预约演示

更新于：2026-10-19

Sodium Chloride/Potassium Chloride/Sodium sulfate anhydrous/Macrogol 4000

氯化钠/氯化钾/无水硫酸钠/聚乙二醇4000

更新于：2026-10-19

概要

基本信息

药物类型

小分子化药

别名

Sodium Chloride/Potassium Chloride/Sodium Sulfate/PEG 4000、Sodium Chloride/Potassium Chloride/Sodium Sulfate/Polyethylene Glycol 4000、塩化ナトリウム/塩化カリウム/無水硫酸ナトリウム/ポリエチレングリコール4000

+ [3]

靶点-

作用方式-

作用机制-

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

权益机构

最高研发阶段批准上市

首次获批日期

日本 (2012-12-25),

肠道疾病

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式ClNa

InChIKeyFAPWRFPIFSIZLT-UHFFFAOYSA-M

CAS号7647-14-5

查看全部结构式(4)

关联

项与氯化钠/氯化钾/无水硫酸钠/聚乙二醇4000 相关的临床试验

JPRN-jRCT1061260004

/ Recruiting临床2期

A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Elobixibat Hydrate in Preparing Patients with Chronic Constipation for Colonoscopy

开始日期2026-04-06

申办/合作机构-

NCT04988841

/ Completed临床2期IIT

Prospective randomIzed Clinical Trial Assessing the Tolerance and Clinical Benefit of feCAl tranSplantation in patientS With melanOma Treated With CTLA-4 and PD1 Inhibitors

Recent studies suggest that patients with metastatic melanoma whose gut microbiome is colonized by eubiotic bacteria have a stronger anti-cancer response to anti CTLA-4 and anti PD1. The hypothesis of this research is that a pooled standardized fecal microbiome transfer (FMT) will shift melanoma patients' gut microbiome towards a composition close to that associated with a better response, and will therefore increase the response to a combination of anti CTLA-4 and anti PD1, without affecting the safety of these drugs. The present trial is the first randomized trial of FMT in patients with unresectable or metastatic melanoma. It will include patients who have neither been exposed to anti CTLA-4 nor anti PD1 or PDL-1, prior to inclusion in the study. The pooled standardized fecal microbiome transfer administered in this study is an experimental drug MaaT013, a microbiome restoration biotherapeutic, produced by MaaT Pharma, and composed of pooled-donor, full-ecosystem intestinal microbiome. The MaaT013 product has a standardized richness (in number of species present) higher than a product obtained from a mono donor (455 species approximately against 274 on average) and contains bacteria species (mentioned in the rationale) associated with better response to anti- CTLA-4 and anti PD1.

开始日期2022-01-20

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT05140057

/ RecruitingN/A

Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield: a Randomized Trial

Small bowel capsule endoscopy (SBCE) has become an important tool in clinical practice since its introduction in 2000. This non-invasive method allows the visualization of small bowel mucosa, being essential in the management of many conditions, such as suspected small bowel bleeding, inflammatory bowel diseases and intestinal polyposis syndromes. Despite recommendations concerning SBCE in different pathologies, there are still some technical concerns to be addressed. The optimal preparation for SBCE has been one of these controversial issues.
Currently, the European Society of Gastrointestinal Endoscopy (ESGE) recommends that patients ingest a purgative agent (2L of polyethylene glycol, PEG) and antifoaming agents for SBCE, because it was associated with a better visualization. However, it remains unclear which is the optimal timing for purgative use. Furthermore, the use of a booster agent after capsule ingestion is already performed in colon capsule endoscopy, but less is known about its application in SBCE. Also, it remains to be clarified whether a better visualization results in higher diagnostic yield and impacts patients' outcomes.
Therefore, the global aim of this prospective, randomized, multi-centric study is to determine the optimal timing and preparation for small-bowel capsule endoscopy (regardless of the equipment used), comparing four groups of different preparation protocols:
* Protocol 1) 1L of Moviprep® solution the night before the procedure
* Protocol 2) 1L of Moviprep® solution up to 2h before the procedure
* Protocol 3) 0.5L of Moviprep® solution up to 2h before the procedure plus 0.5L of Moviprep® solution after the capsule had reached the duodenum (assessed with real-time viewer)
* Protocol 4) 1L of Moviprep® solution after the capsule had reached the duodenum (assessed using real-time viewer)

