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    药物与临床
  • 药物与临床
    CHEN Jiangxia;ZHOU Qingshan;YIN Shuzhou;HUANG Weiqing
    2006, 25(9): 833-0902.
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    To compare the effect between propofol and midazolam on inflammatory response of tissue injury and prognosis in children with conqenital heart disease undergoing correction of ventricular septal defect with CPB.MethodsTwentyfour HYHA class ⅠⅡ children with congential heart disease, aged from 1 through 7 years old, undergoing elective open heart surgery, were randomly divided into two groups:group PF in which anesthesia were induced with propofol (200 μg· kg1) combined with fentanyl (5 μg· kg1) and vecuronium (0.15 μg· kg1) and maintained with propofol (150 -200 μg· kg1·min1) combined with low dose fentanyl (0.025-0.075 μg·kg1·min1) infusion, and group MF in which anesthesia was induced with madazolam (1 mg·kg1) combined with fentanyl (5 μg·kg1) and vecuronium (0.15 mg·kg1) and maintained with midazolam (0.5-1 μg·kg1·min1) combined with low dose fentanyl (0.03-0.06 μg·kg1·min1).The patient was premedicated with intramusule morphine 0.1 mg·kg1 and scopolamine 0.01 mg·kg1.Left radial artery and right internal jugular vein were cannulated for MAP and CVP monitoring , and ECG,SPO2, nasopharyngeal and rectal temperature were continuously monitored during anesthesia and operation . The time of tracheal extubation and the period of staying at ICU were recorded . Blood samples were taken before operation (t0),10 min after induction (t1),15 min after clamping aorta t2,15min after releasing aorta clamp(t3),2 hours after releasing aorta clamp(t4), and 24 hours after operation (t5) to observe the changes in cytokines in serum. Myocardial samples were collected at different time spots to observe myocardium morphologic changes ,the expression of NFκB and ICAM1. ResultsThe tracheal extubation time in PF group was significant earlier ,and its mean ICU staying time decreased (P<0.05).The values of NFκB and ICAM1's gray degree in both groups were decreased, but more decreased in MF group, IL6 and IL8 were significantly increased at t3,t4,t5 in both groups(P<0.05) ,but the values of cytokines in PF group were lower than MF group (P<0.05).ConclusionIt is shown that propofol combined with low dose fentanyl can reduce inflammatory response and allow earlier recovery with an effect better than midazolam.
  • 药物研究
  • 药物研究
    ZHANG Hong;CHENG Zheng;LI Guigang;LI Bin;ZHANG Jinling
    2006, 25(9): 855-0857.
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    To study the influence of water soluble azone on proliferation and structure of human trabecular mashwork cells (HTMC). MethodsHuman trabecular mashwork cells were cultured in vitro and treated with different concentrations of azone. MTT assay , transmission electron microscope and acridine orange fluorescent staining were used to observe the influence of azone on the cells’ vitality and ultrastructure. ResultsAzone,108-105 g·L1,had no significant influence on the proliferation of HTMC after acting for 24 h and 108-106 g·L1 of water soluable azone also had no significant influence on the ultrastructure of human trabecular mashwork cells. Acridine orange fluorescent staining showed that those cells treated with 103 g·L1 or 104 g·L1of azone lost its vitality in some degree. ConclusionWater soluable azone ,108-106 g·L1,had no significant influence on the proliferation, vitality and ultrastructure of human trabecular mashwork cells. Low concentration of azone incorporated into the ophthalmic formulations of drugs is safe to human trabecular mashwork cells in theory.
  • 药物研究
    CHEN Feng;WANG Yan;WANG Guifa
    2006, 25(9): 858-0859.
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    To investigate the
    penetration of gatifloxacin in bloodpancreatic barrier in rats. MethodsVenous bolus injection of gatifloxacin (20 mg·kg1 body weight)
    was performed through caudal vein. At the given time points,the samples were picked up. The concentrations of gatifloxacin in the
    serum and pancreatic tissue were measured by high performance liquid chromatography. ResultsThe peak concentration in serum was
    6.03 μg·mL1 at 5 min,and that of the pancreatic tissue was 18.67 μg·g1 at 10 min. Then the concentrations decreased continously in
    both of them. Concentrations in pancreatic tissue was higher than those in serum at 5 min. The penetration ratio (PR) in the blood
    pancreatic barrier was 1.02 at 5 min and rose to 3.69 at 10 min,then lowered down to nearly 1 at 240 min.ConclusionDue to its
    antimicrobial spectrum and the good penetration in the bloodpancreatic battier,gatifloxacin may be useful in preventing and treating
    pancreatic infection.
