CN101583863A - 用于检测和登记样品性质的方法和设备 - Google Patents
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Abstract
将激光束(4)导引到样品(1)上或者导引激光束(4)穿过样品(1)，在样品(1)被暴露于激光时，利用数字扫描仪(2)扫描样品(1)。用于执行该方法的设备包括激光源(3)和数字扫描仪(2)。
Description
技术领域
本发明涉及利用数字扫描装置检测和存储关于分析样品溶液、特别是药物制剂的性质的信息的方法以及用于执行该方法的设备。
背景技术
已经知道利用平台式扫描仪或其它电子光学装置测定分析样品。在WO 89/07255中，公开了利用平台式扫描仪提取关于化学或生物试验或过程(特别是血样等的分析)的信息。在US 2002/0168784中，公开了使用平台式扫描仪的、特别是确定和存储凝集试验结果的诊断***。所检测的光学性质是样品和产生的凝集物的荧光、颜色、光散射或特性。
对于所有这些已知方法，优选地呈微量滴定板形状的样品试管被放置在扫描台上并被暴露于入射光。
发明内容
已经发现，通过将样品暴露于激光束，产生包含关于样品性质的信息的光学效应，通过对该光学效应进行数字扫描，该信息被存储并且可供电子测定使用。
因此，本发明涉及一种分析方法，其中将激光束导引到样品上或者导引激光束穿过样品，在样品被暴露于激光时，利用数字扫描仪扫描样品。本发明还涉及用于执行该方法的设备，该设备包括：光源，该光源被定位成用于将激光束导引到样品上或者导引激光束穿过样品；以及数字扫描仪，该数字扫描仪被布置在与样品有关的位置、用于对由激光束在样品上或样品中产生的光学效应进行扫描。
附图说明
下面，参照如下附图描述本发明的各优选实施例：
图1示出了用于分析水平定位的小瓶的布置；
图2示出了用于分析竖直定位的小瓶的布置；
图3示出了用于一个样品的多激光器布置；
图4示出了多个样品和激光器的布置；
图5示出了用一个激光器分析多个样品；
图6示出了激光激发与荧光光谱分析相结合；
图7示出了在线分析小瓶中的凝集物；
图8示出了在线分析注射器中的凝集物；
图9示出了在线分析水平定位的注射器中的凝集物；
图10示出了荧光光谱仪布置；
图11示出了用于液相色谱的流通装置；
图12示出了带有荧光检测的用于液相色谱的流通装置；
图13示出了作为散射检测器的一部分的流通装置；
图14示出了要放置在扫描仪表面上的包含荧光和紫外光谱仪的装置。
具体实施方式
在下文描述的本发明的所有实施例中，使用高度聚焦的光束(如激光器、纳米LED等的射束)来激发和显现溶液中的颗粒。使用激光束并且由扫描仪放大图像，允许显现和分析溶液中的使激光束散射的颗粒。可确定给定体积中的限定尺寸的颗粒(如蛋白质凝集物和/或可滤取物)的参数(如尺寸、形态和数量)。对于检测较大颗粒，红色激光是优选的，而使用绿色和蓝色激光允许检测较小颗粒。
包含要分析的样品溶液的容器1(如小瓶、试管、多井板如微量滴定板、注射器等)被放置在平台式扫描仪2的表面上或该表面附近，并且被暴露于由位于该扫描仪的一侧的激光器3产生的激光束4。如图1中所示，小瓶水平地放置在扫描台上，激光器3发射的激光束4通过小瓶的底部进入小瓶。如果小瓶中所含的溶液被颗粒污染，则激光束被散射。散射通过溶液中的每个单独颗粒来实现。对通过激光束的散射产生的光学效应(或者换言之，激光束在溶液中的图像)进行数字扫描，得到在该扫描仪下方示出的图像5。电子放大得到示出多个单独颗粒的放大图像6。利用本身已知的图像处理方法，可通过计数、尺寸分级、形态、尺寸分布等来分析颗粒。
如图2中所示，小瓶1还可站立在扫描台2上。在此情况下，激光器3发射的激光束4通过小瓶的侧壁进入溶液。
为详细研究起见，如图3中所示，布置一排激光器3(两个或更多个)来发射优选为不同颜色的激光束4进入或穿过样品容器1。
如图4中所示，多个容器1(它们亦可以是不同类型的，如小瓶、试管等)被布置在位于扫描仪表面2上的呈框架形状的样品室7中。一排激光器3发射激光束4，用于同时分析位于该样品室中的小瓶或样品试管1。图5示出了另一种可能性，其中位于扫描仪表面2上的多个小瓶1同时暴露于一个激光束4。这些布置允许同时分析大量样品。
