Trombocitopenia severa inducida por un oclusor para DAP: reporte de caso en tecnovigilancia

Introducción: El ductus arterioso persistente (DAP) es una cardiopatía congénita de especial interés. La oclusión intervencionista es el tratamiento de elección, no obstante, el dispositivo médico "oclusor para DAP", usado en este procedimiento, puede dar lugar a la aparición de eventos adversos de rara frecuencia como hemorragia, trombocitopenia, entre otros. Reporte de caso: Se presenta un caso de una paciente pediátrica con trombocitopenia severa posterior a la intervención. Durante su hospitalización, la paciente mantuvo niveles bajos de plaquetas hasta que logra su recuperación y sale de alta sin una nueva manifestación hematológica. El caso fue reportado como sospecha de incidente adverso asociada al oclusor para DAP. Conclusión: Al realizarse el análisis causa-raíz, se concluye que el tamaño del oclusor para DAP podría ser la principal causa de la trombocitopenia. El presente caso es una muestra que los dispositivos médicos pueden causar eventos adversos severos, por lo que, es necesaria la implementación de tecnovigilancia, principalmente a los dispositivos médicos de alto riesgo.

Introduction: Patent ductus arteriosus (PDA) is a congenital heart condition of special interest. Interventional occlusion is the treatment of choice; however, a PDA occlude, used in this procedure, is a medical device that rarely could lead to adverse events such as hemorrhage, thrombocytopenia, etc. Case report: We present a case of a pediatric patient with severe thrombocytopenia after surgery. During her hospitalization, platelet levels remained lower and, finally, she was fully recovered without any hematological manifestation. The case was reported as a suspected adverse incident related to PDA occlude. Conclusion: After performing a cause-root analysis, we concluded that the size of the PDA occlude may be the main cause of thrombocytopenia. This case demonstrates that medical devices could lead to adverse events. Thus, it is important for clinicians to implement medical device surveillance, mainly for high-risk medical devices.

Construction and optimization of a novel plasma membrane model for membrane affinity assay based on polydiacetylene vesicles / 药学学报

Most drugs need to interact with cell membrane to reach the biological target, so that membrane affinity assay is an important early screening step in drug discovery. However, at present, the traditional oil-water distribution method is still used, a new, simple and accurate method for membrane affinity assay is urgently needed. In this study, according to the colorimetric principle, a new assay model based on polydiacetylene vesicles was optimized through a series of experiments including different concentrations of vesicle solution, temperature, or pH reaction environment. On this basis, tetracaine hydrochloride, 2-methylimidazole and histamine were used as model drugs to measure the membrane affinity constants and verify the between-batch precision of the optimized assay model (relative standard deviation less than 5%). In addition, polydiacetylene vesicles were stable for up to 180 days, demonstrating the potential application of the assay model. This strategy is simple, stable, reliable, with high reproducibility, low cost and easy to promote, which provided a new tool and a new direction for the high-throughput assay of membrane affinity.

Clinical Profile and Effects of Ductal Size on Anthropometry of Children with Patent Ductus Arteriosus (PDA)

It is not known at which size a congenital Patent ductus arteriosus (PDA) in children becomes associated with a resultant severe malnutrition in children. Furthermore, the effect of ductal size on anthropometry of children with PDA is yet to be determined. Objectives This study was aimed to asses if the ductal size had any effect on anthropometry of children with PDA and at which size evidence of severe malnutrition ensues Methods This was a five-year observational cross-sectional study of children who presented at three tertiary institutions with PDA. Results There was a negative non-significant correlation between the size of PDA and the weight of patients, (Pearson correlation coefficient = -0.1, p = 0.7). There was also a negative non-significant correlation between the size of PDA and patient’s height/length, (correlation coefficient = -0.1, p = 0.5). The association between the size of PDA and the severity of malnutrition revealed greater proportion of 35.3% (6/17) for wasting and stunting in patients who had large PDA sizes of >7mm, when compared with fewer proportions in those with PDA sizes of 3- 6mm (26.1% (6/23) and those with tiny PDA of <3mm (33.3% (10/30); (?2 = 10.21, p = 0.8). There was a positive correlation between ductal size and nutritional status of patients, and severe malnutrition ensued from ductal size of 3.2mm; with ETA square of 0.072. The majority of children with PDA presented with severe forms of malnutrition (wasting and stunting). Conclusion: Severe malnutrition ensues when ductal size is 3.2mm. The size of PDA has no effect on weight and height of children with PDA.

