Optimization of formulation and processing of Moringa oleifera and spirulina complex tablets

Objective: To prepare a more comprehensive nutrition, more balanced proportion of natural nutritional supplement tablets with Moringa oleifera leaves and spirulina the two nutrients which have complementary natural food ingredients. Method: On the basis of research M. oleifera leaves with spirulina nutrient composition was determined on M. oleifera leaves and spirulina ratio of raw materials, and the choice of microcrystalline cellulose, sodium salt of caboxy methyl cellulose(CMC),magnesium stearate excipient, through single factor and orthogonal experiment, selecting the best formula tablets prepared by powder direct compression technology, for preparation of M. oleifera and spirulina complex tablets. Results: The best ratio of raw material for the M. oleifera leaves powder: spirulina powder was 7:3, the best raw materials for the tablet formulation was 88.5%, 8.0% microcrystalline cellulose, CMC 2.0%, stearin magnesium 1.5%, the optimum parameters for the raw material crushing 200–300 mesh particle size, moisture content of 7%, tableting pressure 40 kN. Conclusion: Through formulation and process optimization, we can prepare more comprehensive and balanced nutrition M. oleifera and spirulina complex tablets, its sheet-shaped appearance, piece weight variation, hardness, friability, disintegration and other indicators have reached the appropriate quality requirements.     

醋酸曲普瑞林与醋酸甲地孕酮片治疗特发性中枢性早熟临床疗效比较

目的:对比醋酸曲普瑞林与醋酸甲地孕酮片治疗特发性中枢性早熟的临床效果。方法:选取我院自2014年2月~2015年2月期间收治的特发性中枢性早熟患儿92例,采取随机数字表法分为2组,其中46例患儿接受醋酸甲地孕酮片治疗(对照组),46例患儿接受醋酸曲普瑞林治疗(观察组),治疗6个月后,观察对比两组患儿的生长指标及性激素水平变化,并统计其不良反应发生情况。结果:观察组治疗后的体重、身高、生长速率、预测身高、骨龄/实际年龄(BA/CA)等生长指标优于对照组(P0.05);两组患者治疗后的雌激素(E2)、黄体生成素(LH)及促卵泡成熟素(FSH)水平较治疗前有明显改善(P0.05),且观察组治疗后的E2、LH、FSH水平优于对照组(P0.05);两组均未见明显不良反应发。结论:相比醋酸甲地孕酮片,醋酸曲普瑞林治疗特发性中枢性早熟患儿临床效果更好,可更好延缓患儿骨龄成熟,降低其性激素水平,在临床中具有良好的应用价值。     

Spectrofluorimetric determination of aliskiren in dosage forms and urine

A new, simple and sensitive spectrofluorimetric method has been developed for the determination of aliskiren (ALS) in dosage forms and human urine. The method is based on the reaction between ALS and fluorescamine in borate buffer solution, pH 9, to give a highly fluorescent derivative which is measured at 482 nm after excitation at 382 nm. The factors affecting the reaction were carefully studied. The fluorescence intensity concentration plots were rectilinear over the range 140–1400 ng/mL with a limit of detection 13.47 ng/mL and limit of quantitation 40.81 ng/mL. The developed method was successfully applied to the analysis of the drug in tablets and human urine; the average recoveries (n = 6) were 99.88 ± 0.38% and 99.57 ± 0.44%, respectively. The analytical performance of the method was fully validated and the results were satisfactory. The stability of the drug was studied by subjecting it to acidic, basic, oxidative and thermal degradation. Copyright © 2012 John Wiley & Sons, Ltd.     

