CN106728666A - 赖氨葡锌片 - Google Patents
赖氨葡锌片 Download PDFInfo
- Publication number
- CN106728666A CN106728666A CN201611094126.5A CN201611094126A CN106728666A CN 106728666 A CN106728666 A CN 106728666A CN 201611094126 A CN201611094126 A CN 201611094126A CN 106728666 A CN106728666 A CN 106728666A
- Authority
- CN
- China
- Prior art keywords
- bulbil
- hawthorn
- parts
- radix astragali
- lysinepuzinc
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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Classifications
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Abstract
本发明公开了一种赖氨葡锌片，是由盐酸赖氨酸、葡萄糖酸锌、零余子、山楂、黄芪为原料制备而成的。本发明在现有赖氨葡锌片配方基础上，加入零余子、山楂、黄芪的有效成分，制成中西药结合的复方赖氨葡锌片，不但能很好的解决小儿及青少年因缺乏赖氨酸和锌而引起的生长发育迟缓、营养不良及食欲缺乏等问题，还可以大大减轻胃肠道刺激、降低药物不良反应，有助于减小胃部不适，恶心、呕吐、便秘等副作用。
Description
技术领域
本发明属于医药技术领域，涉及一种赖氨葡锌片及其制备方法。
背景技术
赖氨酸是儿童生长发育中不可缺少的重要元素；缺乏时食欲不振，生长缓慢，导致智力低下。葡萄糖酸锌是生命体中的重要物质之一；儿童成长过程中，往往会出现缺锌；当缺乏时，厌食，食欲不振，精神萎靡，发育迟缓。赖氨葡锌片很好的解决了小儿及青少年因缺乏赖氨酸和锌而引起的生长发育迟缓、营养不良及食欲缺乏等问题。但是现有赖氨葡锌片对胃肠道具有一定的刺激作用，某些小儿服用后可见轻度恶心、呕吐、便秘等反应。已公开的文献中没有报道“赖氨葡锌片复方中药制成复方制剂”来解决服用赖氨葡锌片对胃肠道产生刺激作用的问题。 同时由于中药成分复杂，即使药材相同，不同的提取制备工艺制备的药物的药效也可能不同。
发明内容
鉴于上述不足之处，本发明的目的在于：提供一种复方赖氨葡锌片，不但能很好的解决小儿及青少年因缺乏赖氨酸和锌而引起的生长发育迟缓、营养不良及食欲缺乏等问题，还可以大大减轻胃肠道刺激、降低药物不良反应，有助于减小胃部不适，恶心、呕吐、便秘等副作用。
为了达到上述目的，本发明采用了以下技术方案：
一种赖氨葡锌片是由盐酸赖氨酸、葡萄糖酸锌、零余子、山楂、黄芪为原料制备而成的。
所述的赖氨葡锌片的制备方法包括下列步骤：
（1）称取下述重量配比的原料：
盐酸赖氨酸25-40份、葡萄糖酸锌25-35份、零余子15-35份、山楂15-35份、黄芪15-35份；
（2）取零余子，50-90℃干燥，粉碎过100目筛，得到零余子细粉；
（3）取山楂用10倍重量的75-90%的乙醇溶液中浸渍60-90min，在40-45℃的条件下以3000-4000W的功率超声提取30-40min后过滤；滤渣再用10倍重量的60-75%的乙醇溶液超声提取，条件同上，过滤，合并两次滤液备用，滤液浓缩至相对密度为1.30-1.40g/ml，得山楂浸膏；
（4）取黄芪加6-10倍量的水煎煮3次，每次1小时，合并煎液，将煎液浓缩至相对密度为1.30-1.40g/ml，得黄芪浸膏；
（5）混合零余子细粉、山楂浸膏、黄芪浸膏，50-90℃干燥、粉碎过100目筛，得浸膏粉；
（6）加入盐酸赖氨酸、葡萄糖酸锌和药学上可接受的辅料，制备成药学上常用的片剂。
进一步的，上述步骤（1）称取的重量份配比的原料为：盐酸赖氨酸40份、葡萄糖酸锌35份、零余子25份、山楂25份、黄芪25份。
