CN108721353A - 一种三七口服液的制备方法 - Google Patents
一种三七口服液的制备方法 Download PDFInfo
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- CN108721353A CN108721353A CN201810927089.4A CN201810927089A CN108721353A CN 108721353 A CN108721353 A CN 108721353A CN 201810927089 A CN201810927089 A CN 201810927089A CN 108721353 A CN108721353 A CN 108721353A
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- radix notoginseng
- oral solution
- solution
- alcohol
- preparation
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Abstract
本发明公开了一种三七口服液的制备方法,该方法是以中药三七为原料经水提、醇沉、脱色、硅藻土抽滤制得三七提取液,将三七提取液直接稀释或稀释后与用于口服液制备的辅料混合,按口服液制备工艺制得三七口服液;本方法不经过高温干燥,保留了三七原有风味和功效,且制得的提取液色泽明亮、苦而回甘、澄清度好,相对于传统的水提工艺三七皂苷含量增加20‑30%,特别是人参皂苷Re、Rg1、Rb1、Rh2含量明显增加,本发明方法简单易行、生产成本低,实验证明产品安全有效,无毒副作用,适于工业化生产和市场推广应用。
Description
技术领域
本发明涉及一种三七口服液的制备方法,属于口服液制备领域。
背景技术
对于三七我们并不陌生,三七是名贵中药材中的一颗璀璨明珠,清朝药学著作《本草纲目拾遗》中记载:“人参补气第一,三七补血第一,味同而功亦等,故称人参三七,为中药中之最珍贵者。”国家唯有两个保密配方,扬名中外的“云南白药”和“片仔癀”,均以三七为主要原料制成。2015版药典记载:三七具有散瘀止血,消肿定痛。用于咯血、吐血、便血、崩漏、外伤出血、胸腹刺痛、跌扑肿痛。早在2002年,我国卫生部公布的可用于保健食品物品名单中就有三七,多年来三七在药物治疗与保健方面发挥了其独特优势。
经国内外科学家研究证明,三七富含三七皂苷、黄酮类化合物、三七多糖等有效成分。特别是近30年,国内外科学家对三七的药理作用进行了广泛研究,发表了大量的研究报告,揭示了三七在血液系统、心血管系统、神经系统、免疫系统、代谢系统,以及抗炎、抗衰老、抗肿瘤等方面的功效作用,特别是三七在心脑血管系统疾病方面的独特作用,为三七作为医疗和保健用品与进一步开发利用提供了重要的科学依据,使三七成为预防、治疗心脑血管系统疾病、调节新陈代谢和生理功能、抗老防衰、保持机体正常生长发育的重要药物。
目前,市场上现有的保健食品三七口服液有效成分总皂苷含量在100-400mg/100mL,即100mg-200mg/d,达不到现代药理研究提高免疫力、降血压、改善血液循环及防治动脉粥样硬化等作用的有效剂量,如刘成明等人研究表明三七粉提高免疫力的有效剂量为2.04-8.04g/d、赵鹏等人研究表明三七皂苷提高免疫力有效剂量为495mg/d。三七口服液保健食品开发中存在传统提取工艺收率低、难以规模化生产,而且颜色太深、澄清度差、苦味不纯正,阻碍三七口服液的开发,而采用纯化技术不仅生产成本太高,颜色过淡,成分过于单一不符合中医药整体观念,达不到中医药的协同增效等技术难题。
