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.

氨糖美辛肠溶片中盐酸氨基葡萄糖有关物质研究

目的 建立测定氨糖美辛肠溶片中盐酸氨基葡萄糖有关物质的高效液相色谱法,并分析其影响因素。方法 色谱柱为纳谱ChromCore AQ C18柱(250 mm×4.6 mm,3μm),流动相为水-乙腈(梯度洗脱),流速为1.0 mL/min,检测波长为280 nm,柱温为30℃,进样量为20μL。采用加速稳定性试验和辅料相容性试验,结合生产工艺分析有关物质的影响因素。结果 已知杂质果糖嗪、2,5-脱氧果糖嗪、吡嗪、5-羟甲基糠醛、糠醛、2-甲基吡嗪、吡咯-2-甲醛、5-甲基糠醛质量浓度分别在0.20~3.30μg/mL、0.20~3.00μg/mL、0.25~7.54μg/mL、0.18~7.04μg/mL、0.25~10.10μg/mL、0.25~10.18μg/mL、0.25~10.17μg/mL、0.26~10.50μg/mL范围内与峰面积线性关系良好(R2≥0.999);检测限为0.3~5.0μg/mL,定量限为0.7~20.1μg/mL;精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率为98.24%~101.20%,RSD为0.33%~2.19%(n=9)。影响制剂有关物质产生的因素为工艺、温度和时间,影响有关物质含量增长速率的因素除工艺外,还有辅料(主要为羟甲基淀粉钠)和水分。结论 该方法简便、准确、专属性好,可用于氨糖美辛肠溶制剂中盐酸氨基葡萄糖有关物质的检测。建议优化工艺中干燥温度及时间,考察添加辅料的合理性,并控制片剂中的水分,进一步提高制剂质量的均一性和稳定性。

富血小板血浆联合氨糖美辛肠溶片治疗早中期膝骨关节炎患者的效果

目的:观察富血小板血浆(PRP)联合氨糖美辛肠溶片治疗早中期膝骨关节炎(KOA)患者的效果。方法:回顾性分析2022年1月至2023年1月该院收治的96例早中期KOA患者的临床资料,根据治疗方案不同将其分为对照组和研究组各48例。对照组予以氨糖美辛肠溶片治疗,研究组在对照组基础上联合PRP治疗。比较两组临床疗效,治疗前后关节功能[膝关节功能评分表(Lysholm)、骨关节炎指数量表(WOMAC)]评分、关节滑液炎性因子[白细胞介素-6(IL-6)、白细胞介素-1β(IL-1β)、肿瘤坏死因子-α(TNF-α)]水平、关节滑液基质代谢相关指标[基质金属蛋白酶-3(MMP-3)、基质金属蛋白酶-13(MMP-13)、透明质酸(HA)]水平、血清微小RNA-140(miR-140)和微小RNA-365(miR-365)水平。结果:研究组治疗总有效率为91.67%(44/48),高于对照组的72.92%(35/48),差异有统计学意义(P<0.05);治疗后,研究组Lysholm评分高于对照组,WOMAC评分低于对照组,差异均有统计学意义(P<0.05);治疗后,研究组关节滑液IL-6、IL-1β、TNF-α、MMP-3、MMP-13水平均低于对照组,HA水平高于对照组,差异有统计学意义(P<0.05);治疗后,研究组血清miR-140水平高于对照组,miR-365水平低于对照组,差异均有统计学意义(P<0.05)。结论:PRP联合氨糖美辛肠溶片治疗早中期KOA患者可提高治疗总有效率和miR-140水平,改善关节功能评分和关节滑液基质代谢相关指标水平,降低关节滑液炎性因子和miR-365水平,效果优于单纯氨糖美辛肠溶片治疗。

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.

吲哚美辛HP MCP肠溶片的制备及溶出度考察

以吲哚美辛为模型药物 ,采用本室新研制开发的肠溶材料羟丙甲纤维素邻苯二甲酸酯(HPMCP)包衣 ,制备了吲哚美辛肠溶片。通过考察吲哚美辛HPMCP包衣片的溶出度 ,并与吲哚美辛HP55(日本信越公司同类材料 )包衣片及 5种市售吲哚美辛肠溶片的溶出度进行比较来研究HPMCP包衣膜的性质。用相似因子法和chow’s法对溶出实验数据进行统计分析 ,结果表明HPMCP包衣片与HP55包衣片溶出行为完全相似 ,相似因子F2 =70 1 ( 5 0≤F2 ≤ 1 0 0 ) ,HPMCP包衣片片心药物溶出速率明显快于 5种市售片。

氨糖美辛的2种肠溶片在健康男性志愿者的药动学和生物等效性比较

目的:研究2种氨糖美辛肠溶片在人体的 药动学过程及其生物等效性。方法:吲哚美辛血药 浓度用高压液相色谱法检测,20名健康男性志愿者 随机分组、自身交叉口服300mg氨糖美辛肠溶片。 结果:试验制剂和参比制剂的主要药动学参数tmax: (3.5±s0.9)和(3.3±0.9)h;cmax:(5.9±2.0)和 (6.1±1.6)mg·L-1;t12ke:(7.6±2.0)和(7.5± 2.9)h;AUC0～24:(18±4)和(16±3)mg·L·h-1;AUC0～∞:(19±4)和(18±4)mg·L·h-1。相对生 物利用度F0～24,F0～∞分别为(109±14)%和(111± 17)%。结论:试验制剂和参比制剂生物等效。

