CN110013533B - 一种具有养胃开胃消食作用的药食两用儿童专用膏滋及其制备方法 - Google Patents
一种具有养胃开胃消食作用的药食两用儿童专用膏滋及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种具有养胃开胃消食作用的药食两用儿童专用膏滋及其制备方法,本发明所述的膏滋产品原料包括以下组成玉竹、薏苡仁、山楂、鸡内金、麦芽、山药、茯苓、桔梗、白扁豆、肉豆蔻、砂仁、冰糖,本发明的产品达到改善儿童胃弱、厌食、积食、消化不良的效果,方便、安全、有效,配方配伍优选、制作工艺改良,按中医理论配伍组合,保证了儿童膏滋的养胃、开胃、消食功效,与中医临床应用高度匹配。
Description
技术领域
本发明涉及一种膏滋及其制备方法,具体地说,是一种具有养胃开胃消食 作用的药食两用儿童专用膏滋及其制备方法。
背景技术
儿童胃弱、厌食、积食、消化不良是一种较为常见的现象,临床主要表现为: 儿童较长时间的食欲减退或者消失、食量减少。厌食日久会造成患儿营养不良、 微量元素缺乏、免疫力低下等,甚至导致反复呼吸道感染、佝偻病等疾病的发生。 近年来,儿童厌食症的发病率日趋上升,城市儿童发病率较高,而临床常见表征 为:儿童少食、厌食;或者进食后积食,又导致下次进餐受阻。这种现象,也可 归结于:儿童饮食亚健康状态。目前治疗成人脾胃功能失调的产品较为常见,而 针对儿童胃弱的研究相对较少。为此,本发明结合中医基础理论、中药性味功效 以及中药膏滋生产技术等,进行配方配伍优选、工艺改良、使其产品方便、安全、 有效,即发明了一种具有养胃、开胃、消食作用的药食两用儿童专用膏滋。
发明内容
本发明的目的是:对儿童胃弱、厌食、积食、消化不良的临床情况进行分析, 结合中医药基础理论,优选药食同源的原料,在配方安全的前提下,进行组方筛 选、工艺筛选、毒理考察、药理考察,从而发明一种安全有效的具有养胃、开胃、 消食作用的药食两用儿童专用膏滋产品。
本发明的具体技术方案如下:
一、本发明公开了一种具有养胃、开胃、消食作用的药食两用儿童专用膏滋, 所述的膏滋产品原料包括以下组成:玉竹、薏苡仁、山楂、鸡内金、麦芽、山药、 茯苓、桔梗、白扁豆、肉豆蔻、砂仁、冰糖。
此具有养胃、开胃、消食作用的药食两用儿童专用膏滋的组方:
君:
鸡内金:健胃消食、涩精止遗、通淋化石,浸出物≥7.5%。
臣:
薏苡仁:利水渗湿、健脾止泻、除痹、排脓、解毒散结,浸出物≥5.5%、 甘油三油酸酯≥0.50%。
麦芽:行气消食、健脾开胃、回乳消涨,黄曲霉素≤10μg/1000g。
山楂:消食健胃、行气散瘀、化浊降脂,浸出物≥21.0%、有机酸≥5.0%。
白扁豆:健脾化湿,和中消暑,水分≤14.0%。
砂仁:化湿开胃、温脾止泻、理气安胎,挥发油≥3.0%、乙酸龙脑脂≥0.90%。
山药:补脾养胃、生津益肺、补肾涩精,浸出物≥10.0%、灰分≤5.0%。
佐使:
玉竹:养阴润燥、生津止渴,浸出物≥50.0%、玉竹多糖≥6.0%。
茯苓:利水渗湿、健脾宁心,浸出物≥2.5%、灰分≤2.0%。
桔梗:宣肺利咽、祛痰排脓,浸出物≥17.0%、桔梗皂苷≥0.10%。
肉豆蔻:温中行气、涩肠止泻,黄曲霉素≤10μg/1000g、挥发油≤6.0%、 去氢二异丁香酚≥0.10%。
