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AIM: To study the bioequivalence of two metformin hydrochloride sustained-release tablets in Chinese healthy subjects. METHODS: A randomized, open-label, two-period, crossover study design was adopted in the study. In fasting test 36 and in fed test 23 healthy subjects were given a single oral dose of metformin hydrochloride sustained-release tablet (0.5 g). The concentration of metformin in plasma was measured by HPLC-MS/MS. The pharmacokinetic parameters were calculated by WinNonlin 7.0 program, and statistical analysis were performed by using SAS9.4 statistics software. RESULTS: In the fasting test, the pharmacokinetic parameters of metformin of the test (T) and reference(R) preparation were as follow: C
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AIM: To study the bioequivalence of two tadalafil tablets in Chinese healthy male subjects. METHODS: A randomized, open-label, two-period, two-sequence, crossover study designing was adopted in the study. Thirty-six healthy male subjects were enrolled under fasting condition and fed condition, respectively. Each subject was given a single oral dose of tadalafil tablet (20 mg). The concentration of tadalafil in plasma was determined by LC-MS/MS. The pharmacokinetic parameters were calculated by WinNonlin 8.0 program, and statistical analysis was performed by using SAS 9.4 statistics software. RESULTS: Under fasting condition, the pharmacokinetic parameters of tadalafil of the test (T) and reference (R) preparation were as follows: C
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OBJECTIVE@#Three fractions (SM, SM-A, SM-B) were prepared from different polarity parts of Ipomoea batatas Lam. (cv.simon) leaves and the anti-tumor potency as well as the dose-response relations were evaluated.@*METHODS@#The anti-tumor activities of fraction SM, SM-A or SM-B were screened by MTS in human hepatic cancer Hep3B cells, lung cancer A549 cells or gastric carcinoma MGC803 cells, respectively.@*RESULTS@#The three fractions all showed anti-tumor activities in three cancer cells with different sensitivity. Among them, SM-B was the most potent fraction with IC50 values at 15.17 mg/L, 72.64 mg/L or 165.47 mg/L in MGC803 cells, A549 cells or Hep3B cells, respectively (P<0.05).@*CONCLUSION@#Th e extraction of Brazil sweet potato leaves displayed anti-tumor activity and SM-B was the most potent fraction.
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Humanos , Antineoplásicos Fitogénicos , Química , Línea Celular Tumoral , Ipomoea batatas , Química , Extractos Vegetales , Química , Hojas de la Planta , QuímicaRESUMEN
OBJECTIVE:To study the effect of HP-?-CD on the stability of potassium dehydroandrographolide succina_ te solution.METHODS:The stability of the testing group(potassium dehydroandrographolide succinate solution+HP-?-CD)was determined by a thermostatic accelerated test with the content variation of potassium dehydroandrographolide succi?nate solution as an index and the potassium dehydroandrographolide succinate solution that was free of HP-?-CD as the control.RESULTS:The content variation of the testing group was less as against the control group,the terms of validity for the2groups were0.657y and3.40y respectively.CONCLUSION:The stability of potassium dehydroandrographolide succi?nate solution can be increased by adding HP-?-CD to which.
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OBJECTIVE:To establish a method for determination of carbazochrome sodium sulfonate for injection.METH_ ODS:C 18 was used as chromatographic column;the mobile phase consisted of0.12%ammonium dihydrogen phosphate buffer solution-absolute alcohol(925∶75)with detection wavelength at363nm and flow rate at0.8ml/min.The sample size was10?l and the column temperature was25℃.RESULTS:Linear relation was achieved when the concentration of carbzochrome sodium sulfonate was within the range of0.08865mg/ml～0.4432mg/ml(r=0.9999,n=5).The mean recovery rate was99.89%(RSD=1.53%,n=9).CONCLUSION:This method is simple,rapid,accurate,precise,and which can be used as the quality control of carbzochrome sodium sulfonate for injection.
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OBJECTIVE:To establish a HS-GC method for determining methanol and ethanol in human plasma METHOD_S:An external standard method was used The stationary phase was a glass column packed with GDX-102 The carrier gas was nitrogen The column temperature was 140℃ and both the injector temperature and the detector temperature were 200℃ RE_SULTS:A good linearity was obtained in the range of 0 2～7 5g/L of methanol and ethanol The within-day RSD was less than 4% and the between-day RSD less than 5 5% The recoveries were (100 9?3 8)% for methanol,(101 5?3 4)% for et_hanol,respectively The limits of detection for both methanol and ethanol were less than 0 01g/L CONCLUSION:This method is simple,rapid and precise
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Object To develop a method for the determination of caffeic acid in Simon Ⅰ. Methods An HPLC method was developed. Kromasil C 18 column and methanol acetic acid as mobile phase. Results Linearity was found in the range of 10 33 165 28 ?g/mL, the average recovery was 99 38%, RSD=1 36%(n=6). Conclusion This method is reliable, accurate and suitable for the determination of caffeic acid.
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Objective To study the stability of potassium dehydroandrographolide succinate solution in different conditions.Methods The classical thermostatic test was adopted to investigate the stability of potassium dehydroandrographolide succinate in phosphate buffer solutions of different pH values,in different buffer solutions of the same pH value and in citrate buffer solutions of different concentrations.Results The stability of potassium dehydroandrographolide succinate solution was different at different pH values and was the best at pH 6.5.In various buffer solutions of pH 6.5,the hydrolyzation of potassium dehydroandrographolide succinate solution was delayed by citrate buffer solution,and the stability of the solution had no correlation with the concentration of citrate buffer solution.Conclusion The stability of potassium dehydroandrographolide succinate solution varies in different conditions.This will supply a reference for the study on potassium dehydroandrographolide succinate solution and its similar preparations.
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OBJECTIVE:To establish the method for determining the contents of neferine and liensinine in plumula nelumbini.METHODS:Neferine and liensinine in plumula nelumbini were extracted by ultrasound method and determined by TLCs.RESULTS:The average recovery and relative standard deviation were(97.91?2.49)% and (99.28?3.22)%,respectively.The correlation coefficient were 0.996 and 0.999,respectively.CONCLUSION:The method,operated simply and attained the reliable results with good reproducibility,can be used to determine the contents of bioactive alkaloid in plumula nelumbini or other compound preparations.