OBJECTIVE:To study the method of preparing PEG-SOD enteric-coated capsuls and quality standard.ME_ THODS:Orthogonal design was used to select the optimal conditions for preparing PEG-SOD enteric-coated capsuls and the relevant quality standard of PEG-SOD enteric-coated capsuls was established according to the China Pharmacopoeia(2000). RESULTS:The optimal conditions were as follows:the content of PEG-SOD per capsule was40000IU;the weight ratio of stabilizer lactose was2.5%;filler was carboxymethyl starch;drying process was at60℃for20min.The preparation was ac?corded with the relevant quality standard.CONCLUSION:The technic of preparation is feasible,the method of quality control is reliable and the quality of preparation is stable.

heart.CONCLUSION:The half-life of PEG-SOD enteric coated capsules is much longer than that of SOD enteric coated capsule and is worth further studying as a new type preparation

Objective To discuss the influence of different doses budesonide aerosol inhalation on serum cytokines levels in children with severe asthma.Methods 96 children with severe asthma aged 4 to 14 years old in our hospital were chosen,and they were randomly divided into the observation group and the control group,48 cases in each group.All patients were given conventional treatment, and the control group was given 1mg/time budesonide treatment on the basis of conventional treatment (3 times a day),while the observation group was given 2mg/time budesonide treatment (3 times a day).Before and 1 week after treatment,the clinical symptoms of two groups were observed and compared,as well as the changes of IL-4,IFN-gamma,IL-10 and TNF-α.Results In the obser-vation group,wheezes,coughing,wheezy sound and rales disappearance time were (2.10 ±0.77)d,(5.45 ±1.20)d, (3.46 ±1.03)d,(5.55 ±1.35),which were significantly shorter than (2.98 ±1.02)d,(7.48 ±1.19)d,(5.43 ± 1.06)d,(7.56 ±1.67)d in the control group (t=4.77,8.32,9.23 and 8.32,all P<0.01).4 weeks after treat-ment,the total effective rate of the observation group was 89.6%,which was significantly higher than 72.9% of the control group (χ2 =4.376,P<0.05).After treatment,the IL-4,IL-10,TNF-alpha,IFN-gamma levels in the observation group were (4.06 ±1.77)pg/mL,(12.77 ±2.05)pg/mL,(4.15 ±1.11)ng/mL,(26.23 ±2.78)pg/mL, which had significant changes compared with (9.02 ±2.23)pg/mL,(10.21 ±1.30)ng/mL,(6.66 ±1.62)pg/mL, (17.33 ±2.31)pg/mL before treatment(t=12.07,24.56,16.20,17.25,all P<0.01).After treatment,the IL-4, IL-10,TNF-alpha,IFN-gamma levels in the control group were (9.11 ±2.05)pg/mL,(6.80 ±1.23)ng/mL, (9.88 ±2.20)pg/mL,(21.22 ±2.80)pg/mL,which had significant changes compared with (9.11 ±2.05)pg/mL, (10.38 ±1.37) ng/mL,(6.71 ±1.77) pg/mL,(17.30 ±2.05) pg/mL before treatment( t=5.36,13.47,7.77, 7.83,all P<0.01).But IL-4,TNF-alpha levels in the treatment group were significantly lower than those in the control group (t=7.32,11.08,all P<0.01),while IL-10 and IFN-gamma levels were significantly higher than those in the control group (t=6.65,8.80,all P<0.01).The incidence of adverse reactions of the two groups had no statistically significant difference (χ2 =0.771,P>0.771).Conclusion High doses of budesonide aerosol inhalation in the treatment of children with severe asthma has obvious clinical curative effects,which could significantly improve the patients'clinical symptoms,and also has low incidence of adverse reactions,which is worthy of clinical promotion.

A rapid and sensitive liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method for quantification of sitagliptin in human plasma and urine had been developed. This method was applied to the pharmacokinetics study of sitagliptin tablet after single- and multiple-dosing in Chinese population. Plasma samples were prepared by a liquid-liquid extracted method, and urine samples were diluted. Compounds were analyzed by multiple reaction monitoring (MRM) mode with a electrospray ionization (ESI) interface. Mobile phase consisted of methanol and water (85 : 15, v/v). The linear concentration range of calibration curve was 0.5-1 000 ng.mL-1. and 0.2-100 µg.mL , intra-run/between-run accuracy was 98.98%-103.69% and 97.63%-102.29%, intra-run/between-run precision was <5.51% and 4.26% for plasma and urine sample, respectively. The stability of sitagliptin stock solution was tested for 55 days at -30 °C. Sitagliptin was stable when stored under the following conditions: 24 hours in the autosampler after sample preparation; 24 hours at room temperature, after 3 freeze and thaw cycles (from -30 °C to room temperature), 40 days at -30 °C for plasma and urine samples. The absolute recovery in plasma was 71.1%, and no matrix effect was founded. This method was proved simple, specific, sensitive, rapid and suitable for pharmacokinetics study of sitagliptin in human being.
Calibration ; Chromatography, Liquid ; Humans ; Liquid-Liquid Extraction ; Sitagliptin Phosphate ; blood ; pharmacokinetics ; urine ; Tandem Mass Spectrometry