冰糖:矫味、调和,蔗糖分≥99.7%、还原糖分≤0.04%、干燥失重≤0.15% 色值≤30IU、不溶于水杂质≤20mg/Kg。
上述配方配伍,按中医理论配伍组合,保证了此儿童膏滋的养胃、开胃、 消食功效,与中医临床应用高度匹配。
二、本发明所述的原料组分的重量配比如下:
方案一:
玉竹:6-12份
薏苡仁:4-10份
山楂:5-10份
鸡内金:2-8份
麦芽:2-6份
山药:2-5份
茯苓:2-3份
桔梗:1-3份
白扁豆:1-3份
肉豆蔻:1-4份
砂仁:1-4份
冰糖:6-8份
此方案的组分范围较宽泛,在此范围内生产的样品同样可以达到改善儿童 胃弱、厌食、积食、消化不良的效果,但其中部分原料量重则影响口感,引起部 分儿童拒服,有的味料又略显力不足;比如肉豆蔻:1-4份、砂仁:1-4份,各 取4份试验,膏滋整体过于浓烈,而薏苡仁:4-10份,取4份试验,祛湿效果 不明显。同理其他料味的使用量,跨度稍大,按此方案组方,在实际应用上,不 同儿童的接受度会有相应的差异,但是同样能实现本发明的技术效果。
方案二:作为进一步地改进,本发明所述的原料组分的重量配比如下:
玉竹:8-10份
薏苡仁:6-8份
山楂:6-9份
鸡内金:2-4份
麦芽:3-6份
山药:2-4份
茯苓:2-3份
桔梗:1-2份
白扁豆:1-2份
肉豆蔻:1-2份
砂仁:1-2份
冰糖:7-8份
此方案在第一种方案的基础上进一步优选,根据配料试验结果,剔除了过 大量或过小量的配方。
方案三:作为进一步地改进,本发明所述的原料组分的重量配比如下:
玉竹:10份
薏苡仁:6份
山楂:6份
鸡内金:3份
麦芽:4份
山药:2份
茯苓:3份
桔梗:1份
白扁豆:1份
肉豆蔻:1份
砂仁:1份
冰糖:8份
此配方作为进一步地改进,选取了方案二范围中更适合儿童服用的滋气味配 比,并据此生产出样品,供后期毒理药理实验用。
三、本发明还公开了一种具有养胃、开胃、消食作用的药食两用儿童专用膏 滋,的制备方法,所述的制备方法步骤包括包括选料检测、原料前处理(含蒸制、 炒制、粉碎等)、煎煮浓缩、灌装灭菌、检验和包装,具体制备步骤如下:
1)选料检测:采用地道当年新货药材,进行检测,有效成分以各药材指标 成分或功效成分,以及水分、灰分、浸出物计,控制原材料质量,定点采购,备 用;
2)原料前处理:玉竹抢水清洗、润软、切制成片段(7-12mm),至数控 中药蒸煮锅蒸制8小时以上,闷至过夜,备用;薏苡仁、山楂、白扁豆、麦芽, 清炒至外壁略有焦斑,备用;鸡内金,沙炒至发泡、酥脆,备用;砂仁置钆扁机 中压钆至表皮破碎,备用;冰糖用高速粉碎机粉碎成20目细粉,备用;其他原 料切片或粉碎成粗颗粒,备用。至数控中药蒸煮锅蒸制8小时以上,闷至过夜, 使其达到玉竹传统加工工艺“九蒸九制”的效果,备用;薏苡仁、山楂、白扁豆、 麦芽,炒制后能增加和胃消食健脾作用,故清炒至外壁略有焦斑。
3)煎煮浓缩:取上述经处理的原料,加饮用水煎煮,煎煮用水量为原料量 的10-20倍,煎煮时间为1.5-3h,煎煮次数为2-3次,保证其原料中的有效成分 能在合适的时间和浓度梯度下全部溶于提取液中。去料渣,料液经减压浓缩(真 空≤-0.75Kpa,温度≤70℃,低温收稠,防止挥发性有效成分散失)至比重为 1.1-1.2。
3)灌装灭菌:将3)稠厚膏滋进行灌装至洗净的玻璃瓶或耐煎煮食品复合 膜,密封,105℃灭菌30分钟。
