Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.

开始日期2025-02-01

申办/合作机构

The General Hospital Corp.

[+1]

CTR20241005 / CompletedN/A

头孢克洛干混悬剂在健康试验参与者中的随机、开放、单次给药、两制剂、两周期人体生物等效性研究

主要研究目的：以江苏正大清江制药有限公司研制的头孢克洛干混悬剂（规格：0.125g）为受试制剂，按生物等效性研究的有关规定，与苏州西克罗制药有限公司生产的头孢克洛干混悬剂（商品名：希刻劳®，参比制剂，规格：0.125g）对比在健康人体内的相对生物利用度，考察两制剂的人体生物等效性。次要研究目的：比较头孢克洛干混悬剂受试制剂（规格：0.125g）和参比制剂（规格：0.125g）在健康试验参与者中的安全性。

开始日期2024-04-18

申办/合作机构

江苏正大清江制药有限公司

CTR20233818 / CompletedN/A

头孢克洛缓释片在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后状态下的生物等效性试验

健康受试者空腹/餐后状态下，口服单剂量头孢克洛缓释片（受试制剂T，广州白云山医药集团股份有限公司白云山制药总厂生产，规格：0.375g/片）与头孢克洛缓释片（Ⅱ）（参比制剂R，苏州西克罗制药有限公司生产，商品名：希刻劳®，规格：0.375g/片）后，考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。

开始日期2024-01-03

申办/合作机构

广州白云山医药集团股份有限公司白云山制药总厂

100 项与头孢克洛相关的临床结果

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100 项与头孢克洛相关的转化医学

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100 项与头孢克洛相关的专利（医药）

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1,917

项与头孢克洛相关的文献（医药）

2024-12-01·MOLECULAR BIOLOGY REPORTS

Multiplex PCR-based genotyping of Salmonella Enteritidis and Salmonella Typhimurium from food sources and assessment of their antimicrobial resistance profiles in Egypt

Article

作者: Abdel-Mawgood, Ahmed ; Mansour, Hussein ; Barac, Deng ; Ghazy, Mohamed ; Awad, Sameh

BACKGROUND:

Salmonellosis is a widespread zoonotic disease that poses a significant threat to livestock and public health. This study aimed to serotype 20 Salmonella isolates obtained from sixty retail chicken meats, assess Salmonella contamination from eggs, and evaluate antibiotic resistance profiles.

METHODS AND RESULTS:

Twenty eggs were randomly collected in the new Borg El Arab market. Bacterial isolation was carried out utilizing both traditional culture, biochemical, and PCR methods. Among the twenty eggs analyzed, three (15%) tested positive for Salmonella, while the remaining seventeen (85%) were confirmed as negative. Genotyping through multiplex PCR revealed the presence of two S. Enteritidis and other serovar, with the use of three specific gene sets: a random sequence for Salmonella spp., sdfI gene for S. Enteritidis, and flagellin (fliC gene) for S. Typhimurium. Out of the 20 isolates obtained from chicken meat, five (25%) were identified as S. Typhimurium, and three (15%) were classified as S. Enteritidis. All isolates sourced from chicken meat exhibited resistance to Rifampicin and Amoxicillin, with 90% displaying sensitivity to cefotaxime, gemifloxacin, and Erythromycin. Importantly, S. Blegdam, identified via serological methods, displayed resistance to all tested antibiotics. For the three isolates obtained from eggs, 66.6% showed sensitivity to cefotaxime, erythromycin, cefuraxime, and cefaclor, while displaying complete resistance (100%) to Amoxicillin, rifampicin, clarithromycin, and cefadroxil. Notably, one serovar exhibited absolute resistance to all tested drugs.

CONCLUSION:

Stakeholders must implement strict control measures and rationalize antibiotic use in veterinary and human medicine due to the rise of antibiotic-resistant strains.

