• Biomolecules & Therapeutics
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• v.2 no.2
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• pp.185-189
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• 1994

The eight combined products composed of ranitidine.HCI, tripotassium dicitrato bismuthate and sucralfate were prepared with various ratios and studied in therapeutic effects of them on various gastrointestinal diseases. These were induced in rats with the porous ligation, ethanol-HCI, acetic acid and cysteamine method, etc. In all experimental setting, the effect of the combined treating was more pronounced than the effect of each drug alone. Specially, the combined treatment consisted of ranitidine : tripotassium dicitrato bismuthate sucralfate ratio of 1.5 : 2 : 6 showed the most powerful therapeutic effect on acute gastric ulcer model and revealed a significant acceleration of the healing on chronic gastroduodenal ulcer model. And that, therapeutic doses of ranitidine, tripotassium dicitrato bismuthate arid sucralfate given in combination had an additive or, in some case, synergistic effect. From the above results, this combined treatment may useful to heal the gastrointestinal diseases that aren't cured well by treatment of each them alone.

• Journal of Pharmaceutical Investigation
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• v.37 no.2
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• pp.79-84
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• 2007

This study was aimed to establish analytical method of Bi to develop a guideline of the bioequivalence test of tripotassium dicitrato bismuthate (TDB). For this purpose, a simple, specific and sensitive inductively coupled plasma-mass spectrometry (ICP/MS) method were developed and validated in human plasma. Various concentrations of bismuth standard solution (0-25ng/mL) were prepared with distilled water and human blank plasma. To 10mL of the volumetric flasks, 2mL of blank plasma was added with 8ml of distilled water. Bi standard solution was added to prepare the calibration samples and injected into ICP-MS. The plasma samples obtained from volunteers given 3 tablets of bismuth (total 900mg as TDB) were analyzed as described above. As a result, the coefficients of variation were <20% in quantitation limit (0.2 ng/mL) and <15% at the rest of concentrations. The stability test by repeated freezing-thawing cycles showed that the samples were stable only for 24hr. The stability tested for samples with a short-term period of storage at room temperature and pre-treatment prior to the analysis showed very stable over 24hr. In 8 healthy Korean subjects received Denol tablets at the dose of 900mg bismuth, AUC, $C_{max},\;T_{max}$ and half-life $(t_{1/2})$ were determined to be $198.33{\pm}173.78 ng{\cdot}hr/mL,\;64.48{\pm}27.06 ng/mL,\;0.52{\pm}0.21 hr,\;and\;5.15{\pm}2.67 hr$, respectively, from the plasma bismuth concentration-time curves. In conclusion, the method was suitable for the determination of bismuth in human plasma samples and could be applied to bioequivalence test of bismuth tablet.

• YAKHAK HOEJI
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• v.37 no.5
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• pp.544-548
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• 1993

The pharmacokinetics of DWP302, a new combined ranitidine preparation in rats and dogs was studied using HPLC. DWP302 was composed of ranitidine, sucralfate and tripotassium dicitrato bismuthate. Especially, this study was focused on the possibilities that the concomitant administration of either sucralfate or TDB may affect the absorption of orally administered ranitidine. Ranitidine and DWP302 were orally administered to rats at a dose of ranitidine 10mg/kg. Several rats showed the biphasic peak of plasma concentration. AUC$_{S_{0-8}}$ of ranitidine and DWP302 group were found to be 1040$\pm$109 and 945$\pm$124 ng.hr/ml, respectively, and there was no significant difference between both AUCs. In a cross-over study for dogs, $C_{max}$, t$_{1/2}$ beta and total AUC of ranitidine group were found to be 625.8$\pm$86.7 ng/ml, 2.80$\pm$0.28 hr and 1688$\pm$127 ng.hr/ml, and those of DWP302 group were 562.6$\pm$120.9 ng/ml, 3.05$\pm$0.30 hr and 1673$\pm$123 ng.hr/ml, respectively. There was no significant difference between those parameters, but Tmax of DWP302 group (1.69$\pm$0.31 hr) was significantly different from ranitidine group (1.13$\pm$0.26 hr). The results suggest that either sucralfate or TDB may affect the lag-time or rate of absorption of ranitidine but not the extent of absorption.

