Translation and psychometric testing of the simplified version of the health-related diet and exercise self-efficacy scale in China.

BACKGROUND: Measuring health-related diet and exercise self-efficacy is an important first step in improving healthy behaviors and health outcomes. However, we did not find a self-efficacy measurement in Chinese that is specifically targeted at diet and exercise self-efficacy among healthy adults. AIM: The present study aimed to translate the Health-Related Diet and Exercise Self-Efficacy Scale -simplified version into Mandarin Chinese (HRDESES) and evaluate its reliability and validity in Chinese healthy adults. METHODS: The HRDESES was translated and adapted to the Chinese context, with a good content validity of 0.86 among seven experts. The survey was then carried out in 216 adults in Hunan, China. Testing of the reliability included internal consistency reliability and test-retest reliability, while validity included content validity, construct validity, and criterion validity. RESULTS: The Cronbach's α of the HRDESES was 0.87 for the total scale, 0.86 for the diet subscale and 0.91 for the exercise subscale; the McDonald's ω of the HRDESES-SC was 0.85 for the total scale, 0.86 for the diet subscale and 0.91 for the exercise subscale, all demonstrating good internal consistency. The test-retest reliability was 0.88 for the total scale, 0.81 for the diet subscale and 0.82 for the exercise subscale, demonstrating good test-retest reliability. For construct validity, the scale effectively distinguished subjects by age, gender, education, occupation, marital status, and family income, showing good discriminant validity. The confirmatory factor analysis (CFA) supported a two-factor structure of the scale: diet and exercise subscale. It was demonstrated that the HRDESES was highly associated with the General Self-Efficacy Scale and its two subscales, with correlation coefficients ranging from 0.83 to 0.86 (p < 0.05), showing high criterion validity. CONCLUSION: The HRDESES had good reliability and validity and could be used as a simple and effective tool for assessing the health-related diet and exercise self-efficacy in Chinese healthy adults.

Inflammatory and immune-related factor Caspase 1 contributes to the development of oral lichen planus.

OBJECTIVE: In this study, we aimed at underlying the potential regulatory mechanism and overall biological functions of caspase 1 (CASP1) in oral lichen planus (OLP). DESIGN: Buccal mucosa tissue samples were gained from healthy subjects or patients diagnosed with OLP. Immunochemical staining was applied to detect CASP1 in OLP tissues. Lipopolysaccharide (LPS) was used to construct OLP in vitro models. Cell counting kit-8 (CCK-8) and flow cytometry assay were applied to detecte cell viability and apoptosis. RESULTS: The upregulation of CASP1 in OLP has been identified through comprehensive bioinformatics analysis and verified in clinical samples. In OLP tissues, inflammation-related factors, including tumor necrosis factor alpha (TNF-α), interleukin (IL)-1ß, IL-6, and IL-18, were elevated and positively correlated with CASP1. In HaCaT cells, LPS stimulation induced CASP1 upregulation, suppressed cell viability, facilitated cell apoptosis, and elevated the levels of TNF-α, IL-1ß, IL-6, and IL-18; silencing of CASP1 attenuated LPS-induced damages to HaCaT cells. Pearson's correlation analysis identified that 45 immune-related genes were positively correlated with CASP1; these 45 genes were enriched in the immune system process, associated with combined immunodeficiency, and spleen-specific and CD56 + NK cell-specific. PPI network among CASP1 and correlated immune-related factors was constructed, and CASP1 was positively correlated with RAC2, CYBB, and ARHGDIB. In HaCaT cells, LPS stimulation induced RAC2, CYBB, and ARHGDIB expression, whereas knocking down CASP1 attenuated LPS-induced increases in RAC2, CYBB, and ARHGDIB. CONCLUSION: CASP1 is upregulated in OLP tissues. Knockdown of CASP1 in HaCaT cells could protect HaCaT cells from LPS-induced inflammatory injury. Comprehensive bioinformatics indicates that the interaction of CASP1 with RAC2, CYBB, and ARHGDIB, might be the potential molecular mechanism.

