CN110720632A - 一种孕晚期营养素组合物及其制备方法与应用 - Google Patents
一种孕晚期营养素组合物及其制备方法与应用 Download PDFInfo
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Abstract
本发明公开了一种孕晚期营养素组合物及其制备方法与应用，组合物的原料包括：碳酸钙、富马酸亚铁、葡萄糖酸锌、富硒酵母、葡萄糖酸铜、醋酸视黄酯、盐酸硫胺素、核黄素、盐酸吡哆醇、烟酸、叶酸、L‑抗坏血酸、维生素K1、D‑泛酸钙、D‑α‑生育酚；辅料包括：微晶纤维素、交联聚维酮、聚维酮K30、辛烯基琥珀酸淀粉钠、糊精、麦芽糊精、硬脂酸镁、蔗糖、食用玉米淀粉、***胶、磷酸三钙、dl‑α‑生育酚、二氧化硅、包衣预混剂。本发明针对孕晚期孕妇的生理特点和营养需求，着重各阶段营养的黄金配比，提供孕晚期孕妇和胎儿所需钙铁锌硒铜等微量元素和维生素，有助于消除或减轻孕晚期妊娠反应，提高胎儿生长发育指标，预防胎儿出生缺陷等妊娠结局。
Description
技术领域
本发明涉及孕妇营养保健品技术领域，具体涉及一种孕晚期营养素组合物及其制备方法与应用。
背景技术
孕晚期指怀孕7-9个月，即从孕妇28周开始，直到分娩(40周)。此期胎儿的生长发育更加迅速，尤其是大脑细胞的增长，营养对胎儿的影响较前两孕期更为重要。因此孕妇膳食要增加优质蛋白、钙、铁的摄入量以备分娩和泌乳期的需要。孕晚期孕妇容易出现心悸、气短、胃胀、烧心、食欲不佳，小腿抽筋、甚至糖尿病症状。此外，孕晚期孕妇易出现轻度高血压、水肿，必须控制食盐摄入。
我国孕晚期妇女的膳食总量基本满足生理要求，但是膳食结构不尽科学合理，膳食营养不均衡，钙、铁、锌的摄入不足。为保证孕晚期营养需求，孕妇应少食多餐；另外应遵循医生或营养师建议，合理安排膳食，科学补充营养，必要时补充孕期专用营养补充剂。然而，目前市面现有产品为孕期四个阶段共用一个组方，还没有针对于孕妇孕晚期的特点而专门提供的孕晚期营养保健食品。
发明内容
本发明的目的是针对孕妇孕晚期胎儿发育特点和营养需求，提供了一种孕晚期营养素组合物，是孕妇孕晚期的理想保健食品。
本发明解决技术问题所采用的技术方案如下：
一种孕晚期营养素组合物，包括以下重量份的原料：
优选地，上述的孕晚期营养素组合物，包括以下重量份的原料：
进一步地，上述的孕晚期营养素组合物，按重量份计，原料中还包括酵素0-5份。
其中，所述酵素为蛋白酶、氧化还原酶中的一种或两种。
进一步地，上述的孕晚期营养素组合物，将其与药学上可接受的辅料混合制成片剂、颗粒剂或胶囊剂。
优选地，将上述原料与以下重量份的辅料混合制成片剂：
更优选地，将其与以下重量份的辅料混合制成片剂：
本发明还提供了上述的孕晚期营养素组合物，其制备方法包括以下步骤：
S1、预混合
将50％所述重量份的交联聚维酮与所述重量份的糊精混合，再与所述重量份的微晶纤维素以等量递增法混合；再与所述重量份的原料以等量递增法混合均匀，制得混合粉；
S2、制粒、干燥
所述重量份的聚维酮K30以60％乙醇溶解，做为润湿剂，加入混合粉润湿，制软材；以18目筛网制粒，将湿颗粒平铺于不锈钢盘中，厚度不能超过2厘米，热风循环烘干燥，温度40℃，干燥至水分3～5％，制得干颗粒；
S3、整粒
收集干颗粒，使通过16目筛整粒，制得整粒后颗粒；
S4、总混
整粒后颗粒中加入余量交联聚维酮，加入所述重量份的硬脂酸镁，进行总混合操作，制得总混料；