  • 药物研究
    JIANG Yiping;JIN Hong;XU Jiangping
    2006, 25(9): 860-0862.
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    To study the effect of total icarrin of epimedium against myocardial injury induced by ischemia and
    reperfusion in rats. MethodsModels of myocardial ischemia were prepared by ligating the left anterior descending coronary artery of rats.
    The antimyocardial ischemia action of total icarrin of epimedium was assessed by determining the changes in myocardial infarct size
    (MIS) and serokinases. ResultsTotal icarrin of epimedium significantly decreased MIS in rats, and the lactic dehydrogenase (LDH) and
    creatine phosphokinase (CK) activity in serum, improved the activity of superoxide dismutase (SOD) and decreased the malondialdehyde
    (MDA) contents in myocardium. ConclusionTotal icarrin of epimedium had protective effect on the acute myocardial injury induced by
    ischemia and reperfusion in rats. The mechanism may be related to its role against oxygen free radicals.
  • 药物研究
    PAN Wei
    2006, 25(9): 863-0864.
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    To investigate the effects of Xinnaoshenli
    liquor(XNSLL) on sedative hypnosis, intelligenceimproving and antifatigue. MethodsOne hundred and sixty Kunming mice were
    randomly divided into 4 groups, 3 experimental groups with orally given drug of the dosage 0.05 g·mL-1,0.10 g·mL-1,0.20 g·mL-1 , and a
    control group with orally given distilled water. After 4 weeks,the mice in 4 groups underwent several tests as stepdown test,
    hypnosis induced by sodium pentobarbital , hypoxia tolerance, and swimming. ResultsThe potential time of 3 experimental groups in the
    first stepdown test was significantly shorter than the control group(P<0.05)(increase in learning ability ), and the potential time of 3
    experimental groups in the second stepdown test was longer than the control group(P<0.05) ,and the frequency of mistakes was much
    less than the control group (P<0.05) (increase in memory function).In test of hypnosis induced by sodium pentobarbital,the potential time
    of 3 experimental groups was shorter than the control group(P<0.05) ,and the sleeping time was also shorter than the control group(P<
    0.05)(effects on sedative hypnosis ). The ability of hypoxia tolerance and the time of swimming in experimental groups were longer than
    the control group(P<0.05)(antifatigue effects ). ConclusionThe XNSLL had a good effect on sedative hypnosis, intelligence
    improving and antifatigue in mice.
  • 药物研究
    LI Jing;CHEN Xingping
    2006, 25(9): 865-0867.
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    To evaluate the therapeutic effect of the Sap inhibitor pepstatin A and
    explore the role of secreted aspartyl protainase(Sap) in disseminated Candida albicans infection in mice.MethodsA murine model of
    disseminated candidiasis was developed with intraperitoneal injection of different doses of pepstatin A to deal with the mice.The survivors
    were observed within 15 days. The results from administration of optimal dose 0.6 mg·kg1 of pepstatin A prior to challenge and on days 1
    to 4 postchanllenge were compared .And the Results were all compared with fluconazole control group. The efficacy of pepstatin A was
    evaluated by calculating the quantity of coloneyforming units(CFUs) in the kidneys. ResultsPretreatment of neutropenic mice with
    pepstatin A afforded strong protection against disseminated candidiasis.The survival time of mice within 15 days was significantly
    prolonged than that receiving saline (P<0.01) and the quatity of day4 kidney CFUs was decreased.The optimal dose of pepstatin A was
    0.6 mg·kg1 with a protective effect similar to the fluconazole at the dose of 1.0 mg·kg1. ConclusionThis study shows the protective
    effect of pretreatment with pepstatin A in disseminated Cadida albincans infection and suggests that Saps play an essential role as
    virulence factors during early dissemination.
  • 药物研究
    HU Xiamin;YE Yujie;YANG Xiaoyan;HU Xianmin;ZHANG Li;GONG Peili
    2006, 25(9): 868-0870.
