CN111869878A - 一种低5-hmf含量的碳水化合物口服清液及其制备方法 - Google Patents
一种低5-hmf含量的碳水化合物口服清液及其制备方法 Download PDFInfo
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 36
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/16—Inorganic salts, minerals or trace elements
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Mycology (AREA)
- Nutrition Science (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
本发明提供了一种低5‑羟甲基糠醛含量的碳水化合物口服清液,该口服清液含有1~50%的单糖含量,5‑HMF限量与《中国药典》对葡萄糖注射液和/或果糖注射液的要求一致,提高消费者食用安全性。本发明采用柠檬酸‑柠檬酸盐缓冲体系控制灭菌前后口服清液的pH值不发生变化,避免葡萄糖注射液和/或果糖注射液采用盐酸调节pH值造成灭菌后pH值降低。同时,该口服清液不添加亚硫酸氢钠,避免给消费者带来健康风险。本发明还提供了该口服清液的制备方法。
Description
技术领域
本发明涉及医学食品技术领域,具体涉及一种低5-HMF含量的碳水化合物口服清液及其制备方法。
背景技术
5-羟甲基糠醛(5-Hydroxymethylfurfural,简称5-HMF),又称5-羟甲基-2-呋喃糠醛,分子式为C6H6O3,是一种呋喃类化合物。其结构式如式(I)所示。
葡萄糖异构化产生5-HMF的反应式如式(II)所示。
5-HMF广泛存在于多种食品中,如罐头食品、谷类衍生物、果汁、干制食品、蜂蜜、牛奶、咖啡中。速溶咖啡中5-HMF的含量最高,平均含量超过3mg/g;烘焙咖啡的5-HMF含量比烘焙咖啡低10倍左右;果汁和果汁中5-HMF的含量取决于生产的水果,尽管大多数产品不超过10mg/L;在碳酸软饮料中,5-HMF的来源既有甜味剂,也有作为食用色素添加的亚硫酸铵焦糖;在干果、烘焙咖啡、大麦和焦糖产品中发现5-HMF含量超过1mg/g。国际饮料科技协会(ISBT)规定果葡糖浆中5-HMF的限量为75mg/kg;国际蜂蜜协会制定5-HMF的限量为80mg/kg;欧盟规定儿童用果汁中5-HMF的限量为20mg/kg。
5-HMF在胃肠道中被迅速吸收后,可通过磺基转移酶和磺基供体3-磷酸腺苷-5-磷酸磺化生成5-磺酸氧甲基糠醛(sulfoxymethylfurfural,简称SMF)。大量的5-HMF代谢物可以通过尿液排泄,然而SMF不能排泄。SMF非常不稳定,具有致突变、致癌、神经毒性和肝毒性特性。因此5-HMF具有潜在的致癌性,能够造成DNA损伤,能与人体蛋白质结合引起中毒,造成横纹肌麻痹和内脏损害。欧盟食品安全委员会推荐每人每日摄入的5-HMF上限为1.6mg,因此关于5-HMF的安全性研究非常重要。
由于具有潜在毒性,我国注射制剂对5-HMF的含量有相关要求。《中国药典》(2015版)对葡萄糖注射液中5-HMF的要求为:精密量取本品适量(约相当于葡萄糖1.0g),置100ml量瓶中,用水稀释至刻度,摇匀,照紫外-可见分光光度法(通则0401),在284nm的波长处测定,吸光度不得大于0.32。CFDA标准颁布件WS1-XG-016-2015对果糖注射液中5-HMF的要求:精密量取本品适量,加水制成每1mL中含果糖2mg的溶液,摇匀,照紫外-可见分光光度法(中国药典2010年版二部附录ⅣA),在284nm的波长处测定,吸光度不得大于0.25。
《中国药典》对葡萄糖注射液、果糖注射液中的5-HMF有限量要求,但在食品领域还没有相关要求。葡萄糖注射液、果糖注射液通过添加盐酸和/或亚硫酸氢钠降低5-HMF产生,灭菌后pH值变化大;而且《GB 2760食品安全国家标准食品添加剂使用标准》中,盐酸只能用于蛋黄酱、沙拉酱,亚硫酸氢钠也不允许用于本发明的口服清液中。
