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1. 发明公开

EP3530650A1 CRYSTALLINE FORM OF (R)-4-HYDROXY-2-OXO-1-PYRROLIDINEACETAMIDE, PREPARATION METHOD THEREFOR AND USE THEREOF 无效
公开(公告)号：EP3530650A1
公开(公告)日：2019-08-28
申请号：EP17864955.4
申请日：2017-07-07
申请人： Chongqing Runze Pharmaceutical Company Limited
发明人： YE, Lei
IPC分类号： C07D207/273 , A61K31/4015 , A61P25/08
摘要： A crystalline form of (R)-4-hydroxy-2-oxo-1-pyrrolidineacetamide is disclosed. The crystalline form has a diffraction peak when a diffraction angle, 2θ, is 16.66±0.2°, 17.54±0.2°, 21±0.2°, 22.16±0.2°, or 30.96±0.2°. The crystalline form can be dissolved quickly in water with a solubility greater than or equal to 90 mg/mL, features high bioavailability, has high stability at high temperature, is suitable for preparing multiple pharmaceutical compositions, and can prepare multiple formulations, such as tablets, capsules, dripping pills, sustained-release and controlled-release formulations, and lyophilized powder for injection. The method for preparing the crystalline form is carried out under a mild condition, is easy to operate, introduces a few impurities, and features good reproducibility, an easy-to-control production process and high safety, and is suitable for industrial production.

2. 发明公开

EP2743258A1 METHOD FOR PURIFYING LEVO-OXIRACETAM 失效转让
标题翻译： VERFAHREN ZUR AUFREINIGUNG VON LEVO-OXIRACETAM
公开(公告)号：EP2743258A1
公开(公告)日：2014-06-18
申请号：EP12822382.3
申请日：2012-04-23
申请人： Chongqing Runze Pharmaceutical Company Limited
发明人： YE, Lei , RONG, Zuyuan
IPC分类号： C07D207/273
CPC分类号： C07D207/273
摘要： A purification method of levo-oxiracetam, dissolving a crude levo-oxiracetam in water, adding an organic solvent until the solution just turns turbid, then the solution is allowed to stand at a temperature of 0∼189°C for 1∼3 days, and colorless transparent crystal is precipitated, filtering and top washing with ice water of 0°C to 5°C, then vacuum drying to obtain levo-oxiracetam with high purity.
摘要翻译：将左旋奥拉西坦的纯化方法，将粗制左旋奥拉西坦溶于水中，加入有机溶剂直至溶液刚好变浊，然后将溶液在0-118℃的温度下静置1 3 3天，得到无色透明结晶沉淀，过滤并用0℃至5℃的冰水洗涤，然后真空干燥以获得高纯度的左旋 - 奥拉西坦。

3. 发明授权

EP2762173B1 PREPARATION METHOD FOR MEDICAL POROUS TANTALUM IMPLANT MATERIAL 有权
公开(公告)号：EP2762173B1
公开(公告)日：2020-10-28
申请号：EP12835956.9
申请日：2012-09-27
申请人： Chongqing Runze Pharmaceutical Company Limited
发明人： YE, Lei
IPC分类号： A61L27/04 , B22F3/11 , A61L27/56 , C22C1/08 , C22C27/02 , B22F3/22

4. 发明公开

EP3530271A1 CRYSTALLINE FORM II OF DEXTRAL OXIRACETAM, PREPARATION METHOD THEREFOR AND USE THEREOF 审中-公开
公开(公告)号：EP3530271A1
公开(公告)日：2019-08-28
申请号：EP17863355.8
申请日：2017-07-07
申请人： Chongqing Runze Pharmaceutical Company Limited
发明人： YE, Lei
IPC分类号： A61K31/4015 , A61P25/08
摘要： The present invention provides a crystalline form of dextral oxiracetam. The crystalline form has a diffraction peak when a diffraction angle, 2θ, is 17.76±0.2°, 20.16±0.2°, 21.20±0.2°, 24.17±0.2°, or 25.88±0.2°. The crystalline form of dextral oxiracetam can promote synthesis of phosphorylcholine and phosphoethanolamine, boosts cerebral metabolism, has a stimulating function on a specific central nervous pathway by means of a blood-brain barrier, and has special biological activity in the field of sedation and the antiepileptic field. The crystalline form of dextral oxiracetam of the present invention is a water-containing crystalline form, contains 0.5 water molecules, loses crystallization water at 73.5±2°C, and is melted and decomposed at 138.0±2°C. The crystalline form of dextral oxiracetam of the present invention can stably exist at room temperature and relative humidity of 0-95%, does not transform, is used for storage and formulation processing, and has low requirements for processing or storage humidity.