开始日期2021-12-01

申办/合作机构

Centro Hospitalar de Vila Nova de Gaia/Espinho EPE

100 项与氯化钠/氯化钾/无水硫酸钠/聚乙二醇4000 相关的临床结果

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100 项与氯化钠/氯化钾/无水硫酸钠/聚乙二醇4000 相关的转化医学

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100 项与氯化钠/氯化钾/无水硫酸钠/聚乙二醇4000 相关的专利（医药）

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项与氯化钠/氯化钾/无水硫酸钠/聚乙二醇4000 相关的文献（医药）

2026-09-12·Cureus Journal of Medical Science

Does a Non-English-Speaking Background Affect the Quality of Bowel Preparation for Colonoscopy?

Article

作者: Lee, Sharon ; Muir, Mathew J ; Abdulrasool, Haider ; Nguyen, Natalie ; Rahme, Jessica ; Wai Keong Choong, Keith ; Chern, Tien Yew ; D'Souza, Basil ; Sidhu, Ankur

Background Bowel preparation quality is critical for colonoscopy diagnostic yield. Whether a non-English-speaking background (NESB) adversely affects preparation quality in Australia is unknown. We aimed to determine whether NESB status is associated with inadequate bowel preparation compared to English-speaking background (ESB) patients, and to identify other clinical predictors. Methods A retrospective audit of consecutive patients undergoing elective colonoscopy at the Northern Hospital, Epping, Victoria (September-November 2017). NESB was defined as a primary language other than English. Preparation quality was assessed using the Aronchick scale, dichotomised as adequate (excellent/good/fair) or inadequate. Multivariable logistic regression was performed to identify independent predictors of inadequate preparation. Results Of 1,385 patients, 1,129 (81.5%) were ESB and 256 (18.5%) NESB. Professional interpreters were used by 73.0% of NESB patients. Inadequate preparation occurred in 8.9% of ESB and 6.2% of NESB patients; no significant difference was found on univariable (p=0.16) or age-adjusted multivariable analysis (adjusted odds ratio (OR) 0.73, 95% confidence interval (CI) 0.42-1.27; p=0.26). No factor reached statistical significance at the 5% level, although extended bowel preparation (adjusted OR 1.83, p=0.06), morning-list colonoscopy (adjusted OR 1.45, p=0.06), Moviprep (adjusted OR 1.47, p=0.09) and age (adjusted OR 0.88 per 10-year increment, in the direction of lower rather than higher risk with increasing age; p=0.06) approached it; male sex was not associated with inadequate preparation (adjusted OR 1.27, p=0.23). Conclusions We found no evidence of an association between NESB status and inadequate bowel preparation at a culturally diverse Australian institution, although the confidence interval remains compatible with both a modest protective and a modest harmful association. High utilisation of professional interpreter services may mitigate language barriers in preparation adherence. In contrast to previous reports, male sex, extended preparation and morning-list timing were not statistically significant independent predictors of inadequate preparation in this cohort, although extended preparation and morning-list timing showed trends consistent with the published literature that this study was underpowered to resolve.

