CN112806578A - 基于口腔微泡速崩配方的复合维生素b片及其制备方法 - Google Patents
基于口腔微泡速崩配方的复合维生素b片及其制备方法 Download PDFInfo
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- CN112806578A CN112806578A CN202011620490.7A CN202011620490A CN112806578A CN 112806578 A CN112806578 A CN 112806578A CN 202011620490 A CN202011620490 A CN 202011620490A CN 112806578 A CN112806578 A CN 112806578A
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- Prior art keywords
- vitamin
- oral
- essence
- tablet
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Classifications
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Abstract
本发明公开了一种基于口腔微泡速崩配方的复合维生素B片，包括按照以下质量比例配置的物料：0.15～0.2％的叶酸、0.25～0.4％的生物素、0.2～0.3％的维生素B2、0.2～0.3％的维生素B6、1.5～2.0％的烟酰胺、0.01～0.04％的维生素B12、0.2～0.35％硝酸硫胺、0.5～0.7％的泛酸钙，20～35％的甘露醇淀粉复合物、15～25％的山梨糖醇、15～25％的异麦芽酮糖醇，15～17％的无水柠檬酸、10～14％的碳酸氢钠，0.2～0.3％的天门冬酰苯丙氨酸甲酯、0.05～0.1％的三氯蔗糖、0.5～1％的甜菊糖苷、1～2％的食用香精，0.45～0.55％的硬脂酸镁。该复合维生素B片能快速口腔崩解，片剂体验感好，并且其制备方法具有过程简单，生产效率高的特点。
Description
技术领域
本发明涉及保健食品技术领域，尤其是一种基于口腔微泡速崩配方的复合维生素B片及其制备方法。
背景技术
保健食品补充片剂常规有泡腾片、吞服片、含片、咀嚼片。
泡腾片由于配方组成原因，泡腾融化后属于酸性的饮品，对牙齿有刺激性作用，如果长期服用或者长时间空腹服用，会造成胃肠道的负荷，引起反酸、烧心，胃酸过多反流和胃酸分泌过多的副作用；同时泡腾片中含钠较多，长时间大量服用会增加患心脑血管疾病的风险。平时血脂、血压较高，有家族史或其他心脑血管疾病危险因素者，应少用或慎用泡腾片。小朋友误食泡腾片造成损伤的情况一直存在。
直接吞服片剂会让消费者体验感差，有服药的感觉，同时存在难以吞服下咽的情况，尤其是小孩、老人。吞服片可能存在体内崩解不完全，影响吸收。
含片一般服用时需含服8-10分钟才能完全溶解，时间长且影响口腔粘膜。
片剂常用的制备方法有湿法制粒压片法、干法制粒压片法和制备方法。湿法制粒压片法是将物料经湿法制粒干燥后进行压片的方法，该法不适用于热敏性、湿敏性物料的制粒；干法制粒压片是将物料干法制粒后进行压片的方法，常用于遇水不稳定的物料的片剂生产，且以上两种方法均需要经过制粒过程，才能进行压片，工艺过程比较复杂，生产效率较低。
发明内容
本发明要解决的技术问题是：克服以上现有技术存在的缺陷，开发一种能快速口腔崩解，片剂体验感好的基于口腔微泡速崩配方的复合维生素B片，以及其制备过程简单，生产效率高的制备方法。
