CN115105482A - 一种降低尿微量白蛋白的泡腾片及其制备方法和应用 - Google Patents
一种降低尿微量白蛋白的泡腾片及其制备方法和应用 Download PDFInfo
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- CN115105482A CN115105482A CN202210821693.5A CN202210821693A CN115105482A CN 115105482 A CN115105482 A CN 115105482A CN 202210821693 A CN202210821693 A CN 202210821693A CN 115105482 A CN115105482 A CN 115105482A
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Abstract
本申请公开了一种降低尿微量白蛋白的泡腾片及其制备方法和应用,属于药品、食品和保健品技术领域。一种降低尿微量白蛋白的泡腾片,包括如下重量配比的原料制备而成:酸樱桃果粉12‑20份、异麦芽酮糖4.0‑5.0份、甜菊糖苷0.4‑0.8份、柠檬酸40‑47份、碳酸钠18‑24份、柠檬酸钠4.5‑5.5份、柠檬酸钾4.5‑5.5份、山梨糖醇4.8‑5.5份。该降低尿微量白蛋白的泡腾片及其制备方法和应用,能够明显降低24小时尿微量白蛋白/肌酐水平,保护肾脏和改善肾功能,降低痛风性关节炎的复发率,并且对人体无毒副作用。
Description
技术领域
本申请涉及一种降低尿微量白蛋白的泡腾片及其制备方法和应用,属于药品、食品和保健品技术领域。
背景技术
痛风是一种常见且复杂的关节炎类型,关节部位出现严重的疼痛、水肿、红肿和炎症,是典型的体内代谢出现问题。痛风发作的诱因主要由于摄入过多的嘌呤,使血尿酸水平升高。
当下降低尿酸生成和碱化尿液是高尿酸和痛风病人治疗的措施包括饮食控制和药品控制,单纯靠控制饮食来降低血尿酸作用是有限的,一部分患者还得需要得到治疗,进行药物的干预治疗,降低尿酸的药物经临床试验,都具有较大的副作用:多排尿酸的同时也把人体其它微量元素也排出体外,会造成低血钠、低血钾、低血钙,不能长期服用,而且还对肝、肾有副作用,所以治疗尿酸高、控制痛风我们应当找到更健康科学的方法。
目前,市场上适用于人们预防与辅助性治疗尿酸高、控制痛风的功能性食品未见报道;因此,有必要研制一种预防与辅助性治疗尿酸高、控制痛风的功能性食品,以满足人们的迫切需求。
发明内容
为了解决上述问题,提供了一种降低尿微量白蛋白的泡腾片及其制备方法和应用,能够明显降低24小时尿微量白蛋白/肌酐水平,保护肾脏和改善肾功能,降低痛风性关节炎的复发率,并且对人体无毒副作用。
本发明采用如下技术方案:
一种降低尿微量白蛋白的泡腾片,包括如下原料制备而成:酸樱桃果粉、异麦芽酮糖、甜菊糖苷、柠檬酸、碳酸钠、柠檬酸钠、柠檬酸钾、山梨糖醇。
可选地,包括如下重量配比的原料制备而成:
酸樱桃果粉12-20份、异麦芽酮糖4.0-5.0份、甜菊糖苷0.4-0.8份、柠檬酸40-47份、碳酸钠18-24份、柠檬酸钠4.5-5.5份、柠檬酸钾4.5-5.5份、山梨糖醇4.8-5.5份。
可选地,包括如下重量配比的原料制备而成:
酸樱桃果粉13份、异麦芽酮糖5.0份、甜菊糖苷0.45份、柠檬酸45份、碳酸钠21.75份、柠檬酸钠4.9份、柠檬酸钾4.9份、山梨糖醇5份。
酸樱桃具有降低尿酸,缓解痛风,改善睡眠的作用,对肝肾和其它器官没有任何刺激;异麦芽酮糖具有抑制脂肪积累,不引起肥胖,不引起血糖上升和胰岛素上升的作用;甜菊糖苷具有降血糖、降血脂、抗炎抗氧化的作用。
可选地,所述酸樱桃果粉是由如下方法制备得到:将酸樱桃果实果汁或水提物浓缩,喷雾干燥,即得酸樱桃果粉。
可选地,所述酸樱桃的品种选自Montmorency、Balaton、奥德、Erdi fubileum、Debreceni botermo、Oblacinska和Lutovka中的一种或多种。
可选地,所述酸樱桃果粉的纯度为50-75%。
根据本申请的另一个方面,提供了根据上述任一项所述的泡腾片的制备方法,包括:
将柠檬酸、柠檬酸钠和柠檬酸钾打粉备用,然后按重量配比称取各原料,混匀,压片,即得泡腾片。
根据本申请的又一个方面,提供了根据上述任一项所述的泡腾片在降低尿微量白蛋白的药品、食品或保健品中的应用。
可选地,所述泡腾片能够降低24小时尿微量白蛋白/肌酐。