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    To study the pharmacokinetics
    and bioavailability of two formulations of valaciclovir hydrochloride tablets.MethodsEighteen male healthy volunteers were administered
    with an oral single dose of 300 mg of test and reference tablets of valaciclovir hydrochloride in an open randomized cross-over study.
    Plasma acyclovir concentrations were determined by HPLC method, the pharmacokinetic parameters were calculated and the
    bioequivalence of the two formulations was evaluated by DAS 1.0.ResultsThe pharmacokinetic parameters for test and reference tablets of
    valaciclovir hydrochloride were as follows: AUC0→twere (6.724±1.407) and (6.250±0.952) mg·h·L1;AUC0→∞were (7.504±1.694) and
    (6.991±0.975) mg·h·L1;Cmax were (1.858±0.434) and (2.090±0.602) mg·h·L1;tmax were (1.44±0.62) and (1.36±0.54) h; The relative
    bioavailability was (107.37±14.78)% and (106.51±14.18)%. ConclusionThe results of statistics analysis show that the test formulations are
    bioequivalent to the reference formulations.
  • 药物研究
    XIA Lei;ZHANG Jianchu;ZHANG Xiaoju;JIN Yang
    2006, 25(9): 871-0873.
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    To study the effects of L-arginine(LArg) on
    pulmonary thromboembolism (PTE) and its possible mechanism. MethodsSeventytwo rats were randomly divided equally into control
    group, model group, and treatment group. PTE model was established by intravenous injection of autoblood clots. In treatment group ,L
    Arg 100 mg·kg1 was injected into peritoneum after model preparation . All rats were sacrificed on 1 hour, 1 , 3 and 7 days after
    pulmonary thromboembolism, respectively. Arterial blood gas analysis and the level of nitric oxide were measured. The changes in lung
    morphology were observed by microscopy. Endothelin1 was assessed by immunohistochemical technique and HMIAS image analysis.
    ResultsThrombi in pulmonary arteries and prominent inflammatory reactions were found by microscopy in model group. The level of NO
    was significantly decreased, while ET1 expressions were significantly increased in model group (P<0.01). After administration of LArg,
    the pathological lesions in lung were relieved with NO level higher than that of the model group, and ET1 expression lower than that of
    the model group on 1,3 and 7 days. ConclusionLArg may prevent the progress of PTE by increasing NO level and inhibiting expression
    of ET1.
  • 内分泌病及代谢病用药专栏
  • 内分泌病及代谢病用药专栏
    QIU Xiangjun;HUANG Chengke;QIAN Xin;HU Guoxin;DAI Zongshun
    2006, 25(9): 874-0876.
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    To study the relative bioavailability and bioequivalence of gliclazide tablets in healthy
    volunteers. MethodsA single oral dose (80 mg of tested and reference formulation) was given to 20 healthy volunteers in a randomized
    crossover study. The concentrations of gliclazide in plasma were determined by HPLC. The pharmacokinetics parameters were calculated
    and the bioavailability and bioequivalence of two formulations were evaluated by DAS program. ResultsAfter a single dose, the
    pharmacokinetics parameters for gliclazide were as follows: Cmax were (5.34±0.66) mg·L1 and (5.12±0.39) mg·L1;tmax were
    (4.30±0.92) h and (4.15±0.67) h; AUC(060) were (92.67±12.12) mg·h·L1 and (89.82±13.33) mg·h·L1; AUC(0inf) were (
    96.36±12.87) mg·h·L1 and (93.37±13.83) mg·h·L1 for T and R, respectively. The 90% confidential interval of Cmax,AUC(060)
    and AUC(0inf) of tested formulation were 100.52%~107.56%,99.16%~107.97% and 99.16%~107.97% respectively. ConclusionThe
    relative bioavailability is (104.5±15.5)%. The results of the statistic analysis show that the two formulations exhibit bioequivalence.
  • 内分泌病及代谢病用药专栏
    ZHAO Linshuang;XIANG Guangda;YUE Ling;HOU Jie;XU Lin;JIANG Wen
    2006, 25(9): 877-0878.
