注射用氨曲南与利巴韦林注射液在输液中的配伍稳定性考察

目的建立氨曲南与利巴韦林的含量测定方法,通过注射用氨曲南与利巴韦林注射液配伍后含量变化来考察其配伍的稳定性,进而为临床采用合理的配制方法提供参考依据。方法在25℃和37℃条件下,将注射用氨曲南与利巴韦林注射液在100ml0．9％氯化钠注射液、5％葡萄糖注射液中配伍,测定溶液的pH值,采用HPLC法测定配伍液中氨曲南和利巴韦林的含量,定时观察溶液的颜色及澄明度。结果本实验所建立的色谱条件对注射用氨曲南和利巴韦林注射液的检测专属性好,氨曲南、利巴韦林的线性范围分别在0．0125～0．2mg·ml^-1（r=0．9999）,0．006—0．1mg·ml^-1（r=0．9999）。25℃和37℃条件下,氨曲南和利巴韦林在0．9％氯化钠注射液和5％葡萄糖注射液中配伍后,溶液24h内配伍液均无外观改变、pH值在5．4左右无明显变化、含量在95％以上、吸收峰的位置无变化,无其它吸收峰产生。结论两种药物的结构稳定,在溶液中稳定性好,临床上可将两药配伍使用。     

喜炎平与利巴韦林联合用药方案治疗小儿手足口病的临床疗效分析

目的：探讨喜炎平与利巴韦林联合用药方案治疗小儿手足口病的临床疗效。方法选择收治的104例小儿手足口病患儿作为此次研究对象,把全部患儿随机分为对照组以及观察组,两组分别有52例患儿,对照组单纯应用利巴韦林治疗,观察组应用利巴韦林联合喜炎平治疗,比较两组患儿的临床治疗效果。结果观察组患儿的发热、疱疹、食欲等临床症状改善时间以及治愈时间均要显著小于对照组（ P＜0．05）;对照组临床治疗总有效率是80．77％,观察组临床治疗总有效率是96．15％,观察组临床疗效要显著优于对照组（ P＜0．05）;观察组不良反应发生率是7．69％,对照组不良反应发生率是17．31％,两组患儿不良反应发生情况对比无统计学意义（ P＞0．05）。结论喜炎平与利巴韦林联合用药方案治疗小儿手足口病的临床疗效要优于单纯应用利巴韦林治疗,可以较快改善患儿临床症状,缩减患儿病程,还能减少不良反应的发生,建议在临床上大力推广应用。     

氧氟沙星凝胶滴耳剂的制备及质量控制

目的 制备氧氟沙星凝胶滴耳剂及其质量控制。方法 以卡波姆－940作为凝胶基质，采用紫外分光光度法测定其中氧氟沙星含量，加速试验法考察制剂的稳定性。结果 制备的凝胶均匀细腻，分散性好，建立的分析方法不受辅料的干扰，相对回收率平均为100．2％，RSD为1．36％（n=5)，结论 制剂制备工艺简单，稳定性好。     

富马酸氯马斯汀凝胶的研制与质量控制

目的 研制富马酸氯马斯汀凝胶剂,建立质量控制方法。方法 用卡波姆-940为凝胶基质,用分光光度法测定含量。考察制剂的稳定性。结果 该制剂均匀性、分散性好;含量测定平均回收率为99．78％,RSD为0．81％（n=3）。结论 该制剂制备工艺简单,质量可控。     

盐酸多西环素牙周用微球温敏性凝胶的制剂学研究简

目的构建盐酸多西环素牙周用微球温敏性凝胶缓释系统。方法通过乳化一交联固化法制备盐酸多西环素羧甲基壳聚糖微球（DXY-CMCTS-MS）。采用壳聚糖和卢．甘油磷酸钠（β-GP）制备凝胶。用扫描电镜和光学显微镜观察微球表面形态;体外动态透析法测定释药性能。结果制备的DXY—CMCTS—MS形态圆整,粒径分布较为均匀,平均粒径约25μm,载药量18．9％,包封率64．6％。DXY微球凝胶在室温下为自由流动的液体,37℃的平均凝胶时间为（1．1±0．3）min,明显低于凝胶剂的凝胶时间。微球凝胶复合载体的释药速度明显低于微球剂,体外释药曲线符合Higuchi拟合方程。结论盐酸多西环素微球温敏凝胶复合载体的处方和制备工艺可行,作为牙周用缓释制剂值得进一步研究。     

