Table of Content

Volume 10 Issue 12
26 December 2005

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Effect of prostaglandin D₂ on sleePregulation

FU Chang-fang, HONG Zong-yuan

2005, 10(12):  1321-1325. 

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Prostaglandin (PG)D₂ is one of unsatur-ated fatty acids with 20 carbon atoms,which is synthe-sized by PGD synthase (PGDS)in the brain.PGD₂ has been identified to be a sleep-inducing substance that be-comes bound to the DPreceptor(DPR)exclusively local-ized on the surface of the basal forebrain,leading to an increase in extracellularadenosine levels there.Through A_2A receptors (A_2A R),the adenosine activates neurons in the ventrolateral preoptic area (VLPO),a putative sleePcenter,and inhibits neurons in the histaminergic tube-romammillary nucleus (TMN),a putative wake center,via GABA to induce sleep.Studying the effect and the molecularmechanismsof sleep-induced by PGD₂ would be helpful in the development of novel sleeping drugs formore rational treatment of sleePdisorders.

Absorption mechanism and absorption site of oxymatrine in rats

WANG Su-jun, WANG Guang-ji, LI Xiao-tian, YANG Min, RUAN Jin-xiu, ZHANG Zhen-qing

2005, 10(12):  1326-1329. 

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AIM: To study the absorption mechanism and absorption site of oxymatrine in rats.METHOD: The absorption kinetics and absorption site of oxymatrine were investigated using in situ perfusion method in rats.RESULTS: The absorption mechanism of oxymatrine complied with the passive diffusion and first orderkinet-ics.The absorption rate decreased according to the turn of jejunum ,ileum ,duodenum and colon.The absorption rate constantswere 0.237,0.225,0.200 and 0.062h-1 at jejunum ,ileum ,duodenum and colon ,respectively.CONCLUSION: Oxymatrine can be prepared and pro-cessed into sustained-release dosages forms.

Study on reproductive toxicity of hydroxyurea in male rat

ZHOU li, WU Chun-qi, LIAO Ming-yang

2005, 10(12):  1330-1334. 

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AIM: To study the toxic effects of HU on reproductive system in male rats.METHOD: By intrap-eritoneal injection,HU were administrated to male Wistarrats at different doses of (100,200,and 400 mg·kg^-1)once a day for10 days,and the rats were randomly sacri-ficed on the 9th and twentieth-third days afterwithdrawal of HU,respectively.RESULTS: Inactive sperm in 200 and 400 mg·kg^-1 grouPwas higherthan that in the con-trol grouPon the 9th afterwithdrawal.On the twentieth-third afterwithdrawal,the testis body ratios,three treat-ment groups were decreased significantly than that in the control grouP(P<0.05,orP<0.01) ,the epididy-mides body ratios was decreased significantly in 400 mg·kg^-1 group,and inactive sperm remains had de-creased significantly (P<0.01) ,200,400 mg·kg^-1 groups of the numberof sperm had decreased significantly than that in the control grouP(P<0.01).In the groups treated,the rates of sperm deformity were signifi-cantly higherthan that of the control,and the higherthe expose concentration of HU,the higherthe rate of sperm deformity on the 9th and the twentieth-third (P<0.01).CONCLUSION: HU can result in the obviously adverse effects on the reproductive system of male rats,its aim organs may be testis and epididymis,and affect the course of spermatogenesis.Afterwithdrawal,these dam-ages are hard to recoverand still development within a certain time.

Repression activity of recombinant oncostatin M on proliferation and mi-gration of tumorcells

OUYANG Li-ming, LIU Jian-wen

2005, 10(12):  1335-1339. 

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AIM: To investigate the inhibition ability of recombinant Oncostatin M(OSM) to proliferation and migration of tumorcells.METHODS: Expressed and purified human OSM from recombinant E.Coli,and as-sayed its pharmacology activity by a series of experiments in vitro to metastatic human lung cancercell line 95-D including MTT assay,clone formationassay in soft agar,cell attachment assay,cell migration assay and invasion cuPassay.RESULTS AND CONCLUSION: rhOSM displayed strong activity of inhibiting the proliferation and migration of 95-D.Prokaryoticly expressed hOSM has po-tential clinical value to lung cancer.

