Therapeutic Drug Monitoring (TDM) with different tolerable doses of memantine for cognitive function preservation in Indian patients with brain metastasis treated with radiation. - NIL

开始日期2025-05-01

申办/合作机构-

ACTRN12624001274561 / Not yet recruiting临床1期

A Phase 1 Open-label Skin Safety, Tolerability and Pharmacokinetic Study of MRX-7MLL (Memantine Transdermal Delivery System) in Healthy Adults

开始日期2024-11-27

申办/合作机构-

NCT06679387 / Recruiting临床2期IIT

"The Effect of Memantine on the Prevention and Amelioration of Paclitaxel-induced Toxicity in Breast Cancer Patients"

Cancer is currently a leading cause of morbidity and mortality worldwide. Chemotherapeutic agents, despite being effective in arresting the progression of cancer by targeting and eliminating rapidly dividing cancer cells, are associated with various adverse effects. Chemotherapy-induced peripheral neuropathy (CIPN) is a serious clinical adverse effect of certain chemotherapeutic agents. For many patients, CIPN symptoms could be severe, disabling, and significantly impairing the activities of daily living (ADL) and diminishing the quality of life (QoL). Paclitaxel-induced peripheral neuropathy may affect up to 97% of paclitaxel-treated patients and become chronic in more than 60% of cases. The initial symptoms of paclitaxel-induced peripheral neuropathy (PIPN) include numbness, tingling, and allodynia (painful sensations in response to normally non-painful stimuli) that can be manifested in the patient's fingers and toes within 24-72 h post-injection. These symptoms may later progress to affect the patient's lower leg and wrists in a "glove and stocking" pattern. Symptoms typically begin distally and continue proximally as the situation worsens. Memantine is a non-competitive NMDA receptor antagonist that inhibits the prolonged influx of Ca2+, responsible for neuronal excitotoxicity while maintaining the physiological NMDA receptor's function and avoiding psychotropic adverse events. Although memantine has been the main treatment option for moderate and severe Alzheimer's disease in the last two decades, numerous studies have investigated its other potential uses. Some studies showed that memantine diminished chronic pain in complex regional pain syndrome, phantom limb pain, and fibromyalgia. Most in vivo and in vitro studies attributed the neuroprotective effects of memantine to the blockade of NMDA receptors on neurons as well as inhibition of microglia activation with subsequent reduction of pro-inflammatory mediators' production such as extracellular superoxide anion, intracellular ROS, nitric oxide, prostaglandin E2, and TNF-α, and stimulation of neurotrophic factor release from astroglia.

开始日期2024-10-30

申办/合作机构

Ain Shams University

100 项与盐酸美金刚相关的临床结果

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100 项与盐酸美金刚相关的转化医学

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100 项与盐酸美金刚相关的专利（医药）

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205

项与盐酸美金刚相关的文献（医药）

2025-02-01·Pharmaceutical nanotechnology

Optimizing Neuroprotective Nano-structured Lipid Carriers for Transdermal Delivery through Artificial Neural Network

Article

作者: Prajapati, Bhupendra ; Dalwadi, Saloni ; Thakkar, Vaishali

Background::

Dementia associated with Alzheimer’s disease (AD) is a neurological disorder. AD is a progressive neurodegenerative condition that predominantly impacts the elderly population, although it can also manifest in younger people through the impairment of cognitive functions, such as memory, cognition, and behaviour. Donepezil HCl and Memantine HCl are encapsulated in Nanostructured Lipid Carriers (NLCs) to prolong systemic circulation and minimize the systemic side effects.

Objective::

This work explores the use of data mining tools to optimize the formulation of NLCs comprising of Donepezil HCl and Memantine HCl for transdermal drug delivery. Neuroprotective drugs and excipients are utilized for protecting the nervous system against damage or degeneration.

Methods::

The NLCs were formulated using a high-speed homogenization technique followed by ultrasonication. NLCs were optimized using Box Behnken Design (BBD) in Design Expert Software and artificial neural network (ANN) in IBM SPSS statistics. The independent variables included the ratio of solid lipid to liquid lipid, the percentage of surfactant, and the revolutions per minute (RPM) of the high-speed homogenizer.

Results::

The NLCs that were formulated had a mean particle size ranging from 67.0±0.45 to 142.4±0.52 nm. Both drugs have a %EE range over 75%, and Zeta potential was determined to be - 26±0.36 mV. CryoSEM was used to do the structural study. The permeation study showed the prolonged release of the formulation.

Conclusion::

The results indicate that NLCs have the potential to be a carrier for transporting medications to deeper layers of the skin and reaching systemic circulation, making them a suitable formulation for the management of Dementia. Both ANN and BBD techniques are effective tools for systematically developing and optimizing NLC formulation.

2024-08-01·BIOMEDICINE & PHARMACOTHERAPY

Mitigating radiation-induced brain injury via NLRP3/NLRC4/Caspase-1 pyroptosis pathway: Efficacy of memantine and hydrogen-rich water

Article

作者: Luo, Hao ; Liu, Huan ; Xu, Kai ; Wang, Yuhao ; Lu, Xiaoyu ; Liu, Mengya ; Wang, Yong ; Qin, Xiujun ; Sun, Ge

Radiation-induced brain injury (RIBI) is a significant challenge in radiotherapy for head and neck tumors, impacting patients' quality of life. In exploring potential treatments, this study focuses on memantine hydrochloride and hydrogen-rich water, hypothesized to mitigate RIBI through inhibiting the NLRP3/NLRC4/Caspase-1 pathway. In a controlled study involving 40 Sprague-Dawley rats, divided into five groups including a control and various treatment groups, we assessed the effects of these treatments on RIBI. Post-irradiation, all irradiated groups displayed symptoms like weight loss and salivation, with notable variations among different treatment approaches. Particularly, hydrogen-rich water showed a promising reduction in these symptoms. Histopathological analysis indicated substantial hippocampal damage in the radiation-only group, while the groups receiving memantine and/or hydrogen-rich water exhibited significant mitigation of such damage. Molecular studies, revealed a decrease in oxidative stress markers and an attenuated inflammatory response in the treatment groups. Immunohistochemistry further confirmed these molecular changes, suggesting the effectiveness of these agents. Echoing recent scientific inquiries into the protective roles of specific compounds against radiation-induced damages, our study adds to the growing body of evidence on the potential of memantine and hydrogen-rich water as novel therapeutic strategies for RIBI.

