CN111388627A - 一种排石利胆颗粒的制备方法 - Google Patents
一种排石利胆颗粒的制备方法 Download PDFInfo
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Abstract
本发明公开了一种排石利胆颗粒的制备方法,一种排石利胆颗粒的制备方法,所述的排石利胆颗粒包括原药材和溶剂,制备方法包括以下步骤:步骤一:将原药材在溶剂中加热回流提取至少三次,合并三次的提取药液,得提取液;步骤二:将步骤一中的提取液依序经过滤和浓缩,得清膏;步骤三:将步骤二中的清膏进行造粒成型工艺,制得排石利胆颗粒。该发明的有益效果是采用多次提取,能够有效提取原药材的活性成份,保证了配方量的准确性,另外,一方面通过适当提高进风温度加快干燥同时对出风口采取降温措施,和/或,通过在辅料中加入高软化点的辅料,有效避免药物颗粒软化而粘壁,制粉率高,使得制得的颗粒成型好。
Description
技术领域
本发明涉及中医药领域,具体讲是一种排石利胆颗粒的制备方法。
背景技术
胆结石病是一种常见的、多发的消化系统疾病,是常见的急腹症之一。在我国胆结石病患病率呈较快的上升趋势,部分地区已达10%,接近世界发达国家胆石病10-15%的发病水平。
胆结石症目前以手术治疗为主,尤其是腹腔镜手术,但复发率较高,再次手术难度和风险将增加,故出现外科手术不能解决胆囊结石问题的观点,而且患者对手术有恐惧心理。西药治疗胆结石症疗效欠佳,副作用大,且价格昂贵,所以采用中药治疗胆结石症越来越有必要。随着对胆汁化学、胆汁酸生化的深入研究,揭示了胆汁酸成分变动于胆石形成的内在联系,推动了溶石药物和溶石疗法的进展。中医学认为本病的病因病机有情志失调致肝胆气郁,肝失疏泄,胆气郁结;或外伤、手术所伤,致淤血内阻,血瘀气滞,影响肝胆疏泄功能,使氮气升降失司,胆汁疏泄失常,郁结日久,结成砂石;感受湿热之邪,或嗜酒肥甘,化生湿热,或脾虚湿郁而化热,湿热蕴蒸,使胆的升降失司,胆汁郁滞,久而成石。而其中排石利胆的中成药颗粒,不需煎服,方便快捷,但是现有的制备方法中使用的干燥造粒工艺出现粘壁现象,一方面浪费药材,另一方面使其干燥造粒效果不好,使得中药颗粒成型较差。
发明内容
本发明的目的在于至少解决现有技术中存在的技术问题之一,提供一种排石利胆颗粒的制备方法。
本发明的技术解决方案如下:
一种排石利胆颗粒的制备方法,所述的排石利胆颗粒包括原药材和溶剂,制备方法包括以下步骤:
步骤一:将原药材在溶剂中加热回流提取至少三次,合并三次的提取药液,得提取液;
步骤二:将步骤一中的提取液依序经过滤和浓缩,得清膏;
步骤三:将步骤二中的清膏进行造粒成型工艺,制得排石利胆颗粒。
优选地,所述的原药材包括以下按重量份数算的5-10份柴胡,1-8份木香,10-15份郁金,10-50份金钱草,10-12份茵陈,5-8份黄芩,1-8份五灵脂,1-8份蒲黄,1-8份川练子,12-15份赤芍,10-16份冬葵子,10-15份滑石粉,10-12份大黄,1-7份枳壳,8-12份莱菔子,5-8份白术,13-18份薏苡仁,1-9份鸡内金,1-10份甘草,5-8份石韦,1-3份龙胆,1-9份玉米须,及麦芽糊精、β-环糊精和微粉硅胶的混合物。。
优选地,所述的麦芽糊精、β-环糊精和微粉硅胶的重量比为1-3:1:1。
优选地,所述的原药材包括以下按重量份数算的166.67份茵陈、50份醋柴胡、166.67份金钱草、83.33份龙胆、50份赤芍、50份郁金、50份蒲黄、50份大黄、50份五灵脂、33.33芒硝及250份蔗糖。
优选地,所述的步骤二中,清膏的相对密度为1-1.5。
优选地,所述的步骤三中,造粒成型工艺具体为将步骤二中的清膏加入辅料,混匀,造粒。
优选地,所述的步骤三中,造粒具体为将加入辅料的清膏经喷雾干燥制得细粉末,再将细粉末通过干法挤压造粒。