本发明中，复方赖氨葡锌片中中药组合物的制备方法基于各药物的有效成分的理化性质特点，如山楂中含有大量的有机酸、果酸、山楂酸、枸橼酸等，如果直接使用会使胃酸猛增，对胃黏膜造成不良刺激，使胃发胀满、泛酸，采用本发明方法所制备的山楂浸膏使得山楂有机酸含量适当和黄酮化合物既具有开胃健脾功效又不会胃肠道产生刺激。零余子为薯蓣科植物山药植株叶腋间生长的大小不一的肉质珠芽，含有淀粉及淀粉酶、粘液蛋白、多种氨基酸、膳食纤维、花青素、尿囊素、山药素、 薯蓣皂苷、B族维生素、维生素C、钾、镁、钙等多种营养元素，其蛋白质含量远远高于山药，为滋补养生佳品。其味甘，性温，无毒，入足少阴经，《本草拾遗》：“主补虚，强腰脚。晒干功用强于署预。”零余子是山药的精华，其微粉覆于胃肠粘膜，有利于胃肠粘膜的生长和修复，维持肠道内环境的平衡，并能增加肠粘膜中免疫球蛋白的数量，促进肠道免疫功能，减少肠内细菌素进入血液，从而保护消化道粘膜肠，消化道细胞更新快，具有滋养强壮，助消化，护肠胃等功效。
本发明复方赖氨葡锌片中中药组合物的制备工艺研究分为两部分。首先以零余子有效成分的得量为指标，通过大量试验研究，确定出山楂、黄芪与零余子的最佳组合方式与组合方法，即前两味药按一定方法制得浸膏之后直接与一定粉碎度的零余子干粉混合，从而尽可能多的保留了零余子有效成分。第二，本发明从制剂工艺出发，考虑到中药组份混合均匀性、耗时性及可操作程度，优选出浸膏的相对密度、零余子干粉的粉碎度；然后以制剂时的颗粒流动性、相关制剂的崩解时间、水分对制剂的影响等因素为指标，通过生产工艺及稳定性考察，最终筛选出该组合物的最佳制备方法。该制备方法与现有常规技术相比具有有效成含量高、疗效确切、价格低廉的特点。
本发明在现有赖氨葡锌片配方基础上，加入零余子、山楂、黄芪的有效成分，制成中西药结合的复方赖氨葡锌片，不但能很好的解决小儿及青少年因缺乏赖氨酸和锌而引起的生长发育迟缓、营养不良及食欲缺乏等问题，还可以大大减轻胃肠道刺激、降低药物不良反应，有助于减小胃部不适，恶心、呕吐、便秘等副作用。
具体实施方式
实施例1
本发明赖氨葡锌片的制备方法：
（1）称取原料：盐酸赖氨酸400g、葡萄糖酸锌350g、零余子250g、山楂250g、黄芪250g；
（2）取零余子，70℃干燥，粉碎过100目筛，得到零余子细粉；
（3）取山楂用10倍重量的75%的乙醇溶液中浸渍60min，在45℃的条件下以4000W的功率超声提取30min后过滤；滤渣再用10倍重量的60%的乙醇溶液超声提取，条件同上，过滤，合并两次滤液备用，滤液浓缩至相对密度为1.35g/ml，得山楂浸膏；
（4）取黄芪加10倍量的水煎煮3次，每次1小时，合并煎液，将煎液浓缩至相对密度为1.35g/ml，得黄芪浸膏；
（5）混合零余子细粉、山楂浸膏、黄芪浸膏，70℃干燥、粉碎过100目筛，得浸膏粉；
（6）加入盐酸赖氨酸、葡萄糖酸锌和药学上可接受的辅料（玉米淀粉、低取代羟丙纤维素、硬脂酸镁以及包衣材料），制备成药学上常用的片剂(10000片)。
实施例2
（1）称取原料：
盐酸赖氨酸250g、葡萄糖酸锌250g、零余子150g、山楂150g、黄芪150g；
（2）取零余子，60℃干燥，粉碎过100目筛，得到零余子细粉；
（3）取山楂用10倍重量的75%的乙醇溶液中浸渍60min，在45℃的条件下以3000W的功率超声提取40min后过滤；滤渣再用10倍重量的60%的乙醇溶液超声提取，条件同上，过滤，合并两次滤液备用，滤液浓缩至相对密度为1.30g/ml，得山楂浸膏；
（4）取黄芪加10倍量的水煎煮3次，每次1小时，合并煎液，将煎液浓缩至相对密度为1.30g/ml，得黄芪浸膏；
（5）混合零余子细粉、山楂浸膏、黄芪浸膏，60℃干燥、粉碎过100目筛，得浸膏粉；
（6）加入盐酸赖氨酸、葡萄糖酸锌和药学上可接受的辅料（玉米淀粉、低取代羟丙纤维素、硬脂酸镁以及包衣材料），制备成药学上常用的片剂(10000片)。
实施例3
（1）称取原料：盐酸赖氨酸400g、葡萄糖酸锌350g、零余子350g份、山楂350g、黄芪350g；
（2）取零余子，90℃干燥，粉碎过100目筛，得到零余子细粉；
（3）取山楂用10倍重量的90%的乙醇溶液中浸渍90min，在45℃的条件下以4000W的功率超声提取40min后过滤；滤渣再用10倍重量的75%的乙醇溶液超声提取，条件同上，过滤，合并两次滤液备用，滤液浓缩至相对密度为1.40g/ml，得山楂浸膏；
（4）取黄芪加10倍量的水煎煮3次，每次1小时，合并煎液，将煎液浓缩至相对密度为1.40g/ml，得黄芪浸膏；
（5）混合零余子细粉、山楂浸膏、黄芪浸膏，90℃干燥、粉碎过100目筛，得浸膏粉；
