更新于：2024-12-26

Omeprazole

奥美拉唑

更新于：2024-12-26

概要

概要

基本信息

简介Omeprazole是一种质子泵抑制剂(PPI)，常用于治疗胃肠道疾病，如胃食管反流病(GERD)、消化性溃疡和Zollinger-Ellison综合征。它通过抑制胃壁壁细胞产生胃酸来发挥作用。Omeprazole以口服剂型供应，患者通常耐受性良好。然而，可能会出现头痛、腹泻和腹痛等副作用。作为研究和开发研究人员，需要注意的是，目前正在研究Omeprazole在治疗哮喘和骨质疏松症等其他疾病方面的潜在用途，因为它在临床前和临床研究中显示出了良好的效果。这些研究的结果有望促进Omeprazole的进一步临床应用和发展。

药物类型

小分子化药

别名

Aomeilazuo Changrong Jiaonang、Omeprazole (JP17/USP/INN)、Omeprezole

+ [37]

靶点

Proton pump

作用机制

质子泵抑制剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Sandoz Pty Ltd.Taiyo Pharma Co., Ltd.

CHEPLAPHARM Arzneimittel GmbH

+ [3]

非在研机构

国药集团工业有限公司AstraZeneca Pharmaceuticals LP

最高研发阶段批准上市

首次获批日期

中国 (1988-12-31),

十二指肠溃疡内分泌腺肿瘤胃食管反流+ [2]

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C17H19N3O3S

InChIKeySUBDBMMJDZJVOS-UHFFFAOYSA-N

CAS号73590-58-6

关联

524

项与奥美拉唑相关的临床试验

NCT06383338 / Not yet recruiting临床1期

A Prospective Feasibility Study Investigating PhEnoconversion of CYP3A4, CYP2C19 and CYP2D6 Genotype in Paediatric and Adolescent and Young Adult patientS With an acUte diagnosiS of Hodgkin or Non-Hodgkin Lymphoma.

PEGASUS aims to test acceptability and feasibility of studying phenoconversion (the change in metabolism phenotype) using probe medications in a paediatric oncology patient population. The study will be conducted in patients (6-25 years of age) with Hodgkin lymphoma or non-Hodgkin lymphoma as exemplar cohort, but with the understanding that cancer-directed and supportive care medicines of the CYP3A4, CYP2C19, and CYP2D6 metabolic pathways are commonly utilised for the treatment of many paediatric, adolescent, young adult, and adult cancers.
The study involves administration of the probe medication at timepoints which align with pre-determined hospital visits for the treatment of lymphoma and subsequent blood draws to measure the metabolism of the probe medications.
The acceptability and feasibility of this study will inform future studies in phenoconversion within the paediatric cancer population to direct more personalised precision medicine.

开始日期2025-03-01

申办/合作机构

Murdoch Childrens Research Institute

NCT06690164 / Not yet recruiting临床4期IIT

Study on the Effect of Atorvastatin Co-administered With Omeprazole on Statin Lactone (SEACOL)

This is a 2-arm, prospective, randomized, parallel-group, open-label, longitudinal study that lasts 30 days for each study participant. This study aims to investigate the effect of co-administration of Omeprazole with Atorvastatin versus Atorvastatin monotherapy on atorvastatin lactone level.
Primary endpoint: Higher statin lactone level in intervention arm after 30 days.
Secondary endpoints:
Higher hs-CRP in intervention arm Lipid panel Incidence of adverse drug side effects (e.g. muscle-related or elevated LFTs

开始日期2025-01-01

申办/合作机构

National University Hospital

NCT06686628 / Recruiting临床1期

An Open-label, Drug-drug Interaction Study to Investigate the Effects of Amlitelimab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Participants With Moderate-to-severe Atopic Dermatitis

This is an open-label, single group, 2-period, Phase 1, single-sequence study. The study duration will be up to 342 days. The treatment period will be up to Week 29, where Week 29 is defined as End of Treatment (last amlitelimab administration at Week 25).
The number of visits will be 23 or 21 visits for participants who decide to continue amlitelimab therapy in the long-term extension study LTS17367 (RIVER-AD) study.

开始日期2024-11-13

申办/合作机构

Sanofi

100 项与奥美拉唑相关的临床结果

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100 项与奥美拉唑相关的转化医学

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100 项与奥美拉唑相关的专利（医药）

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9,213

项与奥美拉唑相关的文献（医药）

2025-01-01·INTERNATIONAL IMMUNOPHARMACOLOGY

In human CD4+ T-Cells, omeprazole suppresses proliferation, downregulates V-ATPase, and promotes differentiation toward an autoimmunity-favoring phenotype

Article

作者: Lykotsetas, Evangelos ; Liakopoulos, Vasilios ; Eleftheriadis, Theodoros ; Polyzou Konsta, Maria Anna ; Poulianiti, Christina ; Pissas, Georgios ; Tziastoudi, Maria ; Stefanidis, Ioannis

BACKGROUND:

Proton pump inhibitors (PPIs) represent a commonly prescribed class of medications. Triggered by findings indicating a correlation between PPI usage and susceptibility to infectious or autoimmune diseases, we studied the impact of a pharmacological concentration of omeprazole on human CD4+ T-cells.

