CN110302165A - 一种用于中药临方制剂的浓缩水丸制备方法 - Google Patents
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Abstract
本发明属于医药领域,具体涉及一种用于中药临方制剂的浓缩水丸制备方法,步骤包括:基于由高至低的单味药材的粉筛率筛选处方中一定重量比的药材经粉碎处理得过五号筛的药材粉末;处方中其余药材经提取并浓缩至适宜粘度得浓缩液;将过五号筛的药材粉末与浓缩液混合,制软材,制丸。本发明浓缩水丸制备方法药辅同用,无需加入处方外的制剂辅料,适用于大多数中药复方,具有高效、高载药量、简单易学等优点。
Description
技术领域
本发明属于医药领域,具体涉及一种用于中药临方制剂的浓缩水丸制备方法。
背景技术
临方制剂是指医生依据患者个体的辨证治疗需要和药物性能开具处方,提出临时的调配要求,再由负责调剂的人员以相关工艺为患者加工成不同剂型的制剂,是个性化药学服务的重要内容。许多人常认可中药具有良好的功效,但在用药过程中却为了省事不愿意煎药、或者因为汤剂不良的口感,常放弃使用中药。这种“认可中医却又拒绝中药”的现象普遍存在。中药临方制剂是中医临床用药的特色与优势,既符合中医辨证施治的内在需求,又能解决药厂无法批量生产的瓶颈问题,特别适合需长期服药或对口感有特别要求的患者。手工泛丸在临方制剂中应用历史悠久,是中药特色制药技术之一,也是目前临方制丸的普遍采用的技术,但其生产效率较低,缺乏相应的制剂规范和标准,难以满足人们对全过程高质量医疗服务的需求。传统手工泛丸法属于非物质文化遗产,其特点是相当依赖“老师傅”的经验,新手的学习培训需要1~3年,且因费时费力,年青人不愿意学,相关技术有失传或断档的趋势。
与中成药、医院制剂相比,中药临方制剂有其特殊性。①处方药味不一:由于辨证用药的需要,不同的病人其处方药味不尽相同,同一病人不同的时间其处方药味也不完全相同。②生产批量小:临方制剂一般用量不大,一料多者500g左右,少者仅20-30g,对于慢性病患者最多2~3kg饮片。③临时完成全部工艺:尽管处方量少,但对每一个处方均需从饮片开始,临时完成粉碎、混合,甚至提取、浓缩、干燥、制剂成型、包装、清洁等全部工艺过程。④加工周期短:临方制剂不可能有成品库存,且由于治疗的需要和病情的可能变化,要求临方制剂的加工越快越好。一般而言,患者在1~3天内获得较为适宜。⑤无预实验,需一次成型:中成药、医院制剂在研究过程中均有涉及处方工艺优化的过程,需要经多次的预实验和实验完成。并且每个药品研发均有从小试、中试到放大生产的研究过程,其实验次数多、研究周期长。而调剂人员在拿到临方制剂处方后,是没有预实验的过程,需要一次性成功完成全部工艺过程,否则其加工成本和周期将成倍提高,并且患者的信任度将大大降低。此外,与西药相比较而言,中药的日服剂量一般较大,因此在制剂的过程中需要考虑高载药量的要求。鉴于以上特点,如何将药味不一的临时处方,快速、高载药量、无预实验、零失败地加工成临方制剂,对药学工作者和调剂人员而言,是一个巨大的挑战,制剂原料的特征物理属性与制剂成型的相关性研究是关键。就丸剂而言,丸条的物理性质决定了丸剂成型的质量;就基于药辅合一的浓缩水丸而言,用于当辅料使用的饮片种类和比例、以及煎煮浓缩液的浓缩程度,决定了丸条的物理性质,是最关键的工艺参数。
