紫外分光光度法测定尼美舒利栓的含量

目的 :建立用紫外分光光度法测定尼美舒利栓中尼美舒利的含量。方法 :用不同的有机溶剂萃取尼美舒利栓中的基质 ,用紫外分光光度法测定尼美舒利的含量。结果 :用正己烷作为萃取剂。用紫外分光光度法测定尼美舒利栓的含量 ,标准曲线线性好尼美舒利线性范围为 3～ 15 μg·ml-1(r =0 .9999)、回收率较好 (98.3% )。结论 :用紫外分光光度法测定尼美舒利栓剂的含量 ,方法简便、快速、结果准确 ,可作为尼美舒利含量测定的方法。     

尼美舒利透明质酸凝胶的制备及质量控制

目的：研究尼美舒利透明质酸凝胶的制备及质量控制。方法：采用卡波姆等为基质制成凝胶剂，用紫外分光光度法测定凝胶中尼美舒利的含量，检测波长296nm。结果：含量测定平均回收率为99．8％，RSD为1．1%(n=5)。结论：该制剂处方合理，制备工艺简便，稳定性好，质量易于控制。     

紫外分光光度法测定尼美舒利片的含量

采用紫外分光光度法测定尼美舒利片的含量,以0.05mol/L的氢氧化钠溶液为溶剂,测定波长为393nm.回收率为99.4%,RSD为0.78%,操作简便,结果准确.     

尼美舒利片溶出度测定方法的研究

目的:建立尼美舒利片溶出度测定方法.方法:以pH8.80磷酸盐缓冲液为溶出介质,采用桨法进行溶出度测定,转速:75 r·min-1,用紫外分光光度法在393 nm波长处测定.结果:尼美舒利在2～30 mg·L-1线性关系良好(r=1.00).结论:测定方法简便、准确度高、可用于尼美舒利片溶出度质量控制.     

紫外分光光度法测定尼美舒利片的含量

采用紫外分光光度法测定尼美舒利片的含量,以0.05mol/L的氢氧化钠溶液为溶剂,测定波长为393nm.回收率为99.4%,RSD为0.78%,操作简便,结果准确.     

尼美舒利颗粒溶出度测定方法研究

目的研究尼美舒利颗粒溶出度。方法以磷酸盐缓冲液(pH=8.8)为溶出介质,采用篮法进行溶出度测定,转速:100 r.min-1,用紫外分光光度法在393 nm波长处测定。结果绘制的溶出曲线表明20 min内尼美舒利颗粒可溶出80%以上,确定的溶出时间30 min,限度为80%。结论测定6批样品的溶出量均符合规定。     

反相高效液相色谱法测定尼美舒利分散片的含量

目的建立测定尼美舒利分散片含量的反相高效液相色谱法。方法采用LBondapak C18色谱柱(300 mm×4.0 mm,5μm),乙腈-水(45∶55)为流动相,柱温为25℃,检测波长为254 nm,流速为1.0 mL/min。结果尼美舒利质量浓度在40～200μg/mL范围内与峰面积线性关系良好(r=0.9999),平均回收率为99.60%,RSD为0.47%(n=6)。结论该方法简便、快速、准确、灵敏度高、重复性好,可用于尼美舒利分散片含量的测定。     

尼美舒利片溶出度测定方法的研究

目的 建立尼美舒利片的溶出度测定方法。方法 以pH8.80±0.05为溶出介质,采用浆法进行溶出度测定,转速为60 r／ min,温度为(37±0.5)℃,进行累积溶出百分率测定,用紫外分光光度法在392 nm的波长处测定。结果 该方法线性关系良好, 回归方程为:C=22.2239A-0.1124 r=0.9999。结论 测定方法简便,结果准确可靠,可适用于该制剂的溶出度质量控制。     

尼美舒利片溶出度测定方法的研究

目的建立尼美舒利片的溶出度测定方法.方法以pH8.80±0.05为溶出介质,采用浆法进行溶出度测定,转速为60 r/min,温度为(37±0.5) ℃,进行累积溶出百分率测定,用紫外分光光度法在392 nm的波长处测定.结果该方法线性关系良好,回归方程为: C=22.2239A-0.1124 r=0.9999.结论测定方法简便,结果准确可靠,可适用于该制剂的溶出度质量控制.     

