Determination of eight active components of Bufei Huoxue Capsules in rat plasma and their pharmacokinetics by UHPLC-MS/MS / 中国中药杂志

An ultra-high performance liquid chromatography-tandem mass spectrometry(UHPLC-MS/MS) method was established to investigate the pharmacokinetic behaviors of psoralenoside, isopsoralenoside, calycosin-7-glucoside, ononin, psoralen, isopsoralen, methylnissolin, and neobavaisoflavone in rat plasma after oral administration of Bufei Huoxue Capsules. After SD rats were administered with Bufei Huoxue Capsules suspension by gavage, blood samples were collected from the inner canthus at different time points. After protein precipitation, plasma samples were separated on ACQUITY UPLC BEH C_(18) column(2.1 mm×100 mm, 1.7 μm). The mobile phase consisted of acetonitrile(A) and water(B) containing 0.1% formic acid in gradient elution. The positive and negative ions were measured simultaneously in the multi-reaction monitoring(MRM) mode. The pharmacokinetic parameters were calculated and fitted by DAS 3.2.8. Psoralenoside, isopsoralenoside, calycosin-7-glucoside, ononin, psoralen, isopsoralen, methylnissolin, and neobavaisoflavone were detected in the rat plasma after drug administration, with AUC_(0-t) of(3 357±1 348),(3 555±1 696),(3.03±0.88),(2.21±0.33),(1 787±522),(2 295±539),(5.69±1.41) and(3.40±0.75) μg·L~(-1)·h, and T_(max) of(1.56±0.62),(1.40±0.70),(0.21±0.05),(0.25±0.12),(0.26±0.11),(0.34±0.29),(0.74±0.59), and 0.25 h. The method is proved specific and repeatable and is suitable for the determination of psoralenoside, isopsoralenoside, calycosin-7-glucoside, ononin, pso-ralen, isopsoralen, methylnissolin, and neobavaisoflavone in the rat plasma, which can be applied to pharmacokinetic study.

Clinical Observation of Bufei Huoxue Capsules Combined with Azithr omycin Tablets in the Treatment of Patients with Stable COPD / 中国药房

OBJECTIVE： To observe the efficacy and safety of Bufei huoxue capsules combined with Azithromycin tablets in the treatment of patients with stable COPD. METHODS： Totally 140 patients with stable COPD were collected from Anhui Chest Hospital during Jun. 2014-Feb. 2018， and then divided into control group and observation group according to random number table， with 70 cases in each group. Both groups received smoking cessation intervention and symptomatic treatment. Control group was additionally given Tiotropium bromide powder for inhalation， once a day+Azithromycin tablets 0.25 g， twice a week. Observation group were additionally given Bufei huoxue capsules 4 pills， 3 times a day， on the basis of control group. Both groups were treated for 180 d continuously. The clinical efficacies of 2 groups were observed， and the levels of serum inflammatory factors （CRP， IL-6 and TNF-α）， lung function related indexes （PEF， FEV1 and FEV1/FVC） and COPD related symptoms （time of AECOPD attack and 6MWT） were observed before and after treatment. The occurrence of ADR was recorded. RESULTS： Totally 9 cases withdrew from the study in control group， and 3 cases in observation group. A total of 128 cases （61 cases in control group， 67 cases in observation group） completed the study. Total response rate was 92.54％ in observation group， which was significantly higher than 80.33％ in control group（P＜0.05）. Before treatment， there was no statistical significance in the levels of serum inflammatory factors， lung function related indexes or COPD related symptoms （P＞0.05）. After treatment， the levels of CRP， IL-6 and TNF-α in 2 groups were decreased significantly， and the times of AECOPD attack were decreased significantly； observation group was significantly lower or less than control group. PEF， FEV1 and FEV1/FVC were increased significantly in 2 groups and 6MWT was prolonged significantly； observation group was significantly higher or longer than control group （P＜0.05）. One case suffered from skin rash in control group， and two cases had mild nausea in observation group； no severe ADR was found in both groups. CONCLUSIONS： Bufei huoxue capsules combined with Azithromycin tablets can significantly reduce the level of serum inflammatory factors of stable COPD patients， improve their lung function， and relieve clinical symptoms with good safety.