Table of Content

Volume 11 Issue 1
06 January 2006

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Progress of clinical pharmacological study on rifabutin

LI Zhao-xu, ZHANG Jin-nan, REN Shuang, GAO Cheng-ying, SUN Yi, WANG Xue

2006, 11(1):  1-9. 

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Rifabutin ( RBT) is a rifamycin deriva- tive, like rifampicin ( RIF) , registered for the prophylaxis and treatment of mycobacterium avium complex ( MAC) in patients with AIDS by FDA in 1992 .Subsequently, the drug was approved by many other countries .But now, it is used not only in the prophlaxis and treatment of mycobac- terium avium complex but also in the treatment of pulmo- nary tuberculosis and Helicobacter pylori .For its high li- pophilic characteristic and weak inducing properties com- pare to other rifamycin derivative, it can be applied in treatment with many diseases successfully, especially when combine with other antibiotics, and can solve the problem of traditional antibiotics resistance and increase the clinical safety of combined medical treatment .This paper just shows the progress of clinical pharmacological study and related aspects on rifabutin in order to instruct prescription .

Nitric oxide synthase inhibitors and cerebral ischemia

HU Miao-miao , LI Yun-man

2006, 11(1):  10-13. 

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As the effects of the nitric oxide and nitric oxide synthase have been investigated a lot , the nitric ox- ide synthase inhibitors were widely explored and become one of the highlights in the cerebral ischemia research . This paper reviewed the effects of nitric oxide synthase in- hibitors especially the nNOS inhibitors and iNOS inhibi- tors on the cerebral ischemia damage.

Progress in anti-multidrug resistance mediated by p-glycoprotein

MA Bing-liang , WU Yu-lin , LIU Guo-qing

2006, 11(1):  14-21. 

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P-glycoprotein (P-gp)plays an important role in multidrug resistance (MDR).This article was fo- cused on the protein structure and the mechanism of P- gp , and especially on the current status in anti-P-gp drug research and discovery .The action of P-gp in MDR was also reviewed .Moreover , the potential adverse reaction of P-gp inhibitors were emphasized since P-gp was involved in the normal function of a lot of organs .

Role of cyclooxyenase and its inhibitors in prevention and treatment of can- cer

LU Li-na, YANG Ting , ZHUANG Ze-hao

2006, 11(1):  22-26. 

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Cyclooxygenase ( COX) and its inhibitors were widely studied for the prevention and treatment of cancer.It is believed that COX is involved in the carcino- genesis through different pathways .COX inhibitors play some roles in the prevention for colon cancer and many other cancers, and can enhance the effects of radio- and chemotherapy .However, the safety and efficacy of those agents are far form perfect .There has COX independent pathway counted for the anti-cancer effects of COX inhibi- tors as well.Therefore, further studies should be taken to evaluate the value of COX as a target of cancer prevention and treatment in clinical .

Regulation effect of arecoline on excess expression of adhesive molecules in endothelial cells injuried with high concentration of D-glucose

DUAN Zhi-bian, WANG Hai

2006, 11(1):  27-32. 

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AIM:To investigate the effects of D-glu- cose on monocyte chemoattractant protein-1 ( MCP-1) , intercellular cell adhesive molecule type-1 ( ICAM-1) , vascular cell adhesive molecule1-1 ( VCAM-1) mRNA ex- pression and the protective effects of arecoline, PPVP, DMHPPP and simvastatin in cultured bovine aorta endo- thelial cells, thereby to explore possible mechanisms by which the compounds prevent the formation of diabetic vascular complications .METHODS:Bovine aorta endo- thelial cells were cultured in vitro with indicated concen- tration of D-glucose for indicated time .After the cells were harvested at the specified situation, the MCP-1, ICAM-1 and VCAM-1 mRNA expression was detected by reverse transcription-polymerase chain reaction( RT-PCR) and normalized to the mRNA level of β-microglobulin in the absence or in the presence of D-glucose or land arec- oline, PPVP, DMHPPP and simvastatin, respectively . RESULTS:The expression of MCP-1, ICAM-1 and VCAM-1 mRNA all increased dose- and time-dependently after treatments with 10, 25, 50 mmol·L ^-1 D-glucose for 16 h and 25 mmol·L^-1 D-glucose for 8, 16, 24 h, re- spectively .Compare with control group, after the bovine aorta endothelial cells were incubated with 10 - 5 mmol·L ^-1 arecoline, PPVP, DMHPPP, simvastatin for 20h in advance, respectively, the injury effects which were subsequently induced by 25 mmol·L ^-1 D-glucose for 16h could be prevented .CONCLUSION:Cultured bovine aorta endothelial cells can express MCP-1, ICAM- 1, and VCAM-1 mRNA at a low level, and high concen- tration of D-glucose can induce excess expression .The regulation effects of arecoline, PPVP, DMHPPP and sim- vastatin on the excess expressions are different, respec- tively .