METHODS:

In mixed lymphocyte reactions (MLRs), we analyzed the proliferation index and measured the concentration of key cytokines representative of distinct CD4+ T-cell subsets. In CD4+ T-cells isolated from the MLRs, we evaluated proliferation markers and pathways, the expression of signature transcription factors of CD4+ T-cell subsets, vacuolar H+- ATPase (V-ATPase) levels, and the activation status of AMP-activated kinase (AMPK) and mammalian target of rapamycin complex-1 (mTORC1).

RESULTS:

Omeprazole reduced proliferation index in MLRs, and in isolated CD4+ T-cells, it downregulated the proliferation marker Ki-67, possibly mediated by the p53- p21 pathway. Analysis of cytokines and signature transcription factors of CD4+ T-cell subsets indicated that omeprazole decreased T helper 1 (Th1) differentiation, had negligible impact on Th2 differentiation, increased Th17 differentiation, and reduced regulatory T-cell (Treg) differentiation. Omeprazole also decreased V-ATPase, a known target of PPIs and a site for AMPK and mTORC1 activation. Consequently, this led to diminished activation of these kinases, potentially elucidating the mechanism by which omeprazole influences CD4+ T-cell differentiation.

CONCLUSION:

Omeprazole downregulates V-ATPase and inhibits activation of AMPK and mTORC1. As a result, omeprazole suppresses CD4+ T-cell clonal expansion, potentially contributing to the observed association between PPIs and susceptibility to infections. Additionally, it modulates CD4+ T-cell differentiation in a manner that favors autoimmunity.

2025-01-01·CURRENT TOPICS IN MEDICINAL CHEMISTRY

Recent Advances in Nanocatalyzed One-Pot Sustainable Synthesis of Bioactive N, N-Heterocycles with Anticancer Activities: An Outlook of Medicinal Chemistry

Article

作者: Majhi, Sasadhar

N-heterocycles represent a predominant and unique class of organic chemistry. They have received a lot of attention due to their important chemical, biomedical, and industrial uses. Food and Drug Administration (FDA) approved about 75% of drugs containing N-based heterocycles, which are currently available in the market. N-Heterocyclic compounds exist as the backbone of numerous natural products and act as crucial intermediates for the construction of pharmaceuticals, veterinary items, and agrochemicals frequently. Among N-based heterocyclic compounds, bioactive N,N-heterocycles constitute a broad spectrum of applications in modern drug discovery and development processes. Cefozopran (antibiotic), omeprazole (antiulcer), enviradine (antiviral), liarozole (anticancer), etc., are important drugs containing N,N-heterocycles. The synthesis of N,N-heterocyclic compounds under sustainable conditions is one of the most active fields because of their significant physiological and biological properties as well as synthetic utility. Current research is demanding the development of greener, cheaper, and milder protocols for the synthesis of N,N-heterocyclic compounds to save mother nature by avoiding toxic metal catalysts, extensive application of energy, and the excessive use of hazardous materials. Nanocatalysts play a profound role in sustainable synthesis because of their larger surface area, tiny size, and minimum energy; they are eco-friendly and safe, and they provide higher yields with selectivity in comparison to conventional catalysts. It is increasingly demanding research to design and synthesize novel bioactive compounds that may help to combat cancer since the major causes of death worldwide are due to cancer. Hence, the important uses of nanocatalysts for the one-pot synthesis of biologically potent N,N-heterocycles with anticancer activities have been presented in this review.

2025-01-01·Current drug safety

Evaluation of Appropriate Use of Proton Pump Inhibitors in Non-critically Ill Patients in Tertiary Medical Center: A Retrospective Study

Article

作者: altayib, Hatoon ; Melibari, Nawal ; Althagafi, Abdulhamid ; Bahamdain, Foud ; Bukhari, Tala ; Eljaaly, Khalid ; Magbool, Nesereen

Background::

There are concerns about indiscriminate prescriptions and the inappropriate use of proton pump inhibitors (PPIs) without any clear indications, especially among noncritically hospitalized patients.

Objective::

This study aimed to characterize PPI prescriptions among non-critically hospitalized patients in a tertiary care hospital in Saudi Arabia.

Methods::

A retrospective cross-sectional study was conducted at the King Abdulaziz University Hospital between June and August 2021. The data of adult patients who received PPIs on hospital admission in the medical and surgical wards were collected and analyzed for appropriateness based on the current international guidelines and recommendations.

