To establish the 14th batch of national reference standards for histamine phosphate.

Histamine phosphate was identified using infrared spectroscopy and bioactivity assay. Its hygroscopicity, moisture content, and uniformity were also examined. Using the 13th batch of national reference standard for histamine phosphate as the standard, 4 laboratories were selected to conduct collaborative calibration of the potency of the reference standard using the cat blood pressure method.

The final combined potency of this batch of standard products was determined to be 97.8%.

This batch of reference materials can be used as the 14th batch of national reference materials for histamine phosphate, with a relative potency set at 100%, batch numbers 150510-202214.

To mine the security alert signals of risk signals of adverse drug events (ADEs) associated with post-marketing use of avacopan based on the FDA Adverse Event Reporting System (FAERS) database. The findings are intended to provide a reference for clinical safety in medication practices.

The study collected ADE reports related to Apixaban from the FAERS database for the period of Q4 2021 to Q2 2024. Potential safety signals associated with Apixaban were identified using various methodologies, including reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS). Weber distribution test was used to determine the occurrence rule of ADE. The reporting odds ratio was used to estimate the relative risk of arvaracopam ADE in different genders.

A total of 6 519 ADE reports involving 2 730 patients with avacopan as the primary suspected drug were collected, and 75 avacopan ADE signals were mined involving 15 systems. ADE occurs mostly within 30 days after administration of avacopan. Consistent with the description in the package insert, ADEs of hepatobiliary system, infection and infection system were commonly observed. In addition, ADEs such as epistaxis, pulmonary hemorrhage, pharyngeal swelling and deep vein thrombosis were not included in the package insert. The analysis of gender differences in the risk signals associated with arvalacopam revealed that female patients were more susceptible to conditions such as jaundice, pulmonary vasculitis, esophageal candidiasis, cheilitis, Escherichia coli urinary tract infection, etc. In contrast, male patients were more likely to have dental hypersensitivity, pulmonary hemorrhage, elevated serum ferritin, and cardiac pacemaker implantation.

In the real-world application of avacopan, it is essential to focus on the ADE related to the hepatobiliary system, respiratory system, thoracic and mediastinal systems, as well as infectious conditions. Additionally, appropriate strategies should be implemented based on gender differences to mitigate the occurrence of ADEs.

To investigate the intestinal absorption characteristics of harmine derivative H-2-168 using Caco-2 cells model and in situ single-pass intestinal perfusion method.

The Caco-2 cell monolayer model and in situ single pass intestinal perfusion model of rat were established. The concentrations of H-2-168 in cell permeation fluid and intestinal perfusion fluid were determined by HPLC. The changes of apparent permeability coefficient (P_app) of H-2-168 in Caco-2 cell model and those of absorption rate constant (K_a) and P_app in in situ single pass intestinal perfusion model of rat under different influence factors (intestinal segment, concentration, pH and P-glycoprotein inhibitor) were investigated.

In Caco-2 cell model, P_app values at medium and high concentrations of H-2-168 were significantly higher than that at low concentration (P<0.05), but P_app at high concentration was slightly lower than that at medium concentration, showing a high concentration saturation phenomenon. H-2-168 was absorbed in the whole intestine of rats, with K_a and P_app decreased significantly with the increase of drug concentration (P<0.05). K_a and P_app at pH 7.4 were significantly higher than those at pH 5.4. There were no significant changes in the absorption parameters before and after the addition of P-glycoprotein inhibitor (P>0.05).

H-2-168 is a well-absorbed drug, and its absorption mechanism may involve active transport or facilitated diffusion, and it is not a substrate of P-glycoprotein.

To set up the quality standards of Reyihan granules.

The identification items for Ocimi basilici Fructus, Roses rugosae Flos, Nardostachyos radlx Et Rhizoma, and Foeniculi fructus were established using TLC. The characteristic chromatogram was established, and the contents of gallic acid and rosmarinic acid in Reyihan granules were determined using HPLC.

