CN1261854A - 用于气雾剂容器的阀 - Google Patents
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Abstract
在此提供一种用于气雾剂容器来配给其内部盛装的由一种物质在液态抛射剂中形成的悬浮液或溶液的阀。该阀包括一个限定一孔的阀体(1),安装在孔上的密封件(9),和具有一配给通道(15)的阀杆(7),阀杆(7)以这样的方式可滑动地穿过密封件,在第一位置阀关闭以阻止需要配给的内容物进入配给通道(15),而在第二位置阀打开以允许需要配给的内容物通过配给通道(15)。密封件(9)由包含含氟聚合物的材料制成。
Description
本发明涉及一种用于气雾剂容器来配给一定量内容物的阀。尽管本发明通常用于气雾剂的配给,但也可以特别的用于药剂的定量配给。
由于怀疑常用的氟氯碳化物抛射剂在大气中会消耗臭氧而使得在含有这种抛射剂的气雾剂连续使用问题上被争论。因此,以替代的抛射剂比如HFA-134a(1,1,1,2四氟乙烷)和HFA-227(1,1,1,2,3,3,3七氟丙烷)为基础的气雾剂得到发展以替代那些常规抛射剂而为大气中臭氧消耗问题作出贡献。
用于气雾剂的容器通常包括一个结合一个阀的瓶体。所述阀包括一个阀杆用来通过它配给制剂。通常所述阀包括一个橡胶的阀密封件来在防止抛射剂从容器中泄漏的同时允许阀杆作往复运动。
已经发现一些常用的配送气雾剂组件在使用时性能的下降跟HFA-134a和HFA-227有关。由于阀组件的材料和制剂的成分,包括抛射剂成分之间的交互作用而使得在选择合适的阀材料来容纳以这些替代抛射剂为基础的气雾剂时变得复杂。在常用的设备中,尤其用于一些药物制剂时阀杆趋于粘滞,停顿,或在运动周期内需费力地拖拉而使得使用者在按压和释放阀杆时感到动作不舒畅。这可能部分是由于需要从容器配给的药剂从药物一抛射剂悬浮液或溶液中沉淀或沉积在内部的阀组件上,而在阀杆和密封件之间的内滑动面上药剂的存在使得在操作时摩擦力增加。
申请号为PCT/US94/06900的国际专利申请描述了一种气雾剂阀其中橡胶的阀密封件由一种经过特殊选取的材料在烘烤的基础上制成而使得通过阀密封件和阀杆之间内表面泄漏的抛射剂最少。相对于使用常规的热固树脂橡胶密封件的设备来说在对一些制剂进行操作时的流畅度得到改善。但是,尽管这种密封件材料可以改善阀的性能,它们仍不能阻止在阀组件上沉积的形成,并且操作不流畅的问题继续存在。
提供一种减轻阀的粘滞问题从而改善操作流畅度的阀体是本发明的一个目的。
根据本发明的一个方面是提供一种用于气雾剂容器中来配给由一种物质溶合于流体抛射剂而形成的悬浮液的阀,其中,所述阀包括一个限定一孔的阀体,安装在孔上的密封件,和一个具有配给通道的阀杆,所述阀杆以这样的可动方式穿过密封件,在第一位置阀关闭以阻止需要配给的内容物进入配给通道,而在第二位置阀打开允许需要配给的内容物通过配给管道,其特征在于所述密封件由一种包含含氟聚合物的材料制成。
根据本发明的另一个方面是提供一种含有氟化聚合物的阀密封件。
根据本发明的另外一个方面是提供一种包括这里所描述的阀的气雾剂容器。
适合于此目的的含氟聚合物包括聚四氟乙烷(PTFE),乙烯—四氟乙烯共聚物(ETFE),全氟烷氧基烷(PFA),氟化的乙烯丙烯共聚物(FEP),聚氟化乙二烯(PVDF)和氯乙烯四氟乙烯共聚物。已经发现PTFE由于其摩擦系数小而特别适合用作润滑剂。另外,聚四氟乙烷(PTFE)也能显著地减少药剂在密封件与阀杆接触表面上沉积的问题,从而消除了一个导致阀粘滞的因素。经过粉碎的聚四氟乙烷(PTFE)可以被直接混合作为填充材料的一部分来在正常的混合工艺中对腈—基橡胶密封件进行标准的过氧化处理。另外一种方法,密封件组件表面也可以经过氟化处理。聚四氟乙烷(PTFE)也是一种无毒的、用于配给药剂的气雾设备的重要材料。
适合地,密封件由100份树脂重量中聚四氟乙烷(PTFE)重量最多占20份的材料制成。最好,密封件包含5-10%重量比的聚四氟乙烷(PTFE)。
适合地,所述阀是一个量取阀包括一个量取腔室,一个将一定量的需要配给的内容物从容器中输送到量取腔室的输送通道,其中在第一位置时由第一密封件将配给通道与量取腔室隔开而量取腔室通过输送通道与容器连通,在第二位置时配给通道与量取腔室连通而输送通道与量取腔室由第二密封件隔开。第二密封件也可以象第一密封件那样由含氟聚合物制成。
适合于配给的物质是一种悬浮于或溶解于液态HFA134a或HFFA-227的药剂。
