CN111840468A - 一种滋阴补肾的口服制剂及其制备方法 - Google Patents

一种滋阴补肾的口服制剂及其制备方法 Download PDF

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CN111840468A
CN111840468A CN202010843692.1A CN202010843692A CN111840468A CN 111840468 A CN111840468 A CN 111840468A CN 202010843692 A CN202010843692 A CN 202010843692A CN 111840468 A CN111840468 A CN 111840468A
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parts
seed
powder
nourishing yin
tonifying kidney
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濮均文
柏丽
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NANJING TONGRENTANG PHARMACEUTICAL CO Ltd
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NANJING TONGRENTANG PHARMACEUTICAL CO Ltd
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Abstract

本发明公开了一种滋阴补肾的口服制剂，具体涉及药物组合物技术领域，包括以下原料：石斛、人参、山药、茯苓、甘草、肉苁蓉、枸杞子、菟丝子、地黄、熟地黄、五味子、天冬、麦冬、苦杏仁、防风、川芎、麸炒枳壳、黄连、牛膝、菊花、盐蒺藜、青葙子、决明子、水牛角浓缩粉、山羊角、女贞子、旱莲草、白八角莲、菩提香。本发明生产的滋阴补肾的口服制剂功效更好，对肝肾两虚、阴虚火旺、内障目暗、视物昏花的治疗效果更好，采用煎煮和微波萃取对多种中药材进行提取，能够将中药材中的滤渣过滤掉，服用相同数量的药物组合物，本发明生产的药物组合物治疗效果更好，提高药物组合物的治疗效果。

Description

一种滋阴补肾的口服制剂及其制备方法
技术领域
本发明涉及药物组合物技术领域，更具体地说，本发明涉及一种滋阴补肾的口服制剂及其制备方法。
背景技术
因现代人生活及精神压力大，“肾虚”就成了许多人常见的病证，肾虚的主要症状是腰膝酸软，两腿无力，心烦易怒，还会有以下诸症：眩晕耳鸣、形体消瘦、失眠多梦、颧红潮热、盗汗、咽干、男子阳痿或阳强不倒、性欲亢进，遗精早泄，妇女经少、经闭、崩漏、不孕、尿短赤黄。
黄帝内经认为，阴的形成需要长期过程，并不是依赖药物能达到的。我们平常所说的滋阴，就是将阳转化成阴。补肾中成药是治疗中医辨证为肾虚证的一类中成药的统称，补肾中成药因其便于服用、疗效良好、副作用小等优点一直是市场热销药。而传统的石斛夜光丸作为滋阴补肾，清肝明目的中药制剂，将中药材全部粉碎后混合，然后通过炼蜜制成大蜜丸或加水泛丸，直接将中药材粉碎混合，使得石斛夜光丸的药效较低，不能满足人们的使用需求。
发明内容
为了克服现有技术的上述缺陷，本发明的实施例提供一种滋阴补肾的口服制剂及其制备方法，本发明所要解决的问题是：如何提高中药丸剂对患者滋阴补肾，清肝明目的功效。
为实现上述目的，本发明提供如下技术方案：一种滋阴补肾的口服制剂，包括以下重量份的原料：石斛28-32份、人参100-140份、山药40-50份、茯苓100-140份、甘草28-32份、肉苁蓉28-32份、枸杞子40-50份、菟丝子40-50份、地黄55-65份、熟地黄55-65份、五味子28-32份、天冬100-140份、麦冬55-65份、苦杏仁40-50份、防风28-32份、川芎28-32份、麸炒枳壳28-32份、黄连28-32份、牛膝40-50份、菊花40-50份、盐蒺藜28-32份、青葙子28-32份、决明子40-50份、水牛角浓缩粉55-65份、山羊角260-340份、女贞子40-50份、旱莲草28-32份、白八角莲40-50份、菩提香55-65份。