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    To investigate the effects of metformin on blood lipids and BMI in obese middle
    aged and elderly patients with impaired glucose tolerance(IGT) .MethodsA total of 180 patients with IGT were divided into two groups,
    metformin(500 mg,tid) or placebo respectively,for a 6month period (the therapy group of 91 patients and the control group of 89
    patients) .Those patients complicated by hypertension were given nifendipin10-20 mg, tid and captopril 25 mg,tid. Blood lipids and BMI
    were measured before and after trail. ResultsThe indexes of blood lipids and BMI were significantly improved in the therapy group as
    compared with those before treatment and in the control group(P<0.05 or P<0.01). ConclusionMetformin can lower the levels of
    blood lipids and BMI in patients with IGT in addition to its effect to lower the blood glucose.
  • 药物与临床
  • 药物与临床
    LI Kejian
    2006, 25(9): 893-0896.
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    To evaluate efficacy and safety of tongxinluo capsule for acute ischaemic stroke. MethodsRandomized controlled trails (RCTs) of tongxinluo capsule for acute ischaemic stroke were identified, eligible studies were included, the methodological quality of inclusive trails was assessed by Jadad scale. Heterogeneity test, Metaanalysis, funnel plot analysis and sensitivity analysis were used to analyse the related data. ResultsTen RCTs were included with all trails of low methodological quality. Tongxinluo capsule vs notreatment control: Metaanalysis indicated that relative risk(RR) of overall effective rate was 1.24 [99%CI (1.12, 1.38)]; weighted mean difference(WMD) of improving neurological impairment was -6.74 [99%CI(-12.59,-0.88)]. ConclusionsThis systematic review showed that tongxinluo capsule is effective and safe for acute ischaemic stroke. However, the evidence is not strong due to the general low methodological quality. To determinately evaluate efficacy and safety of tongxinluo capsule for acute ischaemic stroke, more rationally designed and strictly executed RCTs with large samples are necessary.
  • 药物与临床
    WANG Jing;XIE Shouzhen;LIAN Junhong
    2006, 25(9): 897-0898.
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    To observe the effect of using medroxyprogesterone acetate (MPA) in a dose of 200 mg·d1 for patients with invasive mole and choriocarcinoma during chemotherapy(CT).MethodsTwentyfive patients(20002005) were selfcompared; 10 stageⅢ patients (19901999) were set as the former group, 10 stageⅢ patients in the 25 patients were set as the recent group. Two groups were retrospectively compared and analyzed. The patients were generally treated with 8daysperiod treatment of 5Fu and KSM. Those patients without MPA at their first period of treatment were assigned to control group. Those patients treated with MPA a week before their second period of treatment were assigned to study group. The former group and the recent group respectively were assigned to control group(without MPA) and study group(with MPA). Appetite, nausea, vomiting, stomatocace and the changes in leukocyte and interleukin6(IL6) were evaluated. The numbers of CT and outcome of metastatic foci in lung were compared between the former group and the recent group.ResultsAppetite, nausea, vomiting and stomatocace in study group were significantly reduced than those in control group (P<0.01).In study group, after receiving CT there were no significant difference of leukocyte than before(P>0.05), In control group after receiving CT leukocytopenia was significant (P<0.01); Serum levels of IL6 in study group were significantly lower than those in control group(P<0.01). The number of receiving CT in the recent group was less than that in the former group and the metastatic foci in lung in the recent group disappeared faster than those in the former group (P<0.01) .ConclusionsMPA can reduce the serum level of IL6 and improve the life quality of patients with cancer. MPA can protect bone marrow of the patients from the inhibition by CT, and improve the tolerance to CT. The good clinic effect of MPA may be related to its antiangiogenesis in tumor.
  • 药物与临床
    GOU Lianping;CAO Liting
    2006, 25(9): 905-0906.
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    To compare the effects between amlodipine and enalapril on lowering blood pressure in patients with essential hypertension (EH) and their reverse effects on left ventricular hypertrophy(LVH).MethodsOne hundred cases of EH with LVH were randomized equally into amlodipine group (A group) and enalapril group (E group),both with a dose of 5-10 mg·d1 for 2 years. Two weeks before the treatment , other antihypertensive medicines were removed with the blood pressure measured and the ultrasonic cardiogram taken . Blood pressures were measured at least once a week after the beginning of treatment,and the ultrasonic cardiogram was taken at the end of treatment . ResultsBoth A and E significantly reduced blood pressure (P<0.01) .The time for A group to reach to target blood pressure was much shorter than that of E group,and the LVMI was improved after the treatment in two groups. ConclusionAmlodipine and Enalapril can both reduce the blood pressure and reverse the LVH.
