CN1333690A - 从植物提取物生产固体施用形式的药物的方法 - Google Patents
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Abstract
本发明涉及一种生产片剂或胶囊形式的含植物提取物的药物的方法。根据该方法,先将一种干提取物压缩以减小其体积。随后将该压缩物的颗粒筛分成均匀等级,在一混合过程中用二氧化钛、滑石粉和高度分散的二氧化硅掩蔽,然后在两个进一步的混合阶段中用其它辅助物质处理。被掩蔽的压缩物具有生产片剂所必需的流动特性并且被保护以防水分因子。所述提取物至少占65wt%以便能生产较小的片剂,该片剂因掩蔽而具有低分解速率。
Description
本发明涉及一种生产固体施用形式的药物的方法，该药物含植物提取物、特别是金丝桃属(St.John’s wort)提取物。
固体形式的药物(例如片剂或胶囊)与液体施用形式相比的优点在于，它们在肠道的更下游区域发挥作用。这便于活性成分更加受控的释放，从而便于更好的治疗控制。医生可以根据需要准确地确定治疗患者要施用的每个单一剂量。此外，固体药物极其稳定而且容易包装、储存和运输。
然而，关于施用含植物提取物的片剂或胶囊的一个不另人满意的方面是，它们的特征在于，大比例的辅助剂与较小比例的药物活性植物提取物组合，以致它们在吸收部位的吸收作用和活性剂浓度相当低。而且，这些片剂比较大，这使得患者难以咽下它们。
DE 197 00 788 A1公开了一种基于金丝桃属提取物的药物，它可以干燥的形式作为粉剂、粒化物、胶囊或片剂经口施用。但该文件没有显示关于应如何制造片剂(它高度富含植物提取物)的工程上的说明。
DE 196 39 375 A1描述了一种干的槲寄生(mistletoe)提取物，它要被用作胶囊或片剂中的粉末或粒化物，或用作液体。该发明特别提出口服含碳酸钙或糖类的粒化物。
从DE 196 27 376 A1得知一种类似的施用形式，用于基于洋蓟(artichoke)提取物的药物。
上述药物共同的缺点是，它们不是富含干植物提取物的施用形式。这意味着，如果药物的剂量足够高，就不得不施用多个片剂或一个大得不能咽下的片剂。
DE 36 16 054 A1要求保护一种顺势疗法药物。为生产该药物，通过一个筛将猪骨髓、猪关节软骨、明胶和harpagophytins的研碎的粉末以及极高比例的辅助剂粒化。将该粒化物与更多的辅助剂交联并压成片剂。由于该产品有如此高比例的辅助剂，这种由粒化物生产片剂的方法不能用于由植物提取物生产尺寸适合口服的片剂(这表示辅助剂尽可能低而干提取物尽可能高的片剂)。
从DE 33 28 262 C2得知的得自各种药材提取物的药物制剂可作为液体或作为干提取物(呈粉末、粒化物、片剂或胶囊的形式)施用。在其一个实施方案中，将粉状干提取物与乳糖和硬脂酸镁混合并压成片剂，再将这些片剂粒化成适合应用的药物制剂。在另一个实施方案中，将粉状干提取物与纤维素和硬脂酸镁混合并立即压成片剂。尽管该专利描述了具有高比例植物提取物的固体施用形式，但以这种方式由植物提取物压成的片剂不能保证符合药物要求的参数，例如崩解时间和防潮作用。
JP 78 13 347和JP 77 102 4416各自描述了通过添加各种辅助剂而生产由植物提取物生产的粒化物，但没有具体要求保护工业生产含高比例干提取物、符合常规药物必须满足的其它要求的片剂所需的条件。
因此，本发明的问题是，提出一种生产固体施用形式的现成药物(其活性成分是植物提取物)的方法，从而提供一种植物制剂上稳定的高度有效的药物，该药物在较小的片剂中含有大剂量的提取物，该片剂容易溶解并在释放部位吸收。
本发明通过一种包括权利要求1中描述的特征的方法解决了该问题。
换句话说，本发明的构思是将干提取物压缩成筛分为均匀尺寸的粒化物颗粒并在一个混合过程中用二氧化钛、滑石粉和高度分散的二氧化硅三层掩蔽这些颗粒。然后按常规方式将这些粒化物颗粒—如果需要的话被压缩并用其它辅助剂掩蔽—进一步加工为片剂或胶囊。
一个压缩步骤、一个筛分为均匀粒径的步骤和一个掩蔽步骤的这种组合得到一种具有良好流动特性、极高提取物含量的原料，要求相应较小比例的辅助剂，因此适合片剂和胶囊的工业生产。由于被掩蔽、压缩的物质中的提取物比例至少为65wt％，所以可在典型的片剂尺寸中提供一种基于植物提取物的高度有效的药物。掩蔽粒化物颗粒时按限定顺序使用的辅助剂不与药物的功效相冲突，因为高度分散的二氧化硅外层防止粒化物颗粒在其外表面彼此熔入，以致它们在摄入后迅速崩解而显露其全部功效。
在所述的三步掩蔽过程中，优选被首先涂敷的二氧化钛覆盖了粒化物颗粒的全部表面积，为该特有吸湿性的提取物提供防湿保护。在二氧化钛涂层之后涂敷的滑石粉填充粒化物表面的任何剩余空间而得到光滑而连续的表面。最后，作为外层的高度分散的二氧化硅充当压制片剂中粒化物颗粒之间的隔离层。以这种方式掩蔽的粒化物颗粒还以良好的流动性为特征，这对进一步的加工有利。
从属权利要求和下面对一个实施方案的描述公开了本发明的其它特征和有利改进。
现在更详细地解释用植物提取物生产片剂的本发明方法，它使用金丝桃属作为治疗抑郁的活性成分。
使用乙醇-水混合物由粗切的金丝桃属芽(buds)和花朵(flowertops)制成的液体提取物被蒸发成粘性物质，并且在步骤A中通过喷雾干燥转化为粉状干提取物，向该提取物中以9∶1的比例添加了特定的辅助剂，例如麦芽糖糊精和高度分散的二氧化硅，占干植物提取物重量的10％。也可使用其它糊精。