Effect of puerarin on glucogen synthase Kinase-3 bate in adipocyte of rats with insulin resistance

ZHANG Li-feng, BI Hui-min, BI Xin, WANG Shu-e

2005, 10(12):  1340-1343. 

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AIM: To investigate the effect of puerarin on expression of the glucogen synthase kinase-3 bate(GSK-3β) in adipocyte of rats with insulin resistance in-duced by diets.METHODS: 30 Wisterrats were ran-domized into two groups:control grouP(n =10) and model grouP(n =20).Control groupwere fed with gener-al diets,while model grouPwere fed with the high fat di-ets to induce insulin resistance.After4weeks,the mode-ls have formed then were randomized into two groups:model grouP(n =10) and pueraringrouP(n =10).Pu-erarin grouPwere treated with puerarin (100mg·kg^-1·d^-1,ip) for6 weeks.GSK-3βprotein was de-tected by Western-blot analysis.Body weight,serum trig-lyceride and cholesterol,fasting plasma glucose and serum insulin concentration were detected termly and the insulin sensitivity index was calculated.RESULTS: The model grouPshowed hyperglycemia,hyperinsulinism,obviously obesity and the insulin resistance index (ISI) decrease by high fat diets,insulin resistance was induced by this way.Compared with model group,GSK-3βprotein in ad-ipocyte of puerarin grouPrats decreased (P<0.05).CONCLUSION: Puerarin can decrease the expression of GSK-3βprotein in adipocyte of ratswith insulin resistance which may be involved in the mechanism of amelioration the state of insulin resistance.

Effect of 5-aminosalicylic acid on antioxidant mechanism and attenuation of proinflammatory cytokines in trinitrobenzene sulfonic acid-induced coli-tis in rats

ZHANG Lin, XIA Bing, CHENG Hong

2005, 10(12):  1344-1348. 

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AIM: To investigate the effect and mech-anism of 5-aminosalicylic acid (5-ASA) in topical treat-ment on trinitrobenzene sulfonic acid (TNBS)-induced co-litis in rats.METHODS: Colitis wasinduced by intraco-lonic administration of TNBS and was treated with 5-ASA at the dose of 100 mg·kg^-1 for2 weeks.Normal control grouPwas administrated with normal saline and TNBS control grouPwas treated with TNBS,not with 5-ASA.Macroscopic damage,histological changes and myeloper-oxidase (MPO) activity were evaluated.Superoxide dis-mutase (SOD) activity and malondialdehyde (MDA) level in colonic mucosa were detected by kits.The expression of interleukin-1β(IL-1β) and tumornecrosis factor-α(TNF-α) mRNAs in colonic mucosa was determined by a reverse transcription and polymerase chain reaction meth-od.RESULTS: Compared with TNBS control group,the macroscopic and histological changes and MPO activity in 5-ASA treated groups were improved.SOD activity was increased and the level of MDA in colonic mucosa was re-duced significantly.The expression of IL-1βand TNF-mRNAs in colonic mucosa was also decreased significant-ly.CONCLUSION: 5-ASA enema can significantly ameliorate TNBS-induced colitis in rats via antioxidant mechanism and attenuation of proinflammatory cytokine expression.

Screening of anti-endotoxin traditional Chinese medicine by target of Lipid A

CHEN Yi-guo, YAO Jie, ZHANG Xiang-wu, JIANG Dong-neng, GUO Yi-bin, WEI Li-zhao, CHENG Juan, WU Chong, ZHENG Jiang

2005, 10(12):  1349-1353. 

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AIM: To screen anti-endotoxin traditional Chinese medicine(TCM) from anti-inflammation TCM by Biosensor,and to furtherstudy anti-endotoxin effective materials of TCM.METHODS: Non-derivatised cuvette immobilised Lipid A was used to track the bonding be-tween the Lipid A and aqueous extracts and alcoholic ex-tracts from seventy-eight TCM,and then neutralized endo-toxin in vitro by selecting hypso-bonding TCM that re-moved the tannins.RESULTS: Twelve aqueous extracts and six alcoholic extracts from seventy-eight TCM had hypso-bonding with Lipid A (more than 200 response unit),and twelve aqueous extracts could bind specially endotoxin afterremoved tannins.CONCLUSION: Track of biosensortechnology is a quick,accurate and valid method in screening TCM.Aqueous extracts of twelve TCM can bind lipid A specially besides the tannins,and it is foundation to furthersegregate anti-endotoxin effective materials from twelve TCM in the future.

