In this paper, NIRS (near infrared spectroscopy)-based total quality control system for the Tanreqing injection was introduced briefly. By analyzing and summing up the significance and difficulties, several important problems of the practical applications which need urgent solutions are proposed. And also the applicationprospect of NIRS is fully discussed and put forward in the end.
Drug Compounding ; standards ; Drugs, Chinese Herbal ; administration & dosage ; analysis ; standards ; Injections ; Quality Control ; Reproducibility of Results ; Spectroscopy, Near-Infrared ; methods

During the washing process of coarse bear gall powder extracts, it is necessary to adjust the amount of ethyl acetate according to the properties of raw materials, which aims to improving the yield and purity of the final product. In the research, using NIR spectra to reflect the comprehensive properties of coarse bear gall powder extracts, the process is optimized in a flexible way. Forty batches experiments are designed according to the weight ratio of ethyl acetate and coarse extracts of bear gall powder. The NIR spectra of the coarse extracts of bear gall powder are collected and processed using principal component analysis (PCA) method. The first 8 principal components combined with the amount of the ethyl acetate are used as the input variables, and calibration models are established to predict the yield and purity of the final product 30 batches are used as calibration set, which is used to establish the models, and other 10 batches are used as validation set, which is used for the performance appraisal of the established models. The correlation coefficients of the calibration, inner cross-validation and external validation for the purity model are 0.902, 0.896 and 0.883, respectively, and the RMSEC, RMSECV and RMSEP are 1.22%, 1.48% and 1.59%, respectively. The correlation coefficients of the calibration, inner cross-validation and external validation for the yield model are 0.921, 0.859 and 0.916, respectively, and the RMSEC, RMSECV and RMSEP are 1.39%, 1.65% and 1.53% respectively. This work demonstrated that NIR spectra combined with technology parameter could be used to predict the yield and purity of the final product. Using the established models, the most appropriate amount of the ethyl acetate can be determined according to the properties of the coarse bear gall powder extracts, and the yield and purity of the final product can be improved.
Acetates ; chemistry ; Animals ; Gallbladder ; chemistry ; Medicine, Chinese Traditional ; Powders ; chemistry ; Principal Component Analysis ; methods ; Spectroscopy, Near-Infrared ; methods ; Ursidae

Adult ; Bone Neoplasms ; diagnosis ; surgery ; Humans ; Ilium ; Magnetic Resonance Imaging ; Male ; Osteoma, Osteoid ; diagnosis ; surgery ; Tomography, X-Ray Computed

