CN111671800A - 一种朝医方保肝颗粒及制备方法 - Google Patents
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Abstract
本发明公开了一种朝医方保肝颗粒,包括药材提取、萃取、制粒工序以及不同溶剂提取物和各萃取物制粒条件下的肝保护活性评价工序,本发明以葛根、黄芩、白芷、桔梗、莱菔子、藁本、大黄、升麻按重量比4:4:4:5:3:3:3:2混合,经提取、萃取、制粒工序而得成品。此药方比例清晰,与古方相比,本发明提及的各种制备工艺所制成的成品有效成分更高,方便患者使用,并且工艺简单,成本低,更加有利于制剂加工和市场推广。本发明还公开了一种朝医方保肝颗粒的制备方法。
Description
技术领域
本发明涉及制药领域,具体是指一种朝医方保肝颗粒及制备方法。
背景技术
现今治疗急性肝损伤的方法主要是西药治疗,而西药治疗存在副作用,使用人群,使用剂量,使用方式均受到限制,因此将传统中药应用于临床是现代社会发展的重要趋势。传统上,中药方剂服用方法主要是水煎服,仅一次,制备工艺粗糙,工艺参数不明确,有效成分含量较低,患者携带、服用不便,不适合加工成其他剂型。
发明内容
本发明目的是为了解决上述背景技术中涉及到的用药安全,制备工艺粗糙、有效成分低,携带、服用不便,不适合加工成其他剂型等问题,而提供一种朝医方保肝颗粒,并提供其一种制备方法。
为实现上述目的而提出的技术方案是:
一种朝医方保肝颗粒,是由葛根、黄芩、藁本、莱菔子、桔梗、升麻、白芷、大黄组成,并按重量比4:4:4:5:3:3:3:2混合,经提取、萃取、制粒工序而得成品。
进一步地,所述的提取工序为水煎煮提取或乙醇回流提取。
一种如上所述的朝医方保肝颗粒的制备方法,包括下列步骤:
a.提取:以4:4:4:5:3:3:3:2的重量比例称取葛根、黄芩、藁本、莱菔子、桔梗、升麻、白芷、大黄,分成等量的两组,一组水煎煮提取,一组用乙醇回流提取;每种溶剂提取三次,提取时间依次为2.5h,2h,2h,所得提取液趁热过滤、合并,减压蒸馏回收溶剂,分别得到水提物浸膏和乙醇提取物浸膏;
b.萃取:将上述两种提取物浸膏分别加入蒸馏水混悬,依次用等量石油醚、乙酸乙酯、正丁醇萃取各三次,将相同的萃取部分合并,减压蒸馏回收溶剂,分别得到水提物石油醚部分、水提物乙酸乙酯部分、水提物正丁醇部分、醇提物石油醚部分、醇提物乙酸乙酯部分、醇提物正丁醇部分;
c.制粒:将上述萃取的各部分加入糖粉过筛使其混合均匀,滴入乙醇并用手指不断搓捏,混匀,至“手捏成团,压之即散”;制软材,在14目筛上制粒,放入烘箱内,调整温度60℃、时间为3h。
进一步地,所述的制粒采用干法制粒制成剂型,称取水提物正丁醇部分干浸膏粉,加入糖粉过40目筛后3次,使其混合均匀,滴入乙醇并用手指不断搓捏,混匀,至“手捏成团,压之即散”;制软材,在14目筛上制粒,放入烘箱内,调整温度60℃、时间为3h。
本发明的活性评价:将上述制得的颗粒进行急性肝损伤活性评价,试验用昆明种小鼠80只,分为10组,每组8只,分别为正常组、模型组、水提物颗粒组、醇提物颗粒组、水提物石油醚萃取物颗粒组、水提物乙酸乙酯萃取物颗粒组、水提物正丁醇萃取物颗粒组、醇提物石油醚萃取物颗粒组、醇提物乙酸乙酯萃取物颗粒组、醇提物正丁醇萃取物颗粒组。给药剂量选择120 mg/kg,10天同一时间连续灌胃,正常组和模型组给予等剂量的生理盐水。最后一次灌胃1小时后,除正常组外,所有小鼠腹腔注射0.1%四氯化碳-豆油溶液(10 mL/kg),造小鼠急性肝损伤模型,正常组给予等量的豆油,18 h后,摘眼球取血得到小鼠血样。将血液样品常温静置过夜,离心机3000 r/min离心15 min,取上清液得到血清样品。选择肝各项指标中最具有代表性的两种:谷氨酸氨基转移酶转移酶(AST)及天门冬氨酸氨基转移酶(ALT)为测试指标,测定两种溶剂总提取物及各萃取层对四氯化碳诱导的急性小鼠肝损伤的保护作用。
从实验数据可以看出,AST、ALT的趋势是一致的,水提正丁醇萃取物颗粒的肝保护活性最好,如图1(图1:与正常组比较###P<0.05,与模型组比较**P<0.01,***P<0.001)、图2(图2:与正常组比较###P<0.05,与模型组比较**P<0.01,***P<0.001)。
本发明优点在于,与现有技术相比,本发明的药方中药提取物均以葛根、黄芩、藁本、莱菔子、桔梗、升麻、白芷、大黄为原料,处方比例清晰明确,所涉及的提取物的各种制备工艺所获得的萃取物成分和古方制备工艺相比,有效成分含量更高,成本低,同时还采用了提取工序、萃取工序、活性评价工序和制粒工序等多种方法改变了成品药的形态,保证了药品携带与吸收,更便于加工成制剂,有利于市场推广和应用。
附图说明
