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AIM: To evaluate the bioequivalence of the test and reference formulations of mycophenolate mofetil capsule in Chinese healthy male subjects under fasting and fed conditions. METHODS: This was a 2-treatment, 2-sequence, 4-period, fully replicated crossover study that included 80 Chinese healthy male subjects (40 subjects in the fasting group and 40 subjects in the fed group, respectively). Subjects were assigned to receive a single oral administration of the test or reference formulation at a dose of 0.25 g in each period. The plasma concentration of mycophenolate mofetil (MMF) and metabolite mycophenolic acid (MPA) were analyhed by LC-MS/MS. The major pharmacokinetic parameters of MMF and MPA were calculated using non-compartmental analysis by WinNonlin 8.0. The statistical analysis was performed by SAS 9.4. Average bioequivalence (ABE) analysis was applied where it has been demonstrated that the within-subject standard deviation of the reference formulation (S
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Objective To observe the effect ofTanreqinginjection combined with routine medicines on the treatment of senile patients with bronchial pneumonia.Methods A total of 146 patients were randomly divided into 2 groups according to the random number table, each group 73 patients. Control group was treated with routine medicines and treatment group was added 20 mlTanreqing once a day. All treatments lasta total of 7 days. The Th17 and Treg cells were detected by cytometry analysis. The expression of IL-17, IL-10, IL-6, and TNF-α were detected by ELISA analysis. The clinical effect and adverse effect of the two groups were compared. Results After treatment, the clinical effective rate of control group was 79.5% (58/73), which was significantly lower than that of 91.8% (67/73) in treatment group (χ2=2.406,P=0.045). After treatment, Th17 cells was significantly lower in the treatment group than that in the control group (5.16% ± 1.24%vs. 8.22% ± 1.84%;t=2.564,P=0.017); but Treg cells was significantly higher in the treatment group than that in the control group (6.32% ± 1.79%vs. 4.32% ± 1.23%;t=2.552,P=0.021). The expression of IL-17 (11.43 ± 2.52 ng/mlvs. 14.15 ± 2.61 ng/ml,t=2.684), IL-6 (12.47 ± 2.16 ng/mlvs. 15.58 ± 3.12 ng/ml,t=2.564), and TNF-α (25.43 ± 4.27 ng/ml vs. 32.55 ± 6.14 ng/ml,t=2.594) was significantly lower in the treatment group than those in the control group. However, the expression of IL-10 (10.07 ± 2.13 ng/mlvs. 7.94 ± 1.83 ng/ml;t=2.673,P=0.023) was significantly higher in the treatment group than that in the control group. The temperature decreased time (4.57 ± 1.24 dvs. 3.25 ± 0.92 d,t=2.628), cough disappeared time (7.53 ± 2.13 dvs.6.14 ± 1.59 d,t=2.416), pulmonary rales disappeared time (6.81 ± 1.82 dvs.5.17 ± 1.06 d,t=2.537) was significantly lower in the treatment group than those in the control group.Conclusions TheTanreqing injection combined with routine western medicine could regulate Th17/Treg cells balance in the senile patients with bronchial pneumonia, and showed the significantly clinical effect.
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With the expansion of herbal medicine (HM) market, the issue on how to apply up-to-date analytical tools on qualitative analysis of HMs to assure their quality, safety and efficacy has been arousing great attention. Due to its inherent characteristics of accurate mass measurements and multiple stages analysis, the integrated strategy of liquid chromatography (LC) coupled with time-of-flight mass spectrometry (TOF-MS) and ion trap mass spectrometry (IT-MS) is well-suited to be performed as qualitative analysis tool in this field. The purpose of this review is to provide an overview on the potential of this integrated strategy, including the review of general features of LC-IT-MS and LC-TOF-MS, the advantages of their combination, the common procedures for structure elucidation, the potential of LC-hybrid-IT-TOF/MS and also the summary and discussion of the applications of the integrated strategy for HM qualitative analysis (2006-2011). The advantages and future developments of LC coupled with IT and TOF-MS are highlighted.