适合于此目的的药剂是,比如用于治疗呼吸道不适像哮喘,支气管炎,慢性阻塞性肺疾病以及胸部感染的药剂。另外的药剂可以从任何其它在吸入治疗时有用的并且可以作为悬浮液存在的适合药物中来选择。适合的药剂也可以这样来选择,比如,镇痛剂,如可卡因,双氢吗啡,麦角胺,芬太尼或吗啡;咽峡炎制剂,如地尔硫卓;抗过敏药,如色甘酸盐,酮替芬或(neodocromil);抗感染药,如头孢菌素,青霉素,链霉素,磺胺类药,四环素类和喷他脒;抗组胺药,如美沙吡林;抗炎药,如丙酸氟替卡松,二丙酸氯地米松,氟尼缩松,布地奈德或曲安奈德;镇咳药,如那可丁;支气管扩张药,如沙美特罗,沙丁胺醇,麻黄碱肾上腺素,非诺特罗,福莫特罗,异丙肾上腺素,奥西那林,苯福林,苯丙醇胺,瑞普特罗,特布他林,乙基异丙肾上腺素,妥洛特罗奥西那林,或(-)-4-氨基-3,5-二氯-α-[[[6-[2-吡啶基)乙氧基]-巳烷基]氨基]甲基]苯甲醇;利尿药,如阿米洛利;抗胆碱药,如异丙托品,阿托品或氧托品(oxitropium);肾上腺皮质激素类药,如可的松,氢化可的松,泼尼松龙;黄嘌呤类,如氨茶碱,胆茶碱,赖氨酸茶碱或茶碱以及治疗蛋白和肽,如胰岛素或高血糖素。对于本领域普通技术人员很清楚,在适合的地方,所述药剂可以以盐的形式(如作为碱金属盐或铵盐或作为酸加成盐)来使用或作为酯(如低级烷基酯)或作为溶合物(如水合物)来使得药剂的活动性和/或稳定性最佳。药剂最好是沙丁胺醇,沙丁胺醇硫酸酯,沙美特罗,沙美特罗xinafoate,丙酸氟替卡松,双丙酸倍氯美松和特布它林硫酸酯。可以理解药剂悬浮液或溶液可以包含一种或多种纯的活性成分。
所述药剂最好是(salmeterol xinafoate),沙丁胺醇硫酸酯,丙酸氟替卡松或它们的组合物。
现在将参考附图对本发明进行进一步描述,其中图1为根据本发明量取阀的剖面图。
在图1中表示了根据本发明的阀而该阀包括一个由套管2通过弯曲来密封的阀体1,套管本身被装置在容器(未示出)颈部并以一种公知的方式插入一个垫圈3。容器中灌装有salmeterol xinafoate在液态抛射剂HFA134a中形成的悬浮液。
阀体1在其下部形成有量取腔室4,而在其上部形成有作为容纳复位弹簧6的抽取腔室5。用于容器的词语“上部”和“下部”是指当在使用位置时容器颈部和阀对应于图1中所示的阀方位位于容器的下部。在阀体1中设置有一个阀杆7,一个阀杆部分8穿过下部的第一阀杆密封件9和套管2延伸到阀的外部。阀杆部分8中成形有一个开口于阀杆的外末端并与径向通道11连通的轴向或径向通道10。
阀杆7的上部具有一定的直径从而可以滑动地穿过上部第二阀杆密封件12的孔并且与孔的周边充分贴合来实现密封。密封件9和12均由在100份聚合物中聚四氟乙烷(PTFE)占15份的腈橡胶经过预氧化处理而制成,该组成成分具有在操作期间减小密封件和阀杆之间摩擦的效果,正象下面解释的那样。聚四氟乙烷(PTFE)也具有减少任何在密封件和阀杆接触面上形成药物沉积的作用,否则由于阀杆和密封件之间的滑动内表面上沉积的存将导致在操作期间摩擦增大。上部的杆密封件12由套管14来将其贴靠在由所述上部和所述下部之间的阀体1形成的台阶13上,所述套管14在下部杆密封件9和上部杆密封件12之间形成了量取腔室4。阀杆7具有一个通道15,当阀杆处于所示未操作位置时,在量取腔室4和抽取腔室5之间保持连通,而抽取腔室5本身通过在阀体1侧边上形成的孔16与容器内部连通。
阀杆7在复位弹簧6作用下向下偏移到未操作位置并且紧靠下部的杆密封件9设置一个凸肩17。在如图1所示的未操作位置凸肩17紧靠在下部的杆密封件9上并且径向通道11开设在下部杆密封件9的下方从而使得量取腔室4与通道10隔开并且其中的悬浮液不会泄漏。
具有“U”形横截面并在径向可扩张的环18环绕设置在开口16下方的阀体上以便形成环绕阀体的槽19。如图1中所能看到的那样环作为一个隔离件成形并具有一个环形接触内边缘,该边缘具有一个适合于提供套配在阀体1上部摩擦力的直径,所述环贴靠在开口16下方的台阶13上。但是,环18也可以成形为阀体1整体成形的一部分。
使用该装置时首先摇动容器来使得容器内的悬浮液均匀,而后使用者克服弹簧6的弹力按压阀杆7。当阀杆被按压时通道15的两端从量取腔室4移出到达上部杆密封件12的侧边上方。从而在量取腔室中量取一剂量的药剂。继续按压阀杆将使得在上部杆密封件重新紧贴阀杆体实现密封的同时径向通道11进入量取腔室4。从而,所量取的一剂量药剂可以通过径向通道11和排出通道10排出。
将阀杆释放阀杆将在弹簧6的弹力作用下回复到图示位置。通道15将再一次连通量取腔室4和抽取腔室5。因此,在这个阶段液体在压力作用下从容器经过开口16,通道15并进而进入量取腔室来完成灌充。
已经发现上面所述的阀在其寿命周期内相对于采用不含聚四氟乙烷(PTFE)的常规腈—基橡胶密封件当用于配给同样的物料时能够持续提供较流畅的操作。下表表示了在容器使用周期内的不同阶段两个具有标准腈—基橡胶密封件的气雾剂容器相对于两个具有经过聚四氟乙烷(PTFE)浸润过的密封件在操作期间产生的摩擦能量的所作的一个比较。
阀 | 摩擦能(mj) | ||
开始时 | 100次操作后 | 200次操作后 | |
标准经过聚四氟乙烷(PTFE)浸润过的密封件 | 4038 | 5040 | 5240 |
用来产生这些数据的容器内盛装的是沙丁胺醇硫酸酯在液态HFA134a中形成的悬浮液,而结果表明了根据本发明的阀相对于采用常规密封件的阀其中摩擦力的持续减少量。
在说明书中公开的内容可以理解为仅仅是为了举例说明本发明,而本发明可以扩展到在此基础上的修改,变化和改善。
Claims (9)
1.用于气雾剂容器来配给一种物质在液态抛射剂中形成的悬浮液或溶液的阀其中,该阀包括一个限定一孔的阀体,配置在孔上的密封件,和一个具有配给通道的阀杆,该阀杆以这样可滑动的方式穿过密封件,在第一位置时阀关闭以阻止需要配给的内容物进入配给管道,而在第二位置阀打开以允许需要配给的内容物通过配给管道,其特征在于该密封件由包含含氟聚合物的材料制成。
