OBJECTIVE:To investigate the risk,advantages and disadvantages and countermeasures of new drugs,generic drugs and imported drugs in different transfer opportunities,and to provide basis for improvement of development strategy for phar-maceutical enterprises. METHODS:The analysis was done in accordance with relevant regulations on transferable projects in the process of applying for registrations of new drugs,generic drugs and imported drugs. The transfer period and risk were explored and countermeasures were put forward. RESULTS & CONCLUSIONS:Transferable projects included intellectual property rights (patents,patent application,technical secrets,application information,non-disclosed data,etc.)and ownership rights(clinical tri-al approvals,new drug certificates,drug approval number,pharmaceutical product registration certificates,imported product regis-tration certificates,etc.)in the process of applying for registrations. There are 4 opportunities for drug technology transfer,opportu-nity 1 is before applying clinical trial approvals after the completion of non-clinical research such as pharmacology,toxicology;op-portunity 2 is ahead of clinical trial after the acquirement of clinical trial approvals;opportunity 3 is new drug technology transfer;opportunity 4 is production technology transfer. The new drugs have 4 transfer opportunities,generic drugs and imported drugs can transfer in opportunity 1,2,4. Different transfer opportunities present different risks and profits. The risk gradually decreases with the further promotion of drug registration process,while the innovation decreases at the same time. Pharmaceutical enterprises should combine with the policy,market and their own features to select a suitable transfer period.

Objective To investigate the function of metalloproteinase 2 (MMP 2) and tissue inhibitor of metalloproteinase 2 (TIMP 2) in neonatal acute lung injury(ALI) caused by LPS in rats. Methods Eighty eight newborn rats of 7 days were randomly divided into eight groups: control, 0.5 h, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h after LPS was injected. The changes of lung pathology in newborn rats were observed and the changes of MMP 2 and TIMP 2 expression were measured by immunohistochemistry and RT PCR. Results Pulmonary hemorrhage was seen in newborn rats caused by LPS. The expression of MMP 2 mRNA and protein were 0.523?0.030 and 126.20?17.98; The expression of MMP 2 mRNA increased and the highest level was at 4 h(0.826?0.567, t=3.77, P

Objective To compare the effects of labor epidural analgesia initiated in latent phase and active phase on parturients and neonates. Methods One hundred twenty nulliparous women at full term (single, head presentation, ASA Ⅰ or Ⅱ ) were randomly divided into 3 groups (n=40 each):control group(group C) ; PCEA initiated in latent phase group (cervical dilatation 0.5-3.0 cm) (group L) and PCEA initiated in active phase group (cervical dilatation＞3.0 cm) (group A). Epidural catheter was placed through L2,3 interspace. 0.1% ropivacaine with fentanyl 2 μg/ml was used for PCEA. A test dose of 5 ml was followed by a loading dose of 10 ml. PCEA device was programmed to allow a bolus of 6 ml with a 30 min lockout interval. The intensity of pain was measured with VAS (0=no pain, 10=worst pain) before analgesia, at 5, 10, 15 and 30 min after beginning of PCEA and cervical dilatation of 7-8 cm and 10 cm. Degree of motor block was assessed by lower extremity muscle strength (modified Bromage scale,0=no motor block, 3=inability to flex ankle joints).Plasma cortisol in maternal venous blood obtained before analgesia and at delivery of fetus and in umbilical cord blood and plasma ropivacaine concentrations in umbilical core blood were determined.The length of every stage, duration of analgesia,delivery mode, the amount of oxytocin used, maternal satisfaction, Apgar scores of the neonates and adverse effects were recorded. Results PCEA initiated in latent phase or active phase significantly reduced VAS score, the plasma cortisol level at delivery, the duration of 1st stage of labor, and the rate of cesarean section and increased the use of oxytocin in L and A groups as compared with group C, but there was no significant difference in the above variables between L and A groups. The duration of analgesia was shorter in group A than in group L. Conclusions Labor epidural analgesia initiated in latent phase or active phase can decrease the rate of cesarean section but does not prolong the duration of labor and is safe for the newborn.