Effects of bombesin on cAMPcontent of hypothalamus and plasma in IL-1β-induced feverrats underlowertemperature

ZHANG Liang, TONG Lei, ZHAO Shu-fen

2005, 10(12):  1354-1357. 

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AIM: To study the effectsof bombesin on thermoregulation and its relationshiPwith camPcontent at 4 ℃.METHODS: Bombesin and IL-1βwere microin-jected into the lateral ventricles (LV) of male SD rats.Changes in colonic temperature and content of cAMPin hypothalamus and plasma were measured.RESULTS: (1) In the febrile rats induced by i.c.v.injection of IL-1β,content of cAMPin hypothalamus and plasma in-creased (P<0.01).(2) Bombesin could lowernormal body temperature in rats.Content of cAMPin hypothala-mus was lowerthan that in the control grouP(P<0.01).(3) Feverinduced by IL-1βwas reversed by pretreatment with bombesin,and content of cAMPin hypothalamuswas decreased compared with that in control grouP(P<0.01).CONCLUSION: Bombesin can inhibit IL-1β-in-duced feverat 4 ℃,and the mechanism may be related to the inhibition the synthesis and release of cAMP.

Effects of millimeterwave and adriamycin on superoxide dismutase and malondialdehyde of leukemia cell line K562

SUN Gui-ling, JIANG Yue-hua, LAI Sheng-li, YANG Tai-cheng

2005, 10(12):  1358-1363. 

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AIM: To study the effect of combination millimeterwave with adriamycin on regulating the antioxi-dase system andoxyradical in the cultured cell line system in vitro.METHODS: Leukemic cell line K562 was treated by millimeterwave alone and in combination with adriamycin.Then Intracellularmalondialdehyde(MDA)was analyzed with thiobarbituric acid method,superoxide dismutase (SOD) was analyzed with pyrogallic acid meth-od,and glutathione peroxidase (GSH-Px) was analyzed with improved Hafemanmethod.RESULTS: The combi-nation of millimeterwave and adriamycin had a synergistic effect on inhibiting superoxide dismutase and malondial-dehyde of leukemic cell line K562.The activity of SOD and GSH-Px was decreased and the content of MDA was improved by the combination.CONCLUSION: The combination of millimeterwave and adriamycin shows a synergistic effect on puring leukemic cells in vitro.

Protection of Mn²⁺on Injury of human kidney tubularepithelial cell line induced by bentamicin

WANG Zhi-peng, ZHANG Rong, LIU Li, MEI Qi-bing

2005, 10(12):  1364-1367. 

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AIM: To evaluate the protection of Mn²⁺ on injury of human kidney tubularepithelial cell line in-duced by gentamicin,and investigate its principals.METHODS: Gentamicin was used to injury human kid-ney tubularepithelial cell line (HK-2) to produce model of kidney injury.MTT method was used to measure effect of Mn2+ on proliferation of cells afterthey were injured by gentamicin.The spectrophotometry method was used to observe the change of LDH,NAG and SOD effected by Mn²⁺.Ultrastructure was examined by electron microsco-py.RESULTS: Although HK-2 cells were injured,Mn²⁺ promoted cells proliferation,decreased LDH activity and NAG content,increased SOD activity,and alleviated dilation of the mitochondria and crushing of lysosomes.CONCLUSION: Mn²⁺ can protect human kidney tubularepithelial cell line from injury induced by gentamicin.It may be in relation to inhibiting the oxidative injury,light-ening dilation of the mitochondria,protecting the integrity of lysosomes and decrease the leakage of enzyme.

Effects of alltride on gastric ulcerand promoting bowl movement

LIAO Hui-fang, LIAO Xue-zhen, ZHOU Jiao-yao

2005, 10(12):  1368-1371. 

