加替沙星氯化钠注射液与五种药物的配伍及稳定性研究

目的 在25℃条件下,考察24h内加替沙星氯化钠注射液与五种药物的配伍及稳定性。方法采用高效液相色谱法,测定加替沙星氯化钠注射液及五种药物在24h内的含量变化,光阻法测定不溶性微粒变化,同时观察外观及测定pH值变化。结果 配伍液Ⅴ、Ⅵ、Ⅶ、Ⅷ在放置期间外观及颜色无明显变化。各样品溶液24h内pH值无明显改变;配伍前后不溶 性微粒的测定结果均符合中国药典规定;含量测定结果表明加替沙星氯化钠注射液、甲硝唑磷酸二钠、头孢呋辛钠、头孢他啶放置24h含量下降在10％以内、头孢曲松钠、头孢唑林钠放置2h及6h含量下降大于10％。结论 试验结果表明加替沙星氯化钠注射液与五种药物无明显配伍变化。但配伍后的药液应尽快使用。     

注射用盐酸左氧氟沙星分别与4种药物配伍稳定性研究

目的 考察注射用盐酸左氧氟沙星与维生素C注射液、三磷酸腺苷二钠注射液、注射用辅酶A及肌苷注射液的配伍稳定性。方法 采用紫外分光光度法测定注射用盐酸左氧氟沙足分别与上述4种药物在5％葡萄糖注射液中配伍后室温条件下8h内的含量,同时观察外观及pH值变化。结果 配伍液8h内外观、pH及盐酸左氧氟沙星含量均无显著变化。结论注射用盐酸左氧氟沙星可以与维生素C注射液、三磷酸腺苷二钠注射液、注射用辅酶A及肌苷注射液混合输注。     

盐酸左氧氟沙星注射液与维脑路通注射液配伍稳定性

目的 考察25℃、37℃下0～6h内，盐酸左氧氟沙星注射液与维脑路通注射液配伍稳定性。方法采用紫外分光光度法测定配伍后上述条件下盐酸左氧氟沙星的含量变化及稳定性。结果左氧氟沙星注射液与维脑路通注射液配伍后外观、含量、pH均无显著变化。结论在25℃、37℃下，0～6h内，左氧氟沙星注射液与维脑路通注射液配伍基本稳定。     

盐酸普鲁卡因注射液与3种常用输液配伍的稳定性实验

目的：研究盐酸普鲁卡因注射液与3种常用输液配伍的稳定性,方法：采用紫外分光光度法测定配伍后,4h内不同时间盐酸普鲁卡因注射液的含量,同时观察外观并测定pH值,结果：室温下,盐酸普鲁卡因与葡萄糖注射液配伍含量有明显下降,与10％葡萄糖注射液配伍20min浓度下降22．2％,与氯化钠的注射液配伍无明显变化,盐酸普鲁卡因配伍液外观澄明无色变,未见气泡及沉淀,pH值对盐酸普鲁卡因注射液含量无影响,结论：盐酸普鲁卡因不宜与葡萄糖注射液配伍,可与氯化钠注射液配伍。     

病毒唑与青霉素钠配伍稳定性考察

将病毒唑与青霉素钠按临床用量配伍实验。在连续4h内,溶液外观,pH值,成份含量及薄层行为均无改变,为临床用药提供了实验依据。     

多索茶碱注射液与甲硝唑注射液配伍的稳定性

目的探讨多索茶碱注射液与甲硝唑注射液配伍的稳定性，为临床合理用药提供科学依据。方法选择5℃、25℃和37℃在24h内观察配伍液的外观、pH值、多索茶碱和甲硝唑的含量变化。结果多索茶碱注射液与甲硝唑注射液配伍后外观和pH值无明显变化，多索茶碱含量与温度有关。结论在5℃、25℃和37℃下，在24h内．多索茶碱注射液与甲硝唑注射液配伍基本稳定。     

盐酸左氧氟沙星注射液与五种注射剂配伍的稳定性考察

目的：研究盐酸左氧氟沙星注射液与五种注射剂（利巴韦林,西咪替丁,鱼腥草,三磷酸腺苷二钠,注射用辅酶A）配伍的稳定性,方法：选择25℃在0至4h内观察配伍液的外观,pH值及盐酸左氧氟沙星的含量。结果：在25℃,4h内五种配伍液的外观,pH值及盐酸左氧氟沙星的含量没有明显的变化。结论：盐酸左氧氟沙星注,射液与五种注射剂可以在临床配伍使用。     

西咪替丁与常用药物配伍的稳定性实验

本文对西咪替丁与常用药物配伍的稳定性进行了考察,结果表明:西咪替丁与头孢哌酮、5-氟脲嘧啶、维生素K_1注射液,在5％葡萄糖注射液中配伍,室温下6h内较稳定。含量变化较小,亦无明显物理变化,可配伍静滴使用。     

