Bezlotoxumab:A Novel Agent for the Treatment of Clostridium Difficile Infection / 中国药师

Bezlotoxumab is a human monoclonal antibody that can bind to C. difficile toxin B and neutralize its effects. In October 2016, bezlotoxumab was approved by the food and drug administration(FDA) to reduce the recurrence of Clostridium difficile infection (CDI) in the patients aged equal or above 18 years who are receiving antibacterial therapy. This paper introduced the pharmacology, pharmacokinetics,clinical studies,adverse reactions,interactions and medication attentions of bezlotoxumab.

Simultaneous Determination of Five Components in Guilong Kechuanning Tablets by UPLC with Wave-length Switching / 中国药师

Objective:To develop a UPLC method for the simultaneous determination of 5 components in Guilong Kechuanning tablets including paeoniflorin, berberine hydrochloride, alkaloid, cinnamic acid and cinnamaldehyde. Methods:An ACQUITY UPLC BEH C18(2.1 mm ×100 mm,1.7 μm)chromatographic column was used;the mobile phase was acetonitrile(A)–0.1% formic acid solution (B) with gradient elution (0-10 min, 85% A;10-13 min, 10% A;13-15 min, 85% A) at a flow rate of 0. 4 ml·min-1, the detection wavelengths were:0-1. 8 min, 230 nm;1. 8-6. 0 min, 345 nm;6. 0-9. 0 min, 285 nm;9. 0-12. 0 min, 345 nm, and the column temperature was 30℃. Results:The linear range of paeoniflorin, berberine hydrochloride, alkaloid, cinnamic acid and cinna-maldehyde was 0. 060-1. 202 μg(r=0. 9999),0. 100-2. 010 μg(r=0. 9999),0. 040-0. 794 μg(r=0. 9994),0. 015-0. 302 μg(r=0.9999) and 0.042-0.850 μg(r =0.9999), the average recovery (n = 6) was 99.63%,99.26%,100.17%,98.80% and 100. 26%, and the RSDs were 0. 39%,0. 97%,0. 73%,1. 00% and 0. 71%, respectively. Conclusion:The method is simple, accu-rate and reproducible. It can be used for the quality control of Guilong Kechuanning tablets.

Simultaneous Determination of Five Components in Guilong Kechuanning Tablets by UPLC with Wave-length Switching / 中国药师

Objective:To develop a UPLC method for the simultaneous determination of 5 components in Guilong Kechuanning tablets including paeoniflorin, berberine hydrochloride, alkaloid, cinnamic acid and cinnamaldehyde. Methods:An ACQUITY UPLC BEH C18(2.1 mm ×100 mm,1.7 μm)chromatographic column was used;the mobile phase was acetonitrile(A)–0.1% formic acid solution (B) with gradient elution (0-10 min, 85% A;10-13 min, 10% A;13-15 min, 85% A) at a flow rate of 0. 4 ml·min-1, the detection wavelengths were:0-1. 8 min, 230 nm;1. 8-6. 0 min, 345 nm;6. 0-9. 0 min, 285 nm;9. 0-12. 0 min, 345 nm, and the column temperature was 30℃. Results:The linear range of paeoniflorin, berberine hydrochloride, alkaloid, cinnamic acid and cinna-maldehyde was 0. 060-1. 202 μg(r=0. 9999),0. 100-2. 010 μg(r=0. 9999),0. 040-0. 794 μg(r=0. 9994),0. 015-0. 302 μg(r=0.9999) and 0.042-0.850 μg(r =0.9999), the average recovery (n = 6) was 99.63%,99.26%,100.17%,98.80% and 100. 26%, and the RSDs were 0. 39%,0. 97%,0. 73%,1. 00% and 0. 71%, respectively. Conclusion:The method is simple, accu-rate and reproducible. It can be used for the quality control of Guilong Kechuanning tablets.