• Korean Journal of Clinical Pharmacy
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• v.10 no.3
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• pp.111-119
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• 2000

The objective of this study was to evaluate the efficacy and the pattern of regimens prescribed for the treatment of peptic ulcer disease in a regional community hospital. 226 patients were treated as an outpatient and followed for one year. 88 patients $(38.9\%)$ had gastric ulcer (GU) alone, 6 patients $(2.7\%)$ had duodenal ulcer (DV) alone, 5 patients $(2.2\%)$ had gastroesophageal reflux disease (GERD) alone, 25 patients $(11.1\%)$ had both GU and DU, 88 patients $(38.9\%)$ had both GU and GERD, and 14 patients $(6.2\%)$ had both DU and GERD. During this study period no one was treated for Zollinger-Ellison Syndrome. The disease showed higher occurrence in male population (139 patients, $61.5\%$) and among the ages of 30 and 40 $(62.4\%)$. The average age of these patients was 41.3 years and there was no difference between the genders. $81.4\%$ of these patients underwent CLO test to check for the existence of Helicobacter and $66.3\%$ of these Patients showed the positive response. $65.6\%$ of patients with GU and $80\%$ of patients with DU showed the positive response and there was no difference between the genders $(65.4\%\;vs.\;67.6\%)$. 184 patients $(81.4\%)$ were deemed to be cured based on the disappearance of their symptoms after completing the regimens. Compliance rate did not differ for gender or different diseases, while showing a difference in age. Patients between the ages of 20 to 30 years old showed the worst compliance rate. In addition, the compliance was lower among the patients who had previous occurrence of the disease, and this was more evident among female patients. Although 184 patients out of the total 226 patients were deemed to be cured, 36 patients $(20.65\%)$ of these returned to the hospital for relapsed diseases within one year. The factors that affected for patients to relapse were the diseases accompanied by ulcer and social environments, such as smoking, alcohol consumption, and previous history of the diseases (smoking P<0.001, alcohol consumption P<0.02, previous history of disease P<0.05). The regimen using $H_2$ receptor antagonists+tripotassium dicitrato bismuthate+clarithromycin showed the lower rate of relapse, and the regimens of omeprazole (OMP)+amoxicillin+tripotassium dicitrato bismuthate and OMP+amoxicillin+metronidazole showed better compliance rate. Patient education by pharmacists on the importance of compliance to regimens and the risk factors fer relapse can provide a better patient care. This would ultimately result in more cost-effective treatments by preventing additional cost for treating relapsed symptoms in approximately $20\%$ of patients.

• Biomolecules & Therapeutics
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• v.1 no.2
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• pp.211-219
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• 1993

The general and some pharmacological actions of DWP 302 were investigated in animals and the following results were obtained. In central nervous system, DWP 302 had no effects on the pentobarbital induced anaesthesia, locomotor activity, rotarod test, traction test, analgesic action in the mice and body temperature in the rat. DWP 302 showed no depressive action on the convulsion induced by strychnine and electronic shock. From these results, DWP 302 was considered to have no or little pharmacological effect on the central nervous system. Furthermore, DWP 302 had no influences on the normal blood pressure and heart rate. In the isolated ileum of guinea pig, DWP 302 showed neither contractive nor relaxing effects against the acetylcholine ($10^{-6}g/mι$), histamine ($10^{-6}g/mι$) and $BaCl_2$ ($10^{-4}g/mι$) at a concentration of $1.9{\times}10^{-4}g/mι$ in bath. But it caused a slight increase in basal tone at a concentration of $6.3{\times}10^{-4}g/mι$ and this effect was inhibited by atropine $10^{-7}g/mι.$ In the isolated trachea and vas deference, DWP 302 showed no effect on the contractions produced by histamine and norepinephrine, respectively. And DWP 302 showed no effect on the contractions produced by acetylcholine and oxytocin in the isolated nonpregnant rat uterus. DWP 302 had no effect on bile excretion, urine volume, pH and gastrointestinal motility, But, DWP 302 showed a significant inhibitory effect on gastric secretion in the rat.

