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1.
Detpon Preechagoon Viroj Sumyai Suvatna Chulavatnatol Poj Kulvanich Thanee Tessiri Khanittha Tontisirin Thaned Pongjanyakul Verawan Uchaipichat Sirikul Aumpon Chaiyasit Wongvipaporn 《AAPS PharmSciTech》2010,11(3):1449-1455
The objectives of this study were to develop morphine sulfate sustained-release tablet formulations and to evaluate the bioequivalence
compared with a commercial brand. The physicochemical properties of the formulated and commercial tablets were determined
and compared. The bioequivalence investigation was carried out in 15 healthy male volunteers who received a single dose in
a randomized two-way crossover design. After dosing, serial blood samples were collected for a period of 24 h. Morphine concentration
was assayed by high-performance liquid chromatography with electrochemical detector. The log-transformed C
max and AUCs were statistically compared by analysis of variance, and the 90% confidence intervals (CIs) of the ratio of the log-transformed
C
max and AUCs between the most promising developed formulation and the commercial product were determined. It was found that the dissolution
rate profile of a developed formulation was similar to the commercial brand. Their similarity and difference factors were
well within limits. In the bioequivalence study, the AUClast and AUCinf between the test and the reference products were not statistically different (p = 0.227 and p = 0.468, respectively), with the 90% CIs of 83.4–102.6% and 87.7–139.4%, respectively. However, the C
max of the two formulations was significantly different (p = 0.019). The 90% CI of the developed formulation was 72.0–93.0% compared to the commercial product. In vitro dissolution of locally prepared morphine sulfate sustained-release tablets was comparable to commercial brand. However, the
results justified the conclusion of lack of bioequivalence of the developed product to the commercial one. 相似文献
2.
Jain SK Jain RK Chourasia MK Jain AK Chalasani KB Soni V Jain A 《AAPS PharmSciTech》2005,6(1):E35-E41
The aim of the present study was to design a depot delivery system of acyclovir sodium using multivesicular liposomes (MVLs)
to overcome the limitations of conventional therapies and to investigate its in vivo effectiveness for sustained delivery.
MVLs of acyclovir were prepared by the reverse phase evaporation method. The loading efficiency of the MVLs (45%–82%) was
found to be 3 to 6 times higher than conventional multilamellar vesicles (MLVs). The in vitro release of acyclovir from MVL
formulations was found to be in a sustained manner and only 70% of drug was released in 96 hours, whereas conventional MLVs
released 80% of drug in 16 hours. Following intradermal administration to Wistar rats, the MVL formulations showed effective
plasma concentration for 48 hours compared with MLVs and free drug solution (12–16 hours). Cmax values of MVL formulations were significantly less (8.6–11.4 μg/mL) than MLV and free drug solution (12.5 μg/mL). The AUC0–48 of the MVL formulations was 1.5- and 3-fold higher compared with conventional liposomes and free drug solution, respectively.
Overall, formulations containing phosphatidyl glycerol as negatively charged lipid showed better results. The MVL delivery
system as an intradermal depot offers the advantage of a very high loading and controlled release of acyclovir for an extended
period of time. The increase in AUC and decrease in Cmax reflects that the MVL formulations could reduce the toxic complications and limitations of conventional IV and oral therapies.
Published: September 20, 2005 相似文献
3.
V. Ostry F. Malir T. Roubal J. Skarkova J. Ruprich M. Cerna E. E. Creppy 《Mycotoxin Research》2005,21(1):49-52
AFM1 was determined in 72 (72%) samples of human urine, range 19-6064 pg/g creatinine, mean 367 pg/g creatinine, median 158 pg/g
creatinine and 90% percentile 755 pg/g creatinine in 1997. AFM1 was determined in 46 (43.8%) samples of human urine, range 21-19219 pg/g creatinine, mean 414 pg/g creatinine, median 96
pg/g creatinine and 90% percentile 415 pg/g creatinine in 1998. OTA was determined in 2077 (94.2%) samples of human serum,
range 0.1–13.7 μg/L, mean 0.28 μg/L, median 0.2 μg/L and 90% percentile 0.5 μg/L in 1994–2002. OTA was determined in 12 (40%)
samples of human kidneys, range 0.1–0.2 μg/kg, mean 0.07 μg/kg, and median 0.05 μg/kg in 2001.
