To develop a LC-MS/MS method for the determination of five kinds of trace ginkgolic acids in diterpene ginkgolides meglumine injection materials, the column was Agilent ZORBAX Eclipse plus C18 (3.0 mm x 50 mm, 1.8 µm), and the mobile phase consisted of methanol-water (containing 0.2% formic acid) (95:5) at a flow rate of 0.5 mL · min(-1). The multiple reaction ion monitoring (MRM) with an ESI interface in the negative ion mode was selected. The results showed that the linear ranges of five kinds of ginkgolic acids were in the range of 0.2-36.0 µg · L(-1) (r ≥ 0.999 5). The lowest limit of quantification (LOQ) of ginkgo acid C13: 0, C15:1, C17:2, C15:0 and C17:1 were 0.18, 0.18, 0.21, 0.10 and 0.20 µg · L(-1), respectively. The average recovery was between 73.28% and 87.56%, and the average content of total ginkgolic acids in three batches of samples was in the range of 0.023-0.028 µg · g(-1), which was much lower than 2 µg · g(-1) prescribed in drug registration standards. This method is simple and rapid with high sensitivity, which can be used for the determination of five kinds of trace ginkgolic acids in diterpene ginkgolides meglumine injection materials.
Chromatography, Liquid ; methods ; Ginkgolides ; analysis ; Injections ; Limit of Detection ; Salicylates ; analysis ; Tandem Mass Spectrometry ; methods

Andrographolide total ester sulfonate (ATES) injection is one of the products of traditional Chinese medicine (TCM) currently used against viral infection in China.ATES injection was approved for manufacturing and marketing in January 2002.It is indicated for acute respiratory infections,tonsillitis,chronic obstructive pulmonary disease,influenza,foot and mouth disease,bronchiolitis,herpangina,mumps,infectious mononucleosis and psychosis.However,its usage also carries risk.We investigated the use of ATES at the Wuhan Union Hospital from January 2014 to December 2014 and evaluated its real-word clinical application using the hospital centralized monitoring method.A total of 848 cases were enrolled in this study.In these cases,it was mainly used for postoperative anti-inflammation and treating upper respiratory infection,pneumonia and bronchitis.Among them,39.86％ were contraindicated.Irregular medication of adults and children accounted for 1.91％ and 23.38％,respectively.Improper choice of solvent accounted for 3.18％.The choice of intravenous drip versus aerosol inhalation was reasonable.A case of adverse events (AEs) was observed in the monitoring period,and the incidence of adverse drug reaction (ADR) of ATES injection was 0.12％.ATES injection in our hospital is relatively safe with a low incidence of adverse reactions.The study assesses the clinical usage and adverse reactions of ATES injection,and provides suggestions for rational use in clinical practice.

The changes of microRNA expression in rat hippocampus after traumatic brain injury (TBI) were explored. Adult SD rats received a single controlled cortical impact injury, and the ipsilateral hippocampus was harvested for the subsequent microarray assay at three time points after TBI: 1st day, 3rd day and 5th day, respectively. We characterized the microRNA expression profile in rat hippocampus using the microRNA microarray analysis, and further verified microarray results of miR-142-3p and miR-221 using quantitative real-time PCR. Totally 205 microRNAs were identified and up-/down-regulated more than 1.5 times. There were significant changes in 17 microRNAs at all three time points post-TBI. The quantitative real-time PCR results of miR-142-3p and miR-221 indicated good consistency with the results of the microarray method. MicroRNAs altered at different time points post-TBI. MiR-142-3p and miR-221 may be used as potentially biological markers for TBI assessment in forensic practice.

Objective To analyze the Product-Specific Guidances(PSGs)for generic drugs published by the Food and Drug Administration(FDA),and study the evaluation logic for generic drugs.Methods By querying the official website of the FDA,we collected 2 032 generic PSGs published as of August 31,2022,identified the specific product's active ingredient,dosage forms,administration routes,recommended bioequivalence(BE)research requirements,and research methods,analyzed the FDA's different evaluation requirements for generic products with different administration routes,dosage forms,and complexity levels.Results and Conclusion This article proposed the evaluation logic of Generic Drugs.That is,the evaluation process of generic drugs is based on product characteristics,risk control through scientific comparative tests with reference preparations,and the process of reducing residual risk to an acceptable level.

