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OBJECTIVE：To explore the new management model of Good Clinical Practice （GCP）trial drug dispensing . METHODS：Base on the relevant experience of Pharmacy Intravenous Admixture Services （PIVAS）in daytime chemotherapy center（“daytime PIVAS ”for short ）of our hospital ，the nodes and other matters needing attention were discussed in the workflow of confirmation and development of drug dispensing tasks for clinical trials. RESULTS ：After the successful approval of the new clinical trial ，the supervisor of the sponsor and the principal investigator should first confirm whether the drugs involved in the project needed to be centrally dispensed in the daytime PIVAS ，and then submitted the relevant data to PIVAS for filing. Daytime PIVAS pharmacists could participate in trial drug dispensing of relevant projects only after starting training and authorization. After the doctor issued the medical order for the subjects in the hospital information system ，the research nurse took the drugs out of the GCP pharmacy and handed them to the daytime PIVAS drug receiving window. After receiving the drugs ，the pharmacist would check the dispensing ，and then the preparation pharmacist trained and authorized by the project team would mix and dispense the drugs. The reviewed pharmacist would check and label the prepared infusion. In addition ，daytime PIVAS would regularly summarize the feedback information on the trial drug dispensing and fund management in all links of dispensing process ，so as to improve the standardization of the process. CONCLUSIONS ：Daytime PIVAS for clinical trial drug can arrange batches more rationally，ensure smooth and orderly infusion ，and meet different drug stability requirements ，which can improve trial drug dispensing management and further promote the development of drug clinical trial projects in China.
RESUMO
Objective To observe the effect of penetrating electro-acupuncture at scalp-acupoints on the motor function and oxidative stress action of mice with Parkinson's disease (PD).Methods Mouse model of PD was established by 5-day intraperitoneal injection of 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP,30 mg/kg),and then PD mice were given electro-acupuncture set at different parameters.The effect of the electroacupuncture on the behavior and expression of tyrosine hydroxylase (TH) of mice were observed to screen out the appropriate treatment parameters.Healthy C57BL/6 mice were randomly divided into blank group,model group,positive group (madopar,6.25 mg/kg) and electro-acupuncture group.The mice except for blank group were given intraperitoneal injection of MPTP to induce PD,and then the PD mice of positive group and electroacupuncture group were treated with madopar(6.25 mg/kg) and electro-acupuncture respectively from the 6th day for 7 continuous days.Behavioral test was carried out on the 5~ modeling day and on the Th electro-acupuncture treatment day to evaluate the motor function of the mice.After the mice were killed and their brains were isolated,mitochondrial complex Ⅰ ～Ⅳ activities,reactive oxygen species(ROS) level,malondialdehyde (MDA) content,and total activities of superoxide dismutase (SOD) in the cerebral mitochondria were determined to evaluate the effect of electro-acupuncture at acupoints on anti-oxidative stress of PD mice.Results The motor function of PD mice was improved,the activity of mitochondrial complex Ⅰ was increased,the contents of ROS and MDA in cerebral mitochondria were decreased,and the activity of SOD was increased in the electro-acupuncture group,the differences being significant compared with those of the model group (P ＜ 0.05 or P ＜ 0.01).Conclusion Penetrating electro-acupuncture at scalp-acupoints can increase the anti-oxidative ability of the cerebral mitochondria and improve the motor function of PD mice.
