Drugs, Chinese Herbal ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; methods ; Phytotherapy ; Thrombocytopenia ; etiology ; therapy

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.
China ; Drug Approval ; legislation & jurisprudence ; Drug Evaluation ; legislation & jurisprudence ; Humans ; Legislation, Drug ; Medicine, Chinese Traditional

Sixteen compounds including daphnoretin (1), isofraxidin (2), scopoletin (3), kaempferol (4), quercetin (5), guaijaverin (6), astragalin (7), quercetin-3-O-β-D-glucopyranoside (8), naringenin-7-O-β-D-glucopyranoside (9), 5-O-methylapi- genin-7-O-β-D-glucopyranoside (10), methyl gallate (11), prionitiside A (12), (2S)-2,3-dihydroxypropyl-1,6,8-trihydroxy-3- methyl-9,10- dioxoanthracene-2-carboxylate (13), 3,3'-di-O-methyl ellagic acid (14), 3'-O-methyl-3,4-O,O-metheneellagic acid-4'-O-β-D- glucopyranoside (15) and 3,4-methylenedioxy-3'-O-methylellagic acid (16), were isolated from the 70% acetone extract of Euphorbia dracunculoides Lam. Among them, compounds 1-3, 6-9, 11, and 14 were isolated from E. dracunculoides for the first time, and compounds 10, 12, 13, 15, and 16 were firstly obtained from the genus Euphorbia. Their structures were elucidated by spectroscopic analysis, including 1H-NMR, 13C-NMR, and ESI-MS.
Drugs, Chinese Herbal ; chemistry ; isolation & purification ; Euphorbia ; chemistry ; Molecular Structure ; Plant Leaves ; chemistry ; Plant Stems ; chemistry ; Spectrometry, Mass, Electrospray Ionization

Objective To explore the effect of postasphyxial-serum in neonate on expression of serine protease Omi/HtrA2 in renal tubular cells(HK-2).Methods Human renal proximal tubular cell line HK-2 cell was used as target cell.The cultural cells in orifice were divided into control group and asphyxia-serum attacking group.Blood was cowected from asphyxia newborns by means of femoral venous puncture,then the serum was garthered,anticoagulated by liquemie,3 000 r/min centrifuged 20 min,abstracted serum,thermostatic waterbathed the serum at 56 ℃,so that to inactivate addiment,filtered germ by micropore filte,the attacking concentrtion of serum was 200 mL/L,the cells of the asphyxia-serum attacking group were attacked by asphyxia-serum,and the cells of control group were cultivated with normal nutritive medium when the cells was needed.After 24 hours,the cells were tixed,then the expression of Omi/HtrA2 in cytoplast was detected by the use of immunohistochemical method.Results Omi/HtrA2 was inaurate or yellow brown and localized to the cytoplast.The rate of the cell expressed Omi/HtrA2 was(9.0?2.5)% in control group,after stimulated with postasphyxial-serum,in asphyxia group the rate of the cell expressed Omi/HtrA2 was(25.15?3.5)%,there was significant difference between 2 groups(t=-15.322 P

Adult ; Brain Neoplasms ; metabolism ; pathology ; surgery ; Female ; Ganglioglioma ; metabolism ; pathology ; surgery ; Glial Fibrillary Acidic Protein ; metabolism ; Humans ; Magnetic Resonance Imaging ; Phosphopyruvate Hydratase ; metabolism ; Synaptophysin ; metabolism

Animals ; Behavior, Animal ; drug effects ; Biogenic Monoamines ; metabolism ; Brain ; drug effects ; metabolism ; Dose-Response Relationship, Drug ; Female ; Formaldehyde ; toxicity ; Maze Learning ; drug effects ; Mice ; Mice, Inbred BALB C

Objective Genetic analysis was performed to infer the relationship between hantaviruses carried by Rattus norvegicus from Henan and Neimenggu provinces and the other known hantavirus and the vaccine strain. Methods Total RNA was extracted from lung tissues with Trizol reagent. The complete M and S segment sequences of strains NM133 and Q12 were amplified by RT-PCR. The purified DNA fragments were directly subjected to sequencing, and then to sequence analysis and phylogenetic analysis. Results The complete S segment sequences of strains NM133 and Q12 were found to be 1770 nt and 1772 nt in length respectively, with one open reading frame encoding 429 amino acids. The complete M segment sequences of both two strains are 3654 nucleotide in length encoding a protein of 1133 amino acids. The two strains shared a high degree of homology with most of known Seoul virus (SEOV) but quite different from Hantaan virus and other hantaviruses. Furthermore, the nucleoprotein and glycoprotein of the two strains had the congruent structure with the vaccine strain Z37. On the S- and M-phylogenetic trees, both strains (NM133 and Q12) were grouped into the first cluster of SEOV, and were more closely related to the strains, such as: Hb8610, R22, HB55, L99, and K24-e7. Conclusion Both strains (NM133 and Q12) belonged to SEOV, and sharing a high degree of homology and similar secondary structure with strains including the vaccine strains Z37, our data suggested that the present vaccine used in China could effectively prevent HFRS caused by SEOV.