2024-02-01·Analytical science advances

Screening stabilisers for cyanoenone triterpenoid TX101 in rat plasma samples by simultaneous analysis of parent drug and the epoxidation product

Article

作者: Tian, Lynn ; Tamer, Edward ; Tian, Qingguo

Abstract:

In the development of bioanalytical methods, stabilizing drug molecules in biological matrices is crucial for ensuring reliable exposure data in pharmacokinetic and toxicokinetic sample analyses. This study focuses on the evaluation of stabilizing effects on the synthetic triterpenoid TX101, a cyanoenone triterpenoid Nrf2 activator with known instability in plasma samples. The molecule's unsaturated double bond is susceptible to oxidation, either nonenzymatically via oxygen or enzymatically through cytochrome P450 enzyme‐catalyzed epoxidation. The research explores the impact of antioxidants (L‐ascorbic acid, sodium metabisulfite, sodium sulfite) and P450 enzyme inhibitors (sodium diethyldithiocarbamate, memantine hydrochloride, 1‐aminobenzotriazole) on TX101 stability in rat plasma samples. Results reveal that adding 2.5 mg/mL sodium sulfite or sodium metabisulfite effectively inhibits the nonenzymatic oxidation of TX101 to TX101‐epoxide, while L‐ascorbic acid shows minimal stabilizing effect. Among P450 enzyme inhibitors, sodium diethyldithiocarbamate and memantine hydrochloride exhibit modest stabilizing effects, likely attributed to their antioxidant activity. The developed High‐formance liquid chromatography coupled to tandem mass spectrometry (LC–MS/MS) method, incorporating Supported Liquid Extraction for sample cleanup, allows simultaneous monitoring of TX101 and TX101‐epoxide. Application of this method in a rat dose‐range finding study confirms successful inhibition of TX101‐epoxide formation in samples treated with sodium sulfite or sodium metabisulfite. Overall, the study emphasizes the importance of stabilizers in preventing nonenzymatic oxidation reactions during sample storage, providing valuable insights for bioanalytical method development and validation.

237

项与盐酸美金刚相关的新闻（医药）

5 小时之前

·普利制药300630

【喜讯】安徽普利原料药钆布醇荣膺欧盟CEP认证，诚邀您共谋发展，共铸辉煌未来！

【喜讯】安徽普利原料药钆布醇荣膺欧盟CEP认证，诚邀您共谋发展，共铸辉煌未来！海南普利制药股份有限公司（以下简称“普利制药”）控股子公司安徽普利药业有限公司（以下简称“安徽普利”）已于近日收到欧洲药品质量管理局（European Directorate for the Quality of Medicines & HealthCare，已下简称“EDQM”）签发的原料药钆布醇欧洲药典适用性认证（以下简称“CEP”）证书。本次钆布醇CEP证书的获得，表明该原料药符合欧洲药典的质量要求，显示欧洲规范市场对该原料药质量的认可和肯定。为安徽普利进一步拓展国际市场带来积极影响。并且车间于2023年通过FDA现场检查，药品生产符合美国 FDA的cGMP要求，未来产品将稳定且持续服务于全球客户。 1、钆布醇产品基本情况 1、产品基本情况介绍钆对比剂是最常见的顺磁性对比剂，通过静脉注射引入人体。注射对比剂进行增强扫描后，图像能更加清晰地显示病变边缘或临近组织、内部结构、血供等情况，从而利于病灶检出，帮助疾病诊断。据统计，自从钆对比剂首次被批准用于人类临床诊疗以来，钆对比剂在磁共振检查数量中的应用率高达35%，全世界已进行了4亿多次钆对比剂注射。钆布醇是一种兼具高浓度和高弛豫率的大环状非离子型钆对比剂，显影更清晰，并且集合了对比增强成像的有效性和安全性，适用于全身全年龄段（包括足月新生儿）检查，包括肾功能不全患者。 2、市场情况根据IMS显示，除2020年受全球公共卫生事件影响，不可抗力导致的略微下降外，从2018年至2023年，钆布醇注射剂全球出厂销售额呈现平稳增长，2023年突破4亿美国的市场需求。全球原料药消耗量也呈平稳增长，2023年市场体量达到72吨规模。同比增长率较销售额更高，体现市场对原料药的需求量增长更快。 2023年全球制剂市场占比来看，以欧美市场为主，销售额前五分别为美国、法国、日本、土耳其、意大利，合计占比约57%。 2023年全球原料药消耗量来看，市场消耗前五是美国、土耳其、中国、波兰、德国，合计65%，安徽普利钆布醇原料药已获得美国、土耳其、中国、波兰、德国等主要市场的进入资格。 3、质量优势 1）可同时符合中、美、欧等多方药典标准；产品质量优于参比制剂，无机盐均严格控制，氯离子100ppm以下，锂离子25 ppm以下； 2）钆布醇API为稳定晶型，稳定性更优； 3）有专用生产线，产线自动化程度高，保证稳定供货，年产能可达到20吨以上； 4）可同时提供注射剂辅料考布曲钙钠； 5）钆造影剂生产线车间已通过美国FDA现场检查，符合美国FDA的cGMP要求。 4、注册法规优势本品已在中美等市场进行原料药备案/登记， ①其中US DMF号为039149（状态：A ）; ②CN登记号为Y20240000083，(状态: I ）； ③CEP证书号：CEP 2024-082- Rev 00 ,符合欧洲药典的质量要求； ④获得WC证明，获得土耳其市场的入场资格；其他市场的注册工作也在持续推进中。 2、合作共赢安徽普利将利用自身产品优势，发挥国际注册的能力（已经在多国注册，并且有丰富的国际注册经验），借助国际化制造、质量控制体系和成熟的国际化市场开拓能力，愿与有志于开拓此产品的国内、国际制剂客户提供全方位、深度合作，共创未来。安徽普利安徽普利药业有限公司坐落于安庆国家高新技术产业开发区。是一家活性原料专业供应商，向全球医药、保健和护肤领域提供化学合成、生物合成的高品质特色原料。安徽普利目前拥有11条符合欧美中GMP标准的API 生产线，357台多功能设备。依托强大的研发能力和技术转化能力，已完成造影剂（钆特酸葡胺、钆特醇、钆布醇、碘美普尔、碘普罗胺、碘佛醇、碘帕醇、碘克沙醇等）、合成生物学（司美格鲁肽、熊去氧胆酸、依克多因、红景天苷等）、抗肿瘤（BPA、环磷酰胺等）、其他原料药（盐酸多巴酚丁胺、硝普钠、氢氧化镁、阿普斯特、克立硼罗、伏立康唑、格隆溴铵、盐酸美金刚、特考韦瑞、阿昔洛韦钠、更昔洛韦钠、布美他尼、氟康唑、二硫化硒、别嘌醇等）、其他药用辅料（DOTA、SNAC、磺丁基-β-环糊精钠、卡特利多钙、考布曲钙钠等）等系列产品的研发与生产。欢迎垂询、欢迎合作！ Welcome for enquiry, cooperation！联系人：聂先生 Liangdeng Nie 电话：18857693467 邮箱：nieliangdeng@hnpoly.com 联系人：薛女士 Faye Xue 电话：13616530509 邮箱：ff@hnpoly.com

