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【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.
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【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.
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Objective To evaluate the correlation between the degree of cochlea endolymphatic hydrops(EH) and hearing loss and symptoms in patients with unilateral Meniere's disease. Methods Fifty seven patients with unilateral Meniere's patients were retrospectively quantitatively analyzed, which evaluated the correlation between the cochlea EH and hearing loss and symptoms. The affected ears in the experimental group(57 ears) and the asymptomatic ears in the control group(57 ears), were confirmed by bilateral intratympanic Gd-DTPA injection and 3D real IR MRI scan after 24 h. The maximum length of endolymph space and labyrinth chamber along the modiolus cochleae and their ratio which represented the endolymph space proportion of each turn(R1, the basal turn;R2, the middle turn;R3, the apical turn) were calculated. And the paired t test was used to compare the differences in EH degree between the experimental and control group;Pearson correlation analysis was used to analyze the correlation between the cochlea EH degree and hearing loss and duration of symptoms. Results R1, R1 and R3 of ipsilateral cochlea were higher than normal cochlea(ipsilateral R1:0.354±0.097 vs. normal R1:0.185±0.031, P0.05). In addition, there was a correlation between the degree of EH in the apical turn and low, medium, high-frequency hearing loss(r=0.271, 0.269, 0.329, respectively; all P<0.05). Conclusions The degree of cochlea EH in the basal and second turn showed great relevance with the high-frequency hearing loss, and the apical turn EH degree was relevant with the low, medium, high-frequency hearing loss, but there was no correlation between the EH degree of each turn, ages and symptoms.
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Objective To study the morphology of the persistent foramen of Huschke (PHF)and the weakness of the remains of foramen of Huschke (WRHF)in the external auditory canal (EAC)by high resolution computer tomography (HRCT)in vivo. Methods The thin HRCT images of 525 cases elder than 5 years were retrospectively reviewed by two radiologists,to detect the PHF or WRHF,and to depict the precise location,size and the distance to the tympanic membrane.The incidence,sex differences, and morphologic data of PHF and WRHF were statistical analyzed.Results ①PHFs were found in 146 EACs of 40 males and 77 fe-males with the prevalence of 13.91%,and were found on both sides in 29 cases.Mean maximum axial diameter was 2.35 mm± 1.1 6 mm (0.6-5.8 mm)and sagittal diameter was 2.09 mm±1.2 mm (0.5-6.2 mm).Mean distance between the inner edge of PFH and the sulcus tympanicus was 1.61 mm±2.4 mm (0-10 mm).②WRHFs were found in 233 EACs of 58 males and 122 fe-males with the prevalence of 22.1 9%,and were found on both sides in 53 cases.Mean maximum axial diameter was 2.43 mm± 0.89 mm (0.8-5.4 mm)and sagittal diameter was 2.08 mm±0.73 mm (0.6-4.3 mm).Mean distance between the inner edge of WRPFH and the sulcus tympanicus was 1.55 mm±1.2 mm (0 - 9.9 mm).③The distance to the sulcus tympanicus was within 3 mm in 137 cases (90.73%)of PFHs and 221 cases (94.43%)of WRFHs.Conclusion Both PHF and WRFH are common by the CT morphological study in vivo.The medial part of EAC is predominant and female is predominant.The incidence and the location of PHF and WRFH are no significant difference.
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Objective To study the CT and MRI features of primary middle ear carcinoma invading jugular foramen.Methods CT and MRI images of 7 patients with surgically and pathologically confirmed primary middle ear carcinoma invading jugular foramen were analyzed retrospectively,including high resolution CT (HRCT) scan in 6 cases,CT enhancement scan in 1 case and MR plain and enhancement scan in 7 cases.Results On HRCT,the soft tissue lesions mainly located in tympanum,tympanic sinus,the deep of external auditory canal and jugular foramen,and irregular “moth-eaten” bone destruction could be seen,including the destruction of jugular foramen in 7 cases,eustachian tube in 7 cases,facial nerve canal in 4 cases,carotid artery canal in 4 cases,external auditory canal wall in 3 cases,auditory ossicles in 2 cases,vestibular window and horizontal semicircular canal in 1 case.CT plain scan showed the density of soft tissue mass was uniform in 4 cases with CT value of 30-55 HU,and heterogeneous in 2 cases,in which small pieces high density lesions could be found.CT enhancement scan in 1 case revealed moderate and homogeneous enhancement.On MR plain scan,the soft tissue masses with hazy margins could be seen,and compared to the gray matter of brain,the lesions were isointense or slightly hypointense on T1 WI and isointense or slightly hyperintense on T2 WI.The signal was homogeneous in 5 cases and inhomogeneous in 2 cases with small pieces of hypointensity both on T1WI and T2WI.After enhancement,the lesions were enhanced moderately and homogeneously in 5 cases and inhomogeneously in 2 cases with small pieces of nonenhanced area.MRI also showed the erosion of carotid artery in 4 cases,sigmoid sinus in 1 case.Conclusion The primary middle ear carcinoma can invade the jugular foramen area extensively,which may lead to misdiagnosis.HRCT can precisely depict the bone destruction and the invasion of the important anatomic structures in the primary middle ear carcinoma,and the destruction of eustachian tube can help to reduce misdiagnosis.MRI can more clearly show the extent of tumor and the mass signal and enhancement pattern.
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Objective To analyze the CT and MRI manifestations of congenital cholesteatoma of petrous bone ,and evaluate the efficacy of it in the clinical practice.Methods Imaging findings in 27 pathological-proved cases were review. Imaging materials included CT scan in 26,MRI scan in 11.Results Petrous bone wall erosion and expanding tumor was observed with CT(n=23),tumor was not oberved with CT(n=3).Congenital choleseatoma signal intensity was intermediate or low on T 1W images and high on T 2W images in 11 cases.Conclusion The role of MRI and CT is affirming in the evaluation of congenital choleseatoma of the petrous bone. MRI is superior to CT for the evaluations of involvement of the membranous labyrinth and intracranial structures.
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Objective To evaluate the imaging diagnosis value of glomus tympanicum tumors.Methods Images of 10 patients with surgically and pathologically confirmed glomus tympanicum tumors were reviewed.The image characteristics and diagnostic value were summarized.Results In 8 patients with high resolution CT scan and 2 patients with routine CT scan,soft tissue nodules within the tympanic cavity were identified on axial or coronal images in 7 of them.And in 3 patients with chronic tympanitis,glomus tympanicum tumors were not differentiated on CT images.Eight patients had undergone MR examination,on T2WI the tumors were moderate hyperintense(n=6)and hyperintense(n=2),and the tumors were enhanced obviously after contrast.In 3 patients with chronic tympanitis,moderate high signal of the tumor can be differentiated with the high signal of tympanitis on T2WI.On contrast MRI,the signal of enhanced tumor or unenhanced tympanitis was identified clearly.Conclusion On diagnosis of glomus tympanicum tumors,MRI is prior to CT,especially in patient with glomus tympanicum and tympanitis.