桂龙咳喘宁片联合抗菌药物对肺癌化疗后肺部感染的控制效果

目的:探讨桂龙咳喘宁片联合抗菌药物对肺癌化疗后肺部感染的治疗效果,降低医院肺部感染发生率。方法:选择2013年8月~2015年8月在我院确诊并接受化疗治疗的120例肺癌伴有肺部感染的患者,随机分为对照组(n=60)和实验组(n=60)。对照组患者给予头孢唑肟治疗,实验组在此基础上口服桂龙咳喘宁片,两组患者均持续治疗两周。比较两组治疗前后炎症指标,并观察两组临床疗效、住院时间、退热时间、咳嗽咳痰明显减少时间、肺部啰音消失时间及肺部细菌清除率。结果:实验组总有效率为91.67%,明显高于对照组的73.33%,具有显著性差异(x~2=13.121;P=0.004)。治疗前,两组WBC、CRP及NEUT水平比较,差异无统计学意义(P0.05);治疗后,两组WBC、CRP及NEUT水平均明显低于治疗前(均P0.05),且实验组均明显低于对照组(P0.05)。治疗后实验组患者肺部细菌清除率为99.09%,明显高于对照组的86.94%(x~2=54.876,P=0.000)。结论:桂龙咳喘宁片联合抗菌药物能够有效控制肺癌化疗后肺部感染,改善患者临床症状及炎症反应,值得临床上推广使用。     

苯磺酸左旋氨氯地平片联合厄贝沙坦对老年难治性高血压的临床疗效

目的:探讨苯磺酸左旋氨氯地平片与厄贝沙坦的联合应用对老年难治性高血压患者临床疗效的影响及其可能机制。方法:选取我院确诊并治疗的老年难治性高血压患者72例作受试者,按随机数字表法分为两组,对照组36例予以利尿药联合厄贝沙坦进行血压调控,治疗组36例在对照组基础上予联合苯磺酸左旋氨氯地平片2.5 mg日一次进行治疗。观察两组患者的临床疗效,监控患者血压情况,比较治疗前后患者血清同型半胱氨酸(Hcy)、TNF-α及IL-6水平的变化。结果:对照组总有效率低于治疗组(P0.05);与对照组比较,治疗组患者血压控制情况较好,治疗后血清Hcy、TNF-α及IL-6水平降低,差异具有统计学意义(P0.05)。结论:苯磺酸左旋氨氯地平片与厄贝沙坦的联合应用可有效控制老年难治性高血压患者的血压、尽早恢复患者血压稳定,可能与其降低血清Hcy、TNF-α、IL-6的水平有关。     

双歧杆菌四联活菌片联合谷氨酰胺对酒精性肝硬化患者肠黏膜屏障功能的保护作用

目的探讨双歧杆菌四联活菌片联合谷氨酰胺对酒精性肝硬化患者肠黏膜屏障功能的保护作用。方法选择酒精性肝硬化患者90例,分为观察组和对照组。两组均常规予以对症支持治疗,观察组加用双歧杆菌四联活菌片联合谷氨酰胺治疗,对照组加用单纯双歧杆菌四联活菌片。其中双歧杆菌四联活菌片口服,1.5g/次,3次/d;谷氨酰胺颗粒口服,1.0g/次,3次/d,两组连用8周。观察并比较两组患者治疗前后肝功能指标:丙氨酸转氨酶(ALT)、天门冬氨酸转氨酶(AST)、血总胆红素(TB)和肠黏膜屏障功能指标(血浆二胺氧化酶、降钙素原和尿乳果糖/甘露醇比值)的变化。结果观察组与对照组治疗期间分别失访4例与7例,两组失访率比较差异无统计学意义(χ2=0.79,P0.05)。治疗8周后,两组ALT、AST和TB水平均较前明显下降(P0.05或P0.01),且观察组下降幅度明显高于对照组(P0.05)。同时两组血浆二胺氧化酶、降钙素原和尿乳果糖/甘露醇比值均较前明显下降(P0.05或P0.01),且观察组下降幅度明显高于对照组(P0.05)。结论双歧杆菌四联活菌片联合谷氨酰胺对酒精性肝硬化患者肠黏膜屏障功能的保护作用明显优于单纯的双歧杆菌四联活菌片,能加速肝功能恢复,加速肠黏膜通透性的修复,保护与改善肠黏膜屏障功能,具有辅助治疗酒精性肝硬化的作用。     

Application of liquid chromatographic method with fluorescence detection for the determination of triclabendazole in tablets and biological fluids

A simple and rapid liquid chromatographic method was developed and validated for the determination of triclabendazole with high accuracy and precision within 6 min. Good chromatographic separation was achieved using a CLC Shim‐pack C₈ (250 × 4.6 mm, 5 µm particle size) using the mobile phase containing a mixture of 0.02 m phosphate buffer and methanol with a ratio of (20 : 80 v/v) at pH 4.0 was pumped at a flow rate of 1.2 mL/min with fluorescence detection for the first time at 338 nm after excitation at 298 nm. Losartan potassium was used as an internal standard. The method showed good linearity in the ranges of 0.05–2.0 µg/mL with limits of detection and quantification of 14.1 and 42.6 ng/mL, respectively. The suggested method was successfully applied for the analysis of triclabendazole in tablets. The high sensitivity of the method enabled the determination of the studied drug in spiked human plasma with mean percentage of recoveries of 99.79 ± 5.09. Statistical evaluation of the data was performed according to ICH Guidelines. Copyright © 2013 John Wiley & Sons, Ltd.     

