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.

Phenolic compounds in branches of Tamarix rasissima / 中国中药杂志

To study the chemical constituents of the branches of Tamarix rasissima, repeated silica gel column chromatography, Sephadex LH-20 chromatography and recrystallization were applied for chemical constituents isolation and purification. Ten phenolic compounds were isolated from the n-BuOH fraction and their structures were elucidated by physical properties and spectra analysis such as UV, ESI-MS and NMR as monodecarboxyellagic acid (1), ellagic acid (2), 3, 3'-di-O-methylellagic acid (3), 3, 3'-di-O-methylellagic acid-4-O-beta-D-glucopyranoside (4), 3, 3'-di-O-methylellagic acid-4'-O-alpha-D-arabinfuranoside (5), ferulic acid (6), isoferulic acid (7), caffeic acid (8), 4-O-acetyl-caffeic acid (9), and 4-methyl-1, 2-benzenediol (10). All compounds except for isoferulic acid were isolated firstly from this plant except for isoferulic acid, and compounds 5, 9 and 10 were obtained from Tamarix genus for the first time.

Effects of apolipoprotein E genetic polymorphism on susceptibility of depression and efficacy of antidepressants / 中国医学科学院学报

<p><b>OBJECTIVE</b>To assess the effects of apolipoprotein E (APOE) polymorphism on the susceptibility of depression and the efficacy of antidepressants.</p><p><b>METHODS</b>A total of 275 patients with depression, who met the diagnostic criteria of both CCMD-3 and DSM-4, were randomly assigned into venlafaxine group (n=136)and paroxetine group(n=139). Another 202 healthy subjects were enrolled as the control group. Hamilton Rating Scale for Depression (HAMD)-17 was adopted as the primary rating instrument to evaluate the severity of depression on the baseline and the end of the 1st, 2nd, 4th, 6th week after treatment, respectively. HAMD scores ≤7 was defined as remission, and the reduction of HAMD scores ≥50% was defined as response while <50% was defined as invalid. PCR-restriction fragment length polymorphisms (PCR-RFLP) was applied to detect the genetic polymorphism of the APOE in the case groups and control group.</p><p><b>RESULTS</b>In the venlafaxine group, the remission rate was 52.9%(n=72), the response rate was 26.5%(n=36), and the invalid rate was 20.6%(n=28), whereas the corresponding data in the paroxetine group wee 42.4%(n=59), 31.7%(n=44), and 25.9% (n=36), respectively. There were no significant differences in the efficacy between the two groups(p>0.05). In the venlafaxine group, there were no significant differences in the genotypes and the allele distribution frequency of APOEΕ2/Ε3/Ε4 between the remitters, nonremitters, and healthy controls at the end of the 6th week(p>0.05), but there was significant differences in the allele distribution frequency between the nonremitters and healthy controls(p=0.02). In paroxetine group, there were no significant differences in the genotypes and the allele distribution frequency of APOEΕ2/Ε3/Ε4 among the remitters, nonremitters and healthy controls at the end of the 6th week(p>0.05), but there were significant differences in the allele distribution frequency between the nonremitters and healthy controls (p=0.04); in addition, there were also significant differences in Ε2/Ε3 and Ε4 allele between the two groups (p=0.014).</p><p><b>CONCLUSIONS</b>The APOE gene may not play a major role in the pathogenesis of major depression. The efficacy of venlafaxine is same as paroxetine after treatment for six weeks. The APOE (Ε2+Ε3) allele may be an indicator of the bad efficacy of paroxetine treatment.</p>

A Preliminary Study of Comorbidities Associated with Tourette Syndrome / 中国心理卫生杂志

Objective:To explore the category,prevalence and related factors of comorbidities associated with Tourette syndrome.Methods:125 patients with TS according to CCMD-3(Chinese Classification of Mental Disorders,3rd edition)were assessed with a self-designed family circumstance questionnaire,YGTSS,CBCL,Leyton obsessive-compulsive scale,and Conner's Child Behavior Checklist.Results:Of 125 TS patients,the comorbidities included attention deficit and hyperactivity disorder(ADHD,41.6%),obsessive-compulsive disorder(OCD,25.6%), anxiety disorders(8.0%),depressive disorders(4.8%),conduct disorders(8.0%),self-injurious behavior(3.2%),and sleep disorder(2.4%).Conclusion:There are many kinds of comorbid disorders at high prevalence in TS patients. These comorbidities adversely influence the therapy and prognosis of TS and are taken as the possible reasons for social function deficit.