The chemical composition and antibacterial activity of a methanolic extract of Satureja khuzistanica

Abstract In the present study, the metabolite profiling of methanolic extract from aerial parts of Satureja khuzistanica Jamzad, as an endemic medicinal plant from Iran, was evaluated using HPLC-PDA-ESI. Then, the main compound from the extract was isolated and purified by using extensive chromatographic techniques. In addition, the structure of the isolated compounds was elucidated using 1D, 2D NMR, and MS spectrometry, upon which 22 compounds were identified. The antibacterial activity of diosmetin 7-rutinoside (6) and linarin (13) in combination with carvacrol as a major compound of the essential oil was tested against Pseudomonas aeruginosa and Staphylococcus aureus through disc diffusion and minimum inhibitory concentration methods. The results indicated that the linarin, when mixed with carvacrol as the main compounds in the essential oil of the plant, has a satisfactory activity against both Pseudomonas aeruginosa and Staphylococcus aureus with MIC values of 0.16 and 0.18 µg/mL, respectively. Further, the fractional inhibitory concentration (FIC) index indicated that this compound had synergism with carvacrol.

Application of PDA Barcode Scanning Technology in Automated Tablet Dispensing and Packaging System in Our Hospital / 中国药房

OBJECTIVE：To realize refined management of tablets i n the inpatient pharmacy ，and to ensure the medication safety of patients. METHODS ：Based on intelligent pharmacy ，the dispensing and packaging process under the automated drug dispensing and packaging system （ADDPS）mode was optimized and modified ；PDA barcode scanning technology was applied in all links of taking ，dismantling and adding ，so as to realize the real-time tracking of batch number and inventory ，and improve the drug closed-loop management of tablets. The error rate ，staff consumption time and pharmacist/nurse satisfaction were compared before and after the process improvement. RESULTS ：After the process improvement ，the dispensing error rate was decreased from 1.637‰ before improvement to 0.082‰（P＜0.01）；the staff consumption time decreased from （7.52±0.33）h to （5.11±0.24）h （P＜0.01）；the pharmacist/nurse satisfaction increased from 66.5％ to 93.4％（P＜0.01）. CONCLUSIONS ：Based on ADDPS ，the application of PDA barcode scanning technology standardizes the tablets management of inpatient pharmacy ，supplements and improves the drug closed-loop information ，realizes batch number tracking and inventory management ，reduces the occurrence of tablet dispensing errors ，improves the work efficiency and satisfaction of pharmacists ，and ensures the safety of clinical medication.

Simultaneous Determination of 7 Phenolic Acids in Lycopus lucidus var. hirtus Rhizome by HPLC-PDA / 中国实验方剂学杂志

Objective:A high performance liquid chromatography-photo-diode array（HPLC-PDA） method for the simultaneous determination of the 7 phenolic acids including danshensu，protocatechuic acid，protocatechuic aldehyde，chlorogenic acid，caffeic acid，ferulic acid and rosemary acid in Lycopus lucidus var.hirtus rhizome，analyzing and evaluating the phenolic acids in L.lucidus var.hirtus rhizome collected from different habitats，is reported here. Method:The sample was extracted by ultrasonic with 80% methanol solution，7 kinds of phenolic acids were separated on a CAPCELL PAK C18 column （4.6 mm×250 mm，5 μm） with a mobile phase consisting of methanol-0.02% formic acid aqueous （pH 3.10）by gradient elution，The detection wavelength was at 279，324 nm， the column temperature was 30 ℃ with 20 μL injection volume and the flow rate was 1.0 mL·min-1. Result:The 7 Phenolic acids had a good linear relationship （r≥0.999 9） within their respective mass concentration ranges，the average recovery was 96.49%-103.45% and the RSD was 0.5%-2.8%，the limit of determination was 0.008-0.046 mg·L-1 and the limit of quantification was 0.027-0.154 mg·L-1.The 7 kinds of phenolic acids were all detected in L.lucidus var.hirtus rhizome and the total amount was between 5 811.01 and 11 747.23 µg·g-1 ， the average amount was 7 421.05 µg·g-1.The content of 7 phenolic acids was different and the rosemary acid was the highest in all the samples with an average of 7 111.19 µg·g-1 the ratio to the total phenolic acids was 95.8%.The results of principal component analysis and cluster analysis showed that the quality of L.lucidus var.hirtus rhizome from Heze city in Shandong province was better，followed by Wanzhou district in Chongqing. Conclusion:The method was simple，sensitive，accurate，practical and reliable，and is suitable for the content determination of phenolic acid in L. lucidus var. hirtus rhizome.It is expected to provide a reference for the improvement of quality standard and a new idea for the development and utilization of L.lucidus var.hirtus rhizome.

