1.Risk Analysis on the Collinear Production of Solid Preparations Based on Failure Mode and Effects Analysis as the Quality Risk Management Tools
China Pharmacist 2017;20(6):1117-1119
Objective: To analyze and estimate the risks of failure modes in a pharmaceutical Co.Ltd.in Nanjing producing solid preparations by collinear production, and come up with measurements to improve the quality level accordingly.Methods: The quality risk level evaluation table for the failure modes in the various steps of collinear production was obtained through the failure mode and effects analysis (FMEA).The risk control measurements were put forward in order to control and improve different failure modes with various unacceptable risk levels.Results: The risks of solid preparations by collinear production were greatly reduced through FMEA.Conclusion: The FMEA method is an effective way to improve the quality level of collinear products.Meanwhile, there are limitations of FMEA, and other risk management methods should be combined to control the overall risk of drug production.Moreover, the failure modes at the same risk level with different properties should be analyzed and controlled accordingly.The above methods can improve the risk management level of a company and reduce the risks of cross-contamination, mistakes and air-transferring in order to enhance the efficiency of quality management system and produce safe and effective drugs.
2.Basic research and clinical application of musculocutaneous perforator flaps
wei-jie, SU ; yun-liang, QIAN ; yi-xin, ZHANG
Journal of Shanghai Jiaotong University(Medical Science) 2006;0(07):-
The use of flaps for plastic and reconstructive surgery is very popular today.More and more surgeons have realized that the blood supply plays an important role in the design and survival of flaps.After Ian McGregor and Ian Jackson first introduced the axial flaps into clinics,Mathes divided the flaps into two types in 1981,the fasciocutaneous perforator flaps and musculocutaneous perforator flaps.In 1989,the concept of perforator flap was first brought into clinical practice.With the development of microsurgery and anatomy,the epidermis of human skin is divided into areas based on the vascular anatomy.A new century of musculocutaneous perforator flaps has been established.The terminology,classification,characteristics and application of musculocutaneous perforator flaps are described in this paper.
3.Study on identification of Sarcandra glabra and Chloranthus spicatus's leaves by PCR amplification of specific alleles.
Yi-cong WEI ; Ying CHEN ; Lin-quan LUO ; Qun-xiong YANG ; Yi-Juan CHEN ; Yi-chi LIANG ; Su-Rong CHEN
China Journal of Chinese Materia Medica 2014;39(17):3259-3262
The paper is aimed to identify SNP in Sarcandra glabra and Chloranthus spicatus, and authenticate S. glabra from Ch. spicatus and the mixture by using PCR amplification of specific alleles. SNPs in the ITS sequences of S. glabra and Ch. spicatus were found by ClustulX 2. 1 program and Bioedit software. Primers for authentic S. glabra and Ch. spicatus was designed according to the SNP site, and ITS sequence universal primers plus to the authentic primer to construct a multi-PCR reaction system, and then optimized the PCR reaction system. Five hundred and eighty band special for S. glabra and 470 bp band special for Ch. spicatus were found by using multi-PCR reaction. The multi-PCR reaction system could be applied to identify S. glabra and Ch. spicatus's leaves.
