CN109464566A - 一种中药制剂六味地黄滴丸的制备方法 - Google Patents
一种中药制剂六味地黄滴丸的制备方法 Download PDFInfo
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Abstract
本发明属于药学领域,涉及一种六味地黄滴丸的制备方法,其特征在于,步骤如下:(1)牡丹皮挥发油的制备:取牡丹皮,加水蒸馏,得挥发油,蒸馏后的水溶液另器收集。(2)干膏粉的制备:取酒萸肉,加乙醇回流,滤过,滤液备用;取熟地黄、山药,加水煎煮,煎煮液滤过,滤液加入牡丹皮蒸馏后的水溶液,浓缩,醇沉,醇沉上清液与酒萸肉回流液合并浓缩至无醇味,备用;取茯苓、泽泻,加水煮沸,滤过,滤液与上述浓缩液合并,浓缩,干燥,粉碎,得干膏粉。(3)干膏粉,加入PEG4000,加热熔化,加入挥发油,混合均匀,滴入冷却的二甲硅油,即得。
Description
技术领域
本发明属于药学领域,涉及一种中药滴丸剂及其制备方法,具体涉及一种中药制剂六味地黄滴丸及其制备方法。
背景技术
六味地黄滴丸为一种已经上市的中成药,是由熟地黄、酒萸肉、牡丹皮、山药、茯苓、泽泻提取而成的干膏粉和挥发油加适量辅料制成,如:将干膏粉,加入PEG4000,于80℃加热熔化,加入挥发油,混合均匀,滴入冷却的二甲硅油,制成1000丸或200丸,除去表面二甲硅油,包装,即得。六味地黄滴丸具有滋阴补肾功效。用于头晕耳鸣,腰膝酸软,遗精盗汗。
本发明人在研究现有方法的过程中发现,酒萸肉的主要成份马钱苷和泽泻主要成份23-乙酰泽泻醇B的含量常常不稳定,有时不达标,而现有检测方法大都忽略这两种成分的检测,为此,本发明提供同时检测这两种成分的方法,为使这两种成分含量稳定,本发明进一步提供一种制备方法,通过改变提取工艺,有效提高泽泻有效成份含量,和酒萸肉中马钱苷提取转移率,从而提高六味地黄滴丸的功效和质量。本发明制备工艺方便实用,且易于控制产品质量。
发明内容
本发明的目的在于提供一种六味地黄滴丸制备的新方法,本发明是通过以下方法实现的。
本发明的六味地黄滴丸,其制备方法为:
(1)牡丹皮挥发油的制备:取牡丹皮,加水蒸馏,得挥发油,蒸馏后的水溶液另器收集。
(2)干膏粉的制备:取酒萸肉,加乙醇回流,滤过,滤液备用;取熟地黄、山药,加水煎煮,煎煮液滤过,滤液加入牡丹皮蒸馏后的水溶液,浓缩,醇沉,醇沉上清液与酒萸肉回流液合并浓缩至无醇味,备用;取茯苓、泽泻,加水煮沸,滤过,滤液与上述浓缩液合并,浓缩,干燥,粉碎,得干膏粉。
(3)干膏粉,加入PEG4000,加热熔化,加入挥发油,混合均匀,滴入冷却的二甲硅油,即得本发明滴丸剂。
优选的,本发明的六味地黄滴丸,制备方法如下:
(1)牡丹皮挥发油的制备:取牡丹皮,加15倍量水蒸馏2小时,得挥发油,蒸馏后的水溶液另器收集。
(2)干膏粉的制备:取酒萸肉,加80%乙醇回流2次,每次2小时,滤过,滤液备用;取熟地黄、山药,加水煎煮2次,每次加10倍量水,第一次2小时,第二次1小时,煎煮液滤过,滤液加入牡丹皮蒸馏后的水溶液,浓缩至相对密度1.15-1.20(50℃热测),加乙醇使含醇量达70%,静置48小时,取上清液与酒萸肉回流液合并浓缩至无醇味,备用;取茯苓、泽泻,加水煮沸后,80℃温浸二次,每次1.5小时,滤过,滤液与上述浓缩液合并,浓缩至相对密度1.30-1.32,60℃减压干燥,粉碎,得干膏粉。