5. 发明公开

EP3135666A1 (S)-OXIRACETAM CRYSTAL FORM III, PREPARATION METHOD THEREFOR, AND APPLICATION THEREOF 有权转让
标题翻译：（S）-OXIRACETAM晶体形式III，其制备方法及其应用
公开(公告)号：EP3135666A1
公开(公告)日：2017-03-01
申请号：EP14859924.4
申请日：2014-10-27
申请人： Chongqing Runze Pharmaceutical Company Limited
发明人： YE, Lei
IPC分类号： C07D207/273 , A61K31/4015 , A61P25/28
CPC分类号： C07D207/273 , A61K31/4015 , C07B2200/13
摘要： (S)-4-hydroxy-2-oxo-1-pyrrolidine crystal form III (called crystal form III of (S)-oxiracetam for short) has diffraction peaks at diffraction angles 2θ, wherein the diffraction angles 2θ are equal to 10.54, 13.70, 14.44, 15.60, 17.12, 18.88, 19.24, 20.66, 20.84, 21.18, 21.82, 22.94, 23.24, 24.88, 27.20, 27.48, 28.24, 30.46, 30.80, 31.52, 32.00, 32.34, 32.90, 33.20, 34.40, 34.62, 37.30, 37.50, 38.28, 38.96, and 40.02°. The (S)-oxiracetam crystal form III of the present invention has an obvious effect on memory dysfunction, is dissolved in water fast, has high bioavailability, and can be used to prepare various pharmaceutical compositions. The (S)-oxiracetam crystal form III obtained by using the preparation method of the present invention is high in purity. The preparation method of the present invention is performed in a mild condition, is easy in operation, introduces less impurities, has desirable reproducibility, is easily controlled during production, and is applicable to industrial production.
摘要翻译：（S）-4-羟基-2-氧代-1-吡咯烷晶形III（称为晶形（S） - 奥拉西坦III的简称）具有衍射峰的衍射角2θ，其中，所述衍射角2θ等于10.54， 13.70，14.44，15.60，17.12，18.88，19.24，20.66，20.84，21.18，21.82，22.94，23.24，24.88，27.20，27.48，28.24，30.46，30.80，31.52，32.00，32.34，32.90，33.20，34.40，34.62， 37.30，37.50，38.28，38.96和40.02°。本发明的（S） - 奥拉西坦晶型III对记忆功能障碍具有明显的作用，快速溶于水，生物利用度高，可用于制备各种药物组合物。使用本发明的制备方法得到的（S） - 奥拉西坦晶型III纯度高。本发明的制备方法在温和条件下进行，操作简单，杂质少，再现性好，在生产过程中易于控制，适用于工业生产。

6. 发明公开

EP3530272A1 NOVEL CRYSTALLINE FORM OF DEXTRAL OXIRACETAM, PREPARATION METHOD THEREFOR AND USE THEREOF 审中-公开
公开(公告)号：EP3530272A1
公开(公告)日：2019-08-28
申请号：EP17865136.0
申请日：2017-07-07
申请人： Chongqing Runze Pharmaceutical Company Limited
发明人： YE, Lei
IPC分类号： A61K31/4015 , A61P25/08
摘要： The present invention provides a crystalline form of dextral oxiracetam. The crystalline form has a diffraction peak when a diffraction angle, 2θ, is 17.12±0.2°, 18.88±0.2°, 19.24±0.2°, 21.18±0.2°, 24.88±0.2°. The crystalline form having oxiracetam can promote synthesis of phosphorylcholine and phosphoethanolamine, boosts cerebral metabolism, has a stimulating function on a specific central nervous pathway by means of a blood-brain barrier, improves the intelligence and memory, has an obvious effect on a memory dysfunction, and has special biologic activity in the field of sedation and the antiepileptic field. The method for preparing the crystalline form is simple and is suitable for industrial production.