Objective To investigate the current status of occupational hazards and prevention and control of occupational ， - Methods ， diseases in micro small and medium sized manufacturing enterprises in Jiangxi Province. A total of 1 034 micro - small and medium sized manufacturing enterprises in Jiangxi Province were selected as the research subjects using a stratified cluster sampling method. The exposure of occupational hazards and the implementation of occupational hazards prevention and Results ， control measures were investigated. Among the 1 034 enterprises the small and micro enterprises accounted for ， 91.5%. The enterprises with serious occupational hazards were mainly concentrated in metallurgy building materials industry ， and machinery equipment and electrical appliance manufacturing industry. The exposure rate of occupational hazard factors in ， ， （ vs the categories of occupational hazard factors from high to low was physical factors dust and chemical factors 78.9% 52.8% vs ，P ） （ ）， ， 25.0% <0.01 . The exposure rate from high to low was metallurgy and building materials industry 60.8% machinery （ ）， ， equipment and electrical equipment manufacturing industry 42.9% light industry textile and tobacco processing industry （ ）， ， （ ）（P ） 32.0% chemical petrochemical and pharmaceutical industry 21.0% <0.01 . Noise exposure accounted for 98.3% in the workers exposed to physical factors. The implementation rate of prevention and control measures for occupational hazards ， in enterprises from high to low was the staffing of occupational health management personnel the establishment of ， ， occupational health management institutions the establishment of occupational health management systems the detection ， ， of occupational hazards the evaluation of the control effect of occupational hazards of construction projects and the - （ vs vs vs vs vs ，P ） pre evaluation of occupational hazards of construction projects 32.5% 25.7% 23.7% 16.2% 6.9% 4.2% <0.01 . Conclusion The focus of prevention and control of occupational hazards in manufacturing industry in Jiangxi Province is noise ， - and dust in small and micro metallurgy and building materials industry. Most of the micro small and medium sized manufacturing enterprises have not carried out the detection of occupational hazards and evaluation of occupational hazards in accordance with the law. The situation of occupational disease prevention and control is still challenging.

Objective To investigate the current status of occupational hazards and prevention and control of occupational ， - Methods ， diseases in micro small and medium sized manufacturing enterprises in Jiangxi Province. A total of 1 034 micro - small and medium sized manufacturing enterprises in Jiangxi Province were selected as the research subjects using a stratified cluster sampling method. The exposure of occupational hazards and the implementation of occupational hazards prevention and Results ， control measures were investigated. Among the 1 034 enterprises the small and micro enterprises accounted for ， 91.5%. The enterprises with serious occupational hazards were mainly concentrated in metallurgy building materials industry ， and machinery equipment and electrical appliance manufacturing industry. The exposure rate of occupational hazard factors in ， ， （ vs the categories of occupational hazard factors from high to low was physical factors dust and chemical factors 78.9% 52.8% vs ，P ） （ ）， ， 25.0% <0.01 . The exposure rate from high to low was metallurgy and building materials industry 60.8% machinery （ ）， ， equipment and electrical equipment manufacturing industry 42.9% light industry textile and tobacco processing industry （ ）， ， （ ）（P ） 32.0% chemical petrochemical and pharmaceutical industry 21.0% <0.01 . Noise exposure accounted for 98.3% in the workers exposed to physical factors. The implementation rate of prevention and control measures for occupational hazards ， in enterprises from high to low was the staffing of occupational health management personnel the establishment of ， ， occupational health management institutions the establishment of occupational health management systems the detection ， ， of occupational hazards the evaluation of the control effect of occupational hazards of construction projects and the - （ vs vs vs vs vs ，P ） pre evaluation of occupational hazards of construction projects 32.5% 25.7% 23.7% 16.2% 6.9% 4.2% <0.01 . Conclusion The focus of prevention and control of occupational hazards in manufacturing industry in Jiangxi Province is noise ， - and dust in small and micro metallurgy and building materials industry. Most of the micro small and medium sized manufacturing enterprises have not carried out the detection of occupational hazards and evaluation of occupational hazards in accordance with the law. The situation of occupational disease prevention and control is still challenging.

OBJECTIVETo investigate, from cytoprotein and molecular levels, the action mechanism of astragalus injection (ASI) on the signal conduction of human renal tubular cells (HK-2) injury induced by neonatal postasphyxial-serum (NPS), whether it is through activating the nuclear factor kappaB (NF-kappaB) signaling pathway.

METHODSTaking HK-2 as the target cell and the 20% NPS as the attacking factor, the experiment was conducted by dividing the target cells into two groups before attacking, the blank control group and the ASI pretreated group. The nuclear translocation of NF-kappaB was detected by confocal microscopy with indirect immunofluorescence stain, and the amount of NF-kappaB inhibitor subunit (I-kappaBalpha) was detected by Western blot before attacking. The detections were repeated at various time points in the experiment, i.e., 15 min, 1 h and 2 h after attacking, respectively.

RESULTSBefore attacking, the nuclear translocation of NF-kappaB and the amount of I-kappaBalpha were not different in the two groups. But the former increased and the latter decreased significantly in the ASI group at all the time points after attacking with the topmost changes presented at 1 h after attacking, and significantly different to those in the control group at corresponding time

CONCLUSIONASI pretreatment could inhibit the activation of NF-kappaB induced by postasphyxial-serum.

Apoptosis ; Asphyxia Neonatorum ; blood ; Astragalus Plant ; Cell Line ; Humans ; I-kappa B Proteins ; metabolism ; Infant, Newborn ; Kidney Tubules ; cytology ; metabolism ; NF-KappaB Inhibitor alpha ; Signal Transduction