本发明解决其技术问题所采用的技术方案是：基于口腔微泡速崩配方的复合维生素B片，包括B族维生素、填充剂、泡腾物料、其他辅料以及润滑剂，上述物料按照以下质量比例配置：B族维生素包括：0.15～0.2％的叶酸、0.25～0.4％的生物素、0.2～0.3％的维生素B2、0.2～0.3％的维生素B6、1.5～2.0％的烟酰胺、0.01～0.04％的维生素B12、0.2～0.35％的硝酸硫胺、0.5～0.7％的泛酸钙，填充剂包括20～35％的甘露醇淀粉复合物、15～25％的山梨糖醇、15～25％的异麦芽酮糖醇，泡腾物料包括15～17％的无水柠檬酸、10～14％的碳酸氢钠，其他辅料包括0.2～0.3％的天门冬酰苯丙氨酸甲酯、0.05～0.1％的三氯蔗糖、0.5～1％的甜菊糖苷、1～2％的食用香精，润滑剂包括0.45～0.55％的硬脂酸镁。
进一步，所述的填充剂中甘露醇淀粉聚合物、山梨糖醇、异麦芽酮糖三者的用量比为(1～2)∶(1～1.5)∶1。
进一步，所述的泡腾物料中柠檬酸和碳酸氢钠的用料比为(3～5)∶(3～5)。
进一步，所述的食用香精为西柚味粉末香精、柠檬香精、香蕉香精、橙味香精、菠萝香精、水蜜桃香精其中之一。
基于口腔微泡速崩配方的复合维生素B片的制备方法，包括以下三个步骤：
步骤一：按照质量比例将B族维生素、填充剂、泡腾物料、其他辅料进行预混合；
步骤二：将步骤一所得的预混物料与硬脂酸镁混合；
步骤三：将步骤二制得的混合物料采用直接压片法压片，压片机的主压力在10～15KN之间。
进一步，所述的步骤一的混合时间为15～30分钟，步骤二的混合时间为5～8分钟。
本发明的基于口腔微泡速崩配方的复合维生素B片及其制备方法，其有益效果是：能在口腔中1～2分钟快速溶解，同时达到泡腾的口感，掩盖B族维生素的不良风味。甘露醇淀粉聚合物是一种创新性复合物，具有优良的直压性能和自崩解特性。在配方中加入填充辅料，香精，润滑剂，甜味剂等物料配合食用，无需添加崩解就能达到口腔中快速融化崩解的作用，同时具备良好的口感。添加碳酸氢钠和柠檬酸，使得片剂入口后具备口腔泡腾的体验。
制备方法采用直接压片法，不经过制粒过程，直接把原料和辅料混合均匀后进行压片的方法，该法工艺过程比较简单，不必制粒、干燥，简化工艺流程，提高生产效率，节约能源，而且产品崩解或溶出快，质量稳定，尤其适用于遇湿、热易发生变色、分解的原料。
具体实施方式
现在结合实施例对本发明作进一步详细的说明。
研发中通过调整甘露醇淀粉聚合物与山梨糖醇、异麦芽酮糖醇的配比，同时添加不同量的柠檬酸、碳酸氢钠，加上使用硬脂酸镁为润滑剂增加物料的流动性，考察片剂的硬度、崩解时间、脆碎度三个方面的特性。
实施例1：
一种基于口腔微泡速崩配方的复合维生素B片，包括0.2％的叶酸、0.33％的生物素、0.22％的维生素B2、0.27％的维生素B6、1.52％的烟酰胺、0.04％的维生素B12、0.28％的硝酸硫胺、0.64％的泛酸钙、22.18％的甘露醇淀粉聚合物、22.18％的山梨糖醇、22.18％的异麦芽酮糖醇、12％的柠檬酸、15％的碳酸氢钠、0.5％的硬脂酸镁、0.2％的天门冬酰苯丙氨酸甲酯、0.07％的三氯蔗糖、0.7％的甜菊糖苷、1.5％的西柚味粉末香精，其中甘露醇淀粉聚合物、山梨糖醇、异麦芽酮糖三者的用料比为1∶1∶1，柠檬酸和碳酸氢钠两者的用料比为4∶5。用量配方如下表：
实施例2：
一种基于口腔微泡速崩配方的复合维生素B片，包括0.2％的叶酸、0.33％的生物素、0.22％的维生素B2、0.27％的维生素B6、1.52％的烟酰胺、0.04％的维生素B12、0.28％的硝酸硫胺、0.64％的泛酸钙、33.26％的甘露醇淀粉聚合物、16.63％的山梨糖醇、16.63％的异麦芽酮糖醇、15％的柠檬酸、12％的碳酸氢钠、0.5％的硬脂酸镁、0.2％的天门冬酰苯丙氨酸甲酯、0.07％的三氯蔗糖、0.7％的甜菊糖苷、1.5％的西柚味粉末香精，其中甘露醇淀粉聚合物、山梨糖醇、异麦芽酮糖，三者的用料比为2∶1∶1，柠檬酸和碳酸氢钠，两者的用料比为5∶4，所述的润滑剂选用硬脂酸镁，促吸收物料选用泛酸钙。用量配方如下表：
实施例3：
