HPLC法测定克拉霉素胶囊的溶出度

目的建立高效液相色谱法测定克拉霉素胶囊的溶出度。方法照《中国药典》2005年版(二部)溶出度测定第二法,以醋酸盐缓冲液(pH5.0)900 mL为溶出介质,转速为50 r.min-1,30 min时取样。以高效液相色谱法,采用C18色谱柱(300 mm×3.9 mm,10μm)为固定相,以甲醇-0.067 mol.L-1磷酸二氢钾缓冲溶液(650∶350)(用磷酸调节pH值至4.0)为流动相;检测波长为210 nm,流速为1.5 mL·min-1,柱温为50℃。结果克拉霉素胶囊的线性范围为1.049 1~3.955 6μg(r=0.999 9);克拉霉素胶囊平均回收率为99.6%(RSD=0.38%,n=12)。结论该方法简便,快速,准确,可用于其质量控制。     

HPLC法测定阿奇霉素胶囊的含量

目的建立阿奇霉素胶囊含量的HPLC法。方法采用Shim-pack VP-ODS(4.6 mm×150 mm,5 nm)(岛津柱),流动相为0.067 mol.L-1磷酸二氢铵溶液(三乙胺调pH至6.5)-乙腈(74∶26),检测波长200 nm,流速1 ml.min-1,柱温30℃。结果阿奇霉素在0.76~3.82 g.L-1范围内线性关系良好,r=0.999 9,方法的回收率为100.2%(n=3)。结论本法简便、准确、重现性好,结果可靠,可用于阿奇霉素的含量测定。     

HPLC法测定艾司奥美拉唑钠中3个潜在基因毒性杂质的研究及控制

目的:建立HPLC法测定艾司奥美拉唑钠中潜在基因毒性杂质E、杂质I、2-氯甲基-3,5二甲基-4-甲氧基吡啶。方法:杂质E色谱条件：YMC-Triart C₁₈色谱柱(250 mm×4.6 mm, 5μm),流动相A为0.05 mol·L^-1磷酸二氢钾缓冲液,流动相B为乙腈,梯度洗脱,流速为1.0 mL·min^-1,检测波长为302 nm,柱温为30℃;杂质I色谱条件：Agilent Microspher C₁₈色谱柱(100 mm×4.6 mm, 3μm),流动相A为水-磷酸盐缓冲液(pH 7.6)-乙腈(80∶10∶10),流动相B为乙腈-磷酸盐缓冲液(pH 7.6)-水(80∶1∶19),梯度洗脱,流速为1.0 mL·min^-1,检测波长为302 nm,柱温为30℃;2-氯甲基-3,5二甲基-4-甲氧基吡啶色谱条件：GL Inertsil ODS-3色谱柱(250 mm×4.6 mm, 5μm),流动相A为0.01 mol·L^-1磷酸氢二钠溶液(pH...     

反相高效液相色谱法测定雷美替胺的含量及有关物质

目的建立反相高效液相色谱法测定雷美替胺的含量及有关物质。方法采用Diamond ODSC18色谱柱(250 mm×4.6 mm,5μm),含量测定以0.1 mol·L-1磷酸二氢钾(稀磷酸调pH值至3.0)-乙腈(体积比为70∶30)为流动相,流速为1.0 mL·min-1,检测波长为288 nm,柱温为30℃。有关物质测定采用Diamond ODS-C18色谱柱(250 mm×4.6 mm,5μm),以0.1 mol·L-1磷酸二氢钾缓冲液(稀磷酸调pH值至3.0)-乙腈(体积比为80∶20)(A)、0.1 mol·L-1磷酸二氢钾缓冲液(稀磷酸调pH值至3.0)-乙腈(体积比为60∶40)(B)为流动相进行梯度洗脱,流速为1.0 mL·min-1,检测波长为217 nm,柱温为30℃。结果雷美替胺与相关杂质及其降解产物均分离良好。雷美替胺在4.13³1.00 mg·L-1内具有良好的线性关系(Y=1.281×104x+5.605×103,R2=0.999 3),检测限为1.6 ng,定量限为4.8 ng。结论本法可用于雷美替胺的含量测定及有关物质检查。     

