CN114652801A - 一种益智缩泉口服液组合物及其制备方法 - Google Patents
一种益智缩泉口服液组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种益智缩泉口服液组合物及其制备方法，制得所述组合物的原料包括益智100～500g、山药100～500g、小茴香20～100g、陈皮20～100g、佛手20～100g、薏苡仁20～100g、芡实20～100g、其他中药植物水提取液56～250g、食盐2～10g、番茄红素0.1～0.15g、紫甘薯色素0.5～0.8g。采用传统水提改良工艺制备和密封以及组合配方确保益智有效成分挥发油稳定，所述组合物对历代经典方缩泉丸进行拆方加减，维持了原方中的益智、山药，删除了有虚证禁忌的乌药，可在缩泉、缓解尿频方面效果显著，对比传统的缩泉丸效果更好，无不良反应，质量稳定，既可在临床上药用又可作为功能性饮品日常饮用。
Description
技术领域
本发明涉及植物组份的保健品制备技术领域，具体的是一种益智缩泉口服液组合物及其制备方法。
背景技术
邓义卫等人在《黑龙江医药》，2012,25(1)上《缩泉丸治疗遗尿症临床应用和实验研究概况》述及：缩泉丸出自宋代《妇人良方》，由益智、山药、乌药组成，具有温肾祛寒，缩尿止遗的功效，用于治疗下元虚冷，小便频数，小儿遗尿等症。该方为历代沿用的经典方，具有配伍严谨，药味精炼、疗效显著的特点，其功效可概括为“补肾缩尿”，补肾治其本，缩尿缓其标。
陈瑞生等人在《首都医药》，2013年8月(上)上《乌药的鉴别及临床应用》述及：乌药在临床用药时，气虚及内热证患者禁服、孕妇及体虚者慎服。“疏散宣通，甚于香附，不可多服”(《医学入门》)。“病属气虚者忌之”，“妇人月事先期，小便短赤，及咳嗽内热，口渴、口干、舌苦，不得眠，一切阴虚内热之病，皆不宜服”(《本草经疏》)。由此可知乌药会有些虚证禁忌，部分人群不宜服用，因此，本发明提出一种益智缩泉口服液组合物及其制备方法。
发明内容
为了克服现有技术中的缺陷，本发明实施例提供了一种益智缩泉口服液组合物及其制备方法，以解决上述背景技术中提出的问题。
本申请实施例公开了：一种益智缩泉口服液组合物，制得每10L的所述组合物的原料包括益智100～500g、山药饮片100～500g、小茴香20～100g、陈皮20～100g、佛手20～100g、薏苡仁20～100g、芡实20～100g、其他中药植物水提取液56～250g、食盐2～10g、番茄红素0.1～0.15g、紫甘薯色素0.5～0.8g，所述其他中药植物水提取液中使用的中药包括小蓟、山楂、覆盆子、紫苏、丁香、金银花、甘草中的最少四种。
优选的，制得每10L的所述组合物的原料还包括低聚果糖80～100g、蔗糖素0.2～0.5g、卵磷脂80～100g、黄原胶9～11g中的至少两种。
本发明还公开一种益智缩泉口服液组合物的制备方法，包括以下步骤：
第一步，取益智果实砸碎，将益智种仁碎粒、山药饮片、薏苡仁、芡实加水浸泡半小时，将浸泡好的药材加入中药植物总量1倍的水煮沸，过滤，加入番茄红素、紫甘薯色素，加入卵磷脂、黄原胶中的至少一种，搅匀，得到备用液；
第二步，其他中药植物水提取液：加水没过其他中药植物紫苏、金银花、丁香、甘草或加有小蓟、山楂、覆盆子的液面，浸润30分钟，加热至沸，取滤液，滤出药渣，药渣再加水没过并煮沸，取滤液，合并两次滤液得到备用液；
