OBJECTIVE:To provide approaches and avenues for the Chinese drugs preparations manufacturers in the GMP depuratory authentication.METHODS:The features and difficulties in the GMP depuratory authentication of the Chinese drugs preparations such as the optimizing of depuratory regulations,the determination of the acceptable standards,the choice of testing methods,clarification of expiration date and re-authentication were analyzed.RESULT&CONCLUSION:The depuratory regulations of the manufacturing facilities for the Chinese drugs preparations must be optimized.

OBJECTIVE:To provide references for the improvement of our country's current Good Manufacturing Practice(GMP).METHODS:In consideration of GMP standards and problems in its implementation,the system,customers,suppliers,business leaders and documentation etc.were analyzed.RESULTS&CONCLUSION:Problems in the GMP standards has influenced the practice of GMP.In order to improve and optimize the GMP standards,it was recommended that process system be integrated to make the design quality in conformity with the manufacturing quality,open quality management system be established,business leader's leading effect be emphasized and clear and universal documentation system be established.

BACKGROUND: At present, the scale for evaluating cervical vertigo symptoms and functions applied in clinic can evaluate the overall curative effect in patients with cervical spondylosis of vertebral artery type (CSA).However, this scale lacks the content of functional status and emotional function for evaluating daily life function.OBJECTIVE: To develop a functional scale for cervical spondylosis of vertebral artery type (FS-CSA) including functional status and emotional function based on the vertigo disorder scale made abroad.DESIGN: Cross-sectional survey, interview evaluation after pretest, internal consistency, retest consistency and construct validity were measured by the method of Chronbach's c, Pearson correlation coefficients and factor analysis, respectively.SETTING: Clinical Epidemiology/DME Center, Guangzhou University of Traditional Chinese Medicine.PARTICIPANTS: Totally 111 consecutive patients with CSA, 30 men and 81 women aged 31 to 72 years, in the Clinic for Cervical Spondylosis of Guangdong Provincial Hospital of Traditional Chinese Medicine were recruited from May 2001 to March 2002. Altogether 36 patients had risk factors of vertebral-base artery atherosclerosis. There were 14 cases of mild vertigo, 61 cases of moderate vertigo, and 36 cases of severe vertigo. Informed consent was obtained from the participants.METHODS: FS-CSA was made according to clinical actual condition Functional status (going for a walk during the day by yourself, walking around the house in the dark, doing strenuous housework, social activity,traveling for business or recreation, getting into or out of bed, reading books or newspaper; each item was divided into three categories "No,anxious, worried about your illness, and feeling frustrated; each item consisted of three categories "No, Sometimes, and Yes"). Patients with CSA were evaluated by means of interview and 14 of them were retested. Internal consistency, construct validity and correlation coefficients of the scale were measured with SPSS 10.0 software.tional status dimensionality, emotional functional dimensionality as well as internal consistency of the total scale in FS-CAS: Chronbach's α value was 0.875 9, 0.645 3 and 0.859 5, respectively; retest consistency value was extracted common factor was consistent with the two dimensionalities.tool quantifies the life quality of the patients with CSA and can make a uate curative effects of drugs or screen the best treatment scheme; therefore, it has clinical application value.

Objective To observe the apoptosis of retina and the expression of caspase-3 in mice with premature myopia and to explore the pathogenesis of premature myopia.Methods Together 60 newborn C57BL/6J mice were selected and divided randomly into three groups (n =20):P6 group (opening the eyelid on day 6 after birth),P10 group (opening the eyelid on day 10 after birth) and normal group (opening the eyelid naturally).The right eyes of mice in the P6 and P10 group were subjected to lighting exposure,and the left eyes were left untreated serving controls with its right eyes;while the eyes in the normal group open naturally without any treatment.Then the refraction was checked on day 15 through retinophotoscopy,and ocular axial length was measured by micrometer with electronic digital display.TUNEL assay was used to determine retinal apoptosis.Immunohistochemistry and Western blot were used to detect the expression of caspase-3 in mice retina.Results The right eyes developed significant myopia in the P6 group [(-7.55 ±0.15)D] and P10 group [(-5.25 ±0.10)D],while the eyes in the normal group did not suffer from myopia,and there was significant difference in the three groups (P ＜0.05).The average axial length of right eyes in the P6 group [(2.49 ± 0.08) mm] and the P10 group [(2.51 ±0.03)mm] was shorter than that in the normal group [(2.58 ± 0.04) mm],with significant difference (P ＜ 0.05).Immunohistochemistry showed that the expression of caspase-3 had a dramatically increase in ganglion cell layer and inner nuclear layer of retina of mice in P6 group and P10 group.TUNEL results showed that brown-stained positive apoptotic cells appeared in ganglion cell layer in the P6 and P10 group,while Western blot showed that the expression of caspase-3 protein in mouse retina in P6 group (gray value 52.70％) and P10 group (gray value 35.76％) was upregulated.Conclusion Early lighting exposure can induce premature myopia of mice,and the earlier the mice receive light,the higher the relative degree of myopia is;meanwhile during the process of premature myopia,ganglion cells and nuclear layer cells suffer apoptosis,as well as caspase-3 protein involves in the occurrence of apoptosis.

Objective To explore the significance of case managers using WeChat platform in the treatment process and extended care for patients with laryngeal cancer.Methods From November 2014 to May 2015, 30 patients with partial resection or total resection of laryngeal cancer in the department of head and neck surgery were selected as a research subjects.Case managers provided fully supports,such as establishing WeChat group,replying online consultations,popularizing health education knowledge,providing psychological counselings.Psychological assessment of the patients was conducted by social support scale(SSRS)and anxiety scale(SAS)in the beginning of case management.Results comparison was performed before and after three months intervention.Results The score of subjective support of patients before intervention was (25.13 ±4.81)points,which after intervention was (28.33 ± 4.41)points.The score of support availability before intervention was (7.20 ±1.99)points,which after intervention was (35.27 ±5.90)points.The differences were statistically significant(t =-2.685,-5.280,2.917,all P <0.05).Conclusion The WeChat platform mediated by the case management is effective in the management of the psychological health of patients with laryngeal cancer,which can effectively promote the rehabilitation of patients.

