CN108514551A - 一种中药丸剂的制备方法 - Google Patents
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Abstract
本发明属于中药制备技术领域,涉及一种中药丸剂的制备方法。所述的制备方法包括如下步骤,(1)混合:将制备中药丸剂的原料用自动加水机加水并用搅拌机混合;(2)炼药:将混合好的药坨传入精炼机炼制成合格药坨;(3)制丸:将合格药坨在自动制丸机上进行制丸;(4)整形过筛:将药丸送至整形上光机组进行药丸抛光,抛光后的药丸送至滚筒筛筛选出合格药丸;(5)真空干燥:对合格药丸在真空干燥设备内进行真空干燥;(6)选丸:将真空干燥后的药丸通过离心式自动选丸机进行选丸,再对选丸进行包装。利用本发明的制备方法,能够使制备得到的中药丸剂质量均一性更好,并可在降低工人劳动强度、提高生产效率的同时减少生产过程中的粉尘污染。
Description
技术领域
本发明属于中药制备技术领域,涉及一种中药丸剂的制备方法。
背景技术
传统的中药丸剂(水丸)的制备方法是将中成药处方中的中药饮片粉碎成细粉,用水做黏合剂,以手工泛丸的方式制成药丸,再通过传统的烘房进行烘干,由此得到中药丸剂。该制备方法的典型流程如图1所示,依次包括制备中药细粉、起模、过筛、手工制作泛丸、干燥、过筛、素丸检验的步骤。
但上述制备方法存在如下的问题:
(1)手工泛丸因个人手法的差异性,易造成药丸的水分、丸重、外观等质量标准的不均一,这直接影响成品合格率;
(2)手工泛丸工人劳动强度大,影响产量;
(3)手工泛丸生产时间长,粉尘污染大,不利于生产区域洁净级别的控制,粉尘还会对操作工人的身体健康造成伤害;
(4)传统的烘干方式会使含有特殊成分的中药品种的溶散时限超标、药物有效成分含量损失大,这直接影响到产品质量。
发明内容
本发明的目的是提供一种中药丸剂的制备方法,以能够使制备得到的中药丸剂质量均一性更好,并可在降低工人劳动强度、提高生产效率的同时减少生产过程中的粉尘污染。
为实现此目的,在基础的实施方案中,本发明提供一种中药丸剂的制备方法,所述的制备方法包括如下步骤,
(1)混合:将制备所述的中药丸剂的原料用自动加水机加水并用搅拌机混合;
(2)炼药:将混合好的药坨传入中药精炼机炼制成合格药坨;
(3)制丸:将合格药坨在中药自动制丸机上进行制丸;
(4)整形过筛:将药丸送至中药丸整形上光机组进行药丸抛光,抛光后的药丸送至滚筒筛筛选出合格药丸;
(5)真空干燥:对合格药丸在真空干燥设备内进行真空干燥;
(6)选丸:将真空干燥后的药丸通过离心式自动选丸机进行选丸,再对选丸进行包装。
本发明的中药丸剂自动化生产工艺是利用混合机、炼药机、制丸机、整形上光机、过筛机、真空干燥、选丸机为一体的自动化生产线来完成中药丸剂的全过程生产。生产线采用HMI(人机界面)+PLC(可编程逻辑控制器)控制系统,由计算机化系统对生产过程进行有效控制。
本发明的中药丸剂的制备方法的特点在于:
1、可拆分式混合机有利于物料间的传输、降低粉尘扩散,行星式的搅拌原理使物料混合均匀,物料含水量、搅拌时间和速度可控;
2、制丸过程是由出条孔和搓丸模具控制完成,标准的模具使制成的药丸丸形一致、丸重均一,在线监控丸重差异在内控制标准±5%之内;
3、整形上光和过筛过程使药丸外观光滑圆润、药丸大小统一;
4、真空干燥技术是中药丸剂制备过程的关键技术控制点,通过对设备功率、速度、真空度、温度、时间、水分蒸发等生产工艺参数和技术指标的优化,解决了传统手工泛丸不能解决的含有特殊成分药丸的溶散时限超标、制剂过程中有效成分降解等问题;
5、通过机械化大生产降低了工人劳动强度,提高了生产效率。
在一种优选的实施方案中,本发明提供一种中药丸剂的制备方法,其中所述的中药丸剂为皮肤病血毒丸(批准文号为Z11020834)。
在一种优选的实施方案中,本发明提供一种中药丸剂的制备方法,其中步骤(1)中,所述的原料经过细化处理。
在一种优选的实施方案中,本发明提供一种中药丸剂的制备方法,其中步骤(1)中,所述的搅拌机混合时的搅拌速度为50-70转/分,正转时间为3-10分钟,反转时间为3-10分钟,搅拌时间为6-20分钟,刮料器摆动间隔为5-10秒,出料速度为50-70转/分。
在一种优选的实施方案中,本发明提供一种中药丸剂的制备方法,其中步骤(2)中,所述的精炼机的出条孔直径为10-15mm,炼药速度为50-70转/分,炼药次数为1-3次。
