CN108904601A - 一种复方银杏外种皮油剂的制备方法 - Google Patents
一种复方银杏外种皮油剂的制备方法 Download PDFInfo
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- CN108904601A CN108904601A CN201811155724.8A CN201811155724A CN108904601A CN 108904601 A CN108904601 A CN 108904601A CN 201811155724 A CN201811155724 A CN 201811155724A CN 108904601 A CN108904601 A CN 108904601A
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- A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
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Abstract
本发明一种复方银杏外种皮油剂的制备方法,属于中药制备领域。一种复方银杏外种皮油剂的制备方法,其特征在于,它是由以下重量配比原料组成,在每千克复方银杏外种皮油剂中银杏外种皮150‑350g,五毒草150‑350g,冰片5‑25g,余量为植物油。本发明利用银杏外种皮和五毒草具有的清热解毒、抗菌、抗炎、消肿止痛、止痒等药理功效,采用乙醇渗漉与水煎醇沉工艺结合,能够使其有效成分得到充分提取,与植物油混合研磨均匀制得油剂产品,制得的复方油剂用时涂擦于患处,以杀灭各种细菌和真菌为主,兼顾消炎止痒,对皮炎、神经性皮炎、湿疹、手足癣、花斑癣、体癣等均有较好的协同治疗功效。本发明也为银杏外种皮和五毒草混合提取制得复油剂产品提供了一种新的制备方法。
Description
技术领域
本发明属于中药制备领域,涉及一种复方银杏外种皮油剂的制备方法。
背景技术
银杏外种皮是银杏树种子(即银杏)硬壳外面的部分,俗称白果衣,银杏种子的皮分肉质的外种皮、骨质的中种皮和膜质的内种皮,本发明采用的银杏外种皮是银杏种子的肉质外种皮。科学家经研究发现外种皮含有大量的氢化白果酸、白果酚和白果醇,还含有银杏黄素、异银杏黄素和多糖类成分,还有微量的银杏内酯。其作用性质与环磷酰胺及地塞米松等相似。银杏外种皮的多糖类可增强细胞免疫功能,对体液免疫过程中B淋巴细胞的产生和抗体形成有作用。具文献报道,银杏外种皮中的醇类中间体,对22种临床常见致病性真菌的抑制有效率为81%;0.1%氢化白果酸抑制25种临床常见致病性真菌的有效率为92%。据报道,银杏酸有较强的杀菌和抑制作用,对于葡萄球菌、化脓性球菌、甚至对于其它真菌有抑制作用,用它治疗真菌感染的湿癣有显著的作用。对病毒引起的脓胞疮疹、扁平疣有较好的疗效。五毒草,学名为蓼科植物杠板归Pulygunum perfoliatum L.的地上部分全草,又名贯叶蓼。性味酸、苦、平,微寒。归肺、膀胱经。具有清热解毒,利水消肿,止咳功能,用于咽喉肿痛,肺热咳嗽,小儿顿咳,水肿尿少,湿热泻痢,湿疹,疖肿,蛇虫咬伤。具文献介绍:全草含靛苷、黄酮类、蒽苷、酚类、氨基酸、有机酸、鞣质和糖类等。有机酸有咖啡酸、阿魏酸等;黄酮类有水蓼素、山柰酚、槲皮素、萹蓄苷、芦丁等。