Objective To evaluate the anti-tumor activity of interferon ? with different structures including pegylated interferon ?-1b (PEG IFN ?-1b), pegylated interferon ?-2b (PEG IFN ?-2b) and natural interferon ? (IFN ?) in male BALB/C nude mice with human renal adencarcinoma (ACHN) tumor. Methods Athymic BALB/C nude mice were received a subcutaneous injection of ACHN cells (2?106/0.2ml) on the rear flank. After four weeks, the size of tumor reached a mean volume of 50-100 mm3, and the interferon was administrated. The mice with tumor were divided into four groups, and were administrated with placebo (0.2ml/mouse thrice weekly), IFN ?-1b (50?g/mouse thrice weekly), PEG IFN ?-1b (150?g/mouse once weekly) and PEG IFN?-2b (150?g/mouse once every week), respectively, for five weeks. The tumor volumes were measured weekly prior to treatments until the end of the fifth week. All mice in each group were sacrificed to measure the weight of the residual tumor. The anti-tumor activity of IFN ? in vivo was evaluated by studying their ability to reduce the volume and weight of tumor. Results IFN ? may significantly reduce the volume and weight of ACHN tumor in mice. The average tumor weight was 0.422g in placebo group, while 0.263g, 0.235g and 0.219g in the groups treated with PEG IFN ?-1b, IFN ?-1b and PEG IFN ?-2b, respectively. No significant difference was found among the three groups treated with IFN ?. Moreover, the volume of tumor in three groups treated with IFN ? was significant reduced than that in placebo group. Conclusion IFN ? with different structures have showed the similar ability of ACHN tumor suppression at the dosage of 150?g per week.

Objective To compare the effects of interferon alfa-1b(IFN?-1b) and pegylated IFN?-1b(PEG IFN?-1b) on inhibiting growth of human liver cancer cells in vivo.Methods Human liver cancer cells(HepG-2,2?l06/0.2ml) cultured in log phase were subcutaneously injected into the right rear flank of male BALB/C nude mice to establish the tumor model.After HepG-2 injection,the tumor growth was followed up for 14 days.The mice with HepG-2 tumor were randomly divided into placebo(n=7),PEG IFN?-1b(n=8) and IFN?-1b(n=8) groups.Mice received injection of placebo 0.2ml/mouse each time(three times a week),PEG IFN?-1b 150?g/mouse per injection(once a week) and IFN?-1b 50?g/mouse each time(three times a week),respectively,according to their grouping,and this regime lasted for five weeks.In order to evaluate anti-tumor activity,animals' body weight was measured every week,and the measurements of tumor volume and animals' body weight were continuously done till the mice were sacrificed at the end of the fifth week.Results PEG IFN?-1b and IFN?-1b induced a significant decrease in tumor volume and the animals' weight,the suppression rates onto tumor growth were 56%(2.190g vs.4.979g) and 42%(2.678g vs.4.979g),respectively.However,no significant difference was found in animals' weight among the three groups.Conclusion HepG-2(2?l06/0.2ml) injection into nude mice may induce a typical tumor model.PEG IFN?-1b(150?g/mouse per time,once a week) could significantly inhibit the growth of HepG-2 in vivo,and so does the IFN?-1b(50?g/mouse each time,three times per week).

Child ; Ear Auricle ; pathology ; Ear Neoplasms ; Female ; Humans ; Neurilemmoma

China ; Occupational Health ; statistics & numerical data ; Occupational Health Services ; Organizations ; statistics & numerical data

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 compare the diagnostic ability of triple-phase CT and multiple-phase dynamic MR for patients with suspected hepatocellular carcinoma (HCC). Methods Triple-phase CT and multiple-phase dynamic MR scan were performed in 60 patients. Fifty-nine HCC lesions were confirmed in 39 patients. MR was performed with LAVA technique, the images included masks, dual-artery phases, dual-portal phases, dual-venous phases and delayed phase. Three observers separately evaluated the CT and MR imaging, and the results were compared with alternative-free-response ROC(AFROC)curve, the area under ROC (Az) was calculated to compare the diagnostic ability. Results The mean Az value of CT for the diagnosis of HCC was 0.8120±0.0118, of MR was 0.9093±0.0072 (P>0.05). In the group of HCC less than 1 cm in the diameter, the sensitivity of CT and MR was 63.89% and 80.55%(P＝0.013). In the groups HCCs of 1-3 cm and >3 cm, the sensitivity of CT and MR appeared no significant difference (P>0.05). Of all HCCs, the sensitivity of CT was lower than MR (83.62% vs 88.70%), but the difference was not significant (P>0.05). The positive predict value (PPV) of CT was also lower than MR (93.07% vs 96.31%, P>0.05). Conclusion The diagnostic ability of multiple-phase dynamic-enhancement MR scan for HCCs is similar to that of triple-phase enhancement CT. For HCC less than 1 cm in diameter, dynamic-enhancement MR is superior to that of contrast-enhancement CT scan, while for the larger ones, the difference is not significant.

