CN108670870B - 一种长效防水驱蚊乳剂及其制备方法 - Google Patents
一种长效防水驱蚊乳剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种长效防水驱蚊乳剂，其原料组成以重量百分数之和为100%计，包括5%~35%避蚊胺、1%~5%乳化剂、0.3%~2%缓释材料、0.5%~5%防水材料、0.1%~0.5%防腐剂，余量为水。本发明长效防水驱蚊乳剂具有良好预防蚊虫及昆虫叮咬的效果，且其兼长效和防水功能，可解决现有驱蚊产品驱蚊时间短、使用不便、安全隐患高及无防水功能等不足，适于特殊环境下对长时间驱蚊和防水的需求；且该驱蚊产品为乳剂，具有易于涂抹、舒适感好、润肤等特点；其制备工艺简单，设备要求低，成本低廉，适合工业化大规模生产。
Description
技术领域
本发明属于日化用品领域，具体涉及一种长效防水驱蚊乳剂及其制备方法。
背景技术
夏季高温、高湿，是蚊虫等吸血昆虫危害最严重的季节。蚊虫叮咬除带来瘙痒、疼痛、炎症等不适症状外，还是疟疾、埃博拉热、登革热等多种虫媒疾病的传播途径。部队官兵由于军事训练、野外驻训、抗洪救灾、维和等特殊使命需要，暴露于恶劣环境受蚊虫叮咬的风险更大。蚊虫叮咬不仅直接威胁部队官兵身体健康，造成非战斗性损伤或减员，还影响部队官兵战斗力和任务执行。
目前常用的市售驱蚊产品主要是驱蚊花露水，其由避蚊胺或驱蚊酯、精油和70%乙醇等组成，具有驱蚊、袪痱、止痒等效果。但其驱蚊时间短（约4小时），需反复涂布，遇水或出汗后驱蚊效果更是直线下降，对需长时间处于易被蚊虫叮咬环境下工作的居民和执行军事任务的部队官兵来说尤为不便。同时，驱蚊花露水含高浓度乙醇，对破损皮肤刺激性大，且能促进避蚊胺的透皮吸收，长时间、反复、大面积涂布易造成避蚊胺入血量过高，增加副作用发生风险。此外，高浓度乙醇易燃、易爆，需避开火源使用和储藏。海军军医大学研制的长效驱蚊霜具有较长的驱蚊时间（约9 h），但其同样不具备防水功能，出汗、淋雨等可冲刷去皮肤表面附着的药物，极大降低驱蚊效果，对于滨海、沼泽、雨林等特殊环境和从事高强度军事任务中的部队官兵来说尤为不利。此外，长效驱蚊霜稠度高，油腻感强，较大面积涂布下舒适感较差。
为延长驱蚊产品的作用时间，目前研究主要是通过“载体”包合技术来延缓药物释放，如制成微胶囊、脂质体、环糊精包合物等。这类技术能有效提高避蚊胺的驱蚊时间，但技术难度较大，稳定性和重复性较差，很难实现工业化生产。同时，为达到防水目的，不少研究在组合物中加入疏水性材料。疏水性材料的加入虽然能显著提高防水性，但直接涂抹于皮肤上却难以用水洗净。本发明在利用高分子材料形成大分子网状结构，以达到延长有效驱蚊时间的同时，通过引入具有成膜性的水溶性聚合物而制得一种长效防水驱蚊乳剂，其即可利用聚合物成膜对驱避剂形成一种保护，并达到一定防水功能，又可在人为机械因素下直接用水洗去，更为方便。
发明内容
本发明的目的在于提供一种长效防水驱蚊乳剂及其制备方法，以解决现有驱蚊产品驱蚊时间短、使用不便、安全隐患高及无防水功能等不足。
为实现上述目的，本发明采用如下技术方案：
