更新于：2024-11-08
Perindopril Arginine
精氨酸培哚普利
更新于：2024-11-08
概要
基本信息
原研机构- |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构
分子式C25H46N6O7 |
InChIKeyRYCSJJXKEWBUTI-YDYAIEMNSA-N |
CAS号612548-45-5 |
关联
10
项与 精氨酸培哚普利 相关的临床试验精氨酸培哚普利片在中国成年健康受试者中的生物等效性研究
精氨酸培哚普利片人体生物等效性研究
一项单中心、随机、开放、单次给药、两制剂、两周期交叉设计研究评价杭州仟源保灵药业有限公司的精氨酸培哚普利片与Les Laboratoires Servier的精氨酸培哚普利片在健康受试者中的空腹和餐后状态下的生物等效性研究
100 项与 精氨酸培哚普利 相关的临床结果
登录后查看更多信息
100 项与 精氨酸培哚普利 相关的转化医学
登录后查看更多信息
100 项与 精氨酸培哚普利 相关的专利（医药）
登录后查看更多信息
53
项与 精氨酸培哚普利 相关的文献（医药）2023-09-01Journal of AOAC International
Chromatographic Techniques for Assessment of Bisoprolol Fumarate and Perindopril Arginine in Solid Formulations under Various Stress Conditions and Application to Six Sigma, Content Uniformity, and Comparative Dissolution Approaches.
Article
作者: Omran, Ahmed A ; Mohamed, Mahmoud A ; Binsaleh, Ammena Y ; Mahmoud, Osama A ; Almalki, Manal A
BACKGROUND:
Antihypertensives bisoprolol fumarate (BIS) and perindopril arginine (PER) were simultaneously determined in their pure, bulk, and combined tablet dosage form.
OBJECTIVE:
This study develops a novel, reproducible, and accurate Reversed phase high-performance liquid chromatography (RP-HPLC) and Reversed phase ultra-performance liquid chromatography (RP-UPLC) with photodiode array detection techniques, which were then applied to in vitro dissolution studies.
METHODS:
The first RP-HPLC method relied on isocratic elution using a mobile phase of methanol-0.05 M phosphate buffer pH 2.6 (1 + 1, by volume), and separation was performed using a Thermo Hypersil C8 column (150 mm × 4.6 mm, 5 μm). Ion-pair UPLC was the second method. An acceptable resolution was achieved using an RP-C18 chromatographic column, Agilent Eclipse (100 × 2.1 mm, 1.7 μm), with a mobile phase containing 0.005 M sodium 1-heptane sulfonate-triethylamine (64 + 1 + 35, by volume), adjusted with phosphoric acid to a pH of 2.0. RP-HPLC used a 1.0 mL/min flow rate, while UPLC used 0.5 mL/min, and the two methods used detection at 210 nm.
RESULTS:
Calibration curves of BIS and PER were linear for RP-HPLC and RP-UPLC methods at 0.5-15 and 0.5-40 μg/mL, respectively. BIS and PER had RP-UPLC LODs of 0.22 and 0.10 μg/mL, respectively, and LOQs of 0.68 and 0.31 μg/mL, respectively. As a result, the approach has been effectively applied to in vitro dissolution testing for drugs in generic and reference products, showing that the two products are comparable. The Six Sigma approach was implemented to compare the recommended and United States Pharmacopeia (USP) procedures, which both exhibited process capability index (Cpk) >1.33. A content uniformity test demonstrated that the drugs in their dosage form met the acceptance limit (85-115%). The degradation products were reliably distinguished from pure drugs for a range of retention times.
CONCLUSION:
In their commercial drug product, the proposed method could be used in QC laboratories for concurrent testing, content uniformity, and in vitro dissolution investigations of BIS and PER. The methods were successfully validated per International Council for Harmonisation (ICH) guidelines.
HIGHLIGHTS:
This study is innovative since it is the first to establish and validate specific and reproducible UPLC and HPLC methods for the concurrent quantitation of the studied drugs in their binary mixture and application to lean Six Sigma, content uniformity, and comparative dissolution approaches.
2022-06-01Advances in therapy
Use of Perindopril Arginine/Indapamide/Amlodipine in the Management of Hypertension in Two Sub-Saharan African Island Countries of Madagascar and Mauritius
Article
作者: Ranivoharisoa, Eliane Mikkelsen ; Ramamonjisoa, Haja Andriamiadanarivo ; Ramilitiana, Benja ; Mbanya, Armand ; Ackbarkhan, Azarkhan ; Mbanya, Jean Claude ; Ratsimbazafy, Solohery Jean Noël ; Mittoo, Mohammad Yaseen
INTRODUCTION:
Most patients with hypertension in sub-Saharan Africa require two or more drugs to control their blood pressure. Triple fixed-dose combination therapy of perindopril arginine/indapamide/amlodipine is more effective in lowering blood pressure, offers better target organ protection and has increased adherence compared to monotherapy and free combination therapy, and is safe to use. This observational study evaluates the effectiveness of perindopril arginine/indapamide/amlodipine in controlling blood pressure at least 1 month after treatment initiation and assesses patient- and physician- reported drug tolerance over a 3-month period in Madagascar and Mauritius.
METHODS:
A total of 198 patients with hypertension in ambulatory care who had been on fixed-dose combination of perindopril arginine, indapamide, and amlodipine for at least 4 weeks were included. The main outcome measures were changes in systolic and diastolic blood pressure, attainment of blood pressure control under 140/90 mmHg and 130/80 mmHg, self-reported drug tolerance by the patient, and perceived drug tolerance by the treating physician. Data was collected at 1 month and 3 months.
