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.

国产依托红霉素片和颗粒质量分析

目的对国内上市的依托红霉素片和颗粒的质量进行评价。方法依据现行法定质量标准,对市场中的依托红霉素片、颗粒进行检验,统计分析依托红霉素片、颗粒的质量总体水平,比较不同企业产品的质量。根据专题调研和标准检验结果,结合文献分析,针对依托红霉素标准中组分及有关物质、溶出度、含量测定等的不足开展探索性研究。结果本次抽检涉及的4个生产企业的23批依托红霉素片和16个生产企业的154批依托红霉素颗粒按法定标准检验,有176批次符合规定,合格率为99.4%。探索性研究采用新建的组分和有关物质测定方法,对依托红霉素原料和制剂的组分和有关物质进行了考察;按新增和修订的溶出度检查法,对20家企业的样品的溶出曲线进行了考察;含量测定时,应根据产品的处方工艺情况选择水解条件,才能保证含量测定结果的准确性。结论依托红霉素片和颗粒质量状况较好,现行质量标准中项目和方法有待进一步完善。

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.

HPLC-ELSD法测定依托红霉素片含量的研究

目的建立以高效液相色谱-蒸发光散射检测器(HPLC-ELSD)法测定依托红霉素片含量的方法。方法大曹三耀(OSAKA SODA GROUP)CAPCELL PAK C_(18) MGⅡS5色谱柱,0.03%二乙胺-乙腈(30∶70,V/V)为流动相,流速为0.9 mL·min^(-1),进样量10μL,柱温40℃。ELSD参数:漂移管温度45℃,载气流速3.3 L·min^(-1),增益为6。结果依托红霉素在0.209~1.257 mg·mL^(-1)的浓度范围内线性关系良好(r=0.9991);精密度、稳定性、重复性试验的RSD<1.5%;加标回收率平均值为99.6%;定量限为0.209μg,检测限为0.067μg。结论该方法操作简单、准确灵敏、稳定性好,可用于依托红霉素片的含量测定。

琥乙红霉素口崩片在健康志愿者的生物等效性

目的 研究琥乙红霉素口崩片的人体相对生物利用度和生物等效性。方法 健康志愿者20名,用随机双交叉试验方法,单剂量口服试验制剂琥乙红霉素口崩片和参比制剂琥乙红霉素片,剂量为800 mg,交叉间隔为2周。用微生物法测定血浆中红霉素的浓度。结果 单剂口服试验和参比制剂后血浆红霉素的Cmax分别为(1.16±0.38)和(1.03±0.34) mg.L-1;tmax分别为(1.04±0.30 )和(1.02±0.35) h;t1/2分别为(2.48±0.51) h和(2.51±0.36) h;AUC(0-10)分别为(4.12±1.36)和(3.80±1.17) mg.h.L-1;AUC(0-inf)分别为(4.43±1.38)和(4.12±1.20) mg.h.L-1;相对生物利用度为(109.3 ± 22.1)%。结论 试验和参比制剂具有生物等效性。

国产红霉素肠溶片的质量分析

目的对国产红霉素肠溶片的质量现状进行分析。方法按照国家评价性抽验计划总体要求,采用法定检验方法结合探索性研究,统计分析检验结果。结果按法定标准检验抽取317批次样品,合格率为99.1%,不合格项目为溶出度和含量。探索性研究发现国产红霉素肠溶片整体溶出速率较参比制剂慢,其原因可能与处方中的崩解剂和肠溶衣材料有关;对红霉素杂质来源进行归属,发现与工艺水平相关的指征性杂质D,应在质量标准中加以控制。结论目前国内红霉素肠溶片整体质量一般,建议进一步完善质量标准,在仿制药质量和疗效一致性评价工作中充分考虑处方合理性和工艺稳定性,不断提高产品质量。

红霉素肠溶片剂的体外溶出和体内吸收比较

用微生物方法测定了同一药厂2个批号的红霉素肠溶片的体外溶出和8名健康志愿者口服的体内吸收,结果表明国内文献方法和美国药典方法测定的溶出度无统计学差异;两种肠溶片体外溶出度有明显差异,体外溶出度大的肠溶片其体内吸收和生物利用度也大。提示体外溶出试验应作为红霉素肠溶片剂的质控指标。

国产柱晶白霉素的临床效果探讨

选择呼吸道、尿道、口腔、耳等部位感染及钩体病非重症者70例(病原学阳性75.7％)。随机以国产柱晶白霉素治疗40例及红霉素治疗30例对照观察。柱晶白霉素组420mg一日三次。3～21日痊愈～显效率76％,无效12.5％,清除革兰氏阳性球菌为90.1％,且对耐红霉素者多敏感,而革兰氏阴性杆菌耐药,对淋球菌效果差,仅有消化道反应7.5％。红霉素组375mg,一日三次,3～30日痊愈～显效率77.4％,无效9.7％,清除革兰氏阳性球菌81.3％,对丙型链球菌和淋球菌效果差,消化道反应为23.3％。显示柱晶白霉素是一种安全、有效的抗生素,特别适于门诊应用。

新癀片联合异维A酸红霉素凝胶治疗寻常痤疮临床观察

目的观察新癀片联合异维A酸红霉素凝胶治疗寻常痤疮的临床疗效和安全性。方法将152例轻、中度寻常痤疮患者随机分为试验组(80例)和对照组(72例)。两组患者晚上睡觉前均外用异维A酸红霉素凝胶1次;试验组加用新癀片口服,每日3次,每次3片;疗程共6周。治疗2、4、6周随访,观察其临床疗效和不良反应。结果治疗2周后,试验组和对照组有效率分别为21.51%和14.29%,差异无统计学意义(P>0.05);治疗4、6周后,试验组有效率(54.43%,84.81%)均显著高于对照组(30.00%,54.29%),差异均有统计学意义(P<0.01)。药物相关不良反应主要为局部刺激症状,两组发生率分别为29.11%、29.58%,差异无统计学意义(P>0.05)。结论新癀片联合异维A酸红霉素凝胶治疗寻常痤疮疗效满意、安全。

