Polypill is a fixed-dose combination (FDC) containing three or more drugs in a single pill with the intention of reducing the number of tablets or capsules that need to be taken. Developing a single analytical method ...Polypill is a fixed-dose combination (FDC) containing three or more drugs in a single pill with the intention of reducing the number of tablets or capsules that need to be taken. Developing a single analytical method for the estimation of individual drugs in a Polypill is very challenging, due to the formation of drug-drug and drug-excipients interaction impurities. Here an attempt was made to develop a new, sensitive, single stability-indicating HPLC method for the simultaneous quantitative determination of Aspirin (ASP) Atorvastatin (ATV), Atenolol (ATL) and Losartan potassium (LST) in a polypill form in the presence of degradation products. Efficient chromatographic separation was achieved on a C18 stationary phase with simple mobile phase combination of buffer and Acetonitrile. Buffer consists of 0.1% Orthophosphoric acid (pH 2.9), delivered in a gradient mode and quantitation was carried out using ultraviolet detection at 230 nm with a flow rate of 1.0 mL/min. The retention times of Atenolol, Aspirin, Losartan potassium, and Atorvastatin were 3.3, 7.6, 10.7 and 12.9 min respectively. The combination drug product are exposed to thermal, acid/base hydrolytic, humidity and oxidative stress conditions, and the stressed samples were analyzed by proposed method. The method was validated with respect to linearity;the method was linear in the range of 37.5 to 150.0 μg/mL for ASP, 5.0 to 20.0 μg/mL for ATV and 25.0 to 100.0 μg/mL for ATL and LST. Acceptable precision and accuracy were obtained for concentrations over the standard curve ranges. The validated method was successfully applied to the analysis of Starpill tablets constituting all the four drugs;the percentage recoveries obtained were 99.60% for ASP, 99.30% for ATV, 99.41% for ATL and 99.62% for LST.展开更多
目的:探讨肾复康Ⅱ号胶囊联合氯沙坦钾片对免疫球蛋白A肾病(immunoglobulin A nephropathy,IgAN)伴肾小管间质纤维化患者尿蛋白定量与中医证候积分的影响及其相关性。方法:将80例IgAN伴肾小管间质纤维化患者分为对照组和试验组各40例,...目的:探讨肾复康Ⅱ号胶囊联合氯沙坦钾片对免疫球蛋白A肾病(immunoglobulin A nephropathy,IgAN)伴肾小管间质纤维化患者尿蛋白定量与中医证候积分的影响及其相关性。方法:将80例IgAN伴肾小管间质纤维化患者分为对照组和试验组各40例,对照组予氯沙坦钾片治疗,试验组在对照组基础上予肾复康Ⅱ号胶囊,观察两组患者治疗12、24周后尿蛋白定量及治疗前后中医证候积分。结果:与治疗前比较,试验组治疗12、24周后尿蛋白定量下降(P<0.05),对照组治疗24周尿蛋白定量下降(P<0.05);与对照组比较,试验组治疗12、24周尿蛋白定量降低(P<0.05);治疗24周后试验组中医证候积分较治疗前降低(P<0.05)。结论:IgAN伴肾小管间质纤维化患者尿蛋白定量与中医证候积分之间存在相关性,尿蛋白定量及预后与中医证候、总有效率具有一致性。展开更多
目的探究氯沙坦钾联合复方石韦颗粒治疗慢性肾小球肾炎的临床疗效及对患者血清炎症因子[白细胞诱素-1(LKN-1)、白细胞介素-33(IL-33)及肿瘤坏死因子-α(TNF-α)]水平的影响。方法选取2019年1月至2020年12月衡阳市中心医院收治的95例慢...目的探究氯沙坦钾联合复方石韦颗粒治疗慢性肾小球肾炎的临床疗效及对患者血清炎症因子[白细胞诱素-1(LKN-1)、白细胞介素-33(IL-33)及肿瘤坏死因子-α(TNF-α)]水平的影响。方法选取2019年1月至2020年12月衡阳市中心医院收治的95例慢性肾小球肾炎患者作为研究对象,按照随机数字表法分为观察组(n=47)与对照组(n=48)。对照组单用氯沙坦钾治疗,观察组采用氯沙坦钾联合复方石韦颗粒治疗,比较两组临床疗效、治疗前后尿常规指标[尿红细胞计数(RBC)、24 h尿蛋白定量(24 h Upro)、尿β_(2)-微球蛋白(β_(2)-MG)]和血清炎症因子水平及急性生理学及慢性健康状况评分系统Ⅱ(APACHEⅡ)、健康状况调查简表(SF-36)评分。结果观察组治疗总有效率为95.74%,明显高于对照组的72.92%,差异有统计学意义(P<0.05)。治疗后,两组RBC、24 h Upro、β_(2)-MG水平均明显低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05)。治疗后,两组血清LKN-1、IL-33及TNF-α水平均明显低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05)。治疗后,两组APACHEⅡ评分均明显低于治疗前,SF-36评分均明显高于治疗前,且观察组APACHEⅡ评分低于对照组,SF-36评分高于对照组,差异有统计学意义(P<0.05)。两组治疗过程中均未发生明显不良反应。结论氯沙坦钾联合复方石韦颗粒治疗慢性肾小球肾炎效果显著,能改善患者肾功能,降低血清LKN-1、IL-33及TNF-α水平,提高患者健康状况及生命质量。展开更多
