CN105748505A - 一种用于治疗早期霰粒肿的外用凝胶剂及其制备方法 - Google Patents

一种用于治疗早期霰粒肿的外用凝胶剂及其制备方法 Download PDF

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CN105748505A
CN105748505A CN201610134144.5A CN201610134144A CN105748505A CN 105748505 A CN105748505 A CN 105748505A CN 201610134144 A CN201610134144 A CN 201610134144A CN 105748505 A CN105748505 A CN 105748505A
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刘红丽
窦忠霞
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Abstract

本发明公开了一种用于治疗早期霰粒肿的外用凝胶剂及其制备方法,所述外用凝胶剂按重量组分计,主要是由以下成分组成:丙酸氯倍他索0.0010.003份、玄明粉0.52.0份、海浮石粉0.62.0份、马尾藻多糖0.41.5份、氯丁醇0.10.12份、曲酸0.010.05份、牡丹酚0.010.04份、藻胶酸0.20.5份、芍药甙0.010.2份、松萝酸0.020.1份、咖啡酸0.030.1份、烟酰胺0.050.3份、高级醇硫酸酯盐0.030.1份、凝胶基质512份、增溶剂0.010.015份、表面活性剂0.010.02份。本发明中,玄明粉和海浮石粉具有消肿毒、消积块的功效,能够促进囊肿消散吸收;牡丹酚、松萝酸、曲酸共同作用,有效消炎抗菌、抗病毒侵袭;芍药甙能够扩张局部血管,与牡丹酚共同作用促使眼部分泌物增加,排出毒素,所有成分配合良好,有效治疗早期霰粒肿,对眼睛无毒、无刺激。

Description

一种用于治疗早期霰粒肿的外用凝胶剂及其制备方法
技术领域
本发明涉及眼部用药技术领域,具体是涉及一种用于治疗早期霰粒肿的外用凝胶剂及其制备方法。
背景技术
霰粒肿(chalazion)是一种睑板腺的慢性炎症肉芽肿(lipogranuloma)。是在睑板腺排出管的管道上阻塞和脂性分泌物潴留的基础上而形成的。是由于慢性结膜炎,皮脂腺和汗腺分泌物功能旺盛或睑缘炎所引起的慢性炎症刺激。是一种含有巨细胞的肉芽肿性炎症,最初是腺管上皮细胞增生,其周围的淋巴细胞,巨细胞和大量纤维性组织因受压而形成囊壁,中央部组织逐渐退化形成胶样物质,甚至液化。
病程缓慢,一般并无明显症状,无疼痛有时仅有沉重感,可因有肿块压迫引起暂时性散光,或肿块压迫眼球而引起异物感。眼睑皮下可触及一至数个大小不等的圆形肿块,小至米粒、绿豆,大至黄豆、樱桃,表面光滑,不与皮肤粘连,边缘清楚,无触痛。翻转眼睑在肿块在结膜面,可见紫红色或灰红色局限隆起。如有继发感染,可演变成麦粒肿,则在形成上与内麦粒肿很难区别。小型肿块可自行完全吸收,或自行穿破结膜面,排出胶样内容物,形成蕈状肉芽状增殖,这种肉芽组织亦可通过睑板腺的排出管道,而在睑缘表面形成乳头状的增殖。当有继发感发生时,即可形成内麦粒肿。老年患者,特别是术后反复发作,应将切除的标本送病理检验,以排除睑板腺癌的可能。