在步骤B中，添加乳糖一水合物作为粘合剂的同时将该干提取物机械压缩成粒化物。或者，可以在该步骤中使用诸如乳糖衍生物、纤维素衍生物、淀粉、甘露糖醇和碳酸钙这样的辅助剂。最后的筛分过程提供粒度均匀、最大辅助剂比例为15wt％的压缩物质。
在随后的在步骤C中组合的三个混合过程中的第一个混合过程中，均匀粒径的仍然是吸湿性的粒化物首先用二氧化钛、再用滑石粉、最后用高度分散的二氧化硅掩蔽，得到由具有防湿性、良好的流动性和良好的崩解特性的该粒化物生产的片剂。该粒化物的均匀粒径确保了所有颗粒的均匀而薄的涂层。在第二和第三个混合过程中，进一步将这些颗粒用乳酸一水合物和羧甲基纤维素钠掩蔽，然后用硬脂酸镁/硬脂酸掩蔽。这时辅助剂比例达到最大值35wt％。或者，可应用上述辅助剂而不是乳酸一水合物，而且可应用碳酸氢钠、碳酸钙、淀粉、果胶、氧化镁、碳酸氢钾和碳酸钾代替羧甲基纤维素钠。
被掩蔽的压缩颗粒的良好流动性能使它们适合立即在压片机中加工(步骤D)。随后给这样生产的片剂小片提供一种涂层以防光线、氧和水分。此后干植物提取物的比例为最少60wt％。可以按这种方式由植物提取物生产的片剂具有良好的崩解特性，有利于金丝桃属提取物的高而准确的投药，同时尺寸小而容易咽下。
本发明不限于上述实施方案。可以想象，有关干提取物及其生产或者使用的辅助剂的各种变化都落在本发明构思的范围之内。也就是说，由干提取物生产相同尺寸的颗粒的压制品，所述颗粒随后用特定的辅助剂掩蔽并可以压成提取物比例为65-75wt％的片剂。
Claims (7)
1.一种从植物提取物生产固体施用形式的药物、特别是含金丝桃属提取物的片剂的方法，其中，在添加各种辅助剂时将一种液体植物提取物转化为一种干提取物或干提取物粒化物，其特征在于，将所述干提取物颗粒与改善粒化的物质混合并压缩成空气含量减少了的粒化物，而且在一筛分过程中将压缩过的粒化物筛分成均匀的粒度并将每个压缩过的颗粒用二氧化钛、滑石粉和高度分散的二氧化硅掩蔽，而且随后将这种方式涂敷过的压缩颗粒压成片剂。
2.根据权利要求1的方法，其中，在压缩所述干提取物时添加乳糖一水合物作为一种辅助剂。
3.根据权利要求1的方法，其中，在后继的混合步骤中用其它辅助剂处理所述被掩蔽的压缩颗粒。
4.根据权利要求3的方法，其中，先将乳糖一水合物和羧甲基纤维素钠、再将硬脂酸镁和硬脂酸用作其它辅助剂。
5.根据权利要求1-4的方法，其中，辅助剂相对于所述干植物提取物的比例不超过35wt％。
6.根据权利要求1-4的方法，其中，辅助剂的比例在生产干提取物时不超过10wt％，在压缩过程中不超过5wt％，在掩蔽过程中不超过20wt％。
7.根据权利要求1的方法，其中，将所述压缩过的颗粒用二氧化钛、滑石粉和高度分散的二氧化硅按该特定顺序掩蔽。
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19855287 | 1998-11-24 | ||
| DE19855287.4 | 1998-11-24 | ||
| DE19957472.3 | 1999-11-24 | ||
| DE19957472A DE19957472A1 (de) | 1998-11-24 | 1999-11-24 | Verfahren zur Herstellung von Arzneimitteln in fester Darreichungsform aus pflanzlichen Extrakten |
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| CN1333690A true CN1333690A (zh) | 2002-01-30 |
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| US6340478B1 (en) * | 1999-06-07 | 2002-01-22 | Bio Dar Ltd. | Microencapsulated and controlled-release herbal formulations |
| IL131508A (en) | 1999-08-19 | 2006-12-10 | David Cohen | Micronexulatory formulations and controlled dispersion of isoflavins from rich masses of sesame and other plants |
| DE10127897B4 (de) * | 2001-06-08 | 2006-04-20 | Bionorica Ag | Manteltablette mit Pflanzentrockenextrakten |
| DE10144108A1 (de) | 2001-09-03 | 2003-04-30 | Steigerwald Arzneimittelwerk | Verfahren zur Herstellung von Tabletten aus pflanzlichen Extrakten |
| US20060115555A1 (en) * | 2004-12-01 | 2006-06-01 | Foulger Sidney W | Nutritional supplements containing xanthone extracts |
