Objective:To investigate overall quality status of rose bengal agar culture medium for drug control in China to provide technical support for the drug standard revision. Methods:Four quality control microorganisms, namely Aspergillus niger, Candida al-bicans, Staphylococcus aureus and Escherichia coli, were used to evaluate the quality of rose bengal agar culture medium from 7 domes-tic and foreign manufacturers. Results:Including the control medium, the pH value of all the 8 media was different. The growth rate of Aspergillus niger and Candida albicans in the seven tested media were all above 0. 7 without significant difference (P>0. 05). The selectivity factors of Staphylococcus aureus in the seven media and the control medium was more than 6. The eight media showed differ-ences in the selectivity factors of Escherichia coli. Among them, A, B, C, E, G and the control medium had no inhibitory ( selectivi-ty) , while D and F showed certain selectivity. Conclusion:The rose bengal agar media from different manufacturers for drug control show similar growth-promoting ability with different pH value and selectivity to Escherichia coli.

Objective To investigate the value of quantitative analysis in the diagnosis of renal lesions with contrast-enhanced ultrasound.Methods Sixty cases with renal lesions confirmed by surgery and pathology underwent contrast-enhanced ultrasound preoperatively and quantitative analysis retrospectively.The Sonoliver software was applied in the analysis of CEUS imaging and in the recoustruction of quantitative parameter,s.Five parameters were calculated,including the maximum intensity (IMAX),rise time (RT),time to peak (TTP),mean transit time (mTT) and area under the curve (AUC).Results There were statistically differences in parameters RT,mTT and AUC ( P ＜ 0.05) and significant differences in parameter IMAX ( P ＜0.01).In malignant tumors,the RT and mTT were less than that of the benign while IMAX and AUC were more than that of the benign.Conclusions Contrast-enhanced ultrasound using a quantitative parametric analysis offers more information and is a promising tool in the diagnosis and differentiation of renal masses.

Objective To explore the risk factors of diabetic nephropathy.Methods According to the excretion rate of proteinuria,90 patients were divided into 3 groups:normal diabetic proteinuria group (DM),diabetic micro-proteinuria group (DN1),and clinical diabetic proteinuria group (DN2).We compared patients'ages,diabetic course,cholesterol,triglyceride,glycosylated hemoglobin,high density lipoprotein cholesterol (HDL),low density lipoprotein cholesterol (LDL),serum p-selectin,serum C-reactive protein,urinary monocyte chemotactic protein,and proteinuria excretion rate.Logistic regression analysis was used to analyze the relation between DN and various factors.Results Differences among these groups were statistically significant in type 2 diabetic course,HDL,LDL,p-selectin,C-reactive protein,glycosylated hemoglobin,and urinary monocyte chemotactic protein (P ＜ 0.05).Logistic regression analysis showed that diabetic course,LDL,C-reactive protein,p-selectin,and urinary monocyte chemotactic protein were independent risk factor (OR values were 2.238,1.062,6.723,1.166,and 1.046).Conclusions Occurrence and severity of DN had relationship with course of diabetes,microvascular lesions,and inflammatory reaction.Emphasis on monitoring and evaluation of the DN-related factors would contribute to the prevention and treatment of DN.

The paper introduces the status of TCM symptoms information application,constructs the symptoms knowledge classification system by taking the TCM Diagnostics as the knowledge source,constructs the symptoms knowledge representation model based on the classification and coding technologies,and draws a conclusion that the data analysis result is consistent with the actual clinical situation based on collecting symptom data in the Electronic Medical Records (EMR) and correlation analysis using this model.

Objective:To provide the basic data for the further revision of mycoplasma test method described in Chinese Pharma-copoeia and some references for the operation standardization of drug mycoplasma test. Methods:Two incubation conditions,namely aerobic conditions and microaerophilic conditions,were compared with respect to the growth status of mycoplasma in liquid and solid media. Results:The growth of mycoplasma was obvious difference between the two incubation conditions,and the microaerophilic con-ditions were better than the aerobic conditions. Conclusion:The microaerophilic conditions can be used in the incubation of mycoplas-ma test,which should be defined and standardized in the future Chinese Pharmacopoeia.

Microbiological data deviations ( MDD) investigation differs from out of the standard ( OOS) investigation in chemical inspection items. Investigating Out-of-Specification( OOS) Test Results for Pharmaceutical Production issued by FDA specifically ex-cludes microbiological and other biological assays. Until recently, there is not a definitive guideline for MDD investigation in the world. Some institutions and experts have explored the practice and theory of MDD investigation. Referred to the existing practical experience and theoretical achievement and based on the provisions of Chinese GMP (2010 revision) and the requirements of Chinese Pharmaco-poeia Ⅱ(2010 edition) Appendix XIX Q, the article discussed the methods for MDD laboratory investigation.