医药出海诊断试剂申请上市

2024-11-12

·Business Wire

Alpha Cognition Announces Pricing of $50 Million Upsized Public Offering and Nasdaq Listing

VANCOUVER, British Columbia--( BUSINESS WIRE )--Alpha Cognition Inc. (Nasdaq: ACOG) (CSE: ACOG) (“Alpha Cognition”, or the “Company”), a biopharmaceutical company committed to developing novel therapies for debilitating neurodegenerative disorders, today announced the pricing of its upsized public offering of 8,695,653 common shares at a public offering price of $5.75 per share, for gross proceeds of approximately $50 million, before deducting underwriting discounts, commissions, and estimated offering expenses. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 1,184,592 common shares to cover over-allotments at the public offering price, less the underwriting discount. All of the common shares are being offered by the Company. The offering is expected to close on November 13, 2024, subject to the satisfaction of customary closing conditions. The Company has received approval to list its common shares on the Nasdaq Capital Market under the symbol “ACOG” and is expected to begin trading on Nasdaq today, November 12, 2024. The Company intends to use the proceeds towards the commercialization and launch of ZUNVEYL TM in Alzheimer’s Disease, further research and development of its pipeline product candidates, continued commercial CMC activities (chemistry, manufacturing, and controls), and for working capital and general corporate purposes. “This offering serves as a tremendous milestone for Alpha Cognition, as we begin the commercialization of our FDA-approved drug, ZUNVEYL, for the treatment of mild-to-moderate Alzheimer’s Disease,” said Michael McFadden, Chief Executive Officer and Director of the Company. "This financing puts our balance sheet in a position of meaningful strength and provides the necessary foundation for a successful commercial launch, with ample runway to scale over the next few years. We are thrilled to welcome a number of new, high-quality investors to our Nasdaq listing, who also see the benefits of ZUNVEYL and the exciting opportunity for our platform.” Titan Partners Group, a division of American Capital Partners, is acting as Sole Bookrunner for the offering. The securities were sold pursuant to a registration statement on Form S-1 (File No. 333-280196) relating to these securities and a related registration statement on Form S-1 MEF that became effective upon its filing in accordance with Rule 462(b) under the Securities Act of 1933, as amended. The Offering is being made only by means of a prospectus. A copy of the final prospectus related to the Offering may be obtained, when available, from Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, or via email at prospectus@titanpartnersgrp.com or telephone at (929) 833-1246. In addition, a copy of the final prospectus, when available, relating to the Offering may be obtained via the SEC's website at www.sec.gov . This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Alpha Cognition Inc. Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options. ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor (AChEI) for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it improves the function of neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. Benzgalantamine is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. Forward-looking Statements This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the potential closing of the Offering, the use of proceeds of the Offering, receipt of regulatory and stock exchange approvals in connection with Offering and completion of the Nasdaq uplisting. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future.