SARS抗病毒治疗的药物选择探讨

目的　分析不同SARS抗病毒治疗方法的效果 ,为制定SARS抗病毒治疗方案提供参考。方法　采用临床流行病学回顾研究 ,使用SPSS11.0软件分析我院SARS患者的住院病历 ,分析选择不同抗病毒治疗药物治疗SARS的T细胞亚群、血象、肝肾功能变化及临床效果。结果　本文研究发现 ,利巴韦林治疗病死率为 18.0 3% ;干扰素组T细胞亚群下降值最低 ,但治愈率为 10 0 % ,与利巴韦林组比较 (P <0 .0 0 1)统计学有极显著性差异 ,并有延长T细胞亚群下降至最低值时间的趋势 (P >0 .0 5 ) ;干扰素与利巴韦林联合治疗可延长T细胞亚群下降至最低值的时间 ,CD3 与利巴韦林组比较 (P <0 .0 5 )统计学有显著性差异 ,病死率为 6 .0 6 % ,与利巴韦林组比较 (P <0 .0 5 )统计学有显著性差异 ,并低于文献报道水平 (6 .5 % )。干扰素组对SARS患者血象及肝肾功能的影响最小 ,各组与利巴韦林组比较 (P >0 .0 5 )统计学无显著性差异。结论　干扰素或干扰素联合利巴韦林抗病毒治疗效果优于单独使用利巴韦林的效果。干扰素抗病毒治疗效果最好。     

铁扇癣痒平凝胶的制备及质量评价

目的以外观、稳定性、含量和刺激性为评价指标,筛选铁扇癣痒平凝胶剂的最佳处方工艺。方法以卡波姆为基质及水相,吐温为乳化剂,蓖麻油为油相,制备乳剂型凝胶剂。以均匀性、黏稠度和稳定性为指标,筛选处方用量。以盐酸小檗碱为指标,建立HPLC含量测定方法,评价含量和稳定性。采用家兔皮肤刺激性实验评价局部使用的安全性和刺激性。结果优选处方为卡波姆-940：1．4％（g·g1-1）,蓖麻油：8％（ml·g-1）,吐温-80：3％（ml·g-1）,三乙醇胺：2％（ml·g-1）,甘油：10％（ml·g-1）,乙醇：20％（ml·g-1）,浸膏粉：3％（g·g-1）。制得凝胶剂的均匀性、黏稠度和稳定性良好;含盐酸小檗碱（119．2±1．0）I,Lg·g-1（n=3）;6个月后剩余含量为100．5％,含量无明显下降。凝胶剂对局部皮肤无刺激性。结论铁扇癣痒平凝胶外观细腻、易涂布、含量均匀、性质稳定。     

利巴韦林注射液大鼠体内药代动力学研究

目的研究利巴韦林注射液在大鼠体内的药代动力学,并考察利巴韦林的红细胞蓄积情况。方法采用反相HPLC法测定了大鼠静脉注射利巴韦林注射液后利巴韦林的血药浓度,使用3p87药代动力学软件计算其药代动力学参数。结果利巴韦林注射液在大鼠体内符合二室模型,主要的药动学参数如下:T1/2(α)为(10.82±2.66)min,T1/2(β)为(180.0±27.69)min,AUC为(1109.0±212.0)mg·L-1·min,CL(s)为(0.032±0.009)kg·L-1·min-1。结论利巴韦林在红细胞中有大量蓄积。     

利巴韦林片在健康人体的药动学及生物等效性

目的研究利巴韦林片在健康人体的药代动力学特征及其相对生物等效性。方法24名男性健康志愿者以标准二阶段交叉设计自身对照试验法,分别单剂量口服2种利巴韦林片,采用液相色谱-串联质谱法测定受试者服药后72h内血浆中利巴韦林的浓度。结果受试品和参比品利巴韦林主要的药代动力学参数Tmax分别为3.55±3.06、2.84±2.89h,Cmax分别为:214.12±89.21、223.89±116.83μg·L-1;AUC(0-72h)为5252.63±1896.66、5239.36±2708.07μg·h·L-1,受试品的相对生物利用度为110.5%。结论2种利巴韦林制剂在健康志愿者体内具有生物等效性。     

