HPLC-ELSD法快速测定生脉注射液中糖类成分含量

目的：利用高效液相色谱-蒸发光散射检测法（HPLC-ELSD）建立生脉注射液中糖类成分快速定量分析方法。方法：采用Alltech Prevail^TM Carbohydrate ES （4.6 mm×250 mm,5 μm）色谱柱,以乙腈和水为流动相梯度洗脱,流速0.8 mL·min^-1,柱温30℃,进样量20 μL,ELSD漂移管温度65℃。结果：生脉注射液中果糖、葡萄糖、蔗糖和麦芽糖成分达到基线分离,浓度在179.0~2 864 μg·mL^-1（r=0.996 8）,49~784 μg·mL^-1（r=0.998 1）,39~642 μg·mL^-1（r=0.996 8）,30~480 μg·mL^-1（r=0.999 3）范围内均呈现良好的线性关系。平均回收率（n=3）在98.34%~100.7%之间,RSD ≤ 3.8%。结论：该方法快速、准确,可用于生脉注射液中糖类成分的定量检测。     

高效液相色谱法测定人血清中替考拉宁浓度的不确定度评定

目的：评定高效液相色谱（HPLC）法测定人血清中替考拉宁浓度的不确定度。方法：HPLC法测定人血清中替考拉宁浓度，分析评定测定精密性、天平称量、工作液制备、血清样品制备、液相色谱仪、提取回收率、标准曲线拟合、对照品纯度、样品均匀性以及温度等因素对结果的影响，计算各因素的相对标准不确定度，最终计算合成标准不确定度和扩展不确定度。结果：当置信概率为95%时，人血清中低（6 μg·mL^-1）、中（20 μg·mL^-1）、高（50 μg·mL^-1）浓度替考拉宁的扩展不确定度分别为U（L）=0.63 μg·mL^-1，U（M）=1.87 μg·mL^-1，U（H）=5.08 μg·mL^-1，其测量结果可分别表示为（6.18±0.63）、（20.74±1.87）、（50.09±5.08）μg·mL^-1。结论：HPLC法测定人血清中替考拉宁浓度的不确定度主要由标准曲线拟合、样品提取过程（特别是低、高浓度）引入。     

高效液相色谱法同时测定四逆散中6种抗抑郁成分含量

目的：建立高效液相色谱法同时测定四逆散中6种抗抑郁成分：柴胡皂苷A、芍药苷、橙皮苷、柚皮苷、新橙皮苷和甘草苷含量的方法。方法：采用高效液相色谱法,色谱柱为Agilent Zorbax C₁₈色谱柱（4.6 mm×150 mm,5 μm）,流动相为水（A）-乙腈（B）,梯度洗脱,流速为1.0 mL·min^-1,柱温为30℃,检测波长为203 nm,进样量为20 μL。结果：柴胡皂苷A、芍药苷、橙皮苷、柚皮苷、新橙皮苷和甘草苷的线性范围分别为2.12～33.86 μg·mL^-1（r²=1.000 0）、5.91～94.60 μg·mL^-1（r²=0.999 9）、2.12～33.86 μg·mL^-1（r²=0.999 9）、7.26～116.2 μg·mL^-1（r²=1.000 0）、13.5～216.0 μg·mL^-1（r²=0.999 9）、2.02-32.33 μg·mL^-1（r²=0.999 9）。精密度、重复性和稳定性试验RSD均符合要求。柴胡皂苷A、芍药苷、橙皮苷、柚皮苷、新橙皮苷和甘草苷的加样回收率分别为102.77%、101.49%、101.18%、101.26%、99.06%。结论：本法灵敏简便、准确度高,适用于同时测定四逆散中6种抗抑郁成分柴胡皂苷A、芍药苷、橙皮苷、柚皮苷、新橙皮苷和甘草苷的含量,可用于四逆散的质量控制。     

