药剂科配制肠外静脉营养液的优势

全肠外营养 (ｔｏｔａｌｐａｒｅｎｔｅｒａｌｎｕｔｒｉｔｉｏｎ ,ＴＰＮ)指通过胃肠外途径提供机体代谢过程所需全部营养的营养支持方法。全肠外静脉营养液 (ｔｏｔａｌｎｕｔｒｉｔｉｏｎａｄｍｉｘｔｕｒｅ ,ＴＮＡ)指将机体所需碳水化合物、氨基酸、脂肪乳、维生素、电解质等营养要素按一定比例、一定程序混合于一个输液袋中所得的制剂。1　净化条件下配制ＴＮＡ的必要性ＴＮＡ需要把各种营养要素按一定程序混合于一个输液袋中 ,对环境提出了较高要求。在普通配液环境下 (如护士站化药室 )因环境污染较严重不能确保ＴＮＡ无菌、安全。…     

全肠外营养液中药物配伍禁忌的研究

目的分别对多种药物与全肠外营养液(total nutrient admixture TNA)配伍进行稳定性研究.方法药物按(11)比例与全肠外营养液配伍后,不同药物在不同温度(4℃、25℃)下静置和模拟输液,进行肉眼及显微镜下进行24 h持续观察,并测定其pH值.结果部分药物在全营养混合液中理化性质稳定,而另部分药物不稳定.结论药物在全肠外营养液中的能否配伍与两者的相互作用和pH值有关.     

全肠外营养液中药物配伍禁忌的研究

目的分别对多种药物与全肠外营养液(total nutrient admixture TNA)配伍进行稳定性研究.方法药物按(1:1)比例与全肠外营养液配伍后,不同药物在不同温度(4℃、25℃)下静置和模拟输液,进行肉眼及显微镜下进行24 h持续观察,并测定其pH值.结果部分药物在全营养混合液中理化性质稳定,而另部分药物不稳定.结论药物在全肠外营养液中的能否配伍与两者的相互作用和pH值有关.     

肠外营养液；稳定性；维生素Ｃ；高效液相色谱

摘 要 目的：考察我院临床常见肠外营养液配伍稳定性。方法: 配伍液在4种不同条件下放置8 h,观察其外观、pH变化,测定维生素C含量。结果: 在含有复合氨基酸的溶液中维生素C的含量随着时间推移不断下降,4 h后溶液由无色变为黄色,维生素C含量降低10%,但pH无明显变化;维生素C在不含复合氨基酸的溶液在6 h内性质稳定。结论:维生素Ｃ注射液不建议加入含有复方氨基酸的肠外营养液中使用,宜单独使用。     

全肠外营养液中药物配伍禁忌的研究

目的 分别对多种药物与全肠外营养液(total nutrient admixture TNA)配伍进行稳定性研究。方法 药物按(1：1)比例与全肠外营养液配伍后，不同药物在不同温度(4℃、25℃)下静置和模拟输液，进行肉眼及显微镜下进行24h持续观察，并测定其pH值。结果 部分药物在全营养混合液中理化性质稳定，而另部分药物不稳定。结论 药物在全肠外营养液中的能否配伍与两者的相互作用和pH值有关。     

一份全肠外营养液的稳定性影响考察

目的：考察我院一份全肠外营养液处方在不同配制顺序下溶液pH值变化,以及一价电解质浓度对该TPN液稳定性的影响,为今后同类TPN的稳定性提供参考。方法：6组全肠外营养液分别加入不同复方氨基酸注射液和不同浓度一价电解质（Na＋浓度）,于各步骤混合后0h及20℃--22℃下贮存12、24h后分别取样测定pH值,并肉眼观察其外观变化。结果：不同配制顺序下该全肠外营养液的pH值在24h内稳定,同样处方比例下加入复方氨基酸注射液（18AA-III）的出现分层现象,加入复方氨基酸注射液（18AA-II）的未发生明显变化;加入Na＋终浓度100、150、200、250mmol/L的TPN液24h后均未出现分层析出现象。结论：该份全肠外营养液处方在不同配制顺序下溶液pH值无变化,一价电解质250mmol/L对该处方的24h稳定性无影响,不同复方氨基酸注射液的选择对全肠外营养液稳定性有影响。     