S5、压片
压片机装上冲模，用颗粒调试好装量、压力及转速，进行压片，控制片重范围0.97g±5％，得素片；
S6、包衣
取包衣预混剂，加50％乙醇制成含固量为10％的包衣液；取素片，置包衣机中，将素片预热后，将包衣液均匀地喷洒到素片表面，待包衣液喷完后，继续吹40℃热风5～10分钟，再吹冷风至片面达室温，取出包衣片，即得包衣片，包衣增重2.85-3.15％。
此外，本发明还提供了上述的孕晚期营养素组合物作为营养物质在孕妇孕晚期的应用。具体地，食用量与食用方法为：每日2次，每次1片，温水送食。
上述技术方案中，将碳酸钙、富马酸亚铁、葡萄糖酸锌、富硒酵母、葡萄糖酸铜、醋酸视黄酯、盐酸硫胺素、核黄素、盐酸吡哆醇、烟酸、叶酸、L-抗坏血酸、VK1、D-泛酸钙、D-α-生育酚，并且采用科学的配比，原因是：
孕晚期(28-40周)是胎儿的全面综合发展时期，在这个阶段，胎儿的各部位尤其是脑部，发育迅速，此时除了应摄取足量的钙质供胎儿的成长所需外，还应补充铁、铜、锌、及维他命B6、B12等，不仅能够帮助胎儿健康发育，更能预防宝宝贫血、体重过低等问题。
《中国居民膳食营养素参考量(DRI)》指出：孕妇孕晚期钙的标准供给量为1200mg/日。孕晚期胎儿骨骼生长发育需要大量钙，孕妇出现小腿抽筋时应及时补钙。孕晚期孕妇增加含钙的摄入量可提高新生儿血清钙的水平孕晚期骨密度水平对婴儿期发育有一定影响，补钙可减少和避免对婴儿发育(体高、体重、智能、骨密度等)的影响。孕妇缺铁可导致新生儿先天性铁储备不足，直接影响胎儿及新生儿红细胞代谢，导致胎儿及新生儿慢性缺氧、生长发育障碍，铁缺乏是孕妇贫血的主要原因。孕晚期母亲铁缺乏与婴儿缺铁性贫血有明显的相关性，孕晚期母亲铁的补充可预防婴儿缺铁性贫血。研究发现，孕晚期联合补充钙锌可有效防止妊娠期血钙锌的缺乏。母亲妊娠时缺锌可影响胚胎细胞繁殖周期，导致胎儿发育迟缓，乃至胎儿畸形，维持正常血锌浓度可提高新生儿生长发育指标[10]，胎儿对锌的需要量在妊娠晚期最高。补锌可提高孕妇孕中、晚期的血清锌浓度，有助于增加新生儿的出生体重。体内缺硒的孕妇患先兆子痫的机率比其他孕妇高4倍多，表现为高血压、肾功能障碍和胎盘血供不足，因此孕妇在孕期必须注意硒的补充。孕妇血清硒随孕期进展明显低于非孕妇，新生儿脐血清中硒含量低，可能是发生低体重儿的一个因素，为满足胎儿的正常发育，应注意给孕妇补充硒。孕妇注意摄入足量的钙、镁、铁、锌、铜等微量元素，对预防流产、死胎及胎膜早破的发生具有一定的积极意义。
孕妇体内缺乏VA，孕妇会发生夜盲症、早产、胎儿畸形。殷璐发现，孕妇VA缺乏率较高，孕妇孕晚期血清视黄醇水平与VA膳食摄入量，脐血血清视黄醇水平及新生儿体重均呈正相关。新生儿VA营养水平总体低于孕母，其视黄醇、β-胡萝卜素水平与孕母视黄醇水平具相关性，因此孕晚期孕妇应注意VA的补充。VB1缺乏时，人体会感到暴躁、身体易疲劳无力、下肢水肿、食欲不振等症状；另VB1的低水平与GDM的发生有密切关系。VB2与铁剂联合用药治疗孕期IDA的效果明显优于单纯补铁组，且副作用较低，具有显著的临床意义。VB2营养干预可以提高和维持孕妇妊娠期铁的营养水平，降低孕期贫血患病率和铁缺乏率，具有促进铁吸收利用的作用。孕妇烟酸的摄入量与脐血脂联素水平呈正相关，而脂联素水平对胎儿的生长发育有影响：脐血脂联素水平与胎儿的出生体重、出生身长呈正相关。育龄妇女增补叶酸可以降低胎儿神经管畸形如唇腭裂等、减少妊娠并发症如早产、低体质量儿、引产、死胎、妊娠期高血压疾病等，改善妊娠结局如胎儿窘迫、新生儿窒息，母婴预后较好。