Expert consensus on the technical specifications of the in vitro skin penetration test of cosmetic product by Franz diffusion cell

Background:Diffusion cell test is one of the most commonly used in vitro model to detect the percutaneous absorption of cosmetic ingredients.Although PRC State Administration of Quality Supervision and Quarantine has issued the guideline for the in vitro test method for the percutaneous absorption of drug molecules,there is still a lack of guideline for the percutaneous absorption test of cosmetic components.Objective:In order to improve the standardized level and make the in vitro percutaneous absorption test of cosmetic ingredients more comparable,based on the international and domestic experience,Transdermal Drug Delivery Committee of the World Federation of Chinese Medicine Societies organized the experts to discuss and formed this consensus as reference for the percutaneous absorption test of cosmetic components.Materials and Methods:To standardize the in vitro diffusion cell test technique for transdermal penetration of functional cosmetic ingredients,the Transdermal Drug Delivery Professional Committee of the World Federation of Societies of Traditional Chinese Medicine has organized many discussions among experts.

Efficacy and safety of Phillyrin(KD-1)capsule in the treatment of moderate COVID-19:protocol for a randomized controlled trial

Objective Phillyrin(KD-1)is a traditional Chinese monomer and the main active component in Lianhua Qingwen.At present,sufficient studies have confirmed that KD-1 has significant anti-SARS-CoV-2 activity and antiinflammatory effects in vitro and in vivo.However,evidence-based studies to evaluate its therapeutic effect on COVID-19 are lacking.Therefore,we designed a clinical trial to evaluate the efficacy and safety of KD-1 in the treatment of moderate COVID-19 infection.Methods This is a multicenter,randomized,double-blind,placebo-controlled clinical trial.A total of 120 participants will be recruited and randomized to receive KD-1 capsule or placebo treatment for 14 days,50 mg per capsule,four capsules each time,three times a day.If the SARS-CoV-2 nucleic acid test results are negative twice within 14 days,the KD-1 capsule will be stopped the following day.Symptoms,patient compliance,and adverse reactions will be recorded,and nucleic acid testing will be conducted daily.Primary and secondary outcomes,as well as safety indicators,will be used to evaluate the efficacy and safety of the KD-1 capsule in the treatment of COVID-19.Discussion Herein,we describe the first clinical trial in China to treat COVID-19 using a traditional Chinese medicine monomer.A randomized,double-blind,placebo-controlled clinical trial is the best way to evaluate the efficacy and safety of KD-1 against moderate COVID-19 infection.If a good clinical benefit is observed,this represents the first step toward the use of KD-1 capsules to treat COVID-19.This clinical trial can serve as a model for other evidence-based research of traditional herbal medicines.Trial registration This study is registered at chinadrugtrials.org.cn,with registration number:CTR20211800.

Evaluating the safety of forsythin from Forsythia suspensa leaves by acute and sub-chronic oral administration in rodent models

Objective: To access the toxicity of forsythin from Forsythia suspensa leaves and evaluate its safety,Methods: Acute toxicity was determined by oral administration of a single dose of 18 100 mg/kg forsythin in NIH mice,Sub-chronic toxicity was evaluated by oral administration of several doses of forsythin for 30 days at does of 0,540,1 620,and 6 480 mg/kg in SD rats.Results: In the acute toxicity study,mortality was not observed after 14 days,In addition,clinically relevant adverse effects,or variations in body weight or food consumption were not observed,Similarly,after 30 days in the sub-chronic toxicity study,no mortality or significant toxicological effects such as decreased food consumption,body weight,biochemical parameters and vital organs etc,were noticed,Conclusion: The results revealed that the forsythin from Forsythia suspensa leaves has low or no toxicity via oral administration,and therefore is suitable for further development and applications.

A novel marine-derived anti-acute kidney injury agent targeting peroxiredoxin 1 and its nanodelivery strategy based on ADME optimization

Insufficient therapeutic strategies for acute kidney injury(AKI)necessitate precision therapy targeting its pathogenesis.This study reveals the new mechanism of the marine-derived anti-AKI agent,piericidin glycoside S14,targeting peroxiredoxin 1(PRDX1).By binding to Cys83 of PRDX1 and augmenting its peroxidase activity,S14 alleviates kidney injury efficiently in Prdx1-overexpression(Prdx1-OE)mice.Besides,S14 also increases PRDX1 nuclear translocation and directly activates the Nrf2/HO-1/NQO1 pathway to inhibit ROS production.Due to the limited druggability of S14 with low bioavailability(2.6%)and poor renal distribution,a pH-sensitive kidney-targeting dodecanaminechitosan nanoparticle system is constructed to load S14 for precise treatment of AKI.L-Serine conjugation to chitosan imparts specificity to kidney injury molecule-1(Kim-1)-overexpressed cells.The developed S14-nanodrug exhibits higher therapeutic efficiency by improving the in vivo behavior of S14 significantly.By encapsulation with micelles,the AUC_(0-t),half-life time,and renal distribution of S14 increase 2.5-,1.8-,and 3.1-fold,respectively.The main factors contributing to the improved druggability of S14 nanodrugs include the lower metabolic elimination rate and UDPglycosyltransferase(UGT)-mediated biotransformation.In summary,this study identifies a new therapeutic target for the marine-derived anti-AKI agent while enhancing its ADME properties and druggability through nanotechnology,thereby driving advancements in marine drug development for AKI.