Objective:To investigate the growth-promoting properties and applicability of the mycoplasma test culture media pre-scribed in Chinese pharmacopoeia, and provide reference for the standardization of the drug mycoplasma test method. Methods: Re-spectively using four quantitative detection methods including sensitivity, degree of color change, colony counts and colony diameter, and mycoplasma media widely used in the world as the reference media, the growth-promoting properties of 4 batches of mycoplasma broth and 4 batches of arginine mycoplasma broth from four domestic manufacturers were investigated. Results:The results of sensitivity assay and absorbance detection showed that all the media inoculated with below 100 CFU test microorganisms exhibited visible color change. Furthermore, the results of color change degree and colony diameter showed that there were significant differences among the media products from different manufacturers(P<0. 01). Conclusion:Mycoplasma broth and arginine mycoplasma broth both can sup-port the growth of below 100 CFU test microorganisms. Due to the difference in the growth-promoting properties among the media prod-ucts from different manufacturers, the drug mycoplasma test workers should use more sensitive methods to examine the applicability of the media.

Objective To evaluate the contrast-enhanced ultrasonography (CEUS) in quantitative diagnosis of chronic renal insufficiency. Methods Correlation of CEUS indexes with glomerular filtration rate (GFR) detected by 99mTc-DTPA renography was examined. Thirty-three cases of clinical chronic renal insufficiency were enrolled in the study. They were 15 males and 18 females with average age of (43.33±6.78) years. After intravenous bolus injection of 1 ml SonoVue,CEUS of renal cortex blood perfusion was performed successfully, and a time-intensity curve (TIC)was created with PHILIPS iU22 system's QLAB software. A 148 to 222 MBq dose of 99mTc-DTPA was injected as a bolus from antecubital vein. Renal scintigraphic images were collected immediately and GFR was obtained. Results The significant correlation coefficients between GFR and CEUS quantitative indexes were as follows: rAUC (area under curve)=0.886 (P＜0.05), rA (slope rate of ascending curve, A) =0.804(P＜0.05). However, rDPI (derived peak intensity, DPI)=0.021 (P＞0.05), rTTP (time to peak, TTP) =0.043 (P＞0.05), rα (slope rate of descending curve,α)=0.039 (P＞0.05). Conclusion CEUS can precisely display the hemodynamic change of chronic renal insufficiency, which is well correlated with GFR by 99mTc-DTPA renography.

Objective To evaluate the value of contrast-enhanced ultrasonography (CEUS) in quantitative diagnosis of chronic kidney dysfunction(CKD) by comparing it with color Doppler imaging (CDFI). Methods Tirty-three cases (15 males and 18 females) of clinical confirmed CKD (stage Ⅲ～Ⅴ)were included. Forty-five healthy volunteers were performed as control group. CEUS and CDFI were performed on each patient. After intravenous bolus injection of 1ml SonoVue each side,CEUS of renal cortex blood perfusion was collected successively,and a time-intensity curve(TIC) was created with Philips iU22 system's QLAB software. Resistance index(RI) and peak systolic velocity(PSV) of renal partial arteries were also tested. Results Compared with normal kidney,CKD patients had delayed perfusion and decreased intensity. Changes of area under curve(AUC), derived peak intensity(DPI), slope rate of ascending curve(A)and time to peak(TTP) were statistically significant ( P ＜0. 05). Sensitivities of AUC,DPI,A and TTP in diagnosis of CKD (stage Ⅲ～Ⅴ ) were 91.2% ,84. 9% ,90.9% and 85.3%, their specificities were 95.4%,88.9% ,93.3% and 90.9%, their accuracies were 93.6%, 87. 2%, 92.3% and 88. 5%, respectively. The results of CEUS were better than RI in CDFI (sensitivity 70.4%, specificity 37. 8%, accuracy 52.2%).Conclusions CEUS can precisely display the hemodynamic change in CKD ( stage Ⅲ～Ⅴ ), and is more sensitive than CDFI.

Objective To investigate enhancement appearance of hepatic focal nodular hyperplasia(FNH) at real-time gray-scale contrast enhanced ultrasonography(CEUS),and evaluate the value of CEUS in the diagnosis of FNH. Methods Thirty-four patients (36 lesions) with histologically proved FNH were examined by ultrasonography. Appearance on conventional ultrasonography and the enhancement pattern on CEUS were investigated. Results Thirty-six lesions were mostly hypoechoic.39% (14/36) of lesions had peripheral hypoechogenic circle. Color Doppler flow imaging showed a asteroid-like or spoke-and-wheel pattern in 65% (20/ 31) of lesions.Three enhancement patterns were observed in the early arterial phase: whole-enhancement pattern (28%, 10/36), gushing-spring enhancement pattern (44%, 16/36), and spoke-and-wheel enhancement pattern (28%,10/36).The frequency of central scar on CEUS was 17% (6/36), and detection rate of central scar by CEUS compared with pathology was 40% (6/15).Regarding one of the features (gushing-spring enhancement, spoke-and-wheel enhancement and scar) as standard of FNH, the coincidence of CEUS in this group was 78% (28/ 36) ,which was significantly higher than that of conventional ultrasonography 28% (10/36).Conclusions CEUS can be as a important method for diagnosing FNH.