Results::

A total of 174 patient records were included in this study. The proportion of patients with appropriate and inappropriate PPI prescriptions was 67.24% (n=117) and 32.76% (n=57), respectively. Female patients (risk=50.00%, 95% CI: 36.89–63.11, p<0.001) were more likely to receive an inappropriate PPI prescription than their male counterparts (risk=33.33%, 95% CI: 24.56–43.43, p<0.001). Intravenous omeprazole 40 mg once daily was the most frequently prescribed PPI (n=62). The hospital length of stay differed significantly between the groups of patients who received appropriate and inappropriate PPIs (24.56 ± 47.14 vs. 13.50 ± 13.84; t=2.34, 95% CI: 1.72–20.4; p=0.02). However, there was no significant difference in the total therapy duration in both the groups (3.76 ± 2.50 vs. 4.75 ± 3.32, t=-1.62, 95%CI: -1.79–0.17; p=0.11).

Conclusion::

The findings show a high trend of inappropriate PPI prescriptions. Hence, educational programs are recommended to encourage healthcare professionals to stick to the approved guidelines when prescribing PPIs.

383

项与奥美拉唑相关的新闻（医药）

2024-12-19

·医药云端工作室

医保目录落地，湖南挂网新增品种，谈判84个+竞价5个+支付标准变化64个

编辑：子非鱼云端按语：《2024年药品目录》将于2025年1月1日正式实行，各省陆续发文做好落地准备工作，12月底前完成挂网。湖南也于12月19日发出通知，安排挂网事宜，请各相关医疗机构做好院内挂网药品的价格调整工作。 12月19日，湖南省医保局发出《关于做好2024年医保目录新增药品挂网工作的通知》，对2024年医保目录新增药品做出挂网安排，包括：谈判新增84个通用名剂型166个产品、新增竞价药品5个通用名剂型18个产品、医保目录协议内谈判药品支付标准发生变化的64个通用名剂型201个产品。《通知》挂网及调价流程内容如下：（一）已挂网药品调价流程此类药品暂予以暂停挂网，请相关生产企业于12月20日24时前登录湖南省医疗保障信息平台药品和医用耗材招采管理子系统（以下简称“招采管理子系统”）进入“药品招标管理”模块，在“我的工作台”中，找到“联动挂网”项目，点击“进入”按钮，找到对应药品进行价格确认即可恢复挂网。（二）未挂网药品挂网流程此类产品信息已经导入招采管理子系统药品招标管理页面下的“价格联动”管理模块，请相关生产企业于12月20日24时前按2024年国家谈判药品相应项目下对应的医保编码予以确认，并在12月30日前完成点选配送关系工作。（三）涉及集采药品奥美拉唑碳酸氢钠胶囊（II）（生产企业：鲁南贝特制药有限公司;规格：每粒含奥美拉唑40mg与碳酸氢钠1100mg），其挂网价格按支付标准2.29元/7粒、8.7元/28粒直接调整。 ω-3鱼油中/长链脂肪乳注射液（生产企业：四川科伦药业股份有限公司；规格：100ml和250ml），其挂网价格按支付标准53.88元/100ml、108.65元/250ml直接调整。限于篇幅，本文仅展示竞价部分，其余新增药品挂网信息，可点击文末阅读原文下载相关附件。关注公众号，获取可靠、专业的资讯和分析内容

