CN101020043A - 小建中胶囊的防潮包衣方法 - Google Patents

小建中胶囊的防潮包衣方法 Download PDF

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CN101020043A
CN101020043A CN 200710077673 CN200710077673A CN101020043A CN 101020043 A CN101020043 A CN 101020043A CN 200710077673 CN200710077673 CN 200710077673 CN 200710077673 A CN200710077673 A CN 200710077673A CN 101020043 A CN101020043 A CN 101020043A
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高爱琴
徐康明
谢镇
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TAIHE PHARMACEUTICAL CO Ltd GUIZHOU
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Abstract

本发明公开了一种小建中胶囊的防潮包衣方法,制粒前的中药加工;然后将所得水提干膏粉置于一步制粒机内,以醇提清膏顶喷制粒,控制清膏流量,进风温度,物料温度,所制得的颗粒平均粒径70目,水份2~3.9%;包衣:以羟丙基甲基纤维素(HPMC)或聚丙烯酸钠IV为包衣材,配制成重量百分比3~6%的水溶液,在一步制粒机内采用底部切线喷方式包衣,控制包衣材水溶液流速30~80l/h,包衣材用量为颗粒重量的2~3.5%,颗粒粒度为60目,水份控制≤3%。包衣后颗粒,加入桂枝挥发油,过筛,装入胶囊,即得。本方法所得产品性状符合要求,防潮效果良好,同时本方法能简化工艺过程,缩短工艺时间,节能降耗、降低物料工艺损失,减少了产品污染,提高收率,降低生产成本。