图1为本发明实验测试小鼠急性肝损伤--天门冬氨酸氨基转移酶(ALT)指标图。
图2为本发明实验测试小鼠急性肝损伤--谷氨酸氨基转移酶转移酶(AST)指标图。
具体实施方式
实施例1
一种朝医方保肝颗粒通过以下的制备方法制备,其制备方法包括下列步骤:
a.提取:取葛根400g、黄芩400g、藁本400g、莱菔子500g、桔梗300g、升麻300g、白芷300g、大黄200g,共2.8kg。称取等量的两组,一组水煎煮提取,一组用乙醇回流提取。每种溶剂提取三次,提取时间依次为2.5h,2h,2h。所得提取液趁热过滤、合并。减压蒸馏回收溶剂,得到水提物浸膏981.0g,乙醇提取物浸膏514.0g。
b.萃取:将两种提取物浸膏分别加入1L蒸馏水混悬,依次用等量石油醚、乙酸乙酯、正丁醇萃取三次,将相同的萃取部分合并,减压蒸馏回收溶剂,得到水提物石油醚部分5.3g、水提物乙酸乙酯部分34.1g、水提物正丁醇部分35.3g、醇提物石油醚部分33.6g、醇提物乙酸乙酯部分30.5g、醇提物正丁醇部分34.2g。
c.制粒:根据上述结果,不同溶剂提取物和各萃取物作为有效物质,采用干法制粒的方法制成剂型,称取水提正丁醇萃取物干浸膏粉10g,加入适量糖粉过40目筛后3次,使其混合均匀;将干浸膏粉和糖粉放入坩埚内,滴入适量乙醇并用手指不断搓捏,混匀,至“手捏成团,压之即散”;制软材,在14目筛上制粒,放入烘箱内,调整温度60℃、时间为3h。
d.活性评价:参看上述发明内容部分。
实施例2
取处方中原料药葛根20g、黄芩20g、藁本20g、莱菔子25g、桔梗15g、升麻15g、白芷15g、大黄10g,应用上述提取工序得到水提物浸膏45.3g,乙醇提取物浸膏24.5g。进一步采用上述萃取工序水提物正丁醇部分5.9g,制软材,在14目筛上制粒,放入烘箱内,调整温度60℃、时间为3h。
实施例3
取处方中原料药葛根40g、黄芩40g、藁本40g、莱菔子50g、桔梗30g、升麻30g、白芷30g、大黄20g应用上述提取工序得到水提物浸膏87.6g,乙醇提取物浸膏49.2g。进一步采用萃取工序水提物正丁醇部分11.2g,制软材,在14目筛上制粒,放入烘箱内,调整温度60℃、时间为3h。
本发明制备方法简单,上述实施例仅是本发明中的部分实施例,而不是全部实施例,发明改变了成品药形态,有利于应用于临床,促进传统中药在现代社会的发展。
针对实施例2、3活性评价:将实施例2、3得到的保肝颗粒采用上述活性评价工序进行检测。
评价效果判断的标准
有效:ALT、AST水平显著下降,肝功功能趋于正常。
无效:ALT、AST水平基本没有变化,肝功异常。
疗效结果如表列表1:
表1数据表明,本发明的颗粒对于急性肝损伤疗效显著。
以上实例只用于对本发明内容的具体阐述,而非限制,本领域人员可对实例数据调整或者等同替换,都应该认为在本发明的权利要求书保护范围之内。
Claims (4)
1.一种朝医方保肝颗粒,是由葛根、黄芩、藁本、莱菔子、桔梗、升麻、白芷、大黄组成,并按重量比4:4:4:5:3:3:3:2混合,经提取、萃取、制粒工序而得成品。
2.根据权利要求1所述的一种朝医方保肝颗粒,其特征在于所述的提取工序为水煎煮提取或乙醇回流提取。
3.一种如权利要求1所述的朝医方保肝颗粒的制备方法,包括下列步骤:
a.提取:以4:4:4:5:3:3:3:2的重量比例称取葛根、黄芩、藁本、莱菔子、桔梗、升麻、白芷、大黄,分成等量的两组,一组水煎煮提取,一组用乙醇回流提取;每种溶剂提取三次,提取时间依次为2.5h,2h,2h,所得提取液趁热过滤、合并,减压蒸馏回收溶剂,分别得到水提物浸膏和乙醇提取物浸膏;
b.萃取:将上述两种提取物浸膏分别加入蒸馏水混悬,依次用等量石油醚、乙酸乙酯、正丁醇萃取各三次,将相同的萃取部分合并,减压蒸馏回收溶剂,分别得到水提物石油醚部分、水提物乙酸乙酯部分、水提物正丁醇部分、醇提物石油醚部分、醇提物乙酸乙酯部分、醇提物正丁醇部分;
c.制粒:将上述萃取的各部分加入糖粉过筛使其混合均匀,滴入乙醇并用手指不断搓捏,混匀,至“手捏成团,压之即散”;制软材,在14目筛上制粒,放入烘箱内,调整温度60℃、时间为3h。
4.根据权利要求3所述的一种朝医方保肝颗粒的制备方法,其特征在于所述的制粒采用干法制粒制成剂型,称取水提物正丁醇部分干浸膏粉,加入糖粉过40目筛后3次,使其混合均匀,滴入乙醇并用手指不断搓捏,混匀,至“手捏成团,压之即散”;制软材,在14目筛上制粒,放入烘箱内,调整温度60℃、时间为3h。
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王宏顺等: "中药颗粒剂辅料筛选的研究", 《江西中医药》 * |
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