OBJECTIVE:To strengthen the inspection for qualification of new drugs when introduced in order to guarantee the quality of new drugs and the safety of drug use.METHODS:The problems existing in the inspection for qualification of new drugs were exemplified and classified.RESULTS&CONCLUSION:There existed the problems in the respect of validity,authenticity,effectiveness,and integrality.The good maintainance of the database of SFDA plays a important role in in-specting the new drugs when introduced,while on the other hand such issues as establishment and use of credibility file in medical agencies are worth discussing.

OBJECTIVE:To facilitate the in-depth implementation of Prescription Administrative Policy("New Method" in short).METHODS:The change of the Prescription Administrative Policy and its problems were analyzed through comparison between the "New Method" and the trial edition.RESULTS & CONCLUSIONS:Improvements of Prescription Administrative Policy such as the introduction of prescription comment system,clarifying supervising subjects and strengthening requirement on prescription dispensing rights etc play a role in tightening comprehensive management on prescriptions and promoting rational drug use.However,the defects of Prescription Administrative Policy such as the absence of the regulations unsuitable for medical orders in retail pharmacy and endemic areas and the unidentified prescription forms need to be improved step by step in the practice.

Background Posterior capsule opacification (PCO) is a main cause for visual acuity decline after modern extracapsular cataract surgery.Objective The aim of this study was to investigate the effect of rapamycin on PCO formation following phacoemulsification combined with intraocular lens (IOL) implantation in rabbit eyes.Methods Thirty New Zealand albino rabbits were randomized into three groups according to the difference in the implanted IOLs:conventional IOL without modification,IOL coated by a polymer material and IOL with sustained released rapamycin.Phacoemulsification combined with intraocular lens implantation surgery was performed in the left eye.The anterior ocular segment and PCO formation in the rabbit eyes were examined by slit lamp biomicroscope 1-7 days after operation,and the flare and inflammatory response of the anterior chamber as well as the degree of PCO severity were graded based on the criteria of Yang.The differences in examination outcomes were compared by the Kruskal-Wallis H test.The animals were sacrificed 12 days after surgery and eye specimens were prepared for histopathological examination to evaluate the biological behavior of lens epithelial cells (LECs) on the posterior capsule.Results The coated area of the implanted lens was semi-transparent with a smooth surface.The number of eyes with aqueous flare at grades 3 and 4 insignificantly increased but those with an inflammatory response at grades 3 and 4 significantly increased in the conventional IOL group and the polymer modified IOL group,compared with the rapamycin modified IOL group on the first day after operation (H =4.038,P =0.133 ; H =8.604,P =0.014).On the seventh day,the number of eyes with aqueous flare at grades 3 and 4 and inflammatory response at grades 3 and 4 significantly increased in the conventional IOL group and the polymer modified IOL group,compared with the rapamycin modified IOL group (H =8.891,P =0.012 ; H =7.664,P =0.0220).The histopathological examination showed that marked proliferation of LECs appeared between the anterior and posterior capsule in the conventional IOL group and the polymer modified IOL group;however,less LECs and regenerative cortex were seen in the rapamycin modified IOL group.Conclusions IOL loaded with rapamycin can inhibit the inflammatory response and alleviate the severity of PCO after phacoemulsification combined with IOL implantation.The implantation of IOL loaded with rapamycin may be a new approach to the prevention and treatment of PCO.

0.05).Seven cases in LDH group and 9 cases in HID group were found in FT picture.The mean DCavg value in annulus fibrosus disruption was significantly larger (1.01?0.10)?10~(-9)mm~2/s and the mean FA value(0.15?0.03)was significantly smaller than those in normal place(P

Copper and iron play important roles in a variety of biological processes, especially when being chelated with proteins. The proteins involved in the metal binding,transporting and metabolism have aroused much interest. To facilitate the study on this topic, we constructed two databases (DCCP and DICP) containing the known copper- and iron-chelating proteins, which are freely available from the website http:∥sdbi.sdut.edu.cn/en. Users can conveniently search and browse all of the entries in the databases. Based on the two databases, bioinformatic analyses were performed, which provided some novel insights into metalloproteins.

