CN112641916B - 一种强身健体的中药膏方及其制备方法 - Google Patents
一种强身健体的中药膏方及其制备方法 Download PDFInfo
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Abstract
本发明属于中药领域,涉及一种强身健体的中药膏方及其制备方法,亚健康发病以劳累、情志郁滞而至气血阴阳亏虚、脏腑功能衰退为基本病机。治损之法奈何?《难经》曰:“损其肺者,益其气;损其心者,调其荣卫;损其胆者,调其饮食,适其寒温;损其肝者,缓其中;损其肾者,益其精。此治损之法也。”故强身健体膏以调补肝肾、调畅气机为治疗原则,治疗亚健康引起的疲乏、无力、失眠、头晕、头痛、胸闷、心悸、记忆力减退、注意力不集中等周身不适症状。
Description
技术领域
本发明属于中药领域,具体涉及一种强身健体的中药膏方及其制备方法。
背景技术
公开该背景技术部分的信息仅仅旨在增加对本发明的总体背景的理解,而不必然被视为承认或以任何形式暗示该信息构成已经成为本领域一般技术人员所公知的现有技术。
强身健体方的功效为调补肝肾、调畅气机;治疗亚健康引起的疲乏、无力、失眠、头晕、头痛、胸闷、心悸、记忆力减退、注意力不集中等周身不适症状。现代生活环境使人们处于高压之下,长期忧思耗损阳气,阳气亏损造成身体乏力,易疲劳,畏寒肢冷,性功能减退,腰膝酸软,筋骨萎软等症状。服用强身健体方能够改善现代人们的这些症状。
随着都市亚健康人群的增多和人口老龄化时代的到来,以及中医“治未病”体系的倡导与建立,膏方在临床上的应用越来越受到人们的青睐,不单单是因为民众的接受度越来越高,更重要的临床上的治疗效果显著。然而,我国目前对制作中药膏方的标准与理论没有进行规定。传统的膏方制作工艺较为繁杂,其质量很容易受到原料、设备及制作方式的影响。在膏方的制作标准上,目前还处于摸索过程中,其制作的方式不统一。中药配方颗粒是完全遵循中医理论的煎煮方法制备的颗粒,随着其在临床广泛使用,中药配方颗粒的质量、疗效、安全性逐步得到临床医生及患者的认可,因其免煎、服用方便等优势更是得到了患者的喜爱。使用中药配方颗粒制备膏方有传统饮片无可比拟的优势。
发明内容
为此,本发明提供了一种强身健体的中药膏方及其制备方法。调补肝肾、调畅气机。治疗亚健康引起的疲乏、无力、失眠、头晕、头痛、胸闷、心悸、记忆力减退、注意力不集中等周身不适症状。
为实现上述技术目的,本发明采用如下技术方案:
本发明的第一个方面,提供了一种强身健体的中药膏方,由如下重量份的原料组成:北柴胡30~60份、黄芩15~30份、山药50~100份、熟地黄40~80份、白芍30~60份、当归30~60份、川芎30~60份、党参75~150份、茯苓30~60份、炙甘草15~30份、白蔹20~40份、桂枝20~40份、防风30~60份、燀苦杏仁20~40份、麦冬30~60份、桔梗21~42份、生姜9~18份、大枣25~50份、六神曲30~60份、黄芪30~60份、陈皮21~42份、麸炒枳实20~40份、姜竹茹24~48份、牛膝25~50份、燀桃仁20~40份、红花15~30份、郁金30~60份、枸杞子30~60份、淫羊藿25~50份、盐巴戟天25~50份、盐菟丝子25~50份、盐补骨脂25~50份、百合30~60份、合欢花30~60份、制远志48~96份、法半夏21~42份、鹿角胶20.5~51份、阿胶27~54份。
本发明的第二个方面,提供了一种强身健体的中药膏方的制备方法,包括:
将鹿角胶、阿胶单独称量,其余药味饮片按照处方量进行处方调剂
将鹿角胶和阿胶分别进行烊化,备用;
将除鹿角胶和阿胶以外的其他饮片混合后,浸泡后,上火煎煮,武火加热至沸腾后,改为文火加热,保持沸腾状态,煎煮2~3小时,过滤,第二次加8~10倍量水煎煮1~1.5小时,过滤,合并滤液,静置;
取上清液浓缩,形成清膏;
向清膏中加入烊化开的阿胶、鹿角胶、炼蜜与柠檬酸,熬炼,形成稠膏,冷却,即得。
本发明的第三个方面,提供了一种强身健体的中药配方颗粒膏方的制备方法,包括:
将各原料制备成配方颗粒,1g配方颗粒相当于1-60g原药材;
将配方颗粒复溶、熬膏,得清膏;
向清膏中加入炼蜜与柠檬酸,熬膏,得浓膏,冷却,即得。
本发明的有益效果在于:
本发明应用山药、熟地黄、当归、党参、茯苓、大枣、黄芪、枸杞子等药味用于气血两虚,脾肺不足所致之虚劳;麦冬、阿胶滋阴,联合当归、党参等补气血的药味达到补气血阴阳诸不足之功,达到扶正目的;桂枝、防风、柴胡三者配伍,共协散风祛邪,化湿和中,消食健脾;桔梗、杏仁、白蔹理气开郁,《高注金匮要略》:“于是以甘浮之大枣上托之,利气之杏仁疏导之,开提之桔梗上透之,辛散之白蔹外引之,则其所补之阴阳”;生姜性温味辛,炙甘草性温味甘,二药联合配伍而辛甘发散,辛甘化阳;白芍六分合甘草酸甘化阴,如是又见阴阳并补之妙;竹茹性微寒味甘,具有清热化痰、除烦止呕的功效,炙甘草调和诸药,具有健脾益气、通阳复脉之效,可以改善倦怠乏力,关节肌肉疲软无力的症状,枳实具有行气散结之效,用以舒畅气机,陈皮,为理气健脾的药物,主治脘腹胀满、消化不良等症状,生姜具有发汗解表、温中止呕的功效,上诸药合用同具开郁散结、理气健脾之效,可以明显改善肝郁脾虚型亚健康引发的各临床症状,能够提高机体免疫力,增加机体耐受力,明显改善倦怠乏力,关节肌肉疲软无力,胸闷,气短,善太息,食少纳呆,情绪抑郁或急躁易怒等症状;远志具有宁心安神、祛痰开窍、解毒消肿的功效,现代药理表明具有镇静、抗惊厥