CN87106202A - 中成药胃肠分溶型丸剂的制备工艺 - Google Patents

中成药胃肠分溶型丸剂的制备工艺 Download PDF

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CN87106202A
CN87106202A CN87106202.XA CN87106202A CN87106202A CN 87106202 A CN87106202 A CN 87106202A CN 87106202 A CN87106202 A CN 87106202A CN 87106202 A CN87106202 A CN 87106202A
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梁东康
何振宁
彭德光
罗伟民
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GUANGZHOU CHENLIJI PHARMACEUTICAL FACTORY
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Abstract

本发明为中成药丸剂的制备方法。本发明所述的制备方法是将药方中的药材按其药理作用特点分成肠溶和胃溶二部分，首先将肠溶部分药粉泛丸后用肠溶材料包裹，然后在肠衣丸外包裹胃溶部分药粉，制成胃肠分溶型双层丸。这样，可提高药物的疗效，降低对胃肠道副作用。按本法所制得的补脾益肠丸对脾虚型慢性结肠炎和溃疡性结肠炎有明显的疗效，总有效率达97.5％，疗效确切，系目前治疗慢性结肠炎和溃疡性结肠炎较理想的药物。

Description

本发明属于以丸剂为特征的医药品制备方法。
传统的中成药小丸（水蜜丸）的制备，均是将中药进行前处理后按处方配料、干燥、粉碎，然后将处方中的药粉全部混和加炼蜜、制丸、用炭粉等为衣制成不分层的丸。这样所制得的药丸，口服后在胃内崩解、溶解，所有的药物成分，无论是有效或无效，甚至对胃有刺激性等副作用均首先对胃起作用，大部分经胃吸收。而从中医中药理论，要达到中药治病，即治标又治本的作用，除了处方合理外，还必需考虑药物的作用部位，有的药物需在胃溶解吸收，而有的则应在肠内溶解被吸收才能更好发挥药效作用。已有的解决办法是分别将药物制成胃溶丸和肠溶丸二种，这对制药工业来说增加了不少重复麻烦的手续;而对病人来说，为了治某种疾病需同时服用二种药丸，亦带来很多不便。
为了克服上述缺点，本发明的目的是在中成药丸的传统制备工艺上加以改进，使制得的药丸口服后部分药物先在胃部溶解吸收，而另一部分药物则到达肠后才溶解吸收，从而提高所服药物的药效作用，减少药物的副作用。
本发明是这样实现的：将中药处方中的药材按中医中药理论及药物作用部位分成二部分，一部分是在胃内溶解的作外层药，另一部分是在肠内溶解的作内层药。二部分药材分别粉碎成细粉，过筛，混匀;将内层药粉加适量的炼蜜和水泛丸，干燥后用肠溶材料包衣制成肠溶丸;然后用食用粘合辅料将另一部分外层药粉包裹在肠溶衣丸外层。为了使药丸光洁美观及矫味，或在贮藏过程中加强防潮防蛀防止染菌等，可再用常规的中成药丸剂为衣方法，如用炭粉等包衣，干燥抛光即得成品。
下面见附图详细说明这种胃肠分溶型中成药丸剂的制备工艺：
附图1是本发明的制备工艺流程图。
将所需的原药材除去杂质，洗净，切片，干燥等前处理后，按处方分成肠溶部分为内层药;胃溶部分为外层药二部分。外层药粉碎成细粉，过筛混匀灭菌后待用。内层药粉碎，过筛混匀后制内层丸。即取内层药粉末加适量的水和炼蜜泛丸，干燥。再取内层丸置糖衣缸内包底粉层，然后用肠溶材料包衣至符合要求则为内层肠溶衣丸。肠溶材料可用虫胶混合液，苯甲酸醋酸纤维素（CAP），羧甲基纤维素钠（CMC-Na），丙烯酸树脂等。
然后，取肠溶衣丸置糖衣缸内，用适量的食用粘合辅料如明胶糖浆、炼蜜和水等将定量的外层药粉全部包裹在肠溶衣丸外。为了药丸的美观光洁等，可再进行常规的中成药丸剂的包衣工序，用药用活性炭或滑石粉、赤石脂、铁黑等包衣，干燥，置抛光锅内抛光至药丸表面光亮均匀为成品，再将制好的药丸按质量标准检验合格即可进行分装，包装，装箱。
按本发明所提供的工艺所制得的中成药丸剂具有胃肠分溶的优点，提高了药物疗效，病人服用方便。比分别制备胃溶丸和肠溶丸的二套工艺要简便得多。
实施例：补脾益肠丸胃肠分溶型的制备工艺。
1.称取黄芪4-12%（W/W，以下相同），党参4-15%，白芍7-17%，砂仁1-7%，当归1-4%，白术5-12%，肉桂1-7%。粉碎成细粉，过筛混匀，灭菌出柜后摊凉作外层粉备用。
2.称取元胡5-13%，荔枝核5-10%，干姜1-4%，甘草5-12%，防风2-7%，木香2-6%，补骨脂1-6%，赤石脂7-17%。粉碎成细粉，过筛混匀得内层粉，加炼蜜与适量的水泛丸，干燥得内层丸。
3.取内层丸置糖衣缸内，用明胶糖浆及底粉包底粉层，然后用虫胶混合液及适量滑石粉包肠溶衣层，至符合要求。
4.取肠溶衣丸置糖衣缸内，用适量的炼蜜和水作粘合剂，将定量的外层粉全部包裹在肠溶衣外。
5.以活性炭包衣，干燥，置抛光锅内抛光至表面光亮均匀即得成品。
所制得的补脾益肠丸完全符合药品质量标准。本品临床验证，对慢性结肠炎和溃疡性结肠炎的总有效率为97.5%，疗效确切，系目前治疗慢性结肠炎和溃疡性结肠炎的较理想药物。

