Abstract：
:The IgG activities of antigen recognition, Fc-mediated complement activation and cellular Fcγ-receptors (FcγRs) binding are critical for intravenous immunoglobulin (IVIg) immunotherapy in a variety of immune deficiency diseases. Further, these activities could be influenced by different plasma sources and the IVIg manufacturing processes of different manufacturers. This study evaluated and compared the biological activities of IgG in 7 IVIg preparations produced by different Chinese manufacturers. By using ELISA and two-dimensional immunoblotting, the binding capacity and antibody repertoire of IVIg against typical pathogenic antigens were investigated. Further, Fc-mediated complement activation and receptor binding activities were measured by the haemolysis method and flow-cytometric assay respectively. The results showed that all of the preparations tested have a broad spectrum of antibodies against the E. coli O157:H7 proteome, and each IVIg has its own distinct antibody repertoire. Compared to the European Pharmacopoeia IgG standard, the mean indices of the pathogenic antigen binding capacity, complement activation activity and FcγRs binding activity in Chinese preparations were 152%, 143% and 87%. The biological activities varied widely among the 7 IVIg preparations, and no significant differences were observed between the different batches of most IVIgs from the same manufacturer. This study will contribute to the improvement of the IVIg product quality evaluation system and an increased understanding of the variety of IgG biological activities in Chinese IVIg preparations.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Ye S,Li D,Liu F,Lei M,Jiang P,Wang Z,Zhang R,Du X,Cao H,Ma L,Li Cdoi
10.1016/j.jpba.2018.01.021subject
Has Abstractpub_date
2018-03-20 00:00:00pages
317-323eissn
0731-7085issn
1873-264Xpii
S0731-7085(17)32770-Xjournal_volume
151pub_type
杂志文章abstract：:Three extraction methods for analysis of podophyllotoxin and its derivatives from Linum species were compared. No statistical difference on the percentage of recovery were found between the methods. The "glycosidase-method" showed the best result with respect to the accuracy studies; the "acetone-method" has an advant...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.01.016
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abstract：:This study reports the first ever development and validation of a quantification method for a lantibiotic in plasma. This method was developed for the quantification of total MU1140 in Sprague Dawley rat plasma. The procedure involved acidification of plasma samples with formic acid followed by precipitation of plasma...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2008.12.022
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abstract：:A method is presented for the direct determination of mephenoxalone and acetaminophen in combined pharmaceutical dosage forms without prior separation. The first method, derivative-differential spectrophotometry, comprised of measurement of the difference absorptivities derivatized in the first order (deltaD1) of a ta...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00157-0
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abstract：:A micellar electrokinetic capillary chromatography method was developed for the separation and determination of aliphatic congeners of bis(amidinohydrazones) in standard solution. Eight bis(amidinohydrazones) could be determined in less than 15 min at an applied voltage of 22 kV, using 0.05 M sodium phosphate as buffe...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(92)80081-w
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abstract：:An analytical methodology using square wave voltammetry (SWV) at a hanging mercury drop electrode (HMDE) was developed for the quantitative determination of dipyridamole (DIP), a drug used for the treatment of several cardiovascular diseases, in pharmaceutical tablets and injections of Persantin in phosphate buffer (p...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2004.09.011
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abstract：:A micro-bore liquid chromatographic method was developed for the simultaneous determination of benazepril hydrochloride and hydrochlorothiazide in pharmaceutical dosage forms. The use of a BDS C-18 micro-bore analytical column, results in substantial reduction in solvent consumption and increased sensitivity. The mobi...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00195-8
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abstract：:Macrocyclic antibiotics are present in an increasing number of chiral separation applications. In this study, erythromycin and some derivatives, belonging to the group of macrolide antibiotics, were investigated for their potential as chiral selector. Erythromycin A itself and five related substances namely erythromyc...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2003.11.004
