CN111265609A - 一种辅助治疗真性近视的中药组合物及其制备方法 - Google Patents
一种辅助治疗真性近视的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种辅助治疗真性近视的中药组合物及其制备方法,所述辅助治疗真性近视的中药组合物的原料组分包括:桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七。本发明的有益效果为:本发明所述的辅助治疗真性近视的中药组合物,从补肝益肾、疏经活络、补气清虚热、疏肝理气等多个方面发挥作用,用于辅助治疗真性近视效果显著,临床试验结果表明,本发明用于辅助治疗真性近视总体有效率达98.5%,本发明制备方法简单,安全无毒副作用,使用简便,适宜临床推广应用。
Description
技术领域
本发明属于中药技术领域,具体涉及一种辅助治疗真性近视的中药组合物及其制备方法。
背景技术
近视,中医病名。是眼在调节松弛状态下,平行光线经眼的屈光系统的折射后焦点落在视网膜之前。古代医籍对本病早有认识,称为目不能远视,又名能近怯远症,至《目经大成》始称近视。
目前,西医认为近视问题不可逆,治疗方面主要采取激光手术削薄视网膜厚度来治疗近视,风险较高,且并发症和后遗症严重;现有市场上的各类中医药的相关药物与配方主要以缓解眼部疲劳为主,对治疗真性近视效果不大,中医外治中的外敷产品熬制工艺复杂、流程繁琐,且大多只针对假性近视,对真性近视治疗效果差。
发明内容
本发明的目的在于,提供一种制备方法简单、易操作,能够有效辅助治疗真性近视的中药解决方案。
本发明的技术方案为:
本发明提供一种辅助治疗真性近视的中药组合物,原料组分包括:桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七。
桑椹子,味甘,性寒。补血滋阴,生津润燥,用于眩晕耳鸣,心悸失眠,须发早白,便秘,津伤口渴,内热消渴,血虚便秘,补肝,益肾,熄风,滋液,治肝肾阴亏。
枸杞子,味甘,性平。滋补肝肾,益精明目。用于虚劳精亏,腰膝酸痛,眩晕耳鸣,内热消渴,血虚萎黄,目昏不明。
黄芪,味甘,性微温。益卫固表,补气升阳,托毒生肌,利水消肿。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,自汁盗汗,血虚萎黄,阴疽漫肿,气虚水肿,内热消渴。
大头花,苦辛,性寒。清肝、散结。治瘰疬,瘿瘤,乳痈,乳癌,目珠夜痛,羞明流泪,头目眩晕,口眼歪斜,筋骨疼痛,肺结核,急性黄疸型传染性肝炎,血崩,带下。
红花,味辛,性温。活血通经,散瘀止痛。用于经闭,痛经,恶露不行,症瘕痞块,胸痹心痛,瘀滞腹痛,胸胁刺痛,跌扑损伤,疮疡肿痛。
石菖蒲,味辛,性温。祛痰开窍,化湿开胃,宁神益智。用于神志昏迷,惊悸,失眠,痴呆,健忘,胸腹胀痛,风寒湿痹,疥癣。
覆盆子,味甘、酸,性温。固精缩尿,益肾养肝。用于遗精,尿频,遗尿,阳痿。
青葙子,味苦,性微寒。清肝,明目,退翳。用于肝热目赤,眼生翳膜,视物昏花,肝火眩晕。
五味子,味酸,性温。敛肺滋肾,生津敛汗,涩精止泻,宁心安神。用于久咳虚喘,津伤口渴,自汗盗汗,肾虚遗精,脾肾虚泻,心悸失眠。
决明子,味甘、苦,性微寒。清肝明目,润肠通便。用于肝火目赤,肠燥便秘。
穿山龙,味甘、苦,性温。有祛风除湿,舒筋通络,活血止痛,止咳平喘的作用。用于风湿痹病,关节麻木,跌扑损伤,闪腰岔气,咳嗽气喘。
冰片,味辛、苦,性微寒。开窍醒神,清热止痛。用于窍闭神昏,疮疡,咽喉肿痛,口舌生疮。
白人参,味甘,性微温。补气生津,宁神益智,能够生津、养阴、清虚热。
蜜蒙花,味甘,性微寒。清热泻火,养肝明目,退翳。用于目赤肿痛,多泪羞明,目生翳膜,肝虚目暗,视物昏花。
千里光,味苦,性寒。清热解毒,明目,利湿。痈肿疮毒,感冒发热,目赤肿痛,泄泻痢疾,皮肤湿疹。
楮实子,味甘,性寒。补肾清肝,明目,利尿。用于腰膝酸软,虚劳骨蒸,头晕目昏,目生翳膜,水肿胀满。
女贞子,味甘、苦,性凉。补益肝肾,明目,清虚热。用于头晕目眩,须发早白,视物昏花,阴虚发热。