上市批准临床研究

2024-11-10

·药筛

山东鲁盛多种维生素(12)获批上市，成都苑东甲磺酸萘莫司他上市申请 | 仿制药周报（11.4-11.10）

统计每周仿制药一致性评价申报、上市申请（11.4-11.10） 1、仿制药上市申请获批药品名称企业名称分类受理号阿戈美拉汀片宝利化（南京）制药有限公司;江苏利泰尔药业有限公司4CYHS2302145阿加曲班注射液海南葫芦娃药业集团股份有限公司4CYHS2300184巴氯芬片重庆士立德医药科技有限公司;福安药业集团庆余堂制药有限公司4CYHS2302507玻璃酸钠滴眼液山东华鲁制药有限公司4CYHS2302277玻璃酸钠滴眼液安徽环球药业股份有限公司4CYHS2301913玻璃酸钠滴眼液安徽环球药业股份有限公司4CYHS2301914布洛芬混悬滴剂天大医药科技（珠海）有限公司;天大药业（珠海）有限公司3CYHS2300001地夸磷索钠滴眼液江苏远恒药业有限公司4CYHS2400248地夸磷索钠滴眼液南京黄龙生物科技有限公司;杭州民生药业股份有限公司4CYHS2300464恩扎卢胺软胶囊Dr. Reddy's Laboratories Limited5.2JYHS2200042二甲双胍恩格列净片天大药业（珠海）有限公司4CYHS2301425法莫替丁注射液四川制药制剂有限公司;成都利尔药业有限公司3CYHS2301317伏立康唑干混悬剂健康元药业集团股份有限公司;深圳市海滨制药有限公司4CYHS2301217复方聚乙二醇电解质散(Ⅱ)南京海纳制药有限公司3CYHS2400148复方聚乙二醇电解质散(Ⅱ)黑龙江博宇制药有限公司;四川科伦药业股份有限公司3CYHS2303588己酮可可碱注射液武汉海特生物制药股份有限公司3CYHS2301000甲氨蝶呤片江苏百奥信康医药科技有限公司;浙江浙北药业有限公司3CYHS2300574聚乙烯醇滴眼液四川海梦智森生物制药有限公司;浙江赛默制药有限公司3CYHS2300897克林霉素磷酸酯外用溶液江苏知原药业股份有限公司4CYHS2300147膦甲酸钠注射液华仁药业股份有限公司3CYHS2301137硫辛酸注射液江苏睿实生物科技有限公司;富祥（大连）制药有限公司4CYHS2301742马来酸阿法替尼片江苏华阳制药有限公司4CYHS2301281马来酸氟伏沙明片上海理想制药有限公司4CYHS2301497麦考酚钠肠溶片山东新时代药业有限公司4CYHS2303659米诺地尔搽剂浙江远力健药业有限责任公司;浙江赛默制药有限公司3CYHS2201287莫匹罗星软膏河南羚锐制药股份有限公司;河南羚锐生物药业有限公司4CYHS2301424帕拉米韦注射液陕西博森生物制药股份集团有限公司3CYHS2302082帕米膦酸二钠注射液仁合益康集团有限公司;河北仁合益康药业有限公司3CYHS2300892屈螺酮炔雌醇片南通联亚药业股份有限公司4CYHS2200412瑞巴派特片福安药业集团宁波天衡制药有限公司;福安药业集团庆余堂制药有限公司4CYHS2301188沙库巴曲缬沙坦钠片山东凤凰制药股份有限公司4CYHS2200423头孢氨苄干混悬剂上海金城素智药业有限公司3CYHS2300839维生素B6注射液江苏润恒制药有限公司3CYHS2402860硝普钠注射液成都新恒创药业有限公司3CYHS2301634熊去氧胆酸胶囊浙江寰领医药科技有限公司;浙江康恩贝制药股份有限公司4CYHS2300582盐酸昂丹司琼片杭州和泽坤元药业有限公司;宁波美诺华天康药业有限公司3CYHS2300909盐酸昂丹司琼片杭州和泽坤元药业有限公司;宁波美诺华天康药业有限公司3CYHS2300910盐酸丙卡特罗口服溶液南京艾德加生物制药科技有限公司;山西同达药业有限公司3CYHS2301169盐酸丙卡特罗口服溶液南京艾德加生物制药科技有限公司;山西同达药业有限公司3CYHS2301170盐酸多巴酚丁胺注射液成都瑞尔医药科技有限公司;太极集团四川太极制药有限公司3CYHS2301571盐酸多巴酚丁胺注射液浙江沣华医药科技有限公司;浙江赛默制药有限公司3CYHS2300301盐酸环喷托酯滴眼液山东绅联药业股份有限公司;北京汇恩兰德制药有限公司4CYHS2300007盐酸乐卡地平片兆科药业（广州）有限公司4CYHS2201840盐酸美金刚片四川宏明博思药业有限公司4CYHS2201963盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401448盐酸曲唑酮缓释片山东京卫制药有限公司4CYHS2401449盐酸去氧肾上腺素注射液石家庄四药有限公司3CYHS2300901盐酸去氧肾上腺素注射液南京恒道医药科技股份有限公司;江苏大红鹰恒顺药业有限公司3CYHS2300808伊布替尼胶囊Natco Pharma Limited5.2JYHS2300009依巴斯汀口服溶液湖南金圃医药科技有限公司;南京海纳制药有限公司3CYHS2301495注射用多种维生素(12)山东鲁盛制药有限公司;华北制药股份有限公司4CYHS2201289注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303220注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303219注射用拉氧头孢钠山东晶辉生物技术有限公司;山东润泽制药有限公司3CYHS2303221注射用替考拉宁海南倍特药业有限公司4CYHS2300059注射用替考拉宁四川汇宇制药股份有限公司4CYHS2201552注射用替考拉宁四川汇宇制药股份有限公司4CYHS2201554注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403002注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403004注射用头孢唑肟钠山东晶辉生物技术有限公司;山东润泽制药有限公司4CYHS2403003注射用头孢唑肟钠海南全星制药有限公司4CYHS2301760注射用头孢唑肟钠广州艾奇西新药研究有限公司;福建省福抗药业股份有限公司4CYHS2301641注射用盐酸罗沙替丁醋酸酯郑州维先医药科技有限公司;成都天台山制药股份有限公司3CYHS2301977左卡尼汀口服溶液浙江长典药物技术开发有限公司;浙江凯润药业股份有限公司4CYHS2302108左卡尼汀注射液舒美奇成都生物科技有限公司;四川美大康佳乐药业有限公司4CYHS2301604左卡尼汀注射液舒美奇成都生物科技有限公司;四川美大康佳乐药业有限公司4CYHS2301603左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300334左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300331左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300333左亚叶酸钙注射液浙江普利药业有限公司3CYHS2300332左氧氟沙星滴眼液石家庄凯赛医药科技有限公司;山东海山药业有限公司4CYHS2301194左氧氟沙星片吉林长白山药业集团股份有限公司4CYHS2300552 注：灰色字体部分受理号结论为不批准。 