CN107998337A - 一种治疗近视的贴剂及其制备方法 - Google Patents
一种治疗近视的贴剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗近视的贴剂及其制备方法,由下列重量份的原料组成:赤芍15‑25份,牛膝10‑20份,冬瓜藤10‑20份,茺蔚子5‑15份,没药5‑15份,乳香10‑20份,合欢花5‑15份,黄桷根5‑15份,郁金10‑20份,延胡索10‑20份,瑞苓草5‑15份,丝瓜络10‑20份,天仙藤10‑20份,威灵仙5‑15份,山合香5‑15份,丹参10‑20份,芡实叶5‑15份,川芎10‑20份,金盏菊根10‑20份,麝香10‑20份,冰片5‑15份。本发明贴剂敷贴于眼周穴位,配合眼周穴位按摩、眼部肌肉训练,起到通经活络、行气活血、调节视神经、舒缓睫状肌、放松眼部肌肉、减轻视疲劳、改善眼部血液循环、提高远视力的作用;且起效迅速,效果良好,不反弹,痛苦小,简便易行,易于掌握,费用低,无毒副作用,标本兼治,无后遗并发症。
Description
发明领域
本发明属于中药配方技术领域,具体地说是涉及一种治疗近视的贴剂及其制备方法。
背景技术
近视是屈光不正的一种。在屈光静止的前提下,远处的物体不能在视网膜汇聚,而在视网膜之前形成焦点,因而造成视觉变形,导致远方的物体模糊不清。目前我国人口的眼健康情况确实不容乐观。据最新统计显示,我国人口近视发生率为33%,全国近视眼人数已近4亿,是世界平均水平22%的1.5倍,近视率居世界之首。早在2006年,国家统计局的一项调查显示,我国小学生近视的比例为34%-61%,初中生为68%,重点高中生为90%左右,在校大学生视力合格者更少。2008年,教育部就公布了《中小学学生近视眼防控工作方案》,对于视力还不稳或身体还在发育的青少年,通过医学验光配镜可以有效缓解或抑制轻度近视问题。对于近视度数较高或已成年的近视患者,主要的解决办法还是通过手术治疗,但是手术治疗的后遗并发症较多,且治疗费用较大。
发明内容
为解决上述技术问题,本发明的目的在于提供一种治疗近视的贴剂及其制备方法。该贴剂敷贴于眼周穴位,中药有效成分透皮吸收配合眼周穴位按摩、眼部肌肉训练,起到通经活络、行气活血、调节视神经、舒缓睫状肌、放松眼部肌肉、减轻视疲劳、改善眼部血液循环、提高远视力的作用,有助于眼睛的放松和视力的恢复对于真假性近视均有很好的治疗效果;且起效迅速,效果良好,不反弹,痛苦小,简便易行,易于掌握,费用低,无毒副作用,标本兼治,无后遗并发症等优点。
为实现上述目的,本发明所采取的技术方案为:
一种治疗近视的贴剂,由下列重量份的原料组成:赤芍15-25份,牛膝10-20份,冬瓜藤10-20份,茺蔚子5-15份,没药5-15份,乳香10-20份,合欢花5-15份,黄桷根5-15份,郁金10-20份,延胡索10-20份,瑞苓草5-15份,丝瓜络10-20份,天仙藤10-20份,威灵仙5-15份,山合香5-15份,丹参10-20份,芡实叶5-15份,川芎10-20份,金盏菊根10-20份,麝香10-20份,冰片5-15份。
优选地,一种治疗近视的贴剂,由下列重量份的原料组成:赤芍18-22份,牛膝12-18份,冬瓜藤14-16份,茺蔚子8-12份,没药7-13份,乳香13-17份,合欢花8-12份,黄桷根9-11份,郁金14-16份,延胡索12-18份,瑞苓草7-13份,丝瓜络12-18份,天仙藤13-17份,威灵仙14-16份,山合香9-11份,丹参14-16份,芡实叶8-12份,川芎13-17份,金盏菊根14-16份,麝香12-18份,冰片7-13份。
