OBJECTIVE:To optimize preparation formulation of Tetrandrine solid dispersion tablets. METHODS:Tetrandrine solid dispersion tablets were prepared by direct compression method. Excipients were screened with single factor test. Taking disinte-gration time as index,the formulation of Tetrandrine solid dispersion tablets was optimized by orthogonal design using the amount of PVPP,lactose-microcrystalline cellulose proportion and the amount of gum acacia as factors. The optimized formulation was vali-dated. Prepared tablets were compared with Tetrandrine common tablet in dissolution rate,and the contents of the tablets prepared by optimized formulation were also determined. RESULTS:Optimal formulation was as follows as 9.5% PVPP as disintegrating agent,lactose-microcrystalline cellulose(1∶2)as filler,mixing,1% aerosil as lubricant,direct compression. For 3 batches of tab-lets,disintegration time were 79,81 and 78 s;contents were 98.66%,99.24%,99.85%;RSDs were 0.72%,1.16%,1.33%,re-spectively. Combined with Tetrandrine common tablets,the dissolution rate of prepared tablets had been improved significantly. CONCLUSIONS:Tetrandrine solid dispersion tablets are prepared successfully with rational reproducible formulation.

Objective:To establish an HPLC method for the determination of two components in compound artemisinin analgin tab-lets. Methods:A Waters Symmetry C18 column (250 mm × 4. 6 mm,5 μm) was used with methanol-0. 02 mol·L-1 KH2 PO4 solution (25 ∶75, adjusting pH to 3. 5 with phosphoric acid ) as the mobile phase. The flow rate was 1. 0 ml·min-1 and the detection wave-length was 250 nm. The column temperature was 30℃ and the injection volume was 20 μl. Results:There was a good linear relation-ship when the content of analgin and puerarin was within the range of 50.11-601.36 μg·ml-1(r=0.999 9) and 2.64-31.74 μg· ml-1(r=0. 999 8), respectively. The average recovery was 99. 1%(RSD=0. 7%,n=9)and 99. 9%(RSD=0. 6%,n=9),respec-tively. Conclusion:The method is simple and accurate with good reproducibility,which can be used to control the quality of the prepa-ration.

OBJECTIVE:To further enhance the implementation level of new Good Manufacturing Practices (GMP) in phar-maceutical enterprises. METHODS:Based on the new GMP criteria and Guidelines for Risk Assessment of Pharmaceutical Produc-tion Site Inspection,a tracking inspection was conducted for the 31 pharmaceutical enterprises in 11 prefecture-level cities of Guangxi area. Defects of implementing new GMP and their causes were analyzed,and the suggestions were put forward. RESULTS& CONCLUSIONS:In the 31 pharmaceutical enterprises,there were 30 enterprises(96.8%)passed the new GMP tracking inspec-tion. Totally 331 defect items were found,focusing on equipment(76 items,23.0%),factory and facilities(47 items,14.2%),quality control and quality assurance(43 items,13.0%). Causes for defects were mainly institutions and staff training,factory and facilities,equipments management,maintenance and periodic check were far from satisfactory;material and product did not speci-fy a validity period or a retest period;relevant confirmation was incomplete with verification;the quality control,assurance,man-agement,document and production management were not standard and completed;and self-test program was too simple,etc. It is suggested that drug regulatory authorities should establish and improve the legal system,explore new patterns of drug GMP track-ing inspection (such as sudden unannounced inspection,detailed inspection),strengthen inspector team training and unify inspec-tion scale. And the pharmaceutical enterprises should produce drugs in line with the requirements of new GMP,focus on the update of key knowledge,strengthen relevance of training to ensure the drugs quality effectively by multilateral force.

