CN112353880B - 一种小儿解感中药的制备方法 - Google Patents
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Abstract
本发明公开了一种小儿解感中药的制备方法,该方法通过模拟中药在胃肠道中的吸收和转运条件,通过半仿生提取并结合酶解,提高了小儿解感中药活性成分的含量,同时还保留了较高的提取率,减少了药材的浪费,从而有利于提高中药疗效并降低生产成本。另外,由于本发明模拟了胃肠道环境,使提取的产物更容易被人体消化吸收,能降低药物的毒副作用,使人体更加耐受,尤其适合于小儿用药。本发明还具有提取条件温和,不含有机溶剂,环境污染少等优点。
Description
技术领域
本发明属于中药领域,具体涉及一种小儿解感中药的制备方法。
背景技术
半仿生提取技术是模仿口服给药及药物经胃肠道吸收和转运的过程,采用一定pH值的酸性或碱性溶剂提取中药,得到含目标活性成分更高的提取物,该技术近年来在中草药化学成分提取中发挥了重要作用。酶法是利用酶反应的高度专一性,根据中药有效成分选择一些恰当的酶类,使细胞壁及细胞间质中的某些物质降解,从而降低有效成分从细胞内向提取介质扩散时所受细胞壁及细胞间质等传质屏障的阻力,另外,在半仿生或仿生提取中加入适当的酶类,还可模拟人体胃肠道中的特定消化酶,进一步提高仿生效果,该方法具有反应条件温和、提取时间短、提取率高等优点。
小儿解感中药处方收载于《中国药典》2015版一部,由大青叶、柴胡、黄芩、荆芥、桔梗、甘草六味中药组成,功效为清热解表、消炎止咳,用于感冒发烧、头痛鼻塞、咳嗽喷嚏、咽喉肿痛。目前市售产品为片剂和颗粒剂,生产工艺大多为传统的水提醇沉法,研究表明,该方法对活性成分的提取效率较低,而且大量使用乙醇,易导致有机溶剂残留影响产品的安全性,并且存在有机溶剂耗费量大、污染环境等问题。因此,研究改进其制备工艺,以生产有效成分含量高、起效快、药效好、安全性高、成本低的小儿解感中药,对更好满足临床用药具有非常重要的意义。
发明内容
本发明的目的是针对上述问题,提供一种新的小儿解感中药的制备方法,该方法通过引入半仿生提取并结合酶解,提高了中药活性成分的含量,同时还保留了较高的提取率,从而有利于提高中药疗效并降低生产成本,另外还使得药物更容易被人体消化吸收,能降低药物的毒副作用,使人体更加耐受,从而更适合于小儿。
为实现上述目的,本发明采用如下技术方案:
一种小儿解感中药的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664重量份、柴胡332重量份、黄芩332重量份、荆芥332重量份、桔梗200重量份、甘草132重量份;
(2)上述药材打粉,过10~40目筛,按料液重量比1:6~12,加入缓冲液,调节pH值为1.5~3.5,混匀后65~85℃水浴1~4小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液重量比1:6~12,加入缓冲液,调节pH值为5.5~7.0,混匀后加入由重量比为3~8:1~5:0.5~2的中性蛋白酶、纤维素酶和淀粉酶组成的复合酶,在45~65℃下水浴1~4小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液重量比1:4~6,加入缓冲液,调节pH值为7.5~8.5,混匀后45~65℃下水浴1~4小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于50-60℃浓缩成相对密度为1.30~1.35的稠膏,加入辅料,制成适合临床使用的剂型。
优选地,所述中性蛋白酶、纤维素酶和淀粉酶重量比为5:2:1。
优选地,所述复合酶用量为每克生药加入5~50mg。
进一步优选地,所述复合酶用量为每克生药加入20~30mg。
优选地,所述缓冲液为磷酸氢二钠-柠檬酸缓冲液。
优选地,该方法包括以下步骤:
(1)称取以下原料:大青叶664重量份、柴胡332重量份、黄芩332重量份、荆芥332重量份、桔梗200重量份、甘草132重量份;
(2)上述药材打粉,过20目筛,按料液重量比1:8,加入缓冲液,调节pH值为2.5,混匀后75℃水浴3小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液重量比1:8,加入缓冲液,调节pH值为6.0,混匀后加入由重量比为3~8:1~5:0.5~2的中性蛋白酶、纤维素酶和淀粉酶组成的复合酶,在55℃下水浴3小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液重量比1:5,加入缓冲液,调节pH值为8.0,混匀后55℃下水浴2小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.30~1.35的稠膏,加入辅料,制成适合临床使用的剂型。
优选地,所述剂型为颗粒剂。
本发明的有益效果是:
本发明通过模拟药物在胃肠道中的吸收和转运条件,通过半仿生提取并结合酶解,提高了小儿解感中药活性成分的含量,同时还保留了较高的提取率,减少了药材的浪费,从而有利于提高中药疗效并降低生产成本。另外,由于本发明模拟了胃肠道环境,使提取的产物更容易被人体消化吸收,能降低药物的毒副作用,使人体更加耐受,尤其适合于胃肠道功能不健全、药物耐受能力差的小儿用药。本发明还具有提取条件温和,不含有机溶剂,环境污染少等优点。
具体实施方式
下面通过具体实施例对本发明进行详细说明。以下实施例中的处方来源于《中国药典》2015版一部,所使用的原料均为同一厂家购买的同一批次药材。
实施例1
一种小儿解感颗粒的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过20目筛,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为2.5,混匀后75℃水浴3小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为6.0,混匀后加入50g由重量比为5:2:1的中性蛋白酶、纤维素酶和淀粉酶组成的复合酶,在55℃下水浴3小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液比1:5,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为8.0,混匀后55℃下水浴2小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.32的稠膏,然后真空干燥。
实施例2