DNA, Plant
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analysis
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genetics
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DNA, Ribosomal
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genetics
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DNA, Ribosomal Spacer
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analysis
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genetics
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Magnoliopsida
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classification
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genetics
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Plant Leaves
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genetics
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Polymerase Chain Reaction
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Polymorphism, Single Nucleotide
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RNA, Ribosomal
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genetics
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RNA, Ribosomal, 18S
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genetics
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RNA, Ribosomal, 5.8S
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genetics
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Species Specificity
4.Therapeutic effect and safety of vincamine in anterior non -arteritic ischemic optic neuropathy
Chao-Qun, LIANG ; Chang-Zheng, CHEN ; Yu, SU ; Zuo-Hui-Zi, YI
International Eye Science 2017;17(10):1845-1848
AIM: To observe the clinical efficacy and safety of vincamine sustained release capsules on non- arteritic anterior ischemic optic neuropathy ( NAION) . · METHODS: Patients who were diagnosed with monocular onset NAION in acute stage from January to September 2015 were divided into two groups. Routine treatment such as steroid pulse therapy and neurotrophic treatment were given to all the patients. Vincamine was added to the treatment group patients with 30mg twice a day for 3mo. The best corrected visual acuity ( BCVA), mean deviation ( MD) of visual field, retinal nerve fiber layer ( RNFL ) , ganglion cell complex ( GCC ) , pattern visual evoked potential ( PVEP ) and OCT results were analyzed before and after the treatment. ·RESULTS:Totally 42 eyes of 42 patients were enrolled in our study. There were 27 patients in the treatment group, aged from 33 to 79 years old, the average value was 55. 55± 11. 83 years old. The control group has 15 patients, aged from 40 to 70 years old, the average value was 55. 71 ± 10. 06 years old. There were no statistical differences between the two groups in the baseline. After 3mo of the treatment, MD value of the two groups were lower compared with the baseline, the difference was statistically significant in the treatment and control group respectively (t= 2. 342, 2. 692; P = 0. 027, 0. 041). The difference of PVEP amplitude and potential of the two groups before and after the treatment were not statistically significant. The thickness of retinal nerve fiber layer and the ganglion cell complex were all lower than the baseline, and the difference was statistically significant (P<0. 001). The treatment of the two groups were both effective, the treatment group has better treatment effect than the control group. Adverse events related to the treatment of vincamine had not been found. ·CONCLUSION:Vincamine is helpful in the treatment of non-arteritic anterior ischemic optic neuropathy.
5.Optical coherence tomography angiography in retinal vein occlusion
Yu SU ; Changzheng CHEN ; Zuohuizi YI ; Lan YU ; Yishuang XU ; Chaoqun LIANG
Chinese Journal of Ocular Fundus Diseases 2016;32(4):357-361
Objective To observe the characteristics of optical coherence tomography (OCT) angiography (OCTA) in retinal vein occlusion (RVO).Methods Prospective and observational study.Clinical examination of 81 consecutive patients (86 eyes) diagnosed with RVO were included in the study,in which the branch retinal vein occlusion in 47 eyes,central retinal vein occlusion in 39 eyes.Forty-five patients were male and 36 patients were female.Aged from 28 to 76 years old,the mean age was (55.36±10.01) years old.Comprehensive optical and imaging examination were performed,including fundus photography,fundus fluorescein angiography (FFA),spectral domain OCT,en face OCT and OCTA.The retinal blood flow imaging scan mode and the optic disc blood flow imaging scan mode were performed,the scanning region in the macular area were 3 mm × 3 mm,6 mm × 6 mm,8 mm × 8 mm respectively,around the optic disc were 3 mm × 3 mm and 4.5 mm × 4.5 mm.Each region scans 2 times.The characteristics of foveal avascular zone change,macular edema,non-perfusion and optical disc edema in OCTA and their corresponding FFA and en face OCT were observed.Results By OCTA,67 eyes (77.9%) for foveal avascular zone change,23 eyes (26.7%) for macular edema,40 eyes (46.5%) for non-perfusion,and 33 eyes (38.4%) for optical disc edema can be detected.The foveal avascular zone change can be indentified as the tranformation,destruction and even vanish of the arch in superfacial layer of retinal macular area,acompanied with the dilatation and thickening of capillary vessels,the occlusion and expanding of capillary vessels arounded the foveal avascular zone in the deep layer of macular area.Those performances were more clear than FFA.The main expression of macular edema was low signal and was not as clear as en face OCT.The tortuosity and expansion of retinal vessels,density decreasing and even occlusion or abnormal traffic branch of capillary vessels can be observed in non-perfusion.These observations were similar to FFA.However,pieces of highly signal identical with non-perfusion area can b.e detected in chroid capillary.The representation of optical disc edema was the brush-like expanding of capillary vessels aroud optical disc.Conclusions OCTA can help for observing the abnormal changing of capillary vessels in foveal avascular zone and macular edema,non-perfusion and optical disc edema.Foveal avascular zone change showed occlusion and expanding of capillary vessels around the foveal avascular zone in the deep layer of macular area.Macular edema showed the weak signal.Non-perfusion showed tortuosity and expansion of retinal vessels,density decreasing and even occlusion or abnormal traffic branch of capillary vessels.Optical disc edema showed brush-like expanding of capillary vessels around optical disc.