优选地,一种治疗近视的贴剂,由下列重量份的原料组成:赤芍20份,牛膝15份,冬瓜藤15份,茺蔚子10份,没药10份,乳香15份,合欢花10份,黄桷根10份,郁金15份,延胡索15份,瑞苓草10份,丝瓜络15份,天仙藤15份,威灵仙15份,山合香10份,丹参15份,芡实叶10份,川芎15份,金盏菊根15份,麝香15份,冰片10份。
一种治疗近视的贴剂的制备方法,包括以下步骤:
(1)将赤芍、茺蔚子、没药、乳香、黄桷根、郁金、丝瓜络、天仙藤、芡实叶、金盏菊根混合均匀,粉碎,过40-60目筛后加入相当于药粉质量8-10倍的水煎煮提取2-3h,提取温度为75-85℃,过滤,滤渣再加相当于滤渣质量7-9倍的水煎煮提取1-2h,提取温度为70-80℃,合并提取液,过滤,滤液浓缩至相对密度为1.12-1.16的清膏,然后加体积分数为的90%乙醇溶液使浓缩液含醇量为45-55%,再加入粉碎过100-150目筛的麝香粉,充分搅拌均匀后双频超声波交替处理20-30min,静置过夜,吸取上清液,沉淀过滤,滤液与上清液合并,减压回收乙醇,浓缩至相对密度为1.30-1.35的稠膏A,备用;
(2)将牛膝、冬瓜藤、合欢花、延胡索、瑞苓草、威灵仙、山合香、丹参、川芎混合均匀,粉碎,过50-70目筛后加入相当于药粉质量3-5倍的体积分数为70%的乙醇溶液,双频超声波交替处理15-25min,使药粉充分湿润膨胀后,分次均匀填装于渗漉筒内,加入体积分数为70%的乙醇溶液浸没药粉1-2cm,浸渍15-20min,缓慢渗漉,流速控制在1-3mL/min,先收集相当于药粉重量80-85%的初漉液,另器保存,继续渗漉,待有效成分完全漉出,收集续漉液,浓缩至相对密度为1.10-1.15的清膏,然后将清膏与初漉液混合,加入相当于混合物质量2-3倍的体积分数为70%的乙醇溶液,再加入粉碎过80-120筛的冰片粉,充分搅拌均匀后高速离心分离,取上清液,减压回收乙醇,浓缩至相对密度为1.28-1.32的稠膏B,备用;
(3)以重量份计,称取以下原料:稠膏A 10-15份、稠膏B 8-12份、卡波姆10-15份、聚丙烯酸钠5-10份、三氯化铝2-4份、柠檬酸1-3份、甘油20-30、水50-60份;
(4)取相当于卡波姆质量2-3倍量的水,将卡波姆加入水中,待卡波姆湿润后以250-350r/min的转速搅拌20-30min,得A相;
(5)将聚丙烯酸钠加入甘油中,以100-150r/min的转速搅拌5-10min,得B相;
(6)将三氯化铝、柠檬酸混合均匀,然后加入余下的水,以80-120r/min的转速搅拌4-8min,得C相;
(7)在转速为150-200r/min的搅拌下将C相加入到B相中,然后在转速为200-250r/min的搅拌下将A相加入到B、C相的混合物中,最后在转速为400-500r/min的搅拌下将稠膏A和稠膏B加入到A、B、C相的混合物中,充分搅拌均匀后超声脱气10-20min,于40-45℃迅速均匀涂布于无纺布上,涂布厚度控制在1.2-1.6mm,室温放置,覆背衬,冲切成面积为50-60cm2的圆形贴剂,用纸铝塑袋塑封保存即可。
优选地,步骤(1)中所述双频超声波交替处理的条件为:双频超声波交替频率为35-45KHz/75-85KHz,双频超声波交替工作时间为3-5s,超声波功率为150-200W。
优选地,步骤(2)中所述双频超声波交替处理的条件为:双频超声波交替频率为40-50KHz/80-90KHz,双频超声波交替工作时间为2-4s,超声波功率为200-250W。
优选地,步骤(2)中所述高速离心分离的条件为:离心转速为3000-4000r/min,离心时间为20-30min。
优选地,步骤(7)中所述超声脱气的条件为:超声波频率为25-40KHz,超声波功率为100-150W。
