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@#Mass spectrometry imaging (MSI), a label-free molecular imaging technique, has been applied widely in the spatial localization of small molecule metabolites, lipids, peptides, and proteins, with its unique advantage of high spatial resolving power compared to traditional liquid chromatography-mass spectrometry (LC-MS).With the nonstop advancement of its achievable sensitivity and spatial resolution, MSI technique has been providing novel perspectives into the preclinical studies of drugs, such as in vivo localization of drugs and their metabolites, visualization of drug metabolism, and drug delivery tracking.This review introduces the basics of MSI techniques, including basic principles, key features, technical advantages, and limitations, with particular highlight of the recent applications of MSI in drug efficacy and safety evaluation, drug distribution research, drug delivery research, and analysis of Chinese medicine from recent publications, aiming to promote the utilization and further expansion of MSI in the research and development of drugs.
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Similar to blood,interstitial fluid(ISF)contains exogenous drugs and biomarkers and may therefore substitute blood in drug analysis.However,current ISF extraction techniques require bulky instruments and are both time-consuming and complicated,which has inspired the development of viable alterna-tives such as those relying on skin or tissue puncturing with microneedles.Currently,microneedles are widely employed for transdermal drug delivery and have been successfully used for ISF extraction by different mechanisms to facilitate subsequent analysis.The integration of microneedles with sensors enables in situ ISF analysis and specific compound monitoring,while the integration of monitoring and delivery functions in wearable devices allows real-time dose modification.Herein,we review the progress in drug analysis based on microneedle-assisted ISF extraction and discuss the related future opportunities and challenges.
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Objective:To analyze the current situation of the course of Pharmaceutical Analysis in the education and training of undergraduate students, explore the teaching reform and innovation to better accommodate the pharmacy education in the new era and build an advanced mode for training pharmaceutical talents with interdisciplinary expertise that meet the requirements and needs of job market. Methods:The first stage was to investigate the suggestions and needs of teaching reform; the second stage was to carry out the exploration and practice of the course reform; the third stage was to evaluate the teaching effect.Results:The demand survey showed that the teaching content, course design, and teaching methods of the Pharmaceutical Analysis need to be further optimized and expanded. Conclusion:By adjusting the teaching content, expanding teaching methods, innovating diversified teaching practices, and integrating the "curriculum ideology and politics" into the construction, the course reform has stimulated students' interest in learning and innovative spirit, strengthened their theoretical literacy and practical ability, and cultivated their international vision and lofty professional ethics.
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This paper introduces the preliminary design and practice of the dynamic combination of flipped classroom with traditional classroom in the teaching of pharmaceutical analysis experiment. In the study, the teaching structure sequence of "Low-High-Low" was used. Specifically, before the class, the students conducted a low-structure autonomous learning for cognition and exploration with the intra-campus and public online resources and the traditional teaching resources. In the class, the students conducted a high-structure teacher-assisted learning using the module of "Presentation-Discussion-Experimental Operation-Rediscussion". After class , the students conducted a low-structure autonomous learning for summary and expansion with the various resources. Finally, the teacher integrally assessed students' scores and redesigned the course teaching. The results showed that, compared with traditional classroom, the dynamic combination of flipped classroom with traditional classroom accelerated the improvement of students' abilities in cognition, exploration, practice, and innovation, and also accelerated the transformation of the teachers into teaching researchers and innovators.
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Electrogenerated chemiluminescence (electrochemiluminescence, ECL) generates species at electrode surfaces, which undergoes electron-transfer reactions and forms excited states to emit light. It has be-come a very powerful analytical technique and has been widely used in such as clinical testing, bio-warfare agent detection, and pharmaceutical analysis. This review focuses on the current trends of molecular recognition-based biosensing methods for pharmaceutical analysis since 2010. It introduces a background of ECL and presents the recent ECL developments in ECL immunoassay (ECLIA), im-munosensors, enzyme-based biosensors, aptamer-based biosensors, and molecularly imprinted poly-mers (MIP)-based sensors. At last, the future perspective for these analytical methods is briefly discussed.