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AIM: To study the effects of alltride on experimental gastric ulcerand promoting bowl movement.METHODS: Applying experimental gastric ulcermodels induced by alcohol and hydrochloric acid,ligating pylorus,indomethacin,acetic acid,calculated the index of gastric ulcer.Applying dry stool constipations in mice the first defecation time,moist dejection amounts were observed.In small intestinal propelling test in normal mice,small intestinal contents (charcoal Powder) ropelling ratio was observed.RESULTS: Alltride reduced the index of ulcers in above experimental gastric ulcermodel rats(P<0.05 orP<0.01).KZS shortened the first defecation time and increase moist dejection amounts in dry stool constipations mice and improve apparently intestinal peristalsis (P<0.05 orP<0.01).CONCLUSION: Alltride has antiulcereffects in rats and the action of moistening the intestines and promoting bowl movement.

Argument foreffect of Vitamin K₃ applying to fungal counting with MTT assay

FANG Shi-jie, ZHU Jing, WANG Xu

2005, 10(12):  1372-1375. 

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AIM: To determine the concentration of vitamin K₃ (VK₃) in fungal counting with MTT assay.METHODS: Microplate andMTT colorimetric assay were used to measure the effect of different VK₃ concentrations on fungal counting.RESULTS: The OD(optical density)value was affected by fungal and VK₃ concentration,measure wavelengh,and solvent addition-time at the same time.Generally speaking,the OD value was increased with fungal and VK₃ concentration increased.At a higherfungal concentration,there was little impact from solvent addition-time and remarkably impact from measure wavelength.CONCLUSION: The reliable and stable results will be acquired in the conditions as follows: 106 fungal concentration,0.1 mol·L^-1 VK₃ concentration,and 570 nm measure wavelengh.

Dual action on hydrogen peroxide induced oxidative vascularendothelial cell damage by curcumin

XIAO Jian, LI Xiao-kun, GUO Jian-hong, ZHOU Zhong-lou

2005, 10(12):  1376-1380. 

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AIM: To observe the effect and mechanisms of curcumin to hydrogen peroxide induced oxidative vascularendothelial cells ECV304 damage.METHODS: Estimate cell survival rates of curcumin to H₂O₂ induced oxidative ECV304 damage by trypan blue staining.The observed the change of cell cycle and cell apoptosis rates by FACS.Detect the expression of NO,MDA contents and SOD,Gractivity by test kits.RESULTS: When added simultaneously with 500μmol·L^-1 curcumin (0-100μmol·L^-1) for5 h effectively protected cells form ox-idative damage.However,when the cells were pretreated with curcumin (25-100μmol·L^-1) for1h before H₂O₂ exposure for4 h,curcumin was unable to inhibit H₂O₂-induced cell damage.Instead;when pretreated with H₂O₂ for4h and then added curcumin (25-100μmol·L^-1),cell survival rate also increased.It was no obviously change of cell apoptosis rates by curcumin to H₂O₂-induced cell damage,but curcumin was found to induce Sphase cell cycle arrest in curcumin togetherwith H₂O₂ grouPand post-treatment with curcumin group,and adversely in pretreatment with curcumin group.CONCLUSION: The curcumin has dual action to hydrogen peroxide induced oxidative vascularendothelial cells ECV304 damage,cytoprotective and cytotoxic effects,which is correlated different chronologicaol ordertreated with curcumin.

Effect of TNF-αon the apoptosis of A549 cells

XIA Hui, LI Jie, YU Chang-hai, YU Jian-qi, Hou Zhan-jun

2005, 10(12):  1381-1383. 

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AIM: To observe the effect of TNF-αon the apoptosis of A549 cells.METHODS: A549 cells were cultured and incubated with TNF-α(10,100 U·ml^-1).Western blot was used to observe the change of P53 protein,and the cell apoptosis was observed by the Annexin V/PI staining.RESULTS: The expression of P53 protein and the numberof apoptotic cells increased significantly aftertreatment with TNF-αas compared with the control grouP(P<0.01).The apoptosis rate of A549 cells was 1.22±0.62 and 1.65±0.38 in the TNF-αgrouPwith different dose respectively (P<0.01).CONCLUSIONS: TNF-αcan induce the apoptosis of A549 cells and maybe provide the new idea forthe therapy of lung cancer.

Effect of L-Arginine and vitamin C on left ventricularhypertrophy and endothelial function in spontaneously hypertensive rats

ZHANG Ping-yang, DENG You-bin, YANG Hao-yi, BI Xiao-jun, PAN Min

2005, 10(12):  1384-1388. 

