BACKGROUND:
Iron deficiency limits the neurodevelopmental potential of more than 200 million children each year. Iron therapy is typically started when iron deficiency anemia is first diagnosed after screening for anemia or detection of clinical symptoms of iron deficiency anemia at 12 months of age. But iron started at this time does not fully correct earlier iron-deficiency-mediated brain dysfunction, underscoring the need for low-cost, easily implementable adjunct therapies to iron to treat or prevent this dysfunction in high-risk populations.
GAP Supplementation with the nutrient choline lessens damage to the hippocampus from early-life iron deficiency in pre-clinical models and improves hippocampus-mediated memory in children with Fetal Alcohol Spectrum Disorders. Choline has not been tested in children with iron deficiency anemia, despite strong pre-clinical and clinical evidence supporting a benefit to brain development.
HYPOTHESIS:
Infants with iron deficiency anemia who receive iron and nine months of daily choline supplements will have better scores on specific neurobehavioral tests of recognition memory than infants who receive iron and placebo.
METHODS:
This randomized, double-blinded, placebo-controlled clinical trial will randomize 300 6-month-old infants with iron deficiency anemia at Mulago Hospital, Kampala, Uganda, to iron plus choline or iron plus placebo to test the effect of choline on hippocampus-specific and global neurobehavioral outcomes after nine months.
RESULTS: Pending
IMPACT:
If our hypothesis is correct, choline could be added immediately to standard-of-care treatment for iron deficiency anemia. This intervention could safely mitigate the brain dysfunction of early-life iron deficiency that is often undiagnosed until the hippocampal critical window is closing. This simple, low-cost nutrient could thus have life-long benefit for both individuals and the economic and social prosperity of entire regions.

开始日期2025-08-11

申办/合作机构

University of Minnesota

IRCT20191104045328N16

/ Suspended临床3期IIT

The effect of choline supplementation on biometric parameters of fetal growth and glycemic index in women with gestational diabetes

开始日期2023-10-22

申办/合作机构

Arak University of Medical Sciences

NCT05880849

/ Completed临床1期IIT

Testing Whether Choline Normalizes Lipid Metabolism in APOE4 Carriers

The purpose of this study is to test the safety, tolerability, and effects of choline in people with increased risk of Alzheimer's Disease (AD), also known as pre-symptomatic AD. Choline is a dietary supplement, but is being investigated to see if it has any effects on the progression to AD.

开始日期2023-06-26

申办/合作机构

The University of Texas Health Science Center at Houston

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100 项与重酒石酸胆碱相关的临床结果

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100 项与重酒石酸胆碱相关的转化医学

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100 项与重酒石酸胆碱相关的专利（医药）

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项与重酒石酸胆碱相关的文献（医药）

2025-11-01·JOURNAL OF NUTRITION

Contrasting Effects of Phosphatidylcholine and Betaine Supplementation on Embryonic Development in a Mouse Model of the MTHFD1 R653Q Variant

Article

作者: Rozen, Rima ; Keser, Vafa ; Christensen, Karen E ; Faquette, Marie-Lou ; Bottiglieri, Teodoro ; Gebert, Aaron T

BACKGROUND:

Folate and choline are interconnected nutrients important for embryonic development. Genetic variants in folate enzymes, such as MTHFD1 R653Q (c.1958 G>A, rs2236225), may increase dietary choline requirements.

OBJECTIVES:

To evaluate the impact of phosphatidylcholine or betaine supplementation on embryonic development and maternal choline metabolism in the Mthfd1S^+/- mouse model for the MTHFD1 653QQ genotype.

METHODS:

Female Mthfd1S^+/+ (wild type [WT]) and Mthfd1S^+/- (heterozygous [HET]) mice were fed amino acid-defined control (Ctrl), phosphatidylcholine-supplemented (PtdCho), or betaine-supplemented (BTN) diets for 4-6 wk before mating and during pregnancy (18-33 mice/group). Ctrl contained 2.5 g choline bitartrate/kg diet (based on AIN-93G). Supplemented diets contained additional phosphatidylcholine or betaine to obtain the molar equivalent of 3 times the free choline of Ctrl. Embryos were examined for anatomical developmental delays and morphological defects at embryonic day 10.5. One-carbon metabolites (homocysteine, choline, betaine, methionine, cystathionine, S-adenosylmethionine, S-adenosylhomocysteine) were measured in maternal plasma and liver by liquid chromatography-mass spectrometry (LC-MS/MS). The MTHFR protein in maternal liver was assessed by Western blot. Data were analyzed by binary logistic regression or 2-way analysis of variance.

RESULTS:

PtdCho increased developmental delays, compared with Ctrl, in litters of WT (170%) and HET (125%) mothers (P_diet < 0.05). BTN decreased delays 53% compared with Ctrl in HET mother's litters (P_{diet (HET)} < 0.05). Defects decreased 71% in BTN-fed HET mother's litters compared to WT (P < 0.05). BTN increased total pregnancy losses 360% (P_diet < 0.01); PtdCho had no effect. Both diets decreased maternal plasma homocysteine (30-50%, P_diet < 0.05), increased liver BTN (220-290%, P_diet < 0.0001), and decreased S-adenosylmethionine/S-adenosylhomocysteine (WT: 20-30%, HET: 48-61%, P_diet < 0.05). MTHFR protein expression decreased 25% in PtdCho maternal liver (P_diet < 0.01).