2024-09-01·Drug Research

Cerebroprotective Potential of Andrographolide Nanoparticles: In silico and In vivo Investigations

Article

作者: Gajula, Somasekhar ; Dintakurthi, Prasanth Sree Naga Bala Krishna ; Rudrala, Lakshmi Charitha ; Sirisha Mulukuri, N.V. L. ; Singh, Gagandeep ; Pasala, Praveen Kumar ; Ayyappa Gouru, Sampath ; Rudrapal, Mithun ; Challa, Ranadheer Reddy ; Subramanyam, Sibbala

Abstract:

Ischemic stroke remains the leading cause of death and disability, while the main mechanisms of dominant neurological damage in stroke contain oxidative stress and inflammation. Docking studies revealed a binding energy of − 6.1 kcal/mol for AG, while the co-crystallized ligand (CCl) exhibited a binding energy of − 7.3 kcal/mol with NOS. AG demonstrated favourable hydrogen bond interactions with amino acids ASN A:354 and ARG A:388 and hydrophobic interactions with GLU A:377. Molecular dynamics simulations throughout 100 ns indicated a binding affinity of − 27.65±2.88 kcal/mol for AG, compared to − 18.01±4.02 kcal/mol for CCl. These findings suggest that AG possesses a superior binding affinity for NOS compared to CCl, thus complementing the stability of NOS at the docked site.AG has limited applications owing to its low bioavailability, poor water solubility, and high chemical and metabolic instability.The fabrication method was employed in the preparation of AGNP, SEM analysis confirmed spherical shape with size in 19.4±5 nm and investigated the neuroprotective effect in cerebral stroke rats induced by 30 min of carotid artery occlusion followed by 4 hr reperfusion, evaluated by infarction size, ROS/RNS via GSH, MPO, NO estimationand AchE activity, and monitoring EEG function. Cortex and hippocampal histology were compared between groups. AGNP treatment significantly decreased Infarction size and increased GSH levels (p<0.01**), decreased MPO (p<0.01**), NO (p<0.01**), AchE (p<0.01**), restored to normal EEG amplitude, minimizing unsynchronized polyspikes and histological data revealed that increased pyramidal cell layer thickness and decreased apoptotic neurons in hippocampus, cortex appeared normal neurons with central large vesicular nuclei, containing one or more nucleoli in compared to AG treatment. Based on brain biochemical, histopathology reports AGNP exhibited significant cerebroprotective activity compared to AG on ischemic rats.

2024-07-31·Japanese journal of infectious diseases

β-Lactam Susceptibility of <i>Streptococcus dysgalactiae</i> subsp. <i>equisimilis</i>

Article

作者: Arakawa, Yoshichika ; Jin, Wanchun ; Koyama, Shinobu ; Kimura, Kouji ; Tamai, Kiyoko ; Wachino, Jun-Ichi ; Nakashima, Natsumi

All clinical isolates of Streptococcus dysgalactiae subsp. equisimilis (SDSE) are considered susceptible to β-lactams, the first-line drugs used to treat SDSE infections. However, given that penicillin-non-susceptible SDSE strains have been isolated in Denmark, in this study, we aimed to identify β-lactam-non-susceptible clinical isolates of SDSE in Japan. In 2018, we collected 150 clinical isolates of S. dysgalactiae, and species identification was performed using a Rapid ID Strep API kit. The minimum inhibitory concentrations (MIC) of six β-lactams (penicillin G, oxacillin, ceftizoxime, ceftibuten, cefoxitin, and cefaclor) were determined for the 85 clinical isolates identified as SDSE using the agar dilution method standardized by the Clinical & Laboratory Standards Institute. The MIC ranges of penicillin G, oxacillin, ceftizoxime, ceftibuten, cefoxitin, and cefaclor were 0.007-0.06, 0.03-0.12, 0.015-0.06, 0.25-2, 0.12-2, and 0.06-0.5 μg/mL, respectively. None of the clinical isolates of SDSE were non-susceptible to penicillin G, indicating that all 85 clinical isolates of SDSE were susceptible to β-lactams. Our findings indicate that almost all clinical isolates of SDSE, from several prefectures of Japan, are still susceptible to β-lactams. Nevertheless, there remains a need for continuous and careful monitoring of drug susceptibility among clinical SDSE isolates in Japan.

