1.Ionization interference and its suppressing in determination of heavy metal elements in iron dextran by inductively coupled plasma optical emission spectrometry
Chao MA ; Nan MI ; Simeng FANG ; Kexin ZANG ; Mujun SU
Drug Evaluation Research 2017;40(4):506-512
Objective To establish a method for the determination of eight heavy metal elements ofPb,Cd,As,Hg,Co,V,Se,Mo in iron dextran by inductively coupled plasma optical emission spectrometry (ICP-OES).Method Through selection of detection wavelengths,optimization of instrument parameters,correction of spectral interference,verification of ionization interference and investigation of suppression methods,the eight heavy metal elements were analyzed by ICP-OES.Results The recovery rate of the detected elements increased 5% to 10% by suppression of ionization interference.The accuracy of the method was good.The spiked recovery rates of the detected elements were from 95.7% to 101.1%.The precision of the method were good (RSD < 3.6%,n =6).The linearities of the detected elements were good,and the correlation coefficients were all greater than 0.999.The detection limits were from 0.15 to 8.09 ng/mL.The quantization limits were from 0.46 to 24.26 ng/mL.Conclusion The method was accurate,sensitivity,rapid and reliable,which can be applied to the determination of contents of eight heavy metal elements in iron dextran.
2.Evaluation of dissolution consistency of Iloperidone Tablets
Nan MI ; Chao MA ; Simeng FANG ; Kexin ZANG ; Mujun SU
Drug Evaluation Research 2017;40(2):164-168
Objective To compare the dissolution curves of reference preparation and self-prepared Iloperidone Tablets in four different pH dissolution media (0.1 mol/L HC1 solution,pH 4.5 acetate buffer solution,pH 6.8 phosphate buffer solution,and water).Methods The solubility of Iloperidone in different pH solutions was measured,the dissolution curves of two preparations in four different pH dissolution media were determined by HPLC,and the similarity was investigated according to the f2 factor method.Results The f2 factors between reference preparation and self-prepared Iloperidone Tablets in four different media were more than 50.Conclusion The two preparations are equivalent in four different pH dissolution media in vitro.
3.Determination of eight heavy metal elements in iron dextran by inductively coupled plasma optical emission spectrometry and correction of spectral interference
Chao MA ; Simeng FANG ; Nan MI ; Kexin ZANG ; Mujun SU
Drug Evaluation Research 2017;40(3):335-340
Objective To establish a method for the determination of eight heavy metal elements (Pb,Cd,As,Hg,Co,V,Se,and Mo) in iron dextran by inductively coupled plasma optical emission spectrometry (ICP-OES).Methods Through detection wavelength selection,optimization of instrument parameters and applying interference element correction (IEC) method to correction of spectral interference,the eight heavy metal elements were analyzed by ICP-OES.Results The elements recoveries were from 88.7% to 101.3% by correction of spectral interference with IEC method.The accuracy of the method was good.The linearities of the detected elements were good,and the correlation coefficients were all greater than 0.999.The detection limits were from 0.12 to 7.26 ng/rnL.The quantization limits were from 0.40 to 23.96 ng/mL.The precision of the method was good (RSD<3.5%,n=6).Conclusion The results of the spectral interference correction by IEC method are greatly superior to the results of conventional method.The established method is accurate,sensitive,and rapid,which can be applied to the determination of contents of eight heavy metal elements in iron dextran.
