预约演示
更新于：2026-01-27
Cilnidipine
西尼地平
更新于：2026-01-27
概要
基本信息
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 (1995-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国) |
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结构/序列
分子式C27H28N2O7 |
InChIKeyKJEBULYHNRNJTE-DHZHZOJOSA-N |
CAS号132203-70-4 |
关联
47
项与 西尼地平 相关的临床试验CTR20253720
西尼地平片在中国健康受试者空腹和餐后状态下的单中心、随机、开放、两制剂、两周期、两序列、单次给药、交叉设计生物等效性研究
CTRI/2024/11/077154
A multicenter, randomized, double-blind, parallel-group, comparative, active-controlled, phase III clinical trial to evaluate theefficacy and safety of Fixed-Dose Combination of Bisoprolol 5 mg and Cilnidipine 10 mg tablet versus Fixed-Dose Combinationof Metoprolol Succinate ER 50 mg and Cilnidipine 10mg in subjects with Essential Hypertension associated with coronary arterydisease (CAD) - NIL
CTRI/2024/10/075072
A Multicentric, Open-label, Prospective, Non-comparative, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of FDC of Cilnidipine 20 mg plus Telmisartan 40 mg Film-Coated Tablets in subjects with Essential Hypertension - NIL
100 项与 西尼地平 相关的临床结果
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100 项与 西尼地平 相关的转化医学
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100 项与 西尼地平 相关的专利（医药）
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496
项与 西尼地平 相关的文献（医药）2026-01-02DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY
Cost-effective, scalable synthesis of cilnidipine nanocrystals for enhanced oral bioavailability and hypertension treatment
Article
作者: Alsmadi, Mo’tasem M. ; Jararweh, Aseel ; Obaidat, Rana ; Athamneh, Tamara
OBJECTIVE:
To enhance the aqueous solubility and dissolution rate of cilnidipine (CLN), a BCS Class II antihypertensive drug with poor oral bioavailability (13%), by developing oral nanocrystals (NCs) using a scalable antisolvent precipitation and high-speed homogenization technique.
SIGNIFICANCE:
CLN's therapeutic potential is limited by its low solubility. This study addresses this challenge through nanocrystal formulation, offering a cost-effective and industrially viable strategy to improve bioavailability and dissolution performance.
METHODS:
CLN-NCs were prepared by antisolvent precipitation coupled with high-speed homogenization. Stabilizers (PVPk30, mannitol), drug concentrations, and flow rates were systematically optimized. The lead formulation (F19) was characterized for particle size, saturation solubility, and dissolution rate. Solid-state properties were evaluated using SEM, XRPD, DSC, and FTIR to confirm crystalline stability.
RESULTS:
The optimized NCs (F19) exhibited a nanosized particle diameter (19.1 ± 3.8 nm), a 3.3-fold increase in saturation solubility, and a 4.1-fold faster dissolution rate compared to raw CLN. XRPD and DSC confirmed retained crystallinity, while FTIR revealed no drug-stabilizer interactions. SEM showed uniform morphology with no aggregation.
CONCLUSIONS:
CLN-NCs significantly improved in vitro solubility and dissolution, demonstrating a scalable preparation method suitable for industrial translation. This approach offers a promising pathway to enhance CLN's therapeutic efficacy in hypertension management.