药理作用:①抑菌作用:杠板归水提取液对金黄色葡萄球菌、巴氏杆菌、链球菌、沙门菌、大肠埃希菌等临床常见病原微生物都有较强的抗菌作用。②镇咳作用:杠板归对小鼠氨水引咳实验均呈明显的镇咳作用。③抗炎作用:杠板归总提取物部位具有显著的抗炎活性。利用银杏外种皮和五毒草的特有功效,开发一种油剂产品供外用,将会对皮肤病的治疗产生不同与其他制剂的更为有益的效果。制备油剂产品的基质原料,大多采用植物油或液体石蜡,因具有黏性,对皮肤黏膜有柔润安抚作用,附着于皮肤、黏膜使药物滞留患处而起延效的作用,故常用于皮肤的炎症。经检索文献报道,就银杏外种皮与五毒草制备成复方油剂的制备方法还没见有公开的专利申请和相关文献报道。
发明内容
根据银杏外种皮及五毒草特有的化学成分、对大多细菌或真菌以及病毒引起的湿癣、疱疹的特殊功效,开发一种较为柔润且能延效的油剂制品的制备方法是本发明的主要目的。
为了实现上述目的,本发明具体采用了以下技术方案:
一种复方银杏外种皮油剂的制备方法,其特征在于,它是由以下重量配比原料组成,在每千克复方银杏外种皮油剂中银杏外种皮150-350g,五毒草150-350g,冰片5-25g,余量为植物油,按以下方法制得:分别取银杏外种皮、五毒草碾碎成粗粉,混合,装有带盖的容器中,按药材总重量为1:1比例加入浓度为75%v/v乙醇,均匀湿润,加盖放置24h,装入渗漉筒内放置24h后渗漉,调节流速为1ml·min-1,收集漉液1000g另器保存;漉渣按药材重量的10倍加入蒸馏水,煎煮提取1.5h,滤取水提液,加入滤液4倍量的95%v/v乙醇,搅拌均匀,置1-2℃环境下静置48h,过滤,得提取液;将提取液与上述渗漉液合并,置水浴上加热回收乙醇至无醇味,继续浓缩成稠膏,将稠膏置烘箱中在110℃条件下烘干至含水量在3%,得银杏外种皮和五毒草混合提取物;将植物油加热至120℃至沸20min后,停止加热,待油温降至40℃时,加入混合提取物研磨均匀,再加入研成细粉的冰片,充分研磨均匀,然后再补加经110℃干热灭菌后的植物油至规定量,充分均匀,即得。
优选的,一种复方银杏外种皮油剂的制备方法,其特征在于,它是由以下重量配比原料组成,在每千克复方银杏外种皮油剂中银杏外种皮200-300g,五毒草200-300g,冰片10-20g,余量为植物油,按以下方法制得:分别取银杏外种皮、五毒草碾碎成粗粉,混合,装有带盖的容器中,按药材总重量为1:1比例加入浓度为75%v/v乙醇,均匀湿润,加盖放置24h,装入渗漉筒内放置24h后渗漉,调节流速为1ml·min-1,收集漉液1000g另器保存;漉渣按药材重量的10倍加入蒸馏水,煎煮提取1.5h,滤取水提液,加入滤液4倍量的95%v/v乙醇,搅拌均匀,置1-2℃环境下静置48h,过滤,得提取液;将提取液与上述渗漉液合并,置水浴上加热回收乙醇至无醇味,继续浓缩成稠膏,将稠膏置烘箱中在110℃条件下烘干至含水量在3%,得银杏外种皮和五毒草混合提取物;将植物油加热至120℃至沸20min后,停止加热,待油温降至40℃时,加入混合提取物研磨均匀,再加入研成细粉的冰片,充分研磨均匀,然后再补加经110℃干热灭菌后的植物油至规定量,充分均匀,即得。
