OBJECTIVE:To evaluate the feasibility and effectiveness of Hazard analysis and critical control point (HACCP) system in the process of production of Loratadine tablets. METHODS:Taking wet granulation and tableting technology of Lorata-dine tablets as an example,and through the introduction of the concept of HACCP,the basic theory and method of HACCP were applied for hazard analysis on each production link to find critical control points and set critical limits for production quality man-agement. RESULTS:By HACCP analysis,three links namely drying,granules fitting and mixing,internal and external packaging were finally determined as the critical control points in the process of production of Loratadine tablets,thereby critical control lim-its were set for monitoring. After effective control over the risks in the process was ensured,HACCP work plan was made and veri-fied,and the results showed that HACCP system could effectively control and reduce the risks in the process of production and en-sure quality safety. CONCLUSIONS:Application of HACCP system to wet granulation and tableting technology of Loratadine tab-lets can fully embody its feasibility and effectiveness.

OBJECTIVE:To study the classification of deviation in drug production. METHODS:From the perspective of dom-inant and hidden deviation,combining with the theory of risk management,risk of deviation was evaluated with different risk man-agement tools to define the severity of the deviation,and it was handled by different methods. RESULTS & CONCLUSIONS:Ac-cording to the identifiability of deviation in actual management,the deviation was divided into dominance and hidden deviation. The dominant deviation can be divided into deep and shallow level. Whether the causes of deviation could be cleared and the conse-quences could be estimates were judged after the shallow level classification,and the deviation was further divided into simple and complex deviation. As for deviation complex,it could be evaluated with the tools of risk management to define the deviation severi-ty. As for hidden deviation,it needed beforehand preventing with the tools of risk management directly to define deviation levels and provide reference for preventive measures. In the process of deviation management,key point is to relay on the scientific meth-od to identify and classify deviation,and divide the influence levels. Combining the theory of risk management to select and use risk tools is the effective way to solve the problem.

Communicable Diseases, Emerging ; genetics ; Genomics ; Humans

Objective To observe the effect of vitamin A(VitA) on T help 17(Th17) and regulatory T cells (Treg) in the peripheral blood in children with asthma and their dose effect relationship,and to investigate the immunoregulation mechanism of VitA.Methods Twenty children with asthma (asthma group) and 16 healthy children (healthy control group) were selected.Peripheral blood mononuclear cells(PBMC) were isolated from venous blood by density gradient centrifugation in the aseptic condition.Different concentrations of VitA [0.0μmol/L (blank control),0.5μmol/L,1.0μmol/L,2.0μmol/L] were added into the cultures in the asthma group.The healthy control group were not interfered with VitA.The supernatant was collected after 72 h.The levels of interleukin 17 (IL-17),interleukin 10(IL-10) and transforming growth factor-β1 (TGF-β1) in the supernatant were determined by enzyme-linked immunosorbent assay.Results (1) IL-17 levels produced by PBMC in the asthma group were significantly higher than those in the healthy control group [(960.53±75.59) ng/L vs (425.07±70.71) ng/L,P＜0.01],and the levels of IL-10 and TGF-β1 were significantly lower than those in the healthy control group [(53.13±6.94)ng/L vs (84.41±6.02) ng/L,(304.51±51.52) ng/L vs (489.45±73.68) ng/L,all P＜0.01].(2) IL-17 levels produced by PBMC in the 0.5μmol/L,1.0μmol/L and 2.0μmol/L VitA concentration of the asthma group [(588.95±44.18)ng/L,(573.13±27.43) ng/L,(686.71±38.98) ng/L] were significantly lower than those in the blank control group[(960.53±75.59) ng/L,all P＜0.01],and IL-17 levels in the 2.0 μmol/L VitA concentration were significantly higher than those in 0.5μmol/L and 1.0μmol/L concentration groop (P＜0.01).(3) IL-10 levels produced by PBMC in the 0.5μmol/L,1.0μmol/L and 2.0μmol/L VitA concentration of the asthma group [(105.35±10.79) ng/L,(111.21±16.11) ng/L,(81.09±6.05) ng/L] were significantly higher than those in the blank control group[(53.13±6.94) ng/L,all P＜0.01],TGF-β1 levels produced by PBMC in the 0.5μmol/L,1.0μmol/L and 2.0μmol/L VitA concentration of the asthma group[(933.01±73.98) ng/L,(1223.31±105.99)ng/L,(776.98±145.44) ng/L] were significantly higher than that in blank control group[(304.51±51.52) ng/L,all P＜0.01],and the levels of IL-10 and TGF-β1 in the 0.5 μmol/L and 1.0μmol/L concentration group were significantly higher than those in the 2.0μmol/L concentration group(all P＜0.01).The level of TGF-β1 in the 1.0μmol/L concentration group were significantly higher than that in the 0.5μmol/L concentration group (P＜0.01).Conclusions The function of Th17 in children with asthma during asthma attack was enhanced,and the function of Treg cells was reduced.The balance disorder of the functions of Th17 and Treg cells occurred.VitA can reduce the function of Th17 in peripheral blood,and enhance the activity of Treg cells in the children with asthma.The physiological level of VitA has the best effect,if high VitA concentration is high its effect is significantly decreased.

