CN116098962A - 一种益寿强身颗粒的制备方法 - Google Patents

一种益寿强身颗粒的制备方法 Download PDF

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CN116098962A
CN116098962A CN202211620975.5A CN202211620975A CN116098962A CN 116098962 A CN116098962 A CN 116098962A CN 202211620975 A CN202211620975 A CN 202211620975A CN 116098962 A CN116098962 A CN 116098962A
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parts
root
radix
prolonging
life
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姜慧慧
甘国峰
贾美玲
米阿娜
沈静怡
顾淼
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Wuxi Jiyu Shanhe Pharmaceutical Co ltd
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Abstract

本发明涉及一种益寿强身颗粒及其制备方法，本发明益寿强身颗粒剂的制备方法是以党参(炒)、人参、茯苓、黄芪(炙)、白术(炒)、山药、制何首乌、当归、熟地黄、川芎、泽泻、牡丹皮、牛膝、白芍、杜仲叶、续断、阿胶、红花、三七、甘草(炙)、黄精(制)、陈皮为原料，经过浸泡、煎煮、过滤、浓缩、制粒、干燥、混匀、分装步骤而制得的颗粒剂。该制剂具有补气养血，滋补肝肾，养心安神，强筋健骨，健脾开胃。用于体虚气弱，食欲不振，腰膝酸软，神疲乏力，头晕目眩，失眠健忘，年老体弱。本发明的特点是制备方法简单、稳定性好，剂量较小，便于服用、携带，增加患者的服药顺应性，适用人群广泛。