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The development of pharmaceutical analytical methods represents one of the most significant aspects of drug development. Recent advances in microfabrication and microfluidics could provide new approaches for drug analysis, including drug screening, active testing and the study of metabolism. Microfluidic chip technologies, such as lab-on-a-chip technology, three-dimensional (3D) cell culture, organs-on-chip and droplet techniques, have all been developed rapidly. Microfluidic chips coupled with various kinds of detection techniques are suitable for the high-throughput screening, detection and mechanistic study of drugs. This review highlights the latest (2010–2018) microfluidic technology for drug analysis and dis-cusses the potential future development in this field.
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OBJECTIVE: To analyze 13 judicial precedents involving off-label drug use and explore the legal interpretation on off-label drug use in China in order to provide experience for establishment of off-label drug use and clinical application. METHODS: Based on the law databases (China Judgements Online, Chinalawinfo, Jufaanli, Itslaw), 13 cases were searched and screened involving legal off-label drug use. The relationship was investigated and discussed between different results and characteristics of the 13 cases. RESULTS: In 13 cases, there are 2 cases probably reasonable for off-label use, 2 cases unreasonable but not correlated with patients′ outcomes, 9 unreasonable and with a causal relationship with patients′ outcomes. In the 9 unreasonable cases, there are 4 cases without sufficient evidence, 3 cases without informed consent, 1 case lack of monitoring after off-label use, 1 case with idiosyncratic reaction, and 1 case not consistent with the label of the drug used. CONCLUSION: Major deficiencies of off-label drug use in China are without sufficient evidence, lack of informed consent and with uncompleted system on off-label drug use. Establishing more completed and detailed system, investigating enough clinical evidence, better informed consent and monitoring after off-label use are important measurements to ensure safety on off-label drug use.
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The course of pharmaceutical analysis for pharmacy undergraduate students in National University of Singapore and China Pharmaceutical University was compared, in terms of curriculum, lecturing, assessment and practical teaching.This study provides in-depth analysis by the lecturers from both universities,and can provide reference for teaching reform and course construction of pharmaceutical analysis.
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Objective To investigate the biotransformation of Tongmai formula (TMF) in incubated system of human intestinal flora (HIF). Methods The technique of ultra fast liquid chromatography with diode array detector and coupled with electrospray ionization ion trap time-of-flight multistage mass spectrometry (UFLC-DAD-ESI-IT-TOFMSn) was adopted to determine the products of TMF biotransformed by HIF. Results Totally 66 constituents were detected and identified according to the accurate mass measurements (< 5 ppm) and effective MSn fragment ions. Meanwhile, the potential biotransformational pathways of compounds in TMF transformed by HIF were firstly proposed. Desugarization, hydroxylation, and methylation were the major reactions in the biotransformation mechanism of TMF by HIF. Conclusion This study will be helpful to clarify the material basis of pharmacological activities from TMF in vivo.
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OBJECTIVE:To provide reference for improving the teaching quality of pharmaceutical analysis course. METH-ODS:WeChat public platform was registered firstly,and supplement teaching was provided before class,during class and after class. RESULTS:WeChat public platform named Pharmaceutical Analysis of Chongqing Medical and Pharmaceutical College was registered and included 2 first-level-modules of"excellent resource"and"learning interaction",and 6 second-level-modules of"classic courseware""pre-course lesson plan""classic video""classroom exercises""question answering""classic case". Before class, students could preview through the platform;during class,the teachers could review teaching according to the platform;after class,the teachers could test students'learning results and answer questions for students,and students could consolidate classroom knowledge. Post-course effect evaluation showed that there was statistical significance in pass rate of student's grade between teach-ing reform class and control class (P<0.05). And the students of teaching reform class had good satisfactory degree (87.07%). CONCLUSIONS:WeChat mobile learning model supplements pharmaceutical analysis course,improves students'enthusiasm for learning and students,academic records. Students are satisfied with it. It can provide reference for improving the teaching quality of the course.