4.Effect of Jiedu Limai decoction in septic patients with syndrome of heat-toxin exuberance
Chuanlei LI ; Yun XIE ; Zhihuang ZHENG ; Kexin XU ; Nan ZHU ; Xiujuan ZANG ; Xuemin WANG ; Jinfang BAO ; Qing YU ; Ruilan WANG ; Jun LIU ; Zhigang ZHOU
Chinese Critical Care Medicine 2021;33(7):815-820
Objective:To investigate the clinical effect of Jiedu Limai decoction in septic patients with syndrome of heat-toxin exuberance.Methods:A prospective randomized controlled trial was conducted. From March 2019 to April 2020, septic patients with syndrome of heat-toxin exuberance admitted to intensive care unit (ICU) of Shanghai General Hospital and Songjiang Branch of Shanghai General Hospital were enrolled as the research objects, and they were divided into routine treatment group and Jiedu Limai decoction group by the random number table method. Patients in both groups were given standard treatment in accordance with the guidelines, and patients in the Jiedu Limai decoction group were given Jiedu Limai decoction in addition to the standard treatment, once a day for 14 days. The 28-day survival of patients of the two groups were recorded, the acute physiology and chronic health evaluation Ⅱ (APACHEⅡ) score, sequential organ failure assessment (SOFA) score, coagulation indexes, infection indexes, inflammatory cytokines and organ function indicators before treatment and 7 days after treatment in both groups were recorded, and the prognosis of the two groups were recorded.Results:A total of 259 patients with infection or clinical diagnosis of infection admitted during the experimental observation period were included, and those who did not meet the Sepsis-3 diagnostic criteria, more than 80 years old or less than 18 years old, with multiple tumor metastases, autoimmune system diseases, with length of ICU stay less than 24 hours, with acute active gastrointestinal bleeding and with incomplete data were excluded. One hundred patients were finally enrolled, with 50 patients in the routine treatment group and 50 patients in the Jiedu Limai decoction group. There were no statistically significant differences in coagulation indexes, infection indicators, inflammatory cytokines and organ function indicators before treatment between the two groups. After 7 days of treatment, the coagulation indexes, infection biomarkers and inflammatory cytokines in the Jiedu Limai decoction group were significantly lower than those in the routine treatment group [D-dimer (mg/L): 2.2 (1.8, 8.5) vs. 4.0 (1.5, 8.7), fibrinogen (Fib, g/L): 3.7 (3.4, 4.3) vs. 4.2 (3.7, 4.3), fibrinogen degradation product (FDP, mg/L): 7.2 (5.4, 10.2) vs. 13.2 (9.2, 15.2), procalcitonin (PCT, μg/L): 0.4 (0.2, 2.9) vs. 0.5 (0.2, 0.9), C-reactive protein (CRP, mg/L): 50.1 (9.5, 116.0) vs. 75.1 (23.5, 115.2), interleukin-6 (IL-6, ng/L): 31.6 (21.6, 81.0) vs. 44.1 (14.0, 71.3), all P < 0.05], and the levels of B-type brain natriuretic peptide (BNP) and kidney injury molecule-1 (KIM-1) were significantly lowered [BNP (ng/L): 261.1 (87.5, 360.3) vs. 347.3 (128.8, 439.4), KIM-1 (μg/L): 0.86 (0.01, 1.40) vs. 1.24 (1.05, 1.57), both P < 0.05]. Compared with the routine treatment group, the number of new organ failure in the Jiedu Limai decoction group was decreased (30.0% vs. 50.0%, P < 0.05). Although there was no significant difference in 28-day mortality between the two groups ( P > 0.05), the 28-day mortality in the Jiedu Limai decoction group was lower than that in the routine treatment group (18.0% vs. 24.0%). Conclusion:Combining Jiedu Limai decoction to the sepsis guideline in treating syndrome of heat-toxin exuberance can effectively improve patients' coagulation function, the situation of heart and renal injury, reduce the level of inflammatory cytokines, and fewer people develop new organ failure after treatment.
5.Pure drug nano-assemblies: A facile carrier-free nanoplatform for efficient cancer therapy.
Shuwen FU ; Guanting LI ; Wenli ZANG ; Xinyu ZHOU ; Kexin SHI ; Yinglei ZHAI
Acta Pharmaceutica Sinica B 2022;12(1):92-106
Nanoparticulate drug delivery systems (Nano-DDSs) have emerged as possible solution to the obstacles of anticancer drug delivery. However, the clinical outcomes and translation are restricted by several drawbacks, such as low drug loading, premature drug leakage and carrier-related toxicity. Recently, pure drug nano-assemblies (PDNAs), fabricated by the self-assembly or co-assembly of pure drug molecules, have attracted considerable attention. Their facile and reproducible preparation technique helps to remove the bottleneck of nanomedicines including quality control, scale-up production and clinical translation. Acting as both carriers and cargos, the carrier-free PDNAs have an ultra-high or even 100% drug loading. In addition, combination therapies based on PDNAs could possibly address the most intractable problems in cancer treatment, such as tumor metastasis and drug resistance. In the present review, the latest development of PDNAs for cancer treatment is overviewed. First, PDNAs are classified according to the composition of drug molecules, and the assembly mechanisms are discussed. Furthermore, the co-delivery of PDNAs for combination therapies is summarized, with special focus on the improvement of therapeutic outcomes. Finally, future prospects and challenges of PDNAs for efficient cancer therapy are spotlighted.