This study will answer the following research question:
Is acutaping has therapeutic implications on symptoms of nausea and vomiting during pregnancy?

开始日期2023-02-03

申办/合作机构

Kafrelsheikh University

CTR20202295 / Completed临床3期

评价琥珀酸多西拉敏片治疗短期失眠的有效性和安全性的多中心、随机、双盲、安慰剂、平行对照III期临床试验

1. 与安慰剂相比，通过多导睡眠仪监测受试者入睡潜伏期，评价琥珀酸多西拉敏片治疗短期失眠的有效性。 2. 探索琥珀酸多西拉敏片治疗短期失眠的临床最佳剂量。 3. 评价琥珀酸多西拉敏片治疗短期失眠的安全性。

开始日期2021-05-21

申办/合作机构

苏州第四制药厂有限公司

[+1]

ChiCTR2000032596 / SuspendedN/AIIT

Acupuncture and/or Diclectin Treatment for Nausea and Vomiting of Pregnancy : A Two by Two factorial Trial (NVPAct)

开始日期2020-10-01

申办/合作机构-

100 项与琥珀酸多西拉敏相关的临床结果

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100 项与琥珀酸多西拉敏相关的转化医学

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100 项与琥珀酸多西拉敏相关的专利（医药）

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项与琥珀酸多西拉敏相关的文献（医药）

2024-02-01·Journal of hazardous materials

Oxidation of amine-based pharmaceuticals with unactivated peroxymonosulfate: Kinetics, mechanisms, and elimination efficiency of NDMA formation

Article

作者: Zeng, Zhu ; Fu, Junhao ; Gao, Yuan ; Zhou, Yang ; Ma, Jinxing ; Zhang, Zhong ; Han, Bin ; Jiang, Jin

Amine-based pharmaceuticals are a significant class of N-nitrosodimethylamine (NDMA) precursors. This study investigated the use of unactivated peroxymonosulfate (PMS) to control amine-based pharmaceuticals and their NDMA formation potential. Kinetic analysis and product identification revealed that sumatriptan and doxylamine primarily underwent reactions at their tertiary amine group, while ranitidine and nizatidine had both tertiary amine and thioether group as reaction sites. The NDMA formation from sumatriptan and doxylamine during post-chloramination was significantly reduced with the abatement of the parent contaminants, while the formation of NDMA remained high even if full abatement of ranitidine and nizatidine was achieved. Product formation kinetics and reference standard tests revealed the great contribution of transformation products to NDMA formation. Ranitidine could be oxidized to sulfoxide-type product ranitidine-SO and N-oxide type product ranitidine-NO. Ranitidine-SO exhibited a high NDMA yield comparable to that of ranitidine (>90%), while ranitidine-NO showed a low NDMA yield (2%). With further oxidation of ranitidine-SO at the tertiary amine group, NDMA formation was reduced by more than 90%. The underlying mechanism for the importance of the tertiary amine group in NDMA formation was demonstrated by quantum chemical calculation. These findings underscore the potential of PMS pre-oxidation on NDMA control.

2024-01-01·Advances in therapy

Standardized Extract of Valeriana officinalis Improves Overall Sleep Quality in Human Subjects with Sleep Complaints: A Randomized, Double-Blind, Placebo-Controlled, Clinical Study

Article

作者: Joshua, Lincy ; Chandra Shekhar, Harshith ; Thomas, Jestin V

INTRODUCTION:

Sleep deficit or poor sleep leads to ill-health, whereas sleep deprivation for longer periods of time increases the risk of developing adverse conditions associated with poor quality of life, and high socioeconomic impact. The treatments for sleep disturbances include melatonin and over-the-counter medicines like diphenhydramine and doxylamine, all of which have negative side effects. Valerian (Valeriana officinalis L.) is a traditional herb and the most preferred alternate sleep solution to manage sleep complaints.

METHODS:

Eighty adult subjects with sleep complaints were randomized in 1:1 ratio to receive either V. officinalis extract (VE) or placebo for 8 weeks in a double-blind, placebo-controlled, parallel, clinical study. Primary efficacy endpoints included the Pittsburgh Sleep Quality Index (PSQI) and sleep latency using wrist actigraphy (WA), as well as a number of secondary endpoints, including sleep parameters such as actual sleep time and sleep efficiency using WA, the Epworth Sleepiness Scale (ESS), the Beck Anxiety Inventory (BAI), the Visual Analogue Scale (VAS) for the feeling of waking up refreshed, and a tertiary endpoint of sleep parameters using polysomnography (PSG) in a subset of 20 subjects per group. Safety parameters included physical examination, vital sign measurements, hematology, and clinical chemistry tests. Adverse events and serious adverse events were monitored throughout the study period.