HPLC测定注射用呋布西林钠的含量及有关物质

目的 建立注射用呋布西林钠的含量及有关物质的HPLC测定方法.方法 采用C18柱;以磷酸盐缓冲液(0.1 mol·L-1磷酸二氢钾溶液,用磷酸调pH 3.5)∶乙腈(80∶20)为流动相A;以磷酸盐缓冲液(0.1 mol·L-1磷酸二氢钾溶液,用磷酸调pH 3.5)∶乙腈(75∶25)为流动相B,含量测定以流动相B等度洗脱,有关物质采用线性梯度洗脱;流速1.0 mL·min-1;检测波长为225 nm.结果 呋布西林钠的线性范围为0.022 56～0.902 4 mg·mL-1,r为0.999 9,平均加样回收率为100.1%,RSD为0.65%(n=9).结论 方法简便、准确、灵敏度高,可同时用于产品的产量控制及有关物质检查.     

RP-HPLC法测定乌拉地尔缓释胶囊的含量

目的建立RP-HPLC法测定乌拉地尔缓释胶囊中乌拉地尔的含量。方法色谱柱:DiamonsilC18柱(4.6 mm×200.0 mm,5μm),流动相:甲醇-乙腈-0.13 mol.L-1磷酸二氢钠缓冲液(用磷酸调pH值6.0)(体积比为55∶20∶45),检测波长:268 nm,柱温:35℃,流速:1.0 mL.min-1,以外标法计算乌拉地尔缓释胶囊的含量。结果乌拉地尔线性为2~20 mg.L-1,r=0.999 8,平均回收率为99.7%,RSD为1.6%(n=5)。结论辅料不干扰主药测定,可用于乌拉地尔缓释胶囊的质量控制。     

HPLC法测定克拉霉素胶囊的含量

目的:建立HPLC法测定克拉霉素胶囊的含量.方法:用ODS柱,以0.067 mol·L-1磷酸二氢钾溶液(8 mol·L-1氢氧化钾调pH6.5)-乙腈(60:40)为流动相,检测波长215 nm,流速1.0ml·min-1.结果:进样量在5～25μg范围内与峰面积呈良好的线性关系(r=0.999 8),平均回收率=100.51%,RSD=1.56%(n=6).结论:本法测定克拉霉素胶囊含量专属性强,重现性好,测定准确快速.     

高效液相色谱法测定阿奇霉素胶囊含量

目的建立高效液相色谱法测定阿奇霉素胶囊含量。方法色谱柱为Hypersil ODS2(4.6×250 mm);流动相为0.067 mol.L-1磷酸二氢钾溶液(用磷酸调pH为3.5)-乙腈(70∶30);流速为1.0 ml.min-1;柱温:50℃;检测波长:210 nm。结果阿奇霉素在进样量2.5~50μg的范围内与峰面积呈良好线性关系(r=0.9999),平均回收率为100.38%,RSD为0.91%。结论本法简便快捷,结果准确,重现性好,可用于阿奇霉素胶囊的含量测定。     

阿奇霉素滴眼液有关物质检查方法的研究

目的建立高效液相色谱法测定阿奇霉素有关物质的方法。方法采用硅胶表面经杂化处理的十八烷基硅烷键合硅胶色谱柱Capcell pak MGⅡ(4.6 mm×150 mm,5μm),柱温30℃,以乙腈-磷酸盐缓冲液(0.05 mol.L-1磷酸氢二钾溶液,用20%磷酸调节pH至8.2)(58∶42)为流动相,流速为1.0 mL.min-1,检测波长为210nm。结果阿奇霉素的检测限及定量限分别为300、750 ng.mL-1;阿奇霉素与杂质峰及各杂质峰之间能够有效分离;阿奇霉素在60.2～180.6μg.mL-1范围内线性良好;供试品溶液在8 h内稳定性良好。结论本方法科学、简单、准确,适用于阿奇霉素滴眼液的有关物质检查。     