107

项与头孢克洛相关的新闻（医药）

2024-12-03

·摩熵医药

218个品种过评，22款首家！20亿+大品种，四川制药领衔市场……

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授。 11月仿制药月报月报内容亮点 11月一致性评价仿制药申请情况共有28个品种一致性评价申请获CDE承办；维生素B6注射液为申请企业数最多的品种。 11月新注册分类仿制药申报临床/上市情况 11月期间共有435项新注册分类仿制药申请获CDE承办；新注册分类临床申请23项，新注册分类上市申请412项。 11月过评/新注册分类仿制药获批上市信息 11月期间共有218个品种通过/视同通过一致性评价；一致性评价过评品种数量60个，视同通过一致性评价品种数量168个。每月相关仿制药申报、仿制药临床申报、仿制药通过/视同通过一致性评价等，摩熵咨询团队基于NMPA、CDE渠道数据，真实可溯源，将每月推出「仿制药月报」，以帮助业内人士通盘把握每月行业范围内的仿制药申报及获批情况。 01 11月一致性评价仿制药申报情况根据摩熵数据统计，2024年11月共有28个品种（按受理号计38项）一致性评价申请获CDE承办，申请品种主要为心血管系统药物，申请剂型主要为注射剂。截图来源：摩熵咨询月报从品种来看，11月期间，维生素B6注射液为申请企业数最多的品种，有3家；上海华源药业（宁夏）沙赛制药有限公司是申请品种最多的企业，有2个品种。截图来源：摩熵咨询月报 02 本月新注册分类仿制药申报临床/上市信息根据摩熵数据统计，2024年11月期间共有435项（共计258个品种）新注册分类仿制药申请获CDE承办，其中新注册分类临床申请23项，新注册分类上市申请412项。截图来源：摩熵咨询月报从品种来看，本期申请品种主要为消化系统与代谢药物，申请剂型主要为片剂。富马酸伏诺拉生片为申请企业数最多的品种，有10家；浙江赛默制药有限公司是申请品种最多的企业，有11个品种。截图来源：摩熵咨询月报 03 11月过评/新注册分类仿制药获批上市信息根据摩熵数据统计，2024年11月期间共有218个（共计392个受理号）品种通过/视同通过（新注册分类仿制药获批上市）一致性评价，其中一致性评价过评品种数量60个，视同通过一致性评价品种数量168个。通过一致性评价信息截图来源：摩熵咨询月报 11月过评品种主要为系统用抗感染药物。本期过评品种主要为系统用抗感染药物。过评企业数最多的品种为乳果糖口服溶液，有12家企业过评。首家过评品种有22个，达五家过评品种有13个。 2024年11月一致性评价过评品种信息一览表（部分）截图来源：摩熵咨询月报 04 11月首家通过/视同通过一致性评价品种根据摩熵数据统计，2024年11月期间共有22个（共计30个受理号）品种首次过评/视同过评一致性评价，过评受理号最多的领域为系统用抗感染药物，有5个，包括头孢克洛干混悬剂、头孢氨苄干混悬剂、膦甲酸钠注射液、硫酸异帕米星注射液和吗啉硝唑氯化钠注射液。过评受理号最多的企业为浙江普利药业有限公司，有4个。截图来源：摩熵咨询月报 05 11月达五家通过/视同通过一致性评价品种根据摩熵数据统计，2024年11月期间共有13个（共计29个受理号）品种一致性评价达五家过评。11月29日，国瑞集团国瑞药业的注射用亚胺培南西司他丁钠通过一致性评价，过评总企业数达5家。亚胺培南西司他丁钠是由亚胺培南和西司他丁钠1:1的复方制剂，是一种广谱抗生素，可用于由敏感细菌所引起的下列感染：腹腔内感染、下呼吸道感染、妇科感染、败血症、泌尿生殖道感染、骨关节感染、皮肤软组织感染、心内膜炎。截图来源：摩熵咨询月报国内市场上的亚胺培南西司他丁钠仅有注射剂，2023年其医院端市场规模达到32.71亿元，默沙东以73.56%的市场占比领军市场；本月成都第一制药、瑞阳制药、倍特药业和科伦制药的注射用苯唑西林钠相继过评，过评总企业数达7家。注射用苯唑西林钠为β内酰胺类抗生素、青霉素类药。苯唑西林通过抑制细菌细胞壁合成而发挥杀菌作用，用于治疗产青霉素酶葡萄球菌感染，包括败血症、心内膜炎、肺炎和皮肤、软组织感染等。也可用于化脓性链球菌或肺炎球菌与耐青霉素葡萄球菌所致的混合感染。2023年医院端销售额达20.99亿元，四川制药以43.97%的市场份额领军全场。 2024 年 11 月通过/视同通过一致性评价达五家品种（部分）信息一览表截图来源：摩熵咨询月报本月沐源生物、倍特药业和汇宇制药的注射用替考拉宁相继过评，注射用替考拉宁可用于不能用青霉素类及头孢菌素类抗生素治疗或用上述抗生素治疗失败的严重葡萄球菌感染，或对其他抗生素耐药的葡萄球菌感染。替考拉宁已证明对皮肤和软组织感染，泌尿道感染，呼吸道感染，败血症及持续不卧床腹膜透析相关性腹膜炎有效。在骨科手术具有革兰阳性菌感染的高危因素时，也可作预防用。2023年注射用替考拉宁医院端销售额达5.18亿元，赛诺菲、新昌制药厂和海正药业三家瓜分市场，市场占比分别为41.51%、37.84%和20.66%。 2024年11月仿制药完整报告识别下方二维码获取完整《2024年11月仿制药月报》PDF版本报告在每月初定期发布，敬请期待 END 本文为原创文章，转载请留言获取授权更多详细月报内容获取方式后台回复“2月全球新药”，获取完整《2月全球在研新药与靶点月报》PDF版。后台回复“3月全球新药”，获取完整《3月全球在研新药与靶点月报》PDF版。后台回复“4月全球新药”，获取完整《4月全球在研新药与靶点月报》PDF版。后台回复“5月全球新药”，获取完整《5月全球在研新药与靶点月报》PDF版。联系我们，体验药融云更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

