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    药物研究
  • 药物研究
    LIU Weizhong;CHEN Qingxia;ZHU Jun;WEN Yuguan;HUANGpu
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    ABSTRACTObjectiveTo establish a method for determining the concentration of clozapine and perphenazine in human plasma by HPLC. MethodsThe drug from plasma was analyzed in a reverse phase HPLC system with C18 column(150 mm×4.6 mm,5 μm); mobile phase consisted of 0.03 mol•L1 ammonioummethanol(27:73); the flow rate at 0.8 mL•min1; the detection wavelength at 254 nm. Ethyl acetate and dichloromethane(80:20) were used as extracting solvent. ResultsThe average recoveries of clozapine and perphenazine in high, middle and low concentrations were 98.28%, 97.63%, 101.31% and 97.26%, 98.65%, 100.42%, respectively. The intraday and interday variation(RSD) was less than 7% (n=5). The calibration curve of clozapine and perphenazine showed a good linearity, r=0.999 4 and r=0.999 2(n=9), over the range of 10.0-1 000.0 ng•mL1. The regression equation of clozapine was Y=1.692X+4.390 and perphenazine was Y=0.575X-2.370. The minimum detectable concentration of clozapine and perphenazine was 5.0 ng•mL1. ConclusionThe method is sensitive, accurate, easy and quick, which can be used for clinical drug monitoring and pharmacokinetics studies.
  • 药物研究
    LIU Wei;ZHANG Qing
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    ABSTRACTObjectiveTo establish a sensitive and selective LCMS/MS method for the simultaneous determination of amlodipine besylate and atorvastatin calcium in human plasma. MethodsThe plasma samples were extracted by methyl tertbutyl ether with nimodipine as internal standard. Separation was achieved on an Agilent TCC18 reversedphase column with a mobile phase composed of acetonitrile5.0 mmol•L-1 ammonium acetate buffer (pH4.0) (25:75, V/V) at a flow rate of 0.25 mL•min1. The mass transition pairs of m/z 409.1→238.0, 559.2→440.2, and 419.1→343.1 were used to detect amlodipine besylate, atorvastatin calcium and internal standard. ResultsThe assay was linear over the concentration range 0.05-20.0 μg•L1 for amlodipine besylate and atorvastatin calcium in human plasma. Recoveries at concentrations 0.1, 2.0 and 18.0 μg•L1 for amlodipine besylate were 76.78%, 77.08% and 76.27%, and for atorvastatin calcium were 80.16%, 79.69% and 81.82%, respectively. The method was accurate with all intra and interday mean concentrations within 15% of nominal values at 0.1, 2.0 and 18.0 μg•L1. ConclusionThis method was robust and suitable for clinical pharmacokinetic studies of amlodipine besylate and atorvastatin calcium.
  • 药物研究
    YANG Le;WANG Zhaohua;LI Shusheng;YANG Guangtian;ZHAO Libo
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    ABSTRACTObjectiveTo investigate effects of sodium tanshinone IIA sulfonate (STS) on hypertensioninduced cardiac fibrosis and Th1/Th2 cytokines in aged mice. MethodsHypertensioninduced cardiac fibrosis was established by abdominal aorta constriction in aged mice. Some mice were i.g. injected with STS, the control were injected with physiological saline. The cardiac fibrosis and Th1/Th2 cytokines were detected. ResultsThe collagen fiber was deposited obviously in the cardiac interstitium of the model mice, but less could be seen in STStreated group. In STStreated group, Th1 cytokines (IL12, IFNγ) were decreased and Th2 cytokines (IL4, 5) were increased. The type I collagen expression in STStreated group was less than the model. ConclusionSTS can modulate hypertensioninduced cardiac fibrosis in aged mice and the mechanisms may be related to regulation of Th1/Th2 cytokines levels.