可选地,所述泡腾片还能够保护肾脏和改善肾功能。
本申请的有益效果包括但不限于:
1.本申请的降低尿微量白蛋白的泡腾片,酸樱桃果粉抗氧化、抗炎和降尿酸的天然活性成分与功效,保留了酸樱桃天然的红色、香气和口感,更适于青少年高尿酸血症与痛风患者;柠檬酸钠和柠檬酸钾具有碱化尿液的功效,其中柠檬酸根是钙盐结石抑制因子,不但阻止尿酸盐和钙盐结石的形成,而且促进尿酸盐结晶或结石及钙盐结石的溶解;异麦芽酮糖具有抑制脂肪积累,不引起肥胖,不引起血糖上升和胰岛素上升的作用;甜菊糖苷具有降血糖、降血脂、抗炎抗氧化的作用;将药食同源的各原料制备成泡腾片既便于产品的贮存、运输和包装,且口感良好,便于患者使用。
2.本申请的降低尿微量白蛋白的泡腾片,崩解速度快、发泡量大、不易吸潮、质量稳定,并且对胃肠道刺激轻,碱化尿液的同时还具有溶石作用,能够明显降低24小时尿微量白蛋白/肌酐水平,保护肾脏和改善肾功能,降低痛风性关节炎的复发率,并且对人体无毒副作用。
3.本申请的降低尿微量白蛋白的泡腾片为食品级别,更加安全,充分利用各原料特性,降低尿微量白蛋白含量,保护肾脏和改善肾功能,缓解患者的痛风症状。
4.本申请的降低尿微量白蛋白的泡腾片,制备工艺合理,条件温和,便于操作,能够确保各原料的功能特效充分发挥。
附图说明
此处所说明的附图用来提供对本申请的进一步理解,构成本申请的一部分,本申请的示意性实施例及其说明用于解释本申请,并不构成对本申请的不当限定。在附图中:
图1为本申请实施例涉及的三组随访期间eGFR变化图。
图2为本申请实施例涉及的三组随访期间24小时尿微量白蛋白/肌酐变化图。
图3为本申请实施例涉及的三组随访期间24小时UACR变化幅度图。
图4为本申请实施例涉及的三组随访期间痛风石体积(双源CT)变化1 图。
图5为本申请实施例涉及的三组随访期间痛风石体积(双源CT)变化2 图。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚,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。实施例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者,均为可以通过市售购买获得的常规产品。
实施例1
一种降低尿微量白蛋白的泡腾片,包括如下重量配比的原料制备而成:
酸樱桃果粉12份、异麦芽酮糖4.0份、甜菊糖苷0.4份、柠檬酸40份、碳酸钠18份、柠檬酸钠4.5份、柠檬酸钾4.5份、山梨糖醇4.8份。
制备方法包括以下步骤:
选取Erdi fubileum酸樱桃;然后将酸樱桃水提物浓缩,喷雾干燥,即得纯度为50%的酸樱桃果粉;随后将柠檬酸、柠檬酸钠和柠檬酸钾打粉备用,按重量配比称取各原料,混匀,压片,即得厚度为0.5cm、直径为2.55cm的泡腾片。
实施例2
一种降低尿微量白蛋白的泡腾片,包括如下重量配比的原料制备而成:
酸樱桃果粉20份、异麦芽酮糖4.5份、甜菊糖苷0.8份、柠檬酸47份、碳酸钠24份、柠檬酸钠5.5份、柠檬酸钾5.5份、山梨糖醇5.5份。
制备方法包括以下步骤:
选取质量比为1:1:1的Debreceni botermo、Oblacinska、Lutovka酸樱桃;然后将酸樱桃果实果汁浓缩,喷雾干燥,即得纯度为63%的酸樱桃果粉;随后将柠檬酸、柠檬酸钠和柠檬酸钾打粉备用,按重量配比称取各原料,混匀,压片,即得厚度为0.5cm、直径为2.55cm的泡腾片。
实施例3
一种降低尿微量白蛋白的泡腾片,包括如下重量配比的原料制备而成:
酸樱桃果粉13份、异麦芽酮糖5.0份、甜菊糖苷0.45份、柠檬酸45份、碳酸钠21.75份、柠檬酸钠4.9份、柠檬酸钾4.9份、山梨糖醇5份。
制备方法包括以下步骤:
选取质量比为1:1:1的Montmorency、Balaton、奥德酸樱桃;然后将酸樱桃果实果汁浓缩,喷雾干燥,即得纯度为75%的酸樱桃果粉;随后将柠檬酸、柠檬酸钠和柠檬酸钾打粉备用,按重量配比称取各原料,混匀,压片,即得厚度为0.5cm、直径为2.55cm的泡腾片。
实施例4
与实施例3的区别在于:原料中不包括13份酸樱桃果粉,并将5.0份异麦芽酮糖和0.45份甜菊糖苷替换为18.45份乳糖。
试验例1
1.降低尿微量白蛋白的泡腾片崩解时限检测
烧杯中加入200ml 25℃的蒸馏水,将泡腾片投入烧杯中并计时,待泡腾片完全崩解停止计时,崩解时间见表2。
2.降低尿微量白蛋白的泡腾片的感官评价