Description

一种益寿强身颗粒的制备方法
【技术领域】
本发明属于药物制剂领域，特别涉及一种益寿强身颗粒的制备方法。
【技术背景】
颗粒剂系指提取物与适宜的辅料或饮片细粉混合制成具有一定粒度的干燥颗粒状剂型。颗粒剂曾被称为沖剂或冲服剂，是在汤剂和糖浆剂等剂型的基础上发展起来的剂型。
主要有以下特点：①既保持了汤剂吸收较快、作用迅速的特点，又克服了汤剂临用时煎煮不便、服用量大、易霉败变质等缺点；②剂量较小，便于服用、携带，产品质量稳定，无微生物污染风险；③起效快、生物利用度高、顺应性好，利于老年人、婴幼儿及吞咽困难者服用。
益寿强身膏为一种已经上市的中成药，系原无锡市中医院副院长陶念唐老中医的多年经验方。功能主治：补气养血，滋补肝肾，养心安神，强筋健骨，健脾开胃。用于体虚气弱，食欲不振，腰膝酸软，神疲乏力，头晕目眩，失眠健忘，年老体弱。成份：党参(炒)、人参、茯苓、黄芪(炙)、白术(炒)、山药、制何首乌、当归、熟地黄、川芎、泽泻、牡丹皮、牛膝、白芍、杜仲叶、续断、阿胶、红花、三七、甘草(炙)、黄精(制)、陈皮。益寿强身膏选用人参、阿胶等二十多味中药制成具有延年益寿、滋补强身的“益寿强身膏”，常服可延年益寿，滋补强身。
现有技术中，已经公开的益寿强身的新制剂包括：煎膏剂。
本发明通过研究，以益寿强身膏的配方为基础，研制出一种颗粒制剂，得到一种含糖或无糖颗粒，按照日用包装进行分袋包装，剂量较小，便于服用、携带，增加患者的服药顺应性，且扩大用药人群，糖尿病、高血脂患者也可使用。
本发明通过研究，发现以甘露醇、糊精为辅料制备的益寿强身颗粒剂具有意想不到的技术效果。
【发明内容】
本发明旨在克服现有技术的缺陷，提供一种新的益寿强身颗粒剂及其制备方法。本发明的基础处方来源于益寿强身膏。
一种益寿强身颗粒剂，所述颗粒剂由以下重量配比的中药原料药制备而成：
党参(炒) 25-100份 人参 3-12份
茯苓 25-100份 黄芪(炙) 20-80份
白术(炒) 25-100份 山药 20-80份
制何首乌 25-100份 当归 25-100份
熟地黄 50-200份 川芎 10-40份
泽泻 17.5-50份 牡丹皮 17.5-50份
牛膝 17.5-50份 白芍 20-80份
杜仲叶 30-120份 续断 17.5-50份
阿胶 3-12份 红花 5-20份
三七 3-12份 甘草(炙) 6-24份
黄精(制) 12-48份 陈皮 1.3-5份。
优选的，本发明所述的益寿强身颗粒剂，所述颗粒剂由以下重量配比的中药原料药制备而成：
党参(炒) 50份 人参 6份
茯苓 50份 黄芪(炙) 40份
白术(炒) 50份 山药 40份
制何首乌 50份 当归 50份
熟地黄 100份 川芎 20份
泽泻 25份 牡丹皮 25份
牛膝 25份 白芍 40份
杜仲叶 60份 续断 25份
阿胶 6份 红花 10份
三七 6份 甘草(炙) 12份
黄精(制) 24份 陈皮 2.5份。
本发明所述的益寿强身颗粒剂，为无蔗糖颗粒剂。
本发明所述的益寿强身颗粒剂，是由所述重量配比的中药原料药经过提取得到中药提取物浸膏，进一步加入药用辅料制备而成，其中所述药用辅料为甘露醇和糊精。
本发明所述的益寿强身颗粒剂，其中所述中药提取物浸膏，制备方法如下：
步骤1：将人参、三七加适量水煎煮4次，每次2小时，合并静置，滤过；
步骤2：将除人参、三七、阿胶外，其余党参等十九味加水煎煮3次，第一次3小时，第二、三次各2小时，合并煎液，静置沉淀，滤过；
步骤3：将阿胶加适量水烊化；
步骤4：合并上述药液，浓缩至相对密度为1.20～1.22(70～80℃)的浸膏。
优选的，本发明所述的益寿强身颗粒剂，其中所述中药提取物浸膏，甘露醇，糊精的重量比例如下：
中药提取浸膏         1份
甘露醇               1.5-2.5份
糊精                 1-2份。
本发明所述的益寿强身颗粒剂，其中所述中药提取物浸膏，甘露醇，糊精的重量比例为：
中药提取浸膏          1份
甘露醇                2份
糊精                  1.5份。
优选的，本发明所述的益寿强身颗粒剂的制备方法，步骤如下：
步骤1：将人参、三七加适量水煎煮4次，每次2小时，合并静置，滤过；
步骤2：将除人参、三七、阿胶外，其余党参等十九味加水煎煮3次，第一次3小时，第二、三次各2小时，合并煎液，静置沉淀，滤过；
步骤3：将阿胶加适量水烊化；
步骤4：合并上述药液，浓缩至相对密度为1.20～1.22(70～80℃)的浸膏；加甘露醇、糊精至上述浸膏中混匀，以适量95％乙醇润湿制粒，80℃以下干燥，整粒，分装，即得。
本发明的颗粒剂，其组分组成是经过筛选得到的，筛选过程如下：