围手术期肠外营养支持肝叶切除病人

全肠外营养(PN)从20世纪60年代后期开始应用于临床,至20世纪80年代初已发展为全合一,1995年以后的欧洲及美国90%的肠外营养支持均是采用全合一.全合一(all in one,AIO)指的是将脂肪乳、氨基酸、葡萄糖、电解质、水、维生素和微量元素在体外按一定程序混合组成全营养混合液(TNA).随着临床营养液支持水平的不断提高,在我国混合配制的营养液无论在操作水平还是在临床应用上都较过去有了长足进步.     

电解质对全肠外营养液稳定性的影响考察

目的:考察电解质对全肠外营养液稳定性的影响。方法:对4组加入不同电解质的全肠外营养液,于配制后0h及20℃~22℃下贮存4、8、12、16、24h后分别取样测定pH值和溶液微粒数变化,并肉眼观察其外观变化。结果:4组pH值在24h内均未发生明显变化;≥5μm的微粒数除加入1、2价电解质组(第4组)一开始就急速增至峰值外,其余均随放置时间延长而增加;加入2价电解质组(第3组)和加入1、2价电解质组(第4组)配制后6h即出现分层现象,加入1价电解质组(第2组)12h发生乳凝反应,而未加入电解质组(第1组)24h内无沉淀和分层现象。结论:电解质对全肠外营养液的稳定性有一定影响,在配制时应注意电解质用量,配制后应尽快输注,放置不宜超过24h。     

全肠外营养液配制服务浅析

目的了解我院全肠外营养液配制中心服务的效益.方法收集3组出院病例:A组使用营养配制中心配制的全营养液,B组使用中心成立前各科室自行配制的静脉营养液,C组单独使用脂肪乳、氨基酸等营养液.对A、B两组进行院内感染率、热原反应发生率的分析比较;对A、C两组进行初步疗效对比分析.结果院内感染发生率A组1.3%,B组8.7%(P＜0.05);热原反应发生率A组1.5%,B组10.9%(P＜0.01).治疗后血浆白蛋白浓度A组明显升高(P＜0.05),C组稍有升高(P＞0.05).结论全肠外营养液的集中配制在减少院内感染发生率、热原反应发生率方面具有重要意义.全肠外营养混合液的疗效优于单用氨基酸、脂肪乳等营养液.     

新生儿肠外营养液稳定性及质量控制研究

目的:考察新生儿肠外营养液稳定性及质量控制研究。方法:将营养液分别于4,20,40 ℃下放置,分别于0,12,24 h考察其外观变化、用苏丹红染料检测、测定其pH值、不溶性微粒数、乳粒粒径大小及粒度分布,并进行无菌试验和细菌内毒素检查。结果:于4,20 ℃下放置的营养液的外观、pH值、平均粒径和PDI值均变化不大,无菌试验和细菌内毒素检查均符合质量要求,但40 ℃下放置的营养液的平均粒径和PDI值均变大。结论:4,20 ℃下放置的新生儿肠外营养的稳定性较好。为保证营养液的质量,建议定期进行有效的质量监控。     

3层共挤输液用袋对6种药物的吸附性试验

目的考察国产3层共挤输液用袋对药物的吸附,保证对患者输液治疗过程中合理的治疗药物浓度。方法按照药品说明书配制含有治疗药物的电解质输液,用高效液相色谱法分别测定电解质输液中治疗药物峰面积作为0 h数据,间隔1,3,6 h后再次测定,并于0 h数据进行比较。结果6 h内国产3层共挤输液袋中药物浓度变化均在±5%以内。结论国产3层共挤输液袋与M312c 5层共挤输液袋对试验中6种药物吸附均很小（浓度下降小于10%）,适用于这些药品的包装。     