In MAST (mRNA accessible site tagging),the DNA tags from synthesized library were employed for identifying mRNA accessible sites. A large number of tags were amplified and subcloned for sequencing to verify mRNA binding profiles. A PCR was designed by using one primer which bridges over the tag terminal sequences. In PCR reaction DNA tag fragments were concatemerized by a bridge primer in reaction cycles. The concatemerized tag fragments were subcloned and sequenced. Dozens of the concatemerized sequences contained thousands tags. The PCR was a simple,effective way which for sequencing tags in a high through put manner.

Adult ; Comet Assay ; DNA Damage ; drug effects ; Female ; Humans ; Lipid Peroxidation ; drug effects ; Male ; Peracetic Acid ; toxicity

The nuclear transcription factor nuclear factor erythroid 2-related factor 2 (NRF2) plays a crucial role in maintaining cellular redox homeostasis. The aberrant NRF2 signaling confers enhanced antioxidant capacity, which is linked to tumor progression and therapeutic resistance. The current study investigates the biological effects and molecular mechanism of tribbles homolog 3 (TRIB3), a stress-induced protein, in regulating cell survival and apoptosis in lung cancer. This study first performed the RNA sequencing data analysis with 576 lung adenocarcinoma patients from the cancer genome atlas (TCGA) database. The NRF2- antioxidant response element (ARE) signature was enriched in patients with high TRIB3 expression. Dual-luciferase reporter assay and real-time quantitative polymerase chain reaction (PCR) were used to confirm the effect of TRIB3 on the kelch-like ECH-associated protein-1 (KEAP1)-NRF2 pathway. Abrogation of TRIB3 impaired NRF2 transcriptional activity and reduced the expression of its target genes. Moreover, TRIB3 enhanced NRF2 stability via blocking KEAP1-NRF2 interaction. TRIB3-depletion promoted reactive oxygen species (ROS) production, restrained cell proliferation, and enhanced carboplatin-induced apoptosis. In addition, NRF2 overexpression recovered the tumor inhibition effect of TRIB3-depletion. Consistently, TRIB3 failed to modulate apoptosis in NRF2 depletion cells. In summary, this study shows that TRIB3 inhibits the KEAP1-NRF2 interaction and upregulates the transcriptional activity of NRF2, thereby promoting lung cancer cell proliferation and reducing the sensitivity to chemotherapy. Targeting the TRIB3-NRF2 signal axis may become a new strategy for ROS homeostasis and lung cancer treatment.

