1.Research on the process control method of active pharmaceutical ingredient in pituitrin
Hongbao XUE ; Hualan CHANG ; Lili LIANG ; Chengshan ZHANG ; Wenwu GONG
Chinese Journal of Biochemical Pharmaceutics 2017;37(1):55-59
Objective A novel Active Pharmaceutical Ingredient (API) pituitrin efficacy component content analysis method was explored, and the method is conformed to the requirements of the pharmaceutical production enterprise testing standard. Methods The reverse phase high performance liquid chromatography (RP-HPLC) was performed on a Zorbax Eclipse XDB-C18(250mm×4.6mm, 5 μm) (P/N 993967-902/ 5063-6600) Column, the column temperature was 25℃, the wavelength of detector was set at 220 nm, flow rate was 1.2 mL/min, 50% Acetonitrile- 0.13mol/L sodium dihydrogen phosphate aqueous solution was used as mobile phase for gradient elution. 20 μL sample solution was injected in each perform. Results The content of oxytocin and vasopressin as pituitrin efficacy components were analyzed by this method with advantage of simple and easy operation, good reliability and high precision. Different biological extraction technology process A and B was used on pituitrin injection production, the content of medicinal ingredients in the product: oxytocin and vasopressin is slightly different, but concentration level is different, which process B concentration is higher than that of A. Conclusion In this study, an effective determination the levels of oxytocin and vasopressin in pituitrin API method was established for a pharmaceutical production enterprise, can provide API pituitrin purification process control. Relevant technical information can be provided in the above, which worked on the biological API pituitrin research and development.
2.Method exploration of telephone follow-up in clinical research
Xing WEI ; Qi ZHANG ; Xin GAO ; Wenwu LIU ; Yangjun LIU ; Wei DAI ; Peihong HU ; Yaqin WANG ; Jia LIAO ; Hongfan YU ; Ruoyan GONG ; Ding YANG ; Wei XU ; Yang PU ; Qingsong YU ; Yuanyuan YANG ; Qiuling SHI ; Qiang LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(09):1235-1239
Telephone follow-up is one of the important ways to follow up patients. High-quality follow-up can benefit both doctors and patients. However, clinical research-related follow-up is often faced with problems such as time-consuming, laborious and poor patient compliance. The authors belong to a team that has been committed to the study of patient-reported outcomes for a long time. The team has carried out long-term follow-up of symptoms, daily function and postoperative complications of more than 1 000 patients after lung cancer surgery, and accumulated certain experience. In this paper, the experience of telephone follow-up was summarized and discussed with relevant literatures from the aspects of clarifying the purpose of clinical research follow-up, understanding the needs of patients in follow-up, and using follow-up skills.