CN114681628A - 一种温和无刺激医用超声凝胶及其制备方法 - Google Patents
一种温和无刺激医用超声凝胶及其制备方法 Download PDFInfo
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- CN114681628A CN114681628A CN202210076636.9A CN202210076636A CN114681628A CN 114681628 A CN114681628 A CN 114681628A CN 202210076636 A CN202210076636 A CN 202210076636A CN 114681628 A CN114681628 A CN 114681628A
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- Medicinal Preparation (AREA)
Abstract
本发明公开了一种温和无刺激医用超声凝胶及其制备方法,包括如下组份及质量百分比:卡波姆聚合物增稠剂1~3%;碱性黏度调节剂0.1~0.3%;杀菌剂0.03~0.1%;防腐剂0.1~0.5%;润肤保湿剂0.2~6%;防腐增效剂0.05~0.2%;润滑增效剂、植物组分及pH调节剂0.1~1.0%,余量为纯化水;所述卡波姆聚合物型号为卡波姆941;碱性黏度调节剂为三乙醇胺;杀菌剂为月桂酰精氨酸乙酯盐酸盐;防腐剂为辛二醇或苯氧乙醇;润肤保湿剂为1,2‑丙二醇或透明质酸;防腐增效剂为乙基己基甘油或谷氨酸二乙酸四钠;润滑增效剂为烷基糖苷;植物成分为芦荟汁;pH调节剂为柠檬酸。本发明产品通过有关超声特性阻抗、杀菌率、皮肤刺激性等试验,完全符合超声凝胶使用要求。
Description
技术领域
本发明属于超声凝胶技术领域,涉及一种温和无刺激医用超声凝胶及其制备方法。
背景技术
超声检查是现代医学的重要组成部分,其基本要求是能有效地传输声波,图像清晰,对探头无损伤,对人体无毒、无刺激。由于超声探头频繁地与不同病人检测部位进行接触,容易产生交叉感染,特别对腔道、粘膜、不完整皮肤、针刺等超声检测,因此超声凝胶需要消毒功效。
超声凝胶配方的重点在于选用高效无刺激的杀菌体系,因为其与人体接触,重要的是和某些粘膜接触,对皮肤的温和性,毒理安全性要求。
CN201610528765公开了一种具备杀菌作用的新型腔道用超声凝胶及其制备方法,成分包括壳聚糖,三氯羟基二苯醚,醋酸氯己定,聚山梨酯80,卡波姆,甘油,三乙醇胺,纯化水。由于三氯生的危害性,2016年美国FDA禁止在洗手液和沐浴露中添加三氯生。此前也有研究表示三氯生有轻度致畸性和可损伤肌肉功能的危害。
CN201210069748公开了一种医用消毒超声凝胶组合物及其制备方法,该超声凝胶组合物中包括0.1~3%质量百分比的醛类杀菌剂、0.3~3%质量百分比的水溶性高分子、0.05~1%质量百分比的杀菌增效剂、0.05~1%质量百分比的稳定剂、1~5%质量百分比的润肤保湿剂、pH调控组分、余量为纯化水。由于醛类的危害及气味,使其逐渐失去在医疗产品中的应用。2021年10月14日,欧盟向世界贸易组织WTO递交G/TBT/N/EU/844号通报,旨在修订现行关于含甲醛缓释体化妆品的标签规定,计划将警示语标记阈值由0.05%降至0.001%,这就意味着醛缓蚀剂要退出化妆品市场,因为10ppm的醛类几乎没有杀菌作用,而且由于某些原料可能含醛,产品中绝不会使用醛类杀菌剂,因为极易被监管部门检测醛超标。