发明内容
为解决三七传统提取工艺收率低、难以规模化生产,而且颜色太深、澄清度差、苦味不纯正,阻碍三七口服液的开发,而采用纯化技术不仅生产成本太高,颜色过淡,成分过于单一不符合中医药整体观念,达不到中医药的协同增效等技术难题,本发明提供了一种三七口服液的制备方法,本发明方法工艺简单、产率高、成本低,制得的口服液色泽明亮、苦而回甘、澄清度好且富含三七总皂苷、三七黄酮、三七多糖等有效成分;制得的三七口服液具有提高免疫力,降血压、降血脂,改善血液循环及防治动脉粥样硬化,增加心脑血流量,降低心肌耗氧量,提高缺氧耐受力等保健功效。
本发明三七口服液制备方法如下:
(1)取三七药材,粉碎至10-20目,加水煎煮2-3次,过滤,合并滤液,真空浓缩至比重为1.05-1.25,制得三七水提液;
(2)在三七水提液中添加体积浓度95%的食用酒精进行醇沉,冷藏过夜,过滤,残渣备用,取上清液即为三七醇沉液;
(3)脱色
A、树脂预处理:取脱色树脂用水清洗,再用盐酸溶液浸泡5-7小时,过滤,用纯化水水洗至pH值7,然后用NaOH溶液浸泡5-7小时,过滤,用纯化水水洗至pH为7,备用;
B、脱色树脂湿法上柱,用食用酒精平衡层析柱,除去气泡,洗至流出液不浑浊;
C、将三七醇沉液过柱,收集流出液,然后用食用酒精洗脱,合并流出液和洗脱液,减压浓缩、回收乙醇即得三七脱色液X;
(4)在步骤(2)残渣中添加其等质量的纯化水,搅拌均匀,在混合液中加入体积浓度95%的食用酒精进行低浓度醇沉,过滤,滤液减压浓缩至无醇味;然后在浓缩液中加入体积浓度95%的食用酒精进行高浓度醇沉,过滤,在沉淀物中添加其等质量的纯化水混匀后,过滤,取上清液即得三七脱色液Y;
(5)将三七脱色液X、三七脱色液Y混合均匀,用柠檬酸溶液调节混合液pH值为5.2-6.6,然后用硅藻土抽滤,滤液浓缩至比重为1.05-1.25,即得三七提取液;
(6)将三七提取液直接稀释或稀释后与用于口服液制备的辅料混合,按口服液制备工艺制得三七口服液。
按常规口服液制备工艺制得三七口服液。
所述步骤(1)中每次煎煮1-3h,水的添加量为三七质量的3-8倍。
所述步骤(2)中食用酒精添加量为三七水提液体积5-7倍。
所述步骤(3)中脱色树脂为D900型弱碱性阴离子交换树脂。
所述盐酸溶液的质量浓度为4-5%,NaOH溶液的质量浓度为4-6%。
所述层析柱的高径比≥4,上样时,料胶比为1:30-1:40。
所述平衡层析柱所用食用酒精的体积浓度为80-85%,洗脱所用食用酒精的体积浓度为80-85%。
所述步骤(4)低浓度醇沉中食用酒精添加量为混合液体积的1-2倍;高浓度醇沉中食用酒精添加量为浓缩液体积的6-7倍。
所述步骤(5)中柠檬酸溶液的质量浓度为2-3%,硅藻土是按质量比1-3:2-4的比例,将80-100目粗硅藻土与15-200目细硅藻土混合均匀制得。
本发明口服液中还可以添加其他中药提取物或者药食两用的配料,所使用的口服液辅料均为常规口服液辅料,添加量按常规计量添加。
本发明方法的优点和技术效果:
(1)通过水提、醇沉、脱色、硅藻土抽滤获得低成本、高品质的三七提取液,该提取液液如色泽明亮、苦而回甘、澄清度好;本发明方法除去部分三七中残留的重金属、农残以及纤维、淀粉等杂质,既保障三七口服液的安全性,又最大限度保留三七口服液的功效;另外,在保证三七功效成分的情况下进行脱色处理,改变了传统中药提取物“粗、大、黑”的形象,提升了感性认知,也提高了三七口服液的生物利用率;
(2)该工艺脱色除杂工艺精简而效果好,可以提高三七提取的收率,有利于工业化生产,并且大大的节省了生产成本;除此之外,还可以对工人的工作环境进行改善,降低污染以及简化生产工序;