本发明配方中各中药的药理如下:
赤芍:味苦,性微寒;归肝经;具有清热凉血、活血祛瘀的功效;
牛膝:味苦、酸,性平;归肝、肾经;有补肝肾,强筋骨,逐瘀通经,引血下行的功效;
冬瓜藤:味苦,性寒;归肺,肝经;具有清肺化痰、通经活络之功效;
茺蔚子:味辛、苦,性微寒;归心包、肝经;具有活血调经,清肝明目的功效;
没药:味辛、苦,性平;归心、肝、脾经;具有散血去瘀、消肿定痛之功效;
乳香:味辛、苦,性温;归心、肝、脾经;活血行气止痛,消肿生肌;
合欢花:味甘,性平;归心、肝经;解郁安神,滋阴补阳,理气开胃,活络止痛;
黄桷根:为桑科植物黄葛树的根或根皮;具有祛风,除湿,通络,消肿功效;
郁金:味辛、苦,性寒;归肝、心、肺经;活血止痛,行气解郁,清心凉血,利胆退黄;
延胡索:味辛、苦,性温;归肝、脾经;用于行气止痛、活血散瘀;
瑞苓草:味苦、辛,性凉;归肝、肾经;具有活血调经,清热明目之功效;
丝瓜络:味甘,性平;归肺、胃、肝经;有通络、活血、祛风的作用;
天仙藤:味苦,性温;归肝、脾、肾经;有行气活血,通络止痛的作用。
威灵仙:味辛、咸,性温;归膀胱经;具有祛风湿、通经络的作用;
山合香:味辛、苦,性凉;入肝、脾经;具有清热明目,散风通络,祛湿解毒之功效;
丹参:味苦,性微寒;归心、肝经;具有活血祛瘀,通经止痛,清心除烦,凉血消痈之功效;
芡实叶:味苦、辛,性平;入肝经;具有行气和血,祛瘀止血之功效;
川芎:味辛,性温;入肝、胆经;具有行气开郁,法风燥湿,活血止痛的功效;
金盏菊根:味微苦,性平;具有活血散瘀,行气止痛的功效。
麝香:味辛,性温,归心、脾经;具有开窍醒神,活血通经,消肿止痛的功效;
冰片:味辛、苦,微寒,归心、肝、肺经;具有清香宣散、开窍醒神、清热散毒、明目退翳的功效。
本发明的有益效果:
(1)本发明分别采用水浸提和渗漉法制备两种稠膏,且在两种稠膏提取过程中均采用双频超声交替处理工艺,有利于有效成分的最大化溶出,从而使得药效更加明显;然后采用两种稠膏与卡波姆、聚丙烯酸钠配合制得的凝胶贴剂具有良好的透皮性能,具有临床应用价值,值得在临床大规模推广,具有广阔的应用前景。
(2)本发明是从整体观出发,局部辨证与全身辨证相结合,通过赤芍,牛膝、冬瓜藤、茺蔚子、没药、乳香、合欢花、黄桷根等十九味中药材复合制成的贴剂敷贴于眼周穴位,中药有效成分透皮吸收配合眼周穴位按摩、眼部肌肉训练,起到通经活络、行气活血、调节视神经、舒缓睫状肌、放松眼部肌肉、减轻视疲劳、改善眼部血液循环、提高远视力的作用,有助于眼睛的放松和视力的恢复,对于真假性近视均有很好的治疗效果;且起效迅速,效果良好,不反弹,痛苦小,简便易行,易于掌握,费用低,无毒副作用,标本兼治,无后遗并发症等优点。
具体实施方式
下面结合具体实施例对本发明所述技术方案作进一步的说明。
实施例1:
一种治疗近视的贴剂,由下列重量份的原料组成:赤芍15份,牛膝10份,冬瓜藤10份,茺蔚子5份,没药5份,乳香10份,合欢花5份,黄桷根5份,郁金10份,延胡索10份,瑞苓草5份,丝瓜络10份,天仙藤10份,威灵仙5份,山合香5份,丹参10份,芡实叶5份,川芎10份,金盏菊根10份,麝香10份,冰片5份。
一种治疗近视的贴剂的制备方法,包括以下步骤:
(1)将赤芍、茺蔚子、没药、乳香、黄桷根、郁金、丝瓜络、天仙藤、芡实叶、金盏菊根混合均匀,粉碎,过40目筛后加入相当于药粉质量8倍的水煎煮提取3h,提取温度为75℃,过滤,滤渣再加相当于滤渣质量7倍的水煎煮提取2h,提取温度为70℃,合并提取液,过滤,滤液浓缩至相对密度为1.12的清膏,然后加体积分数为的90%乙醇溶液使浓缩液含醇量为45%,再加入过100目筛的麝香粉,充分搅拌均匀后在双频超声波交替频率为35KHz/75KHz,双频超声波交替工作时间为3s,超声波功率为150W的条件下双频超声波交替处理30min,静置过夜,吸取上清液,沉淀过滤,滤液与上清液合并,减压回收乙醇,浓缩至相对密度为1.30的稠膏A,备用;