Identification of related substances in tofacitinib citrate by LC-MS techniques for synthetic process optimization.

A specific LC-MS method was developed for separation, identification and characterization of the process-related substances and degradation products in tofacitinib citrate. The separation was achieved on a LiChrospher C18 column (250mm×4.6mm, 5µm) by linear gradient elution of 0.1% ammonium acetate solution (pH adjusted to 4.0 by formic acid) and acetonitrile at a flow rate of 1.0mL/min. Forced degradation studies were conducted under hydrolytic (acidic, basic), oxidative, photolytic and thermal stress conditions as described in ICH. It was found that tofacitinib was stable under photolytic condition, but degraded obviously in acidic, basic, thermal and oxidative conditions. The high resolution TOF-MS and MS/MS were used for determination and structural identification of the related substances. Eleven major related substances were detected and identified as five process-related substances and six degradation products, and three of them were further synthesized and characterized by NMR spectroscopy. The most plausible mechanisms involved in the formation of the related substances were also proposed. Since related substances have a significant impact on drug safety, quality and efficacy, the data obtained are valuable for process monitoring and quality assurance of tofacitinib citrate.

[Identification of related substances in nicergoline by HPLC-MS].

To study the related substances in nicergoline, electrospray positive ionization high resolution TOF/MS was used for the determination of the accurate mass and elemental composition of the related substances. Triple quadrupoles tandem MS/MS was employed for the determination of the fragmentations of the parent ions. 16 related substances were detected and identified to be eight synthetic by-products and eight degradation products, by using impurity references matching, product mass spectra fragmentations elucidation, and verified further according to synthetic processes and stress testing results. The results obtained are valuable for nicergoline manufacturing process control and quality assurance.

Stability profiling of anti-malarial drug piperaquine phosphate and impurities by HPLC-UV, TOF-MS, ESI-MS and NMR.

BACKGROUND: Piperaquine, 1,3-bis-[4-(7-chloroquinolyl-4)-piperazinyl-1]-propane, is an anti-malarial compound belonging to the 4-aminoquinolines, which has received renewed interest in treatment of drug resistant falciparum malaria in artemisinin-based combination therapy with dihydroartemisinin. The impurity profile of this drug product is paid an ever-increasing attention. However, there were few published studies of the complete characterization of related products or impurities in piperaquine phosphate bulk and forced degradation samples. METHODS: The impurities in piperaquine phosphate bulk drug substance were detected by a newly developed gradient phase HPLC method and identified by TOF-MS and ESI-MS. The structures of impurities were confirmed by NMR. Forced degradation studies were also performed for the stability of piperaquine phosphate bulk drug samples and the specificity of the newly developed HPLC method. In silico toxicological predictions for these piperaquine phosphate related impurities were made by Toxtree® and Derek®. RESULTS: Twelve impurities (imp-1-12) were detected and identified, of which eight impurities (imp-1, 2, 4, 6-10) were first proposed as new related substances. Based on TOF-MS/ESI-MS and NMR analysis, the structures of imp-2, 6 and 12 were characterized by their synthesis and preparation. The possible mechanisms for the formation of impurities were also discussed. These piperaquine phosphate related impurities were predicted to have a toxicity risk by Toxtree® and Derek®. CONCLUSIONS: From forced degradation and bulk samples of piperaquine phosphate, twelve compounds were detected and identified to be piperaquine phosphate related impurities. Two of the new piperaquine phosphate related substances, imp-2 and imp-6, were identified and characterized as 4-hydroxy-7-chloro-quinoline and a piperaquine oxygenate with a piperazine ring of nitrogen oxide in bulk drug and oxidation sample, respectively. The MS data of imp-1, 2, 4, 6-10 were first reported. The in-silico toxicological prediction showed a toxicity risk for piperaquine related impurities by Toxtree® and Derek®.