Impact of variations in the chemical composition of vitreous mineral fibers on biopersistence in rat lungs and consequences for regulation

The chronic toxicity of vitreous fibers is substantially dependent on their biopersistence. Removal of fibers deposited in the respiratory tract is dependent on a combination of physiological clearance processes (like mechanical translocation) and physico-chemical processes like dissolution and leaching. This publication presents data of about 60 different fibers investigated in the biopersistence test which was standardized in the European Union. This test is based on in vivo investigation of biopersistence after intratracheal instillation in rats of a respirable fiber fraction, and it is a basis for the regulatory classification of vitreous fibers.

Regression analysis is carried out employing the data of glass fiber compositions and the corresponding results of biopersistence tests (half-times). The study leads to a model that enables prediction of half-times for stone wool fibers as well as for glass wool fibers on the basis of their chemical composition. The aim of this paper was to investigate the stringency of the existing limits for the range of the chemical composition of glass and stone wools in view of the currently available data base. For regulatory purposes, however, this model is currently not sufficient to replace biopersistence tests completely.     

注射用丹参多酚酸化学成分及质量控制研究进展

注射用丹参多酚酸是以丹参的水溶性有效部位丹参多酚酸为活性成分制成的冻干粉针剂,主要化学成分为丹酚酸B、迷迭香酸、紫草酸、丹酚酸D及丹酚酸Y等水溶性酚酸类成分。临床上用于中风病中经络（轻中度脑梗死）恢复期瘀血阻络证,治疗轻中度脑梗死引起的半身不遂、口舌歪斜、舌强言蹇、偏身麻木的症状。就近10年注射用丹参多酚酸的化学成分、药材质量评价、产品质量控制方法、配伍合理性及药动学研究进展进行综述,为临床上更加安全合理使用该药提供依据和参考。