Bcl-XL siRNA sensitizes human MGC-803 gastric cancer cells to 5-flu- orouracil and diallyl disulfide

ZHONG Miao, LEI Xiao-yong, FENG Lan-fang, ZHU Bing-yang, TANG Sheng-song, LIAO Duan-fang

2006, 11(1):  33-38. 

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AIM :To determine the inhibitory effect of the hairpin Bcl-XL siRNA on the expression of Bcl-XL gene in human gastric cancer cell line MGC-803, and the effect of Bcl-XL siRNA on drug sensitization in MGC-803 cells.METHODS:Bcl-XL siRNA and negative siRNA were constructed and stably transfected into MGC-803 cells .Immunofluorescence was used to detect the Bcl-XL gene expression .Drug sensitivity of the cells to 5-fluorou- racil ( 5-FU) and diallyl disulfide ( DADS) was analyzed with MTT and flow cytometry .RESULTS:Protein ex- pression level of Bcl-XL in Bcl-XL siRNA stable transfec- tants was reduced to almost background level compared with negative siRNA transfectants or untreated cells .MTT results showed that the cells inhibitary rates of Bcl-XL siRNA transfectants were higher than that of negative vec- tor or untreated cells after treated with 13, 130, 1300, and 13 000 mg·L-1 of 5-FU or treated with 20, 35, and 50 mg·L -1 of DADS .IC50 value of DADS or 5-FU in Bcl-XL siRNA transfected cells was significant lower than that of negative siRNA or untreated cells .Moreover, flow cytometry results demonstrated that Bcl-XL siRNA cells showed higher sub G1 population than negative siRNA or untreated cells after addition 50 mg·L -1 of DADS or 130 mg·L-1 of 5-FU .CONCLUSION:siRNA targeting Bcl- XL gene can specifically down-regulate Bcl-XL expression in MGC-803 cells, and sensitize cells to 5-FU or DADS . Bcl-XL siRNA may be a potential therapy agent against human gastric adenocarcinoma.

Effects of tubeimoside on adhension, invasion and migration of a human highly metastatic giant lung carcinoma cell line PGCL3

WANG Chang-xiu, MA Run-di, YU Li-jian

2006, 11(1):  39-44. 

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AIM:To design to investigate the effects of tubeimoside on adhesion, invasion and migration of PGCL3 cells .METHODS :The cells grow inhibition me- diated by tubeimoside was measured by MTT assay after treatment with tubeimoside .The effects of tubeimoside on adhesion, invasion and migration of PGCL3 cells were de- termined using analysis of adhesion-related basement membrane components fibronectin and laminin, reconsti- tuted basement membrane invasion assay, and Transwell model, respectively .RESULTS:Tubeimoside displayed growth inhibitory activity against PGCL3 cells with IC₅₀ values of 16 .77, 14 .62, and 14 .46 μmol·L ^-1 for 24, 48, 72 hours of tubeimoside treatment .1 .25, 2 .50 and 5 .00 μmol·L^-1 of tubeimoside inhibited PGCL3 cells to invade the reconstituted basement membrane by 20 .6 %, 30 .6 %, 46 .8 %, and decreased the percentages of loco- motion and migration of PGCL3 cells by 14 .2 %, 24 .7 %, 42 .5 %, respectively .In addition, tubeimoside inhibited PGCL3 cells to adhere to the basement mem- brane components fibronectin and laminin, and inhibited the activity of type IV collagenase and its secretion by PGCL3 cells in a dose-dependant manner.CONCLU- SION:Tubeimoside can significantly inhibit the adhe- sion, invasion and migration of PGCL3 cells, and the sup- pression of adhesion of PGCL3 cells to fibronectin and laminin and of secretion and activity of type IV collage- nase in PGCL3 cells mediated by tubeimoside may be re- sponsible for the inhibition of adhesion and invasion of PGCL3 cells .

