CN116726092A - 一种了哥王提取及了哥王咀嚼片的制备方法 - Google Patents
一种了哥王提取及了哥王咀嚼片的制备方法 Download PDFInfo
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Abstract
本发明涉及药剂生产技术领域，具体为一种了哥王提取及了哥王咀嚼片的制备方法，以了哥王的根及根皮为原料，通过净选、洗、切、干燥、粉碎、提取浓缩、干燥得到了哥王的干膏粉，再将干膏粉与其他辅料进行制粒干燥，且依次整粒总混、压片、泡罩得到固体片剂成品。本发明将了哥王干膏粉与其他辅料进行制粒干燥，且依次整粒总混、压片、泡罩得到固体片剂成品，规格：每片重0.45g，相当于原药材3g，本发明的了哥王干膏粉及了哥王咀嚼片生产工艺的具有较好的稳定性及连续性；不论干膏粉还是咀嚼片在温度25±2℃，相对湿度60±5%条件下具有良好的稳定性，与普通片剂相比克服了普通固体制剂的吞咽困难等缺点，且其口感能满足不同年龄阶段的人群的需求。
Description
技术领域
本发明涉及药剂生产技术领域，具体为一种了哥王提取及了哥王咀嚼片的制备方法。
背景技术
了哥王是瑞香科荛花属植物，其用药部位主要为根或根皮， 始载于《岭南采药录》，其性寒，味苦、辛，微温，有毒，入肺、肝经，具有清热解毒、化痰散结、 通经利水的功效。现代研究表明，了哥王化学成分主要包括香豆素类、黄酮类、木质素类等，且多具有生物活性，其药理作用主要有抑菌、抗病毒、抗炎镇痛及抗肿瘤作用。
目前以了哥王为关键主药做成制剂并获批的制药企业，产品涵盖胶囊剂、颗粒剂、片剂三种剂型，其中片剂有普通口服片剂、分散片等，普通固体制剂存在难于吞咽等缺点，且其口感不能满足不同年龄阶段的人群的需求。
发明内容
本发明的目的在于提供一种了哥王提取及了哥王咀嚼片的制备方法，以解决上述背景技术中提出现如今普通固体制剂存在难于吞咽等缺点，且其口感不能满足不同年龄阶段的 人群的需求的问题。
为实现上述目的，本发明提供如下技术方案：
一种了哥王提取方法，具体包括如下步骤：
S10：以了哥王的根及根皮为原料；
S11：通过挑选、剔除非药用部分的药材，用洗药机清洗药材杂物，选取适合的切药机进行药材的粗处理得到饮片，饮片用热风循环干燥箱中保持温度不超过80℃干燥3-4h，为保证了哥王的充分提取，干燥后的饮片采用0.8cm直径的筛网进行粉碎，得到了哥王粗粉；
S12：称取一定重量的了哥王粗粉投入提取罐，加入6BV的提取溶剂浸泡12-40h，浸泡液进入单效外循环蒸发器中浓缩，提取罐则重新补加一定量提取溶剂，且蒸发器内的药液蒸发出的提取溶剂蒸汽一部分重新进入提取罐内，为浸提提供热源，一部分经冷凝器冷却成新鲜溶剂补充到提取罐内，且提取罐与蒸发器保持边提取边浓缩边提取溶剂蒸汽回流状态连续提取6h，得到了哥王提取浓缩液；
S13：优选在60℃温度条件下，将了哥王浓缩液采取真空浓缩方式浓缩至相对密度1.25（80-90℃测）停止浓缩，80-90℃条件下真空干燥，优选干燥时间在7-9h，得到了哥王干膏，干膏经100目筛网粉碎得到了哥王干膏粉。
作为优选，步骤S12中所述提取溶剂采用饮用水、甲醇、乙醇或乙酸乙酯其中的一种。
另一方面，本发明还提供一种了哥王咀嚼片的制备方法，包括上述的了哥王提取方法，具体包括如下步骤：采用所述了哥王干膏粉作为原料，加入适量不同功能的辅料，经过制粒干燥、整粒总混、压片等工艺制备成固体咀嚼片剂。
作为优选，所述辅料包括填充剂、矫味剂、崩解剂、润滑剂、粘合剂和润湿剂。
作为优选，所述填充剂选用微晶纤维素、蔗糖、甘露醇、预胶化淀粉、糊精其中的一种或多种组合。
