To ensure the quality and safety of Panax notoginseng, a method for the simultaneous determination of 10 mycotoxins in Panax notoginseng was developed using ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS). The sample was extracted with acetonitrile and purified by HLB multifunction cleanup column. The separation was performed on a Phenomenex Kinetex XB-C18 column by gradient elution using methanol and 5 mmol·L(-1) ammonium acetate as mobile phase. The targeted compounds were detected in MRM mode by mass spectrometry with electrospray ionization (ESI) source operated in both positive and negative ionization modes. The linear relationships of the 10 mycotoxins were good in their respective linear ranges. The correlation coefficients (r) ranged from 0.9981 to 1.0000. The LOQs of the 10 mycotoxins were between 0.15 and 8.6 μg·kg(-1). The average recoveries ranged from 73.8% to 107.0% with relative standard deviations (RSDs) of 0.10%-10.9%. The results demonstrated that the proposed method was sensitive and accurate, and suitable for the mycotoxins quantification in Panax notoginseng.
Chromatography, High Pressure Liquid ; Chromatography, Liquid ; Drug Contamination ; Mycotoxins ; analysis ; Panax notoginseng ; chemistry ; Tandem Mass Spectrometry

Objective To investigate the mastery degree of GCP (Good Clinical Practice) in Guang’anmen Hospital of China Academy of Chinese Medical Sciences (hereinafter referred to as“Guang’anmen Hospital”). Methods Totally 338 clinical researchers, covering 18 clinical professional sections and medical clinical trial institutions, in Guang’anmen Hospital with both qualification of clinical trials and GCP certificate were investigated in 23th-27th June 2014. The investigation was in the written answer sheet form, including four noun explanations and 36 multiple choice questions, which were related to GCP. Results 338 researchers could accurately explain the concepts of 4 nouns, and 57 (16.86%) researchers could do all multiple choice questions correctly. 141 (41.72%) researchers chose 1 wrong answer and 89 (26.33%) researchers chose 2 wrong answers. 39 (11.54%) researchers failed to answer 3-4 questions. Only 12 (3.55%) researchers failed to answer 5 or more questions. Conclusion The mastery degree of clinical researchers with qualification of clinical trials and GCP certificate in Guang’anmen Hospital is satisfied. In the future, pertinence and diverse training should be strengthened, in order to improve the overall level of the mastery degree of GCP.

Animals ; Apoptosis ; physiology ; Brain Ischemia ; metabolism ; physiopathology ; Down-Regulation ; drug effects ; Ischemic Postconditioning ; methods ; Male ; Rats ; Rats, Sprague-Dawley ; Reperfusion Injury ; metabolism ; prevention & control ; p38 Mitogen-Activated Protein Kinases ; metabolism

Animals ; Apoptosis ; physiology ; Brain Ischemia ; enzymology ; physiopathology ; Caspase 3 ; metabolism ; Ischemic Postconditioning ; methods ; Male ; Rats ; Rats, Sprague-Dawley ; Reperfusion Injury ; enzymology ; pathology ; prevention & control

The quality control of new drug cilnical trial is the effective guaranty for the pharmaceutical safety and effective after available on market. Enhancing the inspection and quality control of new drug clinical trials provide the crucial importance to achieve a persistent profitable standard. This paper mainly discussed the problems of current clinical trials based on annual check of drug clinical trial institution.
Clinical Trials as Topic ; Drug Evaluation ; Health Facilities ; Humans ; Quality Assurance, Health Care ; Quality Control

Objective To explore the ameliorative effects of standardized tertiary rehabilitation(STR)on the quality of life(QOL)of stroke patients with hemiplegia.Methods Eighty-two stroke patients were randomly divided into two groups:a rehabilitation group(R group)and a control group.All patients were given routine inter- nal medicine treatment,but STR was also administered to the R group.The QOL of all of the patients was assessed with the brief scale of quality of life(QOL-BREF)at the beginning,and at the end of the Ist month,3rd month and 6th month after stroke.Results There were two deaths in the control group,but no deaths in the R group.At ever- y stage,the R group returned better scores for physiological health,psychological state,social and environment rela- tionships,the subjective QOL and health items,and in comprehensive self-evaluation.QOL scores,except for social relationships,were consistently,significantly higher in the R group.The R group's QOL scores improved obviously in the first 3 months after stroke,and then more slowly in the next 3 months.Conclusions STR markedly improved the QOL of stroke patients.Their QOL scores improved obviously soon after stroke,but slowly later on.