Lomerizine inhibited the function of P-glycoprotein(P-gp) without decreasing the expression of mdr1 gene and P-gp in primarily cultured rat brain microvessel endothelial cells

WU Yu-lin , MA Bing-liang , ZHU Hao-jie, LIU Guo-qing

2006, 11(1):  45-50. 

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AIM:To study the effect of Lomerizine on the activity of P-glycorprotein (P-gp)in primary cul- tured rat brain microvessel endothelial cells (RBMECs). METHODS:Flow cytometry was used to study the efflux of rhodamine123 (Rh123)and expression of P-gp in RB- MECs.RT-PCR was used to measure the expression in mRNA level of mdr1 gene in RBMECs .Transwell model was used to detect the influence of Lomerizine on the transport of Rh123 through RBMECs monolayer.RE- SULTS :Lomerizine inhibited the efflux of Rh123 in RB- MECs.No changes of P-gp and mdr1 gene mRNA ex- pression were detected in RBMECs after the treatment with 30 μ mol·L ^-1 Lomerizine for 72 h .In the study of Transwell model , Lomerizine increased significantly the transport of Rh123 through RBMECs monolayer from up- per compartments to lower compartments, and inhibited obviously the transport in reverse direction .CONCLU- TION:The effect of Lomerizine on the activity of P-gp was mainly via its direct inhibitory effect on the function of P-gp in RBMECs and the transport of P-gp substrates in BBB may be affected by lomerizine.

Protective effects of Hypericum perforatum on ischemic injury in PC12 cells

DAI Xiao-ming , SUN Rong , WU Dong-dong , WU Yu-lin

2006, 11(1):  51-54. 

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AIM:To investigate the effects of Hype- ricum perforatum on ischemic injury in PC12 cells . METHODS:PC12 cells were treated with 20 mmol·L^-1 NaCN in combination with glucose deprivation .Assay of MTT and lactate dehydrogenase for cell survival , cytosolic creatine kinase (CK)measure , Flow cytometric detection of apoptotic cells and the mitochondral membrance poten- tial in PC12 cells .RESULTS:Hypericum perforatum , within the range of 10^-7 -10^-5mol·L^-1 significantly in- creased the optical density at 570nm tested by colorimetric MTT assay , antagonized LDH efflux , increased CK activi- ty .Hypericum perforatum also decreased NaCN in combi- nation with glucose deprivation-induced PC12 cells apop- totic rate and increased mitochondrial membrance potential in concentration-dependent manner.CONCLUSION: Hypericum perforatum can protect PC12 cells from isch- emic injury .The mechanism is related to antagonizing the loss of CK activity and MMP in PC12 cells .

Role of NF-kappa B in regulating expression of ICAM-1

2006, 11(1):  55-58. 

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AIM :To study the role of NF-kappa B in regulating the expression of adhesion molecule ICAM-1 . METHODS:HUVECs were isolated from human umbili- cal veins by 0 .25 % trypsin and then cultured in RP- MI1640, exposed on LPS ( 100 ng·ml ^-1 ) for different time ( 1, 4, 8, and 24 h) , while pretreated by NF-kappa 中国临床药理学与治疗学 2006 Jan;11( 1) · 57 · B inhibitor pyrrolidine dithiocarbamate ( PDTC) at the 4th hour.Nucleus protein and total RNA were extracted .The activity of NF-kappa B and the expression of ICAM-1 were measured respectively by the electrophoretic mobility shift assay ( EMSA ) and reverse transcriptase-PCR ( RT- PCR) .RESULTS :The activity of NF-kappaB altered in correlate with ICAM-1 .Treating HUVECs with PDTC, the expression of ICAM-1mRNA was significantly down- regulated with the decline activity of NF-kappa B ( 2 .40 ±0 .11 vs 0 .76 ±0 .09, P <0 .01) .CONCLUSION: NF-kappa B plays an important role in regulating the ex- pression of ICAM-1Mrna .