CONCLUSIONS:

Phosphatidylcholine and betaine supplementation had contrasting effects on reproductive outcomes. PtdCho increased developmental delays. BTN reduced delays and defects in the Mthfd1S^+/- mouse model, but may impair the establishment of pregnancy. The timing, form, and dosage of choline supplementation may be important and require further investigation.

2025-10-01·ULTRASONICS SONOCHEMISTRY

Novel ternary deep eutectic solvent coupled with in-situ-ultrasound synergistic extraction of flavonoids from Epimedium wushanense: machine learning, mechanistic investigation, and antioxidant activity

Article

作者: Liu, Cheng ; Lei, Jie ; Huang, Zhaolin ; Liu, Xinyu ; Zhao, Ying

This study innovatively developed a novel ternary deep eutectic solvent coupled with in-situ-ultrasound synergistic extraction (TDES-ISUSE)method for efficient extraction of total flavonoids (TF) fromEpimedium wushanense. Among 20 prepared DESs, the ternary system composed of choline bitartrate, urea, and glycerol (Chb:Ure:Gly) exhibited the highest extraction efficiency. Response surface methodology-artificial neural network-genetic algorithm (RSM-ANN-GA) optimization identified the optimal extraction parameters: water content of 32 %, vortex time of 10 min, liquid/solid ratio of 34:1 mL/g, ultrasound time of 30 min, and ultrasound power of 270 W. Under these conditions, the TF yield reached26.39 ± 0.61 mg/g, which was significantly higher than that of conventional extraction methods. Phytochemical profiling ofE. wushanensevia UHPLC-Q-TOF-MS (positive/negative ion modes) unambiguously annotated 15 compounds, including 9 flavonoids; concurrently, an HPLC method was established for quantitative determination of 4 key flavonoids. FT-IR spectroscopy and nuclear magnetic resonance (NMR)confirmed the successful prepared of the novel TDES, while scanning electron microscopy (SEM) and molecular dynamics (MD) simulations elucidated the underlying extraction mechanism, revealing enhanced cell wall disruption and improved solubility of flavonoids in TDES-ISUSE. Antioxidant assays further demonstrated the potential bioactivity of the TF extract. Overall, this work provides aneco-friendly, efficient, and reproducible approachfor extracting bioactive flavonoids fromE. wushanense, with implications for sustainable utilization of medicinal plant resources and advancement of green extraction technologies.

2025-06-01·JOURNAL OF NUTRITION

Low Protein Diet Exacerbates Experimental Mouse Models of Colitis through Epithelial Autonomous and Nonautonomous Mechanisms

Article

作者: Schmidt, Thomas ; Shah, Yatrik M ; Lee, Jun Hee ; Castillo, Cristina ; Taranto, Joseph ; Rebernick, Ryan ; Ponnusamy, Varun ; Sykes, Madeline M ; Solanki, Sumeet ; Leiser, Scott F

BACKGROUND:

Patients with inflammatory bowel diseases (IBDs) are at risk of protein malnutrition due to increased protein loss or reduced dietary intake. The consequences of protein malnutrition on intestinal epithelial metabolism and disease progression remain poorly understood.

OBJECTIVES:

Given the critical role of the mechanistic target of rapamycin complex 1 (mTORC1) as an amino acid sensor and a key regulator of intestinal epithelial metabolism and homeostasis, along with the well-established influence of diet on the gut microbiota and IBD, we focused on accessing the role of dietary protein in modulating intestinal epithelial mTORC1, determine the contributions of specific amino acids such as leucine and arginine, and examine the interplay between protein malnutrition and gut microbiota driving IBD.

METHODS:

C57BL/6 mice were assigned to a control (20% protein, n = 6), a low protein (4% protein, n = 7), or diets selectively deficient in leucine, arginine, and other essential amino acids (n = 5-6). Colitis was induced by administering 2.5% dextran sulfate sodium in drinking water for 6 d. Intestinal epithelial mTORC1 activity was assessed by immunoblotting. Gut microbiota composition was characterized using 16S sequencing, and the microbiota's role in colitis was evaluated through broad-spectrum antibiotic treatment. Disease severity was quantified by monitoring weight loss, colon shortening, histopathological damage, and inflammatory cytokine expression.

RESULTS:

Protein restriction increased the severity of dextran sulfate sodium-induced colitis compared to the control diet (∗∗∗P < 0.001). Mice fed arginine-restricted diets exhibited increased colitis (∗P < 0.05). Protein restriction induced significant alterations in gut microbiota composition, and antibiotic-mediated microbiota depletion partially ameliorated colitis severity, revealing a microbiota-dependent mechanism underlying disease exacerbation.

CONCLUSIONS:

Our study demonstrates a complex interplay between dietary protein, epithelial mTORC1 signaling, and gut microbiota in modulating IBD pathogenesis and highlights the potential for targeted dietary strategies, including amino acid supplementation, to improve disease management in patients with IBD.

