Archive

• 10 October 2003 Volume 22 Issue 10

    

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  药物研究
  药物与临床
  药物制剂
  药品质量控制
  

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药物研究
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  药物研究

  Treatment of Hypoxicischemic Brain Injury in Neonatal Rats with Monosialoganglioside

  LUO Jingsong;LI Zhijun;ZHANG Yi;JIANG Liguo;LIU Hong;YANG Yang

  2003, 22(10): 673-675.

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  Objective:To probe into the therapeutic effect of monosialoganglioside (GM1) in the treatment of hypoxicischemic brain injury (HIBI) in neonatal rats.Methods:54 7dayold SD rats were divided into 3 groups: shamoperating group (6 rats, in which the right common carotid artery was separated but not ligated); GM1 treated group(24 rats, in which the right common carotid artery was separated and ligated. 1/2 hr after the operation, the animals were kept in a hypoxic chamber for 2 hr. These rats were then given each an intraperitoneal injection of 10 mg•kg1 of GM1 immediately after they had been taken out of the chamber and every 24 hr until they were sacrificed); HIBI group (24 rats, after being rendered ischemic and hypoxic as in rats of the GM1 group, animals of this group were given each an intraperitoneal injection of 0.9% sodium chloride solution). The SOD, NO and ATPase levels in the brain tissue were monitored at different time periods. Results:The SOD and ATPase levels in the brain tissue of rats in the GM1 treated group were significantly higher than those of the HIBI group(P＜0.01). The NO level, however, was apparently lower in rats of the GM1 treated group(P＜0.05).Conclusion:GM1 was shown to have a good therapeutic effect in the treatment of HIBI in neonatal rats.
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  药物研究

  A Study of the Pharmacokinetics of Rufloxacin Capsules in the Human Body

  WU Shenglin;LUO Junhong;HE Tongsheng;SHI Weimin

  2003, 22(10): 676-678.

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  Objective:To determine the pharmacokinetic parameters of rufloxacin capsules in the human body in order to provide scientific basis for the rational clinical use of the drug. Methods:Plasma concentrations of rufloxacin were determined with high performance liquid chromatography at different times after 200 mg of rufloxacin capsules had been given PO to each of the 6 male healthy volunteers. The data were processed by the 3P87 pharmacokinetic program. Results:Rufloxacin was shown to accord with the onecompartment open model after oral administration. The mean achieved peak time (Tmax) was (1.53±0.34) h;mean peak plasma concentration (Cmax) was (1.93±0.41) mg•L1;area under the curve (AUC) was (99.67±10.71) mg•h•L1;and the half elimination time (t1/2), 34.16±8.55 h. Conclusion:Rufloxin was shown to have a high blood concentration and a wide tissue distribution. The drug was absorbed completely and eliminated slowly, showring good pharmacokinetic features.
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  药物研究

  A Comparative Study of the Therapeutic Effects of Clozapine and Risperidone in the Treatment of Schizophrenia

  CAO Wei;LIU Xiaolin;WEI Haiyan

  2003, 22(10): 679-680.

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  Objective:To compare the therapeutic effects and adverse reactions of clozapine and risperidone in the treatment of patients with schizophrenia. Methods:80 patients who met the CCMD3 diagnostic criteria for schizophrenia were randomly divided into 2 equal groups, the treatment group and the control group. Patients of the treatment group were given each an initial dose of 25 mg•d1 of clozapine PO. The dose was increased progressively to 200－500 mg•d1 in 2 weeks. Patients of the control group were given each an initial dose of 1 mg•d1 of risperidone PO. The dose was increased progressively to 2－8 mg•d1 in 2 weeks. The course of treatment in both groups lasted 8 weeks. The therapeutic effects were assessed with BPRS, adverse reactions, with TESS.Results:The rates of excellent effectiveness in the treatment group and control group were 65.0% and 42.5%, respectively(P＜0.05). The main adverse reactions in the treatment group were excessive sedation, salivation, tachycardia and anomalies in leucocytes, while those in the control group were extrapyramidal symptoms, insomnia, agitation, lactation etc..Conclusion:Clozapine was shown to start acting quickly and its therapeutic effects were superior to those of risperidine in the treatment of schizophrenia

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  药物研究

  A Comparative Study of Quetiapine and Chlorpromazine in the Treatment of Patients with Schizophrenia

  HE Youdong;ZHAO Chunmei;SHAO Alin;CHEN Yining

  2003, 22(10): 680-682.