  • 妇产科用药专栏
  • 妇产科用药专栏
    ZHANG Dandan;CHEN Juanjuan;FANG Jianguo;WAN Jin;WANG Nan;CHEN Suhua
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    ABSTRACTObjectiveTo study the in vitro anticytomegalovirus effect and the security of andrographis paniculata. MethodsThe 0% toxic dose (TD0), minimum effective concentration (MEC) and therapeutic index (TI) of anticytomegalovirus activity by andrographis paniculata were detected with cytopathic assay and MTT method, and compared with those of ganciclovir, honeysuckle, houttuynia cordata and folium isatidis. ResultsThe TD0 of ganciclovir, honeysuckle, houttuynia cordata,folium Isatidis and andrographis paniculata were 10,3 000,30 000,30 000,3 000 μg•mL1, the MEC were 10,3 000,3 000,3 000,300 μg•mL1, TI were 1,1,10,10 and 10, respectively. ConclusionsAndrographis paniculata showed a good in vitro anti cytomegalovirus effect, which is higher than honeysuckle, houttuynia cordata and folium isatidis, and a equivalent cytotoxicity to honeysuckle but higher than houttuynia cordata and folium isatidis. The TI of andrographis paniculata is higher than honeysuckle but equivalent to houttuynia cordata and folium isatidis. Therefore, andrographis paniculata has the potential advantages for clinical use and worth further study.
  • 妇产科用药专栏
    BING Feihong;WAN Min;LI Jing;LIAO Yifan;FU Guangfa
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    ABSTRACTObjectiveTo explore the therapeutic effect of shujie yiweian capsule on endometriosis. MethodsThe rabbit model of endometriosis was established by transplantation. The mode rabbits were i.g. shujie yiweian capsule 1.9, 3.8, 7.6 g•kg1 for 4 weeks as low, middle and high dose. The appearance and growth of endometrium were observed and detected by histomorphological analysis; contents of estradiol(E2), gestagen (P), 6kPG, TXB2 were measured by radioimmuno assay. ResultsIt was showed that the quantity of liquid in ectopic endometrial tissue was decreased and the growth was inhibited. The ectopic endomembrane was shrunk, epithelium was thinner, no glandular organ was formed, the mesenchymal cells were small and sparse after the treatment of different doses of shujie yiweian capsules. The serum levels of E2、P、6kPG and TXB2 were decreased in the high and middle doses of shujie yiweian capsules treated rabbits.ConclusionShujie yiweian capsule can holdback the growth of ectopic endometrium by decreasing hormone levels.
  • 药物与临床
  • 药物与临床
    ZHANG Li;DU Zhimin;HAN Yubo;SHAO Yuxia;LV Fuzhen;HAN Shouxin;WU Xiaomei;QIU Xiaohong;REN Yeping
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    ABSTRACTObjectiveTo evaluate the efficacy and safety of gatifloxacin in the treatment of acute bacterial infection. MethodsA multicenter, singleblind, randomized controlled trial was conducted among 205 patients with bacterial infections. The treatment group were treated with gatifloxacin injection 200 mg iv,gtt, bid and the control group were given with levofloxacin 200 mg, iv,gtt, bid. The duration of treatment in both groups was 710 d.ResultsThe recovery rate and effective rate were 68.63% and 93.14% in the treatment group, and 65.05% and 91.26% in the control group respectively (P>0.05). The bacteria clearance rate in the two groups were 92.86% and 91.86%, and the adverse reaction rate were 5.88% and 6.80%, respectively (P>0.05). ConclusionGatifloxacin and levofloxacin have the similar efficacy and safety in the treatment of susceptible pathogen infection.
  • 药物与临床
    QIU Weidong;YANG Jianying;CHEN Liang;XU Meichun
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    ABSTRACTObjectiveTo investigate the perioperative effects of penehyclidine hydrochloride on perioperative respiratory function of patients with chronic obstructive pulmonary disease(COPD). MethodsFortytwo ASA Ⅱpatients with COPD undergoing nonthoracic surgery were divided into control group (group C, n= 20) and penehyclidine hydrochlorid group (group P, n= 22). Patients in group P received intravenous penehyclidine hydrochloride 0.02 mg•kg1 15 minutes before induction of anesthesia. Arterial blood gas was checked and dynamic lung compliance (Cd),oxygenation index(OI), airway resistance, peak pressure were monitored 5 minutes and 30 minutes after endotracheal intubationand . ResultsCd in group P at all points was significant higher than that in group C (P<0.05). Airway resistance in group P at all point was significant lower than that in group C (P<0.05). Ppeak in group P at the point of 30 minutes after endotracheal intubationand was significant lower than that in group C (P<0.05) .ConclusionPenehyclidine hydrochloride has beneficial effects on improving respiratory function of patients with COPD.
