A unique formulation of sodium bicarbonate buffered pantoprazole powder for oral suspension: perspectives from an active controlled cross-over bioequivalence study

Background:The aim was determining bioequivalence between pantoprazole buffered powder for oral suspension and pantoprazole enteric coated tablets under fasting conditions in healthy volunteers.Methods:In randomized cross-over study, participants were administered a single oral dose of pantoprazole powder as suspension 40 mg (sodium bicarbonate as buffer) or one enteric coated tablet of pantoprazole 40 mg, with240�ml of water as per the randomization schedule in each study period. Blood samples were collected at pre-dose and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 12, 14, 16and 24hours post-dose. Plasmaconcentration of pantoprazole was determined with LC-MS and various pharmacokinetic parameters like Cmax, AUC0-t, AUC0-inf were compared between test and reference groups.Results:Amongst 41 subjects, Cmax(3752.4�84.6 vs. 3521.7�99.5 ng/ml)was achieved higher in less Tmaxtime (1 (0.28) vs. 2.3 (0.83) hrs)with test drug as compared to reference drug. The ratios of geometric least square mean and its 90% confidence interval on log transformed Cmax, AUC0-t and AUC0-inffor pantoprazole fall within the acceptance criteria of 80% to 125%. No adverse events were observed.Conclusions:Pantoprazole powder for oral suspension 40 mg (sodium bicarbonate as buffer) was well tolerated and bioequivalent with pantoprazole enteric coated tablets IP 40 mg in terms of rate and extent of absorption under fasting conditions. At same time, the shift in AUC to the left with reduction in Tmaxwith the new formulation is suggestive of faster rate of absorption.

Pharmacokinetics and pharmacodynamics of (S)-pantoprazole sodium enteric-coated tablets in healthy subjects / 中国临床药理学与治疗学

AIM: To evaluate the pharmacokinetics and pharmacodynamics of (S)-pantoprazole sodium enteric-coated tablets in healthy subjects by using pantoprazole sodium enteric-coated tablets as a control drug. METHODS: Thirty healthy Chinese subjects were enrolled in a randomized, open and positive control trial. The subjects were given 20 and 40 mg (S)-pantoprazole sodium enteric-coated tablets and 40 mg pantoprazole sodium enteric-coated tablets, respectively. The concentration of (S)-pantoprazole in the human plasma was determined by LC-MS/MS and the pharmacokinetic parameters were calculated by WinNonlin 6.4 software. The intragastric pH was monitored for 24 hours. The dose-effect relationship of drugs was evaluated. RESULTS: The main pharmacokinetic parameters of (S)-pantoprazole after single administration of 20 and 40 mg (S)-pantoprazole sodium and 40 mg pantoprazole sodium enteric-coated tablets were as follows: The Cmax were (1 635±410), (2 756±1 024) and (1 536±615) ng/mL, the t1/2 were (1.41±0.31), (1.55±0.64) and (1.35±0.22) h, the AUC0-t were (3 623±1 322), (7 383±3 785) and (3 276±1 302) h•ng•mL-1; The main pharmacokinetic parameters of multiple administration were as follows: The Cmax were (1 704±239), (3 297±743) and (1 832±557) ng/mL, the t1/2 were (1.41±0.40), (1.58±0.64) and (1.45±0.22) h, the AUC0-t were (3 587±1 040), (8 189±3 399) and (3 878±1 272) h•ng•mL-1. After the treatment, the time of pH>4.0 as a percentage of total time (%) after single administration were (32.98±10.7)%, (45.37±9.61)% and (32.63±14.63)%; and the time of pH>4.0 as a percentage of total time (%) after multiple administration were (45.12±11.97)%, (50.76±10.63)% and (41.67±7.1)%. CONCLUSION: Healthy subjects have linear kinetic characteristics of (S)-pantoprazole after single and multiple administrations, and the 40 mg (S)-pantoprazole sodium group has better efficacy than other dose groups. Healthy subjects were well tolerated.

