Table of Content

Volume 10 Issue 9
26 September 2005

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Discussion on basic request and standardization in safety pharmacology

SHI Hong, LU Yan-ping, QIAN Bo-chu

2005, 10(9):  961-965. 

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Safety pharmacology is an integrated discipline that has evolved from the distinct fields of pharmacology, physiology and toxicology.Safety pharmacology studies identify, monitor and characterize potentially undesirable pharmacodynamic activities in non-or pre-clinical studies.In this paper the actuality of safety pharmacology is analyzed, the basic request of experiment design is discussed, and the standardization of design for the experiment of central nervous system, cardiovascullar system and respiratory system is discussed.

Role of peripheral NMDA receptor in pain occurrence and management

YU Xue-rong, HUANG Yu-guang

2005, 10(9):  966-969. 

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NMDA(N-Methyl-D-Aspartate)receptor is a kind of ionotropic receptors, which have been widely localized in peripheral somatic tissues and visceral pain pathways.The activation or expression changes of peripheral NMDA receptor may play an important role in pain occurrence.Peripheral administration of NMDA receptor antagonist can alleviate or prevent pain and enhance the analgesic effect of opiate.This method of administration can reduce the side effect of central action induced by the drug.It will be an important research direction of pain management.

China cobra venom active factor (CCVAF) inhibits VEGF and bFGF in lung cancer cell line H1299

YU Hong-e, YU Qing-sheng, LIU Xin-yan, ZHU Liu, LOU Xiao-hua, TENG Mai-kun

2005, 10(9):  970-973. 

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AIM: To study the effect of China cobra venom active factor (CCVAF) on the expression of VEGF and bFGF in human non-small cell lung cancer cell line H1299.METHODS: VEGF and bFGF mRNA level was measured by RT-PCR.VEGF and bFGF protein level in the supernatant was examined by ELISA.RESULTS: The mRNA expression level of bFGF was also reduced after treatment with the CCVAF in dose-dependent manner. Giving the CCVAF 4.0 μg·ml^-1 to cell H1299 for 4 hours could notablely decreased the mRNA expression of bFGF while it had no such effect on VEGF mRNA expression level.The content of VEGF, and bFGF in supernatant of H1299 cells were significantly decreased after treatment for 24 hour with CCVAF in dose-dependent manner.There was significant difference compared with control group (P <0.05).CONCLUSION: CCVAF inhibits the expression of VEGF and bFGF in H1299 cells.

Effects of different dose proportioning the danggui-shaoyao powder on learning and memory and the content of NO in brain in mice

LIU Hong, ZENG Yu, MA Shi-ping

2005, 10(9):  974-983. 

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AIM: To study the effects of different dose proportioning the danggui-shaoyao powder (DS)on learning and memory and the content of NO in brain in mice.METHODS: The ability of learning and memory was measured by the step-through task and the water maze task.The content of NO in brain was determined referring to the reagent manual.RESULTS: All different dose proportion of DS promoted the memory of normal mice. And only DS 1 (1:5.4)and DS 3 (1:1.34)obviously improved the scopolamine-induced mice passive avoidance handicap, prolonged the latency, and decreased number of errors.DS 3(1:1.34)obviously improved reserpineinduced mice spatial orientation handicap and prolonged the latency;others had no remarkable effect on spatial orientation handicap of mice.And all different dose proportions of DS could reduce the content of NO in the brain of passive avoidance disruption mice induced by scopolamine.CONCLUSION: DS 3 (1:1.34)improves passive avoidance handicap and spatial orientation handicap of mice, and reduced the content of NO in the brain of passive avoidance handicap mice induced by scopolamine.The effect of DS 3(1:1.34)is the best on benefiting memory.

Effect of etoricoxib on postoperative patient-controlled analgesia in major gynecological operation

LIU Wei, Loo CC, QIN Xiao-tao, HUANG Yu-guang

2005, 10(9):  984-987. 