2025-12-31Green Chemistry Letters and Reviews
Aligning drug analysis with SDGs: spectrophotometric methods for triple antihypertensive drug using propylene carbonate and statistical Dixon's and Grubb's tests
作者: Obaydo, Reem H. ; Chanduluru, Hemanth Kumar ; Sugumaran, Abimanyu ; Mahmoud Lotfy, Hayam ; Parvathi Kannaiah, Kanaka
Analyzing a drug in a completely overlapping spectrum is always a challenging and inevitable step in the anal. of multi-drug combinations.It requires sophisticated equipment that utilizes more hazardous solvents, which harms environmental safety.Adopting a simple, innovative, low-cost technique for determining compounds in a mixture without affecting the environment is necessary.This study aimed to resolve cilnidipine (CLD), chlorthalidone (CTD), and metoprolol (MTP) combination via an innovative spectrophotometric technique called successive ratio subtraction coupled with the constant multiplication (SRS-CM) and double divisor ratio first derivative method (DD-DD1) without any interference using propylene carbonate (PC) as a green biodegradable solvent.The determination of drugs has been performed in linear concentration ranges of 2.00-14.00, 2.50-11.25, and 2.50-32.50 μg/mL at λmax238.5, 228.5, and 223.2 nm for CLD, CTD, and MTP resp. for method I, and for CLD (243.46 nm), CTD (283.7 nm), and MTP (220.04 nm) using method II.Addnl., the method has been validated by the ICH Q2 R1 guidelines, evaluated through green anal. and sustainability indicators, and confirmed to meet rigorous standards for both environmental responsibility and anal. accuracy while aligning with relevant Sustainable Development Goals (SDGs).
2025-12-01JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS
LC–MS/MS-based simultaneous quantification of chlorthalidone and cilnidipine in rat plasma: Pharmacokinetic evaluation, green analytical assessment, and DoE-driven optimization
Article
作者: Gandu, Sravanthi ; Gandla, Kumaraswamy ; Repudi, Lalitha
A highly sensitive and reproducible liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was systematically developed and optimized using a Quality by Design (QbD) framework for the simultaneous quantification of chlorthalidone and cilnidipine in rat plasma. Critical method variables-organic phase composition, flow rate, and mobile phase pH-were identified through risk assessment and subsequently optimized via Box-Behnken Design to ensure analytical robustness. Optimal chromatographic conditions comprised 20 % organic content, a flow rate of 1.0 mL/min, and a mobile phase pH of 3.0, facilitating efficient resolution of both analytes. Detection was achieved in positive electrospray ionization mode using multiple reaction monitoring, with transitions of m/z 339.8909 → 85.0951 for chlorthalidone, m/z 493.5237 → 300.1587 for cilnidipine, and m/z 515.6423 → 342.6158 for telmisartan, employed as the internal standard. Method validation, performed in accordance with European Medicines Agency (EMA) guidelines, demonstrated excellent linearity (r2 > 0.998), accuracy, and precision, with coefficient of variation consistently <10 %. The method exhibited strong analyte stability and was successfully applied to the pharmacokinetic evaluation of both drugs in Wistar rats. This DoE-optimized LC-MS/MS platform offers a selective, reliable, and environmentally conscious analytical solution for the preclinical assessment of chlorthalidone and cilnidipine.
100 项与 西尼地平 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 高血压 | 日本 | 1995-01-01 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 缺血性卒中 | 临床3期 | 韩国 | 2005-01-01 | |
| 雷诺病 | 临床2期 | 美国 | 2022-07-26 | |
| 硬化肼胝症 | 临床2期 | 美国 | 2022-07-26 | |
| 系统性硬皮病 | 临床2期 | 澳大利亚 | - | |
| 复杂性局部疼痛综合征 | 临床1期 | 美国 | 2022-01-30 | |
| 硬皮病相关的手指溃疡 | 临床1期 | 美国 | 2022-01-30 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 76 | 餘積獵獵壓築壓範蓋製(顧製獵憲觸淵蓋壓襯壓) = Results favoring AISA-021 over placebo were seen on all domains of the SHAQ. 製膚鏇觸夢艱艱築築積 (觸廠鏇襯鹹鏇蓋襯製淵 ) 更多 | 积极 | 2024-11-10 | |||
临床2期 | 27 | 鏇鏇鑰構鬱廠鏇選獵窪(糧簾顧鬱壓獵鬱齋選壓) = no safety issues of concern were demonstrated in the first 27 patients 製顧觸廠鑰鹹艱鏇觸窪 (廠鏇顧襯夢築觸糧鏇願 ) | 积极 | 2022-07-26 |
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