文摘Polypill is a fixed-dose combination (FDC) containing three or more drugs in a single pill with the intention of reducing the number of tablets or capsules that need to be taken. Developing a single analytical method for the estimation of individual drugs in a Polypill is very challenging, due to the formation of drug-drug and drug-excipients interaction impurities. Here an attempt was made to develop a new, sensitive, single stability-indicating HPLC method for the simultaneous quantitative determination of Aspirin (ASP) Atorvastatin (ATV), Atenolol (ATL) and Losartan potassium (LST) in a polypill form in the presence of degradation products. Efficient chromatographic separation was achieved on a C18 stationary phase with simple mobile phase combination of buffer and Acetonitrile. Buffer consists of 0.1% Orthophosphoric acid (pH 2.9), delivered in a gradient mode and quantitation was carried out using ultraviolet detection at 230 nm with a flow rate of 1.0 mL/min. The retention times of Atenolol, Aspirin, Losartan potassium, and Atorvastatin were 3.3, 7.6, 10.7 and 12.9 min respectively. The combination drug product are exposed to thermal, acid/base hydrolytic, humidity and oxidative stress conditions, and the stressed samples were analyzed by proposed method. The method was validated with respect to linearity;the method was linear in the range of 37.5 to 150.0 μg/mL for ASP, 5.0 to 20.0 μg/mL for ATV and 25.0 to 100.0 μg/mL for ATL and LST. Acceptable precision and accuracy were obtained for concentrations over the standard curve ranges. The validated method was successfully applied to the analysis of Starpill tablets constituting all the four drugs;the percentage recoveries obtained were 99.60% for ASP, 99.30% for ATV, 99.41% for ATL and 99.62% for LST.
文摘目的:探讨肾复康Ⅱ号胶囊联合氯沙坦钾片对免疫球蛋白A肾病(immunoglobulin A nephropathy,IgAN)伴肾小管间质纤维化患者尿蛋白定量与中医证候积分的影响及其相关性。方法:将80例IgAN伴肾小管间质纤维化患者分为对照组和试验组各40例,对照组予氯沙坦钾片治疗,试验组在对照组基础上予肾复康Ⅱ号胶囊,观察两组患者治疗12、24周后尿蛋白定量及治疗前后中医证候积分。结果:与治疗前比较,试验组治疗12、24周后尿蛋白定量下降(P<0.05),对照组治疗24周尿蛋白定量下降(P<0.05);与对照组比较,试验组治疗12、24周尿蛋白定量降低(P<0.05);治疗24周后试验组中医证候积分较治疗前降低(P<0.05)。结论:IgAN伴肾小管间质纤维化患者尿蛋白定量与中医证候积分之间存在相关性,尿蛋白定量及预后与中医证候、总有效率具有一致性。
文摘目的探究氯沙坦钾联合复方石韦颗粒治疗慢性肾小球肾炎的临床疗效及对患者血清炎症因子[白细胞诱素-1(LKN-1)、白细胞介素-33(IL-33)及肿瘤坏死因子-α(TNF-α)]水平的影响。方法选取2019年1月至2020年12月衡阳市中心医院收治的95例慢性肾小球肾炎患者作为研究对象,按照随机数字表法分为观察组(n=47)与对照组(n=48)。对照组单用氯沙坦钾治疗,观察组采用氯沙坦钾联合复方石韦颗粒治疗,比较两组临床疗效、治疗前后尿常规指标[尿红细胞计数(RBC)、24 h尿蛋白定量(24 h Upro)、尿β_(2)-微球蛋白(β_(2)-MG)]和血清炎症因子水平及急性生理学及慢性健康状况评分系统Ⅱ(APACHEⅡ)、健康状况调查简表(SF-36)评分。结果观察组治疗总有效率为95.74%,明显高于对照组的72.92%,差异有统计学意义(P<0.05)。治疗后,两组RBC、24 h Upro、β_(2)-MG水平均明显低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05)。治疗后,两组血清LKN-1、IL-33及TNF-α水平均明显低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05)。治疗后,两组APACHEⅡ评分均明显低于治疗前,SF-36评分均明显高于治疗前,且观察组APACHEⅡ评分低于对照组,SF-36评分高于对照组,差异有统计学意义(P<0.05)。两组治疗过程中均未发生明显不良反应。结论氯沙坦钾联合复方石韦颗粒治疗慢性肾小球肾炎效果显著,能改善患者肾功能,降低血清LKN-1、IL-33及TNF-α水平,提高患者健康状况及生命质量。