  • 药物与临床
    YANG Aixia;FENG Yongfang;XIE Dai
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    ABSTRACTObjectiveTo evaluate the efficiacy and adverse reactions of tuire jieduling granules in the treatment of shingles zoster. Methods60 patients with shingles zoster were randomly divided into a treatment group and a controlled group. Patients in the treatment group used tuire jieduling granules and valacyclor tablets 0.3 g orally twice a day for 10 days. Those in the controlled group used valacyclor tablets 0.3 g orally twice a day for 10 days only. The other treatments in both groups were the same. ResultsCompared with the control, the treatment group was obviously superior in relieving pain, vesication, shortening time of scab(P<0.05). And the incidence rate of postherpetic neuralgia was lower than that in the control group. ConclusionTuire jieduling granules is efficacy and deserves for clinical use.
  • 药物与临床
    MA Chunwei;WANG Hua;WU Shimin;YUAN Sheng
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    ABSTRACTObjectiveTo investigate the renoprotective effect of irbesartan on senile patients with type 2 diabetes and hypertension. Methods96 patients over 70 were enrolled in the study and separated into 3 groups equally. The group A with hypertension was treated with irbesartan 150 mg. The group B with type 2 diabetes and hypertension was treated with irbesartan 150 mg. The group C with type 2 diabetes and hypertension was treated without irbesartan. The change of microalbuminuria after treatment for 12 weeks among three groups was observed. ResultsMicroalbuminuria levels were reduced obviously in irbesartan group with type 2 diabetes and hypertension(P<0.01), which was changed in the group with type 2 diabetes and hypertension without the treatment of irbesartan. Microalbuminuria was related to the body mass index (BMI) and HbA1c(P<0.05).ConclusionUsing irbesartan for reducing high blood pressure can protect the kidney function of senile patients with type 2 diabetes and hypertension.
  • 药物制剂
  • 药物制剂
    ZHANG Qian;LIN Yinhua;WANG Juan;ZHOU Xin;YU Xiquan;SONG Hongtao
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    ABSTRACTObjectiveTo prepare nitroglycerin ointment and establish a method for its quality control. MethodsNitroglycerin ointment was prepared by melting agitation method. The contents of nitroglycerin were determined by HPLC. ResultsThe prepared ointment was welldistributed, fine and smooth. A good linearity was obtained over the range of 20 to 180 μg•mL1. The average recovery of nitroglycerin was 96.9% with RSD 0.49% (n=9). ConclusionsThe preparation technology of nitroglycerin ointment was feasible. The method of determination was simple,reliable and suited for the quality control of nitroglycerin ointment.
  • 药物制剂
    DU Jianping;LIU Jun;SHI Zhiqi;
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    ABSTRACTObjectiveTo optimize the emulsification technology of sanhuang jiedu cream. MethodsThe main factors influencing the stability of cream were optimized by orthogonal experiment with the thickness of oil layer obtained after centrifugalization as reference. ResultsThe optimum ratio of oilphase were: stearic acid 150 g,olefin 120 g,petrolatum album 12 g,lanolin 60 g; The ratio of emulsifier were: triethanolamine 5 mL, tween80 20 g; The temperature of emulsification was 90 ℃. ConclusionThe optimized emulsification technology is stable and feasible, and provides experimental evidence for the industrial production of sanhuang jiedu cream.
  • 药物制剂
    DONG Huixian;GUO Meihua;HE Ping
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    ABSTRACTObjectiveTo prepare dantong lixiao capsules and establish the quality standard for them. MethodsTLC was used to identify Radix Paeoniae Alba. HPLC was used to determine the content of tetrahydropalmatine with SinoChrom ODSBP (4.6 mm×250 mm,5 μm) column, mobile phase composed of methanol0.1% phosphoric acid solution (adjusted the pH to 6.0 with triethylamine)(60:40,V/V) and the detection wavelength at 281 nm. ResultsTLC method was distinguished. HPLC method was accurate and reliable with the recovery as (96.85±0.99)%, with RSD=1.02%. ConclusionThis standard is precise and can be used for the quality control of dantong lixiao capsules.
  • 药物制剂
    LIANG Zehua;YIN Lina;XIONG Yaokang
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    ABSTRACTObjectiveTo study the formulation of oral rubidomycinby using similarity factor (f2 ) as an indicator. MethodsThe concordance of metoo rubidomycin and original one was evaluated by using f2 as an indicator, to systemically screen the attenuant and blocker, and determine the objective prescription. ResultsThe developed generic drug was consistent with the original one by using microcrystalline cellulose as attenuant and talc as blocker (f2 >60). Conclusionf2 offered a better method for differentiating the release between preparations, which can be used in studying the formulation of generic drug.