RESULTS:

Seventy-two subjects (35 and 37 subjects in the placebo and VE groups, respectively) completed the study and were included in the efficacy assessments. On Days 14, 28, and 56, the PSQI Total Score in the VE group decreased significantly (p < 0.05) compared to the placebo group. Further, the VE group showed significant improvements (p < 0.05) in sleep latency and actual sleep time on Days 3, 14, 28, and 56, and sleep efficiency on Days 14, 28, and 56, as evaluated by WA. There was a decrease (p < 0.05) in anxiety (BAI) on Days 14, 28, and 56, daytime drowsiness (ESS) on Days 28 and 56, and an increased feeling of waking up refreshed (VAS) on Days 28 and 56 compared to placebo. PSG results carried out in subset of subjects revealed significant improvements (p < 0.05) in total sleep time, sleep latency, and sleep efficiency on Day 56 in the VE group compared to the placebo group. No safety concerns were observed throughout the study.

CONCLUSION:

VE supplementation significantly improved various subjective and objective parameters of sleep in young subjects with mild insomnia symptoms, such as overall sleep quality, sleep latency, sleep efficiency, and total sleep time. We also observed decreased anxiety and daytime sleepiness, and improved feeling of being refreshed after waking up with VE supplementation. VE was found to be safe and well tolerated throughout the study.

TRIAL REGISTRATION:

Clinical Trials Registry of India: CTRI/2022/05/042818.

2023-09-01·Drug testing and analysis

Incorporation of doxylamine and N‐doxylamine‐oxide in human hair and the impact of a permanent oxidative hair dye

Article

作者: Wille, Sarah M. R. ; Ramirez Fernandez, Maria del Mar ; Samyn, Nele

Abstract:

Knowledge of the drug incorporation in hair and impact of cosmetic treatments remains essential to correctly interpret forensic cases. The study shows the analysis of doxylamine and doxylamine‐N‐oxide and the evaluation of the relationship between dose and hair concentration and the impact of hair treatment (oxidative dying). The study included (A) three subjects participated to the study: a regular user (Subject 1) and two single‐dose users (Subject 2, 1 single dose; and Subject 3, 2 single doses spaced 5 months apart). Subject 3 applied a permanent oxidative hair dying monthly. (B) A permanent oxidative hair dying was applied twice to the hair collected from Subject 2. (A) The average concentrations in head hair for doxylamine and its N‐doxylamine‐oxide, respectively, were as follows: Subject 1, 1825 pg/mg and 16 pg/mg; Subject 2, 182 and <limit of quantification (LOQ); and Subject 3, Strand 1 (1 month after last single dose]; 1st cm: 367 pg/mg and 22 pg/mg; 2nd cm: 664 pg/mg and 37 pg/mg; 3rd cm 108 pg/mg and 13 pg/mg; 4th cm 13 pg/mg and 7 pg/mg); Strand 2 (5 months after last single dose: <LOQ). (B) The oxidative hair dying increased the concentration of the metabolite from undetected <LOQ up to 79 pg/mg (n = 3, RSD 6%). The concentration of the parent drug decreased from 128 pg/mg to 40 pg/mg (n = 3, RSD 4%). This is the first time the incorporation of doxylamine and its metabolite was evaluated with adequate and controlled information concerning dose and timing of ingestion for the evaluation of their incorporation and the impact of a cosmetic treatment.

