OBJECTIVE: To introduce the methodology validation and quality control in bioanalytical procedures and its expected trend of development.METHODS: According to the bioanalytical validation reflected in FDA guidelines and other publications,based on the guidance of SFDA and the standard operating procedure of our phase I clinical trial lab,we summarized the procedure and questions of bioanalytical methodology validation.RESULTS: The methodology validation and quality control in bioanalytical procedures and the possible risks involved in the methodology validation were summarized.CONCLUSIONS: The established methodology validation in bioanalytical procedure and quality control contents were basically consummate,but the standards for the methodology validation should be formulated based on reality.

Objective To set up an efficient and rapid method for detecting CK20 expression in peripheral blood of patients with colorectal carcinoma, and explore the relationship between CK20 expression and micrometastasis of colorectal carcinoma. Methods CK20 mRNA expression in peripheral blood of 36 patients with colorectal carcinomas was detected at various time points before and after operation by fluorescent RT-PCR. The mutation of p53 gene was also detected using SSCP. Results The positive rate of CK20 mRNA expression in peripheral blood before and 24 hours after operation was 75%(27/36) and 83.3%(30/36), respectively. After the short-term chemotherapy, the positive rate of CK20 mRNA expression was 36%(13/36). No mutation of p53 gene was found in those patients. Conclusion Fluorescent RT-PCR for detecting CK20 mRNA expression in peripheral blood was simple and efficacious. It was useful to monitor micrometastasis of colorectal carcinoma.

Objectives To analyze the influence factors for promoting appropriate health technologies to rural health workers in Zhejiang province. Methods 1957 health workers from county and township levels were surveyed by questionnaires, regarding their use of appropriate technologies. Results The influence factors for rural health workers to employ such technologies include their medical competency, training approach and technical categories. Those medical workers of higher education are

To prepare and study the pharmacokinetics and release bioavailability in olunteers and concentrations in plasma in patients. METHODS: Ethylcellulose was used matrix in phase separation-coacervation for preparation of microencapsulation. The release experiments were performed in a rotating shaker. The isoniazid concentration in plasma was determined by spectrophotometrical method following a single oral dose of sustained-release cupsule and ordinary tablet respectively given to 10 volunteers in a open randomized cross-over test. MCP86 was used to process main pharmacokinetic parameters. RESULTS: The sustained-release of capsule and ordinary teblet in vitro, T50 was 1 h and 0.032 h respectively. The drug in sustained-release capsule was sustained release over 10 h. The main parameters in body: ordinary tablets: cmax=11.12 μgml-1, tmax=1.41 h, K=0.201 h-1; sustained release capsule: cmax=4.99 μgml-1, tmax=1.80 h, K=0.03 h-1. The concentration of blood at 36 h was (0±0)μgml-1 and 1.63 μgml-1 respectively. Except tmax, there was significant difference between the two fomulations (P＜0.01). The concentration of blood in patient at 1.5 h and 36 h. ordinary tablet and sustained-release capsule respectively were (8.24±2.60)μgml-1, (0±0)μgml-1and (3.69±0.86)μgml-1, (2.09±0.56)μgml-1. CONCLUSION: The sustained-release capsule will play an important part in prevention and treatment of tuberculosis as the result of its reasonable formulation and simple technology.

To discuss the character and application of internal fixation with cervical lateral mass plate fixation in posterior approach of cervical spine operation. Twelve patients with cervical fracture dislocation treated with posterior cervical lateral mass fixation and bony fusion were selected. The patients received spinal decompression or reduction and decompression according to different diseases. A suitable 3.5 mm bi-cortical screw was inserted using Magerl technique. The results showed that solid bony fusion could be obtained at 3-5 months after the surgery, and the intervertebra heights as well as physiological curves were kept well without screw loosening or breaking. Neurological function was recovered to different extent. Cervical lateral mass plate fixation has the advantages of easily operation technique, wide indications, strong stability and short segment fixation.

Flavonoid Pilulae from Gegen were prepared by melting method. Using PEG 4000 and PEG 6000 as carrier. Serious of studies on the in yitro release kinetics were carried out.PEG4000 ; PEG6000 ratio had no effect on the release kinetics. PEG 4000: flavonoids ratio had an evident effect on the release properties of the pilulae, the higher the ratio,the faster the release rate. But when the PEG 4000, flavonoids ratio exceeded 10: 1, a reverse effect could be seen. Compared with "Gegen flavonoids" tablets, "Yufengingxin" tablets(release half time, T50= 94.79min), the pilulae gave a much fast release characteristic (T50 = 11. 56min).