2、一致性评补充申请获批药品名称企业名称受理号阿莫西林胶囊达嘉维康生物制药有限公司;湖南康尔佳生物医药科技有限公司CYHB2350505阿莫西林颗粒四川依科制药有限公司CYHB2350818达肝素钠注射液南京健友生化制药股份有限公司CYHB2450062地西泮注射液安徽长江药业有限公司CYHB2450278二羟丙茶碱注射液天津金耀药业有限公司CYHB2350754非那雄胺片上海现代制药股份有限公司CYHB2350835氟康唑氯化钠注射液辰欣药业股份有限公司CYHB2350856氟哌啶醇注射液山东鲁抗医药集团赛特有限责任公司CYHB2350827复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350360复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350358复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350362复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350361复方电解质注射液(Ⅱ)内蒙古白医制药股份有限公司CYHB2350359铝碳酸镁咀嚼片江西药都仁和制药有限公司CYHB2350887铝碳酸镁咀嚼片修正药业集团长春高新制药有限公司CYHB2250090尼可地尔片锦州九泰药业有限责任公司CYHB2350792葡萄糖酸钙注射液山东新华制药股份有限公司CYHB2350545秋水仙碱片北京嘉林药业股份有限公司CYHB2350922碳酸氢钠片四川德元药业集团有限公司CYHB1950812碳酸氢钠片四川德元药业集团有限公司CYHB1950813碳酸氢钠片青海制药有限公司CYHB1950589头孢克肟分散片广州白云山医药集团股份有限公司白云山制药总厂CYHB2350538头孢克肟分散片广州白云山医药集团股份有限公司白云山制药总厂CYHB2350539头孢克肟片苏州东瑞制药有限公司;华北制药河北华民药业有限责任公司CYHB2450064盐酸多巴酚丁胺注射液无锡凯夫制药有限公司CYHB2350783注射用苯唑西林钠成都第一制药有限公司;山东二叶制药有限公司CYHB2350726注射用苯唑西林钠成都第一制药有限公司;山东二叶制药有限公司CYHB2350727注射用头孢呋辛钠海南灵康制药有限公司CYHB2450250注射用头孢呋辛钠海南灵康制药有限公司CYHB2450251注射用头孢哌酮钠舒巴坦钠华北制药河北华民药业有限责任公司CYHB2350695注射用头孢哌酮钠舒巴坦钠华北制药河北华民药业有限责任公司CYHB2350696 注：灰色字体部分受理号结论为不批准。 3、新增仿制药上市申请药品名称企业名称分类受理号艾拉莫德片海南合瑞制药股份有限公司4CYHS2403841艾拉莫德片江西科伦药业有限公司;四川科伦药业股份有限公司4CYHS2403842氨溴特罗口服溶液山东龙洋生物医药科技有限公司;湖南嘉恒制药有限公司3CYHS2403800氨溴特罗口服溶液山东龙洋生物医药科技有限公司;湖南嘉恒制药有限公司3CYHS2403801氨溴特罗口服溶液湖南状元制药有限公司;南京海纳制药有限公司3CYHS2403763氨溴特罗口服溶液湖南状元制药有限公司;南京海纳制药有限公司3CYHS2403764巴氯芬片浙江诺得药业有限公司4CYHS2403782贝前列素钠片湖南华纳大药厂股份有限公司4CYHS2403758贝前列素钠片湖南华纳大药厂股份有限公司4CYHS2403759吡拉西坦注射液嘉亨（珠海横琴）医药科技有限公司;河南福森药业有限公司3CYHS2403808吡拉西坦注射液嘉亨（珠海横琴）医药科技有限公司;裕松源药业有限公司3CYHS2403809吡美莫司乳膏浙江华海药业股份有限公司4CYHS2403786丙酸氟替卡松雾化吸入用混悬液湖南先施制药有限公司;浙江赛默制药有限公司4CYHS2403724布比卡因脂质体注射液湖南科伦制药有限公司3CYHS2403793布比卡因脂质体注射液湖南科伦制药有限公司3CYHS2403794醋酸钠林格葡萄糖注射液山西诺成制药有限公司3CYHS2403756地屈孕酮片新疆特丰药业股份有限公司;新疆新姿源生物制药有限责任公司4CYHS2403843地屈孕酮片上海延安药业有限公司;浙江赛默制药有限公司4CYHS2403799二羟丙茶碱注射液江西人可医药科技有限公司;裕松源药业有限公司3CYHS2403765非布司他片多多药业有限公司4CYHS2403806非布司他片多多药业有限公司4CYHS2403807非那雄胺片海南药谷云生物科技有限公司;南京海鲸药业股份有限公司4CYHS2403790非那雄胺片海南药谷云生物科技有限公司;南京海鲸药业股份有限公司4CYHS2403791氟伐他汀钠缓释片杭州泓友医药科技有限公司;华益药业科技（安徽）有限公司4CYHS2403826复方聚乙二醇(3350)电解质口服液云南先施药业有限公司;浙江凯润药业股份有限公司3CYHS2403774复方聚乙二醇(3350)电解质散河北智恒医药科技股份有限公司;石家庄龙泽制药股份有限公司3CYHS2403802复方聚乙二醇电解质散(Ⅱ)福州基石医药科技有限公司3CYHS2403839复合磷酸氢钾注射液江苏华阳制药有限公司3CYHS2403766富马酸伏诺拉生片浙江尖峰药业有限公司4CYHS2403820富马酸伏诺拉生片苏州第壹制药有限公司;江苏利泰尔药业有限公司4CYHS2403811富马酸伏诺拉生片苏州第壹制药有限公司;江苏利泰尔药业有限公司4CYHS2403810富马酸伏诺拉生片浙江尖峰药业有限公司4CYHS2403819富马酸福莫特罗吸入溶液齐鲁制药有限公司4CYHS2403814枸橼酸西地那非口崩片江西金世康药业有限公司;济南高华制药有限公司4CYHS2403749黄体酮软胶囊浙江高跖医药科技股份有限公司;浙江赛默制药有限公司4CYHS2403813黄体酮软胶囊浙江高跖医药科技股份有限公司;浙江赛默制药有限公司4CYHS2403812己酮可可碱缓释片海南皇隆制药股份有限公司3CYHS2403772甲氨蝶呤注射液广东岭南制药有限公司4CYHS2403773甲氨蝶呤注射液中寰医药有限公司;无锡紫杉药业股份有限公司4CYHS2403