• Journal of Preventive Medicine and Public Health
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• v.33 no.3
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• pp.285-298
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• 2000

Objectives : To investigate the positive rate of Helicobacter pylori in patients with dyspepsia; medical compliance and related factors; the eradication rate a year after screening and related factors; the relationship between the eradication of Helicobacter pylori and the improvement of symptoms; and the estimated cost of three alternative approaches to treat Helicobacter pylori in the community. Methods : A total of 510 subjects with dyspeptic symptoms were selected and given the serological test in March 1998. The subjects were all adults over 30 years of age residing in Kyongju city. Results : Of the 510 selected subjects, 375 (73.5%) subjects proved positive for Helicobacter pylori on serological testing. Of these 304 (81.1%) who consented to an endoscopic examination, underwent a Campylobacter-like organism (CLO) test. Of these 304 subjects, 204 (67.1%), who had positive CLO test results, were given the triple therapy - tripotassium dicitrato bismuthate, amoxicillin, and metronidazole. To determine the eradication rate of Helicobacter pylori, 181 (88.1%) out of the 204 subjects who were given the triple therapy completed a follow-up urea breath test one year later. Of these, the Helicobacter pylori of 87(48.1%) subjects was eradicated. Among the 122 subjects who were medication compliant, the Helicobacter pylori eradication rate was 57.4% (70 subjects), while the eradication rates was only 28.8% (17subjects) in the non-compliant group. The Helicobacter pylori eradication was significantly related to compliance (p<0.01), but not to other characteristics and habits. The symptom improvement rate tended to be higher 62.1%), in the Helicobacter pylori eradicated group than in the non-eradicated group (59.6%). Conclusions : When the advantages and disadvantages of each alternative treatment were considered in the light of cost, antibiotic tolerance and the number of patients to be treated, alternative II was favorable in terms of cost. Alternative III was favorable in terms of the number of patients to be treated, antibiotic tolerance and early detection of gastric cancer. Further long-term research analyzing the cost-benefit and cost-effectiveness of each treatment will be needed as supporting material in creating new policies.

• Journal of agricultural medicine and community health
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• v.28 no.1
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• pp.79-92
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• 2003

Objectives: To investigate the reinfection rate of Helicobacter pylori and the factors related to reinfection of H. pylori, 86 persons were examined in April 2000 after 1 year follow-up period and 77 persons were examined in October 2001 after two and a half-year follow-up period in Gyeongju-si, Gyeongsangbuk-do, Korea. Methods: The subjects were confirmed as H. pylori negative by urea breath test(UBT), and asked to answer the questionnaire regarding demographic characteristics, dyspepsia symptoms, health-related behaviors and family history. Results: The reinfection rate on the first year of the eradication of H. pylori was 15.6%, when the 77 subjects have finished follow-up observation for one year. In the urea breath test performed after two and a half year, 13 out of 77 were positive, with the reinfection rate of 16.9%. Age, sex, socio-economical status, educational level and family history were not associated with the reinfection, while there was significant association between the reinfection and postprandial fullness and epigastric bloating in subjective dyspepsia that the subjects who were determined to be negative in the urea breath test for the following year. The treatment compliance and drinking were significant variables in univariate analysis. Meanwhile, the cases in which the dyspepsia symptom scores for the recent year were 2 to 3 points served as the only statistically significant variable in multiple logistic regression analysis, with the odds ratio of 4.5. The cases in which salt intake during meals was exceeded were 8.7 in the odds ratio, but statistically insignificant. Conclusions: Conclusively, the first-year reinfection rate was 15.6%, and the second-year reinfection rate was 16.9%. Thecomplaints of subjective dyspeptic symptoms and the treatment compliance, as the basis for predicting the H. pylori reinfection in communities, can be used as the basis to screen the subjects for follow-up examination to find out H. pylori infection.