Evaluation of cultivated and wild Herba Epimedii using UHPLC-PDA-Q-TOF/MSE / 药学学报

Qualitative and relatively quantitative methods were used to study the quality of cultivated Epimedium sagittatum (Sieb. et Zucc.) Maxim., Epimedium myrianthum Stearn, and Epimedium pubescens Maxim by ultra high-performance liquid chromatography coupled with photo-diode array and quadrupole time-of-flight mass spectrometry (UHPLC-PDA-Q-TOF/MSE). Thirty-two compounds in cultivated and wild samples of E. sagittatum, E. myrianthum and E. pubescens were identified using UHPLC-Q-TOF/MSE combined with the UNIFI data analysis platform. Principal component analysis (PCA) was used to compare the cultivated and wild samples of these three species. The results show that the chemical compositions of cultivated samples were consistent with the corresponding wild samples. UHPLC-PDA was used to determine the relative content of 12 flavonoids as well as total flavonoids in all samples. The results show that the relative chemical content of these flavonoids in cultivated and wild samples is similar and the quality of cultivated Epimedium is more stable. These qualitative and relatively quantitative methods using UHPLC-PDA-Q-TOF/MSE combined with the UNIFI data analysis platform and PCA can be used to study the quality of cultivated Herba Epimedii. This research provides a scientific basis for the cultivation and rational development and utilization of Epimedium medicinal materials.

Trace determination and characterization of ginsenosides in rat plasma through magnetic dispersive solid-phase extraction based on core-shell polydopamine-coated magnetic nanoparticles / 药物分析学报

Enrichment of trace bioactive constituents and metabolites from complex biological samples is chal-lenging. This study presented a one-pot synthesis of magnetic polydopamine nanoparticles (Fe3O4@-SiO2@PDA NPs) with multiple recognition sites for the magnetic dispersive solid-phase extraction (MDSPE) of ginsenosides from rat plasma treated with white ginseng. The extracted ginsenosides were characterized by combining an ultra-high-performance liquid chromatography coupled to a high-resolution mass spectrometry with supplemental UNIFI libraries. Response surface methodology was statistically used to optimize the extraction procedure of the ginsenosides. The reusability of Fe3O4@-SiO2@PDA NPs was also examined and the results showed that the recovery rate exceeded 80％ after recycling 6 times. Furthermore, the proposed method showed greater enrichment efficiency and could rapidly determine and characterize 23 ginsenoside prototypes and metabolites from plasma. In com-parison, conventional methanol method can only detect 8 ginsenosides from the same plasma samples. The proposed approach can provide methodological reference for the trace determination and charac-terization of different bioactive ingredients and metabolites of traditional Chinese medicines and food.