制备浓缩丸时,药物处理的一般原则为:粉性药、贵重药材、量小、作用强烈、质地易碎的药材粉碎成细粉,质坚硬、粘性大、体积大、纤维多的药材提取制浸膏。遵循上述一般原则制备的药粉和浸膏混合后,常出现粘性过低导致的丸条无法粘结成型,或者因粘性过大导致的丸条易粘结而产生的损耗大、成型度差,此时,通常需要添加水、乙醇、醇水液、蜂蜜等粘合剂,或者淀粉、糖等赋形剂,无疑复杂化制剂成型工序,降低可控性,延长制剂成型工序及研制周期,且违背浓缩丸降低单次服用剂量的初衷,不能满足临方制剂快速、低损耗、高载药量、高成药率、易操作、易学习掌握、高生产效率等的要求。
发明内容
为解决上述问题,本发明提供一种用于中药临方制剂的浓缩水丸制备方法,该浓缩水丸制备方法采用药辅合一的思路,无需额外加入制剂辅料,具有易成型,易控制,易学习掌握,高载药量,高成药率等优点,满足中药临方制剂单次、小批量、加工周期短、低损耗、降低患者日服剂量等的要求。
本发明的技术方案为,一种用于中药临方制剂的浓缩水丸制备方法,步骤包括:基于由高至低的单味药材的粉筛率筛选处方中一定重量比的药材经粉碎处理得过五号筛的药材粉末;处方中其余药材经提取并浓缩至适宜粘度得浓缩液;将过五号筛的药材粉末与浓缩液混合,制软材,制丸。
还包括基于由高至低的单味药材的粉筛率筛选的处方中一定重量比的药材经粉碎处理得到的除过五号筛的药材粉末外的粗粉与处方中其余药材混合,经提取并浓缩至适宜浓度得浓缩液。
若处方中其余药材包含含有易挥发或热不稳定成分的药材,该含有易挥发或热不稳定成分的药材采用后下煎煮方式提取。
基于由高至低的单味药材的粉筛率筛选的用于粉碎处理的药材在处方中重量比为12%~36%,优选12%~24%。粉筛率测定方法具体为:将药材置于多功能高速粉碎机中粉碎4次,每次15秒,过五号筛,计算粉筛率。粉筛率为过五号筛的药材粉末与药材总量的比例。
粉碎处理的方式为超微粉碎。
处方中其余药材经提取并浓缩所得浓缩液于100℃的粘度值为1.5~10.5pa.s,优选为4.0~10.5pa.s。
作为优选方案,基于由高至低的单味药材的粉筛率筛选的用于粉碎处理的药材在处方中重量比为12%~36%,处方中其余药材经提取并浓缩所得浓缩液于100℃的粘度值为1.5~10.5pa.s。
基于由高至低的单味药材的粉筛率筛选的用于粉碎处理的药材在处方中重量比为12%~24%,处方中其余药材经提取并浓缩所得浓缩液于100℃的粘度值为4.0~10.5pa.s。
还包括制丸后的筛丸和干燥处理。制丸用设备为挤出搓圆设备。
本发明制备方法采用不同于药物处理一般原则的方法筛选用于制粉及制清膏或浸膏的药材种类及用量,即由高至低的粉筛率及处方中制粉药材的比例;并辅以清膏或浸膏的粘度值,药粉作赋形剂,清膏或浸膏作粘结剂,药辅合一,使得药粉与清膏或浸膏混合后的软材粘度适中,无需额外添加制剂辅料,制剂一次成型,损耗小,载药量与成型率高。
本发明制备方法简化工艺影响因素,药辅同用,无需额外添加处方外制剂辅料,简化工艺流程,缩短制备周期,快速制备高载药量浓缩水丸,且成型率高,满足中药临方制剂快速、高效的制备要求。
本发明制备方法考察因素少,制备工艺简便,易于学习掌握。
具体实施方式
以下所述是本发明的优选实施方式,应当指出,对于本技术领域的技术人员,在不脱离本发明原理的前提下,还可以做出若干改进和优选,这些改进和优选也视为本发明的保护范围。
粉筛率测定方法具体为:将药材置于多功能高速粉碎机中粉碎4次进行超微粉碎,每次15秒,过五号筛,计算粉筛率。粉筛率为过五号筛的药材粉末与药材总量的比例。
实施例1
处方:
干姜80g,黄芩80g,大枣80g,黄连24g,党参80g,甘草80g,枳壳80g,赤芍80g,姜半夏80g(处方重量总计:664g)。
工艺:
1、粉碎:按照由高至低的单味药材的粉筛率筛选总处方36%重量比的药材(干姜80g、赤芍40g、枳壳80g、甘草40g)进行粉碎,过5号筛,得粉末217.02g。
