Toxicological evaluation of the red mold rice extract, ANKASCIN 568-R: 13-week chronic toxicity, and genotoxicity studies.

ANKASCIN 568-R is an extract derived from red mold rice (RMR) fermented using Monascus purpureus NTU 568. RMR fermented using M. purpureus NTU 568 prevents cardiovascular diseases and decreases blood lipid levels. This study evaluates the safety of ANKASCIN 568-R, since it has not determined yet. After daily oral ANKASCIN 568-R for 13 consecutive weeks, we evaluated the toxicity tolerance of Sprague-Dawley rats and performed dose formulation analysis on monascin and ankaflavin. The dose formulation analysis showed that ANKASCIN 568-R concentrations were lower than the target concentration and out of range ( ± 15%) at week 8 and on the last dosing day for both monascin (all dose groups) and ankaflavin at the 100 mg/kg dose. The lowest reported concentrations for the low, middle, and high dose formulations were 34.7, 115.2, and 398.1 mg/mL, respectively. We also evaluated the genotoxicity of ANKASCIN 568-R and showed no genotoxicity potential at all ANKASCIN 568-R doses investigated. The no observed adverse effect level of ANKASCIN 568-R was determined to be 796.2 mg/kg/day. This study revealed the first toxicity evaluation data of ANKASICN 568-R, and the data demonstrated ANKASICN 568-R was safe and can be used in daily life.

Ergonomic approach for pillow concept design.

Sleep quality is an essential factor to human beings for health. The current paper conducted four studies to provide a suitable pillow for promoting sleep quality. Study 1 investigated the natural positions of 40 subjects during sleep to derive key-points for a pillow design. The results suggested that the supine and lateral positions were alternatively 24 times a night, and the current pillows were too high for the supine position and too low for lateral positions. Study 2 measured body dimensions related to pillow design of 40 subjects to determine pillow sizes. The results suggested that the pillow height were quite different in supine position and lateral position and needed to take into consideration for a pillow design. Study 3 created a pillow design based on the results of above studies. The pillow was a U-form in the front of view in which the pillow height in the middle area was lower for the supine position, and both sides were higher for the lateral positions. Study 4 assessed sleep quality of 6 subjects by using the proposed pillows and the current pillows. The results showed that the newly designed pillow led to significantly higher sleep quality, and the new design received an innovation patent.

Body dimension measurements for pillow design for Taiwanese.

Study reported a pillow with a uniform height was not suitable for sleeping in supine and lateral positions. The study aims to determine the pillow dimensions for fitting supine and lateral positions for Taiwanese. Ten females and ten males subjects with a mean age of 21.9 years (SD= 1.07 years) participated in the study. Body dimensions of head, neck and shoulder in crown and sagittal planes were measured with the Martins' anthropometer and a curve measurer to determine the pillow's sizes. The results showed that the basic form of pillow for both genders is a U form from the front view. The middle area of the pillow is for supine position and the both side areas are for lateral positions. The base of pillow is a rectangle from the top view. The pillow is designed with a width of 75 and 70 cm for male and female, and a depth of 40 and 35 cm for male and female. The height in middle area and both side are 4 and 14 cm for male, and 2 and 12 cm for female. A neck rest with a height of 1.5 cm was proposed for neck support.

Effects of treadmill running on rat gastrocnemius function following botulinum toxin A injection.

Exercise can improve and maintain neural or muscular function, but the effects of exercise in physiological adaptation to paralysis caused by botulinum toxin A has not been well studied. Twenty-four rats were randomly assigned into control and treadmill groups. The rats assigned to the treadmill group were trained on a treadmill three times per week with the running speed set at 15 m/min. The duration of training was 20 min/session. Muscle strength, nerve conduction study and sciatic functional index (SFI) were used for functional analysis. Treadmill training improved the SFI at 2, 3, and 4 weeks (p = 0.01, 0.004, and 0.01, respectively). The maximal contraction force of the gastrocnemius muscle in the treadmill group was greater than in the control group (p < 0.05). The percentage of activated fibers was higher in the treadmill botox group than the percentage for the control botox group, which was demonstrated by differences in amplitude and area of compound muscle action potential (CMAP) under the curve between the groups (p < 0.05). After BoNT-A injection, treadmill improved the physiological properties of muscle contraction strength, CMAP amplitude, and the recovery of SFI.

Preliminary evaluation of acute toxicity of (188) Re-BMEDA-liposome in rats.

Liposomes can selectively target cancer sites and carry payloads, thereby improving diagnostic and therapeutic effectiveness and reducing toxicity. To evaluate therapeutic strategies, it is essential to use animal models reflecting important safety aspects before clinical application. The objective of this study was to investigate acute radiotoxicity of ¹88Re-N,N-bis (2-mercaptoethyl)-N',N'-diethylethylenediamine (BMEDA)-labeled pegylated liposomes (¹88Re-BMEDA-liposome) in Sprague-Dawley rats. Rats were administered with ¹88Re-BMEDA-liposome, normal saline as blank or non-radioactive liposome as vehicle control via intravenous injection and observed for 14 days. Examinations were conducted with respect to mortality, clinical signs, food consumption, body weight and hematological and biochemical analyses. In addition, gross necropsy, histopathological examinations and cytogenetic analyses were also performed. None of the rats died and no clinical sign was observed during the 14-day study period. Rats administered with ¹88Re-BMEDA-liposome at dosage of 185 MBq displayed a significant weight loss compared with the control from study day (SD) 1 to SD 4, and the white blood cell count reduced to 5-10% of initial value (female: 18.55 ± 6.58 to 0.73 ± 0.26 x 10³ µl⁻¹; male: 14.52 ± 5.12 to 1.43 ± 0.54 x 10³ µl⁻¹) 7 days-post injection, but were found to have recovered on SD 15. There were no significant differences in biochemical parameters and histopathological assessments between the ¹88Re-BMEDA-liposome-treated and control groups. The frequencies of dicentric chromosomes were associated with dosage of ¹88Re-BMEDA-liposome. The information generated from this study on acute toxicity will serve as a safety reference for further subacute toxicity study in rats and human clinical trials.

Evaluation of endotoxin retention by adsorptive-based filtration media.

Control of endotoxin contamination is an important issue in pharmaceutical and bioprocess manufacturing. Endotoxins can contaminate process intermediates used in pharmaceutical formulations, aqueous- and non-aqueous-based CIP fluids used in equipment and vial cleaning, and process fluids such as buffers used for chromatographic elution, diafiltration, and suspension of therapeutic protein-based drugs. A study was undertaken to evaluate the effectiveness of adsorptive-based depth and membrane filtration media in removing suspended endotoxin. The following variables were examined in order to determine their effects on endotoxin reduction: absorptive media type, residence time (flux), challenge solution pH, and interferences in endotoxin reduction as the result of challenge solution composition-water for injection, process buffer, and the presence of protein. The endotoxin removal capacities of the various media studied were also determined. The results of the study demonstrated differences in the effect on endotoxin removal of the variables evaluated. In addition, the results provide a strategy for conducting studies to select and validate an appropriate adsorptive filter media for control of endotoxin contamination.