酮康唑凝胶剂的制备及含量测定

目的：制备一种外用酮康唑的新剂型－凝胶剂,并建立含量测定方法,以控制制剂质量。方法：用卡波姆－９４０作基质制备酮康唑凝胶;采用紫外分光光度法测定酮康唑含量。结果：制剂稳定,无刺激性;含量测定线性关系（４～１２μｇ）良好（ｒ＝０．９９９９,ｎ＝５）。其平均回收弦为９９．６５％,ＲＳＤ为０．５３％（ｎ＝６）。结论：本制剂设计合理,含量测定方法简便可靠。     

Development of a gel phantom for dose distributions by MR imager]

We reported a method of determining spatial dose distributions in tissue-equivalent phantoms using nuclear magnetic resonance imaging. To make a gel phantom, a cross-linked dextran gel (Sephadex G-200) was used as fixation agent of a ferrous sulphate solution. Although high quality images are obtained, the cost is very expensive to make the gel. We developed a new gel which is combined with an extra water absorbent polymer (Sumikagel N-100) and Sephadex G-200. The gel permits the determination of dose distributions for three dimensional treatment planning.     

Monte Carlo modeling of a conventional X-ray computed tomography scanner for gel dosimetry purposes

Our purpose in the current study was to model an X-ray CT scanner with the Monte Carlo (MC) method for gel dosimetry. In this study, a conventional CT scanner with one array detector was modeled with use of the MCNPX MC code. The MC calculated photon fluence in detector arrays was used for image reconstruction of a simple water phantom as well as polyacrylamide polymer gel (PAG) used for radiation therapy. Image reconstruction was performed with the filtered back-projection method with a Hann filter and the Spline interpolation method. Using MC results, we obtained the dose–response curve for images of irradiated gel at different absorbed doses. A spatial resolution of about 2 mm was found for our simulated MC model. The MC-based CT images of the PAG gel showed a reliable increase in the CT number with increasing absorbed dose for the studied gel. Also, our results showed that the current MC model of a CT scanner can be used for further studies on the parameters that influence the usability and reliability of results, such as the photon energy spectra and exposure techniques in X-ray CT gel dosimetry.     

Radiochemical quality control of 99mTc-labeled radiopharmaceuticals

Recognizing the fact that each nuclear medicine facility should be able to perform simple radio-chemical quality tests on currently used radiopharmaceuticals, this study was undertaken to evaluate a number of radiochromatographic methods. No single ideal method exists to assess the radiochemical composition of ^99mTc-labeled antimony sulphur colloid, sulphur colloid, iron ascorbate, citrate, human serum albumin, EHDP, macroaggregates, and microspheres.It is advisable to include thin layer chromatography with both NaCl and methylethylketone for the determination of free pertechnetate in each day's program. More detailed radiochemical analysis can be performed by combining these methods with paper chromatography, paper electrophoresis, and gel filtration. It seems reasonable to regard a constant radio-chromatographic pattern as a measure for constant radiochemical quality.The four chromatographic tests lead to consistent results regarding the percentage of free pertechnetate in the radiopharmaceutical preparations. Quantitative analysis shows that the radiochemical purity for each radiopharmaceutical is unique for the chromatographic method used and needs to be defined when stated.     

Characterization and quality control analysis of 99mTc-bicisate

The aim of this study was to investigate the mini cartridge versus paper chromatography quality control methods for determining the radiochemical purity (RCP) of (99m)Tc-bicisate. The 4 methods that were compared with the manufacturer's method included Whatman 17 paper/ethyl acetate solvent, instant thin-layer chromatography (ITLC) silica gel paper/saline solvent, reverse-phase C18 mini cartridge/saline solvent, and strong anion exchange mini cartridge/water solvent. At 30 min after reconstitution, (99m)Tc-bicisate was formed at 97%-98% RCP as assayed by the paper and cartridge methods, and the strong anion exchange/water for injection (WFI) system slightly underestimated the percentage at 96%. A significantly lower RCP was obtained for the C18/saline method when a faster flow rate was used. The lipophilic complex moved with ethyl acetate on Whatman 17, was separated from origin impurities on ITLC silica gel/saline, and remained on the column with C18/saline. For strong anion exchange/WFI, components in the radioactive formulation are likely to have influenced the percentage of (99m)Tc-bicisate. The time disadvantage for ITLC silica gel/saline analysis made the method less than ideal. The C18 mini cartridge/saline method was found to be the simplest and fastest; a result was obtained in 2 min with use of a safe solvent of elution.     

