CN107028973A - 一种缓解视疲劳用滴眼液及其制备方法 - Google Patents
一种缓解视疲劳用滴眼液及其制备方法 Download PDFInfo
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- CN107028973A CN107028973A CN201710333545.8A CN201710333545A CN107028973A CN 107028973 A CN107028973 A CN 107028973A CN 201710333545 A CN201710333545 A CN 201710333545A CN 107028973 A CN107028973 A CN 107028973A
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Abstract
本发明公开了一种缓解视疲劳用滴眼液及其制备方法,以牛磺酸、泛醇、肌醇、天门冬氨酸、丝氨酸、叶黄素、维生素B2、烟酰胺、维生素B12、冰片、载体液作为原料;制备方法包括:向配制好的载体液中加入牛磺酸、泛醇、肌醇、天门冬氨酸、丝氨酸、叶黄素、维生素B2、烟酰胺、维生素B12、冰片,另加入聚山梨酸酯表面活性剂,快速搅拌均匀,静置;将得到的混合液使用超滤膜过滤后,杀菌灭活,分装,即得。本发明制得的缓解视疲劳滴眼液可以通过多种缓冲溶液体系配制,缓冲范围大,适应能力强,对眼部结构无毒副作用,与眼部环境生物相容性好。
Description
技术领域
本发明涉及医用配制品领域,具体涉及一种缓解视疲劳用滴眼液及其制备方法。
背景技术
眼睛是人类接触世界处理信息的首要感觉器官。人眼每天要处理大量的信息,阅读大规模的文字,一旦用眼不科学不卫生,不能养成良好的作息习惯,尤其容易引发各种视觉疲劳。眼睛干涩酸痛、眼皮沉重、眼球红肿、视物模糊等视疲劳症状极大的困扰着人们的生活和健康。究其原因,视疲劳症状受到眼睛本身及环境因素影响最为突出。眼睛本身屈光不正和眼部肌肉功能障碍更容易引起视疲劳。两眼视力相差大、远近视度数高等导致用眼不当,眼部肌肉受力不均、酸涩压迫、调节能力松弛、控制能力下降等也非常容易造成视疲劳的产生。除此之外,恶劣的周围环境也会加剧视疲劳症状的发生发展。
缓解视疲劳不仅要消除症状还要加强眼部周围的营养供给和环境优化。通过各种药物作用缓解和多种维生素、氨基酸等物质的营养,并注意养成良好的用眼习惯,可以避免视疲劳症状的反复发生。
中国专利CN201410524587.6公开了一种治疗眼疲劳的中药滴眼液及制备方法,中药滴眼液有效成分的原料组成为:胡桃枝、凤尾茶、槟榔、红门兰、荷叶、合萌根、花椒、过坛龙、决明子、魔芋、金沙草、苦瓜、马蹄、龙胆草、荔枝和蔓荆子。但是该专利制得的滴眼液难以解决其有效成分水溶性差的问题,患者使用时有强烈的不适感,难以达到缓解视疲劳的目的。
因此,针对眼部肌肉功能弱化等因素引起的视觉疲劳现象,需要发明一种含有多种营养成分的滴眼液,达到缓解和治疗视疲劳的目的。
发明内容
本发明针对上述问题,提供一种缓解视疲劳用滴眼液及其制备方法。
本发明解决上述问题所采用的技术方案是:一种缓解视疲劳用滴眼液,由以下质量百分数的原料组成:牛磺酸0.1%~0.5%,泛醇0.08%~0.12%,肌醇0.06%~0.2%,天门冬氨酸0.08%~0.2%,丝氨酸0.04%~0.15%,叶黄素0.2%~0.4%,维生素B2 0.01%~0.02%,烟酰胺0.02%~0.04%,维生素B120.03%~0.05%,冰片0.08%~0.16%,其余为载体液。
进一步地,载体液由以下重量份的原料组成:氯化钠10份~20份,氯化钾15份~18份,硫酸镁16份~22份,缓冲溶液950份~1100份,聚氧乙烯3份~8份,甘油2份~6份,玻璃酸钠4份~9份,山梨酸钾0.5份~2份。