作为优选，所述矫味剂采用甜菊糖苷、三氯蔗糖、枸橼酸、薄荷脑其中的一种或多种组合。
作为优选，所述崩解剂采用低取代羟丙纤维素。
作为优选，所述润滑剂采用硬脂酸镁。
作为优选，所述粘合剂采用聚维酮K30，所述聚维酮K30的浓度为10-16%。
作为优选，所述润湿剂采用乙醇溶液，所述乙醇溶液的浓度为80-92%。
与现有技术相比，本发明的有益效果是：本了哥王提取及了哥王咀嚼片的制备方法制备以了哥王的根及根皮为原料，通过净选、洗、切、干燥、粉碎、提取浓缩、干燥得到了哥王的干膏粉，再将干膏粉与其他辅料进行制粒干燥，且依次整粒总混、压片、泡罩得到固体片剂成品，规格：每片重0.45g（相当于原药材3g），并考察了干膏粉及成品片剂的稳定性，了哥王干膏粉及了哥王咀嚼片生产工艺的具有较好的稳定性及连续性；从不同停留时间的考察结果来看，不论干膏粉还是咀嚼片在温度25±2℃，相对湿度60±5%条件下具有良好的稳定性，与普通片剂相比其克服了普通固体制剂的难于吞咽等缺点，且其口感能满足不同年龄阶段的人群的需求。
实施方式
下面将结合本发明实施例，对本发明实施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做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例
（1）将了哥王药材经净选、清洗、切制、干燥后，清除杂质及非药用部分，并用直径0.8cm筛网进行粉碎；取1500kg了哥王粗粉分7次煮提，每次加水煎煮两次，每次5小时，合并煎液，滤过，滤液浓缩至相对密度为1.25的浸膏，80-90℃真空干燥；将干浸膏粉碎成100目细粉得到了哥王干膏粉，1500kg的了哥王粗粉最终对应制剂为50万片。
（2）干膏粉加辅料适量混匀、制粒、干燥、整粒后，继续加入适量辅料混匀，压片所制得的片剂为咀嚼片。制粒所加的辅料：微晶纤维素、低取代羟丙纤维素、甜菊糖苷、硬脂酸镁、聚维酮K30。最佳用量为40%微晶纤维素、5%低取代羟丙纤维素、1.5%甜菊糖苷。
制粒粘合剂为：聚维酮K30乙醇溶液，最佳浓度为10%聚维酮K30乙醇溶液（乙醇浓度为80%）。
口感评测：咀嚼前期，甜腻，伴有涩涩的味道；咀嚼成粉，吞咽过程较困难，粘喉咙；咀嚼后期，甜味淡去，苦味持续时间长。
实施例
将了哥王药材经净选、清洗、切制、干燥后，清除杂质及非药用部分，并用直径0.8cm筛网进行粉碎；取1500kg了哥王粗粉分7次煮提，每次加水煎煮两次，每次5小时，合并煎液，滤过，滤液浓缩至相对密度为1.25（80-90℃测）的浸膏，80-90℃真空干燥；将干浸膏粉碎成100目细粉得到了哥王干膏粉，1500kg的了哥王粗粉最终对应制剂为50万片。
（2）干膏粉加辅料适量混匀、制粒、干燥、整粒后，继续加入适量辅料混匀，压片所制得的片剂为咀嚼片。制粒所加的辅料：甘露醇、蔗糖、三氯蔗糖、枸橼酸、低取代羟丙纤维素、薄荷脑、硬脂酸镁、聚维酮K30。最佳用量为20%甘露醇、20%蔗糖、5%低取代羟丙纤维素、0.5%三氯蔗糖、2%枸橼酸、0.1%薄荷脑。
制粒粘合剂为：聚维酮K30乙醇溶液，最佳浓度为16%聚维酮K30乙醇溶液（乙醇浓度为92%）。
口感评测：为减少药物在口中的苦味，改善口感，将制剂处方中填充剂和矫味剂进行了调整。调整后的咀嚼片，嚼碎后，口感酸酸甜甜，有凉爽感，遇唾液能迅速溶解，利于吞咽，更符合儿童服用的顺应性。
实施例
将了哥王药材经净选、清洗、切制、干燥后，清除杂质及非药用部分，并用直径0.8cm筛网进行粉碎；取1500kg了哥王粗粉分7次煮提，每次加水煎煮两次，每次5小时，合并煎液，滤过，滤液浓缩至相对密度为1.25（80-90℃测）的浸膏，80-90℃真空干燥；将干浸膏粉碎成100目细粉得到了哥王干膏粉，1500kg的了哥王粗粉最终对应制剂为50万片。