、增加体力和智力、抗痴呆和脑保护活性、抗氧化、抗衰老、抗癌、抗菌等作用,合欢花具有解郁安神,活血消肿的功效,现代药理表明具有抗疲劳、抗应激、增强免疫功能、镇静催眠、抗抑郁等作用,百合具有养阴润肺、清心安神的功效,现代药理表明具有抗疲劳、增强机体耐缺氧能力、抗应激、增强免疫功能、镇静催眠、润肺止咳等作用,郁金具有行气解郁、清心凉血、活血止痛的功效,其药理具有保肝、免疫抑制、中枢抑制、抗自由基损伤、抗癌、类糖皮质激素等作用,远志、合欢花、百合合用,具有补益心肺,安神益智的功效,能有效改善气短心悸,头晕眼花、心悸失眠,面色苍白,甚或口唇青紫等症状;淫羊藿和巴戟天,都具有补肾阳,强筋骨、祛风湿的功效,二药相须为用,补火助阳之力更胜,因此可有效改善畏寒肢冷,性功能减退,腰膝酸软,筋骨萎软等症状;补骨脂具有补肾壮阳,固精缩尿,温脾止泻,纳气平喘的功效,淫羊藿和补骨脂配伍,淫羊藿长于补命火,补骨脂兼涩性,二药相合,即补,且涩,益肾固精,壮阳固涩相配,补阳固精效力更强,可改善遗尿、遗精、带下过多等症状;菟丝子具有补肾益精、养肝明目、固精缩尿的功效,枸杞子具有滋补肝肾、益精明目的功效,菟丝子和枸杞子配伍,滋补肝肾效力更强,可治疗遗精、腰膝酸软、头晕眼花、耳聋耳鸣等症状;菟丝子与补骨脂配伍,皆能补肾助阳,用于下元虚冷之症,改善畏寒肢冷的症状;鹿角胶和阿胶制为膏方,鹿角胶具有温补肝肾,益精养血的功效,阿胶具有补血、滋阴、润肺、止血的功效。以上诸位药味联合应用以达到补虚纠偏、平衡阴阳、调和气血、协调脏腑功能的作用,用于虚证、慢性病缓解期或稳定期、亚健康、更年期综合征、老年脏气功能衰退等。
附图说明
构成本发明的一部分的说明书附图用来提供对本发明的进一步理解,本发明的示意性实施例及其说明用于解释本发明,并不构成对本发明的不当限定。
图1是本发明实施例1的中药膏方的实物图。
具体实施方式
应该指出,以下详细说明都是示例性的,旨在对本发明提供进一步的说明。除非另有指明,本发明使用的所有技术和科学术语具有与本发明所属技术领域的普通技术人员通常理解的相同含义。
需要注意的是,这里所使用的术语仅是为了描述具体实施方式,而非意图限制根据本发明的示例性实施方式。如在这里所使用的,除非上下文另外明确指出,否则单数形式也意图包括复数形式,此外,还应当理解的是,当在本说明书中使用术语“包含”和/或“包括”时,其指明存在特征、步骤、操作、器件、组件和/或它们的组合。
一种强身健体的中药膏方及其制备方法,
所述的强身健体中药膏方配方组成:
中草药材配方:
北柴胡60g黄芩30g山药100g熟地黄80g白芍60g
当归60g川芎60g党参150g茯苓60g炙甘草30g
白蔹40g桂枝40g防风60g燀苦杏仁40g麦冬60g
桔梗42g生姜18g大枣50g六神曲60g黄芪60g陈皮42g麸炒枳实40g姜竹茹48g牛膝50g燀桃仁40g
红花30g郁金60g枸杞子60g淫羊藿50g盐巴戟天50g
盐菟丝子50g盐补骨脂50g百合60g合欢花60g制远志96g
法半夏42g鹿角胶51g阿胶54g
中药配方颗粒配方:
北柴胡配方颗粒15g黄芩配方颗粒13.6g山药配方颗粒5g
熟地黄配方颗粒61.5g白芍配方颗粒13.3g当归配方颗粒40g
川芎配方颗粒20g党参配方颗粒45.5g茯苓配方颗粒6g
炙甘草配方颗粒15g白蔹配方颗粒4g桂枝配方颗粒2g
防风配方颗粒30g燀苦杏仁配方颗粒6.2g麦冬配方颗粒18g
桔梗配方颗粒7g生姜配方颗粒1.4g大枣配方颗粒41.7g
六神曲配方颗粒6g黄芪配方颗粒24g陈皮配方颗粒21g
麸炒枳实配方颗粒12g姜竹茹配方颗粒4g牛膝配方颗粒38.5g
燀桃仁配方颗粒6.7g红花配方颗粒10g郁金配方颗粒3g
枸杞子配方颗粒24g淫羊藿配方颗粒10g盐巴戟天配方颗粒15g
盐菟丝子配方颗粒11.1g盐补骨脂配方颗粒10g百合配方颗粒12g
合欢花配方颗粒15g制远志配方颗粒8g法半夏配方颗粒3.5g
鹿角胶配方颗粒34g阿胶配方颗粒27g
所述的配方颗粒的规格
阿胶配方颗粒:取阿胶饮片,烊化,过滤,干燥,制粒,即得。阿胶配方颗粒1g相当于2g原药材。
鹿角胶配方颗粒:取鹿角胶饮片,烊化,过滤,干燥,制粒,即得。鹿角胶配方颗粒1g相当于1.5g原药材。
处方中其他配方颗粒:均是取饮片加水煎煮,滤过,滤液浓缩成清膏,加入适量辅料,干燥,制粒,即得。其中北柴胡配方颗粒1g相当于4g饮片、黄芩胡配方颗粒1g相当于2.2g饮片、山药胡配方颗粒1g相当于20g饮片、熟地黄胡配方颗粒1g相当于1.3g饮片、白芍胡配方颗粒1g相当于4.5g饮片、当归胡配方颗粒1g相当于1.5g饮片、川芎胡配方颗粒1g相当于3g饮片、党参胡配方颗粒1g相当于3.3g饮片、茯苓胡配方颗粒1g相当于10g饮片、炙甘草配方颗粒1g相当于2g原药材、白蔹配方颗粒1g相当于10g饮片、桂枝配方颗粒1g相当于20g饮片、防风配方颗粒1g相当于2g饮片、燀苦杏仁配方颗粒1g相当于6.5g饮片、麦冬配方颗粒1g相当于3.33g饮片、桔梗配方颗粒1g相当于6g饮片、生姜配方颗粒1g相当于12.5g饮片、大枣配方颗粒1g相当于1.2g饮片、六神曲配方颗粒1g相当于10g饮片、黄芪配方颗粒1g相当于2.5g饮片、陈皮配方颗粒1g相当于2g饮片、麸炒枳实配方颗粒1g相当于3.33g饮片、姜竹茹配方颗粒1g相当于12g饮片、牛膝配方颗粒1g相当于1.3g饮片、燀桃仁配方颗粒1g相当于6g饮片、红花配方颗粒1g相当于3g饮片、郁金配方颗粒1g相当于20g饮片、枸杞子配方颗粒1g相当于2.5g饮片、淫羊藿配方颗粒1g相当于5g饮片、盐巴戟天配方颗粒1g相当于3.33g饮片、盐菟丝子配方颗粒1g相当于4.5g饮片、盐补骨脂配方颗粒1g相当于5g饮片、百合配方颗粒1g相当于5g饮片、合欢花配方颗粒1g相当于4g饮片、制远志配方颗粒1g相当于12g饮片、法半夏配方颗粒1g相当于12g饮片。