更新日期：2004-03-10 00:00:00
abstract：:Platycladi Cacumen (PC) is a traditional Chinese medicine used for the treatment of hemorrhages, cough, asthma and hair loss. To get a better understanding of the chemical constituents in PC, ultra-high performance liquid chromatography coupled with electrospray ionization quadrupole time-of-flight tandem mass spectro...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2018.03.005
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abstract：:A rapid clean-up procedure based on solid-phase extraction (SPE) and HPLC determination of lincomycin in premixes with UV detection is described. After extraction of lincomycin from premix with extraction solvent the extract is applied to OASIS HLB column treated with methanol and water. Lincomycin is eluted with meth...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2005.07.041
更新日期：2006-03-03 00:00:00
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journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(99)00010-2
更新日期：1999-06-01 00:00:00
abstract：:This paper describes a new liquid chromatography-tandem mass spectrometric (LC-MS/MS) method for the analysis of three stanozolol metabolites (16β-hydroxystanozolol, 3'-hydroxystanozolol, and 4β-hydroxystanozolol) in urines of animal origins. The solid-phase extraction (SPE) clean-up procedure was optimized to reduce ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2013.08.019
更新日期：2014-01-01 00:00:00
abstract：:Tramadol is a centrally acting analgesic drug used in veterinary and human clinical practice. Its metabolism has been largely characterized in human being but is still long to be comprehended in several animal species, especially in the dog. The aim of the present study was to develop and validate a new analytical pro...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2010.03.016
更新日期：2010-10-10 00:00:00
abstract：:Topical formulations are medications applied locally on the skin to treat ailment. They are made up of complex mixtures of active ingredients and excipients. Till date, no analytical method has been found in literature that is able to simultaneously analyze volatile and semi-volatile actives present in topical formula...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.03.057
更新日期：2019-07-15 00:00:00
abstract：:The new guidelines of the United States pharmacopeia (USP), European pharmacopeia (EP) and international conference on harmonization (ICH) regulating elemental impurities limits in pharmaceuticals signify the end of unspecific analysis of metals as outlined in USP 〈231〉. The new guidelines specify both daily doses and...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2017.06.045
更新日期：2017-10-25 00:00:00
abstract：:Acute lung injury (ALI) is a common and complex inflammatory disease, which has been reasonably associated with carboxyl-containing metabolites in our preliminary non-targeted metabolomic strategy. Qingzao Jiufei Decoction (QZJFD), a classic prescription, is widely used in the treatment of pulmonary inflammatory injuri...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113463
更新日期：2020-09-10 00:00:00
abstract：:Optimization of extraction and chromatographic conditions is essential for the simultaneous analysis of drugs having different physico-chemical properties, especially for in vivo applications. The present work describes concurrent estimation of metformin (MET) and three sodium-glucose co-transporter 2 (SGLT-2) inhibit...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.112790
更新日期：2019-10-25 00:00:00
abstract：:Cadmium (Cd) has toxic effect in human body and exists as the inorganic (Cd2+) and organic (R-Cd) forms in human biological matrix. Due to cadmium toxicity in various forms, the speciation of cadmium in human blood samples is very important. In this study, the Fe3O4-supported naphthalene-1-thiol- functionalized graphe...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2020.113455
更新日期：2020-09-10 00:00:00
abstract：:Biomarkers have emerged as an important tool to optimize the benefit/risk ratio of therapeutics. The scientific impact of biomarker studies is directly related to the quality of the underlying data. It is therefore important that guidance be established for validation of assays used to support drug development. This p...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2011.03.033
更新日期：2011-07-15 00:00:00
abstract：:Standard-size (4 mm ID) and micro-HPLC columns (0.5 mm ID) packed with a quinine-based ion-exchange type chiral stationary phase are comparatively evaluated for the separation of peptide enantiomers with up to six amino acid residues. The results show that downscaling the separation system in order to gain the advanta...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(02)00521-6