尼美舒利干混悬剂含量测定方法研究

目的建立尼美舒利干混悬剂含量测定方法。方法色谱柱为迪玛C18柱(250mm×4.6mm,5μm);流动相为0.1%的磷酸溶液(用氨水调节pH值至7.0)-乙腈(60∶40);检测波长为298nm;流速1mL/min;柱温30℃;进样量20μL。结果尼美舒利在0.856～85.60μg/mL质量浓度范围内线型关系良好,r=0.9999(n=7),平均回收率为100.3%,RSD为0.54%。结论方法操作简便,结果准确,可用于尼美舒利干混悬剂的含量测定。     

High-performance liquid chromatography analysis of anti-inflammatory pharmaceuticals with ultraviolet and electrospray-mass spectrometry detection in suspected counterfeit homeopathic medicinal products

A simple high-performance liquid chromatography (HPLC) method with both ultraviolet (UV) and electrospray ionisation mass spectrometry (ESI-MS) detection has been developed for the determination of seven pharmaceuticals in counterfeit homeopathic preparations. Naproxen, Ketoprofen, Ibuprofen, Diclofenac, Piroxicam, Nimesulide and Paracetamol were separated by reversed phase chromatography with acetonitrile-water (0.1% acetic acid) mobile phase, and detected by UV at 245 nm and by ESI-MS in negative ionisation mode with the exception of Paracetamol which was detected in positive ionisation mode. Benzoic acid was used as internal standard (IS). This method was successfully applied to the analysis of homeopathic preparations like mother tinctures, solutions, tablets, granules, creams, and suppositories. Linearity was studied with UV detection in the 50-400 microg mL(-1) range and with ESI-MS in the 0.1-50 microg mL(-1) range. Good correlation coefficients were found in both UV and ESI-MS. Detection limits ranged from 0.18 to 41.5 ng in UV and from 0.035 to 1.00 ng in ESI-MS.     

尼美舒利口腔崩解片的制备及质量检查

目的制备尼美舒利口腔崩解片。方法采用正交设计筛选尼美舒利口腔崩解片的处方并考察片剂质量。结果由15％乳糖、20%微晶纤维素、30％PVPP、1％CMS-Na组成的优化处方所制备的口腔崩解片口感良好,在45 s内完全崩解,10min释药97 %以上。结论该口腔崩解片处方合理、质量可控。     

提高尼美舒利片溶出度的工艺研究

目的:筛选尼美舒利片的最佳处方工艺,提高其溶出度.方法:考察粘合剂浓度、研磨时间、压片力对尼美舒利片溶出度的影响.结果:按照筛选的最佳处方工艺制备的尼美舒利片溶出度大为改善,符合药典标准.结论:该方法处方合理,工艺简单,适合于工厂化生产的要求.     

尼美舒利肝脏损害不良反应探究

尼美舒利是非甾体类抗炎药,为选择性环氧化酶-2（COX-2）抑制剂,其耐受性好。近年来,尼美舒利因发生多起导致肝脏损害甚至死亡的严重药品不良反应病例,在一些国家已被停止销售。本文通过对国家药品不良反应监测系统相关数据的检索和分析及典型案例的评价,探讨尼美舒利肝脏损害不良反应,为临床安全、有效、合理用药提供参考。     

Pilot study of the antipyretic and analgesic activity of nimesulide paediatric suppositories.

The object of this study was the preliminary evaluation, in paediatric patients, of the analgesic and antipyretic effect of nimesulide given rectally. Nimesulide was studied in comparison with paracetamol, according to a double-blind technique. Forty-eight hospitalized children with fever or pain, between 1 and 8 years old, were included. The drugs were administered with a flexible posology (1 to 4 suppositories/day with an interval between administrations of at least 6 h). Monitoring of symptom intensity was scheduled in the 6 hours after each administration. At the end of the therapy the physician expressed a global judgement on the drug. Both treatments resulted in a significant decrease in body temperature at the 1 h observation. From the second hour onward, a more rapid tendency to temperature normalization was observed with nimesulide than with paracetamol. Repeated measurements with ANOVA did not show significant differences between treatments but the physicians' overall judgements were significantly more favourable to the nimesulide than to the paracetamol antipyretic activity. Good analgesic activity, favouring a rapid decrease in the painful symptomatology, was observed in both groups. No differences were found in the analgesic activity of the treatments, although in this case the clinical evidence was more favourable to paracetamol. Both drugs were very well tolerated.     