更优选的,一种复方银杏外种皮油剂的制备方法,其特征在于,它是由以下重量配比原料组成,在每千克复方银杏外种皮油剂中银杏外种皮250g,五毒草250g,冰片15g,余量为植物油,按以下方法制得:分别取银杏外种皮、五毒草碾碎成粗粉,混合,装有带盖的容器中,按药材总重量为1:1比例加入浓度为75%v/v乙醇,均匀湿润,加盖放置24h,装入渗漉筒内放置24h后渗漉,调节流速为1ml·min-1,收集漉液1000g另器保存;漉渣按药材重量的10倍加入蒸馏水,煎煮提取1.5h,滤取水提液,加入滤液4倍量的95%v/v乙醇,搅拌均匀,置1-2℃环境下静置48h,过滤,得提取液;将提取液与上述渗漉液合并,置水浴上加热回收乙醇至无醇味,继续浓缩成稠膏,将稠膏置烘箱中在110℃条件下烘干至含水量在3%,得银杏外种皮和五毒草混合提取物;将植物油加热至120℃至沸20min后,停止加热,待油温降至40℃时,加入混合提取物研磨均匀,再加入研成细粉的冰片,充分研磨均匀,然后再补加经110℃干热灭菌后的植物油至规定量,充分均匀,即得。
上述所述的植物油为包括花生油,葵花籽油,菜籽油,麻油,豆油,玉米胚芽油,麦胚油,稻糠油,棕榈油,松籽油,瓜子油,棉籽油,火麻油,蓖麻油,核桃油,碧根果油,杏仁油,桃仁油,牡丹籽油,银杏油,红花籽油,黄荠油,椰子油中的任意一种。
进一步优选的是麻油,松籽油,红花籽油,核桃油,杏仁油中的任意一种。
更进一步优选的是麻油,红花籽油,核桃油中的任意一种。
本发明方法制得的一种治疗皮肤真菌感染、湿疹、皮炎和皮肤癣如手足癣、花斑癣、体癣等的用途。
银杏外种皮是银杏树种子(即银杏)硬壳外面的部分,俗称白果衣,银杏种子的皮分肉质的外种皮、骨质的中种皮和膜质的内种皮,本发明采用的银杏外种皮是银杏种子的肉质外种皮。科学家经研究发现外种皮含有大量的氢化白果酸、白果酚和白果醇,还含有银杏黄素、异银杏黄素和多糖类成分,还有微量的银杏内酯。其作用性质与环磷酰胺及地塞米松等相似。银杏外种皮的多糖类可增强细胞免疫功能,对体液免疫过程中B淋巴细胞的产生和抗体形成有作用。具文献报道,银杏外种皮中的醇类中间体,对22种临床常见致病性真菌的抑制有效率为81%;0.1%氢化白果酸抑制25种临床常见致病性真菌的有效率为92%。据报道,银杏酸有较强的杀菌和抑制作用,对于葡萄球菌、化脓性球菌、甚至对于其它真菌有抑制作用,用它治疗真菌感染的湿癣有显著的作用。对病毒引起的脓胞疮疹、扁平疣有较好的疗效。
五毒草,学名为蓼科植物杠板归Pulygunum perfoliatum L.的地上部分全草,又名贯叶蓼。性味酸、苦、平,微寒。归肺、膀胱经。具有清热解毒,利水消肿,止咳功能,用于咽喉肿痛,肺热咳嗽,小儿顿咳,水肿尿少,湿热泻痢,湿疹,疖肿,蛇虫咬伤。具文献介绍:全草含靛苷、黄酮类、蒽苷、酚类、氨基酸、有机酸、鞣质和糖类等。有机酸有咖啡酸、阿魏酸等;黄酮类有水蓼素、山柰酚、槲皮素、萹蓄苷、芦丁等。药理作用:①抑菌作用:杠板归水提取液对金黄色葡萄球菌、巴氏杆菌、链球菌、沙门菌、大肠埃希菌等临床常见病原微生物都有较强的抗菌作用。②镇咳作用:杠板归对小鼠氨水引咳实验均呈明显的镇咳作用。③抗炎作用:杠板归总提取物部位具有显著的抗炎活性。
本发明采用的五毒草为干品全草。
冰片,又名合成龙脑,龙脑含量55.0%以上。性味辛、苦,微寒。归心、脾、肺经。具有开窍醒神,清热止痛功能。适用于热病神昏,惊厥,中风痰厥,气郁暴厥,中息昏迷,胸痹心痛,目赤,口疮,咽喉肿痛,耳道流脓。冰片在药剂中作为透皮促进剂,还能增加透皮给药药物的透过率。
本发明的有益效果