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AIM: To observe the effect of preemptive etoricoxib on postoperative PCA in the major gynecological surgery.METHODS: 40 patients who underwent major gynecological surgery were selected randomly to receive placebo or etoricoxib 120 mg before surgery.The PCA morphine consumption in 24 hours was recorded and patients'satisfaction was evaluated by 0-10 scores.At the same time, side effects were also recorded.RESULTS: Postoperative 24 hours PCA morphine consumption in etoricoxib group was 9.4±7.6 mg, and it was significant lower than which in placebo group 15.7±8.9 mg.The overall PCA attempts was also lower in etoricoxib group than in placebo group(P <0.05).The first 6 hours and first 12 hours morphine consumption of PCA had no significant difference between two groups.There were no significant differences of patients'satisfaction and side effects rates between two groups.CONCLUSION: The preemptive etoricoxib 120mg in major gynecological surgery may decrease postoperative PCA morphine consumption, especially 12 hours after operation.Patients'satisfaction score have no improvements and no significant side effects caused by etoricoxib were found.

Experimental studies on antitumor effects of nobiletin in vivo and in vitro

GE Hui, CHENG Mei-ying, ZHANG Hong-quan

2005, 10(9):  988-991. 

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AIM: To study the anti-tumor effect of nobiletin in vivo and in vitro.METHODS: The models of S180, BGC-823 and EAC inmice were established.Tumor growth inhibitory rates and EAC survival rate were calculated.The growth of two tumor cell lines (K562, HL-60) was observed with MTT assay in vitro.RESULTS: Nobiletin inhibited the proliferation of S180 and BGC-823 at the inhibitory rates of 39.11%-55.67% and 36%-58%, and prolong the life span of EAC mice at survival rate of 15.38%-24.61%.Nobiletin possessed inhibitory activity on the growth of K562 and HL-60 in vitro, the inhibitory rates increase in concentration and time dependent manners of in dose range of 2.5^-10 μg·ml^-1.CONCLUSION: Nobiletin can not only inhibit the growth of tumor cell lines, including S180, BGC-823, K562, and HL-60, but also prolong the life span of EAC mice.

Protection effect of baicalin on isoproterenol induced myocardial ischemia in rats

LU Jian, WU Xiao-dong

2005, 10(9):  992-995. 

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AIM: To study the protection effect of baicalin on isoproterenol (ISO)induced myocardial ischemia in rats and its mechanisms.METHODS: Fortyfive Sprague-Dawley rats were randomly divided into 3 groups.The rats in control group (n =15)received no treatment.The rats in ISO group (n =15)received two times of subcutaneous injection of ISO (20 mg·kg^-1), which was separated by a 24 hours-interval.The rats in baicalin group (n =15)received ISO as described above and received baicalin 50 mg·kg^-1 ip.simultaneously. Two days later the hemodynamic measurement was performed and the serum levels of LDH, CK and TNF-αwere detected.The expression of p38mapk in myocardium was detected by immunohistochemical technique.RESULTS: The heart function of the group treated with baicalin was improved significantly compared with that of control group.The levels of LDH, CK and TNF-αin baicalin group decreased significantly compared with those in control group and the expression of p38mapk in myocardium also decreased markedly.CONCLUSION: Baicalin has protection effect on isoproterenol induced myocardial ischemia in rats, and the effect maybe due to the decrease of TNF-αinduced by reducing the p38mapk expression.

Effects of EGb on apoptosis and NOS activity in rat hippocampal neurons induced by hypoxia

YUAN Ying, SHEN Wei-xing, ZHANG Pei-yun, JIN Shu-yi, ZHU Li

2005, 10(9):  996-1000. 

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AIM: To observe the effects of EGb (Ginkgo biloba extract) and Gin(Ginkgolide) on rat hippocampal neurons induced by H/R(Hypoxia/Reoxigen) with regards of apoptosis and NOS activity.METHODS: Primarily cultured E 15 day-fetal rat hippocampal neurons were used to establish H/R injury model including five groups:Normal group, H/R group, Drug group (EGb group and Gin group) and Positive control group (MK-801 group).The neuronal apoptosis were measured by TUNEL staining.The NOS activity was determined by NADPH-d histochemical analysis.RESULTS: The apoptosis cell numbers of EGb and Gin groups were lower than those of H/R group.The preincubation of EGb and Gin decreased NADPH-positive cells.CONCLUSION: EGb and Gin protects rat hippocampal neurons induced by H/R from apoptosis and suppressed NOS activity.

