Discussion on the disposal methods and expiration extending strategy of expired drug in China / 中国药房

China produces about 15 000 tons of expired drugs every year. Standardized destruction of expired drugs consumes a large number of secondary costs， causing huge economic losses. Improper handling will also lead to serious environmental pollution， endanger national health and even endanger public safety. This paper analyzes the hazards， sources and disposal methods， and research status of expired drugs， introduces the Shelf-Life Extension Program of United States， and put forward feasible measures for the recovery， integration and reuse of expired drugs. It is suggested to construct a scientific and reasonable recovery and disposal system of expired drugs in combination with the actual situation in China， explore the strategy of extending the expiration of drugs， and greatly reduce the waste of drug resources.

Study on quality standard of compound Yuhong suppository / 药学实践杂志

Objective To establish the quality standard of compound Yuhong suppository. Methods Angelica dahurica, colophony and Sophora flavescens Alt. were identified by thin layer chromatography（TLC）method. The contents of sulfadiazine and dyclonine hydrochloride were determined by HPLC with diode array detection method. The mobile phase was methanol-0.02 mol/L potassium dihydrogen phosphate (adjusted to pH 3.3 with phosphoric acid) for gradient elution. The detection wavelength was 280 nm for sulfadiazine and dyclonine hydrochloride. Results The three Chinese traditional medicines were identified by TLC with clear spots. The linear ranges of sulfadiazine and dyclonine hydrochloride were good in 12.40-99.20 μg/ml (r=0.999 9) and 2.56-20.48 μg/ml (r=0.999 9). The average recovery was (99.21±0.43) % (n=9) and (99.54±0.68) % (n=9). Conclusion This method is accurate, sensitive, and reproducible. It can be used as a standard method for the quality control of compound Yuhong suppository.

Optimization of determination method for silver sulfadiazine cream and its stability under extreme conditions / 药学实践杂志

Objective To optimize the method of assay for silver sulfadiazine, and to investigate its stability in high temperature, humidity and salt environment. Methods Agilent ZORBAX SB-C18 column was used in HPLC for the determination of silver sulfadiazine with acetonitrile and 0.1% phosphoric acid as mobile phase.The flowing rate was 1.0 ml/min and column temperature was 30℃. Salt spray test chamber was used to simulate the high temperature, humidity and salt environment. The silver sulfadiazine content was assayed at 0, 2, 4, 6, 8, 10, 12 weeks. Results The calibration curve was linear within the range of 4.00～20.00 μg/ml (r=0.9999). The average recovery was 101.47% (RSD=2.33%). The content of silver sulfadiazine cream began to decrease significantly after 4 weeks. Conclusion This method is convenient, accurate and reliable. It can be used for the content determination of silver sulfadiazine in the cream.The results showed that the silver sulfadiazine cream was unstable in the environment of high temperature, humidity and salt. Therefore, environmental impact should be fully considered in transportation, storage and application. For the long-distance navigation mission, protective measures should be taken for its packaging or replace it with more stable products.

Analysis of clinicopathology and risk of lymph nodes metastasis in 315 patients with early gastric cancer according to World Health Organization criteria / 中华消化杂志

Objective To investigate the clinicopathologic features of Chinese patients with early gastric cancer (EGC) according to the World Health Organization(WHO) diagnostic criteria,and to explore the risk factors of lymph node metastasis (LNM) in EGC.Methods From 2002 to 2017,at the Second Affiliated Hospital of Nantong University,and from 2014 to 2017,at the People's Hospital of Qidong City,the People's Hospital of Haimen City and the People's Hospital of Rugao City,315 EGC patients with complete clinicopathological data were enrolled.The clinicopathologic features were analyzed including gender,age,tumor location,tumor size,macroscopic type,histological type (WHO),differentiation degree,depth of tumor invasion,Lauren subtype,infiltration pattern,ulceration,lymphoid follicles,lymphovascular invasion and perineural invasion.Chi-square test and Fisher's exact test were performed for univariate analysis and the logistic regression was used for multivariate analysis.Results The ratio of EGC was 10.0％ (315/3 140) of patients with gastric cancer and received surgery during the same period.Among the 315 EGC,the ratio of well-differentiated tubular adenocarcinoma was 11.7％ (37/315),which was lower than 24.8％(2 752/11 104) in Japan and 19.9％(41/206) in South Korea,and the differences were statistically significant (x2 =28.208,P＜0.01;x2 =6.51 0,P =0.011),however there was no statistically significant difference when compared with Western countries (11.9 ％,8/67;x2 =0.002,P=0.964).Among the 276 patients who underwent radical gastrectomy,49 (17.8 ％) patients had with LNM.The results of univariate analysis showed that tumor size,macroscopic type,differentiation degree,depth of invasion,infiltration pattern,ulceration and lymphovascular invasion were related with LNM(x2=9.327,6.038,6.381,34.983,19.309,52.297 and 5.058;all P＜0.05).The results of multivariate analysis revealed that lymphovascular invasion and ulceration were the independent risk factors of LNM (odd ratio (OR)=7.028 and 2.566,both P＜0.05).Conclusions There is obvious difference in pathological diagnostic standard of well-differentiated tubular adenocarcinoma between China,Japan and South Korea,which may influence the therapeutic strategy of EGC.Lymphovascular invasion and ulceration are independent risk factors of LNM in EGC.