2025-04-25·Cureus Journal of Medical Science

Impact of Bowel Preparation Type on Colonoscopy Quality and Adenoma Detection: A Comparative Study

Article

作者: Yeap, Elaine ; Maramraj, Sankeerthan

Background Colorectal cancer (CRC) is a leading cause of cancer-related mortality worldwide. Colonoscopy is the gold standard for CRC screening, but its effectiveness depends on bowel preparation quality. This study compares polyethylene glycol (PEG)-based MoviPrep (Norgine Limited, Hengoed, UK) and sodium picosulfate-based Picolax (Ferring GmbH, Kiel, Germany) in terms of bowel cleansing quality, caecal and ileal intubation rates, and adenoma detection rate (ADR). Methods This retrospective observational study analysed 6,921 colonoscopies performed at University Hospital Crosshouse between June 2020 and June 2023. Bowel preparation quality was assessed using the modified Ottawa Bowel Preparation Scale, categorised as Excellent, Good, Fair, or Inadequate. ADR was determined by histologically confirmed adenomas. Statistical comparisons between the two groups were performed using chi-square tests. Results MoviPrep was used in 6,219 (89.9%) of cases, while Picolax was used in 702 (10.1%) cases. MoviPrep was associated with a lower inadequate preparation rate (343 (5.5%) vs. 63 (9.0%)), a higher caecal intubation rate (3,675 (59.1%) vs. 307 (43.7%)) and ileal intubation rate (1,119 (18.0%) vs. 81 (11.5%)), and a higher ADR (2,295 (36.9%) vs. 167 (23.8%)). Conclusion MoviPrep demonstrated superior bowel cleansing, higher completion rates, and greater adenoma detection, supporting its use as a preferred bowel preparation method for colonoscopy in clinical practice.

2025-04-01·GASTROINTESTINAL ENDOSCOPY

Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield (PrepRICE): a multicenter randomized trial

Article

作者: Mesquita, Pedro ; Canha, Maria Inês ; Correia, João ; Pinho, Rolando ; Lopes, Sandra ; Gomes, Catarina ; Rodrigues, Adélia ; Roque Ramos, Lídia ; Pestana, Inês ; Franco, Rita ; Estevinho, Maria Manuela ; Archer, Sara ; Sarmento Costa, Mara ; Marílio Cardoso, Pedro

BACKGROUND AND AIMS:

Current guidelines recommend bowel preparation before small-bowel capsule endoscopy (SBCE). However, the optimal protocol is yet to be defined. To determine the best timing for preparation in SBCE, we compared small-bowel visualization quality (SBVQ), diagnostic yield (DY), and patient-reported outcomes across 4 purgative regimens.

METHODS:

In this prospective, randomized (1:1:1:1), multicenter study, patients with suspected small-bowel bleeding were randomized into 4 arms: G1 (1 L of polyethylene glycol + ascorbic acid [Moviprep, Norgine, Amsterdam, The Netherlands] the night before SBCE), G2 (1 L in the morning up to 2 hours before SBCE), G3 (0.5 L up to 2 hours before SBCE + 0.5 L after the capsule reached the duodenum), and G4 (1 L after the capsule reached the duodenum). To assess DY, lesions were categorized as having high (P2) or low (P0 or P1) bleeding potential. SBVQ was assessed using the Brotz score. Transit times were measured, and patient tolerability was scored from 0 to 5, with higher scores indicating better tolerability.

RESULTS:

A total of 387 patients were included, 59% female and with a median age of 73 years (interquartile range, 23). The examination completion rate was lower in G1 (90%, P < .001). Small-bowel transit time was shorter for patients receiving purgative during SBCE (G3 and G4, P = .001). SBVQ was better in patients receiving purgative after reaching the small bowel (P < .001): a median of 7 for G1, 8 for G2, and 9 for G3 and G4. The overall DY of patients receiving intraprocedure purgatives (G3 + G4) was superior (42.7 vs 31.3%, P = .02); significant differences were found in the second and third terciles. Likewise, G3 and G4 had higher angioectasia detection (P = .04). Patients' satisfaction was significantly superior for G4 (median, 4 points; interquartile range, 1).

CONCLUSIONS:

The group that received the bowel preparation the night before SBCE had poorer outcomes. Intraprocedure purgative regimens reduced SBTT, enhanced visualization, improved DY, and increased angioectasia detection. G4 was the best-tolerated regimen.

