• 약학회지
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• 제37권5호
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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.

• Biomolecules & Therapeutics
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• 제22권2호
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• pp.161-165
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• 2014

The main purpose of this study was to develop a novel, in situ gel system for sustained delivery of ranitidine hydrochloride. Ranitidine in situ gels at 0.2%, 0.5%, and 1.0% gellan gum concentration (w/v) were prepared, respectively, and characterized in terms of preparation, viscosity and in vitro release. The viscosity of the gellan gum formulations in solution increased with increasing concentrations of gellan gum. In vitro study showed that the release of ranitidine from these gels was characterized by an initial phase of high release (burst effect) and translated to the second phase of moderate release. Single photon emission computing tomography technique was used to evaluate the stomach residence time of gel containing $^{99m}Tc$ tracer. The animal experiment suggested in situ gel had feasibility of forming gels in stomach and sustained the ranitidine release from the gels over the period of at least 8 h. In conclusion, the in situ gel system is a promising approach for the oral delivery of ranitidine for the therapeutic effects improvement.

• 대한기관식도과학회지
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• 제10권2호
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• pp.22-27
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• 2004

Background : LPRD(Laryngopharyngeal reflux disease) gives rise to inflammatory change in the pharyngolaryngeal tissue with various otolaryngologic symptoms. Ranitidine, histamine H2receptor antagonists, are currently used as therapeutic medications. However, the efficacy of Ranitidine on LPRD has not been proven yet. Objectives : We intended to analyze the efficacy of the Ranitidine on LPRD. Materials :md Methods : In 20 multicenter, 607 patients with LPR(laryngopharyngeal reflux) symptom were observed to evaluate their symptoms and laryngoscopic findings after 4 weeks, 8 weeks, and 12 weeks of treatment of Ranitidine. Results : The symptom of LPR including globus sensation, sore throat hoarseness, regurgitatioin are improved after 4 weeks $86.2\%,\;8 weeks\;91.5\%,\;12 weeks\;92.9\%$ of Ranitidine treatment and improved after 4 weeks $91.5\%,\;8 weeks\;94.5\%,\;12 weeks\; 97.2\%$ of Ranitidine combined with prokinetics. The rates of sore throat, chronic cough, globus sensation improvement at 8 weeks after treatment are $26.7\%,\;16.7\%,\;16\%$. Conclusion : In patient with LPR, Ranitidine treatment reduces LPR symptoms very effectively.

• Journal of Pharmaceutical Investigation
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• 제17권4호
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• pp.189-195
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• 1987

The effects of cimetidine or ranitidine pretreatment on the intestinal absorption, plasma and urine level of caffeine, gastric acidity of mouse, and sleeping time by hexobarbital sodium were investigated pharmacokinetically. Cimetidine and ranitidine pretreatments were found to increase both the rate and extent of absorption of caffeine in rats. Cimetidine pretreatment increased blood level of caffeine and decreased urine level, while ranitidine pretreatment had no effect on urine level of caffeine. Ranitidine pretreatment inhibited gastric secretion due to caffeine more than cimetidine pretreatment. Cimetidine pretreatment increased the action of caffeine and showed shorter sleeping time by hexobarbital sodium, comparing with ranitidine pretreatment.

• Environmental Analysis Health and Toxicology
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• 제5권3_4호
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• pp.37-45
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• 1990

Experiments were performed on mice to investigate the influences of cimetidine, ranitidine and famotidine on the immune response. Immune response were evaluated by antibody, Arthus reaction (Arthus), delayed type hypersensitivity (DTH), rosette forming cell (RFC), phagocyte activity and whit( blood cell (WBC) in mice, sensitized and challenged with sheep red blood cells (SRBC). The weight of liver, spleen and thymus were measured. Following results obtained in this experiment. 1) The administration of cimetidine as compared to normal group significantly decreased Arthus, Hemagglutinin titer (HA), RFC, DTH, WBC and phagocyte activity, but increased the activity of serum albumin. 2) The administration of ranitidine as compared to normal group decreased RFC and HA. 3) The administration of Famotidine as compared to normal group decreased DTH and RFC, and significantly decreased HA, Arthus and serum protein. 4) The administration of ranitidine and famotidine decreased more humoral immune response than cellular immune response, but the administration of cimetidine significantly decreased humoral and cellular immune response, WBC and phagocyte activity.

• Biomolecules & Therapeutics
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• 제2권2호
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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.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1996년도 춘계학술대회
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• pp.272-272
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• 1996

While ranitidine is well known to be absorbed rapidly, the underlying cause of variable bioavailability in intra- and inter-subjects has not been clarified yet. Intestinal permeability is a key controlling factor for oral absorption of highly soluble drugs, In the present study, intestinal ferfusions have been conducted to determine the intestinal permeabilities(Peffs) of ranitidine in the rats, dogs and humans and compared to the estimated fractions of dose absorbed (FAs) in humans. A new in vivo methodology, using a regional segmental perfusion technique, has been used in the dogs and humans. In situ single-pass perfusion experiments have been performed in the rats. In the dog and human studies, perfusion experiments have been conducted on two periods to determine the intrasubject variability, There was low significant intrasubject variation as compared to intersubject variation. The Peffs of ranitidine were 33%, 51%, and 45% inthe rats, dogs and humans, respectively. The FAs were approximately the same for all three species models, suggesting rats and dogs are good animal models for estimating the oral absorption of ranitidine in humans. In addition, the estimated extent of absorption of this drug is consistent with the average bioavailability, indicating that ranitidine has permeability-limited absorption characteristics. Supported by FDA Grant FD01462.

