Reflections on manufacturer′s reference materials of preventive human vaccines / 中国生物制品学杂志

@#Reference materials for vaccine are the standard rulers for quality control,dose determination and effectiveness evaluation of vaccines. Manufacturer's reference materials are a kind of the working standards that are directly used by vaccine enterprises in the process of production,quality control and evaluation,of which the accuracy and stability play a key role in ensuring the consistency between batches,safety and effectiveness of vaccines. Based on the investigation into the current management situation of manufacturer's reference materials in domestic representative vaccine enterprises,and combined with the relevant guidelines and regulations such as World Health Organization guidelines and Chinese Pharmacopoeia,this paper put forward the key points that should be considered in the establishment and application of manufacturer's reference materials of preventive human vaccines. It is also suggested to formulate the guidelines about manufacturer's reference materials in order to regulate the development and application of working reference materials.

Reflections on national reference materials of preventive human vaccines / 中国生物制品学杂志

@#The national standards for biological products include three types of reference materials,vaccines,biotherapeutics,and diagnostics,among which the national standards for vaccines play a crucial role in the production,issuance,and supervision inspection of vaccines. In recent years,the vaccine industry in China has developed rapidly,and especially,the application of new technology platforms such as mRNA in vaccines has highlighted the urgency of further improving the level of national standards for vaccines in China. Referring to WHO(World Health Organization)development requirements for reference materials of vaccines and taking Chinese national standard for SARS-CoV-2 neutralizing antibody as example,this paper summarized the thinking on national standards for vaccines in China,and presented the priority principles of establishing national standards for vaccines which are not traceable to WHO international standard(IS),in view to provide ideas for the further improvement of development and application of national standards for vaccines in China.

Isocryptolepine, an indoloquinoline alkaloid from Cryptolepis sanguinolenta promotes LDL uptake in HepG2 cells

ABSTRACT About 31 percent of deaths worldwide result from atherosclerotic cardiovascular disease. Hyperlipidemia remains the major risk factor for this disease and therefore, it is necessary to identify antihyperlipidemic compounds for drug development. The crude ethanolic extract of Cryptolepis sanguinolenta (Lindl.) Schltr., Apocynaceae, has demonstrated antihyperlipidemic properties. However, the chemical constituents responsible for this action are unknown. Hence, to identify chemical constituent(s) of C. sanguinolenta with anti-hyperlipidemic effect, five indoloquinoline alkaloids were isolated and evaluated in 1,1′-dioctadecyl-3,3,3′,3′-tetramethyl-indocarbocyanine perchlorate labeled low density lipoprotein uptake assay using HepG2 cells. The minor alkaloid, isocryptolepine, showed strong activity in promoting low lipid lipoprotein uptake by 1.85-fold. Isocryptolepine may, therefore, serve as a lead compound for future studies in the development of novel antihyperlipidemic drugs.