一种基于口腔微泡速崩配方的复合维生素B片，包括0.2％的叶酸、0.33％的生物素、0.22％的维生素B2、0.27％的维生素B6、1.52％的烟酰胺、0.04％的维生素B12、0.28％的硝酸硫胺、22.18％的甘露醇淀粉聚合物、22.18％的山梨糖醇、22.18％的异麦芽酮糖醇、15％的柠檬酸、12％的碳酸氢钠、0.5％的硬脂酸镁、0.64％的泛酸钙、0.2％的天门冬酰苯丙氨酸甲酯、0.07％的三氯蔗糖、0.7％的甜菊糖苷、1.5％的西柚味粉末香精，其中甘露醇淀粉聚合物、山梨糖醇、异麦芽酮糖，三者的用料比为1∶1∶1，柠檬酸和碳酸氢钠两者的用料比为5∶4。用量配方如下表：
实施例4：
一种基于口腔微泡速崩配方的复合维生素B片，包括0.2％的叶酸、0.33％的生物素、0.22％的维生素B2、0.27％的维生素B6、1.52％的烟酰胺、0.04％的维生素B12、0.28％的硝酸硫胺、33.26％的甘露醇淀粉聚合物、16.63％的山梨糖醇、16.63％的异麦芽酮糖醇、12％的柠檬酸、15％的碳酸氢钠、0.5％的硬脂酸镁、0.64％的泛酸钙、0.2％的天门冬酰苯丙氨酸甲酯、0.07％的三氯蔗糖、0.7％的甜菊糖苷、1.5％的西柚味粉末香精，其中甘露醇淀粉聚合物、山梨糖醇、异麦芽酮糖，三者的用料比为2∶1∶1，柠檬酸和碳酸氢钠两者的用料比为4∶5。用量配方如下表：
通过以上4组实施例的试验结果可以看到，4组配方所制片剂的硬度增加，脆碎度都无明显差异。综合微泡口感和速崩效果考虑，因此选择实施例2的配方作为最优配方。
实施例5：
基于口腔微泡速崩配方的复合维生素B片的制备方法，包括以下三个步骤：
步骤一：按照质量比例将B族维生素、填充剂、泡腾物料、其他辅料进行预混合；
步骤二：将步骤一所得的预混物料与硬脂酸镁混合；
步骤三：将步骤二制得的混合物料采用直接压片法压片，压片机的主压力设定为12KN。
步骤一的混合时间为15～30分钟，步骤二的混合时间为5～8分钟。
为了保证物料混合均匀，对两步混合工艺的总混合时间进行了研究。预混合时间分别设定为15分钟、20分钟、25分钟，再加入硬脂酸镁混合5分钟，则考察的总混合时间分别为20分钟、25分钟、30分钟。试验中分别从总混合物料的不同方位、不同深度取样9份来确保取样点的代表性，通过考察VB含量的RSD值来判定物料混合均匀性，考察结果见下表。
从上表可以看出，当总混合时间为25分钟和30分钟时，维生素B12含量的RSD值均比总混合时间为20分钟时两者含量的RSD值小。因此，选取25分钟为本产品的总混合时间，即混合步骤一时间为20分钟，混合步骤二时间为5分钟。
实施例6：
为验证工艺，考查产品质量的稳定性，进行产品样品试制。同时为产品的质量控制研究提供试验样品，按照配方用量制备三批样品，每批10000片，制备方法同实施例5所述。以平均片重、崩解时间、水分和标志性成分含量为评价指标进行考查。实验结果见下表。
| 批号 | 20200801 | 20200802 | 20200803 |
| 平均片重，mg/片 | 500.2 | 500.8 | 501.3 |
| 崩解时间，min | 1’38” | 1’25” | 1’32” |
| 水分，％ | 1.7 | 1.6 | 1.9 |
| 叶酸，g/100g | 0.23 | 0.22 | 0.23 |
| 生物素，g/100g | 0.37 | 0.36 | 0.38 |
| 维生素B2(核黄素)，g/100g | 0.25 | 0.25 | 0.26 |
| 维生素B6(盐酸吡哆醇)，g/100g | 0.30 | 0.29 | 0.30 |
| 泛酸钙，g/100g | 0.72 | 0.71 | 0.70 |
| 烟酰胺，g/100g | 1.64 | 1.66 | 1.69 |
| 维生素B12，g/100g | 0.041 | 0.042 | 0.041 |
结论：小试所制样品各项质量指标均稳定，符合制剂要求，片剂稳定性良好，适合于批量生产。
以上述依据本发明的理想实施例为启示，通过上述的说明内容，相关工作人员完全可以在不偏离本项发明技术思想的范围内，进行多样的变更以及修改。本项发明的技术性范围并不局限于说明书上的内容，必须要根据权利要求范围来确定其技术性范围。
Claims (6)