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  Objective:To compare the therapeutic effectiveness and adverse reactions of quetiapine and chlorpromazine in the treatment of patients with schizophrenia.Methods:40 schizophrenics were randomly divided into two equal groups. Patients in the treatment group received quetiapine treatment, while those of the control group received chlorpromazine treatment. The initial dose of the drugs in both groups was 50 mg•d1, po. The dose of the drugs in both groups was increased by 50 mg every other day. The limits of doses were 300－500 mg•d1. The average dose of quetiapine was (433±19) mg•d1, po, that of chlorpromazine, (468±39) mg•d1, po. The course of treatment in both groups lasted 6 weeks. The therapeutic effectiveness was assessed with the positive and negative symptom scale (PANSS), while adverse reactions were appraised with the treatment emergent symptoms scale(TESS).Results:In patients treated with quetiapine, the effective rate was 90.0% and 75.0% of the patients improved markedly. The effective rate in patients treated with chlorpromazine was also 90.0%, but only 50.0% of the patients had marked improvement.Conclusion:Both quetiapine and chlorpromazine were shown to have definite therapeutic effects in the treatment of schizophrenics, but quetiapine appeared to be more effective in alleviating psychic symptoms.
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  药物研究

  Sertraline Combined with Clonazepam in the Treatment of Clomipramineresistant Obsessivecompulsive Disorders

  JIA Zhanling

  2003, 22(10): 682-683.

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  Objective:To study the therapeutic effects of sertraline combined with clonazepam in the treatment of clomipramineresistant obsessivecompulsive disorders(OCD).Methods:52 patients with OCD resistant to clomipramine were randomly divided into two equal groups. 26 cases in the treatment group were given each 50 mg•d1 of sertraline PO and 4 mg•d1 of clonazepam PO in the beginning. 3 days later, the doses of sertraline and chonzepam were increased to 100 mg•d1 and 8 mg•d1 PO, respectively. 26 cases in the control group were given sertraline only in a dosage same as that of the treatment group. The course of treatment in both groups lasted 8 weeks. The therapeutic effectiveness was assessed with the YaleBorwn obsessivecompulsive disorder rating scale(YBocs) and adverse reactions were appraised with the treatment emergent symptom scale(TESS). Results:The rate of notable effectiveness in the treatment group was 64.5%, while that of the control group, 38.5%. The score of YBocs in the treatment group was significantly lower than that in the control group at the end of the 4th and 8th week(P＜0.05). The difference was insignificant between the adverse reactions of the two groups(P＞0.05).Conclusion:Sertraline combined with clonazepam was shown to be safe and effective in the treatment of clomipramine resistant OCD.
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  药物研究

  Risperidone in the Treatment of 21 Senile Patients with Organic Psychonosema

  FU Juan

  2003, 22(10): 684-685.

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  Objective:To probe into the scheme of medication,therapeutic effectiveness and adverse reactions of risperidone in the treatment of senile organic psychonosema.Method:21 inpatients with senile organic psychonosema were treated with resperidone for more than 4 weeks. All these patients were over 60 years of age. The average initial dose of risperidone was (0.72±0.26) mg•d1, po, the average therapeutic dose, (1.58±0.83) mg•d1, po.Results:The overall effective rate was 85.7%,the incidence of adverse reactions was 23.8%. Conclusion:Risperidone was shown to have fairly good therapeutic effects in the treatment of senile organic psychonosema, and the dose required was low.
药物与临床
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  药物与临床

  Treatment of 47 Cases of Chronic Hepatitis B with Oxymatrine

  LUAN Ling;ZHANG Jingliang

  2003, 22(10): 692-693.

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  Objective:To survey the clinical therapeutic effectiveness of oxymatrine in the treatment of chronic hepatitis B. Methods:89 patients with chronic hepatitis B were randomly divided into two groups. 47 patients in the treatment group were given each 600 mg of oxymatrine I.M.q.d. for 3 months. 42 patients in the control group were given each 100 mg of aciclovir q.d., administered by slow intravenous instillation. One month later, the medication was switched to an oral one: patients were given each 100 mg of aciclovir per day in 5 divided doses PO for 2 months. In the meantime, patients of both groups were subjected to conventional treatment with hepatinica. Changes in clinical symptoms and signs, liver function tests as well as serological markers of HBV in patients of both groups were kept under observation at the termination of the course of treatment. Results:The rate of amelioration in liver functions in patients of the treatment group was significantly higher than that of the control group (P＜0.05). The rates of sera turning negative for HbeAg were 51.1% and 21.4% in the treatment group and control group, respectively(P＜0.05). No major adverse reactions were encountered in both groups. Conclusion:Oxymatrine was shown to have a definite therapeutic effect in the treatment of chronic hepatitis B without notable adverse reactions. Its remote effect, however, remains to be clarified by followup survey.
药物制剂
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  药物制剂

  Technologies for Purification and Separation of Iridoid Glycosides from Dried Rehmannia Root

  WANG Chengyuan;ZHANG Hao;ZHANG Chengping;MENG Li

  2003, 22(10): 707-709.