(2)将牛膝、冬瓜藤、合欢花、延胡索、瑞苓草、威灵仙、山合香、丹参、川芎混合均匀,粉碎,过50目筛后加入相当于药粉质量3倍的体积分数为70%的乙醇溶液,在双频超声波交替频率为40KHz/80KHz,双频超声波交替工作时间为2s,超声波功率为200W的条件下双频超声波交替处理25min,使药粉充分湿润膨胀后,分次均匀填装于渗漉筒内,加入体积分数为70%的乙醇溶液浸没药粉1cm,浸渍15min,缓慢渗漉,流速控制在1mL/min,先收集相当于药粉重量80%的初漉液,另器保存,继续渗漉,待有效成分完全漉出,收集续漉液,浓缩至相对密度为1.10的清膏,然后将清膏与初漉液混合,加入相当于混合物质量2倍的体积分数为70%的乙醇溶液,再加入粉碎过80目筛后的冰片粉,充分搅拌均匀后在3000r/min的转速下离心分离30min,取上清液,减压回收乙醇,浓缩至相对密度为1.28的稠膏B,备用;
(3)以重量份计,称取以下原料:稠膏A 10份、稠膏B 8份、卡波姆10份、聚丙烯酸钠5份、三氯化铝2份、柠檬酸1份、甘油20、水50份;
(4)取相当于卡波姆质量2倍量的水,将卡波姆加入水中,待卡波姆湿润后以250r/min的转速搅拌30min,得A相;
(5)将聚丙烯酸钠加入甘油中,以100r/min的转速搅拌10min,得B相;
(6)将三氯化铝、柠檬酸混合均匀,然后加入余下的水,以80r/min的转速搅拌8min,得C相;
(7)在转速为150r/min的搅拌下将C相加入到B相中,然后在转速为200r/min的搅拌下将A相加入到B、C相的混合物中,最后在转速为400r/min的搅拌下将稠膏A和稠膏B加入到A、B、C相的混合物中,充分搅拌均匀后在超声波频率为25KHz,超声波功率为100W的条件下超声脱气20min,于40℃迅速均匀涂布于无纺布上,涂布厚度控制在1.2mm,室温放置,覆背衬,冲切成面积为50cm2的圆形贴剂,用纸铝塑袋塑封保存即可。
实施例2:
一种治疗近视的贴剂,由下列重量份的原料组成:赤芍20份,牛膝15份,冬瓜藤15份,茺蔚子10份,没药10份,乳香15份,合欢花10份,黄桷根10份,郁金15份,延胡索15份,瑞苓草10份,丝瓜络15份,天仙藤15份,威灵仙15份,山合香10份,丹参15份,芡实叶10份,川芎15份,金盏菊根15份,麝香15份,冰片10份。
一种治疗近视的贴剂的制备方法,包括以下步骤:
(1)将赤芍、茺蔚子、没药、乳香、黄桷根、郁金、丝瓜络、天仙藤、芡实叶、金盏菊根混合均匀,粉碎,过50目筛后加入相当于药粉质量9倍的水煎煮提取2.5h,提取温度为80℃,过滤,滤渣再加相当于滤渣质量8倍的水煎煮提取1.5h,提取温度为75℃,合并提取液,过滤,滤液浓缩至相对密度为1.14的清膏,然后加体积分数为的90%乙醇溶液使浓缩液含醇量为50%,再加入粉碎过120目筛后的麝香粉,充分搅拌均匀后在双频超声波交替频率为40KHz/80KHz,双频超声波交替工作时间为4s,超声波功率为180W的条件下双频超声波交替处理25min,静置过夜,吸取上清液,沉淀过滤,滤液与上清液合并,减压回收乙醇,浓缩至相对密度为1.32的稠膏A,备用;