优选地,所述的步骤三中,喷雾干燥的具体工艺为采用喷雾干燥机进行,喷雾干燥机的进风温度为150-200℃,出风温度为60-80℃,进液温度为90-100℃。
优选地,所述的步骤一之前,还包括有附加步骤,其具体为将原药材进行预处理,预处理包括破碎,然后在清水中浸泡0.5-1h。
优选地,所述的附加步骤中,浸泡温度为20-25℃。
本发明的有益效果是:
(1)本发明的一种排石利胆颗粒的制备方法,原药材配方中的醋柴胡、郁金疏肝利胆,推动结石下移;金钱草、茵陈及黄芩清利肝胆之湿热,退黄排石;五灵脂、蒲黄、川练子和赤芍理气行血散瘀而止痛,可缓解平滑肌痉挛;冬葵子、滑石性滑而下,以助下石,大黄通腑泄热,推陈致新,通利水谷之道;枳壳、莱菔子理气除积,促进结石蠕动;白术、薏苡仁补脾利湿,增进食欲,与苦寒之剂以配伍,可免害胃之弊;鸡内金消石顾护脾胃;甘草和中缓急,调和诸药;石韦利尿通淋,清肺止咳,凉血止血;龙胆和芒硝清肝胆实火、泻下焦痰热;玉米须,利水消肿,泄热,平肝利胆,同时玉米须能促进胆汁排泄,作为利胆药用于没有并发症的慢性胆囊炎或胆汁排出障碍的胆管炎,玉米须还能和退黄的茵陈配合,治疗肝炎导致的黄疸。全方共奏疏肝利胆、清热利湿、通腑排石之功。据现代药理研究证明,本方具有扩管解肌、促进胆汁分泌和排泄,增强胆囊收缩等功能,具有消解溶石等作用。
(2)本发明的一种排石颗粒的制备方法,采用多次提取,能够有效提取原药材的活性成份,保证了配方量的准确性。
(3)本发明的一种排石利胆颗粒的制备方法,清膏在喷雾干燥过程中,由于清膏中的黏液质类成分在干燥过程中表面易成膜,阻碍水分挥发造成粘壁,一方面通过适当提高进风温度加快干燥同时对出风口采取降温措施,和/或,通过在辅料中加入高软化点的辅料,有效避免药物颗粒软化而粘壁,制粉率高,使得制得的颗粒成型好。
具体实施方式
下面结合实施例和实施例详细说明本发明的技术方案,但保护范围不限于此。
本发明中提到的相对密度为清膏密度与水密度的比值。
实施例1
一种排石利胆颗粒,按重量份数算,包含以下原材料:原药材和溶剂,其中所述的原药材包括5份柴胡,1份木香,15份郁金,12份金钱草,12份茵陈,5份黄芩,3份五灵脂,4份蒲黄,2份川练子,13份赤芍,11份冬葵子,12份滑石粉,10份大黄,3份枳壳,8份莱菔子,5份白术,13份薏苡仁,1份鸡内金,2份甘草,5份石韦,1份龙胆草及1份玉米须。
一种排石利胆颗粒的制备方法,包括以下步骤:
步骤一:将原药材在溶剂中加热回流提取三次,合并三次的提取药液,得提取液;溶剂采用水,即分别用6、5、5倍量的水,经1.5h、1h、1h共提取3次,
步骤二:将步骤一中的提取液依序经过滤和在55℃浓缩至相对密度为1.05的清膏;
步骤三:将步骤二中的清膏进行造粒成型工艺,制得排石利胆颗粒。
步骤三中,造粒成型工艺具体为将步骤二中的清膏经喷雾干燥制得细粉末,再将细粉末通过干法挤压造粒。
喷雾干燥的具体工艺为采用喷雾干燥机进行,喷雾干燥机的进风温度为150℃,出风温度为60℃,进液温度为90℃。
实施例2
一种排石利胆颗粒,按重量份数算,包含以下原材料:原药材和溶剂,其中所述的原药材包括10份柴胡,8份木香,15份郁金,17份金钱草,11份茵陈,7份黄芩,5份五灵脂,5份蒲黄,7份川练子,13份赤芍,11份冬葵子,12份滑石粉,11份大黄,5份枳壳,9份莱菔子,6份白术,15份薏苡仁,6份鸡内金,7份甘草,6份石韦,2份龙胆草及5份玉米须。
一种排石利胆颗粒的制备方法,包括以下步骤:
步骤一:将原药材在溶剂中加热回流提取三次,合并三次的提取药液,得提取液;即分别用6、5、5倍量的水,经1.5h、1h、1h共提取3次,
步骤二:将步骤一中的提取液依序经过滤和在55℃浓缩至相对密度为1.05,得清膏;
步骤三:将步骤二中的清膏进行造粒成型工艺,制得排石利胆颗粒。
步骤三中,造粒成型工艺具体为将步骤二中的清膏经喷雾干燥制得细粉末,再将细粉末通过干法挤压造粒。