所述的配方颗粒质量的要求:
北柴胡配方颗粒:
(1)每1g含柴胡皂苷a(C42H68O13)应为1.60mg~5.00mg;
(2)应检出柴胡皂苷a、柴胡皂苷b2、柴胡皂苷b1;
(3)醇溶性浸出物应不少于18.0%。
黄芩配方颗粒:
(1)每1g黄芩苷(C21H18O11)应为148.0mg~274.0mg;
(2)应检出黄芩苷、汉黄芩苷、黄芩素、汉黄芩素;
(3)醇溶性浸出物应不少于19.0%。
熟地黄配方颗粒:
(1)每1g含毛蕊花糖苷(C29H36O15)应为0.18mg~0.34mg;
(2)应检出洋地黄叶苷C、焦地黄苯乙醇苷A1、毛蕊花糖苷、焦地黄苯乙醇苷B1、异毛蕊花糖苷等成分;
(3)醇溶性浸出物应不少于12.0%。
白芍配方颗粒:
(1)每1g含芍药苷(C23H28O11)应为65.0mg~137.0mg;
(2)应检出没食子酸、儿茶素、芍药内酯苷、芍药苷、1,2,3,4,6-五没食子酰葡萄糖、苯甲酰芍药苷;
(3)醇溶性浸出物应不少于35.0%。
当归配方颗粒:
(1)每1g含阿魏酸(C10H10O4)应为0.70mg~1.40mg;
(2)应检出尿苷、腺苷、鸟苷、色氨酸、阿魏酸、洋川芎内酯、洋川芎内酯H;
(3)醇溶性浸出物应不少于10.0%。
川芎配方颗粒:
(1)每1g含阿魏酸(C10H10O4)应为1.5mg~4.5mg;
(2)应检出绿原酸、隐绿原酸、咖啡酸、阿魏酸、洋川芎内酯I、洋川芎内酯A;
(2)醇溶性浸出物应不少于15.0%。
党参配方颗粒:
(1)应检出党参炔苷成分;
(2)醇溶性浸出物应不少于26.0%。
茯苓配方颗粒:
醇溶性浸出物应不少于8.0%
炙甘草配方颗粒:
(1)每1g含甘草苷(C21H22O9)应为6.5mg~23.0mg,含甘草酸(C42H62O16)应为12.9mg~60.0mg;
(2)应检出甘草苷、甘草酸等成分;
(3)醇溶性浸出物应不少于40.0%。
防风配方颗粒:
(1)每1g含含升麻素苷(C22H28O11)和5-O-甲基维斯阿米醇苷(C22H28O10)的总量应为5.0mg~12.0mg;
(2)应检出升麻素苷、升麻素、5-O-甲基维斯阿米醇苷、亥茅酚苷;
(3)醇溶性浸出物应不少于25.0%。
燀苦杏仁配方颗粒:
(1)每1g含苦杏仁苷(C20H27NO11)应为60.0mg~120.0mg;
(2)应检出L-苦杏仁苷、苦杏仁苷;
(3)醇溶性浸出物应不少于32.0%。
麦冬配方颗粒:
醇溶性浸出物应不少于6.0%。
生姜配方颗粒:
(1)本品每1g含6-姜辣素(C17H26O4)应为5.0mg~15.0mg;
(2)应检出6-姜辣素、6-姜烯酚、8-姜酚等成分;
(3)醇溶性浸出物应不少于10.0%。
大枣配方颗粒:
(1)本品每1g含环磷腺苷(C10H12N5O6P)应为0.080mg~0.35mg;
(2)应检出环磷腺苷和5-羟甲基糠醛等成分;
(3)醇溶性浸出物应不少于20.0%。
黄芪配方颗粒:
(1)本品每1g含毛蕊异黄酮葡萄糖苷(C22H22O10)应为0.50mg~2.0mg;每1g含黄芪甲苷(C41H68O14)应为1.20mg~3.50mg。
(2)应检出毛蕊异黄酮葡萄糖苷、毛蕊异黄酮峰、黄芪皂苷Ⅱ、黄芪皂苷Ⅰ等成分;
(3)醇溶性浸出物应不少于18.0%。
陈皮配方颗粒:
(1)本品每1g含橙皮苷(C28H34O15)应为6.5mg~14.5mg;
(2)应检出柚皮芸香苷、橙皮苷、川陈皮素、橘皮素等成分;
(3)醇溶性浸出物应不少于23.0%。
麸炒枳实配方颗粒:
(1)本品每1g含辛弗林(C9H13NO2)应为5.0mg~15.5mg;
(2)应检出柚皮苷、橙皮苷、新橙皮苷、辛弗林;
(3)醇溶性浸出物应不少于20.0%。
牛膝配方颗粒:
(1)本品每1g含含β-蜕皮甾酮(C27H44O7)应为0.39mg~1.17mg;
(2)醇溶性浸出物应不少于8.0%。
燀桃仁配方颗粒:
(1)本品每1g含苦杏仁苷(C20H27NO11)应为21.0mg~70.0mg;
(2)应检出色氨酸、苦杏仁苷等成分;
(3)醇溶性浸出物应不少于17.0%。
红花配方颗粒:
本品每1g的配方颗粒含羟基红花黄色素A(C27H30O15)不得少于0.55mg。
枸杞子配方颗粒:
醇溶性浸出物应不少于18.0%
淫羊藿配方颗粒:
(1)本品每1g含总黄酮以淫羊藿苷(C33H40O15)计,应为
150.0mg~321.0mg;淫羊藿苷(C33H40O15)应为25.0mg~62.0mg;
(2)应检出朝藿定、朝藿定、朝藿定、淫羊藿苷、宝藿苷-Ⅰ;
(3)醇溶性浸出物应不少于29.0%。
盐巴戟天配方颗粒:
(1)本品每1g含水晶兰苷(C16H22O11)应为2.6mg~16.8mg;
(2)应检出水晶兰苷、去乙酰车叶草苷酸、甲基异茜草素-1-甲醚;
(3)醇溶性浸出物应不少于10.0%。
盐菟丝子配方颗粒:
(1)本品每1g含金丝桃苷(C21H20O12)应为2.7mg~8.0mg;
(2)应检出绿原酸、隐绿原酸、金丝桃苷、异槲皮苷;
(3)醇溶性浸出物应不少于16.0%。
盐补骨脂配方颗粒:
(1)本品每1g含补骨脂苷(C17H18O9)、异补骨脂苷(C17H18O9)、补骨脂素(C11H6O3)和异补骨脂素(C11H6O3)的总量应为80.0mg~180.0mg;
(2)应检出补骨脂苷、异补骨脂苷、补骨脂素、异补骨脂素、补骨脂酚;
(3)醇溶性浸出物应不少于30.0%。
百合配方颗粒:
(1)本品每1g含王百合苷B(C20H26O11)应为3.0mg~8.5mg;
(2)醇溶性浸出物应不少于8.0%。
合欢花配方颗粒:
(1)本品每1g含槲皮苷(C27H34O11)应为11.0~30.0mg;
(2)应检出槲皮苷、阿福豆苷;
(3)醇溶性浸出物应不少于24.0%。
制远志配方颗粒:
(1)本品每1g含细叶远志皂苷(C36H56O12)应为20.0mg~40.0mg;远志口山酮Ⅲ(C25H28O15)应为0.80mg~2.50mg,含3.6’-二芥子酰基蔗糖(C36H46O17)应为6.0mg~15.0mg;
(2)应检出西伯利亚远志糖、3,6’-二芥子酰基蔗糖;
(3)醇溶性浸出物应不少于40.0%。
所述的强身健体膏方的制法:
中药草药材膏方的制法
(1)处方调剂:
将鹿角胶、阿胶单独称量。其余药味饮片按照处方量进行处方调剂。
(2)阿胶、鹿角胶烊化:
将阿胶、鹿角胶,加入1-3倍量水,隔水蒸30-60分钟,过滤,备用。
(3)煎煮:
把除阿胶、鹿角胶外的其他饮片,浸泡6-8h,武火加热至沸腾,后改为文火加热,保持沸腾状态,煎煮2小时,过滤,第二次加8倍量水煎煮1小时,过滤,合并滤液,静置。
(4)静置:
将煎煮好的药液进行静置,温度为4~10℃,沉淀时间12h,取上清液。
(5)浓缩:
将上清液倒入锅中,80℃浓缩,在搅拌到药汁滴在纸上不散开来为度(此时应用阿贝折光仪测定折光率,应为1.44-1.48;密度计测得相对密度为1.35-1.39),暂停煎熬,得清膏。
(6)收膏:
把烊化开的阿胶、鹿角胶及炼蜜(128g炼蜜/2093g饮片)与柠檬酸(1.3g柠檬酸/2093g饮片)等辅料,倒入清膏中,放在小火上慢慢熬炼,不断用铲搅拌,搅拌至提起搅拌棒见药汁“挂旗”,“挂丝”或“滴水成珠”,膏体加热时呈蜂窝状“翻斗云”(此时应用阿贝折光仪测定折光率,应为1.44-1.48;密度计测得相对密度为1.35-1.39;固含量为70%-75%),得稠膏,装入容器,冷却。
所述的强身健体方配方颗粒膏方的制法:
(1)调剂处方:
应用中药配方颗粒调剂设备按照处方量进行处方调剂配制。
(2)复溶:
在膏方机锅中,加入颗粒总重量1.3倍量的清水,将保温温度与熬膏温度设置为55℃,时间设置为10min,开始加热搅拌,当温度达到50℃以上时,缓缓加入调剂好的中药配方颗粒。
(3)熬膏:
颗粒完全溶解后,将保温温度与熬膏温度设置为85℃,设置时间(34分钟/500g颗粒),使药液浓缩逐渐变为稠厚的清膏。(此时应用阿贝折光仪测定折光率,应为1.44-1.48;密度计测得相对密度为1.35-1.39)。
(4)收膏:
加入炼蜜(100g炼蜜/500g颗粒)与柠檬酸(5g柠檬酸/500g颗粒)等辅料,盖上盖子,避免在膏体表面形成一层膜。继续85℃加热搅拌熬煮,熬膏时间(5min/500g颗粒)得膏,(此时应用阿贝折光仪测定折光率,应为1.44-1.48;相对密度为1.35-1.39;固含量为70%-75%)。
所述的强身健体中药膏方的中医理论及方解:
亚健康在中医学中并无对应的记载,但根据其临床表现,可将之归属于中医学的“虚劳”等范畴。亚健康发病以劳累、情志郁滞而至气血阴阳亏虚、脏腑功能衰退为基本病机。《难经》曰:“损其肺者,益其气;损其心者,调其荣卫;损其胆者,调其饮食,适其寒温;损其肝者,缓其中;损其肾者,益其精。此治损之法也。”故强身健体膏以调补肝肾、调畅气机为治疗原则。
方中应用山药、熟地黄、当归、党参、茯苓、大枣、黄芪、枸杞子等药味用于气血两虚,脾肺不足所致之虚劳;麦冬、阿胶滋阴,联合当归、党参等补气血的药味达到补气血阴阳诸不足之功,达到扶正目的;桂枝、防风、柴胡三者配伍,共协散风祛邪,化湿和中,消食健脾;桔梗、杏仁、白蔹理气开郁,《高注金匮要略》:“于是以甘浮之大枣上托之,利气之杏仁疏导之,开提之桔梗上透之,辛散之白蔹外引之,则其所补之阴阳”;生姜性温味辛,炙甘草性温味甘,二药联合配伍而辛甘发散,辛甘化阳;白芍六分合甘草酸甘化阴,如是又见阴阳并补之妙;竹茹性微寒味甘,具有清热化痰、除烦止呕的功效,炙甘草调和诸药,具有健脾益气、通阳复脉之效,可以改善倦怠乏力,关节肌肉疲软无力的症状,枳实具有行气散结之效,用以舒畅气机,陈皮,为理气健脾的药物,主治脘腹胀满、消化不良等症状,生姜具有发汗解表、温中止呕的功效,上诸药合用同具开郁散结、理气健脾之效,可以明显改善肝郁脾虚型亚健康引发的各临床症状,能够提高机体免疫力,增加机体耐受力,明显改善倦怠乏力,关节肌肉疲软无力,胸闷,气短,善太息,食少纳呆,情绪抑郁或急躁易怒等症状;远志具有宁心安神、祛痰开窍、解毒消肿的功效,现代药理表明具有镇静、抗惊厥、增加体力和智力、抗痴呆和脑保护活性、抗氧化、抗衰老、抗癌、抗菌等作用,合欢花具有解郁安神,活血消肿的功效,现代药理表明具有抗疲劳、抗应激、增强免疫功能、镇静催眠、抗抑郁等作用,百合具有养阴润肺、清心安神的功效,现代药理表明具有抗疲劳、增强机体耐缺氧能力、抗应激、增强免疫功能、镇静催眠、润肺止咳等作用,郁金具有行气解郁、清心凉血、活血止痛的功效,其药理具有保肝、免疫抑制、中枢抑制、抗自由基损伤、抗癌、类糖皮质激素等作用,远志、合