项与琥珀酸多西拉敏相关的新闻（医药）

2024-05-13

·信狐药迅

杭东中美华东突破性品种迈华替尼和四川科伦博泰塔戈利单抗提交上市申请| 新受理（5.6-5.12）

本周药品注册受理数据，分门别类呈现，一目了然。(5.6-5.12）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号迈华替尼片杭州中美华东制药有限公司1CXHS2400041迈华替尼片杭州中美华东制药有限公司1CXHS2400040塔戈利单抗注射液四川科伦博泰生物医药股份有限公司1CXSS2400049新药临床申请药品名称企业注册分类受理号HRS-4508片江苏恒瑞医药股份有限公司1CXHL2400465HRS-4508片江苏恒瑞医药股份有限公司1CXHL2400464TJ0113胶囊杭州天玑济世生物科技有限公司1CXHL2400459TJ0113胶囊杭州天玑济世生物科技有限公司1CXHL2400458注射用DN022150江西科睿药业有限公司1CXHL2400461注射用PLAT001海南普利制药股份有限公司1CXHL2400457AL2846胶囊正大天晴药业集团股份有限公司1CXHL2400463HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400447HRS-8080片山东盛迪医药有限公司1CXHL2400446HRS-8080片山东盛迪医药有限公司1CXHL2400445HRS-8080片山东盛迪医药有限公司1CXHL2400444HRS-8080片山东盛迪医药有限公司1CXHL2400443注射用盐酸ORIC-1940成都奥睿药业有限公司1CXHL2400442HS-10380片江苏豪森药业集团有限公司1CXHL2400441HS-10380片江苏豪森药业集团有限公司1CXHL2400440HRS-1358片山东盛迪医药有限公司1CXHL2400452HRS-1358片山东盛迪医药有限公司1CXHL2400451HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400450HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400449HRS-6209胶囊江苏恒瑞医药股份有限公司1CXHL2400448LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400456LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400455LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400454LPM787000048马来酸盐缓释片山东绿叶制药有限公司1CXHL2400453HP-001胶囊上海超阳药业有限公司1CXHL2400439HP-001胶囊上海超阳药业有限公司1CXHL2400438HP-001胶囊上海超阳药业有限公司1CXHL2400437HRN01胶囊北京华睿鼎信科技有限公司1CXHL2400436HRN01胶囊北京华睿鼎信科技有限公司1CXHL2400435LW347片上海长森药业有限公司1CXHL2400434LW347片上海长森药业有限公司1CXHL2400433NTQ3617片南京正大天晴制药有限公司1CXHL2400432NTQ3617片南京正大天晴制药有限公司1CXHL2400431NTQ3617片南京正大天晴制药有限公司1CXHL2400430SJP-0132滴眼液千寿制药科技(北京)有限公司1CXHL2400429HP560片海创药业股份有限公司1CXHL2400428HP560片海创药业股份有限公司1CXHL2400427B0123广州帝奇医药技术有限公司2.2CXHL2400460枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400470枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400469枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400468枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400467枸橼酸舒芬太尼注射液宜昌人福药业有限责任公司2.4CXHL2400466西达本胺片深圳微芯生物科技股份有限公司2.4CXHL2400462利多卡因丙胺卡因气雾剂山东华铂凯盛生物科技有限公司3CYHL2400089琥珀酸多西拉敏片江西新赣江药业股份有限公司3CYHL2400