项与重酒石酸胆碱相关的新闻（医药）

2024-09-09

·GlobeNewswire-Health Care

Protara Therapeutics Announces Results from THRIVE-1, a Prospective Observational Study Evaluating the Prevalence of Choline Deficiency and Liver Injury in Patients Dependent on Parenteral Support

78% of patients dependent on parenteral support were choline deficient, with 63% of these patients demonstrating liver dysfunction, including steatosis, cholestasis, and hepatobiliary injuryIV Choline Chloride could fill a significant unmet medical need for this populationCompany expects to dose first patient in pivotal PK trial for IV Choline Chloride in Q1 2025 NEW YORK, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced the results of THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS). Results from the study were featured during a poster session at the 46th European Society for Clinical Nutrition and Metabolism Congress (ESPEN), from September 7, 2024, to September 10, 2024, in Milan. The study found that 78% of patients who are dependent on PS were choline deficient, and that 63% of choline deficient participants had liver dysfunction, including steatosis, cholestasis, and hepatobiliary injury, underscoring the need for intravenous (IV) choline supplementation in this patient population. Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement therapy, as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated. “Findings from this study reinforce that there are a significant number of people dependent on PS who may potentially benefit from treatment with IV Choline Chloride,” said Palle Bekker Jeppesen M.D., Ph.D., Clinical Professor, Department of Intestinal Failure and Liver Diseases, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. “Choline is essential for PS dependent patients, as deficiency can lead to hepatic injury, neuropsychological impairment, muscle damage, and thrombotic abnormalities. Access to an IV formulation of choline has the potential to meaningfully impact patients for whom oral or enteral choline supplementation is not an option.” “Currently, there are no approved IV choline products for patients dependent on PS globally, despite top professional medical societies in both the U.S. and Europe recommending choline treatment for these patients,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We remain committed to bringing the first approved IV formulation of choline to the PS community and look forward to initiating our registrational trial in the first quarter of 2025.” THRIVE-1 Study and Results THRIVE-1 was a multi-center, cross-sectional prospective, observational study involving 78 patients to assess the prevalence of choline deficiency and liver injury in adolescents and adult patients with intestinal failure who are dependent on PS. 78% (61/78) were choline deficient, with 63% (38/60) of these patients demonstrating liver dysfunction including steatosis, cholestasis, and signs of hepatobiliary injury. IV choline is recommended for patients receiving PS by the American Society for Parenteral and Enteral Nutrition (ASPEN) Recommendations for Changes in Commercially Available Parenteral Multivitamin and Multi–Trace Element Products, as well as by ESPEN in its Guideline on Home Parenteral Nutrition. Based on feedback from the U.S. Food and Drug Administration, Protara intends to assess the safety and efficacy of IV Choline Chloride in THRIVE-3, a seamless registrational Phase 2b/3 trial with dose confirmation followed by a double-blinded, randomized, placebo-controlled trial in adolescents and adults receiving parenteral support. About IV Choline Chloride IV Choline Chloride is an investigational, intravenous phospholipid substrate replacement therapy initially in development for patients receiving parenteral support (PS). Choline is a known important substrate for phospholipids that are critical for healthy liver function and also plays an important role in modulating gene expression, cell membrane signaling, brain development and neurotransmission, muscle function, and bone health. PS patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing choline. Approximately 80 percent of patients dependent on PS are choline-deficient and have some degree of liver damage, which can lead to hepatic failure. In the U.S. alone, there are approximately 40,000 patients on long-term parenteral support who could benefit from an IV formulation of choline. IV Choline Chloride has the potential to become the first U.S. Food and Drug Administration (FDA) approved IV choline formulation for PS patients. IV Choline Chloride has been granted Orphan Drug Designation by the FDA for the prevention of choline deficiency in PS patients. The Company was issued a U.S. patent claiming a choline composition with a term expiring in 2041. About Protara Therapeutics, Inc. Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin, as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visit www.protaratx.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “designed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include but are not limited to, statements regarding Protara’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: Protara’s business strategy, including its development plans for its product candidates and plans regarding the timing or outcome of existing or future clinical trials; statements related to expectations regarding interactions with the FDA; Protara’s financial position; statements regarding the anticipated safety or efficacy of Protara’s product candidates; and Protara’s outlook for the remainder of the year. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that contribute to the uncertain nature of the forward-looking statements include: risks that Protara’s financial guidance may not be as expected, as well as risks and uncertainties associated with: Protara’s development programs, including the initiation and completion of non-clinical studies and clinical trials and the timing of required filings with the FDA and other regulatory agencies; general market conditions; changes in the competitive landscape; changes in Protara’s strategic and development and commercial plans; Protara’s ability to obtain sufficient financing to fund its strategic plans and commercialization efforts; having to use cash in ways or on timing other than expected; the impact of market volatility on cash reserves; failure to attract and retain management and key personnel; the impact of general U.S. and foreign, economic, industry, market, regulatory, political or public health conditions; and the risks and uncertainties associated with Protara’s business and financial condition in general, including the risks and uncertainties described more fully under the caption “Risk Factors” and elsewhere in Protara's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Protara undertakes no obligation to update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as required by law. Company Contact:Justine O'MalleyProtara TherapeuticsJustine.OMalley@protaratx.com646-817-2836Source: Protara Therapeutics