(3)干膏粉,加入PEG4000,于80℃加热熔化,加入挥发油,混合均匀,滴入冷却的二甲硅油,即得本发明滴丸剂。
本发明的制备方法,相对于现有的六味地黄滴丸的制备方法,泽泻与茯苓煎煮,不醇沉;酒萸肉回流乙醇浓度由70%提高至80%,这两点改进,产生了意想不到的效果:用改进方法制成的干膏粉,其成份23-乙酰泽泻醇B和马钱苷提取转移率比原方法分别提高一倍以上和50%以上,六味地黄滴丸留样观察24个月23-乙酰泽泻醇B和马钱苷含量稳定。
发明工艺与原工艺干膏粉23-乙酰泽泻醇B和马钱苷含量对比试验结果:
注:提取转移率=干粉量*干粉含量/(药材量*药材含量)
从上表可得出,本发明工艺23-乙酰泽泻醇B平均提取转移率为60.7%,马 钱苷平均提取转移率为81.4%;原工艺23-乙酰泽泻醇B平均提取转移率为25.6%,马钱苷平均提取转移率为54.0%。
六味地黄滴丸采用发明工艺与原工艺对比加速稳定性试验结果:140701
从上表加速稳定性试验结果可以得出,发明专利加速6个月含量稳定,且各项检测指标合格,原工艺生产的样品加速6个月后马钱苷含量不符合标准要求(标准要求≥1.7mg/g)。
具体实施方式
实施例一:
制法:
(1)牡丹皮挥发油的制备:取牡丹皮,加15倍量水蒸馏2小时,得挥发油,蒸馏后的水溶液另器收集。
(2)干膏粉的制备:取酒萸肉,加80%乙醇回流2次,每次2小时,滤过,滤液备用;取熟地黄、山药,加水煎煮2次,每次加10倍量水,第一次2小时,第二次1小时,煎煮液滤过,滤液加入牡丹皮蒸馏后的水溶液,浓缩至相对密度1.15-1.20(50℃热测),加乙醇使含醇量达70%,静置48小时,取上清液与酒萸肉回流液合并浓缩至无醇味,备用;取茯苓、泽泻,加8倍量水煮沸后,80℃温浸二次,每次1.5小时,滤过,滤液与上述浓缩液合并,浓缩至相对密度1.30-1.32,60℃减压干燥,粉碎,得干膏粉。
(3)干膏粉,加入PEG4000,于80℃加热熔化,加入挥发油,混合均匀,滴入冷却的二甲硅油,即得本发明滴丸剂。
实施例二:
制法:
(1)牡丹皮挥发油的制备:取牡丹皮,加15倍量水蒸馏2小时,得挥发油,蒸馏后的水溶液另器收集。
(2)干膏粉的制备:取酒萸肉,加85%乙醇回流2次,每次2小时,滤过,滤液备用;取熟地黄、山药,加水煎煮2次,每次加10倍量水,第一次2小时,第二次1小时,煎煮液滤过,滤液加入牡丹皮蒸馏后的水溶液,浓缩至相对密度1.15-1.20(50℃热测),加乙醇使含醇量达70%,静置48小时,取上清液与酒萸肉回流液合并浓缩至无醇味,备用;取茯苓、泽泻,加8倍量水煎煮2次,每次1.5小时,滤过,滤液与上述浓缩液合并,浓缩至相对密度1.30-1.32,60℃减压干燥,粉碎,得干膏粉。
(3)干膏粉,加入PEG4000,于80℃加热熔化,加入挥发油,混合均匀,滴入冷却的二甲硅油,即得本发明滴丸剂。
实施例三:
制法:
(1)牡丹皮挥发油的制备:取牡丹皮,加15倍量水蒸馏2小时,得挥发油,蒸馏后的水溶液另器收集。
(2)干膏粉的制备:取酒萸肉,加90%乙醇回流2次,每次2小时,滤过,滤液备用;取熟地黄、山药,加水煎煮2次,每次加10倍量水,第一次2小时,第二次1小时,煎煮液滤过,滤液加入牡丹皮蒸馏后的水溶液,浓缩至相对密度1.15-1.20(50℃热测),加乙醇使含醇量达70%,静置48小时,取上清液与酒萸肉回流液合并浓缩至无醇味,备用;取茯苓、泽泻,加8倍量水煎煮2次,每次1.5小时,滤过,滤液与上述浓缩液合并,浓缩至相对密度1.30-1.32,60℃减压干燥,粉碎,得干膏粉。
