CN110812455A - 一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途 - Google Patents
一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途 Download PDFInfo
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Abstract
本发明一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途，是在现有技术国家药品标准记载的芪斛楂颗粒基础上，根据中医辨证理论，对其组方中增加了沙棘、覆盆子、桂圆和牛磺酸成分制备而成液体口服制剂。本发明与现有技术相比加强了调解脾胃、消食导滞功效，具有可调节脾胃功能，提高机体免疫力，改善机体的亚健康状态。治疗小儿厌食、偏食、营养不良、脾虚型腹泻、发热、呼吸道、消化道等部位反复感染等病症。
Description
技术领域
本发明属儿童用中药技术开发领域，具体涉及一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途。
背景技术
厌食症是小儿时期常见一种症状，临床以较长时间厌恶进食，食量减少，体质量增长缓慢为主要特征。病程长的可对小儿的生长发育以及智力发育造成不良影响。
急性上呼吸道感染是儿科常见的疾病，各种病毒和细菌均可引起，但以病毒为多见，约占90％以上，常见症状有高热、咳嗽、食欲下降，可伴有呕吐、腹泻、烦躁，甚至高热惊厥。病程3～5天，如体温不退或病情加重，应考虑感染可能侵袭其他部位。尤其高热是家长就诊的主要目的，常引起家长的娇养，但喂养不当极易引起一系列喂养并发症，降低体质量儿的存活率。
国家药品标准(WS-5745(B-0745)-2014Z)收载的芪胡渣颗粒，是由黄芪、淮山药、炙甘草、茯苓、石斛、炒麦芽、山楂、木瓜、党参、陈皮、白术11味药组成，具有健脾和胃、益气固表消食、消食导滞作用，用于改善小儿脾胃虚弱、脾失健运证引起的厌食、偏食、汗多、大便不调、易感冒等症状。
沙棘(拉丁学名：Hippophae rhamnoides Linn.)，是一种胡颓子科、沙棘属落叶性灌木，沙棘果实中含有胡萝卜素、生物碱、脂肪酸、维生素C等成分，其中维生素C含量最高，素有维生素C之王的美称。能有效调节胃肠功能；提高人体免疫力、止咳平喘、利肺化痰功效。
覆盆子，是蔷薇科植物覆盆子的果实，又名树莓，含有丰富的维生素A、维生素C和很多矿物质，具有很高的营养价值和保健作用。未完全成熟的覆盆子采摘经过炮制，即为中药材，具有滋补肝肾、益精血、固摄、温肾阳的作用。现代研究表明，因为覆盆子中含有大量的黄酮类物质，这种物质不仅具有抗菌消炎、抗过敏的功效，还具有增加免疫力和抗衰老的作用。
桂圆，是桂圆干燥处理后形成的食物，又名益智、龙眼肉。性平，味甘，它含有硫胺素、核黄素、尼克酸、抗坏血酸等化学成份，具有益心脾、补气补血，安神定志，养血安胎的功效。适用于失眠健忘，脾虚腹泻，精神不振，虚劳羸弱等病症。
牛磺酸(Taurine，Tau)，是动物体内一种结构简单的含硫氨基酸，化学名称为2-氨基乙磺酸，在人和动物胆汁中与胆酸结合，牛磺酸有抗炎、解热、镇痛、镇静、抗菌、增强免疫等功能，临床上主要用于治疗支气管炎、扁桃体炎、感冒、发热、小儿痉挛症等病症。
发明内容
