CN110786436A - 一种预防佝偻病、促进钙磷吸收的滴剂饮料 - Google Patents
一种预防佝偻病、促进钙磷吸收的滴剂饮料 Download PDFInfo
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Abstract
本发明公开了一种预防佝偻病、促进钙磷吸收的滴剂饮料,由如下质量份的各组分组成:0.105%维生素D3和99.985%MCT;每个剂量单位中含有400国际单位(IU)的维生素D3。通过以下制备工艺获得:准确称取MCT油投入混料罐,同时开动罐上的搅拌器,加热,温度达到65‑70°C后,保持10‑15分钟;将该液体冷却至室温(20‑25°C),按比例加入维生素D3继续搅拌15分钟至均匀,然后分瓶灌装。本发明预防佝偻病,促进钙,磷吸收,运用滴剂饮料,儿童效果更乐于服用,大大提高了临床使用的顺应性。本发明的制备工艺简单,使用常用辅料,成本较低廉,具有良好的市场前景。
Description
技术领域
本发明属于保健饮品技术领域,具体涉及一种预防佝偻病、促进钙磷吸收的滴剂饮料。
背景技术
维生素D的发现是人们与佝偻症抗争的结果。早在1824年,有人发现鱼肝油可在治疗佝偻病中起重要作用。1918年,英国的梅兰比爵士证实佝偻病是一种营养缺乏症。但他误认为是缺乏维生素A所致。1930年Gottingen大学的A.Windaus教授首先确定了维生素D的化学结构,1932年经过紫外线照射麦角固醇而得到的维生素D2的化学特性被阐明。维生素D3的化学特性直到1936年才被确定。1913年,美国科学家Elmer McCollum和MargueriteDavis在鱼肝油里发现了一种物质,起名叫“维生素A”,后来,英国医生EdwardMellanby发现,喂了鱼肝油的狗不会得佝偻病,于是得出结论维生素A或者其协同因子可以预防佝偻病。1921年Elmer McCollum使用破坏掉鱼肝油中维生素A做同样的实验,结果相同,说明抗佝偻病并非维生素A所为。他将其命名为维生素D,即第四种维生素,但当时的人们还不知道,这种东西和其他维生素不同,因为只要有紫外线,人自己就可以而合成(有悖于维生素的定义)。
目前,维生素D滴剂是一种用于儿童佝偻病的预防和治疗的药物。经过大量循证医学研究和基础研究发现,维生素D滴剂对癌症、高血压、糖尿病、结核病、免疫功能异常的治疗具有一定的疗效。
发明内容
针对现有技术中的不足之处,本发明提供一种预防佝偻病、促进钙磷吸收的滴剂饮料。
为了达到上述目的,本发明技术方案如下:
一种预防佝偻病、促进钙磷吸收的滴剂饮料,包括维生素D3和MCT。
进一步的,所述维生素D滴剂由如下质量份的各组分组成:0.105%维生素D3和99.985%MCT。
进一步的,所述维生素D滴剂中,每个剂量单位中含有400国际单位(IU)的维生素D3。
本发明还提供了一种预防佝偻病、促进钙磷吸收的滴剂饮料的制备工艺,包括以下步骤:
(1)混合液体配料:按设备的生产能力准确称取MCT油投入混料罐,同时开动罐上的搅拌器,加热,温度达到65-70℃后,保持10-15分钟;将该液体冷却至室温(20-25℃),按比例加入维生素D3继续搅拌15分钟至均匀;
(2)灌装:将混全均匀的液体转移至灌装机进行灌装;按灌装量调节灌装机;按要求配备灌装瓶和盖;灌装开始后每小时检测灌装量。
进一步的,步骤(2)中,每个灌装瓶内分装12ml的维生素D滴剂。
本发明维生素D滴剂通过口服给予。本领域技术人员可根据实际情况容易地确定给药剂量。如每天0.4ml,即一滴,含有400国际单位(IU)的维生素D3;因维生素D3的1IU=0.025ug,则400IU=10ug,符合国家标准2-15ug,适用于1-3岁幼儿用量。
本发明的原料:
(1)维生素D3:又名烟碱酸胺、胆骨化醇、胆钙化醇。提高肌体对钙、磷的吸收,使血浆钙和血浆磷的水平达到饱和程度;促进生长和骨骼钙化,促进牙齿健全;通过肠壁增加磷的吸收,并通过肾小管增加磷的再吸收;维持血液中柠檬酸盐的正常水平;防止氨基酸通过肾脏损失。用于佝偻病、骨软化症及婴儿手足搐搦症,佝偻病兼有龋齿者也可防治;