Extraction of anti-CPG ODN component from Terminaliachebula retz and their activity evaluation

YAO Jie , ZHENG Jiang , JIANG Dong-neng , LU Yong-ling , WEI Li-zhao

2006, 11(1):  59-61. 

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AIM:To extract different components from Terminaliachebula retz and evaluate their anti-CPG ODN activities .METHODS :Anti- CPG ODN fractions were extracted through water extraction and ion-exchange HPLC.Their binding activities to CPG ODN were select- ed through sensor technology .Their inhibiting activity to the release of TNF-αfrom RAW 264 .7 was determined . RESULTS :Three anti-CPG ODN fractions were extract- ed from Terminaliachebula ret .Terminaliachebula retz 3 fraction was proved to have most powerful binding activity to CPG ODN , and inhibit the release of TNF-αof RAW 264 .7 .CONCLUSION:The Terminaliachebula retz 3 fraction has marked anti-CPG ODN activity .

Urinary excretion of genistein and its metabolite at different doses in rats

ZHOU Si-yuan, TENG Zeng-hui, LIU Xin-you, RAN Yu-hua, YANG Run-tao, XIAO Yi, WANG Si- wang, MEI Qi-bing

2006, 11(1):  62-65. 

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AIM:To study the urinary excretion of genistein at different doses in rats .METHODS:Sus- pended in 0 .5 %CMC-Na solution, genistein was orally administered to rats at the dose of 6 .25, 12 .5 and 50 mg·kg ^-1 , respectively .At various time intervals, the urine was collected .The urine was treated with β-glucu- ronidase.The genistein in urine was extracted twice by vortexing with 2 .0 ml mixture of methyl tert-tubtyl ether and pentane ( v/v =8 ∶2) .The organic phase was re- moved into the tubes and then evaporated in ventilation cabinet .The residue was dissolved in 50 μl of methanol . The solution of 20 μl was drawn and detected by high-per- formance liquid chromatography .RESULTS:The accu- mulative urine excretion of genistein was 34 .79 ±10 .83, 187 .30±69 .96 and 213 .56 ±30 .58 μg at the dose of 6 .25, 12 .5 and 50 mg·kg ^-1 , respectively .The total drug ( genistein +glucuronidated genistein) excreted from urine was 217 .79 ±52 .06, 583 .05 ±106 .92 and 1108 .37 ±88 .14 μg, and the ratio of glucuronidated genistein was 84 .03 %, 67 .88 % and 80 .73 % at the dose of 6 .25, 12 .5 and 50 mg·kg ^-1 , respectively . CONCLUSION:The genistein is excreted mainly in the form of glucuronidated genistein in rat urine .The genistein and glucuronidated genistein are excreted in the manner of non-linear dose-dependent .

Study of pharmacokinetics of secnidazole vagina effervescent tablets in healthy volunteers

WANG Shao-hua, ZHAO Yan, LIU Zhen-sheng, LI Zhi-ping, WANG Xia, ZHAO Mei-ling, QI Fang-mei

2006, 11(1):  66-69. 