加拿大斯迈索尼卡股份有限公司申请的专利US 62276,927中,制得的超声凝胶需要辐射处理杀菌,但使用时的开启极易二次被微生物污染。虽然其中加入防腐剂山梨酸钾,但从防腐专业的角度讲,不到0.1%的山梨酸钾确实不能起到有效的防腐作用。正像其中实施例1所示包含:纯净水1100g、Carbopol 974P NF 13g、氢氧化钾18g、Club HouseTM绿色食用色素1mL、木糖醇5g、山梨酸钾1g、甘油50g。
现有技术要么使用禁用或毒性高的消毒杀菌剂在凝胶中,要么在使用中会遭到二次污染失去消毒作用。因此,市场急需一种无刺激,无毒副作用,对人体温和友好的医用超声凝胶产品。
发明内容
本发明的目的是提供一种无刺激,无毒副作用,对人体温和友好的医用超声凝胶及其制备方法。
为实现上述目的,本发明采用的技术方案为:
该医用超声凝胶包括如下组份及质量百分比:卡波姆聚合物增稠剂1~3%;碱性黏度调节剂0.1~0.3%;杀菌剂0.03~0.1%;防腐剂0.1~0.5%;润肤保湿剂0.2~6%;防腐增效剂0.05~0.2%;润滑增效剂、植物组分及pH调节剂0.1~ 1.0%,余量为纯化水;所述卡波姆聚合物型号为卡波姆941;碱性黏度调节剂为三乙醇胺;杀菌剂为月桂酰精氨酸乙酯盐酸盐(LAE);防腐剂为辛二醇或苯氧乙醇;润肤保湿剂为1,2-丙二醇或透明质酸;防腐增效剂为乙基己基甘油或谷氨酸二乙酸四钠(GLDA);润滑增效剂为烷基糖苷;植物成分为芦荟汁;pH调节剂为柠檬酸。
上述所述医用超声凝胶优选的组份及质量百分比为:卡波姆聚合物增稠剂 1~2%;碱性黏度调节剂0.1~0.2%;杀菌剂0.06~0.1%;防腐剂0.1~0.3%;润肤保湿剂0.2~3%;防腐增效剂0.05~0.1%;润滑增效剂、植物组分及pH调节剂0.1~0.3%,余量为纯化水。
上述所得医用超声凝胶黏度为12000~18000cP,pH值为5.5~6.5。
该医用超声凝胶的制备方法包括如下步骤:
①搅拌下,将润肤保湿剂及卡波姆聚合物增稠剂溶于纯化水中,直至形成透明的溶液待用;
②将防腐增效剂及杀菌剂溶解在少量纯化水中待用;
③将防腐剂及防腐增效剂溶解在润肤保湿剂中待用;
④搅拌步骤①所得溶液,将步骤②所得溶液加入步骤①所得溶液中并搅拌均匀,再把碱性黏度调节剂加入上述溶液中形成胶体,继续搅拌下,再加入步骤③所得溶液和植物成分得到粘稠的无色透明状膏体,最后,再加入润滑增效剂后得到高黏度高滑润度的膏体,最后用pH调节剂调pH=5.5-6.5,即得;
所述卡波姆聚合物型号为卡波姆941;杀菌剂为月桂酰精氨酸乙酯盐酸盐 (LAE);碱性黏度调节剂为三乙醇胺;防腐剂为辛二醇或苯氧乙醇;防腐增效剂为乙基己基甘油或谷氨酸二乙酸四钠(GLDA);润肤保湿剂为1,2-丙二醇或透明质酸;润滑增效剂为烷基糖苷;植物成分为芦荟汁;pH调节剂为柠檬酸。
与现有技术相比,本发明具有如下有益效果:
1、杀菌防腐剂及增效剂选用最前沿的绿色原料:杀菌剂采用国际上最新用于食品的食品级杀菌剂月桂酰精氨酸乙酯盐酸盐(LAE),其杰出的杀菌效果和极高的毒理安全性得到普遍推崇。LAE对人体表面常见的微生物的最低抑菌浓度均为几个到几十个ppm。2020年12月,国家市场监督管理总局将其列入化妆品防腐剂,对人体体臭具有很好的抑制效果(ES9500027W·1995-03-08)。我国正在参考欧盟相关标准制定其用于食品中防腐杀菌的产品标准。杀菌增效剂选用对人体无刺激的乙基己基甘油,这是一种多功能化妆品添加剂,具有保湿、除臭,促进主杀菌剂效能的作用,因其特殊的亲水亲油特点,促使杀菌剂或防腐剂快速进入微生物细胞内。防腐剂选用使用频度最高的苯氧乙醇,或者温和的辛二醇,与皮肤高度相容。螯合剂(也可称为防腐增效剂,因为金属离子是某些微生物代谢的重要保障,金属离子被螯合后,微生物代谢困难)选用极易降解的以氨基酸为基础的谷氨酸二乙酸四钠,一改传统的EDTA二钠。
2、本发明方法中首次采用润滑促进剂,少量烷基糖苷的加入,极大地改进了凝胶的润滑度。作为一个非离子表面活性剂,在本发明的体系中独特的体现了这一作用,而通常的表面活性剂则无此作用。
3、保湿剂选用1,2-丙二醇或透明质酸。透明质酸的高保湿性及安全性(发酵而得)得到化妆品和医药的广泛使用。1,2-丙二醇除优秀的保湿性外,其粘滞性明显小于甘油,对于凝胶的润滑性提供益处。
4、配方中加芦荟汁,利用了其保湿,抗菌的特点。
5、整个配方集绿色原料为一体,科学配伍,利用专业的抗菌技术与丰富的日化产品制备经验,结合医疗超声检查的特点完成了本发明,产品通过有关超声特性阻抗、杀菌率、皮肤刺激性等试验,完全符合超声凝胶使用要求,使得本发明和现有技术相比具有显著的技术进步。
具体实施方式:
实施例1:
产品配比:透明质酸5g,卡波姆941聚合物10g,谷氨酸二乙酸四钠(GLDA) 1g,月桂酰精氨酸乙酯盐酸盐(LAE)0.6g,苯氧乙醇2g,乙基己基甘油1g, 1,2-丙二醇20g,三乙醇胺2g,芦荟汁20g,烷基糖苷2g,柠檬酸适量,余量为纯化水。
制备方法:①按重量份取透明质酸5g,卡波姆941聚合物10g,搅拌下将透明质酸及卡波姆941聚合物溶于800g水中直到形成透明的溶液待用;
②100g水溶解1g谷氨酸二乙酸四钠(GLDA)和0.6g月桂酰精氨酸乙酯盐酸盐(LAE)待用;
③将2g苯氧乙醇,1g乙基己基甘油溶在20g1,2-丙二醇中待用;
④将步骤②溶液加入①溶液中搅拌均匀,再把2g三乙醇胺加入上述溶液中形成胶体,继续搅拌下加入步骤③溶液和20g芦荟汁得到粘稠的无色透明状膏体。之后加入2g烷基糖苷后得到高黏度高滑润度的膏体,最后用适量柠檬酸调 pH=5.5,用纯化水定容至1000g,真空除气5分钟,灌装即得到黏度为13500cP 的医用凝胶产品。
实施例2:
产品配比:透明质酸6g,卡波姆941聚合物12g,谷氨酸二乙酸四钠(GLDA) 0.8g,月桂酰精氨酸乙酯盐酸盐(LAE)1g,苯氧乙醇2.5g,乙基己基甘油0.8g, 1,2-丙二醇22g,三乙醇胺2g,芦荟汁22g,烷基糖苷2.5g,柠檬酸适量,余量为纯化水。
制备方法:①按重量份取透明质酸6g,卡波姆941聚合物12g,搅拌下将透明质酸及卡波姆941聚合物溶于800g水中直到形成透明的溶液待用;
②100g水溶解0.8g谷氨酸二乙酸四钠(GLDA)和1g月桂酰精氨酸乙酯盐酸盐(LAE)待用;
③将2.5g苯氧乙醇,0.8g乙基己基甘油溶在22g1,2-丙二醇中待用;
④将步骤②溶液加入①溶液中搅拌均匀,再把2g三乙醇胺加入上述溶液中形成胶体,继续搅拌下加入步骤③溶液和22g芦荟汁得到粘稠的无色透明状膏体。之后加入2.5g烷基糖苷后得到高黏度高滑润度的膏体,最后用适量柠檬酸调 pH=5.6,用纯化水定容至1000g,真空除气5分钟,灌装即得到黏度为15500cP 的医用凝胶产品。
实施例3:
产品配比:透明质酸5.5g,卡波姆941聚合物11g,谷氨酸二乙酸四钠(GLDA) 0.9g,月桂酰精氨酸乙酯盐酸盐(LAE)0.9g,苯氧乙醇2.2g,乙基己基甘油 0.9g,1,2-丙二醇25g,三乙醇胺1.8g,芦荟汁20g,烷基糖苷2g,柠檬酸适量,余量为纯化水。
制备方法:①按重量份取透明质酸5.5g,卡波姆941聚合物11g,搅拌下将透明质酸及卡波姆941聚合物溶于800g水中直到形成透明的溶液待用;
②100g水溶解0.9g谷氨酸二乙酸四钠(GLDA)和0.9g月桂酰精氨酸乙酯盐酸盐(LAE)待用;
③将2.2g苯氧乙醇,0.9g乙基己基甘油溶在25g1,2-丙二醇中待用;
④将步骤②溶液加入①溶液中搅拌均匀,再把1.8g三乙醇胺加入上述溶液中形成胶体,继续搅拌下加入步骤③溶液和20g芦荟汁得到粘稠的无色透明状膏体。之后加入2g烷基糖苷后得到高黏度高滑润度的膏体,最后用适量柠檬酸调 pH=5.8,用纯化水定容至1000g,真空除气5分钟,灌装即得到黏度为14600cP 的医用凝胶产品。
实施例4:
产品配比:透明质酸5g,卡波姆941聚合物15g,谷氨酸二乙酸四钠(GLDA) 0.7g,月桂酰精氨酸乙酯盐酸盐(LAE)0.8g,苯氧乙醇2.4g,乙基己基甘油 0.7g,1,2-丙二醇18g,三乙醇胺1.6g,芦荟汁12g,烷基糖苷1.5g,柠檬酸适量,余量为纯化水。
制备方法:①按重量份取透明质酸5g,卡波姆941聚合物15g,搅拌下将透明质酸及卡波姆941聚合物溶于800g水中直到形成透明的溶液待用;
②100g水溶解0.7g谷氨酸二乙酸四钠(GLDA)和0.8g月桂酰精氨酸乙酯盐酸盐(LAE)待用;
③将2.4g苯氧乙醇,0.7g乙基己基甘油溶在18g1,2-丙二醇中待用;
④将步骤②溶液加入①溶液中搅拌均匀,再把1.6g三乙醇胺加入上述溶液中形成胶体,继续搅拌下加入步骤③溶液和12g芦荟汁得到粘稠的无色透明状膏体。之后加入1.5g烷基糖苷后得到高黏度高滑润度的膏体,最后用适量柠檬酸调 pH=6.2,用纯化水定容至1000g,真空除气5分钟,灌装即得到黏度为16200cP 的医用凝胶产品。
实施例5:
产品配比:透明质酸4.5g,卡波姆941聚合物13g,谷氨酸二乙酸四钠(GLDA) 0.6g,月桂酰精氨酸乙酯盐酸盐(LAE)0.9g,苯氧乙醇1.5g,乙基己基甘油 0.6g,1,2-丙二醇10g,三乙醇胺1.8g,芦荟汁16g,烷基糖苷1.2g,柠檬酸适量,余量为纯化水。
制备方法:①按重量份取透明质酸4.5g,卡波姆941聚合物13g,搅拌下将透明质酸及卡波姆941聚合物溶于800g水中直到形成透明的溶液待用;
②100g水溶解0.6g谷氨酸二乙酸四钠(GLDA)和0.9g月桂酰精氨酸乙酯盐酸盐(LAE)待用;
③将1.5g苯氧乙醇,0.6g乙基己基甘油溶在10g1,2-丙二醇中待用;
④将步骤②溶液加入①溶液中搅拌均匀,再把1.8g三乙醇胺加入上述溶液中形成胶体,继续搅拌下加入步骤③溶液和16g芦荟汁得到粘稠的无色透明状膏体。之后加入1.2g烷基糖苷后得到高黏度高滑润度的膏体,最后用适量柠檬酸调 pH=6.3,用纯化水定容至1000g,真空除气5分钟,灌装即得到黏度为14900cP 的医用凝胶产品。
实施例6:
产品配方:透明质酸4.2g,卡波姆941聚合物16g,谷氨酸二乙酸四钠(GLDA) 0.5g,月桂酰精氨酸乙酯盐酸盐(LAE)0.7g,苯氧乙醇1.8g,乙基己基甘油 0.9g,1,2-丙二醇16g,三乙醇胺1.6g,芦荟汁17g,烷基糖苷1.6g,柠檬酸适量,余量为纯化水。