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AIM: To explore the relationshiPbetween left ventricularhypertrophy (LVH) and endothelial function(EF) and to investigate the effects of L-Arginine and Vitamin C on LVH and EF in spontaneously hypertensive rats (SHR).METHODS: 20 SHrwith 8 weeks old were randomly divided into experiment grouP(12 rats)and treated grouP(8 rats) while 8 WKY rats were selected as a control group.The SHrof treated grouPreceived L-Arginine and Vitamin C (7.5 and 4-5 g·L^-1 respectively in drinking water) for12 weeks,but the WKY rats and the SHrof experiment grouPwere given distilled wateras drinking water.The rats with 20 weeks old were killed aftermeasurements of theirblood pressure and body weight.HE and VG staining combined with computed morphometry were employed to evaluate the cardiomyocyte diameter(CDM),the collagen volume fraction (CVF),perivascularcircumferential area (PCA) on the left ventriculartissue.RESULTS: Compared with the WKY,the blood pressure was higher,heart rate was faster,left ventricularmass (LVMI) were higher,NO was lowerin the experimental group.The CVF,PCA and CDM were higherin the experimental group.There were no differences in body weight between the experiment grouPand the control.Bivariate analysis showed that in the experiment grouPLVMI correlated well with NO,CVF,PCA orCDM (r=0.80,0.68,0.66,P<0.01).Besides,NOin the experiment grouPcorrelated well with CDM,CVF orPCA (r=-0.65,-0.54,-0.52,P<0.01 orP<0.05).Compared with the experiment group,LVMI,CDM,CVF,and PCA were lowerin the treated group.There was higherNO level in the treated group.There were no significant differences in blood pressure,body weight and heart rate.Compared with the control,blood pressure,heart rate,LVMI,CDM,CVF and PCA still increased.There were no significant difference in body weight and in NO between WKY and the treated group.CONCLUSIONS: LVH is related with endothelial dysfunction in SHR.The endothelial dysfunction may play a role in the development and progression of LVH by accelerating CDM and CVF and PCA increased.LL-Arginine and Vitamin C can hinderoff LVH to some degree by improving endothelial function.

Effect of berberine on apoptosis in GLC-82 human lung cancercells

ZHANG Gui-ping, ZHANG Wei-wen, OU Hui-jian, WEI Yi, LV Jia-chun

2005, 10(12):  1389-1393. 

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AIM: To study the effect of berberine,alkaloid,on GLC-82 cell apoptosis.METHODS: GLC-82 cells were cultured with different concentrations of berberine.Proliferation inhibition of berberine on GLC-82cells was evaluated by MTT assay.Morphologic changes of berberine-treated cells were observed by light microscope.Apoptotic cells with condensed orfragmented nuclei were visualized by Hoechst33258 by a fluorescence microscope.Nuclei area and apoptotic rate were measured with the use of QWin.The protein expressions of Caspase-3 and PARPwere analyzed by fluorescence immunohistochemical method (SABC-Cy3),fluorescent intensity of Caspase-3 and PARPwere measured with the use of QWin.RESULTS: 48 h afterberberine treatment,apoptotic cells increased dose-dependently,morphological changes of GLC-82 Cells showed many hall-mark features of apoptosis,including nuclei dwindle and chromatin aggregation and fragmented nuclei.Inhibition of GLC-82 cell proliferation was concentration-dependent,the IC50 value forberberine was 19.9 mg·L^-1.36 h afterberberine treatment,the measurement of fluorescent intensity showed 20 mg·L^-1of berberine increased the intensity levels of Caspase-3 and PARP.CONCLUSION: The berberine evoked GLC-82 cell apoptosis is correlation with the up-regulation of Caspase-3.This study indicated that berberine might be a potential Chinese medical component forlung neoplasm.

Meta-analysis on combination of growth hormone and somatostain and single somatostain in treatment of patients with severe acute pancreatitis

ZHU Liang-hong, LI Juan, ZHAO Guo-hai

2005, 10(12):  1394-1396. 