Objective To discuss characteristics of height growth such as Peak Height Velocity (PHV) and Age at Peak Height Velocity (PHA) during adolescence,and to compare the results with other research findings.Methods Primary and middle school students' annual physical examination data of Zhongshan in 2005-2010 was used.The height velocity by age,PHV,PHA,height velocity by PHA were calculated.Results The average peak height velocity boys was ( 10.03 ± 1.67 ) cm/yr.and that of the girls was ( 8.39 ± 1.05 ) cm/yr.Both findings were close to the results from previous similar findings.The average age at which peak height velocity reached 12.28± 1.30 years for boys and 10.78 ± 1.04 years for girls,both lower than the previous findings.The correlation coefficients,between height level and PHA were -0.357 (P＜0.001) for boys and -0.338 (P＜0.001) for girls.Conclusion The height levels were positively related to the height velocity before PHA.The Zhongshan students' PHA was lower than the Beijing,Shanghai and Shenyang students,also lower than American and Britain students',but their PHVs were similar.

Adolescent ; Adult ; Child ; Child, Preschool ; Female ; Hematopoietic Stem Cell Transplantation ; adverse effects ; Hepatic Veno-Occlusive Disease ; etiology ; Humans ; Male ; Middle Aged ; Young Adult

OBJECTIVETo study the effect of vertebrae semi-dislocation on the stress distribution in facet joint and interuertebral disc of patients with cervical syndrome using three dimensional finite element model.

METHODSA patient with cervical spondylosis was randomly chosen, who was male, 28 years old, and diagnosed as cervical vertebra semidislocation by dynamic and static palpation and X-ray, and scanned from C(1) to C(7) by 0.75 mm slice thickness of CT. Based on the CT data, the software was used to construct the three dimensional finite element model of cervical vertebra semidislocation (C(4)-C(6)). Based on the model,virtual manipulation was used to correct the vertebra semidislocation by the software, and the stress distribution was analyzed.

RESULTSThe result of finite element analysis showed that the stress distribution of C(5-6) facet joint and intervertebral disc changed after virtual manipulation.

CONCLUSIONThe vertebra semidislocation leads to the abnormal stress distribution of facet joint and intervertebral disc.

Adult ; Cervical Vertebrae ; injuries ; physiopathology ; Finite Element Analysis ; Humans ; Intervertebral Disc ; physiopathology ; Joint Dislocations ; physiopathology ; Male ; Models, Anatomic ; Stress, Physiological ; Zygapophyseal Joint ; physiopathology

OBJECTIVETo evaluate the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) from HLA-matched sibling donor (MSD allo-HSCT) for severe aplastic anemia (SAA).

METHODSThe clinical data of 41 SAA patients received MSD allo-HSCT from May. 2003 to Aug. 2011 were analyzed retrospectively. 24 patients were male, 17 were female. Median age was 23 (5 - 43) years old. 28 patients had SAA-I, 9 had SAA-II, and 4 had post-hepatitis aplastic anemia. 17 patients received allogeneic bone marrow (BM) transplantation (allo-BMT), and 24 received allogeneic peripheral blood stem cell (PBSC) transplantation (allo-PBSCT). The conditioning regimens: 20 patients received cyclophosphamide (CY) + anti-thymocyte globulin (ATG) + fludarabine (Flu), 21 received CY + ATG + Flu+ cytarabine (Ara-C) ± busulfan (Bu)/melphalan (Mel). Prophylaxis for graft-versus-host disease (GVHD): 25 patients received cyclosporine (CSA) plus short-term methotrexate (MTX), 16 received tacrolimus (FK506) plus short-term MTX. The median number of infused CD34(+) cells were 3.48 (2.39 - 4.80)×10(6)/kg in allo-BMT and 2.95 (1.27 - 5.98)×10(6)/kg in allo-PBSCT, respectively.