制备方法:①按重量份取透明质酸4.2g,卡波姆941聚合物16g,搅拌下将透明质酸及卡波姆941聚合物溶于800g水中直到形成透明的溶液待用;
②100g水溶解0.5g谷氨酸二乙酸四钠(GLDA)和0.7g月桂酰精氨酸乙酯盐酸盐(LAE)待用;
③将1.8g苯氧乙醇,0.9g乙基己基甘油溶在16g1,2-丙二醇中待用;
④将步骤②溶液加入①溶液中搅拌均匀,再把1.6g三乙醇胺加入上述溶液中形成胶体,继续搅拌下加入步骤③溶液和17g芦荟汁得到粘稠的无色透明状膏体。之后加入1.6g烷基糖苷后得到高黏度高滑润度的膏体,最后用适量柠檬酸调 pH=6.5,用纯化水定容至1000g,真空除气5分钟,灌装即得到黏度为17100cP 的医用凝胶产品。
1.产品性能测试:
产品测试方法及要求:黏度按照《中华人民共和国药典(二部)》(2010版) 附录“黏度测定法”规定的方法进行;pH测定按照《中华人民共和国药典(二部)》 (2010版)附录“pH值测定法”规定的方法进行;相关微生物检测按照《中华人民共和国药典(二部)》(2010版)附录中的方法进行。
1.产品外观及性能指标见下表1:
表1 产品外观及黏度、pH值、菌落数
2.标准中对产品超声性能要求(YY0299-2016)见下表2:
表2 产品的声学性能要求(YY0299-2016)
序号 | 理化技术指标 | 单位 | 量值 |
1 | 声速(35℃) | m/s | 1520~1620 |
2 | 声特性阻抗(35℃) | pa·s/m | 1.5x10<sup>6</sup>~1.7x10<sup>6</sup> |
3 | 声衰减(35℃) | dB/(cm·MHz) | ≤0.1 |
测试方法:
声速:按GB/T15261-2008给出的方法在35℃和(2.5~5.0)MHz间某-频率下测量,样品长度应不少于5cm,结果符合标准的规定。
声特性阻抗:声特性阻抗由GB/T15261-2008给出的方法测得声速值(m/s) 与密度值(kg/m3)的积求得。密度按照YY0299-2016附录A中广口容量瓶法测量。
声衰减:按GB/T15261-2008给出的方法在35℃和(2.5~5.0)MHz间某-频率下用双样品法测量,并按照附录B的方法对水中声衰减进行修正。两样品的长度差不小于5cm。
2.产品毒理性能测试
体外细胞毒性试验:取适量产品用细胞培养液稀释至2mg/mL,按 GB/T14233.2-2005中第8章中的比色法检测,结果表明细泡毒性低于2级,符合 YY0299-2016标准中6.2.1要求。
皮肤刺激测试:按照GB/T16886.10-2005中6.3中单次接触方法进行,结果符合YY0299-2016标准中6.2.2要求。
皮肤迟发型超敏反应测试:取适量产品用无菌生理盐水稀释至1mg/mL按照 GB/T16886.10-2005中规定最大剂量法致敏试验方法进行,结果无致敏性,符合 YY0299-2016标准中6.2.3要求。
消毒功效测试:按照《消毒技术规范》(2002年版)进行,其它相关结果列在下表3:
表3 产品其它相关性能测试结果
*实际为无刺激,表4给出更详尽结果
由表3测试结果可知,本专利涉及的一种温和无刺激医用超声凝胶符合相关标准(YY0299-2016)要求。
3.附加测试