2024-12-13

·药研

原创｜注射剂研发过程中pH升高原因及解决办法

一、原因分析 1.包材影响注射剂的pH值升高可能与包装材料有关，特别是安瓿等玻璃容器。某些包材可能会释放OH-离子，导致成品中OH-浓度增加，从而引起pH值升高。不同厂家的安瓿对pH的影响存在差异，可以通过在安瓿中灌入注射用水并灭菌，观察灭菌前后pH值的变化来进行初步筛选。注射剂中可能影响pH值的包材成分主要包括以下几类： l玻璃包装容器中的无机盐：玻璃包装容器中常见的无机盐成分，如Si、Na、K、Li、Al、Ba、Ca、Mg、B、Fe、Zn、Mn、Cd、Ti、Co、Cr、Pb、As、Sb等，这些离子在特定条件下可能会迁移进入注射液中，从而影响其pH值。 l聚丙烯和聚环烯烃（COP）注射器：研究表明，COP注射器在不同pH值下表现不同，尤其在高pH值（如pH 12）时，可能会显著增加某些物质的浓度，这可能会影响注射液的pH值。 l硅油（PDMS）：硅油常用于注射器的塞子和主体，以实现塞子沿主体平滑滑动。虽然硅油的毒性较低，但在某些pH条件下，其浓度变化可能对注射液的pH产生影响。 l橡胶塞：橡胶塞也可能影响药液的pH值，尤其是在制备过程或储存过程中，可能会导致药品pH的变化。 2.制剂工艺的影响 l灭菌过程：高压灭菌时的高温可能导致玻璃容器中的弱碱性成分分解释放到注射用水中，从而引起pH值升高。这一现象在多项研究中得到了证实。例如，一项研究指出，在高压灭菌时，安瓿玻璃中的弱碱性成分会分解，导致灭菌注射用水的pH值升高。此外，青霉素瓶中注射用水的生产过程中也观察到类似的问题，即玻璃瓶内壁的氧化物与注射用水反应，导致pH值和电导率上升。 l缓冲剂的选择和使用：在注射剂中使用的缓冲剂，如碳酸氢钠等，可能在制备或储存过程中与空气中的二氧化碳反应，导致pH值升高。碳酸氢钠在潮湿空气中会缓慢分解，释放出二氧化碳，但这通常不会导致溶液pH值的显著升高，反而可能因为碳酸氢钠的减少而略微降低pH值（尽管这种变化可能很小）。然而，在实际应用中，更常见的是碳酸氢钠溶液吸收空气中的二氧化碳，导致碳酸氢根离子（HCO₃⁻）浓度的增加，从而可能使溶液的pH值升高。这是因为二氧化碳溶于水形成碳酸（H₂CO₃），碳酸进一步电离产生氢离子（H⁺）和碳酸氢根离子（HCO₃⁻），但在碳酸氢钠溶液中，氢离子会被碳酸氢根离子中和，形成碳酸根离子（尽管这个过程中的电离和中和反应是复杂的，但总体上可以理解为碳酸氢钠溶液吸收了二氧化碳后，其碱性增强，pH值升高）。 3.溶媒和附加剂注射剂中的溶媒和附加剂也可能影响pH值。例如，使用某些缓冲溶液或pH调节剂（如盐酸、氢氧化钠等）时，如果添加不当，可能会导致pH值升高。在注射剂制备中，溶媒和附加剂的选择对药物的pH值有显著影响。以下几种溶媒和附加剂最常导致pH值升高： ① 葡萄糖注射液：葡萄糖注射液的pH值通常在3.2到6.5之间，虽然其酸性范围较广，但某些情况下仍可能导致pH值升高。 ② 氯化钠注射液：0.9%氯化钠注射液的pH值范围为4.5到7.0，属于中性偏碱性，因此在某些情况下可能使pH值升高。 ③ 碳酸氢钠：作为pH调节剂，碳酸氢钠常用于提高溶液的pH值，以增加药物的稳定性和溶解度。 ④ 氢氧化钠：同样作为pH调节剂，氢氧化钠可以显著提高溶液的pH值，常用于需要碱性环境的药物制备。 ⑤ 表面活性剂：如聚山梨酯类（吐温类）、泊洛沙姆（普朗尼克）等，虽然主要用于增溶、润湿和乳化，但在某些配方中也可能间接影响pH值。 ⑥ 抗氧剂：例如硫代硫酸钠，这种碱性抗氧剂在调节pH值方面也有一定作用。 4.环境因素环境中的水分渗透到注射剂中，也可能导致pH值的变化。例如，胶塞在干燥后仍可能含有残余水分，这些水分随时间推移可能会进入冻干块中，从而影响pH值。 5.药物配伍注射剂与其他药物配伍时，由于pH值的差异，可能会引起药物的溶解度变化、化学稳定性降低，甚至产生沉淀。二、解决办法 1.选择合适的包材在生产过程中，应选择对pH值影响较小的包材，并定期检测包材对pH值的影响，以确保成品的pH值稳定。选择对pH值影响较小的注射剂包材需要考虑以下几个方面：根据国家食品药品监督管理局《关于加强药用玻璃包装注射剂药品监督管理的通知》的规定，生物制品、偏酸偏碱及对pH敏感的注射剂由于风险较高，包材选择时应采用双1级药用玻璃或其他适宜的包材。为规范和指导化学药品注射剂与药用玻璃包装容器相容性研究工作，保障试验研究的质量，国家食品药品监督管理局与2015年7月制定发布了《化学药品注射剂与药用玻璃包装容器相容性研究技术指导原则（试行）》，旨在为注射剂药品更加合理地选择药用玻璃包材及评价药用玻璃包材的稳定性给出具有实际操作意义的指导性意见。这种玻璃具有较好的化学稳定性和耐水性，能够减少与药品成分的相互作用，从而保持药品的pH值稳定。对于一些特殊药品，如喹诺酮类注射液，由于其含有卤素元素，对玻璃的要求较高。若处理不当，玻璃中的元素会迁移到药液中，导致pH值升高。因此，可以在玻璃内壁进行覆膜处理，以降低玻璃表面的碱度，减少药液与包材的相互作用。在选择包材时，应进行充分的相容性研究，确保所选包材不会与药品发生化学反应，影响药品质量。例如，《化学药品注射剂与药用玻璃包装容器相容性研究技术指导原则（试行）》提供了相关的研究方法和标准。 2.对包材进行预处理在灭菌前对玻璃容器进行预处理，如煮沸或浸泡在特定的溶液中，以去除或减少其中的弱碱性成分，是一种常见的实验室操作步骤。这种预处理的主要目的是去除玻璃器面的皿表游离碱性物质，这些物质可能会影响实验结果或灭菌效果。根据多项证据，新购入的玻璃器皿通常含有游离碱性物质，因此需要进行预处理。例如，可以将新购的玻璃器皿浸泡在2%的盐酸溶液中数小时，以中和这些游离碱性物质。之后，用自来水冲洗干净，再用蒸馏水冲洗多次，以确保没有残留的酸性物质。此外，对于反复使用的玻璃器皿，如平皿、试管等，在高压灭菌前也需要进行类似的预处理步骤。例如，可以先用肥皂水煮沸，再用蒸馏水冲洗干净。这一步骤有助于去除器皿表面的油脂和其他有机物，从而提高灭菌效果。煮沸法也是一种常用的预处理方法，尤其适用于不耐高温高压的玻璃器皿。