儿童伏立康唑治疗药物浓度监测的临床意义

目的：本研究拟评估伏立康唑治疗药物浓度监测在儿童侵袭性真菌感染治疗中的作用。方法：采集76例以常规推荐剂量静脉滴注或口服伏立康唑治疗侵袭性真菌感染患儿的血液标本共99份,应用高效液相色谱-质谱联用技术检测谷浓度。结果：测定伏立康唑谷浓度中位值为0.784 μg·mL^-1（0.025~9.910 μg·mL^-1）,其中44例（44.4%）达到目标浓度范围（1~5.5 μg·mL^-1）,给药剂量与血药浓度之间缺乏相关性（r=0.252,P=0.315）。个体间和个体内血药浓度变异系数分别为97.0%和69.6%。患儿年龄分布2个月~14岁,年龄<6岁的患儿与年龄>6岁的患者相比,谷浓度要达到目标范围需要给予更高剂量的伏立康唑（6.1 mg·kg^-1/次vs. 4.55 mg·kg^-1/次,P<0.05）。谷浓度<1 μg·mL^-1的患儿治疗失败率高于成功率（58.8%vs. 46.5%）,但差异无统计学意义（P=0.390）。5名患儿治疗中监测谷浓度<1 μg·mL^-1且疗效不佳,通过提高给药剂量使谷浓度达1 μg·mL^-1以上,最终治疗有效。2例谷浓度≥ 5.5 μg·mL^-1的患儿均出现肝功能异常。结论：采用常规推荐剂量给药部分儿童难以达到伏立康唑的目标浓度。伏立康唑血药浓度在个体间和个体内均有较大的差异。低龄儿童要达到有效的伏立康唑血药浓度,往往需给予更高的用药剂量。开展伏立康唑药物浓度监测不仅可以保障患儿用药的安全性和有效性,同时可为合理制订我国儿童的伏立康唑初始治疗方案提供研究数据。     

甘草酸对紫杉醇增溶作用考察

目的：考察甘草酸对紫杉醇溶解度的增溶作用。方法：将不同比例甘草酸和紫杉醇,不同比例乙醇和紫杉醇进行配伍,采用高效液相色谱法检测紫杉醇的浓度;并采用电导率法检测甘草酸-紫杉醇溶液的临界胶束浓度。结果：在乙醇比例为7.5%且甘草酸浓度为10 mmol·L^-1时,紫杉醇达到最佳溶解度（823.38±14.41）μg·mL^-1,较紫杉醇水中溶解度增加约1 000倍（0.67→823 μg·mL^-1）,较紫杉醇在7.5%乙醇液中溶解度增加约100倍（8.51→823 μg·mL^-1）。紫杉醇-甘草酸溶液（含7.5%乙醇）的临界胶束浓度为0.42 mmol·L^-1,证明其在更低浓度下能形成胶束状态。结论：首次发现在甘草酸和低体积分数乙醇的协同作用下,紫杉醇水中溶解度得到有效增加,鉴于甘草酸的两亲性,安全性和一些特殊的药理活性,为制备基于甘草酸为载体的新型紫杉醇制剂奠定基础。     

HPLC-DAD波长切换法同时测定化扁汤中10种有效成分的含量

目的：采用高效液相色谱-二极管阵列检测（HPLC-DAD）波长切换法建立同时测定化扁汤中新绿原酸、绿原酸、隐绿原酸、咖啡酸、异绿原酸B、异绿原酸A、异绿原酸C、黄芩苷、连翘苷和牛蒡苷10种有效成分的定量分析方法。方法：采用SHIMADZU Insertsustain C₁₈色谱柱（250 mm×4.6 mm,5 μm）,以流动相乙腈-0.2%磷酸溶液梯度洗脱,DAD检测器,检测波长为327 nm（0~37 min,检测新绿原酸、绿原酸、隐绿原酸、咖啡酸、异绿原酸B、异绿原酸A、异绿原酸C）、278 nm（37~41.3 min,检测黄芩苷）、228 nm（41.3~50 min,检测连翘苷和牛蒡苷）,流速1.0 mL·min^-1,柱温为35℃。结果：各成分均能有效检出且分离度良好;新绿原酸、绿原酸、隐绿原酸、咖啡酸、异绿原酸B、异绿原酸A、异绿原酸C、黄芩苷、连翘苷、牛蒡苷10种成分的进样浓度分别在4.512~1.444×10² μg·mL^-1（r=0.999 9）、14.162~4.532×10² μg·mL^-1（r=1.000 0）、2.538~0.812×10² μg·mL^-1（r=0.999 9）、3.275~1.048×10² μg·mL^-1（r=0.999 9）、2.638~0.844×10² μg·mL^-1（r=0.999 9）、5.912~1.892×10² μg·mL^-1（r=0.999 9）、8.162~2.612×10² μg·mL^-1（r=0.999 9）、30.288~9.692×10² μg·mL^-1（r=0.999 9）、3.288~1.052×10² μg·mL^-1（r=0.999 9）、5.812~1.860×10² μg·mL^-1（r=0.999 9）与峰面积呈良好的线性关系;加样回收率（n=6）分别为99.1%（RSD=1.1%）、99.6%（RSD=0.9%）、100.2%（RSD=1.5%）、99.8%（RSD=1.6%）、99.5%（RSD=1.4%）、100.3%（RSD=1.0%）、100.0%（RSD=2.0%）、99.7%（RSD=1.5%）、99.6%（RSD=1.5%）、99.7%（RSD=1.9%）。结论：利用HPLC-DAD波长切换法可同时测定化扁汤中10种有效成分的含量,该法简便可靠,重现性好,为化扁汤的质量控制与评价提供科学依据。     