088盐酸毛果芸香碱滴眼液湖北远大天天明制药有限公司3CYHL2400087盐酸多塞平片南京泽恒医药技术开发有限公司3CYHL2400086盐酸多塞平片南京泽恒医药技术开发有限公司3CYHL2400085复方硫酸钠片北京韩美药品有限公司3CYHL2400084注射用多黏菌素E甲磺酸钠齐鲁制药(海南)有限公司3CYHL2400083铜[64Cu]氧奥曲肽注射液北京先通国际医药科技股份有限公司3CYHL2400082匹可硫酸钠口服溶液北京柏雅联合药物研究所有限公司3CYHL2400081洛索洛芬钠贴剂四川科伦药业股份有限公司4CYHL2400091洛索洛芬钠贴剂四川科伦药业股份有限公司4CYHL2400090带状疱疹IN001 mRNA疫苗深圳深信生物科技有限公司1.2CXSL240028723价肺炎球菌多糖疫苗复星安特金(成都)生物制药有限公司3.3CXSL2400290CM512注射液康诺亚生物医药科技(成都)有限公司1CXSL2400309重组I型单纯疱疹病毒R130注射液(Vero细胞)上海允英生物医药科技有限公司1CXSL2400308RC148注射液荣昌生物制药(烟台)股份有限公司1CXSL2400305TQB2868注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400307注射用MK-2870默沙东研发(中国)有限公司1CXSL2400304KAL-003成都厌氧君生物科技有限公司1CXSL2400303KAL-003成都厌氧君生物科技有限公司1CXSL2400302注射用BG-C9074广州百济神州生物制药有限公司1CXSL2400301RC1416注射液南京融捷康生物科技有限公司1CXSL2400300RC1416注射液南京融捷康生物科技有限公司1CXSL2400299IBI354信达生物制药(苏州)有限公司1CXSL2400298注射用CB-002上海麦科思生物医药有限公司1CXSL2400297LM-299注射液礼新医药科技(上海)有限公司1CXSL2400296KN069注射液苏州康宁杰瑞生物科技有限公司1CXSL24002949MW2821迈威(上海)生物科技股份有限公司1CXSL2400292注射用BL-M14D1成都百利多特生物药业有限责任公司1CXSL2400291HBM9027注射液和铂医药(上海)有限责任公司1CXSL2400289AFN0328注射液合肥阿法纳生物科技有限公司1CXSL2400288注射用QLS4131齐鲁制药有限公司1CXSL2400286TAL-T细胞注射液广州泛恩生物科技有限公司1CXSL2400285注射用维迪西妥单抗荣昌生物制药(烟台)股份有限公司2.2CXSL2400306德谷胰岛素注射液山东新时代药业有限公司3.3CXSL2400293泰它西普注射液荣昌生物制药(烟台)股份有限公司2.1;2.2CXSL2400295仿制药申请药品名称企业注册分类受理号盐酸多巴胺注射液海南普利制药股份有限公司3CYHS2401431盐酸溴己新口服溶液南京海纳制药有限公司3CYHS2401419盐酸溴己新口服溶液南京海纳制药有限公司3CYHS2401416注射用尼可地尔湖南赛隆药业(长沙)有限公司3CYHS2401411注射用尼可地尔湖南赛隆药业(长沙)有限公司3CYHS2401410注射用尼可地尔湖南赛隆药业(长沙)有限公司3CYHS2401409生理氯化钠溶液重庆药谷制药有限公司3CYHS2401405马来酸依那普利口服溶液成都倍特得诺药业有限公司3CYHS2401404盐酸多西环素片浙江赛默制药有限公司3CYHS2401422盐酸多西环素片浙江赛默制药有限公司3CYHS2401421盐酸曲唑酮片华益药业科技(安徽)有限公司3CYHS2401400吲哚布芬片湖南方盛制药股份有限公司3CYHS2401392依托泊苷注射液四川汇宇制药股份有限公司3CYHS2401384注射用吲哚菁绿海南紫程众投生物科技有限公司3CYHS2401375马来酸曲美布汀片湖南诺纳医药科技有限公司3CYHS2401370门冬氨酸钾镁注射液海南紫程众投生物科技有限公司3CYHS2401369葡萄糖酸钙氯化钠注射液江苏亚尧生物科技有限公司3CYHS2401383葡萄糖酸钙氯化钠注射液江苏亚尧生物科技有限公司3CYHS2401382盐酸纳美芬注射液福建新迪医药科技有限公司3CYHS2401361西咪替丁注射液云南药科院生物医药股份有限公司3CYHS2401360盐酸洛美沙星滴眼液江苏广承药业有限公司3CYHS2401352盐酸甲氧氯普胺注射液南京康发生物科技有限公司3CYHS2401351头孢地尼干混悬剂浙江巨泰药业有限公司3CYHS2401349头孢地尼干混悬剂浙江巨泰药业有限公司3CYHS2401348盐酸奥普力农注射液遂成药业股份有限公司3CYHS2401340利多卡因凝胶贴膏浙江赛默制药有限公司3CYHS2401368米诺地尔搽剂西安德立生物化工有限公司3CYHS2401338吸入用盐酸丙卡特罗溶液海南金瑞宝医药科技有限公司3CYHS2401337吸入用盐酸丙卡特罗溶液海南金瑞宝医药科技有限公司3CYHS2401336阿仑膦酸钠口服溶液山东如至生物医药科技有限公司3CYHS2401335氯化钙注射液广西铭磊维生制药有限公司3CYHS2401334阿伐那非片昆明积大制药股份有限公司3CYHS2401333阿伐那非片昆明积大制药股份有限公司3CYHS2401332吸入用布地奈德混悬液浙江赛默制药有限公司4CYHS2401432盐酸特比萘芬喷雾剂浙江寰领医药科技有限公司4CYHS2401430布洛芬缓释胶囊山东丹红制药有限公司4CYHS2401429沙库巴曲缬沙坦钠片山东新华制药股份有限公司4CYHS2401428盐酸贝尼地平片深圳大佛药业股份有限公司4CYHS2401427盐酸贝尼地平片深圳大佛药业股份有限公司4CYHS2401426单硝酸异山梨酯片珠海润都制药股份有限公司4CYHS2401415枸橼酸西地那非片南京正科医药股份有限公司4CYHS2401420枸橼酸西地那非片南京正科医药股份有限公司4CYHS2401418枸橼酸西地那非片南京正科医药股份有限公司4CYHS2401417克唑替尼胶囊重庆华森制药股份有限公司4CYHS2401414非布司他片四川依科制药有限公司4CYHS2401413非布司他片四川依科制药有限公司4CYHS2401412盐酸贝尼地平片石家庄四药有限公司4CYHS2401408克立硼罗软膏广东华润顺峰药业有限公司4CYHS2401407结构脂肪乳注射液(C6-24)江苏盈科生物制药有限公司4CYHS2401406硫酸氨基葡萄糖胶囊恒昌(广州)新药研究有限公司4CYHS2401425氧海东市平安区永安气体有限公司4CYHS2401424瑞巴派特片浙江赛默制药有限公司4CYHS2401423盐酸奥布卡因滴眼液浙江视方极医药科技有限公司4CYHS2401399甲硝唑凝胶浙江寰领医药科技有限公司4CYHS2401398硫酸特布他林雾化吸入用溶液浙江莎普爱思药业股份有限公司4CYHS2401397蔗糖羟基氧化铁咀嚼片南京恒生制药有限公司4CYHS2401396马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401395马来酸氟伏沙明片重庆赛维药业有限公司4CYHS2401394西格列汀二甲双胍片(II)湖南威特制药股份有限公司4CYHS2401393富马酸伏诺拉生片海口市制药厂有限公司4CYHS2401391富马酸伏诺拉生片海口市制药厂有限公司4CYHS2401390非诺贝特酸胆碱缓释胶囊湖南九典制药股份有限公司4CYHS2401389聚乙二醇钠钾散重庆希尔安药业有限公司4CYHS2401388聚乙二醇钠钾散四川信拓医药技术有限公司4CYHS2401387马来酸氟伏沙明片辰欣药业股份有限公司4CYHS2401386依折麦布阿托伐他汀钙片(I)江苏万高药业股份有限公司4CYHS2401385氧(液态)侨源(金堂)气体有限公司4CYHS2401403腺苷注射液大道隆达(北京)医药科技发展有限公司4CYHS2401402双醋瑞因胶囊赛灵药业科技集团股份有限公司4CYHS2401401左卡尼汀口服溶液广州一品红制药有限公司4CYHS2401381瑞格列奈片成都恒瑞制药有限公司4CYHS2401380恩格列净片浙江宏元药业股份有限公司4CYHS2401379氘丁苯那嗪片南京正大天晴制药有限公司4CYHS2401378氘丁苯那嗪片南京正大天晴制药有限公司4CYHS2401377氘丁苯那嗪片南京正大天晴制药有限公司4CYHS2401376富马酸伏诺拉生片天方药业有限公司4CYHS2401374富马酸伏诺拉生片天方药业有限公司4CYHS2401373二甲硅油乳剂成都倍特得诺药业有限公司4CYHS2401372二甲硅油乳剂成都倍特得诺药业有限公司4CYHS2401371碳酸司维拉姆片江苏天士力帝益药业有限公司4CYHS2401359马来酸非尼拉敏盐酸萘甲唑啉滴眼液浙江视方极医药科技有限公司4CYHS2401358中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液瑞阳制药股份有限公司4CYHS2401357阿司匹林肠溶片浙江易泽达医药科技有限公司4CYHS2401356乙磺酸尼达尼布软胶囊瑞阳制药股份有限公司4CYHS2401355骨化三醇软胶囊浙江浙北药业有限公司4CYHS2401354富马酸卢帕他定片浙江赛默制药有限公司4CYHS2401353盐酸阿莫罗芬搽剂浙江寰领医药科技有限公司4CYHS2401350吡仑帕奈片成都苑东生物制药股份有限公司4CYHS2401347吡仑帕奈片成都苑东生物制药股份有限公司4CYHS2401346贝前列素钠片山东百诺医药股份有限公司4CYHS2401345曲伏前列素滴眼液广州大光制药有限公司4CYHS2401344硫酸镁钠钾口服用浓溶液广西维威制药有限公司4CYHS2401343磷酸奥司他韦胶囊陕西步长高新制药有限公司4CYHS2401342盐酸氟西汀分散片山东达因海洋生物制药股份有限公司4CYHS2401339盐酸达泊西汀片浙江施强制药有限公司4CYHS2401367替米沙坦片河北山姆士药业有限公司4CYHS2401366注射用阿糖胞苷仁合熙德隆药业有限公司4CYHS2401365替米沙坦片河北山姆士药业有限公司4CYHS2401364注射用阿糖胞苷仁合熙德隆药业有限公司4CYHS2401363替米沙坦片河北山姆士药业有限公司4CYHS2401362盐酸多柔比星脂质体注射液河北天成药业股份有限公司4CYHS2401341达比加群酯胶囊天方药业有限公司4CYHS2401331达比加群酯胶囊天方药业有限公司4CYHS2401330乳果糖口服溶液湖南及正医药科技有限公司4CYHS2401329乳果糖口服溶液湖南及正医药科技有限公司4CYHS2401328乌司奴单抗注射液百奥泰生物制药股份有限公司3.3CXSS2400048乌司奴单抗注射液(静脉输注)百奥泰生物制药股份有限公司3.3CXSS2400047乌司奴单抗注射液百奥泰生物制药股份有限公司3.3CXSS2400046进口申请药品名称企业注册分类受理号Fitusiran注射液Genzyme Corporation1JXHS2400034Fitusiran注射液Genzyme Corporation1JXHS2400033盐酸氨酮戊酸己酯软膏光动力治疗系统ASIERIS MEDITEC (Hong Kong) CO., LIMITED2.2JXHS2400035地拉罗司片Annora Pharma Private Limited5.2JYHS2400025地拉罗司片Annora Pharma Private Limited5.2JYHS2400024地拉罗司片Annora Pharma Private Limited5.2JYHS2400023BI 690517片Boehringer Ingelheim International GmbH1JXHL2400106BI 690517片Boehringer Ingelheim International GmbH1JXHL2400105LOXO-435片Eli Lilly and Company1JXHL2400104LOXO-435片Eli Lilly and Company1JXHL2400103LOXO-435片Eli Lilly and Company1JXHL2400102BI 1810631 片Boehringer Ingelheim International GmbH1JXHL2400099RO7434656注射液F. Hoffmann-La Roche Ltd.1JXHL2400098马昔腾坦分散片Actelion Pharmaceuticals Ltd.2.2JXHL2400107Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400097Upadacitinib口服溶液AbbVie Inc.2.2JXHL2400096Capivasertib片AstraZeneca AB2.4JXHL2400101Capivasertib片AstraZeneca AB2.4JXHL2400100BAY 3375968Bayer AG1JXSL2400088Relatlimab注射液Bristol-Myers Squibb Company1JXSL2400085DS-7300aDaiichi Sankyo, Inc.1JXSL2400087古塞奇尤单抗注射液Janssen Research & Development, LLC2.2JXSL2400091古塞奇尤单抗注射液Janssen Research & Development, LLC2.2JXSL2400090古塞奇尤单抗注射液Janssen Research & Development, LLC2.2JXSL2400089Ropeginterferon alfa-2b注射液PharmaEssentia Corporation2.2JXSL2400086中药相关申请药品名称企业注册分类受理号蒿平颗粒新奇康药业股份有限公司1.1CXZL2400024清血败毒丸江苏中雍红瑞制药有限公司1.1CXZL2400023不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市突破性疗法