本发明利用银杏外种皮和五毒草具有的清热解毒、抗菌、抗炎、消肿止痛、止痒等药理功效,采用乙醇渗漉与水煎醇沉工艺结合,能够使其有效成分得到充分提取,使其成分基本得到完全提取的银杏外种皮和五毒草的混合物与植物油混合研磨均匀制得油剂产品,制得的复方油剂用时涂擦于患处,以杀灭各种细菌和真菌为主,兼顾消炎止痒,对皮炎、神经性皮炎、湿疹、手足癣、花斑癣、体癣等均有较好的协同治疗功效。以植物油为基质能够增加药物的黏性,不仅对皮肤有柔润作用,且能更好地附着皮肤,使药物滞留患处时间延长,起到延效作用。银杏外种皮在当地为一废弃物,加工制作成疗效确切的制剂,具有废弃物高效利用的可观价值,五毒草则常作为园林绿化的栽培植物,其产量丰富,因而其生产成本较低,制品用量小,效果满意,是一种具有开发价值复方药物制剂。本发明也为银杏外种皮和五毒草混合提取制得复油剂产品提供了一种新的制备方法。
具体实施方式
实施例1
分称别取经充分干燥后的银杏外种皮150g,五毒草150g,碾成粗粉,混合均匀,装入带盖的容器中,加入浓度为75%v/v乙醇300g,均匀湿润,加盖放置24h,装入渗漉筒内放置24h后渗漉,调节流速为1ml·min-1,自渗漉筒上口补加75%v/v乙醇,收集漉液1000g,另器保存;漉渣加入蒸馏水3000g,煎煮提取1.5h,滤取水提液,加入12000g的95%v/v乙醇,搅拌均匀,置1-2℃环境下静置24h,过滤,得提取液;将提取液与上述渗漉液合并,置水浴上加热回收乙醇至无醇味,继续浓缩成稠膏,将稠膏置烘箱中在110℃条件下烘干至含水量在3%,得银杏外种皮和五毒草混合提取物;将松籽油800g,加热至120℃至沸20min后,停止加热,待油温降至40℃时,加入混合提取物研磨均匀,再加入研成细粉的冰片5g,充分研磨均匀,然后再补加经110℃干热灭菌后的松籽油至全量1000g,充分均匀,定量分装,即得。
实施例2
分称别取经充分干燥后的银杏外种皮350g,五毒草350g,碾成粗粉,混合均匀,装入带盖的容器中,加入浓度为75%v/v乙醇700g,均匀湿润,加盖放置24h,装入渗漉筒内放置24h后渗漉,调节流速为1ml·min-1,自渗漉筒上口补加75%v/v乙醇,收集漉液1000g,另器保存;漉渣加入蒸馏水7000g,煎煮提取1.5h,滤取水提液,加入28000g的95%v/v乙醇,搅拌均匀,置1-2℃环境下静置24h,过滤,得提取液;将提取液与上述渗漉液合并,置水浴上加热回收乙醇至无醇味,继续浓缩成稠膏,将稠膏置烘箱中在110℃条件下烘干至含水量在3%,得银杏外种皮和五毒草混合提取物;将豆油800g,加热至120℃至沸20min后,停止加热,待油温降至40℃时,加入混合提取物研磨均匀,再加入研成细粉的冰片25g,充分研磨均匀,然后再补加经110℃干热灭菌后的豆油至全量1000g,充分均匀,定量分装,即得。
实施例3
分称别取经充分干燥后的银杏外种皮200g,五毒草200g,碾成粗粉,混合均匀,装入带盖的容器中,加入浓度为75%v/v乙醇400g,均匀湿润,加盖放置24h,装入渗漉筒内放置24h后渗漉,调节流速为1ml·min-1,自渗漉筒上口补加75%v/v乙醇,收集漉液1000g,另器保存;漉渣加入蒸馏水4000g,煎煮提取1.5h,滤取水提液,加入16000g的95%v/v乙醇,搅拌均匀,置1-2℃环境下静置24h,过滤,得提取液;将提取液与上述渗漉液合并,置水浴上加热回收乙醇至无醇味,继续浓缩成稠膏,将稠膏置烘箱中在110℃条件下烘干至含水量在3%,得银杏外种皮和五毒草混合提取物;将红花籽油800g,加热至120℃至沸20min后,停止加热,待油温降至40℃时,加入混合提取物研磨均匀,再加入研成细粉的冰片10g,充分研磨均匀,然后再补加经110℃干热灭菌后的红花籽油至全量1000g,充分均匀,定量分装,即得。