将可溶性淀粉、糊精、乳糖、甘露醇、微晶纤维素和羧甲基纤维素钠作为本发明颗粒剂的辅料，对那种辅料或其组合适合本发明进行筛选，发现和本发明药物结合后各种辅料表现不一，见表1。
表1
Figure BDA0004002122070000041
采用不同辅料制备成颗粒剂，进行吸湿性考察。取不同辅料制备的颗粒剂，于30℃烘箱中恒重48h后称取2g，放入已恒重的扁称量瓶中，摊开至厚度2mm，将称量瓶盖打开，置于放有相对湿度(RH)75％的过饱和氯化钠溶液的干燥器中，48h后称定质量，共做两组，计算平均吸湿率，结果见表2。
表2辅料在RH75％环境中的吸湿率
Figure BDA0004002122070000042
根据各辅料吸湿率并考虑价格、口感等因素，以甘露醇+糊精作为复合辅料，效果最佳。
本发明进一步对甘露醇、糊精的重量比例进行了筛选，以粒度合格率、溶化性，流动性，水分为指标，经过筛选获得的，筛选过程如下：
采用湿法制粒，以甘露醇、糊精为辅料，中药提取浸膏、辅料(甘露醇、糊精)选取下表比例放入托盘中混合均匀，以95％乙醇作为润湿剂，制成软材，手握成团，轻按即散，挤压过16目筛制成湿颗粒，置于烘箱中80℃干燥1h，收集能通过一号筛而不能通过五号筛的颗粒，以粒度合格率、水分、溶化性、休止角为考察指标，采用综合评分考察方式，以综合评分结果优选辅料最佳配比(所述配比均为重量比)。如下表所示：
表3无蔗糖颗粒考察结果
Figure BDA0004002122070000051
上表结果表明，无蔗糖颗粒最佳配比工艺为提取浸膏：甘露醇：糊精(1:2:1.5)。
按上述试验得出的最佳工艺，对无蔗糖颗粒分别进行三批样品重复验证性试验，按照药典规定，以粒度合格率、水分、干燥失重、溶化性和装量差异为考察益寿强身颗粒的质量。试验结果如下：
表4无蔗糖颗粒考察结果
批次 粒度合格率(％) 水分(％) 干燥失重(％) 溶化性 装量差异
1 94.85 4.26 1.15 轻微浑浊 符合规定
2 94.71 4.03 0.91 轻微浑浊 符合规定
3 94.43 3.68 1.24 轻微浑浊 符合规定
结果表明：三批样品质量稳定，故该工艺稳定可行。
本发明的优势在于：①既保持了汤剂吸收较快、作用迅速的特点，又克服了汤剂临用时煎煮不便、服用量大、易霉败变质等缺点；②剂量较小，便于服用、携带，产品质量稳定，无微生物污染风险；③起效快、生物利用度高、顺应性好，利于老年人、婴幼儿及吞咽困难者服用；④益寿强身膏为瓶装糖浆剂，制备得无蔗糖颗粒，扩大用药人群，糖尿病、高血脂患者也可使用。
【具体实施方式】
以下通过实施例进一步说明本发明，但不作为对本发明的限制。
实施例1
中药的提取：
1)将人参、三七投入多功能提取罐内，煎煮四次，每次加5倍量水煎煮2小时，至无参味，合并各次煎煮液，静置沉淀。
2)将除人参、三七、阿胶外，其余党参等十九味投入多功能提取罐内，加水煎煮三次，第一次加9倍量水煎煮3小时，第二次加8倍量水煎煮2小时，第三次加6倍量水煎煮2小时。合并煎液，静置沉淀4-6小时，上清液过滤，下沉物进入离心工序。下沉物从储罐进入离心机，经离心后，药液转入中间储罐，保存，备用。
3)阿胶加6倍量水在敞口锅中，加热至全部烊化，备用。烊化时不断搅拌，并控制加热温度，以防沾粘锅底。
4)将上述药液合并减压浓缩，(温度≤85℃)，浓缩至相对密度约1.20～1.22(70～80℃)的浸膏。
实施例2
中药的提取：
1)将人参、三七投入多功能提取罐内，煎煮四次，每次加5倍量水煎煮2小时，至无参味，合并各次煎煮液，静置沉淀。
2)将除人参、三七、阿胶外，其余党参等十九味投入多功能提取罐内，加水煎煮三次，第一次加9倍量水煎煮3小时，第二次加8倍量水煎煮2小时，第三次加6倍量水煎煮2小时。合并煎液，静置沉淀4-6小时，上清液过滤，下沉物进入离心工序。下沉物从储罐进入离心机，经离心后，药液转入中间储罐，保存，备用。
3)阿胶加6倍量水在敞口锅中，加热至全部烊化，备用。烊化时不断搅拌，并控制加热温度，以防沾粘锅底。
4)将上述药液合并减压浓缩，(温度≤85℃)，浓缩至相对密度约1.07(50℃)的清膏。
中药浸膏的干燥：
将上述中药提取清膏进行喷雾干燥，进口温度210～230℃，出口温度75～85℃，得中药提取浸膏粉。
实施例3
中药提取浸膏1份甘露醇2份糊精1份95％乙醇适量
加甘露醇、糊精至中药提取浸膏中混匀，以适量95％乙醇润湿制粒，80℃以下干燥，整粒，分装，即得。
实施例4
中药提取浸膏1份甘露醇2份糊精1.5份95％乙醇适量
加甘露醇、糊精至中药提取浸膏中混匀，以适量95％乙醇润湿制粒，80℃以下干燥，整粒，分装，即得。
实施例5
中药提取浸膏1份甘露醇2.5份糊精1份95％乙醇适量
加甘露醇、糊精至中药提取浸膏中混匀，以适量95％乙醇润湿制粒，80℃以下干燥，整粒，分装，即得。