Presented at the 26th Mykotoxin-Workshop in Herrsching, Germany, May 17–19, 2004. 相似文献
4.
Fusarium toxins are secondary metabolites produced byfungi of these genera in many commodities under certain conditions. A study was carried out to investigate the co-occurrence of
zearalenone (ZEN), deoxynivalenol (DON) and fumonisins (FB1 and FB2) in 52 samples of mixed-feed for poultry contaminated withFusarium verticillioides. The zearalenone and deoxynivalenol were checked using immunoaffinity column and the extraction of fumonisin was performed
by strong anion exchange (SAX) solid phase column. Detection and quantification were determined by high performance liquid
chromatography (HPLC). The limit of detection was 5 μg/kg for ZEN, 100 μg/kg for DON and 50 and 100 μg/kg for FB1 and FB2 respectively.Fusarium toxins were detected in 20 samples. Sixteen samples were positive for ZEN (30.7%) presenting levels that ranged from 7.4
μg/kg to 61.4 μg/kg (mean=27.0 μg/kg). 13.5% of the samples presented contaminations of DON, with levels ranging from 100.0
μg/kg to 253 μg/kg (mean=l18.07 μg/kg). FB1 was detected in 19.2% of samples, with levels ranging from 50.0 μg/kg to 110.0 μg/kg (mean=73.6 μg/kg). FB2 was not detected
in any sample. In positive samples simultaneously contamination with two or three mycotoxins were detected in 9 of them (17.3%). 相似文献
5.
Mucosal crude microsomes, prepared from proximal rat small intestine, exhibited significant Mg-dependent, Zn-ATPase activity;
V
max
= 23 μmoles Pi/mg protein/hr, K
m
= 160 nm, and Hill Coefficient, n= 1.5. Partial purification (∼10-fold) was achieved by detergent extraction, and centrifugation through 250 mm sucrose: V
max
= 268 units, K
m
= 1 nm, and n= 6. In partially purified preparations, the assay was linear with time to 60 min, and with protein concentration to 1 μg/300
μl. Activities at pH 8 and 8.5 were higher than at pH 7.2. The ATP K
m
was 0.7 mm, with an optimal ATP/Mg ratio of ∼2. Ca elicited ATPase activity but did not augment the Zn-dependent activity. In partially
purified preparations, the homologous salts of Co, Cd, Cu, and Mn exhibited no detectable activity. Vanadate inhibition studies
yielded two component kinetics with a K
i
of 12 μm for the first component, and 96 μm for the second component, in partially purified preparations. Tissue distribution analyses revealed gradients of activity.
In the proximal half of the small intestine, Mg/Zn activity increased progressively from crypt to villus tip. In long axis
studies, this activity decreased progressively from proximal to distal small bowel.
Received: 12 September 2000/Revised 6 January 2001 相似文献
6.
We studied the enhanced production of high quality biomass, δ-aminolevulinic acid (δ-ALA), bilipigments, and antioxidants
from five tropical blue green algae (cyanobacteria) in a full factorial design using free and immobilized cells in batch culture.
Production of nutraceuticals was high in spray dried powder prepared from immobilized cell cultures. Nostochopsis lobatus showed superiority over rest of the species with respect to bilipigments, δ-ALA, nutritive value, antioxidant capacity, and
ascorbate oxidase (APX) activity. Antioxidative capacity of phycobiliproteins extracted from these cyanobacteria (121.15 μM
TE/g, Nostoc verrucosum to 217.62 μM TE/g, Nostochopsis lobatus) was invariably higher than those observed for higher plant sources and substantially increased under immobilized cell culture
condition. Antioxidative enzyme, ascorbate oxidase remained stable in dry food preparations with considerably high activity
under immobilized cell preparations (APXmax, 3.40 μmol/min/mg chlorophyll). These observations have important connotations in light of upcoming food and nutraceutical
industries in the global market. Use of immobilized cells in batch culture could be an effective approach for scaling up production
for commercial use. 相似文献
7.