实施例4
分称别取经充分干燥后的银杏外种皮250g,五毒草250g,碾成粗粉,混合均匀,装入带盖的容器中,加入浓度为75%v/v乙醇500g,均匀湿润,加盖放置24h,装入渗漉筒内放置24h后渗漉,调节流速为1ml·min-1,自渗漉筒上口补加75%v/v乙醇,收集漉液1000g,另器保存;漉渣加入蒸馏水5000g,煎煮提取1.5h,滤取水提液,加入20000g的95%v/v乙醇,搅拌均匀,置1-2℃环境下静置24h,过滤,得提取液;将提取液与上述渗漉液合并,置水浴上加热回收乙醇至无醇味,继续浓缩成稠膏,将稠膏置烘箱中在110℃条件下烘干至含水量在3%,得银杏外种皮和五毒草混合提取物;将麻油800g,加热至120℃至沸20min后,停止加热,待油温降至40℃时,加入混合提取物研磨均匀,再加入研成细粉的冰片15g,充分研磨均匀,然后再补加经110℃干热灭菌后的麻油至全量1000g,充分均匀,定量分装,即得。
实施例5
分称别取经充分干燥后的银杏外种皮300g,五毒草30g,碾成粗粉,混合均匀,装入带盖的容器中,加入浓度为75%v/v乙醇600g,均匀湿润,加盖放置24h,装入渗漉筒内放置24h后渗漉,调节流速为1ml·min-1,自渗漉筒上口补加75%v/v乙醇,收集漉液1000g,另器保存;漉渣加入蒸馏水6000g,煎煮提取1.5h,滤取水提液,加入24000g的95%v/v乙醇,搅拌均匀,置1-2℃环境下静置24h,过滤,得提取液;将提取液与上述渗漉液合并,置水浴上加热回收乙醇至无醇味,继续浓缩成稠膏,将稠膏置烘箱中在110℃条件下烘干至含水量在3%,得银杏外种皮和五毒草混合提取物;将核桃油800g,加热至120℃至沸20min后,停止加热,待油温降至40℃时,加入混合提取物研磨均匀,再加入研成细粉的冰片20g,充分研磨均匀,然后再补加经110℃干热灭菌后的核桃油至全量1000g,充分均匀,定量分装,即得。
临床疗效:
采用本发明复方银杏外种皮油剂,治疗足癣22例,采用每日涂擦患处,一日3次,5天为一疗程,经一个疗程治愈10例,二个疗程治愈12例,总治愈率100%。
采用本发明复方银杏外种皮油剂,治疗湿疹10例,局部涂擦一日3次,7天为一疗程,一个疗程治愈3例,二个疗程治愈6例,显效1例,治愈率90%,总有效率100%。
典型病例:
章某某,男,32岁,患足癣1年多,经多次治疗,均复发,未能治愈。经采用本发明复方银杏外种皮油剂,每日局部涂药3次,5天为一疗程,经过两个疗程治愈,后经随访未见复发。
田某某,女,42岁,右小腿内侧内侧患湿疹二年多,经多处反复治疗未愈,采用本发明复方银杏外种皮油剂,浸入纱布使成油纱布,贴敷于患处,外用绷带包扎,每日换药三次,经二个疗程治疗后痊愈,随访一年,未见复发。
Claims (6)
1.一种复方银杏外种皮油剂的制备方法,其特征在于,它是由以下重量配比原料组成,在每千克复方银杏外种皮油剂中银杏外种皮150-350g,五毒草150-350g,冰片5-25g,余量为植物油,按以下方法制得:分别取银杏外种皮、五毒草碾碎成粗粉,混合,装有带盖的容器中,按药材总重量为1:1比例加入浓度为75%v/v乙醇,均匀湿润,加盖放置24h,装入渗漉筒内放置24h后渗漉,调节流速为1ml·min-1,收集漉液1000g另器保存;漉渣按药材重量的10倍加入蒸馏水,煎煮提取1.5