更进一步地,缓冲溶液为:磷酸氢二钠/柠檬酸缓冲液、硼酸钠/硼酸缓冲液、碳酸氢钠/碳酸钠缓冲液中的任一种。
进一步地,丝氨酸为:左旋L-丝氨酸。
本发明的另一发明目的,在于提供一种上述缓解视疲劳用滴眼液的制备方法,包括以下步骤:
步骤S1,载体液配制:将所述重量份的氯化钠、氯化钾、硫酸镁加入到缓冲溶液中,室温条件下搅拌混合均匀,继续加入所述重量份的聚氧乙烯、甘油、玻璃酸钠,混合均匀后,再继续加入所述重量份的山梨酸钾,混合均匀,配制得到载体液;
步骤S2,混合液配制:向步骤S1中得到的载体液中加入所述质量百分数的牛磺酸、泛醇、肌醇、天门冬氨酸、丝氨酸、叶黄素、维生素B2、烟酰胺、维生素B12、冰片,另加入聚山梨酸酯表面活性剂,快速搅拌均匀,静置20min~40min,得混合液;
步骤S3,灭活灌装:将步骤S2得到的混合液使用超滤膜过滤后,杀菌灭活,分装,即得所述缓解视疲劳用滴眼液。
进一步地,步骤S1中,载体液在20℃~37℃时的运动粘度为:10.5×10-6m2/s~22.5×10-6m2/s。
进一步地,步骤S2中,聚山梨酸酯表面活性剂的添加比例为:载体液质量的0.08%~0.22%。
进一步地,步骤S3中,超滤膜的厚度为:0.15μm~0.3μm。
进一步地,步骤S3中,杀菌灭活具体为:在温度为105℃时进行高温蒸汽杀菌灭活60min~90min,然后使用频率为5×1015Hz~15×1015Hz的紫外线辐照8min~20min,重复2次~3次。
进一步地,缓解视疲劳用滴眼液的pH值为5.8~8.2,等渗压浓度为305mmol/L~335mmol/L。
本发明的优点是:
1.本发明制备的滴眼液中含有牛磺酸、多种氨基酸、B族维生素以及肌醇类等营养成分,可以充分保护视网膜,缓解视疲劳症状,营养眼部肌肉,改善眼部血液循环和功能代谢,起到良好的药用营养作用;
2.本发明制备的滴眼液可以通过多种缓冲溶液体系配制,缓冲范围大,适应能力强,对眼部结构无毒副作用,与眼部环境生物相容性好;
3.本发明制备方法简便,原料丰富,控制严格,质量稳定,适合于大规模批量化连续生产。
具体实施方式
以下对本发明的实施例进行详细说明,但是本发明可以由权利要求限定和覆盖的多种不同方式实施。
实施例1
一种缓解视疲劳用滴眼液,由以下质量百分数的原料组成:牛磺酸0.1%,泛醇0.08%,肌醇0.06%,天门冬氨酸0.08%,左旋L-丝氨酸0.04%,叶黄素0.2%,维生素B20.01%,烟酰胺0.02%,维生素B12 0.03%,冰片0.08%,其余为载体液。
其中,载体液由以下重量份的原料组成:氯化钠10份,氯化钾15份,硫酸镁16份,磷酸氢二钠/柠檬酸缓冲液950份,聚氧乙烯3份,甘油2份,玻璃酸钠4份,山梨酸钾0.5份。
实施例2
一种缓解视疲劳用滴眼液,由以下质量百分数的原料组成:牛磺酸0.5%,泛醇0.12%,肌醇0.2%,天门冬氨酸0.2%,左旋L-丝氨酸0.15%,叶黄素0.4%,维生素B20.02%,烟酰胺0.04%,维生素B12 0.05%,冰片0.16%,其余为载体液。
其中,载体液由以下重量份的原料组成:氯化钠20份,氯化钾18份,硫酸镁22份,硼酸钠/硼酸缓冲液1100份,聚氧乙烯8份,甘油6份,玻璃酸钠9份,山梨酸钾2份。
实施例3
一种缓解视疲劳用滴眼液,由以下质量百分数的原料组成:牛磺酸0.3%,泛醇0.1%,肌醇0.13%,天门冬氨酸0.14%,左旋L-丝氨酸0.1%,叶黄素0.3%,维生素B20.015%,烟酰胺0.03%,维生素B12 0.04%,冰片0.12%,其余为载体液。
其中,载体液由以下重量份的原料组成:氯化钠15份,氯化钾16份,硫酸镁19份,碳酸氢钠/碳酸钠缓冲液1025份,聚氧乙烯5.5份,甘油4份,玻璃酸钠6.5份,山梨酸钾1.2份。