  • 药物与临床
    LI Qiongzhi;JIANG Jinxiang
    2006, 25(9): 907-0908.
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    To determine whether mirtazapinne is clinically effective on the treatment of chronic insomnia and to compare the clinical effects between mirtazapine and alpazolam on chronic insomnia. MethodsSeventynine patients were randomly divided into two groups (38 and 41 for each), which received the treatments of mirtazapine and alprazolam respectively for 12 weeks as a course. The patients in mirtazapine group took 10-15 mg 0.5 hour before sleeping, while the patients in alpazolam group took 0.4-0.8 mg 0.5 hour before sleeping. The curative effects were evaluated with Pittsburgh Sleep Quality Index (PSQI) and sleeping dairy before and after the 4th, 8th, and 12th weeks of treatment. ResultsThe effective rate and significantly effective rate of mirtazapine on chronic insomnia were 96.9% and 90.6%, respectively, whereas those of alprazolam, 78.8% and 51.5% respectively. Mirtazapine played significantly better role in the treatment of chronic insomnia than alprazolam did(P<0.05). The side effects of mirtazapine included sleepy, dizzy and getting weight, all of which were acceptable. ConclusionMirtazapine is surely effective on clinical treatment of chronic insomnia with mild side effects . For using mirtazapine, starting with the small dosage is suggested.
  • 药物与临床
    WANG Yong;TANG Shaotao;RAN Qinglan;TONG Qiangsong;MAO Yongzhong;LI Shiwang
    2006, 25(9): 909-0910.
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    To study the clinical effectiveness of group A streptococcus preparation(OK432)in the treatnent of giant haemangioma(GH) and its effects on the serum levels of TNFα、IL6 and Creative protein (CRP).MethodsEightyseven children with GH were submitted to a selfcontrast clinical investigation. OK432(12KE) was injected into each GH with a course of treatment lasting 6 weeks. Before and after the treatment, the diameters of GH were measured, and the serum levels of TNFα、IL6 and CRP were determined. ResultsThe diameters of GH reduced, while the serum levels of TNFα、IL6 and CRP increased after the treatment, the differences being very significant as compared with the values before the treatment (P<0.01). About 34 children with GH had high temperatures after the treatment, and their temperatures declined to normal after 23 days. All these reactions were transient. ConclusionInjecting OK432 intratumorly is effective and safe in treating GH in children.
  • 药物与临床
    YIN Shuzhou;YIN Huilian;YU Qijing
    2006, 25(9): 911-0913.
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    To compare the effect of etominate and midazolam on blood flow dynamics during tracheal intubation in off pump coronary artery bypass graft.MethodsSixty patients scheduled for coronary artery bypass graft surgery without cardiopulmonary bypass shunt were randomly divided into etominate group(Group E,n=30) and midazolam group(Group M,n=30).The drugs used for anaesthetic induction in Group E were etominate 0.3 mg·kg1,sulfentanyl 1.0 μg·kg1,rocuronium bromide 0.9 mg·kg1,and in Group M midazolam 0.15 mg·kg1,sulfentanyl 1.0 μg·kg1,rocuronium bromide 0.9 mg·kg1. Electrocardiagram(ECG),systolic blood pressure(SBP),diastolic blood pressure(DBP),heart rate(HR) and pulse oximetry saturation (SpO2) were measured and recorded continuously,as well as the value of SBP multiplied by HR(RPP). The time used for tracheal intubation was also recorded. ResultsIn Group M,the SBP and DBP were significantly lower from anaesthetic induction and the beginning of tracheal intubation than the values before putting in the tracheal tube(P<0.05),the SBP、 DBP and HR were significantly higher after 1 minute of tracheal intubation than the values at the beginning of tracheal intubation(P<0.01),and the values of RPP after tracheal intubation were significantly different from the values before putting in the tracheal tube(P<0.01).Compared with the values in Group E,the values of SBP or DBP in Group M were significantly decreased when tracheal tube was ready to be put in (P<0.05 or P<0.01),while the values of SBP、 DBP or RPP were significantly increased 1 minute after tracheal intubation (P<0.05 or 0.01).ConclusionCompared with midazolam,etominate used in anaesthetic induction for coronary artery bypass graft surgery without cardiopulmonary bypass shunt may more effectively prevent the cardiovascular response to tracheal intubation.
