Guided by good clinical practice ( GCP) , M hospital cooperated with the Ethics Committee in quali-ty management of clinical trials and took the specific measures including perfecting the institution and standard op-erating procedures, implementing three level quality control institution, strengthening the training of GCP, and closely cooperating with drug and data management of clinical trials, quality control in the clinical trial, ethical re-view and supervision, quality control in the whole process (seamless connection). Seamless connection from the beginning of project acceptance and quality control in the whole process of clinical trials can effectively solve the ex-isting problems in clinical trials and improve the quality of clinical trials.

OBJECTIVE:To prepare Lipoic acid orally disintegrating tablets,and to evaluate its quality. METHODS:Lipoic acid orally disintegrating tablets were prepared with direct compression after wet granulation. With disintegration time and dissolu-tion as index,the constituents of disintegrating agent,filler and lubricant were screened by single factor test combined with orthogo-nal test. The tablet weight,hardness,disintegration time,accumulative rate and percentage content were investigated. RESULTS:The optimal formulation was MCC 167.58 mg,L-HPC 23.94 mg,PVPP 47.88 mg,mannitol 60 mg,lipoic acid 300 mg and mag-nesium stearate 0.6 mg. The parameters of prepared disintegrating tablets was as follows as (0.59 ± 0.05) g in weight,(20.32 ± 0.16)kg in solidity and(23.5±0.4)s in disintegration time,101.49% in 3 min accumulative dissolution rate,96.34% of labeled content. CONCLUSIONS:Lipoic acid orally disintegrating tablets are prepared successfully and controllable in quality.

Acquired Immunodeficiency Syndrome ; epidemiology ; prevention & control ; China ; epidemiology ; Epidemiologic Studies ; Humans

OBJECTIVE:To prepare aspirin gastric floating capsule and to study its in vitro drug-release characteristics.METHODS:Aspirin gastric floating capsule was prepared with aspirin as model drug,and with hydroxypropyl methylcellulose(HPMC)under different viscosity and different quantity and carbopol as main excipients.The release rate of the capsules was determined.RESULTS:When the optimal ratio between HPMC K4M and HPMC K15M was3to1,then the in vitro drug release of aspirin gastric floating capsule within0h～10h conformed to apparent zero-order kinetics with rate constant Kr at10.3%/h and release parameter at0.6173.CONCLUSIONS:The prepared capsule has a marked slow-release effect,the quantity and the viscosity of HPMC were the main factors affecting the release rate of gastric floating capsule,the in vitro drug release characteristics were associated with the joint action of bulk erosion and drug diffusion.

BACKGROUND:There may be tumor stem cells during metastasis and recurrence of liver cancer.The number of tumor stem cells is very few,so it is difficult to be identified.Thy-1 is a surface marking protein of oval cells.Specific marker can indirectly confirm the existence of tumor stem cells in the tumor,which is a focus in recent studies.OBJECTIVE:To study whether Thy-1 positive marked oval cells was expressed in hepatoma carcinoma cells,and investigate its screening and identification.METHODS:Flow cytometry was used to identify that Thy-1 positive expression in hepatoma carcinoma cells HepG2 and BEL-7402 and normal hepatocytes QSG-7701.Immunomagnetic bead sorting was utilized to select hepatoma carcinoma cells with Thy-1.Immunofluorescence was used to identify selected efficiency.Naked mouse inoculated with hepatoma carcinoma cells in the skin test was assigned to three groups.In the Thy-1~+ cells group,naked mice were inoculated with Thy-1~+ cells (5×10~5/mouse)underneath the skin of the back.In the HepG2 cell positive control group,naked mice were inoculated with HepG2 cells(0.5×10~7/mouse)underneath the skin of the back.In the Thy-1' cells negative control group,naked mice were inoculated with Thy-1~- cells(0.5×10~7/mouse)underneath the skin of the back.Tumorigenicity in each group was observed one month later.RESULTS AND CONCLUSION:Thy-1 expression in hepatoma carcinoma cells HepG2 and BEL7402 was significantly greater compared with normal hepatocytes QSG7701(P＜ 0.05).Positive rate of immunofluorescence staining was 85% in the Thy-1~+ cell group,1% in the HepG2 cell positive control group,0% in the Thy-1~- cell negative control group.There were nubble of five mice in HepG2 cell positive control and Thy-1~+ groups,and the volume was large.However,there was one nubble in Thy-1~- group,and the volume was significantly small(F=144.568,P＜ 0.05).Results indicated that hepatoma carcinoma cells contained Thy-1 labeled positive oval cells-like stem cells,which may be tumor stem cells in hepatoma carcinoma cells.

China ; Data Collection ; Disabled Persons ; statistics & numerical data ; Humans

Three different procedures of Guipi Oral Liquid have been studied. By comparison of TLC spots of n-buranol and n-hexane extracts from the sample and the UV absorption spectrum of the main component, ferulic acid, the rational production process was developed, which provides an experimental base for preparation improvement.

The clinical data of 26 cases with pathologically confirmed primary gastrointestinal nonHodgkin's lymphoma (PGINHL) admitted to our hospital from January 2001 to December 2010 were retrospectively analyzed.Among 26 patients,12 cases occurred in stomach,9 cases in small intestine,4 cases in colon and 1 case in multiple sites.The most common symptoms were abdominal pain (73％),followed by gastrointestinal bleeding (23％) and abdominal mass (15％).The main pathological types were MALT lymphoma (35％),diffuse large B-cell lymphoma (35％),and enteropathy-type T-cell lymphoma ( 15％ ).There were 14 patients in stage Ⅰ,6 in stage Ⅱ,1 in stage Ⅲ and 5 in stage ⅣV.Radical surgery and/or chemotherapy was the main therapy for PGINHL.

Objective To investigate the expression of VCAM-1 and E-selectin in vessel walls of the patients with thromboangiitis obliterans(TAO).Methods The vessel tissues were taken from 18 cases of amputation operation due to TAO and 16 cases of amputation operation due to non-vascular diseases.The expression of VCAM-1 and E-selectin were assessed by the immunohistochemical method.Results The positive expression rate of VCAM-1 in vessel wall of the patients with TAO was 77.8%(14/18),which of E-selectin was 72.2%(13/18);both of them were obviously higher than 6.3%(1/16) and 6.3%(1/16) in the control group.The positive rate of VCAM-1 and E-selectin had no correlation with the age,smoking amount,smoking time and drug use (P>0.05).Conclusion The expression of VCAM-1 and E-selectin have close correlation with the occurrence and development of TAO.Detecting the expression of VCAM-1 and E-selectin can serve as a diagnostic indicator of TAO.

Objective To study the practicability and preliminary effect of intraluminal brachytherapy in treatment of malignant obstructive jaundice.Methods Intraluminal brachytherapy was performed in 4 patients who had been treated with biliary stent implantation. Results No complications related to intraluminal brachytherapy had happened.One patient was followed up by means of CT,showing reduction in tumor size. Conclusion Intraluminal brachytherapy is a safe and effective method in treating malignant tumor causing obstructive jaundice.