一种小儿解感颗粒的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过40目筛,按料液比1:12,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为1.5,混匀后85℃水浴2小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:12,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为5.5,混匀后加入50g由重量比为5:2:1的中性蛋白酶、纤维素酶和淀粉酶组成的复合酶,在65℃下水浴2小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液比1:6,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为7.5,混匀后65℃下水浴2小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.32的稠膏,然后真空干燥。
实施例3
一种小儿解感颗粒的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过10目筛,按料液比1:6,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为3.5,混匀后65℃水浴4小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:6,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为7.0,混匀后加入50g由重量比为5:2:1的中性蛋白酶、纤维素酶和淀粉酶组成的复合酶,在45℃下水浴4小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液比1:4,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为8.5,混匀后45℃下水浴4小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.32的稠膏,然后真空干燥。
实施例4
一种小儿解感颗粒的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过20目筛,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为3.0,混匀后75℃水浴3小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为7.0,混匀后加入50g由重量比为5:2:1的中性蛋白酶、纤维素酶和淀粉酶组成的复合酶,在55℃下水浴3小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)合并步骤(2)、(3)中的滤液Ⅰ、滤液Ⅱ,于55℃浓缩成相对密度为1.32的稠膏,然后真空干燥。
实施例5
一种小儿解感颗粒的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过20目筛,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为2.5,混匀后75℃水浴3小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为6.0,混匀55℃下水浴3小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液比1:5,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为8.0,混匀后55℃下水浴2小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.32的稠膏,然后真空干燥。
实施例6
一种小儿解感颗粒的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过20目筛,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为2.5,混匀后75℃水浴3小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为6.0,混匀后加入50g中性蛋白酶,在55℃下水浴3小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液比1:5,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为8.0,混匀后55℃下水浴2小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.32的稠膏,然后真空干燥。
实施例7
一种小儿解感颗粒的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过20目筛,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为2.5,混匀后75℃水浴3小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为6.0,混匀后加入50g由重量比为3:1的中性蛋白酶和纤维素酶组成的复合酶,在55℃下水浴3小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液比1:5,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为8.0,混匀后55℃下水浴2小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.32的稠膏,然后真空干燥。
实施例8
一种小儿解感颗粒的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过20目筛,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为2.5,混匀后75℃水浴3小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为6.0,混匀后加入50g由重量比为4:1的中性蛋白酶和淀粉酶组成的复合酶,在55℃下水浴3小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液比1:5,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为8.0,混匀后55℃下水浴2小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.32的稠膏,然后真空干燥。