(2)将牛膝、冬瓜藤、合欢花、延胡索、瑞苓草、威灵仙、山合香、丹参、川芎混合均匀,粉碎,过60目筛后加入相当于药粉质量4倍的体积分数为70%的乙醇溶液,在双频超声波交替频率为45KHz/85KHz,双频超声波交替工作时间为3s,超声波功率为220W的条件下双频超声波交替处理20min,使药粉充分湿润膨胀后,分次均匀填装于渗漉筒内,加入体积分数为70%的乙醇溶液浸没药粉1.5cm,浸渍18min,缓慢渗漉,流速控制在2mL/min,先收集相当于药粉重量82%的初漉液,另器保存,继续渗漉,待有效成分完全漉出,收集续漉液,浓缩至相对密度为1.13的清膏,然后将清膏与初漉液混合,加入相当于混合物质量2.5倍的体积分数为70%的乙醇溶液,再加入粉碎过100目筛后的冰片粉,充分搅拌均匀后在3500r/min的转速下离心分离25min,取上清液,减压回收乙醇,浓缩至相对密度为1.30的稠膏B,备用;
(3)以重量份计,称取以下原料:稠膏A 12份、稠膏B 10份、卡波姆12份、聚丙烯酸钠8份、三氯化铝3份、柠檬酸2份、甘油25、水55份;
(4)取相当于卡波姆质量2.5倍量的水,将卡波姆加入水中,待卡波姆湿润后以300r/min的转速搅拌25min,得A相;
(5)将聚丙烯酸钠加入甘油中,以120r/min的转速搅拌8min,得B相;
(6)将三氯化铝、柠檬酸混合均匀,然后加入余下的水,以100r/min的转速搅拌6min,得C相;
(7)在转速为180r/min的搅拌下将C相加入到B相中,然后在转速为220r/min的搅拌下将A相加入到B、C相的混合物中,最后在转速为450r/min的搅拌下将稠膏A和稠膏B加入到A、B、C相的混合物中,充分搅拌均匀后在超声波频率为35KHz,超声波功率为120W的条件下超声脱气15min,于42℃迅速均匀涂布于无纺布上,涂布厚度控制在1.4mm,室温放置,覆背衬,冲切成面积为55cm2的圆形贴剂,用纸铝塑袋塑封保存即可。
实施例3:
一种治疗近视的贴剂,由下列重量份的原料组成:赤芍25份,牛膝20份,冬瓜藤20份,茺蔚子15份,没药15份,乳香20份,合欢花15份,黄桷根15份,郁金20份,延胡索20份,瑞苓草15份,丝瓜络20份,天仙藤20份,威灵仙15份,山合香15份,丹参20份,芡实叶15份,川芎20份,金盏菊根20份,麝香20份,冰片15份。
一种治疗近视的贴剂的制备方法,包括以下步骤:
(1)将赤芍、茺蔚子、没药、乳香、黄桷根、郁金、丝瓜络、天仙藤、芡实叶、金盏菊根混合均匀,粉碎,过60目筛后加入相当于药粉质量10倍的水煎煮提取2h,提取温度为85℃,过滤,滤渣再加相当于滤渣质量9倍的水煎煮提取1h,提取温度为80℃,合并提取液,过滤,滤液浓缩至相对密度为1.16的清膏,然后加体积分数为的90%乙醇溶液使浓缩液含醇量为55%,再加入粉碎过150目筛后的麝香粉,充分搅拌均匀后在双频超声波交替频率为45KHz/85KHz,双频超声波交替工作时间为5s,超声波功率为200W的条件下双频超声波交替处理20min,静置过夜,吸取上清液,沉淀过滤,滤液与上清液合并,减压回收乙醇,浓缩至相对密度为1.35的稠膏A,备用;
(2)将牛膝、冬瓜藤、合欢花、延胡索、瑞苓草、威灵仙、山合香、丹参、川芎混合均匀,粉碎,过70目筛后加入相当于药粉质量5倍的体积分数为70%的乙醇溶液,在双频超声波交替频率为50KHz/90KHz,双频超声波交替工作时间为4s,超声波功率为250W的条件下双频超声波交替处理15min,使药粉充分湿润膨胀后,分次均匀填装于渗漉筒内,加入体积分数为70%的乙醇溶液浸没药粉2cm,浸渍20min,缓慢渗漉,流速控制在3mL/min,先收集相当于药粉重量85%的初漉液,另器保存,继续渗漉,待有效成分完全漉出,收集续漉液,浓缩至相对密度为1.15的清膏,然后将清膏与初漉液混合,加入相当于混合物质量3倍的体积分数为70%的乙醇溶液,再加入粉碎过120目筛后的冰片粉,充分搅拌均匀后在4000r/min的转速下离心分离20min,取上清液,减压回收乙醇,浓缩至相对密度为1.32的稠膏B,备用;
