CN1069061C - Film for preventing and treating hyperplastic scar and preparation method thereof - Google Patents
Film for preventing and treating hyperplastic scar and preparation method thereof Download PDFInfo
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- CN1069061C CN1069061C CN97106446A CN97106446A CN1069061C CN 1069061 C CN1069061 C CN 1069061C CN 97106446 A CN97106446 A CN 97106446A CN 97106446 A CN97106446 A CN 97106446A CN 1069061 C CN1069061 C CN 1069061C
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- 231100000241 scar Toxicity 0.000 title claims abstract description 28
- 238000002360 preparation method Methods 0.000 title claims 3
- 206010020718 hyperplasia Diseases 0.000 title description 5
- 230000002390 hyperplastic effect Effects 0.000 title description 2
- 230000001969 hypertrophic effect Effects 0.000 claims abstract description 12
- SHGAZHPCJJPHSC-YCNIQYBTSA-N all-trans-retinoic acid Chemical compound OC(=O)\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C SHGAZHPCJJPHSC-YCNIQYBTSA-N 0.000 claims abstract description 11
- 210000002919 epithelial cell Anatomy 0.000 claims abstract description 11
- 229960001727 tretinoin Drugs 0.000 claims abstract description 11
- 229930002330 retinoic acid Natural products 0.000 claims abstract description 10
- 239000000284 extract Substances 0.000 claims abstract description 7
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 7
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims abstract description 6
- 239000000787 lecithin Substances 0.000 claims abstract description 6
- 229940067606 lecithin Drugs 0.000 claims abstract description 6
- 235000010445 lecithin Nutrition 0.000 claims abstract description 6
- 241001648835 Polygonum cuspidatum Species 0.000 claims abstract description 5
- 235000018167 Reynoutria japonica Nutrition 0.000 claims abstract description 5
- 229940079593 drug Drugs 0.000 claims description 10
- 239000003814 drug Substances 0.000 claims description 10
- 239000003102 growth factor Substances 0.000 claims description 7
- 239000000203 mixture Substances 0.000 claims description 7
- 239000002313 adhesive film Substances 0.000 claims description 6
- 239000004677 Nylon Substances 0.000 claims description 5
- 210000002469 basement membrane Anatomy 0.000 claims description 5
- 239000003995 emulsifying agent Substances 0.000 claims description 5
- 229920001778 nylon Polymers 0.000 claims description 5
- 230000005855 radiation Effects 0.000 claims description 5
- GUTLYIVDDKVIGB-OUBTZVSYSA-N Cobalt-60 Chemical compound [60Co] GUTLYIVDDKVIGB-OUBTZVSYSA-N 0.000 claims description 4
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims description 4
- 230000010261 cell growth Effects 0.000 claims description 4
- 239000011521 glass Substances 0.000 claims description 4
- 230000008472 epithelial growth Effects 0.000 claims description 3
- 239000004033 plastic Substances 0.000 claims description 3
- 239000002131 composite material Substances 0.000 claims description 2
- 239000000084 colloidal system Substances 0.000 claims 3
- 230000002236 anti-hypertrophic effect Effects 0.000 claims 2
- 244000292697 Polygonum aviculare Species 0.000 claims 1
- 235000006386 Polygonum aviculare Nutrition 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 208000032544 Cicatrix Diseases 0.000 abstract description 16
- 230000037387 scars Effects 0.000 abstract description 15
- 230000000694 effects Effects 0.000 abstract description 13
- 210000002950 fibroblast Anatomy 0.000 abstract description 9
- 230000012010 growth Effects 0.000 abstract description 7
- 230000002265 prevention Effects 0.000 abstract description 6
- 208000024891 symptom Diseases 0.000 abstract description 6
- 230000002401 inhibitory effect Effects 0.000 abstract description 5
- 230000035755 proliferation Effects 0.000 abstract description 4
- 206010052428 Wound Diseases 0.000 abstract description 3
- 208000027418 Wounds and injury Diseases 0.000 abstract description 3
- 239000000463 material Substances 0.000 abstract description 3
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 230000002980 postoperative effect Effects 0.000 abstract description 2
- 230000036573 scar formation Effects 0.000 abstract description 2
- 241000411851 herbal medicine Species 0.000 abstract 1
- 239000004615 ingredient Substances 0.000 abstract 1
- 239000000126 substance Substances 0.000 abstract 1
- 235000015110 jellies Nutrition 0.000 description 5
- 239000008274 jelly Substances 0.000 description 5
- 230000015572 biosynthetic process Effects 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- 208000003251 Pruritus Diseases 0.000 description 2
