CN115282122A - 一种中药浓缩丸的制丸工艺 - Google Patents
一种中药浓缩丸的制丸工艺 Download PDFInfo
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Abstract
本发明公开一种中药浓缩丸的制丸工艺,其是根据中药浓缩丸处方将各味药材或饮片成分先进行净制或炮制;将可提取挥发油的药材或饮片成分提取成挥发油;将需粉碎的药材或饮片成分粉碎成细粉;将剩余药材或饮片成分进行提取,滤液浓缩成稠膏;将细粉与稠膏进行混合后得浓缩颗粒;将浓缩颗粒与细粉和/或挥发油进行混料加入稀释剂或崩解剂压制成丸剂;将丸剂包衣制得中药浓缩丸。还提供了通过本发明的工艺制备的金锁固精丸、逍遥丸、补中益气丸、香砂养胃丸。本发明的工艺大大缩短了成丸时间,提高了丸剂收率;与传统制丸工艺对比,丸剂丸重差异小,崩解时限短,挥发性成分含量有保障,质量稳定可控,且生产周期缩短。
Description
技术领域:
本发明属于药物制备领域,涉及一种中药药物制剂的制备,具体是一种中药浓缩丸的制丸工艺。
背景技术:
中药浓缩丸系指饮片或部分饮片提取浓缩后,与适宜的辅料或其余饮片细粉,以水、炼蜜或炼蜜和水为粘合剂制成的丸剂。根据所用粘合剂的不同,分为浓缩水丸、浓缩蜜丸和浓缩水蜜丸等。与传统剂型蜜丸、水丸等相比,浓缩丸体积小,易于服用和吸收,发挥药效好携带运输方便,不添加任何防腐剂,保持中药的天然特色,符合现代人们返璞归真、崇尚自然的需求。由于浓缩丸可以最大程度地提取药材、提高疗效,现如今已经广泛应用。
目前浓缩丸的制法大致分为两种,泛制法和塑制法。水丸型浓缩丸宜采用泛制法制备;蜜丸型浓缩丸宜采用塑制法制丸。泛制法制丸工艺繁琐,周期长,丸重差异大,药尘大,生产效率低。塑制法的核心步骤是混合炼制,药材提取后浸膏与药材细粉混合后物料的粘性是保障软材质量的关键,物料粘性过大,会出现丸剂表面不光滑等现象;粘性过小,经常会出现丸子裂缝等现象。
传统浓缩丸的干燥工艺烘箱干燥直接影响药物的外观及崩解时限,烘干温度过高时间过长,会导致丸剂表明出现干裂等现象。烘干温度过低时间过短,会导致丸剂产品滋生微生物。因此,申请人在现有浓缩丸加工工艺基础上,为提高浓缩丸生产效率,保障产品质量品质,提出一种新的中药浓缩丸的制丸工艺。
发明内容:
本发明的目的旨在解决现有浓缩丸生产过程中存在效率低、裂丸现象、崩解时限过长等技术问题,提供一种丸重差异小、崩解时限短、挥发性成分含量有保障、质量稳定可控且生产周期短的中药浓缩丸制丸工艺。
为了实现以上目的,本发明采取以下技术方案:
一种中药浓缩丸的制丸工艺,包括如下步骤:
A、根据制备的中药浓缩丸处方将各味药材或饮片成分称取后先进行净制或炮制后,备用;
B、将步骤A所述各味药材或饮片成分中可提取挥发油的药材或饮片成分A提取成挥发油,备用;
C、将步骤A中所述药材或饮片成分中需粉碎的药材或饮片成分B粉碎成95%~98%的细粉,备用;
D、将步骤A中所述药材或饮片成分中剩余药材或饮片成分C进行提取,提取的提取液进行过滤,滤液再浓缩成相对密度为1.0~1.4稠膏,备用;
E、将步骤C所述的细粉与步骤D所述的稠膏进行混合后,先用湿法制粒机进行初步制粒,然后采用一步制粒机进行烘干制粒,筛分获得浓缩颗粒;
F、将步骤E中所述的浓缩颗粒与步骤B中所述的细粉和/或步骤A中所述提取的挥发油进行混料后,加入一定量的稀释剂或崩解剂压制成丸剂;