随机挑选男女各5名(其中感官评价专家型人员1名,有经验型3名,无经验型3名,消费者型3名),取一片本发明的产品崩解于300ml水中,评价人员于感官品评室试用产品后,对产品的色泽、香味、口感进行评价,感官评价标准见表1,测定结果见表2。
表1感官评价标准
表2试验结果
崩解时间 | 色泽 | 香味 | 口感 | 总体评价 | |
实施例1 | 2’18” | 5 | 4 | 4 | 4 |
实施例2 | 2’36” | 4 | 5 | 4 | 4 |
实施例3 | 1’50” | 5 | 5 | 5 | 5 |
实施例4 | 2’12” | 3 | 2 | 1 | 2 |
由表2可以看出,本发明的产品在色泽、香味、口感等方面的感官评价得分均较高,总体评价较好,10位感官评价人员都非常喜欢本发明的产品。
试验例2临床试验
1.受试者描述
本试验共入组282例受试者,最终254例(90.07%)完成所有访视,28 例受试者在研究结束前提前退出。碳酸氢钠组、风零组和风零+组分别有86例、 86例和82例完成全部访视。
退组原因:21人因自身依从性原因退组,5人因其它疾病退组,2人因痛风发作退组。
2.给药方案
碳酸氢钠组:非布司他20mg qd+小苏打1g tid(初始治疗);非布司他 40mg qd+小苏打1g tid(基于尿酸水平调整);
风零组:非布司他20mg qd+实施例4泡腾片3.5g bid,非布司他40mg qd+ 实施例4泡腾片3.5g bid(基于尿酸水平调整);
风零+组:非布司他20mg qd+实施例3泡腾片3.5g bid,非布司他40mg qd+ 实施例3泡腾片3.5g bid(基于尿酸水平调整);
每组94受试者,每日服用2次,服用90日。
3.人口统计学及其他基线特征
完成本研究的254例受试者,均为男性且符合2015ACR/EULAR痛风诊断标准。基线特征见表3:
表3
4.疗效分析
4.1尿pH变化情况
随访期间尿pH6-7、6.2-6.9及pH<5.5所占比例:访视第4周,风零组尿 pH介于6-7所占比例明显高于碳酸氢钠组和风零+组(P=0.015),余差异无显著性,具体见表4:
表4
4.2治疗期间血尿酸达标情况
达标率:对随访期间3组UA<420μmol/L、UA<360μmol/L、UA<300μmol/L 的人数进行统计发现:各组各时间点血尿酸达标率均无统计学差异,具体见表 5:
表5
4.3肾功能变化
(1)eGFR(校正肾小球滤过率):与基线相比,第12周,碳酸氢钠组 eGFR有降低趋势,但差异无显著性(P=0.402),风零组eGFR明显降低 (P=0.022),风零+组eGFR有升高趋势,但差异无显著性(P=0.396)。与基线相比,第8周,风零+组eGFR明显升高(P<0.001),余各组均无明显变化,见图1。
(2)24小时UACR(尿微量白蛋白/尿肌酐):与基线相比,第12周, 24小时UACR,碳酸氢钠组有降低趋势,但差异无显著性(P=0.263),风零组明显升高(P=0.006),风零+组明显降低(P<0.001),见图2。
(3)随访12周24小时UACR较基线变化幅度:风零+组与碳酸氢钠组相比,UACR下降幅度更高,有显著性差异(P=0.002)。风零+组与风零组相比,UACR下降幅度更高,有显著性差异(P=0.012);风零组与碳酸氢钠组间差异无统计学意义,见图3。
4.4尿酸盐结晶体积较首次访视时的变化
(1)双源CT结果显示:碳酸氢钠组末次访视痛风石体积较基线明显减小 (P=0.001),风零组末次访视痛风石体积较基线明显减小(P=0.002),风零+ 组末次访视痛风石体积较基线明显减小(P<0.001),见图4。
(2)双源CT结果显示:各组间末次访视痛风石体积较基线的减少幅度无明显差异(P=0.668)。关节B超结果显示,末次访视痛风石体积较基线的减少幅度无显著差异(P=0.824),见图5。
4.5痛风急性发作情况
(1)痛风急性发作至少1次:碳酸氢钠组40人,占46.5%,风零组33 人,占38.4%,风零+组33人,占40.2%,碳酸氢钠组高于风零和风零+组,但差异无显著性。
(2)痛风急性发作患者≥2次:碳酸氢钠组,21人,占24.4%,风零组12人,占14.0%,风零+组11人,占13.4%,碳酸氢钠组高于风零和风零+组,但差异无显著性,结果见表6。
表6
碳酸氢钠组 | 风零组 | 风零+组 | P | |
符合方案集 | ||||
4week | 24(27.9%) | 14(16.7%) | 16(19.8%) | 0.183 |
8week | 27(32.5%) | 20(23.5%) | 14(17.5%) | 0.080 |