5)检验:生产结束,抽样检测,技术要求为:外观性状、比重、灰分、多 糖含量、净含量、卫生学数据;
6)包装:所有项目合格后的瓶或软包装贴签装盒入库。
作为进一步地改进,本发明所述的步骤1)中,控制原材料各药材质量要 求具体为:玉竹:浸出物≥50.0%、玉竹多糖≥6.0%;薏苡仁:浸出物≥5.5%、 甘油三油酸酯≥0.50%;山楂:浸出物≥21.0%、有机酸≥5.0%;鸡内金:浸出物 ≥7.5%;麦芽:黄曲霉素≤10μg/1000g;山药:浸出物≥10.0%、灰分≤5.0%; 茯苓:浸出物≥2.5%、灰分≤2.0%;桔梗:浸出物≥17.0%、桔梗皂苷≥0.10%; 白扁豆:水分≤14.0%;肉豆蔻:黄曲霉素≤10μg/1000g、挥发油≤6.0%、去氢 二异丁香酚≥0.10%;砂仁:挥发油≥3.0%、乙酸龙脑脂≥0.90%;冰糖:蔗糖分 ≥99.7%、还原糖分≤0.04%、干燥失重≤0.15%色值≤30IU、不溶于水杂质≤ 20mg/Kg,如上原料质量指标是保证产品优质有效的基础。
作为进一步地改进,本发明所述的步骤4)中灌装环节生产要求在十万级净 化区内进行。
作为进一步地改进,本发明所述的制备而成的膏滋:外观为深棕色至深褐色 稠厚液体,味甜、回味有植物原料特有的滋气味;灰分≤6.0%、粗多糖含量≥2.0%、 卫生学达到商业无菌要求。
作为进一步地改进,本发明所述的制备而成的膏滋,经药理实验证明:最佳 剂量为3g/kg.d。
本发明的有益效果如下:
本发明的产品达到改善儿童胃弱、厌食、积食、消化不良的效果,方便、安 全、有效,配方配伍优选、制作工艺改良,按中医理论配伍组合,保证了儿童膏 滋的养胃、开胃、消食功效,与中医临床应用高度匹配。
具体实施方式
下面通过具体实施例对本发明的技术方案作进一步地说明:
本发明公开了一种具有养胃、开胃、消食作用的药食两用儿童专用膏滋,涉 及一种含玉竹、薏苡仁、山楂、鸡内金、麦芽、山药、茯苓、桔梗、白扁豆、肉 豆蔻、砂仁、冰糖等中药材的膏滋的配方配伍、生产工艺以及质量控制。
制备一种具有养胃、开胃、消食作用的药食两用儿童专用膏滋的方法步骤包 括包括选料检测、原料前处理(含蒸制、炒制、粉碎等)、煎煮浓缩、灌装灭菌、 检验和包装,具体制备步骤如下:
1)选料检测:采用地道当年新货药材,进行检测,有效成分以各药材指标成分 或功效成分,以及水分、灰分、浸出物计,控制原材料质量,定点采购,备用;
2)原料前处理:玉竹抢水清洗、润软、切制成片段(7-12mm),至数控中药蒸 煮锅蒸制8小时,闷至过夜,备用;薏苡仁、山楂、白扁豆、麦芽,清炒至外壁 略有焦斑,备用;鸡内金,沙炒至发泡、酥脆,备用;砂仁置钆扁机中压钆至表 皮破碎,备用;冰糖用高速粉碎机粉碎成20目细粉,备用;其他原料切片或粉 碎成粗颗粒,备用。
4)煎煮浓缩:取上述经处理的原料,加饮用水煎煮,煎煮用水量为原料量的10-20倍,煎煮时间为1.5-3h,煎煮次数为2-3次。去料渣,料液经减压浓缩(真空≤ -0.75Kpa,温度≤70℃)至比重为1.1-1.2。
5)灌装灭菌:将3)稠厚膏滋进行灌装至洗净的玻璃瓶或耐煎煮食品复合膜, 密封,105℃灭菌30分钟。
5)检验:生产结束,抽样检测,技术要求为:外观性状、比重、灰分、多糖含 量、净含量、卫生学数据;
6)包装:所有项目合格后的瓶或软包装贴签装盒入库。