Claims (2)

1、一种中成药丸剂的制备工艺，其特征是将药物处方中的中药材分成内、外两部分，内层药粉用肠溶材料包裹成丸，在肠溶衣丸外再用食用粘合辅料包裹胃溶中药粉作外层制成双层丸。
2、根据权利要求1.所述的中成药丸剂的制备工艺，其特征是内层药由元胡5-13%（W/W，以下同），荔枝核5-10%，干姜1-4%，甘草5-12%，防风2-7%，木香2-6%，补骨脂1-6%，赤石脂7-17%组成，外层药由黄芪4-12%，党参4-15%，砂仁1-7%，白芍7-17%，当归1-4%，白术5-12%，肉桂1-7%组成。
CN87106202.XA 1987-09-05 1987-09-05 一种补脾益肠丸的制备工艺 Expired CN1003978B (zh)

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CN102688379A (zh) * 2012-05-31 2012-09-26 李珍华 一种治疗便秘的中草药丸
CN104225162A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的桂附地黄丸的制备方法
CN104225161A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的归芍地黄丸的制备方法
CN104225187A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的知柏地黄丸的制备方法
CN104225160A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的七味都气丸的制备方法
CN104225214A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的麦味地黄丸的制备方法
CN104224740A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的百合固金丸的制备方法
CN104257984A (zh) * 2014-09-28 2015-01-07 白杨 一种包衣处理的六味地黄丸的制备方法
CN104288433A (zh) * 2014-09-28 2015-01-21 白杨 一种包衣处理的枸菊地黄丸的制备方法
CN106511316A (zh) * 2016-11-24 2017-03-22 重庆多普泰制药股份有限公司 一种水蛭为原料的包衣胶囊及其制备方法
CN106821754A (zh) * 2017-01-20 2017-06-13 河南华峰制药有限公司 中成药麻仁润肠水蜜丸外观光洁度的加工方法
CN112999326A (zh) * 2019-12-19 2021-06-22 广州白云山陈李济药厂有限公司 补脾益肠胃肠分溶型丸剂及其制备方法
CN115944697A (zh) * 2022-12-30 2023-04-11 内蒙古民族大学 一种治疗胃肠炎作用的蒙药和其制备方法

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JP5054863B2 (ja) 1997-11-04 2012-10-24 帝國製薬株式会社 潰瘍性大腸炎治療剤
CN1768854B (zh) * 2005-10-26 2010-05-12 三九医药股份有限公司 一种用于溃疡性结肠炎的中药胶囊制剂
CN105012528B (zh) * 2015-08-10 2016-12-07 深圳市泛谷药业股份有限公司 具缓释作用的中药组合物、心脑欣丸和其方法及制剂

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CN102688379A (zh) * 2012-05-31 2012-09-26 李珍华 一种治疗便秘的中草药丸
CN102688379B (zh) * 2012-05-31 2013-12-25 李珍华 一种治疗便秘的中草药丸
CN104225162A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的桂附地黄丸的制备方法
CN104225161A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的归芍地黄丸的制备方法
CN104225187A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的知柏地黄丸的制备方法
CN104225160A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的七味都气丸的制备方法
CN104225214A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的麦味地黄丸的制备方法
CN104224740A (zh) * 2014-09-28 2014-12-24 白杨 一种包衣处理的百合固金丸的制备方法
CN104257984A (zh) * 2014-09-28 2015-01-07 白杨 一种包衣处理的六味地黄丸的制备方法
CN104288433A (zh) * 2014-09-28 2015-01-21 白杨 一种包衣处理的枸菊地黄丸的制备方法
CN106511316A (zh) * 2016-11-24 2017-03-22 重庆多普泰制药股份有限公司 一种水蛭为原料的包衣胶囊及其制备方法
CN106821754A (zh) * 2017-01-20 2017-06-13 河南华峰制药有限公司 中成药麻仁润肠水蜜丸外观光洁度的加工方法
CN112999326A (zh) * 2019-12-19 2021-06-22 广州白云山陈李济药厂有限公司 补脾益肠胃肠分溶型丸剂及其制备方法
CN115944697A (zh) * 2022-12-30 2023-04-11 内蒙古民族大学 一种治疗胃肠炎作用的蒙药和其制备方法

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