| US20060115556A1 (en) * | 2004-12-01 | 2006-06-01 | Foulger Sidney W | Nutritional supplement drink containing xanthone extracts |
| US7491202B2 (en) * | 2005-03-31 | 2009-02-17 | Covidien Ag | Electrosurgical forceps with slow closure sealing plates and method of sealing tissue |
| CN101091725A (zh) * | 2006-06-23 | 2007-12-26 | 天津天士力制药股份有限公司 | 一种中药颗粒及其制备方法 |
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| JPS587608B2 (ja) * | 1979-08-22 | 1983-02-10 | 株式会社ツムラ | 漢方薬硬カプセル剤の製法 |
| IL72381A (en) * | 1983-07-20 | 1988-03-31 | Sanofi Sa | Pharmaceutical composition based on valproic acid |
| JPS60136513A (ja) * | 1983-12-26 | 1985-07-20 | Eisai Co Ltd | 糖尿病治療剤 |
| DE69209942T2 (de) * | 1991-09-05 | 1996-09-05 | Tsumura & Co | Verfahren zum Herstellen Hartgelatinekapseln, die chinesische Kräuterextrakte enthalten |
| US5579764A (en) * | 1993-01-08 | 1996-12-03 | Goldreyer; Bruce N. | Method and apparatus for spatially specific electrophysiological sensing in a catheter with an enlarged ablating electrode |
| US5965162A (en) * | 1993-09-10 | 1999-10-12 | Fuisz Technologies Ltd. | Process for forming chewable quickly dispersing multi-vitamin preparation and product therefrom |
| CH687810A5 (de) * | 1995-05-24 | 1997-02-28 | Mepha Ag | Pelletformulierung mit Omeprazol. |
| JP4494539B2 (ja) * | 1997-02-28 | 2010-06-30 | ディーエスエム アイピー アセッツ ビー．ブイ． | 流動自由な乾燥粒子 |
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| EP1135147B1 (de) | 2003-08-20 |
| PL351410A1 (en) | 2003-04-22 |
| CZ20011766A3 (cs) | 2001-10-17 |
| AR020343A1 (es) | 2002-05-08 |
| RU2199312C1 (ru) | 2003-02-27 |
| HUP0104975A3 (en) | 2004-04-28 |
| HUP0104975A2 (hu) | 2002-05-29 |
| BR9916869A (pt) | 2001-08-21 |
| DE59906705D1 (de) | 2003-09-25 |
| US6680072B1 (en) | 2004-01-20 |
| EE200100277A (et) | 2002-12-16 |
| CA2352542A1 (en) | 2000-06-02 |
| ATE247479T1 (de) | 2003-09-15 |
| JP3782936B2 (ja) | 2006-06-07 |
| JP2002530315A (ja) | 2002-09-17 |
| AU761750B2 (en) | 2003-06-12 |
| WO2000030605A2 (de) | 2000-06-02 |
| NO20012518L (no) | 2001-05-22 |
| AU1856900A (en) | 2000-06-13 |
| CA2352542C (en) | 2009-05-19 |
| NO20012518D0 (no) | 2001-05-22 |
| WO2000030605A3 (de) | 2000-08-03 |
| EP1135147A2 (de) | 2001-09-26 |
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