Quality Evaluation And Safety Research Of White Vaseline

Objective:With the continuous deepening of the research on the consistency evaluation of the generic drug,people have higher requirements on the quality of pharmaceutical excipients.White Vaselin is one of the most commonly used pharmaceutical excipients in pharmaceutical preparations.This study evaluated the quality and safety of White Vaselin in the domestic market,explored the impact of functional indicators on quality control and further improved the quality standards of white vaseline by reference to those relevant requirements for pharmaceutic adjuvant in the consistency evaluation of the generic drug.Methods: We collected 74 batches of White Vaselin samples,of which 67 were pharmaceutical excipient grade involved with 14 manufacturers,11 approval numbers and 57 user companies.According to comparative domestic and international standards and quality analysis,74 batches of white petrolatum were tested in terms of effectiveness and safety by the parameters of melting PAHs,hydrogen peroxide,heavy metals,and catalyst and cytotoxicity studies.Results: According to the current standards of White Vaselin,the total test of 67 batches of samples was tested,such as melting point,relative density,identification,coning,impurity absorption,sulfide,heavy metal,arsenic salt and polycyclic aromatic hydrocarbon.There were 63 batches of qualified,4 batches of unqualified,and the pass rate was 94.0%.The total concentrations of 16 PAHs in white vaseline samples were in the wide range from 27.45 to 5367.84 ng/g with an average total concentration of 624.24 ng/g.None of the white petrolatum samples was detected with hydrogen peroxide.The contents of heavy metals such as nickel,cobalt,copper,arsenic,cadmium,mercury and lead in all white vaseline samples were very low with an average value between 0.003 ppm and 0.2ppm.The average value of zinc was1 ppm,and the mean values of magnesium,aluminum,and iron were low between 2~5ppm.All extracted samples had no effect on the proliferation of L929 cells.Conclusions: In general,white petrolatum in domestic market was unsatisfactory.Regarding the safety of white petrolatum,there was no illegal addition of hydrogen peroxide.No cytotoxicity.Residual heavy metals and catalysts were low,we also recommend selecting Mg,Al,Fe and Ni elements which are more detectable than others as evaluation indices for this species.However,there weremany unknown PAHs and their risks were uncertain.Therefore,We are worth paying attention to PAHs.