为了进一步测试本发明涉及的一种温和无刺激医用超声凝胶的抗菌性能,选择自愿者5人(年龄18-62岁),将该实例1的凝胶涂覆于腹部,用医用纱布包裹固定,5小时后取下(模拟超声检查的极限时间)。观察皮肤状况并统计身体感觉;将使用后的凝胶收集,检测其中每一个自愿者使用后凝胶的微生物污染情况:取一定量使用过的凝胶稀释处理,混合在培养基中恒温37℃培养48小时,测试菌落总数。试验结果列在下表4:
表4 人体涂覆5小时后的表面状况及凝胶的菌落总数
自愿者编号 | 菌落总数(cfu/g) | 表面状况及刺激性 |
1 | 未检出 | 正常,无刺激 |
2 | 未检出 | 正常,无刺激 |
3 | 未检出 | 正常,无刺激 |
4 | 未检出 | 正常,无刺激 |
5 | 未检出 | 正常,无刺激 |
上述检测证明,本发明涉及的一种温和无刺激医用超声凝胶是一种理想的超声耦合凝胶。使用结果表明:耦合性能好、图像清晰,润滑性能好,使用方便,对探头无损伤无腐蚀,对人体无刺激、无过敏、无污染、易于清除。本发明耦合凝胶不同于普通医用超声耦合凝胶,其添加有复合杀菌消毒成分,可在诊断检查过程中杀灭和抑制探头与人体接触引起的病原性革兰氏菌、真菌等各菌之间的交叉感染和传播,有效的保障医患人员身体健康。
Claims (4)
1.一种温和无刺激医用超声凝胶,包括如下组份及质量百分比:卡波姆聚合物增稠剂1~3%;碱性黏度调节剂0.1~0.3%;杀菌剂0.03~0.1%;防腐剂0.1~0.5%;润肤保湿剂0.2~6%;防腐增效剂0.05~0.2%;润滑增效剂、植物组分及pH调节剂0.1~1.0%,余量为纯化水;所述卡波姆聚合物型号为卡波姆941;碱性黏度调节剂为三乙醇胺;杀菌剂为月桂酰精氨酸乙酯盐酸盐;防腐剂为辛二醇或苯氧乙醇;润肤保湿剂为1,2-丙二醇或透明质酸;防腐增效剂为乙基己基甘油或谷氨酸二乙酸四钠;润滑增效剂为烷基糖苷;植物成分为芦荟汁;pH调节剂为柠檬酸。
2.根据权利要求1所述的一种温和无刺激医用超声凝胶,其特征是:该医用超声凝胶组份及质量百分比为:卡波姆聚合物增稠剂1~2%;碱性黏度调节剂0.1~0.2%;杀菌剂0.06~0.1%;防腐剂0.1~0.3%;润肤保湿剂0.2~3%;防腐增效剂0.05~0.1%;润滑增效剂、植物组分及pH调节剂0.1~0.3%,余量为纯化水。
3.根据权利要求1或2所述的一种温和无刺激医用超声凝胶,其特征是:所得医用超声凝胶黏度为12000~18000cP,pH值为5.5~6.5。
4.一种温和无刺激医用超声凝胶的制备方法:包括如下步骤:
①搅拌下,将润肤保湿剂及卡波姆聚合物增稠剂溶于纯化水中,直至形成透明的溶液待用;
②将防腐增效剂及杀菌剂溶解在少量纯化水中待用;
③将防腐剂及防腐增效剂溶解在润肤保湿剂中待用;
④搅拌步骤①所得溶液,将步骤②所得溶液加入步骤①所得溶液中并搅拌均匀,再把碱性黏度调节剂加入上述溶液中形成胶体,继续搅拌下,再加入步骤③所得溶液和植物成分得到粘稠的无色透明状膏体,最后,再加入润滑增效剂后得到高黏度高滑润度的膏体,最后用pH调节剂调pH=5.5-6.5,即得;
所述卡波姆聚合物型号为卡波姆941;杀菌剂为月桂酰精氨酸乙酯盐酸盐(LAE);碱性黏度调节剂为三乙醇胺;防腐剂为辛二醇或苯氧乙醇;防腐增效剂为乙基己基甘油或谷氨酸二乙酸四钠(GLDA);润肤保湿剂为1,2-丙二醇或透明质酸;润滑增效剂为烷基糖苷;植物成分为芦荟汁;pH调节剂为柠檬酸。
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