一种长效防水驱蚊乳剂，按重量百分数之和为100%计，所述驱蚊乳剂中含5%~35%避蚊胺、1%~5%乳化剂、0.3%~2%缓释材料、0.5%~5%防水材料、0.1%~0.5%防腐剂，余量为水。
所述乳化剂为鲸蜡基醚磷酸酯、二聚羟基硬脂酸酯、山梨醇月桂酸酯、鲸蜡醇聚醚-10磷酸酯中的任意一种或几种。
所述缓释材料为天然高分子缓释材料或合成高分子缓释材料。所述天然高分子缓释材料为黄原胶、明胶、阿拉伯胶、西黄蓍胶、壳聚糖、羧甲基纤维素钠中的任意一种或几种。所述合成高分子缓释材料为交联聚乙烯吡咯烷酮、聚乙烯吡咯烷酮、聚丙烯酸树脂、丙烯酸树脂中的任意一种或几种。
所述防水材料为聚乙烯吡咯烷酮、聚乙烯醇、羟乙基纤维素、羟丙基纤维素、甲基纤维素中的任意一种或几种。
所述防腐剂为苯氧乙醇、苯甲酸、苯甲酸钠、羟苯甲酯、羟苯乙酯、尼泊金甲酯、尼泊金已酯、尼泊金丙酯、尼泊金丁酯、三氯叔丁醇中的任意一种或几种。
本发明还提供一种所述长效防水驱蚊乳剂的制备方法，其包括以下步骤：
1）将缓释材料于适量水中搅拌均匀，再于2~8℃下溶胀形成均一溶液；
2）将乳化剂加热溶解于适量水中，再加入缓释材料均一溶液中，搅拌均匀，得混合物A；
3）将防水材料加热溶解于适量水中，再加入混合物A中，搅拌均匀，得混合物B；
4）所用防腐剂如为水溶性化合物，则将其与步骤3）中的防水材料一起制成混合物B；如为脂溶性化合物，则溶解于中避蚊胺；
5）将避蚊胺于30~40℃下边搅拌边缓慢加入混合物B中，待冷却至室温后，加水至全量，搅拌均匀，即得所述长效防水驱蚊乳剂。
本发明的有益效果在于：
（1）本发明提供的长效防水驱蚊乳剂能明显改善现有驱蚊产品驱蚊时间短、使用不便、安全隐患高等不足，且具备防水功能，尤其适于滨海、沼泽、雨林等涉水和出汗环境下使用。
（2）相比于霜剂，本发明将避蚊胺制备成乳剂，具有易于涂抹、舒适感好、润肤等特点。
（3）本发明长效防水驱蚊乳剂无明显皮肤刺激性，未引起变态反应，皮肤渗透量和皮肤滞留量显著低于避蚊胺原料药，表明其具有较高的安全性。
（4）本发明长效防水驱蚊乳剂的制备工艺简单，设备要求低，成本低廉，适合工业化大规模生产。
具体实施方式
为了使本发明所述的内容更加便于理解，下面结合具体实施方式对本发明所述的技术方案做进一步的说明，但是本发明不仅限于此。
实施例1
一种长效防水驱蚊乳剂，按重量百分数之和为100%计，所述驱蚊乳剂中含避蚊胺5%、黄原胶0.3%、山梨醇月桂酸酯5%、聚乙烯醇5%、羟苯甲酯0.5%，余量为水。
该驱蚊乳剂的制备方法，包括以下步骤：
取配方量黄原胶，加入适量水搅拌均匀后，置2~8℃下充分溶胀至形成均一溶液；取配方量山梨醇月桂酸酯，于80℃下溶解于适量水中，并混入制备好的黄原胶均一溶液（预热至80℃）中，搅拌均匀，得溶液A；取配方量聚乙烯醇，于80℃下溶解于适量水中，并混入溶液A中，搅拌均匀，得溶液B；取羟苯甲酯，溶解于配方量避蚊胺中，然后于40℃下将其边搅拌边缓慢加入到溶液B（预先放冷至40℃）中，搅拌均匀；待冷却至室温后，加水至全量，搅拌均匀，即得长效防水驱蚊乳剂。
实施例2
一种长效防水驱蚊乳剂，按重量百分数之和为100%计，所述驱蚊乳剂中含避蚊胺15%、聚乙烯吡咯烷酮1%、鲸蜡基磷酸酯2%、羟丙基纤维素2%、苯氧乙醇0.1%，余量为水。
该驱蚊乳剂的制备方法，包括以下步骤：