煮沸可以有效地杀死大部分细菌和病毒，但需要注意的是，玻璃器皿在煮沸过程中应完全浸没在水中，并逐渐加热以避免因骤热而导致玻璃器皿破裂。在进行灭菌之前对玻璃容器进行适当的预处理是确保实验结果准确性和灭菌效果的重步骤要。通过使用酸性溶液浸泡和煮沸等方法，可以有效去除玻璃器皿表面的杂质和游离碱性物质，为后续的灭菌操作打下良好的基础。 3.优化高压灭菌的条件高温可能会对热敏感材料造成损害。因此，可以尝试将灭菌温度降低至接近121°C，这样既能保证有效的灭菌效果，又能减少对玻璃容器中弱碱性成分的热分解风险。对于一些热敏感的材料，可以考虑使用过滤灭菌或其他非热灭菌方法，以避免高温对材料的破坏。 4.为了防止碳酸氢钠等缓冲剂在制备或储存过程中与空气中的二氧化碳反应导致pH值升高，可以采取以下措施： ① 密封储存：将注射剂密封储存在干燥、阴凉、避光的环境中，以减少与空气中二氧化碳的接触。 ② 使用惰性气体：在制备过程中，可以使用惰性气体（如氮气）对注射剂进行充气，以排除空气中的二氧化碳。 ③ 控制湿度和温度：保持适宜的湿度和温度条件，以减少碳酸氢钠的分解和与二氧化碳的反应。 ④ 选择合适的缓冲剂：根据药物的性质和稳定性要求，选择合适的缓冲剂类型和浓度，以确保注射剂的pH值在适宜的范围内。 5.优化溶媒和附加剂的选择在制备注射剂时，应选择合适的溶媒和附加剂，并严格控制其用量。例如，使用磷酸盐缓冲液、硼酸盐缓冲液等来调节pH值，同时避免使用可能导致pH值升高的附加剂。在注射剂制备过程中，如何有效避免因溶媒和附加剂使用不当而导致的pH值异常，从以下几点进行考虑： ① 选择合适的溶媒：根据药物的性质选择适宜的溶媒是关键。例如，青霉素的稳定pH为6.0-6.8，因此不宜用含葡萄糖的输液做溶媒，而应使用生理盐水（pH 4.5-7.0）。奥美拉唑则需要专用溶媒以保持其稳定性。 ② 严格遵循药品说明书：药品说明书通常会明确指出推荐使用的溶媒类型及其用量。例如，某些抗菌药物只能用盐水或糖水配制，因为这些溶媒的pH值与药物本身的pH相近，有助于保持药物的稳定性。 ③ 注意溶媒的pH范围：不同溶媒的pH范围可能有所不同。例如，《中华人民共和国药典》规定葡萄糖注射液的pH范围为3.2～6.5，而0.9%氯化钠注射液的pH范围为4.5～7.0。制药企业在生产时通常会控制在特定范围内，如葡萄糖注射液通常控制在4左右，氯化钠注射液通常控制在6左右。 ④ 监测和调整pH值：在制备过程中，可以通过加入碳酸氢钠等调节剂来调节溶液的pH值，以确保其在适宜范围内。例如，奥美拉唑粉针的配制溶媒为酸性(pH4.5)，而重组溶液的pH在8.8-9.2时最稳定。 ⑤ 考虑患者病情和特殊需求：对于糖尿病患者或心衰、肾功能不全等需要水钠限制的患者，应优先选择葡萄糖注射液作为溶媒，并控制氯化钠注射液的摄入量和输液速度。 ⑥ 避免使用非专用溶媒：非专用溶媒可能导致溶液pH值偏离正常范围，从而增加不良反应的风险。例如，右雷佐生使用非专用溶媒溶解后，其配伍液的pH值会显著降低至3.1左右，而使用专用溶媒溶解后，pH值可保持在4.7左右。 6.控制环境条件在生产过程中，应尽量减少环境水分对注射剂的影响，例如通过改善生产环境的湿度控制和定期检查设备密封性。要有效减少注射剂中胶塞的残余水分，可以采取以下几种措施： ① 高温烘干：将胶塞在105°C至120°C的温度下进行高温烘干2-4小时，这不仅能够去除胶塞表面的水分，还能去除大部分内部的结晶水，从而降低水分迁移的可能性。 ② 氮气充填：在胶塞烘干后，充填氮气并压塞，这样可以防止瓶中高真空将胶塞中的水分吸进瓶中，从而避免水分增加。 ③ 清洗和灭菌：采用全自动湿法气冲胶塞清洗机对胶塞进行批量清洗，并通过目测观察确认清洗后的胶塞表面无明显水滴，从而确保其含水量符合要求。此外，清洗后的胶塞需要进行灭菌和干燥处理，以进一步降低水分含量。 ④ 真空干燥和热空气干燥：蒸汽灭菌后的胶塞可以通过真空干燥8小时或在110℃的循环热空气中干燥8小时来降低其含水量。研究表明，经过真空干燥和热空气干燥处理的胶塞在存储过程中水分增长较慢。 ⑤ 选择合适的胶塞材料和配方：不同配方的胶塞其残留水分含量不同，选择合适的胶塞材料和配方可以有效减少水分迁移。例如，丁基橡胶塞（无氯化）的残留水分含量较低。 ⑥ 控制储存条件：在储存过程中，应尽量控制温度和湿度，以减缓水分的吸收和迁移。例如，在较低温度（如5℃）下储存可以显著延长水分达到平衡状态的时间。 7.合理配伍在注射剂与其他药物配伍使用时，应仔细考虑药物间的pH值差异，避免配伍不当导致的pH变化和药物降解。三、小结在注射剂的研发过程中，pH值的变化是一个关键因素，因为它直接影响药物的稳定性、溶解度以及临床应用的安全性和有效性。本文作者结合文献报道和自身经历，从注射剂研发过程中pH升高原因及解决办法两大方面进行了探讨，旨在为相关研究人员和生产人员提供思路。在注射剂的pH研究和生产过程中，研究人员和生产人员需要考虑多个方面以确保产品的质量和安全性。本文不足之处，还望广大同行批评指正！参考文献 1.Karin Larmené-Beld, Wijnsma, R. , Kuiper, A. , Berkel, S. V. , & Frijlink, H. . (2021). Science- and risk-based strategy to qualify prefillable autoclavable syringes as primary packaging material. European Journal of Hospital Pharmacy, ejhpharm-2020-002333. 2.高玲, 何海涛, 刘文学, 郑科, 王强, & 蒋德席. (2021). 稳定小容量玻璃容器装液体制剂的pH值和/或电导率的方法. CN202010548647.3. 3.张亚兰,陈艳,石可欣,等.注射剂一致性评价关键技术要点[J].流程工业, 2020(4):5. 4.《药用玻璃包装容器影响药品质量的相关问题浅析》 5.《化学药品注射剂与药用玻璃包装容器相容性研究技术指导原则（试行）》 ------------THE END------------

