Guidelines and strategy of the International Conference of Harmonization (ICH) and its member states to overcome existing impurity control problems for antibiotics in China / 中国天然药物

In the present report, we review the technical guidelines and principles on impurity research and control for antibiotics established by various agencies, including the International Conference of Harmonization (ICH), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the China Food and Drug Administration (CFDA). Progresses with the US Pharmacopoeia (USP), the European Pharmacopoeia (EP) and the Chinese Pharmacopoeia (ChP) to control impurities in antibiotics are also presented. Next, our discussion is focused on analyzing the CFDA's requirements on impurity research and control for antibiotics, and the implementation of ICH, FDA and other technical guidelines for generic drugs impurity control in China. Existing problems are further reviewed, in order to improve the overall process for the control of antibiotic purity.

Monitoring of the multiple resistant bacteria and development of new antibiotics / 中国药学杂志

METHODS: To collect and retrieve the literature reports, subject summary and case report related to the multiple drug resistance of bacteria both at home and abroad. Summarize, analyze and evaluate the current grim situation for multiple drug resistance in our country as well as analyze the possible reasons, investigate the related successful experience abroad and discuss the basic idea of our country against multiple drug resistance of bacteria.

Study on the enantiomer separation of cetirizine dihydrochloride using proteinate- and amylose-based chiral stationary phase / 药学学报

<p><b>AIM</b>To study the chromatographic behavior of cetirizine dihydrochloride on the proteinate- and amylose- based chiral stationary phases so as to optimizate the chromatographic condition of its enantiomers separation.</p><p><b>METHODS</b>When using amylose-based, alpha1-acid glycoprotein and ovomucoid protein chiral stationary phase, the mobile phase was hexane-isopropyl alcohol-alcohol-trifluoroacetic acid (430:45:25:1), acetonitrile-10 mmol x L(-1) phosphate buffer solution (adjusted to pH 7.0 with sodium hydroxide) (4:96) and acetonitrile-20 mmol x L(-1) KH, PO4 solution (adjusted to pH 7.0 with triethylamine) (12.7:87.3), respectively. The temperature of proteinate column was 25 degrees C. The detective wavelength was 230 nm.</p><p><b>RESULTS</b>The two enantiomers could be separated on the two kinds of chiral stationary phases without derivatization and the resolution was above 2.0. The methods developed on the two kinds of chiral stationary phases are accurate, sensitive and specific.</p><p><b>CONCLUSION</b>Both the proteinate- and amylose-based chiral stationary phases can be used to separate the enantiomers of cetirizine.</p>