Hydrogen sulfide degradation characteristics of Bordetella sp. Sulf-8 in a biotrickling filter 总被引:1,自引:0,他引:1
Grace M. Nisola Enkhdul Tuuguu Danvir Mark D. Farnazo Mideok Han Younghee Kim Eulsaeng Cho Wook-Jin Chung 《Bioprocess and biosystems engineering》2010,33(9):1131-1138
The applicability of Bordetella sp. Sulf-8 to degrade Hydrogen Sulfide (H2S) gas in a biotrickling system was investigated. The isolate is a heterotrophic gram-negative, catalase- and oxidase-positive,
rod-shaped bacterium which can metabolize thiosulfate or sulfide into sulfate. The mesophilic Bordetella sp. Sulf-8 can grow within a wide pH range using yeast as carbon source, with or without the presence of sulfur. In batch
experiments, kinetic constants such as maximum specific growth rate (μ
max = 0.12 1/h), saturation constant (K
S = 0.017 g/L), and specific sulfur removal rate (88 mg S/g cells h) were obtained. In biotrickling experiments removal efficiencies
were satisfactory, but the system performance was observed to be more influenced by empty bed residence time than by H2S feed gas concentration. Critical and maximum elimination capacities were 78.0 and 94.5 g H2S/m3 day, respectively. Macrokinetic analysis of the biotrickling system revealed maximum H2S removal rate V
max = 15.97 g S/kg media-day and half saturation constant K
S′ = 12.45 ppmv. 相似文献
8.
Shahzad Zafar Iqbal R. Russell M. Paterson Ijaz A. Bhatti Muhammad R. Asi 《Mycotoxin Research》2011,27(2):75-80
A comparison was made of total aflatoxins (AFs) in 43 samples of chilies collected during winter and 42 in summer to determine
the effect of season on contamination. The samples were analyzed by HPLC with fluorescence detection. The limits of detection
and quantification for AFB1 and AFG1 were 0.05 μg/kg and 0.50 μg/kg, whilst for AFG2 and AFB2 they were 0.10 μg/kg and 0.60 μg/kg. In the winter samples, AFs were detected in 18 (72%) whole and 14 (60%) ground chilies,
with concentration ranges 0.00-52.30 μg/kg and 0.00-74.60 μg/kg respectively. In the summer samples, 17 (64%) whole and 12
(76%) ground chilies were contaminated with AFs at concentrations 0.00-61.50 μg/kg and 0.00-95.90 μg/kg respectively. The
percentage of samples greater than the European Union statutory limit for AFB1 and total AF for whole chilies were 48 and 36%, compared with ground chili values of 50 and 45%, respectively, in the winter
season. In the summer season, the samples greater than the European Union limit for AFB1 and total AF in whole chilies were 52 and 38%, compared with values of 54 and 49% in ground chilies respectively. AF contamination
was found to be higher in summer chili samples and hence winter chilies may provide a better quality product with respect
to AF contamination. The ability to undertake this analysis in Pakistan will enhance greatly the ability to improve chili
production in that country, as described herein. 相似文献
9.
Preparation and characterization of epoxy-functionalized magnetic chitosan beads: laccase immobilized for degradation of reactive dyes 总被引:1,自引:0,他引:1
Gulay Bayramoglu Meltem Yilmaz M. Yakup Arica 《Bioprocess and biosystems engineering》2010,33(4):439-448
Cross-linked magnetic chitosan beads were prepared by phase-inversion technique in the presence of epichlorohydrin under alkaline
condition, and used for covalent immobilization of laccase. The activity of the immobilized laccase on the magnetic chitosan
was about 260 U (g/dry beads) with an enzyme loading of about 16.33 ± 0.39 mg [(g/dry beads) mg/g]. Kinetic parameters, V
max and K
m values were determined as 21.7 U/mg protein and 9.4 μM for free enzyme, and 15.6 U/mg protein and 19.7 μM for the immobilized
laccase, respectively. The operational and thermal stabilities of the immobilized laccase were improved compared to free counterpart.
The immobilized laccase was operated in a batch reactor for the decolorization of reactive dyes from aqueous solution. The
laccase immobilized on magnetic chitosan beads was very effective for removal of textile dyes from aqueous solution which
creates an important environmental problem in the discharged textile dying solutions. 相似文献
10.