蕤仁,味甘,性寒。祛风,散热,养肝,明目。祛风,散热,养肝,明目。治目赤肿痛,昏暗羞阴,眦烂多泪,鼻衄。亦治心腹邪热,结气痰痞。
石决明,味咸,性平。平肝潜阳,除热,明目。治风阳上扰、头痛眩晕,惊搐,骨蒸芳热,青盲内障。
三七,味甘、微苦,性温。化瘀止血,消肿止痛。用于内外出血,跌打损伤,瘀血肿痛。
肝主藏血,主疏泄,开窍于目,肝血旺盛则目有所养,若肝血亏虚,目失所养则目视不明。肾主藏精,目之瞳神内应于肾,目之精光得益于肾阳的滋养,肾精亏虚,肾阳不足,目视所养则目视不明,故近视常与肝肾有关。另一方面,视力与经络关系密切,经络失衡,经络之气缺乏,眼睛缺少营养物质的输送,视物功能降低。本发明的中药组合物,添加了包括桑椹子、枸杞子、覆盆子等在内的多种补肝益肾的药物,辅以疏经活络、补气清虚热、疏肝理气的药物,进而达到调理经络平衡。其中,枸杞子滋养肝肾、益精明目;决明子补肝明目、目赤涩痛的功效;千里光清热解毒,明目退翳;桑葚子疏散风热、清肺、明目;密蒙花治疗肝虚目暗,视物昏花;穿山龙祛风除湿、活血通络;黄芪有益正气、壮脾胃;大头花清热泻火、明目、散结消肿;红花通经、活血;石菖蒲理气、活血、散风、去湿;覆盆子益肾养肝补气虚、明目;其余药味具有滋补肝肾、通经活络、活血化瘀等功效。本发明组方从近视的根本原因出发,科学配伍,标本兼治,因而具有较好的辅助治疗近视作用,最终制备得到的药物,对于脏腑功能失调、经络不通等各方面引起的近视疗效显著,且都是中药材,安全无毒副作用,制备方法简单,易操作。
优选的,按重量份计,原料组分包括:桑椹子40-60份、枸杞子20-40份、黄芪25-35份、大头花30-70份、红花15-30份、石菖蒲10-45份、覆盆子5-35份、青葙子10-60份、五味子30-60份、决明子50-100份、穿山龙30-60份、冰片2-5份、白人参20-50份、蜜蒙花35-55份、千里光10-30份、楮实子40-70份、女贞子30-50份、蕤仁25-55份、石决明10-20份、三七20-40份。临床试验研究表明,本发明各原料之间的配比对治疗效果影响较大,在本发明所述配比下,辅助治疗近视效果明显更优。
优选的,按重量份计,原料组分包括:桑椹子45-55份、枸杞子25-35份、黄芪28-32份、大头花40-60份、红花20-25份、石菖蒲20-40份、覆盆子10-30份、青葙子20-50份、五味子40-50份、决明子60-90份、穿山龙40-50份、冰片3-4份、白人参30-40份、蜜蒙花40-50份、千里光15-25份、楮实子50-60份、女贞子35-45份、蕤仁30-50份、石决明12-18份、三七25-35份。
优选的,本发明所述辅助治疗真性近视的中药组合物,是由原料药的原生药粉,或者原料药的水或有机溶剂提取物为活性成分,再加上药学上可接受的辅料制备而成的制剂。
优选的,所述制剂为外用制剂,进一步优选的,所述制剂为膏剂。
本发明提供一种辅助治疗真性近视的中药膏剂的制备方法,包括如下步骤:
(1)取桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七,经分别干燥、粉碎后,得到各原料粉,将所述各原料粉按各原料重量配比混合均匀,得到混合药粉;(2)向混合药粉中加入植物油、水,搅拌成为膏状,即得。
优选的,步骤(1)中,所述干燥为晒干或40-60℃烘干;采用中草药破壁粉碎机进行破壁粉碎成粒径小于10μm的微粉。将原料破壁粉碎成微粉,能够使得原料药中的有效成分充分释放出来,制备得到的破壁微粉,更易于透皮吸收,从而极大地提高了使用效果,同时减少了对皮肤的刺激性。
优选的,步骤(2)中,所述植物油为麻油或橄榄油,所述混合药粉、植物油以及水之间的重量比为28-32:3:100。
优选的,步骤(2)中,还加入促渗透剂,所述混合药粉、植物油、促渗透剂以及水之间的重量比为28-32:3:3:100。所述促渗透剂优选为氮酮,通过加入促渗透剂,能够提高有效成分透皮吸收率,因而有助于提高药物治疗效果。
本发明的有益效果为:
本发明所述的辅助治疗真性近视的中药组合物,通过采用桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七为原料并进行合理配比,最终制备得到的中药组合物,从补肝益肾、疏经活络、补气清虚热、疏肝理气等多个方面发挥作用,用于辅助治疗真性近视效果显著,临床试验结果表明,本发明用于辅助治疗真性近视总体有效率达98.5%,本发明制备方法简单,安全无毒副作用,使用简便,适宜临床推广应用。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚,下面将对本发明的技术方案进行详细的描述。显然,所描述的实施例仅仅是本发明的一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所得到的所有其它实施方式,都属于本发明所保护的范围。以下实施例中以1重量份代表1g。
实施例1
本实施例提供一种辅助治疗真性近视的中药组合物,由以下重量份原料组成:
桑椹子40份、枸杞子40份、黄芪25份、大头花70份、红花15份、石菖蒲45份、覆盆子5份、青葙子60份、五味子30份、决明子100份、穿山龙30份、冰片5份、白人参20份、蜜蒙花55份、千里光10份、楮实子70份、女贞子30份、蕤仁55份、石决明10份、三七40份。
制备方法为:(1)取桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七,经分别晒干后,采用中草药破壁粉碎机进行破壁粉碎成粒径小于10μm的微粉,得到各原料粉,将所述各原料粉按各原料重量配比混合均匀,得到混合药粉;(2)向混合药粉中加入麻油、水(混合药粉:麻油:水=30:3:100),搅拌成为膏状,即得。
实施例2
本实施例提供一种辅助治疗真性近视的中药组合物,由以下重量份原料组成:
桑椹子60份、枸杞子20份、黄芪35份、大头花30份、红花30份、石菖蒲10份、覆盆子35份、青葙子10份、五味子60份、决明子50份、穿山龙60份、冰片2份、白人参50份、蜜蒙花35份、千里光30份、楮实子40份、女贞子50份、蕤仁25份、石决明20份、三七20份。
制备方法为:(1)取桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七,经分别晒干后,采用中草药破壁粉碎机进行破壁粉碎成粒径小于10μm的微粉,得到各原料粉,将所述各原料粉按各原料重量配比混合均匀,得到混合药粉;(2)向混合药粉中加入麻油、水(混合药粉:麻油:水=28:3:100),搅拌成为膏状,即得。
实施例3
本实施例提供一种辅助治疗真性近视的中药组合物,由以下重量份原料组成:
桑椹子45份、枸杞子35份、黄芪28份、大头花60份、红花20份、石菖蒲40份、覆盆子10份、青葙子50份、五味子40份、决明子90份、穿山龙40份、冰片4份、白人参30份、蜜蒙花50份、千里光15份、楮实子60份、女贞子35份、蕤仁50份、石决明12份、三七35份。
制备方法为:(1)取桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七,经分别晒干后,采用中草药破壁粉碎机进行破壁粉碎成粒径小于10μm的微粉,得到各原料粉,将所述各原料粉按各原料重量配比混合均匀,得到混合药粉;(2)向混合药粉中加入橄榄油、水(混合药粉:橄榄油:水=32:3:100),搅拌成为膏状,即得。
实施例4
本实施例提供一种辅助治疗真性近视的中药组合物,由以下重量份原料组成:
桑椹子55份、枸杞子25份、黄芪32份、大头花40份、红花25份、石菖蒲20份、覆盆子30份、青葙子20份、五味子50份、决明子60份、穿山龙50份、冰片3份、白人参40份、蜜蒙花40份、千里光25份、楮实子50份、女贞子45份、蕤仁30份、石决明18份、三七25份。
制备方法为:(1)取桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七,经分别晒干后,采用中草药破壁粉碎机进行破壁粉碎成粒径小于10μm的微粉,得到各原料粉,将所述各原料粉按各原料重量配比混合均匀,得到混合药粉;(2)向混合药粉中加入橄榄油、水(混合药粉:橄榄油:水=30:3:100),搅拌成为膏状,即得。
实施例5
本实施例提供一种辅助治疗真性近视的中药组合物,由以下重量份原料组成:
桑椹子50份、枸杞子30份、黄芪30份、大头花50份、红花22份、石菖蒲30份、覆盆子20份、青葙子30份、五味子45份、决明子70份、穿山龙45份、冰片3份、白人参35份、蜜蒙花45份、千里光20份、楮实子55份、女贞子40份、蕤仁40份、石决明15份、三七30份。
制备方法为:(1)取桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七,经分别晒干后,采用中草药破壁粉碎机进行破壁粉碎成粒径小于10μm的微粉,得到各原料粉,将所述各原料粉按各原料重量配比混合均匀,得到混合药粉;(2)向混合药粉中加入橄榄油、氮酮、水(混合药粉:橄榄油:氮酮:水=30:3:3:100),搅拌成为膏状,即得。
实施例6
本实施例在实施例1的基础上改变部分原料配比,但原料总量不变,具体的,提供一种辅助治疗真性近视的中药组合物,由以下重量份原料组成:
桑椹子70份、枸杞子20份、黄芪15份、大头花70份、红花45份、石菖蒲45份、覆盆子5份、青葙子60份、五味子30份、决明子100份、穿山龙30份、冰片5份、白人参20份、蜜蒙花55份、千里光10份、楮实子40份、女贞子30份、蕤仁55份、石决明10份、三七40份。
制备方法为:(1)取桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七,经分别晒干后,采用中草药破壁粉碎机进行破壁粉碎成粒径小于10μm的微粉,得到各原料粉,将所述各原料粉按各原料重量配比混合均匀,得到混合药粉;(2)向混合药粉中加入橄榄油、氮酮、水(混合药粉:橄榄油:氮酮:水=30:3:3:100),搅拌成为膏状,即得。
对比例1
本对比例在实施例1的基础上,去掉了穿山龙,具体的,本对比例由以下重量份原料组成:
桑椹子40份、枸杞子40份、黄芪25份、大头花70份、红花45份、石菖蒲45份、覆盆子5份、青葙子60份、五味子30份、决明子100份、冰片5份、白人参20份、蜜蒙花55份、千里光10份、楮实子70份、女贞子30份、蕤仁55份、石决明10份、三七40份。
对比例2
本对比例在实施例1的基础上,以络石藤代替穿山龙,具体的,本对比例由以下重量份原料组成:
桑椹子40份、枸杞子40份、黄芪25份、大头花70份、红花15份、石菖蒲45份、覆盆子5份、青葙子60份、五味子30份、决明子100份、络石藤30份、冰片5份、白人参20份、蜜蒙花55份、千里光10份、楮实子70份、女贞子30份、蕤仁55份、石决明10份、三七40份。
本发明辅助治疗近视的临床试验研究
1、试验对象:2018年10月至2019年10月的一年时间内,在四川御瞳府中医旗下的新南门诊所、杭州丁桥诊所、新辉路诊所就诊的共计1228例近视患者。
2、排除标准:(1)患有感染性、外伤性眼部疾患者;(2)患有角膜、晶体、玻璃体、眼底病变等内外眼疾患者;(3)妊娠或哺乳期妇女、过敏体质患者;(4)短期内服用治疗视力的药物,保健品或使用其他治疗方法未能终止者。
3、治疗方法:所有近视患者随机分为6组,即内服+穴位按摩组、内服+穴位按摩+外敷实施例1组、内服+穴位按摩+外敷实施例2组、内服+穴位按摩+外敷实施例6组、内服+穴位按摩+外敷对比例1组、内服+穴位按摩+外敷对比例2组。各组内服药物为女真子、川芎、丹参、五味子、枸杞子、褚实子、青菜子、白芍、黄精、升麻、熟地、黄芪共12味药的水煎剂,服用方法为早晚各一次,每次100ml,连续服用60天。穴位按摩每3天一次,外敷中药的,穴位按摩与中药外敷依次进行,先穴位按摩通经络,然后外敷中药。穴位按摩方法为:取头部、眼部、背部、腹部、手足的百会、通天、络却、神庭、阳白、睛明、攒竹、鱼腰、丝竹空、瞳子髎、球后、承泣、四白、角孙、率谷、翳风、翳明、肺俞、心俞、膈俞、肝俞、脾俞、肾俞、太溪、三阴交、地机、阴陵泉、承山、委中、解溪、光明、足三里、阳陵泉、劳宫、内关、尺泽、少海、合谷、后溪、养老、外关、曲池、小海等70多个与调理脏腑、气血上行、恢复视力相关的重要穴位,根据不同的穴位采取点、按、推、拿、揉、滚等手法进行。外敷中药使用方法:取20-30g本发明实施例或对比例组合物外敷于眼部及眼部周边,每次50min,轻度近视(近视度数为300以内)外敷20次,中度近视(近视度数为300度至600度之间)外敷40次,高度近视(近视度数为600度以上)外敷60次。