本发明一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途，是在国家药品标准(WS-5745(B-0745)-2014Z)记载的芪斛楂颗粒基础上，根据中医辨证理论，对其组方中增加了沙棘、覆盆子、桂圆和牛磺酸4种成分。在原功用的基础上，加强了调解脾胃、消食导滞等功效。其具体的功用为：具有可调节脾胃功能，提高机体免疫力，改善机体的亚健康状态。治疗小儿厌食、偏食、营养不良、脾虚型腹泻、发热、呼吸道、消化道等部位反复感染等病症。
实现本发明的技术方案如下：
一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途，包括含糖型和无糖型两种液体口服制剂，其组方是由原料、辅料和适量的溶剂组成。
所述原料包括黄芪、淮山药、炙甘草、茯苓、石斛、炒麦芽、山楂、木瓜、党参、陈皮、白术、沙棘、覆盆子、桂圆、牛磺酸。
所述辅料包括矫味剂、防腐剂、香精。
所述溶剂包括去离子水、纯化水、蒸馏水。
一、组方及配比为：
1本发明所述液体口服制剂，以重量份计，其组方及配比为：
1.1、原料：黄芪10-50份、淮山药20-100份、炙甘草10-50份、茯苓10-50份、石斛5-50份、炒麦芽5-50份、山楂10-80份、木瓜5-50份、党参5-50份、陈皮10-50份、白术5-50份、沙棘10-100份、覆盆子5-30份、桂圆5-50份、牛磺酸1-10份；
1.2辅料：矫味剂100-800份、防腐剂0.1-50份、香精0.5-5份；
1.3溶剂：适量。
2、还可以是：
2.1原料：黄芪30份、淮山药35份、炙甘草20份、茯苓30份、石斛25份、炒麦芽25份、山楂32份、木瓜25份、党参28份、陈皮20份、白术30份、沙棘35份、覆盆子20份、桂圆30份、牛磺酸5份；
2.2辅料：矫味剂200-700份、防腐剂0.2-40份、香精0.5-4份；
2.3溶剂：适量。
3、还可以是：
3.1原料：黄芪10-50份、淮山药20-100份、炙甘草10-50份、茯苓10-50份、石斛5-50份、炒麦芽5-50份、山楂10-80份、木瓜5-50份、党参5-50份、陈皮10-50份、白术5-50份、沙棘10-100份、覆盆子5-30份、桂圆5-50份、牛磺酸1-10份；
3.2辅料：矫味剂1-50份、防腐剂0.1-50份、香精0.5-5份；
3.3溶剂：适量。
4、还可以是：
4.1原料：黄芪30份、淮山药35份、炙甘草20份、茯苓30份、石斛25份、炒麦芽25份、山楂32份、木瓜25份、党参28份、陈皮20份、白术30份、沙棘35份、覆盆子20份、桂圆30份、牛磺酸5份；
4.2辅料：矫味剂1-50份、防腐剂0.1-50份、香精0.5-5份；
4.3溶剂：适量。
组方及配比1或2中所述矫味剂为蔗糖。
组方及配比3或4中所述矫味剂包括甜菊素、阿斯巴甜、安赛蜜、蛋白糖、甘草甜素、纽甜、三氯蔗糖中的任意一种或几种。
组方及配比1-4中所述防腐剂包括苯甲酸、山梨酸及其盐类中的任意一种或几种的混合；
组方及配比1-4中所述香精包括但不限于柠檬香精、水蜜桃香精、哈密瓜香精、葡萄香精、杂果香精、蓝莓香精、香蕉香精、草莓香精、橙子香精中的任意一种或几种。
组方及配比1-4中所述溶剂包括纯化水、去离子水、蒸馏水。
二、制备方法：
1、制备方法1(含糖型口服液体制剂)：
取上述组方及配比1或2中所述原料、辅料和溶剂，按下述方法制备；
1.1取牛磺酸，加少量纯化水溶解，得牛磺酸水溶液，备用；
1.2取黄芪等其余13味药材，加水煎煮二次，第一次加水10-12倍量，煎煮2-3小时，第二次加水8-10倍量，煎煮1-2小时，合并两次煎煮液，过滤，滤液静止20-40小时，取上清液过滤，滤液减压浓缩至55-60℃时相对密度为1.2-1.3的清膏，得黄芪等药材提取清膏，备用；