项与氯化钠/氯化钾/无水硫酸钠/聚乙二醇4000 相关的新闻（医药）

2026-04-10

·上海市药物研发协同创新中心

NMPA新药审批汇总—2026年3月

NMPA批准新药——2026年3月 2026年3月份，国家药品监督管理总局（NMPA）共批准了30个新药1（含创新药6个、改良新药21个，古代经典名方中药复方制剂3个），其中化药11个，生物药16个和中药3个。创新药 1类创新药为6个，其中，包含全球首个自主研发的靶向整合素αvβ3的放射性核素偶联药物锝[99mTc]佩昔瑞特加肽注射液，全球首个获批用于治疗蠕形螨睑缘炎的药物洛替拉纳滴眼液，全球首个靶向胸腺基质淋巴细胞生成素特泽利尤单抗注射液，国内首个核素心肌灌注显像心脏负荷试验的药物盐酸去甲乌药碱注射液。吉伦泰®（锝[99mTc]佩昔瑞特加肽注射液，99mTc-3PRGD2）及用于制备该药品注射用锝[99mTc]佩昔瑞特加肽药盒是佛山瑞迪奥医药有限公司研发的一款靶向整合素αvβ3（Integrin αvβ3）的创新核药，获批用于单光子发射及X射线计算机断层成像系统（SPECT/CT）显像的放射性诊断和可疑肺癌患者区域淋巴结转移的辅助检查。吉伦泰®是以整合素αvβ3为靶点的“First-in-Class”放射性核素偶联药物，也是全球首个用于SPECT显像的广谱肿瘤显像剂。基于该平台技术，公司针对乳腺癌HER2阳性患者的诊断核药99mTc-HP-Ark2已获批IND；另外，靶向αvβ3的治疗核药177Lu-AB-3PRGD2已启动1类新药申报，未来将有望惠及临床患者。（全球首批：中国2026年3月）新比澳®（罗赛促红素α注射液）是三生制药研发的一款高糖基化重组蛋白，获批用于治疗因慢性肾脏病引起的贫血且正在接受促红细胞生成素治疗的血液透析患者。新比澳®长效优势在于其利用基因重组技术，优化分子结构，与传统促红素相比，半衰期延长，实现了“两周一次”的给药方案，提高了患者治疗依从性。新比澳®是国产首个长效重组人促红细胞生成素类双周制剂。（全球首批：中国2026年3月）欣可青®（盐酸去甲乌药碱注射液）是珠海润都制药股份有限公司研发的一款靶向肾上腺素β受体激动剂，获批用于核素心肌灌注显像，以评估心肌缺血。盐酸去甲乌药碱是在发现药用植物“附子”强心有效成分的基础上，进行化学全合成的药物。目前用于核素心肌显像的药物包括血管扩张类药物腺苷、双嘧达莫和瑞加诺生等。（全球首批：中国2026年3月） Xedmvy®（洛替拉纳滴眼液）是远大医药引进Tarsus Pharmaceuticals的一款靶向γ-氨基丁酸门控氯离子（GABA-Cl）通道的非竞争性拮抗剂，获批用于治疗蠕形螨睑缘炎症患者。洛替拉纳的作用机制是通过选择性抑制蠕形螨体内的GABA-Cl，使虫体麻痹和死亡，从而发挥治疗作用。此外，洛替拉纳具有高度亲脂性，可促进其在螨虫栖息的睫毛毛囊油脂中的吸收。Xedmvy®是全球首个批准用于治疗蠕形螨睑缘炎的产品。（全球首批：美国2023年7月；国内首批：2026年3月）易适来/Exdensur®（德莫奇单抗注射液）是葛兰素史克研发的一款新一代抗白介素-5（IL-5）单克隆抗体，获批用于成人和12岁及以上青少年重度嗜酸性粒细胞性哮喘的维持治疗。易适来®是全球首个半年一次给药的超长效生物制剂，通过精准治疗提高患者的依从性。