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abstract：:An integrated strategy based on characteristic fragment filter (CFF) supplemented by multivariate statistical analysis (MSA) for MSn chromatograms [(CFF)s MSA] was proposed for the large-scale detection of natural plant-derived ingredients in vivo. To prove the practicability of this [(CFF)s MSA] strategy, rhubarb was...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.05.049
更新日期：2019-09-10 00:00:00
abstract：:A simple and sensitive high-performance liquid chromatographic method for the determination of piperacillin in plasma is described. A C8 reversed-phase column was used with a mobile phase consisting of methanol-water-triethylamine (550:450:4, v/v/v) adjusted to pH = 3 with orthophosphoric acid and UV detection at 270 ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(91)80142-v
更新日期：1991-01-01 00:00:00
abstract：:An electroanalytical study of the oxidation of Novalgin (dipyrone) at a glassy carbon electrode in aqueous solution has been carried out. A flow-injection method with amperometric detection based on this oxidation process is also described. The influence of flow rate, coil length and injection volume on the sensitivit...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(94)e0033-w
更新日期：1994-09-01 00:00:00
abstract：:Liquid chromatography-ion-spray mass spectrometry was used to elucidate the structures of the decomposition products of salbutamol. The best sensitivity in mass spectrometry was achieved by using a mixture of acetonitrile and ammonium formate (10 mM, pH 3.3) as the mobile phase in liquid chromatography. Fragmentation ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/0731-7085(93)e0001-4
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abstract：:The identification of spatial structures of drugs and the researches on their interaction mechanism with DNA are always attractive to the researchers. However, their realization is lack of simple and fast method. This paper reports the establishment of multiple-functional detection platform based on the "turn off-on" ...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2016.11.033
更新日期：2017-02-05 00:00:00
abstract：:The relationship of glutamate acid decarboxylase (GAD) activity with the reaction products was developed. It was based on incubating sodium glutamate substrate (S) with GAD enzyme (E) when the enzyme-substrate-complex (ES) product was obtained along with gamma aminobutyric acid (GABA) and unreacted sodium glutamate. T...
journal_title：Journal of pharmaceutical and biomedical analysis
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doi：10.1016/s0731-7085(98)00140-x
更新日期：1999-05-01 00:00:00
abstract：:Cyto-architectural diversity of brain structures emphasizes need for analytical tools for discriminative investigation of distinctive neural structures. Glycogen is the major energy reserve in the brain. There is speculation that brain utilization of this fuel source may affect detection of hypoglycemia. To evaluate s...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.112884
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abstract：:The current work describes the development and validation of a simple, efficient, and fast method using solid phase microextraction coupled to liquid chromatography-tandem mass spectrometry (SPME-LC-MS/MS) for the concomitant measurement of eight beta-blockers and bronchodilators in plasma and urine. The presented ass...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
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更新日期：2016-08-05 00:00:00
abstract：:A study was performed to compare the pharmacokinetics of major bioactive analytes in rhubarb plants to explore the pharmacological differences between raw pieces (RP) and steamed pieces (SP) of rhubarb. A rapid and efficient ultra-performance liquid chromatographic coupled with mass/mass spectrometry (UPLC-MS/MS) meth...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/j.jpba.2019.04.002
更新日期：2019-07-15 00:00:00
abstract：:The diuretic drug indapamide has been characterized voltammetrically at carbon paste electrodes by means of cyclic and differential pulse voltammetry. An adsorptive stripping method at carbon paste electrode modified with castor oil for trace determination of indapamide was described. A study of the variation of the p...
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(00)00457-x
更新日期：2001-01-01 00:00:00
abstract：:The electrochemical reduction of meloxicam has been studied at a mercury electrode using various electrochemical methods in aqueous solutions over a wide pH range. The reduction of the drug produced a single reduction step in acidic media, whereas in slightly acidic and neutral media two reduction steps were observed....
journal_title：Journal of pharmaceutical and biomedical analysis
pub_type： 杂志文章
doi：10.1016/s0731-7085(01)00528-3
更新日期：2002-02-01 00:00:00
