1.Common questions and suggestions of evaluation for NDA of TCM.
Xiu-Jing MA ; Yong-Wen ZHANG ; Chang-Ming YANG
China Journal of Chinese Materia Medica 2014;39(17):3395-3398
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
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Drug Approval
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legislation & jurisprudence
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Drug Evaluation
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legislation & jurisprudence
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Humans
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Legislation, Drug
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Medicine, Chinese Traditional
3.Chemical constituents of Euphorbia dracunculoides.
Li WANG ; Ming-Ming YU ; Yu-Qian CHI ; Wen-Bin OUYANG ; Zhen ZANG ; Yong ZHAO
China Journal of Chinese Materia Medica 2014;39(20):3969-3973
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
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chemistry
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isolation & purification
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Euphorbia
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chemistry
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Molecular Structure
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Plant Leaves
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chemistry
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Plant Stems
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chemistry
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Spectrometry, Mass, Electrospray Ionization
5.Effect of Postasphyxial-Serum in Neonate on Expression of Omi/HtrA2 in Renal Tubular Cells
yong, ZHANG ; wen-bin, DONG ; cun-liang, DENG ; ming-yong, WANG ; feng, CHEN ; kai-gui, XU
Journal of Applied Clinical Pediatrics 1992;0(06):-
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
7.Genetic analysis of hantaviruses carried by Rattus norvegicus collected from Henan and Neimenggu provinces, China
Wen WANG ; Xian-Dan LIN ; Wen-Ping GUO ; Ming-Hui LI ; Yong-Zhen ZHANG
Chinese Journal of Epidemiology 2010;31(9):1030-1034
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.
8.Effect of an integrative medical regimen on levels of vascular endothelial function and hypersensitive C-reactive protein in elderly patients with isolated systolic hypertension.
Hao LI ; Wen-Ming ZHAO ; Yong-Xiang HAN
Chinese Journal of Integrated Traditional and Western Medicine 2009;29(2):115-119
OBJECTIVETo observe the effect of a integrative medical regimen (IMR), i.e. combined use of Jiangya Capsule (JYC) and Nimodipine (ND), on blood pressure, TCM clinical symptoms, and blood levels of vascular endothelial function and hypersensitive C-reactive protein (hs-CRP) in elderly patients with isolated systolic hypertension (EISH).
METHODSAdopting randomized, double-blinded and controlled principle, a trial was conducted on 135 patients with EISH by randomized them into three groups, they were administered IMR (Group A), JYC plus ND simulator (Group B) and ND plus JYC simulator (Group C) respectively, for 4 weeks. Changes of blood pressure and TCM symptoms, as well as the levels of serum nitric oxide (NO), plasma endothelin-1 (ET-1), 6-keto-prostaglandin 1alpha (6-keto-PGF(1alpha)), thromboxane B2 (TXB2) and hs-CRP were observed before and after treatment.
RESULTSAfter treatment the systolic blood pressure reduced and clinical symptoms improved, with serum NO and 6-keto-PGF(1alpha) lelels elevated, plasma ET-1, TXB2 and serum hs-CRP decreased in all the three groups (P<0.05 or P<0.01). But the inter-group comparisons showed that the effect in Group A was superior to the other two groups in decreasing systolic pressure, and superior to Group C in improving clinical symptoms, elevating serum NO and decreasing plasma TXB2 (P <0.05).
CONCLUSIONThe integrative medical regimen of combined use JYC and ND has markedly effect in lowering blood pressure, it could obviously improve the symptoms and vascular endothelial function, and inhibit the level of inflammatory factor in patients with EISH.
Aged ; C-Reactive Protein ; metabolism ; Double-Blind Method ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Endothelin-1 ; blood ; Female ; Humans ; Hypertension ; drug therapy ; Integrative Medicine ; Male ; Middle Aged ; Nimodipine ; therapeutic use ; Nitric Oxide ; blood ; Phytotherapy ; Thromboxane B2 ; blood
9.Chemical constituents from endophyte Chaetomium globosum in Imperata cylindrical.
Li SHEN ; Li ZHU ; Zhong-qi WEI ; Xiao-wen LI ; Ming LI ; Yong-chun SONG
China Journal of Chinese Materia Medica 2015;40(23):4645-4649
Isolation and purification of chemical constituents from solid culture of endophyte Chaetomium globosum in Imperata cylindrical was performed through silica gel column chromatography, gel filtration over Sephadex LH-20 and preparative HPLC. Nine compounds were obtained and their structures were determined as chaetoglobosin F(1), chaetoglobosin Fex(2), chaetoglobosin E(3) cytoglobosin A(4), penochalasin C(S), isochaetoglobosin D (6), N-benzoylphenylalaninyl-N-benzoyphenylalaninate(7), uracil(8) and 5-methyluracil(9), respectively, based on HR-MS and NMR data and comparison with literatures. Compound 7 was isolated from Chaeeomium sp. for the first time. In vitro cytotoxicity of compounds was evaluated using MTT mothed and 1,3,4 and 5 showed inhibition activity to the human cervical carcinoma cell HeLa with IC50 values of 99.43, 23.77, 97.92, 86.25 micromol x L(-1), while positive cotolocisnin Ad apno1ch alse IC50 24.33 micromol x L(-1).
Biological Factors
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chemistry
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pharmacology
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Cell Line
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Cell Survival
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drug effects
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Chaetomium
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chemistry
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Endophytes
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chemistry
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Humans
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Molecular Structure
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Poaceae
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microbiology
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Spectrometry, Mass, Electrospray Ionization
10.Effect of Astragalus injection on the signal conduction of neonatal postasphyxial-serum induced human renal tubular cell injury.
Tao XIONG ; Wen-bin DONG ; Ming-yong WANG
Chinese Journal of Integrated Traditional and Western Medicine 2010;30(4):398-402
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