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Affinity chromatography (AC)is a type of liquid chromatography that makes use of biological-like interactions for separation and specific analysis of bioactive components. It has been widely used as a high-throughput screening method for the separation,screening and purification of the target molecules from complex samples with advantages such as high selectivity and high recovery efficiency.This article summarizes the biological effects of affinity chromatography, molecular imprinting chromatography, and dye ligands affinity chromatography.The review also encompasses the application of AC in the separation of chiral drugs,screening of active components,purification of target protein,and mechanism of the drug-protein interaction.Moreover,the prospects of its applications are also discussed.
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Affinity chromatography (AC)is a type of liquid chromatography that makes use of biological-like interactions for separation and specific analysis of bioactive components. It has been widely used as a high-throughput screening method for the separation,screening and purification of the target molecules from complex samples with advantages such as high selectivity and high recovery efficiency.This article summarizes the biological effects of affinity chromatography, molecular imprinting chromatography, and dye ligands affinity chromatography.The review also encompasses the application of AC in the separation of chiral drugs,screening of active components,purification of target protein,and mechanism of the drug-protein interaction.Moreover,the prospects of its applications are also discussed.
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3D printing, as a new rapid prototyping technology, has been widely used in the aerospace, medicine, industry, cultural relics protection, and other fields. This paper made a brief summary of the study and application of 3 D printing in drug synthesis, pharmaceutical preparation, pharmaceutical analysis, and new drug research. The future applications and challenges of 3D printing technology were also discussed. This paper aims to provide a reference for the use of 3 D printing technology in the study of pharmacy.
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Due to the advantages of fast and noninvasive, requiring almost no sample preparation, supplying chemical and physical information, near infrared (NIR) spectroscopy is widely used in the pharmaceutical industry. In the life cycle of an established analytical method, rigorous validation should be performed before routine use. However,there is no detailed experimental standards or decision rules for the NIR methods validation currently, and various approaches were applied to validate the established NIR quantification models in literatures.In this paper, progress on the validation of NIR methods developed for the pharmaceutical application was reviewed, concentrating on the standard documents and main ideas of validation.It will provide references for the standardized application of NIR spectroscopy in the pharmaceutical industries.
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Acyclovir is a purine-based nucleoside antiviral agent used in the management of Herpes simplex and other viral infections. The present study is aimed at developing and validating a simple and rapid spectrophotometric method for its determination. The mechanism of the proposed method is based on the condensation/coupling reaction between Acyclovir and Ninhydrin-Ascorbic acid at pH 5. A purple colored product with maximum absorption at 540 nm was assayed to quantitatively evaluate the drug content in the formulation. The calibration curve was found to be linear up to 30 μg/ml. Analyte recovery tests carried out by the proposed method gave recovery of between 96.9 – 102.0%. Molar absorptivity and Sandells’ sensitivity were determined to be 41,071.43 L mol-1 cm-1 and 1.84 μg cm-2 respectively. The precision was assessed by determining the inter-day and intra-day variation which ranged between 1.45 – 1.63 % and 0.81 – 1.12 % respectively. The results show that the reaction produced a stable product and the proposed method is cost-effective and possesses adequate accuracy, precision and sensitivity. It can therefore be conveniently applied for the determination of acyclovir in dosage forms.
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OBJECTIVE:To investigate the reform mode of experiment teaching in pharmaceutical analysis in the new situation of vocational education and provide reference for improving the teaching quality of secondary vocational education. METHODS:The present situation of experiment teaching in pharmaceutical analysis was assessed deeply and in detail,and the problems exist-ing in teaching were analyzed;the reform plan and measures according to the disadvantages of the current teaching were raised. RE-SULTS:The experiment teaching in pharmaceutical analysis existed some problems,involving lagging textbook compilation,single teaching mode,“heavy theory,light practice”for time arrangement,obsolete laboratory apparatus and lack of advanced equipments. So a series of measures were adopted,including writing supplementary teaching materials and experimental guidance;reforming the contents of the experiment teaching;reforming the model of teaching and improving the students’participation;reforming the time arrangements;increasing the investment in laboratory equipment and attaching great importance to extramural cooperation;estab-lishing the virtual laboratory;and establishing a flexible,comprehensive and effective experimental evaluation mechanism.CON-CLUSIONS:Reform experimental teaching mode has fully mobilized the enthusiasm and initiative of students and improved the abil-ity of operating skills,and cultivated the strict scientific research style of students. The reform mode of experimental teaching in pharmaceutical analysis is in accordance with the students’learning needs of pharmaceutical majors,and lay a good foundation for the students better and faster adaption to the job.