喷雾干燥的具体工艺为采用喷雾干燥机进行,喷雾干燥机的进风温度为150℃,出风温度为60℃,进液温度为90℃。
实施例3
一种排石利胆颗粒,按重量份数算,包含以下原材料:原药材和溶剂,其中所述的原药材包括9份柴胡,3份木香,12份郁金,30份金钱草,11份茵陈,6份黄芩,7份五灵脂,8份蒲黄,6份川练子,13份赤芍,15份冬葵子,12份滑石粉,11份大黄,6份枳壳,10份莱菔子,6份白术,15份薏苡仁,6份鸡内金,5份甘草,7份石韦,2份龙胆草及9份玉米须。
一种排石利胆颗粒的制备方法,包括以下步骤:
步骤一:将原药材在溶剂中加热回流提取三次,合并三次的提取药液,得提取液;即分别用6、5、5倍量的水,经1.5h、1h、1h共提取3次,
步骤二:将步骤一中的提取液依序经过滤和在55℃浓缩至相对密度为1.05,得清膏;
步骤三:将步骤二中的清膏进行造粒成型工艺,制得排石利胆颗粒。
步骤三中,造粒成型工艺具体为将步骤二中的清膏加入矫味剂,混匀,造粒。
步骤三中,造粒成型工艺具体为将步骤二中的清膏经喷雾干燥制得细粉末,再将细粉末通过干法挤压造粒。
步骤三中,喷雾干燥的具体工艺为采用喷雾干燥机进行,喷雾干燥机的进风温度为150℃,出风温度为60℃,进液温度为90℃。
实施例4
本实施例是在实施例2的基础上作出的变化,具体是步骤一:将原药材在溶剂中加热回流提取四次,合并四次的提取药液,得提取液;即分别用6、5、5、4倍量的水,经1.5h、1h、1h、0.5h共提取4次,其余同实施例2。
实施例5
本实施例是在实施例2的基础上作出的变化,具体是步骤二:将步骤一中的提取液依序经过滤和在55℃浓缩至相对密度为1.25的清膏,其余同实施例2。
实施例6
本实施例是在实施例2的基础上作出的变化,具体是步骤二:将步骤一中的提取液依序经过滤和在55℃浓缩至相对密度为1.45的清膏,其余同实施例2。
实施例7
本实施例是在实施例2的基础上作出的变化,具体是喷雾干燥机的进风温度为180℃,出风温度为70℃,进液温度为100℃,其余同实施例2。
实施例8
本实施例是在实施例2的基础上作出的变化,具体是喷雾干燥机的进风温度为180℃,出风温度为70℃,进液温度为100℃,其余同实施例2。
实施例9
本实施例是在实施例5的基础上作出的变化,具体是:所述的排石利胆颗粒还包括辅料,其具体为麦芽糊精、β-环糊精和微粉硅胶的混合物。其中,芽糊精、β-环糊精和微粉硅胶的重量比为1:1:1,辅料的添加量占原药材的2%,在制备方法中造粒成型工艺具体为将步骤二中的清膏加入辅料,混匀,造粒;造粒具体为将加入辅料的清膏经喷雾干燥制得细粉末,再将细粉末通过干法挤压造粒。
实施例10
本实施例是在实施例9的基础上作出的变化,具体是将原药材进行预处理,预处理包括破碎,然后在清水中浸泡0.5h,浸泡温度为20℃。
实施例11
本实施例是在实施例1的基础上作出的变化,具体是原药材包括以下按重量份数算的166.67份茵陈、50份醋柴胡、166.67份金钱草、83.33份龙胆、50份赤芍、50份郁金、50份蒲黄、50份大黄、50份五灵脂、33.33芒硝及250份蔗糖,其余同实施例1。
对比例1
本对比例是在实施例9的基础上进行变化,具体是辅料采用蔗糖。
对比例2
本对比例是在实施例2的基础上进行变化,具体是进风温度为100℃,出风温度为100℃,进液温度为50℃。
对比例3
本对比例是在实施例2的基础上进行变化,具体是步骤一:将原药材在溶剂中加热回流提取1次,得提取液;即分别用6倍量的水,经1.5h提取1次,其余同实施例2。
将上述实施例1-10以及对比例1-3中的细粉末进行得粉率实验测试,具体测试方法如下:得粉率=所得粉体重量/(辅料重量+清膏的总固含量)×100%。
同时对实施例1-9以及对比例1-3的颗粒进行芍药苷的有效成分进行测试,以提取率作为指标,芍药苷采用色谱仪进行测定,提取率(%)=提取后颗粒中芍药苷含量/提取前赤芍药材芍药苷含量×100%。
