CN2320230Y - Scar-eliminating silica-gel film - Google Patents
Scar-eliminating silica-gel film Download PDFInfo
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- CN2320230Y CN2320230Y CN 98223065 CN98223065U CN2320230Y CN 2320230 Y CN2320230 Y CN 2320230Y CN 98223065 CN98223065 CN 98223065 CN 98223065 U CN98223065 U CN 98223065U CN 2320230 Y CN2320230 Y CN 2320230Y
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- cicatrix
- scar
- gel film
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Abstract
The utility model relates to a medical material, particularly a silica gel film which is used for preventing and treating hyperplastic scars. The scar eliminating silica gel film of the utility model (additional name ' a scar contact') comprises a bottom skin layer (1), a terylene net layer (2) and a mixed layer (3). The scar contact has good effect on preventing scar hyperplasia and treating hyperplastic scars, having the advantages of nontoxicity, no stimulation, no antigenicity, no carcinogenicity and teratogenicity, no complications, safe utilization and no pain. The utility model can carry out treatment without the need of hospitalization.
Description
This utility model relates to a kind of medical material, is specifically related to the silicate gel film of a kind of prevention and treatment hypertrophic cicatrix.
The control of all kinds hypertrophic cicatrix remains a great problem of burn and shaping wound subject at present.Though traditional Therapeutic Method also has certain effect, mostly fail to reach ideal effect.Up to the eighties initial stage, foreign scholar Perkins is applied to silicate gel film cicatrix patient's treatment first, and thinks that this method can promote cicatrix ripe softening effectively, improves because of the joint caused dysfunction state of scar contracture.For needs clinically, the brainstrust of the collaborative domestic burn shaping subject of Shanghai Dong Yue Medical Health Product Co., Ltd is summed up and has been studied external nearly ten years relevant documents and materials, succeeds in developing Scar-eliminating silica-gel film (having another name called " cicatrix subsides ").
This utility model provides a kind of Scar-eliminating silica-gel film (cicatrix subsides), and it comprises end cortex, terylene stratum reticulare and mixed layer.End cortex is that the aspect that consolidates that cicatrix pastes is again simultaneously flexible reductive basic layer, and it is to adopt to have high-tensile silicone rubber and be made; The terylene stratum reticulare is close between end cortex and the mixed layer, and for strengthening stratum reticulare, its effect is the twisting that restriction stretches, slows down the wound cicatrix, promotes the seriality of wound cicatrix inherent mechanism motion; Mixed layer is made up of silicon gel and silicone oil, direct and skin is pasted, main physical therapy layer and bacterial barriers for the cicatrix subsides, its effect is to promote the cicatrix maturation to soften, suppress scar hyperplasia etc., have simultaneously characteristics such as preserve moisture, breathe freely again, silicone oil becomes the suspendible shape among being mixed in the silicon gel, and the slow releasing function of silicone oil does not influence the viscosity of mixed layer, and it is smooth, moist to help the cicatrix skin surface.I, Scar-eliminating silica-gel film of the present utility model (cicatrix subsides) cell toxicity test are as follows: one, test sample:
Title: cicatrix pastes specification: 12 * 15cm, is provided by Shanghai Dong Yue Medical Health Product Co., Ltd.Two, test period:
On May 22, three in one nine nine seven on April 8, to one nine nine seven, cell strain:
L-929 fibroblast four, capital equipment and reagent:
Superclean bench, optical microscope, inverted microscope, RPMI-1640, calf serum, cell dissociation buffer etc.Five, test method and basis for estimation:
Carry out with reference to GB/T16175-1996 " medical organosilicon material biological assessment test method " the 4th clause method.Six, result of the test:
Cellular morphology is observed and is seen that test sample group cellular morphology is normal, and adherent growth is good, is prismatic or sealene triangle, and even visible cell circle contracts, and test sample group cellular morphology is same as negative control group.Propagation degree test relatively: the relative propagation degree of test sample group is 1 grade (classification: 0～5 grade).Seven, conclusion:
This product degree of propagation relatively is 1 grade, is nontoxic in conjunction with the cellular morphology analysis, and overall merit is qualified.II, the acute general toxicity of Scar-eliminating silica-gel film of the present utility model (cicatrix subsides) are tested as follows: one, test sample:
Title: cicatrix pastes specification: 12 * 15cm, is provided by Shanghai Dong Yue Medical Health Product Co., Ltd.Two, test period:
On March 21, three in one nine nine seven on March 18, to one nine nine seven, laboratory animal:
Kunming mouse, health and epidemic prevention station provides by Shanghai City.Four, capital equipment and reagent:
Pressure steam sterilizer, animal balance, 0.9% sodium chloride injection and plant wet goods.Five, test method and basis for estimation:
Carry out with reference to GB/T16175-1996 " medical organosilicon material biological assessment test method " the 10th clause method.Six, result of the test:
Test sample 0.9% sodium chloride injection lixiviating solution is organized interior 5 mices in 72 hour observation period after giving mouse mainline, there is no signs of toxicity.
