CN108261482A - 一种马莲根颗粒剂的制备方法 - Google Patents
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Abstract
本发明公开了一种马莲根颗粒剂的制备方法，包括如下步骤：将马莲根用粉碎机进行粉碎处理后，过100目筛，所得粉末用水提取3次，每次煎煮60分钟，料液比为1∶10，过滤，合并滤液，倒入表面皿中，在水浴锅上蒸发浓缩，得浸膏；将所得浸膏置于恒温干燥箱中在70℃的温度下进行干燥处理，得马莲根干浸膏粉末；将所得的马莲根干浸膏粉末与微晶纤维素、糊精以质量比2∶3∶1的比例混合均匀后，加入15％的淀粉浆作为润湿剂，制软材，直至能够手握成团，轻压即散，过16目筛，70℃下干燥1.5小时，整粒，即得。本发明所制得的马莲根颗粒剂比较适合当前生产要求，质量检查方法方便且易于操作、产品合格率高。
Description
技术领域
本发明涉及中药制剂制备领域，具体涉及一种马莲根颗粒剂的制备方法。
背景技术
马莲在本草纲目中名为马蔺，民间俗称马莲，为鸢尾科植物。具有一定的药理作用，所含的化学成分主要为黄酮类化合物，在前期研究的过程中发现马莲根具有良好的退热、抗炎等功效，但对于马莲的制剂研究的较少。
发明内容
为解决上述问题，本发明提供了一种马莲根颗粒剂的制备方法。
为实现上述目的，本发明采取的技术方案为：
一种马莲根颗粒剂的制备方法，包括如下步骤：
S1、将马莲根用粉碎机进行粉碎处理后，过100目筛，所得粉末用水提取3次，每次煎煮60分钟，料液比为1∶10，过滤，合并滤液，倒入表面皿中，在水浴锅上蒸发浓缩，得浸膏；
S2、将所得浸膏置于恒温干燥箱中在70℃的温度下进行干燥处理，得马莲根干浸膏粉末；
S3、将所得的马莲根干浸膏粉末与微晶纤维素、糊精以质量比2∶3∶1的比例混合均匀后，加入15％的淀粉浆作为润湿剂，制软材，直至能够手握成团，轻压即散，过16目筛，70℃下干燥1.5小时，整粒，即得。
本发明通过水提法对马莲根的有效成分进行了充分的提取，并将其制作成了便于食用和保存的颗粒状，为新药来源奠定一定基础；所制得的马莲根颗粒剂比较适合当前生产要求，质量检查方法方便且易于操作、产品合格率高。
具体实施方式
为了使本发明的目的及优点更加清楚明白，以下结合实施例对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
实验例
马莲根干浸膏的制备
选定煎煮时间、料液比、提取次数作为考察因素，以得到的干浸膏量为评价指标。将中药马莲根用粉碎机进行粉碎(过100目)之后，得马莲根粉末。按下表L9(34)进行正交试验，进行煎煮、静置、过滤、合并滤液并浓缩。将滤液倒入表面皿中，在水浴锅上蒸发浓缩得到浸膏，并在恒温干燥箱温度为70℃下干燥，称量并记录所得的浸膏重。
表1水平因素表
通过对马莲根煎煮、静置、过滤、合并滤液并浓缩。在水浴锅上蒸发浓缩得到浸膏，并在恒温干燥箱温度为70℃下干燥，得到干浸膏351.4428g。马莲根的最佳提取工艺条件为A2B2C3，提取工艺为每次煎煮60分钟，料液比为1∶10。
表2正交试验表
处方的筛选
分别选择甘露醇、糊精、玉米淀粉、微晶纤维素等常用辅料，以浸膏粉：赋性剂以一定的比例混，加适量的润湿剂制软材，过16号筛，在恒温干燥箱为70℃、干燥30min，过筛整粒、包装。
表3处方辅料的筛选
可见，以干浸膏粉末与微晶纤维素和糊精按2∶3∶1的比例制软材，制出的颗粒形状较好、颜色适宜，且成粒率最高。
质量检查
外观：所制得的马莲根颗粒剂颜色一致，颗粒重量均匀，无结块、无软化现象。
粒度：除另外规定，按照粒度和粒度分布测定法检查，将所得芍药颗粒分别过一号筛网(200μm)和五号筛(180μm)网进行测定，要求不能通过一号筛和能通过五号筛的总和不得超过供示量的15％。
溶化性：取供试品10g，加热水200mL，搅拌5分钟，立即观察，全部溶化或轻微浑浊。按上述方法检查，均不得有异物，中药颗粒还不得有焦屑。
水分：按照水分测定法测定，除另有规定外，本品含水量不得超过8.0％。
干燥失重：除另有规定外，化学药品和生物制品颗粒剂照干燥失重测定法测定，于105℃干燥(含糖颗粒应在80℃减压干燥)至恒重，减失重量不得超过2.0％。
综上所述马莲根颗粒剂的最佳制备工艺如下；
S1、马莲根提取：提取工艺为每次煎煮60分钟，料液比为1∶10，提取3次。
S2、将马莲根干浸膏粉末与微晶纤维素、糊精以2∶3∶1的比例混合均匀，加入适量的15％淀粉浆作为润湿剂，制软材，直至能够手握成团，轻压即散，过16目筛，70℃下干燥1.5小时，整粒。将制好的颗粒剂进行质量检查。
马莲根颗粒剂质量检查结果
马莲根颗粒剂颜色一致，颗粒重量均匀，无结块、无软化现象；成型率以微晶纤维素为最好达92.32％；溶化性按标准方法进行，供试品全部溶化，无异物，无焦屑；水分含量为5.6％；干燥失重部分选马莲根颗粒剂质量为2g，经干燥失重后，损失质量均小于2.0％；均符合标准。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以作出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。
Claims (1)
1.一种马莲根颗粒剂的制备方法，其特征在于，包括如下步骤：
S1、将马莲根用粉碎机进行粉碎处理后，过100目筛，所得粉末用水提取3次，每次煎煮60分钟，料液比为1∶10，过滤，合并滤液，倒入表面皿中，在水浴锅上蒸发浓缩，得浸膏；
S2、将所得浸膏置于恒温干燥箱中在70℃的温度下进行干燥处理，得马莲根干浸膏粉末；
S3、将所得的马莲根干浸膏粉末与微晶纤维素、糊精以质量比2∶3∶1的比例混合均匀后，加入15％的淀粉浆作为润湿剂，制软材，直至能够手握成团，轻压即散，过16目筛，70℃下干燥1.5小时，整粒，即得。
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1137914A (zh) * | 1996-05-17 | 1996-12-18 | 云南白药实业股份有限公司 | 附片颗粒剂及其制备方法 |
| CN1785233A (zh) * | 2005-11-09 | 2006-06-14 | 天津大学 | 甘草配方颗粒的制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1137914A (zh) * | 1996-05-17 | 1996-12-18 | 云南白药实业股份有限公司 | 附片颗粒剂及其制备方法 |
| CN1785233A (zh) * | 2005-11-09 | 2006-06-14 | 天津大学 | 甘草配方颗粒的制备方法 |
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