取配方量聚乙烯吡咯烷酮，加入适量水搅拌均匀后，置2~8℃下充分溶胀至形成均一溶液；取配方量鲸蜡基磷酸酯，于80℃下溶解于适量水中，并混入制备好的聚乙烯吡咯烷酮均一溶液（预热至80℃）中，搅拌均匀，得溶液A；取配方量羟丙基纤维素，于80℃下溶解于适量水中，并混入溶液A中，搅拌均匀，得溶液B；取苯氧乙醇，溶解于配方量避蚊胺中，然后于40℃下将其边搅拌边缓慢加入到溶液B（预先放冷至40℃）中，搅拌均匀；待冷却至室温后，加水至全量，搅拌均匀，即得长效防水驱蚊乳剂。
实施例3
一种长效防水驱蚊乳剂，按重量百分数之和为100%计，所述驱蚊乳剂中含避蚊胺35%、丙烯酸树脂2%、二聚羟基硬脂酸酯2%、聚乙烯吡咯烷酮2%、苯甲酸钠0.2%，余量为水。
该驱蚊乳剂的制备方法，包括以下步骤：
取配方量丙烯酸树脂，加入适量水搅拌均匀后，置2~8℃下充分溶胀至形成均一溶液；取配方量二聚羟基硬脂酸酯，于80℃下溶解于适量水中，并混入制备好的丙烯酸树脂均一溶液（预热至80℃）中，搅拌均匀，得溶液A；取配方量聚乙烯吡咯烷酮和苯甲酸钠，于80℃下溶解于适量水中，并混入溶液A中，搅拌均匀，得溶液B；取配方量避蚊胺，于40℃下将其边搅拌边缓慢加入到溶液B（预先放冷至40℃）中，搅拌均匀；待冷却至室温后，加水至全量，搅拌均匀，即得长效防水驱蚊乳剂。
性能测试
测试药物：实施例2、3制备的长效防水驱蚊乳剂（15%、35%避蚊胺）；长效驱蚊霜（15%避蚊胺，现我军装备，慈溪市宏远医药科技有限公司生产）；Insect repellent lotion（34.34%避蚊胺，3M ULTRATHONTM，现美军装备，Minnesota Mining and ManufacturingCompany生产）。
防水性能评价
根据《化妆品安全技术规范》（2015版）要求进行防水性能评价：裁剪3MTransporeMT多孔薄膜（3 cm×2 cm），将测试样品均匀涂抹于薄膜上（1 mg·cm-2），将涂有样品的薄膜置32 ℃烘箱中，保温15 min后，将薄膜浸入32 ℃生理盐水中，100 r·min-1速度搅拌。浸泡30 min后，用乙腈洗下薄膜上残留样品，并定容至一定体积，作为试验组，采用高效液相色谱法测定试验组中避蚊胺含量。同法，取同一份测试样品，照上述方法操作，但不浸入32 ℃生理盐水中，测定未经水处理的薄膜上避蚊胺残留量，作为对照组。试验组与对照组的含量比值即为WRR（%），WRR=试验组/对照组×100%。结果见表1。
表1 防水性能测定结果
结果表明，本发明驱蚊乳剂防水性能显著优于长效驱蚊霜和3M ULTRATHONTM。
驱蚊效能评价
1）试验动物
昆明小鼠，体重10~30 g，雌雄各半，购自上海斯莱克实验动物有限责任公司，合格证号SCXK（沪）2014-0005，实验前于福州总医院比较医学科动物房适应性饲养一周。
白纹伊蚊，由福建省疾病预防控制中心提供。
2）攻击力评价
将300只左右白纹伊蚊置于蚊虫笼（35 cm×35 cm×35 cm）内，放入昆明小鼠（除去腹部40 mm×40 mm毛发，其余部位严密遮蔽），2 min内，有10%的蚊虫停落吸血则代表攻击力合格，则该笼蚊虫可用于驱蚊时间测定。
3）驱避时间测定