成品膏滋的检测结果需在如下数据范围内:
检测项目 | 实测数据 |
外观性状 | 应为深棕色至褐色稠膏 |
滋气味 | 具有配料中原料特有芳香,略粘稠,味甜。 |
灰分 | ≤6.0% |
多糖含量 | ≥2.0% |
净含量 | 按规格12g |
相对密度 | ≥1.1 |
商业无菌 | 符合规定 |
本发明养胃、开胃、消食儿童专用膏滋具有:改善脾虚、健脾消食、促进食 欲,增加体重的作用。
三、药理及毒理研究及实验:
A药理研究及实验:
对于本发明养胃、开胃、消食儿童专用膏滋具有的功效,发明人进行了药理 实验,具体如下:
(一)儿童养胃膏滋对肠的推进作用
1.实验材料
1.1受试品与试剂:
受试品:儿童养胃膏滋由杭州胡庆余堂天然食品有限公司提供;
材料与试剂:利血平注射液(批号:2018060074,天津金耀药业有限公司);
水合氯醛(批号:20180819,成都市科伦化学试剂场);
活性炭(批号:20170908,天津市天正精细化学试剂场);
动物饲料:普通饲料(由南方医科大学提供)。
1.2实验动物:SD大鼠,SPF级,雌雄各半,体重180±20g,动物合格证号:SCXK 粤2018-0285,由南方医科大学实验动物中心提供。
2.实验方法:
取大鼠50只,随机分成5组,每组10只,即脾虚组、实验组1、2、3和空白组。 为建立脾虚模型,脾虚组、实验组每天每只腹腔注射利血平注射液0.25mg/kg, 连续注射15天;空白组注入相同剂量的生理盐水。从第16天起,实验组1、2、3 分别注入剂量为1g/kg.d、3g/kg.d、5g/kg.d的儿童养胃膏滋,脾虚组和空白 组注入等剂量的生理盐水每天1次,连续7天。末次给药后,禁食12h,正常饮水, 每只活性炭水溶液2mL,15min后腹腔注射浓度为10%的水合氯醛麻醉,打开腹腔, 取出小肠,将其拉直,测量幽门至回盲肠部长度与幽门至黑色活性炭的长度,计 算小肠推进率:小肠推进率=幽门至活性炭距离/幽门至回盲肠x100%。所得数据 用SPSS 15.0软件进行采用方差分析。
3.实验结果:
连续15天注射利血平注射液后,观察到大鼠精神不佳、喜卧不动、排泄稀进 食明显减少;空白组无以上特征表现,说明脾虚大鼠造模成功。灌服儿童养胃膏 滋后,实验组大鼠生理状态和精神状态明显好转;排泄出现正常趋势,食欲增加。 各组别的肠推进率结果如表1所示;各组别肠推进率有显著性差异。
注:▲P<0.05
4.实验结论
从表1的实验结果可看出,脾虚组的肠推进率较其他组别高,实验组2(即儿 童养胃膏滋剂量为3g/kg.d)在三个不同剂量下的肠推进率最低,与空白组健康 大鼠肠推进率最接近。说明儿童养胃膏滋对肠推进率有抑制作用,能改善脾虚, 达到一定的健脾功能,且儿童养胃膏滋的剂量为3g/kg.d时,肠推进率更接近正 常状态,对脾虚的改善作用最强。
(二)儿童养胃膏滋对胃蛋白酶的影响
1.实验材料
1.1受试品与试剂:
受试品:儿童养胃膏滋由杭州胡庆余堂天然食品有限公司提供;
材料与试剂:利血平注射液(批号:2018060074,天津金耀药业有限公司);
水合氯醛(批号:20180819,成都市科伦化学试剂场);
胃蛋白酶试剂盒(批号:20181011,南京建成生物工程研究所);
动物饲料:普通饲料(由南方医科大学提供)。
