The study and control of elemental impurities are crucial for ensuring the quality and safety of drugs.The ICH has published the Q3D guideline as a globally harmonised approach for the research and control of elemental impurities in drugs.In accordance with the requirements of the ICH Q3D guideline for risk assessment and control of elemental impurities,how to carry out the development and validation of detecting methods for elemental impurities is important to analysts.In this research,the key points of ICP-AES and ICP-MS method development are summarized,including the determination of the types and limits of the elements to be measured,the selection of pretreatment methods,interferences and corrections;the validation requirements for the two methods in ICH Q2(R2)and different pharmacopoeial general rules are analyzed,and the evaluation methods of each validation experiments are compared in detail.This paper can provide a reference for the development and validation of detecting methods for elemental impurities,and research ideas for related research workers.

The study and control of elemental impurities are crucial for ensuring the quality and safety of drugs.The ICH has published the Q3D guideline as a globally harmonised approach for the research and control of elemental impurities in drugs.In accordance with the requirements of the ICH Q3D guideline for risk assessment and control of elemental impurities,how to carry out the development and validation of detecting methods for elemental impurities is important to analysts.In this research,the key points of ICP-AES and ICP-MS method development are summarized,including the determination of the types and limits of the elements to be measured,the selection of pretreatment methods,interferences and corrections;the validation requirements for the two methods in ICH Q2(R2)and different pharmacopoeial general rules are analyzed,and the evaluation methods of each validation experiments are compared in detail.This paper can provide a reference for the development and validation of detecting methods for elemental impurities,and research ideas for related research workers.

Ferroptosis is a form of iron-dependent cell death caused by a disorder of iron lipid metabolism.Its mechanism mainly includes lipid metabolism and iron metabolism,which are complicated and strictly regulated by various metabolic and signaling pathways.Current studies have shown that ferroptosis is associated with cancer,atherosclerosis,and neurological diseases.Traditional Chinese medicine(TCM)is characterized by various active ingredients,relatively high safety,and lower treatment costs,which possess unique advantages in clinical applications.It has been widely used in the treatment of various diseases.Taking the regulation of ferroptosis by traditional Chinese medicine as the entry point may be a new direction for the future prevention and treatment of various diseases.In this review,we discussed the mechanism of iron lipid metabolic disorders based on ferroptosis and the research progress of traditional Chinese medicine intervention to provide reference and treatment strategies for the prevention and treatment of related diseases.

Objective To study the effect of recombinant interlukin-2 plus chemotherapy in treatment of multiple myeloma. Methods We divided into two groups: chemotherapy plus rIL-2 group and simple chemotherapy group. The patients were given at dose of rIL-2 1×l06 IU/d, iH, qd, for 4 weeks and 4cycles. After 4 cycles the changes of T-cell subsets of their peripheral blood were determined. Response was evaluated according to Blad criteria. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria,version 3.0. Results The positive percentages of CD_3, CD_4 NK, CD_(69) and CD_4/CD_8ratio after chemotherapy in chemotherapy plus rIL-2 group were significantly higher than those before chemotherapy in the same group and those after chemotherapy in the other group. The overall response rate and complete response rate were 66.7 % and 25.0 % vs 50.0 % and 8.3 % respectively. The side effects of rIL-2 were predictable and manageable. Conclusion Recombinant interlukin-2 plus chemotherapy could increase immune function of patients with multiple myeloma and has a higher response rate as compared with simple chemotherapy.