Bibliometrics ; Biochemistry ; Biotechnology ; China ; Journal Impact Factor ; Periodicals as Topic ; statistics & numerical data ; Science

Objective To summarize the experience on diagnosis and treatment of splenic neoplasm. Methods Clinical data of 40 patients with primary splenic space occupying lesion treated in our hospital were retrospectively analyzed. Results Thirty four out of the 40 cases were diagnosed as primary splenic neoplasm preoperatively. The detectable rate of B-US was 94%, and that of CT was 96%. The discrimination rate of benignancy and malignancy by CT was 84%. Serum AKP and ?-GT were significanfiy increased in most of the malignancies. Seventeen among 22 cases with benignancy were treated by splenectomy, and the others underwent partial splenectomy or tumor resection. Sixteen of 18 patients with malignancy underwent splenectomy, and two did biopsy. Pathology revealed cysts in 13, angiocavernoma in 4, inflammatory pseudotumor in 3, caverous lymphangioma in 1, and cystic degeneration of liomyoma in 1; malignant lymphoma and lymphsarcoma in 9, hemangiosarcoma in 3, and fibrosarcoma, liomyosarcoma, malignant fibrous histiocytoma in 1 each. Three cases with malignancy have survived more than 5 years. Conclusions Splenic neoplasm is diagnosed mainly according to clinical manifestation and image examination. The discrimination of benignancy and malignancy depends on CT, angiography, and serous AKP and ?-GT level. Radical operation and complex treatment could improve the prognosis of splenic malignant tumor.

The contents of schisandrin, schizandrin A, B and C were determined by HPLC, and the effects of the climate factors and altitude on lignin contents were analyzed in order to select the optimal cultivation area of S. chinensis. The lignin contents were analyzed by HPLC using a ZORBAX SB-C18 column (4.6 mm x 250 mm, 5 microm). The column temperature and detection wave length were set at 35 degrees C and 254 nm, respectively. Methanol-water was used as the mobile phase in gradient elution mode and the flow-rate was 1.0 mL min(-1). The method had a good repeatability, stability and accuracy. The correlation of climate factors and lignins contents was analyzed by SPSS software. The results showed that the schizandrin A content in S. chinensis fruits were higher than 0.4% in Ji'an, Liuhe, Antu and Fusong in Jilin province, which met the quality requirement. It had significant linear negative correlation relationship between schisandrin, schizandrin A, B and altitude, the contents decreased with the increase of altitude. The significant negative linear fitting coefficient was 0.844 1 between schisandrin and altitude; but it had not significant correlation between schizandrin C and altitude. A significant positive correlation of climate factors and the contents of S. chinensis lignins were mainly the temperature factors (the average annual temperature, the highest temperature in July, the average temperature in July, the highest temperature in January, the average temperature in January) and precipitation factor (average annual precipitation), which reveals that higher temperature and precipitation were helpful to the formation and accumulation of lignins of S. chinensis. So the cultivation area of S. chinensis should be in the low elevations region with warm and rainy climate.
Chromatography, High Pressure Liquid ; Ecological and Environmental Phenomena ; Geography ; Lignin ; metabolism ; Schisandra ; metabolism

AIM:To evaluate the recovery about the visual cortex function of stereopsis in anisometropic amblyopia after regular amblyopia treatment 6, 12 and 18mo with blood oxygenation level dependent - function magnetic resonance imaging techniques ( BOLD-fMRI) .
METHODS: In this study, self-controlled study before and after treatment was used, and blocks-designed fMRI was performed on 11 children which was the first phase of research for amblyopic treatment. Functional MRI data were processed by using SPM8 which based on the Matlab 7. 12. 0. 635. Through the hypothesis drive method, the differences range of activated area in each group were compared by before and after amblyopia treatment matched t-test.
RESULTS: The functional area that was left occipital lobe (BA18), middle occipital gyrus (BA19), limbic lobe (BA19), lingualis gyrus of the right occipital lobe (BA17) and the bilateral parietal lobe ( BA7 ) expanded after amblyopia treatment 6, 12mo, compared those treatment phase, mean t value was 1. 5762, 1. 6856 respectively (P<0. 001). However, the difference of activated intensity was lower after 18mo, mean t value was 1. 1473 (0. 001 CONCLUSION: In children anisometropic amblyopia, the speed of function reconstruction about visual cortical functional mediating stereopsis increase slowly after amblyopia treatment 1a.