1.2实验动物:SD大鼠,SPF级,雌雄各半,体重180±20g,动物合格证号:SCXK 粤2018-0285,由南方医科大学实验动物中心提供。
2.实验方法:
取大鼠50只,随机分成5组,每组10只,即脾虚组、实验组1、2、3和空白 组。为建立脾虚模型,脾虚组、低剂量组与高剂量组每天每只腹腔注射利血平注 射液0.25mg/kg,连续注射15天;空白组注入相同剂量的生理盐水。从第16天起, 实验组1、2、3分别注入剂量为1g/kg.d、3g/kg.d、5g/kg.d的儿童养胃膏滋, 脾虚组和空白组注入等剂量的生理盐水每天1次,连续7天。末次给药后,禁食12h, 正常饮水。腹腔注射浓度为10%的水合氯醛麻醉,腹腔取血后,结扎幽门和贲门, 取下称重;取胃内容物于试管,照试剂盒的方法检测大鼠胃蛋白酶的活性。所得 数据用SPSS 15.0软件进行采用方差分析。
3.实验结果:
连续15天注射利血平注射液后,观察到大鼠精神不佳、喜卧不动、排泄稀进 食明显减少;空白组无以上特征表现,说明脾虚大鼠造模成功。灌服儿童养胃膏 滋后,实验组大鼠生理状态和精神状态明显好转;食欲增加。各组别的胃蛋白酶 活性结果如表2所示;各组别胃蛋白酶活性有显著性差异。
注:▲P<0.05
4.实验结论
从表2的实验结果可看出,脾虚组的胃蛋白酶活性显著低于其它组别,实验 组2(即儿童养胃膏滋剂量为3g/kg.d)在三个不同剂量下的胃蛋白酶活性最高, 与空白组健康大鼠的胃蛋白酶活性最接近。说明儿童养胃膏滋有促进胃蛋白酶活 性的作用,改善脾虚,达到一定的健脾消食功能,且儿童养胃膏滋的剂量为3 g/kg.d时,胃蛋白酶活性更接近正常状态,对脾虚的改善作用最强。
(三)儿童养胃膏滋对大鼠食欲和体重的影响
1.实验材料
1.1受试品与试剂:
受试品:儿童养胃膏滋提取物由杭州胡庆余堂天然食品有限公司提供;
材料与试剂:利血平注射液(批号:2018060074,天津金耀药业有限公司);
水合氯醛(批号:20180819,成都市科伦化学试剂场);
胃蛋白酶试剂盒(批号:20181011,南京建成生物工程研究所);
动物饲料:普通饲料(由南方医科大学提供)。
1.2实验动物:SD大鼠,SPF级,雌雄各半,体重180±20g,动物合格证号:SCXK 粤2018-0285,由南方医科大学实验动物中心提供。
2.实验方法:
取大鼠50只,随机分成5组,每组10只,即脾虚组、实验组1、2、3和空白组。 为建立脾虚模型,脾虚组、低剂量组与高剂量组每天每只腹腔注射利血平注射液 0.25mg/kg,连续注射15天;空白组注入相同剂量的生理盐水。从第16天起,实 验组1、2、3分别注入剂量为1g/kg.d、3g/kg.d、5g/kg.d的儿童养胃膏滋,脾 虚组和空白组注入等剂量的生理盐水每天1次,连续7天。称重,所得数据用SPSS 15.0软件进行采用方差分析。
3.实验结果:
连续15天注射利血平注射液后,观察到大鼠精神不佳、喜卧不动、排泄稀进 食明显减少;空白组无以上特征表现,说明脾虚大鼠造模成功。灌服儿童养胃膏 滋后,实验组大鼠生理状态和精神状态明显好转;食欲明显增加。各组别的大鼠 体重结果如表3所示;各组别大鼠体重有显著性差异。
注:▲P<0.05
4.实验结论
从表3的实验结果可看出,脾虚组的体重显著低于其它组别,实验组2(即儿 童养胃膏滋剂量为3g/kg.d)在三个不同剂量下的体重恢复更正常,与空白组健 康大鼠体重最接近。说明儿童养胃膏滋有促进食欲,增加体重的作用,改善脾虚, 达到一定的健脾消食功能,且儿童养胃膏滋的剂量为3g/kg.d时,大鼠更接近正 常状态,对脾虚的改善作用最强。