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To realize the object of the pharmacy college education training,some teaching ideas and methods on pharmaceutical analysis course was explored.In the teaching practice,the course hour of pharmaceutical analysis was adjusted to deepen the understanding of the theoretical knowledge;the practice basic skills training was also strengthened and the professional ethics and quality education was taken throughout the course.Besides,emphasis on the systemic college education was put forward,Pharmacy college education not only be targeted in training applied technical persons but also should meet the students' need for continuing education and continue learning development.
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The article presents a comparison between microbiological and high performance liquid chromatographic (HPLC) assays for quantification of moxifloxacin in tablets, ophthalmic solutions and human plasma. The microbiological method employed a cylinder-plate agar diffusion assay using a strain of Esherichia coli ATCC 25922 as the test organism and phosphate buffer (pH8) as the diluent. The calibration curves were linear (R²> 0.98) over a concentration range of 0.125 to 16 µgml-1. The within day and between days precisions were < 4.47% and < 6.39% respectively. Recovery values were between 89.4 and 110.2%. The HPLC assay used Hypersil® BDS C18 reversed phase column (250×4.6 mm, 5µm) with a mobile phase comprising 20 mM ammonium dihydrogen orthophosphate (pH3) and acetonitrile (75:25) and flowing at 1.5 ml/min. The detection was at 295nm. The calibration curves were linear (R²> 0.999) over the range of 0.125 to 16 µg ml-1. The within day and between days precisions were < 4.07% and < 5.09% respectively. Recovery values were between 97.7 and 107.6%. Similar potencies were obtained after the analysis of moxifloxacin tablets and ophthalmic solutions by both methods. Also pharmacokinetic parameters were calculated after the analysis of plasma samples of six male healthhy volunteers by both validated methods.
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Humans , Male , Anti-Bacterial Agents , Floxacillin/analysis , Floxacillin/isolation & purification , Pharmacokinetics , Chromatography, High Pressure Liquid , Methods , Reference Standards , PatientsABSTRACT
A validated simple and selective spectrophotometric method was developed for the selective determination of amlodipine and nicardipine in bulk powders and pharmaceutical formulation. The proposed method was based on the formulation of a binary complex between either of the studied drugs and eosin Y in aqueous buffered medium. The surfactant, methylcellulose, was added to enhance the solubility of the formed complex. The binary complexes showed absorption maxima at 549 nm. The different experimental parameters affecting the development of stability of the colors were studied and optimized. Under the optimum reaction conditions, linear relationship with good correlation coefficients (0.9981 and 0.9995) were found between the absorbances and the concentrations of amlodipine and nicardipine respectively in the range of 5-60 g/ml for both drugs. The limits of detection were 1.8 and 1.2 g/ml while the limits of quantitation were 6.0 and 3.6 g/ml for both drugs respectively. The analytical parameters were fully validated and results were satisfactory. No interference was observed from the excipients that are commonly present in pharmaceutical formulations. The proposed method was successfully applied to the analysis of the cited drugs in some pharmaceutical formulations. The mean percentage recoveries were 100.04 ± 0.83 and 99.98 ± 0.80. The results obtained are reproducible with a coefficient of variation less than 2% and were in good agreement with those obtained using the reference methods.
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As the curriculum was unreasonable and teaching approac h was simple in the course of pharmaceutical analysis,the course curriculum was reconstructed and optimized to be more advanced and more scientific.Reasonable teaching approaches will be adopted according to different teaching contents and diverse teaching model which is benefit to the cultivation of students' innovative capability will be constructed.