（全球首批：美国2025年12月；国内首批：2026年3月）泰适卓/Tezspire®（特泽利尤单抗注射液）是阿斯利康研发的一款靶向胸腺基质淋巴细胞生成素（TSLP）的单克隆抗体，获批两项适应症：用于成人和12岁及以上青少年重度哮喘的附加维持治疗；与鼻用糖皮质激素联合使用治疗系统性糖皮质激素和/或手术治疗无法充分控制疾病的慢性鼻窦炎伴鼻息肉成人患者。特泽利尤单抗是全球首个获批靶向TSLP，通过阻断上皮细胞因子作用于炎症级联反应顶端，从根源上抑制多种炎症细胞因子和趋化因子的释放。（全球首批：美国2021年12月；国内首批：2026年3月）改良新药改良新药中，值得关注的是：国内首个普拉睾酮栓剂剂型和用于治疗婴幼儿维生素K缺乏性出血的维生素K₁混合胶束注射液；新增适应症中，IL-17A/F双靶点药物比奇珠单抗注射液的适应症从风湿免疫领域拓展至皮肤科领域。新剂型先维盈®（埃诺格鲁肽注射液）是先为达生物研发的偏向型GLP-1受体激动剂，本次获批是新剂型和新增适应症，剂型由笔芯改良为预填充注射笔，适应症用于在控制饮食和增加体力活动基础上对成人超重/肥胖患者的长期体重管理。哌立安®（布瑞哌唑口溶膜）是四川科伦药业研发的口溶膜剂型，同月，齐鲁制药的布瑞哌唑口溶膜也获得了批准。目前，布瑞哌唑在国内已有剂型为口服片和口崩片。长效注射剂、口服混悬液和注射用微球正在研发中。茵若飒/Intrarosa®（普拉睾酮阴道栓）是李氏大药厂引进加拿大Endoceutics的一款改良新剂型。国外已获批栓剂，国内已有注射剂剂型。维生素K₁注射液是泊诺（天津）创新医药引进CHEPLAPHARM Arzneimittel GmbH的混合胶束注射液，该剂型适用于预防和治疗新生儿和婴儿维生素K缺乏性出血。国内已有片剂、滴剂、注射液、粉剂、混合胶束注射剂；口腔崩解片、注射用乳剂和软胶囊正在研究开发中。葆舒宜®（注射用人玻璃酸酶）是上海宝济药业研发的一款基于重组DNA技术与先进纯化工艺开发的皮下注射制剂。复方制剂诺和杰/Kyinsu®（依柯胰岛素司美格鲁肽注射液）是诺和诺德研发的一款胰岛素/胰高糖素样肽-1受体激动剂（GLP-1RA）周制剂，由胰岛素周制剂依柯胰岛素和GLP-1RA周制剂司美格鲁肽组成，获批用于接受基础胰岛素或GLP-1RA治疗后血糖控制不佳的成人2型糖尿病患者，在饮食和运动基础上联合口服降糖药物进行治疗。 Plenvu®（复方聚乙二醇（3350）电解质维C散（Ⅱ））是Norgine B.V研发的一种低容量聚乙二醇（PEG）肠道准备制剂，获批用于成人结肠镜检查前的肠道清洁。Plenvu®相较于广泛使用的替代性肠道准备剂CitraFleet®和Moviprep®具有显著优势。重大技术改进芮妥欣®（注射用重组A型肉毒毒素）是重庆誉颜制药研发的一款重大技术改进的生物制品，获批用于改善成人中度至重度眉间纹。芮妥欣®是全球首个利用基因工程技术生产的重组A型肉毒毒素药品，实现了从天然提取到基因重组的技术突破。葆舒宜®（注射用人玻璃酸酶）是上海宝济药业研发的一款基于重组DNA技术与先进纯化工艺开发的皮下注射生物制品。改良类型为重大技术改进和新剂型。该药采用了重组DNA技术构建人源玻璃酸酶表达体系，实现了从动物提取向工程化生产的跨越。与传统静脉输液相比，皮下输液通过将药物或液体注入皮下组织，经毛细血管网络逐步吸收进入循环系统。新增适应症速福达/Xofluza®（玛巴洛沙韦干混悬剂）新增第2项适应症：用于治疗1岁至5岁以下单纯性甲型和乙型流感儿童患者，包括既往健康的患者以及存在流感并发症高风险的患者。此前，速福达®已获批的适应症为5至12岁以下单纯性甲型和乙型流感儿童患者。恒曲®（海曲泊帕乙醇胺片）新增第3项适应症：联合免疫抑制治疗适用于15岁及以上初治重型再生障碍性贫血患者。