780甲氨蝶呤注射液中寰医药有限公司;无锡紫杉药业股份有限公司4CYHS2403781甲苯磺酸艾多沙班口崩片江苏和晨药业有限公司3CYHS2403760甲磺酸倍他司汀片天津恒翊药业有限公司;江苏诚康药业有限公司4CYHS2403751酒石酸美托洛尔片白云山东泰商丘药业有限公司4CYHS2403834酒石酸美托洛尔片白云山东泰商丘药业有限公司4CYHS2403833克立硼罗软膏山东诚创蓝海医药科技有限公司;津药和平（天津）制药有限公司4CYHS2403789来特莫韦注射液华北制药股份有限公司4CYHS2403784利那洛肽胶囊成都圣诺生物制药有限公司4CYHS2403816膦甲酸钠注射液海南爱科制药有限公司3CYHS2403785硫酸氨基葡萄糖胶囊江苏贝佳制药有限公司4CYHS2403840硫酸镁注射液河北天成药业股份有限公司3CYHS2403798硫酸镁注射液河北天成药业股份有限公司3CYHS2403797硫辛酸片江苏和晨药业有限公司3CYHS2403769硫辛酸片江苏和晨药业有限公司3CYHS2403768氯化钾颗粒湖南千金湘江药业股份有限公司3CYHS2403838氯化钾颗粒湖南千金湘江药业股份有限公司3CYHS2403837罗沙司他胶囊湖南明瑞制药股份有限公司4CYHS2403775吗啉硝唑氯化钠注射液江苏长江药业有限公司;江苏大红鹰恒顺药业有限公司4CYHS2403822美阿沙坦钾片江西施美药业股份有限公司4CYHS2403817美阿沙坦钾片江西施美药业股份有限公司4CYHS2403818米库氯铵注射液河南科伦药业有限公司4CYHS2403746米库氯铵注射液河南科伦药业有限公司4CYHS2403747米力农注射液云南药科院生物医药股份有限公司;楚雄和创药业有限责任公司4CYHS2403835莫匹罗星软膏北京北陆药业股份有限公司;江苏知原药业股份有限公司4CYHS2403795尼麦角林片华润双鹤利民药业（济南）有限公司3CYHS2403829普拉洛芬滴眼液艾视制药有限公司;杭州民生药业股份有限公司4CYHS2403745氢溴酸依他佐辛注射液成都倍特药业股份有限公司3CYHS2403831曲伏前列素滴眼液海南斯达制药有限公司4CYHS2403832乳酸钠林格注射液江苏长江药业有限公司;江苏大红鹰恒顺药业有限公司4CYHS2403821瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403753瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403752瑞格列奈片惠升生物制药股份有限公司;南京海纳制药有限公司4CYHS2403754噻托溴铵粉雾剂正大天晴药业集团南京顺欣制药有限公司;正大天晴药业集团股份有限公司4CYHS2403755羧甲司坦口服溶液万特制药（海南）有限公司3CYHS2403779他达拉非片南京方生和医药科技有限公司;江苏利泰尔药业有限公司4CYHS2403796碳酸氢钠注射液海南如康生物科技有限公司;海南爱科制药有限公司3CYHS2403788托拉塞米注射液江苏恒新药业有限公司3CYHS2403762维生素B12滴眼液四川禾亿制药有限公司4CYHS2403830维生素K1注射液海南美康达药业有限公司;安徽长江药业有限公司3CYHS2403776吸入用乙酰半胱氨酸溶液重庆药友制药有限责任公司4CYHS2403757西格列汀二甲双胍缓释片长春海悦药业股份有限公司3CYHS2403771西咪替丁注射液海韬新药研发（江苏）有限公司;山东威智百科药业有限公司3CYHS2403778腺苷钴胺胶囊成都欣捷高新技术开发股份有限公司;广州博济生物医药科技园有限公司3CYHS2403750熊去氧胆酸片美享生物科技（海南）有限公司;宿州亿帆药业有限公司3CYHS2403770盐酸阿莫罗芬搽剂湖北华傲制药有限公司;武汉爱民制药股份有限公司4CYHS2403748盐酸甲氧氯普胺注射液长春海悦药业股份有限公司3CYHS2403836盐酸莫西沙星滴眼液润尔眼科药物（广州）有限公司4CYHS2403815盐酸莫西沙星氯化钠注射液重庆药谷制药有限公司;哈尔滨三联药业股份有限公司4CYHS2403767盐酸莫西沙星片辰欣药业股份有限公司4CYHS2403827盐酸纳美芬注射液海南元盈医药科技有限公司;酒泉大得利制药股份有限公司3CYHS2403823盐酸帕洛诺司琼软胶囊齐鲁制药有限公司4CYHS2403825盐酸屈他维林片石家庄四药有限公司3CYHS2403792盐酸西替利嗪滴剂成都澜锦医药科技有限公司;成都利尔药业有限公司4CYHS2403805盐酸西替利嗪滴剂成都澜锦医药科技有限公司;成都利尔药业有限公司4CYHS2403804注射用苯唑西林钠广州艾奇西新药研究有限公司;成都倍特药业股份有限公司3CYHS2403761注射用厄他培南钠广州瑞尔医药科技有限公司;广东隆赋药业股份有限公司4CYHS2403803注射用甲磺酸萘莫司他成都苑东生物制药股份有限公司3CYHL2400214注射用卡非佐米江苏诚康药业有限公司4CYHS2403787注射用两性霉素B脂质体齐鲁制药（海南）有限公司4CYHS2403828注射用硫酸艾沙康唑湖北凯安晨医药科技有限公司;山西普德药业有限公司4CYHS2403824注射用盐酸地尔硫卓石家庄四药有限公司4CYHS2403777左卡尼汀注射液云南药科院生物医药股份有限公司;楚雄和创药业有限责任公司4CYHS2403783 4、新增一致性评价补充申报药品名称企业名称受理号黄体酮注射液河南科伦药业有限公司CYHB2450553己酮可可碱注射液西安高科陕西金方药业公司CYHB2450558马来酸氨氯地平分散片江苏万高药业股份有限公司CYHB2450561马来酸依那普利片上海现代制药股份有限公司CYHB2450556匹维溴铵片北京福元医药股份有限公司CYHB2450557普伐他汀钠片第一三共制药（上海）有限公司CYHB2450551普伐他汀钠片第一三共制药（上海）有限公司CYHB2450552维生素B6注射液桂林南药股份有限公司CYHB2450560盐酸伐昔洛韦片珠海润都制药股份有限公司CYHB2450554盐酸林可霉素注射液江苏吴中医药集团有限公司苏州制药厂CYHB2450555盐酸舍曲林分散片浙江京新药业股份有限公司CYHB2450559 数据来源：摩熵医药相关阅读：黄体酮阴道缓释凝胶仿制申请全被否，伏诺拉生片新增3家仿制申请 | 仿制药周报（10.28-11.3）四川汇宇乙酰半胱氨酸注射液首家过评，南京海纳酮洛芬凝胶贴膏上市申请 | 仿制药周报（10.21-10.27）正大天晴来特莫韦首仿获批，石家庄科仁艾普拉唑肠溶片第2家仿制申请 | 仿制药周报（10.14-10.20） 2个氟比洛芬凝胶贴膏被否，安必生美沙拉秦肠溶缓释颗粒获批 | 仿制药周动态（10.7-10.13）