2、煎煮:余下粗粉与剩余药材进行煎煮(煎煮两次,加8倍量水,每次1小时),药液合并,过滤,浓缩,浓缩至1.7pa.s(100℃)。
3、制丸:浓缩液与上述粉末混合,制软材,在挤出滚圆机中挤出-搓圆,得到湿丸,烘箱干燥(60℃,2h)即得。
4、工艺评价:得丸率88.94%(得丸率=湿丸重量/软材重量*100%),丸粒光滑圆整。
实施例2
处方:
荷叶60g,决明子60g,生薏苡仁60g,赤小豆60g,夏枯草60g,海藻60g,水蛭6g,山楂30g,枳实30g,生大黄12g,桃仁20g,白芥子30g,陈皮20g,法半夏20g,茯苓30g,黄连12g,肉桂2g,石膏60g,泽泻30g(处方重量总计:662g)。
工艺:
1、粉碎:按照由高至低的单味药材的粉筛率筛选总处方30%重量比的药材(茯苓30g、泽泻30g、生薏苡仁60g、赤小豆60g、枳实20)进行粉碎,过5号筛,得粉末178.19g。
2、煎煮:余下粗粉与剩余粗粉与剩余药材进行煎煮(煎煮两次,加8倍量水,每次1小时),药液合并,过滤,浓缩,浓缩至3.2pa.s(100℃)。
3、制丸:浓缩液与上述粉末混合,制软材,在挤出滚圆机中挤出-搓圆,得到湿丸,烘箱干燥(60℃,2h)即得。
4、工艺评价:得丸率87.20%,丸粒光滑圆整。
实施例3
处方:
砂仁100g,灵芝140g,人参60g,天冬150g,麦冬150g,麸炒苍术150g,茯苓225g,生地200g(处方重量总计:1175g)。
工艺:
1、粉碎:按照由高至低的单味药材的粉筛率筛选总处方28%重量比的药材(人参60g、茯苓225g、砂仁45g)进行粉碎,过5号筛,得粉末302.32g。
2、煎煮:余下粗粉与剩余药材进行煎煮(煎煮两次,加8倍量水,每次1小时),药液合并,过滤,浓缩,浓缩至2.9pa.s(100℃)。
3、制丸:浓缩液与上述粉末混合,制软材,在挤出滚圆机中挤出-搓圆,得到湿丸,烘箱干燥(60℃,2h)即得。
4、工艺评价:得丸率97.20%,丸粒光滑圆整。
实施例4
处方:
党参150g,白术100g,茯苓100g,甘草50g,陈皮75g,麦芽200g,鸡内金100g,六神曲100g,山楂50g(处方重量总计:925g)。
工艺:
1、粉碎:按照由高至低的单味药材的粉筛率筛选总处方25%重量比的药材(鸡内金100g、茯苓100g、白术32g)进行粉碎,过5号筛,得粉末214.82g。
2、煎煮:余下粗粉与剩余药材进行煎煮(煎煮两次,加8倍量水,每次1小时),药液合并,过滤,浓缩,浓缩至2.6pa.s(100℃)。
3、制丸:浓缩液与上述粉末混合,制软材,在挤出滚圆机中挤出-搓圆,得到湿丸,烘箱干燥(60℃,2h)即得。
4、工艺评价:得丸率82.18%,丸粒光滑圆整。
实施例5
处方:
西洋参50g,石斛150g,麦冬90g,黄连30g,竹叶60g,荷梗150g,知母60g,甘草30g,粳米150g,西瓜翠衣300g(处方重量总计:1070g)。
工艺:
1、粉碎:按照由高至低的单味药材的粉筛率筛选总处方24%重量比的药材(西洋参50g、粳米150g、黄连30g、荷梗27g)进行粉碎,过5号筛,得粉末238.59g。
2、煎煮:余下粗粉与剩余药材进行煎煮(煎煮两次,加8倍量水,每次1小时),药液合并,过滤,浓缩,浓缩至6.2pa.s(100℃)。
3、制丸:浓缩液与上述粉末混合,制软材,在挤出滚圆机中挤出-搓圆,得到湿丸,烘箱干燥(60℃,2h)即得。
4、工艺评价:得丸率87.18%,丸粒光滑圆整。
实施例6
处方:
党参75g,紫苏叶75g,葛根75g,前胡75g,茯苓75g,制半夏75g,陈皮50g,炒枳壳50g,桔梗50g,甘草50g,木香50g(处方重量总计:700g)。