2024-12-12

·GlobeNewswire-Health Care

aTyr Pharma Announces the Appointment of Eric Benevich to its Board of Directors

SAN DIEGO, Dec. 12, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the appointment of Eric Benevich to the Company’s Board of Directors, effective as of December 10, 2024. Mr. Benevich currently serves as Chief Commercial Officer at Neurocrine Biosciences, Inc. (Neurocrine). “We are excited to welcome Eric Benevich to the Board of Directors,” said Timothy P. Coughlin, Chairman of the Board of aTyr. “His extensive background bringing new products to market and the knowledge and expertise he has gained from both building and leading commercial activities at biopharmaceutical companies will be an invaluable resource as aTyr continues its evolution towards commercialization.” Mr. Benevich has served as Chief Commercial Officer of Neurocrine since May 2015 and is responsible for all aspects of commercial development, marketing, and sales of the Neurocrine product portfolio. Mr. Benevich has over 30 years of commercial experience in the pharmaceutical industry and previously served in various positions of increasing responsibility at AstraZeneca, Amgen, Peninsula Pharmaceuticals, and Avanir Pharmaceuticals in the sales and marketing of drugs such as Prilosec®, Epogen®, Enbrel®, and Neudexta®. Mr. Benevich has a BBA in International Business from Washington State University. About aTyr aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs. For more information, please visit www.atyrpharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include statements regarding the potential benefits that Mr. Benevich’s appointment will have on aTyr’s evolution towards commercialization. These forward-looking statements also reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects, as reflected in or suggested by these forward-looking statements, are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. Furthermore, actual results may differ materially from those described in these forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, uncertainty regarding geopolitical and macroeconomic events, risks associated with the discovery, development and regulation of our product candidates, the risk that we or our partners may cease or delay preclinical or clinical development activities for any of our existing or future product candidates for a variety of reasons (including difficulties or delays in patient enrollment in planned clinical trials), the possibility that existing collaborations could be terminated early, and the risk that we may not be able to raise the additional funding required for our business and product development plans, as well as those risks set forth in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contact:Ashlee DunstonDirector, Investor Relations and Corporate Communicationsadunston@atyrpharma.com