HPLC法测定盐酸溴己新注射液的含量

目的建立高效液相色谱法测定盐酸溴己新注射液的含量。方法色谱柱:Apollo C18柱(4.6mm×250mm,5μm),柱温:30℃;流动相:乙腈-0.05mol.L-1磷酸盐缓冲液(磷酸调节pH=3.0)(40∶60),流速:1.0mL.min-1,检测波长为249nm。结果盐酸溴己新在2.264~45.28μg.mL-1浓度范围内线性良好(r=0.9999,n=5),平均回收率为100.4%(RSD=0.15%,n=6)。结论本法快速、简便、准确,重复性好。     

胃平片联合奥美拉唑胶囊治疗胃溃疡疗效观察

目的观察胃平片联合奥美拉唑胶囊在治疗胃溃疡中的疗效。方法 230例胃溃疡患者随机分为2组,治疗组120例,给予胃平片(每次3片,tid.)联合奥美拉唑胶囊(20 mg,qd.)治疗;对照组110例,给予奥美拉唑胶囊(20 mg,qd.)治疗;2组幽门螺杆菌阳性患者同时增加阿莫西林胶囊(1.0 g,b id.),克拉霉素片(0.25 g,b id.),治疗;疗程8 w。结果治疗组治愈率82.5%,总有效率95.0%,幽门螺杆菌阴转率85.4%,1 y复发率6.7%;对照组分别为61.8%、85.5%、80.5%、15.7%;2组比较差异有统计学意义(P<0.05)。结论胃平片联合奥美拉唑胶囊治疗胃溃疡,可有效减轻胃黏膜损伤,提高治疗质量,降低复发率。     

Metronidazole-based quadruple versus standard triple therapy: which is better as first-line therapy for Helicobacter pylori eradication?

The eradication rate of 7-day standard triple therapy for Helicobacter pylori eradication (a proton pump inhibitor combined with amoxicillin and clarithromycin) has decreased as a consequence of the increase in the resistance rates to clarithromycin. The authors of the article under evaluation conducted a multicenter, randomized, noninferiority, Phase III trial in Europe to compare the efficacy and safety of a 10-day treatment with omeprazole plus a single capsule containing bismuth subcitrate potassium, metronidazole and tetracycline (quadruple therapy) versus a 7-day treatment with omeprazole, amoxicillin and clarithromycin (standard triple therapy) in adults, and demonstrated that the quadruple therapy yielded superior H. pylori eradication rates compared with the standard triple therapy. The results suggest that quadruple therapy merits consideration as first-line eradication therapy for H. pylori in regions with high resistance rates to clarithromycin. However, several issues need to be considered, such as the optimal doses of bismuth and amoxicillin, as well as the treatment duration, before quadruple therapy can be established as the standard first-line therapy for H. pylori eradication.     

四种治疗方案对儿童幽门螺杆菌感染的临床疗效观察

目的观察4种治疗方案对根除儿童幽门螺杆菌感染(Helicobacter Pylori,H.pylori)的疗效。方法200例H.pylori感染患儿随机分到4组,疗程均为14 d。A组(52例):奥美拉唑、阿莫西林联合克拉霉素混悬液;B组(51例):奥美拉唑、阿莫西林联合甲硝唑;C组(45例):奥美拉唑、甲硝唑联合克拉霉素混悬液;D组(52例):奥美拉唑、阿莫西林、克拉霉素混悬液联合枸橼酸铋剂。结果四组治疗方案对H.pylori感染根除率的差异有统计学意义(P<0.05)。A组和D组的根除率均大于90%。结论这些方案均有较高的根除率(≥80%),青霉素过敏患儿推荐C方案,奥美拉唑、阿莫西林联合克拉霉素混悬液组为最佳儿童H.pylori感染根除疗法。     

奥美拉唑联合克拉霉素治疗十二指肠溃疡疗效分析

目的探讨奥美拉唑联合克拉霉素治疗十二指肠溃疡临床疗效。方法将笔者所在医院135例经纤维胃镜检查确诊的十二指肠溃疡患者,随机分成观察组与对照组,观察组70例患者采用奥美拉唑与克拉霉素联合用药治疗,对照组采用单纯奥美拉唑进行治疗,对临床疗效进行比较分析。结果观察组患者的总有效率明显优于对照组,差异有统计学意义(P<0.05);观察组患者出现轻微头晕现象4例(5.71%),对照组患者出现轻微头晕现象5例(7.69%),差异无统计学意义(P>0.05);观察组患者愈合时间、复发率明显优于对照组,差异均有统计学意义(P<0.05)。结论奥美拉唑联合克拉霉素用药治疗十二指肠溃疡可有效改善临床症状、促进溃疡愈合时间、降低复发率的发生,且疗程短、总有效率及痊愈率高、不良反应小,值得临床广泛推广、应用。     

Pharmacokinetic interactions between omeprazole/pantoprazole and clarithromycin in health volunteers.