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AIM:To study the pharmacokinetics of secnidazole vagina effervescent tablets in healthy volun- teers.METHODS :250, 500 and 750 mg secnidazole vagina effervescent tablets were used in single-dose groups;500 mg secnidazole vagina effervescent tablets were used for 7 days in multi-dose group .The concentra- tions of secnidazole in plasma were determined by HPLC . The parameters of pharmacokinetics were calculated by DAS software .RESULTS AND CONCLUSION:The pharmacokinetic parameters after administration of a single dose of secnidazole vagina effervescent tablets( 250, 500, 750 mg) in health married female volunteers were as fol- lows :T_{1/ 2β} were 18 .84, 15 .25, and 21 .86 h, in accor- dance with the literatures ;T_max were 12 .22, 14 .00, and 18 .00 h ;C_max were 3 .58, 5 .42, and 8 .00 mg·L ^-1 ; AUC were 103 .52, 190 .99, and 296 .92 mg·h^-1·L ^-1 , respectively.The absorption of secnidazole vagina effer- vescent tablets was slower and lower than oral tablets . The systemic actions and adverse reactions were fewer and rudimental concentrations were higher so as to show more local actions .The pharmacokinetic parameters after ad- ministration of multi doses of secnidazole vagina efferves- cent tablets ( 500 mg ) were as follows :T_1/2β =22 .74 h, C_max =14 .30 mg·L^-1 , T_max =11 .60 h, and AUC = 520 .14 mg·h^-1·L ^-1 .C_max and AUC were higher than the results of a single dose.These showed that the drug can cumulate after a long-time administration because of its long half-life and required more caution .

Experimental study on radioprotective and cytoprotective activities of fac- teur thymic serique in mice

LI Zhan-jun, LIAO Xiao-quan, XU Kang-sen

2006, 11(1):  70-73. 

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AIM :To evaluate the radioprotective ef- fects and cytoprotective activities of the facteur thymic se- rique ( FTS) to reduce certain side-effects in the chemo- therapy in mice .METHODS:Except of control group, all mice which received acute whole-body Co-60-gamma irradiation were randomized to 5 groups :Saline solution was given to model group, 0 .025, 0 .25, and 2 .5 mg·kg ^-1·day ^-1 for 7 consecutive days FTS to low or me- dial or large dose of FTS group by s .c., 2 .5 mg·kg ^-1 nilestriol to control drug group by i .g .at 1st day and the radioprotective efficacy of FTS was determined by immuni- ty effects and by measuring 30-day survival at 6 .0 Gy or 7 .0 Gy .The same doses above of FTS were investigated by measuring 20-day survival at 100 mg·kg ^-1 d-1 for 14 consecutive days cyclophosphamide injury in mice with H22 liver cancer cell for its cytoprotective activities to re- duce certain side-effects in the chemotherapy of cancer. RESULTS :The leucocyte total number, phagocyte com- petence and thymus index were enhanced significantly when compared with the model group ( P <0 .05) , but spleen index increased than those of nilestriol group ( P > 0 .05) .Thirty-day survival for 0 .25 mg·kg ^-1 FST ad- ministered mice at 7 .0 Gy was significantly increased in comparison with saline administered mice ( P <0 .05) and the survival days were longer ( P <0 .01) , the same as nilestriol group .20-day survival was increased for FST to inhibit cyclophosphamide-induced injury in mice with tumors .CONCLUSIONS:FTS developed in our labora- tory provides significant protection from acute whole-body gamma irradiation or chemotherapy ( cyclophosphamide) injury in mice .It may play an important role in the mani- festation of its radioprotective and cytoprotective efficacy .

Meta-analysis of effectiveness of fluoxetine in treatment of post-stroke de- pression

JIANG Ya-bin

2006, 11(1):  74-77. 

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AIM :To further investigate the effective- ness and safety of fluoxetine in treatment of post-stroke depression ( PSD) .METHODS :The effectiveness and safety of fluoxetine in treatment of PSD patients in 13 con- trolled studies were analyzed by meta-analysis again in or- der to assess the comprehensively significant differences and effect size ( ES ) .RESULTS:( 1) The scores of Hamilton, and degrees of neurological functional defect and Barthel index in PSD patients before and after treat- ment with fluoxetine had significant difference ( P < 0 .0005) , and ES :dmean >0 .8 .( 2) Improving degrees of depression symptom, neurological functional defect and activity of daily living scale ( ADL) between fluoxetine treatment group and control group had significant differ- ence ( P <0 .0005) , and ES :dmean >0 .8 .CONCLU- SION:Fluoxetine can significantly ameliorate the depres- sion symptom, neurological functional defect and ADL of patients with PSD, and it has few side effects .