- 210000000589 cicatrix Anatomy 0.000 description 2
- 230000007803 itching Effects 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 201000004624 Dermatitis Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 208000002260 Keloid Diseases 0.000 description 1
- 206010023330 Keloid scar Diseases 0.000 description 1
- 206010039580 Scar Diseases 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000007012 clinical effect Effects 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000005553 drilling Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 210000001117 keloid Anatomy 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 239000002985 plastic film Substances 0.000 description 1
- 229920006255 plastic film Polymers 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 210000001626 skin fibroblast Anatomy 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 230000029663 wound healing Effects 0.000 description 1
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- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
本发明提供一种防治增生性疤痕胶膜,其药物组合物含有促上皮细胞生长物质、维甲酸、卵磷脂、中草药虎杖提取物等有效成份,能促进上皮细胞生长,抑制成纤维细胞增殖,达到抑制疤痕生成和减少、减轻增生性疤痕临床症状的效果。本发明制作简单,取材方便,价格较同类产品低,防治效果明显,可广泛使用于创伤、烧伤、外科手术等术后疤痕的防治。The invention provides a film for preventing and treating hypertrophic scars. The pharmaceutical composition contains effective ingredients such as epithelial cell growth-promoting substances, retinoic acid, lecithin, and Chinese herbal medicine Polygonum cuspidatum extract, which can promote the growth of epithelial cells and inhibit the proliferation of fibroblasts. The effect of inhibiting scar formation and reducing and alleviating the clinical symptoms of hypertrophic scars. The invention is simple to manufacture, convenient to obtain materials, lower in price than similar products, and has obvious prevention and treatment effects, and can be widely used in the prevention and treatment of postoperative scars such as wounds, burns, and surgical operations.
Description
本发明属医药卫生材料领域,具体涉及一种防治皮肤疤痕增生的胶膜。The invention belongs to the field of medical and health materials, and in particular relates to an adhesive film for preventing and curing skin scar hyperplasia.
人类皮肤在创伤、烧伤后的愈合过程中,由于成纤维细胞的过度增生,会不同程度地出现疤痕增生现象,可表现为皮肤变形,有痒、痛等感觉,症状重者,会影响病人的健康和生活,以至工作。为解除广大患者的痛苦,近年来,国内外专家、学者从不同角度对创伤后疤痕增生的防治进行了研究,与本发明相关的研究有:(1)用弹力套加压治疗烧伤和整形后增生性疤痕(郭振荣等,中华医学杂志,1984(7)),临床效果较好;(2)维甲酸对体外培养成纤维细胞超微结构的影响(宋维铭等,中华整形烧伤外科杂志,1996,12(1));(3)疤痕疙瘩成纤维细胞胶原合成及调节因素的实验研究(第三军医大学学报,1996,18(1))。上述研究尚无适宜的用药途径,不能保持内环境的稳定性,用药后出现副作用,如湿疹等。During the healing process of human skin after wounds and burns, due to the excessive proliferation of fibroblasts, scar hyperplasia will appear to varying degrees, which can be manifested as skin deformation, itching, pain and other sensations. If the symptoms are severe, it will affect the patient's health. Health and life, as well as work. In order to relieve the misery of the majority of patients, in recent years, domestic and foreign experts and scholars have carried out research on the prevention and treatment of post-traumatic scar hyperplasia from different angles. Hypertrophic scars (Guo Zhenrong, etc., Chinese Medical Journal, 1984 (7)), the clinical effect is better; (2) retinoic acid on the impact of fibroblast ultrastructure in vitro (Song Weiming, etc., Chinese Journal of Plastic and Burn Surgery, 1996, 12(1)); (3) Experimental study on collagen synthesis and regulation factors of keloid fibroblasts (Journal of Third Military Medical University, 1996, 18(1)). There is no suitable drug route in the above studies, and the stability of the internal environment cannot be maintained, and side effects, such as eczema, occur after the drug is used.
本发明的目的是提供一种患者使用方便、价格便宜,能抑制疤痕生成和减少、减轻增生性疤痕临床症状的胶膜。The purpose of the present invention is to provide an adhesive film which is easy to use for patients, cheap in price, and capable of inhibiting scar formation and reducing and alleviating clinical symptoms of hypertrophic scars.
本发明根据上皮细胞生长因子能促进上皮细胞生长和一定浓度的维甲类药物能抑制皮肤成纤维细胞增殖的原理,采用接近于皮肤性能的高分子材料制成含药物组合物的胶状物,以基底膜作为载体,制成可防治增生性疤痕的胶膜。According to the principle that the epithelial cell growth factor can promote the growth of epithelial cells and a certain concentration of retinoids can inhibit the proliferation of skin fibroblasts, the present invention adopts a polymer material close to the performance of the skin to make the jelly containing the pharmaceutical composition, The basement membrane is used as a carrier to make an adhesive film that can prevent and treat hypertrophic scars.
