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Objective To standardize the method of microbiological examination on Shegan Mixture in Chinese Pharmacopoeia 2015. Methods Chinese Pharmacopoeia 2015 was used. Microbial enumeration test and specified microorganisms test were used to verify Shegan Mixture. The samples were treated by membrane filtration. Six kinds of strains for microbiological counting and limiting bacteria were used to study applicability. Results Microbial counts of the five strains of the recovery ratio were between 0.5 to 2, and Escherichia coli tested by control bacteria was qualified. Conclusion The microbiological examination methods for Shegan Mixture can meet the requirements of Chinese Pharmacopoeia 2015.
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Objective:To establish an UHPLC-MS/MS method to determine the contents of baicalin,scutellarin,wogonin,caffeic acid,ephedrine,belamcandin,irisflorentin and baicalein in Shegan mixtures. Methods:The chromatographic separation was performed on a ZORBAX SB-C18 column(2. 1 mm × 50 mm,1. 8 μm)with the mobile phase consisting of acetonitrile and water(0. 1% formic acid),the flow rate was 0.3 ml·min-1,and the column temperature was 35℃. Electrospray ionization source(ESI)was used with multiple reaction monitoring( MRM)combined with positive and negative scanning switch. üegative ion mode detection was used for caf-feic acid,belamcandin and scutellarin ,while positive ion mode detection was used for baicalin,wogonin,irisflorentin,baicalein and e-phedrine. Results:The quantification limit of baicalin,scutellarin,wogonin,caffeic acid,ephedrine,belamcandin,irisflorentin and ba-icalein was 1. 44 × 10-4 ,4. 20 × 10-3 ,2. 95 × 10-4 ,7. 80,4. 90 × 10-3 ,4. 6 × 10-2 ,3. 18 × 10-4 ng·ml-1 and 4. 85 ng·ml-1 . The detection limit was 4.32 ×10-5,1.3 ×10-3,8.84 ×10-5,0.77,2.90 ×10-4,3.33 ×10-4,9.5 ×10-5 ng·ml-1 and 1.46 ng· ml-1 ,respectively. The correlation coefficients( R2 )were all higher than 0. 992 3 within the linear ranges. Both intra- and inter-day RSD were less than 5%. The average recoveries of the eight components were within the range of 80%-120%. Conclusion:The method is simple,rapid,sensitive and accurate. It can be used to determine the contents of baicalin,scutellarin,wogonin,caffeic acid,ephed-rine,belamcandin,irisflorentin and baicalein in Shegan mixtures for the quality control.
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Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes ,and was developed by AstraZen-eca Pharmaceuticals LP .Olaparib has therapeutic potential for treating cancers associated with impaired DNA repair capabili-ties ,particularly those with deficiencies in the homologous recombination repair (HRR) pathway .Olaparib is an available ther-apy option for ovarian cancer patients with deficiencies in the BRCA 1 and BRCA2 genes .Olaparib can selectively kill cancer cells without compromising normal cells .Compared to traditional chemotherapy means ,adverse reactions are much smaller .
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Objective To assess the efficacy and safety of lamotrigine for absence seizures in children and adolescents . Methods Databases of PubMed ,the Cochrane Library ,EMbase ,CENTRAL ,VIP ,WanFang ,CBM and CNKI were electron-ically searched till August ,2014 for clinical trials on lamotrigine for absence seizures in children and adolescents .All literature were screened by two reviewers independently according to the inclusion and exclusion criteria .The data was extracted ,and the methodological quality was assessed .Then ,meta-analysis was performed using RevMan 5 .2 .Results Seven trials were in-cluded involving a total of 721 patients .The results of methodological qualities were two studies rated as A-class ,three studies rated as B-class and two studies rated as C-class .Meta-analysis results showed that the efficacy of lamotrigine monotherapy for absence seizure in children and adolescents was better than placebo ,but efficacy of lamotrigine was lower than valproic acid and ethosuximide .The adverse reaction rates of lamotrigine were with no significant difference compared with valproic acid and et-hosuximide .Conclusion Lamotrigine monotherapy was effective for absence seizures in children and adolescents and was well tolerated .Lamotrigine was a good choice for patients that are intolerable to valproic acid or ethosuximide .
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Objective To study absorption of shegan heji marker components in blood and their excretion in urine and feces of rats, after intragastric administration of shegan heji. Methods LC-MS/MS was used for determination of marker compounds. Rat metabolic cage technology was employed. Results Excretion of marker components were completed 24 hours after administration. Conclusion Ephedrine can be excreted from rats within 24 hours. The possibility of mutual transformation of flavonoids exists in the body. Taking shegan heji will not cause accumulation of ephedrine and flavonoids in the body.