此前，恒曲®已获批用于治疗慢性原发免疫性血小板减少症和免疫抑制治疗疗效不佳的SAA患者。优罗华/Polivy®（注射用维泊妥珠单抗）新增第2项适应症：联合利妥昔单抗、吉西他滨和奥沙利铂方案，用于不适合接受造血干细胞移植的复发或难治性弥漫大B细胞淋巴瘤（DLBCL）成人患者。此前，优罗华®已获批联合利妥昔单抗、环磷酰胺、多柔比星和泼尼松，用于治疗既往未经治疗的DLBCL成人患者。爱地希®（注射用维迪西妥单抗）新增第4项适应症：用于治疗既往在转移性疾病阶段接受过至少一种系统治疗的，或在辅助化疗期间或完成辅助化疗之后12个月内复发的，不可切除或转移性HER2低表达（IHC 1+或IHC 2+/ISH-）且存在肝转移的成人乳腺癌患者。此前，爱地希®已获批用于治疗胃癌、尿路上皮癌、HER2 阳性晚期乳腺癌伴肝转移患者。艾维达®（注射用瑞康曲妥珠单抗）新增第2项适应症：用于治疗既往接受过一种或一种以上抗HER2药物治疗的局部晚期或转移性HER2阳性成人乳腺癌患者。此前，艾维达®已获批治疗存在HER2 ERBB2激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌患者。科赛优/Koselugo®（硫酸氢司美替尼胶囊）新增第2项适应症，用于3岁及3岁以上伴有症状、无法手术的丛状神经纤维瘤（PN）的1型神经纤维瘤病（NF1）儿童及成人患者的治疗。此前，科赛优®仅获批用于3岁及3岁以上儿童患者。泰适卓/Tezspire®（特泽利尤单抗注射液）新增2项适应症：用于成人和12岁及以上青少年重度哮喘的维持治疗；与鼻用糖皮质激素联合使用，治疗系统性糖皮质激素和/或手术治疗无法充分控制疾病的慢性鼻窦炎伴鼻息肉（CRSwNP）成人患者。这是该药在国内首次获批的适应症。倍捷乐/Bimzelx®（比奇珠单抗注射液）新增2项适应症：用于治疗适合系统治疗或光疗的中度至重度斑块状银屑病成人患者，以及治疗常规系统性治疗疗效不佳的中度至重度化脓性汗腺炎（反常性痤疮）成人患者。此前，倍捷乐®已获批用于活动性强直性脊柱炎成人患者治疗。昕越/Uplizna®（伊奈利珠单抗注射液）新增第3项适应症：与常规治疗药物联合用于治疗抗乙酰胆碱受体（AChR）或抗肌肉特异性酪氨酸激酶抗体阳性的成人全身型重症肌无力患者。此前，昕越®已获批用于视神经脊髓炎谱系疾病和免疫球蛋白G4相关性疾病治疗。优赫得/Enhertu®（德曲妥珠单抗）新增第7项适应症：序贯紫杉醇、曲妥珠单抗和帕妥珠单抗，用于HER2阳性II期（高危）或III期乳腺癌成人患者的新辅助治疗。此前，优赫得®已获批适应症涉及瘤种包括乳腺癌、胃或胃食管结合部腺癌和非小细胞肺癌。易适来/Exdensur®（德莫奇单抗注射液）新增第2项适应症：与鼻用糖皮质激素联合使用，治疗系统性糖皮质激素和/或手术治疗无法充分控制疾病的慢性鼻窦炎伴鼻息肉成人患者。此前，易适来®已获批用于成人和12岁及以上青少年重度嗜酸性粒细胞性哮喘的维持治疗。古代经典名方中药复方制剂3个，为广东一方制药的桃核承气汤颗粒、海南葫芦娃药业的易黄汤颗粒和神威药业的二冬汤颗粒。新药是指NDA，范围包含化药1类、2类和5.1类，治疗用生物制品1类、2类、3类，中药1类、2类和3类。创新药范围：包括1类创新药、5类化药和3类治疗用生物制品中的进口原研药品；改良新药范围：包括2类改良型新药、5类化药和3类治疗用生物制品中的进口改良药品，以及1类创新药中的新增适应症品种。点击“阅读原文”查看更多精彩内容

