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Standards provide technical basis for the development of health food, which are the technical cornerstone for health food to base on and the technical methods for the promotion of quality improvement of health food.Under the new situation of the Thirteenth Five-year period, a more systematic, safer and more effective inspection standard system for health food is urgently needed to establish, which can fully satisfy the growing needs of health food products and meet the requests of industry development at high level.Based on the current standards of health food, this paper stated the present development situation of inspection standard system of health food, and studied and summarized the main problems in the standard source, classification and existing standard system.On this basis, the author put forward some exploratory suggestions to improve the standard system of health food.
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Objective: To provide a method of microbial limit test for Changyanning tablets and carry out the verification of the mothod.Methods: A plate method was used in the total aerobic microbial count and the concentration of the test liquid was 1∶100.A plate method was used in the total yeast and mold count while the concentration of the test liquid was 1∶10.The direct inoculation method was used for the detection of Escherichia coli,bile-tolerant gram-negative bacteria and Salmonella enterica subsp.Results: The recoveries of the five strains were from 0.5 to 2.0.Conclusion: The method is suitable for the microbial limit examination of Changyanning tablets.
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Objective To investigate the blood-saving effect of tranexamic acid in patients undergoing Stanford type A aortic dissection surgery.Methods Fifty-six patients of both sexes with acute Stanford type A aortic dissection, aged 34-58 yr, weighing 62-84 kg, of American Society of Anesthesiologists physical status Ⅱ or Ⅲ , with their left ventricular ejection fraction ＞ 40％, undergoing emergency surgery, were randomly divided into 2 groups: control group (group C, n=26) and tranexamic acid group (group TA, n=30).Tranexamic acid was infused as a bolus of 10 mg/kg over 30 min before skin incision followed by an infusion of 10 mg · kg-1 · h-1 throughout the surgery in group TA.The equal volume of normal saline was given instead in group C.The total volume of drainage at 24 h after operation, the postoperative requirement of allogeneic red blood cells, fresh frozen plasma and platelets, and re-thoracotomy for bleeding were recorded.The postoperative mechanical ventilation time, duration of intensive care unit stay, and complications after operation were also recorded.Results Compared with group C, the total volume of drainage at 24 h after operation, and the requirement of allogeneic red blood cells, fresh frozen plasma and platelets were significantly reduced, the incidence of rethoracotomy for bleeding was decreased, the postoperative mechanical ventilation time, and duration of intensive care unit stay were shortened, and the incidence of postoperative acute lung injury and transient neurological dysfunction were decreased in group TA.Conclusion Tranexamic acid has blood-saving effect and can reduce postoperative bleeding and allogeneic blood transfusion in patients undergoing Stanford type A aortic dissection surgery.
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Objective:To detect the related substances in norfloxacin glutamate and sodium chloride injections on the basis of nor-floxacin related substances analysis method described in Chinese Pharmacopoeia 2010 edition to establish a more scientific and feasible method. Methods:HPLC was performed under the following conditions:a Diamonsil C18(2)(250 mm ×4.6 mm,5μm) column, mo-bile phase A of 0. 025 mol·L-1 phosphoric acid-acetonitrile(87∶13), phase B of acetonitrile, with gradient elution at a flow rate of 1. 0 ml·min-1 , the detection wavelength of 278nm and 262nm, the injection volume of 20 μl, and the column temperature of 25℃. Results:Under the HPLC conditions, the samples had good stability and separation. An excellent linear relationship was achieved within the range of 0. 032-3. 179μg·ml-1(r=1. 000 0),the detection limit of impurity A was 0. 159 ng,and the average recovery was 98. 3% with RSD of 0. 64%(n=9). Conclusion:Compared with the existing methods, the gradient elution method is accurate, sen-sitive, specific and reproducible, and can be used in the determination of related substances in norfloxacin glutamate and sodium chlo-ride injections.
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Interferon beta (IFN-beta) and TNF-related apoptosis-inducing ligand (TRAIL) are effective anticancer agents. Adeno-associated virus (AAV) is one of the current most promising gene delivery vectors. Previously, we constructed tumor-targeting AAV-hTERT-IFN-beta and AAV-hTERT-TRAIL by inserting IFN-beta or TRAIL gene into AAV controlled by hTERT promoter. The studies showed that either single IFN-beta or TRAIL gene therapy exhibited a certain extent anticancer effect. Here, we report their inhibitory effects on A549 lung cancer cell growth in vitro and in vivo by combined AAV-hTERT-IFN-beta and AAV-hTERT-TRAIL. Expression of secreted IFN-beta in lung cancer A549 cells infected by AAV-hTERT-IFN-beta was detected by enzyme-linked immunosorbent assay (ELISA). The growth-suppressing effect of AAV-hTERT-IFN-beta in combination with AAV-hTERT-TRAIL on several cancer cell lines was assessed by MTT assay. Apoptosis of A549 cancer cells infected by AAV-hTERT-IFN-beta alone, AAV-hTERT-TRAIL alone, and their combination was evaluated by apoptotic cell staining and flow cytometry (FCM), respectively. The antitumor effect of the combination of AAV-hTERT-IFN-beta with AAV-hTERT-TRAIL in vivo was further evaluated through A549 lung cancer xenograft in nude mice. The results showed that the combinational treatment was superior to any alone and presented intensified tumor cytotoxic and apoptotic effect on A549 cancer cells. Most importantly, the combination of AAV-hTERT-IFN-beta with AAV-hTERT-TRAIL exhibited significant antitumor effect and eliminated all tumor masses in nude mice, which lay a foundation for exploring the molecular mechanisms of combined IFN-beta and TRAIL anti-tumor activity.