1.3取上述黄芪等药材提取清膏，加乙醇使含醇量为60-80％，搅拌15-30分钟，3-25℃条件下静止18-24小时，取上清液，过滤，滤液回收乙醇至无醇味后，浓缩至55-60℃时相对密度为1.25-1.35稠膏，得醇沉稠膏，备用；
1.4取矫味剂、防腐剂及香精，加少量纯化水溶解，过滤，得矫味剂等辅料溶解液，备用；
1.5取上述醇沉稠膏，加牛磺酸水溶液及矫味剂等辅料溶解液，加纯化水至配制量的70-80％，搅拌溶解后，静置18-24小时，过滤，滤液加纯化水至配制总量，搅拌15-30分钟，灌装，灭菌，即得。
2、制备方法2(无糖型液体口服液制剂)：
取上述组方及配比3或4中所述原料、辅料和溶剂，按下述方法制备；
2.1、取牛磺酸，加少量纯化水溶解，得牛磺酸水溶液，备用；
2.2、取黄芪等其余13味原料，加水煎煮二次，第一次加水10-12倍量，煎煮2-3小时，第二次加水8-10倍量，煎煮1-2小时，合并两次煎煮液，过滤，滤液静止18-24小时，取上清液，过滤，滤液减压浓缩至55-60℃时相对密度为1.2-1.3的清膏，得黄芪等药材提取清膏，备用；
2.3、取上述黄芪等药材提取清膏，加乙醇使含醇量为60-75℃，搅拌30分钟，5-7℃条件下静止18-24小时，取上清液，过滤，滤液回收乙醇至无醇味后，浓缩至55-60℃时相对密度为1.25-1.35稠膏，得醇沉稠膏，备用；
2.4、取矫味剂、防腐剂及香精，加少量纯化水溶解，过滤，滤液，备用；
2.5、取上述醇沉稠膏，加上述牛磺酸水溶液及滤液，加纯化水至配制量的70-80％，搅拌30分钟，加纯化水至配制量，搅匀，过滤，灌装，105℃湿热灭菌45分钟，即得。
制备方法1.2或2.2中所述过滤，是指用100-250目不锈钢筛网过滤。
制备方法1.3或2.3中所述过滤，是指用孔径为0.8μm的砂滤棒或瓷滤棒或过滤毡过滤。
制备方法1.4、1.5、2.4或2.5所述过滤，是指用孔径为0.45-0.68μm微孔滤膜过滤。
制备方法1.5或2.5所述灭菌，是指用105℃湿热灭菌45分钟或121℃湿热灭菌25分钟所述的液体口服制剂还包括口服液、混悬液或糖浆剂等剂型。
本发明还可以制备成冲剂、片剂、胶囊剂等固体制剂剂型。
本发明的用途：可调节脾胃功能，提高机体免疫力，改善机体的亚健康状态，治疗小儿厌食、偏食、营养不良、脾虚型腹泻、发热、呼吸道、消化道等部位反复感染等病症。
有益效果
本发明一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途，是在现有技术国家药品标准记载的芪斛楂颗粒基础上，根据中医辨证理论，对其组方中增加了沙棘、覆盆子、桂圆和牛磺酸成分制备而成液体口服制剂。本发明与现有技术相比加强了调解脾胃、消食导滞功效，具有可调节脾胃功能，提高机体免疫力，改善机体的亚健康状态。治疗小儿厌食、偏食、营养不良、脾虚型腹泻、发热、呼吸道、消化道等部位反复感染等病症。
具体实施方式
下列实施例进一步描述和证明了本发明范围内的实施方案，所给出的这些实施例为了举例说明目的，不可看作是对本发明的限制。
以下是本发明液体口服制剂的各种示例性非限制性实施例。
实施例1(制备1000ml)
原料：黄芪30份、淮山药35份、炙甘草20份、茯苓30份、石斛25份、炒麦芽25份、山楂32份、木瓜25份、党参28份、陈皮20份、白术30份、沙棘35份、覆盆子20份、桂圆30份、牛磺酸5份；
辅料：蔗糖400份、苯甲酸钠10份及葡萄香精1份；
溶剂：纯化水。
制备方法：
1、取牛磺酸，加少量纯化水溶解，得牛磺酸水溶液，备用；
