Cinacalcet Hydrochloride (CIN) is a new calcimimetic agent indicated for the use in hypercalcemia. The present work is aimed at development and validation of a novel and simple high-performance thin-layer chromatograp...Cinacalcet Hydrochloride (CIN) is a new calcimimetic agent indicated for the use in hypercalcemia. The present work is aimed at development and validation of a novel and simple high-performance thin-layer chromatographic (HPTLC) method for the analysis of Cinacalcet Hydrochloride (active pharmaceutical ingredient, API. In the method, Aluminum-backed silica gel 60 F254 plates (10 × 10 cm) were used as stationary phase and chloroform: acetonitrile (6:4, v/v) as the mobile phase, which showed compact bands of Cinacalcet HCl (RF 0.30 ± 0.02). Quantitative analysis was carried out by densitometry at a wavelength of 282 nm. Linear regression analysis for the calibration spots showed good correlation ship with regression co-efficient r2 = 0.9994 in the range of 40 - 160 ng/band. The developed method suitability for quantification of CIN was learned by validating it as per the ICH guidelines. CIN detection limit was 0.48 ng/band and the quantification limit was 1.59 ng/band. The proposed method was found to be linear (r2 = 0.999), precise (%RSD < 2% for intraday and intermediate precision), accurate, specific, and robust. Further, the developed method was validated and found suitable for stress induced studies, since presence of degradants has no effect on CIN estimation. The proposed method was found to be simple, sensitive, precise, accurate and reproducible for the estimation of CIN.展开更多
Raised levels of the cardiac biomarker, Troponin I, are frequently encountered in hemodialysis patients and appear to be prognostic indicators for cardiovascular risk. Though evidence suggests that control of secondar...Raised levels of the cardiac biomarker, Troponin I, are frequently encountered in hemodialysis patients and appear to be prognostic indicators for cardiovascular risk. Though evidence suggests that control of secondary hyperparathyroidism may reduce cardiac endpoints, the effect of the calcimimetic agent, cinacalcet, remains controversial. This retrospective study aimed at evaluating troponin levels in hemodialysis patients with severe secondary hyper parathyroidism (SHPT) who are on cinacalcet vs controls on conventional treatment. In addition, clinical outcomes including all-cause, cardiovascular morbidity and mortality were compared among both groups. A decline in Troponin I levels was observed in the cinacalcet group, this however was not translated clinically into improved survival. In fact, all-cause and cardiac mortality was similar in the two groups. Conversely, comparison of the incidence of cardiovascular events revealed lower rates in the cinacalcet group including cardiac, cerebral and peripheral vascular complications. Given some of our study limitations, further long-term, placebo-controlled trials are necessary to definitively establish the effect of cinacalet on cardiac biomarkers and ultimately its impact on clinical outcomes.展开更多
Secondary hyperthyroidism(SHPT)is a common complication of maintenance hemodialysis(MHD).In China the prevalence of chronic kidney disease(CKD)is 10.8%and there are about 0.2 million patients treated with maintenance ...Secondary hyperthyroidism(SHPT)is a common complication of maintenance hemodialysis(MHD).In China the prevalence of chronic kidney disease(CKD)is 10.8%and there are about 0.2 million patients treated with maintenance hemodialysis.These number are still increasing.Cinacalcet is a new calcium sensing receptor agonist to treat SHPT and the first calcimimetics be approved by Food and Drug Administration(FDA)to treat human.It can activate the calcium sensing receptor in parathyroid to improving control of parathyroid hormone(PTH),serum calcium,phosphorus,and calcium phosphorus product.Then decrease vascular calcification and parathyroid gland volume and reduce the occurrence of fracture and calcific uremic arteriolopathy(CUA).A better understanding of the clinical evaluation for Cinacalcet will hopefully help us to reduce the incidence of SHPT.展开更多
Objective:To investigate calcitriol, cinacalcet plus comprehensive intervention on maintenance hemodialysis (MHD) patients with secondary hyperparathyroidism (SHPT) calcium (Ca), phosphorus (P) metabolism and parathyr...Objective:To investigate calcitriol, cinacalcet plus comprehensive intervention on maintenance hemodialysis (MHD) patients with secondary hyperparathyroidism (SHPT) calcium (Ca), phosphorus (P) metabolism and parathyroid hormone (PTH) effect.Methods: A total of 80 cases of patients with SHPT from January 2014 to January 2016 in our hospital were randomly divided into observation group and control group, control group to eat the whole piece of cinacalcet hydrochloride oral tablets, the initial dose of 25 mg/d, every 2 to 4 weeks, according to Ca×P, parathyroid hormone (iPTH) test results adjust the dose, the maximum dose of not more than 75 mg/d, the observation group in the control group on the basis of oral administration of Calcitriol Soft Capsules 0.25 g/d, 3 times/week, 2 groups were given comprehensive intervention measures, to evaluate the curative effect after 3 months of treatment. The 2 groups before and after treatment collected fasting peripheral venous blood, the determination of Ca, P and alkaline phosphatase by colorimetric method (ALP), Ca, P product calculation (Ca×P), to detect the level of iPTH before and after treatment by ELISA method;TY-6858-HI type ultrasound instrument, measuring length, width and thickness of the parathyroid glands, and calculate the parathyroid gland volume.Results:in the observation group after treatment, Ca, Ca×P increased degree, P, ALP, iPTH lower than the control group, the size of the parathyroid gland was better than the control group.Conclusion:calcitriol, cinacalcet combined intervention therapy has good clinical effect in patients with MHD SHPT, Ca, P can effectively improve the metabolism, reduce the level of iPTH, reduce the parathyroid gland volume is worthy of promotion.展开更多
文摘Cinacalcet Hydrochloride (CIN) is a new calcimimetic agent indicated for the use in hypercalcemia. The present work is aimed at development and validation of a novel and simple high-performance thin-layer chromatographic (HPTLC) method for the analysis of Cinacalcet Hydrochloride (active pharmaceutical ingredient, API. In the method, Aluminum-backed silica gel 60 F254 plates (10 × 10 cm) were used as stationary phase and chloroform: acetonitrile (6:4, v/v) as the mobile phase, which showed compact bands of Cinacalcet HCl (RF 0.30 ± 0.02). Quantitative analysis was carried out by densitometry at a wavelength of 282 nm. Linear regression analysis for the calibration spots showed good correlation ship with regression co-efficient r2 = 0.9994 in the range of 40 - 160 ng/band. The developed method suitability for quantification of CIN was learned by validating it as per the ICH guidelines. CIN detection limit was 0.48 ng/band and the quantification limit was 1.59 ng/band. The proposed method was found to be linear (r2 = 0.999), precise (%RSD < 2% for intraday and intermediate precision), accurate, specific, and robust. Further, the developed method was validated and found suitable for stress induced studies, since presence of degradants has no effect on CIN estimation. The proposed method was found to be simple, sensitive, precise, accurate and reproducible for the estimation of CIN.
