CN105920121B - 一种痔疮片的制备方法 - Google Patents
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Abstract
本发明公开了一种痔疮片的制备方法，属于中药制备技术领域，旨在提供一种提取效率高、产品药效好的痔疮片制备新方法，其技术要点包括将部分白芷粉碎成细粉，剩余白芷与蒺藜、功劳木的煎煮提取，大黄的煎煮提取，提取液浓缩、稠膏与白芷粉、猪胆粉混合，制粒，干燥，与冰片混匀，加辅料后压片，其中所述的大黄提取条件是第一次加7～8倍水，第二次加5～6倍水，煮沸后保持温度为96±2℃，每次的提取时间为1小时；本发明用于中国药典中痔疮片的制备。
Description
技术领域
本发明涉及一种中药制备方法，更具体地说，它涉及一种痔疮片的制备方法。
背景技术
中国药典中，痔疮片的处方为：大黄323g、蒺藜323g、功劳木645g、白芷323、冰片16g、猪胆粉4g；制法：以上六味，取白芷162g粉碎成细粉，剩余白芷与蒺藜、功劳木加水煎煮两次，每次两小时，滤过，合并滤液；大黄加水煎煮两次，每次一小时，滤过，合并滤液；上述两种滤液合并，浓缩成稠膏，再加入白芷粉、猪胆粉混匀，制粒，干燥，将冰片研细与适量淀粉混匀，再研细，与上述颗粒混匀后，加淀粉、滑石粉适量，混匀，压制成1000片，包糖衣或薄膜衣，即得。
上述制法存在一定的不足，如其中的中药材大黄在痔疮片中的主要成分为大黄素和大黄酚，其含量是药物测量的重要指标；由于大黄的上述主要成分受煎煮时间、加热温度的影响较大，加热时间过长会使其含量降低，加热时间太短，则提取不完全，中国药典中关于大黄的提取方法为：加水煎煮两次，第一次10倍量水，第二次9倍量水，由于加水量较多，加热时间较长，其生药大黄中的大黄素和大黄酚提取率通常只有30％左右。
另外，药典制法中将白芷粉与稠膏一起混合制粒干燥，由于稠膏的数量较大，干燥时间较长，颗粒性状不稳定造成素片较硬、颜色不均等，给压片和包衣带来困难。
发明内容
本发明要解决的技术问题是针对现有技术的上述不足，提供一种提取效率高、产品药效好的一种痔疮片制备新方法。
本发明的技术方案是这样的：一种痔疮片的制备方法，包括将部分白芷粉碎成细粉，剩余白芷与蒺藜、功劳木的煎煮提取，大黄的煎煮提取，提取液浓缩、稠膏与白芷粉、猪胆粉混合，制粒，干燥，与冰片混匀，加辅料后压片，其中所述的大黄提取条件是第一次加7～8倍水，第二次加5～6倍水，煮沸后保持温度为96±2℃，每次的提取时间为1小时。
进一步的，上述的痔疮片的制备方法中，所述的大黄提取条件是第一次加7倍量水，第二次加5倍量水。
优选的，上述的痔疮片的制备方法中于，所述的制粒是将一半的稠膏与白芷粉、猪胆粉混合，另一半稠膏先用真空干燥成干膏，再一起混合均匀。
本发明的方法与传统方法相比，具有下述优点：
1、由于减少了用水量，缩短了加热时间，在保证提取效果的前提下，大大降低了能源消耗。
2、由于缩短了加热提取时间，减少了大黄有效成分受到高温破坏，从而提高大黄有效成分的提出率，平均可提高30％以上。
3、通过改进制粒工艺，得到的颗粒性均匀，压出的片质量稳定。
具体实施方式
下面结合具体实施例对本发明做进一步的详细说明，但不构成对本发明的任何限制。
实施例1
按中国药典进行提取，中药材大黄30公斤，放入500L多功能提取罐内，第一次加水300公斤，加热至沸腾，提取一小时，收集提取液；第二次加水270公斤，加热至沸腾，提取一小时，合并两次提取液，浓缩干燥得干膏13.4公斤。
实施例2
中大药材黄50公斤，放入500L多功能提取罐内，第一次加水350公斤，加热至沸腾，保持温度在96±2℃，提取一小时，收集提取液；第二次加水300公斤，加热至沸腾，保持温度在96±2℃，提取一小时，合并两次提取液，浓缩干燥得干膏17.8公斤。
实施例3