如图6中所示，激光激发的使用可与荧光光谱分析相结合。如在前面描述的例子中，激光器3发射的激光束4被引导穿过位于扫描仪表面2上的样品容器1。同时，可从荧光光谱仪通过光纤传送的激发光8被导引到样品中，且荧光由可以是与荧光光谱仪相连的光纤的检测器接收。
如图7中所示，本发明的优选实施例可用于连续在线检测包含例如药物产品溶液的小瓶中的聚集物。包含产品的小瓶1沿着示意性表示的生产线10移动。移动方向由箭头示出。在测量站11，小瓶从竖直定位的扫描仪表面12前经过。当小瓶经过扫描仪时，它们被暴露于由位于生产线的一侧的激光器3发射的激光4。
图8示出了一个类似的应用，即，检测经过类似的测量站11的被预填充的注射器13中的颗粒，在测量站11，注射器13被暴露于激光器3发射的激光束4。因溶液中的颗粒物质而可视的激光束4由竖直布置的扫描仪12进行扫描。如果检测到诸如蛋白质聚集物和/或可滤取物的颗粒，则小瓶或注射器被自动分隔开。
如图9中所示，注射器13还可平放在带14上传送，带14在扫描仪表面2的上方移动。激光器3被定位于该移动带的一侧以发射穿过注射器中的溶液的激光束4。
图10示出了待***试管保持器15中的用于测量荧光的设备。如在用于在线分析产品的测量站中，在样品保持表面的一侧布置小的竖直扫描仪。定位激光器来发射平行于扫描仪表面的激光束。与激光器相对地布置荧光激发光源16，并且相对于激发光束在角度上移位地布置检测器17，检测器17可以是将荧光传送到荧光光谱仪的光纤。类似的此类设备可适合于其它光谱分析方法，如紫外-可见、圆二色性、红外或拉曼光谱测定。
荧光激发在样品中频繁地产生可视效应，该可视效应甚至无需激光束也可由扫描仪记录。因此，扫描仪与荧光测量设备的结合也是本发明的一个方面。
图11中所示的本发明的又一个实施例是流通装置18，流通装置18用不同的液相色谱方法比如尺寸排除(SEC)、高压液相色谱(HPLC)、场流分离(FFF)、离子交换色谱、等电聚焦(iso-electric focusing)或毛细管区带电泳(CZE)在线鉴定聚集物。图12示出了与图10中所示的实施例中的布置相同的布置，但附加了荧光测量设备。
除了通过扫描仪检测和显现颗粒以外，该在线设备还可结合其它检测，如荧光、紫外、动态或静态光散射。
图13示出了作为具有流通毛细管20的已知动态或静态光散射检测器19的一部分的扫描仪和激光器的使用。使用视像扫描仪允许分析大的颗粒。扫描仪2位于光散射检测器19的下面，而激光器被布置在其一侧。该***对于色谱技术如场流分离特别有用。
图14中所示的装置主要是待放置在扫描仪2上的盒子21。它具有用于***样品试管23的开口22。该盒子包含被布置成引导激光束穿过样品的激光器24。激光束25平行于试管的长边而穿过样品，但是也可在对角线等角度下导引激光束25。还被包含并且被布置在试管的一侧的是光源26，光源26发射比如来自荧光光谱仪的荧光激发光以及紫外-可见单色光。在试管的上方定位荧光发射检测器27。并且，在与该光源相对的一侧，布置紫外-可见吸收检测器28。通过微小的修改，此装置当然亦可用于多井板。
Claims (9)
1.一种利用数字扫描装置检测和存储关于分析样品溶液、特别是药物制剂的性质的信息的方法，其特征在于：将激光束导引到样品上或者导引激光束穿过样品，在所述样品被暴露于激光时，利用数字扫描仪扫描所述样品。
2.根据权利要求1所述的方法，其特征在于：将多个激光束导向样品。
3.根据权利要求2所述的方法，其特征在于：所述多个激光束是不同颜色的激光束。
4.根据权利要求1所述的方法，其特征在于：同时引导激光束穿过多个样品。
5.根据权利要求1所述的方法，其特征在于：将荧光检测与激光激发相结合。
6.根据权利要求1所述的方法，其特征在于：在线分析容器的内容。
7.根据权利要求1所述的方法，其特征在于：在流通装置中使用激光激发。
8.根据权利要求7所述的方法，其特征在于：所述流通装置是液相色谱***的一部分。
9.一种用于执行根据前述权利要求所述的方法的设备，其特征在于包括：光源，所述光源被定位成用于将激光束导引到样品上或者导引激光束穿过样品；以及数字扫描仪，所述数字扫描仪被布置在与所述样品有关的位置、用于对由所述激光束在所述样品上或所述样品中产生的光学效应进行扫描。
