CN102488685B - 含复方氨基酸成分的脂质体制剂的应用方法 - Google Patents
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Abstract
本发明公开了含复方氨基酸成分的脂质体制剂的应用方法，该方法是将通过201110442862.6号专利申请件制备的含复方氨基酸成分的脂质体制剂制成能够直接应用于各类急慢性伤口的产品，即将制剂灌装于铝管或铝塑管或塑料管中，每管装入1～500g，封尾，然后用钴－60辐射灭菌，制得含复方氨基酸成分的脂质体制剂的应用产品。本方法使采用特殊脂质体技术及成膜技术制备的制剂得以应用于伤口，优点是涂于创面后在较短时间内能形成一层膜，该膜能够为创面提供半密闭湿润透气的环境，有利于创面愈合；装载氨基酸等细胞生长因子的脂质体通过吸附、融合方式直接进入创面细胞内，参与细胞的新陈代谢，促进细胞生长与爬行；从而促进伤口愈合，缩短创面愈合时间。
Description
技术领域
本发明涉及以特殊物理形状为特征的医药配制品，特别涉及脂质体，具体来说，涉及含复方氨基酸成分的脂质体制剂的应用。
背景技术
脂质体技术的发展有近50年的历史，20世纪50年代，医学界的Odland(1958).Winter(1962).Hinman和Maibach（1963）分别通过他们的研究得出了同样的结论：保持湿润环境能够加速创面愈合。由于这一里程碑式的发现诞生了湿润环境愈合理论，湿性敷料逐渐成为伤口敷料的主流。2000年8月，美国FDA在新颁布的《创面医疗用品（外用药和敷料）的行业指南》以及中华医学会创伤学分会组织修复专业委员会编著的2011年本版《慢性伤口诊疗指导意见》中均特别强调：保持创面的湿润环境是标准的处理方法。
密闭性（湿性）敷料的推广使用大大加速了创面的愈合，既减轻了患者的痛苦，也降低了护理人员的工作强度。但是，由于湿性敷料的局限性（只能改善创面愈合的环境），大部分久治不愈的慢性伤口仍然是令临床医护工作者头痛的问题。
在湿性敷料基础上研究开发一种能为伤口愈合提供湿润密闭的环境，而且以脂质体为载体直接为创面细胞提供“脂质体靶向”营养，并且能够加快伤口愈合的速度，而且使大多数难愈性伤口的快速愈合成为可能，成了科研人员一直不断追求的目标。为此，发明人提供了含复方氨基酸成分的脂质体制剂配方及其制备方法，申请了专利，申请号201110442862.6。但尚未有这种含复方氨基酸成分的脂质体制剂的具体应用方法问世。
发明内容
本发明的目的是提供含复方氨基酸成分的脂质体制剂的应用方法，使脂质体得以实际应用，从而更好地为人类健康服务。
发明人提供的含复方氨基酸成分的脂质体制剂的应用方法，是将通过201110442862.6号专利申请件制备的含复方氨基酸成分的脂质体制剂制成能够直接应用于各类急慢性伤口的产品，即将制剂灌装于铝管或铝塑管或塑料管中，每管装入1～500g，封尾，然后用钴－60辐射灭菌，制得含复方氨基酸成分的脂质体制剂的应用产品。
上述方法中，含复方氨基酸成分的脂质体制剂是由大豆磷脂、胆固醇、氨基酸、维生素、防腐剂、成膜材料和工艺用水制成的，按1000份产品的配方为：大豆磷脂10～150份，胆固醇6～80份，盐酸半胱氨酸0.3～1.2份，色氨酸0.03～0.6份，缬氨酸 0.4～1.3份，异亮氨酸0.5～2.0份，亮氨酸0.8～2.5份，醋酸赖氨酸0.2～1.2份，蛋氨酸0.06～0.5份，苯丙氨酸0.09～0.7份，苏氨酸0.1～0.6份，精氨酸0.1～1.6份，甘氨酸0.2～2份，脯氨酸0.05～0.3份，维生素A 0.03～2份，维生素C 0.3～2份，维生素E 0.4～3份，维生素K 0.01～0.1份，成膜材料 65～200份，防腐剂山梨酸钾或尼泊金乙酯 0.5～4份，余为工艺用水；所述各种原料均为市售产品，所述成膜材料是海藻酸钠（褐澡酸钠）或海藻酸（褐澡酸）的衍生物或海藻多糖复合胶。该配方可以使用上述氨基酸中的几种或全部、上述维生素中的一种或全部。