Background Studieshowed thaDelta-like ligand 4 (Dll4) participatein the deveopmenof retinal celland angiogenesis.The Dll4-Notch pathway and vasculaendothelial growth facto(VEGF) are thoughto be critical mediatorof neovascularization undehypoxiconditions.The relationship between Dll4 and VEGF inovery cleaand furtheresearch ineeded.Objective Thistudy wato observe the inhibition of Dll4 on experimental retinal neovascularization and VEGF expression.MethodThe retinal neovascularization animal model wainduced by oxygen-induced retinopathy (OIR) in 5-day-old SPF SD ratby rearing the new postnatal ratwith the motherattogethein closed box with oxygen level a(80±2) ％ till 12-day-old.The ratwere then raised in normal aifo5 days.Aftethat,2.5μl (0.5 μg) of Dll4 monoclonal antibody wainjected into the mid-vitreoucavity in the righeye(Dll4 injected group) and PBwaused in the same way in the fellow eye(PBcontrol group) in the 12-day-old rats.Retinawere isolated in the 17-day-old rats,and retinal vasculamorphology waexamined by adenosine diphosphatease (ADPase) staining of retinal flatmounts,and the endotheliocyte nuclei above the internal limiting membrane were counted in the retinal tissue-slices.Reverse transcription PC(RT-PCR) waused to detecthe mRNexpression level of Dll4,VEGF,VEGF receptor-1 (VEGFR-1),VEGFR-2 and neuropilin-1 mRNin the retinas.Statistical analysiwaperformed by the paired t-test.The care and use of the animalcomplied with the Guidance Suggestion issued by the Ministry of Science and Technology of Chinin 2006.ResultThe Dll4 mRNexpression in the retin(Dll4 mRNA/β-actin mRNA) wa0.22± 0.06 and 0.98 ± 0.13 in the Dll4 injected group and the PBcontrol group,respectively,with statistically significandifference (=21.839,P =0.000).No significandifferencewere found in the expression of the VEGF mRNA,VEGFR-1 mRNand VEGFR-2 mRNin the retinabetween the two group(t=0.463,P=0.649;=1.687,P=0.109;=-1.674,P=0.111).Compared with the PBcontrol group,the expression of neuropilin-1 mRNwasignificantly elevated in the Dll4-injected group (0.73±0.08 vs.0.64±0.07) (t=-2.677,P=0.015).ADPase staining showed thathere were much more new blood vesselin the Dll4 injected group than those of the PBcontrol group.The numbeof nuclei structurally adjacento the vitreal side of the internal limiting membrane wa(63.6± 11.6)/slide in the Dll4 injected group,which wamore than thaof the PBcontrol group a(35.1±5.2)/slide (=-7.879,P =0.000).ConclusionDll4 playan essential role in the procesof pathological angiogenesiin the retina.Dll4 ithoughto be feedback regulatoof VEGFR,which participatein the procesof restraining pathological vasculogenesis.

The high price of the reference substances is an obstacle for the HPLC analysis of Lonicerae Japonicae Flos. To solve this problem, a new method based on the standard reference extract (SRE) was proposed. In this study, the extract of Lonicerae Japonicae Flos was calibrated, and the long-term stability was investigated. Different concentration solutions of SRE were prepared for establishment of the calibration profiles, and 6 organic acids were determined. T-test was used for the comparison of the determination results via reference substances and SRE, and the results demonstrated that there is no significant difference between the two methods. The presented method can be used for the quality control of Lonicerae Japonicae Flos, and will also offer reference to resolve similar problems.
Flowers ; chemistry ; Lonicera ; chemistry ; Plant Extracts ; standards ; Quality Control ; Reference Standards

OBJECTIVETo evaluate the feasibility and efficacy of cytocine deaminase-thymidine kinase (CD-TK) fusion double suicide gene therapy using adenovirus mediated CD-TK gene and green fluorescent rotein (GFP) gene combined with ganciclovir(GCV) or 5-flourocytosine(5-FC) in a murine subcutaneous bladder carcinoma model.

METHODSA replication defective adenovirus vector containing CD-TK gene was used. Subcutaneous tumors were established in syngenic C57BL/6 female mice with 1 x 10(6) Mb49 cells. Intratumoral injection of AdCD-TK (1.58 x 10(8) PFU, qd x days) in combination with GCV (40 mg.kg(-1).d(-1), ip, qd x 10 days) or 5-FC (400 mg.kg(-1).d(-1), ip, qd x 10 days) was administered in vivo for the determination of treatment efficacy in separate controlled experiments.

RESULTSIn vivo experiments demonstrated that the mean volume of tumor in the group of AdCD-TK/GCV(326.58+/-109.56 mm(3)), AdCD-TK/5-FC (235.33+/-62.94 mm(3)) and AdCD-TK/(GCV+5-FC) (23.58+/-6.78 mm(3)) was reduced significantly compared with that of control group (993.51+/-158.32 mm(3)) (P=0.00), the mean volume of tumor in the group of AdCD-TK/(GCV+5-FC) was significantly less than that in the group of AdCD-TK/GCV or AdCD-TK/5-FC (P=0.04). Tumor necrosis was revealed by histomorphology compared with control animals.