Etodolac (ET) is a nonsteroidal anti-inflammatory drug with proved potential antitumor and uric acid lowering effects. It
shows dissolution rate-dependent bioavailability. This work was carried out to improve the dissolution rate of etodolac using
three carriers of known potential to improve solubility and hence dissolution rate of poorly soluble drugs through coevaporation
technique. The polymeric surfactant inutec, 2-hydroxypropyl-β-cyclodextrin, and tromethamine were used at three different
drug/carrier ratios. The dissolution rate of ET at pH 1.2 and 6.8 is improved in all of the solid dispersion systems compared
to that of the pure drug and physical mixtures. DSC of coevaporates at 1:5 drug/carrier ratio providing the fastest dissolution
rate suggested loss of ET crystallinity which was further confirmed by X-ray diffraction. Inutec-based coevaporate was chosen
for the formulation of ET chewable tablets. Chewable tablets (F3) that met the USP monograph specifications for ET tablets,
with 86% dissolved amount within 15 min, was chosen for in vivo absorption study in comparison with pure ET-filled hard gelatin capsules. The results showed significantly higher mean C
max and shorter mean T
max (about 2 h earlier) and about 1.32-fold higher mean AUC0–24 values for the F3 chewable tablets compared to ET-filled capsules. 相似文献
11.
Roya Talari Jaleh Varshosaz Saied Abolfazl Mostafavi Ali Nokhodchi 《AAPS PharmSciTech》2010,11(2):786-792
The low water-solubility of gliclazide (GL) leads to a low dissolution rate and variable bioavailability. The aim of this
study was to investigate the effect of micronization on the absorption and pharmacokinetics of GL after oral administration
in rats. GL microcrystals were prepared using solvent-change and pH-shift methods. Scanning electron microscopy showed considerable
changes in the shape and size of crystals using both methods. In the optimized formulation of each method, the particle size
of treated GL was reduced about 30 (from 290 to 9.9 μm) and 61 times (to 4.76 μm) by solvent-change and pH-shift methods,
respectively. Recrystallized samples showed faster dissolution rate than untreated GL particles. Glucose-lowering effect,
C
max, and area under the drug concentration-time profile (area under the curve (AUC)) were compared in diabetic and normal rats.
AUC and C
max were increased by microcrystals in both groups of animals. Administration of 40 mg/kg of GL in the form of untreated drug
and microcrystals obtained by solvent-change and pH-shift methods caused 12.49% and 21.04% enhancement in glucose-lowering
effect of GL in diabetic rats, respectively. 相似文献
12.
Cometabolic biodegradation of methyl t-butyl ether by Pseudomonas aeruginosa grown on pentane 总被引:1,自引:0,他引:1
A bacterial strain identified as Pseudomonas aeruginosa was isolated from a soil consortium able to mineralize pentane. P. aeruginosa could metabolize methyl t-butyl ether (MTBE) in the presence of pentane as the sole carbon and energy source. The carbon balance for this strain, grown
on pentane, was established in order to determine the fate of pentane and the growth yield (0.9 g biomass/g pentane). An inhibition
model for P. aeruginosa grown on pentane was proposed. Pentane had an inhibitory effect on growth of P. aeruginosa, even at a concentration as low as 85 μg/l. This resulted in the calculation of the following kinetic parameters (μmax = 0.19 h−1, K
s = 2.9 μg/l, K
i = 3.5 mg/l). Finally a simple model of MTBE degradation was derived in order to predict the quantity of MTBE able to be degraded
in batch culture in the presence of pentane. This model depends only on two parameters: the concentrations of pentane and
MTBE.
Received: 16 July 1998 / Received revision: 11 November 1998 / Accepted 31 November 1998 相似文献
13.