临床结果临床2期孤儿药

2024-08-26

·CPHI制药在线

会议报名 | 东南亚医药市场开拓机遇与挑战主题会议

✦ ✦ ✦ 随着中国经济的快速增长和科技实力的提升，国内新药研发蓬勃发展，为出海打下良好基础。一直以来，中国医药、原料药出口贸易在东南亚市场占有举足轻重的份额。其中，印度尼西亚、泰国、越南、菲律宾和马来西亚五个国家占据了东南亚医药市场的90%以上。未来这些国家将会成为国内企业转战的重要市场，包括投资建厂等深度合作开发。为助力中国药企加速布局东南亚医药市场，9月11日，东南亚医药市场开拓机遇与挑战主题会议将于CPHI & PMEC 制药工业展（深圳）展会期间在深圳会展中心（福田）举办。会议将从当下市场的最新国际形势出发，结合案例与报告，与上下游企业共同探讨东南亚市场的发展机遇。 ✦ ✦ ✦ 东南亚医药市场开拓机遇与挑战主题会议会议时间 9月11日会议地点深圳会展中心（福田）论坛区A（展位：9A56）主办单位上海博华国际展览有限公司承办单位北京东方比特科技有限公司协办单位 E药经理人扫描太阳码 0元领票并报名听会 8月30日前完成预登记现场可领取电子会刊一份 SHENZHEN 会议议程 09:30 主持人致辞 09:40-10:20 东南亚国家医药国际贸易报告嘉宾介绍吴惠芳北京东方比特（健康网）总经理兼首席研究员，北京玉德未来控股有限公司副总裁吴女士在军事医学科学院药物分析专业获理学硕士学位，1980年起从事药学相关工作，2000年前在部队医疗、科研机构从事临床药学、科研管理等工作，技术职务副主任药师。2000年退役后从事医药信息研究工作，专注于医药行业研究、市场研究、产业链结构研究等领域。在医药原料药、医药商品进出口、医药产业数据等信息方面有发布了大量文献资料和报告发表。为国内外企业、政府和科研机构提供咨询服务。连续多年为“中国化学制药工业协会”所著《医药发展蓝皮书》、《中国医药手册》作者之一；是《中国医药报》、《医药经济报》的特约撰稿人，在国内重要医药报刊发表大量文章。多次被邀请在中国医药行业大型会议和展览上做有关中国医药市场专题演讲。她的演讲以实际数据和案例阐明问题、总结变化规律，在中国制药企业中广为流传，受到医药界的好评。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 10:20-10:50 中国制药企业出海东南亚国家的案例分享嘉宾介绍王亚锋上海医药国际业务事业部东南亚区域负责人、上药泰国总经理中国药科大学本科，中欧国际工商学院Global EMBA。从事医药国际营销工作十余年，深厚的医药行业知识和专业能力。拥有丰富的海外子公司运营和营销团队管理经验。深度参与海外工厂立项，写字楼，仓库等绿地项目建设。海外常驻包括非洲加纳，尼日利亚，乌干达，科特迪瓦，东南亚泰国，菲律宾等多个国家。熟悉多个市场药政法规以及行业准入要求。多次在海外国家从零开始设立全资公司、合资公司，组建销售团队，实现业绩从零突破，运作药品进入国家用药指南和国家医保。所在团队曾实现单品种中国制剂出口第一。历任复星医药集团桂林南药国际商务代表，销售经理，海外国家经理，大区经理等，现任上海医药国际业务事业部东南亚区域负责人，上药泰国总经理。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 10:50-11:20 印度尼西亚制药业的机遇和市场开拓实践嘉宾介绍张君丽成都市一诺医药化工有限公司总经理采购总监公司团队深耕印尼市场十年，专注医药API等产品出口；聘请多名印尼本地员工，长期穿梭在印尼各个制剂工厂，拜访客户，与当地前十大药企均有超级深度的合作与链接！ 11:20-11:45 印尼清真医药产品市场情况更新嘉宾介绍 Dr. Ir. Muslich, M.Si Halal Partnership and Audit Services Director, LPPOM 获得IPB大学学士(S1)、研究生(S2)和博士(S3)学位;此前曾在多家私营公司工作(1991年至1993年)，PT TELKOM WITEL IX Jayapura农业和农用工业发展中心经理(1993年至1994年)，LPPOM MUI清真保证体系负责人(2010年至2015年)，QA和LPPOM MUI标准负责人(2015年至2019年)，LPPOM MUI高级顾问(2020年)，MUI清真认证要求开发团队负责人(2010年至2011年);现为IPB大学农业技术学院农业工业工程系讲师(自1994年起)，清真审核员(自1995年起)，清真管理体系标准制定技术委员会(SNI 99 001)成员，清真家禽屠宰场(SNI 99 002)，家庭切清真反刍(SNI 99 003)，清真食品(SNI 99 004)国家标准化机构(自2015年起)，SKKNI主管能力测试设备开发团队负责人Halal & SKKNI清真审核员(自2017年起)，国家认证机构能力评估员职业(BNSP)(自2015年起)，食品安全能力评估员，机构专业认证(LSP)食品质量保证与安全(JMKP)(自2015年起);于2020-2022年被任命为LPPOM MUI清真合作与审计服务总监。 ☝🏿☝🏿上下滑动了解嘉宾完整简介 11:20-12:00 圆桌讨论：寻找东南亚市场的机会讨论嘉宾深圳市远邦医药有限公司湖南尔康制药股份有限公司成都倍特药业有限公司广州康臣药业有限公司 ...... 扫描太阳码 0元领票并报名听会 8月30日前完成预登记现场可领取电子会刊一份把握东南亚市场发展机遇加速融入全球制药供应链随着东南亚医药市场的发展潜能进一步释放，中国医药企业将迎来更多发展机遇。作为中国药企链接国际市场的重要纽带，CPHI & PMEC 制药工业展（深圳）将携手400余家优质展商，共同探索企业在东南亚乃至全球市场的发展路径。下面就请跟随小编的步伐，一起走近本期的优选展商吧！浙江瑞邦药业股份有限公司展位：9F08 浙江瑞邦药业股份有限公司成立于1956年，具有60多年生产医药原料药和食品添加剂的生产经验。公司以药品生产质量管理规范（GMP) 标准组织生产和销售。本公司的产品获得了美国FDA，欧洲CEP和中国GMP的认证。主要产品有葡萄糖酸盐系列，莫匹罗星，莫匹罗星钙，环孢菌素，夫西地酸等。浙江瑞邦药业股份有限公司在国内外都享有良好的声誉。产品远销美国，欧洲，日本，印度及其他南美和东南亚地区。主推产品环孢菌素、莫匹罗星、莫匹罗星钙、葡萄糖酸钙、葡萄糖酸锌、葡萄糖酸钾、葡萄糖酸镁、葡萄糖酸亚铁、葡萄糖酸铜、葡萄糖酸锰、葡萄糖酸钠、多粘菌素B、夫西地酸、夫西地酸钠、米尔贝肟、葡萄糖酸内酯、非达霉素、甘草次酸、原儿茶酸。 ☝🏿☝🏿上下滑动查看完整展商介绍河北华晨药业集团有限公司展位：9D46 河北华晨药业集团有限公司，始建于1991年，坐落于黄骅经济开发区。是一家集研发、生产、销售药用包装材料、原料药、制剂、医疗器械，开展国内外贸易为一体的医药企业。集团公司现下设河北华晨药业有限公司、黄骅华宾生物科技有限公司、河北华迪药业有限公司、华晨吉海（北京）药物研究院。目前华晨药业拥有通过GMP认证的药用氯化钠、碳酸氢钠、氯化钾及新增制剂包括片剂、硬胶囊制剂、颗粒剂、散剂、软膏剂、凝胶贴膏剂、口服液等数十种，同时生产药用PE袋、膜、包装桶、瓶等药用包装材料等。主推产品氯化钠、碳酸氢钠、氯化钾、氯化钙、氯化铵、依地酸二钠、重酒石酸胆碱、富马酸（辅料、富马酸亚铁、醋酸钙、醋酸钠、硫酸镁、碘化钾、氯化镁、富马酸亚铁、葡萄糖酸锌、葡萄糖二酸钙、双乙酸钠、树脂再生剂、碳酸镧、硫酸钾、利多卡因、氟比洛芬、氯化镁、麝香草粉、盐酸利多卡因、葡萄糖酸钙、洛索洛芬钠、磷酸奥司他韦、无水硫酸钠、氨苯蝶啶、托匹司特、硫酸亚铁、西甲硅油、硫酸双肼屈嗪、甘羟鋁、葡萄糖酸亚铁、叔丁醇镁、异丙醇镁、二甲硅油、碳酸钙、亚硫酸镁（六水）、硫酸钾、乳酸钙、乳酸钠、乳果糖、丙胺卡因、喷托维林、丁卡因、双氯芬酸依泊胺、克立硼罗、阿达帕林、盐酸异丙嗪、高岭土、克罗米通、盐酸异丙嗪、氨苯蝶啶、叔丁醇镁、异丙醇镁、亚硫酸镁知名。 ☝🏿☝🏿上下滑动查看完整展商介绍山西阳和药业有限公司展位号：9A13 山西阳和药业有限公司成立于2017年，坐落于山西省大同市阳高县龙泉工业园区。公司注册资本5100万元，总占地面积100亩。阳和药业作为化学原料药的商业化生产基地，专业从事特色化学原料药的研发、生产、销售。公司现拥有多条原料药生产线，产品涉及呼吸系统、消化系统等多个领域。目前公司可大批量生产乙酰半胱氨酸、间苯三酚、间苯三酚三甲醚、聚乙烯醇等原料药。主推产品乙酰半胱氨酸、间苯三酚、聚乙烯醇、间苯三酚三甲醚。 ☝🏿☝🏿上下滑动查看完整展商介绍浙江荣耀生物科技股份有限公司展位：9C51 浙江荣耀生物科技股份有限公司创立于1999年，位于台州湾经济技术开发区，是一家集研发、生产、销售于一体的创新型医药企业，是国家高新技术企业、浙江省专精特新中小企业、浙江省科技型中小企业。业务涵盖医药原料药及中间体、兽药原料药及中间体、CDMO等。