1.ICP-MS determination of ten elemental impurities in meglumine
Junmin LAI ; Zhifang LI ; Minshan ZENG ; Juan ZHANG ; Xiaohong YAN
Drug Standards of China 2024;25(5):452-457
Objective:To establish an ICP-MS method for the determination of 10 elemental impurities in meglu-mine(APIs).Methods:The samples were processed by closed high-pressure microwave digestion,and the con-tents of the Class 1 elemental impurities arsenic(As),cadmium(Cd),mercury(Hg)and lead(Pb),the Class 2 A elemental impurities cobalt(Co),nickel(Ni)and vanadium(V),and the Class 3 elemental impurities lithium(Li),antimony(Sb)and copper(Cu)were detected by ICP-MS with total quantification.Results:The linear correlation coefficients(r)of each elemental impurity were greater than 0.997.The recoveries of the spiked samples ranged from 93.6%to 116.8%with RSD values of the recoveries lower than 7.4%.RSD values of the precision were lower than 5.4%.The content of nickel in 11 batches of the samples was lower than the permissible daily exposure(PDE)of the impurities of the elements of category 2A in the elemental guideline of ICH Q3D(R2)for oral use but higher than that of PDE of the impurities of category 2A for injection.Conclusion:The method is sensitive and precise enough to accurately determine the levels of Class 1,2A and 3 elemental impurities in meglumine.Nine batches of meglumine were found to have a high risk of nickel residue.
2.Research in physical exercise among rural adolescents based on the theory of planned behavior in Sichuan Province
Chinese Journal of School Health 2021;42(1):41-45
Objective:
To verify the applicability of the theory of planned behavior(TPB) in the physical exercise behaviors of rural adolescents in Sichuan Province, and to explore the possible influencing factors of physical exercise behaviors, and to provide a theoretical basis for further effective intervention measures.
Methods:
A total of 2 302 students were selected from grade seven and grade ten of two rural middle schools in Zizhong, Sichuan Province. The survey was conducted with a structured questionnaire. Using TPB as the research framework and basis, the structural equation model was constructed for analysis.
Results:
Lack of physical exercise was 1 527(66.3%).Physical exercise behavior was statistically different among schools, grades(t=-7.40,-2.90,10.90,P<0.05), and genders. Based on TPB, the structural equation model was established and corrected to obtain the revised model, and the fitting index GFI=0.93, CFI=0.94, NFI=0.94, TLI=0.93, IFI=0.94,RMSEA=0.07, indicating the model fitted good. Exercise intention directly affected exercise behaviors. The standardized effect was 0.45(95%CI=0.39-0.52). Subjective norms and perceived power were the main two mediators of the relationship between value evaluation and exercise intention. The standardized effect values were 0.66(95%CI=0.57-0.73), 0.23(95%CI=0.16-0.93)(P<0.01).
Conclusion
There is serious lack of physical exercise in rural adolescents in Sichuan Province. TPB has a good applicability for physical exercise in rural adolescents in Sichuan Province. Subjective norm is the most important factors to promote exercise intentions.
3.Comparison of 1-week terbinafime hydrochloride cream, 1- and 4-week miconazole nitrate cream in the treatment of interdigital tinea pedis: a multi-center, randomized and double-blind study
Min LI ; Jianzhong ZHANG ; Jiajun WANG ; Qiangqiang ZHANG ; Hai WEN ; Jun GU ; Fanqin ZENG ; Wei LAI ; Chen YAO ; Wenjuan ZHANG ; Julin GU ; Hong XU ; Jianghan CHEN ; Xinling BI ; Junmin ZHANG ; Huaiqiu HUANG ; Ming ZHU ; Chaoying ZHANG ; Li LI ; Guixia LV ; Yongnian SHEN ; Weida LIU
Chinese Journal of Dermatology 2011;44(9):658-660
ObjectiveTo compare the efficacy and tolerability of 1-week 1% terbinafine hydrochloride cream, 1- and 4-week 2% miconazole nitrate cream in the treatment of interdigital tinea pedis, and to observe the relapse in patients treated with these regimens. MethodsA multi-center, randomized, double-blind and parallel group study was conducted. By using a stratified randomization protocol, patients were divided into 3 groups to apply terbinafine cream twice daily for 1 week and inert cream(placebo) for the next 3 weeks (1week terbinafine group), miconazole cream twice daily for 1 week and inert cream(placebo) for the next 3 weeks (1-week miconazole group), and miconazole cream twice daily for 4 weeks (4-week miconazole group),respectively. Clinical and mycological assessment was made on week 1, 3, 4, 6, 9 and 12 after the initiation of treatment. ResultsA total of 152 patients with positive baseline mycological culture were eligible for the efficacy analysis. After 4-week treatment, the mycological cure rates were 94.7%, 87.8% and 82.6%, global effective rates 89.5%, 81.6% and 63.0%, respectively for the 1-week terbinafine group, 4-week miconazole group and 1-week miconazole group. On week 12, the mycological relapse rates in 1-week terbinafine, 4-week miconazole and 1-week miconazole group were 13%, 14% and 21% respectively, and the incidence of adverse reaction was 2.38%, 2.38% and 3.57%, respectively. ConclusionsAs far as the efficacy and recurrence in patients are concerned, the 1-week terbinafine cream regimen is similar to the 4-week miconazole cream regimen for the treatment of interdigital tinea pedis.