Objective To evaluate the detectability of dual-arterial phase of MRI and single-artery phase of CT scan for hepatocellular carcinoma (HCC). Methods A total of 39 patients with HCC underwent CT and MR scan, and 59 lesions of HCC were confirmed definitely. According to lesion size, the lesions were divided into 3 groups: >3 cm group (n=20), 1-3 cm group (n=27) and <1 cm group (n=12). CT was performed with 25 seconds delaying for artery phase. MR imaging was performed with liver accelerate volume acquisition (LAVA) technique, dual-artery phases included early artery phase of 17 seconds delaying and a mid-artery phase of 24 seconds delaying. The detectability of dual-artery phase of MR was compared with that of single-artery phase of CT. Results In <1 cm group, the sensitivity of CT single-artery phase images and MR dual-artery phase images in detecting HCC lesions was 50.00% (6/12) and 75.00% (9/12), respectively;the later showed a higher sensitivity (P=0.04). In groups of 1-3 cm and ＞3 cm, the sensitivity of the two technique had no statistical difference (66.67% vs 81.48% and 95.00% vs 95.00%). Conclusion For the detection of <1 cm HCC, dual-artery phase MRI has higher detectability than single artery phase enhancement CT.

Objective To explore the effect of the administration time of HS6101 on hematopoietic recovery in ICR mice injured by cyclophosphamide (CTX). Methods One hundred and three male ICR mice were divided into 4 groups: CTX control, HS6101 prevention, HS6101 treatment, and HS6101 prevention+treatment groups. CTX was intraperitoneally injected into the ICR mice at a dose of 100mg/(kg.d) for three consecutive days to establish a chemotherapeutics-injured model. HS6101 at a dose of 27μg/mouse in 0.2ml was subcutaneously injected into the mice 1h before the first administration of CTX in HS6101-preventiongroup, 1h after the last administration of CTX in HS6101 treatment group, and both at 1h before the first administration and 1h after the last administration of CTX in HS6101 prevention + treatment group. Physiological saline was subcutaneously injected into the mice in CTX control group (0.2ml/mouse). 10μl peripheral blood was collected from the caudal vein for WBC, neutrophil lymphocyte, RBC and platelet counts on day -1, 3, 5, 7, 9, 11, 13, 15, 17 with the MEK-7222K cell analyzer, and the cell count was compared between HS6101 treatment mice and CTX control mice. Another 30 male ICR mice were used for bone marrow colony forming unit (CFU) assay and bone marrow histopathological examination, and they were assigned into normal control, CTX control, HS6101 prevention, HS6101treatment and HS6101 prevention + treatment groups (each n=6). On the day 4 and day 9 after CTX injection, mice were sacrificed and bone marrow cells were collected from the left femur for mononuclear cell (MNC) isolation. 1×10⁴ MNCs were planted in 1.0ml mouse CFU culture medium M3434 and cultured in incubator with the temperature of 37℃, and 5% CO2 for 7 days. After that, granulocyte macrophage-colony-forming unit (GM-CFU), megakaryocyte colony forming unit (MK-CFU), mixture-colony-forming unit (Mix-CFU), burst-forming unit-erythroid (BFU-E) and colony-forming unit-erythroid (CFU-E) were counted. Then the right femur was taken for histopathology examination. Results After CTX injection, counts of WBC, neutrophils, lymphocytes, RBC and platelets of all the mice decreased rapidly. However, the nadirs of WBC, neutrophils and lymphocytes counts in HS6101 prevention group were higher than those in CTX control group, and the counts on day 3 were higher than those in HS6101 treatment group and HS6101 prevention+ treatment group. On day 3, RBC count in HS6101 prevention group was the highest. It was higher on day 5 and day 7 than that of mice in CTX group. In addition, the platelet count in HS6101 prevention group was also the highest on day 3, although that in HS6101 treatment group and 6101 prevention + treatment group was lower than CTX control group. Bone marrow colony forming unit assay showed that the counts of GM-CFU, MK-CFU, BFU-E and CFU-E in all the HS6101 treatment mice were significantly higher than those in CTX control mice. On day 4, histopathological examination of bone marrow from HS6101-treated mice displayed more intact architecture compared with CTX control mice. Three of eighteen (3/18) mice died in HS6101 treatment group, and nine of eighteen (9/18) died in HS6101 prevention + treatment group, suggesting that HS6101 should not be administered after CTX injection. Conclusion Administration of HS6101 at 1h before giving CTX could significantly promote hematopoietic recovery in ICR mice injured by CTX.

Health Promotion ; methods ; Japan

Crystal structures of chemical drugs has been being investigated widely. But few attention has been paid to polymorphs-phenomena of active ingredients from Traditional Chinese Medicine(TCM). Taking anhydrous dehydroandrographolide and hydrousprim-O-glucosylcimifugin as example, differences between TCM reference substances (RSs) with different crystal structures were discussed by using microscopy, melting point determination, differential thermal analysis (DTA) and infrared (IR) methods. The results showed that different crystal structures could lead to change of melting points, thermal behaviors and IR spectrum. It's indicated that polymorphs may be considered if different physicochemical properties were obtained when applying TCM RS. Differences of chemical properties of active ingredients from TCM with different crystal structures need further investigation.
Crystallization ; Differential Thermal Analysis ; methods ; standards ; Drugs, Chinese Herbal ; chemistry ; standards ; Medicine, Chinese Traditional ; Molecular Structure ; Reference Standards ; Spectrophotometry, Infrared ; methods ; standards ; Transition Temperature