浊度法测定琥乙红霉素片的效价

目的建立浊度法测定琥乙红霉素片效价的方法。方法用标准曲线法,以金黄色葡萄球菌为实验菌,加菌量0.3%(V/V),37℃培养3～4h测定。结果抗生素浓度在0.40～0.97μg/ml的范围内成良好的线性关系,标准曲线法测定琥乙红霉素片效价的平均回收率为99.9%,RSD=1.4%(n=9)。结论浊度法灵敏、快速,可作为测定琥乙红霉素片效价的方法。

琥乙红霉素缓释片的处方工艺及其对释放度影响的研究

目的:研制琥乙红霉素缓释片并考察处方工艺对释放度的影响。方法:采用单因素方法考察不同辅料对琥乙红霉素缓释片释放度的影响,并通过正交试验设计,优化处方工艺。结果:优选工艺为:以羟丙甲基纤维素(用量为16%)为缓释骨架材料,乳糖(用量为14%)为填充剂,5%的HPMC(50%乙醇溶液)为黏合剂。释放度研究结果表明,琥乙红霉素缓释片释放度符合规定。结论:筛选优化的制备工艺稳定可控,重复性好。

红外光谱内标法测定红霉素肠溶片中红霉素的含量

用红外光谱内标法（K3[Fe（CN）6）]·6H2O为内标物）测定了红霉素肠溶片中红霉素的含量.实验表明：混合物红外光谱中红霉素的测量峰（1714.6cm-1）和K3[Fe（CN）6）]·6H2O的内标峰（2119.0cm-1）的峰高比（y=h i/h s）与两者质量比（x=m i/m s）有良好的线性关系,其线性回归方程为y=0.2642x-0.0579,相关系数R2=0.9973.据此测得红霉素肠溶片中红霉素的含量为标示量的101%,相对标准偏差为0.51%,加标回收率分别为96.8%-101.9%.该方法无需分离提取,简便,快速,成本低,测定结果准确,特别适合批量检测和药品质量的快筛,有应用价值.

红霉素口服片剂国内外质量现状分析

红霉素作为第一个药用的十四元环大环内酯类抗生素,属于国家和世界卫生组织的基本药物。本文介绍了红霉素口服片剂的基本信息、国内外上市情况、参比制剂等信息,并对国内外制剂的处方、工艺、质量标准和质量控制进行比较分析,为该品种的一致性评价工作提供参考。

红霉素片微生物限度检查方法的建立

目的建立红霉素片微生物限度检查方法。方法采用薄膜过滤并在冲洗液中加入增溶剂的方法,去除红霉素片的抗菌活性。结果本方法满足《中国药典》2005年版验证试验的基本要求。5株验证菌株中枯草芽孢杆菌对红霉素片最敏感,可作为红霉素片微生物限度检查方法的质控菌株。结论该方法可作为红霉素片的常规微生物限度检查方法。

环酯红霉素片溶出度测定方法研究

以磷酸盐缓冲液(pH6.8)为溶出介质,利用紫外分光光度法测定,建立环酯红霉素片溶出度的测定方法.实验结果表明,环酯红霉素在24.08～48.16μg.mL-1的浓度范围内线性关系良好,该方法可用于完善环酯红霉素片的质量标准.

口占吨氢醇比色法用于红霉素片溶出度中的定量测定

目的：红霉素片溶出度中的定量测定。方法：以口占吨氢醇比色法用于红霉素片溶出度中的定量测定，并与药典上原有的方法进行了比较，讨论了口占吨氢醇试剂的浓度、反应温度、时间和冷却方法等因素对结果的影响。结果：定量测定回归方程中ｒ＝０．９９９７，线性范围为９０．９４９～１８１．８９８单位／ｍｌ，测定原料的回收率为９９．８６％，测定片剂的回收率１００．０５％。结论：新方法准确度和精密度均较好。

基于GA-BP人工神经网络的红霉素肠溶片效价预测研究

目的建立一种基于GA-BP人工神经网络模型,根据组分含量数据对红霉素肠溶片效价进行预测。方法测定552个批次红霉素肠溶片的红霉素组分A、红霉素组分B、红霉素组分C、杂质A~F和总杂质的百分含量及效价,构建GA-BP人工神经网络模型,预测红霉素肠溶片的效价。结果预测效价误差百分率最高值为-4.61%,均未超过5%,误差百分率平均值为2.22%,优于一般仪器分析相对标准偏差2.50%。结论GA-BP人工神经网络对红霉素肠溶片效价预测具有较高的精度,稳定性也较好,可以用于红霉素的质量控制。

琥乙红霉素缓释片释放度研究

目的建立琥乙红霉素缓释片体外释放研究分析的硫酸显色法。方法以900 mL经脱气处理的0.1 mol/L盐酸溶液为释放介质,转速为75 r/min,75%的硫酸溶液为显色剂,采用紫外-可见分光光度法于482 nm波长处对琥乙红霉素缓释片的释放度进行测定。结果琥乙红霉素显色后质量浓度在40～72μg/mL范围内与吸收度呈良好线性关系(r=0.999 9);平均回收率为99.75%,RSD为0.76%;12 h内3批样品的释放量均在标示量的90%以上。结论该方法操作简便、准确可靠,可用于琥乙红霉素缓释片释放度的测定,为质量标准的制订提供了依据。