Objective: To study the diagnostic characteristics of cardiac amyloidosis (CA) by non-invasive electrocardiography (ECG) in relevant patients. Methods: We retrospectively analyzed 60 CA patients diagnosed in our hospital from 2008-08 to 2013-12 for their clinical and ECG characteristics. Results: There were 48 male and 12 female patients with the ratio of 4: 1. The ifrst time diagnosis rate was low and the average age for conifrmed diagnosis was at (54. 5±14. 2) years.①There were 32 (53. 3%) cases combining heart failure, 12 (20%) with pleural effusion, 20 (33. 3%) with atrial arrhythmia, 8 (13. 3%)with ventricular arrhythmia, 4 (6. 7%)with sino-atrial block, 15 (25%)with atrio-ventricular block, 4 (6. 7%) with left bundle branch block (LBBB), 5 (8. 3%)with RBBB and 8 (13. 3%)with intra-ventricular block.②There were 32 (53. 3%) cases with low voltage on limb leads, 52 (86. 7%) with pseudo-infarct pattern, 48 (60%) with ST-T abnormality and 30 (50%) combining low voltage on limb leads with pseudo-infarct pattern.③The patients combining pleural effusion and with pseudo-infarct pattern had the increased ratio of low voltage on limb leads, while there were still 22 (45. 8%) cases without pleural effusion had low voltage on limb leads.④ ECG characteristics for 60 CA patients were as follows: QRS duration (104±26) ms, QT interval (404±34) ms, QTc (462±35) ms; the R wave of avR 0. 17 mV, QRS wave 0.30 mV; the R wave of limb leads and V1-3 were all<0.5mV, the S wave of V1-3 were 0. 62mV, 1. 61mV, 1. 56mV; the R/S ratio of V1-3 were 0. 19, 0. 12, 0. 20 respectively. Conclusion: CA patients had the highest incidence of pseudo-infarct pattern; meanwhile, combining with low voltage on limb leads, pseudo-infarct with long Q or S wave and ST-T abnormality but normal QRS duration was helpful for differential diagnosis of CA in clinical practice.

Objectives To discuss the characteristics of late gadolinium enhancement (LGE) magnetic resonance (MR) imaging in patients with hypertrophic cardiomyopathy (HCM) and left ventricular apical aneurysm (LVAA) and its related prognostic value. Methods Thirty HCM patients with LVAA were collected from August 2004 to August 2013. All cases with coronary artery diseases were ruled out, and all patients underwent LGE derived by cardiac MR (CMR). Five cases of LVAA were pathological confirmed. Atrial and ventricular diameters, apical aneurysm diameters and left ventricular ejection fraction were measured, and apical aneurysm LGE was evaluated. All patients were then followed up. Comparisons in continuous parameters between patients with or without LGE were performed by independent t test. A Cox proportional hazard model was used to estimate the hazard rate for adverse cardiovascular events. Results LGE was identified in 21 LVAAs and non-LGE in 9 LVAAs. Between two groups, there was no significant difference in the size of LVAA [(16.4 ± 11.5) mm vs. (20.3 ± 9.8) mm, P=0.63]. In particular, the complete transition from non-LGE to LGE LVAA was recorded during follow-up in one patient. Pathological findings confirmed that LGE indicated fibrous tissue in LVAA, and LVAA without LGE indicated viable myocardium. The follow-up suggested that the patterns and the size of LVAA were associated with the adverse events in these patients (LGE of LVAA, HR=7.94, P=0.064; the size of LVAA, HR=1.08, P=0.009). Conclusions LGE-MR had important clinical significance in HCM patients with LVAA. LGE in LVAA corresponded with the fibrous tissue and was associated with the prognosis.