实施例4
一种缓解视疲劳用滴眼液的制备方法,包括以下步骤:
步骤S1,载体液配制:将所述重量份的氯化钠、氯化钾、硫酸镁加入到缓冲溶液中,室温条件下搅拌混合均匀,继续加入所述重量份的聚氧乙烯、甘油、玻璃酸钠,混合均匀后,再继续加入所述重量份的山梨酸钾,混合均匀,配制得到载体液;其中,采用运动黏度自动测定仪,对载体液在20℃~37℃时的运动粘度进行测试,测试结果为:
步骤S2,混合液配制:向步骤S1中得到的载体液中加入所述质量百分数的牛磺酸、泛醇、肌醇、天门冬氨酸、丝氨酸、叶黄素、维生素B2、烟酰胺、维生素B12、冰片,另加入聚山梨酸酯表面活性剂,快速搅拌均匀,静置20min,得混合液;其中,聚山梨酸酯表面活性剂的添加比例为载体液质量的0.08%;
步骤S3,灭活灌装:将步骤S2得到的混合液使用厚度为0.15μm的超滤膜过滤;然后在温度为105℃时进行高温蒸汽杀菌灭活60min,然后使用频率为5×1015Hz的紫外线辐照8min,重复2次;分装,即得所述缓解视疲劳用滴眼液;其中,缓解视疲劳用滴眼液的pH值为5.8,等渗压浓度为305mmol/L。
实施例5
一种缓解视疲劳用滴眼液的制备方法,包括以下步骤:
步骤S1,载体液配制:将所述重量份的氯化钠、氯化钾、硫酸镁加入到缓冲溶液中,室温条件下搅拌混合均匀,继续加入所述重量份的聚氧乙烯、甘油、玻璃酸钠,混合均匀后,再继续加入所述重量份的山梨酸钾,混合均匀,配制得到载体液;其中,采用运动黏度自动测定仪,对载体液在20℃~37℃时的运动粘度进行测试,测试结果为:
步骤S2,混合液配制:向步骤S1中得到的载体液中加入所述质量百分数的牛磺酸、泛醇、肌醇、天门冬氨酸、丝氨酸、叶黄素、维生素B2、烟酰胺、维生素B12、冰片,另加入聚山梨酸酯表面活性剂,快速搅拌均匀,静置40min,得混合液;其中,聚山梨酸酯表面活性剂的添加比例为载体液质量的0.22%;
步骤S3,灭活灌装:将步骤S2得到的混合液使用厚度为0.3μm的超滤膜过滤;然后在温度为105℃时进行高温蒸汽杀菌灭活90min,然后使用频率为15×1015Hz的紫外线辐照20min,重复3次;分装,即得所述缓解视疲劳用滴眼液;其中,缓解视疲劳用滴眼液的pH值为8.2,等渗压浓度为335mmol/L。
实施例6
一种缓解视疲劳用滴眼液的制备方法,包括以下步骤:
步骤S1,载体液配制:将所述重量份的氯化钠、氯化钾、硫酸镁加入到缓冲溶液中,室温条件下搅拌混合均匀,继续加入所述重量份的聚氧乙烯、甘油、玻璃酸钠,混合均匀后,再继续加入所述重量份的山梨酸钾,混合均匀,配制得到载体液;其中,采用运动黏度自动测定仪,对载体液在20℃~37℃时的运动粘度进行测试,测试结果为:
步骤S2,混合液配制:向步骤S1中得到的载体液中加入所述质量百分数的牛磺酸、泛醇、肌醇、天门冬氨酸、丝氨酸、叶黄素、维生素B2、烟酰胺、维生素B12、冰片,另加入聚山梨酸酯表面活性剂,快速搅拌均匀,静置30min,得混合液;其中,聚山梨酸酯表面活性剂的添加比例为载体液质量的0.15%;
步骤S3,灭活灌装:将步骤S2得到的混合液使用厚度为0.25μm的超滤膜过滤;然后在温度为105℃时进行高温蒸汽杀菌灭活75min,然后使用频率为10×1015Hz的紫外线辐照14min,重复2次;分装,即得所述缓解视疲劳用滴眼液;其中,缓解视疲劳用滴眼液的pH值为7.0,等渗压浓度为320mmol/L。
实验例1
对实施例1~6制得的缓解视疲劳用滴眼液标记为样品1~样品6,根据视疲劳症状判定方法对样品1~样品6的性能进行测试,判定方法如表1所示,测试结果如表2所示。