1.基于口腔微泡速崩配方的复合维生素B片，其特征是：包括B族维生素、填充剂、泡腾物料、其他辅料以及润滑剂，上述物料按照以下质量比例配置：B族维生素包括：0.15～0.2％的叶酸、0.25～0.4％的生物素、0.2～0.3％的维生素B2、0.2～0.3％的维生素B6、1.5～2.0％的烟酰胺、0.01～0.04％的维生素B12、0.2～0.35％的硝酸硫胺、0.5～0.7％的泛酸钙，填充剂包括20～35％的甘露醇淀粉复合物、15～25％的山梨糖醇、15～25％的异麦芽酮糖醇，泡腾物料包括15～17％的无水柠檬酸、10～14％的碳酸氢钠，其他辅料包括0.2～0.3％的天门冬酰苯丙氨酸甲酯、0.05～0.1％的三氯蔗糖、0.5～1％的甜菊糖苷、1～2％的食用香精，润滑剂包括0.45～0.55％的硬脂酸镁。
2.根据权利要求1所述的基于口腔微泡速崩配方的复合维生素B片，其特征是：所述的填充剂中甘露醇淀粉聚合物、山梨糖醇、异麦芽酮糖三者的用量比为(1～2)∶(1～1.5)∶1。
3.根据权利要求1所述的基于口腔微泡速崩配方的复合维生素B片，其特征是：所述的泡腾物料中柠檬酸和碳酸氢钠的用料比为(3～5)∶(3～5)。
4.根据权利要求1所述的基于口腔微泡速崩配方的复合维生素B片，其特征是：所述的食用香精为西柚味粉末香精、柠檬香精、香蕉香精、橙味香精、菠萝香精、水蜜桃香精其中之一。
5.根据权利要求1～4任一项所述的基于口腔微泡速崩配方的复合维生素B片的制备方法，其特征是：包括以下三个步骤：
步骤一：按照质量比例将B族维生素、填充剂、泡腾物料、其他辅料进行预混合；
步骤二：将步骤一所得的预混物料与硬脂酸镁混合；
步骤三：将步骤二制得的混合物料采用直接压片法压片，压片机的主压力在10～15KN之间。
6.根据权利要求5所述的基于口腔微泡速崩配方的复合维生素B片的制备方法，其特征是：所述的步骤一的混合时间为15～30分钟，步骤二的混合时间为5～8分钟。
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| CN114041521A (zh) * | 2021-11-30 | 2022-02-15 | 宣城柏维力生物工程有限公司 | 一种便捷式可在多场合应用提神的气泡含片及其生产工艺 |
| CN114287549A (zh) * | 2021-12-30 | 2022-04-08 | 江苏艾兰得营养品有限公司 | 一种泡腾粉及其制备方法 |
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| CN109303334A (zh) * | 2018-10-17 | 2019-02-05 | 汤臣倍健股份有限公司 | 一种口腔微泡腾片及其制备方法 |
| CN109430669A (zh) * | 2018-12-25 | 2019-03-08 | 江苏艾兰得营养品有限公司 | 提高耐力补充运动所需营养的泡腾片制剂及其制备方法 |
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| CN109303334A (zh) * | 2018-10-17 | 2019-02-05 | 汤臣倍健股份有限公司 | 一种口腔微泡腾片及其制备方法 |
| CN109430669A (zh) * | 2018-12-25 | 2019-03-08 | 江苏艾兰得营养品有限公司 | 提高耐力补充运动所需营养的泡腾片制剂及其制备方法 |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114041521A (zh) * | 2021-11-30 | 2022-02-15 | 宣城柏维力生物工程有限公司 | 一种便捷式可在多场合应用提神的气泡含片及其生产工艺 |
| CN114287549A (zh) * | 2021-12-30 | 2022-04-08 | 江苏艾兰得营养品有限公司 | 一种泡腾粉及其制备方法 |
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