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AIM: To explore the difference of efficacy and safety between combination of growth hormone and somatostain and single somatostain in treatment of patients with severe acute pancreatitis.METHODS: The case fatality rates and complication incidence of patients with severe acute pancreatitis were analyzed by Meta-analysis in homogeneity test and combined test in 6 studies.RESULTS: Homogeneity test showed that the cited studies of case fatality rates and complication incidence were homogeneous withχ² =3.156,χ² =1.210,P>0.05.In combined test,the combined Or=3.164,Or=3.209 and its 95 % confidence interval was in 1.390 ~ 7.200 and 1.747 ~ 5.900,respectively.CONCLUSION: The case fatality rates in combination grouPwere significantly lowerthan those in single somatostain group.The efficacy of combination grouPwas superiorto that of single somatostain group.

Different role of aldosterone in cardiac hypertrophy and cardiac fibrosis

LUO Bi-hui, ZENG Zhao-hua, WANG Xin-liang, HE Zhao-chu, SU Chen-jian

2005, 10(12):  1397-1402. 

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AIM: To observe the different role of aldosterone in cardiac hypertrophy and cardiac fibrosis.METHODS: The salt-Sensitive hypertensive rats induced by sensory denervation by injecting capsaicin were used to study the cardiac remodeling.The rats were divided into 4 groups and subject to the following treatment for4 months: Control+normal salt diet (0.5 %Nacl) (CON+NS);capsaicin +normal salt diet(CAP+NS);capsaicin+high salt diet (4 %Nacl) (CAP+HS);capsaicin +high salt diet +Spironolactone (CAP+HS+S,80mg·kg^-1·d^-1).Tail-cuff systolic blood pressure and body weight were measured statedly.At the end of experiment,left ventricularweight index,cardiac muscle pathology morphology,invasive cardiac function and serum concentration of hyaluronic acid (HA) and procollagen typeⅢ(PCⅢ) were examined.RESULTS: Tail-cuff systolic blood pressure,serum concentration of HA and PCⅢ,LVSPand LVEDPwere lowerin CAP+HS+S grouPthan in CAP+HS group.There were no marked differences in left ventricularweight index,myocyte short diameterand isovolumetric relaxation period Time constant(T value) between the two groups,but significantly higherthan controls.It was seen that cardiac muscle fibrillarcollagen was lessen in CAP+HS+S group.CONCLUSION: Aldosterone is involved in the development of hypertension and the process of cardiac induce by high salt intake,but it is not involved in the process of cardiac hypertrophy which also induce by high salt intake.

Effects of cell adhesion molecule CD₅₄ and CD₄₄ on apoptosis inducted by momordin in erythroleukemic K562 Cells

XIONG Shu-dao, YIN Li-hui, LI Jing-rong, HAN Yi-xiang, ZHANG Sheng-hui, WU Jian-bo, YAN Yue, Li Guan-wu, WEN Bo-gui

2005, 10(12):  1403-1407. 

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AIM: To explore the change of the expression of cell adhesion molecule CD₅₄ and CD₄₄ in erythroleukemic K562 apoptosis cells induced by momordin from momordica charantia seeds and study the effects of cell adhesion molecule CD₅₄ and CD₄₄ on cell apoptosis induced by momordin.METHODS: Afterthe treatment of K562 cells with appropriated concentration momordin,CCK-8 test was employed to determine K562 cells growth;flow cytometry FACScan (FITC-Annexin V staining) and electron microscopy were used to detect apoptosis;The expression of CD₅₄ and CD₄₄ were examined by flow cytometry FACScan (FITC-CD₅₄ and PE-CD₄₄ staining).RESULTS: CCK-8 test showed K562 cells growth was significant inhibited by momordin;the apoptosis was detected by cell morphology and flow cytometry FACScan(FITC-Annexin V) in K562 cells aftertreatment by appropriated concentration momordin.The expressions of CD₅₄ and CD₄₄ in momordin treated K562 cells were 18.62 % and 1.32 % respectively,and in negative momordin treated K562 cells were 0.25 % and 0.17 % respectively,and momordin could up-expresses the protein of CD₅₄ 18.37 % and CD₄₄ 1.15 %.CONCLUSION: Momordin can markedly induce the K562 cell to apoptosis s.The up-expressions of CD₅₄ exist in the process of apoptosis induced by momordin.The change of cell adhesion molecule maybe one of the key factors in the mechanisms of apoptosis induced by momordin,and its mechanism maybe involve in adhesion-dependent apoptosis.

Analysis of body weight effects on human equivalent dose calculations in clinical trials for therapeutics in adult healthy volunteers

ZHANG Xiao-hui, LI Juan, ZHENG Qing-shan

2005, 10(12):  1408-1411. 