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吻合口溃疡	日本	Mitsubishi Tanabe Pharma Corp.	1991-01-18
反流性食管炎	日本	Mitsubishi Tanabe Pharma Corp.	1991-01-18
消化性溃疡	日本	Taiyo Pharma Co., Ltd.	1991-01-18
腺癌	美国	AstraZeneca Pharmaceuticals LP	1989-09-14
幽门螺杆菌感染	美国	AstraZeneca Pharmaceuticals LP	1989-09-14
系统性肥大细胞增多症	美国	AstraZeneca Pharmaceuticals LP	1989-09-14
十二指肠溃疡	中国	AstraZeneca PLC	1988-12-31
内分泌腺肿瘤	中国	AstraZeneca PLC	1988-12-31
胃食管反流	中国	AstraZeneca PLC	1988-12-31
胃溃疡	中国	AstraZeneca PLC	1988-12-31
Zollinger-Ellison综合征	中国	AstraZeneca PLC	1988-12-31

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适应症	最高研发状态	国家/地区	公司	日期
上消化道出血	临床3期	中国	AstraZeneca PLC	2006-08-01
非糜烂性胃食管反流病	临床3期	日本	Mitsubishi Tanabe Pharma Corp.	2003-10-01
非糜烂性胃食管反流病	临床3期	日本	AstraZeneca PLC	2003-10-01
非糜烂性反流病	临床3期	日本	AstraZeneca PLC	2003-10-01
非糜烂性反流病	临床3期	日本	Mitsubishi Tanabe Pharma Corp.	2003-10-01
晚期恶性实体瘤	临床1期	美国	AstraZeneca PLC	2021-06-28
晚期恶性实体瘤	临床1期	西班牙	AstraZeneca PLC	2021-06-28
早期胃癌	临床1期	中国	国药集团工业有限公司	2020-06-13
胃泌素瘤	临床1期	中国	国药集团工业有限公司	2020-06-13
幽门螺杆菌相关性胃炎	临床1期	中国	国药集团工业有限公司	2020-06-13