G、将步骤F中的丸剂采用高效包衣机进行包衣,即制得中药浓缩丸。
上述步骤B中所述可提取挥发油的药材或饮片成分A为陈皮、生姜、柴胡、薄荷、当归等其中一种或一种以上。
上述步骤F中所述稀释剂按百分比计,为5%~10%的微晶纤维素、3%~5%的滑石粉、0.5%~1%的硬脂酸镁、10%~15%的淀粉中的一种和/或多种。
上述步骤E中所述制粒的过程是所述混合组合物于一步制粒机中,在80~120℃下进行流化干燥、整粒过筛为16~30目筛,获得浓缩颗粒。
上述步骤F中所述崩解剂为按百分比计,为2%~5%的羧甲基淀粉钠、3%~6%的羧甲基纤维素钠、5%~8%的低取代羟丙基纤维素中的一种和/或多种。
上述步骤F中所述压制成丸是以高速压片机将颗粒与细粉和/或挥发油混合后,用直径为4.5mm~6.5mm的10%~15%的冲头,压制成球形的丸。
上述步骤G中所述的包衣是以黑色或棕色水溶性或醇溶性高分子材料用高效包衣机进行。
本发明制丸工艺所述制得的中药浓缩丸包括金锁固精丸、逍遥丸、补中益气丸、香砂养胃丸。
上述金锁固精丸的配方为:沙苑子(炒)55~65份、芡实(蒸)55~65份、莲须55~65份、龙骨(煅)20~35份、牡蛎(煅)20~35份、莲子110~125份。
上述逍遥丸的配方为:柴胡90~110份、当归90~110份、白芍90~110份、白术(炒)90~110份、茯苓90~110份、炙甘草75~85份、薄荷15~25份、生姜90~110份。
上述补中益气丸的配方为:黄芪(蜜炙)180~210份、党参55~65份、甘草(蜜炙)90~110份、白术(炒)55~65份、当归55~65份、升麻55~65份、柴胡55~65份、陈皮55~65份、生姜55~65份、大枣35~45份。
上述香砂养胃丸的配方为:木香200~220份、砂仁200~220份、白术290~320份、陈皮290~320份、茯苓290~320份、半夏(制)290~320份、醋香附200~220份、枳实(炒)200~220份、豆蔻(去壳)200~220份、姜厚朴200~220份、广藿香200~220份、甘草85~95份、生姜85~95份、大枣135~155份。
与现有传统的制丸工艺相比,本发明的有益效果在于:
(1)本发明工艺过程中采用了先进的一步制粒机、高速压片机、高效包衣机,通过一步制粒机进行制粒、干燥,与一定用量的稀释剂和崩解剂,处方中挥发油成分等量稀释混匀后,运用高速压片机球形冲模压制,高效包衣机包衣而成中药浓缩丸,大大缩短了成丸时间,并有效地提高了丸剂收率。
(2)本发明制丸工艺步骤的特点:a.中药材提取的挥发油是在与干颗粒总混过程中再加入的,有效降低了挥发性成分的损失;b.与一定稀释剂和崩解剂混合后再压片,解决了传统工艺制成丸剂出现裂丸的现象,且丸剂崩解时限大大缩短,药物有效成分迅速释放,更有利于人体吸收;c.利用现代高速压片机设备进行压丸工艺,能够有效减少丸重差异,提高工艺过程稳定性。因此,与传统制丸工艺通过多个品种多次实验对比,经质量检测,采用本发明压制而成的丸剂丸重差异小,崩解时限短,挥发性成分含量有保障,质量稳定可控,且生产周期缩短。
附图说明:
图1:本发明中药浓缩丸的制丸工艺流程图。
具体实施方式:
下面结合具体实施例对本发明加以详细的描述。
实施例1
金锁固精丸(浓缩丸)
1、处方:
2、制法:
(1)将芡实、龙骨、牡蛎、莲子粉碎成细粉,过80目筛,即得“芡实等四味药粉”,备用。
(2)将沙苑子、莲须二味药材加入直筒提取罐中,加水煎煮两次。第一次加8倍水量,煎煮3小时,第二次加6倍量水,煎煮2小时,煎液过滤。将提取液加入浓缩器中,合并浓缩至比重d=1.05~1.10(50℃),过滤出膏,标以“沙苑子、莲须浸膏(金锁固精浓缩丸)”,备用。
(3)将98%的浸膏与99%的药材细粉搅拌混匀,置湿法制粒机内,过18目筛网制粒;将湿颗粒抽入一步制粒机中80~120℃烘干,过18目筛进行整粒,备用。
(7)将崩解剂和稀释剂等量稀释加入上述颗粒中,三维混合罐混合均匀后。采用高速压片机,选用φ6.5球形冲模,压丸。
(8)上述丸剂投入高效包衣机内,用黑色胃溶性薄膜衣进行包衣,得到所述的金锁固精丸(浓缩丸)。
3、通过实验,实施例1制得的金锁固精丸(浓缩丸)与传统工艺塑制法制备的浓缩丸比较,见下表1:
从以上实验结果可知:本发明实施例1制丸工艺制备的金锁固精丸(浓缩丸)较传统塑制法,缩短了成丸时间,丸重差异减小,丸剂硬度减小,且崩解时限大大缩短,产品更易吸收,收率有所提高。
实施例2
逍遥丸(浓缩丸)
1、处方:
2、制法:
(1)取柴胡、处方量一半的当归,薄荷与生姜,置多功能提取罐中,加4倍量水,水蒸汽蒸馏提取挥发油2-4小时。收集挥发油,标以“柴胡等四味挥发油”,冷藏,备用;蒸馏水液弃去,药液及药渣留用。
(2)将柴胡、当归、薄荷、生姜提油后的药液及药渣与白术、茯苓共六味药材加水煎煮提取两次,每次2小时。第一次加5倍量水,第二次加3倍量水,煎液滤过,转入药液储罐内备用。
(3)将处方量三分之一的炙甘草加入多功能提取罐中,加水煎煮三次,第一次加7倍量水,第二次加6倍量水,第三次加6倍量水,每次2小时。煎液过滤,转入药液储罐中备用。
(4)取白芍、剩余处方量一半的当归、处方量四分之一的炙甘草粉碎成细粉,混匀,置90目筛网进行检查,应能通过90目筛,不得有纤维或细小颗粒状物,备用。
(5)取柴胡等六味药提取液加入浓缩器中,合并减压浓缩至体积约500L-600L,得稀膏1。取甘草提取液加入浓缩器中,减压浓缩至体积约300-400L,得稀膏2。将上述两种浸膏合并,减压浓缩至比重d=1.35~1.40(50℃)的稠膏,装入不锈钢桶中,标以“逍遥浓缩丸浸膏”,入冷库暂存。
(6)将97%的浸膏与99%的药材细粉搅拌混匀,置湿法制粒机内,过20目筛网制粒;将湿颗粒抽入一步制粒机中100~120℃烘干,过20目筛进行整粒,备用。
(7)将挥发油、崩解剂和稀释剂等量稀释加入上述颗粒中,三维混合罐混合均匀后。采用高速压片机,选用φ6.0球形冲模,压丸。
(8)上述丸剂投入高效包衣机内,用棕黑色胃溶性薄膜衣包衣液进行包衣。得到所述的逍遥浓缩丸。
3、通过实验,实施例2制得的逍遥丸(浓缩丸)与传统工艺塑制法制备的浓缩丸比较,见下表2:
从以上实验结果可知:本发明实施例2制丸工艺制备的逍遥丸(浓缩丸)较传统塑制法,缩短了成丸时间,丸重差异减小易控,丸剂硬度减小,崩解时限缩短,指标性成分芍药苷含量无损失,且提高了产品质量。
实施例3
补中益气丸(浓缩丸)
1、处方:
2、制法
(1)以上十味,党参、当归与处方量40%的甘草粉碎成细粉,取少量粉碎后药粉,过100目筛,备用。
(2)取处方量陈皮、生姜共置多功能提取罐中,加4倍量水,浸泡1小时后,水蒸汽蒸馏法提取挥发油2-4小时。收集挥发油,药液打出备用。