(3)该工艺相对于传统的水提工艺三七皂苷含量增加20-30%,特别是人参皂苷Re、Rg1、Rb1、Rh2含量明显增加,三七黄酮含量增加了8-15%,三七多糖增加了3-5%,且色泽明亮、苦而回甘、澄清度好;
(4)本发明三七口服不经过高温干燥,既保留了三七原有风味,又能免去复杂的饮料配制程序,直接按不同规格稀释成色泽明亮、苦而回甘、澄清度好的三七口服液,或者复配其他中药材、食药两用物料、新资源食品等复配成三七口服液。
具体实施方式
下面通过实施例对本发明作进一步详细说明,但本发明保护范围不局限于所述内容,实施例中方法如无特殊说明均为常规方法,使用的试剂如无特殊说明均为常规市售或按常规方法配制的试剂。
实施例1:本三七口服液的制备方法步骤如下:
(1)取三七药材1.0kg,粉碎至10目,加水煎煮2次(水的添加量为三七质量的3倍),每次煎煮2h过滤,合并滤液,真空浓缩至比重为1.05,制得三七水提液;
(2)在三七水提液中添加体积浓度95%的食用酒精进行醇沉,冷藏过夜,过滤,残渣备用,上清液即为三七醇沉液,其中食用酒精添加量为三七水提液体积5倍;
(3)脱色
A、树脂预处理:取D900型弱碱性阴离子交换树脂用纯化水清洗,再用质量浓度为4%盐酸溶液浸泡7小时,过滤,用纯化水水洗至pH值7,然后用质量浓度为5%NaOH溶液浸泡6小时,过滤,用纯化水水洗至pH为7,装柱,层析柱规格为10×100cm;
B、脱色树脂湿法上柱,料胶比为1:30,用体积浓度为80%的食用酒精平衡层析柱,除去气泡,洗至流出液不浑浊,其中流速为1柱体积/h;
C、将三七醇沉液过柱,收集流出液,上柱流速2柱体积/h;然后用体积浓度为80%食用酒精洗脱,流速为1柱体积/h,合并流出液和洗脱液,减压浓缩、回收乙醇即得三七脱色液X;
(4)在步骤(2)残渣中添加其等质量的纯化水,搅拌均匀,加入混合液体积1倍的95%食用酒精进行低浓度醇沉,过滤,滤液减压浓缩至无醇味,在浓缩液中加入其体积6倍的95%食用酒精进行高浓度醇沉,过滤,在沉淀物中添加其等质量的纯化水混匀后,过滤,取上清液即得三七脱色液Y;
(5)将三七脱色液X、三七脱色液Y混合均匀,用质量浓度为2%柠檬酸溶液调节溶液pH值为5.5,然后用硅藻土(按质量比2:3的比例将80目粗硅藻土与200目细硅藻土混合均匀制得)抽滤,滤液浓缩至比重为1.1,即得三七提取液;
(6)将三七提取液直接稀至5L,分装,灭菌即得三七口服液。
(7)经检测本工艺所得三七提取液干燥物,按2003版《保健食品检验与评价技术规范》中的总皂苷、总黄酮、粗多糖的检测方法进行含量测定;总皂苷含量为56.8%、总黄酮含量为1.62%,粗多糖含量为12.7%;相对于传统提取工艺三七皂苷增加21.8%、三七黄酮增加8.0%、三七多糖增加3.1%。
实施例2:本三七口服液的制备方法步骤如下:
(1)取三七药材1.0kg,粉碎至20目,加水煎煮3次(水的添加量为三七质量的5倍),每次煎煮1h过滤,合并滤液,真空浓缩至比重为1.1,制得三七水提液;
(2)在三七水提液中添加体积浓度95%的食用酒精进行醇沉,冷藏过夜,过滤,残渣备用,上清液即为三七醇沉液,其中食用酒精添加量为三七水提液体积6倍;
(3)脱色
A、树脂预处理:取D900型弱碱性阴离子交换树脂用纯化水清洗,再用质量浓度为5%盐酸溶液浸泡6小时,过滤,用纯化水水洗至pH值7,然后用质量浓度为4%NaOH溶液浸泡7小时,过滤,用纯化水水洗至pH为7,装柱,层析柱规格为10×100cm;
B、脱色树脂湿法上柱,料胶比为1:35,用体积浓度为85%的食用酒精平衡层析柱,除去气泡,洗至流出液不浑浊,其中流速为2柱体积/h;
C、将三七醇沉液过柱,收集流出液,上柱流速1柱体积/h;然后用体积浓度为82%食用酒精洗脱,流速为2柱体积/h,合并流出液和洗脱液,减压浓缩、回收乙醇即得三七脱色液X;