Transcatheter closure of patent ductus arteriosus using duct occluder: an eleven-year experience from a single tertiary cardiac center

Background: Patent Ductus Arteriosus (PDA) is a common congenital disorder. As an isolated lesion, PDA constitutes 6 to 11% of all congenital heart disease. PDA needs closure to eliminate pulmonary over circulation leading to volume overload of left ventricle, pulmonary vascular obstructed disease.Methods: This retrospective study was carried out in pediatric cardiology unit of Institute of Postgraduate Medical Education and Research, Kolkata from September 2005 to August 2016, which included 503 patients.Results: Device closure was attempted in 492 patient’s Procedural success was achieved in 85% cases on table, in who check aortogram revealed complete closure of PDA. In 15% cases, residual shunt was present. In 12% of cases, residual shunt disappeared during follow-up echocardiogram over 6-month follow-up. In 3% cases, small shunt remained at 6-month and 1-year follow up.Conclusion: Transcatheter closure of PDA by duct occluder is safe and effective with good mid-term outcome. The optimum assessment of ductul size and anatomy is crucial for optimum device size, which prevents residual shunt, device embolization and protrusion.

Characterization of hepatoprotective metabolites from Artemisia annua and Cleome droserifolia using HPLC/PDA/ESI/MS-MS

ABSTRACT The hepatoprotective activities of two traditionally used plants, Cleome droserifolia (Forssk.) Delile, Cleomaceae, and Artemisia annua L., Asteraceae, were recently reported. However, the biologically active metabolites responsible for this activity were not identified. The aqueous extract of C. droserifolia aerial parts, and the polar fraction of A. annua leaves were screened for their antioxidant activities using the 2,2′-azino-bis (3-ethylbenzothiazoline-6-sulphonic acid) assay. The in vitro viability of HepG-2 cells treated with CCl4 and the extracts were assessed by MTT assay. The effects of the extracts on the liver enzymes and the total soluble protein in CCl4-intoxicated HepG-2 cells were investigated. An HPLC/PDA/ESI/MS-MS based analysis was carried out for extract of C. droserifolia and polar fraction of A. annua. Both exhibited pronounced free radical scavenging activities (86 and 83%, respectively). Both showed a significant increase in cell viability: 86.43% for the extract of C. droserifolia and 79.32% for polar fraction of A. annua. Only the extract of C. droserifolia (39.6 ± 5.41 and 20.4 ± 6.91 IU/dl, respectively) and polar fraction of A. annua (40.8 ± 2.14 and 24.5 ± 3.11 IU/dl, respectively) restored the levels of liver enzymes (aspartate transaminase and alanine transaminase, respectively) compared to the CCl4 intoxicated group (87.5 ± 4.34 and 34.1 ± 8.12 IU/dl, respectively) and other herbal extracts. More than fifty phenolic secondary metabolites were identified in the extracts under investigation. The significant hepatoprotective activities of both extracts seemed to be strongly connected to their content of hydroxycinnamoyl quinic acids and flavonoids.

A study of prevalence and pattern of congenital heart disease at Sopore, Kashmir, North India

Background: Early detection of congenital heart disease is of paramount importance to improve the quality of life of children and prevent morbidity and mortality. Congenital heart disease (CHD) is one of the major causes of mortality and morbidity in the pediatric population of both the developing and developed countries. Present aim was to study the prevalence, age and sex wise distribution, and clinical spectrum of congenital heart disease (CHD) at Sopore, Kashmir, North India.Methods: Around 39829 children in the age group 0 months to 18 years were screened for Defects at birth, Diseases in children, Deficiency conditions and Developmental Delays including Disabilities over the period of 18 months under RBSK. Clinical examination, echocardiography and color Doppler were used as diagnostic tools.Results: A prevalence of 5.3 per 1000 population was observed. VSD (ventricular septal defect) was the commonest lesion (30.1%), followed by PDA (patent ductus arteriosus) in 21.6 % and ASD (atrial septal defect) in 20.2%. Tetralogy of Fallot was the commonest cyanotic heart disease (8.0%). Maximum numbers of children with heart disease were diagnosed in the age group 6 weeks to 6 years.Conclusions: For better estimation of prevalence of congenital heart diseases, more elaborate community-based studies are needed. Such community based studies can be easily done by collecting and analyzing data collected from screening programs like RBSK. Such community based screening programs helps in detecting silent cardiac ailments, their prevalence and pattern, and early therapeutic intervention. A few prevalence studies have been carried out piecemeal in different locations of India; and more such studies can be easily done by collecting and analyzing data collected under RBSK screening program.