中大药材黄50公斤，放入500L多功能提取罐内，第一次加水400公斤，加热至沸腾，保持温度在96±2℃，提取一小时，收集提取液；第二次加水250公斤，加热至沸腾，保持温度在96±2℃，提取一小时，合并两次提取液，浓缩干燥得干膏17.2公斤。
实施例4
中药材大黄50公斤，放入500L多功能提取罐内，第一次加水350公斤，加热至沸腾，保持温度在96±2℃，提取一小时，收集提取液；第二次加水250公斤，加热至沸腾，保持温度在96±2℃，提取一小时，合并两次提取液，浓缩干燥得干膏18.1公斤。
上述4个实例按2015年版中国药典中大黄药材的含量测定方法测定。结果如下表1:
表1大黄中有效成分含量测定表
| 项目 | 实施例2 | 实施例3 | 实施例4 | 实施例1(传统法) |
| 总蒽醌(公斤) | 0.75 | 0.76 | 0.78 | 0.37 |
从上面的几个实施例可以看出：
1、本发明的提取方法不仅用水量少，而且具有加热时间短，提取效率高，有效成分提取量大的优点；
2、降低了能源消耗的同时，减少了有效成分受到破坏和无效成分的浸出，提高了药物提取的有效性；
3、由于膏量减少，解决了中药制粒困难的主要因素是膏量过多的问题，为制剂成型工艺创造了最佳的条件。
实施例5
处方：大黄323g、蒺藜323g、功劳木645g、白芷323、冰片16g、猪胆粉4g
制备方法：
(1)取白芷162g粉碎成细粉，备用；
(2)将剩余白芷与蒺藜、功劳木加水煎煮两次，每次两小时，滤过，合并滤液；备用；
(3)大黄加水煎煮两次，第一次加7倍量水，第二次加5倍量水，每次一小时，滤过，合并滤液；备用；
(4)将步骤(2)和步骤(3)所得到的两种滤液合并，浓缩成稠膏，然后将一半稠膏用真空干燥成干膏；再将干膏和白芷粉、猪胆粉加入到剩余的一半稠膏中混匀，制粒，干燥；
(5)将冰片研细与适量淀粉混匀，再研细，与上述颗粒混匀后，加淀粉、滑石粉适量，混匀，压制成1000片，包糖衣或薄膜衣，即得。
通过对5批次的片剂抽检，测得其中大黄素和大黄酚每片含量在0.17～0.22mg之间，远高于国标规定的0.1mg标准，保证了药物的治疗效果。
Claims (3)
1.一种痔疮片的制备方法，包括将部分白芷粉碎成细粉，剩余白芷与蒺藜、功劳木的煎煮提取，大黄的煎煮提取，提取液浓缩、稠膏与白芷粉、猪胆粉混合，制粒，干燥，与冰片混匀，加辅料后压片，其特征在于，所述的大黄提取条件是第一次加7～8倍水，第二次加5～6倍水，煮沸后保持温度为96±2℃，每次的提取时间为1小时。
2.根据权利要求1所述的痔疮片的制备方法，其特征在于，所述的大黄提取条件是第一次加7倍量水，第二次加5倍量水。
3.根据权利要求1所述的痔疮片的制备方法，其特征在于，所述稠膏与白芷粉、猪胆粉混合的步骤具体是：将一半的稠膏与白芷粉、猪胆粉混合，另一半稠膏先用真空干燥成干膏，再一起混合均匀。
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| CN1362169A (zh) * | 2001-01-02 | 2002-08-07 | 杨孟君 | 一种纳米痔疮制剂药物及其制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1362169A (zh) * | 2001-01-02 | 2002-08-07 | 杨孟君 | 一种纳米痔疮制剂药物及其制备方法 |
Non-Patent Citations (1)
| Title |
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| 五指毛桃水煎液的药理安全性实验研究;罗骞等;《今日药学》;20120731;第22卷(第7期);第398-399、407页，尤其是第398页左栏最后1段至右栏第1段 * |
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