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  Objective:To seek for an effective method for the purification and separation of iridoid glycosides from dried rehmannia root.Methods:The water extract of dried rehmamnia root was subjected to HPLC, with catalpol as the assay standard of iridoid glycosides, so as to compare the purification effect of 101 fruit juice clarifier with that of Keyang 1＋1 natural clarifier, as well as to compare the separation effect of alcohol with that of nonpolar macroreticular resin. Results:Iridoid glycosides in the water extract of dried rehmannia root could be effectively separated with nonpolar macroreticular resin after the glycosides had been purified with Keyang 1＋1 natural clarifier.Conclusion:In industrial production, iridoid glycosides of dried rehmanniae root can be purified and separated with Keyang 1＋1 natural clarifier in combination with nonpolar macroreticular resin.
药品质量控制
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  药品质量控制

  Detection of Bacterial Endotoxin in Mannitol Injection with Kinetic Turbidimetry and Gel Clot Test

  WANG Fuxin;LUO Qi;LI Jun

  2003, 22(10): 714-716.

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  Objective:To detect the content of bacterial endotoxin in mannitol injection with kinetic turbidometry and gel clot test for the control of the quality of the drug and prevention of pyrogen reaction in clinical practice. Methods:According to the Methods of Detection of Bacterial Endotoxin and Guidelines for Detection of Bacterial Endotoxin in the Appendix of The Pharmacopoeia of the People’s Republic of China of the year 2000 edition, a systematic study was carried out of the interference of mannitol injection with limulus reagent and agglutination reaction to bacterial endotoxin. The authors were then determined to use kinetic turbidimetry and gel clot test for detecting the noninterference concentration of bacterial endotoxin. Results:The bacterial endotoxin in the mannitol injection could be detected quantitatively with kinetic turbidimetry if the solution had been diluted for 4 times. The requirements for optimal detection with the gel clot test were: 1∶8 dilution of the specimen, sensitivity of the limulus reagent(λ)＝0.06 EU`mL1; 1∶4 dilution of the specimen(refrigerated), sensitivity of the limulus reagent (λ)＝0.125 EU`mL1. Conclusion:Accurate results can be obtained in the quantitative detection of bacterial endotoxin in the mannitol injection with kinetic turbidimetry and the gel clot test may be used in routine duties. Pyrogen tests in rabbits for bacterial endotoxin in the mannitol injection can be replaced by both of the methods presented in this paper.
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  药品质量控制

  Determination of the Content of Psoralen in Migu Capsules with RPHPLC

  WANG Hu;CHEN Huating;ZHENG Jing;XU Chuhong

  2003, 22(10): 717-718.

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  Objective:To set up a method for the content determination of psoralen in migu capsules. Methods:RPHPLC was used for the analysis of samples, with a Hypersil C18 column(5 μm,ID 4.6 mm×250 mm); the mobile phase consisted of methanol and water (43∶57), the flow rate was 1 mL`min1 and the UV detection wave length, 245 nm. Results:The average rate of recovery of psoralen in samples was 99.3%; RSD was 2.2%.Conclusion:The method was shown to be simple and convenient, with accurate results, high sensitivity and good reproducibility. The authors therefore suggest to apply the method for the content determination of psoralen in migu capsules.
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  药品质量控制

  Determination of the Content of Phenolphthalein in Phenolphthalein Tablets with First Order Derivative Spectrophotometry

  LIANG Xuange

  2003, 22(10): 719-720.

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  Objective:To set up a method for the detection of the content of phenolphthalein in phenolphthalein tablets and elimination of the foreign matter fluorane and excipients. Methods:First order derivative spectrophotometry was used in the determination. The quantitative calculations were based on amplitude values of the peak height at 225 nm and valley height at 240 nm. Results:A good linear relationship was demonstrated when the concentration of phenolphthalein was in a range of 0.88－10.56 mg`L1. The correlation coefficient was 0.999 9. The average rates of recovery were 100.12% and 100.54%,with RSD of 0.56% and 0.74%, respectively, when the content of fluorane were 0.10% and 1.00%, respectively. Conclusion:The method was shown to be simple,convenient, rapid, accurate and reliable and capable of eliminating the interference of fluorane with a content below 1.0%.