6.Research on vacant drowning rescuer
Su GUO ; Mijun WANG ; Lili XIONG ; Caoyang CHEN ; Liang FANG ; Chang WANG ; Yi DU
Chongqing Medicine 2015;(7):937-938
Objective To design a new vacant drowning rescuer in self-help can be effective and free when swimming.Meth-ods Vacant drowning rescuer includes the vacant,life-saving device,the waist straps and the ropes.Results Vacant drowning res-cuer has light weight,high strength,and small size.It is secured to the swimmer′s waist through waist strap and easy to operate. Conclusion Vacant drowning rescuer provides the security for the water activity,which can realize self-help or save others.It can be universally applied for the majority of swimming enthusiasts.
7.Research advancement of the distal radius fracture.
Liang ZHAO ; Yi-bo TANG ; Jia-can SU
China Journal of Orthopaedics and Traumatology 2010;23(8):638-641
Distal radius fracture is one of the most common injuries of human beings, particularly in young males and elderly females. There are various classifications among which classification by author' names and the AO fracture classification system are most frequently used. Although the latter one is overall and consummate, a precise classification system with complete description of the fracture remains to be raised. Recently, with the development of wrist biomechanics and microscope anatomy, more and more studies were made to treat distal radius fracture. Good reduction and fixation are the key points for treatment. In tenns uf treatment, several options exist. Nonoperative management consists of closed replacoment and external fixation. Operative treatments includes intrafocal pinning ,non-bridging and bridging external fixation , various methods of open reduction internal fixation and hone or bone substitute transplantation. Besides, arthroscopic-assisted external fixation and artificial joint for wrist become a new hot spot. However,any single therapy could not treat all sorts of distal radius fractures. Therefore, it is better to institute individualized therapy according to different fracture characteristics of each patient in order to achieve the best curative effect. This review aims to make a conclusion about advancement in distal radius fractures, in aspects of epidemiology, classification and treatment.
External Fixators
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Fracture Fixation, Internal
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Humans
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Radius Fractures
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classification
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epidemiology
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surgery
8.Rotablation in the treatment of high-risk patients with heavily calcified left-main coronary lesions
Menghsiu CHIANG ; Hungtao YI ; Chengrong TSAO ; Weichun CHANG ; Chiehshou SU ; Tsunjui LIU ; Kaewoei LIANG ; Chihtai TING ; Wenlieng LEE
Journal of Geriatric Cardiology 2013;(3):217-225
Objective Heavily calcified left-main coronary diseases (LMCA) remain a formidable challenge for percutaneous interventions (PCI). This study was to investigate the safety and efficacy of using rotational atherectomy (RA) in treating such lesions in actual practice. Methods From February 2004 to March 2012, all consecutive patients who received RA for heavily-calcified LMCA lesions in our cath lab were en-rolled. The relevant clinical and angiographic characteristics at the time of index PCI, as well as the clinical follow-up outcomes, were re-trieved and analyzed. Results A total of 34 consecutive patients were recruited with a mean age 77.2 ± 10.2 years. There were 82.4%pre-sented with acute coronary syndrome and 11.8%with cardiogenic shock. Chronic renal disease and diabetes were seen in 64.7%and 52.9%, respectively. Triple-vessel coronary disease was found in 76.5%of them. The mean SYNTAX score was 50 ± 15 and EuroSCORE II scale 5.6 ± 4.8. The angiographic success rate was 100%with a procedural success rate of 91.2%. The mean number of burrs per patient was 1.7 ± 0.5. Crossing-over stenting was used in 64.7%. Most stents were drug-eluting (67.6%). Intra-aortic ballon pump was used in 20.6%of the procedures. Three patients died during hospitalization, all due to presenting cardiogenic shock. No major complication occurred. Among 31 hospital survivors, the major adverse cardiac events (MACE) rate was 16.1%, all due to target lesion revascularization or target vessel revas-cularization. Conclusions In high-surgical-risk elderly patients, plaque modification with RA in PCI of heavily-calcified LMCA could be safely accomplished with a minimal complication rate and low out-of-hospital MACE.
