Matrix effect on the determination of Potency in Recombinant Coagulation Factor Ⅷ for injection / 中国输血杂志

【Objective】 To investigate the matrix effect on the determination of potency in Recombinant Human Coagulation Factor Ⅷ for Injection (rFⅧ). 【Methods】 Two different detection matrices were used to establish two methods for detecting the potency in Recombinant Human Coagulation Factor Ⅷ for Injection. And the matrix effect on the determination of potency was determined, including specificity, linearity, repeatability, accuracy and intermediate precision. 【Results】 As to the specificity, the recoveries of the two substrates at high vs low concentration level were 112% and 110% vs 104% and 109%, respectively. As to the linearity, in the range of (0.125-1.000) IU/mL, the correlation coefficient between concentration and coagulation time of standard/ sample was higher than 0.99. As to the accuracy/repeatability, the recoveries of two matrices was 104% and 102%, and RSD was 2.4% and 1.9%. As to the intermediate precision, personnel factor of two matrices was 0.72 and 0.23, date factor was 0.79 and 0.85, and RSD(for 12 times) was 4.2% and 3.0%. Comparison of two matrices was as follows: Deviation in test results of 6 batches of rFⅧ was all lower than 5%. There was no significant difference between two matrices. 【Conclusion】 The two matrices for potency detection show good performance including specificity, linearity, repeatability, accuracy, and intermediate precision. They are suitable for the determination of potency in rFⅧ products.

Establishment and optimization of inductively coupled plasma mass spectrometry (ICP-MS) for the determination of aluminum residues / 中国输血杂志

【Objective】 To establish and optimize a method for the determination of aluminum (Al) residue by inductively coupled plasma mass spectrometry (ICP-MS). 【Methods】 Nitric acid solution was used to treat samples and standards. The concentration of nitric acid solution and equipment parameters were optimized, and the specificity, linearity, repeatability, accuracy, detection limit, quantitative limit and intermediate precision of the optimized detection method were investigated to confirm whether it was suitable for the determination of Al residue in human serum albumin. 【Results】 The concentration of nitric acid was 5%, and digest time was 4 h. The equipment condition of ICP-MS was as follows: RF power: 1600 W, sampling depth: 10 mm, atomizer / carrier gas flow rate: 1.0 L/ min, compensation flow rate: 0.5 L/ min, experimental mode: standard mode, integration time: 0.2 s, data acquisition: 3 times. Specificity: The recoveries of Al: 92% (high concentration, RSD=3.5%), 98% (low concentration, RSD=4.9%). Linearity: In the range of (0~40) μg/L, the correlation coefficient between concentration and optical energy signal (CPS) of standard / sample were higher than 0.999 0. Accuracy/ Repeatability: The recoveries of sample (3 concentration): 108% (RSD=4.7%), 110% (RSD=4.9%) and 110% (RSD=2.8%). The detection limit was 0.006 μg/L, and the quantitation limit was 0.019 μg/L. Intermediate precision: personnel factor and date factor, P>0.05, RSD (12 times)=2%. Comparison between ICP-MS and atomic absorption spectrometry (AAS): the deviation between ICP-MS and AAS was 8%, and that of samples was 3%, with no significant difference noticed between the two methods. 【Conclusion】 After optimization, ICP-MS method has shown good performance in terms of specificity, linearity, repeatability, accuracy, detection limit, quantitative limit and intermediate precision, and is suitable for the determination of Al residue in human albumin products of our company.

Micro-determination on activating complement in detecting biological properties of Fc fragment of IVIG / 中国输血杂志

【Objective】 To improve method for determinating of biological potency of IgG Fc fragment in Chinese Pharmacopoeia and establish a method which is suitable for enzyme-labeled instrument. 【Methods】 The biological properties of FC fragment of IVIG in Chinese Pharmacopiea(General 3514) was adjusted, including sensitization process, sample treatment and dynamic curve parameters. Meanwhile, the kinetic curve of hemolysis was fitted with Origin, which made the method more suitable for enzyme plate. The biological properties of Fc fragment of IVIG was calculated by kinetics curve reaction of reference and sample. 【Results】 The method are stable, the RSD of repeatability and intermediate is 10%, also with significant improvement in efficiency. 【Conclusion】 The detection of properties of Fc fragment of IVIG is stable and efficient, it can be used for properties of Fc fragment of IVIG.

Comparative imaging studies of congenital pyriform sinus fistula using barium esophagography and CT / 实用放射学杂志

Objective To evaluate the value of barium esophagography and CT in the diagnosis of congenital pyriform sinus fistula (CPSF).Methods The preoperative radiographic data of 5 9 CPSF patients were analyzed retrospectively,which were confirmed by operation.5 5 patients underwent barium esophagography,and 5 7 patients underwent pre-and post-contrast CT scans.The images of barium esophagography and CT were analyzed and the positive diagnostic rates (PDR)between the two imaging modalities and among the different CT features were compared.Results Among the 5 9 patients,left fistula was found in 5 5 cases,right fistula was found in 2 cases and bilateral fistula in 2 cases.For the patients examined with barium esophagography,53 sinus tracts or fistulas from the pyriform in 52 patients(including 2 patients with bilateral fistula)were depicted.The other 3 patients had negative results.The overall PDR of barium esophagography was 93.0%(53/57).CT findings of CPSF included the narrowness of pyriform fossa,sinus tract or fistula in the neck,bubble sign medial to the superior pole of thyroid,low density in thyroid,thyroid morphologic change,and so on.For the 5 7 patients (including 2 patients with bilateral fistula)examined with CT.The PDR of narrowness of pyriform fossa was 44.1%(26/59),the PDR of sinus tract or fistula was 1 3.6%(8/5 9),the PDR of bubble sign medial to the superior pole of thyroid was 55.9%(33/5 9),the PDR of low density in thyroid was 1 6.9%(1 0/5 9),the PDR of thyroid morphologic change(defect sign of superior pole of thyroid)was 9 1.5%(54/5 9 ).And the total PDR of thyroid density or morphologic change was 94.9%(56/59).Conclusion Barium esophagography can be the main modality to diagnose CPSF because of its high PDR.Although the PDR of CT for direct sign(sinus tract or fistula)is not high,its PDR for indirect sign (thyroid density or morphologic change)is very high.So CT has great value for patients suspected of CPSF.