B、毒理研究及实验
本发明养胃、开胃、消食儿童专用膏滋是专门应用于儿童的脾虚积食,消化 不良的专用膏滋,所有原料均为药食同源的安全原料,但为了保障儿童安全,发 明人仍进行了毒理实验,以全保本发明的安全性,具体如下:
1.实验材料
1.1受试品与试剂:
受试品:儿童养胃膏滋提取物由杭州胡庆余堂天然食品有限公司提供;
材料与试剂:利血平注射液(批号:2018060074,天津金耀药业有限公司);
水合氯醛(批号:20180819,成都市科伦化学试剂场);
胃蛋白酶试剂盒(批号:20181011,南京建成生物工程研究所);
动物饲料:普通饲料(由南方医科大学提供)。
1.2实验动物:清洁剂昆明小鼠,SPF级,雌雄各半,体重25±5g,动物合格证 号:SCXK粤2018-0271,由南方医科大学实验动物中心提供。
2.实验方法:
取小鼠50只,分成5组,雌雄各半,分开饲养,称量初始体重;各组小鼠一 次性灌服剂量分别为为0.5g/kg.d、1.0g/kg.d、3g/kg.d、5g/kg.d、7g/kg.d 的儿童养胃膏滋,连续灌服7天。记录小鼠体重,记录小鼠的中毒症状、中毒发 生时间、持续时间、恢复期以及死亡情况,测定LD50。
3.实验结果:
3.1儿童养胃膏滋对小鼠体重的影响
试验过程中,各组小鼠均未见死亡现象;测得各组小鼠,均在正常体重范围内。 小鼠体重信息如表4,各组小鼠体重无显著性差异。
3.2儿童养胃膏滋对小鼠其他生命体征的影响
第5组小鼠,在给药3小时后,雌性组的其中一只出现震颤,弓背现象;雌性 组反应稍有延迟;给药9小时后小鼠正常。其他剂量组均无发生中毒现象,24小 时内无死亡记录。毒性试验结果如表5。
表5剂量为7g/kg.d小鼠毒性试验24小时观察结果
3.3儿童养胃膏滋毒性试验LD50
有毒性试验结果可知,儿童养胃膏滋毒性试验的LD50大于7000mg/kg。
综上药理实验与毒理实验,儿童养胃膏滋有健脾、消食的作用,且在剂量为 3g/kg.d时,对大鼠脾虚的恢复作用最强;以上实验剂量均在安全范围内。
以上所述并非是对本发明的限制,应当指出:对于本技术领域的普通技术人 员来说,在不脱离本发明实质范围的前提下,还可以做出若干变化、改型、添加 或替换,这些改进和润饰也应视为本发明的保护范围。
Claims (8)
1.一种具有养胃开胃消食作用的药食两用儿童专用膏滋,其特征在于,所述的膏滋使用的原料组成为:玉竹、薏苡仁、山楂、鸡内金、麦芽、山药、茯苓、桔梗、白扁豆、肉豆蔻、砂仁、冰糖,所述的原料组分的重量配比如下:
玉竹:6-12份
薏苡仁:4-10份
山楂:5-10份
鸡内金:2-8份
麦芽:2-6份
山药:2-5份
茯苓:2-3份
桔梗:1-3份
白扁豆:1-3份
肉豆蔻:1-4份
砂仁:1-4份
冰糖:6-8份。
2.根据权利要求1所述的具有养胃开胃消食作用的药食两用儿童专用膏滋,其特征在于,所述的原料组分的重量配比如下:
玉竹:8-10份
薏苡仁:6-8份
山楂:6-9份
鸡内金:2-4份
麦芽:3-6份
山药:2-4份
茯苓:2-3份
桔梗:1-2份
白扁豆:1-2份
肉豆蔻:1-2份
砂仁:1-2份
冰糖:7-8份。