对于交大的囊肿,需要进行手术摘除,对于早期较小的囊肿,一般不需要进行手术治疗,一般通过热敷或者理疗按摩均有效,但是疗效不是非常好,若不及时治愈择容易发展演变成大囊肿,所以需要研制出一种能够有效治疗早期霰粒肿的药物。
发明内容
本发明解决的技术问题是提供一种疗效好、副作用小的用于治疗早期早期霰粒肿的外用凝胶剂及其制备方法。
本发明的技术方案是,一种用于治疗早期霰粒肿的外用凝胶剂,按重量组分计,主要是由以下成分组成:丙酸氯倍他索0.001-0.003份、玄明粉0.5-2.0份、海浮石粉0.6-2.0份、马尾藻多糖0.4-1.5份、氯丁醇0.1-0.12份、曲酸0.01-0.05份、牡丹酚0.01-0.04份、藻胶酸0.2-0.5份、芍药甙0.01-0.2份、松萝酸0.02-0.1份、咖啡酸0.03-0.1份、烟酰胺0.05-0.3份、高级醇硫酸酯盐0.03-0.1份、凝胶基质5-12份、增溶剂0.01-0.015份、表面活性剂0.01-0.02份。
优选配比为:丙酸氯倍他索0.002份、玄明粉1.25份、海浮石粉1.3份、马尾藻多糖0.95份、氯丁醇0.11份、曲酸0.03份、牡丹酚0.025份、藻胶酸0.35份、芍药甙0.105份、松萝酸0.06份、咖啡酸0.065份、烟酰胺0.175份、高级醇硫酸酯盐0.065份、凝胶基质8.5份、增溶剂0.0125份、表面活性剂0.015份。
进一步地,所述海浮石粉的制备方法为:将海浮石经筛选、洗净、晾干、粉碎至200目,即得到海浮石粉。
进一步地,所述凝胶基质为水凝胶基质,吸收度良好,对皮肤无刺激。
更进一步地,所述水凝胶基质是由羧甲基纤维素、甘油、泊洛沙姆、尼泊金乙酯、纯化水按照1:4:0.2:0.03:15的质量比配制而成。该水凝胶基质的配制方法为:将羧甲基纤维素用纯化水溶胀,待完全溶解后,加入甘油、泊洛沙姆、尼泊金乙酯,搅匀,即得。
进一步地,所述增溶剂为聚山梨醇酯80,增溶效果好,且有一定的乳化作用。
进一步地,所述表面活性剂为醇醚糖苷,低浓度的醇醚糖苷对眼睛无刺激、无毒、易于降解,还可显著降低整体配方的刺激性。
一种用于治疗早期霰粒肿的外用凝胶剂,其制备方法为:
(1)制备海浮石粉:将海浮石经筛选、洗净、晾干、粉碎至200目,得到海浮石粉;
(2)备料:按所述配比称取丙酸氯倍他索、玄明粉、海浮石粉、马尾藻多糖、氯丁醇、曲酸、牡丹酚、藻胶酸、芍药甙、松萝酸、咖啡酸、烟酰胺、醇硫酸酯盐、凝胶基质、增溶剂、表面活性剂;
(3)将所述高级醇硫酸酯盐、增溶剂、表面活性剂用2-3份药用溶解水溶解,得A相;
(4)将所述丙酸氯倍他索、玄明粉、海浮石粉、马尾藻多糖、氯丁醇、曲酸、牡丹酚、藻胶酸、芍药甙、松萝酸、咖啡酸、烟酰胺、加入到所述凝胶基质中,搅拌均匀,形成B相;
(5)将A相加入到B相中,并调节PH值到5.0-6.0,搅拌均匀即得。
本发明的有益效果是:本发明的外用凝胶剂中,玄明粉和海浮石粉具有消肿毒、消积块的功效,并能够清热解毒,能够促进囊肿消散吸收,牡丹酚、松萝酸、曲酸共同作用,有效消炎抗菌、抗病毒侵袭的功效,芍药甙能够扩张局部血管,与牡丹酚共同作用能够促使眼部分泌物增加,排出毒素,通过醇醚糖苷可显著降低整体配方的刺激性,本发明所选用的所有成分配合良好,有效治疗早期霰粒肿,对眼睛无毒、无刺激。