Investigation of bioequivalence of capsules and tablets of complex chlorzoxazone in healthy volunteers

ZHU Jin-xiu, LI Jian-chun, HU Qi-sheng , DONG Hai-jun, GAO Shu, JIANG Zhi-wen

2006, 11(1):  78-81. 

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AIM :To investigate the bioequivalence between capsules and tablets of complex chlorzoxazone in healthy volunteers .METHODS:twenty volunteers were randomly divided into two groups ( test and reference) , ten in each, with crossover design .The concentration of com- plex chlorzoxazone was determined by HPLC and pharma- cokinetic parameters were calculated with DAS 2 .0 practi- cal pharmacokinetics program.RESULTS:The relative bioavalibility of chlorzoxazone and acetaminophen in com- plex chlorzoxazone capsules were ( 109 .1 ±30 .9) %and ( 114 .0 ±50 .5) %, respectively .CONCLUSION :The statistical analysis showed that the test and reference preparation were bioequivalent .

Protection of hepatic stimulator substance against chemotherapeutic liver damage induced by cyclophosphamide in mice inoculated with S₁₈₀ cells

YAO Qi , NI Xiu-xiong , CHEN Wei

2006, 11(1):  82-85. 

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AIM :To study the protective effect of hepatic stimulator substance (HSS)on chemotherapeutic liver damage induced by cyclophosphamide and its possi- ble mechanism.METHODS:The serum biochemical pa- rameters, oxidative parameters and anti-oxidative parame- ters of liver tissue of male Kunming mice inoculated with S₁₈₀ cells were measured .The pathology of the liver was observed with microscope .The weight of S180 sarcom was weighted .RESULTS:The elevation of MDA content of liver tissue and the less of GSH content and CAT , GSH- PX , GST , and SOD activities induced by CP were re- stored remarkably by HSS .The ALT and LDH activities of serum in HSS group which was compared with control group and CP group were not statistically distinctive .In the pathologic examination , spotty and focal necroses of hepatocytes in the liver of CP group were found with a great deal of inflammatory cells infiltration in the necrotic and portal areas, while the damage in the liver of HSS group was ameliorated obviously ;The weight of S₁₈₀ sar- com in CP group and HSS group was not statistically dis- tinctive .CONCLUSION:The effect of HSS on CP-in- duced chemotherapeutic liver damage maybe due to anti- oxidative activity .

Effects of psychological stress on pathogenetic condition and rapeutic effect of ulcerative colitis

WANG Hao, WU Wan-chun, HAN Zhen, JIN Dao-you, WANG Meng-ya

2006, 11(1):  86-90. 

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AIM:To investigate the effects of psy- chological stress on ulcerative colitis rats and to explore the mechanisms of this ;meanwhile to investigate the ef- fects of anxiolytic drug on symptoms of ulcerative colitis rats under psychological stress and the mechanisms of it . METHODS:eighty male Wistar rats were randomly di- vided into four groups ( n =20) :UC control group ;UC stress group ;UC +clonazepam group ;UC stess +clonaz- epam group .After UC model was established with immu- nization, these rats were fightened by cat to set up psy- chological stress model .During establishing stress model, each groups were respectively received physiologic saline or clonazepam by intragastric administration .After 15d treatment, all rats were sacrified simultaneously .Colon mucosal inflammationand damage were assessed by mea- suring colon mass, morphologic damage score, colonic MPO and NO activity levels .Morphologic damage score was examined under microscope.Colonic MPO and NO was measured by spectrophotometric method .Serum hydrocortisone was determined by radioimmunoassay ( RIA) .RESULTS :Morphologic damage score, colonic MPO and NO, serum hydrocortisone of UC stress group were significantly increased compared with those of UC control group ;morphologic damage score, colonic MPO and NO, serum hydrocortisone of UC +clonazepam group were decreased markedly vs UC stress group ;Little differ- ence was observed between UC +clonazepam group and UC control group .CONCLUSION:Psychological stress can aggravate symptoms of UC.Although benzodiazepine have no anti-inflammatory action, it relieve effects on in- ternal organs of psychological stress and aggravation of symptoms of UC by to effect limbic system and formatio reticularis .