0.99). DC: reproducibility was good for neutrophils, lymphocytes monocytes, eosinophils and basophils. Comparison of the results by instrument with manual for normal samples in morphology, the correlation was better for neutrophils, lymphocytes and eosinophils (r:0.968～0.983) ,good for monocytes(r=0.917), not good for basophils(r=0.659);The WBC scattergram would change and alarm flags would display when there are neutrophilic stab granulocytes, abnormal or atypical lymphocytes and immature cells in higher proportion.Conclusions The analyzer can be used to test blood cell parameters accurately and reliably. Its main performance indices accorded with the experimental requirements; The results were credible. It is necessary to check with microscopy for DC before reported when it were doubtted.

Objective To investigate the effect and its mechanism of diazoxide on the blood-brain barrier (BBB) of rats after cerebral ischemia/reperfusion (I/R) injury.Methods Sixty Wistar rats were randomly divided into sham operation group,I/R group,and diazoxide pretreatment groups of low,middle,large dose (5,10,20 mg/kg).The I/R models of rats were performed to undergo middle cerebral artery embolism by thread.BBB permeability was estimated by Evans blue (EB) dyeing,transmission electron microscope (TEM) was used to observe the modification of interendothelial tight junction (TJ) of capillaries.The expression of aquaporin-4 (AQP4) in every rat brain tissues was detected by immunity histochemistry technique.Results (1) Compared to sham operation group,the permeability extent of EB were significantly increased by I/R,which was distinctly attenuated in middle and large dose of diazoxide pretreatment rats,while no obvious changes were found between I/R and low dose groups.(2) TEM showed that TJ of the brain tissue opened after I/R injury and no significant opening of TJ was observed in middle and large dose of diazoxide preconditioning groups.(3) Compared to sham operation group,the expression of AQP4 in the brain tissue of the I/R group was apparently increased (P ＜0.01).Compared to I/R group,the expression of AQP4 was apparently increased in middle and large dose pretreatment groups (P ＜ 0.01),and there were no obvious difference between low dose group and the I/R group.Conclusions Preconditioning of ischemia/reperfusion injury with diazoxide protects the blood-brain barrier,which may due to keep the TJ closed and decrease expression of AQP4 protein.

Objective To study the diagnosis and treatment of hepatic hemangioma. Methods (Retrospective) analysis was made on the clinical data of 50 patients with hepatic hemangioma in our hospital from January 1998 to January 2003. Results The accuracy diagnotic rate of ultrasound, CT, MRI were 90%(45/50), 97.6%(40/41), 100%(5/5) respectively.The correct diagnostic rate was 96.0% in this series. The operative indications were symptomatic hemangioma, diameter of tumor larger than 4.0 cm, or tumor with uncertain diagnosis. The operations performed were as follows:Laparoscopic(enucleation) of hemangioma in one cases. 3 patients treated by transcatheter arterial embolization, and(thirty-nine) patients underwent surgical(excision).No death occurred in this series. Four(10.3%, 4/39) had postoperative complications. (Conclusions) Hepatic hemangioma can usually be correctly diagnosed.Ultrasound, CT and MRI are the main(diagnostic) methods for the diagnosis of hepatic hemangioma.For patients with hepatic hemangioma that is(symptomatic), increasing in size,or of uncertain diagnosis, surgical treatment is safe and effective. Laparoscopic(enucleation) of hemangioma can be performed in selected cases.