按《农药登记用卫生杀虫剂室内药效试验及评价》第九部分：驱避剂GB/T13917.9-2009要求进行驱避时间测定：选择6只昆明小鼠（雌雄各半），除去腹部40 mm×40mm毛发，并均匀涂抹0.1 g测试物，其余部位严密遮蔽；将小鼠放入攻击力合格的蚊虫笼中，每30 min观察一次有无蚊虫停落吸血，每次观察5 min，直至有蚊虫前来吸血，记录测试物的完全有效驱避时间。结果见表2。
表2 完全有效驱避时间测定结果
结果表明，本发明，避蚊胺浓度为35%的驱蚊乳剂，其完全有效驱避时间长达12.33±0.29 h，与美军装备3M ULTRATHONTM性能相当；避蚊胺浓度为15%的驱蚊乳剂，完全有效驱避时间长达11.16±0.29 h，亦优于现部队装备长效驱蚊霜。
皮肤刺激性试验
1）实验动物
清洁级家兔，雌雄各半，体重2~3 kg，购自福建省连江玉华山自然生态农业试验厂，合格证号SYXK（闽）2014-0001，实验前于福州总医院比较医学科动物房适应性饲养一周。
2）试验方法
单次刺激性试验：选择健康家兔，采用同体左右侧自身对比法，设置给药组（长效防水驱蚊乳剂、长效驱蚊霜、3M ULTRATHONTM）与空白基质组，每次涂抹1 g，单次涂抹给药后12 h除去测试物并用温水清洁给药部位，在自然光或全光谱灯光下观察清洗测试物后的1、24、48、72 h涂抹部位皮肤反应。按表3进行皮肤刺激反应评分，以受试动物积分的平均值进行综合评价，根据24、48、72 h各观察时点最高积分均值，按表4判断皮肤刺激强度。
多次刺激性试验：每天涂抹1次，连续涂抹14 d。从第二天开始，每次涂抹前应剪毛，用水或无刺激性溶剂清除残留测试物。1 h后观察结果，按表3评分，计算每天每只兔子平均积分，按表4判断皮肤刺激强度。
表3 皮肤刺激反应评分
表4 皮肤刺激强度分级
3）试验结果
单次刺激性试验结果见表5~8。
表5 单次刺激性试验结果-本发明驱蚊乳剂（15%避蚊胺）
表6 单次刺激性试验结果-本发明驱蚊乳剂（35%避蚊胺）
表7 单次刺激性试验结果-长效驱蚊霜（15%避蚊胺）
表8 单次刺激性试验结果-3M ULTRATHONTM（34.34%避蚊胺）
多次刺激性试验结果见表9~12。
表9 多次刺激性试验结果-本发明驱蚊乳剂（15%避蚊胺）
表10 多次刺激性试验结果-本发明驱蚊乳剂（35%避蚊胺）
表11 多次刺激性试验结果-长效驱蚊霜（15%避蚊胺）
表12 多次刺激性试验结果-3M ULTRATHONTM（34.34%避蚊胺）
由结果表明，单次刺激性试验及多次刺激性试验时，测试药物给药区和对照区皮肤均未出现红斑、水肿等刺激症状，皮肤刺激反应总积分值均小于0.5，说明本发明驱蚊乳剂对皮肤无明显刺激性。
皮肤变态反应试验
1）实验动物
清洁级成年豚鼠，雌雄各半，购自上海斯莱克实验动物有限公司，合格证号SCXK（沪）2014-0005。
2）试验方法
选用健康豚鼠，设置阳性对照组（二硝基氯苯）、试验组（长效防水驱蚊乳剂、长效驱蚊霜、3M ULTRATHONTM）和阴性对照组（空白基质），分别于第0、7、14天进行诱导接触，末次诱导后14~28天进行激发接触，激发接触后24 h和48 h观察皮肤反应，按表13评分，当受试动物出现皮肤反应积分≥2时，判为该动物出现皮肤变态反应阳性，按表14判定受试物的致敏强度。