(3)以重量份计,称取以下原料:稠膏A 15份、稠膏B 12份、卡波姆15份、聚丙烯酸钠10份、三氯化铝4份、柠檬酸3份、甘油30、水60份;
(4)取相当于卡波姆质量3倍量的水,将卡波姆加入水中,待卡波姆湿润后以350r/min的转速搅拌20min,得A相;
(5)将聚丙烯酸钠加入甘油中,以150r/min的转速搅拌5min,得B相;
(6)将三氯化铝、柠檬酸混合均匀,然后加入余下的水,以120r/min的转速搅拌4min,得C相;
(7)在转速为200r/min的搅拌下将C相加入到B相中,然后在转速为250r/min的搅拌下将A相加入到B、C相的混合物中,最后在转速为500r/min的搅拌下将稠膏A和稠膏B加入到A、B、C相的混合物中,充分搅拌均匀后在超声波频率为40KHz,超声波功率为150W的条件下超声脱气10min,于45℃迅速均匀涂布于无纺布上,涂布厚度控制在1.6mm,室温放置,覆背衬,冲切成面积为60cm2的圆形贴剂,用纸铝塑袋塑封保存即可。
临床试验:
1、治疗对象:以随机抽样法检查眼科门诊青少年近视患者,其抽样60例,均为双眼近视,男30例,女30例,年龄9-18岁,平均年龄13.5,远视力不足5.0,近视力正常,外眼部正常,眼底检查无近视弧改变的,无明显家族史,-3.00以上的近视;
2、治疗方法:采用本发明贴剂敷贴于眼周穴位,并配合眼周穴位按摩,每天1次,12天为1疗程,共治疗1-3个疗程;
3、疗效判断标准:治愈:视力恢复正常,显效:视力提高3-4行,有效:视力提高1-2行;无效:视力不变;
4、结果:使用本发明贴剂后治疗效果如下表1所示:
表1
由上表可知,本发明贴剂的疗效达到96.7%的总有效率以及68.3%的治愈率,且治愈跟踪一年后无反弹现象,说明本发明敷贴于眼周穴位,中药有效成分透皮吸收配合眼周穴位按摩,有助于眼睛的放松和视力的恢复,且起效迅速,效果良好。
以上所述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 (8)
1.一种治疗近视的贴剂,其特征在于,由下列重量份的原料组成:赤芍15-25份,牛膝10-20份,冬瓜藤10-20份,茺蔚子5-15份,没药5-15份,乳香10-20份,合欢花5-15份,黄桷根5-15份,郁金10-20份,延胡索10-20份,瑞苓草5-15份,丝瓜络10-20份,天仙藤10-20份,威灵仙5-15份,山合香5-15份,丹参10-20份,芡实叶5-15份,川芎10-20份,金盏菊根10-20份,麝香10-20份,冰片5-15份。
2.根据权利要求1所述的治疗近视的贴剂,其特征在于,由下列重量份的原料组成:赤芍18-22份,牛膝12-18份,冬瓜藤14-16份,茺蔚子8-12份,没药7-13份,乳香13-17份,合欢花8-12份,黄桷根9-11份,郁金14-16份,延胡索12-18份,瑞苓草7-13份,丝瓜络12-18份,天仙藤13-17份,威灵仙14-16份,山合香9-11份,丹参14-16份,芡实叶8-12份,川芎13-17份,金盏菊根14-16份,麝香12-18份,冰片7-13份。
3.根据权利要求1所述的治疗近视的贴剂,其特征在于,由下列重量份的原料组成:赤芍20份,牛膝15份,冬瓜藤15份,茺蔚子10份,没药10份,乳香15份,合欢花10份,黄桷根10份,郁金15份,延胡索15份,瑞苓草10份,丝瓜络15份,天仙藤15份,威灵仙15份,山合香10份,丹参15份,芡实叶10份,川芎15份,金盏菊根15份,麝香15份,冰片10份。
4.一种如权利要求1-3任一项所述的治疗近视的贴剂的制备方法,其特征在于,包括以下步骤:
