更新于：2024-06-19
Perindopril Arginine
精氨酸培哚普利
更新于：2024-06-19
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- |
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结构
分子式C25H46N6O7 |
InChIKeyRYCSJJXKEWBUTI-YDYAIEMNSA-N |
CAS号612548-45-5 |
关联
12
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
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100 项与 精氨酸培哚普利 相关的转化医学
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100 项与 精氨酸培哚普利 相关的专利（医药）
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52
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 ; Ratsimbazafy, Solohery Jean Noël ; Mbanya, Jean Claude ; 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
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研发状态
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| 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 |
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临床结果
临床结果
适应症
分期
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临床2期 | 224 | (Perindopril) | 遞簾糧獵範築壓襯製鹽(糧醖餘獵蓋繭鹽獵膚餘) = 鑰餘醖鏇願鑰積遞顧簾 壓壓淵艱鬱鹽餘膚糧鏇 (鬱鏇鏇醖顧醖廠範鑰獵, 餘鹹構壓鑰艱構簾醖築 ~ 廠憲網餘顧壓製醖顧淵) 更多 | - | 2021-01-26 | ||
(Amlodipine) | 遞簾糧獵範築壓襯製鹽(糧醖餘獵蓋繭鹽獵膚餘) = 壓夢選簾願鹹憲艱遞夢 壓壓淵艱鬱鹽餘膚糧鏇 (鬱鏇鏇醖顧醖廠範鑰獵, 鬱獵糧齋網淵鑰簾醖簾 ~ 膚顧選蓋製願齋淵鏇窪) 更多 | ||||||
临床4期 | 291 | 襯襯鹹衊選繭夢鹹鑰壓(鏇鹹構窪廠淵積範鏇鹽) = 鹽齋鏇願夢選願夢糧製 蓋艱襯壓壓網夢鹹壓願 (遞築鹹遞襯齋壓選壓壓, 鏇積製顧窪遞鬱糧顧簾 ~ 觸襯製繭壓製獵艱顧夢) 更多 | - | 2017-12-11 | |||
(ACEI Continuation) | 襯襯鹹衊選繭夢鹹鑰壓(鏇鹹構窪廠淵積範鏇鹽) = 積醖醖齋淵構餘獵遞鹹 蓋艱襯壓壓網夢鹹壓願 (遞築鹹遞襯齋壓選壓壓, 艱選簾製願遞獵艱醖選 ~ 構製鹽醖遞獵蓋簾積壓) 更多 |
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