Subject(s)
Animals , Humans , Mice , Antineoplastic Agents , Metabolism , Pharmacology , Cell Line, Tumor , Dependovirus , Genetics , Metabolism , Genetic Therapy , Genetic Vectors , Genetics , Interferon-beta , Genetics , Pharmacology , Lung Neoplasms , Pathology , Therapeutics , Mice, Nude , Neoplasm Transplantation , Recombinant Fusion Proteins , Genetics , Pharmacology , TNF-Related Apoptosis-Inducing Ligand , Genetics , PharmacologyABSTRACT
Objective To evaluate the impact of the percentage of residual blasts in bone marrow at the end of induction chemotherapy ( T1 ) or during myelosuppression phase (T2) on prognosis of de novo acute myeloid leukemia(AML) (non M3) in 105 cases.To refine AML risk-stratification by combining the percentage of residual blast cells (T1 or/and T2) with cytogenetic data based the South West Oncology Group (SWOG) criteria.Methods The data of 105 de novo AML ( non M3 ) patients hospitalized between January 1st 1999 and February 1st 2008 were retrospectively reviewed.Results were analyzed with SPSS15.0 software.Results ( 1 ) Patients were divided into two subgroups by a cutoff of 5% residual bone marrow blasts at T1 or 12 time point.Patients with percentage of residual bone marrow blast cells <5% had better complete remission (CR) rate,relapse-free survival (RFS) and overall survival (OS) than the patients with percentage ≥5% at T1 or T2.The percentage of residual bone marrow blast cells at T1 was correlated with that at T2.(2) The prognosis of patients with intermediate karyotypes with percentage < 5 % at T1 or T2 was similar to that of the patients with favorable karyotypes.The patients with intermediate karyotypes and percentage of residual bone marrow blasts ≥5% at TI or T2 are defined as a subgroup with prognosis similar to that of patients with unfavorable karyotypes.(3) COX regression analysis showed that the percentage of residual bone marrow blasts at T1 or T2 is an independent prognostic factor of AML.The percentage of residual bone marrow blasts at T1 may be more helpful in prognostification than that at T2.Conclusion AML patients with percentage of residual bone marrow blasts < 5% after induction chemotherapy ( T1 or T2) have better CR rate,RFS,OS than the patients with percentage ≥5% at the same time point.Combination of cytogenetics and percentage of residual bone marrow blasts at T1 or T2 is helpful to divide patients with intermediate karyotypes into two subgroups with different prognosis.Thus,a better decision of treatment strategy can be designed.
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Objective To evaluate the clinical application of May-Grunwald-Giemsa staining followed by fluorescence in situ hybridization (MGG-FISH) technique in the differentiation diagnosis of Ph-chromosome positive acute lymphoid leukemia (Ph + ALL) from chronic myeloid leukemia in lymphoid blast crisis(CML-LBC). Methods The bone marrow smears of 4 patients with Ph+ ALL, 4 patients with CML-LBC, 1 patient with CML in myelocytic blast crisis complicated with lymphoma and 1 patient with CML in mixed blast crisis were assayed with the MGG-FISH technique in which the spectrum green labeled BCR and spectrum orange labeled ABL dual color dual fusion probes were used. Based on the morphological classification, the percentages of BCR-ABL positive cells were subsequently determined respectively in the erythroid, myeloid and lymphoid hneages for the 10 specimens. Results According to the MGG-FISH analysis, the erythroid lineage was not involved in the 4 Ph+ ALL specimens without BCR/ABL positive cells. While the BCR/ABL positive percentage of myeloid cells was 11% (1/9), 8% (1/12), 0% (0/8) and 10% (1/10) respectively and that of lymphoid cells was 97% (76/78), 98% (87/89), 98% (97/99) and 97% (75/77) respectively. On the other hand, the BCR/ABL positive percentage was 100% (8/8), 91% (10/11), 82% (9/11), 88% (7/8) in the erythroid lineage, 89% (8/9), 96% (94/98), 100% (47/47), 98% (40/41)in the myeloid lineage and 96% (78/81), 93% (52/56), 96% (68/71), 95% (58/61) in the lymphoid lineage respectively for the 4 CML-LBC specimens. The BCR/ABL positive percentages of the other 2 specimens were all above 80% and through MGG-FISH analysis we also identified the source of the malignant clones and ascertained the diagnosis of the 2 patients. Conclusions The MGG-FISH technique has proved useful in providing rapid and precise differentiation between Ph + ALL and CML-LBC. The source of the malignant clones can also be analyzed by this technique.