(3)干膏粉,加入PEG4000,于80℃加热熔化,加入挥发油,混合均匀,滴入 冷却的二甲硅油,即得本发明滴丸剂。
Claims (9)
1.一种六味地黄滴丸的制备方法,其特征在于,步骤如下:
(1)牡丹皮挥发油的制备:取牡丹皮,加水蒸馏,得挥发油,蒸馏后的水溶液另器收集。
(2)干膏粉的制备:取酒萸肉,加乙醇回流,滤过,滤液备用;取熟地黄、山药,加水煎煮,煎煮液滤过,滤液加入牡丹皮蒸馏后的水溶液,浓缩,醇沉,醇沉上清液与酒萸肉回流液合并浓缩至无醇味,备用;取茯苓、泽泻,加水煮沸,滤过,滤液与上述浓缩液合并,浓缩,干燥,粉碎,得干膏粉。
(3)干膏粉,加入PEG4000,加热熔化,加入挥发油,混合均匀,滴入冷却的二甲硅油,即得本发明滴丸剂。
2.根据权利要求1的制备方法,其特征在于,步骤如下:
(1)牡丹皮挥发油的制备:取牡丹皮,加15倍量水蒸馏2小时,得挥发油,蒸馏后的水溶液另器收集。
(2)干膏粉的制备:取酒萸肉,加80-90%乙醇回流2次,每次2小时,滤过,滤液备用;取熟地黄、山药,加水煎煮2次,每次加10倍量水,第一次2小时,第二次1小时,煎煮液滤过,滤液加入牡丹皮蒸馏后的水溶液,浓缩至相对密度1.15-1.20(50℃热测),加乙醇使含醇量达70%,静置48小时,取上清液与酒萸肉回流液合并浓缩至无醇味,备用;取茯苓、泽泻,加水煮沸后,80℃温浸二次,每次1.5小时,滤过,滤液与上述浓缩液合并,浓缩至相对密度1.30-1.32,60℃减压干燥,粉碎,得干膏粉。
(3)干膏粉,加入PEG4000,于80℃加热熔化,加入挥发油,混合均匀,滴入冷却的二甲硅油,即得。
3.根据权利要求1的制备方法,其特征在于,步骤如下:
处方:熟地黄4800g 酒萸肉2400g 牡丹皮1800g
山药2400g 茯苓1800g 泽泻1800g
制法:
(1)牡丹皮挥发油的制备:取牡丹皮,加15倍量水蒸馏2小时,得挥发油,蒸馏后的水溶液另器收集。
(2)干膏粉的制备:取酒萸肉,加80%乙醇回流2次,每次2小时,滤过,滤液备用;取熟地黄、山药,加水煎煮2次,每次加10倍量水,第一次2小时,第二次1小时,煎煮液滤过,滤液加入牡丹皮蒸馏后的水溶液,浓缩至相对密度1.15-1.20(50℃热测),加乙醇使含醇量达70%,静置48小时,取上清液与酒萸肉回流液合并浓缩至无醇味,备用;取茯苓、泽泻,加8倍量水煮沸后,80℃温浸二次,每次1.5小时,滤过,滤液与上述浓缩液合并,浓缩至相对密度1.30-1.32,60℃减压干燥,粉碎,得干膏粉。
(3)干膏粉,加入PEG4000,于80℃加热熔化,加入挥发油,混合均匀,滴入冷却的二甲硅油,即得。
4.根据权利要求1的制备方法,其特征在于,步骤如下:
处方:熟地黄4800g 酒萸肉2400g 牡丹皮1800g
山药2400g 茯苓1800g 泽泻1800g
制法:
(1)牡丹皮挥发油的制备:取牡丹皮,加15倍量水蒸馏2小时,得挥发油,蒸馏后的水溶液另器收集。
(2)干膏粉的制备:取酒萸肉,加85%乙醇回流2次,每次2小时,滤过,滤液备用;取熟地黄、山药,加水煎煮2次,每次加10倍量水,第一次2小时,第二次1小时,煎煮液滤过,滤液加入牡丹皮蒸馏后的水溶液,浓缩至相对密度1.15-1.20(50℃热测),加乙醇使含醇量达70%,静置48小时,取上清液与酒萸肉回流液合并浓缩至无醇味,备用;取茯苓、泽泻,加8倍量水煎煮2次,每次1.5小时,滤过,滤液与上述浓缩液合并,浓缩至相对密度1.30-1.32,60℃减压干燥,粉碎,得干膏粉。