在一个优选的实施方式中，包括以下重量份的原料：石斛28份、人参100份、山药40份、茯苓100份、甘草28份、肉苁蓉28份、枸杞子40份、菟丝子40份、地黄55份、熟地黄55份、五味子28份、天冬100份、麦冬55份、苦杏仁40份、防风28份、川芎28份、麸炒枳壳28份、黄连28份、牛膝40份、菊花40份、盐蒺藜28份、青葙子28份、决明子40份、水牛角浓缩粉55份、山羊角260份、女贞子40份、旱莲草28份、白八角莲40份、菩提香55份。
在一个优选的实施方式中，包括以下重量份的原料：石斛30份、人参120份、山药45份、茯苓120份、甘草30份、肉苁蓉30份、枸杞子45份、菟丝子45份、地黄60份、熟地黄60份、五味子30份、天冬120份、麦冬60份、苦杏仁45份、防风30份、川芎30份、麸炒枳壳30份、黄连30份、牛膝45份、菊花45份、盐蒺藜30份、青葙子30份、决明子45份、水牛角浓缩粉60份、山羊角300份、女贞子45份、旱莲草30份、白八角莲45份、菩提香60份。
在一个优选的实施方式中，包括以下重量份的原料：石斛32份、人参140份、山药50份、茯苓140份、甘草32份、肉苁蓉32份、枸杞子50份、菟丝子50份、地黄65份、熟地黄65份、五味子32份、天冬140份、麦冬65份、苦杏仁50份、防风32份、川芎32份、麸炒枳壳32份、黄连32份、牛膝50份、菊花50份、盐蒺藜32份、青葙子32份、决明子50份、水牛角浓缩粉65份、山羊角340份、女贞子50份、旱莲草32份、白八角莲50份、菩提香65份。
本发明还提供一种滋阴补肾的口服制剂的制备方法，具体制备步骤如下：
步骤一：称取上述重量份的各原料备用，将称取的山羊角锉研成细粉，将山药和决明子粉碎成细粉，经过筛网对山羊角、山药和决明细粉分别进行筛选，筛选完成后与水牛角浓缩粉混合均匀备用；
步骤二：将步骤一中称取的人参、地黄、熟地黄、苦杏仁、川芎和麸炒枳壳分别粉碎成粗粉，混合均匀后放入到微波萃取装置中添加60-70％的乙醇进行微波萃取，萃取两次，将两次萃取液进行收集合并浓缩，加到D101大孔吸附树脂柱上，50％乙醇洗脱，收集5倍量柱体积洗脱液，减压回收乙醇，浓缩并干燥得到清膏备用；
步骤三：将步骤一中称取的茯苓、甘草、肉苁蓉、枸杞子、菟丝子、五味子、天冬、麦冬、防风、黄连、牛膝、菊花、盐蒺藜、青葙子、女贞子、旱莲草、白八角莲、菩提香混合后加入提取罐中，向提取罐中加水煎煮两次次，将两次的煎煮液进行过滤收集，将收集的煎煮液合并后减压浓缩，浓缩后得到稠膏备用；
步骤四：将步骤二中得到的清膏和步骤三中得到的稠膏在超微粉碎机中粉碎，粉碎后利用筛网进行筛选，将步骤一混合的粉料与步骤二中筛选的粉料和步骤三中筛选的粉料混合均匀；
步骤五：向步骤四中混合均匀的粉料中加入炼蜜和水制丸，干燥后得到水蜜丸。
在一个优选的实施方式中，所述步骤一中山羊角锉研的细粉和山药与决明子粉碎的细粉均通过100目的筛网进行筛选，所述步骤四中清膏和稠膏在超微粉碎机中粉碎后利用100目的筛网进行筛选。
在一个优选的实施方式中，所述步骤二中微波萃取时第一次加入6倍量乙醇，萃取时间为10分钟，第二次微波萃取加入4倍量的乙醇，萃取时间为8分钟。
在一个优选的实施方式中，所述步骤三中第一次煎煮加入8倍的水，煎煮温度为50-60℃，蒸汽压力≤0.1Mpa，煎煮时间为2h，第二次煎煮加入6倍的水，煎煮温度为50-60℃，蒸汽压力≤0.1Mpa，煎煮时间为1h，两次煎煮液均通过150目的筛网进行过滤。
在一个优选的实施方式中，所述步骤二中清膏的相对密度为1.2-1.4，所述步骤三中稠膏的相对密度为1.3-1.5。
在一个优选的实施方式中，所述步骤五中每100g粉料加入炼蜜35-50g和水50-65g。
本发明的技术效果和优点：