(1)将赤芍、茺蔚子、没药、乳香、黄桷根、郁金、丝瓜络、天仙藤、芡实叶、金盏菊根混合均匀,粉碎,过40-60目筛后加入相当于药粉质量8-10倍的水煎煮提取2-3h,提取温度为75-85℃,过滤,滤渣再加相当于滤渣质量7-9倍的水煎煮提取1-2h,提取温度为70-80℃,合并提取液,过滤,滤液浓缩至相对密度为1.12-1.16的清膏,然后加体积分数为的90%乙醇溶液使浓缩液含醇量为45-55%,再加入粉碎过100-150目筛后的麝香粉,充分搅拌均匀后双频超声波交替处理20-30min,静置过夜,吸取上清液,沉淀过滤,滤液与上清液合并,减压回收乙醇,浓缩至相对密度为1.30-1.35的稠膏A,备用;
(2)将牛膝、冬瓜藤、合欢花、延胡索、瑞苓草、威灵仙、山合香、丹参、川芎混合均匀,粉碎,过50-70目筛后加入相当于药粉质量3-5倍的体积分数为70%的乙醇溶液,双频超声波交替处理15-25min,使药粉充分湿润膨胀后,分次均匀填装于渗漉筒内,加入体积分数为70%的乙醇溶液浸没药粉1-2cm,浸渍15-20min,缓慢渗漉,流速控制在1-3mL/min,先收集相当于药粉重量80-85%的初漉液,另器保存,继续渗漉,待有效成分完全漉出,收集续漉液,浓缩至相对密度为1.10-1.15的清膏,然后将清膏与初漉液混合,加入相当于混合物质量2-3倍的体积分数为70%的乙醇溶液,再加入粉碎过80-120目筛后的冰片粉,充分搅拌均匀后高速离心分离,取上清液,减压回收乙醇,浓缩至相对密度为1.28-1.32的稠膏B,备用;
(3)以重量份计,称取以下原料:稠膏A 10-15份、稠膏B 8-12份、卡波姆10-15份、聚丙烯酸钠5-10份、三氯化铝2-4份、柠檬酸1-3份、甘油20-30、水50-60份;
(4)取相当于卡波姆质量2-3倍量的水,将卡波姆加入水中,待卡波姆湿润后以250-350r/min的转速搅拌20-30min,得A相;
(5)将聚丙烯酸钠加入甘油中,以100-150r/min的转速搅拌5-10min,得B相;
(6)将三氯化铝、柠檬酸混合均匀,然后加入余下的水,以80-120r/min的转速搅拌4-8min,得C相;
(7)在转速为150-200r/min的搅拌下将C相加入到B相中,然后在转速为200-250r/min的搅拌下将A相加入到B、C相的混合物中,最后在转速为400-500r/min的搅拌下将稠膏A和稠膏B加入到A、B、C相的混合物中,充分搅拌均匀后超声脱气10-20min,于40-45℃迅速均匀涂布于无纺布上,涂布厚度控制在1.2-1.6mm,室温放置,覆背衬,冲切成面积为50-60cm2的圆形贴剂,用纸铝塑袋塑封保存即可。
5.根据权利要求4所述的治疗近视的贴剂的制备方法,其特征在于,步骤(1)中所述双频超声波交替处理的条件为:双频超声波交替频率为35-45KHz/75-85KHz,双频超声波交替工作时间为3-5s,超声波功率为150-200W。
6.根据权利要求4所述的治疗近视的贴剂的制备方法,其特征在于,步骤(2)中所述双频超声波交替处理的条件为:双频超声波交替频率为40-50KHz/80-90KHz,双频超声波交替工作时间为2-4s,超声波功率为200-250W。
7.根据权利要求4所述的治疗近视的贴剂的制备方法,其特征在于,步骤(2)中所述高速离心分离的条件为:离心转速为3000-4000r/min,离心时间为20-30min。
8.根据权利要求4所述的治疗近视的贴剂的制备方法,其特征在于,步骤(7)中所述超声脱气的条件为:超声波频率为25-40KHz,超声波功率为100-150W。
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