(4)在步骤(2)残渣中添加其等质量的纯化水,搅拌均匀,在混合液中加入其体积2倍的95%食用酒精进行低浓度醇沉,过滤,滤液减压浓缩至无醇味,在浓缩液中加入其体积6.5倍的95%食用酒精进行高浓度醇沉,过滤,在沉淀物中添加其等质量的纯化水混匀后,过滤,取上清液即得三七脱色液Y;
(5)将三七脱色液X、三七脱色液Y混合均匀,用质量浓度为3%柠檬酸溶液调节溶液pH值为6,然后用硅藻土(按质量比1:2的比例将90目粗硅藻土与150目细硅藻土混合均匀制得)抽滤,滤液浓缩至比重为1.2,即得三七提取液;
(6)将三七提取液直接稀释,然后添加10%的甜味剂山梨醇、0.02%的防腐剂山梨酸钾,搅拌溶解,定容至6L,混合均匀,分装,灭菌即得三七口服液。
(7)经检测本工艺所得三七提取液干燥物,按2003版《保健食品检验与评价技术规范》中的总皂苷、总黄酮、粗多糖的检测方法进行含量测定。总皂苷含量为60.2%、总黄酮含量为1.68%,粗多糖含量为14.2%,相对于传统提取工艺三七皂苷增加25.2%、三七黄酮增加12.0%、三七多糖增加4.6%。
实施例3:本三七口服液的制备方法步骤如下:
(1)取三七药材1.0kg,粉碎至12目,加水煎煮2次(水的添加量为三七质量的7倍),每次煎煮3h过滤,合并滤液,真空浓缩至比重为1.2,制得三七水提液;
(2)在三七水提液中添加体积浓度95%的食用酒精进行醇沉,冷藏过夜,过滤,残渣备用,上清液即为三七醇沉液,其中食用酒精添加量为三七水提液体积7倍;
(3)脱色
A、树脂预处理:取D900型弱碱性阴离子交换树脂用纯化水清洗,再用质量浓度为4%盐酸溶液浸泡7小时,过滤,用纯化水水洗至pH值7,然后用质量浓度为5%NaOH溶液浸泡6小时,过滤,用纯化水水洗至pH为7,装柱,层析柱规格为10×100cm;
B、脱色树脂湿法上柱,料胶比为1:40,用体积浓度为82%的食用酒精平衡层析柱,除去气泡,洗至流出液不浑浊,其中流速为1.5柱体积/h;
C、将三七醇沉液过柱,收集流出液,上柱流速1.5柱体积/h;然后用体积浓度为85%食用酒精洗脱,流速为1.5柱体积/h,合并流出液和洗脱液,减压浓缩、回收乙醇即得三七脱色液X;
(4)在步骤(2)残渣中添加其等质量的纯化水,搅拌均匀,在混合液中加入其体积1.5倍的95%食用酒精进行低浓度醇沉,过滤,滤液减压浓缩至无醇味,在浓缩液中加入其体积7倍的95%食用酒精进行高浓度醇沉,过滤,在沉淀物中添加其等质量的纯化水混匀后,过滤,取上清液即得三七脱色液Y;
(5)将三七脱色液X、三七脱色液Y混合均匀,用质量浓度为2.5%柠檬酸溶液调节溶液pH值为6.5,然后用硅藻土(按质量比3:4的比例将100目粗硅藻土与180目细硅藻土混合均匀制得)抽滤,滤液浓缩至比重为1.1,即得三七提取液;
(6)三七提取液中添加5%的黄芪提取物、6%山楂提取物、8%桑叶提取物以及12%的甜味剂山梨醇、0.03%的防腐剂山梨酸钾,搅拌溶解,定容至5L,分装,灭菌即得三七口服液。
(7)经检测本工艺所得三七提取液干燥物,按2003版《保健食品检验与评价技术规范》中的总皂苷、总黄酮、粗多糖的检测方法进行含量测定。总皂苷含量为62.5%、总黄酮含量为1.72%、粗多糖为14.5%,相对于传统提取工艺三七皂苷增加27.5%、三七黄酮增加14.6%、三七多糖增加4.9%。
实施例4:提高免疫力功效验证试验
1、为了验证上述三七口服液功效及安全性,做小鼠碳粒廓清功能试验
(1)材料与分组:昆明种小鼠48只,雌雄各半,体重(20±2)g ,随机分为正常组、模型组、阳性对照组(匹多莫德,按5倍等效量即1040mg/(kg·bw)给药)和三七口提取液(该提取液为上述实施例制得的三七口提取液,稀释5倍)每组12只;
