更新于：2024-12-11
Perindopril Arginine
精氨酸培哚普利
更新于：2024-12-11
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
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
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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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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 ; 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.
2022-02-15SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY
Advanced chemometric methods as powerful tools for impurity profiling of drug substances and drug products: Application on bisoprolol and perindopril binary mixture.
Article
作者: Abbas, Samah S ; Elghobashy, Mohamed R ; Hassan, Said A ; Moustafa, Azza A ; Nashat, Nancy W
Impurity profiling has a rising importance nowadays due to the increased health problems associated with impurities and degradation products found in several drug substances and formulations. Three advanced, accurate and precise chemometric methods were developed as impurity profiling methods for a mixture of bisoprolol fumarate (BIS) and perindopril arginine (PER) with their degradation products which represent drug impurity or a precursor to such impurity. The methods applied were Partial Least Squares (PLS-1), Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS) and Artificial Neural Networks (ANN). Genetic Algorithm (GA) was used as a variable selection tool to select the most significant wavelengths for the three chemometric models. For proper analysis, a 5-factor 5-level experimental design was used to establish a calibration set of 25 mixtures containing different ratios of the drugs and their degradation products (impurities). The validity of the proposed methods was assessed using an independent validation set. The designed models were able to predict the concentrations of the drugs and the degradation products/impurities in the validation set and pharmaceutical formulation. The proposed methods presented a powerful alternative to traditional and expensive chromatographic methods as impurity profiling tools.
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
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适应症
分期
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临床2期 | 224 | (Perindopril) | 膚窪窪願顧鹽製獵鬱夢(網糧餘積壓膚構餘蓋觸) = 顧遞廠範網糧鏇衊廠膚 觸壓壓蓋選鹽築鏇簾衊 (鑰繭鏇膚淵鏇繭糧淵艱, 鹽築網艱窪範獵蓋製簾 ~ 廠憲積齋鬱齋廠餘簾繭) 更多 | - | 2021-01-26 | ||
(Amlodipine) | 膚窪窪願顧鹽製獵鬱夢(網糧餘積壓膚構餘蓋觸) = 願蓋鹹鏇願製醖襯鹽齋 觸壓壓蓋選鹽築鏇簾衊 (鑰繭鏇膚淵鏇繭糧淵艱, 選製糧鹽憲觸糧鹹積鬱 ~ 糧範選憲糧顧鏇艱憲淵) 更多 | ||||||
临床4期 | 291 | 願齋壓膚醖範衊構衊襯(醖廠製淵夢憲夢餘繭繭) = 淵窪衊廠艱壓餘繭醖製 糧壓膚憲製網襯觸製簾 (餘衊鬱鏇淵糧鹽遞糧鑰, 選網觸鬱壓鑰選獵廠積 ~ 鬱製鹹壓衊鹽遞鹹衊顧) 更多 | - | 2017-12-11 | |||
(ACEI Continuation) | 願齋壓膚醖範衊構衊襯(醖廠製淵夢憲夢餘繭繭) = 廠艱鹽夢繭構鹹衊憲構 糧壓膚憲製網襯觸製簾 (餘衊鬱鏇淵糧鹽遞糧鑰, 齋鏇製廠糧築醖蓋顧壓 ~ 憲獵膚鏇蓋壓鏇鏇廠襯) 更多 |
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