HPTLC determination of nimesulide from pharmaceutical dosage forms

A simple, rapid, reproducible and stability indicating high performance thin-layer chromatographic method for the analysis of Nimesulide both the bulk drug and from pharmaceutical formulations is reported. The mobile phase selected consists of Cyclohexane-Ethylacetate [60:40, v/v]. It gave compact spots both for Nimesulide and its degraded products at Rf values 0.44 and 0.712, respectively. Densitometric analysis of nimesulide was carried out at 295 nm. The calibration curve of Nimesulide in methanol was linear in the range of 100-900 ng. The mean value of correlation coefficient, slope and intercept were 0.9989+/-0.0011, 504.655+/-0.0013 and 85331.56+/-0.0253, respectively. The limits of detection and quantitation were 60 and 100 ng, respectively. The drug content was within the limits (+/-5% of the labelled content of the formulations). The recovery of Nimesulide was about 99.5%.     

国产尼美舒利的药效学研究

本文研究了国产尼美舒利在小鼠、大鼠及家兔体内的抗炎、镇痛和解热作用.结果表明.尼美舒利抑制巴豆油致小鼠耳廓肿胀(ED_(50)为49.2mg·kg~(-1));抑制角叉菜胶致大鼠足肿(ED_(50)为2.75mg·kg(-1));0.6mg·kg~(-1)剂量对大鼠佐剂关节炎有显著预防和治疗作用。100mg·kg~(-1)对小鼠醋酸扭体法的抑制率为68％;对热板法致痛的痛阈提高率为55％。ip给药对蛋白胨致家兔发热的解热作用.其最小有效剂量为2mg·kg~(-1);5mg·kg~(-1)ig可显著降低啤酒酵母致大鼠升高的体温.证实国产尼美舒利具有很强的抗炎、镇痛和解热作用。     

尼美舒利干混悬剂溶出度检查方法研究

目的：建立尼美舒利干混悬剂溶出度检查方法。方法：参照中国药典2005年版二部溶出度测定法第二法，以磷酸盐缓冲液（pH8．8）为溶出介质，40min时取样，用紫外-可见分光光度法检测溶出量，检测波长为393nm。结果：尼美舒利在2-20mg·L^-1范围内溶液浓度与吸收值呈良好线性关系（r=0．9999）；平均回收率为99．6％（n=9，RSD为0．51％）；测定溶液在8h内稳定；样品的溶出均一性良好，RSD为3．86％，40min时平均溶出率为88．2％。结论：该方法简便易行、准确可靠，可用于尼美舒利干混悬剂溶出度检查.     

Formulation and Evaluation of Tramadol hydrochloride Rectal Suppositories

Rectal suppositories of tramadol hydrochloride were prepared using different bases and polymers like PEG, cocoa butter, agar and the effect of different additives on in vitro release of tramadol hydrochloride was studied. The agar-based suppositories were non-disintegrating/non-dissolving, whereas PEGs were disintegrating/dissolving and cocoa butter were melting suppositories. All the prepared suppositories were evaluated for various physical parameters like weight variation, drug content and hardness. The PEG and cocoa butter suppositories were evaluated for macromelting range, disintegration and liquefaction time. In vitro release study was performed by USP type I apparatus. The prepared suppositories were within the permissible range of all physical parameters. In vitro drug release was in the order of PEG>Agar>cocoa butter. Addition of PVP, HPMC in agar suppositories retards the release. The mechanism of drug release was diffusion controlled and follows first order kinetics. The results suggested that blends of PEG of low molecular weight (1000) with high molecular weight (4000 and 6000) in different percentage and agar in 10% w/w as base used to formulate rapid release suppositories. The sustained release suppositories can be prepared by addition of PVP, HPMC in agar-based suppositories and by use of cocoa butter as base.     

硝酸益康栓制备工艺与质量控制

目的研制硝酸益康栓工艺,并制定合适的定量分析方法。方法以半合成脂肪酸甘油脂为基质制备硝酸益康唑栓,以HPLC法测定本品中硝酸益康唑的含量。结果硝酸益康唑的平均回收率为100.1%,RSD为1.13%。结论硝酸益康唑栓工艺可行,HPLC法测定本品中硝酸益康栓的含量可作为控制本品质量的指标。