CN104491730A - 一种用于治疗电光眼药物制剂的制备工艺 - Google Patents
一种用于治疗电光眼药物制剂的制备工艺 Download PDFInfo
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Abstract
本发明属于药物技术领域,公开了一种用于治疗电光眼药物制剂的制备工艺,包括如下步骤:步骤1)称取原料,步骤2)制备复合物A,步骤3)制备复合物B以及步骤4)高压灭菌。本发明制备工艺简单可行,原料成本低廉,其制备的药物制剂不仅治疗周期短,见效快,而且毒副作用小。
Description
技术领域
本发明属于药物技术领域,具体的,涉及一种用于治疗电光眼药物制剂的制备工艺。
背景技术
电光眼,常见于从事电焊、气焊的人,主要表现是患者感到眼部不适、剧烈疼痛、怕光、流泪、眼红肿等。在不同的场合由于紫外线辐射造成的眼部损伤习惯上统称之为电光性眼炎或电光眼,是由于受到紫外线过度照射所引起的眼结膜、角膜的损伤。紫外线来源于自然光源和人工光源。在自然界,如高山地区空气稀薄,大气层对紫外线的吸收和散射作用减少;在冰川、雪地、沙漠等眩目耀眼的地区,反射光的紫外线含量增高,都会引起眼部的损害。生产条件下常见的紫外线作业有:电焊和气割、紫外线消毒、印刷工业的摄影制版、电影行业各种灯光应用、温度在3000℃以上的电极炼钢等。受紫外线辐射的角膜可见细胞核肿胀、染色质溶解、细胞坏死脱落,角膜上皮脱落,暴露基质细胞,结膜上皮外层脱离,基底细胞退行性变,引起眼部疼痛、畏光、流泪等症状。
电光眼的预防和保护主要包括:严格执行安全操作规程,在强紫外线环境工作时,戴上墨绿色滤光玻璃防护眼镜或面罩。电光性眼炎自疗和保护主要包括:可口服止痛药和镇静药;用抗菌素眼药水或眼膏,以防止眼部感染。
现有技术大多主要采用抗生素消炎治疗,毒副作用大,对眼睛会造成损伤。开发研制一种治疗效果好,毒副作用低,不含抗生素物质的药物制剂尤为重要。
发明内容
本发明的目的在于提供一种用于治疗电光眼药物制剂的制备工艺,本发明制备工艺简单可行,原料成本低廉,其制备的药物制剂不仅治疗周期短,见效快,而且毒副作用小。
为实现本发明目的,本发明采用的技术方案如下:
一种用于治疗电光眼药物制剂的制备工艺,该制备工艺包括如下步骤:
步骤1)称取原料,步骤2)制备复合物A,步骤3)制备复合物B以及步骤4)高压灭菌。
优选地,包括如下步骤:
步骤1)称取原料:按照重量份称取各原料备用;其中,黄连20-25份、石决明15-18份、泽泻12-15份、蛇床子10-12份、川牛膝10-12份、白芍8-10份、葛根7-9份、谷精草7-9份、青葙子6-8份、野菊花5-7份、莪术4-5份、连翘3-4份、枸杞3-4份、白蔻2-3份、夏枯草2-3份、陈皮2-3份、甘草1-2份、麦冬1-2份、地肤子1-2份、当归1-2份;
步骤2)制备复合物A:取黄连、石决明、谷精草、青葙子、野菊花、麦冬、地肤子以及当归,混合均匀,加相对于混合物5倍重量95%的乙醇,回流提取2次,每次1小时,合并提取液,浓缩至密度为1.2g/ml的清膏,80℃烘干后,粉碎成粉末,即为复合物A;
步骤3)制备复合物B:取泽泻、蛇床子、川牛膝、白芍、葛根、莪术、连翘、枸杞、白蔻、夏枯草、陈皮以及甘草,加5倍水煎煮两次,第一次2小时,第二次1小时,合并两次煎煮液,减压干燥获得密度为1.2g/ml的浸膏,80℃烘干后,粉碎成粉末,即为复合物B;
步骤4)高压灭菌:将复合物A和复合物B混合搅拌均匀,然后添加到水中,配制成质量浓度为1%的水溶液,高压灭菌即得。
本发明制备工艺制备的药物制剂可以与其他药物协同使用,也可单独使用,每八小时滴一次眼睛;也可根据病情修改滴加次数。
本发明药物制剂的组分均采用天然的中药原料,其配制简便,药源广泛,成本低廉,其遵循中医的处方用药原则,诸药合用,相得益彰,药性平和,其具备如下效果:治疗周期短,见效快,毒副作用低,对眼睛无损伤,不易复发,而且无抗生素添加;使用方法简单,使用次数少;制备工艺简单,原料成本低廉,容易被广大患者接受。
具体实施方式
为了使本技术领域的人员更好地理解本申请中的技术方案,下面将结合本申请具体实施例,对本申请的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本申请一部分实施例,而不是全部的实施例。基于本申请中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都应当属于本发明保护的范围。
实施例1
一种用于治疗电光眼药物制剂的制备工艺,其包括如下步骤:
1)按照重量份称取各原料备用;黄连20份、石决明15份、泽泻12份、蛇床子10份、川牛膝10份、白芍8份、葛根7份、谷精草7份、青葙子6份、野菊花5份、莪术4份、连翘3份、枸杞3份、白蔻2份、夏枯草2份、陈皮2份、甘草1份、麦冬1份、地肤子1份、当归1份;