12week | 19(22.1%) | 15(17.4%) | 14(17.1%) | 0.647 |
≥1次 | 40(46.5%) | 33(38.4%) | 33(40.2%) | 0.527 |
≥2次 | 21(24.4%) | 12(14.0%) | 11(13.4%) | 0.101 |
全分析集 | ||||
4week | 25(27.5%) | 16(17.4%) | 18(20.2%) | 0.234 |
8week | 28(32.2%) | 22(24.4%) | 14(16.7%) | 0.062 |
12week | 19(21.8%) | 15(17.2%) | 14(17.1%) | 0.662 |
≥1次 | 42(44.7%) | 36(37.9%) | 35(37.6%) | 0.535 |
≥2次 | 21(22.3%) | 13(13.7%) | 11(11.8%) | 0.111 |
以上所述,仅为本申请的实施例而已,本申请的保护范围并不受这些具体实施例的限制,而是由本申请的权利要求书来确定。对于本领域技术人员来说,本申请可以有各种更改和变化。凡在本申请的技术思想和原理之内所作的任何修改、等同替换、改进等,均应包含在本申请的保护范围之内。
Claims (10)
1.一种降低尿微量白蛋白的泡腾片,其特征在于,包括如下原料制备而成:酸樱桃果粉、异麦芽酮糖、甜菊糖苷、柠檬酸、碳酸钠、柠檬酸钠、柠檬酸钾、山梨糖醇。
2.根据权利要求1所述的降低尿微量白蛋白的泡腾片,其特征在于,包括如下重量配比的原料制备而成:
酸樱桃果粉12-20份、异麦芽酮糖4.0-5.0份、甜菊糖苷0.4-0.8份、柠檬酸40-47份、碳酸钠18-24份、柠檬酸钠4.5-5.5份、柠檬酸钾4.5-5.5份、山梨糖醇4.8-5.5份。
3.根据权利要求2所述的降低尿微量白蛋白的泡腾片,其特征在于,包括如下重量配比的原料制备而成:
酸樱桃果粉13份、异麦芽酮糖5.0份、甜菊糖苷0.45份、柠檬酸45份、碳酸钠21.75份、柠檬酸钠4.9份、柠檬酸钾4.9份、山梨糖醇5份。
4.根据权利要求3所述的降低尿微量白蛋白的泡腾片,其特征在于,所述酸樱桃果粉是由如下方法制备得到:将酸樱桃果实果汁或水提物浓缩,喷雾干燥,即得酸樱桃果粉。
5.根据权利要求4所述的降低尿微量白蛋白的泡腾片,其特征在于,所述酸樱桃的品种选自Montmorency、Balaton、奥德、Erdi fubileum、Debreceni botermo、Oblacinska和Lutovka中的一种或多种。
6.根据权利要求4所述的降低尿微量白蛋白的泡腾片,其特征在于,所述酸樱桃果粉的纯度为50-75%。
7.根据权利要求1-6任一项所述的泡腾片的制备方法,其特征在于,包括:
将柠檬酸、柠檬酸钠和柠檬酸钾打粉备用,然后按重量配比称取各原料,混匀,压片,即得泡腾片。
8.根据权利要求1-6任一项所述的泡腾片在降低尿微量白蛋白的药品、食品或保健品中的应用。
9.根据权利要求8所述的应用,其特征在于,所述泡腾片能够降低24小时尿微量白蛋白/肌酐。
10.根据权利要求9所述的应用,其特征在于,所述泡腾片还能够保护肾脏和改善肾功能。
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CN104922178A (zh) * | 2015-06-09 | 2015-09-23 | 德令哈林生生物科技开发有限公司 | 一种降血糖泡腾片剂及其用途 |
CN105495258A (zh) * | 2015-12-07 | 2016-04-20 | 广东盛元中天生物科技有限公司 | 一种有助降尿酸的水果饮料 |
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CN111685246A (zh) * | 2020-06-30 | 2020-09-22 | 山东国和堂制药有限公司 | 一种含玫瑰花精华及玫瑰提香的饮料及其制备方法 |
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CN104922178A (zh) * | 2015-06-09 | 2015-09-23 | 德令哈林生生物科技开发有限公司 | 一种降血糖泡腾片剂及其用途 |
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