主推产品二硝托胺148-01-6、甲砜霉素15318-45-3、氟苯尼考73231-34-2、非班太尔58306-30-2、芬苯达唑43210-67-9、莫昔克丁113507-06-5、赛拉菌素220119-17-5、氟雷拉纳864731-61-3、奥拉替尼1208319-26-9、2-氨基-N-(2、2、2-三氟乙基)乙酰胺盐酸盐1171331-39-7、三氯苯达唑68786-66-3、癸氧喹酯18507-89-6、尼卡巴嗪330-95-0、3′、5′-二氯-2、2、2-三氟苯乙酮130336-16-2、4-氯吡咯并嘧啶3680-69-1、反式-N-甲基-[4-(甲氨基)环己基]甲磺酰胺1809995-95-6、依帕司他82159-09-9、盐酸氨溴索23828-92-4、盐酸金刚乙胺1501-84-4、盐酸溴己新611-75-6、西司他丁82009-34-5、3-甲基-6-硝基-1H-吲唑6494-19-5、2-[4-(2-吡啶基)苄基]-肼羧酸叔丁酯198904-85-7、2-氨基-1-(2、5-二甲氧基苯基)乙醇3600-87-1、3-(三氟甲基)-5、6、7、8-四氢-[1、2、4]三唑并[4、3-a]吡嗪盐酸盐762240-92-6、(3S、4R)-4-(4-氟苯基)-1-甲基-3-哌啶甲醇105812-81-5、1-(4-氨基苯基)环戊甲腈115279-73-7、3-氨基-1-金刚烷醇702-82-9、1-金刚烷甲酸828-51-3、2-金刚烷酮700-58-3、1-金刚烷胺768-94-5、1-金刚烷甲醇770-71-8、2-金刚烷醇700-57-2、1-金刚烷醇768-95-6。 ☝🏿☝🏿上下滑动查看完整展商介绍江苏宇田医药有限公司展位：9E31 江苏宇田医药有限公司是一家从事现代医药研发、生产、销售为一体的新型特色API及CDMO制药企业，致力于为国内各大制药企业提供高质量的原料药与中间体，公司产品同时远销欧洲、日韩、印度等数十个国家，为国家重点高新技术企业、市科技小巨人企业、中华药港新医药产业基地骨干企业之一。宇田医药始终把科研开发作为企业可持续发展的支撑力量，是国内科研投入较多的药企之一，公司以连云港研发中心为科研载体，配合杭州科巢生物科技、连云港万科生物科技、黑龙江迪诺医药，自主创新能力不断增强。形成了“以一带三”的良性格局。宇田医药在江苏连云港、黑龙江佳木斯建有两个生产基地，获得国家高新技术企业、省级工程技术研究中心、江苏省瞪羚企业、江苏省科技型中小企业、安全标准化二级企业、省两化融合示范试点企业，同时也获得了原料药品种的GMP和注册现场核查的二合一认证，先后承担省/市级成果转换等多个省/市级科技项目；获得授权专利与商标数十项；通过ISO9000、ISO14000认证。这些荣誉的取得标志着企业药品生产质量和管理水平走在了全国医药行业前列。主推产品原料药：碘克沙醇、碘海醇、阿托伐他汀钙、瑞舒伐他汀钙、盐酸伊伐布雷定、利奈唑胺、西洛多辛、盐酸厄洛替尼、盐酸莫西沙星及各中间体。中间体：造影剂系列中间体、多尼培南侧链、比阿培南侧链、1,4-丁二磺酸。 ☝🏿☝🏿上下滑动查看完整展商介绍江苏同禾药业有限公司展位：9D26 江苏同禾药业有限公司是江苏万兴创业投资有限公司的全资子公司，是一家集制剂药、原料药和保健食品的研发、生产、销售为一体的国家高新技术企业。连续8年，跻身于常熟市百强企业前50 名。公司拥有原料药、片剂、胶囊剂和颗粒剂的GMP证书。硫辛酸、6.8-二氯辛酸乙酯、右旋硫辛酸钠、环丙贝特、10-甲氧基亚氨基芪等多个产品被评为江苏省高新技术产品；硫辛酸、盐酸二甲双胍等取得了原料药品批件，厄多司坦片、氨酚伪麻分散片和新雪胶囊等取得药品注册批件和新药证书；硫辛酸片和胶囊即将取得新药证书，另有10多个新药正在SFDA审批中。调节血糖和控制并发症的保健食品唐苹片正在全国热销中。主推产品硫辛酸系列、右旋硫辛酸、右旋硫辛酸钠盐、右旋硫辛酸氨基丁三醇盐。 ☝🏿☝🏿上下滑动查看完整展商介绍 CPHI & PMEC 制药工业展（深圳）致力于打造国际化制药产业生态圈，汇集产业链上下游实力企业，以技术驱动产业提升，助推更多中国药企扬帆“出海”，聚势共赢！扫描二维码 0元领票 8月30日前完成预登记现场可领取电子会刊一份金秋九月·不见不散！联系我们参观咨询林女士电话：021-33392105 邮箱：ashley.lin@imsinoexpo.com 张女士电话：010-58036315 邮箱：zhangyuanyuan@cccmhpie.org.cn 参展咨询茅女士电话：021-33392250 邮箱：chris.mao@imsinoexpo.com 吴女士电话：010-58036296 邮箱：wuyushuang@cccmhpie.org.cn 👇点击“阅读原文”，免费领取展会参观门票！！

