Latest ArticlesCharged aerosol detector (CAD) is a new universal liquid chromatography detector rapidly developed in recent years. It has the advantages of high sensitivity, broad linear range, the signal response consistency independent of chemical structures, as well as the feature of simple operation. It is especially suitable for detecting substances without ultraviolet absorption. This paper briefly summarizes the working principle and detection characteristics of CAD detector and its application in the analysis fields of traditional Chinese medicine and natural products, chemical drugs, sugars, biochemical drugs, pharmaceutic adjuvant and surfactants, so as to provide reference for its better application in the liquid chromatographic analysis.
To provide recommendations for clinicians on rational use of Chinese patent medicine for treatment of heart failure, the study was conducted by systematically collecting and analyzing clinical randomized controlled trials (RCTs). Based on three international electronic databases (PubMed, Embase and Cochrane library) and three Chinese literature databases (Chinese Journal Full Text Database, Wanfang Medical Database and Chinese Science and Technology Journal Database (Weipu)), all relevant RCTs from the beginning of the establishment of each database to July 1, 2022 were included, a total of 83 proprietary Chinese medicines were retrieved, and finally 15 proprietary Chinese medicines were chosen to be recommended for treatment of heart failure, including 7 injections and 8 oral proprietary Chinese medicines. The basic information, sample size, intervention and outcome indicators of the 15 proprietary Chinese medicines were compared and analyzed, and the quality of evidence for the efficacy of the included proprietary Chinese medicines was evaluated using the GRADE classification method to assess their efficacy and safety on heart failure with reduced ejection fraction (HFrEF), heart failure with preserved ejection fraction (HFpEF) and acute heart failure (AHF). Combined with the evidence-based medicine approach, a comprehensive evaluation of 15 proprietary Chinese medicines currently in use and with sufficient evidence for the treatment of heart failure were conducted, with the intention to provide some basis for clinicians to use proprietary Chinese medicines rationally.
To explore the main active components, potential targets and mechanisms of Polygonatum in the treatment of Alzheimer's disease (AD) by using network pharmacological techniques and methods.
The active components of Polygonatum were screened in TCMSP. AD-related targets were retrieved from GeneCards database, TTD database and DrugBank database. Cytoscape 3.7.2 software was used to establish the "yellow essence-component-target" network, which was imported into STRING database to obtain the target PPI network. Key genes were screened using "CytoHubba" function, and GO biological process and KEGG pathway enrichment analysis were performed.
β-Sitosterol, baicalin, diosgenin and other active components in Polygonatum may exert an effect of prevention and treatment of AD through AKT1, CASP3, TP53, VEGFA, HIF1, mTOR and other key gene targets to regulate neurodegenerative pathways, including various diseases, PI3K-Akt signaling pathway, MAPK signaling pathway, and apoptosis signaling pathway.
Polygonatum may regulate and integrate multi-components, multi-targets and multi-pathways to achieve prevention and treatment of AD.
To study the pharmacokinetics of metformin hydrochloride tablets (manufactured by Beijing Zhongxin Pharmaceutical Co., Ltd.) and the reference preparation metformin hydrochloride tablets (trade name: Glycoran®, manufactured by Nippon Shinyaku Co., Ltd., Japan) in healthy subjects after single-dose administration under postprandial state, evaluate their bioequivalence, and observe the safety.
Thirty-six healthy subjects were randomly divided into two groups, 18 in each group. After having high-fat meal, the subjects took the test or reference preparations. Blood samples were collected at 0 h (after meal and before administration) and at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12 and 24 h after administration. Plasma levels of metformin were measured. The trial consisted of two periods of cross administration and 7-day washout period. PhoenixTM WinNonlin® 8.1 software was used to estimate the non-compartmental pharmacokinetic parameters, and SAS9.4 software was used for statistical description and bioequivalence analysis. If the 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters (Cmax, AUC0-T, AUC0-∞) of T/R were within 80.00%~125.00% equivalent interval, it was safely proved that the two preparations were bioequivalent.
One out of 36 subjects dropped-out due to adverse events. The main pharmacokinetic parameters of the test and reference preparations were as follows: Cmax were (418.42±94.72) and (399.52±79.49) ng·mL-1, AUC0-t were (3 402.04±803.32) and (3 219.06±704.13) ng·h·mL-1; AUC0-∞ (3 458.50±815.42) and (3 276.11±715.12) ng·h·mL-1. The geometric mean ratios of Cmax, AUC0-t, AUC0-∝, and their 90% confidence intervals were 103.11% (98.69%~107.72%), 104.73 (100.11%~109.57%), and 104.63% (100.03%~109.44%), respectively. All were within the bioequivalent range of 80.00%~125.00%. No serious adverse events and unexpected adverse events occurred during the trial.
The test preparation is bioequivalent to the reference preparation after a single-dose oral administration under postprandial condition in healthy Chinese subjects. The two preparations have good safety and tolerability.