(2)MCT:是中链甘油三酯(Medium Chain Triglycerides)的简称,是由碳链长度6-12的饱和中链脂肪酸组成的甘油三酯。医药行业中常用作溶剂、载体和乳化剂,也可以作为食品行业中香精、色素和维生素的溶剂,其具有不易被胃酸分解,易在肠道中水解的特性。天然存在于棕榈仁油、椰子油等食品和母乳中,是膳食脂肪的来源之一。作为食品添加剂,中链甘油三酯仅由饱和脂肪酸构成,凝固点低,室温下为液体,粘度小。与大豆油比较,完全是无臭、无色的透明液体。与普通的油脂和氢化油脂相比,中链甘油三酯不饱和脂肪酸的含量极低,氧化稳定性非常好,其碘值不超过0.5,MCT在高温和低温下特别稳定。
有益效果:本发明预防佝偻病,促进钙,磷吸收,运用滴剂饮料,儿童效果更乐于服用,大大提高了临床使用的顺应性。本发明的制备工艺简单,使用常用辅料,成本较低廉,具有良好的市场前景。
具体实施方式
以下参照具体的实施例来说明本发明。本领域技术人员能够理解,这些实施例仅用于说明本发明,其不以任何方式限制本发明的范围。
一种预防佝偻病、促进钙磷吸收的滴剂饮料,由如下质量份的各组分组成:0.105%维生素D3和99.985%MCT。每个剂量单位中含有400国际单位(IU)的维生素D3。其制备工艺,包括以下步骤:
(1)混合液体配料:按设备的生产能力准确称取MCT油投入混料罐,同时开动罐上的搅拌器,加热,温度达到65-70℃后,保持10-15分钟;将该液体冷却至室温(20-25℃),按比例加入维生素D3继续搅拌15分钟至均匀;将混全均匀的液体转移至灌装机进行灌装;
(2)灌装:按灌装量调节灌装机;按要求配备灌装瓶和盖;灌装开始后每小时检测灌装量,每个灌装瓶内分装12ml的维生素D滴剂。
维生素D滴剂的性能测试
分别取实施例1中所制备得到的维生素D滴剂进行性能评价,评价项目及结果如下表1-4。
表1实施例中维生素D滴剂感官指标及评价
项目 | 指标 | 实施例 |
色泽 | 淡黄色至黄色 | 符合指标 |
滋味、气味 | 无异味 | 符合指标 |
状态 | 澄清油状液体,无正常视力可见外来异物 | 符合指标 |
表2实施例中维生素D滴剂理化指标及评价
项目 | 指标 | 检验方法 | 实施例 |
铅(以Pb计),mg/kg | ≤0.02 | GB5009.12 | 未检出 |
总砷(以As计),mg/kg | ≤0.3 | GB5009.11 | 未检出 |
总汞(以Hg计),mg/kg | ≤0.02 | GB5009.17 | 未检出 |
酸价,mg/g | ≤4 | GB5009.229 | 0.36 |
过氧化值,g/100g | ≤0.25 | GB5009.227 | 0.022 |
表3实施例中维生素D滴剂微生物指标及评价
项目 | 指标 | 检验方法 | 实施例 |
菌落总数,CFU/g | ≤1000 | GB 4789.2 | <10 |
大肠菌群,mpn/g | ≤0.43 | GB 4789.3 | <0.3 |
霉菌和酵母,CFU/g | ≤50 | GB 4789.15 | <10 |
金黄色葡萄球菌 | ≤0/25g | GB 4789.10 | 未检出 |
沙门氏菌 | ≤0/25g | GB 4789.4 | 未检出 |
通过GB5009.82检测维生素D滴剂标志性成分:每瓶含维生素D(指标288-450ug),以胆钙化醇计,300ug。
Claims (5)
1.一种预防佝偻病、促进钙磷吸收的滴剂饮料,其特征在于:包括维生素D3和MCT。
2.如权利要求1所述的预防佝偻病、促进钙磷吸收的滴剂饮料,其特征在于:所述维生素D滴剂由如下质量份的各组分组成:0.105%维生素D3和99.985%MCT。
3.如权利要求1所述的预防佝偻病、促进钙磷吸收的滴剂饮料,其特征在于:所述维生素D滴剂中,每个剂量单位中含有400国际单位(IU)的维生素D3。
4.如权利要求1至3所述的预防佝偻病、促进钙磷吸收的滴剂饮料,其特征在于:其制备工艺,包括以下步骤:
(1)混合液体配料:按设备的生产能力准确称取MCT油投入混料罐,同时开动罐上的搅拌器,加热,温度达到65-70°C后,保持10-15分钟;将该液体冷却至室温(20-25°C ),按比例加入维生素D3继续搅拌15分钟至均匀;
(2)分瓶灌装:将混全均匀的液体转移至灌装机进行灌装;按灌装量调节灌装机;按要求配备灌装瓶和盖;灌装开始后每小时检测灌装量。
5.如权利要求4所述的预防佝偻病、促进钙磷吸收的滴剂饮料,其特征在于:步骤(2)中,每个灌装瓶内分装12ml的维生素D滴剂。
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