孕期补充VC能预防胎膜早破，而且补充VC可在一定程度上预防子痫前期的发生。孕晚期孕妇常规补充VK1，可防止新生儿出血症的发生。泛酸能帮助细胞形成，维持正常发育和中枢神经***的发育；防止疲劳，舒缓食欲不振、恶心症状；具有制造抗体功能，帮助抵抗传染病，并有助于减轻过敏症状。妊娠过程中缺乏VE可导致流产、早产、先兆子痫和胎儿生长受限。此外，酵素具有协助蛋白分解，促进营养吸收，提高免疫力的作用，有助胎儿的发育成长。
本发明了解胎儿发育的每个阶段，针对孕晚期孕妇的生理特点和营养需求，着重各阶段营养的黄金配比，提供孕晚期孕妇和胎儿所需钙铁锌硒铜等微量元素和维生素，有助于消除或减轻孕晚期妊娠反应，提高胎儿生长发育指标，预防胎儿出生缺陷等妊娠结局，是针对孕晚期的理想营养保健食品，填补目前孕期营养素分段研制的空白。
具体实施方式
本发明的一种孕晚期营养素组合物，包括：
原料：碳酸钙、富马酸亚铁、葡萄糖酸锌、富硒酵母、葡萄糖酸铜、醋酸视黄酯、盐酸硫胺素、核黄素、盐酸吡哆醇、烟酸、叶酸、L-抗坏血酸、维生素K1、D-泛酸钙、D-α-生育酚；
辅料：微晶纤维素、交联聚维酮、聚维酮K30、辛烯基琥珀酸淀粉钠、糊精、麦芽糊精、硬脂酸镁、蔗糖、食用玉米淀粉、***胶、磷酸三钙、dl-α-生育酚、二氧化硅、包衣预混剂(羟丙基甲基纤维素、聚乙二醇6000、甘油、滑石粉、二氧化钛、黄氧化铁)。
上述原辅料经混合、制粒、干燥、整粒、总混、压片、包衣、铝铝包装、外包装等主要工艺加工制成。
原辅料质量要求：
1.碳酸钙：应符合GB1886.214《碳酸钙(包括轻质和重质碳酸钙)》的相应规定。
2.富硒酵母：应符合国家药品标准WS1-(x-005)-99Z《硒酵母》的相应规定。
3.富马酸亚铁：应符合中国药典(2015版)二部《富马酸亚铁》的相应规定。
4.葡萄糖酸锌：应符合GB8820《葡萄糖酸锌》的相应规定。
5.醋酸视黄酯：应符合GB14750《维生素A》的相应规定。
6.盐酸硫胺素：应符合GB14751《维生素B1(盐酸硫胺素)》的相应规定。
7.核黄素：应符合GB14752《维生素B2(核黄素)》的相应规定。
8.盐酸吡哆醇：应符合GB14753《维生素B6(盐酸吡哆醇)》的相应规定。
9.烟酸：应符合GB14757《烟酸》的相应规定。
10.叶酸：应符合GB15570《叶酸》的相应规定。
11.维生素C(L-抗坏血酸)：应符合GB14754《维生素C(抗坏血酸)》的相应规定。
12.D-泛酸钙：应符合中国药典(2015版)二部《泛酸钙》的相应规定。
13.微晶纤维素：应符合GB1886.103《食品安全国家标准食品添加剂微晶纤维素》的相应规定。
14.交联聚维酮：应符合中国药典(2015版)四部《交联聚维酮》的相应规定。
15.聚维酮K30：应符合中国药典(2015版)四部《聚维酮K30》的相应规定。
16.麦芽糊精：应符合GB/T20884《麦芽糊精》的相应规定。
17.糊精：应符合中国药典(2015版)四部《糊精》的要求。
18.硬脂酸镁：应符合GB1886.91《硬脂酸镁》的相应规定。
19.蔗糖：应符合中国药典(2015版)四部《蔗糖》的相应规定。
20.食用玉米淀粉：应符合GB/T8885《食用玉米淀粉》的相应规定。
21.***胶：应符合GB29949《食品安全国家标准食品添加剂***胶》的相应规定。
22.dl-α-生育酚：应符合GB29942《食品安全国家标准食品添加剂维生素E(dl-α-生育酚)》的相应规定。