鉴于此,特提出本发明。
发明内容
本发明的第一目的在于提供一种低5-HMF含量的碳水化合物口服清液。
本发明的第二目的在于提供上述口服清液的制备方法。
为实现上述目的,本发明的技术方案如下:
本发明涉及一种低5-HMF含量的碳水化合物口服清液,包括以下重量份的原料:葡萄糖0~50份,果糖0~20份,麦芽糊精0~20份,柠檬酸-柠檬酸盐缓冲体系0.5~10份,氯化钠0~0.2份,氯化钾0~0.3份,甜味剂0~0.01份,食用香精0~0.05份,水93~99份,其中葡萄糖、果糖和麦芽糊精的含量共计1~50份。
优选地,所述柠檬酸-柠檬酸盐缓冲体系包括柠檬酸0.5~4份,柠檬酸钠0~4份,柠檬酸钾0~2份。
优选地,以磷酸-磷酸盐缓冲体系替代所述柠檬酸-柠檬酸盐缓冲体系,所述磷酸-磷酸盐缓冲体系包括磷酸氢二钠0.1~5份,磷酸二氢钠0.1~5份。
优选地,所述口服清液中5-HMF的限量为:用紫外可见分光光度计在284nm处测吸光度≤0.32X+0.25Y/0.2。式中X为口服清液中的葡萄糖含量,Y为果糖含量,X和Y的单位均为g/100mL。
本发明还涉及所述口服清液的制备方法,包括以下步骤:
(1)向部分纯水中加入柠檬酸-柠檬酸盐缓冲体系,搅拌溶解后得到浓配溶液;
优选地,浓配溶液中的纯水用量占原料纯水中的20%~60%。
(2)搅拌条件下,向所述浓配溶液中依次加入麦芽糊精、葡萄糖、果糖中的一种或多种,完全溶解后加入除纯水以外的其余原料并溶解;
(3)向步骤(2)得到的所述浓配溶液中加入剩余纯水得到稀配溶液;
优选地,所述浓配溶液和稀配溶液的pH值范围均为3.0~5.0。
优选地,所述稀配溶液的糖酸比为(12~60):1。
(4)对所述稀配溶液灭菌后得到所述口服清液。
优选地,所述灭菌方式为:灌装后在121℃下灭菌,F0≥8min;或进行UHT灭菌,灭菌温度为135℃,灭菌时间为3~6s,灭菌后进行无菌灌装。
本发明的有益效果为:
本发明提供了一种低5-羟甲基糠醛含量的碳水化合物口服清液,该口服清液含有1~50%的单糖含量,5-HMF限量与《中国药典》对葡萄糖注射液和/或果糖注射液的要求一致,提高消费者食用安全性。本发明采用柠檬酸-柠檬酸盐缓冲体系控制灭菌前后口服清液的pH值不发生变化,避免葡萄糖注射液和/或果糖注射液采用盐酸调节pH值造成灭菌后pH值降低。同时,该口服清液不添加亚硫酸氢钠,避免给消费者带来健康风险。
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。
本发明实施例涉及一种低5-HMF含量的碳水化合物口服清液,包括以下重量份的原料:葡萄糖0~50份,果糖0~20份,麦芽糊精0~20份,柠檬酸-柠檬酸盐缓冲体系0.5~10份,氯化钠0~0.2份,氯化钾0~0.3份,甜味剂0~0.01份,食用香精0~0.05份,水93~99份,其中葡萄糖、果糖和麦芽糊精的含量共计1~50份。
与现有技术在葡萄糖注射液/果糖注射液中使用盐酸调节pH值,以及使用亚硫酸氢钠减少5-HMF的生成量相比,本发明采用柠檬酸-柠檬酸盐缓冲体系控制产品灭菌前后的pH值不发生变化。同时该口服清液不添加亚硫酸氢钠,避免给消费者带来健康风险。
在本发明的一个实施例中,甜味剂可以选自甜菊糖苷、甘草甜素、阿斯巴甜、罗汉果甜苷、三氯蔗糖、木糖醇中的至少一种。食用香精可以选自天然香精或合成香精(如果蔬类香精、谷物类香精、参茶类香精等)。
在本发明的一个实施例中,柠檬酸-柠檬酸盐缓冲体系包括柠檬酸0.5~4份,柠檬酸钠0~4份,柠檬酸钾0~2份。也可以用磷酸-磷酸盐缓冲体系替代柠檬酸-柠檬酸盐缓冲体系,磷酸-磷酸盐缓冲体系包括磷酸氢二钠0.1~5份,磷酸二氢钠0.1~5份。然而磷酸和磷酸盐对上消化道粘膜均有局部刺激,为避免服用风险,本发明中优选使用柠檬酸-柠檬酸盐缓冲体系。
在本发明的一个实施例中,口服清液中5-HMF的限量为:用紫外可见分光光度计在284nm处测吸光度≤0.32X+0.25Y/0.2。式中X为口服清液中的葡萄糖含量,Y为果糖含量,X和Y的单位均为g/100mL。
