Liofilisasi Hemolisat Packed Red Cell Limbah Darah Palang Merah Indonesia dengan Penambahan Lioprotektan sebagai Alternatif Standar Hemoglobin

Bambang Supriyanta, Ullya Rahmawati, M. Martsiningsih, Rita Rena Pudyastuti
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Abstract

Lyophilization of PRC waste added with 20% sucrose as lyoprotectant. This study aimed to create an alternative Hb standard, replacing the manufacturer's Hb standard. This study used an experimental with pre and posttest without control group design. PMI blood waste PRC was  processed into hemolysate, added with lyoprotectant, lyophilized, checked Hb levels using the Cyanmethemoglobin method as a grouppre test, stored at 4OC for six months, checked Hb levels with the Cyanmethemoglobin method as a grouppost test. Homogeneity Test and Stability Test were carried out according to ISO 13528:2015. The average Hb level of PRC lyophilisate before storage (Xr)=15.06 g/dl, obtained Ss≤0.3σpt, so that it was  declared homogeneous according to the homogeneous acceptability value according to ISO 13528: 2015. After being stored for six months at 4OC, the average level of Hb lyophilisate PRC (Yr) =14,68 g/dl, obtained |Xr-Yr| ≤ 0.3σpt so that it was  declared stable according to the stable acceptability value according to ISO 13528: 2015. Hb levels of PRC lyophilisate were stated to be homogeneous and stable for six months. Hb standard from PRC lyophilisate can be used as an alternative to commercial Hb standard.
添加锂保护剂的印尼红十字会废血包装红细胞溶血液冻干法可替代血红蛋白标准品
冻干 PRC 废料添加 20% 蔗糖作为冻干保护剂。本研究旨在创建一种可替代的血红蛋白标准,以取代制造商的血红蛋白标准。本研究采用了实验前和实验后无对照组设计。将 PMI 血液废弃物 PRC 加工成溶血酸盐,加入冻干保护剂,冻干,使用氰基高铁血红蛋白法检测 Hb 含量,在 4OC 温度下储存 6 个月,使用氰基高铁血红蛋白法检测 Hb 含量。根据 ISO 13528:2015 标准进行了均匀性测试和稳定性测试。PRC冻干粉储存前的平均血红蛋白水平(Xr)=15.06 g/dl,Ss≤0.3σpt,因此根据ISO 13528:2015规定的均一可接受性值宣布其为均一产品。在 4OC 条件下储存 6 个月后,PRC 冻干血红蛋白的平均水平(Yr)=14,68 g/dl,得出|Xr-Yr|≤0.3σpt,因此根据 ISO 13528:2015 规定的稳定可接受性值宣布其为稳定。PRC冻干粉中的 Hb 含量在 6 个月内是均匀和稳定的。中华人民共和国冻干血红蛋白标准品可用作商用血红蛋白标准品的替代品。
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