一般项目：医护人员防护用品生产（Ⅰ类医疗器械）；医护人员防护用品零售；医护人员防护用品批发；第二类医疗器械销售；软件销售；软件开发；技术服务、技术开发、技术咨询、技术交流、技术转让、技术推广；仓储设备租赁服务；医院管理；诊所服务；医学研究和试验发展；日用百货销售；化妆品零售；卫生用品和一次性使用医疗用品销售；消毒剂销售（不含危险化学品）；保健食品（预包装）销售；食品销售（仅销售预包装食品）；劳动保护用品销售；劳动保护用品生产；电子元器件与机电组件设备销售（除依法须经批准的项目外，凭营业执照依法自主开展经营活动）。许可项目：医护人员防护用品生产（Ⅱ类医疗器械）；第三类医疗器械生产；第三类医疗器械经营；第二类医疗器械生产；医疗服务；药物临床试验服务；药品零售（依法须经批准的项目，经相关部门批准后方可开展经营活动，具体经营项目以相关部门批准文件或许可证件为准）。
Objective To achieve effective polymerization rate (molecular weight of 64-600 KD) ≥70% and average molecular weight of 100-300 KD across the way of Gennipin (Genipin, Gnp) crosslinked hemoglobin isolated from fetal (hemoglobin isolated from fetal, HbF). Methods HbF was used as raw material, and Gnp as crosslinker. Orthogonal test involving four factors as hemoglobin concentration (HbC), molar ratio of Gnp to HbF, reaction time and reaction pH, and three levels were selected (n=3) to determine better matching condition. Three batches of Gnp-HbF samples were prepared under the optimal conditions, and the effective polymerization rate, dimer, average molecular weight, the content of methemoglobin (MetHb) and P50 were determined during the preparation process. Results The optimal matching conditions for Gnp-HbF obtained by orthogonal test were HbC: 80g/L, molar ratio of Gnp to HbF: 7∶1, reaction time: 18 h, pH: 8.5, with effective polymerization rate at (73.03±2.03)%, dimer (26.97±2.03)%, average molecular weight (167.70±28.40)KD, the content of methemoglobin(2.60±0.17)% and P50 (13.13±1.02) mmHg. Conclusion Gnp can effectively cross-link HbF, and the obtained key indicators of Gnp-HbF products meet the requirements, which reduces the preparation difficulty for the subsequent process.
Objective To investigate the preparation conditions of hemoglobin-based oxygen carrier (HBOC) at room temperature without oxygen isolation and the quality of poly-COHb. Methods Using human cord blood hemoglobin as raw material and glutaraldehyde as crosslinking agent, the experimental group selected hemoglobin concentration, glutaraldehyde to COHb molar ratio, reaction time and reaction temperature to do four factors and three levels of orthogonal test (n=3), to determine the best matching conditions and prepare three batches of poly-COHb, continuously.In the control, 3 batches of poly-Hb were prepared under low temperature and oxygen isolation.The contents of superlarge molecules, degree of polymerization, average molecular weight, methemoglobin and P50 of crosslinked products were compared between the two groups. Results The optimal matching conditions of poly-COHb were as follows: [Hb] 70g/L, the molar ratio of glutaraldehyde to COHb was 11∶1, the reaction time was 60 min, and the reaction temperature was 25℃.Comparison of poly-COHb and poly-Hb: The superlarge molecular content (%) was 0.67±0.51 vs 0.60±0.01 (P>0.05); degree of polymerization (%) and average molecular weight (kD) were 84.25±0.99 vs 54.16±5.12, and 235.27±13.50 vs 97.62±6.57, respectively.(P<0.05); methemohemoglobin ratio (%) was 2.40±0.66 vs 2.47±0.46 (P>0.05); P50 (mmHg) was 6.37±0.30 vs 14.20±1.09 (P<0.05). Conclusion Poly-COHb can be prepared at room temperature without oxygen isolation.Compared with poly-Hb, poly-COHb prepared under the experimental conditions can improve the polymerization degree and average molecular weight, and greatly reduce the difficulty of preparation.