A biomechanical system that can apply fluid shear stress to osteoclast-like cells in vitro / 生物医学工程学杂志

On the basis of the well-established principles and techniques about flow chamber, we have designed and made a kind of parallel plate system to apply steady fluid shear stress to osteoclast-like cells etc. in vitro. Biocompatible rubber and metal clamping apparatus made of aluminium alloy are used to seal the flow chamber without changing its even height designed beforehand. The influence of hydrostatic pressure on cells is minimized by adjusting the glass slide and the fluid surface in the upper reservoir to the same horizontal plane. This system can be used to investigate the responses of osteoclast-like cells etc. to fluid shear force in terms of morphology, physiology or biochemistry.

Bioequivalence and relative bioavailability of domestic and imported repaglinide tablets in healthy volunteers / 第二军医大学学报

Objective：To evaluate bioequivalence and relative bioavailability of domestic and imported repaglinide tablets in healthy volunteers. Methods： Twenty two healthy male volunteers were randomized into A and B groups. A single dose (4 mg) of domestic and imported repaglinide tablets were given respectively according to an open 2-way crossover study design. The washout period was 1 week. Plasma concentrations of repaglinide were determined by HPLC method. Results：The pharmacokinetic parameters of domestic and imported drugs were as follows: t1/2 were(0.86±0.24) and (0.83±0.31) h；tmax were( 0.79±0.37) and (0.75±0.41) h；cmax were (52.43±20.92) and (53.32±24.94) μg/L. AUC0-t were (79.87±36.48) and (74.95±30.57) μg*h*L-1，respectively. The relative bioavailability of domestic formulation was (106.55±16.15)%. Conclusion： The results of variance analysis and two one-side t test show that 2 formulations are of bioequivalence.

Effects of sodium ferulate on hepatocyte growth inhibited by transforming growth factor ?_1 / 中国药理学通报

AIM To research effects of sodium ferulate(SF) on transforming growth factor ?_1 inhibited hepatocyte growth. METHODS Human cultured hepatocytes(L02 cells) served as control group ,TGF?_1(5 ?g?L -1 ) was used to inhibited L02 cells to construct the cell model. MTT methods were used to study the growth inhibitory effect of TGF?_1 on L02 cells. DNA synthesis was analyzed by measuring 3H-TdR incorporation. The effects of SF on the changes of cell cycle were analyzed by flow cytometry. Generation of intracellular ROS was determined by the emission of fluorescence in L02 cells proloaded with DCFH-DA fluoresin and then treated them with TGF?_1 or SF. After 4h,control, TGF?_1 and TGF?_1+SF-treated cells were analyzed by flow cytometry. RESULTS ①Incubated in the presence of TGF?_1 for 24 h, 67.93% of L02 cells survived (P

Pharmacokinetic and pharmacodynamic studies on repaglinide in 20 healthy Chinese volunteers / 第二军医大学学报

Objective: To evaluate pharmacokinetic and pharmacodynamic of repaglinide tablets in Chinese subjects.Methods: Twenty healthy male volunteers were enrolled in the study. A single dose (4 mg) of repaglinide tablets was givenorally. Plasma concentrations of repaglinide were determined by HPLC method. Blood glucose and serum insulin leve1s weremeasured by biochemistry and radioimmunoassay methods respectively. Results: Plasma concentration-time curve conformedto one-compartment open model. The pharmacokinetic parameters were as follows: tmax (0. 75?0.43 ) h,cmax (54.44?24.97)ng/ml, t1/2 (0. 80?0. 31) h, MRT (1. 55?0. 41) h, C1/F (61. 43?20. 10) L/h and AUC (73. 34?29.95) h? ng/ml. Thelevel of serum insulin was raised and the level of blood glucose decreased after administration of repaglinide. The highest levelof serum insulin was (l26. 24?95.93) mU/L at 0.75h and blood glucose level reached its lowerest vaIue (2. 34I0.44) mmol/L 1 h after oral administration. Conclusion: Repaglinide is characterised by fast-acting and short effects on in-sulin secretion. It decreases serum glucose level by stimulating insulin secretion from the pancreatic ?-cells. It is a novel oralprandial glucose regulator for the treatment of type 2 diabetes mellitus.

Simultaneous determination of mycophenolic acid and its glucuronide in human plasma by HPLC / 第二军医大学学报

Objective: To establish a method for determining mycophenolic acid(MPA) and its glucuronide(MPAG) inhuman plasma. Methods: A high performance liquid chromatographic assay with diode array detection was developed, and thedetector wavelength was set at 254nm. The plasma sample purification was limited to protein precipitation with acetonitrile.The sample was separated on Hypersil ODS2 column (200 mm ?4. 6mm, 5?m), the mobile phase consisted of solution A(25% acetonitrile and 75% 0.02 mol/L KH2PO4,pH 3.0)and solution B(70% acetonitrile and 30% 0.02 mol/L K2HPO4,pH6.5)with gradient elution. The flow rate was 1. 0 ml/min. Results: Calibration curves of MPA and MPAG were linear be-tween 1. 0-5. 0 ?g/ml (r=0.994 4,n=6) and (2.5-100) ?g/ml (r= 0.999 5,n=7),respectively. The detection limit of MPAand MPAG were 0. 5?g/ml, and 1.0 ?g/ml, respectively. The mean recoveries of high, medium and low concentrations ofMPA were (95. 75?2.3l)%, (104.10?1.91) % and (98.11?4.24)%, and MPAG were (97.37?1. 43)%, (101.10?5. 41)%and (105. 44?7.59)%. Conclusion: The present study provides a reliable quantitative method for pharmacokineticstudy and monitor of MPA and MPAG.