CONCLUSIONSAdenovirus mediated CD-TK double suicide gene combining with GCV or 5-FC could provide an effective therapy in an experimental murine bladder carcinoma by significantly inhibiting tumor growth. The treatment efficacy of AdCD-TK combining GCV and 5-FC was superior to that of AdCD-TK combining GCV or AdCD-TK combining 5-FC.

Adenoviridae ; genetics ; Animals ; Cell Line ; Cell Line, Tumor ; Cytosine Deaminase ; genetics ; metabolism ; Defective Viruses ; genetics ; Female ; Flucytosine ; pharmacology ; therapeutic use ; Ganciclovir ; pharmacology ; therapeutic use ; Genes, Transgenic, Suicide ; genetics ; Genetic Therapy ; methods ; Genetic Vectors ; Mice ; Mice, Inbred C57BL ; Neoplasm Transplantation ; Thymidine Kinase ; genetics ; metabolism ; Treatment Outcome ; Urinary Bladder Neoplasms ; pathology ; therapy

Objective To investigate the prevalence of endemic fluorosis and the progress acchieved through control measures in Taian County of Gansu Province so as to provide basis and technique support for endemic fluorosis control. Methods The survey was carried out according to the National Surveillance Scheme of Endemic Fluorosis. Fulfillment of control measures and the quality of water improving projects were surveyed. Samples of household water and urine in children aged 8-12 years were collected and fluoride content was detected by iron selective electrode method. Children's dental fluorosis were examined with Dean method. Results In Qinan County, water was improved in a rate of 100%. In water-improving and defluoridation projects investigated, 81.15% (99/122) projects worked well, 18.85% (23/122) projects were closed or abandoned. The number of water improvement projects monitored were 24,81,9,8,respectively in the year through 2004 to 2007, revealing 13 projects having water fluorine content(>1.0-2.0 mg/L) in 2004, 15 and 5 projects having water fluorine content higher that 1.0-2.0 and 2.0-4.0 mg/L respectively in 2005, 2 projects having water fluorine content(>1.0-2.0 mg/L) in 2006, and no projects above 4.0 mg/L. In Anfu Village, the fluorine content of source and drinking water were all below 1.0 mg/L in 2006 and 2007. The urinary fluoride content of 8-12 years old children was equal and higher than 1.5 mg/L, dental fluorosis rate was 34.47% (354/1027), and dental fluorosis index was 0.65 in 2004-2007. Conclusions Projects running out of status and excessive levels of water fluorine are frequently seen, dental fluorosis is not controlled in Taian County of Gansu Province

Objective To understand distribution of the endemic fluorosis areas and running status of water-improving defuoridation projects in Gausu province. Methods In 2006, Gansu province endemic fluorosis areas, the content of fluoride in drinking water was measured in villages where water was not improved, running status of delluoridation projects was investigated and the content of fluoride in drinking water were determined in villages where water was improved. Dental fluorosis and skeletal fluorosis prevalence were examined in children in identified high-fluorlde villages. The fluorine content in drinking water was determined by F-ion selective electrode, dental fluorosis of children was diagnosed using Dean method, and adults skeletal fluorosis was diagnosed according to "National Standard for Clinical Diagnosis of Endemic Skeletal Fhiorosis" (GB 16396-1996). Results Water samples were examined in 1997 villages of 26 countries, among which water fluoride content was higher than 1.0 mg/L in 598 villages, accounting for 29.94%(598/1997). All 1215 water-improving and defluoridation projects had been investigated, among which 94.90%(1153/1215) of the projects were functioning well, and intermittent and abandoned projects accounted for 2.96%(36/1215) and 2.14%(26/1215). Mean fluoride of treated water of 1084 water-improving and defluoridation projects had water fluoride content ≤ 1.0 mg/L, accounted for 90.79%(1084/1194) ; mean fluoride of water from 1068 water-improving and defluoridation projects had water fuoride content ≤ 1.0 mg/L, accounting for 91.75%(1068/1164). Total 86 390 children of 8 to 12 year-old were examined, the detectable rate of dental fluorosis was 22.47%(19 414/86 390) and 142 211 adults above 16 year-old were examined, the detectable rate of skeletal fluorosis was 4.20%(5967/142 211). Conclusions Some villages yet have water fluoride content exceeding the standard. Some projects are abandoned and running badly, leading to fluoride content exceeding the standard. In a few areas, the prevalence of children dental fluorosis and adult skeletal fluorosis still exists in Gansu province, the task of prevention and control for endemic fluorosis is still arduous. We must raise the effect of prevention and treatment of this disease.

