OBJECTIVE:To study the pharmacokinetics of domestic zaleplon tablets in Chinese healthy volun?teers.METHODS:20male healthy subjects received a single oral dose of15mg zaleplon tablets.The plasma concentrations of zaleplon were determined by an improved HPLC method.RESULTS&CONCLUSION:The main pharmacokinetic parameters of zaleplon were as follow:C max was55.90?16.20ng/ml,T max was1.05?0.32h,Ke was0.74?0.18h -1 ,T 1/2Ke was1.00?0.29h,AUC 0～8 was123.70?25.64ng?h/ml,AUC 0～∞ was125.20?25.80ng?h/ml.The results are compara?ble to those reported in foreign literature.

In the recent 2 decades,the clinical medical mode has been changed greatly.The experience-based medical mode is gradually replaced by evidence-based mode,ie,evidence-based medicine.Large scale clinical trials provide robust evidence for clinical practice and quality control is critical for the success of one trial.We discuss six facets on this subject,including protocol design,staff training,manual formulating,organization,data management and monitoring.The objective of quality control is to ensure the study conducted according to the protocol,the results are reliable and protect the human rights of participants.

Acupuncture Therapy ; Female ; Humans ; Middle Aged ; Syringomyelia ; therapy

OBJECTIVETo explore the optimal intervention time of acupuncture and moxibustion in the treatment of peripheral facial paralysis.

METHODSTwo hundred and four cases of peripheral facial paralysis were collected in clinic for retrospective analysis. According to the time between the disease onset and the intervention of acupuncture and moxibustion, 3 groups (groups A, B and C) were divided. In group A, the treatment was given in 1 to 3 days after onset; in group B, the treatment was given in 4 to 7 days after onset; in group C the treatment was given in 8 to 10 days after onset. The treatment with acupuncture and moxibustion was applied according to the regular stages of disease in the three groups. At the acute stage, the less points and shallow puncture therapy combined with distal acupoints at the limbs were adopted on the affected side. At the stable stage, the more points and shallow puncture therapy were used on the affected side. At the recovery stage, the deep puncture or penetrating punctures was applied on the affected side. The curative effects was given once every day and the treatment of 10 days made one session. The curative effects were analyzed statistically at the end of three sessions of treatments separately.

RESULTSAt the end of the 1st session of treatment, the total effective rate was 58.8% (40/68) in group A, 69.7% (53/76) in group B and 46.6% (28/60) in group C. At the end of the 2nd session of treatment, the total effective rate was 85.3% (58/68), 90.8% (69/76) and 71.6% (43/60) in group A, B and C separately. At the end of 3rd session of treatment, the total effective rates were 89.7% (61/68), 97.4% (74/76) and 83.3% (50/60) in the three groups separately. The differences were significant statistically at the same session of treatment among three groups (all P<0.05), in which, the results in group B was the best, followed by group A and C in sequence.

CONCLUSIONthe best intervention time of acupuncture and moxibustion is in 4 to 7 days after onset of facial paralysis.

Acupuncture Therapy ; Adolescent ; Adult ; Aged ; Child ; Child, Preschool ; Combined Modality Therapy ; Facial Paralysis ; therapy ; Female ; Humans ; Male ; Middle Aged ; Moxibustion ; Retrospective Studies ; Treatment Outcome ; Young Adult

Climate Change ; Health ; Humans ; Risk Adjustment

Adolescent ; Diagnosis, Differential ; Diverticulum, Stomach ; complications ; diagnosis ; pathology ; Gastrointestinal Hemorrhage ; diagnosis ; etiology ; pathology ; Gastroscopy ; Humans ; Male

The transplants of one-year-old Glycyrrhiza uralensis Fisch. were subjected to five concentrations of MnSO4-H2O (0, 1.81, 18.1, 36.2 and 54.3 mg·L(-1)) culturing in vermiculite. qRT-PCR and HPLC were respectively used to measure the relative expression of SQS1 gene and the content of glycyrrhizic acid of G. uralensis in different concentrations of MnSO4·H2O. This is to explore discuss the effects of the expression of SQS1 gene and the accumulation of glycyrrhizic acid by Mn treatment. The results showed both the expression of SQS1 gene and the content of glycyrrhzic acid of G. uralensis tended to rise after the fall of the first with the increase of concentration of Mn treatment. And they were of very significant positive correlation (P<0.01, r=0.737). Relative expression of SQS1 gene reached the highest 7.90 under 18.1 mg·L(-1) MnSO4·H2O treatment. It was very significantly different between 18.1 mg·L(-1) concentration of MnSO4·H2O treatment and CK (0 mg·L(-1)), 1.81, 36.2 and 54.3 mg·L(-1) (P<0.01), and 1.75, 1.37, 1.37, 2.33 times respectively. The content of glycyrrhizic acid reached the highest under 1.81 and 18.1 mg·L(-1) MnSO4·H2O treatment, and there were not significant difference (P>0.05). It was very significantly different between them and other concentrations of MnSO4·H2O treatment (P<0.01). This study suggests the appropriate concentration of Mn treatment could certain promote the expression of SQS1 gene and the accumulation of glycyrrhizic acid of G. uralensis.
Chromatography, High Pressure Liquid ; Genes, Plant ; Glycyrrhiza uralensis ; chemistry ; genetics ; Glycyrrhizic Acid ; analysis ; Manganese

Based on collecting data at home and abroad, we combined clinical practice of scientific researches. We also summarized key points for design and evaluation of clinical studies in treating children's attention deficit hyperactivity disorder by Chinese medical new drugs from objective and design, selection of diagnostic criteria, recruitment and dropping-out of subjects, effectiveness evaluation, safety evaluation, drug combination, and quality control, and so on. We hope to provide reference for design and evaluation of clinical studies by Chinese medical new drugs.
Attention Deficit Disorder with Hyperactivity ; drug therapy ; Biomedical Research ; Child ; Clinical Studies as Topic ; Data Collection ; Drugs, Chinese Herbal ; therapeutic use ; Humans

Physiologically based pharmacokinetic model (PBPK), a mechanistic mathematic model, which can simulate the absorption, distribution, metabolism and excretion of drugs, is being more widely used in pharmaceutical research and development areas. This article reviews primarily the recent advances in the procedure of establishing a PBPK model, including specifying of the PBPK model structure, specification of the tissue model, writing of equations, set of model parameters, simulation and evaluation. Application significance, major challenges and future developments of PBPK model in pharmaceutical areas are also discussed.
Animals ; Biological Transport ; Computer Simulation ; Humans ; Models, Biological ; Pharmaceutical Preparations ; chemistry ; metabolism ; Pharmacokinetics ; Software ; Tissue Distribution