Spectrofluorimetric determination of amisulpride and bumidazone in raw materials and tablets

A highly sensitive, simple and rapid spectrofluorimetric method was developed for the determination of amisulpride (AMS) and bumidazone (BUM) in tablet form. The proposed method is based on measuring the native fluorescence of the studied drugs in methanol at 360 and 344 nm after excitation at 276 and 232 nm for AMS and BUM, respectively. The fluorescence–concentration plots were rectilinear over the ranges of 5.0–60.0 ng/mL for AMS and 0.5–5.0 µg/mL for BUM. The lower detection limits were 0.70 ng/mL and 0.06 µg/mL, and the lower quantification limits were 2.0 ng/mL and 0.18 µg/mL for AMS and BUM, respectively. The method was successfully applied for the analysis of AMS and BUM in commercial tablets. Statistical evaluation and comparison of the data obtained using the proposed and comparison methods revealed good accuracy and precision for the proposed method. Copyright © 2014 John Wiley & Sons, Ltd.     

双歧杆菌四联活菌片对急性胰腺炎患者血清内毒素和降钙素原水平的影响及疗效观察

目的探讨双歧杆菌四联活菌片对急性胰腺炎患者血清内毒素和降钙素原（PCT）水平的影响及疗效观察。方法将66例急性胰腺炎患者随机分为观察组和对照组。两组患者均予以禁食禁饮、持续胃肠减压、预防感染、抑酸、解痉镇痛、抑制胰酶分泌和纠正水电解质酸碱紊乱等常规治疗。观察组患者加用双歧杆菌四联活菌片1.5 g进行水化后自胃管灌注,夹管2 h,3次/d,对照组除不使用双歧杆菌四联活菌片外余治疗同观察组。观察两组患者治疗前后血清内毒素和PCT水平的变化,并比较其临床疗效。结果治疗7 d后,两组患者血清内毒素和PCT水平均有不同程度的下降（P〈0.05或P〈0.01）,且观察组下降值比对照组更明显（P〈0.05）;同时观察组临床总有效率为93.94%,明显高于对照组的75.76%（χ2=4.24,P〈0.05）。结论双歧杆菌四联活菌片辅助治疗急性胰腺炎具有较好疗效,能明显降低血清内毒素和PCT水平,减轻肠源性内毒素血症,对肠黏膜屏障功能具有良好的保护作用。     

双歧杆菌四联活菌片对肝硬化腹泻患者肠道sIgA水平和细胞免疫功能的影响及疗效观察

目的探讨双歧杆菌四联活菌片对肝硬化腹泻患者肠道sIgA水平和细胞免疫功能的影响及疗效观察。方法选择肝硬化腹泻患者90例,随机分为对照组和观察组。两组患者均予以低盐饮食、保肝利尿和纠正水电解质紊乱等治疗。观察组加用双歧杆菌四联活菌片1.5 g,3次/d,连用6周。观察两组患者治疗前后肠道sIgA水平和细胞免疫功能的变化,并比较其临床疗效。结果治疗6周后,两组患者肠道sIgA水平较前明显上升（P〈0.05或P〈0.01）,且观察组上升比对照组更明显（P〈0.05）;观察组CD4＋水平及CD4＋/CD8＋比值较前明显上升（P〈0.05）,CD8＋水平较前变化不明显（P〉0.05）,而对照组治疗前后CD4＋、CD8＋和CD4＋/CD8＋比值无明显改变（P〉0.05）;同时观察组患者的临床总有效率为93.33%,明显高于对照组的73.33%（χ2=6.48,P〈0.05）。结论双歧杆菌四联活菌片治疗肝硬化腹泻具有较好疗效,能提高肠道sIgA水平和纠正外周血T淋巴细胞亚群紊乱,从而增强肠道局部黏膜防御力和机体细胞免疫功能。