上述方法中，所述用钴－60辐射灭菌的辐射剂量为4～40kGy，灭菌时间为3～30h。
上述方法中，所述急性伤口包括创伤、手术切口、皮肤磨削伤、烧伤、烫伤、冻伤等；所述慢性伤口包括压力性溃疡、动脉性溃疡、静脉性溃疡、糖尿病足溃疡、创伤性溃疡、皮肤溃疡等。
上述方法中，所述直接用于各类急慢性伤口的具体操作方法是将本制剂涂于事先清洁、消毒和清除坏死组织的创面上，使其边缘超出创面范围1cm左右向伤口及创面的组织提供营养，使其迅速愈合；创面较深者须增加涂抹厚度，等待7分钟左右即成膜；外加无菌纱布包扎。
发明人指出：在具体操作中应当注意：
1.使用本品前一般应按常规外科方法消毒及清洁创面，必要时用无菌纱布吸干创面分泌物。
2.打开包装按无菌要求，用75％酒精消毒帽尖后再刺穿启封。
3.取本制剂涂于创面上，使其边缘超出创面范围1cm左右；如创面较深，应适当增加涂抹厚度，等待7分钟左右即成膜；外加无菌纱布包扎。
4. 如果创面感染较深，使用本品时请结合抗炎治疗手段。
5．如创面渗出液较多，应先进行抗渗出治疗。
6. 一般每天涂抹一次，如无感染可直接涂抹。
本发明方法使采用特殊脂质体技术及成膜技术制备的制剂可以直接应用于伤口与创面，优点是涂于创面后在较短时间内能形成一层膜，该膜能够为创面提供半密闭湿润透气的环境，有利于创面愈合；装载氨基酸等细胞生长因子的脂质体通过吸附、融合的方式直接进入创面细胞内，参与细胞的新陈代谢，促进细胞的生长与爬行；从而促进伤口愈合，大大缩短创面愈合时间。
具体实施方式
现通过下列实施例详细说明本发明的具体实施方式。
实施例l 制备含复方氨基酸成分的脂质体制剂的第一种应用产品
按201110442862.6号专利申请件制备的含复方氨基酸成分的脂质体制剂灌装于铝管中，每管装入30g，折边封尾后进行外包装，然后用钴－60辐射灭菌，辐射剂量为16kGy，灭菌时间为15h，制得含复方氨基酸成分的脂质体制剂的应用产品。
实施例2 制备含复方氨基酸成分的脂质体制剂的第二种应用产品
按201110442862.6号专利申请件制备的含复方氨基酸成分的脂质体制剂灌装于铝塑管中，每管装入10g，热熔封尾后进行外包装，然后用钴－60辐射灭菌，辐射剂量为25kGy，灭菌时间为8h，制得含复方氨基酸成分的脂质体制剂的应用产品。
实施例3 制备含复方氨基酸成分的脂质体制剂的第三种应用产品
按201110442862.6号专利申请件制备的含复方氨基酸成分的脂质体制剂灌装于塑料管中，每管装入20g，热熔封尾后进行外包装，然后用钴－60辐射灭菌，辐射剂量为28kGy，灭菌时间为4h，制得含复方氨基酸成分的脂质体制剂的应用产品。
实施例4 应用于压力性溃疡
用生理盐水清洗患者压力性溃疡部位，打开实施例1的应用产品，按无菌要求，用75％酒精消毒帽尖后再刺穿铝管口启封。取铝管中的制剂涂于创面上，使其边缘超出创面范围1cm；如创面较深，应适当增加厚度，等待7分钟，成膜，外加无菌纱布包扎；同时结合抗炎治疗。创面渗出液较多时，应先进行抗渗治疗。每天涂抹1次，10天左右创面愈合。
