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Determination of major boswellic acids in plasma by high-pressure liquid chromatography/mass spectrometry
Until now, dexamethasone is the medication of choice to reduce peritumoral edema associated with primary and secondary brain tumors. Because of the severe side effects accompanying such a treatment the interest in alternative agents that may be co-administered with glucocorticoids and help to reduce...
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Published in: | Journal of pharmaceutical and biomedical analysis 2011-12, Vol.56 (5), p.998-1005 |
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Main Authors: | , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
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Summary: | Until now, dexamethasone is the medication of choice to reduce peritumoral edema associated with primary and secondary brain tumors. Because of the severe side effects accompanying such a treatment the interest in alternative agents that may be co-administered with glucocorticoids and help to reduce the required dose is constantly increasing.
Boswellia serrata gum resin extracts (
BSE), which have been designated an orphan drug status by the European Medicines Agency (EMA) in 2002 for the treatment of peritumoral edema, may represent a promising supplemental herbal remedy. However, clinical studies on the effect of
BSE on brain edema as well as analyzes of serum levels are very scarce. Based on that background a prospective, placebo controlled, and double blind clinical pilot trial was conducted on 14 patients applying for the first time a high dose of 4200
mg
BSE per day and 13 patients receiving placebo. For monitoring the serum levels of all major boswellic acids (BAs) a highly sensitive HPLC–MS method has been developed that allows the determination of KBA and AKBA from 5.0
ng/ml to 3000
ng/ml and of αBA, βBA, AαBA and AβBA from 0.5
ng/ml to 12,000
ng/ml. It is the first validated method that covers such a wide concentration range, which makes it suitable to be used as standard method in clinical trials as it compensates for the great pharmacokinetic variability in the plasma levels of BAs observed in clinical practice. Average steady concentrations (ng/ml) in the range of 6.4–247.5 for KBA, 0–15.5 for AKBA, 36.7–4830.1 for αBA, 87.0–11948.5 for βBA, 73.4–2985.8 for AαBA and 131.4–6131.3 for AβBA were determined in the verum group. The here quantified steady state levels suggest βBA to be a possible candidate for the anti-inflammatory and anti-edemateous effects of
BSE. In general, the serum level analysis underlines the promising clinical results of
BSE on cerebral edema. |
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ISSN: | 0731-7085 1873-264X |
DOI: | 10.1016/j.jpba.2011.07.026 |