上市批准一致性评价

100 项与盐酸美金刚相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04905	盐酸美金刚	N06DX01	DB01043

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
阿尔茨海默症	欧盟	H. Lundbeck A/S	2002-05-15
阿尔茨海默症	冰岛	H. Lundbeck A/S	2002-05-15
阿尔茨海默症	列支敦士登	H. Lundbeck A/S	2002-05-15
阿尔茨海默症	挪威	H. Lundbeck A/S	2002-05-15
痴呆	德国	H. Lundbeck A/S	2000-08-11

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
血管性痴呆	临床3期	俄罗斯	Merz Pharmaceuticals GmbH	2018-01-23
额颞痴呆	临床3期	加拿大	H. Lundbeck A/S	2007-10-01
复发-缓解型多发性硬化	临床3期	法国	H. Lundbeck A/S	2005-09-01
阿尔茨海默病引起的痴呆症	临床3期	美国	Forest Laboratories LLC	2005-06-01
阿尔茨海默病引起的痴呆症	临床3期	阿根廷	Forest Laboratories LLC	2005-06-01
阿尔茨海默病引起的痴呆症	临床3期	智利	Forest Laboratories LLC	2005-06-01
阿尔茨海默病引起的痴呆症	临床3期	墨西哥	Forest Laboratories LLC	2005-06-01
躁动	临床3期	美国	Forest Laboratories LLC	2004-09-01
认知功能障碍	临床3期	美国	Forest Laboratories, Inc.	2004-04-01
多发性硬化症	临床3期	美国	Forest Laboratories, Inc.	2004-04-01

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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