欢花、百合合用,具有补益心肺,安神益智的功效,能有效改善气短心悸,头晕眼花、心悸失眠,面色苍白,甚或口唇青紫等症状;淫羊藿和巴戟天,都具有补肾阳,强筋骨、祛风湿的功效,二药相须为用,补火助阳之力更胜,因此可有效改善畏寒肢冷,性功能减退,腰膝酸软,筋骨萎软等症状;补骨脂具有补肾壮阳,固精缩尿,温脾止泻,纳气平喘的功效,淫羊藿和补骨脂配伍,淫羊藿长于补命火,补骨脂兼涩性,二药相合,即补,且涩,益肾固精,壮阳固涩相配,补阳固精效力更强,可改善遗尿、遗精、带下过多等症状;菟丝子具有补肾益精、养肝明目、固精缩尿的功效,枸杞子具有滋补肝肾、益精明目的功效,菟丝子和枸杞子配伍,滋补肝肾效力更强,可治疗遗精、腰膝酸软、头晕眼花、耳聋耳鸣等症状;菟丝子与补骨脂配伍,皆能补肾助阳,用于下元虚冷之症,改善畏寒肢冷的症状;鹿角胶和阿胶制为膏方,鹿角胶具有温补肝肾,益精养血的功效,阿胶具有补血、滋阴、润肺、止血的功效。以上诸位药味联合应用以达到补虚纠偏、平衡阴阳、调和气血、协调脏腑功能的作用,用于虚证、慢性病缓解期或稳定期、亚健康、更年期综合征、老年脏气功能衰退等。
下面结合具体的实施例,对本发明做进一步的详细说明,应该指出,所述具体实施例是对本发明的解释而不是限定。
实施例1:
采用配方颗粒熬制膏方,需对配方颗粒复溶加水量、复溶方式、加水的温度、熬膏温度、熬膏时间、蜂蜜用量、柠檬酸用量等参数进行实验研究及验证。
1.1处方及处方量:
北柴胡配方颗粒15g黄芩配方颗粒13.6g山药配方颗粒5g
熟地黄配方颗粒61.5g白芍配方颗粒13.3g当归配方颗粒40g
川芎配方颗粒20g党参配方颗粒45.5g茯苓配方颗粒6g
炙甘草配方颗粒15g白蔹配方颗粒4g桂枝配方颗粒2g
防风配方颗粒30g燀苦杏仁配方颗粒6.2g麦冬配方颗粒18g
桔梗配方颗粒7g生姜配方颗粒1.4g大枣配方颗粒41.7g
六神曲配方颗粒6g黄芪配方颗粒24g陈皮配方颗粒21g
麸炒枳实配方颗粒12g姜竹茹配方颗粒4g牛膝配方颗粒38.5g
燀桃仁配方颗粒6.7g红花配方颗粒10g郁金配方颗粒3g
枸杞子配方颗粒24g淫羊藿配方颗粒10g盐巴戟天配方颗粒15g
盐菟丝子配方颗粒11.1g盐补骨脂配方颗粒10g百合配方颗粒12g
合欢花配方颗粒15g制远志配方颗粒8g法半夏配方颗粒3.5g
鹿角胶配方颗粒34g阿胶配方颗粒27g
1.2配方颗粒复溶工序研究
(1)加水方式研究
平均称取两份强身健体方配方颗粒,其中一份将称量好的配方颗粒缓缓倒入热水中,搅拌溶解,另一份是将热水缓缓倒入颗粒中,搅拌溶解,观察溶解情况并记录时间,结果见表1-1
表1-1配方颗粒加水方式考察
加水方式 | 复溶时间(min) | 现象 |
颗粒加到热水中 | 10 | 颗粒全部溶解 |
热水倒入颗粒中 | 大于20 | 颗粒成球,不易溶解 |
结论:加水方式为调剂好的配方颗粒加入到热水中搅拌溶解。
(2)加水温度考察:
平均称取3份强身健体方配方颗粒,分别将称量好的配方颗粒缓缓倒入30-40℃温水、50-60℃热水、80-90℃热水中,搅拌溶解,观察溶解情况并记录时间,结果见表1-2。
表1-2配方颗粒加水温度考察
加水温度 | 复溶时间(min) | 现象 |
30-40℃ | 大于20 | 不易溶解 |
50-60℃ | 10 | 颗粒全部溶解 |
80-90℃ | 大于20 | 颗粒成球,不易溶解 |
结论:取调剂好的配方颗粒加入到热水50-60℃中搅拌溶解。
(3)加水量考察:
平均称取4份强身健体方配方颗粒,分别加入0.8、1.0、1.3、1.5倍水考察颗粒溶解度,确定加水量,结果见表1-3。
表1-3配方颗粒复溶加水量
结论:取调剂好的配方颗粒缓缓倒入1.3倍量热水(50-60℃)中搅拌溶解。
(4)强身健体膏方配方颗粒确定的复溶工序
取调剂好的强身健体配方颗粒,缓缓倒入1.3倍量50-60℃的热水中,搅拌溶解10min。
1.3熬膏工序研究
熬膏终点判定,传统以挂旗、吸水纸、冷水测3种常用方法,由于该3种判定方法主观性强、凭经验,不同的人制备膏方很容易导致质量差异过大,所以将这3种主观指标转化成客观指标固含量、折光率、相对密度。
(1)熬膏温度考察:
平均称取两份强身健体方配方颗粒,分别缓缓倒入1.3倍量50-60℃的热水中,搅拌溶解10min。一份将熬膏温度设置为85℃,另一份设置为95℃,熬制收膏后测定膏滋溶化性,结果见表1-4
表1-4熬膏温度考察
熬膏温度(℃) | 溶化性 |
80-90 | 无焦屑,溶化性合格 |
90-100 | 有焦屑,溶化性不合格 |
结论:熬膏温度控制在80-90℃。
(2)熬膏时间确定:
取调剂好的强身健体颗粒250g、500g、1000g,分别熬膏,记录达到终点判定指标的时间,结果见表1-5。
表1-5不同量配方颗粒熬制时间
结论:不同配方颗粒量熬制时间可以看出,随着配方颗粒量成倍增加,熬制时间也是等比例增加,可记为熬制时间为34min/500g。
(3)蜂蜜加入量的确定:
平均称取3份强身健体方配方颗粒,在熬制收膏时分别加入配方颗粒15%、20%、25%蜂蜜,搅拌熬制后,评价该三个膏滋口感,结果见表1-6
表1-6添加不同量蜂蜜评分及口感情况
评分:10分为满分,口感越好,分数越高。
结论:熬膏加入蜂蜜量为配方颗粒的20%。
(4)柠檬酸加入量考察:
平均称取4份强身健体方配方颗粒,在熬制收膏时加入20%蜂蜜后,再分别加入配方颗粒0%、0.6%、1%、1.2%的柠檬酸,搅拌熬制后,评价该4个膏滋口感情况,结果见表1-7.
