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。     

Derivative emission spectrofluorimetry for the simultaneous determination of guaifenesin and phenylephrine hydrochloride in pharmaceutical tablets

Rapid, simple and sensitive derivative emission spectrofluorimetric methods have been developed for the simultaneous analysis of binary mixtures of guaifenesin (GUA) and phenylephrine hydrochloride (PHE). The methods are based upon measurement of the native fluorescence intensity of the two drugs at λ_ex = 275 nm in methanolic solutions, followed by differentiation using first (D1) and second (D2) derivative techniques. The derivative fluorescence intensity–concentration plots were rectilinear over a range of 0.1–2 µg/mL for both GUA and PHE. The limits of detection were 0.027 (D1, GUA), 0.025 (D2, GUA), 0.031 (D1, PHE) and 0.033 (D2, PHE) µg/mL and limits of quantitation were 0.089 (D1, GUA), 0.083 (D2, GUA), 0.095 (D1, PHE) and 0.097 (D2, PHE) µg/mL. The proposed derivative emission spectrofluorimetric methods (D1 and D2) were successfully applied for the determination of the two compounds in binary mixtures and tablets with high precision and accuracy. The proposed methods were fully validated as per ICH guidelines. Copyright © 2014 John Wiley & Sons, Ltd.     

双歧三联活菌胶囊联合莫沙必利片对便秘型肠易激综合征患者血清胃肠激素水平的影响及疗效观察

目的探讨双歧三联活菌胶囊联合莫沙必利片对便秘型肠易激综合征(IBS-C)患者血清胃肠激素水平的影响及疗效。方法将内科门诊治疗的IBS-C患者72例随机分为联合组(n=36例)和对照组(n=36例)。联合组患者予以双歧三联活菌胶囊(420 mg/次,3次/d,温开水口服)联合莫沙必利片(5 mg/次,3次/d,饭前半小时服用)治疗8周,对照组患者予以单纯的莫沙必利片治疗,剂量、方法与疗程均同联合组。观察并记录两组患者治疗前后血清血管活性肠肽(VIP)和一氧化氮(NO)水平的变化,并评估其临床效果及药物不良反应。结果治疗8周后,两组患者血清VIP和NO水平较前均有不同程度下降(P0.05或P0.01),且联合组下降幅度较对照组更明显(P0.05);联合组患者临床总有效率明显优于对照组(X~2=4.18,P0.05);两组患者治疗中共出现不良反应8例,其中对照组5例,联合组3例,症状较轻,两组不良反应比较差异无统计学意义(X~2=0.14,P0.05)。结论双歧三联活菌胶囊联合莫沙必利片治疗IBS-C患者的疗效较显著,两者具有协同增效作用,能明显改善患者便秘症状,其安全性较佳,作用机制可能与其能降低血清VIP和NO水平,纠正血清胃肠激素水平异常,从而改善其胃肠道动力功能密切相关。     

双歧杆菌活菌制剂治疗小儿秋季腹泻50例疗效观察

目的观察丽珠肠乐胶囊同乳酸菌素片治疗小儿秋季腹泻的临床疗效.方法治疗组服用丽珠肠乐胶囊1粒,每日2次,疗程6 d;对照组服用乳酸菌素片1片,每日2次,疗程6 d.结果治疗组与对照组临床总有效率分别为98%和55.6%, χ2=22.38,P＜0.01,差异有高度显著性.结论丽珠肠乐胶囊治疗小儿秋季腹泻比乳酸菌素片更有效.     

高效液相色谱法测定比卡鲁胺片的含量

目的:建立高效液相色谱法测定比卡鲁胺片含量和含量均匀度的方法。方法:采用SHIMADZUCLC-ODS(150mm×6.0mm,5μ)色谱柱,以0.1%磷酸二氢钾溶液-乙腈(50:50)为流动相,272nm波长处检测。结果:比卡鲁胺在0.05mg·ml-1～0.20mg.ml-1浓度范围内线性关系良好(r=0.9995),平均回收率为99.5%,RSD=0.9%(n=9)。结论:本方法简便、准确度好、精确度高。     

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。