Formation of99mTc-immunoglobulin G complexes free from radiocolloids,quality controlled by radioimmunoelectrophoresis

A method for the formation of^99mTc-human immunoglobulin G (^99mTc-IgG) complexes free from radiocolloids is described. A concentrated hydrochloric acid reduction/vacuum evaporation/gentisic acid method was applied. Although no preparative chromatography was performed, no sign of^99mTc-radiocolloids was observed in the chemical quality controls of the^99mTc-IgG formation. High radiochemical purities of^99mTc-IgG were obtained either by precipitation in 32 vol.% ethnnol in water at-10°C, or by removal of other^99mTc-complexes by simply adding a suspension of sterilized Dowex 1 in gentisic acid solution.Besides gel chromatography and thin layer chromatography, the^99mTc-IgG formation was quality controlled by radioimmunoelectrophoresis in agarose gel with rabbit anti-human IgG-antibodies present in the gel. The^99mTc-IgG complexes were complex bound to the rabbit antihuman IgG antibodies, and precipitated as rockets in the gel. These rockets could be scintigraphed and their radioactivities could be quantified, thereby a quantitatively radiochemical quality control based on the antigenicities of the^99mTc-IgG complexes was obtained. The^99mTc-IgG complexes were highly stable with no sign of dissociation even when the radioimmunoelectrophoresis was performed for 24 h. Improvements of the radioimmunoelectrophoretic system for the quality control of^99mTc-complexes with specific purified antibodies, are proposed.     

Nickel-doped agarose gel phantoms in MR imaging

A method for the production of a tissue-mimicking phantom material for MR imaging is described. The material consists of a nickel-doped agarose gel. The T1 and T2 values of the gel can be varied independently by changing the relative amounts of nickel and agarose. Practically any T1 and T2 combination of clinical interest can be obtained. The long-term stability was studied and found to be good. The relaxation times were estimated using an MR analyzer. The accuracy and the reproducibility of these measurements were evaluated and found to be reassuring. Gel phantoms were also scanned in an MR unit. The signal strength of an inversion recovery sequence was evaluated using the gel phantoms in order to verify their usefulness. These measurements were compared to theory with good agreement. Furthermore, tissue-equivalent phantoms were made. Gels resembling gray matter, white matter, and CSF were scanned. Comparisons with clinical in vivo scans, as well as calculated levels were made. It is anticipated that the gel phantoms described here will be useful in quality assurance as well as in pulse sequence optimization.     

雾化吸入干扰素α-1b对呼吸道合胞病毒治疗的实验研究

目的：探讨雾化吸入干扰素α-1b治疗小鼠呼吸道合胞病毒（RSV）肺炎的疗效。方法：BALB/c小鼠感染RSV后分4组：生理盐水组;干扰素组;利巴韦林组;干扰素＋利巴韦林组。观察肺组织病理变化;支气管肺泡灌洗液（BALF）白细胞计数及分类。结果：①治疗组肺病理变化较对照组明显减轻;②治疗组BALF白细胞计数及淋巴细胞比例低于对照组（P〈0.05）,且干扰素组低于利巴韦林组（P〈0.05）。结论：雾化吸入干扰素α-1b是治疗RSV感染的有效方法。     

四唑蓝比色法测定肝素酶活性

目的：建立一种检测肝素酶活性的简便快捷的方法。方法：肝素酶作用于肝素／硫酸肝素特定位点的β-1，4糖苷键生成还原性醛基末端，还原性醛基末端可将生色底物四唑蓝还原成蓝色产物。颜色变化反映还原性醛基基团数量的改变的特性，被用于肝素酶活性的检测。结果：四唑蓝比色法的结果表明，颜色的改变程度与酶活性戍正比；凝胶和SDS-PAGE电泳法验证了四唑蓝比色法的结果。结论：四唑蓝比色法可较准确地反映肝素酶活性，可以成为测定肝素酶活性的简便、经济、有效的方法。