Research direction is applying modern analytical technology to evaluate the quality of innovative drugs in vitro and in vivo, especially the evaluation and detection of genotoxic and elemental impurities in drugs and the compatibility of drug packaging materials. Presided over the preclinical quality research of two innovative drugs of Class I, one of which has been approved by the clinic and entered the clinical research; Presided over a number of generic drug quality research, many of which have passed the consistency evaluation; In the past five years, 44 academic papers in professional journals at home and abroad have been published. Presided over a number of national natural science funds and special funds for basic scientific research fees of central universities; Seven patents are in application, of which 3 have been authorized, and 1 has been transferred.

1. Research Projects

(1) National Natural Science Foundation project “A new method for evaluating genotoxic impurities based on DNA damage fluorescence sensing technology” (project number: 82073815).

(2) Cooperating with Jiangsu Chiatai Qingjiang Pharmaceutical Co., ltd “Development of fermentation technology for medicinal glucosamine hydrochloride” (120w)

(3) Cooperating with Nanjing CoreTech biomedical Co., ltd. “Development of determination method for genotoxic impurities in phloroglucinol” (38w)

(4) Cooperating with Beijing Yueze Biomedical Technology Center (Limited Partnership) “Preparation and detection method for photodegradation product of moxifloxacin hydrochloride” (Patent application right transfer, achievement transformation, 12w)

(5) Cooperating with Changzhou Siyao Pharm Co., ltd. “Structure analysis and determination method of the impurity in CSWLT and JHSLSL” (20w)

(6) Cooperating with Heronpharma technology co., ltd “Determination of Diethylene Glycol Ether and Study on Impurities” (15w)

(7) Cooperating with Changzhou Siyao Pharm Co., ltd. “Structural analysis and determination method of SY-001 (code) and the related samples” (15w)

(8) Cooperating with Changzhou Siyao Pharm Co., ltd. “Structural analysis and determination of DBNF (code) and the related samples” (15w)

(9) Cooperating with Yangtze River Pharmaceutical Group “Structure confirmation of citafloxacin and purification of its impurities” (15w)

(10) Cooperating with Lianyungang JaripharmPharmaceutical Co., ltd. “Determination of methyl mesylate, ethyl mesylate and Imamine in Imatinib mesylate and its preparations” (15w)

2. Academic Awards

(1) 2018, The Second National Pharmacy/Chinese Medicine World College Students Innovation and Experimental Teaching Reform Competition in Medical Colleges and Universities. (2/5)

(2) 2017, A training system of pharmaceutical analysis talents with innovative research and pharmaceutical service.

(3) 2020, Key textbooks of colleges and universities in Jiangsu Province.

(4) 2018, Textbook of the 13th Five-Year Plan of China Pharmaceutical University.

(5) 2016, Award for Excellent Undergraduate Graduation Thesis Instructor.

3. Representative Research Achievements

(1) Evaluation of genotoxicity of nitrosamine impurities in drugs by whole cell sensors.

(2) Evaluating the quality of innovative drugs in vitro and in vivo applying modern analytical technology.

1. Wang, H. S.; Wang, X. Y.; Ding, H. T.; Hu, X. Y.; Li, J.; Cheng, C.; Zheng, F., Oral Metal-Organic Gel Protected Whole-Cell Biosensor for in Situ Monitoring Nitrosamines in the Gastrointestinal Tract. Nano letters 2022, 22 (21), 8688-8694. (IF: 12.262)

2. Wang, J. L.; Hu, X. Y.; Han, C. G.; Hou, S. Y.; Wang, H. S.; Zheng, F., Lanthanide Complexes for Tumor Diagnosis and Therapy by Targeting Sialic Acid. ACS Nano 2022, 16 (9), 14827-14837. (IF: 18.027)

3. He, Y.; Ding, H.; Xia, X.; Qi, W.; Wang, H.; Liu, W.; Zheng, F., GFP-fused yeast cells as whole-cell biosensors for genotoxicity evaluation of nitrosamines. Applied microbiology and biotechnology 2021, 105 (13), 5607-5616. (IF: 5.56)

4. Li, M. X.; Gu C. C.; Luo, L.; Zhou, J.; Liu J.; Zheng, F. Determination of trace methanesulfonates in drug matrix using derivatization and headspace single drop microextraction followed by high-performance liquid chromatography with ultraviolet detection. Journal of Chromatography A. 2019, 1951: 131-137. (IF: 4.601)

5. Ji, S. L.; Gao, H. B.; Xia, X. Y.; Zheng, F. A new HPLC-UV derivatization approach for the determination of potential genotoxic benzyl halides in drug substances. RSC Advances. 2019, 9: 25797-25804. (IF: 4.036)

There are 24 postgraduate student and one student pursing PhD degree.