2)取黄连、石决明、谷精草、青葙子、野菊花、麦冬、地肤子以及当归,混合均匀,加相对于混合物5倍重量95%的乙醇,回流提取2次,每次1小时,合并提取液,浓缩至密度为1.2g/ml的清膏,80℃烘干后,粉碎成粉末,即为复合物A;
3)取泽泻、蛇床子、川牛膝、白芍、葛根、莪术、连翘、枸杞、白蔻、夏枯草、陈皮以及甘草,加5倍水煎煮两次,第一次2小时,第二次1小时,合并两次煎煮液,减压干燥获得密度为1.2g/ml的浸膏,80℃烘干后,粉碎成粉末,即为复合物B;
4)将复合物A和复合物B混合搅拌均匀,然后添加到水中,配制成质量浓度为1%(w/w)的水溶液,高压灭菌即得。
实施例2
一种用于治疗电光眼药物制剂的制备工艺,其包括如下步骤:
1)按照重量份称取各原料备用;黄连25份、石决明18份、泽泻15份、蛇床子12份、川牛膝12份、白芍10份、葛根9份、谷精草9份、青葙子8份、野菊花7份、莪术5份、连翘4份、枸杞4份、白蔻3份、夏枯草3份、陈皮3份、甘草2份、麦冬2份、地肤子2份、当归2份;
2)取黄连、石决明、谷精草、青葙子、野菊花、麦冬、地肤子以及当归,混合均匀,加相对于混合物5倍重量95%的乙醇,回流提取2次,每次1小时,合并提取液,浓缩至密度为1.2g/ml的清膏,80℃烘干后,粉碎成粉末,即为复合物A;
3)取泽泻、蛇床子、川牛膝、白芍、葛根、莪术、连翘、枸杞、白蔻、夏枯草、陈皮以及甘草,加5倍水煎煮两次,第一次2小时,第二次1小时,合并两次煎煮液,减压干燥获得密度为1.2g/ml的浸膏,80℃烘干后,粉碎成粉末,即为复合物B;
4)将复合物A和复合物B混合搅拌均匀,然后添加到水中,配制成质量浓度为1%的水溶液,高压灭菌即得。
实施例3
本发明工艺制备的药物制剂的临床试验:
一般资料
2011年3月至2014年1月市眼科医院接诊电光眼患者120例,男106例,女14例,年龄18-59岁,平均41岁,均为双眼发病。其中,电焊工作辐射114例,紫外线灯误照射6例。
临床表现
患者均有紫外线灯或电焊强光照射史, 起病后出现剧痛、畏光、查可见球结膜充血水肿,角膜上皮点状、簇状或片状剥脱, 荧光素染色阳性。分型:根据病情严重程度分轻、中、重三种类型;轻型:轻度疼痛或仅有异物感,角膜荧光素染色面积在1/3以下;中型:眼部疼痛,有异物感,畏光流泪,结膜充血,眼睑潮红,角膜荧光素染色面积在1/3-2/3;重型:双眼剧烈疼痛, 结膜充血水肿明显, 眼睑痉挛,皮肤红肿,异物感明显,角膜荧光素染色面积在2/3以上。上述病例中轻型42例,中型46例,重型32例。
每型随机分为两组。
对照组:轻型21例,中型23例,重型16例。治疗方法:
①给予0.5%地卡因滴眼表面麻醉;②局部持续冷敷;③复方硫酸新霉素滴眼液滴眼4次/d预防感染。
实验组: 轻型21例,中型23例,重型16例。治疗方法:在对照组治疗方法基础上加用本发明实施例1的药物制剂,每8小时滴眼一次。
治疗结果
全部患者治愈,未出现眼部感染和并发症。两组患者治愈天数见表1。
表1 两组患者不同治愈天数
组别 | 轻型 | 中型 | 重型 |
对照组 | 2.1 | 3.7 | 4.2 |
实验组 | 1.2 | 1.6 | 2.1 |
两组别各型之间有显著差异,p<0.05。
虽然,上文中已经用一般性说明及具体实施方式对本案作了详尽的说明,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所作的修改或改进,均属于本发明要求保护的范围。
Claims (2)
1.一种用于治疗电光眼药物制剂的制备工艺,其特征在于,所述工艺包括如下步骤:步骤1)称取原料,步骤2)制备复合物A,步骤3)制备复合物B以及步骤4)高压灭菌。
2.根据权利要求2所述的工艺,其特征在于,所述工艺包括如下步骤:
步骤1)称取原料:按照重量份称取各原料备用;其中,黄连20-25份、石决明15-18份、泽泻12-15份、蛇床子10-12份、川牛膝10-12份、白芍8-10份、葛根7-9份、谷精草7-9份、青葙子6-8份、野菊花5-7份、莪术4-5份、连翘3-4份、枸杞3-4份、白蔻2-3份、夏枯草2-3份、陈皮2-3份、甘草1-2份、麦冬1-2份、地肤子1-2份、当归1-2份;
步骤2)制备复合物A:取黄连、石决明、谷精草、青葙子、野菊花、麦冬、地肤子以及当归,混合均匀,加相对于混合物5倍重量95%的乙醇,回流提取2次,每次1小时,合并提取液,浓缩至密度为1.2g/ml的清膏,80℃烘干后,粉碎成粉末,即为复合物A;
步骤3)制备复合物B:取泽泻、蛇床子、川牛膝、白芍、葛根、莪术、连翘、枸杞、白蔻、夏枯草、陈皮以及甘草,加5倍水煎煮两次,第一次2小时,第二次1小时,合并两次煎煮液,减压干燥获得密度为1.2g/ml的浸膏,80℃烘干后,粉碎成粉末,即为复合物B;
步骤4)高压灭菌:将复合物A和复合物B混合搅拌均匀,然后添加到水中,配制成质量浓度为1%的水溶液,高压灭菌即得。
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