干膏粉加辅料适量混匀、制粒、干燥、整粒后，继续加入适量辅料混匀，压片所制得的片剂为咀嚼片。制粒所加的辅料：甘露醇、预胶化淀粉、糊精、三氯蔗糖、枸橼酸、低取代羟丙纤维素、薄荷脑、硬脂酸镁、聚维酮K30。最佳用量为15%预胶化淀粉、20%糊精、5%低取代羟丙纤维素、5%甘露醇、0.8%三氯蔗糖、2%枸橼酸、0.1%薄荷脑。
制粒粘合剂为：聚维酮K30乙醇溶液，最佳浓度为16%聚维酮K30乙醇溶液（乙醇浓度为92%）。
口感评测：为满足糖尿病人的用药需求，将实施例2中的蔗糖用其它辅料替代，在保证其口感的前提下，对制剂处方进行调整。调整后的咀嚼片，咀嚼时有脆性，不成粉，易吞咽，口感酸甜度同实施例2，伴有轻微的薄荷味。
实施例
（1）将了哥王药材经净选、清洗、切制、干燥后，清除杂质及非药用部分，并用直径0.8cm筛网进行粉碎；取1500kg了哥王粗粉分4次煮提，每次加水动态回流提取6小时，滤过，滤液浓缩至相对密度为1.25（80-90℃测）的浸膏，80-90℃真空干燥；将干浸膏粉碎成100目细粉得到了哥王干膏粉，1500kg的了哥王粗粉最终对应制剂为50万片。
（2）干膏粉加辅料适量混匀、制粒、干燥、整粒后，继续加入适量辅料混匀，压片所制得的片剂为咀嚼片。制粒所加的辅料：甘露醇、预胶化淀粉、糊精、三氯蔗糖、枸橼酸、低取代羟丙纤维素、薄荷脑、硬脂酸镁、聚维酮K30。最佳用量为15%预胶化淀粉、20%糊精、5%低取代羟丙纤维素、5%甘露醇、0.8%三氯蔗糖、2%枸橼酸、0.1%薄荷脑。
制粒粘合剂为：聚维酮K30乙醇溶液，最佳浓度为16%聚维酮K30乙醇溶液（乙醇浓度为92%）。
按实施例4进行3批验证生产，得到3批了哥王干膏粉及三批咀嚼片，在温度25±2℃ 相对湿度60±5%条件下对了哥王干膏粉及对应生产的三批制剂了哥王咀嚼片进行长期稳定性考察，结果如下：
从三批了哥王干膏粉及对应生产的三批了哥王咀嚼片稳定性数据来看，初始0月时，干膏粉的水分、浸出物等指标均合格，且数据相当，咀嚼片的脆碎度、浸出物及重量均合格且相当，证明了了哥王干膏粉及了哥王咀嚼片生产工艺的具有较好的稳定性及连续性；从不同停留时间的考察结果来看，不论干膏粉还是咀嚼片在温度25±2℃，相对湿度60±5%条件下具有良好的稳定性。
本发明以了哥王的根及根皮为原料，通过净选、洗、切、干燥、粉碎、提取浓缩、干燥得到了哥王的干膏粉，再将干膏粉与其他辅料进行制粒干燥，且依次整粒总混、压片、泡罩得到固体片剂成品，规格：每片重0.45g（相当于原药材3g），并考察了干膏粉及成品片剂的稳定性。
以上显示和描述了本发明的基本原理、主要特征和本发明的优点。本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的仅为本发明的优选例，并不用来限制本发明，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。
Claims (10)
1.一种了哥王提取方法，其特征在于：具体包括如下步骤：
S10：以了哥王的根及根皮为原料；
S11：通过挑选、剔除非药用部分的药材，用洗药机清洗药材杂物，选取适合的切药机进行药材的粗处理得到饮片，饮片置热风循环干燥箱中保持温度不超过80℃干燥3-4h，为保证了哥王的充分提取，干燥后的饮片采用0.8cm直径的筛网进行粉碎，得到了哥王粗粉；