上述计算式是根据葡萄糖注射液和果糖注射液吸光度限量要求计算得到的。如果口服清液中含有麦芽糊精,则应检测麦芽糊精的葡萄糖含量,并代入上式中计算吸光度限量。
本发明还涉及口服清液的制备方法,包括以下步骤:
(1)向部分纯水中加入柠檬酸-柠檬酸盐缓冲体系,搅拌溶解后得到浓配溶液;
由于后续还要将浓配溶液进行稀释,因此在步骤(1)中加入的是部分纯水。在本发明的一个实施例中,浓配溶液中的纯水用量占原料纯水中的20%~60%。
(2)搅拌条件下,向浓配溶液中依次加入麦芽糊精、葡萄糖、果糖中的一种或多种,完全溶解后加入除纯水以外的其余原料,即氯化钠、氯化钾、甜味剂、食用香精中的一种或多种,上述原料也可以一种都不添加,并将加入的原料再次溶解;
(3)向浓配溶液中加入剩余纯水得到稀配溶液;
由于步骤(2)中加入的原料对浓配溶液的pH值几乎没有影响,在柠檬酸-柠檬酸盐缓冲体系加入量一定的前提下,浓配溶液和稀配溶液的pH值均在3.0~5.0的范围内。申请人研究发现,先加入柠檬酸-柠檬酸盐缓冲体系,得到酸性浓配溶液,再加入麦芽糊精、葡萄糖、果糖等糖类物质,能够减少单糖降解产生5-HMF的量。
通过感官评定,该稀配溶液的糖酸比范围为(12~60):1。
(4)对稀配溶液灭菌后得到口服清液。
在本发明的一个实施例中,灭菌方式为:将稀配溶液灌装后,在121℃下灭菌,F0≥8min;或对稀配溶液进行UHT灭菌,灭菌温度为135℃,灭菌时间为3~6s,灭菌后进行无菌灌装。
实施例1~5
实施例1~5为本发明提供的低5-HMF含量的碳水化合物口服清液,原料添加量如表1所示。除非另外指出,否则实施例1~5中所有成分量都在表1中以g/L的形式列出。
上述口服清液的制备方法包括以下步骤:
(1)向40%的原料纯水中加入柠檬酸-柠檬酸盐缓冲体系,搅拌溶解后得到浓配溶液;
(2)搅拌条件下,向浓配溶液中依次加入麦芽糊精、葡萄糖、果糖中的一种或多种,完全溶解后加入除纯水以外的其余原料,即氯化钠、氯化钾、甜味剂、食用香精中的一种或多种,上述原料也可以一种都不添加,并将加入的原料再次溶解;
(3)向浓配溶液中加入剩余纯水得到稀配溶液;
(4)将稀配溶液灌装后在121℃下灭菌,热穿透F0≥8min,灭菌结束后得到口服清液。
表1
可以看出,上述实施例的pH值在灭菌前后均保持不变。对实施例1~5所得口服清液中葡萄糖/果糖含量和吸光度限量如下:
实施例1的口服清液含有1.35%的葡萄糖(即100mL中含有1.35g葡萄糖,后面的百分数含义相同),5-HMF的控制限量为:用紫外可见分光光度计在284nm处测吸光度≤0.432。适用于1岁以上腹泻或高温引起的轻度至中度脱水人群。
实施例2的口服清液含有2.5%的葡萄糖,5-HMF的控制限量为:用紫外可见分光光度计在284nm处测吸光度≤0.800。适用于1岁以上腹泻或高温引起的轻度至中度脱水人群。
实施例3的口服清液含有1%果糖和2%葡萄糖,5-HMF的控制限量为:用紫外可见分光光度计在284nm处测吸光度≤1.890。适用于18岁以上择期手术人群。
实施例4的口服清液含有5%的果糖质量百分含量,5-HMF的控制限量为:用紫外可见分光光度计在284nm处测吸光度≤6.250。适用于烧创伤、术后及感染等胰岛素抵抗状态下或不适宜使用葡萄糖时需补充水分或能量的人群。
实施例5的口服清液含有50%的葡萄糖质量百分含量,5-HMF的控制限量为:用紫外可见分光光度计在284nm处测吸光度≤16.0。适用于饥饿性酮症和低血糖人群。
因此,本发明提供了一种低5-HMF含量的碳水化合物口服清液,其根据单糖的种类及比例,采用柠檬酸盐缓冲体系调节pH值,5-HMF的限量符合《中国药典》中对葡萄糖注射液和/或果糖注射液的要求。该口服清液中的碳水化合物来源包括单糖、双糖、寡糖和多糖,其中单糖质量百分含量为1.35%~50%。
本发明还提供了该采用口服清液的制备方法,其中采用终端灭菌或UHT灭菌,最终灭菌产品中的微生物存活概率(即无菌保证水平)SAL≤10-6,达到无菌药品级别。
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)