Claims (9)

1.一种益寿强身颗粒剂，其特征在于，所述颗粒剂由以下重量配比的中药原料药制备而成：
2.根据权利要求1所述的益寿强身颗粒剂，其特征在于，所述颗粒剂由以下重量配比的中药原料药制备而成：
3.根据权利要求1或2任意一项权利要求所述的益寿强身颗粒剂，为无蔗糖颗粒剂。
4.根据权利要求1或2任意一项权利要求所述的益寿强身颗粒剂，是由所述重量配比的中药原料药经过提取得到中药提取物浸膏，进一步加入药用辅料制备而成，其中所述药用辅料为甘露醇和糊精。
5.根据权利要求4所述的益寿强身颗粒剂，其中所述中药提取物浸膏，制备方法如下：
步骤1：将人参、三七加适量水煎煮4次，每次2小时，合并静置，滤过；
步骤2：将除人参、三七、阿胶外，其余党参等十九味加水煎煮3次，第一次3小时，第二、三次各2小时，合并煎液，静置沉淀，滤过；
步骤3：将阿胶加适量水烊化；
步骤4：合并上述药液，浓缩至相对密度为1.20～1.22(70～80℃)的浸膏。
6.根据权利要求4所述的益寿强身颗粒剂，其中所述中药提取物浸膏，甘露醇，糊精的重量比例如下：
中药提取浸膏         1份
甘露醇               1.5-2.5份
糊精                 1-2份。
7.根据权利要求6所述的益寿强身颗粒剂，其中所述中药提取物浸膏，甘露醇，糊精的重量比例为：
中药提取浸膏              1份
甘露醇                    2份
糊精                      1.5份。
8.权利要求6所述的益寿强身颗粒剂的制备方法，步骤如下：
步骤1：将人参、三七加适量水煎煮4次，每次2小时，合并静置，滤过；
步骤2：将除人参、三七、阿胶外，其余党参等十九味加水煎煮3次，第一次3小时，第二、三次各2小时，合并煎液，静置沉淀，滤过；
步骤3：将阿胶加适量水烊化；
步骤4：合并上述药液，浓缩至相对密度为1.20～1.22(70～80℃)的浸膏；加甘露醇、糊精至上述浸膏中混匀，以适量95％乙醇润湿制粒，80℃以下干燥，整粒，分装，即得。
9.权利要求7所述的益寿强身颗粒剂的制备方法，步骤如下：
步骤1：将人参、三七加适量水煎煮4次，每次2小时，合并静置，滤过；
步骤2：将除人参、三七、阿胶外，其余党参等十九味加水煎煮3次，第一次3小时，第二、三次各2小时，合并煎液，静置沉淀，滤过；
步骤3：将阿胶加适量水烊化；
步骤4：合并上述药液，浓缩至相对密度为1.20～1.22(70～80℃)的浸膏；加甘露醇、糊精至上述浸膏中混匀，以适量95％乙醇润湿制粒，80℃以下干燥，整粒，分装，即得。
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