h,滤取水提液,加入滤液4倍量的95%v/v乙醇,搅拌均匀,置1-2℃环境下静置48h,过滤,得提取液;将提取液与上述渗漉液合并,置水浴上加热回收乙醇至无醇味,继续浓缩成稠膏,将稠膏置烘箱中在110℃条件下烘干至含水量在3%,得银杏外种皮和五毒草混合提取物;将植物油加热至120℃至沸20min后,停止加热,待油温降至40℃时,加入混合提取物研磨均匀,再加入研成细粉的冰片,充分研磨均匀,然后再补加经110℃干热灭菌后的植物油至规定量,充分均匀,即得。
2.一种复方银杏外种皮油剂的制备方法,其特征在于,它是由以下重量配比原料组成,在每千克复方银杏外种皮油剂中银杏外种皮200-300g,五毒草200-300g,冰片10-20g,余量为植物油,按以下方法制得:分别取银杏外种皮、五毒草碾碎成粗粉,混合,装有带盖的容器中,按药材总重量为1:1比例加入浓度为75%v/v乙醇,均匀湿润,加盖放置24h,装入渗漉筒内放置24h后渗漉,调节流速为1ml·min-1,收集漉液1000g另器保存;漉渣按药材重量的10倍加入蒸馏水,煎煮提取1.5h,滤取水提液,加入滤液4倍量的95%v/v乙醇,搅拌均匀,置1-2℃环境下静置48h,过滤,得提取液;将提取液与上述渗漉液合并,置水浴上加热回收乙醇至无醇味,继续浓缩成稠膏,将稠膏置烘箱中在110℃条件下烘干至含水量在3%,得银杏外种皮和五毒草混合提取物;将植物油加热至120℃至沸20min后,停止加热,待油温降至40℃时,加入混合提取物研磨均匀,再加入研成细粉的冰片,充分研磨均匀,然后再补加经110℃干热灭菌后的植物油至规定量,充分均匀,即得。
3.一种复方银杏外种皮油剂的制备方法,其特征在于,它是由以下重量配比原料组成,在每千克复方银杏外种皮油剂中银杏外种皮250g,五毒草250g,冰片15g,余量为植物油,按以下方法制得:分别取银杏外种皮、五毒草碾碎成粗粉,混合,装有带盖的容器中,按药材总重量为1:1比例加入浓度为75%v/v乙醇,均匀湿润,加盖放置24h,装入渗漉筒内放置24h后渗漉,调节流速为1ml·min-1,收集漉液1000g另器保存;漉渣按药材重量的10倍加入蒸馏水,煎煮提取1.5h,滤取水提液,加入滤液4倍量的95%v/v乙醇,搅拌均匀,置1-2℃环境下静置48h,过滤,得提取液;将提取液与上述渗漉液合并,置水浴上加热回收乙醇至无醇味,继续浓缩成稠膏,将稠膏置烘箱中在110℃条件下烘干至含水量在3%,得银杏外种皮和五毒草混合提取物;将植物油加热至120℃至沸20min后,停止加热,待油温降至40℃时,加入混合提取物研磨均匀,再加入研成细粉的冰片,充分研磨均匀,然后再补加经110℃干热灭菌后的植物油至规定量,充分均匀,即得。
4.如权利要求1-3所述的复方银杏外种皮油剂的制备方法,其特征在于,所述的植物油为花生油,葵花籽油,菜籽油,麻油,豆油,玉米胚芽油,麦胚油,稻糠油,棕榈油,松籽油,瓜子油,棉籽油,火麻油,蓖麻油,核桃油,碧根果油,杏仁油,桃仁油,牡丹籽油,银杏油,红花籽油,黄荠油,椰子油中的任意一种。
5.如权利要求4所述的复方银杏外种皮油剂的制备方法,其特征在于,所述的植物油为麻油,松籽油,红花籽油,核桃油,杏仁油中的任意一种。
6.如权利要求5所述的复方银杏外种皮油剂的制备方法,其特征在于,所述的植物油为麻油,红花籽油,核桃油中的任意一种。
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