2026-03-13

·药品圈

0313 II 78个品种新获批准！

前言： 2022年11月1日起，行政相对人可登录网上办事大厅的法定代表人空间查看电子证照，按照法人空间内相关提示自行打印。今日（3月13日），NMPA官网发布药品批准证明文件待领取信息发布（共计193个），78个品规新获批准（含化药5.1、2.2、3、4类和5.2类等）。我们一起看看都是哪些品规获批吧！值得关注的是品种：（1）布瑞哌唑口溶膜（化药2.2类，齐鲁制药有限公司）布瑞哌唑是一款非典型抗精神病小分子药物，可以部分激动5-羟色胺受体1A和多巴胺受体D2，并靶向拮抗5-羟色胺受体2A，从而调节血清素和多巴胺水平，起到治疗精神病的作用。布瑞哌唑的原研公司为大冢制药（Otsuka）。2011年11月，灵北制药（Lundbeck）与大冢制药达成合作协议，获得布瑞哌唑在大部分亚洲国家（例如日本、土耳其、埃及）的权益。 2015年7月，布瑞哌唑首次在美国获批上市，商品名为Rexulti，用于治疗重度抑郁症（MDD）或精神分裂症。2023年5月，布瑞哌唑的适应症扩大至阿尔兹海默病激越症状。2024年6月，布瑞哌唑在中国获批上市。另，除了齐鲁制药，国内还有10家企业递交了布瑞哌唑口溶膜的上市申请，包括科伦药业、欣峰制药、博志研新等企业。（2）复方聚乙二醇（3350）电解质维C散（Ⅱ）（化药5.1类，北京普德康利医药科技发展有限公司） 2024年10月9日，舒泰神（北京）生物制药股份有限公司收到了国家药品监督管理局核准签发的复方聚乙二醇(3350)电解质维C散《药品注册证书》（国药准字H20244968）。该药品注册分类为化学药品3类，其参比制剂为英国Norgine公司生产的Moviprep®，该药于2006年1月19日在英国上市。本品是该参比制剂在国内的首个仿制药，属于用于肠道清洁的药品。 2025年9月，因未按要求调整药品价格，该药品被上海市医药集中招标采购事务管理所暂停采购资格。