2.根据权利要求1所述的阀,其特征在于该密封件包括聚四氟乙烷(PTFE)的重量比含量最高达到20%的材料。
3.根据权利要求1或2之一所述的阀,其特征在于阀杆包括润滑材料。
4.根据权利要求3所述的阀,其特征在于润滑材料为聚四氟乙烷(PTFE)。
5.根据权利要求1至4之一所述的阀,其特征在于阀是一个量取阀包括一个量取腔室,一个通过它一定量需要配给的内容物可以从容器进入量取腔室的输送通道,其中在第一位置配给通道与量取腔室隔开而量取腔室通过输送通道与容器连通,在第二位置配给通道与量取腔室连通而输送通道和量取腔室连通。
6.根据权利要求5所述的阀,其特征在于,需要配给的内容物是一种悬浮于液态HFA134a的药剂。
7.根据权利要求6所述的阀,其特征在于药剂是(salmeterol xinafoate),沙丁胺醇硫酸酯,丙酸氟替卡松或它们的组合物。
8.由含氟聚合物组成的阀密封件。
9.包括根据权利要求1至7之一所述的阀的气雾剂容器。
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GB9715855.4 | 1997-07-29 | ||
GB9715855A GB2332712A (en) | 1997-07-29 | 1997-07-29 | Valve for aerosol container |
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CN1127432C CN1127432C (zh) | 2003-11-12 |
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Application Number | Title | Priority Date | Filing Date |
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CN98806178A Expired - Fee Related CN1127432C (zh) | 1997-07-29 | 1998-07-27 | 气雾剂容器 |
Country Status (26)
Country | Link |
---|---|
US (1) | US6345740B1 (zh) |
EP (1) | EP0999987B1 (zh) |
JP (1) | JP2001512044A (zh) |
KR (1) | KR20010022357A (zh) |
CN (1) | CN1127432C (zh) |
AT (1) | ATE243645T1 (zh) |
AU (1) | AU744384B2 (zh) |
BR (1) | BR9811060A (zh) |
CA (1) | CA2297983A1 (zh) |
CZ (1) | CZ2000330A3 (zh) |
DE (1) | DE69815851T2 (zh) |
EA (1) | EA002060B1 (zh) |
ES (1) | ES2202893T3 (zh) |
GB (1) | GB2332712A (zh) |
HK (1) | HK1026407A1 (zh) |
HR (1) | HRP990418A2 (zh) |
HU (1) | HUP0003817A3 (zh) |
ID (1) | ID24099A (zh) |
IL (1) | IL133362A0 (zh) |
IS (1) | IS5299A (zh) |
NO (1) | NO20000365D0 (zh) |
NZ (1) | NZ501662A (zh) |
PL (1) | PL337519A1 (zh) |
TR (1) | TR200000203T2 (zh) |
WO (1) | WO1999006303A1 (zh) |
YU (1) | YU71799A (zh) |
Families Citing this family (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB2332712A (en) * | 1997-07-29 | 1999-06-30 | Glaxo Group Ltd | Valve for aerosol container |
GB9814717D0 (en) * | 1998-02-23 | 1998-09-02 | Bespak Plc | Improvements in drug delivery devices |
GB9805938D0 (en) * | 1998-03-19 | 1998-05-13 | Glaxo Group Ltd | Valve for aerosol container |
FR2776741B1 (fr) * | 1998-03-30 | 2000-05-19 | Valois Sa | Valve doseuse amelioree |