3.根据权利要求2所述的具有养胃开胃消食作用的药食两用儿童专用膏滋,其特征在于,所述的原料组分的重量配比如下:
玉竹:10份
薏苡仁:6 份
山楂:6 份
鸡内金:3份
麦芽:4份
山药:2份
茯苓:3份
桔梗:1份
白扁豆:1份
肉豆蔻:1份
砂仁:1份
冰糖:8份。
4.一种制备如权利要求1或2或3所述的具有养胃开胃消食作用的药食两用儿童专用膏滋的方法,其特征在于,所述的制备方法包括选料检测、原料前处理、煎煮浓缩、灌装灭菌、检验和包装步骤,所述的原料前处理含蒸制、炒制、粉碎,具体制备步骤如下:
1)选料检测:采用地道应季药材,进行检测,有效成分以各药材指标成分或功效成分,以及水分、灰分、浸出物计,控制原材料质量,定点采购,备用;
2)原料前处理:玉竹抢水清洗、润软、切制成片段7-12mm,至数控中药蒸煮锅蒸制8小时以上,闷至过夜,备用;薏苡仁、山楂、白扁豆、麦芽,清炒至外壁略有焦斑,备用;鸡内金,沙炒至发泡、酥脆,备用;砂仁置钆扁机中压钆至表皮破碎,备用;冰糖用高速粉碎机粉碎成20目细粉,备用;其他原料切片或粉碎成粗颗粒,备用;
3)煎煮浓缩:取上述经处理的原料,加饮用水煎煮,煎煮用水量为原料量的10-20倍,煎煮时间为1.5-3h,煎煮次数为2-3次,去料渣,料液经减压浓缩至比重为1.1-1.2,浓缩时,真空≤-0.75Kpa,温度≤70°C;
4)灌装灭菌:将步骤3)稠厚膏滋进行灌装至洗净的玻璃瓶或耐煎煮食品复合膜,密封,105°C灭菌30分钟;
5)检验:生产结束,抽样检测,技术要求为:外观性状、比重、灰分、多糖含量、净含量、卫生学数据;
6)包装:所有项目合格后的瓶或软包装贴签装盒入库。
5.根据权利要求4所述的制备具有养胃开胃消食作用的药食两用儿童专用膏滋的方法,其特征在于,所述的步骤1)中,所述的控制原材料各药材质量要求具体为:玉竹:浸出物≥50.0%、玉竹多糖≥6.0%;薏苡仁:浸出物≥5.5%、甘油三油酸酯≥0.50%;山楂:浸出物≥21.0%、有机酸≥5.0%;鸡内金:浸出物≥7.5%;麦芽:黄曲霉素≤10μg/1000g;山药:浸出物≥10.0%、灰分≤5.0%;茯苓 :浸出物≥2.5%、灰分≤2.0%;桔梗:浸出物≥17.0%、桔梗皂苷≥0.10%;白扁豆:水分≤14.0%;肉豆蔻:黄曲霉素≤10μg/1000g、挥发油≤6.0%、去氢二异丁香酚≥0.10%;砂仁:挥发油≥3.0%、乙酸龙脑脂≥0.90%;冰糖:蔗糖分≥99.7%、还原糖分≤0.04%、干燥失重≤0.15%色值≤30IU、不溶于水杂质≤20mg/Kg。
6.根据权利要求4所述的制备具有养胃开胃消食作用的药食两用儿童专用膏滋的方法,其特征在于,所述的步骤4)中灌装环节生产要求在十万级净化区内进行。
7.根据权利要求5或6所述的制备具有养胃开胃消食作用的药食两用儿童专用膏滋的方法,其特征在于,所述的制备而成的膏滋:外观为深棕色至深褐色稠厚液体,味甜、回味有植物原料特有的滋气味;灰分≤6.0%、粗多糖含量≥2.0%、卫生学达到商业无菌要求。
8.根据权利要求5或6所述的制备具有养胃开胃消食作用的药食两用儿童专用膏滋的方法,其特征在于,所述的制备而成的膏滋,经药理实验证明:最佳剂量为3 g/kg.d。
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