1.Current research on injury to the distal tibiofibular syndesmosis and prospects of its treatment
Xiangjie YIN ; Wankui ZHANG ; Pengfei WANG ; Wenjie LIANG ; Tianyun ZHAO
Chinese Journal of Orthopaedic Trauma 2023;25(8):732-736
Among ankle injuries, the injury to the distal tibiofibular syndesmosis is common and likely neglected. The stability of the distal tibiofibular syndesmosis is related to the depth of the fibular notch. In imaging diagnosis, X-ray examination cannot be used for a definite diagnosis of the injury to the distal tibiofibular syndesmosis. For diagnosis of the distal tibiofibular separation>3 mm, CT scan can be accurate but is not sensitive enough for a separation<1 mm while MRI is more sensitive in diagnosis of the injury. Arthroscopy has gradually been used as the "gold standard" in diagnosis of the injury to the distal tibiofibular syndesmosis due to its advantage of direct vision. The distal tibiofibular separation occurs in the injuries of pronation external rotation Ⅳ°, supination external rotation Ⅲ° and Ⅳ°, and pronation abduction Ⅱ° and Ⅲ° by the Lange-Hansen classification. Most patients with simple stable injury to the distal tibiofibular syndesmosis may have a good prognosis after nonoperative treatment. Surgical anatomic reduction and maintenance of stability of the distal tibiofibular syndesmosis are the basic management principles for unstable distal tibiofibular syndesmosis or the injury to the distal tibiofibular syndesmosis combined with ankle fracture. Screw fixation is the most commonly used in the surgical treatment of the injury. Elastic fixation has the advantages of maintaining the biological characteristics of the distal tibiofibular syndesmosis fretting joint, better reduction fault tolerance, and lower rates of complications and long-term reduction loss. The angle of nail placement is the key to maintaining good reduction of the distal tibiofibular syndesmosis, but there has been little description of the specific methods to ensure the theoretical angle of nail placement in practice. This article also reviews the prospects of the future treatment of the injury to the distal tibiofibular syndesmosis.
2.Investigation and determination of relative correction factor of pre-vitamin D
Jieming SHI ; Cheng WANG ; Liwen ZHANG ; Shunling DONG ; Jian LE ; Song YUAN ; Yihong LU ; Dandan WANG ; Wankui XU ; Shufeng ZHENG
Drug Standards of China 2024;25(2):147-153
Objective:To determine the relative correction factor of pre-vitamin D and simplify the calculation method of vitamin D assay.Methods:By studying the calculation method of vitamin D content in drug standards of various countries,HPLC was used to determine the relative correction factor of pre-vitamin D,and the influencing factors of determination were investigated.Results:The relative correction factors of pre-vitamin D at 254 nm and 265nm wavelength were determined by statistical analysis of 7 laboratories in China.Conclusion:Using the pre-vi-tamin D relative correction factor method to calculate the total amount of vitamin D simplified the experimental steps can be simplified by the pre-vitamin D relative correction factor method to calculate the total amount of vitamin D and the random operating errors can be avoided.The method is rapid and accurate,and lay a solid foundation for further improving the standard of vitamin D preparations.
3.Cubital tunnel syndrome complicated with elbow osteoarthritis -- subcutaneous or submuscular transposition of the ulnar nerve?
Pengfei WANG ; Wenjie LIANG ; Yabing JIANG ; Xiao WANG ; Wankui ZHANG ; Tianyun ZHAO
Chinese Journal of Orthopaedic Trauma 2024;26(8):728-731
At present, most surgeons use release and subcutaneous transposition of the ulnar nerve to treat cubital tunnel syndrome (CuTS). However, subcutaneous transposition of the ulnar nerve is not effective enough and leads to a high rate of recurrence in clinic when CuTS is complicated with elbow osteoarthritis (EOA). Therefore, an appropriate surgical treatment should be adopted as early as possible if the symptoms are not relieved by a conservative treatment in cases of EOA complicated with CuTS. Different surgical methods lead to different physiological environments of the ulnar nerve, resulting in different outcomes. As a result, the recurrence rate of subcutaneous transposition motion is higher in patients with EOA. Surgical submuscular transposition of the ulnar nerve under the muscle significantly reduces its angular formation during elbow flexion, provides it with a more favorable biological environment and a better anatomical position, benefits the vascular reconstruction and regeneration of the injured nerve, and reduces its chance of secondary entrapment, leading to a better prognosis and a lower recurrence rate. This literature review evaluates the surgical methods for patients with CuTS plus EOA in an attempt to provide helpful references for their treatment.