Description

小建中胶囊的防潮包衣方法
技术领域
本发明涉及制药领域,特别涉及颗粒包衣后防潮的方法。
背景技术
小建中胶囊系中药全浸膏粉产品,只允许添加3.5%的辅料。由于该产品的主要原料白芍系采用醇提工艺提取,其浸膏粉吸湿性相当强。原有工艺是经喷雾干燥后填充胶囊,由于喷雾干燥所得粉末细,平均粒径在40微米左右,导致其比表面积高达240平方米/公斤,众所周知,比表面积越大,表面活性越高,越容易吸湿团聚,对水分、热都很敏感,直接导致的后果是:①在胶囊充填过程中很容易吸潮,造成粘冲或影响充填质量,重差极不容易控制;②空心胶囊中的水份容易被浸膏粉吸收,导致胶囊发脆;③经包装后,由于包装材料存在毛细小孔(如PVC、PTP、铝塑复合膜等),浸膏粉仍然会缓慢吸湿,在产品有效期内(24个月)水分超出国家标准;④浸膏粉板结,性状不合格,崩解不合格,最终无法保证质量,成为劣药。
对于上述问题现有的解决方法如下:
①优化中药提取工艺,在不影响产品质量的前提下使收得的干膏粉减少,使制剂工艺有较大的调整空间,以增加辅料用量,通过选用合适的辅料来改善颗粒的吸湿性。但由于小建中胶囊提取工艺已经确定,因而无法降低收率;②对制剂环境进行控制。现在的GMP厂房一般使用中央空调系统,对特定房间的控制能力很弱,可以考虑将胶囊混粉、充填间安装相对独立的空调系统严格控制温度湿度。但需要专门的生产线改造,硬件投入大,运行成本高,只能暂时解决生产中的问题。③对药粉进行处理加入润滑剂减少粘冲等现象,增加流动性,以控制重差。但不能从根本上解决问题。④生产管理方面的控制。在中药胶囊充填时可要求混粉和充填同时进行或混一小部分充填一小部分,让药粉在空气中暴露的时间越短越好,但却增加了生产成本和管理难度。由此可见,采取以上措施,即使是在生产过程中不吸潮,上市后不长时间还是吸潮结块,成为劣药,不仅不能保证病患者的健康权利,而且也会使企业面临调消文号,蒙受巨大损失的困境。
发明内容
本发明的目的在于克服上述缺点而提供的一种防潮效果良好、简化工艺过程,能缩短工艺时间,节能降耗、降低物料工艺损失,减少了产品污染,提高收率,降低生产成本的小建中胶囊的防潮包衣方法。
本发明是一种小建中胶囊的防潮包衣方法,包括下述步骤:
(1)制粒前的中药加工:取桂枝用水蒸汽蒸馏提取挥发油,药渣与甘草、大枣加水煎煮2次,每次2小时合并煎液,滤过,滤液浓缩至相对密度1.25(60℃),真空干燥(80℃,-0.08Mpa)得干膏粉碎成80目粉备用;
白芍、生姜用50%乙醇回流提取2小时,提取液回收乙醇并浓缩至相对密度1.12~1.15(20℃)的清膏;
(2)制粒:将干膏粉置于一步制粒机内,以清膏顶喷制粒,控制清膏流量2 0~35L/h,进风温度90~120℃,物料温度42~78℃,所制得的颗粒平均粒径70目,水份2~3.9%;
(3)包衣:以羟丙基甲基纤维素(HPMC)或聚丙烯酸钠IV为包衣材,配制成重量百分比3-6%的水溶液,在一步制粒机内采用底部切线喷方式包衣,控制包衣材水溶液流速30~80L/h,进风温度90~120℃,物料温度55~60℃,包衣材用量为颗粒量的2~3.5%(w/w)包衣完成后,包衣完成后继续干燥2小时,颗粒粒度为60目,水份控制≤3%;
(4)胶囊制备:所制得包衣后颗粒,加入桂枝挥发油,过筛,装入胶囊,即得。
本发明与现有技术相比,将水提干膏粉作为吸收剂,解决了醇提浸膏使用传统干燥方法(真空干燥)无法干燥的问题;所制得的颗粒平均粒径为60目,约240微米,比表面积下降为39.8平方米/公斤,颗粒表面活性大大降低,吸湿速度减缓;使用辅料量小,颗粒包衣使用包衣材料控制在3.5%以内,完全符合质量标准的要求;使用优选的包衣材料,控制工艺技术参数如进料速率,进风温度,物料温度颗粒一次达到技术要求粒度,不需要粉碎过筛及添加任何辅料,流动性好,可直接填充胶囊使装量稳定;包衣后防潮效果良好,同样环境条件下(22℃,75%相对湿度),吸潮速度下降90%;制粒、包衣在一步制粒一套设备内完成,简化工艺过程,缩短工艺时间,节能降耗、降低物料工艺损失,减少了产品污染,提高收率,降低了生产成本;颗粒流动性好,易于填充,崩解时间15分钟;经加速实验考察,在产品有效期内,产品性状符合规定,无板结,水份含量低于6%,成品在有效期内水份合格。
具体实施方式
实施例1
本发明的防潮包衣方法,包括下述步骤:
(1)按国家药品标准配方称取下述原料
桂枝235.6kg、白芍471.2kg、炙甘草157kg、生姜235.6kg、大枣235.6kg;
(2)取桂枝用水蒸汽蒸馏提取挥发油,药渣与甘草、大枣加水煎煮2次,每次2小时合并煎液,滤过,滤液浓缩至相对密度1.25(60℃),真空干燥(80℃,-0.08Mpa)得干膏粉碎成80目粉,得干膏粉约65kg备用;
白芍、生姜用50%乙醇回流提取2小时,提取液回收乙醇并浓缩至相对密度1.12~1.15(20℃)的清膏约50L;
(3)制粒:将干膏粉置于一步制粒机内,以清膏顶喷制粒,控制清膏流量20L/h,进风温度90℃,物料温度50℃,所制得的颗粒平均粒径70目,水份3.9%,颗粒重量约80kg;
(4)包衣:以羟丙基甲基纤维素(HPMC)为包衣材,配制成重量百分比3%的水溶液90kg,在一步制粒机内采用底部切线喷方式包衣,控制HPMC溶液流速80L/h,进风温度120℃,物料温度60℃,包衣完成后,包衣完成后继续干燥2小时,颗粒粒度为60目,水份3.0%;
(5)胶囊制备:所制得包衣后颗粒,加入桂枝挥发油,过筛,装入胶囊,每粒0.4g,即得。
实施例2
本发明的防潮包衣方法,包括下述步骤:
(1)按国家药品标准配方称取下述原料
桂枝235.6kg、白芍471.2kg、炙甘草157kg、生姜235.6kg、大枣235.6kg;
(2)取桂枝用水蒸汽蒸馏提取挥发油,药渣与甘草、大枣加水煎煮2次,每次2小时合并煎液,滤过,滤液浓缩至相对密度1.25(60℃),真空干燥(80℃,-0.08Mpa)得干膏粉碎成80目粉,得干膏粉约65kg备用;
白芍、生姜用50%乙醇回流提取2小时,提取液回收乙醇并浓缩至相对密度1.12~1.15(20℃)的清膏约50L;
(3)制粒:将干膏粉置于一步制粒机内,以清膏顶喷制粒,控制清膏流量20L/h,进风温度100℃,物料温度42℃,所制得的颗粒平均粒径70目,水份3.1%,颗粒重量约80kg;
(4)包衣:以聚丙烯酸钠IV为包衣材,配制成重量百分比6%的水溶液40kg,在一步制粒机内采用底部切线喷方式包衣,控制聚丙烯酸钠IV水溶液流速30L/h,进风温度90℃,物料温度55℃,包衣完成后,包衣完成后继续干燥2小时,颗粒粒度为60目,水份2.3%;
(5)胶囊制备:所制得包衣后颗粒,加入桂枝挥发油,过筛,装入胶囊,每粒0.4g,即得。
实施例3
本发明的防潮包衣方法,包括下述步骤:
(1)按国家药品标准配方称取下述原料
桂枝235.6kg、白芍471.2kg、炙甘草157kg、生姜235.6kg、大枣235.6kg;
(2)取桂枝用水蒸汽蒸馏提取挥发油,药渣与甘草、大枣加水煎煮2次,每次2小时合并煎液,滤过,滤液浓缩至相对密度1.25(60℃),真空干燥(80℃,-0.08Mpa)得干膏粉碎成80目粉,得干膏粉约65kg备用;
白芍、生姜用50%乙醇回流提取2小时,提取液回收乙醇并浓缩至相对密度1.12~1.15(20℃)的清膏约50L;
(3)制粒:将干膏粉置于一步制粒机内,以清膏顶喷制粒,控制清膏流量35L/h,进风温度120℃,物料温度78℃,所制得的颗粒平均粒径70目,水份2%,颗粒重量约80kg;
(4)包衣:以羟丙基甲基纤维素(HPMC)为包衣材,配制成重量百分比6%的水溶液35kg,在一步制粒机内采用底部切线喷方式包衣,控制HPMC水溶液流速60L/h,进风温度100℃,物料温度60℃,包衣完成后,包衣完成后继续干燥2小时,颗粒粒度为60目,水份2.8%;
(5)胶囊制备:所制得包衣后颗粒,加入桂枝挥发油,过筛,装入胶囊,每粒0.4g,即得。