Test sample vegetable oil lixiviating solution is organized interior 5 mices in 72 hour observation period after injecting to mouse peritoneal, there is no signs of toxicity.Seven, conclusion:
According to above-mentioned test result, this product lixiviating solution meets acute general toxicity test requirements document.III, Scar-eliminating silica-gel film of the present utility model (cicatrix subsides) Intradermal irritant test are as follows: one, test sample:
Title: cicatrix pastes specification: 12 * 15cm, is provided by Shanghai Dong Yue Medical Health Product Co., Ltd.Two, test period:
On April 17, three in one nine nine seven on April 14, to one nine nine seven, laboratory animal:
Healthy new zealand rabbit is provided by pine connection feed lot.Four, capital equipment and reagent:
Pressure steam sterilizer, rabbit holder, intradermal syringe, 0.9% sodium chloride injection and plant wet goods.Five, test method and basis for estimation:
Carry out with reference to GB/T16175-1996 " medical organosilicon material biological assessment test method " the 6th clause method.Six, result of the test:
After test sample 0.9% sodium chloride injection lixiviating solution, test sample vegetable oil lixiviating solution and the injection of contrast liquid, observed in 24 hours, 48 hours, 72 hours, test sample 0.9% sodium chloride injection lixiviating solution injection site and surrounding skin are organized and erythema, edema and necrosis are not occurred; O'clock complete obiteration in 24 hours of intradermal injection protuberance.Test sample vegetable oil lixiviating solution injection site and surrounding skin are organized and erythema, edema and necrosis are not occurred; The slow phenomenon that disappears all appearred in intradermal injection protuberance point at 24 hours, 48 hours, the basic disappearance of protuberance point in 72 hours.Seven, conclusion:
According to above-mentioned test result, after rabbit was given two kinds of lixiviating solution injections of test sample, keep the score was 0 to its dermoreaction (erythema, edema), shows that this product lixiviating solution has no stimulation to skin.IV, Scar-eliminating silica-gel film of the present utility model (cicatrix subsides) sensitization of skin are tested as follows: one, test sample:
Title: cicatrix pastes specification: 12 * 15cm, is provided by Shanghai Dong Yue Medical Health Product Co., Ltd.Two, test period:
On April 19, three in one nine nine seven on March 19, to one nine nine seven, laboratory animal:
Albino guinea-pig is provided along precious medical laboratory animal breeding farm by Shanghai Tao Pu.Four, capital equipment and reagent:
Pressure steam sterilizer, electric razor, blank substrate cream (providing), 2 by Shanghai Dong Yue Medical Health Product Co., Ltd, 4-chloronitrobenzene (DNCB) (producing) etc. by Shanghai reagent one factory.Five, test method and basis for estimation:
Carry out with reference to GB/T16175-1996 " medical organosilicon material biological assessment test method " the 6th clause method.Six, result of the test: 1, anaphylaxiss such as erythema, edema all do not appear in all guinea pig skins of test sample group.The sensitivity response meansigma methods of keeping the score is 0, and the sensitization rate is 0%.2, anaphylaxiss such as erythema, edema all do not appear in all guinea pig skins of blank matrix group.The sensitivity response meansigma methods of keeping the score is 0, and the sensitization rate is 0%.3, DNCB organizes all guinea pig skins and anaphylaxis such as erythema, edema in various degree all occurs.The sensitivity response meansigma methods of keeping the score is 3, and the sensitization rate is 100%.Seven, conclusion:
According to The above results, the sensitization of skin reaction that cicatrix pastes is negative.