4.Content Determination of 20 Element Impurities in Aminomethylbenzoic Acid Injections and Its Compatibility Investigation
Hai HUANG ; Yaowen ZHANG ; Jiaxuan SONG ; Ming YU ; Wankui XU
China Pharmacy 2021;32(11):1330-1336
OBJECTIVE:To establish a m ethod to determine the cont ents of 20 elements impurities in Aminomethylbenzoic acid injection ,and to investigate its compatibility in low-borosilicate glass ampoules. METHODS :The sample was diluted with 5% nitric acid solution ,and then determined by ICP-MS using scandium ,indium and bismuth as internal standards. The nebulizer flow(argon)was 0.92 L/min,collision gas flow (helium)was 4.5 L/min,RF power was 1 895 W,plasma flow was 18 L/min, pump speed was 40 r/min,injection delay time was 65 s. The collision mode was used as measurement mode ,the data sampling adopted peak skipping mode ,and repeated for 3 times. The accelerated test was carried out after sample was stored at 70 ℃ for 1 and 3 months,and the compatibility was investigated by comparing the change trend of element impurity content. RESULTS :The linear range of vanadium ,cobalt,chromium,arsenic,cadmium,antimony,mercury,thallium and lead were 0.01-20 μg/L;those of magnesium ,aluminium,ferrum,nickel,copper,zinc,barium were 0.1-200 μg/L;those of boron ,silicon,potassium and calcium were 1-2 000 μg/L(r≥0.999 8). RSDs of precision ,intermediate precision ,stability(8 h)and repeatability test were all lower than 6%. The limits of quantitation were 0.000 7-2.986 3 μg/L;the limits of detection were 0.000 2-0.895 9 μg/L. The average recoveries were 88.50%-111.00%(RSDs were 0.52%-2.33%,n=9). The minimum content of 20 element impurities was less than detection limits ,the maximum contents were 3 835.9 μg/L(0 month),10 448.4 μg/L(1 month),17 261.2 μg/L(3 month) in Aminomethylbenzoic acid injection from 8 manufacturers. Among the 20 elements impurities ,except that boron , aluminum,magnesium,silicon,calcium and potassium were not specified ,the contents of other elements were less than the threshold. The research of compatibility showed that the impurity contents of seven elements such as boron ,aluminum,silicon, potassium,zinc,arsenic and barium showed an increasing trend. The silicon concentration ,silicon/aluminum concentration ratio and silicon/boron concentration ratio in the accelerated samples after stored for one and three months were significantly different from those stored for 0 month. CONCLUSIONS :The established method is sensitive ,reproducible and accurate ,and can be used for the content determination of 20 element impurities in Aminomethylbenzoic acid injection. The interaction between low-borosilicate ampoule and Aminomethylbenzoic acid injection is obvious.
5.Simultaneous determination of 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material and its formulations by GC-MS/MS
Shangying LI ; Qingyang YUE ; Yaowen ZHANG ; Wankui XU
China Pharmacy 2023;34(15):1830-1834
OBJECTIVE To establish a method for simultaneous determination of the contents of 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material and its formulations. METHODS GC-MS/MS was adopted to determine 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material, Losartan potassium tablet, Losartan potassium capsule and Losartan potassium hydrochlorothiazide tablets, such as N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), N-ethyl-N-nitroso-2-propanamine (NEiPA), N-nitrosodiisopropylamine (NDiPA), N-nitrosodipropylamine (NDPA) and N-nitrosodibutylamine (NDBA). The separation was performed on SHIMADZU SH-L-17Sil MS capillary column by temperature- programmed GC, with injector temperature of 250 ℃ , sample size of 1 μL, carrier gas of helium, and carrier flow rate of 1 mL/min. Electron ionization and multiple reaction monitoring (MRM) data acquisition mode were used, with an ion source temperature of 250 ℃ and solvent delay time of 3.1 min. RESULTS The separation among NDMA, NDEA, NEiPA, NDiPA, NDPA, NDBA and adjacent chromatographic peaks was good, and the separation rate was higher than 3.8; the linear ranges of them were 4.9-486.0, 4.9-488.5, 4.5-451.5, 6.8-683.5, 5.2-525.0 and 5.2-520.0 ng/mL(all r≥0.999 8). The limits of quantitation were 4.86, 4.88, 4.52, 6.84, 5.25 and 5.20 ng/mL; the limits of detection were 0.97, 0.98, 0.90, 1.37, 1.05 and 1.04 ng/mL. RSDs of repeatability tests were 2.2%-5.6%(n=6), those of precision tests were 0.5%-1.4%(n=6), and those of stability tests were 1.5%-3.4%(n=5), respectively. Average recoveries of low-, medium- and high-concentration solution were 83.4%-103.0% (RSDs were 1.2%-6.3%, n=3), respectively. No one among the 6 kinds of N-nitrosamines genotoxic impurities was detected in both losartan potassium raw material and formulations. CONCLUSIONS The method is good in separation effect, highly accurate, sensitive and simple. It can be used in the determination of the 6 kinds of N-nitrosamines genotoxic impurities.