Objective To explore the effects of cannabinoid receptor agonist WIN55,212-2 preconditioning on spinal cord ischemia reperfusion injury in rats.Methods A total of 32 male Sprague-Dawley rats was randomly divided into four groups (n =8):sham group,control group,dimethyl sulfoxide(DMSO) group which was given intraperitoneally DMSO 0.3 ml 30 min before ischemia reperfusion,and WIN group which was given intraperitoneally WIN55,212-2 1 mg/kg 30 min before ischemia reperfusion.Each rat was neurologically assessed at 24 h and 48 h after reperfusion by Tarlov scale,and the number of normal motor neurons at anterior horn of the spinal cord was recorded.Res uits The Tarlov scale of WIN group was significantly higher than that control and DMSO groups (P ＜ 0.05).There were more normal motor neurons at anterior horn of the spinal cord in WIN group than those in control and DMSO groups (P ＜ 0.05).Conclusions Cannabinoid receptor agonist WIN55,212-2 preconditioning might attenuate spinal cord ischemia reperfusion injury.

Objective: To evaluate the clinical efficacy and safety of ticagrelor in the patients with acute coronary syndrome ( ACS) . Methods:A retrospective study was applied to investigate the ACS patients treated with ticagrelor in our hospital from July to December in 2015. The basic information of patients, drug administration, platelet aggregation induced by ADP, major adverse cardio-vascular events ( cardiac death,nonfatal myocardial infarction,target vessel revascularization and stent thrombosis) , and adverse drug reactions ( ADR) were recorded. The incidence of end point events was calculated and the change of platelet aggregation induced by ADP before and after the drug administration was analyzed by SPSS statistical software. Results:A total of 161 patients were collected. The incidence of cardiovascular adverse events was 1. 2%, while the incidence of adverse drug reactions was 30. 4% including bleeding (15. 5%) without severe bleeding events and dyspnea (10. 6%) with 3 severe ones. The platelet aggregation rate before and after the ticagrelor treatment respectively was (54. 96 ± 14. 654)%and(24. 37 ± 13. 183)% in 122 patients with low reaction to clopidogrel( P<0. 01). Conclusion:Ticagrelor at the recommended dose can further reduce the platelet aggregation induced by ADP. In spite of high incidence of ADR, ticagrelor has slight ADR with good tolerance.

Based on the "requirements on the submitted documents for consistency evaluation of generic oral solid dosage forms of chemical drugs" and relevant guidance, this article summarized and formulated the decision tree of in vitro consistency evaluation of oral solid generic drugs, discussed the differences and common problems of in vitro evaluation research projects under different conditions, selective analyzed the technical requirements and concern problems of unconventional research projects, and proposed corresponding recommendations for concern problems, in order to provide more references for the follow-up study on consistency evaluation of oral solid generic drugs.

With the development of antibody manufacturing technology and improvement of new drug research in domestic industry, more innovative monoclonal antibody products submitted investigational new drug (IND) application. At the same time, monoclonal antibody products from abroad which have been approved marketing authorization and/or conducted clinical trials submitted IND applications in China. The National Medical Products Administration (NMPA) issued the "Guideline of Investigational New Drug Application" (No. 16, 2018) which emphasized the chemical, manufacturing, and control (CMC) regulatory, and dossier requirements in IND application, greatly promoted the application quality of innovative biological products. However, compared to the Food and Drug Administration (FDA) and European Medicines Agency (EMA), our particular guidelines are insufficient, such as guideline on virus safety evaluation of biotechnological investigational medicinal products. This review investigated the questions raised by sponsors from 2018 to 2020, including the end of production cell (EOPC) and/or unprocessed bulk (UPB) testing and virus removal or inactivation validation. Meanwhile, sponsors submitted different dossiers due to differences in understanding of stage requirements of guidelines from domestic and abroad. Based on the guidelines of virus safety from NMPA, FDA, and EMA, and the technical considerations, this review puts forward personal suggestions on the adventitious agents testing and virus removal or inactivation validation in manufacturing process, aim to ensure virus safety of innovative monoclonal antibody products in clinical trials.

Objective To investigate the effects of kui-yang-fang on trefoil factor 1 ( TFF1 ) , epidermal growth fac-tor ( EGF) and epidermal growth factor receptor( EGFR) in acetic acid induced gastric ulcers of rats. Methods50 rats were randomly divided into five groups. The rats of the gastric ulcer model were used by the icy acetic acid. After drug treatment for 14 days,the rats gastric mucosa was collected to compare to the ulcer index,then check the content of TFF1,EGF and EGFR with RT-PCR,and observe TFF1,EGFR with immunohistochemical staining. Re-sults Compared to the control,the levels of TFF1 and EGF in model group decreased, and the difference was not statistically significant. The EGFR level of model group was higher than that of normal group with no statistically significant difference. But the increase of kui-yang-fang groups and ranitidine group was more obvious,the difference was statistically significant (P<0.01). Compared to the model group,kui-yang-fang and ranitidine groups signifi-cantly elevated the level of TFF1,EGF and EFR in gastric ulcer,the difference was statistically significant ( P<0.01 ) . Immunohistochemical staining showed that TFF1 and EGFR expression in kui-yang-fang and ranitidine groups were significantly increased,the difference was statistically significant (P<0.01), but the increase of kui-yang-fang of high-dose group was more obvious. Conclusion One of the possible mechanism is kui-yang-fang pro-motes expression of TFF1,EGF and EGFR to protect and repair gastric tissue.