Paula Macedo Cerqueira Evandro Jos Cesarino Fabiano Henrique Mateus Yussif Mere Silvia Regina Cavani Jorge Santos Vera Lucia Lanchote 《Chirality》1999,11(7):591-597
In the present study we investigated the enantioselectivity in the pharmacokinetics of metoprolol administered in a multiple‐dose regimen as the racemate. The study was conducted on 10 patients of both sexes with mild to severe essential hypertension, aged 28 to 76 years, with normal hepatic and renal function and phenotyped as extensive metabolizers of debrisoquine (urine debrisoquine to 4‐hydroxydebrisoquine ratios of 0.28 to 6.56). The patients were treated with racemic metoprolol (two 100 mg tablets every 24 h) for 7 days. Serial blood samples were collected at times zero, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 22, and 24 h and urine at each 6 h period until 24 h after metoprolol administration. The plasma concentrations of the (−)‐(S)‐ and (+)‐(R)‐metoprolol enantiomers were determined by HPLC using a chiral stationary phase (Chiralpak AD, 4.6 × 250 mm) and fluorescence detection. The enantiomeric ratios differing from one were evaluated by the paired t test and the results are reported as means (95% CI). No differences were observed between metoprolol enantiomers in half‐lives and absorption, distribution and elimination rate constants. However, the following differences (p < 0.05) were observed between the (−)‐(S) and (+)‐(R) enantiomers: maximum plasma concentration, Cmax, 179.99 (123.33–236.64) versus 151.30 (95.04–207.57) ng/mL; area under the plasma concentration versus time curve, AUC, 929.85 (458.02–1401.70) versus 782.11 (329.80–1234.40) ng h/mL; apparent total clearance, ClT/f, 1.70 (0.79–2.61) versus 2.21 (1.06–3.36) L/h/kg, apparent distribution volume, Vd/f, 10.51 (6.35–14.68) versus 13.80 (6.93–20.68) L/kg, and renal clearance, ClR, 0.06 (0.05–0.08) versus 0.07 (0.05–0.09) L/kg. The enantiomeric ratios AUC(−)‐(S)/AUC(+)‐(R) ranged from 1.14 to 1.44, with a mean of 1.29. The data obtained demonstrate enantioselectivity in the kinetic disposition of metoprolol, with plasma accumulation of the pharmacologically more active (−)‐(S)‐metoprolol enantiomer in hypertensive patients phenotyped as extensive metabolizers of debrisoquine. Chirality 11:591–597, 1999. © 1999 Wiley‐Liss, Inc. 相似文献
14.
Inês Almeida Hermínia Marina Martins Sara Santos José M. Costa Fernando Bernardo 《Mycotoxin Research》2011,27(3):177-181
A total of 404 samples of commercial swine feed from Portugal feed mills were analysed by HPLC methods for the presence of
mycotoxins: 277 samples of feed for fattening pigs were analysed for ochratoxin A (OTA), zearalenone (ZEA), and deoxynivalenol
(DON), and 127 samples of feed for sows were analysed for ZEA and fumonisins (FB1 + FB2). Concerning feed for fattening pigs, 21 (7.6%) samples were positive for OTA, (2–6.8 μg/kg), 69 (24.9%) were positive for
ZEA (5–73 μg/kg), and 47 (16.9%) were positive for DON (100–864 μg/kg). In feed for sows, the results showed 29.9% of positive
samples for ZEA (5–57.7 μg/kg) and 8.7% positive samples for FB1 and FB2 (50–391.4 μg/kg). Co-occurrence of DON/ZEA was found most frequently, but simultaneous contamination with OTA/ZEA and OTA/DON
was also found. 相似文献
15.
Amin Osman Elzupir Amar O. A. Salih Suliman A. Suliman Ali A. Adam Abdelrahim M. Elhussein 《Mycotoxin Research》2011,27(3):183-186
Forty-three peanut butter samples from Khartoum State, Sudan, were analyzed for aflatoxins (AFs, AFB1 + AFB2 + AFG1 + AFG2) using high performance liquid chromatography (HPLC) with fluorescence detection after extraction with methanol:water (8:1,
v/v) and clean-up using chloroform. All samples were contaminated with AFs, with total AF levels ranging between 26.7 and
853 μg/kg, and a mean total AF level of 287 ± 200.5 μg/kg. The highest concentrations were found for AFB1, (28 positive samples, maximum 534 μg/kg), while AFG1 was most frequently detected (43 positive samples, maximum 401 μg/kg). AFB2 (42 positive samples, maximum 3.2 μg/kg) and AFG2 (4 positive samples, maximum 30 μg/kg) were also present in these samples. The mean AF contamination levels found in this
study exceeded by far all international regulations concerning maximum levels for this group of toxins. From the data, it
is concluded that the levels of AF contamination in peanut butter from the Kartoum area are quite alarming, and may pose serious
health hazards to consumers. Therefore, an intervention strategy to manage AF in peanut butter is urgently needed. 相似文献
16.