具体实施方式
实施例1:
一种用于治疗早期霰粒肿的外用凝胶剂,按重量组分计,主要是由以下成分组成:丙酸氯倍他索0.001份、玄明粉0.5份、海浮石粉0.6份、马尾藻多糖0.4份、氯丁醇0.1份、曲酸0.01份、牡丹酚0.01份、藻胶酸0.2份、芍药甙0.01份、松萝酸0.02份、咖啡酸0.03份、烟酰胺0.05份、高级醇硫酸酯盐0.03份、凝胶基质5份、增溶剂0.01份、表面活性剂0.01份。
其中,所述海浮石粉的制备方法为:将海浮石经筛选、洗净、晾干、粉碎至200目,即得到海浮石粉。所述凝胶基质为水凝胶基质,吸收度良好,对皮肤无刺激,该水凝胶基质是由羧甲基纤维素、甘油、泊洛沙姆、尼泊金乙酯、纯化水按照1:4:0.2:0.03:15的质量比配制而成,该水凝胶基质的配制方法为:将羧甲基纤维素用纯化水溶胀,待完全溶解后,加入甘油、泊洛沙姆、尼泊金乙酯,搅匀,即得。所述增溶剂为聚山梨醇酯80,增溶效果好,且有一定的乳化作用。所述表面活性剂为醇醚糖苷,低浓度的醇醚糖苷对眼睛无刺激、无毒、易于降解,还可显著降低整体配方的刺激性。
该用于治疗早期霰粒肿的外用凝胶剂的制备方法为:
(1)制备海浮石粉:将海浮石经筛选、洗净、晾干、粉碎至200目,得到海浮石粉;
(2)备料:按所述配比称取丙酸氯倍他索、玄明粉、海浮石粉、马尾藻多糖、氯丁醇、曲酸、牡丹酚、藻胶酸、芍药甙、松萝酸、咖啡酸、烟酰胺、醇硫酸酯盐、凝胶基质、增溶剂、表面活性剂;
(3)将所述高级醇硫酸酯盐、增溶剂、表面活性剂用2份药用溶解水溶解,得A相;
(4)将所述丙酸氯倍他索、玄明粉、海浮石粉、马尾藻多糖、氯丁醇、曲酸、牡丹酚、藻胶酸、芍药甙、松萝酸、咖啡酸、烟酰胺、加入到所述凝胶基质中,搅拌均匀,形成B相;
(5)将A相加入到B相中,并调节PH值到5.0,搅拌均匀即得。
实施例2:
一种用于治疗早期霰粒肿的外用凝胶剂,按重量组分计,主要是由以下成分组成:丙酸氯倍他索0.002份、玄明粉1.25份、海浮石粉1.3份、马尾藻多糖0.95份、氯丁醇0.11份、曲酸0.03份、牡丹酚0.025份、藻胶酸0.35份、芍药甙0.105份、松萝酸0.06份、咖啡酸0.065份、烟酰胺0.175份、高级醇硫酸酯盐0.065份、凝胶基质8.5份、增溶剂0.0125份、表面活性剂0.015份。
其中,所述海浮石粉的制备方法为:将海浮石经筛选、洗净、晾干、粉碎至200目,即得到海浮石粉。所述凝胶基质为水凝胶基质,吸收度良好,对皮肤无刺激,该水凝胶基质是由羧甲基纤维素、甘油、泊洛沙姆、尼泊金乙酯、纯化水按照1:4:0.2:0.03:15的质量比配制而成,该水凝胶基质的配制方法为:将羧甲基纤维素用纯化水溶胀,待完全溶解后,加入甘油、泊洛沙姆、尼泊金乙酯,搅匀,即得。所述增溶剂为聚山梨醇酯80,增溶效果好,且有一定的乳化作用。所述表面活性剂为醇醚糖苷,低浓度的醇醚糖苷对眼睛无刺激、无毒、易于降解,还可显著降低整体配方的刺激性。
该用于治疗早期霰粒肿的外用凝胶剂的制备方法为:
(1)制备海浮石粉:将海浮石经筛选、洗净、晾干、粉碎至200目,得到海浮石粉;
