dry screen must carry out in ten thousand grades of districts, humidity must be controlled at more than 55% in the district, the granule of each specification after the lyophilizing is crossed 10 orders-14 order-18 order-26 order-32 order-50 order-100 mesh sieve respectively carry out primary dcreening operation, the gained granule is pressed the separately independent placement of different size, each format diameter qualification rate is advisable with 50-60%, removes with ST504A ion aluminium bar when producing a large amount of static when screening.
Fine screen: the goods after will sieving, press the particle diameter method of inspection, detect each diameter respectively greater than repeatedly sieving with granule less than this regulation, until each format diameter qualification rate meet 〉=80% standard till.
(10) the sieve granule of 7 following specifications obtaining: 50-100 μ m, 150-350 μ m, 350-560 μ m, 560-710 μ m, 710-1000 μ m, 1000-1400 μ m, 1400-2000 μ m, and in ten thousand grades of districts, divided in the cillin bottle that installs to through sterilizing, every bottled amount is answered 〉=100mg, and the product that branch installs is gland at once.
(11) open the freeze dryer evacuation, when the vacuum of indication during less than 10Pa, keep 3min after, carry out tamponade.Gland is operated in 100,000 grades of districts and carries out.Different size is distinguished with the different colours bottle cap.
(12) gland is good goods carry out radiation sterilization with cobalt 60, and exposure dose is 25k, time 10h.
Claims (9)
1. one kind is the technology of feedstock production absorbable gelatin sponge particle suppository with the gelatin, may further comprise the steps:
(1) gelatin is soluble in water, add formalin under the water bath condition and stir, make white porous spongy product after freezing;
(2) white porous spongy product is thawed, remove water and formaldehyde after the washing, make gelfoam;
(3) the freezing back of gelfoam is pulverized, make absorbable gelatin sponge particle;
(4) absorbable gelatin sponge particle is thawed, insert in the water and sieve, the screening after drying;
(5) with exsiccant absorbable gelatin sponge particle screening back sterilization, make absorbable gelatin sponge particle suppository.
2. technology according to claim 1 is characterized in that: may further comprise the steps gelatin is water-soluble in the step (1):
A. gelatin is added in the entry, leave standstill swelling to gelatin particle and be pellucidity;
B. under 20-50 ℃ of water bath condition, the solution that step (a) is prepared carries out stirring and dissolving, is pellucidity until solution.
3. technology according to claim 1 is characterized in that: bath temperature is 20-50 ℃ in the step (1).
4. technology according to claim 1 is characterized in that: described formalin concentration is 1-15%, the weight ratio of formaldehyde addition and gelatin 3: 140～45: 280.
5. technology according to claim 1 is characterized in that: cryogenic temperature is-50～-10 ℃ in the step (1), and cooling time is 5-50h.
6. technology according to claim 1 is characterized in that: remove water after the washing in the described step (2) and formaldehyde may further comprise the steps:
A. the platinum sponge shape product after will thawing tentatively washs the back dehydration;
B. the porous spongy product after will dewatering is cut into small pieces, and cleans the back dehydration once more;
C. repeat the above-mentioned steps several times, make free content of formaldehyde≤50 μ g in every 100mg gelfoam.
7. technology according to claim 1 is characterized in that: stir in 20-50 ℃ of water-bath after absorbable gelatin sponge particle adds entry in the step (4), stir the back dehydration, carry out several times repeatedly, thaw.
8. technology according to claim 1 is characterized in that: the drying in the described step (4) is lyophilizing.