EAN	N/A	癫痫性脑病 GRIN2A mutation	88	Memantine 0.5 mg/kg	壓齋齋簾鹽構願蓋積築(築膚範醖簾壓顧廠窪膚) = slight changes in cognitive skills, overall improvement was noted 繭淵壓選膚選艱醖衊積 (簾夢觸積餘淵鑰繭膚鹹 ) 更多	积极	2024-06-28
NCT04792645 (CTgov)	临床2期	拔毛癖 \| 皮肤疾病	100	Placebo (Placebo)	繭網獵齋餘淵鹹鏇簾鏇(糧簾構簾顧壓構構淵選) = 糧夢齋夢餘鑰築廠廠鑰襯獵窪衊製繭襯鹽醖顧 (構顧鏇膚憲鏇構構廠艱, 齋鑰範顧糧構餘窪膚蓋 ~ 憲願壓艱積鑰鑰顧壓憲) 更多	-	2023-08-01
				Memantine (Memantine)	繭網獵齋餘淵鹹鏇簾鏇(糧簾構簾顧壓構構淵選) = 獵淵簾鑰積選壓選獵夢襯獵窪衊製繭襯鹽醖顧 (構顧鏇膚憲鏇構構廠艱, 觸蓋齋窪簾鬱襯繭憲鏇 ~ 網餘鬱壓簾鏇膚製網鹽) 更多
NCT04698525 (CTgov)	临床3期	偏头痛	33	Valproate Sodium (Valproate Group)	夢獵繭窪窪顧艱網衊簾(醖蓋範鹽襯膚壓鹹夢製) = 鏇鏇鹽鬱壓網淵範憲夢觸鹽繭鑰製壓醖憲選糧 (衊蓋壓艱鏇夢壓顧網憲, 襯鑰廠網鑰繭製願餘餘 ~ 構積淵糧鑰窪範選糧網) 更多	-	2023-05-17
				memantine (Memantine)	夢獵繭窪窪顧艱網衊簾(醖蓋範鹽襯膚壓鹹夢製) = 築衊願範壓壓觸願餘願觸鹽繭鑰製壓醖憲選糧 (衊蓋壓艱鏇夢壓顧網憲, 構膚構構窪餘願襯製遞 ~ 鏇鑰製醖鹹構蓋鑰醖遞) 更多
NCT03860597 (CTgov)	临床4期	分裂情感性障碍 \| 精神分裂症	42	Placebo+Memantine (Subjects With Schizophrenia: Placebo 1st, Then 20 mg Memantine)	齋鹽範築夢鹽簾壓網鹽(鬱壓範遞廠鬱觸網糧築) = 繭壓築觸鹽構觸襯獵艱遞鹹衊範鏇夢廠鹽醖襯 (蓋範繭憲糧構獵鑰衊壓, 鹽淵餘顧憲鹹醖衊構夢 ~ 窪膚餘願顧範網繭遞膚) 更多	-	2022-12-21
				Placebo+Memantine (Subjects With Schizophrenia: 20 mg Memantine 1st, Then Placebo)	齋鹽範築夢鹽簾壓網鹽(鬱壓範遞廠鬱觸網糧築) = 襯醖窪糧壓糧淵艱選網遞鹹衊範鏇夢廠鹽醖襯 (蓋範繭憲糧構獵鑰衊壓, 糧壓壓鑰憲願繭鹹鹽蓋 ~ 醖齋衊觸憲廠遞醖獵鹹) 更多
NCT00646204 (CTgov)	临床4期	帕金森病	40	Memantine-1 (Memantine-1)	觸鹹襯觸範構網廠範積(襯糧簾構鹹夢窪廠夢醖) = 網襯壓選築餘憲齋壓壓糧獵夢鬱壓構觸築艱遞 (簾鹽繭範廠遞顧衊壓網, 艱衊築餘網淵鏇築觸範 ~ 壓積糧繭製齋簾壓膚夢) 更多	-	2022-12-13
				Placebo (Placebo-2)	觸鹹襯觸範構網廠範積(襯糧簾構鹹夢窪廠夢醖) = 齋窪築壓願廠繭網蓋壓糧獵夢鬱壓構觸築艱遞 (簾鹽繭範廠遞顧衊壓網, 醖鏇願壓壓範艱觸構齋 ~ 齋範醖築膚願餘選鹽襯) 更多
NCT02118727 (TAME, CTgov)	临床2期	额颞痴呆 \| 肌萎缩侧索硬化	89	Memantine (Memantine)	顧鬱獵淵遞鑰廠簾鏇網(鏇襯淵遞網鹽積襯遞遞) = 膚築鹽艱顧鏇夢構觸網壓淵鹽蓋衊築願糧鹽範 (艱壓網製壓簾窪衊襯蓋, 醖積願壓蓋構窪遞鬱鏇 ~ 窪遞鹽蓋鹽窪鹽膚衊鑰) 更多	-	2022-11-29
				Placebo (for Memantine) (Placebo)	顧鬱獵淵遞鑰廠簾鏇網(鏇襯淵遞網鹽積襯遞遞) = 醖餘糧蓋窪醖選鏇窪鬱壓淵鹽蓋衊築願糧鹽範 (艱壓網製壓簾窪衊襯蓋, 醖襯顧願網繭願願艱繭 ~ 鬱衊夢淵顧鑰襯網鑰鏇) 更多
NCT04033419 (ASCO2022) 人工标引	临床2期	早期乳腺癌	56	memantine	壓構觸選築願齋願獵願(鏇鑰蓋獵艱獵網積憲顧) = 鹹觸齋艱醖廠艱願壓鹹選選膚簾淵憲淵選範膚 (夢壓襯觸鏇膚憲醖築積 ) 更多	积极	2022-06-02
NCT02304302 (CTgov)	临床2期	唐氏综合征	160	Placebo (Placebo)	簾壓觸範艱遞餘獵觸膚(構餘糧鹽襯蓋壓繭廠鹽) = 鹹顧餘窪鏇餘顧鏇淵餘艱糧衊鬱淵繭築襯衊製 (艱壓衊齋艱繭窪簾願鹽, 餘齋範壓願鑰膚鬱鑰顧 ~ 範鏇鹹鹹鑰範廠蓋範壓) 更多	-	2022-04-05
				Memantine (Memantine)	簾壓觸範艱遞餘獵觸膚(構餘糧鹽襯蓋壓繭廠鹽) = 糧繭範蓋窪鑰築夢鬱醖艱糧衊鬱淵繭築襯衊製 (艱壓衊齋艱繭窪簾願鹽, 鏇蓋顧顧鏇積築鬱選廠 ~ 鹹鑰網鬱壓鑰艱鑰襯鹹) 更多
NCT02304302 (Pubmed) 人工标引	临床2期	唐氏综合征	160	memantine	蓋鹽糧鹽窪襯製繭築選(鹹鹹範製選襯壓憲選襯): difference = 0.34 (95% CI, -0.98 ~ 1.67), P-Value = 0.61 更多	不佳	2022-01-01
				Placebo
NCT02535611 (EMISO, CTgov)	临床3期	缺血性卒中	47	Memantine (Memantine)	鑰鹹醖鑰鹽鬱顧淵憲齋(膚廠鏇窪構鑰窪顧衊餘) = 簾鑰遞廠選鏇糧獵積蓋築蓋網鑰餘壓觸艱觸遞 (鑰鬱襯齋廠糧齋範觸範, 餘觸廠獵鹽積憲壓觸網 ~ 網願淵窪餘鏇憲遞觸壓) 更多	-	2020-09-16
				Placebo (Placebo)	鑰鹹醖鑰鹽鬱顧淵憲齋(膚廠鏇窪構鑰窪顧衊餘) = 窪選鑰餘壓窪鹽範範鹹築蓋網鑰餘壓觸艱觸遞 (鑰鬱襯齋廠糧齋範觸範, 衊廠鏇憲顧衊糧膚築遞 ~ 簾範憲襯衊醖醖積鬱鹽) 更多