表1-7添加不同量柠檬酸评分及口感情况
评分:10分为满分,口感越好,分数越高。
结论:熬膏加入柠檬酸量为配方颗粒的1%。
(5)强身健体膏方配方颗粒确定的熬膏工序
以强身健体配方颗粒500g为例,熬制温度80-90℃,熬膏时间34min,加入蜂蜜量100g,柠檬酸5g。
1.4膏方标准化工艺流程
在膏方机锅中,加入颗粒总重量1.3倍量的清水,将保温温度与熬膏温度设置为55℃,时间设置为10min,开始加热搅拌,当温度达到50℃以上时,缓缓加入调剂好的中药配方颗粒;复溶10min结束,将熬膏温度设置为85℃,设置时间(34分钟/500g颗粒),使药液浓缩逐渐变为稠厚的清膏;加入炼蜜(100g炼蜜/500g颗粒)与柠檬酸(5g柠檬酸/500g颗粒),盖上盖子,避免在膏体表面形成一层膜,继续85℃加热搅拌熬煮,熬膏时间(5min/500g颗粒)得膏滋,(此时应用阿贝折光仪测定折光率,应为1.44-1.48;相对密度为1.35-1.39;固含量为70%-75%)。
实施例2
强身健体膏方中胶类组分用量考察,与实施例的不同之处在于,分别比较实施例1熬制的膏方,去掉半量阿胶、鹿角胶配方颗粒熬制的膏方,去掉阿胶、鹿角胶配方颗粒熬制的膏方,通过熬制成的膏滋色泽进行比较,结果见表2-1。
表2-1不同阿胶、鹿角胶添加量膏滋色泽比较
结果,阿胶、鹿角胶用量应为实施例1的用量(61g/640g)。
实施例3
与实施例1的不同之处在于,去掉鹿角胶配方颗粒,其余配方颗粒按“1.4膏方标准化工艺流程”制得膏方,记为“强身健体膏II”。临床上选取50名虚劳患者,随机分成两组,A组服用原强身健体膏,B组服用“强身健体膏II”,服用一个疗程后,对疗效进行评价,A组患者均评价能够缓解体虚、抗疲劳的作用;B组反映仍有身体虚冷的症状。从临床实验结果可以得出,原强身健体膏补虚抗疲劳效果更明显。
实施例4
与实施例1的不同之处在于,去掉淫羊藿配方颗粒、盐巴戟天配方颗粒、盐菟丝子配方颗粒、牛膝配方颗粒、盐补骨脂配方颗粒,其余配方颗粒按“1.4膏方标准化工艺流程”制得膏方,记为“强身健体膏III”。
采用药效实验比较原强身健体膏方、强身健体膏II、强身健体膏III补虚、抗疲劳的效果。
强身健体膏处方优化药效学研究
40只小鼠适应性喂养7d后,被随机分为4组:空白对照组、强身健体膏组、强身健体膏II组和强身健体膏III组,每组10只,各给药组每天灌服相应剂量的强身健体膏溶液1.0mL,2次/d,空白对照组灌服同体积的生理盐水,连续给药10d。各组于末次给药后2h,尾根部按其体重1/10负重,观察小鼠力竭游泳时间。研究发现,强身健体膏各组和空白对照组比较,力竭游泳时间均明显增加(P<0.05),抗疲劳作用明显,但各组间比较,强身健体膏组效果更明显,整体数据均高于其他两组,但差异没有显著性。(如表4-1)
注:与空白对照组比较,*P<0.05。
40只小鼠,采用常压耐缺氧实验,以小鼠呼吸停止为指标,观察小鼠因缺氧而死亡的时间。与空白对照组相比,强身健体膏组小鼠存活时间均显著延长,差异具有统计学意义(P<0.05),研究表明,强身健体膏能够显著提升小鼠耐缺氧能力,各处方间比较,强身健体膏组处方效果最优,数据明显优于其他两组,但各组间差异没有统计学意义(P>0.05)。(表4-2)
注:与空白对照组比较,*P<0.05。
实验结果,原强身健体膏补虚、抗疲劳效果更明显。
强身健体膏方药效学研究
5.1材料与试剂
5.1.1材料与仪器
实验动物:健康成年昆明种小鼠,SPF级,体重20±2g,置于观察室内饲养适应环境(室温25±1℃、相对温度50-60%),自然光照,昼夜明暗交替时间为12h,自由进食饮水,通风洁净良好。
主要仪器:分光光度计(岛津公司);多功能酶标仪、CO2细胞培养箱(Thermo);电子天平(METTLER);生化培养箱(上海一恒科技有限公司)。
5.1.2药物及试剂
强身健体膏,MTT、刀豆球蛋白A(SIGMA);RPMI-1640培养基(invitrogen)、生理盐水等。
5.2实验方法
5.2.1小鼠负重游泳实验
40只小鼠适应性喂养7d后,被随机分为4组:空白对照组、强身健体膏低剂量组、强身健体膏组和强身健体膏高剂量组,每组10只,各给药组每天灌胃相应剂量的强身健体膏溶液1.0mL,2次/d,空白对照组灌服同体积的生理盐水,连续给药10d。各组于末次给药后2h,尾根部按其体重1/10负重,然后分别投入直径50cm,水深40cm,水温23℃,记录自游泳开始至头部全部沉入水中10s不能浮出水面的时间,作为小鼠力竭游泳时间。
5.2.2对小鼠免疫器官指数的影响
40只小鼠,随机分为4组,组别同上述试验分组,每日灌胃两次,连续10d,并于末次给药24h后,称终体质量,并迅速将动物脱颈椎处死,在无菌条件下剖取胸腺和脾脏分别称重,得出脏器指数(脾指数(mg/g)=脾质量mg/终体质量g;胸腺指数(mg/g)=胸腺质量mg/终体质量g)。
5.2.3对小鼠淋巴细胞增殖的影响
小鼠得出脏器指数后,马上将脾脏用100目筛网制成单个脾细胞悬液,用含10%灭活小牛血清的RPMI-1640培养液调节细胞浓度为1×107个/mL,加入96孔细胞培养板,每孔100μL,再加入含Con A的培养液100μL,置于37℃、5%CO2条件下培养72h。吸取上清液100μL,加入MTT溶液20μL。放置37℃、5%CO2条件下培养2h后加入消化液100μL,再放置至次日测各孔570nm波长处OD值,计算刺激指数(刺激指数=OD给药组/OD空白对照组)。
5.2.4对小鼠常压耐缺氧能力的影响
40只小鼠,随机分为4组,组别同上述试验分组,每日灌胃两次,连续10d,末次给药45min后,逐只放入盛有15g钠石灰的广口瓶内(每瓶放1只鼠),密封瓶口,使之不漏气,立即计时。以小鼠呼吸停止为指标,观察小鼠因缺氧而死亡的时间。
5.3数据分析
5.4实验结果
5.4.1强身健体膏对小鼠负重游泳时间的影响
实验过程中,各组小鼠的精神状态、活动状态及摄食饮水状态均正常。如表1所示,各给药组小鼠与空白对照组比较,力竭游泳时间均明显增加(P<0.05),提示强身健体膏具有提高小鼠抗疲劳能力的作用,给药组力竭游泳持续时间明显长于空白对照组。
注:与空白对照组比较,*P<0.05。
5.4.2强身健体膏对小鼠免疫器官指数的影响
