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 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 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 compare and analyze the similarities and differences of the blood perfusion characteristics of the renal pelvic carcinoma displayed by contrast-enhanced ultrasonography(CEUS) and contrast-enhanced computed tomography(CECT).Methods The characteristics of CEUS and CECT were anzlyzed retrospectively in 40 confirmed renal pelvic carcinoma cases by operation and pathology.The modality and phases of enhancement,including wash-in and washout time,as well as the perfusion appearances,were observed by CEUS and CECT.Results CEUS detected the cortical phase enhancement in all renal pelvic tumors,including synchronously enhancement in 14 tumors and delayed enhancement in 26 tumors.At peak times,hypoechogenicity compared to the normal renal cortex was shown in 31 tumors,hyperechogenicity in 4 tumors and isoechogenicity in 5 tumors.Fast wash-out in medulla phase was displayed in 35 tumors,isochronously wash-out in 2 tumors and delayed wash-out in 3 tumors.The minimum diameter in 40 renal pelvic tumors was 1.5 cm.CECT showed the enhancement in 38 tumors,mostly mild to moderate homogeneous enhancement,and enhancement was lower than the surrounding renal parenchyma.The diagnostic accuracy of CEUS was 77.5％ (31/40),and the diagnostic accuracy of CECT was 82.5 ％ (33/40).The difference was not statistically significant between CEUS and CECT ( P ＞0.05).Conclusions CEUS and CECT have higher diagnostic accuracy of the renal pelvic carcinoma,so the joint detection can increase the detection rate of early diagnosis of the renal pelvic carcinoma.

Objective To explore the diagnostic value of contrast-enhanced ultrasonography (CEUS) in ureteral lesions.Methods The ultrasonogram of conventional ultrasound and CEUS were retrospectively analyzed in 19 confirmed ureteral lesions cases by operation and pathology.The size,inner echoes,boundary and color blood signal of ureteral lesions were observed by conventional ultrasound.The modality and phases of enhancement,including arrival time,peak time,washout time and appearance of internal structure,were observed by CEUS.Results The 19 ureteral tumors were of maximum widths between 2.1 to 7.7 cm.Conventional ultrasound showed 7 hypoechoic masses,10 isoechoic masses,1 hyperechoic mass and 1 unclear mass.Color Doppler flow imaging showed fairly rich blood signal in 8 tumors,a small amount of blood signal around tumor in 6 tumors and no blood signal in the rest.In early phase,CEUS showed enhancement in all 19 ureteral lesions,including synchronously enhancement in 8 tumors and delayed enhancement in 11 tumors.In peak time,hypoechogenicity compared to the normal renal cortex was shown in 3 tumors,hyperechogenicity in 11 tumors and isoechogenicity in 5 tumors.In late phase,fast wash-out was displayed in 16 tumors,isochronously wash-out in 1 tumor,delayed wash-out in 1 tumor and unclear in 1 tumor.The detection rates of blood supply and clear boundary in ureteral lesions and the diagnostic sensitivity for ureteral cancer were 74% (14/19),16% (3/19),50% (8/16) by conventional ultrasound respectively.The detection rates of blood supply and clear boundary in ureteral lesions and the diagnostic sensitivity for ureteral cancer were 100% (19/19) ,58% (11/19) ,94% (15/16) by CEUS respectively.The change of these performances was statistically significant between conventional ultrasound and CEUS.Conclusions CEUS can improve blood supply,boundary and the diagnostic sensitivity of ureteral lesions.

Objective To evaluate contrast-enhanced ultrasound imaging of carotid atherosclerosis with different stenostic degree as a clinical tool to study intraplaque neovascularization.Methods Fifty-eight patients suspected of carotid stenosis with 73 plaques were studied by standard and contrast-enhanced ultrasound.Plaque echogenicity at standard ultrasound were evaluated.Contrast enhancement within the plaques was categorized as 0 - 4 degree and compared to the stenosis degree and the plaque echogenicity.The degree of stenosis was determined by intravenous digital subtraction angiography.Results In the group with stenosis less than 90% ,stenosis degree was not associated with the grade of contrast enhancement (P =0.358),while the grade of enhancement was significantly higher in the group with sever stenosis(＞90%).The grades of enhancement were significantly different between plaques with different echogenicity (P =0.000).Conclusions Contrast-enhanced real-time ultrasound imaging can demonstrate the enhancement of carotid plaques non-invasively,which is helpful for assessing intraplaque neovascularization and provide valuable information for plaque risk stratification