4、疗效判断标准:治愈:裸眼视力(E视表检测)恢复正常水平,完全不需要佩戴眼镜也能正常的工作、学习和生活;显效:近视度数比治疗前(E视表检测和最后配镜度数)下降300度到500度之间;有效:近视度数(E视表检测和最后配镜度数)比治疗前下降100度到300度之间;无效:近视度数较治疗前无变化。治愈率=治愈例/例数×100%;显效率=显效例/例数×100%;有效率=有效例/例数×100%;无效率=无效例/例数×100%;总有效率=(治愈例+显效例+有效例)/例数×100%。
5、试验结果:见表1。
表1
结果表明,在内服和穴位按摩的基础上结合外敷本发明组合物,能够显著提高治疗效果,且实施例1最优,治愈率为60.7%,显效率为29.1%,有效率为8.7%,无效率仅为1.5%,总体有效率为98.5%。其次为实施例2、实施例6、对比例2以及对比例1,说明本发明组合物的治疗效果与本发明特定的原料配比有关,且对本发明组合物中的原料所作的改变,尤其是穿山龙的省略或替换会直接影响治疗效果。
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以所述权利要求的保护范围为准。
Claims (10)
1.一种辅助治疗真性近视的中药组合物,其特征在于,原料组分包括:桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七。
2.根据权利要求1所述的辅助治疗真性近视的中药组合物,其特征在于,按重量份计,原料组分包括:桑椹子40-60份、枸杞子20-40份、黄芪25-35份、大头花30-70份、红花15-30份、石菖蒲10-45份、覆盆子5-35份、青葙子10-60份、五味子30-60份、决明子50-100份、穿山龙30-60份、冰片2-5份、白人参20-50份、蜜蒙花35-55份、千里光10-30份、楮实子40-70份、女贞子30-50份、蕤仁25-55份、石决明10-20份、三七20-40份。
3.根据权利要求1所述的辅助治疗真性近视的中药组合物,其特征在于,按重量份计,原料组分包括:桑椹子45-55份、枸杞子25-35份、黄芪28-32份、大头花40-60份、红花20-25份、石菖蒲20-40份、覆盆子10-30份、青葙子20-50份、五味子40-50份、决明子60-90份、穿山龙40-50份、冰片3-4份、白人参30-40份、蜜蒙花40-50份、千里光15-25份、楮实子50-60份、女贞子35-45份、蕤仁30-50份、石决明12-18份、三七25-35份。
4.根据权利要求1所述的辅助治疗真性近视的中药组合物,其特征在于,它是由原料药的原生药粉,或者原料药的水或有机溶剂提取物为活性成分,再加上药学上可接受的辅料制备而成的制剂。
5.根据权利要求4所述的辅助治疗真性近视的中药组合物,其特在于,所述制剂为外用制剂。
6.根据权利要求5所述的辅助治疗真性近视的中药组合物,其特在于,所述制剂为膏剂。
7.权利要求6所述膏剂的制备方法,其特征在于,包括如下步骤:
(1)取桑椹子、枸杞子、黄芪、大头花、红花、石菖蒲、覆盆子、青葙子、五味子、决明子、穿山龙、冰片、白人参、蜜蒙花、千里光、楮实子、女贞子、蕤仁、石决明、三七,经分别干燥、粉碎后,得到各原料粉,将所述各原料粉按各原料重量配比混合均匀,得到混合药粉;(2)向混合药粉中加入植物油、水,搅拌成为膏状,即得。
8.根据权利要求7所述的制备方法,其特征在于,步骤(1)中,所述干燥为晒干或烘干;采用中草药破壁粉碎机进行破壁粉碎成微粉。
9.根据权利要求7所述的制备方法,其特征在于,步骤(2)中,所述植物油为麻油或橄榄油,所述混合药粉、植物油以及水之间的重量比为28-32:3:100。
10.根据权利要求7所述的制备方法,其特征在于,步骤(2)中,还加入促渗透剂,所述混合药粉、植物油、促渗透剂以及水之间的重量比为28-32:3:3:100。
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