胸腺和脾脏是动物的重要免疫器官,胸腺指数和脾指数的大小直接反映机体免疫水平高低。40只小鼠,每日灌胃两次,连续10d,并于末次给药24h后,称终体质量,并迅速将动物脱颈椎处死,在无菌条件下剖取胸腺和脾脏分别称重,得出脏器指数。实验结果显示,强身健体膏各剂量间的胸腺指数和脾脏指数无显著差异(P>0.05)。强身健体膏组、高剂量组与空白对照组相比,各指标差异均达显著水平(P<0.05)。说明强身健体膏对胸腺、脾脏等免疫器官具有一定的刺激增生作用。(表4-4)
注:与空白对照组比较,*P<0.05。
5.4.3强身健体膏对小鼠淋巴细胞增殖的影响
淋巴细胞分裂增殖能力在一定程度上反映了机体细胞免疫功能的强弱,40只小鼠得出脏器指数后。马上进行刺激指数计算。与空白对照组相比,强身健体膏各剂量组淋巴细胞增殖能力均未呈现显著性差异(P>0.05),但是增殖能力均显示增强的趋势,并且呈现一定的剂量依赖性。
5.4.4强身健体膏对小鼠常压耐缺氧时间的影响
40只小鼠,逐只放入盛有钠石灰的广口瓶内,密封瓶口,以小鼠呼吸停止为指标,观察小鼠因缺氧而死亡的时间。与空白对照组比较,强身健体膏各剂量组小鼠存活时间均显著延长,差异具有统计学意义(P<0.05),研究表明强身健体膏能够显著提升小鼠缺氧耐力。(表4-6)
注:与空白对照组比较,*P<0.05。
5.5结论
强身健体膏调补肝肾、调畅气机,适用于治疗亚健康引起的疲乏、无力、失眠、头晕、头痛、胸闷、心悸、记忆力减退、注意力不集中等周身不适症状。本实验结果表明,强身健体膏可以延长负重小鼠游泳时间,增强小鼠免疫抵抗力,提升小鼠耐缺氧能力,对胸腺、脾脏等免疫器官具有一定的刺激增生作用。对于因亚健康引起的运动性疲劳、免疫力低下和血氧载量下降等原因造成的周身不适症状,具有很好的调节作用。
最后应该说明的是,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,尽管参照前述实施例对本发明进行了详细的说明,对于本领域的技术人员来说,其依然可以对前述实施例所记载的技术方案进行修改,或者对其中部分进行等同替换。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。上述虽然对本发明的具体实施方式进行了描述,但并非对本发明保护范围的限制,所属领域技术人员应该明白,在本发明的技术方案的基础上,本领域技术人员不需要付出创造性劳动即可做出的各种修改或变形仍在本发明的保护范围以内。
Claims (10)
1.一种强身健体的中药膏方,其特征在于,由如下重量份的原料制成:北柴胡30~60份、黄芩15~30份、山药50~100份、熟地黄40~80份、白芍30~60份、当归30~60份、川芎30~60份、党参75~150份、茯苓30~60份、炙甘草15~30份、白蔹20~40份、桂枝20~40份、防风30~60份、燀苦杏仁20~40份、麦冬30~60份、桔梗21~42份、生姜9~18份、大枣25~50份、六神曲30~60份、黄芪30~60份、陈皮21~42份、麸炒枳实20~40份、姜竹茹24~48份、牛膝25~50份、燀桃仁20~40份、红花15~30份、郁金30~60份、枸杞子30~60份、淫羊藿25~50份、盐巴戟天25~50份、盐菟丝子25~50份、盐补骨脂25~50份、百合30~60份、合欢花30~60份、制远志48~96份、法半夏21~42份、鹿角胶20.5~51份、阿胶27~54份。
2.如权利要求1所述的强身健体的中药膏方,其特征在于,由如下重量份的原料制成:北柴胡30~45份、黄芩15~22.5份、山药50~75份、熟地黄40~60份、白芍30~45份、当归30~45份、川芎30~45份、党参75~112.5份、茯苓30~45份、炙甘草15~22.5份、白蔹20~30份、桂枝20~30份、防风30~45份、燀苦杏仁20~30份、麦冬30~45份、桔梗21~31.5份、生姜9~13.5份、大枣25~37.5份、六神曲30~45份、黄芪30~45份、陈皮21~31.5份、麸炒枳实20~30份、姜竹茹24~36份、牛膝25~37.5份、燀桃仁20~30份、红花15~22.5份、郁金30~45份、枸杞子30~45份、淫羊藿25~37.5份、盐巴戟天25~37.5份、盐菟丝子25~37.5份、盐补骨脂25~37.5份、百合30~45份、合欢花30~45份、制远志48~72份、法半夏21~31.5份、鹿角胶20.5~32份、阿胶27~30.5份。
3.如权利要求1所述的强身健体的中药膏方,其特征在于,由如下重量份的原料制成:北柴胡45~60份、黄芩22.5~30份、山药75~100份、熟地黄60~80份、白芍45~60份、当归45~60份、川芎45~60份、党参112.5~150份、茯苓45~60份、炙甘草22.5~30份、白蔹30~40份、桂枝30~40份、防风45~60份、燀苦杏仁30~40份、麦冬45~60份、桔梗31.5~42份、生姜13.5~18份、大枣37.5~50份、六神曲45~60份、黄芪45~60份、陈皮31.5~42份、麸炒枳实30~40份、姜竹茹36~48份、牛膝37.5~50份、燀桃仁30~40份、红花22.5~30份、郁金45~60份、枸杞子45~60份、淫羊藿37.5~50份、盐巴戟天37.5~50份、盐菟丝子37.5~50份、盐补骨脂37.5~50份、百合45~60份、合欢花45~60份、制远志72~96份、法半夏31.5~42份、鹿角胶32~51份、阿胶30.5~54份。
4.如权利要求1所述的强身健体的中药膏方,其特征在于,所述中药膏方为配方颗粒膏方,各组分为各原料的配方颗粒。
5.如权利要求4所述的强身健体的中药膏方,其特征在于,除阿胶、鹿角胶外,其他配方颗粒的制备方法为:取原料药,加水煎煮,滤过,滤液浓缩成清膏,加入辅料,干燥,制成颗粒,即得。
6.如权利要求4所述的强身健体的中药膏方,其特征在于,阿胶或鹿角胶配方颗粒的制备方法为取阿胶或鹿角饮片,烊化,制成颗粒,即得。
7.如权利要求4所述的强身健体的中药膏方,其特征在于,北柴胡配方颗粒中,每1g颗粒含柴胡皂苷 a C42H68O13为 1.60mg~5.00mg;检出柴胡皂苷a 、柴胡皂苷b2、柴胡皂苷b1;醇溶性浸出物应不少于18.0%;
或,黄芩配方颗粒中,每1g颗粒含黄芩苷C21H18O11为 148.0mg~274.0mg;检出黄芩苷、汉黄芩苷、黄芩素、汉黄芩素;醇溶性浸出物应不少于19.0%;