Jayne Byakika-Tusiime Leslie W. Chinn Jessica H. Oyugi Celestino Obua David R. Bangsberg Deanna L. Kroetz 《PloS one》2008,3(12)
Background
Generic antiretroviral therapy is the mainstay of HIV treatment in resource-limited settings, yet there is little evidence confirming the bioequivalence of generic and brand name formulations. We compared the steady-state pharmacokinetics of lamivudine, stavudine and nevirapine in HIV-infected subjects who were receiving a generic formulation (Triomune®) or the corresponding brand formulations (Epivir®, Zerit®, and Viramune®).Methodology/Principal Findings
An open-label, randomized, crossover study was carried out in 18 HIV-infected Ugandan subjects stabilized on Triomune-40. Subjects received lamivudine (150 mg), stavudine (40 mg), and nevirapine (200 mg) in either the generic or brand formulation twice a day for 30 days, before switching to the other formulation. At the end of each treatment period, blood samples were collected over 12 h for pharmacokinetic analysis. The main outcome measures were the mean AUC0–12h and Cmax. Bioequivalence was defined as a geometric mean ratio between the generic and brand name within the 90% confidence interval of 0.8–1.25. The geometric mean ratios and the 90% confidence intervals were: stavudine Cmax, 1.3 (0.99–1.71) and AUC0–12h, 1.1 (0.87–1.38); lamivudine Cmax, 0.8 (0.63–0.98) and AUC0–12h, 0.8 (0.65–0.99); and nevirapine Cmax, 1.1 (0.95–1.23) and AUC0–12h, 1.1 (0.95–1.31). The generic formulation was not statistically bioequivalent to the brand formulations during steady state, although exposures were comparable. A mixed random effects model identified about 50% intersubject variability in the pharmacokinetic parameters.Conclusions/Significant Findings
These findings provide support for the use of Triomune in resource-limited settings, although identification of the sources of intersubject variability in these populations is critical. 相似文献17.
The present study aimed to investigate the pharmacokinetic properties of febuxostat in healthy Chinese male volunteers and evaluate whether the two formulations of febuxostat 40-mg and 80-mg tablets are bioequivalent. A randomized, open-label, 4-way crossover study was conducted in healthy Chinese male volunteers under fasting conditions. 24 eligible subjects were randomized in a 1:1:1:1 ratio to receive a single dose of test or reference formulation of febuxostat 40-mg or 80-mg tablet. The washout period between each administration was 1 week. Plasma febuxostat was quantified by a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Tolerability was evaluated by monitoring adverse events, physical examinations, 12-lead ECG and laboratory tests. After single-dosing of 1 tablet of 40-mg febuxostat, the pharmacokinetic parameters of test and reference formulations were: Tmax 1.22±0.87 and 1.85±1.03 h, Cmax 1689.16±461.31 and 1613.80±608.43 ng·mL-1, AUC0-t 5139.87±1349.28 and 5517.91±2024.26 ng·mL-1·h, AUC0−∞ 5263.06±1339.16 and 5640.48±2040.22 ng·mL-1·h, t1/2 4.82±2.61 and 4.85±1.78 h, respectively. After single-dosing of 1 tablet of 80-mg febuxostat, the pharmacokinetic parameters of test and reference formulations were: Tmax 1.71±1.21 and 2.23±1.55 h, Cmax 2744.47±1157.44 and 2998.17±1200.13 ng·mL-1, AUC0-t 9634.03±2768.25 and 10467.95±3501.65 ng·mL-1·h, AUC0−∞ 9834.32±2730.51 and 10626.63±3504.08 ng·mL-1·h, t1/2 6.25±2.44 and 5.46±1.65 h, respectively. For single-dosing of 1 tablet of 40-mg febuxostat, 90% CIs for the test/reference ratio of AUC0-t, AUC0−∞ and Cmax were 89.79 to 102.55, 90.14 to 102.56 and 93.99 to 129.63, respectively. For single-dosing of 1 tablet of 80-mg febuxostat, 90% CIs for the test/reference ratio of AUC0-t, AUC0−∞ and Cmax were 86.67 to 100.00, 87.50 to 100.51 and 79.48 to 105.99, respectively. This single dose study revealed similar pharmacokinetic properties in healthy Chinese male volunteers as those found in Caucasic population. The test and reference febuxostat tablets formulations met the regulatory criteria for bioequivalence at 40-mg and 80-mg strengths in fasting healthy Chinese male volunteers.Trial Registration: Chictr.org ChiCTR-TTRCC-14004288 相似文献
18.