High Performance Liquid Chromatography Coupling with Photo-diode Array Detector Method for Monitoring Voriconazole and Its Main Metabolite N-oxidized Voriconazole and Its Application to Medication Guidance for Childhood Leukemia / 中国药学杂志

OBJECTIVE: To establish a method for simultaneous determination of voriconazole and its main metabolite N-oxidized voriconazole in blood, and monitor the levels of voriconazole and N-oxidized voriconazole in leukemia children aged 2-12 years. METHODS: Agilent ZORBAX SB-C18 column (4.6 mm×250 mm,5 μm) was used, and the mobile phase was acetonitrile, methanol and ammonium acetate buffer (10 mmol•L-1, pH adjusted with acetic acid to 3.0)=27∶23∶50, the flow rate was 1 mL•min-1, and the wavelength was set at 262 nm. The sample was extracted with ethyl acetate.Carbamazepine was used as the internal standard. RESULTS: The calibration curves of voriconazole and N-oxidized voriconazole were linear in the range of 0.1-8.0 μg•mL-1, the lower limit of quantitation was 0.1 μg•mL-1, and the intra-assay and inter-assay precision RSDs were between 2% and 10%. The accuracy, method recovery and stability all met the requirements.Twenty-nine patients were monitored with a total of 100 blood samples.The medians (IQRs) of voriconazole concentration, N-oxidized voriconazole concentration, and ratio of N-oxidized voriconazole to voriconazole were 0.87 μg•mL-1 (0.32-1.65 μg•mL-1) and 1.15 μg•mL-1 (0.55-1.67 μg•mL-1) and 1.10(0.66-1.22), respectively. There was a correlation relationship between the concentrations of voriconazole and N-oxidized voriconazole (r=0.603 1, P<0.000 1). CONCLUSION: The method is simple, accurate, highly specific, and can simultaneously monitor the concentrations of voriconazole and N-oxidized voriconazole, thus can be used for the pharmacokinetic research of voriconazole and clinical drug monitoring.

Quantification of the Bioactive Components of the Rhizomes of Curcuma wenyujin and Assessment of Its Anti-inflammatory Effect in Benign Prostatic Hyperplasia-1 Cells

In this study, the marker compounds of Curcumae Rhizoma (CR) were simultaneously quantified by high-performance liquid chromatography equipped with a photodiode array detector and the anti-inflammatory effects of CR extract and marker compounds in human benign prostatic hyperplasia epithelial-1 (BPH-1) cell lines were investigated. The marker components (4S,5S)-(+)-germacrone-4,5-epoxide, furanodienone, and germacrone, were separated on Gemini C₁₈ columns (250 mm × 4.6 mm, 5 µm) at 40 ℃ by using a gradient of two mobile phases eluting at 1.0 mL/min. Prostaglandin E₂ (PGE₂) levels in Human BPH-1 cells were determined with an ELISA kit. The coefficients of determination in a calibration curve of each analyte were all 0.9997. The limits of detection and quantification of the three compounds were 0.10 – 0.32 µg/mL and 0.30 – 0.98 µg/mL, respectively. The content of three compounds, (4S,5S)-(+)-germacrone-4,5-epoxide, furanodienone, and germacrone, in the CR sample were found to be 5.79 – 5.92 mg/g, 4.72 – 4.86 mg/g, and 1.06 – 1.09 mg/g, respectively. Regarding pharmacological activity against benign prostatic hyperplasia, CR and its components significantly suppressed PGE₂ levels of BPH-1 cells. The established analysis method will help to improve quality assessment of CR samples and related products. In addition, CR and its components exhibit anti-inflammatory activity in BPH-1 cells, suggesting the inhibitory efficacy of these compounds against the pathogenesis of BPH.