S12：称取一定重量的了哥王粗粉投入提取罐，加入6BV的提取溶剂浸泡12-40h，浸泡液进入单效外循环蒸发器中浓缩，提取罐则重新补加一定量提取溶剂，且蒸发器内的药液蒸发出的提取溶剂蒸汽一部分重新进入提取罐内，为浸提提供热源，一部分经冷凝器冷却成新鲜溶剂补充到提取罐内，且提取罐与蒸发器保持边提取边浓缩边提取溶剂蒸汽回流状态连续提取6h，得到了哥王提取浓缩液；
S13：将了哥王浓缩液采取真空浓缩方式浓缩至相对密度1.25（80-90℃测）停止浓缩，80-90℃条件下真空干燥得到了哥王干膏，干膏经100目筛网粉碎得到了哥王干膏粉。
2.根据权利要求1所述的了哥王提取方法，其特征在于：步骤S12中所述提取溶剂采用饮用水、甲醇、乙醇或乙酸乙酯其中的一种。
3.一种了哥王咀嚼片的制备方法，包括权利要求1和2所述的了哥王提取方法，其特征在于：具体包括如下步骤：采用所述了哥王干膏粉作为原料，加入适量不同功能的辅料，经过制粒干燥、整粒总混、压片等工艺制备成固体咀嚼片剂。
4.根据权利要求3所述的了哥王咀嚼片的制备方法，其特征在于：所述辅料包括填充剂、矫味剂、崩解剂、润滑剂、粘合剂和润湿剂。
5.根据权利要求4所述的了哥王咀嚼片的制备方法，其特征在于：所述填充剂选用微晶纤维素、蔗糖、甘露醇、预胶化淀粉、糊精其中的一种或多种组合。
6.根据权利要求4所述的了哥王咀嚼片的制备方法，其特征在于：所述矫味剂采用甜菊糖苷、三氯蔗糖、枸橼酸、薄荷脑其中的一种或多种组合。
7.根据权利要求4所述的了哥王咀嚼片的制备方法，其特征在于：所述崩解剂采用低取代羟丙纤维素。
8.根据权利要求4所述的了哥王咀嚼片的制备方法，其特征在于：所述润滑剂采用硬脂酸镁。
9.根据权利要求4所述的了哥王咀嚼片的制备方法，其特征在于：所述粘合剂采用聚维酮K30，所述聚维酮K30的浓度为10-16%。
10.根据权利要求4所述的了哥王咀嚼片的制备方法，其特征在于：所述润湿剂采用乙醇溶液，所述乙醇溶液的浓度为80-92%。
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1562233A (zh) * | 2004-03-30 | 2005-01-12 | 一笑堂（湖南）制药有限公司 | 了哥王分散片及其制备方法 |
| CN1726979A (zh) * | 2005-07-26 | 2006-02-01 | 深圳海王药业有限公司 | 了哥王缓释制剂 |
| CN1772122A (zh) * | 2005-10-20 | 2006-05-17 | 叶耀良 | 一种具有消炎、解毒功效的了哥王制剂 |
-
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1562233A (zh) * | 2004-03-30 | 2005-01-12 | 一笑堂（湖南）制药有限公司 | 了哥王分散片及其制备方法 |
| CN1726979A (zh) * | 2005-07-26 | 2006-02-01 | 深圳海王药业有限公司 | 了哥王缓释制剂 |
| CN1772122A (zh) * | 2005-10-20 | 2006-05-17 | 叶耀良 | 一种具有消炎、解毒功效的了哥王制剂 |
Non-Patent Citations (1)
| Title |
|---|
| 彭国缘等: "了哥王片治疗化脓性皮肤病200例的体会", 《中国医院药学杂志》, vol. 26, no. 08, 28 August 2006 (2006-08-28), pages 1022 * |
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