Objective To evaluate the reliability and validity of the application of condensed Chinese version of the MOS 36-item short form health survey (SF-36) in assessment of quality of life among adult patients with Kashin-Beck disease,and to provide a scientific basis in rehabilitation of the patients.Methods Four hundred and twenty seven eases of adult patients with Kashin-Back disease and 419 healthy individuals randomly selected in Kashin-Beck disease endemic areas in 8 counties of Gansu province were surveyed with the SF-36.The reliability of the SF-36 was assessed by split-half reliability and Cronbach's α coefficient and the validity through principal component factor analysis and correlation analysis,etc.The dimension scores of different people were obtained by analysis of variance and univariate t-test.Results The split-half reliability of all the 8 dimensions was greater than 0.6 and the Cronbach's α coefficient was greater than 0.8; the pearson correlate coefficients of all the items to their dimensions were greater than 0.391.SF-36 contained 8 domains and 2 summary scales in the factor analysis.The score differences of quality of life in different ages of the patients,different stages of the disease were statistically significant (all P ＜ 0.05).Conclusion The SF-36 is practical in studying the quality of life among adult patients with Kashin-Beck Disease.

BACKGROUNDProper rotational alignment during total knee arthroplasty (TKA) is important for adequate postoperative patellofemoral and tibiofemoral kinematics, as well as for achieving balanced flexion space at 90. The effects of computer navigation-assisted total knee replacement and conventional total knee arthroplasty on rotational alignment, mechanical axis, component position and clinical outcomes were compared.

METHODSTwo methods were used in 82 patients and the rotation of the femoral and tibial components in the transverse plane, the combined rotation of the two components, the mismatch between them, and the mechanical axis of the lower limb were analyzed. All of these parameters were measured from postoperative radiographs and computed tomography images. Functional outcomes were compared at 6 weeks and 6 months postoperatively.

RESULTSSignificant differences were found between the two techniques (P < 0.05) in the following parameters: average rotation of the femoral component ((1.51 ± 3.55)° vs. (-0.63 ± 3.04)°); combined rotation of the femoral and tibial components (2.85 ± 4.07)° vs. (0.28 ± 3.43)°); and mismatch between the femoral and tibial components ((1.44 ± 4.55)° vs. (-0.43 ± 2.86)°). Differences in the rotation of the tibial component were not statistically significant. The prevalence of outliers (malalignment > ± 3° internal/external rotation) of the femoral component (31.7% vs. 12.5%) and the tibial component (36.6% vs. 15%) were significantly reduced when the navigation system was used (P < 0.05). In addition, while patients in the navigation group had significantly better mechanical axis and functional outcomes at 6 weeks after surgery (P < 0.05), there was no significant difference between the two groups (P > 0.05) with respect to functional outcomes at 6 months.

CONCLUSIONThe navigation system exhibited higher accuracy than the conventional technique in the transverse and coronal plane, and provided better early functional outcomes.

Arthroplasty, Replacement, Knee ; methods ; Female ; Femur ; diagnostic imaging ; surgery ; Humans ; Knee Joint ; diagnostic imaging ; surgery ; Male ; Middle Aged ; Prospective Studies ; Radiography ; Range of Motion, Articular ; Surgery, Computer-Assisted ; methods ; Tibia ; diagnostic imaging ; surgery