The check unit of above I～IV is medicine test institute of Shanghai City Drug Administration.The clinical experiment of V, Scar-eliminating silica-gel film of the present utility model (cicatrix subsides) is as follows:
1995-1997, successively in Shanghai attached the 9th the People's Hospital of second medical courses in general, Hangzhou, Zhejiang province redly defend hospital, Chongqing attached southwestern hospital of medical university of the army, breathe out how tame hospitals such as attached first and second hospital of medical university, Zhenjiang, Jiangsu Province hospital attached to a medical college, Anyang, Henan Province iron and steel hospital totally 862 routine cicatrix cases carry out the clinical experiment observation, wherein lose visit person's 68 examples midway, do not adhere to therapist 17 examples, 777 examples that have the data of following up a case by regular visits to make an appraisal, totally 997 positions.One, pastes the prevention of scar hypertrophy with cicatrix
Have 568 examples, 687 positions.(1) using method: all promptly begin to use after wound surface or operative incision heal fully, be 2-6 month service time, till not having a scar hyperplasia sign.(2) efficacy assessment standard produce effects: cicatrix is not higher than the normal skin face, and matter is soft, and color and luster is normal, no telangiectasis,
Painless, itch.Effectively: cicatrix is higher than the normal skin face and is no more than 1mm, and matter is slightly hard, and color is little red, have by chance bitterly,
Itch.Not good enough or invalid: cicatrix is higher than normal skin face 1mm, and the cicatrix symptom is obvious.(3) result
Different-effect may occur in order to distinguish different situations application cicatrix subsides prevention of scar hypertrophy, classify, be divided into four types, see Table 1 according to the different causes of disease of wound surface.Table 1 pastes the outgrowth clinical effectiveness of prevention of scar with cicatrix
| The statistics group | Add up to | Produce effects | Effectively | Not good enough or invalid | ||||
| The example number | The position | Example number (%) | Position (%) | Example number (%) | Position (%) | Example number (%) | Position (%) | |
| Burn back healing wound surface | 74 | 136 | 55 (74.3) | 102 (75) | 12 (16.2) | 22 (16.2) | 7 (9.5) | 12 (8.8) |
| Wound behind the operation stitching | 314 | 342 | 261 (83.1) | 287 (83.9) | 37 (11.8) | 39 (11.4) | 16 (5.1) | 16 (4.7) |
| In thick cortical areas | 101 | 113 | 81 (80.2) | 88 (77.9) | 12 (11.9) | 13 (11.5) | 8 (8) | 12 (10.6) |
| Middle pachydermia value dermatotome | 79 | 96 | 62 (78.5) | 72 (75) | 12 (15.2) | 13 (13.5) | 5 (6.3) | 11 (11.5) |
| Add up to | 568 | 687 | 459 (79.2) | 549 (77.95) | 73 (13.78) | 87 (13.15) | 36 (7.23) | 51 (8.9) |
Show that more than best results is a wound behind the operation stitching.Preferable through observing with the very fast person's effect of wound healing, burn back healing wound surface, wherein boiled water is scalded and will be got well than the effect of flame, blast or chemical burn.Two, paste the treatment hypertrophic cicatrix with cicatrix
Have 209 examples, 310 positions.(1) using method: decide on the cicatrix time of origin service time, and be 3-12 month service time.(2) efficacy assessment standard: produce effects: cicatrix thickness surpasses 0.45cm person, and the treatment back reduces more than 2/3; Cicatrix thickness is low
In 0.45cm person, treatment back cicatrix flattens substantially, and qualitative change is soft, and color and luster obviously shoals,