文摘Raised levels of the cardiac biomarker, Troponin I, are frequently encountered in hemodialysis patients and appear to be prognostic indicators for cardiovascular risk. Though evidence suggests that control of secondary hyperparathyroidism may reduce cardiac endpoints, the effect of the calcimimetic agent, cinacalcet, remains controversial. This retrospective study aimed at evaluating troponin levels in hemodialysis patients with severe secondary hyper parathyroidism (SHPT) who are on cinacalcet vs controls on conventional treatment. In addition, clinical outcomes including all-cause, cardiovascular morbidity and mortality were compared among both groups. A decline in Troponin I levels was observed in the cinacalcet group, this however was not translated clinically into improved survival. In fact, all-cause and cardiac mortality was similar in the two groups. Conversely, comparison of the incidence of cardiovascular events revealed lower rates in the cinacalcet group including cardiac, cerebral and peripheral vascular complications. Given some of our study limitations, further long-term, placebo-controlled trials are necessary to definitively establish the effect of cinacalet on cardiac biomarkers and ultimately its impact on clinical outcomes.
基金Guangdong Obers Blood Purification Aca demi cian Work station(2013B090400004)Guangdong University blood purifica tion technology and Engineering Re search Center(GCZX-A1104)+1 种基金Guangzhou en trepreneurial leader talent/LCY201215Guangdong Provincial Center for clinical engineer ing of blood purification(507204531040)
文摘Secondary hyperthyroidism(SHPT)is a common complication of maintenance hemodialysis(MHD).In China the prevalence of chronic kidney disease(CKD)is 10.8%and there are about 0.2 million patients treated with maintenance hemodialysis.These number are still increasing.Cinacalcet is a new calcium sensing receptor agonist to treat SHPT and the first calcimimetics be approved by Food and Drug Administration(FDA)to treat human.It can activate the calcium sensing receptor in parathyroid to improving control of parathyroid hormone(PTH),serum calcium,phosphorus,and calcium phosphorus product.Then decrease vascular calcification and parathyroid gland volume and reduce the occurrence of fracture and calcific uremic arteriolopathy(CUA).A better understanding of the clinical evaluation for Cinacalcet will hopefully help us to reduce the incidence of SHPT.
文摘Objective:To investigate calcitriol, cinacalcet plus comprehensive intervention on maintenance hemodialysis (MHD) patients with secondary hyperparathyroidism (SHPT) calcium (Ca), phosphorus (P) metabolism and parathyroid hormone (PTH) effect.Methods: A total of 80 cases of patients with SHPT from January 2014 to January 2016 in our hospital were randomly divided into observation group and control group, control group to eat the whole piece of cinacalcet hydrochloride oral tablets, the initial dose of 25 mg/d, every 2 to 4 weeks, according to Ca×P, parathyroid hormone (iPTH) test results adjust the dose, the maximum dose of not more than 75 mg/d, the observation group in the control group on the basis of oral administration of Calcitriol Soft Capsules 0.25 g/d, 3 times/week, 2 groups were given comprehensive intervention measures, to evaluate the curative effect after 3 months of treatment. The 2 groups before and after treatment collected fasting peripheral venous blood, the determination of Ca, P and alkaline phosphatase by colorimetric method (ALP), Ca, P product calculation (Ca×P), to detect the level of iPTH before and after treatment by ELISA method;TY-6858-HI type ultrasound instrument, measuring length, width and thickness of the parathyroid glands, and calculate the parathyroid gland volume.Results:in the observation group after treatment, Ca, Ca×P increased degree, P, ALP, iPTH lower than the control group, the size of the parathyroid gland was better than the control group.Conclusion:calcitriol, cinacalcet combined intervention therapy has good clinical effect in patients with MHD SHPT, Ca, P can effectively improve the metabolism, reduce the level of iPTH, reduce the parathyroid gland volume is worthy of promotion.
