Comparative analysis of the activity and content of different streptokinase preparations

Hermentin, P.; Cuesta-Linker, Thomas; Weisse, Joerg; Schmidt, Karl‐Heinz; Knorst, Marion; Scheld, Michael; Thimme, Michael

doi:10.1093/eurheartj/ehi093

Cited by 34 publications

(22 citation statements)

References 16 publications

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“…This was demonstrated in a comparative study by Hermentin et al (2005), in which they compared the activities of 16 different SK preparations and found that only three fulfilled the minimum requirements of the European Pharmacopoeia (Hermentin et al 2005;Thimme, 2005).…”

Section: Purification and Activity Of R-skmentioning

confidence: 95%

Expression of recombinant Streptokinase from local Egyptian Streptococcus sp. SalMarEg

El-Sohaimy¹,

Aleem²,

Hafez³

et al. 2011

Afr. J. Biotechnol.

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Streptokinase (SK) is a therapeutically important thrombolytic agent. Cardiovascular disease is the first cause of adult death worldwide. In Egypt about 13% of the population die every year due to ischemic heart disease. In spite of this fact, there is no local production of cardiovascular therapeutics. We reported for the first time the expression of a recombinant SK from a local Streptococcus strain. When produced on industrial scale this r-SK may substantially contribute to reducing the costs of thrombolytic therapy in developing countries. In this study, a highly purified r-SK from Streptococcus sp. isolated from Egyptian pharyngitis patients was obtained. The isolated strain was partially identified using 16S rDNA sequencing and named Streptococcus sp. SalMarEg. It was found to be phylogenetically related to Streptococcus pyogenes. Analysis of the obtained sequence showed high similarity with other SK genes. The protein expression in a prokaryotic system obtained a 47-kDa SK protein that could be purified using a single-step his-tagged affinity purification chromatography, with nearly 80% recovery. The clot lytic activities of both recombinant and commercial SK were similar, thus giving the basis to scale up this SK product in order to evaluate the possibilities of its commercialization in local and/or regional markets.

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Section: Purification and Activity Of R-skmentioning

confidence: 95%

Expression of recombinant Streptokinase from local Egyptian Streptococcus sp. SalMarEg

El-Sohaimy¹,

Aleem²,

Hafez³

et al. 2011

Afr. J. Biotechnol.

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“…The information given specifies the acceptable limits for the amount of the API that should be present in a given formulation. However, many examples from a range of drug classes have been published of over/underconcentration of APIs in marketed drugs (see Table ). In some cases, all sampled antibiotics or antimalarials were found to contain API concentrations outside the officially specified limits .…”

Section: Defective Drug Formulationmentioning

confidence: 99%

Substandard drugs: a potential crisis for public health

Johnston

Holt

2014

Brit J Clinical Pharma

212

175

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Poor-quality medicines present a serious public health problem, particularly in emerging economies and developing countries, and may have a significant impact on the national clinical and economic burden. Attention has largely focused on the increasing availability of deliberately falsified drugs, but substandard medicines are also reaching patients because of poor manufacturing and quality-control practices in the production of genuine drugs (either branded or generic). Substandard medicines are widespread and represent a threat to health because they can inadvertently lead to healthcare failures, such as antibiotic resistance and the spread of disease within a community, as well as death or additional illness in individuals. This article reviews the different aspects of substandard drug formulation that can occur (for example, pharmacological variability between drug batches or between generic and originator drugs, incorrect drug quantity and presence of impurities). The possible means of addressing substandard manufacturing practices are also discussed. A concerted effort is required on the part of governments, drug manufacturers, charities and healthcare providers to ensure that only drugs of acceptable quality reach the patient.

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“…Sixteen preparations of STK available world-wide for clinical use were compared by a SCSA and SDS-PAGE electrophoresis showing wide variations of the activities, purity and composition [10]. Potencies of different preparations of STK were also evaluated by the euglobulin lysis test and the SCSA, showing significant variations between the products available for clinical use [11].…”

Section: Introductionmentioning

confidence: 99%

Validation of the Chromogenic Bioassay for the Potency Assessment of Streptokinase in Biopharmaceutical Formulations

2015

J Anal Bioanal Tech

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JABT, an open access journal and quantitation limits, were multiplied by the ratio of the standard deviation of the intercept and the slope, respectively. The QL was also evaluated in an experimental assay. Robustness:The robustness of an analytical procedure refers to its ability to remain unaffected by small and deliberate variations in method parameters and provides an indication of its reliability for the routine analysis. The robustness of the SCSA was determined by analyzing the same samples containing 1 500 000 IU/mL and 750 000 IU/mL, respectively, under a variety of conditions of the assay parameters, such as: reaction time with plasminogen (5, 10 and 15 minutes), reaction time with substrate chromogenic (1, 2 and 3 minutes), pH of buffer solution (pH 7.4, 7.7 and pH 8.0), assay temperature (34, 37, 40°C) and stability of the analytical solution at 2-8°C.

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Comparative analysis of the activity and content of different streptokinase preparations

Abstract: There are wide variations in the activity, purity, and composition of the available streptokinase preparations.

Cited by 34 publications

References 16 publications

Expression of recombinant Streptokinase from local Egyptian Streptococcus sp. SalMarEg

Expression of recombinant Streptokinase from local Egyptian Streptococcus sp. SalMarEg

Substandard drugs: a potential crisis for public health

Validation of the Chromogenic Bioassay for the Potency Assessment of Streptokinase in Biopharmaceutical Formulations

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