• Clinical and Experimental Pediatrics
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• 제59권5호
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• pp.226-230
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• 2016

Purpose: Gastroesophageal reflux disease (GERD) occurs in pediatric patients when reflux of gastric contents presents with troublesome symptoms. The present study compared the effects of omeprazole and ranitidine for the treatment of symptomatic GERD in infants of 2-12 months. Methods: This study was a clinical randomized double-blind trial and parallel-group comparison of omeprazole and ranitidine performed at Children Training Hospital in Tabriz, Iran. Patients received a standard treatment for 2 weeks. After 2 weeks, the patients with persistent symptoms were enrolled in this randomized study. Results: We enrolled 76 patients in the present study and excluded 16 patients. Thirty patients each were included in group A (ranitidine) and in group B (omeprazole). GERD symptom score for groups A and B was $47.17{\pm}5.62$ and $51.93{\pm}5.42$, respectively, with a P value of 0.54, before the treatment and $2.47{\pm}0.58$ and $2.43{\pm}1.15$, respectively, after the treatment (P=0.98). No statistically significant differences were found between ranitidine and omeprazole in their efficacy for the treatment of GERD. Conclusion: The safety and efficacy of ranitidine and omeprazole have been demonstrated in infants. Both groups of infants showed a statistically significant decrease in the score of clinical variables after the treatment.

• Archives of Pharmacal Research
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• 제13권2호
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• pp.180-186
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• 1990

A bioequivalence study of ranitidine tablets was conducted according to the Korean Guidine for the Bioequivalence Test using twelve healthy male subjects. The plasma concentration-timecurves of ranitidine from the test and reference tablets showed profound multiple peak phenomenon in each subject as reported earlier. However, the area under the plasma concentration-time curve (AUC) and the maximum ploasma concentration at the first peak ($C_{max1}$) of the two preparations was proven to be equal when analyzed satistically according to the criteria of the guidline;i. e., statistical power (1-$\beta$)was calculated to be over 0.8 under the condition of $\alpha$ = 5% and $\Delta$(minimum detectable difference) = 20%, and the confidence interval of the difference in AUC at 95% confidence level was in the range of $\pm$ 20%, which statisfied the criteria of bioequivalence. Equivalence of the peak concentration of ranitidine at the second peak ($C_{max2}$), and the time to reach the first ($T_{max1}$) and second verify the bioequivalence of $c_{max2}$ , $T_{max1}$ and $T_{max2}$ between the two tablets. However, we conclude that the test and reference tablets are bioequivalent taking the therapeutic characteristics of the ranitidine preparations into consideration.

• 분석과학
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• 제22권5호
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• pp.432-438
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• 2009

Ranitidine HCl을 함유하는 의약품 정제에 대한 네모파 전압전류법(SWV) 분석방법을 개발하고자 다양한 pH의 인산염 완충용액을 지지전해질로 하여 $5.00{\times}10^{-5}M$ ranitidine HCl용액의 SWV를 실행한 결과 ranitidine의 구조 내 $-NO_2$기의 전기화학적 환원에 기인한 주 봉우리는 Ep가 -70 mV/pH로 이동하여 수소가 관여함을 나타내었다. Ranitidine HCl용액 $1.00{\times}10^{-7}{\sim}1.00{\times}10^{-5}M$에 대하여 봉우리 전류(Ip)를 도시하여 검량곡선을 작성 시 좋은 직선성을 나타내었으며 기울기는 $232,530{\mu}A/M$ (pH 6.14), $289,015{\mu}A/M$ (pH 7.07)과 $232,843{\mu}A/M$ (pH 8.01)이었다. 의약품 정제 1정을 단순히 pH 6.14 인산염 완충용액에 용해시켜 표준물 첨가법에 의해 SWV로 정량분석 할 때 하루 중 정밀도 검사(n=4)는 큐란$^{(R)}$의 경우 1정 중 $171{\pm}2.1mg$(규정된 함량의 $102{\pm}1.3%$)의 ranitidine HCl이 함유되어 1.2% RSD를 보였으며, 5일에 걸쳐 날짜 간 정밀도 검사를 행하였을 때에도 1.1%의 RSD를 나타내었다. 잔탁$^{(R)}$ 역시 하루 중 정밀도 검사(n=4)를 하였을 때 1정 중 $167{\pm}0.8mg$(규정된 함량의 $99{\pm}0.5%$)의 ranitidine HCl이 함유되어 0.5%의 RSD를, 날짜 간 정밀도 검사도 0.3%의 RSD로 좋은 정밀도를 나타내었다.