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Objective:To analyze the chemical constituents in Radix astragali by high-performance-liquid chromatography-time of flight mass spectrometry(HPLC-TOF/MS). Methods:An Agilent poroshell 120 SB-C18 column(100 mm × 3 mm,2. 7 μm)was adopt-ed. The mobile phase was composed of acetonitrile-0. 1% formic acid with nonlinear gradient elution. The flow rate was 0. 4 ml· min-1 . The UV detection wavelength was set at 254nm, the column temperature was 25℃ and the injection volume was 10μl. Electron spray ionization and positive mode was adopted, the flow and temperature of the carrier gas( N2 ) was 10 L·min-1 and 350℃, respec-tively. The capillary voltage was 4 kV, the bombardment voltage was 165 V, the spectra were recorded within the range of m/z 100~1 100. Results:A total of 24 chemical constituents were identified from Radix astragali by HPLC-TOF/MS simultaneously. Conclu-sion:An efficient and fast HPLC-TOF/MS approach has been established for studying the chemical constituents in Radix astragali, which lays the foundation for the study on pharmacodynamic material basis and quality control of Radix astragali.
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Objective: To determine the pharmacokinetics of ephedrine hydrochloride in rats after intragastric administration of Shegan mixtures. Methods:Shegan mixtures (1. 0 ml/100 g) were administered to each rat by gavage. Blood samples were collected after the administration. Plasma concentration of ephedrine hydrochloride was determined by LC-MS/MS. The pharmacokinetic parame-ters of ephedrine hydrochloride were obtained using the pharmacokinetic software. Urine and fecal samples were collected in 24 hours after the administration using metabolic cage to determine the recovery of ephedrine hydrochloride. Results: The pharmacokinetic pa-rameters of ephedrine hydrochloride were as follows:Tmax of (1. 30 ± 0. 23)h,T1/2 of (21. 17 ± 1. 35)h, Cmax of (278. 86 ± 46. 41)ng ·ml-1,AUC0~∞ of (1221.98 ±412.64)ng·ml-1 and Vc/F of (1.70 ±0.15)L. Totally 85.66% ephedrine hydrochloride could be recovered from urine in 24 hours after the administration;however, it was not detected in the fecal samples. Conclusion: Most of e-phedrine hydrochloride is excreted through kidney in 24h,therefore, Shegan mixtures can't cause the accumulation of ephedrine hydro-chloride in rats.
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OBJECTIVE: To establish a HPLC method for the determination of plasma level of cefuroxime in experimental dogs. METHODS: 1. 0mL plasma samples were taken from experimental dogs at different time after intravenous injection of cefuroxime sodium 50mg? kg-1. Following pretreatment, the samples were subjected to determination on XDB-C18 chromatographic column. The mobile phase consisted of CH3CN-1‰ ( NH4) 2SO4 ( 12∶ 88) with a flow rate of 1. 0mL? min-1. The detection wavelength was 273nm and the column temperature was 25℃ . The quantification was performed by external standard method. RESULTS: Good linear relationship was achieved when the detection concentration of cefuroxime was within the range of 0. 5～ 250? g? ml-1( r=0. 999 5) . The average recovery of cefuroxime was 97. 76～ 116. 00% ( RSD
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OBJECTIVE:To establish a scientific evidence for evaluation of individualized administration among children.METHODS:Hydrocortisone probe was used for determination of CYP3A activity in children with quantitative method.RESULTS:CYP3A activity in the health children volunteers showed Gaussian distribution in the form of natural logarithm,the average value was1.69?1.04,with the value of1.63?0.99in males and1.75?1.09in females.CONCLUSION:There is no significant difference in CYP3A activity between the two sexes.
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OBJECTIVE: To establish HPLC method for the determination of plasma etoposide level in children with leukemia. METHODS: The determination was performed on column Hypersil ODS. The mobile phase was water-methanol (45∶55) and the wavelength for detection was 284nm. RESULTS: The intraday recovery ranged from 93.56 to 96.24% with SD ranged at 1.07%～2.63%, and the inter-day recovery ranged from 92.85% to 94.26% with SD ranged at 3.55%～5.89%. CONCLUSION: This method is simple and sensitive, showed a good specificity, and suitable for the determination of etoposide in clinic samples.
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OBJECTIVE:To establish a HPLC method for the determination of ferulic acid in pedo spleen energy activating Misture.METHODS:The determination was performed on Hypersil ODS column,the mobile phase consisted of1%acetic acid-methanol(70∶30)with a flow rate of0.8ml/min,the column temperature was26℃,the detection wavelength was320nm and the sample size was20?l.RESULTS:Good linear relationship with peak area score was achieved when the detection con?centration range of ferulaic acid was within a range of0.02～1.2mg/ml(r=0.9997),the average recovery was97.88%(RSD=1.19%).CONCLUSION:The method can be served as a quality control for pedo spleen energy activating Misture.
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OBJECTIVE:To study the difference and implication of 6?-OHFC/FC ratio at different phases of chemother-apy for leukemia children.METHODS:Urine samples were used for determination of 6?-OHFC/FC by HPLC.RESULTS:6?-OHFC/FC ratio had marked differences at different phases of treatment for leukemia children.CONCLUSIONS:6?-OHFC/FC ratio is of certain value in providing reference for treatment of children with leukemia,prognostic evaluation and risk classification.
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OBJECTIVE:To establish the preparation process of inclusion complex of diclofenac sodium-?-cyclodextrin (DS-?-CD) eyedrops METHODS:The DS-?-CD was prepared by the stir method and identified with instrumental method The content of diclofenac sodium was detected by UV,HPLC RESULTS:The inclusion ratio of DS-?-CD was(67 48?2 96)% There was no difference between diclofenac sodium and DS-?-CD in UV absorption spectrum The crystal diffraction peak of DS inclosed in DS-?-CD disappeared in X-ray CONCLUSION:The DS-?-CD can be used as eyedrops in clinical practice
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OBJECTIVE:To establish a HPLC method for determination of prodatin in Polygonum cuspidatum injection.M_ETHODS:The analytical column was Hypersil ODS column(100mm?2.1mm,5?m).The mobile phase consisted of methanol-water(25∶75).The flow rate was 1.0ml/min.The UV detection wavelength was 290nm.RESULTS:The linear range was 0.145～2.32?g/ml(r=0.9 999).The average recovery of prodatin was 98.8%(RSD=1.15%).CONCLUSION:The method is convenient,accurate and could be used for quality control in the production of Polygonum cuspidatum injection.
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OBJECTIVE:To discuss the development strategy of hospital preparations in new situation METHODS:To analyse existing circumstance and problems confronting us in development of hospital preparations RESULTS & CONCLUSION:In order to promote the development of hospital preparations,we should reform our work in respect to transformation of production,adjustment of kinds,promotion of R & D of new preparations and establishment of regional hospital preparation center
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OBJECTIVE:To evaluate the economic effectiveness in different pharmacotherapeutic schemes for Hp infection in children.METHODS:To analyze four therapeutic schemes for Hp infection in children with cost - effectiveness analysis.RESULTS: The cost- effectiveness ratios of four therapeutic schemes were 14.92,8.85,8.37 and 8.58 respectively. CONCLUSIONS: scheme C(clarithromycin + bismuth potassium citrate + metronidazole)is the best one.
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Objective:To find out the current situation of and objectively evaluate the use of the antidiabetic agents so as to provide reference information to the departments of production, sales and consumption of the agents. Methods:A analytic review of 6,639 020 prescriptions during the period of 1995～1999 was made regarding the costs and DDDs. Results: In recent 5 years, the annual increase rate of the expenses for was(36.03±11.92)%; and that of DDDs was 20.05%. The order of expenses for various antidiabetic agents from high to low was as follows: glicalazide, acarbose, glipizide and metformin, while that of DDDs was glicalazide, glipizide, metformin and acarbose. The percentage of expenditure for oral versus the injection antidiabetic agents was(87.08±3.50)% to(12.92±3.50)%. Conclusion: The antidiabetic agents is a kind of common drugs with a bright future of development.
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OBJECTIVE: To establish HPLC method for the determination of thioguanosine in human red blood cells. METHODS: The determination was performed on Hypersil ODS colum. The mobile phase consisted of methanol-water (10∶90) with detection wavelength at 342nm. 6-Thioguanine(6-TG)was generated from thioguanosine through heating and hydrolyzing. 6-TG was extracted into 0.1mol/L hydrochloric acid for sample injection assay with external reference method for the quantification. RESULTS: The linear range of 6-TG was 30～1 200pmol/8?108RBCs. Its optimum hydrolyzing time was 1 hour and optimal extraction pH value ranged from 11 to 12. The content of phenyl mercury acetate in the extraction solution was 1.3mmol/L. CONCLUSION: Under optimized conditions, HPLC method for the determination of thioguanosine is fast, accurate and sensitive.
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OBJECTIVE:To establish a HPLC assay for determining stability of5%aciclovir ointment.METHODS:A HPLC method was used for the content determination of aciclovir in the ointment.The stablity of aciclovir ointment under humidity,light and heat was studied.RESULTS:The regression equation of aciclovir with the concentration C to the peak heights A∶C=9.310?10 -3 A+0.159,r=0.9999(n=6);the linear confine was0.6～19.2?g/ml;recovery was98.51%;RSD was0.42%.The quality and content showed no significant changes under humidity and light.The labelling amount percentages of aciclovir were98.36%,98.47%and98.26%in the test at40℃,60℃and80℃respectively.CONCLUSION:The HPLC assay is proved to be sensitive,accurate and simple.The ointment preparation has good stability in the test at40℃and under high light.
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OBJECTIVE:To evaluate the economic effectiveness in different pharmacotherapeutic schemes for Hp infection in children.METHODS: To analyze four therapeutic schemes for Hp infection in children with cost - effectiveness analy-sis. RESULTS: The cost - effectiveness ratios of four therapeutic schemes were 14.92, 8.85, 8.37 and 8.58 respective-ly. CONCLUSIONS: scheme C(clarithromycin + bismuth potassium citrate + metronidazole)is the best one.