GB9918627D0 (en) | 1999-08-07 | 1999-10-13 | Glaxo Group Ltd | Valve |
GB9918626D0 (en) | 1999-08-07 | 1999-10-13 | Glaxo Group Ltd | Valve |
MXPA02003784A (es) | 1999-10-16 | 2002-12-13 | Glaxo Group Ltd | Alojamiento de dispositivo para recipiente de aerosol. |
WO2001089616A1 (en) * | 2000-05-23 | 2001-11-29 | Glaxo Group Limited | Aerosol container for formulations of salmeterol xinafoate |
JP2002331260A (ja) | 2001-05-10 | 2002-11-19 | Bioactis:Kk | ガス噴射弁及びガス注入に用いられる注入治具 |
FR2833584B1 (fr) * | 2001-12-13 | 2004-04-23 | Valois Sa | Valve de distribution de produit fluide et dispositif de distribution de produit fluide comportant une telle valve |
AU2003263077B2 (en) * | 2002-09-06 | 2010-04-29 | 3M Innovative Properties Company | Metering valve for a metered dose inhaler providing consistent delivery |
FR2852301B1 (fr) * | 2003-03-13 | 2006-02-10 | Valois Sas | Dispositif de distribution de produit fluide |
ATE519543T1 (de) * | 2003-07-28 | 2011-08-15 | 3M Innovative Properties Co | Membrandichtung zur verwendung in einem medizinischen aerosol |
CA2536876A1 (en) * | 2003-08-29 | 2005-03-17 | Glaxo Group Limited | Pharmaceutical metered dose inhaler and methods relating thereto |
FR3024521B1 (fr) * | 2014-07-29 | 2017-02-24 | Nemera La Verpilliere | Valve doseuse de distribution d'un aerosol comprenant un joint |
FR3049275B1 (fr) * | 2016-03-23 | 2019-07-19 | Aptar France Sas | Valve doseuse et dispositif de distribution de produit fluide comportant une telle valve |
GB201702406D0 (en) | 2017-02-14 | 2017-03-29 | Norton (Waterford) Ltd | Inhalers and related methods |
GB201702407D0 (en) | 2017-02-14 | 2017-03-29 | Norton (Waterford) Ltd | Inhalers and related methods |
GB201702408D0 (en) | 2017-02-14 | 2017-03-29 | Norton (Waterford) Ltd | Inhalers and related methods |
FR3065891B1 (fr) * | 2017-05-05 | 2021-12-24 | Aptar France Sas | Valve doseuse et dispositif de distribution de produit fluide comportant une telle valve. |
KR20220164894A (ko) | 2021-06-07 | 2022-12-14 | 서준범 | 정화조 일체형 이동식 주택 |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5027A (en) * | 1847-03-20 | Box fob jotjbnals | ||
US3595589A (en) * | 1969-08-26 | 1971-07-27 | Du Pont | Composite gasket |