The sufferings symptom disappears substantially.Effectively: treatment back cicatrix thickness reduces 1/3-2/3, and color and luster shoals, the obvious deliquescing of hardness,
Do not have or mild pain is only arranged, itch.Not good enough or invalid: the cicatrix symptom only has slight improvement or does not have significant change.(3) result
Under different situations, use the different-effect that cicatrix subsides treatment hypertrophic cicatrix may occur for distinguishing, classify according to the time and the different causes of disease of wound surface that cicatrix takes place.It the results are shown in Table 2.Table 2 pastes the clinical effectiveness of treatment hypertrophic cicatrix with cicatrix
| The statistics group | Add up to | Produce effects | Effectively | Not good enough or invalid | ||||
| The example number | The position | Example number (%) | Position (%) | Example number (%) | Position (%) | Example number (%) | Position (%) | |
| 6 months with interior burn back cicatrix | 38 | 53 | 27 (71) | 38 (72) | 7 (18.5) | 11 (20.5) | 4 (10.5) | 4 (7.5) |
| 6 months with interior operation back cicatrix | 52 | 72 | 43 (82.7) | 60 (83.3) | 6 (11.6) | 8 (11.1) | 3 (5.7) | 4 (5.6) |
| 6-12 month burn back cicatrix | 27 | 44 | 17 (63) | 28 (63.6) | 6 (22.2) | 9 (20.5) | 4 (14.8) | 7 (15.9) |
| 6-12 month operation back cicatrix | 32 | 47 | 25 (78.1) | 36 (76.6) | 4 (12.5) | 6 (12.8) | 3 (9.4) | 5 (10.6) |
| Burn back cicatrix more than 12 months | 31 | 49 | 17 (54.8) | 27 (55.1) | 7 (22.6) | 12 (24.5) | 7 (22.6) | 10 (20.4) |
| Operation back cicatrix more than 12 months | 29 | 45 | 20 (69.2) | 31 (69) | 5 (17.2) | 7 (15.5) | 4 (13.8) | 7 (15.5) |
| Add up to | 209 | 310 | 149 (69.8) | 220 (69.9) | 35 (17.4) | 53 (17.5) | 25 (12.8) | 37 (12.58) |
Show that more than therapeutic effect was with 6 months hypertrophic cicatrix best results with interior wound or the generation of operation back.The time that cicatrix takes place is long more, and treatment time is also just corresponding long more, and effect is also relatively poor.In the case that curative effect takes place, the cicatrix precipitin takes place at first to shoal, sx, quality deliquescing gradually then just occurred cicatrix thickness later on and reduces in general 2 months.If cicatrix is in the propagation phase, in case the cicatrix of stopping using pastes, cicatrix still can develop.
The utility model is described in further detail below in conjunction with drawings and Examples.
Fig. 1 is the generalized section of cutting of the alleged Scar-eliminating silica-gel film of this utility model (cicatrix subsides).
In Fig. 1,1 is end cortex, and 2 is the terylene stratum reticulare, and 3 is mixed layer.When making the cicatrix subsides, refine glue, vulcanize and make end cortex 1 with regard to silicone rubber earlier.Prepare silicon gel then, and make silicone oil become mixed layer 3, evacuation among being suspended in the silicon gel.Shop fixtures cortex 1, terylene stratum reticulare 2 and mixed layer 3 successively in mould are smoked then, are vulcanized.Precut packing at last.
The a large amount of clinical trials of Scar-eliminating silica-gel film (cicatrix subsides) process that this utility model is alleged illustrate it aspect prevention of scar hypertrophy and treatment hypertrophic cicatrix two, and effect is good.Cicatrix pastes avirulence, nonirritant, and no antigen does not have carcinogenic teratogenecity, and no complication is safe in utilization, no pain, and can not need be in hospital and just can treat.In sum, use cicatrix subsides control hypertrophic cicatrix and obviously be better than traditional operative therapy, pressure therapy, steroid hormone pharmacotherapy and X-ray therapy etc.