9.The correlation between nosocomial infections and the serum levels of interleukin-10,interleukin-13,interlenkin-15 in patients with chronic hepatic failure
Zhi-Jun SU ; Jian-Liang ZHUANG ; Ru-Yi GUO ; Xiao-Dong QIU ; De-Song MING ; Qi LIN ;
Chinese Journal of Infectious Diseases 2007;0(12):-
Objective To investigate the significance of the serum levels of interleukin-10 (IL-10),IL-13,IL-15 of patients with chronic hepatic failure and the correlation between those inter- leukin levels and nosocomial infections.Methods The serum levels of IL-10,IL-13,IL-15 of 58 patients with chronic hepatic failure were measured by double antibody sandwich enzyme-linked immu- nosorbent assay at the time of admission and 2 weeks after admission.Results The serum levels of IL-15 and the propotion of IL-15/IL-10 and IL-15/IL-13 in patients with chronic hepatic failure group at the time of admission were significantly higher than those in healthy control group[(358.16?290.91) ng/L vs (38.55?21.49) ng/L,12.93?14.26 vs 1.10?0.55,98.55?97.5.5 vs 9.70?5.03,respectively,all P=0.000].Those in death group were significantly higher than those in improving group[(479.93v205.52) ng/L vs (244.51?236.29) ng/L,17.65?17.78 vs 8.53?7.98,130.69?115.50 vs 68.55?65.99,respectively,all P
10.Association of E-cadherin and beta-catenin with metastasis in nasopharyngeal carcinoma.
Zhi LI ; Yi REN ; Su-xia LIN ; Ying-jie LIANG ; Hui-zhen LIANG
Chinese Medical Journal 2004;117(8):1232-1239
BACKGROUNDThis study was designed to detect methylation of E-cadherin gene promoter and gene mutation of beta-catenin in exon 3 and their expression of protein and mRNA in primary tumor and lymph node metastatic tumor of nasopharyngeal carcinoma (NPC), and investigate the mechanism of invasion and metastasis of neoplastic cells in NPC.
METHODSFourty-two fresh biopsy samples were taken from untreated NPC patients at the Affiliated Hospital of Sun Yat-sen Medical College, Sun Yat-sen University, Guangzhou, China during the period of 1999-2002. Among them 21 were taken from primary tumors and the other 21 from lymph node metastatic tumors. The gene promoter methylation of E-cadherin was detected by methylation-specific PCR (MSP). The mutation in exon 3 of beta-catenin was detected by direct sequencing analysis. RT-PCR, Western blot and immunohistochemical staining were used to detect the mRNA and protein expression patterns in both primary and metastatic tumors of NPC.
RESULTSDown-regulated expression of E-cadherin in metastatic tumor was compared with that in primary tumor. Reduced expression of E-cadherin was found to be correlated with lymph node metastatic tumor of NPC (P = 0.004); but there was no obvious correlation between primary and metastatic tumors in the expression of beta-catenin (P = 0.698). The mRNA expression level of E-cadherin in metastatic tumors decreased significantly compared with that in primary tumors. However, little change was observed in the mRNA level of beta-catenin in different tumor tissues. Only 4 samples (19.1%) displayed gene promoter methylation of E-cadherin in primary tumor and 10 samples (47.6%) showed methylated form of E-cadherin. The gene promoter methylation of E-cadherin was more common in metastatic tumor than in primary tumor of NPC (P = 0.024). Only 2 (4.76%) of the 42 samples showed mutations in exon 3 of beta-catenin at 41 (T41A, ACC-->GCC) and codon 47 (S47T, AGT-->ACT). The cytoplasmic and nuclear expression of beta-catenin in tumor was not found in any samples of NPC.
CONCLUSIONSThe results suggest that the downregulation of E-cadherin results from the gene promoter aberrant methylation of E-cadherin and that the methylation of E-cadherin plays an important role in invasion and metastasis of tumor cells in NPC. However, beta-catenin mutation is an infrequent event in NPC, and beta-catenin is not a critical factor influencing the invasion and metastasis of tumor cells in NPC.
Adult ; Aged ; Blotting, Western ; Cadherins ; analysis ; genetics ; Cytoskeletal Proteins ; analysis ; genetics ; DNA Methylation ; Female ; Humans ; Immunohistochemistry ; Male ; Middle Aged ; Mutation ; Nasopharyngeal Neoplasms ; chemistry ; genetics ; pathology ; Neoplasm Metastasis ; Promoter Regions, Genetic ; Trans-Activators ; analysis ; genetics ; beta Catenin