(2)备料:按所述配比称取丙酸氯倍他索、玄明粉、海浮石粉、马尾藻多糖、氯丁醇、曲酸、牡丹酚、藻胶酸、芍药甙、松萝酸、咖啡酸、烟酰胺、醇硫酸酯盐、凝胶基质、增溶剂、表面活性剂;
(3)将所述高级醇硫酸酯盐、增溶剂、表面活性剂用2.5份药用溶解水溶解,得A相;
(4)将所述丙酸氯倍他索、玄明粉、海浮石粉、马尾藻多糖、氯丁醇、曲酸、牡丹酚、藻胶酸、芍药甙、松萝酸、咖啡酸、烟酰胺、加入到所述凝胶基质中,搅拌均匀,形成B相;
(5)将A相加入到B相中,并调节PH值到5.5,搅拌均匀即得。
实施例3:
一种用于治疗早期霰粒肿的外用凝胶剂,按重量组分计,主要是由以下成分组成:丙酸氯倍他索0.003份、玄明粉2.0份、海浮石粉2.0份、马尾藻多糖1.5份、氯丁醇0.12份、曲酸0.05份、牡丹酚0.04份、藻胶酸0.5份、芍药甙0.2份、松萝酸0.1份、咖啡酸0.1份、烟酰胺0.3份、高级醇硫酸酯盐0.1份、凝胶基质12份、增溶剂0.015份、表面活性剂0.02份。
其中,所述海浮石粉的制备方法为:将海浮石经筛选、洗净、晾干、粉碎至200目,即得到海浮石粉。所述凝胶基质为水凝胶基质,吸收度良好,对皮肤无刺激,该水凝胶基质是由羧甲基纤维素、甘油、泊洛沙姆、尼泊金乙酯、纯化水按照1:4:0.2:0.03:15的质量比配制而成,该水凝胶基质的配制方法为:将羧甲基纤维素用纯化水溶胀,待完全溶解后,加入甘油、泊洛沙姆、尼泊金乙酯,搅匀,即得。所述增溶剂为聚山梨醇酯80,增溶效果好,且有一定的乳化作用。所述表面活性剂为醇醚糖苷,低浓度的醇醚糖苷对眼睛无刺激、无毒、易于降解,还可显著降低整体配方的刺激性。
该用于治疗早期霰粒肿的外用凝胶剂的制备方法为:
(1)制备海浮石粉:将海浮石经筛选、洗净、晾干、粉碎至200目,得到海浮石粉;
(2)备料:按所述配比称取丙酸氯倍他索、玄明粉、海浮石粉、马尾藻多糖、氯丁醇、曲酸、牡丹酚、藻胶酸、芍药甙、松萝酸、咖啡酸、烟酰胺、醇硫酸酯盐、凝胶基质、增溶剂、表面活性剂;
(3)将所述高级醇硫酸酯盐、增溶剂、表面活性剂用3份药用溶解水溶解,得A相;
(4)将所述丙酸氯倍他索、玄明粉、海浮石粉、马尾藻多糖、氯丁醇、曲酸、牡丹酚、藻胶酸、芍药甙、松萝酸、咖啡酸、烟酰胺、加入到所述凝胶基质中,搅拌均匀,形成B相;
(5)将A相加入到B相中,并调节PH值到6.0,搅拌均匀即得。
典型病例:
1、杨某某,女,22岁,眼部有肿块压迫感,经检查发现其眼睑皮下有数个米粒大小的圆形肿块,表面光滑,不与皮肤粘连,诊断为霰粒肿,使用本发明实施例1制备的外用凝胶剂进行治疗,涂抹于眼周,每日3次,每次0.5-1g,3日后,肿块变小,压迫感减轻,6日后肿块完全消失,无压迫感,经检查为痊愈。3个月后随访,未见复发。
2、苏某某,女,25岁,于一次体检时发现其睑皮下有结节隆起,无压痛,无自觉症状,隆起与皮肤无粘连,翻转眼睑,正对囊肿处之结膜而呈紫红色或灰白色,诊断为霰粒肿,使用本发明实施例2制备的外用凝胶剂进行治疗,涂抹于眼周,每日3次,每次0.5-1g,4日后,隆起变小,结膜颜色恢复正常,6日后,隆起完全消失,经检查为痊愈。3个月后随访,未见复发。