Evaluation of childhood exposure to di(2-ethylhexyl) phthalate from perfusion kits during long-term parenteral nutrition

Leachability of the plasticizer di(2-ethylhexyl) phthalate (DEHP) from administration sets into intravenous parenteral emulsions containing fat was investigated. DEHP is added to polyvinyl chloride (PVC) to impart flexibility. However, DEHP is a lipid-soluble suspected carcinogen that is hepatotoxic and teratogenic in rodents, and has been shown to leach from PVC products containing lipophilic mixtures. Consequently, total parenteral nutrition (TPN) mixtures containing fat emulsions should be stored in ethylvinyl acetate (EVA) bags rather than PVC packs. However, while TPN bags are made of EVA, they contain PVC-DEHP residues and the lines used between TPN bags and venous catheters are made of PVC-DEHP. The present study quantified the amount of DEHP leached from bags and tubing that could potentially contaminate patients during home TPN. Four types of emulsions containing fat were studied. Levels of DEHP in the bag and at the outlet tubing were measured by high-performance liquid chromatography (HPLC). This was measured during simulated TPN at different times after starting perfusion, 1 day after reconstitution of solutions in the bags, and 1 week later after storage at 4 degrees C. Detectable and stable amounts of DEHP were found to leach from bags (0.2 +/- 0.008 mg to 0.7 +/- 0.02 mg) and DEHP content increased in the outlet tubing (0.8 +/- 0.09 mg to 2 +/- 0.07 mg) during simulated infusions. The same phenomenon was observed after 1 week of storage at 4 degrees C. DEHP extraction by TPN depends on the lipid content of each TPN preparation and the flow rate. These results suggest that children treated with prolonged TPN are regularly exposed to significant amounts of DEHP.     

Stability,compatibility and plasticizer extraction of miconazole injection added to infusion solutions and stored in PVC containers

The stability of miconazole in various diluents and polyvinyl chloride (PVC) containers was determined and the release of diethylhexyl phthalate (DEHP) from PVC bags into intravenous infusions of miconazole was measured. An injection formulation (80 ml) containing a 1% solution of miconazole with 11.5% of Cremophor EL was added to 250-ml PVC infusion bags containing 5% glucose injection or 0.9% sodium chloride injection, to give an initial nominal miconazole concentration of 2.42 mg ml⁻¹, the mean concentration commonly used in clinical practice. Samples were assayed by stability-indicating high-performance liquid chromatography (HPLC) and the clarity was determined visually. Experiments were conducted to determine whether the stability and compatibility of miconazole would be compromised, and whether DEHP would be leached from PVC bags and PVC administration sets during storage and simulated infusion.There was no substantial loss of miconazole over 2 h simulated infusion irrespective of the diluent, and over 24 h storage irrespective of temperature (2–6°C and 22–26°C). All the solutions initially appeared slightly hazy. Leaching of DEHP was also detected during simulated delivery using PVC bags and PVC administration sets. There was a substantial difference between the amounts of DEHP released from PVC bags and from administration sets, and also between the amounts released in solutions stored in PVC bags at 2 6°C and 22–26°C over 24 h.At the dilution studied, miconazole was visually and chemically stable for up to 24 h. The storage of miconazole solutions in PVC bags seems to be limited by the leaching of DEHP rather than by degradation. To minimize patient exposure to DEHP, miconazole solutions should be infused immediately after their preparation in PVC bags.     