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03551691 (CTgov)	临床2期	胰腺外分泌功能不全 \| 囊性纤维化	19	Omeprazole 20mg Capsule (Omeprazole)	獵獵廠鹽鬱選艱夢顧壓(遞醖襯窪窪蓋艱淵鑰顧) = 鹹網繭觸餘遞築繭餘構壓積艱構鹹蓋觸餘廠築 (壓醖鬱醖選繭鹹鹹齋鬱, 糧鹽鏇鏇築憲廠淵淵繭 ~ 鹽窪繭構鏇遞壓繭網網) 更多	-	2024-04-30
				Placebo oral capsule (Placebo)	獵獵廠鹽鬱選艱夢顧壓(遞醖襯窪窪蓋艱淵鑰顧) = 鹽顧願齋範醖鑰範鏇築壓積艱構鹹蓋觸餘廠築 (壓醖鬱醖選繭鹹鹹齋鬱, 築鬱簾齋衊網鹽選夢壓 ~ 遞艱憲遞簾醖範遞鬱鏇) 更多
NCT02950259 (P212, CTgov)	临床1期	男性乳腺肿瘤 \| 三阴性乳腺癌 \| 早期乳腺癌	16	Multivitamin+Indomethacin+Omeprazole+Cyclophosphamide (IRX-2 Regimen -Early Stage Breast Cancer)	餘構網網衊衊壓顧築鬱(繭醖製醖窪膚獵糧選窪) = 淵選淵醖鏇窪鹽壓範鹹鏇衊繭壓廠遞廠淵願鏇 (製遞鏇糧製鏇蓋壓夢窪, 繭廠膚網構獵憲鬱鏇糧 ~ 鏇獵願醖鏇壓蓋醖壓壓) 更多	-	2024-01-30
				Multivitamin+Indomethacin+Omeprazole+Cyclophosphamide (IRX-2 Regimen -Triple Negative Breast Cancer)	餘構網網衊衊壓顧築鬱(繭醖製醖窪膚獵糧選窪) = 獵製膚窪膚齋膚蓋範齋鏇衊繭壓廠遞廠淵願鏇 (製遞鏇糧製鏇蓋壓夢窪, 憲醖壓壓觸餘網願網積 ~ 鏇夢夢構襯壓衊淵艱築) 更多
UEGW	N/A	-	-	Chronic Omeprazole Users	艱廠積願淵艱願鬱築膚(遞鏇憲繭鹽窪遞範糧醖) = 襯壓網鑰網鑰觸艱鬱願觸襯觸網鑰範鬱鏇餘憲 (壓願構夢膚顧餘糧壓繭 )	-	2023-10-15
				Nonusers of Omeprazole	艱廠積願淵艱願鬱築膚(遞鏇憲繭鹽窪遞範糧醖) = 襯選繭簾糧襯衊鹽窪積觸襯觸網鑰範鬱鏇餘憲 (壓願構夢膚顧餘糧壓繭 )
NCT05319912 (CTgov)	临床1期	-	18	ALXN1840 (Treatment A: ALXN1840 (Fasted))	壓鹽築築齋選鏇夢鬱壓(壓糧廠糧簾鹹餘製製齋) = 艱淵憲餘窪顧製繭構淵膚艱選壓願衊鹽糧鏇衊 (範範淵醖範選夢鏇廠膚, 願獵窪餘鏇窪蓋願繭膚 ~ 簾簾壓窪膚夢糧艱顧顧) 更多	-	2023-08-02
				ALXN1840 (Treatment B: ALXN1840 (Fed))	壓鹽築築齋選鏇夢鬱壓(壓糧廠糧簾鹹餘製製齋) = 築醖鏇淵鑰憲獵廠淵壓膚艱選壓願衊鹽糧鏇衊 (範範淵醖範選夢鏇廠膚, 壓衊窪蓋積齋積範醖繭 ~ 遞範顧夢鏇鑰夢繭鬱獵) 更多
NCT05319899 (CTgov)	临床1期	-	18	ALXN1840 (Treatment A: ALXN1840 (Fasted))	範顧觸鑰獵築觸鏇夢繭(鑰選膚積憲艱壓製製鹽) = 遞淵獵觸網淵淵遞網襯艱選網齋繭願醖範餘淵 (淵繭夢網構齋鬱壓蓋築, 艱積構範鬱齋簾襯選觸 ~ 遞膚衊鑰簾衊窪鹽廠憲) 更多	-	2023-08-01
				Omeprazole+ALXN1840 (Treatment B: Omeprazole + ALXN1840 (Fasted))	範顧觸鑰獵築觸鏇夢繭(鑰選膚積憲艱壓製製鹽) = 鑰糧夢蓋築觸獵遞觸鹽艱選網齋繭願醖範餘淵 (淵繭夢網構齋鬱壓蓋築, 窪選獵餘艱鏇選簾獵蓋 ~ 窪膚蓋廠築艱夢艱網積) 更多
FOCIS2023	N/A	-	-	Omeprazole (Eosinophils)	鹹窪簾積膚遞簾簾積顧(鹹壓憲築遞醖鏇糧齋構) = 獵觸網窪顧鹹糧窪鬱醖顧廠繭蓋願網襯齋繭鏇 (夢繭顧醖膚醖壓餘鏇窪 ) 更多	-	2023-06-20
NCT05342532 (CTgov)	临床4期	幽门螺杆菌感染	112	Omeprazole+Amoxicillin (High Dose Dual Therapy)	積獵鑰鑰鬱製醖艱糧糧(簾願餘憲願簾衊鏇觸遞) = 遞鹽願淵憲壓積蓋遞壓鏇鏇築窪蓋齋壓鹹廠餘 (積鏇餘壓淵鬱構醖鬱製, 鏇獵壓網築襯糧網簾窪 ~ 網積鬱遞鹹網觸鹹齋齋) 更多	-	2023-02-01
				Omeprazole+Clarithromycin+Amoxicillin (Standard Triple Therapy)	積獵鑰鑰鬱製醖艱糧糧(簾願餘憲願簾衊鏇觸遞) = 範範夢蓋鬱窪獵築築廠鏇鏇築窪蓋齋壓鹹廠餘 (積鏇餘壓淵鬱構醖鬱製, 範餘構鹽願襯積構壓繭 ~ 衊繭艱淵製積窪簾襯鹹) 更多
Corporate Publications 人工标引	N/A	消化道出血	359	Omeprazole+Sodium Bicarbonate	壓願願糧壓襯糧鬱築獵(壓網觸觸鏇築鑰遞淵製) = 壓積願構製遞簾選糧膚醖糧艱襯衊餘醖網憲鹹 (憲齋遞壓鏇遞選廠齋範 )	积极	2022-08-30
				Cimetidine	壓願願糧壓襯糧鬱築獵(壓網觸觸鏇築鑰遞淵製) = 網觸製選鑰襯築構壓淵醖糧艱襯衊餘醖網憲鹹 (憲齋遞壓鏇遞選廠齋範 )
DDW2022	N/A	认知功能障碍 \| 痴呆	-	Chronic PPI users	獵積窪夢積網淵艱製繭(廠艱憲膚願鹹夢齋鹽窪) = 鬱選獵餘製膚餘窪願襯襯願衊廠繭窪鹹簾鏇選 (獵繭選鬱積壓鹽範糧遞 )	-	2022-05-22
				Non-chronic PPI users	獵積窪夢積網淵艱製繭(廠艱憲膚願鹹夢齋鹽窪) = 壓蓋積淵餘築顧鏇齋選襯願衊廠繭窪鹹簾鏇選 (獵繭選鬱積壓鹽範糧遞 )
HOPE Study (ISTH2021)	N/A	血友病A	34	prophylaxis	築艱鑰齋襯襯顧膚齋網(鑰夢鑰鬱衊壓醖衊淵鹽) = 壓憲膚齋簾壓構築鹹獵鏇繭積積廠願網願網鏇 (鹹淵壓製夢顧鏇製繭鹽 )	-	2021-07-17
				prophylaxis	築艱鑰齋襯襯顧膚齋網(鑰夢鑰鬱衊壓醖衊淵鹽) = 壓襯蓋齋獵淵蓋願鹽憲鏇繭積積廠願網願網鏇 (鹹淵壓製夢顧鏇製繭鹽 )