Ultrasonic study on effects of simvastatin on left ventricular mass in patients with essential hypertension

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

2005, 10(9):  1001-1004. 

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AIM: To evaluate the effect of simvastatin on the left ventricular mass in patients with essential hypertension (EH).METHODS: 50 patients with hypertension without severe complication were randomly divided into two treatment groups:combination treatment group and hydragogue group, and 25 normal subjects without any treatment were taken as the control.The 25 patients in combination treatment group were given simvastatin and hydragogue for 12 weeks while the other patients in hydragogue group were given hydragogue during the same time.The left ventricular mass was examined from ultrasonography in all patients before and after treatment.RESULTS: The left ventricular mass index (LVMI) was higher in the two treatment groups of patients (133.61±31.02, 118.04±39.62 g^。m^-2) than that in the control group (88.79±22.73 g^。m^-2) before treatment (P <0.01, 0.0001, respectively) while the blood pressure was higher.There was no significantly difference in age, serum concentrations of total cholesterol or triglyceride, sugar and blood pressure between the two treatment groups and the control group (P >0.05).There was no significant difference in all variables between the two treatment groups before treatment.After treatment, the LVMI was decreased (133.61±31.02 vs 91.07±16.01 g^。m^-2, P <0.01) in the combination treatment group while there was no significant change in LVMI in the hydragogue group compared with the control group.The blood pressure in the two treatment groups was decreased to the normal.Compared with hydragogue group, the change of LVMI was higher in the combination group though the serum concentrations of total cholesterol, triglyceride or sugar were not significantly different.No significant change in serum concentrations of total cholesterol, triglyceride or sugar was found during treatment in the two groups.The change of LVMI did not correlate with the change of blood pressure, serum concentrations of total cholesterol, triglyceride or sugar in the combination treatment group(P >0.05).CONCLUSION: Being independent of the changes of serum concentrations of total cholesterol, triglyceride or sugar and blood pressure, simvastatin can inhibit the increase of left ventricularmass in patients with essential hypertension.

Investigation of morphological characteristics, membrance potential and membance patency in Escherichia coli following ciprofloxacin exposure

ZHU Man, WANG Rui, ZHANG Yong-qing, LIANG Bei-bei

2005, 10(9):  1005-1009. 

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AIM: To study the changes of bacterial ultrastructure, membrance potential and membrance patency of Escherichia coli during the postantibiotic effect after exposure to gatifloxacin and ciprofloxacin in order to investigate the mechanisms of PAE.METHODS: During the Postantibiotic effect after exposure to gatifloxacin and ciprofloxacin, the aliquots were taken from the bacterial culture at regular intervals.Then the fluorescence microscope was used to observe changes in bacterial ultrastructure and at the same time we studied the changes of membrance potential and membrance patency in Escherichia coli during the postantibiotic effect by flow cytometry in conjunction with fluorescent probes.RESULTS: The PAE phase characterized by filament formation after exposure to gatifloxacin by fluorescence microscopy, yet no significant changes in membrance potential and membrance patency of Escherichia coli were observed.CONCLUSION: Gatifloxacin and ciprofloxacin can induce filamentation, and this change is indifferent with membrance potential and membrance patency of Escherichia coli.

Protective effects of preconditioning of Ginsenoside Rb1 on neonatal rat cardiomyocytes against hypoxia-reoxygenation injury

GUO Jia, LIU Xiao-kang, WU Wen, ZHANG Xiao-wen

2005, 10(9):  1010-1014. 