1、采用本发明的原料配方所制备出的滋阴补肾的口服制剂，通过添加有女贞子、旱莲草、白八角莲和菩提香，女贞子具有补肝肾和强腰膝的功效，用于阴虚内热、头晕、目花、耳鸣、腰膝酸软、须发早白；旱莲草具有滋补肝肾和凉血止血的功效，用于牙齿松动、须发早白、眩晕耳鸣、腰膝酸、阴虚血热、吐血、血衄、尿血、血痢、崩漏下血、外伤出血；白八角莲具有滋阴补肾、清肺润燥、解毒消肿的功效，用于劳伤筋骨痛、阳痿、胃痛、无名肿毒、刀枪外伤；菩提香具有滋阴补肾、平肝明目、消肿止痛的功效，用于感冒、头晕头痛、高血压、贫血、慢性肠胃炎、月经不调、乳腺炎、疮毒；女贞子与旱莲草、青葙子和菩提香配合使用，使得中药制剂滋阴补肾的效果更好，本发明中药制剂滋阴补肾、清肝明目的功效更好，对肝肾两虚、阴虚火旺、内障目暗、视物昏花的治疗效果更好；
2、本发明通过煎煮和微波萃取对多种中药材进行提取，能够将中药材中的滤渣过滤掉，服用相同数量的药物组合物，本发明生产的药物组合物治疗效果更好，提高药物组合物的治疗效果。
具体实施方式
下面将结合本发明中的实施例，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：
本发明提供了一种滋阴补肾的口服制剂，包括以下重量份的原料：石斛28份、人参100份、山药40份、茯苓100份、甘草28份、肉苁蓉28份、枸杞子40份、菟丝子40份、地黄55份、熟地黄55份、五味子28份、天冬100份、麦冬55份、苦杏仁40份、防风28份、川芎28份、麸炒枳壳28份、黄连28份、牛膝40份、菊花40份、盐蒺藜28份、青葙子28份、决明子40份、水牛角浓缩粉55份、山羊角260份、女贞子40份、旱莲草28份、白八角莲40份、菩提香55份。
本发明还提供一种滋阴补肾的口服制剂的制备方法，具体制备步骤如下：
步骤一：称取上述重量份的各原料备用，将称取的山羊角锉研成细粉，将山药和决明子粉碎成细粉，经过筛网对山羊角、山药和决明细粉分别进行筛选，筛选完成后与水牛角浓缩粉混合均匀备用；
步骤二：将步骤一中称取的人参、地黄、熟地黄、苦杏仁、川芎和麸炒枳壳分别粉碎成粗粉，混合均匀后放入到微波萃取装置中添加65％的乙醇进行微波萃取，萃取两次，将两次萃取液进行收集合并浓缩，加到D101大孔吸附树脂柱上，50％乙醇洗脱，收集5倍量柱体积洗脱液，减压回收乙醇，浓缩并干燥得到清膏备用；
步骤三：将步骤一中称取的茯苓、甘草、肉苁蓉、枸杞子、菟丝子、五味子、天冬、麦冬、防风、黄连、牛膝、菊花、盐蒺藜、青葙子、女贞子、旱莲草、白八角莲、菩提香混合后加入提取罐中，向提取罐中加水煎煮两次次，将两次的煎煮液进行过滤收集，将收集的煎煮液合并后减压浓缩，浓缩后得到稠膏备用；
步骤四：将步骤二中得到的清膏和步骤三中得到的稠膏在超微粉碎机中粉碎，粉碎后利用筛网进行筛选，将步骤一混合的粉料与步骤二中筛选的粉料和步骤三中筛选的粉料混合均匀；
步骤五：向步骤四中混合均匀的粉料中加入炼蜜和水制丸，干燥后得到水蜜丸。
在一个优选的实施方式中，所述步骤一中山羊角锉研的细粉和山药与决明子粉碎的细粉均通过100目的筛网进行筛选，所述步骤四中清膏和稠膏在超微粉碎机中粉碎后利用100目的筛网进行筛选。
在一个优选的实施方式中，所述步骤二中微波萃取时第一次加入6倍量乙醇，萃取时间为10分钟，第二次微波萃取加入4倍量的乙醇，萃取时间为8分钟。
在一个优选的实施方式中，所述步骤三中第一次煎煮加入8倍的水，煎煮温度为55℃，蒸汽压力≤0.1Mpa，煎煮时间为2h，第二次煎煮加入6倍的水，煎煮温度为55℃，蒸汽压力≤0.1Mpa，煎煮时间为1h，两次煎煮液均通过150目的筛网进行过滤。
在一个优选的实施方式中，所述步骤二中清膏的相对密度为1.3，所述步骤三中稠膏的相对密度为1.4。
在一个优选的实施方式中，所述步骤五中每100g粉料加入炼蜜35-50g和水50-65g。
实施例2：
与实施例1不同的是，所述中药组合物包括以下重量份的原料：石斛30份、人参120份、山药45份、茯苓120份、甘草30份、肉苁蓉30份、枸杞子45份、菟丝子45份、地黄60份、熟地黄60份、五味子30份、天冬120份、麦冬60份、苦杏仁45份、防风30份、川芎30份、麸炒枳壳30份、黄连30份、牛膝45份、菊花45份、盐蒺藜30份、青葙子30份、决明子45份、水牛角浓缩粉60份、山羊角300份、女贞子45份、旱莲草30份、白八角莲45份、菩提香60份。