一致性评价上市批准

2024-12-03

·echemi

Zhejiang Anglikang Invests 79.91 Million for 4,105 Tons of Key Antibiotic Raw Material Production

Recently, Zhejiang Anglikang Pharmaceutical Co., Ltd. has completed the filing and public announcement for a project to produce 4,105 tons of D(-)-Hydroxyphenylglycine Methyl Ester and 1,230 tons of D(-)-Phenylglycine Hydrochloride. The planned investment for this project is 79.91 million yuan, aimed at utilizing the company's existing land resources to build new production facilities, production lines, and supporting ancillary facilities, with a total construction area expected to be 2,900 square meters. The project will employ advanced synthetic process technology and acquire key production equipment such as reactors and condensers. Upon completion, the project is expected to achieve an annual production capacity of 4,015 tons (dry weight) of D(-)-Hydroxyphenylglycine Methyl Ester and 1,230 tons (dry weight) of D(-)-Phenylglycine Hydrochloride, with an anticipated annual output value of 300 million yuan and tax contributions of 20 million yuan. By-products will include 20% hydrochloric acid (5,686.92 tons/year), ammonium sulfate (4,114.2 tons/year), and ammonium chloride (1,191.8 tons/year). D-Hydroxyphenylglycine Methyl Ester is an important raw material used in the enzymatic production of β-lactam antibiotics such as amoxicillin, cefuroxime axetil, cefaclor, and cefepime. According to previous environmental impact assessment reports, Zhejiang Anglikang Pharmaceutical Co., Ltd.'s project to produce 8,000 tons of amoxicillin and 2,000 tons of ampicillin plans to invest 300 million yuan and is expected to have an annual production capacity of 8,000 tons of amoxicillin and 2,000 tons of ampicillin upon completion, with a by-product of ammonium chloride at 3,164.68 tons/year. The current project can be seen as a further extension of the industrial chain. Zhejiang Anglikang Pharmaceutical Co., Ltd. is a modern pharmaceutical enterprise integrating the research, development, production, and sales of pharmaceutical intermediates, active pharmaceutical ingredients, and drug formulations, focusing on cardiovascular, oral cephalosporin, nephrology, and anesthetics. According to the company's latest financial report, in the first three quarters of the year, it achieved operating revenue of 1.122 billion yuan, a year-on-year decrease of 5.51%; the net profit attributable to the parent company was 49.93 million yuan, a year-on-year decrease of 54.52%; and the net profit after deducting non-recurring gains and losses was 39.91 million yuan, a year-on-year decrease of 54.33%.