Development of Analytical Method and Validation using HPLC/PDA for Discrimination between Artemisiae Argyi Folium and Artemisiae Iwayomogii Herba

In this study, we described the new developed method to simultaneously discriminate two herbal drugs of Artemisiae Argyi Folium and Artemisiae Iwayomogii Herba using eight marker compounds (1 – 8) on an HPLC-PDA system. The developed method was applied to quantify the major components of two herbal drugs. The pattern analysis successfully discriminated and evaluated different components between Artemisiae Argyi Folium and Artemisiae Iwayomogii Herba. Results were used for classification of different species from collected samples.

Quantitation and Radical Scavenging Activity Evaluation of Iridoids and Phenylethanoids from the Roots of Phlomis umbrosa (Turcz.) using DPPH Free Radical and DPPH-HPLC Methods, and their Cytotoxicity

The roots of Phlomis umbrosa (Turcz.) (Phlomidis Radix) have been traditionally used to treat cold, reduce swelling and staunch bleeding. Four iridoids (1 – 3 and 5) and six phenylethanoid derivatives (4, and 6 – 10) were isolated from the roots of P. umbrosa. A simple, sensitive, and reliable analytical HPLC/PDA method was developed, validated, and applied to determine 10 marker compounds in Phlomidis Radix. Furthermore, the isolates were evaluated for cytotoxic and anti-oxidant activities as well as DPPH-HPLC method. Among them, compounds 4 and 6 – 9 displayed potent anti-oxidant capacities using DPPH assay with IC50 values of 27.7 ± 2.4, 10.2 ± 1.1, 18.0 ± 0.8, 19.1 ± 0.3, and 19.9 ± 0.6 µM, and compounds 6, 8, and 9 displayed significant cytotoxic activity against HL-60 with IC50 values of 35.4 ± 3.1, 18.6 ± 2.0, and 42.9 ± 3.0 µM, respectively.

Investigation on intestinal absorption ingredients and their absorption characteristics in Pterocephali Herba by everted intestinal sac method / 中国中药杂志

The intestinal absorption characteristics of ten iridoid glycosides and phenolic acids in the Pterocephali Herba were evaluated via rat intestinal valgus model. The intestinal sac fluids at different time after administration of high,medium and low concentrations of Pterocephali Herba extract were collected and ten chemical components in fluid samples were detected by UPLC-PDA. Accumulative absorbed doses( Q) and absorption rate constants( Ka) of ten chemical constituents were calculated,while proportions between Pterocephali Herba extract and intestinal absorption liquid were compared. The results showed that the intestinal absorption of 10 chemical components was linear absorption( R2>0. 9) at different concentrations,which accorded with the zero-order absorption rate. The absorption rate constant was related to the concentration of the drug and the intestinal site,which indicated that intestinal adsorption mechanism of the components were passive diffusion and active transport. Proportions of chemical constituents in intestinal sac fluid were different from those in Pterocephali Herba extract. Therefore,those ten chemical components in Pterocephali Herba extract can be absorbed in whole intestine. Everted intestinal sac model can be used to evaluate intestinal absorption characteristics of ingredients in Pterocephali Herba extract effectively.

Development and Validation of HPLC-PDA Method and Pattern Recognition Analyses Using Eight Marker Compounds for the Quality Control Between the Seeds of Cuscuta chinensis Lam. and Cuscuta japonica Choisy

Cuscuta chinensis Lam. and Cuscuta japonica Choisy are parasitic plants. C. chinensis seeds were traditionally used for treatment of kidney and liver deficiencies. C. japonica seeds were used as tonic medicine to improve liver function and strengthen kidneys, treatment of high blood pressure, chronic diarrhea, and sore eyes. Cuscutae Semen are seeds of only C. chinensis in Korean Herbal Pharmacopoeia (K.H.P.). The developed HPLC-PDA method easily, accurately, and sensitively quantified using eight marker compounds [hyperoside (1), astragalin, (2), quercetin (3), kaempferol (4), chlorogenic acid (5), 3,4-di-O-caffeoylquinic acid (6), 1,5-di-O-caffeoylquinic acid (7), and 4,5-di-O-caffeoylquinic acid (8)]. In addition, the method may be used to distinguish seeds between C. chinensis Lam. and C. japonica Choisy. Furthermore, the result from the current study was applied to clarify samples between steam processed and unprocessed samples of C. chinensis by pattern analysis.