Objective To establish a new automatic lung segmentation method in order to deal with the omission of pleural nodules and pulmonary vessels. Methods Lung parenchyma were extracted from chest CT images with the inversed operation of 2D region growing and connected area classification, then the contours and locating the contour points were traced with scan line searching. Finally, the parameters of lung contour points were analyzed to locate the contours distorted by nodules, and curve spline was used to correct distorted contours. Results The experimental results of many sets of CT images verified that the technique proposed was effective. The comparison with other contour correction algorithm verified that line searching contour correction was superior. Conclusion The proposed algorithm includes tumors in the segment results, and confirms the integrality, veracity, real-time quality of this auto-segmentation method.

Objective To investigate the effects of waist and abdomen liposuction on glucose and lipid me-tabolism in patients.Methods 30 female patients with central obesity who underwent the waist and abdomen lipo-suction in our hospital from April 6, 2013 to October 6, 2013 were selected.For all cases, morning fasting blood within 3 months was collected before and after surgery respectively to examine blood glucose, blood lipids, glycated hemoglobin and other inspections.Results Glycated hemoglobin levels of the 30 cases undergoing liposuction sur-gery after 3 months were significantly lower than those at 3 months before surgery (p<0.05).Meanwhile, levels of glucose, lipids, fasting insulin were lower than those before surgery (p<0.05).Conclusion Liposuction can re-duce glycated hemoglobin levels in cases of central obesity.Meanwhile, it can change levels of blood sugar, blood lipids, fasting insulin, which will help reduce risks of complications of diabetics.

Objective To observe the effect of tetramethylpyrazine (TMP) on serum interleukin 8 (IL-8),interleukin 12 ( IL-12) and interleukin 33 ( IL-33) levels and MMP-10 and NF-κB protein expression in joint synovial tissues in rats with collagen-induced arthritis ( CIA) ,and further to investigate the mechanism for treating rheumatoid arthritis. Methods Rats were randomly divided into normal control group( n=10) ,model control group,dexamethasone group,low-dose of TMP and high-dose of TMP groups ( n=9 each) . The CIA model was established in all the groups except for the normal control group. Rats of dexamethasone group were give 2 mg.kg-1 of dexamethasone;Rats of low-dose and high-dose of TMP group were given 50,100 mg.kg-1 of TMP, respectively.The toe volume and arthritis index (AI) were used to evaluate joint inflammation. The levels of IL-8,IL-12 and IL-33 in the serum of rats were detected by ELISA. The expression levels of MMP-10 and NF-κB in joint synovial were detected by Western blotting. Results Compared with CIA group,the toe volume and AI were significantly reduced in high-dose of TMP groups and dexamethasone groups,and levels of IL-8,IL-12 and IL-33 and the expression levels of MMP-10 and NF-κB were decreased significantly (P<0.01). TMP (50 mg.kg-1) could obviously decrease the toe volume and the levels of IL-8 and IL-33. There was no statistical difference in other indices (P>0.05). Conclusion TMP at 100 mg.kg-1 showed obvious inhibition on CIA rats. The mechanism may be correlated to balancing the effect of proinflammatory factor and anti-inflammatory cytokines,improving immune function in rats,reducing joint synovial inflammation,and alleviating the destruction of the articular cartilage.

This study was to investigate the protective effects and mechanisms of breviscapine on endothelial cells.ox-LDL was used to induce oxidative damage on human umbilical vein endothelial cells(HUVEC)for 20 h with or without 4 h pretreatment of various concentrations of breviscapine(10;20;40 μmol/L);then observe the protective effect and mechanism of breviscapine on endothelial cells insulted by ox-LDL.MTT method was used to detect cell viability;flow cytometry was used to detect cell apoptosis and reactive oxygen species;and Western blot and RT-PCR was used to detect cell signaling pathways.The results showed that breviscapine recovered HUVEC cell viability in a dose-dependent manner which inhibited by ox-LDL;and it also protected cell from apoptosis induced by ox-LDL.To explore the mechanisms of breviscapine;reactive oxygen species (ROS)was determined after pretreatment of various concentrations of breviscapine or different durations(2;4;6 h)of brevis-capine.Results showed that breviscapine decreased ROS production in a dose-and time-dependent manner.Fur-thermore;cell signaling pathway analysis showed that breviscapine increased the expression of BCL-2;decreased the expression of BAX and the release of Cytochrome C and cleavage of caspase-3.Breviscapine decreased Keap1 and activated the nuclear import of Nrf2;and subsequently increased the mRNA and protein expression of down-stream antioxidant enzyme as NAD(P)H:quinone oxidoreductase 1(NQO1)and glutathione transferase-S-Mu 1(GSTM1);and increasing the activity of NQO1.Besides;breviscapine decreased IKK and IKB;and inhibited nuclear translocation of NF-κB;while increasing the expression of eNOS.This study demonstrated that breviscap-ine has a protective role on ox-LDL-induced endothelial cell injury;which may be related to its antioxidant effects and inhibition of NF-κB activation.