第三步，合并第一步和第二步中制得的两份备用液，搅拌，加入低聚果糖、蔗糖素中的至少一种，搅匀，调pH值为5.8～6.8，加水至全量，过200目筛网，再用0.45μm微孔滤膜过滤，灌装密封，灭菌消毒。
优选的，所述第一步、第二步和第三步中用的水均为纯水。
优选的，所述第二步中，将紫苏、金银花、丁香、甘草或加有小蓟、山楂、覆盆子的其他中药植物搅拌后再加水浸润，并煮沸后提取滤液。
本发明的有益效果如下：所述组合物对历代经典方缩泉丸进行拆方加减，维持了原方中的益智、山药，删除了有虚证禁忌的乌药，可在缩泉、缓解尿频方面效果显著，对比传统的缩泉丸效果更好，无不良反应，质量稳定，既可在临床上药用又可作为功能性饮品日常饮用。
为让本发明的上述和其他目的、特征和优点能更明显易懂，下文特举较佳实施例，作详细说明如下。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述，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前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1
一种益智缩泉口服液组合物，制得所述组合物的原料见配方1：
配方：
所述其他植物水提取液为其他中药植物紫苏、甘草、金银花、丁香、小蓟、山楂、覆盆子的水提取液。
制法：第一步，取益智果实砸碎，将益智种仁碎粒、山药饮片、薏苡仁、芡实加水浸泡半小时，将浸泡好的药材加入中药植物总量1倍的水煮沸，过滤，加入番茄红素、紫甘薯色素，加入卵磷脂、黄原胶中的至少一种，搅匀，得到备用液；
第二步，其他中药植物水提取液：加水没过包括紫苏、金银花、丁香、甘草、小蓟、山楂和覆盆子在内的其他中药材植物，浸润30分钟，加热至沸，取滤液，滤出药渣，药渣再加水没过并煮沸，取滤液，合并两次滤液得到备用液；
第三步，合并第一步和第二步中制得的两份备用液，搅拌，加入低聚果糖、蔗糖素中的至少一种，搅匀，调pH值为5.8～6.8，加水至全量，过200目筛网，再用0.45μm微孔滤膜过滤，灌装密封，灭菌消毒。
所述第一步、第二步和第三步中用的水均为纯水。
所述第二步中，将紫苏、金银花、丁香、甘草或加有小蓟、山楂、覆盆子的其他中药植物搅拌后再加水浸润，并煮沸后提取滤液。
包装成45ml/瓶，益智缩泉口服液组合物，有补肾缩尿摄唾的功效，主治肾虚所致的小便频数，夜间遗尿，流口水。
实施例2
一种益智缩泉口服液组合物，制得所述组合物的原料见配方2：
配方：
所述其他植物水提取液为其他中药植物紫苏、甘草、金银花、丁香、小蓟、山楂、覆盆子的水提取液。
制法：第一步，取益智果实砸碎，将益智种仁碎粒、山药饮片、薏苡仁、芡实加水浸泡半小时，将浸泡好的药材加入中药植物总量1倍的水煮沸，过滤，加入番茄红素、紫甘薯色素，加入卵磷脂、黄原胶中的至少一种，搅匀，得到备用液；
第二步，其他中药植物水提取液：加水没过包括紫苏、金银花、丁香、甘草、小蓟、山楂和覆盆子在内的其他中药材植物，浸润30分钟，加热至沸，取滤液，滤出药渣，药渣再加水没过并煮沸，取滤液，合并两次滤液得到备用液；
第三步，合并第一步和第二步中制得的两份备用液，搅拌，加入低聚果糖、蔗糖素中的至少一种，搅匀，调pH值为5.8～6.8，加水至全量，过200目筛网，再用0.45μm微孔滤膜过滤，灌装密封，灭菌消毒。
所述第一步、第二步和第三步中用的水均为纯水。
所述第二步中，将紫苏、金银花、丁香、甘草或加有小蓟、山楂、覆盆子的其他中药植物搅拌后再加水浸润，并煮沸后提取滤液。
包装成45ml/瓶，益智缩泉口服液组合物，有补肾缩尿摄唾的功效，主治肾虚所致的小便频数，夜间遗尿，流口水。