高管变更

2024-08-23

·ETPharma

Govt bans 156 medicines including antibiotics, painkillers, multivitamins: Here is the full list

New Delhi: In a significant move aimed at safeguarding public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs, including a variety of antibiotics, painkillers, multivitamins, and medications for treating fever and hypertension. This decision marks the largest crackdown on FDCs since 2016, when 344 such drugs were prohibited. The Union Ministry of Health and Family Welfare issued a gazette notification on Thursday, officially prohibiting the manufacture, sale, and distribution of the banned FDCs. The ban was based on the recommendations of an expert panel that reviewed a total of 324 FDCs. Impact on Pharmaceutical Industry The banned FDCs include popular combinations such as mefenamic acid and paracetamol injections, commonly used for pain relief and fever, and omeprazole magnesium with dicyclomine HCl, used to treat abdominal pain. The ban is expected to impact major pharmaceutical companies, including Sun Pharmaceuticals, Cipla, Dr. Reddy's Laboratories, Torrent Pharmaceuticals, and Alkem Laboratories. Fixed Dose Combinations Drug Banned List Here is a table listing all 156 banned Fixed Dose Combinations (FDCs) SN Fixed Dose Combination (FDC) 1 Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain 2 Antimony Potassium Tartrate + Dried Ferrous Sulphate 3 Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride 4 Bismuth Ammonium Citrate + Papain 5 Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide 6 Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride 7 Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide 8 Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol 9 Mefenamic Acid + Paracetamol Injection 10 Omeprazole Magnesium + Dicyclomine HCl 11 S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L- Methylfolate + Choline bitartratee + Silymarin + L-ornithine Laspartate + Inositol + Taurine 12 Silymarin + Thiamine Mononitrate + Riboflavin + Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12 13 Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid 14 Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate 15 Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol 16 Sucralfate + Acelofenac 17 Sucralfate + Domperidone + Dimethicone 18 Sucralfate + Domperidone 19 Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol 20 Ursodeoxycholic Acid + Metformin HCl 21 Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit + Chloroform + Sodium Bicarbonate + Compound Cardamom + Alcohol 22 Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate 23 Aloe + Vitamin E Soap 24 Povidone Iodine+ Metronidazole + Aloe 25 Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles 26 Azithromycin + Adapalene 27 Calamine + Aloes + Allantoin 28 Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor 29 Chlorphenesin + Zinc oxide + Starch 30 Clindamycin Phosphate + Zinc acetate 31 Gamma Benzene Hexachloride + Benzocaine 32 Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin 33 Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w 34 Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes 35 Ketoconazole +Aloe vera+ Vitamin A Acetate 36 Ketoconazole +Aloes + ZPTO 37 Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry 38 Lornoxicam +capsaicin +menthol+ camphor 39 Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate 40 Menthol + Aloe vera Topical Spray 41 Menthol +Lignocaine HCl +Aloe vera gel +Clotrimazole +Diphenhydramine 42 Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate 43 Miconazole +Tinidazole 44 Minoxidil +Aminexil+ Alcohol 45 Minoxidil +Azelaic acid + saw palmetto 46 Minoxidil +Aminexil 47 Pine Bark extract+ Kojic acid +Sodium Ascorbyl Phosphate 48 Povidone Iodine +Tinidazole +Zinc sulphate 49 Povidone Iodine + Ornidazole + Dexpanthenol 50 Salicyclic acid +Aloe vera+ Allantoin +D-Panthenol 51 Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate 52 Sodium salicylate + Zinc gluconate + Pyridoxine HCl 53 Tetracycline + Colistin Sulphate 54 Clomiphene +Ubidecarenone 55 Combikit of Clomiphene Citrate + Estradiol Valerate 56 Flavoxate HCl +Ofloxacin 57 Clomiphene Citrate +N-Acetylcysteine 58 Primerose Oil +Cod liver oil 59 Sildenafil Citrate +Papaverine +L-Arginine 60 Tranexamic acid +Mefenamic acid + Vitamin K1 61 Divalproex Sodium +Oxcarbazepine 62 Divalproex Sodium + Levetiracitam 63 Ergotamine tartrate +Caffeine + Paracetamol +Prochlorperazine maleate 64 Piracetam + Ginkgo biloba extracts + Vinpocetin 65 Ginkgo biloba + methylcobalamin 66 Ginkgo biloba + methylcobalamin + Alpha lipoic acid +Pyridoxine HCl 67 Ginseng Extract +Dried extract of Ginkgo Biloba 68 Meclizine HCl+ Paracetamol + Caffeine 69 Nicergoline + Vinpocetine 70 Gamma Linolenic Acid + Methylcobalamin 71 Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl 72 Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor 73 Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose 74 Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 75 Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose 76 Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl 77 Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine 78 Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose 79 Ketorolac Tromethamine + Flurometholone 80 Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate 81 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor 82 Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate SN Fixed Dose Combination (FDC) 83 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Menthol + Camphor 84 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Hydroxy Propyl Methyl Cellulose 85 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Methylparaben 86 Methenamine + Sodium Benzoate + Benzyl Alcohol 87 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 88 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate + Caffeine 89 Propoxyphene + Chlorpheniramine Maleate 90 Propoxyphene + Phenylephrine Hydrochloride + Chlorpheniramine Maleate 91 Propoxyphene + Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride 92 Sodium Benzoate + Sodium Citrate + Citric Acid 93 Vitamin A Palmitate + Vitamin C + Vitamin E + Vitamin B6 + Vitamin B12 94 Vitamin A Palmitate + Vitamin C + Vitamin E + Niacinamide 95 Vitamin B6 + Vitamin B12 + Vitamin C 96 Vitamin B6 + Vitamin B12 + Niacinamide 97 Vitamin B12 + Vitamin B6 + Vitamin C + Folic Acid 98 Vitamin B12 + Vitamin B6 + Niacinamide + Folic Acid 99 Vitamin C + Vitamin E + Vitamin A + Niacinamide 100 Vitamin D + Calcium + Magnesium 101 Vitamin D + Calcium + Magnesium + Zinc 102 Calcium + Vitamin D + Vitamin K 103 Calcium + Vitamin D + Magnesium + Zinc 104 Calcium + Vitamin D + Vitamin K + Magnesium 105 Calcium + Vitamin D + Vitamin K + Magnesium + Zinc 106 Vitamin E + Vitamin A + Vitamin C + Niacinamide 107 Vitamin E + Vitamin A + Vitamin C + Folic Acid 108 Vitamin E + Vitamin A + Vitamin C + Biotin 109 Vitamin E + Vitamin A + Vitamin C + Vitamin B12 110 Vitamin E + Vitamin C + Folic Acid 111 Vitamin E + Vitamin C + Biotin 112 Vitamin E + Vitamin C + Vitamin B12 113 Vitamin E + Vitamin C + Zinc 114 Calcium + Vitamin D + Omega-3 Fatty Acids 115 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K 116 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Magnesium 117 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Zinc 118 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene 119 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene + Zinc 120 Vitamin C + Vitamin E + Beta-Carotene 121 Vitamin C + Vitamin E + Beta-Carotene + Zinc 122 Vitamin C + Vitamin E + Selenium 123 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids 124 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Magnesium 125 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Zinc 126 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Biotin 127 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 128 Vitamin E + Vitamin A + Vitamin C + Zinc 129 Vitamin E + Vitamin A + Vitamin C + Selenium 130 Vitamin E + Vitamin A + Vitamin C + Biotin 131 Vitamin E + Vitamin A + Vitamin C + Folic Acid + Niacinamide 132 Vitamin E + Vitamin C + Beta-Carotene + Zinc 133 Vitamin C + Vitamin E + Biotin + Folic Acid 134 Vitamin C + Vitamin E + Beta-Carotene + Folic Acid 135 Vitamin C + Vitamin E + Beta-Carotene + Selenium 136 Vitamin E + Vitamin C + Beta-Carotene + Biotin 137 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Biotin 138 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium 139 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B12 140 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B6 141 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Folate 142 Calcium + Vitamin D + Magnesium + Vitamin K + Omega-3 Fatty Acids 143 Calcium + Vitamin D + Magnesium + Vitamin K + Biotin 144 Calcium + Vitamin D + Magnesium + Vitamin K + Selenium 145 Calcium + Vitamin D + Magnesium + Vitamin K + Vitamin B12 146 Calcium + Vitamin D + Magnesium + Vitamin K + Folate 147 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B6 148 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B12 149 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Folic Acid 150 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Biotin 151 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Selenium 152 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids 153 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Zinc 154 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Biotin 155 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Selenium 156 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Vitamin B12