IT958638B (it) * | 1971-06-30 | 1973-10-30 | Union Carbide Corp | Materiali per la fabbricazione di gambi della valvola per siste mi di distribuzione di aerosoli |
US5027986A (en) * | 1989-06-09 | 1991-07-02 | Heinzel Irving Charles | Actuating valve for aerosol foam product |
GB9200148D0 (en) * | 1992-01-06 | 1992-02-26 | Minnesota Mining & Mfg | Aerosol valves |
US5551706A (en) * | 1993-04-20 | 1996-09-03 | W. L. Gore & Associates, Inc. | Composite gasket for sealing flanges and method for making and using same |
AU680530B2 (en) | 1993-07-15 | 1997-07-31 | Minnesota Mining And Manufacturing Company | Seals for use in an aerosol delivery device |
GB9507768D0 (en) * | 1995-04-13 | 1995-05-31 | Glaxo Group Ltd | Method of apparatus |
BR9604977A (pt) * | 1995-04-14 | 1998-06-09 | Glaxo Wellcome Inc | Inalador de dose medida sistema inalador de dose medida e uso do mesmo |
FR2740527B1 (fr) * | 1995-10-31 | 1998-01-02 | Valois | Tige de soupape a faibles frottements |
GB2332712A (en) * | 1997-07-29 | 1999-06-30 | Glaxo Group Ltd | Valve for aerosol container |
KR102126382B1 (ko) | 2014-02-19 | 2020-06-25 | 삼성디스플레이 주식회사 | 유기 발광 표시 장치 |
-
1997
- 1997-07-29 GB GB9715855A patent/GB2332712A/en not_active Withdrawn
-
1998
- 1998-07-27 BR BR9811060-8A patent/BR9811060A/pt not_active IP Right Cessation
- 1998-07-27 NZ NZ501662A patent/NZ501662A/en unknown
- 1998-07-27 DE DE69815851T patent/DE69815851T2/de not_active Expired - Lifetime
- 1998-07-27 CZ CZ2000330A patent/CZ2000330A3/cs unknown
- 1998-07-27 YU YU71799A patent/YU71799A/sh unknown
- 1998-07-27 KR KR1020007000936A patent/KR20010022357A/ko not_active Application Discontinuation
- 1998-07-27 WO PCT/EP1998/004681 patent/WO1999006303A1/en not_active Application Discontinuation
- 1998-07-27 CA CA002297983A patent/CA2297983A1/en not_active Abandoned
- 1998-07-27 ES ES98945097T patent/ES2202893T3/es not_active Expired - Lifetime
- 1998-07-27 AU AU92550/98A patent/AU744384B2/en not_active Ceased
- 1998-07-27 TR TR2000/00203T patent/TR200000203T2/xx unknown
- 1998-07-27 AT AT98945097T patent/ATE243645T1/de not_active IP Right Cessation
- 1998-07-27 EP EP98945097A patent/EP0999987B1/en not_active Expired - Lifetime