本发明的药物组合物组成:重量百分比浓度为20%的上皮细胞生长因子20-30毫升,维甲酸20-80毫克,中草药虎杖提取物200-300毫克,所述的虎杖提取物为本领域普通技术人员所公知的水提取物,卵磷脂200-250毫克,乳化剂1.5-2.0毫升,加压敏胶至100毫升,测PH值为6.5-7.4,调制成胶状物。使用玻璃棒将本发明药物组合胶状物均匀涂抹在针织尼龙基底膜上,厚度为0.5-0.8毫米,置空气中自然干燥后,经剂量不小于20KGY钴60辐射消毒后,制成不同规格可防治增生性疤痕胶膜。经测试,胶膜透气性每24小时达30%-50%,纵向弹性达30%左右,有利于关节部位的伸缩。The composition of the pharmaceutical composition of the present invention: 20-30 milliliters of epithelial cell growth factor with a concentration of 20% by weight, 20-80 milligrams of retinoic acid, 200-300 milligrams of Chinese herbal Polygonum cuspidatum extract, which is common in the art Water extract known to the skilled person, lecithin 200-250 mg, emulsifier 1.5-2.0 ml, pressure-sensitive adhesive to 100 ml, measured pH value 6.5-7.4, prepared into jelly. Use a glass rod to evenly smear the jelly of the pharmaceutical combination of the present invention on the knitted nylon basement membrane with a thickness of 0.5-0.8 mm. After drying naturally in the air, after radiation disinfection with a dose of not less than 20KGY cobalt 60, it can be made into different specifications. Prevention and treatment of hypertrophic scar film. After testing, the air permeability of the film reaches 30%-50% every 24 hours, and the longitudinal elasticity reaches about 30%, which is conducive to the expansion and contraction of joint parts.
本发明提供下列实施例:实施例一:取浓度为20%的上皮细胞生长因子22毫升,分别加入维甲酸50毫克,虎杖提取物200毫克,卵磷脂200毫克,乳化剂1.5毫升,搅拌,加压敏胶至100毫升,测PH值为6.5,调制成胶状物,用玻璃棒均匀涂抹在针织尼龙基底膜上,厚度为0.5毫米,置空气中自然干燥后,制成4×6厘米规格的胶膜,用铝塑复合包装,经钻60辐射消毒,灭菌剂量为20KGY。实施例二:取浓度为20%的上皮细胞生长因子24毫升,分别加入维甲酸80毫克,虎杖提取物300毫克,卵磷脂250毫克,乳化剂2.0毫升,搅拌,加压敏胶至100毫升,测PH值为7.0,调制成胶状物,用玻璃棒均匀涂抹在针织尼龙基底膜上,厚度为0.8毫米,置空气中自然干燥后,制成8×12厘米规格的胶膜,用铝塑复合包装,经钴60辐射消毒,灭菌剂量为20KGY。The present invention provides the following examples: Embodiment 1: Take 22 milliliters of epithelial growth factor with a concentration of 20%, add 50 milligrams of retinoic acid, 200 milligrams of Polygonum cuspidatum extract, 200 milligrams of lecithin, 1.5 milliliters of emulsifier, stir, add Pressure-sensitive adhesive to 100 ml, the measured pH value is 6.5, prepared into a jelly, spread evenly on the knitted nylon basement membrane with a glass rod, with a thickness of 0.5 mm, and let it dry naturally in the air to make a size of 4 × 6 cm The plastic film is packaged with aluminum-plastic compound, sterilized by drilling 60 radiation, and the sterilization dose is 20KGY. Example 2: Take 24 ml of epithelial growth factor with a concentration of 20%, add 80 mg of retinoic acid, 300 mg of Polygonum cuspidatum extract, 250 mg of lecithin, 2.0 ml of emulsifier, stir, add pressure-sensitive adhesive to 100 ml, The measured pH value is 7.0, prepared into jelly, spread evenly on the knitted nylon base film with a glass rod, with a thickness of 0.8 mm, and let it dry naturally in the air to make a film with a size of 8 × 12 cm. Composite packaging, sterilized by cobalt 60 radiation, the sterilization dose is 20KGY.