吲哚美辛肠溶滴丸在比格犬体内的药动学研究

目的:对吲哚美辛(IDM)肠溶滴丸的药动学进行考察。方法:以比格犬为实验动物,以市售IDM肠溶片为对照,对同剂量IDM肠溶滴丸单剂量给药的药动学进行研究,用SPSS 21.0软件进行模型拟合及参数计算,并进行生物等效性评价。结果:IDM肠溶滴丸及肠溶片均符合一室模型,C_(max)、T_(max)、AUC_(0-∞)、Tlag等差异均有统计学意义(P<0.05),C_(max)及AUC_(0~∞)均显著升高,T_(max)及Tlag均显著缩短,肠溶滴丸的相对生物利用度为(121.0±7.7)%。结论:IDM肠溶滴丸相对于肠溶片而言,吸收显著增加,起效明显加快,值得进一步研发。

6厂家吲哚美辛肠溶片体外溶出试验比较

目的 :考察 6厂家吲哚美辛肠溶片的体外溶出度。方法 :采用转篮法进行体外溶出度试验 ,用紫外分光光度法检测溶出介质中药物浓度 ,计算累积释放量 ,以威布尔分布拟合溶出参数 ,并对溶出参数进行统计分析。结果 :6家药厂生产的吲哚美辛肠溶片在酸性介质 (0 .1mol/L的盐酸 )中的溶出度均符合规定 ,有一家药厂生产的吲哚美辛肠溶片在pH 6 .8的磷酸盐缓冲液中的溶出度不符合中国药典的要求。结论

地奥司明联合吲哚美辛三七冰片栓治疗混合痔术后肛门水肿

目的观察地奥司明片与吲哚美辛三七冰片栓联合治疗混合痔术后肛门水肿的疗效。方法将60例混合痔术后肛门水肿患者随机分为对照组(口服地奥司明片)和治疗组(口服地奥司明片联合吲哚美辛三七冰片栓纳肛),观察治疗后3、7、11、16天肛门水肿改善状况。结果用药第3天治疗组较对照组肛门水肿改善不明显,无统计学意义(P>0.05);用药第7、11、16天治疗组较对照组肛门水肿明显减轻,差异具有统计学意义(P<0.01)。结论地奥司明片联合吲哚美辛三七冰片栓治疗混合痔术后肛门水肿疗效较好,值得临床应用推广。

复方甘草酸苷片联合复方吲哚美辛酊治疗面部糖皮质激素依赖性皮炎疗效观察

目的:探讨应用复方甘草酸苷片联合复方吲哚美辛酊治疗面部糖皮质激素依赖性皮炎的临床疗效。方法:选取的100例均来自于河北省唐山市丰润区中医医院皮肤科门诊患者,随机分为治疗组和对照组。治疗组:口服复方甘草酸苷片,每次2片,每日3次。患处涂抹复方吲哚美辛酊,每日2次;对照组:采用0.9%氯化钠注射液湿敷,每日2次,湿敷后外用丁苯羟酸乳膏,每日2次。两组疗程均为2个月,随访6个月。结果:治疗组总有效率为96%,对照组总有效率为72%,两组总有效率比较,差异有统计学意义(P<0.05),治疗组疗效明显优于对照组。结论:复方甘草酸苷片联合复方吲哚美辛酊是治疗以红斑、丘疹、脓疱为主要表现的面部激素依赖皮炎安全、有效的方法,值得临床推广应用。

氨糖美辛肠溶片中吲哚美辛含量测定方法的比较研究

目的:比较氨糖美辛肠溶片中吲哚美辛3种含量测定方法的差异,对检测方法进行评价,选择一种最适宜的测定方法。方法:采用高效液相色谱法、紫外分光光度法及容量分析法对氨糖美辛肠溶片中吲哚美辛进行含量测定,对含量测定的结果、回收率、重复性以及各方法的优缺点进行比较和研究,并给出综合评价。结果:容量分析法作为现行标准的方法,回收率低,准确度差,质量控制水平低;高效液相色谱法测定结果准确,回收率高,重复性好;而紫外分光光度法操作简便,但重复性和专属性差于高效液相色谱法。结论:综合专属性、准确性等因素,高效液相色谱法优于其他两种方法,可用于氨糖美辛肠溶片的质量控制。