（6）加入盐酸赖氨酸、葡萄糖酸锌和药学上可接受的辅料（玉米淀粉、低取代羟丙纤维素、硬脂酸镁以及包衣材料），制备成药学上常用的片剂(10000片)。
本发明赖氨葡锌片服用方法如下：口服。预防用量：1-6个月新生儿，一次0.5片，一日1次；7-12个月儿童，一次0.5片，一日2次；1-10岁儿童，一次1片，一日2次；10岁以上儿童及成人，一次1片，一日3次。14天为一疗程。多个疗程遵医嘱。
本发明的药效试验观察报告如下：
试验对象：200名4-10岁儿童病例，病症：均有不同程度的食欲缺乏、营养不良、锌缺乏症等疾病。
方法：200名分A、B、C、D、E共5组各40人，A组服用：由实施例1所制得的赖氨葡锌片；B组服用：由400g盐酸赖氨酸、350g葡萄糖酸锌和药学上可接受的辅料（玉米淀粉、低取代羟丙纤维素、硬脂酸镁以及包衣材料），制备成药学上常用的片剂(10000片)。C组服用：由400g盐酸赖氨酸、350g葡萄糖酸锌、750g零余子按实施例1所述制备方法制备成药学上常用的片剂(10000片)；D组服用：由400g盐酸赖氨酸、350g葡萄糖酸锌、750g山楂按实施例1所述制备方法制备成药学上常用的片剂(10000片)；E组服用：由400g盐酸赖氨酸、350g葡萄糖酸锌、750g黄芪按实施例1所述方法制备成药学上常用的片剂(10000片)，每日早、晚各1次，每次1片，连续14天。
结果：
A组服用后均食欲增加、精神活泼、对锌缺乏症有很好疗效，近期临床疗效满意。在服药期间未见胃肠道不适、恶心、呕吐、便秘等不良反应。
B组服用后均食欲增加、精神活泼、对锌缺乏症有很好疗效，近期临床疗效较满意。在服药期间有13例存在一定程度的胃肠道不适或轻微恶心、呕吐、便秘等不良反应。
C组服用后均食欲增加、精神活泼、对锌缺乏症有很好疗效，近期临床疗效较满意。在服药期间有7例存在一定程度的胃肠道不适或轻微恶心、呕吐、便秘等不良反应。
D组服用后均食欲增加、精神活泼、对锌缺乏症有很好疗效，近期临床疗效较满意。在服药期间有9例存在一定程度的胃肠道不适或轻微恶心、呕吐、便秘等不良反应。
E组服用后均食欲增加、精神活泼、对锌缺乏症有很好疗效，近期临床疗效较满意。在服药期间有8例存在一定程度的胃肠道不适或轻微恶心、呕吐、便秘等不良反应。
上述结果表明：与未加中药组分的B组相比较，本发明所制得的赖氨葡锌片不但能解决小儿及青少年因缺乏赖氨酸和锌而引起的生长发育迟缓、营养不良及食欲缺乏等问题，还可以大大减轻胃肠道刺激、降低药物不良反应，有助于减小胃部不适，恶心、呕吐、便秘等副作用。C、D、E三组均单独分别加有零余子、山楂以及黄芪等中药有效成分，虽相较于B组，其胃部不适，恶心、呕吐、便秘等副作用优于B组，但其效果远远低于A组，因此，本发明赖氨葡锌片用各原料之间配伍使用对改善胃部不适，恶心、呕吐、便秘等副作用具有明显的协同增效作用。
Claims (3)
1.一种赖氨葡锌片,其特征在于：它是由盐酸赖氨酸、葡萄糖酸锌、零余子、山楂、黄芪为原料制备而成的。
2.一种如权利要求1所述的赖氨葡锌片的制备方法，其特征在于：该方法包括下列步骤：
（1）称取下述重量配比的原料：
盐酸赖氨酸25-40份、葡萄糖酸锌25-35份、零余子15-35份、山楂15-35份、黄芪15-35份；
（2）取零余子，50-90℃干燥，粉碎过100目筛，得到零余子细粉；
（3）取山楂用10倍重量的75-90%的乙醇溶液中浸渍60-90min，在40-45℃的条件下以3000-4000W的功率超声提取30-40min后过滤；滤渣再用10倍重量的60-75%的乙醇溶液超声提取，条件同上，过滤，合并两次滤液备用，滤液浓缩至相对密度为1.30-1.40g/ml，得山楂浸膏；
（4）取黄芪加6-10倍量的水煎煮3次，每次1小时，合并煎液，将煎液浓缩至相对密度为1.30-1.40g/ml，得黄芪浸膏；
（5）混合零余子细粉、山楂浸膏、黄芪浸膏，50-90℃干燥、粉碎过100目筛，得浸膏粉；
（6）加入盐酸赖氨酸、葡萄糖酸锌和药学上可接受的辅料，制备成药学上常用的片剂。
3.一种如权利要求2所述的赖氨葡锌片的制备方法，其特征在于：步骤（1）称取的重量份配比的原料为：盐酸赖氨酸40份、葡萄糖酸锌35份、零余子25份、山楂25份、黄芪25份。
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