2、取黄芪等其余13味原料，加水煎煮二次，第一次加水12倍量，煎煮2.5小时，第二次加水8倍量，煎煮1小时，合并两次煎煮液，用250目筛网过滤，滤液静止24小时，取上清液，用250目筛网过滤，滤液减压浓缩至55-60℃时相对密度为1.2-1.3的清膏，得黄芪等药材提取清膏，备用；
3、取上述黄芪等药材提取清膏，加乙醇使含醇量为75℃，搅拌30分钟，5-7℃条件下静止24小时，取上清液，用孔径为0.60μm砂滤棒过滤，滤液回收乙醇至无醇味后，浓缩至55-60℃时相对密度为1.25-1.35稠膏，得醇沉稠膏，备用；
4、取蔗糖、苯甲酸钠及葡萄香精，加少量纯化水溶解，用孔径为0.60μm微孔滤膜过滤，滤液，备用；
5、取上述醇沉稠膏，加上述牛磺酸水溶液及滤液，加纯化水至配制量的70-80％，搅拌30分钟，加纯化水至1000ml，搅匀，用0.60μm微孔滤膜过滤，灌装，105℃湿热灭菌45分钟，即得。
实施例2(制备1000ml)
原料：黄芪30份、淮山药35份、炙甘草20份、茯苓30份、石斛25份、炒麦芽25份、山楂32份、木瓜25份、党参28份、陈皮20份、白术30份、沙棘35份、覆盆子20份、桂圆30份、牛磺酸5份；
辅料：甜菊素3份、苯甲酸5份及葡萄香精1份；
溶剂：纯化水。
制备方法：
取牛磺酸，加少量纯化水溶解，得牛磺酸水溶液，备用；
取黄芪等其余13味药材，加水煎煮二次，第一次加水12倍量，煎煮2小时，第二次加水8倍量，煎煮1.5小时，合并两次煎煮液，用250目筛网过滤，滤液静止24小时，取上清液，用250目筛网过滤，滤液减压浓缩至55-60℃时相对密度为1.2-1.3的清膏，得黄芪等药材提取清膏，备用；
取上述黄芪等药材提取清膏，加乙醇使含醇量为75℃，搅拌30分钟，5-7℃条件下静止24小时，取上清液，用孔径为0.60μm砂滤棒过滤，滤液回收乙醇至无醇味后，浓缩至55-60℃时相对密度为1.25-1.35稠膏，得醇沉稠膏，备用；
取甜菊素、苯甲酸及葡萄香精，加少量纯化水溶解，用孔径为0.60μm微孔滤膜过滤，滤液，备用；
取上述醇沉稠膏，加上述牛磺酸水溶液及滤液，加纯化水至配制量的70-80％，搅拌30分钟，加水至1000ml，搅匀，用0.60μm微孔滤膜过滤，灌装，120℃湿热灭菌25分钟，即得。
实施例3
用本发明实施例2制备的液体口服制剂治疗小儿厌食症50例。
1、患者筛选：
选取具有厌食且中医辨证为脾虚型的患儿50例，随机表分为2组。治疗组25例，2～3岁5例，3～5岁28例，5岁以上17例；对照组50例，2～3岁7例，3～5岁30例，6岁以上13例，经统计学计算：差异无统计学意义(P＞0.05)，具有可比性。
2、诊断标准：
参照《中医儿科学》厌食的诊断标准：(1)长期食欲不振、食量减少，而无其他疾病者；(2)面色少华，形体消瘦，但精神尚好；(3)有喂养当史，如进食无定时、定量，过食生冷、甘甜厚味、零食，或偏食等；(4)厌恶进食，食而乏味或偶然多食后则脘腹胀满，大便不调，精神良好，舌质淡红，苔白腻或微黄，脉濡缓或滑数。脾胃气虚型症见：不思饮食，形体偏瘦，食少便多，面色少华，神倦乏力，易出汗，易感冒，舌体胖嫩，舌质淡，苔薄白，脉缓无力。
3、治疗方法：
治疗组口服本发明实施例2所得液体口服制剂：1～3岁1次5ml，1天3次；3～5岁1次10ml，1天3次；6岁以上1次20ml，1天3次。1周为1个疗程，连续用药2个疗程；对照组给予乳酸菌素片和葡萄糖酸锌口服液，疗程同1.3。
统计学处理：采用X2检验对数据进行统计分析，P＜0.05有统计学意义。
4、治疗结果：
疗效判定标准：参照《常见疾病诊断依据与疗效判断标准》，显效：食欲明显恢复，食量恢复到原有水平的3/4，原有症状基本消失者；有效：食欲有改善，食量有所恢复，但未达到原有水平的3/4，原有症状减轻者；无效：食欲与食量均无改善，两组临床疗效结果见表1。