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AIM: To study the effects and mechanisms of preconditioning of Ginsenoside Rb1 (Rb1) on neonatal rat cardiomyocytes against hypoxia-reoxygenation (H/R) injury.METHODS: Myocytes hypertrophy model was induced by Angiotensin II in neonatal rat and determined by assaying the cell surface area(CSA) and total protein content (TP) of cardiomyocytes.The H/R model was established after treatment with Rb1 for 48 h.The cell survival ability was assayed by MTT method.The apoptotic rate was assayed by flow cytometry.The activities of lactate dehydrogenase (LDH), content of nitric oxide (NO) and malondialdehyde (MDA) in medium were measured.RESULTS: After treatment of cells with Rb1 (0.01^-10.00 μmol·L^-1) for 48 h, compared with the H/R group, the myocyte CSA reduced by 41.56%, the TP lowered by 43.37%.The LDH activity reduced by 59.20%, the content of MDA decreased by 72.03%, the apoptosis rate reduced by 85.29%, the cell survival increased by 2.28 fold and NO activity enhanced by 2.67 fold (P <0.01).CONCLUSION: Ginsenoside Rb1 preconditioning can protect AngII-induced hypertrophy myocardium against H/R injury, increase myocyte viability and decrease total protein content.And these effects are related to reducing apoptosis and the release of LDH, improving activities of NO and decreasing the level of lipid peroxidation.

Study on mechanisms of circumventing multidrug-resistant human leukemia cell line K562/A02 by fraction CⅡ from Naja naja Actra Venom

ZUO Chang-qing, LIN Zhen-tao, KONG Tian-han

2005, 10(9):  1015-1024. 

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AIM: To investigate the inhibitory effect of fraction C Ⅱ from Naja naja Actra Venom (FC Ⅱ NNAV) on multidrug-resistant human leukemia cell line K562/A02 and its mechanisms.METHODS: The cytotoxicity of FC ⅡNNAV on K562/A02 and k562 cells was measured by MTT assay.The protein expression of P-gp and Bcl-2 of K562/A02 was observed by flow cytometry. The activation of Caspase-3 was detected by colorimetric assay.RESULTS: FC ⅡNNAV had the inhibitory effect on K562/A02 and K562.The values of IC50 were 0.75±0.01 and 0.67±0.11 μg·ml^-1, respectively.The expression of P-gp and Bcl-2 decreased after application of FC Ⅱ NNAV and Caspase-3 was activated by FC Ⅱ NNAV.CONCLUSION: FC ⅡNNAV has the inhibitory effect on K562/A02 and K562.FC ⅡNNAV can induce K562/A02 cell apoptosis through down-regulation expression of P-gp and Bcl-2 and activating Caspase-3.

Safety and primary efficacy of recombinant human adenovirus-p53 injection on advanced solid tumor

DING Ya, ZHANG Xiao-shi, PENG Rui-qing, ZHANG Rong, ZHANG Nian-hua, LI Zhi-ming, LIU Ji-yan, MA Jin, CHENG Xia, SU Yi-shun, ZENG Yi-xin

2005, 10(9):  1025-1029. 

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AIM: Recombinant human adenovirusp53 injection (rAd-p53) is the first marketed gene therapeutic drug worldwide.This study aimed to evaluate the safety and primary efficacy of rAd-p53 administrated on advanced solid tumors.METHODS: 24 patients with advanced solid tumor treated with rAd-p53 were reviewed, including 5 cases of renal carcinoma, 4 of nasopharyngeal carcinoma, 4 of colorectal carcinoma, 2 of melanoma, 1 of non-small-celllung cancer, 1 of esophageal carcinoma, 1 of gastric cardia carcinoma, 1 of thymic carcinoma, 1 of duodenal carcinoma, 1 of thyroid carcinoma, 1 of pancreatic carcinoma, 1 of endometrial carcinoma and 1 of rhabdomyosarcoma.RAd-p53 was weekly administrated at the dose of 1 ×1012 VP, and 4 times of administration was defined as one cycle.Administration approach included intratumoral injection, intrabronchial drop in, intraperitoneal injection, intra-arterial infusion and intravenous drip.Combined therapy was given with chemotherapy in 18 cases, radiotherapy in 2, concomitant chemotherapy and radiotherapy in 1, abdomi-nal thermotherapy and orally gefitinib in 1, cytokine immunotherapy in 1 and without combination therapy in 1.RESULTS: 23 cases underwent 35 cycles of therapy except for 1 case discontinued because of early progression. Among the 21 evaluable cases 5 PR, 5 SD and 11 PD were observed.Overall response rate was 23.8%(5/21) and disease control rate was 47.6%(10/21).Grade I-II injection site pain, chill, fever and myalgiawere the most frequent side effects.Grade III fever developed in 2 cases and grade III-IV myelosuppression in 4 cases combined with chemotherapy.Furthermore, severe ostealgia occurred in 2 cases and transient hypotension in 1.CONCLUSION: RAd-p53 is tolerable in patients with advanced solid tumor.A further randomized clinical trial is necessary to confirm the antitumor activity of rAd-p53 combined with conventional strategies.