The association omeprazole/clarithromycin is of current wide use in the treatment of Helicobacter pylori associated gastroduodenal ulcer. This combination may result in increased levels of omeprazole with potential interactions with commonly associated drugs. Kinetic/metabolic changes occurring after omeprazole/clarithromycin were compared to those occurring after pantoprazole/clarithromycin in healthy volunteers. Eight healthy volunteers, all males, age 25-34 years, all EM for CYP2C19, participated in a randomized, double blind crossover study in two periods of 7 days, separated by a 14-day washout. In each treatment period, subjects took either omeprazole 20mg b.i.d. together with clarithromycin 500 mg b.i.d., or pantoprazole 40 mg b.i.d. with the same dose of the antibiotic. The pharmacokinetic parameters of omeprazole and pantoprazole were compared to those after intake of both agents alone. Kinetics of unchanged clarithromycin was evaluated at the end of the two periods. The mean value of the area under the plasma concentration versus time curve (AUC) of unchanged omeprazole increased almost two-fold after concomitant administration of clarithromycin; the average 5-OH-omeprazole AUC was instead significantly reduced by 42%. Omeprazole clearance and volume of distribution were reduced significantly by 75 and 56%, respectively, after administration of the drug with clarithromicyn. No significant changes of the kinetic of pantoprazole and metabolites were observed. Kinetics of clarithromycin did not differ after the two associated treatments. The administration of clarithromycin with two different proton pump inhibitors indicates that the antibiotic can markedly increase omeprazole, not pantoprazole, levels. This observation may result in a better therapeutic response to omeprazole, but it may also potentially affect either the metabolism of CYP3A4 substrates or interfere with the absorption of drugs requiring an intact gastric digestion system.     

舒胃愈胆胶囊联合奥美拉唑治疗慢性浅表性胃炎肝胃不和证的疗效观察

目的 观察舒胃愈胆胶囊联合奥美拉唑治疗慢性浅表性胃炎肝胃不和证的临床疗效。方法 102例慢性浅表性胃炎肝胃不和证患者随机分为治疗组和对照组,每组51例。治疗组给予舒胃愈胆胶囊合奥美拉唑治疗,对照组给予奥美拉唑,对照组中幽门螺杆菌感染者加服阿莫西林胶囊及克拉霉素胶囊,治疗组中幽门螺杆菌感染者不予加服其他药物。治疗组和对照组均服用2周为1个疗程。结果 治疗组有效率为94.12%;对照组有效率为78.43%,2组疗效差异有统计学意义（P<0.05）。2组患者治疗前后症状积分比较,差异有统计学意义（P<0.05）。治疗组血清前列腺素E2、人生长抑素、表皮生长因子与对照组比较,差异有统计学意义（P<0.05）。结论 舒胃愈胆胶囊联合奥美拉唑治疗慢性浅表性胃炎肝胃不和证疗效显著,值得临床推广应用。     

A randomized prospective comparison of clarithromycin versus amoxycillin in combination with omeprazole for eradication of Helicobacter pylori

Aim: To compare H. pylori eradication rates using omeprazole in conjunction with either amoxycillin or clarithromycin. Background: Omeprazole with amoxycillin is the most widely used dual therapy regimen for eradication of H. pylori. A recent open study suggested a high eradication rate combining omeprazole with the newer macrolide, clarithromycin. Methods: A randomized prospective trial in 54 patients was conducted to compare 2 weeks of treatment with omeprazole 40 mg once daily and either amoxycillin 500 mg three times daily or clarithromycin 500 mg three times daily. H. pylori eradication was assessed using the ¹³C urea breath test. Results: Eradication was achieved in 18/26 (69.2%) of subjects treated with omeprazole and amoxycillin and 18/25 (72.0%) of those treated with omeprazole and clarithromycin (P= N.S.). Minor side effects, most commonly altered taste, were reported by 16% of patients and were more frequent in those randomized to clarithromycin (P= 0.01). Conclusions: These regimens are similarly effective. However, clarithromycin is more expensive, associated with a greater frequency of side effects and, unlike amoxycillin, resistance by H. pylori has been reported. This suggests that clarithromycin may be a useful alternative when there is penicillin allergy or previous treatment failure, but it should not replace amoxycillin as first choice in omeprazole-based dual therapy.     