表1：两组临床疗效比较
| 组别 | 病例数 | 显效 | 有效 | 无效 | 总有效率(％) |
| 治疗组 | 25 | 15 | 9 | 1 | 96 |
| 对照组 | 25 | 8 | 12 | 6 | 80 |
两组疗效比较 治疗组疗效优于对照组，差异有统计学意义(P＜0.01)。
实施例4
用本发明实施例2制备的液体口服制剂，治疗儿童营养不良疗效观察。
1、患者筛选：
选取67例2～7岁小儿营养不良儿童，随机分为治疗组与对照组，治疗组36例与对照组31例。治疗组男15例，女21例；对照组男20例，女11例。
2、治疗方法：
对照组给予一般对症治疗，治疗组口服本发明实施例2所得液体口服制剂，2～4岁每次10ml，每天3次；4～7岁每次20ml，每天3次，连服8周。试验期间每周记录患儿食欲、食量改善情况。治疗前及治疗后6个月分别测量体重，以了解体重变化情况。
3、疗效判定标准：
显效，观察期内治疗后体重达标；有效，治疗后发病次数减少50％，治疗后体重达标；无效，治疗后体重仍未达标。
统计学方法：
计量资料以均数±标准差(x±s)表示，两两比较采用t检验。
4、治疗结果：两组临床疗效比较，见表2。
表2：两组临床疗效比较
| 组别 | 病例数 | 显效 | 有效 | 无效 | 总有效率(％) | p |
| 治疗组 | 36 | 18 | 13 | 5 | 86.11 | ＜0.01 |
| 对照组 | 31 | 1 | 15 | 16 | 51.61 | ＜0.01 |
治疗组治疗后患儿食欲明显改善，总有效率为86.11％患儿食量恢复正常。而对照组患儿仅16食欲改善总有效率51.61％。
实施例5
用本发明实施例2制备的液体口服制剂治疗小儿脾虚性腹泻。
1、诊断标准：参照《现代中医儿科诊疗全书》诊断标准。
2、患者筛选：
依据上述标准将78例门诊确诊的小儿脾虚型患儿，病程1～6个月，随机分为治疗组56例和对照组22例。治疗组男38例，女18例；对照组男14例，女8例。治疗组年龄最小2岁，最大7岁，平均4.3岁；对照组年龄最小9个月，最大8岁，平均6.2岁。两组年龄比较差异无显著性(P＞0.05)。
3、治疗方法
治疗组口服本发明实施例2制备的口服液体制剂，2～4岁，5ml/次，3次/天；5～7岁，10ml/次，3次/天。对照组口服乳酸菌素片，9个月～3岁，0.5ml/天，3次/天；4岁～8岁10ml/次，3次/天。两组均以7天为一疗程，连续观察2个疗程。
4、临床疗效评定标准
参照国家中医药管理局医政司制定的《中医内外妇儿科病证诊断疗效标准》(1)痊愈：大便每日1次，成形软便无黏液，全身症状消失，食欲好转，大便镜检无异常；(2)显效：大便次数明显减少，减至治疗前的1/3以下，成形或软糊，全身症状和大便镜检明显改善；(3)有效：大便次数减至治疗前的1/2，形状、症状、大便镜检有所改善；(4)无效：大便次数及形状无改善，大便镜检仍异常。
5、治疗结果：两组疗效比较，见表3。
表3
| 组别 | 病例数 | 痊愈 | 显效 | 有效 | 无效 | 总有效率 |
| 治疗组 | 56 | 18 | 22 | 15 | 1 | 98.22 |
| 对照组 | 22 | 1 | 3 | 12 | 6 | 72.72 |
经统计学处理及分析，治疗组在总有效率、痊愈率、显效率诸方面均优于对照组，说明本发明制备的液体口服制剂治疗小儿脾虚型腹泻的疗效肯定。
说明：上述实施例3-5，委托内蒙古医院进行临床试验。
Claims (20)