Relationship between different level of blood pressure and incidence of cerebral complication in patients with essential hypertension

CAI Ping, HONG Hua-shan, WANG Yi-bo

2005, 10(9):  1030-1032. 

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AIM: To investigate the relationship between different level of blood pressure and the incidence of cerebral complication in patients with essential hypertensive.METHODS: 696 cases of untreated primary hypertensive patients (387 male and 309 female) were divided into different groups according to the level of systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse pressure (PP).The relationship between different level of SBP, DBP and PP was analyzed.RESULTS: The incidence of cerebral complication were positively correlated to SBP, DBP and PP (all P < 0.05).The impact ranking was PP >SBP >DBP.CONCLUSION: The cerebral complication in essential hypertension is correlated to SBP, DBP and PP.However, PP plays the most important role among the different parameters of blood pressure in the pathogenesis of the cerebral complication.

In vitro study on cytotoxicity of combination of some chemotherapy reagents towards arsenic trioxide-resistant leukemic cells

ZHUO Jia-cai, WANG Ming-chun, TAO Xiao-mei, LIMing, YOU Wei-wen, CAI Li-sheng, LIU Huan-xun

2005, 10(9):  1033-1037. 

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AIM: To explore the cytotoxicity of combination of some chemotherapy reagents towards K562/AS2, an arsenic trioxide (As2O3)-resistant leukemic cell line.METHODS: MTT assay was used to detect the cytotoxicity, and the combined drug effect of two drugs was analyzed with Chou-Talalay Combination Index (CI). Flow Cytometry was used to detect the P-glycoprotein on the cell surface and the introcellular concentration of daunorubicin (DNR).RESULTS: The relative resistant folds of K562/AS2 cell line to As2O3, DNR, VP16, harringtonine (H), NVT and Ara-cwere 7.4, 2.9, 3.8 and 1.1, respectively.The fluorescence of the P-glycoprotein on the surface or of the DNR inside the cells detected was not significantly different between the K562 and the K562/A02 cell line (P >0.05).The combination indexes of As2O3 combined with DNR, VP16, H or NVT to K562, K562/AS2 and K562/A02 cell lines were all above 1.The combination indexes of Verapamil combined with DNR to both K562 and K562/AS2 cell lines were above 1, and to the K562/A02 were below 1.CONCLUSION: K562/AS2 cell line is resistant to As2O3, DNR, VP16 and NVT.The mechanism of the drug resistance is not associated with the expression of P-gp.Verapamil combined with DNR can reverse the resistance of Pgp expressing leukemia cell, K562/A02, to DNR, but can not reverse the resistance of K562/AS2 cell line.The cytotoxicity of As2O3 combined with DNR, VP16, H and NVT shows antagonism to K562, K562/AS2 and K562/A02 cell lines.

Determination of valsartan in human plasma by HPLC with fluorimetric detection

ZHAO Rong-wei, YU Jia

2005, 10(9):  1038-1040. 