实施例3：
与实施例1-2均不同的是，所述中药组合物包括以下重量份的原料：石斛32份、人参140份、山药50份、茯苓140份、甘草32份、肉苁蓉32份、枸杞子50份、菟丝子50份、地黄65份、熟地黄65份、五味子32份、天冬140份、麦冬65份、苦杏仁50份、防风32份、川芎32份、麸炒枳壳32份、黄连32份、牛膝50份、菊花50份、盐蒺藜32份、青葙子32份、决明子50份、水牛角浓缩粉65份、山羊角340份、女贞子50份、旱莲草32份、白八角莲50份、菩提香65份。
本发明在居住地所在周边地区共调查160例由风痰所致的头晕目眩、痰涎壅盛、神志混乱、言清不清及惊风抽搐患者，男性100例，女性60例，年龄均在45-60岁，随机分为四组，分别为实验组1、实验组2、实验组3和对照组，对照组服用传统的石斛夜光丸，每天服用两次，每次一丸，两个月为一疗程，实验组1、实验组2和实验组3分别服用本发明实施例1、实施例2和实施例3生产的药物组合物，每天服用两次，每次一丸，两个月为一疗程，并在患者服用药物后第20天、第40天和第60天进行调查。调查结果如表一：
Figure BDA0002642319860000071
Figure BDA0002642319860000081
表一
诊疗评定标准为：
显效：体质明显增强，肝肾两虚、阴虚火旺、内障目暗、视物昏花的症状基本消失；
有效：体质增强，肝肾两虚、阴虚火旺、内障目暗、视物昏花的症状有所缓解；
剩余的为无效，无效：临床症状无明显改善，甚或加重。
由表一可知，服用本发明生产药物组合物的实验组1、实验组2和实验组3对患者的显效率和有效率均高于服用传统石斛夜光丸的显效率和有效率，而且采用实施例2生产的药物组合物效果最好，显效率达到60％，总有效率为92.5％，由此证明，本发明生产的药物组合物对肝肾两虚、阴虚火旺、内障目暗、视物昏花的治疗效果显著。采用本发明的原料配方所制备出的滋阴补肾的口服制剂，通过添加有女贞子、旱莲草、白八角莲和菩提香，女贞子具有补肝肾和强腰膝的功效，用于阴虚内热、头晕、目花、耳鸣、腰膝酸软、须发早白；旱莲草具有滋补肝肾和凉血止血的功效，用于牙齿松动、须发早白、眩晕耳鸣、腰膝酸、阴虚血热、吐血、血衄、尿血、血痢、崩漏下血、外伤出血；白八角莲具有滋阴补肾、清肺润燥、解毒消肿的功效，用于劳伤筋骨痛、阳痿、胃痛、无名肿毒、刀枪外伤；菩提香具有滋阴补肾、平肝明目、消肿止痛的功效，用于感冒、头晕头痛、高血压、贫血、慢性肠胃炎、月经不调、乳腺炎、疮毒；女贞子与旱莲草、青葙子和菩提香配合使用，使得中药制剂滋阴补肾的效果更好，本发明中药制剂滋阴补肾、清肝明目的功效更好，对肝肾两虚、阴虚火旺、内障目暗、视物昏花的治疗效果更好。
最后：以上所述仅为本发明的优选实施例而已，并不用于限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (10)

1.一种滋阴补肾的口服制剂，其特征在于：包括以下重量份的原料：石斛28-32份、人参100-140份、山药40-50份、茯苓100-140份、甘草28-32份、肉苁蓉28-32份、枸杞子40-50份、菟丝子40-50份、地黄55-65份、熟地黄55-65份、五味子28-32份、天冬100-140份、麦冬55-65份、苦杏仁40-50份、防风28-32份、川芎28-32份、麸炒枳壳28-32份、黄连28-32份、牛膝40-50份、菊花40-50份、盐蒺藜28-32份、青葙子28-32份、决明子40-50份、水牛角浓缩粉55-65份、山羊角260-340份、女贞子40-50份、旱莲草28-32份、白八角莲40-50份、菩提香55-65份。