2024-05-10

·FierceHealthcare

New specialty care provider Harmonia Healthcare opens clinic to treat extreme morning sickness

Harmonia Healthcare's chief scientific officer, Marlena Fejzo, Ph.D., will also leverage her groundbreaking discovery of the hormone associated with HG to drive innovations in prognostics, prevention and treatments. Harmonia Healthcare, a new provider focused on specialty women’s health, has opened a clinic in New Jersey to treat hyperemesis gravidarum (HG). HG can bring nausea and vomiting during pregnancy severe enough to prevent proper food intake and can lead to weight loss, dehydration and ultimately hospitalization. It can cause complications for mothers and their babies and is estimated to affect up to nearly 11% of pregnant women. Harmonia’s new clinic will offer evidence-based treatments and educate patients on the latest science around HG. Its offerings include medication and vitamin infusion, electrolyte replacement plans, prescription management, diagnostic bloodwork and telehealth. A second clinic is planned to open in New York City this fall. The clinic does not require referrals. Its chief scientific officer, Marlena Fejzo, Ph.D., a women’s health researcher with lived experience of HG, will also leverage her and colleagues' groundbreaking discovery of the hormone associated with the condition—GDF15—to drive innovations in prognostics, prevention and treatment. Fejzo was a 2023 Fiercest Women in Life Sciences awardee. “We really want to fix the broken care model in women’s health and improve care,” Fejzo told Fierce Healthcare. “We hope to expand this to be the future of care for these undertreated and underdiagnosed diseases.” Harmonia’s online platform will offer educational resources and eventually telehealth, though women should still ideally first come into the clinic in person. The current status quo for women with HG is unacceptable and costly, Fejzo says. If they end up in an emergency room, they are treated with fluids or antiemetic drugs and released. But because HG causes persistent nausea and vomiting, women need persistent medication management, Fejzo argues. If they are discharged without a prescription, many will inevitably wind up back in the hospital again; 60% of women have multiple hospital visits, per Fejzo. And, while HG is starting to be diagnosed properly more often, Fejzo said, it can still be misdiagnosed or not diagnosed at all. “A lot of people think that it’s just regular nausea and vomiting and that everything’s going to be fine … when actually there are really adverse outcomes associated with HG for the mother and the baby,” Fejzo said. During a recent conference, Fejzo said she discovered ER doctors affiliated with Harvard discharge HG patients without a prescription. Their justification for it was that the medications might make them tired, and then they would have to miss work. “That’s a real misunderstanding of HG,” Fejzo said, adding that if Harvard-affiliated docs are doing it, “I assume it is common.” RELATED: New study finds cause and potential treatment for dangerous morning sickness Part of the reason Fejzo believes this is happening is due to a famous historic incident known as the thalidomide disaster. After women being treated with thalidomide for nausea had babies with birth defects, it launched a widespread hesitancy to prescribe medications during pregnancy, Fejzo said. There also remains a misguided belief that HG is psychological or resolves on its own. And because HG typically starts early in pregnancy, many women see ER docs before even seeing their obstetrician, meaning many providers may not be aware of how sick their patients have really been. Obstetricians are also generally not trained to ask their patients about their levels of nausea and vomiting—and patients, too, may not talk about it, Fejzo explained. To address this, Harmonia will be monitoring women receiving medication management and coordinating with their other providers, like OB-GYNs, midwives and doulas. The goal is to intervene as early as possible with more aggressive treatment before the condition spirals out of control. The best medications for HG being prescribed off-label include Zofran, Phenergan and Reglan, according to Fejzo. Yet doctors usually begin with doxylamine and pyridoxine, as recommended by the American College of Obstetricians and Gynecologists, which Fejzo says are “pretty much a placebo for HG.” By serving patients with HG, Harmonia will have the infrastructure in place to run clinical trials on potential new treatments, Fejzo said. She is already advising NGM Bio, which recently announced it is interested in testing its drug NGM120 in HG patients. While Fejzo doesn’t anticipate challenges with patients getting their scripts filled, Harmonia providers will educate patients on how to have conversations with pharmacists in case they do run into pushback. In recent years, pharmacists have sometimes refused to fill opioid prescriptions with doses they perceived as too high or poorly monitored by the prescriber. One of the country’s only other clinics in this space, Alabama’s Morning Sickness Clinic, claims its model has led to a 95% reduction in ER visits and a 90% decrease in total cost of care. Its co-founder, an emergency medicine physician, is one of Harmonia’s clinical advisers. Harmonia eventually hopes to expand to serve other under-researched women’s health conditions. While the company does not currently plan to pursue formal health system partnerships, it hopes that its clinics will come to be known locally as the go-to expert for these conditions. And, while it isn’t yet, Harmonia plans to be working with commercial and Medicaid insurance plans by the end of this year.