实施例3
一种益智缩泉口服液组合物，制得所述组合物的原料见配方3：
配方：
所述其他植物水提取液为其他中药植物紫苏、甘草、金银花和丁香的水提取液。
制法：第一步，取益智果实砸碎，将益智种仁碎粒、山药饮片、薏苡仁、芡实加水浸泡半小时，将浸泡好的药材加入中药植物总量1倍的水煮沸，过滤，加入番茄红素、紫甘薯色素，加入卵磷脂、黄原胶中的至少一种，搅匀，得到备用液；
第二步，其他中药植物水提取液：加水没过包括紫苏、金银花、丁香和甘草的其他中药材植物，浸润30分钟，加热至沸，取滤液，滤出药渣，药渣再加水没过并煮沸，取滤液，合并两次滤液得到备用液；
第三步，合并第一步和第二步中制得的两份备用液，搅拌，加入低聚果糖、蔗糖素中的至少一种，搅匀，调pH值为5.8～6.8，加水至全量，过200目筛网，再用0.45μm微孔滤膜过滤，灌装密封，灭菌消毒。
所述第一步、第二步和第三步中用的水均为纯水。
所述第二步中，将紫苏、金银花、丁香、甘草或加有小蓟、山楂、覆盆子的其他中药植物搅拌后再加水浸润，并煮沸后提取滤液。
包装成45ml/瓶，益智缩泉口服液组合物，有补肾缩尿摄唾的功效，主治肾虚所致的小便频数，夜间遗尿，流口水。
为了验证本发明的有益效果，进行以下效果对照试验方法并进行数据统计分析：
1、试验过程
招募平常有尿频、尿急和遗尿的人事作为实验者共400名，年龄分别为3～8岁第一实验组、第二实验组、第三实验组、对照组，60～70岁第一实验组、第二实验组、第三实验组、对照组，男女不限，每组试验者50名，试验者随机分为8组。分别进行试验，试验者在实验前5分钟如厕排尽尿液，3～8岁第一实验组、第二实验组、第三实验组分别服用上述配方 1、配方2和配方3的益智缩泉口服液45ml一瓶，再喝矿泉水300ml，对照组每人喝矿泉水 345ml；60～70岁第一实验组、第二实验组、第三实验组分别服用上述配方1、配方2和配方3的益智缩泉口服液45ml一瓶，再喝矿泉水300ml，对照组每人喝矿泉水345ml；8组试验者在服用后在固定房间自由活动1.5小时，试验时间1.5小时内自由如厕排尿，1.5小时时间到规定如厕排尿,厕所外摄像头自动记录如厕时间，如厕时用容器全部回收尿液、量取并记录尿量，结果判断：(1)1.5小时未主动如厕且时间到按规定如厕，排尿量在150ml以内为显效；(2)1小时内未主动如厕且试验1.5小时时间到，按规定如厕排尿总量在250ml以内为有效；(3)1小时内主动如厕排尿在2次以上或试验1.5小时时间到，按规定排尿总量在 300ml以上视为无效。
2、数据统计
表13～8岁实验组缩尿效果数据统计
| 受试组 | 总例数 | 显效例数 | 有效例数 | 无效例数 | 总有效率％ |
| 第一试验组 | 50 | 12 | 36 | 2 | 96 |
| 第二试验组 | 50 | 18 | 28 | 4 | 92 |
| 第三试验组 | 50 | 19 | 26 | 5 | 90 |
| 对照组 | 50 | 0 | 3 | 47 | 6 |
表260～70岁实验组缩尿效果数据统计
(1)8组试验组在数据统计方面无显著性差异，具有可比性；
(2)由表中数据可知本发明提出的益智缩泉口服液组合物在缩泉、缓解尿频方面效果显著，且由配方1制得的益智缩泉口服液组合物疗效更好。