7. 发明公开

EP3409720A1 POROUS NON-METALLIC MATERIAL 审中-公开
公开(公告)号：EP3409720A1
公开(公告)日：2018-12-05
申请号：EP16863591.0
申请日：2016-11-07
申请人： Chongqing Runze Pharmaceutical Company Limited
发明人： YE, Lei
IPC分类号： C08L27/18 , C08L5/08 , C08J9/00
CPC分类号： C08J9/00 , C08L5/08 , C08L27/18
摘要： The present invention provides a porous non-metallic material including a material body, the material body is composed of pore cavities and cavity walls formed by surrounding the pore cavities in three-dimensional space. The pore cavities are uniformly distributed, and each pore cavity is three-dimensionally interconnected. The pore cavities are uniformly distributed means that the pore cavities are uniformly distributed under any unit-level volume on the porous material. The present invention provides a specific and clear measurement method for pore cavities distribution uniformity of the porous material, that is, the pore distribution uniformity of the porous material and the hierarchical structure thereof is measured on the scale of the small unit-level volume. Such porous structure is highly uniform, thereby ensuring the uniformity of the properties of the porous material.

8. 发明公开

EP2783685A1 USE OF LEVO-OXIRACETAM AND OXIRACETAM IN PREPARATION OF MEDICINES FOR PREVENTING OR TREATING COMA 有权转让
标题翻译： LEVO奥拉西坦药品的生产使用昏迷的预防和治疗
公开(公告)号：EP2783685A1
公开(公告)日：2014-10-01
申请号：EP12850864.5
申请日：2012-04-24
申请人： Chongqing Runze Pharmaceutical Company Limited
发明人： YE, Lei
IPC分类号： A61K31/4015 , A61P25/00
CPC分类号： A61K31/4015
摘要： The present invention is to provide uses of the L-oxiracetam in preparation of medicines for preventing or treating coma. Experimental results show that L-oxiracetam wake-promoting effects of alcoholism-induced coma is obvious, and D-oxiracetam has basically no effect. The effect of the above wake-promoting effects of L-oxiracetam is 2 times greater than racemic oxiracetam. The wake-promoting effects of L-oxiracetam on trauma or anesthesia-induced coma are both significant.
摘要翻译：本发明是在制备用于预防或治疗药物昏迷以提供L-奥拉西坦用途。实验结果表明，没有左旋奥拉西坦酒精中毒引起的昏迷的促醒作用是显而易见的，D-奥拉西坦具有基本没有影响。的L-奥拉西坦的上述觉醒促进作用的影响比外消旋奥拉西坦大于2倍。 L-奥拉西坦对创伤或麻醉诱导昏迷的促醒作用都显著。