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。     

左氧氟沙星注射液与8种中药注射液的配伍稳定性

目的：考察25℃室温，盐酸左氧氟沙星注射液与葛根素等8种药物配伍的稳定性。方法：采用紫外分光光度法测定左氧氟沙星和中药配伍后8h内的左氧氟沙星的含量，同时观察配伍液的外观，pH值及左氧氟沙星紫外光谱的变化。结果：左氧氟沙星注射液除与复方丹参注射液配伍有沉淀外，其它均无显变化，结论：25℃条件下，盐酸左氧氟沙星注射液应避免与复方丹参注射液配伍使用，其它在8h内可以配伍使用。     

甲氨蝶呤与恩丹西酮、格拉司琼的相互作用

目的：研究甲氨蝶呤与恩丹西酮、格拉司琼配伍的稳定性。方法：采用紫外分光光度法考察甲氨蝶呤与恩丹西酮、格拉司琼在8h内的吸收度变化情况,同时观察外观、pH值及薄层层析检查。结果：在室温条件下,甲氨蝶呤与格拉司琼在0－8h内外观稳定,特征峰吸收度、pH值无明显变化,薄层层析检查无新物质产生。甲氨蝶呤与恩丹西酮在0－8h内含量、pH值亦均无明显变化。二者的低浓度稀释混合液外观稳定,但甲氨蝶呤（1mg/ml)与恩丹西酮（2mg/ml)混合有沉淀产生。结论：甲氨蝶呤与格拉司琼在生理盐水中可以配伍使用。甲氨蝶呤与恩丹西酮由于在浓度高时会析出沉淀,故不宜在生理盐水中使用。     

高效液相色谱法考察胰岛素在能量合剂中的稳定性

目的：考察室温下8h以内胰岛素在输液用能量合剂中的稳定性情况。方法：采用高效液相色谱法，结合外观与pH值的观察，以高效液相色谱法来定量表达胰岛素的含量变化情况。结果：能量合剂在室温8h以内无色澄明，pH值较稳定。胰岛素的含量变化〈5．O％。结论：室温8h以内，胰岛素在能量合剂配伍中稳定。     

丹参川芎嗪注射液与常用溶媒配伍稳定性研究

目的建立同时测定丹参川芎嗪注射液中丹参素和盐酸川芎嗪的含量,考察丹参川芎嗪注射液与常用溶媒配伍后的稳定性情况。方法采用HPLC法测定丹参素和盐酸川芎嗪含量,并进行方法学研究,根据临床应用,按比例将丹参川芎嗪注射液与常用溶媒混合,观察配伍后的外观变化、pH值及含量变化。结果该方法能准确测定丹参川芎嗪注射液中丹参素和盐酸川芎嗪含量,丹参川芎嗪注射液与常用溶媒配伍后的稳定性受储藏时间、温度的影响。结论丹参川芎嗪注射液不宜在高温、长时间光照的条件下使用。     

注射用盐酸头孢替安与三种大输液配伍稳定性研究

目的考察注射用盐酸头孢替安与0.9%氯化钠注射液、5%葡萄糖注射液、5%葡萄糖氯化钠注射液配伍的稳定性。方法采用HPLC法,在室温条件下放置0、1、2、4 h,测定样品有关物质及含量的变化,同时观察pH值变化。结果随着放置时间的延长,各样品的主成分含量均下降,总杂质及单个最大杂质均显著增加,杂质个数也明显增多,室温放置4 h后总杂质含量部分超限;各样品在放置4 h后pH值无明显变化。结论室温条件下,注射用盐酸头孢替安在上述3种溶液中均不稳定,应临床使用前配制。     

多西他赛磷脂／胆盐复合胶束的制备及性质研究

目的：制备多西他赛磷脂／胆盐复合胶束（ DOX MMs）并进行处方筛选及初步性质研究。方法以共沉淀法制备多西他赛磷脂胆盐复合胶束,利用高效液相色谱法考察不同条件（磷脂比例、辅料总浓度、pH值、离子强度）对多西他赛在复合胶束中溶解度的影响。通过激光粒度仪测定胶束的粒径分布和电位,透射电子显微镜测定胶束的表面形态,稀释实验考察胶束的稳定性。结果 DOX MMs优化处方中磷脂／总辅料比例为0．4;辅料总浓度为2．5％;水化介质为纯水。载药胶束平均粒径为18．56 nm,Zeta电位为－24．3 mV,胶束为类圆多边形,分布均匀。胶束具有较好的稀释稳定性。结论 DOX MMs的制备工艺简单,能有效提高多西他赛的溶解度,稳定性好,有望成为多西他赛的新型药物传递系统。     

复方茵陈注射液与几种注射液的配伍稳定性考察

目的考察复方茵陈注射液在5%葡萄糖注射液等3种注射液中的配伍稳定性。方法将复方茵陈注射液加入到3种注射液中,采用临床用药浓度和配制方法,在配伍后不同时间,用高效液相色谱法检测配伍液的栀子苷含量,同时检查配伍液的pH值、微粒、澄明度。结果复方茵陈注射液与3种注射液配伍后在室温放置8 h,其pH、澄明度、含量、微粒等指标均无明显异常。结论复方茵陈注射液与5%葡萄糖注射液、10%葡萄糖注射液、氯化钠注射液配伍,8 h内稳定,临床应用时可与上述注射液配伍。     