在一种优选的实施方案中,本发明提供一种中药丸剂的制备方法,其中步骤(3)中,所述的自动制丸机在制丸过程中,搓丸刀为6.5-7.0mm,出条嘴孔径为6.0-6.8mm,推料速度为10-50转/分,切丸速度为10-50转/分,搓刀上方酒精滴速控制在10-20滴/10秒。
在一种优选的实施方案中,本发明提供一种中药丸剂的制备方法,其中步骤(4)中,所述的整形上光机组的运转速度为20-30转/分,出料速度为20-30转/分。
在一种优选的实施方案中,本发明提供一种中药丸剂的制备方法,其中步骤(4)中,所述的滚筒筛的速度为10-30转/分。
在一种优选的实施方案中,本发明提供一种中药丸剂的制备方法,其中步骤(5)中,所述的真空干燥的真空度为-0.05MPa至-0.10MPa,温度为70-80℃,温度回差为2-5℃,时间为60-90分钟。
本发明的有益效果在于,利用本发明的中药丸剂的制备方法,能够使制备得到的中药丸剂质量均一性更好,并可在降低工人劳动强度、提高生产效率的同时减少生产过程中的粉尘污染。
本发明的制备方法将传统的手工泛丸改成机制丸,经自动化生产线生产出的药丸一次成形、大小均一、外观一致、质量标准可控性强、产品均一性好,这有效的保证了产品质量。因此,利用本发明的丸剂自动化生产工艺生产出的中药丸剂产品关键技术指标(重量差异、溶散时限、有效成分的含量等)都有了显著的提升。
而且,本发明的制备方法极大的降低了干燥过程对产品溶散时限和有效成分的影响。
此外,本发明的自动化生产工艺粉尘污染小,将物料、人员、环境对制丸过程的污染降至最低;人为因素少、机械化程度高,生产能力较手工泛丸有了大幅的提高,这提升了中药制剂的科技含量,实现了传统丸剂的自动化生产线生产。
附图说明
图1为现有技术的中药丸剂的制备方法的流程图。
图2为示例性的本发明的中药丸剂的制备方法的流程图。
具体实施方式
以下结合实施例和附图对本发明的具体实施方式作出进一步的说明。
实施例1:中药丸剂的制备
本实施例中的中药丸剂的制备流程如图2所示,具体制备步骤如下。
1、领料
依批生产指令领取检验合格的“皮肤病血毒丸”(批准文号为Z11020834;质量标准为国家药品监督管理局标准WS3-B1320-2002)原料药粉一批,批量为处方量的3900倍,即4212kg。
原料药粉处方组成如下:
2、混合
将双人复核重量后药粉投入XQJ-200行星式搅拌机(黑龙江迪尔制药机械有限责任公司)中,每锅投入原料药粉为75kg,根据原料药粉重量及含水量,计算加水量,使湿坨含水量为42%,将计算的加水量数值设定至自动加水机上。点击搅拌机主界面上的“参数设定”按钮,设置搅拌速度为64转/分,正转5分钟,反转5分钟,搅拌时间10分钟。待混合达到设定时间后,进入出料界面操作,设置刮料器摆动间隔时间8秒,出料速度为64转/分,混合好的药坨将被刮料器刮出,自动出料。
3、炼药
安装出条孔直径为12mm的出条板,将混合好的药坨经传送带传入GSL-450B型高效中药精炼机(黑龙江迪尔制药机械有限责任公司)料斗内,开启精炼机,炼药速度为60转/分,炼药一次,炼制成合格药坨。
4、制丸
将6.8mm的搓丸刀安装在WZB-180型中药自动制丸机(黑龙江迪尔制药机械有限责任公司)上,选择孔径为6.5mm的出条嘴,将药坨放入装料斗内,开机推料,待所出药条表面平整光滑时,开始制丸,制丸速度保持为10-44转/分,切丸速度为10-44转/分,搓刀上方酒精滴速控制在10-15滴/10秒。制丸时,每10粒湿丸重量应控制在2.24-2.47g,待湿丸重差符合要求后,开启传送带传送药丸至过筛系统。
5、整形过筛
药丸经传送带送至QGZ-06全自动整形上光机组(黑龙江迪尔制药机械有限责任公司)进行药丸抛光,其参数设置为正转30s,反转30s,换向间隔2s,运转速度为23转/分,出料速度为28转/分。抛光后的药丸经传送带传送至滚筒筛,前筛网孔径为6.5mm,后筛网孔径为7.5mm,滚筒筛速度保持为13转/分,通过后筛网(7.5mm)筛出的药丸为合格药丸,经传送带送入真空微波干燥间进行干燥。
6、真空干燥
将传送带传入的药料均匀铺于每个盛料盘内,每个盛料盘装药料最多不超过10kg,将盛料盘放入BDMD-M-V-30型真空干燥设备(河南勃达微波装备股份有限公司)。设定温度75℃,时间60-90分钟,温度回差3℃。开启真空泵,当压力达到-0.060MPa时,控制压力不超过-0.090MPa。随时观察物料当前温度、功率,控制温度不得超过80℃。开启自动排水,排水间隔时间设定为10分钟,排水时间设定为3分钟。干燥药丸应控制在每10粒重1.45g±5%(1.38-1.52g),水分应控制在3.0-5.0%。
7、选丸