Study on the Marker Steroids of New Zealand Deer (Cervus elaphus var. scoticus) Velvet Antler by UPLC-MS/MS and HPLC-PDA Methods

Eleven steroid hormones (SHs: androstene-3,17-dione, estrone, β-estradiol, α-estradiol, testosterone, dehydroepiandrosterone, 17á-hydroxyprogesterone, medroxyprogesterone, megestrol acetate, progesterone, and androsterone) were detected from New Zealand deer (Cervus elaphus var. scoticus) velvet antler (NZA, 鹿茸). A method for the quantification of eleven SHs was established by using ultraperformance liquid chromatography (UPLC)-MS/MS. The linearities (R² > 0.991), limits of quantification (LOQ values, 0.3 ng/mL to 23.1 ng/mL), intraday and interday precisions (relative standard deviation: RSD 0.999), LOQ values (30 ng/mL to 350 ng/mL), intraday and interday precisions (RSD < 1.93%), and recovery rates (97.2% to 103.5%) for the three 7-O-CSs were determined. These quantitative methods are accurate, precise, and reproducible. As a result, it is suggested that the five steroid compounds of androstene-3,17-dione, androsterone, 7-ketocholesterol, 7α-hydroxycholesterol, and 7β-hydroxycholesterol could be marker steroids of NZA. These methods can be applied to quantify or standardize the marker steroids present in NZA.

Study on degradation kinetics of epalrestat in aqueous solutions and characterization of its major degradation products under stress degradation conditions by UHPLC-PDA-MS/MS / 药物分析学报

Drug stability is closely related to drug safety and needs to be considered in the process of drug production, package and storage. To investigate the stability of epalrestat, a carboxylic acid derivative, a reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed in this study and applied to analyzing the degradation kinetics of epalrestat in aqueous solutions in various conditions, such as dif-ferent pH, temperatures, ionic strengths, oxidation and irradiation. The calibration curve was A=1.6 × 105C–1.3 × 103 (r=0.999) with the liner range of 0.5–24 μg/mL, the intra-day and inter-day precision was less than 2.0%, as was the repeatibility. The average accuracy for different concentrations was more than 98.5%, indicating that perfect recoveries were achieved. Degradation kinetic parameters such as degradation rate constants (k), activation energy (Ea) and shelf life (t0.9) under different conditions were calculated and discussed. The results indicated that the degradation behavior of epalrestat was pH-dependent and the stability of epalrestat decreased with the rised irradiation and ionic strength;however, it was more stable in neutral and alkaline conditions as well as lower temperatures. The results showed that the degradation kinetics of epalrestat followed first-order reaction kinetics. Furthermore, the degradation products of epalrestat under stress conditions were identified by UHPLC-PDA-MS/MS, with seven degradation products being detected and four of them being tentatively identified.

Stenting of patent ductus arteriosus in low birth weight newborns less than 2 kg- procedural safety, feasibility and results in a retrospective study

Objective Retrospective analysis of the feasibility, safety and results of patent ductus arteriosus (PDA) stenting in low birth weight babies weighing < 2 kg. Background: Stenting of patent ductus arteriosus is a well known palliative technique for several years as an alternative to shunt surgery in babies weighing > 2.5–3 kg. Ductal stenting in babies weighing less than 2 kg is not done routinely all around the world due to limited experience and concerns regarding its feasibility and safety in such small subset. Methods Records of patients who underwent PDA stenting at our institution from June 2014 to December 2016 were reviewed. In this period, we attempted to do PDA stenting using femoral artery approach in babies weighing < 2 kg. Echocardiography and colour Doppler were used for patient selection and assessment of procedural outcome. Results PDA stenting using femoral artery approach was successful in all 5 patients weighing < 2 kg. In this group, patient age ranged from 2 days to 16 days and weighed 1.8 kg to 1.97 kg. All patients had good post-procedure outcome. One patient had stent malposition from aortic end towards main pulmonary artery which was managed by an additional stent. Conclusion PDA stenting is feasible and safe with good end results in carefully selected low birth weight babies weighing < 2 kg.