选择140名18岁-65岁长期用眼的视力易疲劳者作为受试对象,采用双盲法,随机将受试者分为7组,每组20名受试者;试验组1~试验组6采用样品1~样品6作为滴眼液,每天3次,每次两滴/眼;试验组7作为对照组,采用普通市售滴眼液,每天3次,每次两滴/眼;每个受试者试用周期为30天。
统计结果如表2所示。治疗结束后对疗效进行评价,计数资料采用χ2检验,计量资料以χ±s表示,治疗前后比较采用t检验,以P<0.05为差异有统计学意义。
表1视疲劳症状判定方法(半定量积分法)
注:“偶感”是指1-2次/2天;“时有”是指1-3次/天;“经常”是指>3次/天。
表2制得的缓解视疲劳用滴眼液的性能测试结果
由表2可知,实施例1~6制得的缓解视疲劳用滴眼液相对于普通市售滴眼液具有良好的缓解视疲劳性能。说明本申请制得的滴眼液具有良好的缓解视疲劳功效。
以上仅为本发明的优选实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种缓解视疲劳用滴眼液,其特征在于,所述缓解视疲劳用滴眼液由以下质量百分数的原料组成:牛磺酸0.1%~0.5%,泛醇0.08%~0.12%,肌醇0.06%~0.2%,天门冬氨酸0.08%~0.2%,丝氨酸0.04%~0.15%,叶黄素0.2%~0.4%,维生素B2 0.01%~0.02%,烟酰胺0.02%~0.04%,维生素B120.03%~0.05%,冰片0.08%~0.16%,其余为载体液。
2.根据权利要求1所述的缓解视疲劳用滴眼液,其特征在于,所述载体液由以下重量份的原料组成:氯化钠10份~20份,氯化钾15份~18份,硫酸镁16份~22份,缓冲溶液950份~1100份,聚氧乙烯3份~8份,甘油2份~6份,玻璃酸钠4份~9份,山梨酸钾0.5份~2份。
3.根据权利要求2所述的缓解视疲劳用滴眼液,其特征在于,所述缓冲溶液为:磷酸氢二钠/柠檬酸缓冲液、硼酸钠/硼酸缓冲液、碳酸氢钠/碳酸钠缓冲液中的任一种。
4.根据权利要求1所述的缓解视疲劳用滴眼液,其特征在于,所述丝氨酸为:左旋L-丝氨酸。
5.一种根据权利要求1~4中任一项所述的缓解视疲劳用滴眼液的制备方法,其特征在于,包括以下步骤:
步骤S1,载体液配制:将所述重量份的氯化钠、氯化钾、硫酸镁加入到缓冲溶液中,室温条件下搅拌混合均匀,继续加入所述重量份的聚氧乙烯、甘油、玻璃酸钠,混合均匀后,再继续加入所述重量份的山梨酸钾,混合均匀,配制得到载体液;
步骤S2,混合液配制:向步骤S1中得到的载体液中加入所述质量百分数的牛磺酸、泛醇、肌醇、天门冬氨酸、丝氨酸、叶黄素、维生素B2、烟酰胺、维生素B12、冰片,另加入聚山梨酸酯表面活性剂,快速搅拌均匀,静置20min~40min,得混合液;
步骤S3,灭活灌装:将步骤S2得到的混合液使用超滤膜过滤后,杀菌灭活,分装,即得所述缓解视疲劳用滴眼液。
6.根据权利要求5所述的制备方法,其特征在于,步骤S1中,所述载体液在20℃~37℃时的运动粘度为:10.5×10-6m2/s~22.5×10-6m2/s。
7.根据权利要求5所述的制备方法,其特征在于,步骤S2中,所述聚山梨酸酯表面活性剂的添加比例为:载体液质量的0.08%~0.22%。
8.根据权利要求5所述的制备方法,其特征在于,步骤S3中,所述超滤膜的厚度为:0.15μm~0.3μm。
9.根据权利要求5所述的制备方法,其特征在于,步骤S3中,所述杀菌灭活具体为:在温度为105℃时进行高温蒸汽杀菌灭活60min~90min,然后使用频率为5×1015Hz~15×1015Hz的紫外线辐照8min~20min,重复2次~3次。
10.根据权利要求5所述的制备方法,其特征在于,所述缓解视疲劳用滴眼液的pH值为5.8~8.2,等渗压浓度为305mmol/L~335mmol/L。
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