Abrocitinib is a selective small-molecule Janus kinase-1 inhibitor. It was approved by the U.S. FDA for the treatment of adults with refractory, moderate-to-severe atopic dermatitis on January 14, 2022. It is the third oral JAK inhibitors for atopic dermatitis in the world, slightly later than baricitinib and upadacitinib developed by Incyte and AbbVie, respectively. Although the U.S. FDA label contains a black box warning against JAK inhibitors, safety data from clinical trials reveal a manageable tolerability and longer-term safety. This paper introduces the mechanism of action, dosage and administration, pharmacokinetics, clinical studies and safety evaluation of the drug.
To prepare and optimize the formulation of resveratrol in situ floating gel using common gel materials with high safety and good biocompatibility, in order to obtain a temperature-sensitive gel that can float and continuously release drug in bladder and can be used for bladder perfusion in chemotherapy of bladder cancer.
The gel was prepared by cold dissolution method. Poloxam 407, Poloxam 188, sodium alginate, calcium carbonate and ammonium bicarbonate were used as main excipients. Gelling temperature and gelling time were selected as the indicators to optimize the quantity of poloxamer 407, poloxamer 188 and calcium carbonate in formulation by central combination-response surface method. Temperature sensitivity, floating performance and drug releasing performance of the optimized formulation were evaluated.
The optimal formulation was composed of resveratrol 30%, Poloxam 407 17.2%, Poloxam 188 5.5%, sodium alginate 0.15%, calcium carbonate 0.06%, ammonium bicarbonate 0.15%. The gelling temperature was 28~29 ℃ and the gelling time was 50 s. The drug were released from the gel in a way of diffusion for more than 48 days.
The resveratrol in situ floating gel had the property of continuous drug release for a long time in bladder. It can be used as an alternative form of bladder perfusion chemotherapy in the treatment of bladder cancer to improve patient compliance.
In order to implement the new regulatory policy for radiopharmaceuticals and adapt to the new trend of industry and development of nuclear medicine, this research combining with the working experience of radiopharmaceutical inspection proposes, suggests on the development of inspection institutions and the effective connection between supervision and inspection using review of regulations and literature, expert interviews. It is recommended that the provincial drug inspection agencies should accelerate to expand the qualification of radiopharmaceutical inspection in order to meet the requirement of territorial supervision and solve the problems that do not match the current industrial development. It is also recommended to clarify the requirements for the initiation of production license inspection and medical institution filing inspection, further improve the working procedures for the connection between supervision and inspection, and effectively play the supporting role of inspection technology.
Camptothecin is a kind of quinoline alkaloid and is also a natural topoisomerase I inhibitor isolated from Camptotheca involucrata. After complexing with topoisomerase I-DNA, camptothecin prevents DNA replication and RNA synthesis, indicating an anti-tumor effect. Clinical studies have shown that camptothecin and its derivatives have good antitumor activity. However, the high toxicity and low bioavailability limited its clinical application. Novel drug delivery systems can make up the defects through enhancing the drug stability, bioavailability and targeting ability to improve the anti-tumor effect, which can help reduce the toxicity, and solve the problems of camptothecins to a certain extent. This paper analyzes and summarizes the research progress of camptothecin-based antitumor drug delivery systems in recent published literatures, in order to provide theoretical guidance and suggestion for the development of new preparations of camptothecins that meet the needs of clinical applications.
To analyze the characteristics of perampanel-related treatment emergent adverse events (TEAEs), providing references for clinical rational drug use.
The literatures about TEAEs caused by perampanel were retrieved from databases like CNKI, Wanfang, VIP, PubMed, ScienceDirect and Web of Science. The cases were divided into treatment group and overdose group according to the drug dose.
A total of 20 literatures including 25 cases were reported, with 14 cases in the treatment group and 11 cases in the overdose group. Most TEAEs occurred within 60 days after drug administration in the treatment group (8 cases, 32.00%), mainly involving TEAEs in mental system (7 cases, 28.00%) and nervous system (3 cases, 12.00%). The TEAEs occurred in the treatment group were relieved after withdrawal and/or symptomatic treatment. All TEAEs mainly occurred in nervous system (9 cases, 36.00%) and the mental system (5 cases, 20.00%) on the day of medication in the overdose group, among which 9 cases were completely improved, and 2 cases had sequelae after treatment.
TEAEs caused by perampanel should be paid attention to, and medication education should be strengthened to avoid the occurrence of serious TEAEs and ensure the safety of clinical medication.
Direct data capture (DDC) by means of digital health technology (DHT) has been played a significant role in the evaluation of clinical benefits in either traditional centralized clinical trials or novel decentralized clinical trials of medicinal products. As a part of e-source data, a trial execution with the regulatory compliance of the DHT is one of the challenges in clinical data flow managements. In the views of developmental trends in GCP and global regulatory and supervisory requirements, DHT applications in clinical trials should meet the validation standards of an e-clinical system, conforming to the ALCOA principle regarding the trial data flow managements with roles and qualifications of relevant stakeholders, such as sponsors, investigators and subjects. In the standpoints of project management views, this paper discusses how the DHT application is complied with regulations, rational monitoring and supervisions on the DHT data flow, and responsibilities of relevant stakeholders, ensuring the approvability of clinical outcomes on DHT-based clinical data by regulatory authorities.
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