1.一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途，其特征在于其组方是由原料、辅料和适量的溶剂组成，所述原料包括黄芪、淮山药、炙甘草、茯苓、石斛、炒麦芽、山楂、木瓜、党参、陈皮、白术、沙棘、覆盆子、桂圆、牛磺酸；所述辅料包括矫味剂、防腐剂、香精；所述溶剂包括去离子水、纯化水、蒸馏水。
2.根据权利要求1所述的原料、辅料和适量的溶剂，其特征在于以重量份计，其组方及配比为：
2.1、原料：黄芪10-50份、淮山药20-100份、炙甘草10-50份、茯苓10-50份、石斛5-50份、炒麦芽5-50份、山楂10-80份、木瓜5-50份、党参5-50份、陈皮10-50份、白术5-50份、沙棘10-100份、覆盆子5-30份、桂圆5-50份、牛磺酸1-10份；
2.2辅料：矫味剂100-800份、防腐剂0.1-50份、香精0.5-5份；
2.3溶剂：适量。
3.根据权利要求2所述的原料、辅料和适量的溶剂，其特征在于其特征在于以重量份计，其组方及配比还可以是：
3.1原料：黄芪30份、淮山药35份、炙甘草20份、茯苓30份、石斛25份、炒麦芽25份、山楂32份、木瓜25份、党参28份、陈皮20份、白术30份、沙棘35份、覆盆子20份、桂圆30份、牛磺酸5份；
3.2辅料：矫味剂200-700份、防腐剂0.2-40份、香精0.5-4份；
3.3溶剂：适量。
4.根据权利要求1所述的原料、辅料和适量的溶剂，其特征在于以重量份计，其组方及配比还可以是：
4.1原料：黄芪10-50份、淮山药20-100份、炙甘草10-50份、茯苓10-50份、石斛5-50份、炒麦芽5-50份、山楂10-80份、木瓜5-50份、党参5-50份、陈皮10-50份、白术5-50份、沙棘10-100份、覆盆子5-30份、桂圆5-50份、牛磺酸1-10份；
4.2辅料：矫味剂1-50份、防腐剂0.1-50份、香精0.5-5份；
4.3溶剂：适量。
5.根据权利要求4所述的原料、辅料和适量的溶剂，其特征在于以重量份计，其组方及配比还可以是：
5.1原料：黄芪30份、淮山药35份、炙甘草20份、茯苓30份、石斛25份、炒麦芽25份、山楂32份、木瓜25份、党参28份、陈皮20份、白术30份、沙棘35份、覆盆子20份、桂圆30份、牛磺酸5份；
5.2辅料：矫味剂1-50份、防腐剂0.1-50份、香精0.5-5份；甜菊素3份、苯甲酸5份及葡萄香精1份；
5.3溶剂：适量。
6.根据权利要求2或3所述原料、辅料和适量的溶剂，其特征在于所述矫味剂为蔗糖。
7.根据权利要求4或5所述原料、辅料和适量的溶剂，其特征在于所述矫味剂包括甜菊素、阿斯巴甜、安赛蜜、蛋白糖、甘草甜素、纽甜、三氯蔗糖中的任意一种或几种。
8.根据权利要求1-5所述的原料、辅料和适量的溶剂，其特征在于所述防腐剂包括苯甲酸、山梨酸及其盐类中的任意一种或几种的混合。
9.根据权利要求1-5所述的原料、辅料和适量的溶剂，其特征在于所述香精包括但不限于柠檬香精、水蜜桃香精、哈密瓜香精、葡萄香精、杂果香精、蓝莓香精、香蕉香精、草莓香精、橙子香精中的任意一种或几种。
10.根据权利要求1-5所述的原料、辅料和适量的溶剂，其特征在于所述溶剂包括纯化水、去离子水、蒸馏水。
11.根据权利要求1所述一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途，其特征在于制备方法包括含糖型口服液体制剂和无糖型口服液体制剂。
12.根据权利要求10所述含糖型口服液体制剂制备方法，其特征在于制备方法是取上述权利要求2或3中所述原料、辅料和溶剂及其配比，按下述方法制备；
12.1取牛磺酸，加少量纯化水溶解，得牛磺酸水溶液，备用；