财报

2024-11-15

·立国制药

科普知识 | 注意！饭前服药和空腹服药不是一回事！你真的做对了吗？

有些患者认为空腹服用就是饭前服用其实这二者是有区别的空腹服用一般指在餐前1小时或饭后2小时，要确保胃和小肠内几乎没有食物残留的状态下服药。饭前服用则更具体地指进食前半小时服药。而空腹服药也分相对空腹和绝对空腹，相对空腹只能保证胃内食物尽可能少，绝对空腹则是指清晨空腹服用。一些需要空腹服用的药物 ★抗菌药物：罗红霉素，头孢克洛等 ★免疫抑制剂：吗替麦考酚酯，他克莫司等 ★抗乙肝病毒药：恩替卡韦片 ★抗骨质疏松药：阿仑膦酸钠片（晨起空腹，服药后保持上身直立半小时，且半小时内不得进食饮水） ★抗结核药：利福平，异烟肼（晨起空腹） ★甲状腺激素类：左甲状腺素钠片（晨起空腹） ★止泻药：盐酸洛哌丁胺胶囊 ★降糖药：格列xx ★终止早孕药：米非司酮片，米索前列醇片（晨起空腹）每天一次，每天两次，每天三次，每天多次的药物该如何服用？每天一次可以在每天清晨或晚上服用，并保持每天同一时间服用。每天两次可以在早餐、晚餐时段各一次，间隔12小时。每天三次可以在早中晚饭三个时间段服用，主要是为了让患者能更有依从性，规律性地服药。除非是说明书上明确规定的服药时间，如抗菌药、抗癫痫药、帕金森治疗药等，这些药物的说明书上会写明“每8小时服用1次”。每天多次服用的药物尽量在24小时内均分，并协调好自己的作息时间。如果忘记吃药该怎么办？安全的操作方式就是忽略忘记的这一顿，按原计划服用下一顿药物。除非说明书上明确表示可以，否则不要服用两顿的量。希望大家都能正确合理用药，提高药物的疗效。（本文仅供专业人士参考；药品请按药品说明书或者在药师指导下购买和使用。）来源：药店人、中国合理用药Chinahlyy、中国食品药品监管杂志

100 项与头孢克洛相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02352	头孢克洛	J01DC04	DB00833

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
慢性支气管炎	奥地利	Viatris Pty Ltd.	1997-03-14
急性支气管炎	日本	Kyowa Pharmaceutical Industry Co., Ltd.	1988-06-28
淋巴结炎	日本	Kyowa Pharmaceutical Industry Co., Ltd.	1988-06-28
咽喉炎	日本	Kyowa Pharmaceutical Industry Co., Ltd.	1988-06-28
脓皮症	日本	Kyowa Pharmaceutical Industry Co., Ltd.	1988-06-28
继发感染	日本	Kyowa Pharmaceutical Industry Co., Ltd.	1988-06-28
革兰氏阴性菌感染	美国	Eli Lilly & Co.	1979-04-04
革兰氏阳性细菌感染	美国	Eli Lilly & Co.	1979-04-04
下呼吸道感染	美国	Eli Lilly & Co.	1979-04-04
中耳炎	美国	Eli Lilly & Co.	1979-04-04
咽炎	美国	Eli Lilly & Co.	1979-04-04
皮肤和皮肤结构感染	美国	Eli Lilly & Co.	1979-04-04
扁桃体炎	美国	Eli Lilly & Co.	1979-04-04
泌尿道感染	美国	Eli Lilly & Co.	1979-04-04
细菌感染	英国	Flynn Pharma Ltd.	1978-08-21