OBJECTIVETo investigate the inhibitory effects of Kangjia Pill (KJP) on the cell proliferation in rat goiter model induced by methimazole (MMI).

METHODSFifty-six Wistar rats were randomly divided into four groups: the normal group, MMI model group (MMI), low dose of KJP group (LKJP), and high dose of KJP (HKJP). Except the normal group (20 rats), the other groups (12 rats in each) were given 0.04% (w/v) MMI through the drinking water until the end of the experiment. One week later, the rats in the LKJP and HKJP groups were given KJP by gastrogavage at the dose of 250 mg/(kg x d) and 1,000 mg/(kg x d), respectively for 12 weeks. The relative thyroid weight (mg/100 g body weight) of each rat was accessed. The expression of proliferating cell nuclear antigen (PCNA) was determined by immunohistochemistry, and the correlation analysis between the PCNA positive thyrocytes and the relative thyroid weight was performed. The expressions of PCNA and cyclin D1 were examined with Western blotting.

RESULTSAfter KJP treatment for 12 weeks, compared with the MMI group, the relative thyroid weight of the HKJP group decreased significantly, and the positive thyrocyte populations of PCNA in the two KJP groups reduced markedly (all P<0.05). The correlation analysis showed that PCNA was closely correlated with thyrocyte proliferation (r=0.685, P<0.05). KJP significantly decreased the protein expression of PCNA and cyclin D1 in the thyroid specimens (P<0.05), the high dose showed better effects.

CONCLUSIONKJP played a therapeutic role via inhibiting cell proliferation in the rat goitrous glands.

Animals ; Cell Proliferation ; drug effects ; Cyclin D1 ; metabolism ; Disease Models, Animal ; Down-Regulation ; drug effects ; Drug Evaluation, Preclinical ; Drugs, Chinese Herbal ; administration & dosage ; pharmacology ; Goiter ; chemically induced ; drug therapy ; metabolism ; pathology ; Male ; Methimazole ; Organ Size ; drug effects ; Proliferating Cell Nuclear Antigen ; metabolism ; Random Allocation ; Rats ; Rats, Wistar ; Tablets ; Thyroid Gland ; drug effects ; metabolism ; pathology

OBJECTIVETo establish a method for culturing dental follicle cells of rat and observe the growth characteristics of the cultured cells in vitro.

METHODSDental follicle and associated enamel organs were dissected from the first and second mandibular molars of 6-7-day-old rats, and then cultured in vitro. Purified dental follicle cells derived from the third or the fourth passage cells were utilized in the following experiments. The shape and ultrastructure of dental follicle cells were observed by light-microscopy and transmission electron microscopy. Immunocytochemistry was used to detect the expression of vimentin, type I collagen and fibronectin.

RESULTSThe cultured cells were fibroblastic in shape, elongate with processes, and transmission electron microscopy revealed that they contained electron-dense granules, an abundant rough endoplasmic reticulum, but did not form desmosomes. Vimentin, type I collagen and fibronectin were present in dental follicle cell.

CONCLUSIONThe dental follicle cells of rat could be successfully cultured in vitro and the cultured cells had the same characteristics of dental follicle cells of normal rat.

Animals ; Animals, Newborn ; Cells, Cultured ; Collagen Type I ; analysis ; Dental Sac ; chemistry ; cytology ; ultrastructure ; Fibroblasts ; cytology ; ultrastructure ; Fibronectins ; analysis ; Immunohistochemistry ; Molar ; chemistry ; cytology ; Rats ; Rats, Sprague-Dawley ; Tooth Eruption ; Vimentin ; analysis