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The maximum recommended starting dose(MRSD) for “first in human” clinical trials of new molecular entities in adult healthy volunteers derived from that no observed adverse effect level was converted to human equivalent dose using standard conversion factor determined in the tested species,judging reasonably, then was divided by the safety factor from the fittest animal.This article analysis of body weight effects on HED calculations.

Study of pharmacokinetics and bioequivalence about cefprozil granules in healthy volunteers

SU Meng-xiang, DI Bin, YU Feng, SHENG Jian-ping, ZHANG Yin-di

2005, 10(12):  1412-1415. 

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AIM: Use the HPLC-UV method to determine the contents of cis-cefprozil and trans-cefprozil in human plasma in orderto evaluate the pharmacokinetics and bioequivalence of cefprozil granules (testing granules and reference tablets) in healthy volunteers.METHODS: 20 healthy volunteers were classified into two groups forsingle dose and two-crossing test,with the dose of 500 mg,10 volunteers each grouPand seven days interval between two tests.Afterthe plasma protein was precipitated by 20 % trichloroacetic acid,endogenesis impurities in plasma was extracted with the mixtuerof acetonitrile and dichloromethane,then the supernatant was analyzed by HPLC.LichrospherC8 column(5μm,4.6 mm×30 cm)was applied,using acetonitrile-1.5 % acetic acid watersolution (15∶85,v/v)as mobile phase with the flow rate of 1.0 ml·min^-1.The detection wavelength was 280 nm and column temperature was 30 ℃,the internal standard was cefradine.RESULTS: Endogenous materies didn' t disturb the determination of cefprozil.Within the range of 0.0209-10.47μg·ml^-1,peak area and injection quantity were in linearcorrelation (r=0.9993).The limit of quantification was 0.0209 mg·L^-1.The main pharmacokinetic parameters Tmax,Cmax and t_1/2 were 1.7±0.3 h,4.45±1.25 mg·L^-1,1.89±0.45 h forthe reference tablets;1.8±0.2 h,4.88±1.08 mg·L-11.79±0.39 h forthe test granules respectively.AUC_0-12were 12.11±2.62,12.34±2.93 mg·L^-1·h^-1 and the relative bioavailability was (101.9±8.8)%.CONCLUSION: The method is simple,accurate and reliable.There is no significant difference between the two formulations in the C_max,and AUC_0-12.The two formulations are bioequivalence.

Study of relative bioavailability of chlorpheniramine maleate tablets in healthy volunteers

QIAO Hai-ling, TIAN Xin, GUO Yu-zhong, ZHANG Li-rong, JIA Lin-jing, GAO Na, XIE Min

2005, 10(12):  1416-1419. 

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AIM: To study pharmacokinetics and bioavailability of chlorpheniramine maleate tablets in young healthy volunteers.METHODS: The chlorpheniramine concentrations in plasma were determined by HPLC method with UV detectoraftera single oral dose 8 mg of the reference formulation and the tested formulation were respectively given to 18 volunteers in randomized cross-overtest.The pharmacokinetics parameters were calculated by 3P97 software.RESULTS AND CONCLUSION:The concentration-time curves of two formulations fitted to a one-compartment open model.The C_max was 15.74±7.06μg·L^-1 and 14.88±4.40μg·L^-1,t_max was 3.9±1.2 h and 4.5±0.8 h,t_1/2ke was 15.54±3.76 h and 14.49±3.24 h,AUC_0-t was 248.86±78.52μg·h·L^-1 and 245.09±90.77μg·h·L^-1,AUC_0-∞ was 292.64±99.21μg·h·L^-1 and 282.04±98.64μg·h·L^-1,respectively.The pharmacokinetic parameters obtained from ourstudies showed no significant difference between two formulations (P>0.05).The relative bioavailability of F_0-t and F_0∞ of tested formulation were (104.1±36.1) % and (103.2±35.6) %,respectively.The two formulations are bioequivalent.

Meta-analysis of effectiveness of omeprazole and otherdrugs in treatment of active peptic ulcerand bleeding

CHEN Yong-rong

2005, 10(12):  1420-1422. 