2023-07-22

·医药地理

【好文推荐】克拉霉素-琥珀酸共晶的晶体结构研究

未经授权，不得转载克拉霉素-琥珀酸共晶的晶体结构研究Crystal Structure Investigation of Clarithromycin-succinic Acid Cocrystal马丽文，巩艳青，李岗，马玉莹，单汉滨，钟家亮*(中国医药工业研究总院上海医药工业研究院，创新药物与制药工艺国家重点实验室，上海 201203)摘要：采用溶剂挥发法培养得到克拉霉素- 琥珀酸的共晶，并运用X 射线单晶衍射技术对其立体结构进行解析。结果表明，晶态下克拉霉素与琥珀酸之间存在氢键，二者形成共晶，而非成盐。同时，1 分子结晶溶剂甲醇和0.5 分子结晶水也参与到氢键的形成中，多组氢键加强了晶态下分子间的稳定堆积排列。关键词：克拉霉素；琥珀酸；X 射线单晶衍射；共晶；氢键以下为文章节选克拉霉素是一种十四元大环内酯类抗菌药，为红霉素衍生物，抗菌谱广泛，临床上可用于治疗上、下呼吸道感染，皮下软组织感染等疾病[1]。同时因阻断了红霉素A 酸的降解过程，其克服了第一代红霉素在胃酸中易分解的缺点，具有良好的体内外抗菌活性和药代动力学性质[2—3]，具有较大的市场潜力。已报道克拉霉素涉及多种多晶型，分别为晶型O[4]、晶型Ⅰ [5]、晶型Ⅱ [6]、晶型Ⅲ [7] 和晶型Ⅳ [8]。其中，克拉霉素的早期专利中定义晶型O 为克拉霉素溶剂化物；通过从晶格中去除溶剂而转化为晶型Ⅰ ；晶型Ⅱ可以通过用有机溶剂重结晶或通过加热晶型Ⅰ而获得；晶型Ⅲ是( 乙腈) 溶剂化物；而晶型Ⅳ是一种无定形物。通过统计剑桥晶体学数据中心(Cambridge Crystallographic Data Centre，CCDC) 中已收载的克拉霉素15 套单晶数据[9—21]，发现已报道的克拉霉素单晶数据涉及单一克拉霉素、甲醇溶剂化物、乙醇溶剂化物、水合物、乙腈溶剂化物、盐酸盐、枸橼酸盐等。其晶体的对称性主要体现为正交晶系和单斜晶系，分别占总数据的87％和13％。琥珀酸是常用的药用有机酸，临床应用的药物中有较多种类以有机酸形式成药，如琥珀酸美托洛尔缓释片、琥珀酸亚铁片、琥珀酸舒马普坦片、琥珀酸普芦卡必利片、琥珀酸索利那新片和琥珀酸多西拉敏等。克拉霉素的水溶性较差，在甲醇或乙醇中微溶，在丙酮或乙酸乙酯中可溶，在三氯甲烷中易溶。本研究采用共晶筛选的方式，以有机酸( 琥珀酸) 为配体，尝试制备克拉霉素的共晶。采用溶剂挥发法进行共晶制备，成功获得了克拉霉素琥珀酸共晶的单晶体，并对获得的单晶体进行单晶X 射线衍射分析，获得了其精确的三维立体结构，以期为克拉霉素共晶的应用研究提供参考。↑长按二维码阅读全文作者简介：马丽文(1996—)，女，硕士研究生，专业方向：药物分析。通信作者：钟家亮(1980—)，男，研究员，博士生导师，从事药物固体状态分析。E-mail：zhongjialiang@sinopharm.com文章详情欢迎登录《中国医药工业杂志》官网查看。年度发布2023年《全球药研新动态》《中国医院市场用药格局》（2023版）2023年《数图药讯》权威发布2021年度中国医药工业百强榜单解读中国仿制药发展报告（2022版）医药行业专项报告中国医药中间体和原料药行业调研报告中国非甾体抗炎类原料药市场调研报告中国祛痰类原料药市场调研报告中国钙拮抗剂类原料药市场调研报告中国血管紧张素Ⅱ受体拮抗剂类原料药市场调研报告中国口服血糖调节类原料药市场调研报告中国中枢兴奋类原料药市场调研报告中国抗痛风类原料药市场调研报告中国脑血管病类原料药市场调研报告END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

100 项与琥珀酸多西拉敏相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02327	琥珀酸多西拉敏	R06AA09	DB00366

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
超敏反应	美国	Sanofi-Aventis U.S. LLC	1948-04-07
早孕反应	美国	Sanofi-Aventis U.S. LLC	1948-04-07
入睡和睡眠障碍	美国	Sanofi-Aventis U.S. LLC	1948-04-07

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临床结果

适应症

分期

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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


NCT00290732 (CTgov)	临床1期	浸润性乳腺癌	20	Doxil TM+Dox-SL (Intraductal Arm)	築簾艱夢網製積繭顧築(窪襯鏇壓築衊簾憲顧繭) = 醖餘夢壓鬱淵壓鬱齋蓋築觸餘遞積獵壓鏇獵觸 (襯窪壓鏇齋網廠鹽壓鹹, 遞獵鹹齋獵範範選窪窪 ~ 艱鬱膚衊膚製齋簾夢醖)	-	2013-09-26
				Intravenous arm (Intravenous Arm)	觸觸醖構艱獵願願艱醖(鑰範膚顧淵餘願鹹壓壓) = 鑰齋鬱鹹壓壓構齋糧鏇積糧醖鬱齋顧壓壓醖鑰 (願構艱繭壓觸遞選鑰窪, 築淵簾壓簾壓襯選遞襯 ~ 繭築觸壓積鏇顧築製膚) 更多
NCT00796315 (CTgov)	临床1期	过敏性鼻炎	41	Doxylamine Succinate (Subjects Aged 2-5 Years)	壓膚願鏇襯範遞壓構襯(淵範衊壓蓋襯製顧鹽築) = 鹹構蓋獵膚繭獵餘鏇觸遞鹹顧繭夢鏇簾範壓願 (餘憲醖獵餘餘鹽淵夢鑰, 積網鬱淵範築構窪願鹹 ~ 膚簾壓鑰鬱網繭選夢簾) 更多	-	2013-01-25
				Doxylamine Succinate (Subjects Aged 6-11 Years)	壓膚願鏇襯範遞壓構襯(淵範衊壓蓋襯製顧鹽築) = 積醖鬱築廠鬱齋選衊鏇遞鹹顧繭夢鏇簾範壓願 (餘憲醖獵餘餘鹽淵夢鑰, 糧網積製鏇繭餘選繭衊 ~ 鹽築夢淵衊鬱憲餘獵襯) 更多