12.2取黄芪等其余13味药材，加水煎煮二次，第一次加水10-12倍量，煎煮2-3小时，第二次加水8-10倍量，煎煮1-2小时，合并两次煎煮液，过滤，滤液静止20-40小时，取上清液过滤，滤液减压浓缩至55-60℃时相对密度为1.2-1.3的清膏，得黄芪等药材提取清膏，备用；
12.3取上述黄芪等药材提取清膏，加乙醇使含醇量为60-80％，搅拌15-30分钟，3-25℃条件下静止18-24小时，取上清液，过滤，滤液回收乙醇至无醇味后，浓缩至55-60℃时相对密度为1.25-1.35稠膏，得醇沉稠膏，备用；
12.4取矫味剂、防腐剂及香精，加少量纯化水溶解，过滤，得矫味剂等辅料溶解液，备用；
12.5取上述醇沉稠膏，加牛磺酸水溶液及矫味剂等辅料溶解液，加纯化水至配制量的70-80％，搅拌溶解后，静置18-24小时，过滤，滤液加纯化水至配制总量，搅拌15-30分钟，灌装，灭菌，即得。
13.根据权利要求10所述无糖型口服液体制剂制备方法，其特征在于制备方法为取上述组方及配比3或4中所述原料、辅料和溶剂，按下述方法制备；
13.1取牛磺酸，加少量纯化水溶解，得牛磺酸水溶液，备用；
13.2取黄芪等其余13味原料，加水煎煮二次，第一次加水10-12倍量，煎煮2-3小时，第二次加水8-10倍量，煎煮1-2小时，合并两次煎煮液，过滤，滤液静止18-24小时，取上清液，过滤，滤液减压浓缩至55-60℃时相对密度为1.2-1.3的清膏，得黄芪等药材提取清膏，备用；
13.3取上述黄芪等药材提取清膏，加乙醇使含醇量为60-75℃，搅拌30分钟，5-7℃条件下静止18-24小时，取上清液，过滤，滤液回收乙醇至无醇味后，浓缩至55-60℃时相对密度为1.25-1.35稠膏，得醇沉稠膏，备用；
13.4取矫味剂、防腐剂及香精，加少量纯化水溶解，过滤，滤液，备用；
13.5取上述醇沉稠膏，加上述牛磺酸水溶液及滤液，加纯化水至配制量的70-80％，搅拌30分钟，加纯化水至配制量，搅匀，过滤，灌装，105℃湿热灭菌45分钟，即得。
14.根据权利要求12或13所述制备方法，其特征在于权利要求11.2或12.2中所述过滤，是指用100-250目不锈钢筛网过滤。
15.根据权利要求12或13所述制备方法，其特征在于权利要求11.3或12.3中所述过滤，是指用孔径为0.8μm的砂滤棒或瓷滤棒或过滤毡过滤。
16.根据权利要求12或13所述制备方法，其特征在于权利要求11.4、11.5、12.4或12.5所述过滤，是指用孔径为0.45-0.68μm微孔滤膜过滤。
17.根据权利要求12或13所述制备方法，其特征在于权利要求11.5或12.5所述灭菌，是指用105℃湿热灭菌45分钟或121℃湿热灭菌25分钟。
18.根据权利要求1所述一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途，其特征在于所述的液体口服制剂还包括口服液、混悬液或糖浆剂等剂型。
19.根据权利要求1所述一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途，其特征在于所述的液体口服制剂还可以制备成冲剂、片剂、胶囊剂等固体制剂剂型。
20.根据权利要求1所述一种治疗儿童厌食、偏食等病症的液体口服制剂及其制备方法和用途，其特征在于所述用途：可调节脾胃功能，提高机体免疫力，改善机体的亚健康状态，治疗小儿厌食、偏食、营养不良、脾虚型腹泻、发热、呼吸道、消化道等部位反复感染等病症。
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