Attention-deficit/hyperactivity disorder (ADHD)is one of the most common comorbidities of ASD.This article reviews the assessment tools and clinical research (prevalence,clinical characteristics and treat-ment)and fundamental research (iconography,genetics,neurophychology,electronerophysiology)of ASD with ADHD according to lately related articles.The findings suggested that there was lack of researches on treatment and iconography of ASD with ADHD and the conclusions were inconformity.Furthermore,most of the objects in these researches were children of normal intelligence.Thus future research should expand its objects to patients of adult and children with mental retardation and do further explore in iconography and treatment.

BACKGROUND:Diabetic foot ulcers threaten the patients’ health and even survival seriously. It is an international difficult problem and lacks an effective treatment. But gene therapy and stem celltherapy possess special advantages and potential in wound healing. OBJECTIVE:To assess the therapeutic effect of transplantation of bone marrow mesenchymal stem cells transfected by human vascular endothelial growth factor 165 (hVEGF165) gene on foot wound healing in diabetic rats. METHODS:Recombinant adenovirus was established in vitro which expressed hVEGF165 gene and transfected into the third generation of bone marrow mesenchymal stem cells. Total y 120 male Wistar rats were divided into five groups:group A (non-diabetic controls), group B (diabetic controls), group C (Ad-hVEGF165 therapy), group D (stem celltherapy) and group E (transplantation of bone marrow mesenchymal stem cells transfected by Ad-hVEGF165 gene). Rats in the latter four groups were intraperitoneal y injected with streptozotocin to induce diabetic models. In al rats, a 3 mm×7 mm rectangular ful-thickness skin sample was cut from the instep of the hind foot to make a model of foot wound. The rats were subcutaneously injected at equidistant six points 5 mm distal to the wound edge on the dorsum of the foot:50μL PBS per point for group A, 50μL adenovirus suspension (1×1013 pfu/L) per point for group C, 50μL stem cellsuspension (1×1010/L) per point for group D, and 50μL adenovirus suspension+50μL stem cellsuspension per point for group E. RESULTS AND CONCLUSION:After injection, the rate of wound healing, the expression of VEGF and the qualities of capil aries in group E were higher when compared with groups B, C, D (P<0.05), but were lower than those in group A (P<0.05). Transplantation of bone marrow mesenchymal stem cells transfected by hVEGF165 gene can promote foot wound healing, angiogenesis and expression of VEGF in diabetic rats.

OBJECTIVEThe aim of the present study was to prepare uniform-sized silybin loaded poly (lactic-co-glycolic acid) (PLGA) microspheres in study of silybin with stainless steel membrane.

METHODSilybin PLGA microspheres were prepared by stainless steel membrane emulsification. The preparation conditions were optimized by single-factor test and orthogonal experiment, and evaluating the mean diameters, the particle size distribution, drug loading, entrapment efficiency and morphology of microsphere.

RESULTPrepared microspheres were round and surface was smooth. The mean diameter was (4.961 +/- 0.56) microm. The span was (1.75 +/- 0.18). The entrapment efficiency was (54.997 +/- 4.05)% and the average drug loading was (23.6 +/- 1.70)%.

CONCLUSIONThe stainless steel membrane emulsification can be used to prepare the silybin PLGA microspheres. The mean diameters of the silybin PLGA microspheres can be controlled in certain level. Stainless steel membrane emulsification has great potentiality exploitation and utilization.

Drug Compounding ; methods ; Emulsions ; chemistry ; Lactic Acid ; chemistry ; Microspheres ; Particle Size ; Polyglycolic Acid ; chemistry ; Silymarin ; chemistry ; Stainless Steel ; chemistry

Carcinoma, Non-Small-Cell Lung ; genetics ; Exons ; genetics ; Genes, erbB-1 ; genetics ; Humans ; Lung Neoplasms ; pathology

To study the relationship between the late postmortem interval (PMI) and trimethylamine-nitrogen (TMA-N) in postmortem tissues of cadaver, TMA-N in muscles, livers and kidneys of rats was measured at different postmortem intervals (PMI) by using a modified spectrophotometric method. The results indicated that the detection sensitivity of TMA-N was 1 mg/L, and there was a good linear correlation between the value of absorbance (A value) and TMA-N at the concentration of 1-10 mg/L (R (2) = 0.9991). Although TMA variation in muscles was different from that in inner organs during the time since death, TMA-N changes in cadaver tissues was positively correlated with PMI. During 2 to 7 d since death, the best correlation between PMI and TMA-N concentration was found in muscles. With PMI as an independent variable, the cubic polynomial regression equation was y= -0.457x(3)+6.519x(2)-24.574x+27.207 (R (2)=0.969). During 3 to 8 days since death, PMI was best correlated with TMA-N concentration in inner organs. With PMI as the independent variable, the cubic polynomial regression equation was y=0.509x(3)-9.153x(2)+55.727x-95.819 (R (2)=0.953). It was concluded that TMA-N in tissues could be used as a new estimator for late PMI. The method used in this study offered advantages such as accuracy, sensitivity, little samples required and wide PMI estimation.
Cadaver ; Forensic Pathology ; Methylamines/*analysis ; Nitrogen/*analysis ; Pilot Projects ; Postmortem Changes ; Random Allocation ; Rats, Sprague-Dawley ; Spectrophotometry ; Time Factors