Objective To investigate the daily total fluoride intake in relating to the prevalence of skeletal fluorosis in two villages in Jiangsu Province,in order to provide the scientific evidences for the control and prevention of endemic fluorosis.Methods Adults sampled from a high-fluoride Village,Wamiao,and a low-fluoride Village,Xinhuai,were surveyed in this study according to the fluoride concentration in their household shallow well.The average daily total fluoride intake from difierent sources and the skeletal fluorosis were investigated in each subject.Then the subjects from two villages were allocated into five subgroups(＜2.00,2.00～,3.00～,4.00～,≥5.00 mg/d),the relation fluoride intake and prevalence of osteofluorosis was analyzed.Results The prevalence of skeletal fluorosis in Wamiao Village was 31.06%(41/132),but no skeletal fluorosis case(0/35)was found in Xinhuai Village.According to the daily total fluoride intake,subjects with higher daily total fluoride intake tended to associated with a higher prevalence of skeletal fluorosis in a significant dose-response relationship(regression equation:y=2.624-6.855x+3.424x2:r=0.997).The benchmark dose lower limitation of daily total fluoride intake with 95% confidencewas 2.50 mg/d calculated according to this dose-response relationship,the reference dose(RfD)was 2.50 mg/d.In Wamiao Village a significant difference was also found between daily total fluoride intake in 41 subjects[(5.09±1.20)mg/d]with X-ray detectable skeletal fluorosis and in 91 subjects[(3.08±1.12)mg/d]without X-ray detectable skeletal fluorosis(t=-9.32,P＜0.01).Conclusions These findings indicate that the daily total fluoride intake has a significant dose-response relationship with the prevalence of skeletal fluorosis in an endemic fluorosis area associated with high-fluoride drinking water;and the RfD in this study was lower than that in the national standard of"Chinese hygienic standard for daily total fluoride intake(WS/T 87-1996)"(3.50 mg/d).

BACKGROUNDInterleukin 10 (IL-10) is an important cytokine with anti-inflammatory, anti-immune and anti-fibrotic functions. This study aimed at evaluating the relationship between allele polymorphisms in the IL-10 promoter region and hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

METHODSThe odds ratios (ORs) of IL-10 allele distributions in patients with HBV or HCV infection were analyzed against healthy controls. All the relevant studies in PubMed were identified, and poor qualified studies were excluded. The meta-analysis software REVMAN 4.2 was applied for investigating heterogeneity among individual studies and summarizing all the studies. The publication bias was also evaluated.

RESULTSThis study demonstrated a significant association between the IL-10-592 A/C polymorphism and HBV infection in the Asian population under the overall effect size of allele A versus C. In our subgroup meta-analysis, we found a significant association of IL-10-592 A/C polymorphism to HCV infection susceptibility in Asian populations, although sensitivity analysis showed that the combined result was not associated with the worldwide population. Other IL-10 allele polymorphisms were not associated with HBV or HCV infection.

CONCLUSIONIL-10-592 A/C allele might be a risk factor for HBV or HCV in Asians but not in Europeans.

Alleles ; Genetic Predisposition to Disease ; genetics ; Hepatitis B ; epidemiology ; genetics ; Hepatitis C ; epidemiology ; genetics ; Humans ; Interleukin-10 ; genetics ; Polymorphism, Genetic ; genetics ; Promoter Regions, Genetic ; genetics

OBJECTIVETo establish a HPLC method for simultaneous determination of 4 effective components from total flavonoids of Scutellaria barbata (FSB).

METHODSThe HPLC method was developed on an Agilent Zorbax C₁₈ column (4.6 mm × 250 mm, 5 μm). The mobile phase was composed of 1% HAc and CH₃OH:CH₃CN (80:20) with a linear gradient elution. The flow rate was 1.0 ml/min, and UV detection wave length was set at 280 nm. The column temperature was maintained at 30°C.

RESULTThe linear range of 4 effective components (scutellarin, isoscutellarein-8-O-glucuronide, isoscutellarein and luteolin) was 0.14-11.20 μg, 0.03-2.40 μg, 0.007-0.560 μg and 0.027-2.160 μg, respectively. The average recovery for 4 effective components was (101.9 ± 1.4)%, (103.5 ± 0.6)%, (98.1 ± 2.9)% and (100.5 ± 2.3)%, respectively. The contents of 4 flavonoids were determined, with scutellarin 7.3%-14.3%, isoscutellarein-8-O-glucuronide 2.4%-9.3%, isoscutellarein 0.3%-0.5%, and luteolin 0.2%-0.6%, respectively.

CONCLUSIONThe method can be used effectively to evaluate the quality of FSB.

Apigenin ; analysis ; Chromatography, High Pressure Liquid ; methods ; Flavones ; analysis ; Flavonoids ; analysis ; Glucuronates ; analysis ; Luteolin ; analysis ; Scutellaria ; chemistry