- 1998-07-27 PL PL98337519A patent/PL337519A1/xx not_active Application Discontinuation
- 1998-07-27 CN CN98806178A patent/CN1127432C/zh not_active Expired - Fee Related
- 1998-07-27 HU HU0003817A patent/HUP0003817A3/hu unknown
- 1998-07-27 EA EA200000083A patent/EA002060B1/ru not_active IP Right Cessation
- 1998-07-27 IL IL13336298A patent/IL133362A0/xx unknown
- 1998-07-27 US US09/446,163 patent/US6345740B1/en not_active Expired - Lifetime
- 1998-07-27 JP JP2000505076A patent/JP2001512044A/ja active Pending
- 1998-07-27 ID IDW20000191A patent/ID24099A/id unknown
-
1999
- 1999-12-14 IS IS5299A patent/IS5299A/is unknown
- 1999-12-30 HR HR9715855.4A patent/HRP990418A2/hr not_active Application Discontinuation
-
2000
- 2000-01-25 NO NO20000365A patent/NO20000365D0/no not_active Application Discontinuation
- 2000-09-04 HK HK00105549A patent/HK1026407A1/xx not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
PL337519A1 (en) | 2000-08-28 |
EP0999987A1 (en) | 2000-05-17 |
YU71799A (sh) | 2001-09-28 |
NO20000365L (no) | 2000-01-25 |
JP2001512044A (ja) | 2001-08-21 |
IL133362A0 (en) | 2001-04-30 |
GB9715855D0 (en) | 1997-10-01 |
BR9811060A (pt) | 2000-09-19 |
EA200000083A1 (ru) | 2000-08-28 |
US6345740B1 (en) | 2002-02-12 |
DE69815851T2 (de) | 2004-04-22 |
NZ501662A (en) | 2001-09-28 |
HUP0003817A3 (en) | 2001-08-28 |
ATE243645T1 (de) | 2003-07-15 |
KR20010022357A (ko) | 2001-03-15 |
HRP990418A2 (en) | 2000-04-30 |
ID24099A (id) | 2000-07-06 |
NO20000365D0 (no) | 2000-01-25 |
TR200000203T2 (tr) | 2000-07-21 |
AU9255098A (en) | 1999-02-22 |
GB2332712A8 (en) | 1999-09-24 |
CN1127432C (zh) | 2003-11-12 |
HK1026407A1 (en) | 2000-12-15 |
WO1999006303A1 (en) | 1999-02-11 |
EA002060B1 (ru) | 2001-12-24 |
ES2202893T3 (es) | 2004-04-01 |
GB2332712A (en) | 1999-06-30 |
IS5299A (is) | 1999-12-14 |
EP0999987B1 (en) | 2003-06-25 |
CA2297983A1 (en) | 1999-02-11 |
CZ2000330A3 (cs) | 2001-11-14 |
AU744384B2 (en) | 2002-02-21 |
HUP0003817A2 (en) | 2001-03-28 |
DE69815851D1 (de) | 2003-07-31 |
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SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
C19 | Lapse of patent right due to non-payment of the annual fee | ||
CF01 | Termination of patent right due to non-payment of annual fee |