Objective To clarify the MRI characteristics and outcomes of patients with end stage hypertrophic cardiomyopathy (ES-HCM).Methods Clinical and MRI data of 57 ES-HCM patients were retrospectively analyzed.ES-HCM pa tients were divided into dilated phenotype group (D-ES group,n=39) and restrictive phenotype group (R-ES group,n=18).MRI characteristics and outcomes of patients were compared between both groups.Results The incidence of atrial fi brillation and edema of lower extremity was significantly higher in R-ES than those in D-ES (72.22％ [13/18] vs 30.77％ [12/39];50.00％ [9/18] vs 23.08％ [9/39];both P＜0.05).The left ventricular ejection function,left and right atrial anteroposte rior diameter of D-ES group were significant smaller than those of RRES group (all P＜0.05),while the left ventricular (LV) short axis diameter,LV end diastolic/systolic volume and LV end diastolic/systolic volume index of D-ES were significantly greater than those of R-ES group (all P＜0.05).Log-rank test found no significant difference between both groups in cardiovascular death/ heart transplant events (x2 =1.135,P=0.287).Late gadolinium enhancement (LGE) volume fraction was significantly larger in D-ES ([36.1±14.8]％) than in R-ES ([21.0±9.0]％;P＜0.05).There was a significant correlation between LGE volume fraction and cardiovascular death/heart transplant events (HR:1.054,P＜0.05).Conclusion ES-HCM patients have expanded clinical expression and MRI characteristics,including dilated phenotype and restrictive phenotype.MRI has an important application value in the diagnosis and prognosis evaluation of ES-HCM.

ObjectiveTo investigate the effects of autologous bone marrow-derived mesenchymal stem cells (MSCs)transplantation on acute myocardial infarction in swine models using MRI. MethodsFourteen Chinese mini-pigs(27±3 kg)were divided into control group(n=7)and transplantation group(n=7).Acute myocardial infarction(AMI)model was made by occlusion of the left anterior descending coronary artery for 90 minutes,and then 10 ml autologous MSCs(3 × 106 cell/ml)were injected into LAD by over-wire-balloon catheter after one week. MRl was performed to assess the cardiac function and myocardial perfusion 1 week after AMI and 6 weeks after transplantation.The implanted cells in vitro were analyzed by immunofluorescence.ResuitsThe left ventricular ejection fraction(LVEF)in transplantation group was increased from(42.7 ±7.5)%to(50.1±10.1)%,which was significantly different from that in control group(P＜0.01).In addition,the dyskinetic segments in infarcted region and the infareted area were decreased by 4 and 3.2 cm2 respectively(P＜0.01),and the left ventricular weight index was increased by 4.1 g/m2 in transplantation group(P＜0.05)compared with control group.The DAPI-labeled cells in infarcted and peri-infarcted region indicated the survived MSCs.Immunofluoreseence also confirmed that those cells expressed cardiomyocyte-specific troponin T,connexin 43 and vessel-specific smooth muscle actin.Capillary density in both infarcted and peri-infarcted region were higher in transplantation group than the control group(P＜0.01).Conclusion MRI is a reliable imaging method for assessing the effects of stem cell transplantation in acute myocardial infartion of swine models.

Objective To explore the imaging characteristics and the complementarity of contrast?enhanced cardiac magnetic resonance CMR and nuclear myocardial perfusion/metabolic imaging in the evaluation of myocardial viability in patients with ischemic cardiomyopathy. Methods A total of 111 patients with diagnosed coronary artery disease and left ventricular dysfunction were retrospectively enrolled in this study. All patients underwent CMR and nuclear myocardial imaging within 1 month. Cine CMR was employed to evaluate cardiac function and wall motion. Contrast?enhanced CMR and myocardial perfusion/metabolic images were quantitatively assessed using a standard 17-segment and 5-score system. Dysfunctional segments were classified as viable or non?viable based on contrast?enhanced CMR and myocardial perfusion/metabolic imaging, respectively. No enhancement or sub?endocardial enhancement was defined as viable, while transmural enhancement was defined as non?viable. Severely matched perfusion/metabolism defects on nuclear imaging were assigned as non?viable while other patterns were considered as viable. Kappa index was calculated to evaluate the diagnostic concordance in assessing myocardial viability between contrast?enhanced CMR and myocardial perfusion/metabolic imaging. Results Among 1 887 segments in 111 patients, 80.3%(1 516/1 887) were dysfunctional. Of them, 63.3%(959/1 516) were viable and 36.7%(557/1 516) were non?viable on contrast?enhanced CMR, while 79.7%(1 208/1 516) were viable and 20.3%(308/1 516) were non?viable on nuclear myocardial imaging. The two modalities had a moderate concordance (Kappa=0.46,P<0.01). In segments with normal perfusion and metabolism, 73.9% (431/583) had various extent of enhancement but most of them(84.2%, 363/431) were subendocardial. On the other hand, 21.0%(117/557) segments with transmural enhancement had hibernating myocardium on nuclear imaging. Conclusions Contrast?enhanced CMR and nuclear myocardial imaging have a moderate concordance in the evaluation of myocardial viability in ischemic cardiomyopathy. Combination of the two modalities is expected to improve the diagnostic accuracy in assessing myocardial viability.