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| PCT/CH2007/000025 WO2008086632A1 (en) | 2007-01-19 | 2007-01-19 | Method and apparatus for detecting and registering properties of samples |
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| EP (1) | EP2106541B1 (zh) |
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| CN (1) | CN101583863A (zh) |
| ES (1) | ES2662027T3 (zh) |
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| CN104487816A (zh) * | 2012-05-24 | 2015-04-01 | 艾伯维公司 | 用于检测有益制剂中的颗粒的***及方法 |
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| JP5248625B2 (ja) | 2007-12-21 | 2013-07-31 | ディーティーエス・エルエルシー | オーディオ信号の知覚ラウドネスを調節するシステム |
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- 2007-01-19 EP EP07700123.8A patent/EP2106541B1/en not_active Not-in-force
- 2007-01-19 JP JP2009545784A patent/JP2010516999A/ja active Pending
- 2007-01-19 CN CNA2007800499751A patent/CN101583863A/zh active Pending
- 2007-01-19 PL PL07700123T patent/PL2106541T3/pl unknown
- 2007-01-19 US US12/522,877 patent/US9417176B2/en active Active
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104487816A (zh) * | 2012-05-24 | 2015-04-01 | 艾伯维公司 | 用于检测有益制剂中的颗粒的***及方法 |
| US10126226B2 (en) | 2012-05-24 | 2018-11-13 | Abbvie Inc. | Systems for inspection of protein particles in a liquid beneficial agent |
| US10132736B2 (en) | 2012-05-24 | 2018-11-20 | Abbvie Inc. | Methods for inspection of protein particles in a liquid beneficial agent |
Also Published As
| Publication number | Publication date |
|---|---|
| ES2662027T3 (es) | 2018-04-05 |
| EP2106541B1 (en) | 2017-12-13 |
| US20100102247A1 (en) | 2010-04-29 |
| US9417176B2 (en) | 2016-08-16 |
| WO2008086632A1 (en) | 2008-07-24 |
| EP2106541A1 (en) | 2009-10-07 |
| PL2106541T3 (pl) | 2018-05-30 |
| WO2008086632A8 (en) | 2009-08-13 |
| JP2010516999A (ja) | 2010-05-20 |
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