23.磷酸三钙：应符合GB25558《食品安全国家标准食品添加剂磷酸三钙》的相应规定。
24.葡萄糖酸铜：应符合GB1903.8《葡萄糖酸铜》的相应规定。
25.维生素K1：应符合中国药典(2015版)二部《维生素K1》的相应规定。
26.D-α-生育酚：应符合GB1886.233《维生素E》的相应规定。
27.辛烯基琥珀酸淀粉钠：应符合GB28303《食品安全国家标准食品添加剂辛烯基琥珀酸淀粉钠》的相应规定。
28.二氧化硅：应符合GB25576《食品安全国家标准食品添加剂二氧化硅》的相应规定。
药用铝箔符合《药用铝箔》(YBB00152002-2015)；聚酰胺/铝/聚氯乙烯冷冲压成型固体药用复合硬片符合《聚酰胺/铝/聚氯乙烯冷冲压成型固体药用复合硬片》(YBB00242002-2015)。
下面结合实施例对本发明做进一步详细说明。
实施例1孕晚期营养素组合物的制备
本发明的一种孕晚期营养素组合物，包括以下原辅料：
其中，包衣预混剂由羟丙甲纤维素、聚乙二醇6000、甘油、滑石粉、二氧化钛、黄氧化铁采用常规方法混合而成。
孕晚期营养素组合物的制备方法，包括以下步骤：
1预混合
将上述50％的交联聚维酮与糊精混合；再与微晶纤维素以等量递增法混合；再与预混原料以等量递增法混合均匀，制得混合粉。
2制粒、干燥
将聚维酮K30以60％乙醇溶解，做为润湿剂，加入混合粉润湿，制软材；以18目筛网制粒，将湿颗粒平铺于不锈钢盘中，厚度不能超过2厘米，热风循环烘干燥，温度40℃，干燥至水分3～5％，制得干颗粒。
3整粒
收集干颗粒，使通过16目筛整粒，制得整粒后颗粒。
4总混
整粒后颗粒中加入余量交联聚维酮，加入硬脂酸镁，进行总混合操作，制得总混料。
5压片
压片机装上冲模，用颗粒调试好装量、压力及转速，进行压片，共1000片(1.0g/片)，控制片重范围0.97g±5％，得素片。压片过程中，操作人员每15分钟检查一次片重。
6包衣
取包衣预混剂，加50％乙醇制成含固量为10％的包衣液。取素片，置包衣机中，启动包衣机，将素片预热，然后启动排风机和喷雾***，将包衣液均匀地喷洒到素片表面，待包衣液喷完后，继续吹40℃热风5～10分钟，再吹冷风至片面达室温，取出包衣片，即得包衣片。包衣增重约3％。
7内包装
领取铝铝包装的内包材，调试好内包装机，按5片/板进行铝铝包装。
8外包装
领取产品说明书、包装盒等外包装用材料，进行外包装，制得成品。
9检验、入库
取样，检验，出具检验报告书。凭合格的检验报告书办理入库手续。
10工艺要求
从投料到内包装，均在10万级洁净区进行，外包装在一般生产区进行。
实施例2孕晚期营养素组合物的制备
酵素采用氧化还原酶(SOD)2g，蛋白酶1g，其他原辅料如下：
制备方法与实施例1相同。
实施例3孕晚期营养素组合物的制备
酵素采用蛋白酶5g，其他原辅料如下：
制备方法与实施例1相同。
实施例4成品质量检测
随机抽取实施例1-3制备的成品内包装两板，一板片剂样品进行全检，另一板封存备查。其中，感官要求符合表1要求，理化指标符合表2要求，微生物指标符合表3要求，功效成分含量测定符合表4要求。产品的检测结果全部符合要求。
表1感官要求
| 项目 | 要求 | 检测方法 |
| 色泽 | 包衣淡黄色，片芯淡黄色或淡粉色 | 目测 |
| 滋味、气味 | 具本品特有的滋味和气味，无异味 | 鼻嗅、口尝 |
| 状态 | 薄膜衣片，完整光洁；无正常视力可见外来异物 | 目测 |