S. A. Ghiasian M. R. Aghamirian A. H. Maghsood G. S. Shephard L. van der Westhuizen 《Mycotoxin Research》2009,25(1):25-28
Fumonisins, fungal toxins found primarily in maize and produced by various Fusarium species, have been shown to cause a variety of significant adverse health effects in livestock and experimental animals,
and are probable human carcinogens. Thirty-three maize samples were collected at ports from bulk shipments, which were imported
into Iran from six countries during 2001–2002, and analysed by HPLC for the most abundant of the naturally occurring fumonisin
analogues, namely fumonisins B1 (FB1), B2 (FB2) and B3 (FB3). Of the 33 samples, 21 (64%) were found to contain FB1 (58–512 μg/kg) at levels above 10 μg/kg. The frequency of FB1 found in maize samples imported from Uruguay and Canada was 75%, followed by China and Argentina (67%), USA (60%), and Brazil
(50%). The average FB1 level was 266 and 169 μg/kg for positive and all samples, respectively. Medians were 250 and 146 μg/kg for positive and all
samples, respectively. FB2 levels ranged from not detected (<10 μg/kg) to 53 μg/kg, whereas no sample had an FB3 level above the detection level (10 μg/kg). This is the first report of fumonisin contamination of imported maize in Iran.
Although, the level of all detected fumonisins were below the Iranian and FDA tolerance levels for foods and feeds, It is
necessary to maintain the strict rules to ensure continued safety of imported maize. 相似文献
19.
An effective and timesaving analytical method was developed for the determination of 12 ergot alkaloids (ergometrine, ergotamine,
ergocristine, α-ergokryptine, ergosine, ergocornine, and their respective -inine isomers) in rye and rye flour. Samples were
extracted with dichloromethane/ethyl acetate/methanol/aqueous ammonia (25%) (50/25/5/1, v/v/v/v), and extracts were purified
using a basic alumina column. The eluate was dried in the nitrogen stream and redissolved in acetonitrile/ ammonia carbamate-buffer
(0.2 g/1), (1/1, v/v), and injected into an HPLC-FLD system (λEx 330 nm, λEm 415 nm), using the same mixture as mobile phase and a Phenyl-Hexyl column. Detection limits for the individual compounds
ranged from 0.01 μg/kg to 0.5 μg/kg. In sample material spiked with a mixture of these compounds at two different levels (13
μg/kg and 27 μg/kg per compound), mean (n=5) recoveries were at 101% (sr 6.4%) and 89% (sr 3.1%), respectively.
Presented at the 28th Mykotoxin-Workshop, Bydgoszcz, Poland, May 29–31, 2006 相似文献
20.
The Alternaria mycotoxin tenuazonic acid (TA) was quantified in fruit juices (n = 50), cereals (n = 12) and spices (n = 38) using a recently developed stable isotope dilution assay (SIDA). [13 C6,15 N]-TA was used as the internal standard. Method validation revealed low limits of detection (LODs) of 0.15 μg/kg (fruit juices),
1.0 μg/kg (cereals) and 17 μg/kg (spices). The respective limits of quantitation were about three times higher. Recovery was
about 100% for all matrices. The precision (relative standard deviation of replicate analyses of naturally contaminated samples)
was 4.2% (grape juice; 1.7 μg/kg), 3.5% (whole wheat flour; 36 μg/kg) and 0.9% (curry powder; 215 μg/kg). The median content
of TA in the analyzed samples was 1.8 μg/kg (fruit juices), 16 μg/kg (cereals) and 500 μg/kg (spices). Positive samples amounted
to 86% (fruit juices), 92% (cereals) and 87% (spices). 相似文献