RESULTS:
Mean systolic blood pressure was significantly lower at the 1-month (- 3.4 mmHg, p = 0.002) and 3-month (- 8.5 mmHg, p < 0.0001) visits. Diastolic blood pressure also decreased significantly (- 2.4 mmHg at 1-month, p = 0.017 and - 5.4 mmHg at the 3-month visits, p < 0.0001). At 3 months, 80.4% of the patients attained blood pressure targets less than 140/90 mmHg and 42.7% attained targets less than 130/80 mmHg on the basis of their baseline blood pressure. Excellent drug tolerance was reported by more than 90% of patients and physicians at the 1-month visit and by more than 95% at the 3-month visit.
CONCLUSION:
Triple fixed-dose therapy of perindopril arginine/indapamide/amlodipine continues to show additional blood pressure-lowering capacity even months after initiating the treatment in patients with hypertension in Madagascar and Mauritius. It is also well tolerated by patients with hypertension and assessed as safe to use by physicians.
2020-12-01Advances in therapy3区 · 医学
Effect of Perindopril/Indapamide on Cerebral Blood Flow in Middle-Aged, Treatment-Naïve Patients with Hypertension
3区 · 医学
Article
作者: Perepelov, Vsevolod A ; Perepelova, Elena M ; Ostroumova, Tatiana M ; Parfenov, Vladimir A ; Kochetkov, Alexey I ; Ostroumova, Olga D
INTRODUCTION:
The relationship between blood pressure (BP) and cerebral blood flow (CBF) is not fully understood. This study evaluated the impact of a perindopril arginine/indapamide (Pa/I) single-pill combination (SPC) on CBF in middle-aged patients.
METHODS:
A total of 22 treatment-naïve patients with essential hypertension and at least one hypertension-mediated organ damage and 41 healthy controls were enrolled. At baseline, all participants underwent brain magnetic resonance imaging (MRI); patients with hypertension underwent an additional MRI at end of follow-up. Arterial spin labeling (ASL) was used to calculate CBF in the frontal lobe cortical plate. Patients with hypertension received once-daily Pa/I 5 mg/1.25 mg SPC, which could be increased to Pa/I 10 mg/2.5 mg at 2 weeks if necessary. Patients with hypertension underwent 24-h ambulatory BP monitoring (ABPM) at baseline and end of follow-up.
RESULTS:
Mean baseline BP values were 146.2/93.1 and 119.1/76.1 mmHg in the hypertension and control groups, respectively. Patients with hypertension had significantly (p < 0.001) lower CBF in the cortical plate of both left (36.2 ± 8.3 vs. 45.3 ± 3.5 ml/100 g/min) and right (37.9 ± 7.9 vs. 45.8 ± 3.2 ml/100 g/min) frontal lobes compared to normotensive controls. At the end of follow-up, there was a statistically significant (p < 0.001) increase in CBF in the cortical plate of both left (from 36.2 ± 8.3 to 47.5 ± 9.8 ml/100 g/min) and right frontal lobes (from 37.9 ± 7.9 to 47.4 ± 10.1 ml/100 g/min) compared to baseline. No significant difference was found between end of follow-up CBF levels in frontal lobes of patients with hypertension and those of healthy controls at baseline. Office BP decreased by 24.2/15.5 mmHg and 24-h ABPM from 145.5/95.3 to 120.8/79.3 mmHg.
CONCLUSION:
In middle-aged, treatment-naïve patients with hypertension, Pa/I SPC was associated with increased CBF in the cortical plate of the frontal lobes, which achieved levels of normotensive controls. The increase in CBF had no clear association with observed BP changes.
REGISTRATION NUMBER:
ISRCTN67799751.
100 项与 精氨酸培哚普利 相关的药物交易
登录后查看更多信息
研发状态
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 原发性高血压 | 中国 | 2014-10-17 | |
| 冠状动脉疾病 | 澳大利亚 | 2005-06-08 | |
| 心脏衰竭 | 澳大利亚 | 2005-06-08 | |
| 高血压 | 澳大利亚 | 2005-06-08 |
登录后查看更多信息
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 | 224 | (Perindopril) | 簾選艱齋鏇願壓鑰築願(鹽壓淵憲醖齋鏇鹹網壓) = 鏇獵窪蓋艱鹽觸鬱衊襯 醖繭艱襯選醖襯製獵繭 (壓繭憲夢蓋衊願鏇顧憲, 窪窪網選壓顧齋選餘蓋 ~ 選構廠蓋簾網壓簾製觸) 更多 | - | 2021-01-26 | ||
(Amlodipine) | 簾選艱齋鏇願壓鑰築願(鹽壓淵憲醖齋鏇鹹網壓) = 鑰蓋齋廠夢願網窪窪廠 醖繭艱襯選醖襯製獵繭 (壓繭憲夢蓋衊願鏇顧憲, 簾廠鹽淵鹽觸範襯壓願 ~ 壓選觸鹹範鹽夢衊膚膚) 更多 | ||||||
临床4期 | 291 | 獵夢鹹憲艱蓋獵積製蓋(觸醖遞蓋觸鏇糧窪衊膚) = 網願鏇鏇築蓋夢積鹹繭 簾膚鬱網積餘蓋鬱構構 (願夢觸壓選衊襯醖窪窪, 觸廠艱製選鹹膚糧築簾 ~ 網糧鬱膚鹽襯齋網網襯) 更多 | - | 2017-12-11 | |||
(ACEI Continuation) | 獵夢鹹憲艱蓋獵積製蓋(觸醖遞蓋觸鏇糧窪衊膚) = 夢願積餘衊淵衊築糧範 簾膚鬱網積餘蓋鬱構構 (願夢觸壓選衊襯醖窪窪, 餘獵淵齋壓鹽憲選遞鹽 ~ 積觸衊築繭簾窪鹹繭窪) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用