(3)将柴胡、当归、薄荷、生姜提油后的药液及药渣与白术、茯苓共六味药材加水煎煮提取两次,每次2小时。第一次加5倍量水,第二次加3倍量水,煎液滤过,备用。
(4)将处方量60%甘草投入多功能提取罐中,加水煎煮三次,每次2小时。第一次加8倍量水,第二次加7倍量水,第三次加6倍量水。煎液过滤后,合并备用。
(5)将上述三种提取液合并减压浓缩至适宜比重后,转入球形浓缩器中,煮沸灭菌20-40分钟,继续减压浓缩成比重d=1.35~1.40(50℃)的稠膏,出膏,包装,标以“补中益气浓缩丸浸膏”,入库。
(6)将97%的浸膏与99%的药材细粉搅拌混匀,置湿法制粒机内,过18目筛网制粒;将湿颗粒抽入一步制粒机中90~120℃烘干,过18目筛进行整粒,备用;
(7)将挥发油、崩解剂和稀释剂等量稀释加入上述颗粒中,三维混合罐混合均匀后。采用高速压片机,选用φ5.5球形冲模,压丸。
(8)上述丸剂投入高效包衣机内,用棕黑色胃溶性薄膜衣包衣液进行包衣。得到所述的补中益气浓缩丸。
3、通过实验,实施例3制得的补中益气丸(浓缩丸)与传统工艺塑制法制备的浓缩丸比较,见下表3:
从以上实验结果可知,本发明实施例3制丸工艺制备的补中益气丸(浓缩丸)较传统塑制法,缩短了成丸时间,丸重差异减小易控,丸剂硬度减小,且崩解时限大大缩短,产品更易吸收,收率有所提高。
实施例4
香砂养胃丸(浓缩丸)
1、处方:
2、制法:
(1)称取处方量80%的木香、陈皮、香附、枳实、厚朴、广藿香、生姜七味药材,置多功能提取罐中,加入8倍水量,水蒸汽蒸馏提取挥发油2-4小时,收集挥发油,标以“木香等七味药挥发油”,备用;药液及药渣留用。
(2)将提油后的药渣与白术、茯苓、姜半夏、甘草、大枣共置提取罐中,加水煎煮提取两次,每次2小时。第一次补水至药材7倍量,第二次加水至药材5倍量,煎液滤过,转入药液储罐内备用。
(3)将剩余处方量20%的木香、半夏(制)、砂仁、豆蔻(去壳)粉碎成细粉,过100目筛,备用。
(4)取提取液加入浓缩器中,浓缩成比重d=1.35~1.40(60℃)的稠膏,标以“木香等十二味药浸膏”,入冷库暂存。
(5)将96%的浸膏与98%的药材细粉搅拌混匀,置湿法制粒机内,过20目筛网制粒;将湿颗粒抽入一步制粒机中90~120℃烘干,过20目筛进行整粒,备用;
(6)将挥发油、崩解剂和稀释剂等量稀释加入上述颗粒中,三维混合罐混合均匀后。采用高速压片机,选用φ5.5球形冲模,压丸。
(7)上述丸剂投入高效包衣机内,用棕黑色胃溶性薄膜衣包衣液进行包衣。得到所述的香砂养胃浓缩丸。
3、通过实验,实施例4制得的香砂养胃丸(浓缩丸)与传统工艺塑制法制备的浓缩丸比较,见下表4:
从以上实验结果可知,本发明实施例4的香砂养胃丸(浓缩丸)较传统塑制法,成丸时间缩短了,丸重差异减小易控,丸剂硬度减小,崩解时限缩短,指标性成分橙皮苷,厚朴酚与和厚朴酚总和含量无损失,且提高了产品质量。
Claims (11)
1.一种中药浓缩丸的制丸工艺,其特征在于:包括如下步骤:
A、根据制备的中药浓缩丸处方将各味药材或饮片成分称取后先进行净制或炮制后,备用;
B、将步骤A所述各味药材或饮片成分中可提取挥发油的药材或饮片成分A提取成挥发油,备用;
C、将步骤A中所述药材或饮片成分中需粉碎的药材或饮片成分B粉碎成95%~98%的细粉,备用;