或,熟地黄配方颗粒中,每1g 颗粒含毛蕊花糖苷C29H36O15为0.18mg~0.34mg;检出洋地黄叶苷C、焦地黄苯乙醇苷A1、毛蕊花糖苷、焦地黄苯乙醇苷B1、异毛蕊花糖苷;醇溶性浸出物应不少于12.0%;
或,白芍配方颗粒中,每1g 颗粒含芍药苷C23 H28 O11为 65.0mg~137.0mg;检出没食子酸、儿茶素、芍药内酯苷、芍药苷、1,2,3,4,6-五没食子酰葡萄糖、苯甲酰芍药苷;醇溶性浸出物应不少于35.0%;
或,当归配方颗粒中,每1g 颗粒含阿魏酸C10H10O4为 0.70mg~1.40mg;检出尿苷、腺苷、鸟苷、色氨酸、阿魏酸、洋川芎内酯、洋川芎内酯 H;醇溶性浸出物应不少于10.0%;
或,川芎配方颗粒中,每1g颗粒含阿魏酸 C10H10O4为 1.5mg~4.5mg;检出绿原酸、隐绿原酸、咖啡酸、阿魏酸、洋川芎内酯 I 、洋川芎内酯 A;醇溶性浸出物应不少于15.0%;
或,党参配方颗粒中,检出党参炔苷成分;醇溶性浸出物应不少于26.0%;
或,茯苓配方颗粒中,醇溶性浸出物应不少于18.0%;
或,炙甘草配方颗粒中,每1g 颗粒含甘草苷 C21H22O9为6.5mg~23.0mg,含甘草酸C42H62O16为12.9mg~60.0mg;检出甘草苷、甘草酸;醇溶性浸出物应不少于40.0%;
或,防风配方颗粒中,每1g颗粒含升麻素苷C22H28O11和5-O-甲基维斯阿米醇苷C22 H28O10的总量应为 5.0mg~12.0mg;检出升麻素苷、升麻素、5-O-甲基维斯阿米醇苷、亥茅酚苷;醇溶性浸出物应不少于25.0%;
或,燀苦杏仁配方颗粒中,每1g 颗粒含苦杏仁苷C20H27NO11为 60.0mg~120.0 mg;检出L-苦杏仁苷、苦杏仁苷;醇溶性浸出物应不少于32.0%;
或,麦冬配方颗粒中,醇溶性浸出物应不少于6.0%;
或,生姜配方颗粒中,每1g含6-姜辣素C17H26O4为5.0mg~15.0mg;检出6-姜辣素、6-姜烯酚、8-姜酚;醇溶性浸出物应不少于10.0%;
或,大枣配方颗粒中,每1g 含环磷腺苷C10H12N5O6P为0.080mg~0.35mg;检出环磷腺苷和5-羟甲基糠醛;醇溶性浸出物应不少于20.0%;
或,黄芪配方颗粒中,每1g 含毛蕊异黄酮葡萄糖苷C22H22O10为0.50mg~2.0mg;每1g 含黄芪甲苷C41H68O14为1.20mg~3.50mg;检出毛蕊异黄酮葡萄糖苷、毛蕊异黄酮峰、黄芪皂苷Ⅱ、黄芪皂苷Ⅰ;醇溶性浸出物应不少于18.0%;
或,陈皮配方颗粒中,每1g颗粒含橙皮苷C28H34O15为6.5mg~14.5mg;检出柚皮芸香苷、橙皮苷、川陈皮素、橘皮素;醇溶性浸出物应不少于23.0%;
或,麸炒枳实配方颗粒中,每1g颗粒含辛弗林C9H13NO2为 5.0mg~15.5mg;检出柚皮苷、橙皮苷、新橙皮苷、辛弗林;醇溶性浸出物应不少于20.0%;
或,牛膝配方颗粒中,每1g颗粒含 β-蜕皮甾酮C27H44O7为 0.39mg~1.17mg;醇溶性浸出物应不少于8.0%;
或,燀桃仁配方颗粒中,每1g颗粒含苦杏仁苷C20H27NO11为21.0mg~70.0 mg;检出色氨酸、苦杏仁苷;醇溶性浸出物应不少于17.0%;
或,红花配方颗粒中,每 1g的配方颗粒含羟基红花黄色素 AC27H30O15不得少于0.55mg;
或,枸杞子配方颗粒中,醇溶性浸出物应不少于18.0%
或,淫羊藿配方颗粒中,每1g 含总黄酮以淫羊藿苷C33H40O15计,应为150.0mg~321.0mg;淫羊藿苷C33H40O15为 25.0mg~62.0mg;检出朝藿定、朝藿定、朝藿定、淫羊藿苷、宝藿苷-Ⅰ;醇溶性浸出物应不少于29.0%;
或,盐巴戟天配方颗粒中,每1g颗粒含水晶兰苷C16H22O11为2.6mg~16.8mg;检出水晶兰苷、去乙酰车叶草苷酸、甲基异茜草素-1-甲醚;醇溶性浸出物应不少于10.0%;
或,盐菟丝子配方颗粒中,每1g含金丝桃苷C21H20O12为 2.7mg~8.0mg;检出绿原酸、隐绿原酸、金丝桃苷、异槲皮苷;醇溶性浸出物应不少于16.0%;
或,盐补骨脂配方颗粒中,每1g含补骨脂苷C17H18O9、异补骨脂苷C17H18O9、补骨脂素C11H6O3和异补骨脂素C11H6O3的总量应为80.0mg~180.0mg;检出补骨脂苷、异补骨脂苷、补骨脂素、异补骨脂素、补骨脂酚;醇溶性浸出物应不少于30.0%;
或,百合配方颗粒中,每1g含王百合苷 B C20H26O11为 3.0mg~8.5mg;醇溶性浸出物应不少于8.0%;
或,合欢花配方颗粒中,每1g含槲皮苷C27H34O11为 11.0~30.0mg;检出槲皮苷、阿福豆苷;醇溶性浸出物应不少于24.0%;
或,制远志配方颗粒中,每1g含细叶远志皂苷C36H56O12为20.0mg~40.0mg;远志口山酮ⅢC25H28O15为 0.80mg~2.50mg,含 3,6’-二芥子酰基蔗糖 C36H46O17为 6.0mg~15.0mg;检出西伯利亚远志糖、3,6’-二芥子酰基蔗糖;醇溶性浸出物应不少于40.0%。
8.一种权利要求1-3任一项所述的强身健体的中药膏方的制备方法,其特征在于,包括:
将鹿角胶、阿胶单独称量,其余药味饮片按照处方量进行处方调剂;
将鹿角胶和阿胶分别进行烊化,备用;
将除鹿角胶和阿胶以外的其他饮片混合后,浸泡后,上火煎煮,武火加热至沸腾后,改为文火加热,保持沸腾状态,煎煮2 ~3小时,过滤,第二次加8~10倍量水煎煮1~1.5小时,过滤,合并滤液,静置;
取上清液浓缩,形成清膏;
向清膏中加入烊化开的阿胶、鹿角胶、炼蜜与柠檬酸,熬炼,形成稠膏,冷却,即得。
9.如权利要求4所述的强身健体的中药膏方的制备方法,其特征在于,包括:
将各原料制备成配方颗粒,1g配方颗粒相当于1-60g原药材;
将配方颗粒复溶、熬膏,得清膏;
向清膏中加入炼蜜与柠檬酸,熬膏,得浓膏,冷却,即得。
10.如权利要求9所述的强身健体的中药膏方的制备方法,其特征在于,所述复溶的具体步骤为:将颗粒加入到50-60℃的热水中,溶解8~15min,加水量为颗粒量的1.2~1.4;
或,所述熬膏的温度控制在80~90℃,熬制时间为30~40min/500g;
或,炼蜜量为配方颗粒的18~22%;
或,柠檬酸量为配方颗粒的0.9~1.05%。
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