工艺:
1、粉碎:按照由高至低的单味药材的粉筛率筛选总处方18%重量比的药材(茯苓75g、炒枳壳50g)进行粉碎,过5号筛,得粉末116.28g。
2、煎煮:余下粗粉与剩余药材进行煎煮(煎煮两次,加8倍量水,每次1小时),药液合并,过滤,浓缩,浓缩至7.8pa.s(100℃)。
3、制丸:浓缩液与上述粉末混合,制软材,在挤出滚圆机中挤出-搓圆,得到湿丸,烘箱干燥(60℃,2h)即得。
4、工艺评价:得丸率87.18%,丸粒光滑圆整。
实施例7
处方:
柴胡40g,黄芩40g,白芍40g,茯苓80g,陈皮40g,益母草60g,生黄芪48g,当归40g,川芎40g,桃仁40g,红花40g,厚朴40g,炒酸枣仁60g,浮小麦120g,炙甘草40g,合欢皮60g,大枣(20枚)51g,夜交藤60g(处方重量总计:939g)。
工艺:
1、粉碎:按照由高至低的单味药材的粉筛率筛选总处方16%重量比的药材(茯苓80g、白芍40g、浮小麦30g)进行粉碎,过5号筛,得粉末136.46g。
2、煎煮:余下粗粉与剩余药材进行煎煮(煎煮两次,加8倍量水,每次1小时),药液合并,过滤,浓缩,浓缩至9.2pa.s(100℃)。
3、制丸:浓缩液与上述粉末混合,制软材,在挤出滚圆机中挤出-搓圆,得到湿丸,烘箱干燥(60℃,2h)即得。
4、工艺评价:得丸率84.00%,丸粒光滑圆整。
实施例8
处方:
柴胡40g,郁金40g,党参40g,白芍40g,当归40g,川芎40g,茯苓80g,生白术40g,干姜32g,炒枳壳40g,清半夏40g,枸杞子40g,炒杜仲40g,茯神120g,合欢皮60g,夜交藤20g,益母草60g,桃仁40g(处方重量总计:852g)。
工艺:
1、粉碎:按照由高至低的单味药材的粉筛率筛选总处方12%重量比的药材(茯苓80g、茯神22g)进行粉碎,过5号筛,得粉末94.68g。
2、煎煮:余下粗粉与剩余药材进行煎煮(煎煮两次,加8倍量水,每次1小时),药液合并,过滤,浓缩,浓缩至10.4pa.s(100℃)。
3、制丸:浓缩液与上述粉末混合,制软材,在挤出滚圆机中挤出-搓圆,得到湿丸,烘箱干燥(60℃,2h)即得。
4、工艺评价:得丸率85.74%,丸粒光滑圆整。
Claims (6)
1.一种用于中药临方制剂的浓缩水丸制备方法,其特征在于,包括以下步骤:基于由高至低的单味药材的粉筛率筛选处方中一定重量比的药材经粉碎处理得过五号筛的药材粉末;处方中其余药材经提取并浓缩至适宜粘度得浓缩液;将过五号筛的药材粉末与浓缩液混合,制软材,制丸。
2.根据权利要求1所述的浓缩水丸制备方法,其特征在于,还包括基于由高至低的单味药材的粉筛率筛选的处方中一定重量比的药材经粉碎处理得到的除过五号筛的药材粉末外的粗粉与处方中其余药材混合,经提取并浓缩至适宜浓度得浓缩液。
3.根据权利要求1所述的浓缩水丸制备方法,其特征在于,若处方中其余药材包含含有易挥发或热不稳定成分的药材,该含有易挥发或热不稳定成分的药材采用后下煎煮方式提取。
4.根据权利要求1所述的浓缩水丸制备方法,其特征在于,基于由高至低的单味药材的粉筛率筛选的用于粉碎处理的药材在处方中重量比为12%~36%。
5.根据权利要求1所述的浓缩水丸制备方法,其特征在于,处方中其余药材经提起并浓缩所得浓缩液于100℃的粘度值为1.5~10.5pa.s。
6.根据权利要求1所述的浓缩水丸制备方法,其特征在于,还包括制丸后的筛丸和干燥处理。
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