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AIM: To establish a high performance liquid chromatography (HPLC) method to determine the concentration of valsartan in human plasma.METHODS: Using lrbesartan as internal standard, valsartan in plasma samples was determined by HPLC with liquid-liquid extraction, achieved by the column of Agilent ZORBAXSB-C18(150 mm ×4.6 mm, 5 μm) at room temperature.The mobile phase consisted of a mixture acetonitrile:water:phosphoric acid:triethylamine was the ratio of 40:60:1.0:1.5 (v/v), pumped at a flow rate of 1.0 ml·min^-1, the wavelengths of fluorimetric excitation and emission were set at 265 and 378 nm respectively.RESULTS: The drug-free plasma did not interfere with the determination of drugs and internal standard.There was good linear relationships (1/C 2 weighted) between peak area ratio of valsartan to internal standard and C (r =0.9996) within the range of 25-2 500 ng·ml^-1.The precision of within-day and between-day was good.The lower limit of quantification was 25 ng·ml^-1.The analytes reconstituted in the mobile phase were also stable at ambient conditions for at least 24 h.Furthermore, valsartan was stable for at least three freeze thaw cycles.CONCLUSION: The HPLC method can be used to determine the concentration of valsartan in human plasma.

Effects of progesterone on apoptosis and expression of p53 protein in rats during focal cerebral ischemia/reperfusion injury

LU Na, LI Chao, LI Dong-liang

2005, 10(9):  1041-1045. 

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AIM: To study the neuroprotective effect and molecular mechanism of progesterone on reperfusion injury following ischemia.METHODS: The rats with transient middle cerebral artery occlusion (MACO) was described by Zea-longa for 2 h and reperfusion for 24 h. 48 male rats were divided randomly into 6 groups that were the sham, ischmia/reperfusion (I/R), dimethl sulfoxide (DMSO), and posttreatment, pretreatment, pre + posttreament with PROG groups.The immunohistochemistry staining and TUNEL reaction were used to facilitate the quantities of p53 protein and apoptosis in the brain tissuses.RESULTS: There were 26.25±3.54 cells in p53 immunostaining in the I/R group, 22.88±3.52 cells in DMSO group, 15.00±2.07 cells in the pretreatment group, 16.75±2.60 cells in the posttreatment group, and 10.38±1.69 cells in the pre and posttreament group.The number of apoptosic cells was 1.88±0.25 in the sham group, 41.38±3.85 in the I/R group, 38.13±5.69 in the DMSO group, 22.88±2.70 in the pretreatment group, 25.63±2.93 in the posttreatment group, and 20.88±2.30 in the pre + posttreament group.The difference among drug management groups (pretreament, posttreament, and pre +posttreament) and control groups(I/R, DMSO) was significant (P <0.05).CONCLUSION: PROG may protect the ischemia brain on reperfusion injury.Reducing the expression of p53 protein and apoptosis would be one of the molecular mechanism.

Neuroprotection of estrogen against injury induced by β-amyloid protein (25-35) in rat cortical neurons

ZHOU Lin, REN Mu-lan

2005, 10(9):  1046-1049. 

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AIM: To study the effect of estrogen on injury induced by β-amyloid protein (Aβ) in primary cultures of rat cortical neurons.METHODS: The effect of 17β-E2 on Aβ(25-35)-induced cell death in primary rat cortical neurons was observed by phase contrast light microscopy, Giemsa staining and determination of lactate dehydrohenase (LDH) release rate.RESULTS: Aβ(25-35) induced cell death in rat primary cortical neurons. Forty eight hours pretreatment with 17β-E2 protected rat primary cortical neurons from Aβ(25-35)-induced injury.CONCLUSION: Aβ evokes toxicity in rat primary cortical neurons.Estrogen can protect the rat primary cortical neurons against injury induced by Aβ (25-35).

Effects of extract of astragalus on inflammatory reaction during global cerebral ischemia and reperfusion in rats

LI Jing, MING Liang, HUANG Rong-rong, CAO Xi, WU Qiang, LI Wei-ping

2005, 10(9):  1050-1052. 

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AIM: To explore the protective effect of extract of astragalus (EA) on inflammatory reaction during global cerebral ischemia and reperfusion.METHODS: The model of global cerebral ischemia-reperfusion was established by four-vessel occlusion method.After global cerebral ischemia and reperfusion peripheral white blood cell and neutrophil were counted.The cortex and hippocampus myeloperoxidase (MPO) activities were determined by spectrophotometry.The pathological changes of cortex tissue were observed by light microscope.RESULTS: Compared with those in sham group, after global cerebral ischemia and reperfusion, the numbers of peripheral white blood cell and neutrophil and the activities of cortex and hippocampus MPO in control group were increased significantly.Compared with those in control group, the numbers of peripheral white blood cell and neutrophil of EA group were declined.Cortex and hippocampus MPO activities of EA group (40, and 80 mg·kg^-1) were lower than those in control group.The pathological changes of cortex tissue were less serious in rats treated with EA.CONCLUSION: EA has protective effect on cerebral ischemia and reperfusion injuries that may be relate to its anti-inflammatory effect.