2025-07-09

·Mayoly消化界

结肠镜检查前肠道准备：聚乙二醇 vs 复方匹可硫酸钠

研究背景结直肠癌（CRC）是全球癌症相关死亡的第二大原因，而结肠镜检查作为CRC筛查的金标准，其效果高度依赖肠道准备的质量。研究表明，高达20%的腺瘤可能因肠道清洁不充分而被漏诊。研究目的比较了PEG和复发匹可硫酸钠在肠道清洁质量、检查完成率及腺瘤检出率（ADR）上的表现，为临床实践提供了重要证据。研究设计回顾性临床研究研究方法回顾了2020年6月至2023年6月期间在University Hospital Crosshouse进行的6,921例结肠镜检查，其中：PEG组：6,219例（89.9%），分次剂量方案。复方匹克硫酸钠组：702例（10.1%），分次剂量方案。研究通过改良渥太华肠道准备量表（Ottawa Scale）评估清洁质量，并统计盲肠插管率及ADR。研究结果 1. 肠道清洁质量：PEG优于复方匹克硫酸钠PEG的肠道准备不充分发生率率显著低于复方匹克硫酸钠（5.5% vs. 9.0%，P=0.0013）。清洁质量分级（优秀/良好/一般）中，MoviPrep组占比均高于Picolax组。表1：两组肠道准备质量比较结果2. 检查完成率盲肠插管率：PEG组优于复方硫酸钠组（59.1% vs. 43.7%，P<0.0001）。回肠插管率：PEG组优于复方硫酸钠组（18.0% vs. 11.5%，P<0.0001）。3. 腺瘤检出率（ADR）PEG组ADR显著更高（36.9% vs. 23.8%，P<0.0001）。即使在“优秀”清洁分级中，PEG的ADR仍高于Picolax（27% vs. 20.3%）。表2：两组腺瘤检出率比较结果研究总结 1. PEG全面优于复方匹克硫酸钠：在清洁质量、检查完成率和ADR三项核心指标上均表现更优。2. 临床优先推荐：若无禁忌证（如电解质紊乱），PEG应作为结肠镜准备的首选方案。3. 质量与检出率的关联：肠道清洁质量与ADR呈正相关，优化准备方案可提升CRC早期诊断率。【参考文献】1. Maramraj S, Yeap E. Impact of Bowel Preparation Type on Colonoscopy Quality. Cureus. 2025.Document Number: FOR-CN-002241有效截止日期：2027年7月8日声明本视频/资讯/文章是由博福益普生医学团队编辑/医疗卫生专业人士撰写提供。以上内容仅限医疗卫生专业人士学术交流使用，不用于任何推广目的，且不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。更多精彩内容请持续关注Mayoly消化界 ✦ ✦ ✦ ✦ ✦

临床结果临床研究放射疗法

100 项与氯化钠/氯化钾/无水硫酸钠/聚乙二醇4000 相关的药物交易

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研发状态

批准上市

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适应症	国家/地区	公司	日期
肠道疾病	日本	EA Pharma Co., Ltd.	2012-12-25

未上市

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适应症	最高研发状态	国家/地区	公司	日期
结直肠癌	临床2期	日本	-	2014-08-15
结肠癌	临床2期	德国	Norgine Ltd.	2012-10-01
胃轻瘫	临床1期	英国	Norgine Ltd.	2006-09-01

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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


NCT01978509 (CTgov)	N/A	-	32	Low volume prep (Prepopik) (Low Volume Prep (Prepopik))	遞餘鹽網繭觸鹹膚糧範(齋鹽夢築顧鹽艱選積憲) = 淵窪簾觸餘夢淵構艱積鏇壓窪糧願製廠積簾網 (構網鏇憲齋選襯糧鏇鬱, 1.62) 更多	-	2020-07-17
				Moviprep (Moderate Volume Prep (Moviprep))	遞餘鹽網繭觸鹹膚糧範(齋鹽夢築顧鹽艱選積憲) = 齋壓遞簾膚獵糧鹹膚憲鏇壓窪糧願製廠積簾網 (構網鏇憲齋選襯糧鏇鬱, 1.55) 更多
NCT01732692 (CTgov)	临床3期	-	140	MOVIPREP (MOVIPREP (Morning-only Dose))	遞糧齋鑰鹽顧鑰繭艱餘 = 餘齋窪壓夢憲築襯鏇製窪鏇鹹願襯壓淵鹽繭膚 (餘淵鹽餘顧鹽鹹衊憲壓, 餘膚網憲窪構襯鏇蓋壓 ~ 鑰鹹蓋鹽艱襯鹹鏇製願) 更多	-	2014-05-15
				MOVIPREP (MOVIPREP (Split-dose))	遞糧齋鑰鹽顧鑰繭艱餘 = 夢構餘觸築壓壓夢遞鏇窪鏇鹹願襯壓淵鹽繭膚 (餘淵鹽餘顧鹽鹹衊憲壓, 窪窪顧選齋糧願顧鹽鹽 ~ 繭窪壓鑰齋襯構齋醖鑰) 更多