Stability investigation of total parenteral nutrition admixture prepared in a hospital pharmacy

BACKGROUND/AIM: In the cases when nutrition of patients can not be orally nor enterally performed, parenteral nutrition is a method of the therapy that provides more successful and rapid recovery. In that way, hospitalization can be significantly shorter, healing costs reduced and mortality minimized. Total parenteral nutrition (TPN) admixtures are the most complex systems which contain amino acids, carbohydrates, lipid emulsion, macroelectrolytes (Na+, K+, Ca2+, Mg2+, Cl(-), SO4(2-), PO4(3-)), oligoelements, hydro- and liposoluble vitamines, heparin, insulin and water. Concerning the mentioned complexity, special attention should be payed to physicochemical and microbiological stability of a mixture, because of interactions among components, that can be very hard to analyze. The aim of this study was to investigate the problem of stability of TPN admixtures prepared in a hospital pharmacy. METHODS: Admixture TPN was aseptically prepared in laminar air--flow environment on the basis of the specified order in supplementing components and additives to basic solutions. Solutions were kept in sterile multicompartment ethylene-vinyl-acetate bags. After preparation and slow homogenization, TPN admixtures were submitted to physicochemical and microbiological stability analyses in various period of time. The assessment of physical stability of TPN admixture was done on the basis of visual inspection, determination of pH value and measuring of particle size. The investigation of sterility and pyrogenic test were performed according to Ph. Yug. V regulations. RESULTS: Physico-chemical and microbiological analyses were applied and no significant changes in visual sense, pH value and droplet size stability of the TPN admixture were observed during the period of 60 hours The lipid droplets were smaller in size than 5 microm, that is the most common pharmacopoeia requirement. CONCLUSION: The results of our study confirmed that a TPN admixture prepared in a hospital pharmacy can be stored without stability loss for at least 60 hours.     

多巴胺转运蛋白显像剂^99Tc^m—TRODAT-1药盒及注射液的质量控制

目的对自制多巴胺转运蛋白显像剂^99Tcm-TRODAT-1药盒及注射液进行质量控制研究。方法对3批^99Tc^m-TRODAT-1药盒及注射液进行澄清度、pH值、氯化亚锡与TRODAT-1含量、标记率、放化纯、半衰期测定,无菌以及细菌内毒素检查,可见异物、不溶性微粒检查,并分析药盒在不同存放环境下的稳定性。结果^99Tc^m-TRODAT-1药盒澄清度好,pH值为5．9±0．1,药盒中氯化亚锡与TRODAT-1含量稳定,标记率大于95％。药盒在0-4℃下6个月、室温（20～25℃）下10d内稳定性好。注射液澄清透明、pH值在5．5～7．0之间,放化纯≥95％,室温（20～25℃）下8h内放化纯〉90％。药盒及注射液无菌、细菌内毒素检查合格。结论自制的^99Tc^m-TRODAT-1药盒及注射液的质量控制方法简便易行,药盒及注射液质量符合临床应用要求。     

Preparation and testing of solutions for organ perfusion and preservation in transplantation

BACKGROUND/AIM: Histidine-tryptophan-ketoglutarate (HTK) solution is the most frequently used solution for the preservation of abdominal organs by leading transplant centers worldwide. The aim of the study was to investigate whether it is possible to prepare this kind of perfusion solution in the hospital pharmacy. In the hospital pharmacy setting we prepared HTK preservation solution and tested its quality, and in accordance with the obtained results recommended its shelf-life. METHODS: A multicomponent HTK solution was prepared following standardized aseptic procedures for sterile products. Components of HTK solution were dissolved in water for injection under aseptic conditions and the obtained solution was sterilized by bacteriological membrane filtration (0.22 microm). The quality of the produced solution was examined using physical and physico-chemical methods and biological tests. Following pharmacopoeial regulations, we examined clarity, pH value, sterility and performed testing on pyrogens. The content of the amino acids histidine and triptophan was determined by using high pressure liquid chromatography (HPLC) method. The concentrations of chloride ions were investigated by retitration method. Atomic absorption spectrometry and ion-exchange chromatography with conductometric detection were used for determining the level of magnesium and calcium ions and the concentrations of sodium and potassium ions in HTK solution, respectively. RESULT: It was shown that the quality of the prepared HTK solution complied with the regulation demands. Also, pH value of the solution as a function of storage temperature, remained in the physiological range (pH 7.4). CONCLUSION: According to the obtained results of physico-chemical and biological testing it can be concluded that in the hospital pharmacy setting with the applied technological procedure, we can produce HTK preservation solution of the required quality. Keeping of HTK preservation solution in a refrigerator at 4 degrees C warrants its shelf-life of six months.