1.Quality Consistency Evaluation of Omeprazole Enteric-coated Capsules
Chun GUO ; Minhui CHEN ; Zhonghong LI ; Fei YAN ; Mei CAI ; Zhiyu YAO ; Xiying DUAN
China Pharmacist 2016;19(10):1990-1993
Objective:To establish a method for the determination of omeprazole delayed release capsules and investigate the be-havior of reference preparations to provide experimental basis for generic drugs quality consistency evaluation. Methods:According to the first dissolution method (basket method) stated in 0. 931 of Chinese Pharmacopeia (2015 edition), the type of release media, solu-bility and stability of omeprazole in different media, effect of different treatment methods on the drug adsorption in the solution, differ-ent rotation speed and the methodology of ultraviolet spectrophotometry were investigated. Results:The rotation speed was 75 r·min-1 with the dissolution medium volume of 900 ml. The dissolution profiles of omeprazole delayed release capsules in three different media ( pH 6. 0 phosphate buffer, pH 6. 8 phosphate buffer and water containing 3% Tween-80) were determined with online filteration. The solubility of omeprazole in the different media was 0. 123, 0. 078 and 0. 275 mg·ml-1 , respectively. The results showed that ome-prazole was degraded 44%, 8% and 14% in 2 h in the above three release media, and degraded up to 43% in 6 h in water containing 3% Tween-80. The linear of omeprazole was 0. 209 4-20. 94, 0. 204 8-20. 48 and 0. 2016-20. 16 μg·ml-1 with the average recovery of 99.3% (RSD=0.7%,n=12), 99.7% (RSD=0.9%,n=12) and 99.5% (RSD=0.6%,n=12) respectively in the three media. Conclusion:The method is accurate and reliable, which can be used to study the quality consistency of omeprazole delayed re-lease capsules.
2.Clinical Characteristics and Prognosis in Patients With Mid-ventricular Obstructive Hypertrophic Cardiomyopathy
Shuoyan AN ; Chaomei FAN ; Shihua ZHAO ; Yueqin TIAN ; Yanling LIU ; Fujian DUAN ; Zhimin WANG ; Hongyue WANG ; Chi CAI ; Lirong YAN ; Xiying GUO ; Yinjian YANG ; Yishi LI
Chinese Circulation Journal 2015;(11):1053-1057
Objective: To describe the clinical characteristics with long-term prognosis in patients with mid-ventricular obstructive hypertrophic cardiomyopathy (MVOHCM).
Methods: A total of 66 MVOHCM patients treated in our hospital were retrospectively studied for their morbidity, clinical characteristics and mortality. The cumulative survival rate was calculated by Kaplan-Meier method; the risk factors for cardiac death and cardiovascular events were analyzed by uni- and multivariate Cox proportional hazard model.
Results: There were 66 (2.74%) patients suffering from MVOHCM among 2413 patients of hypertrophic cardiomyopathy and the average diagnostic age was (40.16 ± 14.64) years. With (7.30 ± 6.25) years of follow-up study, the cardiovascular mortality was 13.6% and unexplained syncope (HR=13.37, 95% CI: 1.65-114.46, P=0.015) was the independent predictor for cardiovascular death. There were 45.45% (30/66) patients experienced at least 1 time of cardiovascular event and the most frequent one was non-sustained ventricular tachycardia (NSVT); 19.70% (13/66) of patients combined with apical aneurysms, and they were more inclined to experience NSVT.
Conclusion: MVOHCM patients usually have unfavorable prognosis with the higher incidence of cardiovascular events, some patients may develop apical aneurysm. The early diagnosis of MVOHCM is important for appropriate treatment.

Result Analysis
Print
Save
E-mail