To investigate the compatibility between Shenlu Tablets and drug packaging materials by screening and determination of 20 elements in Shenlu Tablets.

For accelerated testing, the samples were stored at a temperature of 40 ℃ and a relative humidity of 90% for 0, 1, 2, and 3 months. Compatibility study was carried out by comparing the content of elements. At the same time, elemental determination was carried out on the corresponding raw and auxiliary materials of Shenlu Tablets to determine the source of the elements. Elements that were classified as 1, 2A, 2B (As,Cd,Pb,Hg,Co,V,Ni,Ag) were used as risk assessment elements using ICH Q3D. Risk elements in ginseng deer supplements were assessed according to "Chinese Pharmacopoeia" 2020 Edition Fourth General Chapter 9302 Harmful Traditional Chinese Medicine Guidelines.

The 20 elements showed a good linearty, with the correlation coefficient r of 0.997 3~0.999 9, the recovery rate of spiked sample of 92.7%~98.4%, and the recovery rate of drug packaging material of 82.1%~101.7%. The detection limits of all elements were within 0.000 17~0.17 μg·g^-1. 19 elements except Hg were detected in Shenlu Tablets. Except for As, Ag, Sb, Hg, Bi, the other 15 elements were detected in the packaging materials used for the patch. Among the raw and auxiliary materials corresponding to Shenlu Tablets, the elements detected in the traditional Chinese medicinal materials are basically the same without obvious element aggregation. The compatibility results show that, compared with the results of the accelerated test in 3 months and in 0 months, six was no obvious migration of each element in the patch and the corresponding packaging material for the three batches of Shenlu Tablets. The maximum theoretical limit of 8 risk elements in Shenlu Tablets was compared with the average content of the accelerated test samples, and the average content of the samples was far less than the maximum theoretical limit L value.

The microwave digestion-ICP-MS was used to determine 20 elements in Shenlu Tablets with high precision, repeatability and stability. There is no significant difference in the contribution of different Chinese herbal medicines to the elements in Shenlu supplement, and there does not exist single source. Combining the results of compatibility and risk analysis, the compatibility between the drug and the packaging material is good, and the risk of element intake is low. This study helps comprehensively evaluate the safety and compatibility of the drug, providing a reference for the quality control of similar drugs and the establishment of element intake risk assessment.