参照国家药品标准药物稳定性试验指导原则，按照配方1制备的药品即一种益智缩泉口服液组合物进行了6个月加速试验和长期试验，以益智挥发油为含量控制指标，同时检测微生物细菌总数和pH值，0个月微生物细菌总数为未检出，含量指标和pH值在合格范围，6 个月加速试验已经完成，长期留样试验已进行到第6个月仍在继续进行中，检测结果为含量指标、pH值、微生物细菌总数等关键指标均无明显变化，表明本发明的一种益智缩泉口服液组合物质量稳定，根据稳定性试验结果分析，本发明的药品级益智缩泉口服液有效期为2年，食品饮料级益智缩泉口服液有效期为1年，可以确保分别符合相关国家药品标准和国家食品标准要求。
综上所述，采用实施例1所提供的一种益智缩泉口服液组合物及其制备方法，所述组合物配方来自古方缩泉丸经拆方加减而成；维持缩泉丸方中益智、山药，拆方删除乌药，增加小茴香、陈皮、佛手、薏苡仁、芡实等药食两用的中药植物，在生产制备上将已制备好的益智、山药、薏苡仁、芡实水提取液和其他中药植物水提取液合并，搅匀，加入其他配料，过滤，包装轧盖，密封，灭菌消毒制得。采用传统水提改良工艺制备和密封以及组合配方确保益智有效成分挥发油稳定，确保一种益智缩泉口服液组合物在缩泉、缓解尿频方面效果显著，对比传统的缩泉丸效果更好，显效更强，似有立竿见影之效，无不良反应，质量稳定，既可在临床上药用又可作为功能性饮品日常饮用。
本发明中应用了具体实施例对本发明的原理及实施方式进行了阐述，以上实施例的说明只是用于帮助理解本发明的方法及其核心思想；同时，对于本领域的一般技术人员，依据本发明的思想，在具体实施方式及应用范围上均会有改变之处，综上所述，本说明书内容不应理解为对本发明的限制。
Claims (5)
1.一种益智缩泉口服液组合物，其特征在于：制得每10L的所述组合物的原料包括益智100～500g、山药饮片100～500g、小茴香20～100g、陈皮20～100g、佛手20～100g、薏苡仁20～100g、芡实20～100g、其他中药植物水提取液56～250g、食盐2～10g、番茄红素0.1～0.15g、紫甘薯色素0.5～0.8g，所述其他中药植物水提取液中使用的中药包括小蓟、山楂、覆盆子、紫苏、丁香、金银花、甘草中的最少四种。
2.根据权利要求1所述的一种益智缩泉口服液组合物，其特征在于：制得每10L的所述组合物的原料还包括低聚果糖80～100g、蔗糖素0.2～0.5g、卵磷脂80～100g、黄原胶9～11g中的至少两种。
3.一种益智缩泉口服液组合物的制备方法，其特征在于，包括以下步骤：
第一步，取益智果实砸碎，将益智种仁碎粒、山药饮片、薏苡仁、芡实加水浸泡半小时，将浸泡好的药材加入中药植物总量1倍的水煮沸，过滤，加入番茄红素、紫甘薯色素，加入卵磷脂、黄原胶中的至少一种，搅匀，得到备用液；
第二步，其他中药植物水提取液：加水没过包括紫苏、金银花、丁香、甘草或加有小蓟、山楂、覆盆子的其他中药植物，浸润30分钟，加热至沸，取滤液，滤出药渣，药渣再加水没过并煮沸，取滤液，合并两次滤液得到备用液；
第三步，合并第一步和第二步中制得的两份备用液，搅拌，加入低聚果糖、蔗糖素中的至少一种，搅匀，调pH值为5.8～6.8，加水至全量，过200目筛网，再用0.45μm微孔滤膜过滤，灌装密封，灭菌消毒。
4.根据权利要求3所述的一种益智缩泉口服液组合物的制备方法，其特征在于：所述第一步、第二步和第三步中用的水均为纯水。
5.根据权利要求3所述的一种益智缩泉口服液组合物的制备方法，其特征在于：所述第二步中，将紫苏、金银花、丁香、甘草或加有小蓟、山楂、覆盆子的其他中药植物搅拌后再加水浸润，并煮沸后提取滤液。
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