测试值见下表:
从表中可以看出,对比例1和2的得粉率低于实施例1-9,其中实施例9的得粉率最高,主要是由于实施例9与实施例5和对比例2的区别就是,实施例9中添加了高软化点的辅料,在喷雾干燥的过程中,高软化点的辅料能够有效避免颗粒的软化,从而影响后续的造粒成型。而对比例1中喷雾干燥中进风温度偏低,出风温度偏高,进液温度偏低,主要是由于清膏中的黏液质类成分在干燥过程中表面易成膜,阻碍水分挥发造成粘壁,从而也影响干燥效果,因此本发明一方面通过提高进风温度加快干燥同时对出风口采取降温措施,也能有效避免药物颗粒软化而粘壁,得粉率提高,干燥也更加均匀,颗粒成型好;通过对比例3的对比分析可知,实施例1-11采用多次提取,测得的芍药苷提取率比一次性提取,提取率提高,说明多次提取效果好,更接近原药材配方量,利于诊断治疗,同时通过实施例10与实施例9优化可知,在提取之前进行原药材预处理,使得原药材泡软,更利于后续的提取工艺。
在不出现冲突的前提下,本领域技术人员可以将上述附加技术特征自由组合以及叠加使用。
以上所述仅为本发明的优先实施方式,只要以基本相同手段实现本发明目的的技术方案都属于本发明的保护范围之内。
Claims (10)
1.一种排石利胆颗粒的制备方法,其特征在于,所述的排石利胆颗粒包括原药材和溶剂,制备方法包括以下步骤:
步骤一:将原药材在溶剂中加热回流提取至少三次,合并三次的提取药液,得提取液;
步骤二:将步骤一中的提取液依序经过滤和浓缩,得清膏;
步骤三:将步骤二中的清膏进行造粒成型工艺,制得排石利胆颗粒。
2.根据权利要求1所述的一种排石利胆颗粒的制备方法,其特征在于,所述的原药材包括以下按重量份数算的5-10份柴胡,1-8份木香,10-15份郁金,10-50份金钱草,10-12份茵陈,5-8份黄芩,1-8份五灵脂,1-8份蒲黄,1-8份川练子,12-15份赤芍,10-16份冬葵子,10-15份滑石粉,10-12份大黄,1-7份枳壳,8-12份莱菔子,5-8份白术,13-18份薏苡仁,1-9份鸡内金,1-10份甘草,5-8份石韦,1-3份龙胆,1-9份玉米须,及麦芽糊精、β-环糊精和微粉硅胶的混合物。
3.根据权利要求2所述的一种排石利胆颗粒的制备方法,其特征在于,所述的麦芽糊精、β-环糊精和微粉硅胶的重量比为1-3:1:1。
4.根据权利要求1所述的一种排石利胆颗粒的制备方法,其特征在于,所述的原药材包括以下按重量份数算的166.67份茵陈、50份醋柴胡、166.67份金钱草、83.33份龙胆、50份赤芍、50份郁金、50份蒲黄、50份大黄、50份五灵脂、33.33芒硝及250份蔗糖。
5.根据权利要求1所述的一种排石利胆颗粒的制备方法,其特征在于,所述的步骤二中,清膏的相对密度为1-1.5。
6.根据权利要求1所述的一种排石利胆颗粒的制备方法,其特征在于,所述的步骤三中,造粒成型工艺具体为将步骤二中的清膏加入辅料,混匀,造粒。
7.根据权利要求6所述的一种排石利胆颗粒的制备方法,其特征在于,所述的步骤三中,造粒具体为将加入辅料的清膏经喷雾干燥制得细粉末,再将细粉末通过干法挤压造粒。
8.根据权利要求7所述的一种排石利胆颗粒的制备方法,其特征在于,所述的步骤三中,喷雾干燥的具体工艺为采用喷雾干燥机进行,喷雾干燥机的进风温度为150-200℃,出风温度为60-80℃,进液温度为90-100℃。
9.根据权利要求1所述的一种排石利胆颗粒的制备方法,其特征在于,所述的步骤一之前,还包括有附加步骤,其具体为将原药材进行预处理,预处理包括破碎,然后在清水中浸泡0.5-1h。
10.根据权利要求9所述的一种排石利胆颗粒的制备方法,其特征在于,所述的附加步骤中,浸泡温度为20-25℃。
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