Claims (2)

1、一种小建中胶囊的防潮包衣方法,包括下述步骤:
(1)制粒前按常规方法进行中药加工;
(2)制粒:将干膏粉置于一步制粒机内,以清膏顶喷制粒,控制清膏流量20~35L/h,进风温度90~120℃,物料温度42~78℃,所制得的颗粒平均粒径70目,水份2~3.9%;
(3)包衣:以羟丙基甲基纤维素或聚丙烯酸钠IV为包衣材,配制成重量百分比3~6%的水溶液,在一步制粒机内采用底部切线喷方式包衣,控制包衣材水溶液流速30~80L/h,进风温度90~120℃,物料温度55~60℃,包衣材用量为颗粒重量的2~3.5%包衣完成后,包衣完成后继续干燥2小时,颗粒粒度为60目,水份控制≤3%;
(4)胶囊制备:所制得包衣后颗粒,加入桂枝挥发油,过筛,装入胶囊,即得。
2、如权利要求1所述的小建中胶囊的防潮包衣方法,其中制粒前常规方法进行中药加工的方法为:
取桂枝用水蒸汽蒸馏提取挥发油,药渣与甘草、大枣加水煎煮2次,每次2小时合并煎液,滤过,滤液浓缩至60℃测相对密度1.25,80℃、-0.08Mpa真空干燥得干膏粉碎成80目粉备用;
白芍、生姜用50%乙醇回流提取2小时,提取液回收乙醇并浓缩至20℃测相对密度1.12~1.15的清膏。
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104258337A (zh) * 2014-09-29 2015-01-07 洛阳御平国生物科技有限公司 一种针对虚寒腹痛的中药配方

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104258337A (zh) * 2014-09-29 2015-01-07 洛阳御平国生物科技有限公司 一种针对虚寒腹痛的中药配方

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