上市批准

100 项与重酒石酸胆碱相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
铁缺乏	临床3期	美国	University of Minnesota	2025-08-11
胎儿酒精谱群障碍	临床2期	美国	University of Minnesota	2016-06-01
阿尔茨海默症	临床1期	美国	Balchem Corp.	2023-06-26

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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


NCT02735473 (CTgov)	临床2期	胎儿酒精谱群障碍	46	Choline bitartrate (Choline Bitartrate)	糧觸廠築齋簾鹽遞膚製(淵廠艱壓襯夢願衊獵鑰) = 窪鏇憲夢膚網糧齋遞齋範繭蓋選齋鬱齋選餘鹹 (獵範鑰獵鬱餘膚鹽網鹽, 0.578) 更多	-	2022-11-01
				Placebo (Placebo)	糧觸廠築齋簾鹽遞膚製(淵廠艱壓襯夢願衊獵鑰) = 憲製構鹽鹽餘壓簾網觸範繭蓋選齋鬱齋選餘鹹 (獵範鑰獵鬱餘膚鹽網鹽, 0.213) 更多
NCT01149538 (CTgov)	临床1/2期	胎儿酒精谱群障碍	60	Choline bitartrate (Choline Bitartrate)	膚衊構蓋衊鏇網艱憲鏇 = 簾觸製廠鬱選遞願膚憲艱製襯顧製顧鑰遞網膚 (網窪壓鑰願繭選鏇繭願, 窪繭鑰構衊淵鹹築廠廠 ~ 構壓遞壓鹽淵鹹膚選簾) 更多	-	2016-08-11
				Placebo for choline bitartrate (Placebo)	膚衊構蓋衊鏇網艱憲鏇 = 鹹構鬱簾襯餘選壓製窪艱製襯顧製顧鑰遞網膚 (網窪壓鑰願繭選鏇繭願, 積積鏇築顧艱製範鑰醖 ~ 選鹹膚襯選壓鬱鏇簾鏇) 更多