4种输液包装材料对注射用美罗培南吸附性的考察

目的考察玻璃瓶、聚丙烯塑料瓶(PP)、聚氯乙烯软袋(PVC)、非聚氯乙烯复合膜软袋(NPVC)4种包装材料在葡萄糖和氯化钠两种溶媒大输液中对注射用美罗培南的吸附情况。方法将注射用美罗培南与4种不同材料包装的50g·L-1葡萄糖注射液及9g·L-1氯化钠注射液分别配制成配伍液,在室温(25℃)和5℃条件下,于0,1,2,3,4,5,6,7和8h取样,用高效液相色谱法测定美罗培南的含量,并观察其颜色变化。结果与葡萄糖注射液配伍时,4种包装材料对美罗培南的吸附性无显著差异(P>0.05),PVC软袋中溶液在5℃时放置8h后、室温时放置5h后变成微黄色,PP塑料瓶中溶液在室温放置7h后变成微黄色,其余颜色无变化。与氯化钠注射液配伍时,PVC软袋的吸附性大于PP塑料瓶和非PVC复合膜软袋,差异显著(P<0.05),PVC软袋中溶液在5℃和室温时均放置8h后变微黄色,其余颜色无变化。结论非PVC复合膜软袋是较理想的输液包装材料,具有广阔的前景。     

重组人血管内皮抑制素在静脉输液中的稳定性研究

目的 考察重组人血管内皮抑制素注射液（恩度）在静脉输液中的稳定性,为临床合理用药提供依据。方法 模拟临床给药剂量和给药时间,采用高效液相色谱法测定重组人血管内皮抑制素注射液在聚氯乙烯（PVC）输液袋、非PVC输液袋及全自动注药泵中不同温度、不同时间点的药物浓度。结果 在25 ℃或37 ℃下,重组人血管内皮抑制素注射液在PVC和非PVC氯化钠输液中至少保持稳定4 h,在全自动注药泵中48 h内保持稳定。结论 在临床实践中,重组人血管内皮抑制素注射液以PVC和非PVC材质的0.9%氯化钠注射液500 mL静脉点滴2 h或全自动注药泵（250 mL）恒速给药24 h,从药品稳定性角度讲是可行的。     

Stability, compatibility and plasticizer extraction of quinine injection added to infusion solutions and stored in polyvinyl chloride (PVC) containers

The stability of quinine was determined in various diluents and in polyvinyl chloride (PVC) containers. The release of diethyhexyl phthalate (DEHP) from PVC bags into intravenous infusions of quinine was also measured. We used an injection of two doses of quinine; quiniforme at 500 mg and quinimax at 400 mg in either 250- or 500-ml PVC infusion bags containing 5% dextrose, to give initial nominal concentrations of 2 or 1 mg ml(-1) quiniforme and 1.6 or 0.8 mg ml(-1) quinimax, the mean concentrations commonly used in clinical practice. Samples were assayed by stability-indicating high-performance liquid chromatography (HPLC) and the clarity was determined visually. Experiments were conducted to determine whether the stability and compatibility of quinine would be compromised, and whether DEHP would be leached from PVC bags and PVC administration sets during storage and simulated infusion. There was no substantial loss of quiniforme and quinimax over 1- or 2-h simulated infusion irrespective of the diluent, and storage during 8 h at 22 degrees C, 48 or 72 h at 4 degrees C and 96 h at 45 degrees C. Leaching of DEHP was also detected during simulated infusion delivery using PVC bags and PVC administration sets. The quantity was less than 2 microg ml(-1). During storage at 4 degrees C and room temperature the leaching of DEHP was low, but when the temperature was 45 degrees C the quantity was high, 21 microg ml(-1). To minimise patient exposure to DEHP, quinine solutions with all drugs should be infused immediately or stored for a maximum of 48 h at 4 degrees C.     

Stability study of fotemustine in PVC infusion bags and sets under various conditions using a stability-indicating high-performance liquid chromatographic assay