Effect of compound salivia miltorrhiza injection on LPS-induced renal mi- crovascular thrombosis

LIN Xi, ZUO Chang-qing, WU Tie, LU Cheng-yu

2006, 11(1):  91-94. 

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AIM :To evaluate the effects of com- pound salivia miltorrhiza injection on an experimental model of kidney thrombus induced by lipopolysaccharide ( LPS) .METHODS:The model of microvascular throm- bosis in the rabbits' kidney was performed by the method of Hermida, which was induced by infusing LPS .Treat- ments were begun simultaneously with LPS infusion, through the contralateral marginal ear vein .Six different groups were established :NS 10 ml·h^-1 was infused as the negative control group, compound salivia miltorrhiza injection was infused with the dosage of 0 .1 ( Low-dose) , 0 .2 ( medium-dose ) , and 0 .4 ( high-dose ) ml·kg ^-1·h^-1 , heparin 600, 000 IU·kg ^-1·h^-1 as positive control group .The further rabbits, which were given nei- ther LPS nor compound salivia miltorrhiza injection, were infused with saline solution through both marginal ear veins .The measurement of fibrinogen concentrations and platelet counts were used to assess the degradation of mi- crovascular thrombosis .Kinney sections were examined for the presence of fibrin microthrombi .^RESULTS: Compound salivia miltorrhiza injection was infused with the dosage of 0 .1 ( Low-dose) , 0 .2 ( medium-dose) , and 0 .4 ( high-dose) ml·kg ^-1·h^-1 , and the fibrinogen con- centrations and blood platelet counts were improved, and the fibrin deposition was degraded .CONCLUSION: Compound salivia miltorrhiza injection can inhibit effec- tively LPS-induced renal microvascular thrombosis .

Neuroprotective effects of nGBE against glutamate excitotoxicity

SUN Jing, SUN Chang-kai , FAN Ming , DING Ai-shi, YIN Lin, WU Wei, WANG Xiao-tong

2006, 11(1):  95-98. 

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hippocampal neuron ;rat ;excitotoxicity ; cell culture ;apoptosis

Study of toxicokinetics of bromoxynil in rabbits

LIU Xiao, LU Zhong-qiu , HU Guo-xin, XU Xue-song , LIN Hong-liang

2006, 11(1):  99-103. 

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AIM:To develop a gas chromatography- mass spectrography method for the determination of Bro- moxynil in rabbit plasma, and to study the toxicokinetics of Bromoxynil in rabbits .METHODS:Seven male rab- bits were involved in the study .Each subject received a single dose of 30 mg·kg^-1 Bromoxynil tested formulation . Blood samples were conducted consequently within 72 hours .The plasma Bromoxynil concentrations were deter- mined by GC-MS .The plasma Bromoxynil concentration were calculated by ADS and calculated the toxicokinetics parameters.RESULTS:After a single dose of 30 mg·kg ^-1 tested formulation, the oxicokinetics parameters of Bromoxynil were as following :t_{1 /2ke} was 11 ±3 hours, · 102 · Chin J Clin Pharmacol Ther 2006 Jan;11( 1) T_max 5 .6 ±1 .2 hours, C_max 110 ±43 mg·L ^-1 , AUC_{0 -tn} 2275 ±959 mg·L ^-1·h^-1 and AUC_{0 -∞} 2315 ±980 mg·L ^-1·h^-1 , MRT_0-tn 16 .9 ±2 .5 hours, and MRT_{0 -∞} 18 .1 ±2 .9 hours .CONCLUSION:After 30 mg·kg ^-1 ig administration demonstrates that plasma Bromoxynil concentration against time profile is fitted well to the one- compartment open model with 1st order absorption .Ab- sorption and elimination of Bromoxynil in rabbits were all slow.The method for determination of Bromoxynil con- centration in plasma by GC-MS is simple, sensitive, and accurate .

