CN113995784A - 白芍配方颗粒制备工艺 - Google Patents
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Abstract
本发明公开了白芍配方颗粒制备工艺,涉及中药配方颗粒制备技术领域,本发明包括如下步骤:Step1:先加9倍量饮用水,待水温达到50℃时,投入工艺用量的白芍浸泡60min,煎煮1.5小时,煎液120目滤过;Step2:第二次加7倍量水,煎煮1小时,120目滤过,合并滤液;Step3:将提取液浓缩至浸膏后进行喷雾干燥;Step4:将浓缩后的浸膏收料于洁净区配料罐中;Step5:加入辅料麦芽糊精和β‑环糊精混合均匀;Step6:用喷雾干燥法干燥;Step7:将喷雾干燥后的浸膏粉干法制粒。本发明技术应用于中药配方颗粒的制备,以传统中药饮片为原料,经过提取、分离、浓缩、干燥、制粒、包装等生产工艺,加工制成一种统一规格、统一剂量、统一质量标准的新型配方用药。
Description
技术领域
本发明涉及中药配方颗粒制备技术领域,特别涉及白芍配方颗粒制备工艺。
背景技术
白芍为毛茛科植物芍药的干燥根,夏、秋二季采挖,洗净,除去头尾和细根,置沸水中煮后除去外皮或去皮后再煮,晒干,具有养血调经、敛阴止汗、柔肝止痛、平抑肝阳之功效,常用于血虚萎黄、月经不调、自汗、盗汗、胁痛、腹痛、四肢挛痛、头痛眩晕;
目前的白芍配方颗粒制备工艺提取效果不佳,由于白芍中的芍药苷在水中稳定性不好,且对温度比较敏感,在ph值4~6之间相对稳定,以致白芍中芍药苷的转移率在40~50%之间,含量不足,影响产品质量;为此,我们提出白芍配方颗粒制备工艺。
发明内容
本发明的主要目的在于提供白芍配方颗粒制备工艺,以传统中药饮片为原料,经过提取、分离、浓缩、干燥、制粒、包装等生产工艺,加工制成一种统一规格、统一剂量、统一质量标准的新型配方用药,以解决背景技术中提出的问题。
为实现上述目的,本发明采取的技术方案为:白芍配方颗粒制备工艺,包括提取工艺、浓缩工艺和干燥工艺;
所述白芍配方颗粒制备提取工艺,包括如下步骤:
Step1:先加9倍量饮用水,待水温达到50℃时,投入工艺用量的白芍浸泡60min,煎煮1.5小时,煎液120目滤过;
Step2:第二次加水7倍量水,煎煮1小时,120目滤过,合并滤液储存于提取液贮罐;
所述白芍配方颗粒制备浓缩工艺,包括如下步骤:
Step3:将提取液进料至浓缩器中,浓缩至相对密度1.05~1.10(50~60℃)的浸膏后进行喷雾干燥;
Step4:将浓缩后的浸膏收料于洁净区配料罐中;
Step5:趁热及时加入称量后的辅料麦芽糊精和β-环糊精,开启搅拌混合均匀;
所述白芍配方颗粒制备干燥工艺,包括如下步骤:
Step6:将加入辅料后搅拌均匀后的浸膏,用喷雾干燥法干燥;
Step7:将喷雾干燥后的浸膏粉干法制粒,得白芍配方颗粒。
优选的,所述Step1白芍浸泡过程中保持水温50℃。
优选地,所述Step2中合并滤液为Step1中所得滤液和Step2中所得滤液。
优选地,所述Step3中浓缩器中控制一效温度65~75℃、一效真空度-0.06~-0.07Mpa;二效温度50~60℃、二效真空度-0.07~-0.08Mpa。
优选地,所述Step5中辅料麦芽糊精使用占比5%,β-环糊精使用占比5%。
优选地,所述Step6中控制加热蒸汽压力0.4~0.6Mpa,控制进风温度140~160℃,排风温度75~85℃,喷雾压力10~14Mpa,塔内温度85~95℃。
本发明具有如下有益效果:
本发明白芍配方颗粒制备工艺,相较于一般白芍提取工艺中芍药苷的转移率在40~50%之间,本工艺可以使白芍的转移率保持在65%以上,最大的保留了其含量,从而更大限度保证其产品的质量。
当然,实施本发明的任一产品并不一定需要同时达到以上所述的所有优点。
附图说明
图1为本发明白芍配方颗粒制备工艺的操作制备方法流程图。
具体实施方式
下面将对本实用发明例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其它实施例,都属于本发明保护的范围。
如图1所示:白芍配方颗粒制备工艺,包括提取工艺、浓缩工艺和干燥工艺;
白芍配方颗粒制备提取工艺,包括如下步骤:
Step1:先加9倍量饮用水,待水温达到50℃时,投入工艺用量的白芍浸泡60min,煎煮1.5小时,煎液120目滤过;其中,白芍浸泡过程中保持水温50℃;
Step2:第二次加水7倍量水,煎煮1小时,120目滤过,合并滤液储存于提取液贮罐;
白芍配方颗粒制备浓缩工艺,包括如下步骤:
Step3:将提取液进料至浓缩器中,浓缩至相对密度1.05~1.10(50~60℃)的浸膏后进行喷雾干燥;其中,浓缩器中控制一效温度65~75℃、一效真空度-0.06~-0.07Mpa;二效温度50~60℃、二效真空度-0.07~-0.08Mpa;
Step4:将浓缩后的浸膏收料于洁净区配料罐中;
Step5:趁热及时加入称量后的辅料麦芽糊精(5%)和β-环糊精(5%),开启搅拌混合均匀;
白芍配方颗粒制备干燥工艺,包括如下步骤:
Step6:将加入辅料后搅拌均匀后的浸膏,用喷雾干燥法干燥;干燥过程中控制加热蒸汽压力0.4~0.6Mpa,控制进风温度140~160℃,排风温度75~85℃,喷雾压力10~14Mpa,塔内温度85~95℃;
Step7:将喷雾干燥后的浸膏粉干法制粒,得白芍配方颗粒。
本发明工艺在实际操作过程中在提取环节应注意投料顺序、浸泡时间与温度,提取次数、时间及用水量,在浓缩环节应注意浓缩温度、浸膏相对密度和辅料加入量,在干燥环节应注意干燥温度;
本发明方案中,由于中药配方颗粒为国家新型配方用药,白芍配方颗粒质量标准于2021年国家药监局才公示,目前改产品的制备工艺每个制药企业不尽相同,且均为保密阶段,故此次申请的白芍配方颗粒的制备工艺,不但可以满足国家标准,而且可以达到均值之上,且稳定可行;
本发明方案为了得出白芍配方颗粒的制备工艺,进行了相关药学研究,比如从筛选全国主产地白芍药材共18批次进行质量对比研究,并根据《医疗机构中药煎药室管理规范》进行了18批次的标准汤剂的制备,并进行了质量对比研究,得出了白芍有效成分其量值的转移一致后,再进行白芍配方颗粒小试,分别从浸泡、提取、浓缩、喷雾干燥的时间与温度,进行影响因素筛查,得出小试产品再与标准汤剂进行质量对比研究,在确定质量无差异的情况下,在进行中试及工业批次的生产,以确保其质量稳定,并符合国家质量标准。
在本说明书的描述中,参考术语“一个实施例”、“示例”、“具体示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中,对上述术语的示意性表述不一定指的是相同的实施例或示例。而且,描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
以上公开的本发明优选实施例只是用于帮助阐述本发明。优选实施例并没有详尽叙述所有的细节,也不限制该发明仅为的具体实施方式。显然,根据本说明书的内容,可作很多的修改和变化。本说明书选取并具体描述这些实施例,是为了更好地解释本发明的原理和实际应用,从而使所属技术领域技术人员能很好地理解和利用本发明。本发明仅受权利要求书及其全部范围和等效物的限制。
Claims (6)
1.白芍配方颗粒制备工艺,其特征在于,包括提取工艺、浓缩工艺和干燥工艺;
所述白芍配方颗粒制备提取工艺,包括如下步骤:
Step1:先加9倍量饮用水,待水温达到50℃时,投入工艺用量的白芍浸泡60min,煎煮1.5小时,煎液120目滤过;
Step2:第二次加水7倍量水,煎煮1小时,120目滤过,合并滤液储存于提取液贮罐;
所述白芍配方颗粒制备浓缩工艺,包括如下步骤:
Step3:将提取液进料至浓缩器中,浓缩至相对密度1.05~1.10(50~60℃)的浸膏后进行喷雾干燥;
Step4:将浓缩后的浸膏收料于洁净区配料罐中;
Step5:趁热及时加入称量后的辅料麦芽糊精和β-环糊精,开启搅拌混合均匀;
所述白芍配方颗粒制备干燥工艺,包括如下步骤:
Step6:将加入辅料后搅拌均匀后的浸膏,用喷雾干燥法干燥;
Step7:将喷雾干燥后的浸膏粉干法制粒,得白芍配方颗粒。
2.根据权利要求1所述的白芍配方颗粒制备工艺,其特征在于,所述Step1白芍浸泡过程中保持水温50℃。
3.根据权利要求1所述的白芍配方颗粒制备工艺,其特征在于,所述Step2中合并滤液为Step1中所得滤液和Step2中所得滤液。
4.根据权利要求1所述的白芍配方颗粒制备工艺,其特征在于,所述Step3中浓缩器中控制一效温度65~75℃、一效真空度-0.06~-0.07Mpa;二效温度50~60℃、二效真空度-0.07~-0.08Mpa。
5.根据权利要求1所述的白芍配方颗粒制备工艺,其特征在于,所述Step5中辅料麦芽糊精使用占比5%,β-环糊精使用占比5%。
6.根据权利要求1所述的白芍配方颗粒制备工艺,其特征在于,所述Step6中控制加热蒸汽压力0.4~0.6Mpa,控制进风温度140~160℃,排风温度75~85℃,喷雾压力10~14Mpa,塔内温度85~95℃。
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