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 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).

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.

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 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 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.

OBJECTIVE:To provide reference and evidence for rational use of clinical nutrition. METHODS:The types of en-teral and parenteral nutrition and the cost of prescription were analyzed statistically in 17 third grade class A general hospitals,3 third grade class A special hospitals and 14 secondary general hospitals from Shanghai area during 2011 to 2013. RESULTS:Nutri-tion preparations were mainly used by hospitalized patients. Total cost of nutrition preparations in outpatient and emergency depart-ment respectively occupied 8.14%,8.77% and 8.89% of total cost of nutrition preparations in the hospital during 2011-2013. The parenteral nutrition was the main form of nutritional support. There were only three kinds of enteral nutrition in top ten nutrition preparations in the list of prescription cost. Although seven out of ten kinds of nutrition preparations were given enterally which was the main mode for outpatients and emergency patients,the cost of prescriptions of parenteral nutrition increased faster compared to enteral nutrition,especially alanyl-glutamine. CONCLUSIONS:Parenteral nutrition is the main mode of nutrition support,especial-ly for inpatients;great attention should be paid to the increase of the cost of prescriptions about parenteral nutrition in outpatients and emergency patients.