ObjectiveTo evaluate the quantitative and qualitative changes of peripheral-type benzodiazepine recepors (PBRs) in brain mitochodria and in platelet membrane in aging rats. MethodsMale Sprague-Dawley rats were divided into 3- and 24-month groups. All animals were sacrificed by decapitation and the brains were immediately removed. Mitochondrial components from dissected cerebral cortex were isolated. The membrane of platelets from venous blood was prepared by the method of hypotonic hemolysis. The specific binding assay of the radioactive PBRs antagonist ［3H］PK11195 to membrane was performed. Scatchard analysis was performed to estimate the equilibrium dissociation constant (Kd) and the maximal binding site density (Bmax). ResultsA significant increase in ［3H］PK11195 binding activity in the mitochodria from cerebral cortex in 24-month rats was observed compared to that in 3-month rats(P<0-001). Meanwhile, the Scatchard analysis revealed that there was an increase in Bmax, with a significant increase in Kd in 24-month rats. The same change of ［3H］PK11195 binding activity was noted for platelet membrane in 24-month rats(P<0-001).ConclusionThe density of PBRs increases in cortex mitochondria in aging rats, but the binding affinity of PBRs decreases which may be attributable to the progressive pathogenesis of aging in rats. ［3H］ PK11195 binding activity of platelet membrane might reflect the change of PBRs in the brain tissue.

OBJECTIVE:To establish quality control system by using modern scientific idea and advanced method in in?patient pharmacy.METHODS:Under the situation o f running authentication of ISO9001quality control system in our department,inpatient pharmacy should take the patients as focus to offer good and normative services to patients and clinical departments and continue to make our work better.RESULTS&CONCLUSION:Implementation of ISO9001quality control system has standardized the management of quality of inpatient pharmacy as well as increased the patients'satisfaction.And satisfactory social and economical benefits have been obtained and self-perfect and continuous improvement have been realized in the inpatient pharmacy.

OBJECTIVE:To control scientifically the limits of stock drugs in Hospital.METHODS:The method of setting the upper and lower limit of stored drugs through Hospital Information System(HIS)and the influencing factors were discussed by taking the outpatient pharmacy of our hospital as an example.RESULTS&CONCLUSION:Working out scientific and reasonable upper and lower limit for stock drugs is helpful for the improvement of the management quality of hospital pharmacy.

OBJECTIVE:To improve hospital's drug control level.METHODS:Quantized medicine provision management aims like stock limit,conformity rate of object-account of single category,medicine loss,mistake rate of recipe preparation,etc.were made and enforced.RESULTS:Through the above aims,medicine stock has been reduced effectively;the conformity rate of object-account has been increased;the medicine loss and incidences of mistakes in recipe preparation have been decreased.CONCLUSION:Working out feasible medicine provision management aims is an effective way to strengthen drug control.

OBJECTIVE:To carry out the ISO9001standard quality control system in the department of pharmacy.METHODS:The procedures and methods of PDCA cycle(Plan-Do-Check-Action)were applied to our department's ISO9001quality authentication standardization.RESULTS:The application of PDCA cycle-based ISO9001standards proved to be successful in the standardization of our department.CONCLUTION:The ISO9001quality authentication following the PDCA cycle is effective.

OBJECTIVE: To implement scientific drug control in inpatient dispensary by means of “Army No.1” system and to establish digitalized drug quality control system. METHODS: The “Army No.1” network system was put into wide operation in our hospital to establish interconnection among doctor workstation, nurse workstation and pharmacy workstation. Hence, the central dispensing mode was established. RESULTS: The operation of Army No.1 system not only relieved the workload of both clinic and pharmacy, increased whose working efficiency and transparency but also reduced overstock and run-off of drugs and enforced drug monitoring; meanwhile it facilitate the carrying out of pharmaceutical care and evaluation of drug utilization. CONCLUSIONS: Central dispensing mode in inpatient dispensary drug control by means of “Army No.1” system is advisable and which deserves generalization.