D、将步骤A中所述药材或饮片成分中剩余药材或饮片成分C进行提取,提取的提取液进行过滤,滤液再浓缩成相对密度为1.0~1.4稠膏,备用;
E、将步骤C所述的细粉与步骤D所述的稠膏进行混合后,先用湿法制粒机进行初步制粒,然后采用一步制粒机进行烘干制粒,筛分获得浓缩颗粒;
F、将步骤E中所述的浓缩颗粒与步骤B中所述的细粉和/或步骤A中所述提取的挥发油进行混料后,加入一定量的稀释剂或崩解剂压制成丸剂;
G、将步骤F中的丸剂采用高效包衣机进行包衣,即制得中药浓缩丸。
2.根据权利要求1所述的一种中药浓缩丸的制丸工艺,其特征在于:步骤B中所述可提取挥发油的药材或饮片成分A为陈皮、生姜、柴胡、薄荷、当归等其中一种或一种以上。
3.根据权利要求1所述的一种中药浓缩丸的制丸工艺,其特征在于:步骤F中所述稀释剂按百分比计,为5%~10%的微晶纤维素、3%~5%的滑石粉、0.5%~1%的硬脂酸镁、10%~15%的淀粉中的一种和/或多种。
4.根据权利要求1所述的一种中药浓缩丸的制丸工艺,其特征在于:步骤E中所述制粒的过程是所述混合组合物于一步制粒机中,在80~120℃下进行流化干燥、整粒过筛为16~30目筛,获得浓缩颗粒。
5.根据权利要求1所述的一种中药浓缩丸的制丸工艺,其特征在于:步骤F中所述崩解剂为按百分比计,为2%~5%的羧甲基淀粉钠、3%~6%的羧甲基纤维素钠、5%~8%的低取代羟丙基纤维素中的一种和/或多种。
6.根据权利要求1所述的一种中药浓缩丸的制丸工艺,其特征在于:步骤F中所述压制成丸是以高速压片机将颗粒与细粉和/或挥发油混合后,用直径为4.5mm~6.5mm的10%~15%的冲头,压制成球形的丸。
7.根据权利要求1所述的一种中药浓缩丸的制丸工艺,其特征在于:步骤G中所述的包衣是以黑色或棕色水溶性或醇溶性高分子材料用高效包衣机进行。
8.一种如权利要求1所述的制丸工艺制备的金锁固精丸,其特征在于:所述金锁固精丸的配方为:沙苑子(炒)55~65份、芡实(蒸)55~65份、莲须55~65份、龙骨(煅)20~35份、牡蛎(煅)20~35份、莲子110~125份。
9.一种如权利要求1所述的制丸工艺制备的逍遥丸,其特征在于:所述逍遥丸的配方为:柴胡90~110份、当归90~110份、白芍90~110份、白术(炒)90~110份、茯苓90~110份、炙甘草75~85份、薄荷15~25份、生姜90~110份。
10.一种如权利要求1所述的制丸工艺制备的补中益气丸,其特征在于:所述补中益气丸的配方为:黄芪(蜜炙)180~210份、党参55~65份、甘草(蜜炙)90~110份、白术(炒)55~65份、当归55~65份、升麻55~65份、柴胡55~65份、陈皮55~65份、生姜55~65份、大枣35~45份。
11.一种如权利要求1所述的制丸工艺制备的香砂养胃丸,其特征在于:所述香砂养胃丸的配方为:木香200~220份、砂仁200~220份、白术290~320份、陈皮290~320份、茯苓290~320份、半夏(制)290~320份、醋香附200~220份、枳实(炒)200~220份、豆蔻(去壳)200~220份、姜厚朴200~220份、广藿香200~220份、甘草85~95份、生姜85~95份、大枣135~155份。
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