9. technology according to claim 1 is characterized in that: described sterilization is the co-60 radiation sterilization, and radiation dose is 5-25K, and radiated time is 10-60h.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101569344A CN101161298A (en) | 2007-11-20 | 2007-11-20 | A technique for preparing absorbable gelatin sponge particle suppository with glutin as raw material |
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| CNA2007101569344A CN101161298A (en) | 2007-11-20 | 2007-11-20 | A technique for preparing absorbable gelatin sponge particle suppository with glutin as raw material |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102139127A (en) * | 2011-03-17 | 2011-08-03 | 杭州艾力康医药科技有限公司 | Developable gelatin sponge suppository and preparation process thereof |
| CN104127909A (en) * | 2014-08-19 | 2014-11-05 | 张秀华 | Gelatin sponge for trauma hemostasis, as well as preparation method of gelatin sponge |
| CN106421882A (en) * | 2016-08-29 | 2017-02-22 | 江西天虎特种医用制品有限公司 | Absorptive hemostatic sponge |
| CN106512015A (en) * | 2015-12-18 | 2017-03-22 | Hj医疗器械有限公司 | Drug delivery system by gelatin sponge or gelatin microsphere and drug delivery system prepared thereby |
| CN107261216A (en) * | 2017-07-21 | 2017-10-20 | 四川大学 | A kind of preparation method of gelfoam support |
| CN108187128A (en) * | 2018-02-07 | 2018-06-22 | 广州迈普再生医学科技有限公司 | A kind of absorbable hemostasis bone wax and preparation method thereof |
| CN108187129A (en) * | 2018-02-07 | 2018-06-22 | 广州迈普再生医学科技有限公司 | A kind of absorbable gelatin styptic powder and preparation method thereof |
| CN108310448A (en) * | 2018-02-07 | 2018-07-24 | 广州迈普再生医学科技有限公司 | A kind of preparation method of fluid gelatin hemostatic material |
| CN110876812A (en) * | 2019-12-06 | 2020-03-13 | 赛克赛斯生物科技股份有限公司 | Gelatin sponge suppository, preparation method and application thereof, and medicine for treating vascular diseases or tumors |
| CN115252910A (en) * | 2017-10-18 | 2022-11-01 | 生命细胞公司 | Adipose tissue products and methods of production |
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2007
- 2007-11-20 CN CNA2007101569344A patent/CN101161298A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102139127A (en) * | 2011-03-17 | 2011-08-03 | 杭州艾力康医药科技有限公司 | Developable gelatin sponge suppository and preparation process thereof |
| CN104127909A (en) * | 2014-08-19 | 2014-11-05 | 张秀华 | Gelatin sponge for trauma hemostasis, as well as preparation method of gelatin sponge |
| CN106512015A (en) * | 2015-12-18 | 2017-03-22 | Hj医疗器械有限公司 | Drug delivery system by gelatin sponge or gelatin microsphere and drug delivery system prepared thereby |
| CN106421882A (en) * | 2016-08-29 | 2017-02-22 | 江西天虎特种医用制品有限公司 | Absorptive hemostatic sponge |
| CN107261216A (en) * | 2017-07-21 | 2017-10-20 | 四川大学 | A kind of preparation method of gelfoam support |
| CN115252910A (en) * | 2017-10-18 | 2022-11-01 | 生命细胞公司 | Adipose tissue products and methods of production |
| CN108187128A (en) * | 2018-02-07 | 2018-06-22 | 广州迈普再生医学科技有限公司 | A kind of absorbable hemostasis bone wax and preparation method thereof |
| CN108187129A (en) * | 2018-02-07 | 2018-06-22 | 广州迈普再生医学科技有限公司 | A kind of absorbable gelatin styptic powder and preparation method thereof |
| CN108310448A (en) * | 2018-02-07 | 2018-07-24 | 广州迈普再生医学科技有限公司 | A kind of preparation method of fluid gelatin hemostatic material |
| CN108310448B (en) * | 2018-02-07 | 2021-03-02 | 广州迈普再生医学科技股份有限公司 | Preparation method of fluid gelatin hemostatic material |
| CN108187128B (en) * | 2018-02-07 | 2021-08-31 | 广州迈普再生医学科技股份有限公司 | Absorbable hemostatic bone wax and preparation method thereof |
| CN110876812A (en) * | 2019-12-06 | 2020-03-13 | 赛克赛斯生物科技股份有限公司 | Gelatin sponge suppository, preparation method and application thereof, and medicine for treating vascular diseases or tumors |
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Open date: 20080416 |