Enzymatically Synthesized Ph-Responsive Ipn For In-Situ Release Of Pantoprazole Sodium

Objective: This study involves the synthesis of Gum tragacanth (gt) based interpenetrating polymer network (ipn) and its utilization for sustained release of anti-ulcerative drug i.e. pantoprazole sodium. Methods: IPN was synthesized from Gum tragacanth, polyacrylic acid (gt-cl-paa) hydrogel. gt-cl-paa was kept in distilled water. Further, acryamide (aam) and methylmethacrylate (mma) was added and then kept for overnight. Later on, lipase and glutaraldehyde were added. Homopolymers and the unreacted monomers were removed using acetone. Synthesized IPN was dried at 50 °C for further study. Synthesized ipn was swelled in water and the drug was added to it. The drug was entrapped in the pores of the synthesized ipn and then drug release behavior was studied using uv-vis spectrophotometer. Results: Gt, paa and mma based crosslinked IPN were synthesized using lipase-glutaraldehyde as initiator-crosslinker system. The synthesized IPN was pH sensitive and possessed the desired swelling capacity required for the controlled and systematic liberation of pantoprazole sodium at 37 °C. The kinetic of drug release was studied and found that lateral diffusion (DL) of drug was higher as compared to the initial diffusion (DI). The prepared IPN can be used as prospective carrier for prolonged drug delivery. Conclusion: A novel pH sensitive and colon targeted IPN was synthesized. It acts as an effective device for the controlled release of drug pantoprazole sodium.

Esomeprazole and pantoprazole enhance the antiproliferative effects of cisplatin on the human neuroblastoma SH-SY5Y cell line

Background: Proton pump inhibitors (PPIs) largely used a drug to treat gastroesophageal disease such as gastric ulcers. Moreover, in recent years, several studies suggest that PPIs have an important anti-cancer effect in monotherapy and or combination with chemotherapy. The aim of this study was to investigate whether esomeprazole and pantoprazole exhibit anti-cancer effect alone or could enhance chemosensitivity on the human neuroblastoma cell line SH-SY5Y to cisplatin.Methods: The human neuroblastoma SH-SY5Y cells were cultured and treated with different concentrations of esomeprazole, pantoprazole, and cisplatin alone. Also, these cells exposed to cisplatin+ esomeprazole and cisplatin + pantoprazole combinations, respectively and incubated 24 h. The antiproliferative activities of the (PPIs) alone or in a combination of cisplatin was evaluated using the XTT colorimetric assay.Results: According to experimental data, neither PPIs showed no cytotoxicity on the human neuroblastoma cell line SH-SY5Y at all concentrations. However, when combined with cisplatin separately, they were found to have significant antiproliferative effects on the human neuroblastoma SH-SY5Y cell lines when compared to cell lines treated with cisplatin alone (p<0.05).Conclusions: Taken together, the inhibition of V-ATPase via esomeprazole and pantoprazole might enhance the chemosensitivity of cisplatin on the human neuroblastoma cell line SH-SY5Y. However, further studies are needed to be able to utilize PPIs in human neuroblastoma cells.

Prospects to the formation and control of potential dimer impurity E of pantoprazole sodium sesquihydrate / 药物分析学报

Pantoprazole sodium, a substituted benzimidazole derivative, is an irreversible proton pump inhibitor which is primarily used for the treatment of duodenal ulcers, gastric ulcers, and gastroesophageal reflux disease (GERD). The monographs of European Pharmacopoeia (Ph. Eur.) and United States Pharmaco-poeia (USP) specify six impurities, viz.; impurities A, B, C, D, E and F, respectively for its active phar-maceutical ingredient (API). The identification and synthesis of all impurities except impurity E are well described in the literature; however, there is no report related to impurity E. The prospects to the for-mation and controlling of impurity E up to ≤0.03％ in the synthesis of pantoprazole sodium sesquihydrate (PAN) were discussed in detail for the first time. The present work described the journey towards the successful development of an optimal preparation procedure of dimer impurity E. The most plausible mechanism involved in the formation of impurity E has been proposed.

Clinical observation of acupuncture at Zhiyang (GV 9) points combined with pantoprazole for gastroesophageal reflux cough with damp-heat type / 中国针灸

<p><b>OBJECTIVE</b>On the basic treatment, to observed the effect difference between acupuncture at Zhiyang (GV 9) points combined with pantoprazole and simple pantoprazole for gastroesophageal reflux cough with damp-heat type.</p><p><b>METHODS</b>A total of 102 patients were randomly assigned into an observation group and a control group, 51 cases in each group. The patients in the two groups were given domperidone tablets (10 mg each time, 3 times a day). The patients in the control group were treated with pantoprazole capsule (40 mg each time, once a day). On the basis of the control group, the patients in the observation group were treated with Zhiyang (GV 9) points, once a day, 5 times a week. All the treatment was given for 8 weeks. The indexes were observed before and after treatment, including cough symptom at daytime and nighttime scores, TCM symptom (heartburn, acid regurgitation, chest pain, epigastric pain, throat discomfort) scores and quality of life scores of cough questionnaire in Leicester (physiological, psychological and social aspects). The clinical effects were compared.</p><p><b>RESULTS</b>After treatment, the daytime and nighttime cough scores, TCM symptom (heartburn, acid regurgitation, chest pain, epigastric pain, throat discomfort) scores were lower, and the quality of life scores of cough questionnaire in Leicester (physiological, psychological and social aspects) were higher than those before treatment in the two groups (all <0.05), with better results in the observation group (all <0.05). The total effective rate of the observation group was 94.1% (48/51), which was better than 80.4% (41/51) of the control group (<0.05).</p><p><b>CONCLUSION</b>On the basic treatment, acupuncture at Zhiyang (GV 9) points combined with pantoprazole can improve TCM symptoms, such as cough, of the patients with gastroesophageal reflux cough with damp-heat type, and improve their quality of life.</p>

The level of serum hypoxia-inducible factor-1α and the regulation of pantoprazole in patients with gouty arthritis / 中华风湿病学杂志

Objective To explore the level of serum hypoxia-inducible factor (HIF)-1α and the effect of pantoprazole on HIF-1α in patients with gouty arthritis.Methods Subjects were divided into acute gouty arthritis (group A),intermittent gouty arthritis (group B) and healthy controls (group C).Patients in group A were divided into mild (A1) and severe (A2) subgroups according to the severity of inflammation.Levels of serum HIF-1α in the three groups,and the levels of interleukin (IL)-1β and tumor necrosis factor (TNF)-α in group A1 and group A2 were detected by enzyme-linked immunosorbent assay (ELISA).Patients in group A2 were randomly divided into three groups,saline 100 ml/twice a day,20％ pantoprazole 100 ml,twice a day and 40％ panto-prazole 100 ml,twice a day were administered respectively.After 7 days,the levels of serum HIF-1α were measured by ELISA.One-way analysis of variance (ANOVA) and two independent sample t test were conducted in this study.Results ① Levels of serum HIF-1α in group A [(48±13) ng/L] were significantly higher than those in group B [(40±12) ng/L,P＜0.01] and group C [(28±12) ng/L,F=29.838,P＜0.01].② Levels of serum HIF-1α [(56±10) ng/L],IL-1β [(51 ±13) ng/L] and TNF-α [(161 ±45) ng/L] in the experimental group A2 were higher than those in the experimental group A1 [HIF-1α:(42±11) ng/L,t=4.600,P＜0.01;IL-1β:(42±12) ng/L,t=2.552,P＜0.05;TNF-α:(122±34) ng/L,t=3.432,P＜0.01].③ Levels of HIF-1α [(26±6) ng/L],IL-1β [(23±4) ng/L],TNF-α [(92±6) ng/L] in the 40％ pantoprazole group were lower than those in 20％ pantoprazole 100 ml,twice a day group [HIF-1α:(33±4) ng/L];IL-1β:(30±5) ng/L;TNF-α:(102±7) ng/ L] and saline group [HIF-1α:(37±5) ng/L];IL-1β:(38±5) ng/L];TNF-α:(108±9) ng/L](all P＜0.05);Levels of HIF-1α,IL-1β and TNF-αin the 20％ pantoprazole group were lower than those in saline group (all P＜0.05).Conclusion ① HIF-1α may be one of the indicators of acute inflammation,which may reflect the degree of inflammation in patients with gout.② Pantoprazole can reduce the level of serum HIF-1α,IL-1β and TNF-α in patients with gouty arthritis,with a concentration dependent characterisit.

Effect of pantoprazole in tumor bleeding prevention in patients with unresectable gastric cancer: a randomized,double-blind, placebo-controlled clinical trial / 中国综合临床

Objective To investigate the effects of pantoprazole treatment in the prevention of gastric tumor bleeding in patients with unresectable gastric cancer. Methods This study was a prospective double-blind,randomized,placebo-controlled trial. From January 2014 to July 2015,patients with gastric tumor bleeding in Xuzhou Cancer Hospital were included in this study. 131 cases of unresectable gastric cancer were randomly divided into two groups. In the experimental group,66 cases were taken pantoprazole 40 mg,1 time / d,and 65 cases in the control group were given placebo 40 mg and 1 time/ d. The course of treatment was 8 weeks. The differences in tumor bleeding,blood transfusion requirements and overall survival time between the two groups were observed during the follow-up period. Results The median follow-up time was 6. 5 ( 3. 3, 13. 2 ) months. Seven cases ( 10. 61%) in pantoprazole group had tumor bleeding, and 13 ( 20%) in the placebo group. There was no significant difference in cumulative risk of tumor bleeding between the two groups (Gray's test: P = 0. 426) . However,in the first 5 months of follow-up,the cumulative incidence of tumor bleeding in pantoprazole group was 0,lower than that in placebo group (9. 23%) (6/ 65) (Gray's test: P = 0. 039). There was no significant difference in blood transfusion requirement and overall survival between the two groups. No drug-related adverse reactions and bleeding related deaths occurred during the follow-up period. Conclusion Pantoprazole can not significantly reduce tumor bleeding in patients with unresectable gastric cancer.

Effect of Ulinastatin Combined with Pantoprazole on Inflammatory Factors and Gastrointestinal Tract in Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery / 医药导报

Objective To investigate the effect of ulinastatin combined pantoprazole on inflammatory factors and gastrointestinal tract in patients undergoing cardiopulmonary bypass ( CBP) cardiac surgery. Methods A total of 200 patients who suffered rheumatic heart disease were scheduled for valve replacement surgery with CPB, were randomly divided into four groups:control group (CON),ulinastatin (UTI),pantoprazole groups (PTZ) and ulinastatin+pantoprazole groups(UTI+PTZ),50 cases in each group.Before CBP,group UTI was given ulinastatin 10 000 U·kg-1,group PTZ was given pantoprazole 40 mg,group UTI+PTZ was given ulinastatin 10 000 U·kg-1and pantoprazole 40 mg,group CON was given 0.9% sodium chloride soution.The gastric mucosa pHi and blood samples would be collected in all four groups at the preoperative (t1),CPB 30 min (t2),after CBP (t3),6 h after surgery (t4),24 h (t5) five time points.The IL-6 and TNF-α would be detected by enzyme linked immunosorbent (ELISA) method,and abdominal distension,abdominal pain,hematemesis,black and defecate occult blood test positive for digestive tract related complications would be collected after the surgery 1,2 days. Results The concentration of TNF-α and IL-6 at t2,t3, t4,t5were higher than those at t1in all four groups(P<0.05).Compared with CON group,the concentration of TNF-α and IL-6 at t2, t3,t4,t5in UTI,PTZ and UTI+PTZ group were significantly decreased (P<0.05).The concentration of TNF-α and IL-6 in UTI and UTI+PTZ group were better than in PTZ group.The pHi at t2,t3,t4was lower than that at t1in four groups(P<0.05),and pHi at t5 was obviously lower than that at t1in group CON (P<0.05).The pHi at t2,t3,t4in UTI,PTZ and UTI+PTZ group was higher than that in CON group ( P<0. 05), and pHi in UTI+PTZ group was better than that in UTI and PTZ group. The postoperative gastrointestinal complications in CON group were higher than those in UTI,PTZ and UTI+PTZ group (P<0.05). Conclusion Ulinastatin combined with pantoprazole for patients undergoing CPB heart surgery,can significantly reduce the release of TNF-α and IL-6、increase gastric pHi and reduce the incidence of gastrointestinal complications.

The dose, efficacy and safety analysis of pantoprazole in the prevention of duodenal ulcer / 中国基层医药

Objective To investigate the dose,efficacy and safety of pantoprazole in the prevention of duodenal ulcer.Methods The patients from October 2014 to October 2016,105 cases of neurosurgery,thoracic surgery,neurosurgery and orthopedic surgery were divided into group A,group B and group C according to random number table method,35 cases in each group.The three groups were treated with intravenous pantoprazole,the dosage of group A was 40mg,1 time/d;the dosage of group B was 80mg,1 time/d;the dosage of group C was 40mg,1 time/12h,treatment cycle was 1 week.Before and after treatment,the gastric pH change and onset time,the incidence of adverse reactions were compared among the three groups.Results After treatment for 24h,the gastric pH of group B was (5.15 ± 0.87),which was significantly higher than (2.35 ± 0.45) in group A and (3.59 ± 0.65) in group C,which in group C was significantly higher than that in group A(t =10.809,24.407,13.598,all P ＜ 0.05).The onset time of group B [(48.6 ± 12.2)] was significantly shorter than (88.7 ± 23.4) of group A and (85.4 ± 26.5) of group C (t =10.987,10.083,all P ＜ 0.05).In group B,the time of gastric pH ＞ 3 [(954.5 ± 156.4) rin],pH ＞ 4 time [(865.4 ±135.2)rin]and pH ＞5 time[(714.2 ± 115.4)min]were significantly longer than those in group A and group C,which in group C were significantly longer than that in group A,the differences were statistically significant (t =8.852,30.177,21,325,3.864,40.879,44.713,all P ＜ 0.05).The incidence rates of adverse reactions in group A,group B and group C were 5.71％,14.3％ and 8.6％,respectively,there was no statistically significant difference (t =4.175,45.149,43.974,all P ＜ O.05).Conclusion 80mg qd pantoprazole can significantly improve gastric pH,effectively prevent and treat duodenal ulcer,with high safety.

Analysis on the effect of pantoprazole and omeprazole in the treatment of gastric ulcer / 中国生化药物杂志

Objective To investigate and analyze the effect of pantoprazole and omeprazole in the treatment of gastric ulcer.Methods a total of 100 patients with gastric ulcer treated in Shizuishan First People's Hospital from January 2014 to June 2016 were selected and randomly divided into the control group and the experimental group, with 50 patients in each group.The control group was treated with omeprazole, and the experimental group was treated with pantoprazole.After taking one course of treatment, the clinical efficacy, treatment cost, eradication rate of Helicobacter pylori and recurrence rate of gastric ulcer were compared between the 2 groups.Results The total effective rate of the experimental group was 94%, which was significantly higher than that of the control group(72%), and the difference was statistically significant(P<0.05).After the corresponding treatment, the experimental group of 50 cases, Helicobacter pylori eradication rate was 72%, the recurrence rate of gastric ulcer was 12%.In the control group of 50 cases, the eradication rate of Helicobacter pylori was 52%, and the recurrence rate of gastric ulcer was 36%.As a result, the eradication rate of H.pylori in the experimental group was significantly higher than that in the control group.The cost of treatment in the control group was(499.78±74.81)yuan, and the treatment cost of the experimental group was(413.26±56.39)yuan.The treatment cost and gastric ulcer recurrence rate in the control group were significantly higher than those in the experimental group, with statistical difference(P<0.05).Conclusion Pantoprazole in the treatment of gastric ulcer is much better than omeprazole, high treatment efficiency, is the preferred drug for the treatment of gastric ulcer, after the treatment of gastric ulcer recurrence rate is low, the cost of treatment is low and high eradication rate, with the further promotion and application in clinic significance.

Clinical control study of omeprazole and pantoprazole in treatment of peptic ulcer hemorrhage / 药物评价研究

Objective To discuss the efficacy of omeprazole and pantoprazole in treatment of peptic ulcer hemorrhage.Methods 80 patients with peptic ulcer hemorrhage were selected,they were divided into two groups randomly.The observation group (41 cases) was given pantoprazole by intravenous drip.The control group (39 cases) was given omeprazole by intravenous drip.The efficacy and safety of omeprazole and pantoprazole in treatment of peptic ulcer hemorrhage was evaluated by efficacy,pH before and after treatment,bleeding time,hospitalization and bleeding volume,and adverse reaction during treatment.Results The effective rate was 92.7％ in the observation group and 89.7％ in the control group.There was no statistical significance on effective rate between two groups.But the excellent rate of observation group was higher than that of the control group (P ＜ 0.05).Before treatment,the gastric acid was acidic.There were no statistical significance on pH value between two groups.After treatment,the pH value was increased in two groups.The pH value of observation group was higher than that of the control group (P ＜ 0.05).The hospitalization,hemostasis time and bleeding volume was shorter than that of the control group (P ＜ 0.05).During treatment,the patients given pantoprazole had less adverse reaction (P ＜ 0.05).Conclusion Pantoprazole and omeprazole are suitable for treating peptic ulcer hemorrhage.But the antacid and hemostatic effect of pantoprazole was better with high safety.It was worthy of clinical application.

Psychological intervention method and effect analysis of pantoprazole sodium in the treatment of gastric ulcer / 中国生化药物杂志

Objective To explore the effect of psychological intervention with pantoprazole sodium in treatment of gastric ulcer. Methods A total of 80 patients with gastric ulcer from March 2015 to January 2017 were randomly divided into two groups, control group and observation group; Two groups were treated with pantoprazole sodium, the control group received conventional care, while the observation group was given psychological care.The rehabilitation of the two groups was observed and compared . Results The effective rate of observation group was 92.5％, significantly higher than that of the control group(77.5％); The satisfaction rate of the observation group was 97.5％, significantly higher than that of the control group 72.5％; the differences between the two groups were statistically significant.Conclusion The implementation of psychological nursing of pantoprazole in treatment of gastric ulcer in the process, can consolidate the curative effect to be fully reflected, help patients recover in time, and improve patient care for acceptance,it is worthy of reference.

Observation of the clinical effect of pantoprazole combined with domperidone in the treatment of chronic superficial gastritis / 中国基层医药

Objective To investigate the clinical efficacy of pantoprazole combined with domperidone in the treatment of chronic superficial gastritis.Methods 50 patients with chronic superficial gastritis were selected,and they were randomly divided into single drug treatment group and two drugs treatment group by the random number table method,25 cases in each group.The single drug treatment group was treated with domperidone,the two drugs treatment group was given pantoprazole combined with domperidone treatment.After 3 weeks of treatment,the total effective rate,disappearing time of abdominal pain,postprandial fullness belching disappeared time,the disappearance time of patients before meals;and after treatment,fullness,belching,abdominal pain score difference;psychological function of patients before and after treatment,differences in physical function indicators of the quality of life were compared between the two groups.Results The total effective rate of the two drugs treatment group was higher than that of the single drug treatment group (96.00％ vs.76.00％,x2 =4.153,P ＜ 0.05).The disappearance time of abdominal pain,postprandial fullness disappeared time,belching disappeared time of the two drugs treatment group were shorter than those of the single drug treatment group(t =8.201,9.155,10.762,all P ＜ 0.05).Before.treatment,the postprandial fullness,belching,abdominal pain points between the two groups had no statistically significant differences(all P ＞ 0.05).After treatment,the postprandial fullness,belching,abdominal pain of the two drugs treatment group decreased more significant (t =5.255,4.923,6.245,all P ＜ 0.05).Before treatment,the psychological function,physical function and quality of life index between the two groups showed no statistically significant differences (all P ＞ 0.05).After treatment,the psychological function,physical function and quality of life index of the two drugs treatment group increased more greatly (t =5.242,4.153,4.733,4.255,4.562,4.715,all P ＜ 0.05).Conclusion The clinical efficacy of pantoprazole combined with domperidone in the treatment of chronic superficial gastritis is effective,it can effectively improve the patients’ clinical symptoms and quality of life,shorten the treatment time,it is worthy of promoting.

Determination of Related Substances in Pantoprazole Sodium for Injection by HPLC / 中国药房

OBJECTIVE:To establish a method for the determination of related substances in Pantoprazole sodium for injec-tions. METHODS:HPLC method was adopted. The determination was performed on Kromasil Hypersil ODS column with mobile phases consisting of 0.01 mol/L potassium dihydrogen phosphate buffer solution(pH adjusted to 7.0)-acetonitrile(gradient elution) at a flow rate of 1.0 mL/min. The detection wavelength was set at 290 nm,and the column temperature was 40 ℃,and injection volume was 20 μL. RESULTS:The linear ranges of impurity A,impurity B,impurity C+E,and impurity D were 0.4168-1.0420μg/mL(r=0.9998),0.1950-0.4875 μg/mL(r=0.9999),0.3890-0.9725 μg/mL(r=0.9998),0.1986-0.4965 μg/mL(r=0.9998), respectively. The limits of quantitation were 0.834,0.780,1.556,0.794 ng/mL;the limits of detection were 0.417,0.390,0.778, 0.397 ng/mL,respectively. RSD of precision test was lower than 1.0%;in repetitive test,RSD for total peak area of impurity was lower than 1.0% ;the recoveries were 98.81% -102.49%(RSD=1.18% ,n=9),95.31% -98.44%(RSD=0.91% ,n=9), 96.88%-98.44%(RSD=0.52%,n=9)and 97.87%-101.28%(RSD=1.05%,n=9). CONCLUSIONS:The method is convenient, accurate and suitable for the determination of related substance in Pantoprazole sodium for injection.

Quadruple therapy with pantoprazole based effect of combined protective agent of gastric mucosa of Hp positive duodenal ulcers of intestinal microflora / 中国综合临床

Objective To investigate the use of protective agent of gastric mucosa of helicobacter pylori quadraple therapy with pantoprazole based plus (Hp) positive duodenal ulcer intestinal microflora influence.Methods One hundred and twenty cases patients with Hp positive duodenal ulcer who were treated in Fuzhou University Hospital from September 2015 to September 2016 were selected and randomly divided into triplet group,quadruplet group,quadruplet + protective agent group.Triplet group were treated with pantoprazole 40 mg,oral amoxicillin 1 000 mg and oral clarithromycin 500 mg,2 times one day,for 14 d treatment.Quadruplet group were given triple group therapy plus bismuth potassium citrate 220 mg,2 times one day,oral treatment,for 14 d treatment.Quadruplet+protective agent group was given quadruple group therapy plus oral rebamipide 200 mg,3 times one day.The effect of Hp eradication and the distribution of intestinal microflora after treatment were compared.Results The eradication rate of Hp in triple group was 65.00％(26/40),in quadruplet was 82.50％(33/40),in quadruplet+protective agent group was 87.50％ (35/40),Hp eradication rate in quadruplet +protective agent group was higher than the triple group and quadruplet group (P ＜ 0.05).Overall symptom improvement rate in quadruplet + protective agent group(95.00％) was better than quadruple group(80.00％)and triplet Group (75.00％),the difference was significant (P＜ 0.05).After the eradication of gastric antrum,gastric body was higher than the number of Lactobacillus((1.7424±0.162) vs.(1.6796±0.223),t=4.023,P＜0.05).Ggastric acid bacillus,clostridium,and number of enterobacteriaceae were higher than the before eradication((1.742±0.162) lg cfu/mg vs.(1.505±0.250) lg cfu/mg,(2.106±0.083) lg cfu/mg vs.(2.010± ±0.131) lg cfu/mg,(2.030±0.119)lg cfu/mg vs.(1.609±0.399) lg cfu/mg),the differences were significant (t =3.225,3.174,3.571,P ＜ 0.05).The number of clostridium quasiballs lower than before eradication((1.654± 0.177) lg cfu/mg vs.(1.808 ± 0.300) lg cfu/mg),the difference was significant (t=2.896,P＜0.05).The body of the stomach Lactobacillus number was higher than before eradication((1.680± ±0.223) lg cfu/mg vs.(1.524±0.294) lg cfu/mg),the difference was significant(t =2.974,P ＜0.05).Clostridium quasiballs quantity was lower than before eradication ((1.694±0.216) lg cfu/mg vs,(1.8526± ±0.1193) lg cfu/mg),the difference was significant(t =1.332,P＜0.05).The number of fecal lactobacillus was higher than that before treatment ((40.406 ± 3.242) lg cfu/mg vs.(38.2034 + 3.036) lg cfu/mg),the difference was significant (t =3.115,P ＜ 0.05).Conclusion Pantoprazole based quadruple therapy plus the eradication rate of gastric mucosal protective agent can improve the use of Hp positive duodenal ulcer Hp,improve the overall symptoms,and it is more conducive to the balance of intestinal micro flora after Hp eradication.

Comparison of pantoprazole and omeprazole in the prevention of postoperative stress ulcer / 中国生化药物杂志

Objective To investigate the efficacy of pantoprazole and omeprazole in the prevention of postoperative stress ulcer.MethodsThe patients were divided into control group (pantoprazole) and observation group (omeprazole) according to the random number table method from December 2015 to December 2016 in 200 cases of abdominal surgery.The incidence and adverse effects of stress ulcer were measured and the cost and effect were calculated.ResultsIn the observation group, the incidence of stress ulcer was 4.0% (4/100) in the observation group compared with 5.0% (5/100) in the control group(χ2=0.11, P=0.73).Compared with the control group, Both groups were treated with liver and kidney function and blood routine examination, no obvious abnormalities, and no significant adverse reactions during treatment.ConclusionAbdominal surgery patients with pantoprazole and omeprazole can effectively prevent postoperative stress ulcers, the cost of no significant difference, no significant adverse reactions.

Clinical study of pantoprazole and octreotide in treatment of gastrointestinal hemorrhage / 药物评价研究

Objective Discuss the efficacy of pantoprazole and octreotide in treatment of gastrointestinal hemorrhage.Methods Selecting 220 cases patients with gastrointestinal hemorrhage.They were divided into two groups randomly.The observation group (115 cases) was given pantoprazole combined with octreotide.The observation group (105 cases) was given pantoprazole.The efficacy of pantoprazole and octreotide in treatment of gastrointestinal hemorrhage was evaluated by efficacy,perioperative index,SF-36 scores and adverse reaction during 1 month follow-up.Results The effective rate of observation group was significantly higher than that of the control group (P ＜ 0.05).The bleeding time of observation group was shorter than that of control group (P ＜ 0.05).The blood transfusion of observation group was less than that of control group (P ＜ 0.05).The hemoglobin level and pH value observation group was higher than that of control group (P ＜ 0.05).Before treatment,there were no statistical significance on SF-36 scores.After 1 months treatment,physiological function,physical function and pain scores of observation group was higher than that of control group(P ＜ 0.05).During 1 months follow-up,there were no statistical significance on adverse reaction between two groups.Conclusion The pantoprazole combined with octreotide had a good therapeutic effect on gastrointestinal hemorrhage.It could stop bleeding quickly,reduce blood loss and blood transfusion.It could improve the quality of life and use safely with worthy of clinical use.

Effect of Pantoprazole on Skeletal Muscle Loss in a Mouse Model of Cancer Cachexia / 中山大学学报(医学科学版)

[Objective]To investigate the effect of pantoprazole on skeletal muscle wasting in cancer cachexia and the possible mechanism.[Methods]24 male BALB/c mice were randomly divided into control group(NN),cancer cachexia group(CC),pantrop?razole treatment group(PPI). The mice in CC and PPI were inoculated subcutaneously with mouse colon adenocarcinoma C26 cells to establish a model of cancer cachexia. The mice in PPI group were gavaged with 75 mg/kg pantoprazole dissolving in physiological saline,while those in NN and CC group were gavaged with 0.1 mL/10 g physiological saline. The mice were killed 12d after treatment. The weight of gastrocnemius and tumour and the size of tumour were measured. The morphological change of skeletal muscle were evalu?ated by the method of stain with hematoxylin and eosin(H&E). The levels of IL-6 and TNF-αin serum were tested by ELISA. qRT-PCR was used to assess the expression of mRNA of Myod1 and myf5 in skeletal muscle. The protein expressions of MuRF1,MAFBx, Myod1 and myf5 were measured by Western blot.[Results]Compared with CC group ,pantoprazole can increase the weight of mice and gastrocnemius(39.8% and 24.2%,respectively),cross section area(25.4%),levels of mRNA and protein of Myod1 and myf5(P<0.05),while the levels of IL-6 and TNF-αdecreased(30.7%and 18.9%,respectively),as well as the levels of protein ex?pression of MuRF1 and MAFBx(P < 0.05).[Conclusion]Pantoprazole can attenuate the wasting of skeletal muscle,the potential mechanism may be related to the inhibition of inflammatory factors and UPS ,and up-regulation of Myod1 and myf5.

Comparison of the efficacy of pantoprazole and omeprazole in the treatment of elderly patients with peptic ulcer / 中国基层医药

Objective To compare the clinical effect of pantoprazole and omeprazole in the treatment of elderly patients with peptic ulcer.Methods 200 patients with peptic ulcer were selected as study subjects,and they were randomly divided into two groups.The control group (100 cases) was orally given clarithromycin,amoxicillin and omeprazole triple therapy.The observation group (100 cases) was given clarithromycin,amoxicillin and pantoprazole triple therapy.The clinical efficacy,clinical symptoms disappeared time and adverse reactions occurred in the two groups were compared.Results The total effective rate of the observation group was 96％,which of the control group was 94％,the difference between two groups was not significant (x2 =0.421,P ＞ 0.05).The disappear time of abdominal pain,belching,burning and bleeding in the observation group after treatment were significantly shorter than those of the control group(t =35.545,56.680,98.896,61.109,all P ＜ 0.05).The incidence rate of adverse reaction of the observation group(5.0％) had no significant difference compared with the control group(7.0％) (x2 =0.354,P ＞ 0.05).Conclusion There is no significant difference in efficacy and safety between pantoprazole and omeprazole in the treatment of elderly patients with peptic ulcer,but the effect of pantoprazole on relieving symptoms is better than omeprazole.