3、林某某,男,起初,发现自己眼睑结膜面上有较小肿块,呈紫红色或灰红色局布隆起,无自觉症状,后来逐渐增殖为乳头状,能明显看到肉芽组织,诊断为霰粒肿,使用本发明实施例3制备的外用凝胶剂进行治疗,涂抹于眼周,每日2次,每次0.5-1g,5日后,乳头状的肉芽组织变小,结膜颜色恢复正常,8日后,肉芽组织完全消失,经检查为痊愈。3个月后随访,未见复发。
最后应说明的是:以上实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明实施例技术方案的精神和范围。

Claims (8)

1.一种用于治疗早期霰粒肿的外用凝胶剂,其特征在于,按重量组分计,主要是由以下成分组成:丙酸氯倍他索0.001-0.003份、玄明粉0.5-2.0份、海浮石粉0.6-2.0份、马尾藻多糖0.4-1.5份、氯丁醇0.1-0.12份、曲酸0.01-0.05份、牡丹酚0.01-0.04份、藻胶酸0.2-0.5份、芍药甙0.01-0.2份、松萝酸0.02-0.1份、咖啡酸0.03-0.1份、烟酰胺0.05-0.3份、高级醇硫酸酯盐0.03-0.1份、凝胶基质5-12份、增溶剂0.01-0.015份、表面活性剂0.01-0.02份。
2.如权利要求1所述的一种用于治疗早期霰粒肿的外用凝胶剂,其特征在于,其特征在于,按重量组分计,主要是由以下成分组成:丙酸氯倍他索0.002份、玄明粉1.25份、海浮石粉1.3份、马尾藻多糖0.95份、氯丁醇0.11份、曲酸0.03份、牡丹酚0.025份、藻胶酸0.35份、芍药甙0.105份、松萝酸0.06份、咖啡酸0.065份、烟酰胺0.175份、高级醇硫酸酯盐0.065份、凝胶基质8.5份、增溶剂0.0125份、表面活性剂0.015份。
3.如权利要求1或2所述的一种用于治疗早期霰粒肿的外用凝胶剂,其特征在在于,所述海浮石粉的制备方法为:将海浮石经筛选、洗净、晾干、粉碎至200目,即得到海浮石粉。
4.如权利要求1或2所述的一种用于治疗早期霰粒肿的外用凝胶剂,其特征在于,所述凝胶基质为水凝胶基质。
5.如权利要求1或2所述的一种用于治疗早期霰粒肿的外用凝胶剂,其特征在于,所述水凝胶基质是由羧甲基纤维素、甘油、泊洛沙姆、尼泊金乙酯、纯化水按照1:4:0.2:0.03:15的质量比配制而成。
6.如权利要求1或2所述的一种用于治疗早期霰粒肿的外用凝胶剂,其特征在于,所述增溶剂为聚山梨醇酯80。
7.如权利要求1或2所述的一种用于治疗早期霰粒肿的外用凝胶剂,其特征在于,所述表面活性剂为醇醚糖苷。
8.如权利要求1-7所述的一种用于治疗早期霰粒肿的外用凝胶剂,其特征在于,制备方法为:
(1)制备海浮石粉:将海浮石经筛选、洗净、晾干、粉碎至200目,得到海浮石粉;
(2)备料:按所述配比称取丙酸氯倍他索、玄明粉、海浮石粉、马尾藻多糖、氯丁醇、曲酸、牡丹酚、藻胶酸、芍药甙、松萝酸、咖啡酸、烟酰胺、醇硫酸酯盐、凝胶基质、增溶剂、表面活性剂;
(3)将所述高级醇硫酸酯盐、增溶剂、表面活性剂用2-3份药用溶解水溶解,得A相;
(4)将所述丙酸氯倍他索、玄明粉、海浮石粉、马尾藻多糖、氯丁醇、曲酸、牡丹酚、藻胶酸、芍药甙、松萝酸、咖啡酸、烟酰胺、加入到所述凝胶基质中,搅拌均匀,形成B相。
(5)将A相加入到B相中,并调节PH值到5.0-6.0,搅拌均匀即得。
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