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AIM: To explore the difference of efficacy between omeprazole and otherdrugs in treatment of active peptic ulcerand bleeding.METHODS: The efficacy of omeprazole orotherdrugs in treatment of active peptic ulcerand bleeding was analyzed by Meta-analysis in homogeneity test and combined test in 9 studies.RESULTS: Homogeneity test showed that the cited studies were homogeneous withχ² =9.84,P>0.05;and in combined test,the combined Or=4.42 and its 95 %confidence interval was in 2.83-6.68 (χ²=44.4,P<0.01).CONCLUSION: Omeprazole is a very effective and well-tolerated proton pumPinhibitorand it is worthy of being recommended foradministration in patients with active peptic ulcerand bleeding.

Effect and mechanism of NAC on patients with chronic obstructive pulmonary disease

LI Hua-ying, CHEN Xiu-gui

2005, 10(12):  1423-1426. 

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AIM: To explore the clinical effect and mechanism of NAC on patients with chronic obstructive pulmonary disease (COPD).METHODS: 78 patients with COPD in stable phase were randomly divided into the treated grouPand the control group.Total and differential count of inflammatory cell in sputum,NF-kB,IL-8,TNF-α,and clinical symptom,FVC,FEV1,mPAPand the blood levels of malondialdchyde (MDA),superoxide dismutase (SOD),angiotensin-converting enzyme (ACE)and endothelins-1 (ET-1)were measured before and aftertreatment.RESULTS: 5 cases of the 78 patients dropped out.The rate of total marked effect and total effect were72.50 %,and 87.50 % respectively,in the treated group.All the indexes measured in patients before and aftertreatment were significantly different from those in healthy subjects (P<0.05).Differential count of polymorphonuclearneutrophil (PMN),the levels of IL-8 and TNF-α,the activity of NF-kB in sputum in the treated grouPdecreased aftertreatment (P<0.01),while the FEV1,FVC,mPAP,MDA,SOD,ACE,and ET-1 were ameliorated (P<0.05),and all were betterthan those in the control grouP(P<0.05).No obvious adverse effects were found.CONCLUSION: NAC used fortreating COPD is able to relive the clinical symptom and improve the lung function,with a fairly good safety,and can play a therapeutic role on patients with COPD by way of increasing anti-oxidative ability and reducing the airway inflammatory reaction.

Clinical trial design of compound lisinopril in treatment essential hypertension in Chinese patients

HE Ying-chun, ZHENG Qing-shan

2005, 10(12):  1427-1429. 

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This paperdiscusses the design of compound lisinopril in clinical trial in the treatment systemic hypertension in Chinese patients,including inclusion and exclusion criteria,procedure,sample size,double blind technique,etc.

Some of problems in inclusion criteria and evaluation indexes of clinical trials in traditional herbs medicine forpatients with cerebral infarction

LI Tao

2005, 10(12):  1430-1433. 

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Depending upon the characteristics of the pathological and clinical types encountered,inclusion criteria and evaluation indexes should be done in accordance with the treatment purpose.The duration of the trail,types and degree of the infarction should be delaminated,and the relationshiPbetween these factors and the evaluative indexes analized.A standardized procedures forclinical trials on cerebral infarction should be established forclinical trails of Traditional Chinese Medicine.

Application of proc tabulate in new medicine research report

YAO Li-xiang, WANG Wen-hui, QU Feng, LIU Yu-e

2005, 10(12):  1434-1436. 

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This paperdescribed the procedure of SAS foroutputting directly the statistical form,and it provides some practical references to relate new medical research and data analysis.

Ethic review in clinical research:medical devices

WANG Xiu-qin, XIONG Ning-ning, LIU Shen-lin, LI Qi-yi, JIANG Meng, LIU Fang, GAOWei-min

2005, 10(12):  1437-1440. 

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Medical devices are administered according to certain classification by the state,and Class I medical devices need not be evaluated by clinical trial,while clinical evaluation must be conducted forboth Class II and Class III medical devices before they are put into production.Main points to considerwhen reviewing clinical trial with medical devices are as follows: scientific design of clinical trial;benefits and risks of the trial,differentiating clinical trial of significant risk and that of nonsignificant risk;informed consent;selection of subjects group;medical care and protection of subjects,etc.The criteria forapproval must be meet when approve a clinical trial of medical device,emergency use of medical devices should also meet corresponding standard.