  • 药品质量控制
  • 药品质量控制
    LI Jinhong;LI Wei;DU Shengqi;ZHANG Manling
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    ABSTRACTObjectiveTo establish the quality standard of lianzhi xiaoyan tablet. MethodsHerba andrographitis, screwtree were identified by TLC,and the contents of andrographolide and dehydroandrographolide were determined by HPLC. ResultsThe identification by TLC was distinct and clearly. The qualititative evaluation of andrographolide and dehydroandrographolide had a good linearity over the range of 0.082 71-0.827 10 μg, r=0.999 3; 0.241 7-2.417 μg,r=0.999 8, respectively. The average recovery of andrographolide and dehydroandrographolide was 97.8%,RSD=1.03% and 96.7%,RSD=1.14%, respectively. ConclusionThe identification and determination methods established were specific, simple, accurate and reliable, and can be used to control the quality of lianzhi xiaoyan tablet effectively.
  • 药品质量控制
    GUO Shengcai;GU Na;LI Hua
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    ABSTRACTObjectiveTo set up a simple, accurate and sensitive reversedphase high performance liquid chromatographic ( RPHPLC) method for the simultaneous determination of salicylic acid and chloramphenicol in compound chloramphenicol alcoholic solution. MethodsThe chromatographic analysis was carried out with a ZORBAX EclipsXDBC18(4.6 mm×150 mm,5 μm) and photodiode array ( PDA) detector, using methanolwater (50:50) as the mobile phase, at a flow rate of 0.6 mL•min1. The absorbance of eluent was simultaneously monitored at 300 nm and 278 nm for salicylic acid and chloramphenicol, respectively. Separation was completed in less than 6 min.The content of salicylic acid and chloramphenicol was determined by external standard method. ResultsThe calibration curves were in good linearity over the range of 0.01 mg•mL-1 to 0.10 mg•mL-1,and the relevant coefficient were 0.999 9 for two drugs. Their average recovery approached 100.0%. ConclusionThis developed HPLC method is simple, rapid, reliable and suitable for rountine quality control and the simultaneous determination of salicylic acid and chloramphenicol in compound chloramphenicol alcoholic solution.
  • 药品质量控制
    KE Zhengfang;WU Peisheng
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    ABSTRACTObjectiveTo establish a method for content determination of the residual solvent of butanone and cyclohexanone in infusion sets for single use by GC. MethodsThe analysis was performed on capillary column of DBFFAP(30 m×0.32 mm,0.5 μm) ,with FID detector, using nitrogen as carrier gas. The column temperature was initially 60 ℃,increased at a rate of 20 ℃•min1 to 120 ℃ and maintained at 120 ℃ for 3 min. The injector temperature was set at 170 ℃ and the detector temperature was 250 ℃. The split ratio was 1:1. The residual solvents were calculated by internal standard method. ResultsThe standard curve of butanone was Y=0.023 1X-0.040 8,within the range of 5.06-101.18 μg•mL1,r=0.998 9(n=7).The average recovery of butanone was 98.93%(RSD=4.30%,n=9). The standard curve of cyclohexanone was Y=0.030 3X-0.028 9,within the range of 4.88-97.50 μg•mL1,r=0.999 5(n=7).The average recovery of butanone was 104.52%(RSD=2.20%,n=9). ConclusionThe method is simple and rapid, which can be used for detection of the residual solvents of butanone and cyclohexanone accurately.
  • 用药指南
  • 用药指南
    LI Xianghui;ZHANG Yifei;TIAN Tian;ZHANG Bo
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    ABSTRACTObjectiveTo study the compatible stability of aminophylline injection mixing with cefoperazone and sulbactam. MethodsThe contents of 2 constituents of the mixed solution stored at 25 ℃ within 6 hours were determined by spectrophotometry with dual ultraviolet wavelength, and the appearance, pH value of the mixture were compared before and after mixing. ResultsAfter mixing, the content of cefoperazone and sulbactam reduced 18%, that of aminophylline did not change significantly. But the mixed solution was clear and the colour became yellowish and pH decreased 0.65 at 6 h. ConclusionAminophylline injection is incompatible with cefopernzone and sulbactam in sodium chloride injection.