Claims (1)
1, a kind of Scar-eliminating silica-gel film (cicatrix subsides), it is characterized in that it comprises end cortex (1), terylene stratum reticulare (2) and mixed layer (3), wherein end cortex (1) is made by silicone rubber, terylene stratum reticulare (2) is close between end cortex (1) and the mixed layer (3), mixed layer (3) is made up of silicon gel and silicone oil, and direct and skin is pasted.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 98223065 CN2320230Y (en) | 1998-01-14 | 1998-01-14 | Scar-eliminating silica-gel film |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 98223065 CN2320230Y (en) | 1998-01-14 | 1998-01-14 | Scar-eliminating silica-gel film |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN2320230Y true CN2320230Y (en) | 1999-05-26 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 98223065 Expired - Lifetime CN2320230Y (en) | 1998-01-14 | 1998-01-14 | Scar-eliminating silica-gel film |
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| Country | Link |
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| CN (1) | CN2320230Y (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100405994C (en) * | 2001-09-07 | 2008-07-30 | 米歇尔·吉洛特 | Orthosis for scar tissue treatment |
| CN100425216C (en) * | 2003-02-13 | 2008-10-15 | 上海东月医疗保健用品有限公司 | Filling type fortified scar plaster and method for making same |
| CN100544728C (en) * | 2005-08-12 | 2009-09-30 | 中国人民解放军第三军医大学第二附属医院 | A kind of anti-scar drug film and preparation method thereof |
| CN103495155A (en) * | 2013-09-25 | 2014-01-08 | 南阳市汇博生物技术有限公司 | Film for hyperplastic scar repair and preparation method thereof |
| CN105288701A (en) * | 2015-11-27 | 2016-02-03 | 上海诺月医疗科技有限公司 | Silica gel dressing film and production method thereof |
| CN105816271A (en) * | 2015-01-05 | 2016-08-03 | 陕西远光高科技有限公司 | Medical functional silica gel dressing material |
-
1998
- 1998-01-14 CN CN 98223065 patent/CN2320230Y/en not_active Expired - Lifetime
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100405994C (en) * | 2001-09-07 | 2008-07-30 | 米歇尔·吉洛特 | Orthosis for scar tissue treatment |
| CN100425216C (en) * | 2003-02-13 | 2008-10-15 | 上海东月医疗保健用品有限公司 | Filling type fortified scar plaster and method for making same |
| CN100544728C (en) * | 2005-08-12 | 2009-09-30 | 中国人民解放军第三军医大学第二附属医院 | A kind of anti-scar drug film and preparation method thereof |
| CN103495155A (en) * | 2013-09-25 | 2014-01-08 | 南阳市汇博生物技术有限公司 | Film for hyperplastic scar repair and preparation method thereof |
| CN103495155B (en) * | 2013-09-25 | 2015-10-14 | 南阳市汇博生物技术有限公司 | For pad pasting that hypertrophic cicatrix is repaired and preparation method thereof |
| CN105250995A (en) * | 2013-09-25 | 2016-01-20 | 南阳市汇博生物技术有限公司 | Hyperplastic scar repair plaster and preparing method thereof |
| CN105250995B (en) * | 2013-09-25 | 2018-06-22 | 河南汇博医疗股份有限公司 | Hyperplastic scar repairs pad pasting and preparation method thereof |
| CN105816271A (en) * | 2015-01-05 | 2016-08-03 | 陕西远光高科技有限公司 | Medical functional silica gel dressing material |
| CN105288701A (en) * | 2015-11-27 | 2016-02-03 | 上海诺月医疗科技有限公司 | Silica gel dressing film and production method thereof |
| CN105288701B (en) * | 2015-11-27 | 2018-12-28 | 上海诺月医疗科技有限公司 | Silica hydrogel dressing membrane and preparation method thereof |
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|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |