Clinical Effect of Ilaprazole Enteric-Coated Tablets in Patients with Peptic Ulcer

Objective: To discuss the actual effect of ilaprazole enteric-coated tablets in the treatment of peptic ulcer patients. Methods: 200 peptic ulcer patients who received treatment from January to December 2023 were selected as the study sample, and all patients were randomly and evenly divided into the study group (n = 100) and the control group (n = 100), and the serum inflammatory factors and the disappearance time of symptoms were compared. Results: After treatment, the serum inflammatory factors in the observation group were better than those in the control group, and the time of belching and burning sensation in the observation group was shorter than that in the control group, all of which were statistically significant (P Conclusion: Ilaprazole enteric-coated tablets in the treatment of peptic ulcer have a good effect and can effectively improve the symptoms of patients with clinical signs, with reference significance.

Analysis of the Therapeutic Effect of Clopidogrel Bisulfate Tablets + Aspirin Enteric-Coated Tablets on Acute Myocardial Infarction

Objective:To investigate and analyze the clinical effect of clopidogrel bisulfate tablets combined with aspirin enteric-coated tablets on acute myocardial infarction(AMI)patients.Methods:The study period was from January 2020 to December 2023,the sample source was 82 AMI patients admitted to our hospital,grouped into an observation group(n=41)and a control group(n=41)by the numerical table method.The patients in the control group were treated with aspirin enteric-coated tablets,and the patients in the observation group were treated with aspirin enteric-coated tablets combined with clopidogrel bisulfate.The clinical efficacy,coagulation indexes,and the incidence of cardiovascular adverse events between the two groups were compared.Results:The clinical efficacy of the observation group was higher than that of the control group(P<0.05);the platelet aggregation rate(PAR)of the observation group was lower than that of the con-trol group after treatment(P<0.05),and there was no significant difference in the prothrombin time(PT)and activated partial thromboplastin time(APTT)between the two groups(P>0.05).The incidence of cardiovascular adverse events in the observation group was lower than that of the control group(P<0.05).Conclusion:The treatment effect of clopidogrel bisulfate tablets combined with aspirin enteric-coated tablets on AMI patients is remarkable.It reduces the PAR and the incidence of cardiovascular adverse events,so this treatment method should be popularized.

Gradient high performance liquid chromatography method for simultaneous determination of ilaprazole and its related impurities in commercial tablets

A methodology(HPLC)proposed in this paper for simultaneously quantitative determination of ilaprazole and its related impurities in commercial tablets was developed and validated.The chromatographic separation was carried out by gradient elution using an Agilent C8 column(4.6 mm×250 mm,5 mm)which was maintained at 25℃.The mobile phase composed of solvent A(methanol)and solvent B(solution consisting 0.02 mmol/l monopotassium phosphate and 0.025 mmol/l sodium hydroxide)was at a flow rate of 1.0 ml/min.The samples were detected and quantified at 237 nm using an ultraviolet absorbance detector.Calibration curves of all analytes from 0.5 to 3.5 mg/ml were good linearity(r≥0.9990)and recovery was greater than 99.5% for each analyte.The lower limit of detection(LLOD)and quantification(LOQ)of this analytical method were 10 ng/ml and 25 ng/ml for all impurities,respectively.The stress studies indicated that the degradation products could not interfere with the detection of ilaprazole and its related impurities and the assay can thus be considered stability-indicating.The method precisions were in the range of 0.41-1.21 while the instrument precisions were in the range of 0.38-0.95 in terms of peak area RSD% for all impurities,respectively.This method is considered stabilityindicating and is applicable for accurate and simultaneous measuring of the ilaprazole and its related impurities in commercial enteric-coated tablets.

Development of triple-layered tablets containing laxatives with a hydrophilic polymer

Constipation is a common functional gastrointestinal disorder which has caused much discomfort affecting the quality of life. The prevalence of constipation in the general population is approximately 20%(1)Various kinds of laxatives were introduced such as bulking agent, stool softener, stimulant, and osmotic agent (2)Fixed dose combination with bisacodyl as a stimulant and docusate sodium as a stool softener, Ducolax STM, was developed as enteric coated tablets targeting colon.

Delayed-release oral mesalamine tablet mimicking a small jejunal gastrointestinal stromal tumor:A case report

BACKGROUND Enteric-coated medications are supposed to pass intact through the gastric environment and to release the drug content into the small intestine or the colon.Before dissolution of the enteric coating,they may appear hyperdense on computed tomography(CT).Unfortunately,few reports have been published on this topic so far.In this case report,the hyperdense appearance on contrastenhanced CT of an enteric-coated mesalamine tablet was initially misinterpreted as a jejunal gastrointestinal stromal tumor(GIST).CASE SUMMARY An asymptomatic 81-year-old male patient,who had undergone laparoscopic right nephrectomy four years earlier for stage 1 renal carcinoma,was diagnosed with a jejunal GIST at the 4-year follow-up thoraco-abdominal CT scan.He was referred to our hub hospital for gastroenterological evaluation,and subsequently underwent 18-fluorodeoxyglucose positron emission tomography,abdominal magnetic resonance imaging,and video capsule endoscopy.None of these examinations detected any lesion of the small intestine.After reviewing all the CT images in a multidisciplinary setting,the panel estimated that the hyperdense jejunal image was consistent with a tablet rather than a GIST.The tablet was an 800 mg delayed-release enteric-coated oral mesalamine tablet(Asacol®),which had been prescribed for non-specific colitis,while not informing the hospital physicians.CONCLUSION Delayed-release oral mesalamine(Asacol®),like other enteric-coated medications,can appear as a hyperdense image on a CT scan,mimicking a small intestinal GIST.Therefore,adetailed knowledge of the patients’medications and a multidisciplinary review of the images areessential.

RP-HPLC法测定比沙可啶片剂含量及有关物质

目的建立RP-HPLC法测定比沙可啶片剂含量及有关物质。方法色谱柱为Hypersil ODS C18(300mm×4mm,5μm),以乙腈-水(45∶55)为流动相,流速为1.0mL/min,进样量为10μL,检测波长为265nm。结果比沙可啶浓度在0.115～1.150g/L范围内,色谱峰面积与浓度线性关系良好,r=0.9999;线性范围内3个浓度的平均回收率(n=3)分别为99.2%(RSD=0.68%)、99.3%(RSD=0.21%)和99.1%(RSD=0.87%)。样品中有关物质检查符合质量要求。结论该方法简便、快速、准确、重现性好,可用于比沙可啶片剂的含量测定和有关物质检查。

HPLC法测定比沙可啶肠溶片的有关物质

目的建立测定比沙可啶肠溶片有关物质的高效液相色谱法。方法采用色谱柱：Kromasil C18柱；流动相：甲醇-水-冰醋酸（65：35：0．1）；流速：1mL·min^-1；检测波长：263nm；进样量：20μL；柱温：室温。结果比沙可啶肠在2～10μg·mL^-1（r=0．9999）范围内线性关系良好。结论实验表明，该方法准确、可靠、重现性好，可用于测定比沙可啶肠溶片的有关物质。

中药导入气流弥散法治疗便秘的疗效观察

目的:比较中药导入气流弥散法治疗便秘和口服西药治疗便秘的临床疗效。方法:选择2008年9月至2010年9月门诊治疗的便秘患者82例,分为气弥组56例(中药导入气流弥散法治疗);西药组26例(口服西药比沙可啶片治疗),分别记录临床症状,经统计学处理比较两种方法治疗便秘的有效率和复发率。结果:两种方法治疗便秘的有效率和复发率经统计学检验有显着性差异(P<0.05)。结论:中药导入气流弥散法治疗便秘疗效明显优于口服西药治疗便秘,且疗效确切,治疗方法无痛苦,值得广泛应用。

加味六磨汤联合针灸治疗老年习惯性便秘

目的观察加味六磨汤联合针灸治疗老年习惯性便秘的症状改善情况及中医症候的临床疗效。方法收集中医门诊102例患者,经患者同意后随机分为观察组和对照组。对照组患者给予比沙可啶肠溶片(口服,每次5 mg,每晚1次);观察组患者用加味六磨汤,1剂/d,取汤汁500 m L,分2次早晚温服,联合针灸,取大肠腧、天枢、支沟、上巨虚4穴,毫针刺,平补平泻法,得气留针20 min,1次/d。2组疗程均为2周。结果观察组总有效率达到94.11%,明显高于对照组患者72.55%,观察组明显优于对照组(P<0.05)。组间治疗后比较,观察组排便间隔、粪质性质、排便困难症状积分均低于对照组,差异具有统计学意义(P<0.05)。组间治疗后比较,观察组腹部胀满、神志、舌苔积分、中医症候总积分低于对照组,差异具有统计学意义(P<0.05)。其余症状积分差异无统计学意义(P>0.05)。结论加味六磨汤能够养血滋阴,行气润肠,结合针灸通导肠腑之功,治疗老年习惯性便秘的疗效显著,能显著改善患者排便情况,且有助于缓解患者的抑郁情绪。

HPLC法测定比沙可啶肠溶片含量的测量不确定度评定

目的:建立测定比沙可啶肠溶片含量的测量不确定度的评定方法。方法:采用高效液相色谱(HPLC)外标法测定比沙可啶肠溶片的含量,并建立评定其不确定度的数学模型,对来自于溶液配制过程和仪器测定过程的各种不确定度影响因素进行系统分析并予以评估。结果:HPLC外标法测定比沙可啶肠溶片的含量为97.8%,置信概率为95%时,其扩展测量不确定度为2.8%,测量结果表示为(97.8±2.8)%,k=2。结论:建立的方法适用于HPLC外标法测定比沙可啶肠溶片含量的测量不确定度评定。HPLC仪器的定期校准检定和称量过程的严格控制有利于提高HPLC法测定的准确度。

不同厂家比沙可啶肠溶片仿制制剂与参比制剂溶出曲线的相似性评价

目的:考察比沙可啶肠溶片不同仿制制剂与参比制剂在多种溶出介质中溶出曲线的相似性,为其仿制制剂的生产工艺和内在质量提升提供参考。方法:采用桨法,转速75 r/min,分别以1 000 m L的含2%十二烷基硫酸钠的p H 6.0磷酸盐缓冲液、p H 6.8磷酸盐缓冲液、水为溶出介质进行溶出试验,采用高效液相色谱法测定比沙可啶肠溶片3种仿制制剂与参比制剂中主成分在不同时间点的平均累积溶出度,并绘制溶出曲线,进而采用相似因子(f_2)法评价其溶出曲线的相似性。结果:参比制剂在3种溶出介质中的溶出曲线基本一致;3个厂家生产的仿制制剂中有1种与参比制剂溶出曲线的f_2≥50,即具有相似性。结论:不同厂家生产的比沙可啶肠溶片仿制制剂质量存在明显差异,其在生产工艺和内在质量上有待提高。有必要加强对仿制制剂溶出曲线的实时监控,确保药品质量的可控性。

HPLC法测定比沙可啶肠溶片的含量及含量均匀度

目的：建立测定比沙可啶肠溶片含量及含量均匀度的方法。方法：采用高效液相色谱法。色谱柱为Agilent ZORBAX C18，流动相为乙腈-20 mmol/L乙酸铵溶液（冰醋酸调pH至5.0）（55∶45，V/V），检测波长为265 nm，柱温为30℃，流速为1.0 ml/min，进样量为20μl。结果：比沙可啶检测质量浓度线性范围为50～1000μg/ml（r＝0.9999）；精密度、稳定性、重复性试验的RSD＜1％；回收率为99.50％～101.17％，RSD＝0.5％（n＝9）。结论：该方法重复性好、准确度高，适用于比沙可啶肠溶片的质量控制。

比沙可啶原料药和肠溶片中有关物质测定方法研究

目的：建立测定比沙可啶原料药和肠溶片中有关物质的方法。方法：采用高效液相色谱法。色谱柱为Hibar C18,流动相为乙腈-20 mmol/L乙酸铵溶液（冰乙酸调p H至5.0）（55∶45,V/V）,检测波长为265 nm,流速为1.0 ml/min,柱温为30℃,进样量为20μl。结果：在该色谱条件下各杂质及其与主成分之间均分离良好;比沙可啶检测质量浓度线性范围为0.25～5.0 mg/ml（r=0.999 9）;比沙可啶以及杂质A、B、C、D、E的检测限和定量限分别为19～25 ng和61～68 ng;精密度、稳定性、重复性试验的RSD〈2%;比沙可啶回收率为99.50%～101.00%,RSD=0.5%（n=9）。结论：该方法专属性强、灵敏度高、重复性好,可用于比沙可啶原料药和肠溶片剂中有关物质的测定。

HPLC法测定比沙可啶肠溶片的含量和含量均匀度

目的 建立HPLC法测定比沙可啶肠溶片的含量和含量均匀度方法。方法 采用Waters Sun Fire C18（5μm,150×4.6mm）色谱柱,流动相为甲醇-水-冰醋酸（35∶65∶1）,流速：1.0m L·min-1,检测波长264nm。结果 比沙可啶在12.12μg·m L-1~121.20μg·m L-1（R=1.0000）范围内具有良好的线性,回收率为101.10%,RSD为0.91%。结论 该方法结果准确,重现性好,可用于比沙可啶肠溶片的质量控制。

HPLC测定比沙可啶肠溶片体外释放度

目的建立高效液相色谱法测定比沙可啶肠溶片的体外释放度。方法采用Agilent ZORBAX SB-C_(18)色谱柱(4.6 mm×150 mm,5μm),以20 mmol·L^(-1)的乙酸铵溶液(冰醋酸调节pH 5.0)-乙腈(45∶55)为流动相,检测波长为265 nm。结果比沙可啶在1.0~15μg·m L^(-1)内线性关系良好;平均回收率为100.4%,RSD为0.8%。A企业3批样品45 min内比沙可啶肠溶片的释放度分别为83%,81%,79%;B企业3批样品45 min内比沙可啶肠溶片的释放度分别为56%,59%,61%。结论该释放度实验条件可以较客观地反映产品的内在质量,为不同厂家同一制剂质量的区分提供可靠依据。

四磨汤口服液联合比沙可啶治疗老年功能性便秘的疗效观察

目的观察四磨汤口服液联合比沙可啶治疗老年功能性便秘的临床疗效。方法选取2017年1月—2017年12月在秦皇岛军工医院就诊的患者106例,随机分为对照组和治疗组,每组各53例。对照组口服比沙可啶肠溶片,5mg/次,1次/d。治疗组在对照组治疗基础上口服四磨汤口服液,20m L/次,3次/d。两组均连续治疗4周。观察两组的临床疗效,比较两组治疗前后排便间隔时间、排便时长的变化情况。随访6个月,观察两组的复发情况。结果治疗后,对照组和治疗组的总有效率分别为75.47%、90.57%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者排便间隔时间、排便时长均较治疗前显著缩短,同组治疗前后比较差异有统计学意义(P<0.05);治疗后,治疗组排便间隔时间、排便时长均显著短于对照组,两组比较差异具有统计学意义(P<0.05)。随访6个月,对照组和治疗组的复发率分别为58.49%、32.08%,两组比较差异具有统计学意义(P<0.05)。结论四磨汤口服液联合比沙可啶治疗老年功能性便秘具有较好的临床疗效,可缩短患者排便间隔时间和排便时间,降低复发率,具有一定的临床推广应用价值。