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Objective To explore the clinical efficacy of different course of colloidal bismuth pectin quadruple therapy for Helicobacter pylori (Hp) eradication in patients with peptic ulcer (PU) and the condition of digestive tract symptom improvement by a single-center,prospective,random-control study,and to provide theoretic evidence for clinicians on the selection of the schedule upon unti-PU Hp infection.Methods 90 active stage PU initial treated patients with Hp infection diagnosed by gastroscope were enrolled randomly.The patients were given oral unti-Hp treatment including rabeprazole sodium (20mg,2/day),clarithromycin (0.5 g,2/day),amoxicillin (1 g,2/day) and colloidal bismuth subcitrate (0.6g,2/day),and were divided into three groups with different course of treatment randomly acconding to the digital table:A group (7 days),B group (10 days) and C group (14 days),each group including 30 cases.The condition of digestive symptom improvement and adverse effect were recorded during treatment.After the quadruple therapy,and at least 4 weeks without using proton pump inhibitor (PPI) and antibiotics,the outcome of Hp eradication was evaluated by 14C carbamide breath test (14C-UBT).The difference of Hp eradication among the three groups was analyzed.The clinical efficacy of different course was evaluated and the cost/effect was calculated.Results The Hp eradication rates of the A group,B group and C group were 46.67％,73.33 ％ and 76.67％,respectively,the differences was statistically significant (x2 =7.184,P =0.028).After treatment,the scores of the digestive symptom of the three groups were lower than before treatment (A group:t =3.272,P =0.038;B group:t =6.424,P ＜ 0.001;C group:t =8.086,P ＜ 0.001),and the scores of the B group and C group were lower than A group (F =3.110,P =0.028),while the three groups showed no obvious difference in the incidence of adverse effects(x2 =0.274,P =0.872).The C/E of the A group,B group and C group were 4.7,4.3 and 5.7,respectively.Conclusion The 10-day and 14-day course of colloidal bismuth pectin quadruple therapy including rabeprazole sodium,clarithromycin,amoxicillin and colloidal bismuth subcitrate demonstrated better clinical efficacy of unti-PU Hp infection than the 7-day treatment,with obvious improvement of digestive symptom,and the 10-day quadruple therapy has the best economical advantage.
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Objective:To prepare enteric-coated pellets of ( R)-rabeprazole sodium and investigate the drug release behavior in vitro. Methods:The pellets of ( R)-rabeprazole sodium were prepared by a fluid bed coating technology, and HPMC and Eudragit L30D-55 was used as the material of isolation layer and enteric coating, respectively. The similarity of in vitro drug release was com-pared between the reference preparation and the self-prepared preparation. Similar factor ( f2 ) was used to evaluate the similarity of re-lease curves. Results:The coating formula of ( R)-rabeprazole sodium enteric-coated pellets was as follows: the weight of HPMC E5 and Eudragit L30D-55 was 12. 0% and 45. 0%, respectively, and the plasticizer was 8. 0% of the weight of the polymers. The f2 of the reference preparation and the self-prepared preparation was more than 50, which indicated the release behavior was similar. Con-clusion:The release behavior of ( R)-rabeprazole sodium enteric-coated pellets is quite promising, and the preparation technology can be used in the industrial production.
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Objective To establish an HPLC method for the determination of related substances of rabeprazole sodium.Methods The determination was performed on a Xtimate C18 column.The mobile phase consisted of 2 g/L ammonium acetate-acetonitrile (95:5)and 2 g/L ammonium-methanol(15:85), with linear gradient elution and the flow rate of 1.0 mL/min.Detection wavelength was 290 nm.Results Related substances were completely separated from the main constituent.The limit of detection of rabeprazole was 0.25 ng and the limit of quantification was 0.75 ng,which were 0.01% and 0.03% of test sample and met the detection.With the selected solvents, principal component could be extracted efficiently and good stability.The sample solution was not stable at room temperature.Conclusion The method is simple, rapid and accurate, and can be used to control the quality of rabeprazole sodium enteric-coated pellets.
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Background:To date,clinical studies on intravenous rabeprazole sodium for treatment of duodenobulbar ulcer bleeding are still lacking.Aims:To evaluate the efficacy and safety of intravenous rabeprazole sodium with different doses and times of administration in treating patients with duodenobulbar ulcer bleeding.Methods:A multicenter,randomized, double-blind,positive drug parallel-group controlled trial was performed.One hundred and five patients with duodenobulbar ulcer bleeding proved by gastroscopy were randomly divided into four groups.Patients in group A,B and C were treated with intravenous rabeprazole sodium 20 mg qd,40 mg qd and 20 mg bid for 5 days,respectively.Patients in control group received intravenous omeprazole sodium 40 mg bid for 5 days.Hemostatic rate was the primary endpoint,hemostatic time and amount of blood transfusion were the secondary endpoints.Results:Hemostatic rates in group A,B,C and control group were 96.2% (25 /26),92.6% (25 /27),100.0% (26 /26)and 100.0% (26 /26),respectively,no significant difference was seen between the four groups (P >0.05).Median hemostatic time in group A,B,C and control group were 24 (24,72)h,24 (24,72)h,24 (24,48)h and 24 (24,48)h,respectively,no significant difference was seen between the four groups (P >0.05).No patient need blood transfusion during the treatment course.Slight leucopenia was the exclusive adverse effect seen in one case in group C after accomplishment of treatment.Conclusions:Three intravenous rabeprazole sodium regimens with different doses and times of administration were all effective and safe for treatment of mild to moderate duodenobulbar ulcer bleeding.Administration with 20 mg bid seems more effective among the three regimens.
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This work presents two simple and direct spectrophotometric methods for determination of rabeprazole sodium (RB) through charge transfer complexation reactions. The first method is based on the reaction of the drug with p-chloranilic acid (p-CA) in acetonitrile to give a red colored product with maximum absorbance at 518 nm. The second method is based upon the interaction of RB and 7,7,8,8‐tetracyanoquinodimethane (TCNQ) in acetone resulting in the formation of a bluish-green complex measured at 845 nm. Factors affecting the color development were studied and optimized. The proposed colorimetric procedures were effectively validated with respect to linearity, ranges, precision, accuracy, robustness, detection and quantification limits. Regression analysis for the calibration curves of the formed color products with p-CA and TCNQ showed good linear relationships over the concentration ranges of 20–200 and 2–16 μg/mL respectively. The method was successfully applied to the assay of rabeprazole enteric coated tablets with good accuracy and precision. Assay results were statistically compared to a reference HPLC method where no significant differences were observed between the proposed methods and reference method.
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The aim of the present work was to develop simple, shorter and effective HPLC method with UV detection (285nm) and subsequent validation for the content uniformity determination of Rabeprazole Sodium in marketed tablet samples. The method uses isocratic mobile phase of 0.1M sodium phosphate buffer (pH adjusted to 6.5 with sodium hydroxide solution) and acetonitrile 65:35 compositions on reverse phase Lichrosphere RP-100 C8 column. The RSD was observed to 0.21 percentage and linearity range of (LOQ) 0.025 – 150 percentage of label claim established with 0.9999 correlation, 8 different brands marketed samples were successfully analysed for content uniformity and compared the results with the USP and other guidelines for acceptance criteria. The developed method was found precise, linear, rugged and robust for validated parameters. The method can be used for assay and the content uniformity determination of Rabeprazole Sodium in its tablet dosage form.