Abstract：Objective To evaluate the quality status of domestic penicillamine tablets. Methods 31 batches of samples from national drug plan and scientific research institutions were tested and investigated by combining statutory standard test with exploratory research. The quality status of preparations and the rationality of quality standard were analyzed. Results The qualified rate of all batches of tablets was 100%. The exploratory research showed that the related substances of the 4 batches were too high, the results may be caused by the production process; the dissolving behaviors of productions showed significantly differences in and between batches, analysis of the causes showed that the coating of domestic penicillamine tablets were uneven. In view of the lack of related substances and dissolution methods in the legal standard, methods for measuring penicillamine tablets related substances and dissolution were established to further control the quality of drugs. Conclusion According to the current research and conclusion, the quality of the tablets was moderate. Suggestions for interested companies should investigate and optimize prescription manufacturing process to improve the drug dissolution. It is suggested that the relevant substances and dissolution test should be added in the current standard to ensure the controllability of the standard and the safety and effectiveness of drug use.
李倚天1 李茜1 王立萍1 杨博涵1 王晨2 刘英1,*. 青霉胺片的质量评价[J]. 中国抗生素杂志, 2021, 46(03): 244-250.
Li Yi-tian1, Li Qian1, Wang Li-ping1, Yang Bo-han1, Wang Chen2 and Liu Ying1. Quality evaluation of penicillamine tablets. CJA, 2021, 46(03): 244-250.