Randomized study comparing omeprazole plus amoxycillin versus omeprazole plus clarithromycin for eradication of Helicobacter pylori

Background : Dual therapy with omeprazole plus amoxycillin or with omeprazole plus clarithromycin has been proposed for eradication of Helicobacter pylori . The main problem is the great variability in the rate of eradication.
Methods : A group of 287 consecutive patients with active peptic ulcers and H. pylori infections were admitted to a prospective, randomized, multicentre study, to be given omeprazole 20 mg b.d. plus either amoxycillin 1 g b.d. or clarithromycin 500 mg t.d.s. for 2 weeks. Cure was defined as the absence of H. pylori infection, 4–6 weeks after completing anti-microbial therapy, assessed by urease activity and histology of antral and body gastric biopsies.
Results : The bacteria were eradicated in 68/143 patients (48%) treated with amoxycillin and omeprazole and 70/144 patients (49%) treated with clarithromycin and omeprazole (intention-to-treat analysis). The ulcers were healed in 118/127 patients (93%) treated with amoxycillin and in 115/123 (94%) of those treated with clarithromycin. Undesirable effects were rare with both treatments.
Conclusions : Combined treatment with omeprazole plus either amoxycillin or clarithromycin produced a high percentage of short-term healing of ulcers and was well tolerated, but is not useful as first-line anti- Helicobacter pylori treatment.     

雷尼替丁枸橼酸铋联合克拉霉素根除幽门螺杆菌疗效观察

目的 比较雷尼替丁枸橼酸铋联合克拉霉素与奥美拉唑、甲硝唑、克拉霉素两种疗法对幽门螺杆菌（Hp）的根除效果。方法 123例Hp阳性的消化性溃疡患者分为2组：A组62例，以雷尼替丁枸橼酸铋1片（含：雷尼替丁100mg，枸橼酸铋钾110mg）、克拉霉素250mg口服，2次／d，疗程7d；B组61例，以奥美拉唑20mg、克拉霉素250mg加甲硝唑400mg口服，2次／d，疗程7d。结果 A、B两组的Hp根除率分别为86．9％和85．2％，活动期溃疡愈合率分别为97．6％和100％，副反应发生率分别为6．6％和8．2％，两组间Hp根除率、活动期溃疡愈合率和副反应发生率差异均无显著性（均P〉0．05）。结论 雷尼替丁枸橼酸铋联合克拉霉素与奥美拉唑、甲硝唑、克拉霉素两种疗法疗效相当，而雷尼替丁枸橼酸铋联合克拉霉素因价廉、安全在临床上更为实用。     

抗幽门螺杆菌药物与质子泵抑制剂治疗消化性溃疡的成本-效果分析

目的:比较3种联合疗法治疗消化溃疡的疗效和成本。方法:将89例患者随机分为3组,A组:用奥美拉唑(奥克)200mg、克拉霉素250mg、甲硝唑200mg,b.i.d,连服7d后改为单用奥美拉唑(奥克)20mg,q.d,继续服用14d;B组:用奥美拉唑(洛赛克)20mg、克拉霉素250mg、甲硝唑200mg;b.i.d,连服7d后改为单用奥美拉唑(洛赛克)20mg,q.d,继续服用14d;C组:用雷贝拉唑10mg、克拉霉素250mg、甲硝唑200mg,b.i.d,连服7d后改为单用雷贝拉唑10mg,q.d,继续服用14d。结果:A、B、C组方案的成本-效果比(C/E)分别为1.87,4.29,2.52。结论:A组方案是A、B、C组方案中最经济、合理的方案。