表13 皮肤过敏反应评分标准
表14 皮肤过敏性评价标准
3）试验结果
结果见表15。
表15 皮肤变态反应结果
结果表明，本发明驱蚊乳剂未引起皮肤变态反应。
皮肤渗透性试验
1）实验动物
SD大鼠，体重180~220g，雄性，上海斯莱克实验动物有限公司，合格证号SCXK（沪）2014-0005。
2）试验方法
采用Franz扩散池法，以离体大鼠皮肤为模型，角质层朝上，接收池内装生理盐水，32 ℃平衡1 h，给药池中加入测试物，分别于给药后0.5、1.0、2.0、4.0、6.0、8.0、24 h从接收池中取样，同时加入相同温度和体积的接收液，测定接收液中避蚊胺浓度，计算药物累积透过量（Q n ，μg·cm-2）。末次取样后，取下皮肤，除去皮肤表面药物，剪碎皮肤，以乙腈为提取溶解，细胞超声粉碎仪提取皮肤中药物，测定皮肤滞留量。
Q n =
，
其中，C n 、C ί 分别为第n、ί个取样点测得的药物浓度；V为接收液总体积；V ί 为第ί个取样点的取样体积；S为渗透面积。
3）试验结果
结果见表16~17。
表16 累积渗透量测定结果
表17 皮肤滞留量测定结果
结果表明，本发明驱蚊乳剂累计渗透量和皮肤滞留量显著低于避蚊胺原料药，也低于相同药物浓度的长效驱蚊霜和3M ULTRATHONTM，表明本发明驱蚊乳具有较好的安全性。
以上所述仅为本发明的较佳实施例，凡依本发明申请专利范围所做的均等变化与修饰，皆应属本发明的涵盖范围。
Claims (4)
1.一种长效防水驱蚊乳剂的制备方法，其特征在于：按重量百分数之和为100%计，所述驱蚊乳剂中各成分及其含量为5%~35%避蚊胺、1%~5%乳化剂、0.3%~2%缓释材料、0.5%~5%防水材料、0.1%~0.5%防腐剂，余量为水；其制备包括以下步骤：
1）将缓释材料于适量水中搅拌均匀，再于2~8℃下溶胀形成均一溶液；
2）将乳化剂加热溶解于适量水中，再加入缓释材料均一溶液中，搅拌均匀，得混合物A；
3）将防水材料加热溶解于适量水中，再加入混合物A中，搅拌均匀，得混合物B；
4）将防腐剂与混合物B或避蚊胺混合，然后将避蚊胺于30~40℃下边搅拌边缓慢加入混合物B中，待冷却至室温后，加水至全量，搅拌均匀，即得所述长效防水驱蚊乳剂；
所述乳化剂为鲸蜡基醚磷酸酯、二聚羟基硬脂酸酯、山梨醇月桂酸酯、鲸蜡醇聚醚-10磷酸酯中的任意一种或几种；
所述缓释材料为天然高分子缓释材料或合成高分子缓释材料；
所述防水材料为聚乙烯吡咯烷酮、聚乙烯醇、羟乙基纤维素、羟丙基纤维素、甲基纤维素中的任意一种或几种。
2.根据权利要求1所述的长效防水驱蚊乳剂的制备方法，其特征在于：所述天然高分子缓释材料为黄原胶、明胶、阿拉伯胶、西黄蓍胶、壳聚糖、羧甲基纤维素钠中的任意一种或几种。
3.根据权利要求1所述的长效防水驱蚊乳剂的制备方法，其特征在于：所述合成高分子缓释材料为交联聚乙烯吡咯烷酮、聚乙烯吡咯烷酮、聚丙烯酸树脂、丙烯酸树脂中的任意一种或几种。
4.根据权利要求1所述的长效防水驱蚊乳剂的制备方法，其特征在于：所述防腐剂为苯氧乙醇、苯甲酸、苯甲酸钠、三氯叔丁醇中的任意一种或几种。
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