本发明通过含药物组合物胶膜药物活性作用和结构上的调整达到抑制增生性疤痕形成的目的。实验证明,维甲酸在低浓度时,对成纤维细胞生长有明显抑制作用,在临床上通过外敷给药,使维甲酸透过上皮细胞来影响成纤维细胞的生长时,需要很高的浓度,此时会对皮肤产生不同程度的副作用,所以采用临床不出现副作用浓度的维甲酸类药物,对成纤维细胞无明显的抑制作用,而对上皮细胞生长有明显的促进作用,通过上皮细胞产生较多的类上皮细胞降解因子(EDF),来抑制成纤维细胞的生长。The invention achieves the purpose of inhibiting the formation of hypertrophic scars by adjusting the drug activity and structure of the film containing the drug composition. Experiments have proved that retinoic acid has a significant inhibitory effect on the growth of fibroblasts at low concentrations. In clinical practice, retinoic acid can penetrate epithelial cells to affect the growth of fibroblasts through external application. A high concentration is required. At this time, it will produce different degrees of side effects on the skin, so the use of retinoic acid drugs at concentrations that do not appear in clinical side effects has no obvious inhibitory effect on fibroblasts, but has a significant promoting effect on the growth of epithelial cells. Multi-like epithelial cell degradation factor (EDF), to inhibit the growth of fibroblasts.
本发明将276例病人分成三组:①深Ⅱ度以上创面愈合后;②增生性疤痕早期(年内);③陈旧性疤痕。进行观察治疗2个月,记录疤痕厚度、硬度、色泽以及自觉症状的变化,与瑞士产疤痕敌比较,副作用明显小,疗效显著。The present invention divides 276 cases of patients into three groups: ① after wound healing of more than 2 degrees deep; ② early hypertrophic scars (within a year); ③ old scars. Observed and treated for 2 months, and recorded the changes in scar thickness, hardness, color and subjective symptoms. Compared with Swiss Scardi, the side effects were significantly less and the curative effect was remarkable.
表一为不同类型疤痕用本发明治疗效果Table 1 is the treatment effect of the present invention for different types of cicatrix
表二为不同症状疤痕用本发明治疗效果Table two is that different symptom cicatrixes are treated with the present invention
本发明防治增生性疤痕胶膜,可促进上皮细胞生长,抑制成纤维细胞增殖;抑制疤痕生成,减轻局部炎症反应。本发明制作简单,取材方便,价格较同类产品低,防治效果好,可广泛使用于创伤、烧伤、外科手术、产科手术等的术后疤痕的防治。The invention prevents and treats the hyperplastic scar film, can promote the growth of epithelial cells, inhibit the proliferation of fibroblasts, inhibit the formation of scars, and reduce local inflammatory reactions. The invention is simple to manufacture, convenient to obtain materials, lower in price than similar products, good in prevention and treatment effect, and can be widely used in the prevention and treatment of postoperative scars in wounds, burns, surgical operations, obstetrical operations and the like.
表一:不同类型疤痕治疗效果
表二:不同症状疤痕治疗效果
Claims (6)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97106446A CN1069061C (en) | 1997-06-03 | 1997-06-03 | Film for preventing and treating hyperplastic scar and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97106446A CN1069061C (en) | 1997-06-03 | 1997-06-03 | Film for preventing and treating hyperplastic scar and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1177500A CN1177500A (en) | 1998-04-01 |
| CN1069061C true CN1069061C (en) | 2001-08-01 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN97106446A Expired - Fee Related CN1069061C (en) | 1997-06-03 | 1997-06-03 | Film for preventing and treating hyperplastic scar and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100405994C (en) * | 2001-09-07 | 2008-07-30 | 米歇尔·吉洛特 | Orthotics for scar tissue treatment |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1047802A (en) * | 1989-04-17 | 1990-12-19 | 马克森姆有限公司 | Moisturing vehicle for topical application of vitamin a acid |
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1997
- 1997-06-03 CN CN97106446A patent/CN1069061C/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1047802A (en) * | 1989-04-17 | 1990-12-19 | 马克森姆有限公司 | Moisturing vehicle for topical application of vitamin a acid |
Non-Patent Citations (3)
| Title |
|---|
| 中华整形烧伤外科杂志11卷2期 1995.3.1 宋维铭等,维甲酸对体外培养成纤维细胞DNA合成的影响 * |
| 中华整形烧伤外科杂志11卷2期 1995.3.1 宋维铭等,维甲酸对体外培养成纤维细胞DNA合成的影响;中华整形烧伤外科杂志12卷1期 1996.1.1 宋维铭等,维甲酸对体外培养成纤维细胞超微结构的影响 * |
| 中华整形烧伤外科杂志12卷1期 1996.1.1 宋维铭等,维甲酸对体外培养成纤维细胞超微结构的影响 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100405994C (en) * | 2001-09-07 | 2008-07-30 | 米歇尔·吉洛特 | Orthotics for scar tissue treatment |
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| CN1177500A (en) | 1998-04-01 |
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