Reverse effects and its mechanisms of Xueyaping on left ventricle remodeling resulting from renal hypertension induced by 2K1C in rats

SHI Jie, HU You-zhi, QU Song-bai, XIANG Nan, KE Yu-he, FENG De-xun, LI Da-feng

2005, 10(9):  1053-1058. 

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AIM: To investigate the reverse effects and its mechanisms of Xueyaping on left ventricle remodeling resulting from renal hypertension induced by 2K1C in rats (RHR).METHODS: Renal hypertension rat was induced by 2K1C.40 RHRs were randomly divided into 5 groups with 8 rats in each group 8 weeks after induction including:group 1 was the large dosage Xueyaping (73 g·kg^-1·d^-1) group, group 2 was the medium dosage Xueyaping (36.5 g·kg^-1·d^-1) group, group 3 was the low dosage Xueyaping (18.25 g·kg^-1·d^-1) group, group 4 was the enalapril group (10mg·kg^-1·d^-1), and group 5 was the model group.Besides, psydeo-operation was performed on another 8 rats and set as the control group.Iso-volume pure water was poured into stomach in group 4 and group 5 for 8 weeks.Blood pressure was taken before operation and once a week after operation.By the end of the eighth week, the body weight was measured and 2 ml blood was taken through eye sockets.The rats were then put to death by cuttign off their heads.The heart was removed rapidly and atrium and free wall of right ventricle were abounded.The left ventricle and interventricular septal weight (LVW) were measured. LVW/BW ratios were calculated.Serum PCIII was measured using radio-immune method.Paraffin embedded heart tissue was cut and stained with HE and SP immunohistochemistry.Conformation parameters and mean light density of positive c-myc and c-fos expression heart muscle cells were measured using high resolution picture analyzing system.RESULTS: Xueyaping had the effects of lowering blood pressure, decreasing LVW, LVW/BW, heart muscle cell volume, serum PCIII, and the expression of c-myc and c-fos.SBP, LVW, LVW/BW and serum PCIII in group 1 and 2 were significantly lower than those in group 5 (P <0.01).Conformation parameters of heart muscle cells (area, circle length, mean diameter, length of long and short axes) and mean light density of positive c-myc and c-fos expression cell in group 1 and 2 were significantly lower than those in group 5 (P < 0.01), and were close to those in the sham operation group (P >0.05).CONCLUSION: Xueyaping has the effects of reversing left ventricle remodeling in hypertensive rats induced by 2K1C.The effects may be related to the partial mechanisms of reversing left ventricle remodeling in hypertensive rats induced by 2K1C.

Effects of epimedium pubescens flavonoids on skeleton of ovariectomized rats

XU Bi-lian, WU Tie, CUI Liao, LIU Yu-yu, ZOU Li-yi

2005, 10(9):  1059-1064. 

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AIM: To study the effects of epimedium pubescens flavonoids (EF) on the skeleton in ovariectomized rats.METHODS: Forty 4.5-month-old Sprague-Dawley female rats were randomly divided into 4 groups. Rats in sham group were sham-operated and treated by daily oral gavage with vehicle.Rats in other three groups were bilaterally ovariectomized (OVX) and treated by either daily oral gavage with vehicle, or diethylstilbestrol (DES) at 22.5 μg·kg^-1·d^-1, or EF at 300 mg·kg^-1·d^-1 for 90 days.Bone histomorphometric analysis of the proximal tibial metaphysis (PTM), fifth lumbar vertebrae (LV5) and tibial shaft (Tx) was performed in undecalcified sections.The left femurwas collected to determine bone weight, contents of calcium (Ca), phosphorus (P) and hydroxyproline.The uterine weight and the uterine luminal epithelial thickness (ULET) were determined.RESULTS: A significant increase in contents of Ca and P of femur was found in EF group.A tendency of increase was found in%Tb.Ar of PTM, but no significant change was found in bone histomorphometric parameters of LV5 and Tx in EF group.EF had no effect on uterine weight and ULET.CONCLUSION: EF can prevent OVX-induced bone mineral loss of femur, but does not prevent bone loss of PTM and LV5.