2.根据权利要求1所述的一种滋阴补肾的口服制剂，其特征在于：包括以下重量份的原料：石斛28份、人参100份、山药40份、茯苓100份、甘草28份、肉苁蓉28份、枸杞子40份、菟丝子40份、地黄55份、熟地黄55份、五味子28份、天冬100份、麦冬55份、苦杏仁40份、防风28份、川芎28份、麸炒枳壳28份、黄连28份、牛膝40份、菊花40份、盐蒺藜28份、青葙子28份、决明子40份、水牛角浓缩粉55份、山羊角260份、女贞子40份、旱莲草28份、白八角莲40份、菩提香55份。
3.根据权利要求1所述的一种滋阴补肾的口服制剂，其特征在于：包括以下重量份的原料：石斛30份、人参120份、山药45份、茯苓120份、甘草30份、肉苁蓉30份、枸杞子45份、菟丝子45份、地黄60份、熟地黄60份、五味子30份、天冬120份、麦冬60份、苦杏仁45份、防风30份、川芎30份、麸炒枳壳30份、黄连30份、牛膝45份、菊花45份、盐蒺藜30份、青葙子30份、决明子45份、水牛角浓缩粉60份、山羊角300份、女贞子45份、旱莲草30份、白八角莲45份、菩提香60份。
4.根据权利要求1所述的一种滋阴补肾的口服制剂，其特征在于：包括以下重量份的原料：石斛32份、人参140份、山药50份、茯苓140份、甘草32份、肉苁蓉32份、枸杞子50份、菟丝子50份、地黄65份、熟地黄65份、五味子32份、天冬140份、麦冬65份、苦杏仁50份、防风32份、川芎32份、麸炒枳壳32份、黄连32份、牛膝50份、菊花50份、盐蒺藜32份、青葙子32份、决明子50份、水牛角浓缩粉65份、山羊角340份、女贞子50份、旱莲草32份、白八角莲50份、菩提香65份。
5.根据权利要求1-4任意一项所述的一种滋阴补肾的口服制剂的制备方法，其特征在于：具体制备步骤如下：
步骤一：称取上述重量份的各原料备用，将称取的山羊角锉研成细粉，将山药和决明子粉碎成细粉，经过筛网对山羊角、山药和决明细粉分别进行筛选，筛选完成后与水牛角浓缩粉混合均匀备用；
步骤二：将步骤一中称取的人参、地黄、熟地黄、苦杏仁、川芎和麸炒枳壳分别粉碎成粗粉，混合均匀后放入到微波萃取装置中添加60-70％的乙醇进行微波萃取，萃取两次，将两次萃取液进行收集合并浓缩，加到D101大孔吸附树脂柱上，50％乙醇洗脱，收集5倍量柱体积洗脱液，减压回收乙醇，浓缩并干燥得到清膏备用；
步骤三：将步骤一中称取的茯苓、甘草、肉苁蓉、枸杞子、菟丝子、五味子、天冬、麦冬、防风、黄连、牛膝、菊花、盐蒺藜、青葙子、女贞子、旱莲草、白八角莲、菩提香混合后加入提取罐中，向提取罐中加水煎煮两次次，将两次的煎煮液进行过滤收集，将收集的煎煮液合并后减压浓缩，浓缩后得到稠膏备用；
步骤四：将步骤二中得到的清膏和步骤三中得到的稠膏在超微粉碎机中粉碎，粉碎后利用筛网进行筛选，将步骤一混合的粉料与步骤二中筛选的粉料和步骤三中筛选的粉料混合均匀；
步骤五：向步骤四中混合均匀的粉料中加入炼蜜和水制丸，干燥后得到水蜜丸。
6.根据权利要求5所述的一种滋阴补肾的口服制剂的制备方法，其特征在于：所述步骤一中山羊角锉研的细粉和山药与决明子粉碎的细粉均通过100目的筛网进行筛选，所述步骤四中清膏和稠膏在超微粉碎机中粉碎后利用100目的筛网进行筛选。
7.根据权利要求5所述的一种滋阴补肾的口服制剂的制备方法，其特征在于：所述步骤二中微波萃取时第一次加入6倍量乙醇，萃取时间为10分钟，第二次微波萃取加入4倍量的乙醇，萃取时间为8分钟。
8.根据权利要求5所述的一种滋阴补肾的口服制剂的制备方法，其特征在于：所述步骤三中第一次煎煮加入8倍的水，煎煮温度为50-60℃，蒸汽压力≤0.1Mpa，煎煮时间为2h，第二次煎煮加入6倍的水，煎煮温度为50-60℃，蒸汽压力≤0.1Mpa，煎煮时间为1h，两次煎煮液均通过150目的筛网进行过滤。
9.根据权利要求5所述的一种滋阴补肾的口服制剂的制备方法，其特征在于：所述步骤二中清膏的相对密度为1.2-1.4，所述步骤三中稠膏的相对密度为1.3-1.5。
10.根据权利要求5所述的一种滋阴补肾的口服制剂的制备方法，其特征在于：所述步骤五中每100g粉料加入炼蜜35-50g和水50-65g。
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