实施例5 应用于创面
用生理盐水反复冲洗患者创面部位，先进行抗渗治疗，再打开实施例2的应用产品，按无菌要求，用75％酒精消毒帽尖后再刺穿铝塑管口启封。取铝塑管中的制剂涂于创面上，使其边缘超出创面范围1cm；创面较深者应适当增加厚度，等待7分钟，成膜，外加无菌纱布包扎；每天涂抹1次，如无感染，可直接涂抹，2周创面愈合。
实施例6 应用于皮肤溃疡
用生理盐水清洗患者溃疡部位，先对溃疡患处进行消毒处理，再打开实施例3的应用产品，按无菌要求，用75％酒精消毒帽尖后再刺穿塑料管口启封。取塑料管中的制剂涂于创面上，使其边缘超出创面范围1cm；每天涂抹1次，如无感染，可直接涂抹，6天左右创面愈合。
实施例7 应用于创伤伤口
用生理盐水反复冲洗患者创伤伤口部位，先对创伤伤口部位进行消毒处理，再打开实施例2的应用产品，按无菌要求，用75％酒精消毒帽尖后再刺穿铝塑管口启封。取铝塑管中的制剂涂于创面上，使其边缘超出创面范围1cm；创面较深者应适当增加厚度，等待7分钟，成膜，外加无菌纱布包扎；每天涂抹1次，如无感染，可直接涂抹，2天伤口愈合。
上述实施例仅列举了部分含复方氨基酸的脂质体制剂的应用方法实例，凡与本发明方法相似，无须付出创造性劳动的技术方案均在本申请件的保护范围之内。
Claims (2)
1.一种含复方氨基酸成分的脂质体制剂在制备治疗急性伤口和慢性伤口的产品中的应用方法，其特征在于将含复方氨基酸成分的脂质体制剂制成能够直接应用于各类急性伤口和慢性伤口的产品；所述含复方氨基酸成分的脂质体制剂按1000份产品的配方为：大豆磷脂10～150份，胆固醇6～80份，盐酸半胱氨酸0.3～1.2份，色氨酸0.03～0.6份，缬氨酸0.4～1.3份，异亮氨酸0.5～2.0份，亮氨酸0.8～2.5份，醋酸赖氨酸0.2～1.2份，蛋氨酸0.06～0.5份，苯丙氨酸0.09～0.7份，苏氨酸0.1～0.6份，精氨酸0.1～1.6份，甘氨酸0.2～2份，脯氨酸0.05～0.3份，维生素A0.03～2份，维生素C0.3～2份，维生素E0.4～3份，维生素K0.01～0.1份，褐藻酸钠或褐藻酸或海藻多糖复合胶65～200份，防腐剂山梨酸钾或尼泊金乙酯0.5～4份，余为工艺用水；所述急性伤口包括创伤、手术切口、皮肤磨削伤、烧伤、烫伤、冻伤；所述慢性伤口包括压力性溃疡、动脉性溃疡、静脉性溃疡、糖尿病足溃疡、创伤性溃疡、皮肤溃疡。
2.如权利要求1所述的应用方法，其特征在于所述治疗急性伤口和慢性伤口产品的制备是将含复方氨基酸成分的脂质体制剂用铝管或铝塑管或塑料管灌装，每管装入1～500g，封尾，然后用钴-60辐射灭菌，灭菌的辐射剂量为4～40kGy，灭菌时间为3～30h，其中所述含复方氨基酸成分的脂质体制剂按1000份产品的配方为：大豆磷脂10～150份，胆固醇6～80份，盐酸半胱氨酸0.3～1.2份，色氨酸0.03～0.6份，缬氨酸0.4～1.3份，异亮氨酸0.5～2.0份，亮氨酸0.8～2.5份，醋酸赖氨酸0.2～1.2份，蛋氨酸0.06～0.5份，苯丙氨酸0.09～0.7份，苏氨酸0.1～0.6份，精氨酸0.1～1.6份，甘氨酸0.2～2份，脯氨酸0.05～0.3份，维生素A0.03～2份，维生素C0.3～2份，维生素E0.4～3份，维生素K0.01～0.1份，褐藻酸钠或褐藻酸或海藻多糖复合胶65～200份，防腐剂山梨酸钾或尼泊金乙酯0.5～4份，余为工艺用水。
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