The stability and compatibility of fotemustine, a nitrosourea anticancer agent, in 5% dextrose solution with polyvinyl chloride (PVC) containers and administration sets were studied under different conditions of temperature and light. The drug was diluted to 0.8 and 2 mg ml(-1) in 100 or 250 ml 5% dextrose injection solutions for 1-h simulated infusions using PVC bags and administration sets with protection from light. After preparation in the PVC bags containing 5% dextrose, fotemustine was also prepared at the same concentrations and stored at 4 degrees C for 48 h and at room temperature (22 degrees C) or at sunray exposure ( > 30 degrees C) over 8 h with or without protection from light. The solution samples were removed immediately at various time points of simulated infusions and storage, and stored at -20 degrees C until analysis. The physical compatibility with PVC and chemical stability in solution of fotemustine were assessed by visual examination and by measuring the concentration of the drug in duplicate using a stability-indicating high-performance chromatographic assay. When admixed with a 5% dextrose solution, fotemustine 2 and 0.8 mg ml(-1) was compatible and stable over 1-h of simulated infusion using PVC bags through PVC administration sets with protection from light. On the other hand, in the same diluent, fotemustine was compatible and stable with PVC bags for at least 8 h at 22 degrees C with protection from light and for at least 48 h at 4 degrees C with protection from light. There were no pH variation, no visual change, no color change, no visible precipitation and no loss of the drug. Conversely, when the solutions were exposed to light (ambient or solar), the drug concentration decreased rapidly, leading to the production of a degradation product as shown by mass spectral analysis and a discoloration of the solutions. Finally, in all cases, no DEHP (di-2-ethylhexyl phthalate) was detected in the injection solution.     

Amino acid stability and microbial growth in total parenteral nutrient solutions

The stability of amino acids in total parenteral nutrient (TPN) solutions stored for 30 days and the potential for stored TPN solutions to support growth of microbial contaminants were studied. Solutions of 3.5% crystalline amino acids and 25% dextrose with electrolytes were prepared either by using a commercially available amino acid solution with electrolytes or by adding electrolytes individually to a base TPN solution. Solutions were stored in polyvinyl chloride bags at refrigerated (4 degrees C) or room (25 degrees C) temperature for 30 days. Some bags were inoculated with Candida albicans or Pseudomonas maltophilia before storage to serve as positive controls for evaluation of microbial contamination. At appropriate intervals, bags of each type of solution under each storage condition were analyzed for amino acid content. Microbial growth was evaluated by filtering the contents of each bag and incubating the filter in brain-heart infusion broth. No microbial growth was detected in any of the study solutions, but all solutions inoculated with C. albicans and 2 of 16 solutions inoculated with Ps. maltophilia had evidence of growth. No significant decreases in the concentrations of any of the amino acids were noted for solutions stored at refrigerated temperature, but significant decreases in the concentrations of arginine and methionine were noted for solutions stored at room temperature. Total parenteral nutrient solutions can be stored for up to 30 days if they are kept at refrigerated temperatures and protected from light; however, quality assurance measures for these solutions should include end-product microbiologic testing.     

谷氨酸钠在全合一肠外营养液中的稳定性研究

目的:考察谷氨酸钠对全合一肠外营养液稳定性的影响。方法:将不同剂量的谷氨酸钠分别加入不同配方的全合一肠外营养液中,放置不同时间(0、24、48h)后测定pH和渗透压等相关指标,观察稳定性。结果:每增加5mL谷氨酸钠,pH升高0.04±0.18,渗透压升高41±12mOsm。溶液的渗透压<800mOsm时,24、48h后脂肪乳颗粒的大小形态正常,表面不受破坏,未出现凝集现象;渗透压>800mOsm时,24h后脂肪乳颗粒表面破损,形态异常并发生凝集。结论:谷氨酸钠可加入全合一肠外营养液中进行配伍使用,建议在48h内输注完毕。     

环磷酰胺注射液在玻璃瓶和PVC软输液袋中的稳定性考察

目的 考察环磷酰胺注射液在玻璃瓶和PVC软袋（聚氯乙烯输液袋）输液中的稳定性是否存在差异.方法 环磷酰胺用0.9%氯化钠注射液配制于玻璃瓶和PVC软袋中,于室温下放置24 h,分别于0、1、2、4、8、12和24 h取样,检测其外观和性状,并用高效液相色谱法检测其含量.结果 环磷酰胺在玻璃瓶和PVC软袋输液中外观和性状均无明显变化,12 h内2组输液稳定,2组之间无显著性差异（P＞0.05）.结论 在室温12 h内,环磷酰胺溶于0.9%氯化钠注射液均较稳定,其在玻璃瓶和PVC软输液袋中的稳定性无差异.