Objective To investigate the clinical and skeletal muscular pathological features of chronic progressive external ophthalmoplegia(CPEO).Methods The clinical and skeletal muscular pathological data of 6 patients with CPEO were analyzed retrospectively.Results All of the 6 patients onset were 4 to 18 years old.The first symptom was blepharoptosis.The clinical mainly manifestations were limited activity of eyeball,accompanied with limbs muscle fatigue,weakness and level elevatation of serum creatine kinase(CK).5 cases had myogenic changes in electromyography(EMG).The skeletal muscular pathological examination showed that the ragged red fibers(RRF)were scattered among the muscle fibers,and the deficient or absent of COX activity in many fibers.A few degenerating and necrotic fibers were observed in 4 cases.Lipid-drops were increased by oil red "O" stain in 3 cases.Electromicroscope showed that abnormal mitochondria increased in number and aggregated under sarcolemma or in cytoplasm.Crystalloid inclusion body could be observed.Conclusions The clinical mainly features of CPEO are external ophthalmoplegia and accompanied with limbs weakness.RRF and COX activity deficiency or absence according to skeletal muscle pathology can be suggest and support the diagnosis of CPEO.Gene sequencing based on skeletal muscle biopsy is necessary to make the final diagnosis of CPEO.

Objective To determine the content of icariin and flavonids in Epimedium koreanum Nakai of different place of production and different pharmaceutical genetic in Liaoning Province. Methods Icariin was used as the chemical reference substance to establish HPLC and ultraviolet spectrophotometry methods for content determination of icariin and total flavonoids. Results The content of icariin in leaves was from 0.197% to 0.347%,and in stem was from 0.043% to 0.050%. The content of total flavonids in leaves was from 6.68% to 8.85%,and in stem was from 1.3% to 2.7%. The calibration curves of icariin was in good linearity over the range of 0.3～1.8 ?g (r=0.999 9) and total flavonids was 0.5～3 ?g/mL (r=0.999 9). The average recovery of icariin was 99.43% (n=6,RSD=0.29%) and total flavonids was 100.38% (n=9,RSD= 1.60%). Conclusions The content of flavonids in Epimedium koreanum Nakai of different place of production and different pharmaceutical genetic has large difference,the content in leaves is far higher than in stem.

Objective To observe the inhibitory action of Qigefang on cell proliferation,movement,secreting MMP-2 and MMP-9 of MGC gastric cancer cell line.Methods MGC cell line of gastric cancer was cultured and divided into five groups randomly:low-,middle-,high-dose group of Qigefang,5-FU group,control group.Qigefang was added in Qigefang group to make final concentration of 35,70,140 mg/mL,5-FU in chemothapy group to 50 ?g/mL,and PBS in control group.Tumor cell proliferation was detected by MTT,moving ablity of tumor cell by agar drop,and MMP-2,MMP-9 activity by gelatinase zymography.Results Qigefang had obviously depressant effect on proliferation of MGC cell.It became more obviously with raising drug density.Moving ability of all dose Qigefang groups and 5-FU group were more feeble than control group.The difference was significant(P

Objective To observe the regulatory effects of the preventive acupuncture and moxibustion at Guanyuan (RN4) points in ovariectomized rats, and discuss the mechanism of preventive acupuncture and moxibustion on hyoathalamus-pituitary-ovary (HPO) axis. Methods Totally 48 female SD rats were divided into 5 groups, including normal group, sham operation group, ovariectomized rats group, preventive acupuncture group and preventive moxibustion group. Except normal group and sham operation group, rats were ovariectomized after preventive acupuncture and preventive moxibustion for 30 d in corresponding groups. ELISA was used to determine the levels of E2, ER, GnRH, FSH and LH in the tissues including hypophysis, hypothalamus and uterus. Results Compared with the normal group, E2, ER and GnRH level in the tissue of the model group was significantly lower (P<0.01), the levels of FSH and LH increased obviously (P<0.01). Compared with the model group, E2, ER and GnRH level of preventive acupuncture group and preventive moxibustion group increased in different degree (P<0.05). FSH and LH level reduced in different degree (P <0.05). There was no obvious difference between preventive acupuncture and preventive moxibustion group (P>0.05). Conclusions The preventive acupuncture and preventive moxibustion at Guanyuan (RN4) has benign modulation to disordered HPO axis of ovariectomized rats. The ability of preventive acupuncture and preventive moxibustion are almost the same.