The TLC identification method for Ocimi basilici Fructus, Roses rugosae Flos, Nardostachyos radlx Et Rhizoma, Foeniculi fructus had clear spots, with no interference from negative controls. There were 35 characteristic peaks in the HPLC characteristic chromatogram of Reyihan granules. Through comparison with reference standards, 13 compounds were identified. Gallic acid showed a good linear relationship within the range of 1.303 2~13.032 0 μg·mL^-1 (r=0.999 7), with an average recovery rate of 97.23% and an RSD of 1.20% (n=6). Rosmarinic acid showed a good linear relationship within the range of 2.462 4~24.624 0 μg·mL^-1 (r=0.999 3), with an average recovery rate of 102.79% and RSD of 1.10% (n=6).

This method has strong specificity, good repeatability and stability, and can achieve quality control of Reyihan granules.

To systematically evaluate the efficacy and safety of ferrous succinate tablets in the treatment of iron deficiency anemia during pregnancy.

Retrieved from PubMed, Embase, Cochrane Library, CNKI, Wanfang, randomized controlled trials (RCTs) about ferrous succinate versus polysaccharide iron complex capsules and ferrous sulfate tablets in the treatment of anemia during pregnancy and different dosage forms of ferrous succinate tablets for the treatment of iron-deficiency anemia in pregnancy were collected from January 2016 to April 2024. Meta-analysis was performed using RevMan 5.3 and Stata 17.0 software.

A total of 47 RCTs were retrieved with 6 655 patients. Results of meta-analysis showed that ferrous succinate tablets were significantly better than ferrous sulfate tablets in terms of overall efficacy [OR=4.65, 95%CI (3.68,5.88), P<0.000 01] and incidence of adverse reactions (P<0.05). There was no statistical significance in total response rate [OR=1.47，95％CI (0.45，4.79)，P=0.52] and specific adverse effect rates (P>0.05) between ferrous succinate tablets and polysaccharide iron complex capsules. The overall effectiveness and total incidence of adverse drug reactions in ferrous succinate sustained-release tablets were significantly better than that of ferrous succinate film-coated tablets.

The efficacy and safety of ferrous succinate tablets in treating iron deficiency anemia in pregnancy are both good.

To compare the effects of methylphenidate sustained-release tablets and atomoxetine on sleep in patients with attention deficit hyperactivity disorder (ADHD).

A total of 70 patients with ADHD were enrolled and randomly divided into methylphenidate sustained-release tablets (MPH) and atomoxetine (ATX) treatment groups according to a random number table. Overnight polysomnography (PSG) was performed at baseline and the end of 2 and 6 weeks of medication.

Totally 48 patients with ADHD (23 in the MPH group, 65.7%; 25 in the ATX group, 71.4%) completed a total of 3 PSGs. At baseline, there was no significant difference in the values of each sleep parameter between the MPH group and the ATX group (P>0.05). At the end of 2 weeks, the sleep onset latency (SOL), REM onset latency (ROL) of the MPH group were longer than those of the ATX group; the REM time was shorter than that of the ATX group; the sleep efficiency SE (%) was worse than that of the ATX group, and the differences were statistically significant (P<0.05 for all). At 6 weeks, there was no significant difference in SOL, ROL, REM time and sleep efficiency SE (%) between the MPH group and the ATX group (P>0.05). The percentage of total sleep time (%TST) for N1, N2, N3 and R stages and the number of awakenings and wake after sleep onset WASO were not significantly different between the two groups (P>0.05).

Compared with the ATX group, the MPH group had a certain negative impact on the sleep condition of ADHD patients after 2 weeks of medication. There was no obvious difference in the effect on sleep between the two drugs after 6 weeks of continuous treatment. There was a certain correlation between the improvement of ADHD core symptoms and the improvement of sleep. Both MPH and ATX can be used as first-line drugs for treating ADHD patients with comorbid sleep problems.