Objective To investigate the clinical effects and postoperative complications of arthrotomy and arthroscopy in repair of 170 menisci in 168 cases.Methods One hundred and sixty-eight patients with meniscus injury were repaired by arthrotomy or arthroscopy.They were 121 males and 47 females.There were 77 left knees and 91 right knees;117 medial menisci and 53 lateral ones.Their average age was 25.5?8.4 years old.Arthro- scopic repair methods included puncture and grinding,bio-absorbable meniscus arrow fixation,Outside-In suturing, Inside-Out suturing,Elite scuff instrument repairing,T-Fix fixation and FasT-Fix fixation techniques.The clinical results were assessed on the basis of symptoms,physical signs,Tegner scores and Lysholm scores of the cases. Postoperative complications were also investigated.Re-arthroscopic exploration was done for patients with obvious symptoms and physical signs.Results The average folluw-up time was 49.3?28.8 months.Their mean pre- operative Tegner score was 3.3?2.3,and their postoperative one 6.8?2.1 (P＜0.05).Their preoperative Lysholm score was 30.1?18.2,and their postoperative one 87.5?22.5 (P＜0.01).There were significant differences in Tegner and Lysholm scores before operation and after operation.Ninety-eight repaired menisci were rated as excellent(57.7%),57 as good (33.5%),10 as fair (5.9%),and five as poor (2.9%).The total ex- cellent and good result was 91.2%.Of the 19 patients with obvious symptoms and physical signs,re-arthroscopic exploration found no healing in five and partial healing in six.Postoperative complications included pain at the Outside-In suture nodes in three cases,referred pain at posterior articular capsule resulted from failed Outside-In meniscus anterior horn suturing in one case,and twinge at the meniscus arrow site in the posterior capsule in five cases.No serious lesion occurred at blood vessels or nerves.The postoperative complication incidence was 5.3%. Conclusion The eight methods of arthrotomy and arthroscopy to repair injured menisci investigated in our study can have a high successful rate and low perioperative and postoperative risk.

Objective: To determine the molecular weight and p urity of porcine platelet-derived growth factor (pPDGF) and to investigate its effect on DNA synthesis of human umbilical vein endothelial cells. Metho ds: In the present experiment, the high performance liquid chromatograph y was used and the molecular weight and purity of pPDGF were studied. Human umbi lical vein endothelial cells was cultured and effects of pPDGF on DNA synthesis of endothelial cells was observed by 3H-TdR incorporation in vitro. Results: The findings of high performance liquid chromatography showed that the molecular weight of pPDGF was 29 120 and the purity was 89.46%, a nd pPDGF significantly promoted DNA synthesis of quiescent endothelial cells wit h a maximal response at a concentration of 40 ng/ml at 48 h. Conclusion: The molecular weight of pPDGF is 29 120, and it can promote DNA synthes is of cultured human umbilical vein endothelial cells.

OBJECTIVETo investigate the antithrombotic effects and its molecular mechanisms of prazosin combined with anisodamine (Ani).

METHODSIsolated rat tail artery rings model was employed to evaluate the vasodilative effects of drugs, mice tail thrombosis model induced by carrageenan was used to study the antithrombotic effects and its molecular mechanisms of the drug composition.

RESULTSAmong alpha1-adrenoreceptor antagonists, prazosin(Pra) had the greatest relaxation rate, which was (82.6 +/- 8.9)%, and the EC50 value was 0.44 micromol/L. The drug composition of anisodamine and prazosin of different doses could decrease the length of the tail thrombosis from (24.6 +/- 4.6)mm to (6.9 +/- 2.7)mm, and the rate of thrombosis was decreased from 86.6% to 50.0%. The drug composition could prolong the prothrombin time (PT) distinctively, but it had no effect on the activated partial thromboplastin time (APTT). It also could restrain the decrease of serum levels of tissue plasminogen activator (t-PA) and 6- Keto -PGF1alpha as well as the increase of type-1 plasminogen activator inhibitor (PAI-1) and thromboxane B2 (TXB2) in the mice.

CONCLUSIONThe drug composition formed by anisodamine and prazosin has good effects of relaxing extremities tiny blood vessels and it can fight against thrombosis, its antithrombotic mechanisms may be related to the influence of the extrinsic coagulation pathway, inhibition of platelet activation functions and the promotion of fibrinolysis function.

Adrenergic alpha-1 Receptor Antagonists ; pharmacology ; Animals ; Disease Models, Animal ; In Vitro Techniques ; Male ; Prazosin ; pharmacology ; Rats ; Rats, Wistar ; Solanaceous Alkaloids ; pharmacology ; Thrombosis ; drug therapy