9. 发明公开

EP2700371A1 POROUS TANTALUM ROD 有权转让
标题翻译： PORÖSETANTALSTANGE
公开(公告)号：EP2700371A1
公开(公告)日：2014-02-26
申请号：EP12773503.3
申请日：2012-04-19
申请人： Chongqing Runze Pharmaceutical Company Limited
发明人： YE, Lei
IPC分类号： A61B17/74 , A61L27/56 , A61L27/04 , B22F3/11
CPC分类号： A61L31/146 , A61B17/742 , A61B17/864 , A61B17/8875 , A61B2017/90 , A61L31/022 , B22F3/1003 , B22F3/1137 , B22F3/1146 , B22F5/10 , B22F2005/004 , B22F2301/20 , B22F2999/00 , C22C1/045 , C22C1/08 , B22F2003/248 , B22F2201/20
摘要： A porous tantalum rod is provided, which is a medical implantation used for treating collapsed articular surface of the femoral head or necrosis of the femoral head in phase I or phase II. The implantation includes a fastening structure formed on one end of the porous tantalum rod used for connecting with the osseous tissues and a through hole formed on the center of the porous tantalum rod. The porous tantalum rod is made of the porous tantalum material, which is produced by foam impregnation and had a foam structure with three-dimensional interconnecting pores, wherein the foam structure has a foam skeleton, tantalum particles located on the foam skeleton, and multiple sintering neck structures formed between the tantalum particles. The through hole of the porous tantalum rod provides the convenience of precisely positioning in the surgery and convenience to remove and inject correlate, and achieves effect of decompression continually.
摘要翻译：提供了一种多孔钽杆，其是用于在I期或II期治疗股骨头的折叠关节面或股骨头坏死的医疗植入物。植入物包括形成在用于与骨组织连接的多孔钽棒的一端上的紧固结构和形成在多孔钽棒的中心的通孔。多孔钽棒由多孔钽材料制成，其通过泡沫浸渍制成并具有具有三维互连孔的泡沫结构，其中泡沫结构具有泡沫骨架，位于泡沫骨架上的钽颗粒和多个烧结在钽颗粒之间形成的颈部结构。多孔钽棒的通孔提供了在手术中精确定位的便利性，便于去除和注射相关性，并且连续地实现减压效果。

10. 发明公开

EP2762173A1 PREPARATION METHOD FOR MEDICAL POROUS TANTALUM IMPLANT MATERIAL 有权
标题翻译： VERFAHREN ZUR HERSTELLUNGPORÖSERMEDISINISCHER TANTALIMPLANTATMATERIALIEN
公开(公告)号：EP2762173A1
公开(公告)日：2014-08-06
申请号：EP12835956.9
申请日：2012-09-27
申请人： Chongqing Runze Pharmaceutical Company Limited
发明人： YE, Lei
IPC分类号： A61L27/04 , A61L27/56 , C22C1/08 , C22C27/02
CPC分类号： A61L27/047 , A61L27/56 , A61L2400/08 , A61L2430/02 , A61L2430/24 , B22F3/1137 , B22F2999/00 , B32B5/18 , C22C27/02 , B22F3/22 , B22F2202/01
摘要： A preparation method for medical porous tantalum implant material is provided, which includes mixing polyethylene glycol aqueous solution and tantalum powder to form tantalum slurry, casting the tantalum slurry into an organic foam body through vibrant pressurization, and going through steps of drying, degreasing, vacuum sintering and thermal treatment to obtain the porous tantalum. The solution is a 2-8 wt% polyethylene glycol aqueous solution, the frequency of vibration is 20-80 times/min, the thermal treatment is performed under 10 -4 -10 -3 Pa of vacuity and the temperature is increased to 800-900°C at a rate of 10-20°C/min and keeping the temperature for 240-480 minutes, then decreased to 400°C at a rate of 2-5°C/min and keeping the temperature for 120-300 minutes, and cooled down to the room temperature naturally in the furnace. Accordingly, the porous tantalum made by the method of the present invention is a suitable for medical implantation as an alternative support of bony tissue, and assured good biocompatibility and mechanical properties. Furthermore, the reagents and the organic foam body, which are can be decomposed and resulting no residue during sintering, are used to guarantee the bio-safety of the medical porous tantalum implant material.
摘要翻译：提供了一种医用多孔钽植入材料的制备方法，其包括将聚乙二醇水溶液和钽粉混合以形成钽浆料，通过充分的加压将钽浆浇铸成有机泡沫体，并经过干燥，脱脂，真空烧结和热处理得到多孔钽。溶液为2-8重量％聚乙二醇水溶液，振动频率为20-80次/ min，热处理在10 -4 -10 -3 Pa的真空下进行，温度升至800〜 900℃，速度为10-20℃/ min，保持温度为240-480分钟，然后以2-5℃/ min的速度降至400℃，保持温度为120-300分钟并在炉内自然冷却至室温。因此，通过本发明的方法制造的多孔钽适用于医学植入，作为骨组织的替代支持，并确保良好的生物相容性和机械性能。此外，可以将分解并在烧结期间不产生残留物的试剂和有机泡沫体用于保证医用多孔钽植入材料的生物安全性。

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