1.
Experimental and mathematical studies on the drug release properties of aspirin loaded chitosan nanoparticles.
Shi, Y, Wan, A, Shi, Y, Zhang, Y, Chen, Y
BioMed research international. 2014;:613619
Abstract
The study of drug release dynamic is aiming at understanding the process that drugs release in human body and its dynamic characteristics. It is of great significance since these characteristics are closely related to the dose, dosage form, and effect of the drugs. The Noyes-Whitney function is used to represent how the solid material is dissolved into solution, and it is well used in study of drug dynamic. In this research, aspirin (acetylsalicylic acid (ASA)) has been encapsulated with different grades of chitosan (CS) varying in molecular weight (Mw) for the purpose of controlled release. The encapsulation was accomplished by ionic gelation technology based on assembly of positively charged chitosan and negatively charged sodium tripolyphosphate (TPP). The encapsulation efficiency, loading capacity, and drug release behavior of aspirin loaded chitosan nanoparticles (CS-NPs) were studied. It was found that the concentration of TPP and Aspirin, molecular weights of chitosan have important effect on the drug release patterns from chitosan nanoparticles. The results for simulation studies show that the Noyes-Whitney equation can be successfully used to interpret the drug release characteristics reflected by our experimental data.
2.
Clinical trial: the incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone.
Goldstein, JL, Hochberg, MC, Fort, JG, Zhang, Y, Hwang, C, Sostek, M
Alimentary pharmacology & therapeutics. 2010;(3):401-13
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Abstract
BACKGROUND Gastroprotective co-therapy may reduce the risk of nonsteroidal anti-inflammatory drug (NSAID)-associated gastric ulcers, but adherence is suboptimal. AIM: To compare the incidence of gastric ulcers with PN 400 [enteric-coated (EC) naproxen 500 mg and immediate-release esomeprazole 20 mg], or EC naproxen. METHODS Two randomized, double-blind, multicentre studies (PN400-301, PN400-302). Patients [stratified by low-dose aspirin (< or =325 mg) use] aged > or =50 years or 18-49 years with a history of ulcer, received PN 400 BID (301, n = 218; 302, n = 210) or EC naproxen 500 mg BID (301, n = 216; 302, n = 210) for 6 months. The primary endpoint was the cumulative incidence of endoscopic gastric ulcers. RESULTS The cumulative incidence of gastric ulcers was significantly lower with PN 400 vs. EC naproxen (301: 4.1% vs. 23.1%, P < 0.001; 302: 7.1% vs. 24.3%, P < 0.001). PN 400 was associated with a lower combined incidence of gastric ulcers vs. EC naproxen in low-dose aspirin users (n = 201) (3.0% vs. 28.4%, P < 0.001) and non-users (n = 653) (6.4% vs. 22.2%, P < 0.001). The incidence of, and discontinuations due to, upper gastrointestinal (UGI) AEs was significantly lower with PN 400 relative to EC naproxen (P < 0.01, both studies). CONCLUSIONS PN 400 significantly reduces the incidence of gastric ulcers, regardless of low-dose aspirin use, in at-risk patients, and is associated with improved UGI tolerability relative to EC naproxen (ClinicalTrials.gov, NCT00527782).
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[Effects of oxymatrine on microinflammatory state in patients undergoing continuous hemodialysis: a randomized controlled trial].
Zhou, WX, Zheng, WB, Huang, XM, Zhang, Y, Nie, XZ, Li, HB, He, D, Xie, LQ
Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine. 2009;(8):736-40
Abstract
BACKGROUND Chronic microinflammatory state is common in the patients undergoing maintenance hemodialysis (MHD), which seriously affects the long-term survival rate of MHD patients. It is important to improve the microinflammatory state in MHD patients. OBJECTIVE To investigate the effects of oxymatrine on microinflammatory state in patients undergoing continuous hemodialysis. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS Sixty MHD patients in Blood Purification Center, Wuhan No.1 Hospital, from June to September 2008, were randomized into treatment group (30 cases) and control group (30 cases). Oxymatrine Capsule was orally administered to the patients in the treatment group 0.4 g once a day for 3 months, while the patients in the control group were not given oxymatrine. MAIN OUTCOME MEASURES The serum concentrations of high-sensitivity C-reactive protein (hs-CRP), interleukin-1beta (IL-1beta), tumor necrosis factor-alpha (TNF-alpha), albumin (Alb), pre-albumin (PAB), total cholesterol (TC) and triglyceride (TG) were detected before and after 3-month treatment. RESULTS Three patients in the treatment group had a stomachache on the first day of treatment, and two out of the three quitted the trial. The stomachache disappeared in one patient after stopping taking the drug, and did not recur after continuing to receive the intervention. Two patients in the treatment group had skin rash with pruritus on the second day of treatment. The rash disappeared after the patients stopped taking the drug, and did not recur after continuing to receive the intervention. A total of 58 cases accessed to the statistical analysis, while 2 cases were excluded. In the treatment group, the concentrations of hs-CRP, IL-1beta and TNF-alpha significantly decreased (P<0.01) and the mean values of Alb, PAB, TC and TG significantly increased after the treatment as compared with those before the treatment (P<0.01), but there were no significant differences in all parameters between before and after treatment in the control group. There were significant differences in all parameters between the treatment group and the control group after treatment (P<0.01, P<0.05). CONCLUSION Oxymatrine can improve the microinflammatory state in the patients undergoing continuous hemodialysis.