Determination of omeprazole concentration in plasma by RP-HPLC and its pharmacokinetics in healthy male volunteers

HU Yu-rong, ZHANG Nan, SHAN Li-hong, TIAN Xin, QIAO Hai-ling

2005, 10(9):  1065-1068. 

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AIM: To establish a reversed phase high performance liquid chromatography (RP-HPLC) method for determination of omeprazole in human plasma and the pharmacokinetic study of omeprazole in 9 healthy volunteers. METHODS:The RP-HPLC method was used. The separation was carried out using krumasil C18 (4.6 mm ×200 mm, 5 μm) column with mobile phase of acetonitrile and 0.01 mol·L^-1 phosphate buffer (55:45, v/v).The pH of the water phase was adjusted to 7.5 with triethylamine at flow rate of 1.3 ml·min^-1.The detection wavelength for omeprazole was 302 nm.A single oral dose 40 mg of omeprazole was given to 9 healthy males.RESULTS: The linear range for omeprazole was 10-2 000 μg·L^-1 (r =0.9999).The quantitation limit for omeprazole was 10 μg·L^-1.The relative recoveries were 92.35%, 96.90% and 100.04%, and RSD for intra-day and inter-day were both less than 15%.The pharmacokinetic analysis of omeprazole was studied.It was found to be fit for a one-compartment openmodel.CONCLUSION: The method is sensitive, accurate and simple, and suitable for the study on pharmacokinetic of omeprazole in human.

Clinical efficacy and safety of shexiang xintongning tablets in treatment of patients with coronary heart disease and angina pectoris

ZHANG Qiong, ZHANG Xiang-nong, TU Xiu-hua

2005, 10(9):  1069-1072. 

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AIM: To evaluate the clinical efficacy and safety of the shexiang xintongning tablets in treatment of patients with coronary heart disease and angina pectoris.METHODS: 206 subjects were involved in a multi-center, randomized, double-blinded, double-simulation and positive drug parallel-controlled clinical trail, and the trial group was treated with the shengxiang xintongning tablets, the control group was treated with the xinkeshu tablets.Among them, 103 patients were enrolled in experimental group, while 103 cases enrolled in the control group.RESULTS: The total therapeutic effective rate of the experimental group has reached 90.29%, and was significantly better than that in the control group which has reached 75.91% (P <0.01).There was a significant decrease on the score of symptoms of the traditional Chinese medicine in trial group in comparison with those in control group (P <0.01).CONCLUSION: The shengxiang xintongning tablet is an effective drug against coronary heart disease and angina pectoris and no side-effect was found.

Some problems in clinical trials design of new traditional Chinese medicine

DU Bao-jun

2005, 10(9):  1073-1075. 

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Some problems of clinical trial design of new traditional Chinese medicine were discussed in this article, including the establishment of TCM syndromes, the determination of efficacy level, the implement of different stage of clinical trial, the selection of diagnose standard and efficacy effect standard, the use of placebo, and the safety evaluation.

Choice of data base structure for clinical trail

LI Xue-ying, KANG Xiao-ping, YAO Chen

2005, 10(9):  1076-1080. 

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The goal of this work is to understand the difference between vertical structure and horizontal structure on data management.We take adverse event report as an example to find out the relationship between the storage space and the factors related to the trail.From the study we find out the difference of storage space between horizontal structure and vertical structure goes up with the increase of the storage space of each adverse event record and the number of adverse event allowed to record in the horizontal structure and goes down with the increase of the happening rate and the average times of the adverse event.When using the most widely used study design, vertical structure always takes less storage space than the horizontal structure.This vertical structure database is more suitable for the data management than the horizontal structure database.