表2理化指标
| 项目 | 指标 | 检测方法 |
| 灰分，％ | ≤65.0 | GB5009.4 |
| 铅(Pb)，mg/kg | ≤2.0 | GB5009.12 |
| 总砷(As)，mg/kg | ≤1.0 | GB5009.11 |
| 总汞(Hg)，mg/kg | ≤0.3 | GB5009.17 |
| 崩解时限，min | ≤60 | 《中华人民共和国药典》2015年版四部 |
表3微生物指标
| 项目 | 指标 | 检测方法 |
| 菌落总数，CFU/g | ≤30000 | GB4789.2 |
| 大肠菌群，MPN/g | ≤0.92 | GB4789.3MPN计数法 |
| 霉菌和酵母，CFU/g | ≤50 | GB4789.15 |
| 金黄色葡萄球菌 | ≤0/25g | GB4789.10 |
| 沙门氏菌 | ≤0/25g | GB4789.4 |
表4功效成分指标
尽管本发明的实施方案已公开如上，但其并不仅仅限于说明书和实施方式中所列运用。它完全可以被适用于各种适合本发明的领域。对于熟悉本领域的人员而言，可容易地实现另外的修改。因此在不背离权利要求及等同范围所限定的一般概念下，本发明并不限于特定的细节和这里示出与描述的实施例。
Claims (9)
1.一种孕晚期营养素组合物，其特征在于，包括以下重量份的原料：
2.如权利要求1所述的孕晚期营养素组合物，其特征在于，包括以下重量份的原料：
3.如权利要求1或2所述的孕晚期营养素组合物，其特征在于，按重量份计，原料中还包括酵素0-5份。
4.如权利要求3所述的孕晚期营养素组合物，其特征在于，所述酵素为蛋白酶、氧化还原酶中的一种或两种。
5.如权利要求4所述的孕晚期营养素组合物，其特征在于，将其与药学上可接受的辅料混合制成片剂、颗粒剂或胶囊剂。
6.如权利要求5所述的孕晚期营养素组合物，其特征在于，将其与以下重量份的辅料混合制成片剂：
7.如权利要求6所述的孕晚期营养素组合物，其特征在于，将其与以下重量份的辅料混合制成片剂：
8.如权利要求6或7所述的孕晚期营养素组合物，其特征在于，其制备方法包括以下步骤：
S1、预混合
将50％所述重量份的交联聚维酮与所述重量份的糊精混合，再与所述重量份的微晶纤维素以等量递增法混合；再与所述重量份的原料以等量递增法混合均匀，制得混合粉；
S2、制粒、干燥
所述重量份的聚维酮K30以60％乙醇溶解，做为润湿剂，加入混合粉润湿，制软材；以18目筛网制粒，将湿颗粒平铺于不锈钢盘中，厚度不能超过2厘米，热风循环烘干燥，温度40℃，干燥至水分3～5％，制得干颗粒；
S3、整粒
收集干颗粒，使通过16目筛整粒，制得整粒后颗粒；
S4、总混
整粒后颗粒中加入余量交联聚维酮，加入所述重量份的硬脂酸镁，进行总混合操作，制得总混料；
S5、压片
压片机装上冲模，用颗粒调试好装量、压力及转速，进行压片，控制片重范围0.97g±5％，得素片；
S6、包衣
取包衣预混剂，加50％乙醇制成含固量为10％的包衣液；取素片，置包衣机中，将素片预热后，将包衣液均匀地喷洒到素片表面，待包衣液喷完后，继续吹40℃热风5～10分钟，再吹冷风至片面达室温，取出包衣片，即得包衣片，包衣增重2.85-3.15％。
9.如权利要求1-7任一项所述的孕晚期营养素组合物作为营养物质在孕妇孕晚期的应用。
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