实施例9
一种小儿解感颗粒的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过20目筛,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为2.5,混匀后75℃水浴3小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为6.0,混匀后加入10g由重量比为5:2:1的中性蛋白酶、纤维素酶和淀粉酶组成的复合酶,在55℃下水浴3小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液比1:5,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为8.0,混匀后55℃下水浴2小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.32的稠膏,然后真空干燥。
实施例10
一种小儿解感颗粒的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过20目筛,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为2.5,混匀后75℃水浴3小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为6.0,混匀后加入100g由重量比为5:2:1的中性蛋白酶、纤维素酶和淀粉酶组成的复合酶,在55℃下水浴3小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液比1:5,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为8.0,混匀后55℃下水浴2小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.32的稠膏,然后真空干燥。
实施例11
一种小儿解感颗粒的制备方法,包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过20目筛,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为2.5,混匀后75℃水浴3小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为6.0,混匀后加入50g由重量比为3:3:2的中性蛋白酶、纤维素酶和淀粉酶组成的复合酶,在55℃下水浴3小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液比1:5,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为8.0,混匀后55℃下水浴2小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.32的稠膏,然后真空干燥。
对真空干燥后的干膏进行称重,使用HPLC法检测干膏中黄芩苷和甘草酸的含量,结果见下表:
干膏重量(g) | 黄芩苷含量(mg/g) | 甘草酸含量(mg/g) | |
实施例1 | 157 | 91.3 | 17.7 |
实施例2 | 164 | 86.6 | 17.1 |
实施例3 | 146 | 81.5 | 18.2 |
实施例4 | 125 | 75.8 | 16.5 |
实施例5 | 112 | 67.6 | 15.9 |
实施例6 | 122 | 78.9 | 16.7 |
实施例7 | 133 | 80.7 | 17.0 |
实施例8 | 126 | 82.3 | 16.3 |
实施例9 | 149 | 85.6 | 16.9 |
实施例10 | 166 | 89.1 | 17.1 |
实施例11 | 155 | 87.3 | 17.3 |
对比例 | 173 | 63.6 | 14.5 |
注:对比例是将处方量药材按常规的水煎醇沉工艺提取后得到的干膏。
从以上结果可以看出,与对比例相比,实施例1、2、3、9、10、11的黄芩苷和甘草酸含量均明显提高;实施例4虽然黄芩苷和甘草酸含量也有提高,但干膏总量很少,说明提取不够充分;实施例5中的黄芩苷含量没有明显增加,而且提取的干膏总量更少,说明酶解对增加提取物的产量和活性成分含量发挥重要作用;实施例6、7、8的黄芩苷和甘草酸含量虽然有所提高,但干膏总量仍很低,导致提取不充分,说明复合酶的种类对提取效率也有重要影响。
本发明通过模拟药物在胃肠道中的吸收和转运条件,通过半仿生提取并结合酶解,提高了小儿解感中药活性成分的含量,同时还保留了较高的提取率,减少了药材的浪费,从而有利于提高中药疗效并降低生产成本。另外,由于本发明模拟了胃肠道环境,使提取的产物更容易被人体消化吸收,能降低药物的毒副作用,使人体更加耐受,尤其适合于小儿用药。
Claims (2)
1.一种小儿解感中药的制备方法,其特征在于包括以下步骤:
(1)称取以下原料:大青叶664g、柴胡332g、黄芩332g、荆芥332g、桔梗200g、甘草132g;
(2)上述药材打粉,过20目筛,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为2.5,混匀后75℃水浴3小时,过滤,得滤渣Ⅰ和滤液Ⅰ;
(3)取步骤(2)中的滤渣I,按料液比1:8,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为6.0,混匀后加入50g由重量比为5:2:1的中性蛋白酶、纤维素酶和淀粉酶组成的复合酶,在55℃下水浴3小时,过滤,得滤渣Ⅱ和滤液Ⅱ;
(4)取步骤(3)中的滤渣Ⅱ,按料液比1:5,加入磷酸氢二钠-柠檬酸缓冲液,调节pH值为8.0,混匀后55℃下水浴2小时,过滤,得滤渣Ⅲ和滤液Ⅲ;
(5)合并步骤(2)、(3)、(4)中的滤液Ⅰ、滤液Ⅱ、滤液Ⅲ,于55℃浓缩成相对密度为1.32的稠膏,加入辅料,制成适合临床使用的剂型。
2.根据权利要求1所述小儿解感中药的制备方法,其特征在于:所述剂型为颗粒剂。
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