1.Determination of phosphorus content in calcium hydrogen phosphate tablets by 31P-qNMR
Zhewei XIA ; Yuanye ZENG ; Haifei ZHU ; Yu LI ; Xiaofei CHEN
Journal of Pharmaceutical Practice and Service 2024;42(9):399-401,406
Objective To establish a high-precision and high-specificity quantitative nuclear magnetic resonance phosphorus spectrometry method(31P-qNMR)for detecting the phosphorus content in calcium hydrogen phosphate chewable tablets.Methods Hexamethyl phosphoramide was used as an internal standard,phosphorus spectrum data of calcium hydrogen phosphate chewable tablets solution was collected.The linear relationship of calcium hydrogen phosphate within the concentration range of 1.0 to 9.0 mg/ml was studied,and sample recovery rate and repeatability experiments were conducted.Results Calcium hydrogen phosphate and the internal standard demonstrated a good linear relationship within the concentration range of 1.0 to 9.0 mg/ml,with a regression equation A=0.004 3+0.183 6C.The recovery rates for low,medium,and high concentrations were 98.0%,98.1%,and 98.4%,respectively,with relative standard deviations(RSD)of 0.31%,0.68%,and 0.62%,respectively(n=9).The average content of calcium hydrogen phosphate in the chewable tablets was determined to be 98.1%.Conclusion This study successfully established a high-precision and highly specific method for quantifying the content of calcium hydrogen phosphate in chewable tablets,which did not require a self-reference substance,was simple in sample preparation,and had a fast detection speed.The method could provide a new technical support for the quality control of phosphorus-containing drugs.
2.Alanine transferase test results and exploration of threshold adjustment strategies for blood donors in Shenzhen, China
Xin ZHENG ; Yuanye XUE ; Haobiao WANG ; Litiao WU ; Ran LI ; Yingnan DANG ; Tingting CHEN ; Xiaoxuan XU ; Xuezhen ZENG ; Jinfeng ZENG
Chinese Journal of Blood Transfusion 2025;38(4):488-494
[Objective] To conduct a retrospective statistical comparison of alanine aminotransferase (ALT) test values in blood donors prior to blood collection, aiming to analyze the objective characteristics of the population with elevated ALT levels (ALT>50 U/L) and provide reference data for adjusting the screening eligibility threshold for ALT. [Methods] The preliminary ALT screening data of 30 341 blood donor samples collected prior to blood donation from three smart blood donation sites at the Shenzhen Blood Center between 2022 and 2023 were extracted and compared with data from a health examination department of a tertiary hospital in Shenzhen (representing the general population, n=24 906). Both datasets were categorized and statistically described. A retrospective analysis was conducted to examine the associations between ALT test results and factors such as donors' gender, age, ethnicity, donation site, donation season, and frequency of blood donation. [Results] The ALT levels in both blood donors and the general population were non-normally distributed. The 95th percentile of ALT values was calculated as 61.4 U/L (male: 67.8 U/L, female: 39.3 U/L) for blood donors and 58.1 U/L (male: 63.7 U/L, female: 51.2 U/L) for the general population. The non-compliance rates (ALT>50 U/L) were 7.65% (2 321/30 341) in blood donors and 7.08% (1 763/24 906) in the general population. There were significant differences (P<0.05) in the ALT failure rate among blood donors based on gender, age, and donation site, but no significant differences (P>0.05) during the blood donation season. There was no statistically significant difference (P>0.05) in the positive rates of four serological markers (HBsAg, anti HCV, HIV Ag/Ab, anti TP) for blood screening pathogens between ALT unqualified and qualified individuals (2.05% vs 1.5%). If the ALT qualification threshold was raised from 50 U/L to 90 U/L, the non qualification rates of male and female blood donors would decrease from 9.82% (2 074/21 125) to 2.23% (471/21 125) and from 2.70% (249/9 216) to 0.75% (69/9 216), respectively. Among the 154 blood donors who donated blood more than 3 times, 88.31% of the 248 ALT test results were in the range of 50-90 U/L. Among them, 9 cases had ALT>130 U/L, and ALT was converted to qualified in subsequent blood donations. [Conclusion] There are differences in the ALT failure rate among blood donors of different genders and ages, and different blood donation sites and operators can also affect the ALT detection values of blood donors. The vast majority of blood donors with ALT failure are caused by transient and non pathological factors. With the widespread use of blood virus nucleic acid testing, appropriately increasing the ALT qualification threshold for blood donors can expand the qualified population and alleviate the shortage of blood sources, and the risk of blood safety will not increase.
3.Research progress on chemical composition and clinical efficacy of Lianhua Qingwen (LHQW) capsule, a traditional Chinese medicine (TCM) used to treat COVID-19
Yuanye ZENG ; Yingying HE ; Qinglong TANG ; Kang LI ; Yanqiu GU ; Xiaofei CHEN
Journal of Pharmaceutical Practice 2021;39(4):291-294
The outbreak of COVID-19 posed a huge threat to human health and social stability. With the rapid spread of the virus around the world, the drug development and related research of novel coronavirus (SARS-CoV-2) have become an urgent issue in the medical field. COVID-19 fails into the category of epidemics in the theory of TCM. LHQW capsule has repeatedly played an important role in many major epidemics. Previous studies have shown that LHQW capsule can inhibit the biological activity of varied viruses including MERS-CoV and SARS-CoV. The paper summarizes the relevant research data and achievements of LHQW capsule in the past few years, reviews the chemical constituents, clinical efficacy and pharmacological effects of LHQW capsule, and provides scientific basis for the anti-virus mechanism of LHQW capsule and clinical treatment of COVID-19.
4.Evaluation of donor ALT screening strategies based on random sampling simulation with large sample sizes
Liqin HUANG ; Yuanye XUE ; Le CHANG ; Lunan WANG ; Jinfeng ZENG
Chinese Journal of Blood Transfusion 2025;38(8):1094-1100
Objective: To comprehensively evaluate the current alanine aminotransferase (ALT) screening strategies and provide a basis for their optimization. Methods: ALT test results of 21 345 blood samples were collected from 33 blood collection institutions. Multiple probability distribution functions were employed to fit the data, and the akaike information criterion (AIC) was used to determine the optimal fitting model. Based on this model, 1 million random samplings were conducted to simulate the final ALT test results of blood donors under different ALT screening strategies, eligibility criteria, and pre-donation ALT detection deviations. A decision tree was subsequently constructed for health economic analysis. Results: The log-normal distribution with a mean of 2.96 and a variance of 0.65 provided the best fit for the data. When the eligibility criteria was 50 U/L and the pre-donation detection deviation was ±20%, not conducting pre-donation testing increased blood donation by 1.14%. When the pre-donation detection deviation was ±20% and the eligibility criteria was raised from 50 U/L to 100 U/L, conducting and not conducting pre-donation testing increased blood donation by 7.59% and 6.60%, respectively. With a eligibility criteria of 50 U/L and a pre-donation detection deviation of ±20%, 1.14% of eligible blood donors would be disqualified from donating blood. Health economic analysis showed that when the eligibility criteria was adjusted to 56 U/L or higher, not conducting pre-donation ALT testing was the dominant strategy; under other conditions, conducting pre-donation testing was the dominant strategy. Conclusion: The selection of ALT testing strategies is a complex process influenced by multiple factors, and it is necessary to adopt an appropriate ALT screening strategy based on specific testing circumstances.