HPLC法测定吲哚美辛片剂的含量

建立吲哚美辛片剂HPLC含量测定方法。用KromasilTMC18色谱柱 (4 6mm× 2 5 0mm ,5 μm) ,以甲醇 -0 0 1mol·L- 1磷酸二氢钾溶液 (85∶15 ) (用磷酸调pH至 2 6 )为流动相 ,流速为 1 0ml·min- 1,检测波长为 32 0nm。吲哚美辛在 1 899～ 37 980 μg·ml- 1范围内呈良好的线性关系 ,r =0 9998,平均回收率为 10 0 0 7% ,RSD =0 39%(n =5 )。本法适用于吲哚美辛片剂的含量测定。

吲哚美辛肠溶片处方工艺对释放度的影响

通过对吲哚美辛肠溶片处方及工艺的改进 ,如添加适量乳糖和十二烷基硫酸钠及 PVP、控制原药细度、修改包衣工艺等措施 ,解决了原产品存在的释放度低及在贮存期间释放度下降的问题 ,使吲哚美辛肠溶片释放度增加 。

HPLC法测定吲哚美辛片含量及有关物质

目的建立吲哚美辛片含量及有关物质的测定方法。方法采用HPLC法,乙腈-0.1mol.L-1冰醋酸(55∶45)为流动相;流速为1.0mL.mi-n1;检测波长为228nm。结果在该色谱条件下,吲哚美辛与有关物质分离良好;吲哚美辛在20.192～504.800μg.mL-1范围内呈良好的线性关系(r=1.0000);平均回收率为99.96%,RSD=1.26%(n=6)。结论该方法简便、重复性好,可用于本品的含量测定及有关物质检查。

HPLC法测定吲哚美辛肠溶片含量

目的:采用HPLC法测定吲哚美辛肠溶片含量。方法:色谱柱:C18柱(岛津VP-ODS,150mm×4.6mm,5μm);流动相:0.1mol·L^(-1)冰醋酸溶液-乙腈(50:50);流速1ml·min^(-1);检测波长228nm。结果:吲哚美辛在5～500μg·ml^(-1)浓度范围内呈良好的线性关系(r=0.999 9),平均回收率为99.7%,RSD为0.1%(n=6)。结论:本方法简便快速,重现性好,结果准确可靠。

双波长高效液相色谱法同时测定肠溶片中氨基葡萄糖和吲哚美辛的含量及含量均匀度

目的建立氨糖美辛肠溶片中盐酸氨基葡萄糖和吲哚美辛的含量及含量均匀度的测定方法。方法采用高效液相色谱法,乙腈-磷酸盐缓冲液(取3.5 g磷酸氢二钾和0.25 mL氢氧化铵,加水至1 000 mL,用磷酸调节pH至7.5)(70∶30)为流动相;流速为1.0 mL/min;检测波长为195 nm和254 nm。结果盐酸氨基葡萄糖在98.10～1 962.00 mg/L范围内呈良好的线性关系,r=0.999 9,平均回收率为99.15%,相对标准偏差(RSD):0.97%(n=9);吲哚美辛在32.86～657.20 mg/L范围内呈良好的线性关系,r=0.999 8,平均回收率为99.28%,RSD:0.66%(n=9)。结论该方法简便、准确、重复性好,能同时测定氨糖美辛肠溶片中双组分盐酸氨基葡萄糖和吲哚美辛的含量及含量均匀度。

改进HPLC法测定吲哚美辛肠溶片中的有关物质

目的：改进高效液相色谱法测定吲哚美辛肠溶片中2-甲基-5-甲氧基-1H-吲哚-3-乙酸（以下简称杂质I）和4．氯苯甲酸（以下简称杂质Ⅱ）的含量。方法：色谱柱为PhenomenexPhenyl．Hexyl，流动相为10g／L醋酸溶液．乙腈（梯度洗脱），流速为1．0ml/min，检测波长为254nm，柱温为40℃，进样量为20μl。结果：杂质Ⅰ和杂质Ⅱ的检测质量浓度线性范围分别为0.2622～5．2430、0．2525～5．0500μg／ml（r均为0．9998）；定量限分别为1．12、0．48ng，检测限分别为0.340、0．146ng；精密度、稳定性、重复性试验的RSD〈2％；杂质Ⅰ和杂质Ⅱ的加样回收率分别为99．71％～100．52％（RSD：0．28％。n=9）、100．84％～102．14％（RSD=0．47％，n=9）。结论：该方法准确、快速，可用于吲哚美辛肠溶片中杂质Ⅰ和杂质Ⅱ的含量测定。

高效液相色谱法测定新癀片中吲哚美辛的含量

目的 建立 HPL C法测定新癀片中吲哚美辛的含量。方法 色谱柱 C1 8柱 ( 4 .0 mm× 2 5 0 mm,5 μm) ,流动相 :0 .1mol·m L- 1醋酸钠 (用冰醋酸调 p H5 .0 ) -甲醇 ( 3 0∶ 70 ) ,检测波长 :2 5 4nm,流速 :0 .8ml· min- 1 ,柱温 :室温 ,进样量 :10μL。 结果 吲哚美辛在 160～ 480μg· m L- 1浓度范围内线性关系良好 ( r=0 .9999) ,平均回收率为 10 0 .5 % ,RSD为 0 .8%。 结论 本法简便快速 ,准确可靠。