Objective:To discuss the effects of panax notoginseng saponins (PNS) enteric-coated pellets on hemorrheology in rabbits.Methods:The rabbits were divided into the normal control group,the model control group,Xueshuangtong injection (lyophilization) group(15 mg·kg-1·d-1 ,im),PNS enteric-coated pellets groups respectively at high(45 mg·kg-1·d-1,ig),medium(30 mg·kg-1·d-1,ig) and low (15 mg·kg-1·d-1,ig) dose.The model was established by intragastric administration of high-fat diet.The whole-blood viscosity,plasma viscosity,erythrocyte aggregational index,crythrocyte index of rigidity and erythrocyte electro-phoresis rate in the groups were detected using hemorheological methods.Results:The above indices of hemorheology in the model control group were all significantly higher than those in the normal control group (P<0.01),suggesting the successful establishment of the model.Compared with the model control group,PNS enteric-coated pellets at high and medium doses could significantly reduce the whole blood viscosity and plasma viscosity(P<0.01 or P<0.05);PNS enteric-coated pellets group at low dose could significantly reduce the whole blood middle shear viscosity and plasma viscosity(P<0.05);the three PNS enteric-coated pellets groups could significantly reduce the agglutination index(P<0.01);PNS enteric-coated pellets at high and medium doses could significantly reduce the crythrocyte index of rigidity(P<0.01 or P<0.05);the three PNS enteric-coated pellets groups could significantly reduce the erythrocyte electro-phoresis rate,while there was no significant difference(P>0.05).Compared with Xueshuangtong injection (lyophilization) group,PNS enteric-coated pellets group at medium dose could significantly reduce the whole blood middle shear viscosity(P<0.05).Conclusion:PNS enteric-coated pellets can reduce the whole-blood viscosity,plasma viscosity,erythrocyte aggregational index,crythrocyte index of rigidity and erythrocyte electro-phoresis rate,and effectively promote blood circulation and remove stasis,inhibit thrombosis formation and increase blood supply for heart and cerebral vessels.

Objective To assess multi-detector CT (MDCT), MR and single photon emission computed tomography (SPECT) in detection of chronic myocardial ischemia in Chinese mini-swine models. Methods Six male pigs received MDCT scan firstly. Then Ameroid narrow ring was placed in the left descending branch and MDCT, MR were performed at the same day. On the 2nd, 27th day, SPECT was given. Coronary angiography (CAG) was given on the 28th day, and then MDCT and MRI. The animals were killed after allexaminations. The pathological examination was given at last. Results Two pigs died during the rearing and another 4 had results. Pathology showed 3 had subendocardium infarction and 1 had no infarction. CAG showed infarction in 3 pigs with stenosis more than 50%. Areas of reduced perfusion in arterial phase MSCT, first-pass MRI and SPECT were consistent to findings of TTC staining. MDCT detected that ESV on the 28th day was higher than that of preoperative and postoperative day (P<0.05), the other indexes had no difference. MRI displayed that EDV on the 28th day was higher than that of postoperative day (P<0.001), the other indexes had no differences. SV and EDV measured with MDCT were higher than those with MRI (all P<0.05). ESV and EF measured with MDCT and MRI had no statistical difference (all P>0.05). CT value of left ventricular anterior wall on preoperative, postoperative day and the 28th day were statistically different (F=10.274, P=0.011). Conclusion Arterial phase of MDCT, first-pass perfusion of MRI and SPECT all show reducing perfusion in left ventricular anterior wall corresponded to myocardial infarction with TTC staining. CT value of myocardial ischemia decreases after myocardial ischemia.