将干燥后的药丸通过XW-I离心式自动选丸机(黑龙江迪尔制药机械有限责任公司)进行选丸,挑选出待包装产品,装入洁净的容器内,抽取素丸进行检验,经检验合格后,开具检验报告单。
上述丸剂一批4212kg的生产时间为24-28小时。
实施例2:中药丸剂的检测
将实施例1制备的中药丸剂分别进行水分测定(按照《中华人民共和国药典》2015年版四部制剂通则0832的方法进行,标准为≤9.0%)、重量差异检查(按照《中华人民共和国药典》2015年版四部丸剂重量差异项下的方法进行,标准为每10粒重1.45g±9%)、溶散时限检查(按照《中华人民共和国药典》2015年版四部丸剂溶散时限项下的方法进行,标准为≤1小时)、有效成分含量测定(标准为:每1g含黄柏以盐酸小檗碱(C20H18ClNO4)计,不得少于0.30mg),结果如下表1所示。
表1实施例1制备的中药丸剂的检测结果
水分 | 重量差异 | 溶散时限 | 含量测定 |
4.5% | 每10粒重1.45g±5% | ≤40分钟 | 0.39mg |
其中有效成分含量测定按照《中华人民共和国药典》2015年版四部制剂通则0512高效液相色谱法的要求进行,具体步骤如下。
色谱条件与系统适用性试验:以十八烷基硅烷键合硅胶为填充剂;乙腈–0.1mol/l磷酸(50∶50)(每100ml加十二烷基磺酸钠0.1g)为流动相;检测波长345nm。理论塔板数按盐酸小檗碱计算应不低于4000。
对照品溶液的制备:取盐酸小檗碱对照品适量,精密称定,加甲醇制成每1ml含0.02mg的溶液,即得。
供试品溶液的制备:取本品适量,研细,取约1g,精密称定,置具塞锥形瓶中,精密加入50%甲醇-盐酸(100∶1)50ml,密塞,称定重量,超声处理((功率250W,频率40kHz)30分钟,放冷,再称定重量,用50%甲醇-盐酸(100∶1)补足减失的重量,摇匀,滤过,取续滤液,即得。
测定法:分别精密吸取对照品溶液与供试品溶液各10ul,注入高效液相色谱仪,测定,即得。
显然,本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若对本发明的这些修改和变型属于本发明权利要求及其同等技术的范围之内,则本发明也意图包含这些改动和变型在内。上述实施例或实施方式只是对本发明的举例说明,本发明也可以以其它的特定方式或其它的特定形式实施,而不偏离本发明的要旨或本质特征。因此,描述的实施方式从任何方面来看均应视为说明性而非限定性的。本发明的范围应由附加的权利要求说明,任何与权利要求的意图和范围等效的变化也应包含在本发明的范围内。
Claims (8)
1.一种中药丸剂的制备方法,其特征在于,所述的制备方法包括如下步骤,
(1)混合:将制备所述的中药丸剂的原料用自动加水机加水并用搅拌机混合;
(2)炼药:将混合好的药坨传入精炼机炼制成合格药坨;
(3)制丸:将合格药坨在自动制丸机上进行制丸;
(4)整形过筛:将药丸送至整形上光机组进行药丸抛光,抛光后的药丸送至滚筒筛筛选出合格药丸;
(5)真空干燥:对合格药丸在真空干燥设备内进行真空干燥;
(6)选丸:将真空干燥后的药丸通过离心式自动选丸机进行选丸,再对选丸进行包装。
2.根据权利要求1所述的制备方法,其特征在于:步骤(1)中,所述的原料经过细化处理。
3.根据权利要求1所述的制备方法,其特征在于:步骤(1)中,所述的搅拌机混合时的搅拌速度为50-70转/分,正转时间为3-10分钟,反转时间为3-10分钟,搅拌时间为6-20分钟,刮料器摆动间隔为5-10秒,出料速度为50-70转/分。
4.根据权利要求1所述的制备方法,其特征在于:步骤(2)中,所述的精炼机的出条孔直径为10-15mm,炼药速度为50-70转/分,炼药次数为1-3次。
5.根据权利要求1所述的制备方法,其特征在于:步骤(3)中,所述的自动制丸机在制丸过程中,搓丸刀为6.5-7.0mm,出条嘴孔径为6.0-6.8mm,推料速度为10-50转/分,切丸速度为10-50转/分,搓刀上方酒精滴速控制在10-20滴/10秒。
6.根据权利要求1所述的制备方法,其特征在于:步骤(4)中,所述的整形上光机组的运转速度为20-30转/分,出料速度为20-30转/分。
7.根据权利要求1所述的制备方法,其特征在于:步骤(4)中,所述的滚筒筛的速度为10-30转/分。
8.根据权利要求1所述的制备方法,其特征在于:步骤(5)中,所述的真空干燥的真空度为-0.05MPa至-0.10MPa,温度为70-80℃,温度回差为2-5℃,时间为60-90分钟。
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