RESULTSHematopoietic reconstitution was observed in all 41 patients (100%). The median time of neutrophils (ANC) reached to 0.5×10(9)/L and platelets (PLT) reached to 20×10(9)/L were 14 (10 - 23) days and 19 (8 - 38) days, respectively. 12 patients developed acute GVHD (aGVHD), out of which 11 developed grade I-II aGVHD, and one developed grade IV. 2 patients occurred chronic GVHD (cGVHD), out of which one with local cGVHD and the other with extensive. 4 patients occurred graft rejection (GR), all of them recovered haemopoiesis and survived after donor PBSC infusion. 5 patients (12.2%) died, out of which one died of extensive cGVHD, and 4 died of invasive fungal infections (IFI). Median follow-up time was 23 (3 - 79) months. 36 patients survived. 5-year estimated overall survival (OS), disease free survival (DFS), and transplant-related mortality (TRM) was (81.1 ± 9.0)%, (68.4 ± 11.0)%, and (18.9 ± 9.0)%, respectively. Univariate analysis showed that lover OS had significant correlation with receiving PBSCT, occurrence of aGVHD, the number of infused CD34(+) cells no more than 2.5×10(6)/kg, the number of red blood cell (RBC) transfusion before transplant more than 30 U and occurrence of IFI after transplantation (P = 0.034, 0.001, 0.006, 0.000, 0.001, respectively). Occurrence of aGVHD had significant correlation with the disparity between donor and recipient ABO blood groups, the number of PLT transfusion more than 100 U, and the number of RBC transfusion more than 30 U before transplantation, the number of infused CD34(+) cells no more than 2.5× 10(6)/kg (P = 0.019, 0.038, 0.005, 0.005, respectively). The occurrence of GR had significant correlation with the number of PLT transfusion more than 100 U before transplantation (P = 0.038).

CONCLUSIONMSD allo-HSCT is an effective therapy for patients with SAA. Lower number of blood transfusion before transplantation, use of BMT, more number of infused CD34(+) cells can effectively prevent and treat aGVHD and IFI after transplantation, which may improve the efficacy of MSD allo-HSCT for SAA.

Adolescent ; Adult ; Anemia, Aplastic ; therapy ; Child ; Child, Preschool ; Female ; HLA Antigens ; Hematopoietic Stem Cell Transplantation ; Humans ; Male ; Retrospective Studies ; Siblings ; Tissue Donors ; Treatment Outcome ; Young Adult

The objective of this study was to explore the useful value of circulating galactomannan (GM) for early diagnosis of invasive aspergillosis. All 141 patients were classified as 103 patients of clinical and possible diagnosis, and 38 non-Aspergillus patients. 209 serum samples for the detection of GM by Platelia Aspergillus were collected before anti-fungal vaccine therapy. ELISA method was used in detection of GM. The results showed that (1) the sensitivity of 87.5%, specificity of 81.6%, positive prediction of 66.7% and negative prediction of 93.9% were determined by using cut-off value. According to the result of ELISA, the clinical diagnosed patients was up to 48, while the possible diagnosed patients were 55. (2) Among 62 patients with consecutive examinations of serum samples, 50 patients were successfully diagnosed and treated, while 12 patients died. A progressive reduction of GM level was found in survivors, however, the patients of poor prognosis showed higher antigen titres. It is concluded that GM test has more significance for earlier diagnosis of aspergillosis, the concentration of GM is related to prognosis of disease.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Aspergillosis ; diagnosis ; Aspergillus ; Enzyme-Linked Immunosorbent Assay ; Female ; Hematologic Diseases ; diagnosis ; microbiology ; Humans ; Male ; Mannans ; blood ; Middle Aged ; Predictive Value of Tests ; Sensitivity and Specificity ; Young Adult

OBJECTIVETo evaluate the efficacy and safety of antifungal prophylaxis of itraconazole in patients with acute myeloid leukemia (AML) to probe the relationship of the antifungal effect and the adverse events with serum concentration.

METHODSFrom April 2009 to May 2011, a total of 310 courses from 112 patients referred to our institute were enrolled in this study; of them, 297 courses were eligible for analysis. Eligible cases were randomized into oral group and injection/oral group according to different chemotherapy of induction and consolidation. Blood samples were collected at different time points for measurements of serum itraconazole levels. The morbidity of IFI and the adverse events were analyzed.

RESULTSThe morbidities of IFI in injection/oral and oral groups were 10.1% and 20.9%, respectively (P=0.010). 7 and 9 cases in injection/oral and oral groups, respectively were withdrawn from the study because of adverse events, and the difference between these two groups was of no significance. Serum itraconazole levels of injection/oral and oral groups were 672(299-1097) μg/L and 534(210-936) μg/L, respectively (P<0.01).

CONCLUSIONAntifungal prophylaxis with itraconazole in AML patients was effective and safe. Prophylactic effect with injection/oral itraconazole was superior to oral itraconazole solution; moreover, prophylactic effect of itraconazole was highly correlated with its serum level.

Adolescent ; Adult ; Antibiotic Prophylaxis ; Antifungal Agents ; therapeutic use ; Female ; Humans ; Itraconazole ; blood ; therapeutic use ; Leukemia, Myeloid, Acute ; drug therapy ; microbiology ; Male ; Middle Aged ; Mycoses ; etiology ; prevention & control ; Young Adult