  • 药物与临床
    FENG Hongjiang;XU Xiaojun;TIAN Zaiquan;DENG Changquan
    2006, 25(9): 914-0915.
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    To compare the effectiveness and safety of leflunomide (LEF)with those of methotrexate (MTX) in patients with active rheumatoid arthritis(RA).MethodsNintyfive patients were randomly assigned to receive LEF or MTX. The patients in the treatment group received LEF 20 mg·d1 , and those in the control group received MTX 15 mg week, totally 12 weeks as a course of treatment . ResultsThe total effective rates of the treatment group and the control group were 90.0%(n=50)and 95.6%(n=45)respectively . There was no significant difference between the two groups in the effectiveness (P>0.05) .The adverse reaction rate was 14.0%(7 case) in the treatment group and 15.6%(7 case) in the control group with no significant difference between the two groups (P>0.05) . But the adverse reactions were more tolerable in treatment group than those in control group . ConclusionThis study suggests that LEF is an effective drug with minor adverse reactions for active rheumatoid arthritis.
  • 药物制剂
  • 药物制剂
    ZHI Bingfang;GUO Linqun;KONG Yin
    2006, 25(9): 942-0944.
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    To prepare tiopronin pellets by extrusionspheronization and fluid bed coating technology and determine the pellets’ properties. MethodsTiopronin pellets were prepared using home product,extrusionspheronization equipment. L9(34)orthogonal design was used to obtain optimal formulation. Using fluid bed coating equipment,the pellets were coated with enteric coats. The micromeritic properties and in vitro disso1ution of the pellets were determined. ResultsTiopronin pellets prepared by extrusionspheronization were round,smooth and even. The disso1ution test in vitro from the coated pellets was perfect. ConclusionsThe process of preparing pellets by extrusionspheronization is simple and quick with excellent quality of pellets. Appling a proper technology of coating,the coated pellets can be made successfully.
  • 药品质量监控
  • 药品质量监控
    LIU Chan;CHEN Zhiliang;LI Guofeng;GUO Dan;HUANG Sihang
    2006, 25(9): 953-0954.
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    To establish the HPLC method for the determination of podophyllotoxin in podsln.MethodsODSC18 (4.6 mm×250 mm, 5 μm) was used as the stationary phase. The mobile phase was the solution containing methanolwaterglacial acetic acid(59:41:0.6);flow rate :0.8 mL·min1; wavelength of UV detection :285 nm, sample: 20 μL and temperature of column: 26 ℃.ResultsThe calibration curves was linear in the concentrations of 1.6~80.0μg·L1(r=0.999 9, n=5).The average recovery of three doses was 99.09%,99.88%,100.92%; the contents of podophyllotoxin in 3 batches podsln were 94.89%,94.76%,97.24% ,respectively.ConclusionThe method is simple,accurate,rapid and reproducible. It is suitable to assay the content of the drug.KEY WORDSPodophyllotoxin;Content determination;HPLC
  • 药品质量监控
    DOU Zhihua;DING Anwei;ZHANG Bing;LI Weihong;WU Chenjun;YOU Fuyi;CAO Weiju;SHI Zhong
    2006, 25(9): 955-0956.
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    To improve and consummate the standard of quality control for compound wurenchun capsules. MethodsBased on the fingerprint, the standard of quality control for compound wurenchun capsules by HPLC fingerprint has been established, which includes the amount of common peaks, similarity and ratio of peak areas. Three batches of samples have been detected. ResultsThe quality of 3 batches samples accorded with the standard of quality control which had been established. ConclusionThis standard is sensitive, quick, simple, accurate and can be used for quality control of compound wurenchun capsules.
  • 用药指南
  • 用药指南
    SU Yinfa
    2006, 25(9): 965-0967.
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    To establish a simplified method of dosage regimen design of extra venous administration. MethodsMicrosoft Excel was used to make a program by the pharmacokinetic parameters to show the dosage regimen. ResultsAfter inputting the pharmacokinetic parameters,dosing interval (τ),and maintenance dose (d),the Excel spreadsheet displayed plasma concentration and area under curve (AUC)after the 1st administration. The time of the effective plasma concentration (tec),the minimum dose (dmin)and maximum dose (dmax) were obtained by program solution on Excel. ConclusionThis design method can provide safe and effective dosage for clinical administration and evaluate a dosage regimen.