Study On The Quality Standards Of Baicao Qudu Granules And Determination Of Five Heavy Metal Elements

Objective Baicao Qudu granules(tentative name)was derived from folk clinical experience and has been applied in cancer treatment for many years,with certain clinical efficacy verification.The prescription was composed of 5traditional Chinese medicines with complex ingredients.The research group plans to develop Baicao Qudu granules into preparations for medical institutions.Based on the properties and pharmacological effects of the active ingredients in the prescription,the quality standards and stability of Baicao Qudu granules were studied,laying a foundation for the extensive clinical application in the future.At the same time,the contents of 5 heavy metal elements in the samples were determined to ensure the industrial production of Baicao Qudu granules and the safety of clinical medication.Methods(1)In the study of quality standards,the thin layer chromatography(TLC)method was established to identify two kinds of Chinese herbal medicines in the prescription;According to the standard of 2015 edition of Chinese Pharmacopoeia,routine items and microbiological examination of Baicao Qudu granules were conducted.The high performance liquid chromatography(HPLC)method was used to determine the content of isofraxidin and rosmarinic acid,which are the main effective components of Herba Sarcandrae,and select the best extraction method to establish a method for the determination of the content of isofraxidin and rosmarinic acid.(2)The preliminary study on stability,taking humidity,granularity and content as indicators,carried out accelerated test and influencing factor test on three batches of pilot products(batch number: 180302,180304,180305).(3)In the study of heavy metal elements,a method for the determination of Pb,Cd,Cu,Hg,and As in Baicao Qudu granules by inductively coupled plasma mass spectrometry(ICP-MS)was established.Results(1)The studies on its quality standard indicated that identifying Herba Sarcandrae and Hedyotis diffusa Willd by TLC.It’s simple,practicable,and negative without interference.A method for the determination of isofraxidin and rosmarinic acid in Baicao Qudu granules was established,and the minimum content of the index was specified;According to the routine inspection,the results of water content,particle size,solubility,loading difference and microbial limit are all in line with the standard of 2015 edition of Chinese Pharmacopoeia.In a word,the established quality standard can control the quality of Baicao Qudu granules accurately.(2)In the preliminary study of stability,there was no significant change in the indexes of Baicao Qudu granules after 6 months of accelerated stability experiment.Except for high humidity conditions,the product is not affected by temperature and light,and all indexes are in compliance with regulations.(3)In the study of heavy metal elements,it was found that the contents of Cu,Hg,Pb and As in 5 batches of Baicao Qudu granules were all within the controllable range.Conclusions The TLC method and the content determination method established in this study,have strong specificity,good sensitivity and high reproducibility,which indicate that the quality standard is practical and feasible and can be used for the production quality of Baicao Qudu granules.The product is unstable under high humidity conditions,but all indicators are stable and controllable under other conditions.Therefore,Baicao Qudu granules should be keep seal well.In addition,the determination method of heavy metal content is accurate and feasible,which can be used to detect the content of harmful heavy metal elements in Baicao Qudu granules.