1.一种低5-HMF含量的碳水化合物口服清液,其特征在于,包括以下重量份的原料:葡萄糖0~50份,果糖0~20份,麦芽糊精0~20份,柠檬酸-柠檬酸盐缓冲体系0.5~10份,氯化钠0~0.2份,氯化钾0~0.3份,甜味剂0~0.01份,食用香精0~0.05份,水93~99份,其中葡萄糖、果糖和麦芽糊精的含量共计1~50份。
2.根据权利要求1所述的口服清液,其特征在于,所述柠檬酸-柠檬酸盐缓冲体系包括柠檬酸0.5~4份,柠檬酸钠0~4份,柠檬酸钾0~2份。
3.根据权利要求2所述的口服清液,其特征在于,以磷酸-磷酸盐缓冲体系替代所述柠檬酸-柠檬酸盐缓冲体系,所述磷酸-磷酸盐缓冲体系包括磷酸氢二钠0.1~5份,磷酸二氢钠0.1~5份。
4.根据权利要求1至3任一项所述的口服清液,其特征在于,所述口服清液中5-HMF的限量为:用紫外可见分光光度计在284nm处测吸光度≤0.32X+0.25Y/0.2,式中X为口服清液中的葡萄糖含量,Y为果糖含量,X和Y的单位均为g/100mL。
5.根据权利要求1至4任一项所述口服清液的制备方法,其特征在于,包括以下步骤:
(1)向部分纯水中加入柠檬酸-柠檬酸盐缓冲体系,搅拌溶解后得到浓配溶液;
(2)搅拌条件下,向所述浓配溶液中依次加入麦芽糊精、葡萄糖、果糖中的一种或多种,完全溶解后加入除纯水以外的其余原料并溶解;
(3)向步骤(2)得到的浓配溶液中加入剩余纯水得到稀配溶液;
(4)对所述稀配溶液灭菌后得到所述口服清液。
6.根据权利要求5所述的方法,其特征在于,步骤(1)中,所述浓配溶液中的纯水用量占原料纯水中的20%~60%。
7.根据权利要求5所述的方法,其特征在于,步骤(3)中,所述浓配溶液和稀配溶液的pH值范围均为3.0~5.0。
8.根据权利要求5所述的方法,其特征在于,步骤(3)中,所述稀配溶液的糖酸比为(12~60):1。
9.根据权利要求5所述的方法,其特征在于,步骤(4)中,所述灭菌方式为:灌装后在121℃下灭菌,F0≥8min。
10.根据权利要求5所述的方法,其特征在于,步骤(4)中,所述灭菌方式为UHT灭菌,灭菌温度为135℃,灭菌时间为3~6s,灭菌后进行无菌灌装。
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CN105998056A (zh) * | 2016-05-12 | 2016-10-12 | 江苏正大丰海制药有限公司 | 一种口服糖电解质组合物 |
CN109044966A (zh) * | 2018-09-21 | 2018-12-21 | 辽宁康博士制药有限公司 | 一种葡萄糖口服液及其制备方法、应用 |
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US20070259054A1 (en) * | 2006-05-03 | 2007-11-08 | Nelson Ayala | Oral rehydration compositions |
CN105747208A (zh) * | 2016-02-23 | 2016-07-13 | 江苏正大丰海制药有限公司 | 一种口服糖液体组合物 |
CN105998056A (zh) * | 2016-05-12 | 2016-10-12 | 江苏正大丰海制药有限公司 | 一种口服糖电解质组合物 |
CN109044966A (zh) * | 2018-09-21 | 2018-12-21 | 辽宁康博士制药有限公司 | 一种葡萄糖口服液及其制备方法、应用 |
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CN115316573A (zh) * | 2022-08-23 | 2022-11-11 | 西安冰峰饮料股份有限公司 | 一种含气型酸梅汤风味饮料及其制备方法 |
CN116420880A (zh) * | 2023-04-25 | 2023-07-14 | 贵州金玖生物技术有限公司 | 一种无色透明含葡萄糖的电解质配方液体食品的制备方法 |
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