Antibody-drug conjugate (ADC) is a new class of therapeutics composed of a monoclonal antibody and small cytotoxin moieties conjugated through a chemical linker. ADC molecules bind to the target antigens expressed on the tumor cell surfaces guided by the monoclonal antibody component. The binding ADC molecules can be internalized and subsequently the toxin moieties can be released within the tumor cells via chemical and/or enzymatic reactions to kill the target cells. The conjugation combines the merits of both components, i.e., the high target specificity of the monoclonal antibody and the highly potent cell killing activity of the cytotoxin moieties. However, such complexities make the pharmacokinetic and metabolic studies of ADCs highly challenging. The major challenges should include characterization of absorption, distribution, metabolism and excretion, investigation of underlying mechanisms, assessment of pharmacokinetic- pharmacodynamic relationship, and analytical method development of ADC drugs. This review will discuss common pharmacokinetic issues and considerations, as well as tools and strategies that can be utilized to characterize the pharmacokinetic and metabolic properties of ADCs.
Antibodies, Monoclonal ; pharmacokinetics ; Cytotoxins ; pharmacokinetics ; Humans ; Immunoconjugates ; pharmacokinetics ; Neoplasms ; drug therapy

OBJECTIVETo reconstruct 3D shape of edentulous jaw by using improved measurement system and to analyze the precision of this method.

METHODSStandard edentulous jaw models were measured with a improved measurement system by cutting and scanning layer-by-layer, and the 3D shape of the models was reconstructed by image processing with specialty software. Ten cubic plaster modes were reconstructed by the same way, data of every border before and after reconstruction were measured and analyzed.

RESULTSData of edentulous jaw models were obtained. The errors in ten cubic before and after reconstruction were not significantly different (P > 0.05), data measured in horizontal plane were not significantly different (P > 0.05), and data measured in altitude direction were significantly different (P < 0.01), data measured after reconstruction were less than before, the error was (0.09 +/- 0.08) mm.

CONCLUSIONThe improved cutting and scanning measurement system can be fit for the 3D reconstruction of stomatognathic system with high precision.

Humans ; Image Processing, Computer-Assisted ; Imaging, Three-Dimensional ; Jaw, Edentulous ; Reproducibility of Results ; Software ; Stomatognathic System ; Tomography, X-Ray Computed

OBJECTIVETo establish WZS miniature swine model of beta-conglycinin (7 S) allergy for evaluating the potential allergenicity of genetically modified food.

METHODSTwelve 45-day-old WZS miniature swines from three litters were randomly divided into three groups (control group; 4% 7 S group and 8% 7 S group, n = 4), which were respectively gastric sensitized (day 0 - 10) and oral challenged (day 6 - 18, 31) to induce anaphylactic reactions. Clinical symptoms, skin prick reactions were recorded. At day 10, 19 and 32, serum IgG, IgE, histamine and cytokines levels were measured by ELISA.

RESULTSDiarrhea at different degrees were observed in 4% and 8% 7 S groups. The skin erythema reactions in grade "-", "+/-", "+", "++" of control group respectively were 2/4, 2/4, 0/4, 0/4, of 4% 7 S group were 0/4, 0/4, 2/4, 2/4 and of 8% 7 S group were 0/4, 0/4, 1/4, 3/4. The serum IgE and histamine levels of day 11, 19 and 32 were all significantly and positively correlated (Pearson coefficients = 1, P = 0.000). The serum IgG, IgE and histamine levels all reached the peak after 7 S groups were oral challenged at day 19.Compared with the control group, serum IgG (lg IgG: 2.95 +/- 0.31 vs 2.29 +/- 0.25, t = 3.19, P = 0.011), IgE (lg IgE: 2.45 +/- 0.30 vs 1.77 +/- 0.23, t = 3.31, P = 0.009) and histamine levels(lg histamine:2.13 +/- 0.30 vs 1.45 +/- 0.23, t = 3.34, P = 0.009) of 4% 7 S group at day 19 were all significantly higher, while the serum IFN-gamma content [(35.78 +/- 6.42) pg/ml vs (51.10 +/- 9.67) pg/ml, t = -2.33, P = 0.045] of 4%7 S group was significantly lower.

CONCLUSIONThe WZS miniature swine model orally induced by soybean beta-conglycinin is type I hypersensitivity mediated by IgE, which can be used to predict the potential allergenicity of genetically modified food.

Animals ; Antigens, Plant ; adverse effects ; Disease Models, Animal ; Food Hypersensitivity ; etiology ; Globulins ; adverse effects ; Seed Storage Proteins ; adverse effects ; Soybean Proteins ; adverse effects ; Swine ; Swine, Miniature