(2)实验方法:三七提取液组,以稀释5倍的三七提取液,灌胃给药( 0.2mL/(10g·bw))每天1次,连续7天,正常组、模型组、阳性对照组则给予等量纯化水。第5天除正常组外,其余各组每只小鼠腹腔注射环磷酰胺(Cy)50mg(kg·bw),连续3天。第8天每鼠尾静脉注入经稀释的印度墨汁(0.10 mL/10g),2min(t1)和10 min(t2)后分别从眼底静脉丛取血40μL,并将其加到4 mL经离心的0.1 %Na2CO3溶液中,用752N分光光度计在600 nm 波长处分别测定其吸光度值A(2 min取血所测吸光度值)和B(10 min取血所测吸光度值),以0.1 %Na2CO3 溶液作空白调零;同时称体重、胸腺重和肝脾重,按下列公式计算胸腺指数、脾指数、碳粒廓清指数K 和吞噬指数α:
胸腺指数=胸腺重/体重;脾指数=脾脏重/体重
碳粒廓清指数K =(lgA -lgB)/(t2 -t1)
吞噬指数α=k1/3 ×体重/(肝重+脾重)
(3)实验结果:
表1 对Cy 诱导免疫低下小鼠巨噬细胞吞噬功能的影响
;
注:与正常组比较,△P<0.05 ,△△P<0.01;与模型组比较,*P<0.05 ,**P<0.01,***P<0.001。
表2 对Cy 诱导免疫低下模型小鼠胸腺及脾指数的影响
;
注:与正常组比较,△P<0.05 ,△△P<0.01;与模型组比较,**P<0.01,***P<0.001。
(4)实验结论:
从表1可以看出,与正常组比较,模型组小鼠第八天体重明显小于正常组小鼠体重(P<0.01),且碳廓清指数明显小于正常组(P<0.05)、吞噬指数显著小于正常组(P<0.01),说明造模成功;另外,与模型组对比,三七口提取液组小鼠体重极显著增加,且碳廓清指数K明显大于模型组、吞噬指数α显著大于模型组(P<0.001),说明三七提取液能抑制Cy对小鼠产生的损伤,还能提高小鼠碳廓清指数K和吞噬指数α。
从表2可以看出,与正常组比较,模型组胸腺指数、脾指数均显著小于正常组(P<0.01),说明造模成功。另外,与模型组对比,三七提取液组胸腺指数、脾指数显著高于模型组(P<0.001),说明三七提取液能提高小鼠胸腺指数、脾指数。
我们可以得知三七口服液,安全性好、无毒副作用,一方面能防治免疫系统抑制剂环磷酰胺造成的器官损伤与降低免疫力,另一方面,能提高碳粒廓清指数K、吞噬指数α、胸腺指数、脾指数,提高免疫力。
实施例5:高血压治疗试验
一般资料:收集符合西医及中医证候诊断标准、未用药或服用高血压药但已停药2周、获得知情同意书的原发性高血压患者60例,年龄18~65岁,平均37岁,病情0.5~3年。病例中大部分均有眩晕、头痛、腰膝酸软、心烦急躁、口干、心悸、气短、失眠、健忘、口淡食少、便秘、尿赤、耳鸣、呕吐痰涎、胸闷、烦热、夜尿频等症。
诊断标准:符合《WHO/ISH四次高血压指南诊断标准》高血压诊断标准、高血压临床分期诊断标准及《中医病证诊断疗效标准》高血压诊断标准。全部病例均排除妊娠或哺乳期妇女,继发性高血压患者,合并有心、脑、肝、肾和造血系统等严重原发疾病、精神病患者以及过敏体质或多种药物过敏者。
用法用量:服用本发明上述实施例1所制得三七口服液,早、晚各一次;疗程7天,服用5个疗程。
疗效标准及治疗结果:疗效标准:(1)显效:①舒张压下降10mmHg以上,并达到正常范围;②舒张压虽未降至正常但已下降20mmHg或者以上。(2)有效:①舒张压下降不及10mmHg,但已达到正常范围;②舒张压较治疗前下降10-19mmHg,但未达到正常范围;③收缩压较治疗前下降30mmHg以上。(3)无效:未达到以上标准者。每周定时定人测量血压、心率1次,测量前患者休息15~20 min,服用三七口服液第3周询问并记录头痛、心悸、便秘、失眠、腰膝酸软等症状改善情况。治疗结果如下:
表3 高血压患者舒张压检验结果
;
表4 高血压患者证候改善情况
;
表3显示,服用三七口服液第一周,血压开始有效下降(p<0.05)、服用三七口服液第二周血压开始显著下降(p<0.01),连续服用至第5周血压恢复正常水平。
表4显示,服用三七口服液3周后,高血压患者的头痛、心悸、便秘、眩晕、腰膝酸软等主要临床症状明显改善。
本发明三七口服液对原发性高血压有很好的降血压效果,能明显改善高血压患者主要临床症状如头痛、心悸、便秘、眩晕、腰膝酸软等。
Claims (10)
1.一种三七口服液的制备方法,其特征在于,步骤如下:
(1)取三七药材,粉碎至10-20目,加水煎煮2-3次,过滤,合并滤液,真空浓缩至比重为1.05-1.25,制得三七水提液;
(2)在三七水提液中添加体积浓度95%的食用酒精进行醇沉,冷藏过夜,过滤,残渣备用,取上清液即为三七醇沉液;
(3)脱色
A、树脂预处理:取脱色树脂用水清洗,再用盐酸溶液浸泡5-7小时,过滤,用纯化水水洗至pH值7,然后用NaOH溶液浸泡5-7小时,过滤,用纯化水水洗至pH为7,备用;
B、脱色树脂湿法上柱,用食用酒精平衡层析柱,除去气泡,洗至流出液不浑浊;
C、将三七醇沉液过柱,收集流出液,然后用食用酒精洗脱,合并流出液和洗脱液,减压浓缩、回收乙醇即得三七脱色液X;
(4)在步骤(2)残渣中添加其等质量的纯化水,搅拌均匀,在混合液中加入体积浓度95%的食用酒精进行低浓度醇沉,过滤,滤液减压浓缩至无醇味;然后在浓缩液中加入体积浓度95%的食用酒精进行高浓度醇沉,过滤,在沉淀物中添加其等质量的纯化水混匀后,过滤,取上清液即得三七脱色液Y;
(5)将三七脱色液X、三七脱色液Y混合均匀,用柠檬酸溶液调节混合液pH值为5.2-6.6,然后用硅藻土抽滤,滤液浓缩至比重为1.05-1.25,即得三七提取液;
(6)将三七提取液直接稀释或稀释后与用于口服液制备的辅料混合,按口服液制备工艺制得三七口服液。
2.根据权利要求1所述的三七口服液的制备方法,其特征在于:步骤(1)中每次煎煮1-3h,水的添加量为三七质量的3-8倍。
3.根据权利要求1所述的三七口服液的制备方法,其特征在于:步骤(2)中食用酒精添加量为三七水提液体积5-7倍。
4.根据权利要求1所述的三七口服液的制备方法,其特征在于:步骤(3)中脱色树脂为D900型弱碱性阴离子交换树脂。
5.根据权利要求1所述的三七口服液的制备方法,其特征在于:盐酸溶液的质量浓度为4-5%,NaOH溶液的质量浓度为4-6%。
6.根据权利要求1所述的三七口服液的制备方法,其特征在于:层析柱的高径比≥4,上样时,料胶比为1:30-1:40。
7.根据权利要求1所述的三七口服液的制备方法,其特征在于:平衡层析柱所用食用酒精的体积浓度为80-85%,洗脱所用食用酒精的体积浓度为80-85%。
8.根据权利要求1所述的三七口服液的制备方法,其特征在于:步骤(4)低浓度醇沉中食用酒精添加量为混合液体积的1-2倍;高浓度醇沉中食用酒精添加量为浓缩液体积的6-7倍。
9.根据权利要求1所述的三七口服液的制备方法,其特征在于:步骤(5)中柠檬酸溶液的质量浓度为2-3%,硅藻土是按质量比1-3:2-4的比例,将80-100目粗硅藻土与150-200目细硅藻土混合均匀制得。
10.根据权利要求1所述的三七口服液的制备方法,其特征在于:制得的三七口服液添加其他中药提取物或添加药食两用的配料。
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