Neuroprotection effect of Milkvetch injection in neonates with hypoxic- ischemic-encephalopathy

DOU Chang-cheng, ZHOU Ming-xiong, ZHANG Shi-fa, TAO Qing-song

2006, 11(1):  104-106. 

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AIM:To investigate the therapeutic ef- fects of Milkvetch injection in neonates with hypoxic isch- emic encephalopathy ( HIE ) .METHODS:Neonates with HIE were randomly divided into two routine group( n =30) and a Milketch treatment group ( n =30) .NBNA were done at different time session and the dynamic levels of MDA in serum were investigated at the time of admis- sion, the 3 d and 7 d .RESULTS:The grades at the third day in traditional group were 8 .67 ±2 .50, which had no statistical significance compared with Milkvetch group ( 8 .27 ±2 .53) ( P >0 .05) .There had significant difference ( 25 .47 ±8 .27 vs 32 .40 ±5 .86) between them at the seventh day ( P <0 .01) .The differences of MDA levels between traditional and Milkvetch group be- fore treatment ( 4 .96 ±0 .37 vs 5 .00 ±0 .38) showed no statistical significance but there were marked difference between the two groups at the third day ( 7 .28 ±0 .86 vs 6 .18 ±0 .79) and seventh day ( 6 .43 ±0 .79 vs 5 .43 ± 0 .64) ( P <0 .05) .CONCLUSION:Milkvetch can significantly decrease abnormally elevatory MDA serum levels of neonates with HIE and improve the NBNA grades, and have the neuroprotective effect .

Evaluation of efficacy and safety of amoxicillin and potassium clavulanate chewable tablets in treatment patients with respiratory apparatus or uri- nary system infection

LI Wei, ZHANG Zhen-jun

2006, 11(1):  107-110. 

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AIM:To evaluate the efficacy and safety of the amoxicillin and potassium clavulanate chewable tablets .METHODS:With the amoxicillin and clavu- lanate potassium tablets serving as the reference, a total of 120 patients with respiratory apparatus or urinary system infection were treated with amoxicillin and potassium cla- vulanate chewable tablets in the randomized double-blind- ed multicentre research .RESULTS:There was no sig- nificant difference( P >0 .05) between the tested tablets and the reference on their clinical efficacy, antibiosis effi- cacy and safety .The tested tablets were effective to respi- ratory apparatus or urinary system infection,with effective rate at 88 .33 % and recovery rate at 76 .67 %.CON- CLUSIONS:The amoxicillin and potassium clavulanate chewable tablet is an effective and safe antibiotic agent in the treatment of patients with respiratory apparatus or uri- nary system infection .

A SAS macro for analyzing measurement data in clinical trial of new drug

YU Li-li, XUE Fu-bo, LI Chan-juan, WANG Su-zhen, XU Li, WANG Ling, XIA Jie-lai

2006, 11(1):  111-115. 

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Based on ttest, npar1way, anova and glm procedures, we developed a SAS macro for analyzing mea- surement data in clinical trial .With some examples, the main parameters and calling approach of the SAS macro was illustrated in detail .The development of this SAS macro and its successful implementation in practical work show a good perspective of efficient approach of measure- ment data analysis in clinical trial of new drug .

ICH E14 :a new global regulatory guideline on clinical evaluation of car- diac safety for new drug development programs

Daniel Liu

2006, 11(1):  116-120. 

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In May 2005, resolutions on how cardia safety of a new drug should be monitored during its clini- cal studies were concluded with publication of an intensive International Conference on Harmonization ( ICH) pro- cess, leading to the document :ICH Harmonized Tripatite Guideline:The clinical evaluation of QT QTc interval prolongation and proarrhythmic potential for non -antiaa- hythmic drugs ( ICH E 14) .The review presented this guidance with commentary on areas requiring more clarifi- cations that will be useful in developing China' s strategies of cardiac safety programs of new drugs to ensure compli- ance with good clinical practice .