(3)干膏粉,加入PEG4000,于80℃加热熔化,加入挥发油,混合均匀,滴入冷却的二甲硅油,即得。
5.根据权利要求1的制备方法,其特征在于,步骤如下:
处方:熟地黄4800g 酒萸肉2400g 牡丹皮1800g
山药2400g 茯苓1800g 泽泻1800g
制法:
(1)牡丹皮挥发油的制备:取牡丹皮,加15倍量水蒸馏2小时,得挥发油,蒸馏后的水溶液另器收集。
(2)干膏粉的制备:取酒萸肉,加90%乙醇回流2次,每次2小时,滤过,滤液备用;取熟地黄、山药,加水煎煮2次,每次加10倍量水,第一次2小时,第二次1小时,煎煮液滤过,滤液加入牡丹皮蒸馏后的水溶液,浓缩至相对密度1.15-1.20(50℃热测),加乙醇使含醇量达70%,静置48小时,取上清液与酒萸肉回流液合并浓缩至无醇味,备用;取茯苓、泽泻,加8倍量水煎煮2次,每次1.5小时,滤过,滤液与上述浓缩液合并,浓缩至相对密度1.30-1.32,60℃减压干燥,粉碎,得干膏粉。
(3)干膏粉,加入PEG4000,于80℃加热熔化,加入挥发油,混合均匀,滴入冷却的二甲硅油,即得。
6.一种六味地黄滴丸的制备方法,包括以下步骤:
(1)牡丹皮挥发油的制备:牡丹皮加15倍量水蒸馏提取挥发油,蒸馏后的水溶液另器收集;
(2)六味地黄滴丸干膏粉的制备:酒萸肉加8倍量70%乙醇回流提取二次,每次2小时,合并提取液,滤过,滤液备用;熟地黄、山药、泽泻加水煎煮二次,每次加10倍量水,第一次2小时,第二次1小时,合并煎液,滤过,滤液与牡丹皮水溶液合并,减压浓缩至相对密度为1.15~1.20(50℃热测)的清膏,放冷,加乙醇使含醇量达70%,静置48小时,取上清液与上述山茱萸提取液合并,减压回收乙醇至无醇味,备用;茯苓加水煮沸后,于80℃温浸二次,每次1.5小时,合并浸出液,滤过,滤液和上述备用液合并,浓缩至相对密度1.30-1.40,减压干燥,粉碎,即得;
(3)聚乙二醇4000加热熔融,加入六味地黄滴丸干膏粉、牡丹皮挥发油混匀,用胶体磨研磨20-40分钟,滴制成200丸(每丸重300mg)或1000丸(每丸重60mg),即得。
7.根据权利要求6所述的制备方法,其特征在于,所述胶体磨的型号:JM-L65。
8.根据权利要求6所述的制备方法,其特征在于,所述胶体磨的研磨速度:3000r/min。
9.根据权利要求6所述的制备方法,其特征在于,所述胶体磨的研磨时间:30分钟。
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CN102727712A (zh) * | 2012-06-28 | 2012-10-17 | 江苏颐海药业有限责任公司 | 六味地黄滴丸 |
CN107744506A (zh) * | 2017-09-06 | 2018-03-02 | 江西济民可信药业有限公司 | 一种匀浆技术运用于六味地黄滴丸的制备方法 |
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CN102727712A (zh) * | 2012-06-28 | 2012-10-17 | 江苏颐海药业有限责任公司 | 六味地黄滴丸 |
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