173例次万古霉素血药浓度监测与临床应用分析

目的：分析某院万古霉素（VAN）血药浓度监测结果,为临床合理应用提供依据。方法：采用酶放大免疫分析法监测VAN血药浓度,并对该院2013-2017年113例患者173例次VAN血药浓度监测结果进行回顾性总结分析。结果：VAN血药质量浓度均值为（17.7±14.2）μg·mL^-1,在治疗窗范围内（10~20 μg·mL^-1）的仅占31.79%,其中首次监测在治疗窗范围内的仅占28.57%,达到中毒浓度（>20 μg·mL^-1）的患者占32.95%;>60岁组患者进行血药浓度监测的比例最大（38.73%）,且血药浓度均值（23.9±17.4）μg·mL^-1超出治疗窗范围;日剂量<2 g组,<18岁及>60岁患者血药浓度均值都达到中毒浓度;肾功能异常患者与肾功能正常患者血药谷浓度有显著性差异。结论：VAN血药浓度个体差异较大,该院VAN血药浓度在治疗窗内的比例较低,需加强血药浓度监测;临床医生和药师需重视血药浓度结果与临床应用相结合,及时调整给药方案,实现个体化给药。     

二维高效液相色谱法测定血浆中氨甲环酸血药浓度方法的建立及其在关节置换术患者中的应用

目的：建立全自动二维色谱法（2D-LC-UV）测定血浆中氨甲环酸浓度的方法,用于临床上行关节置换术患者围术期氨甲环酸治疗药物浓度的监测。方法：待测物在一维柱ASTON SPX（100 mm×4.6 mm,5 μm）上初步分离,通过中间柱ASTO N SHC（10 mm×4.6 mm,3 μm）截取保留并在二维柱ASTON SX1（150 mm×4.6 mm,5 μm）上进一步分离,200 μL样品进样,并最终测定。流速均为1.0 mL·min^-1,柱温为40℃,紫外检测波长为220 nm。所建立方法运用于58名行膝关节/髋关节置换术的患者围术期中氨甲环酸血浆样本的检测分析。结果：在所建立的色谱条件下,氨甲环酸与各杂质分离良好,线性范围为5~300 μg·mL^-1,最低检测限为5 μg·mL^-1,批间批间精密度均小于6.6%,提取回收率大于72.4%。58名患者围术期中氨甲环酸首次给药后3个时间点（5 min,30 min和2 h）平均血浆浓度分别为：（103.3±20.4）μg·mL^-1,（53.0±14.8）μg·mL^-1和（22.8±8.3）μg·mL^-1。手术中男女之间氨甲环酸血药浓度无显著性差异（P>0.05）,而不同手术种类之间（膝关节/髋关节置换术）氨甲环酸血药浓度存在显著性差异（P<0.05）。结论：此法操作简单,准确、精密度好,适用于临床氨甲环酸血浆浓度的监测及浓度-疗效关系研究。     

正交设计研究丹皮酚与丹参酮ⅡA联合rhG-CSF对大鼠EPCs增殖的影响

目的：研究丹皮酚与丹参酮ⅡA联合重组人粒细胞刺激因子对大鼠内皮祖细胞（EPCs）增殖的影响。方法：采用密度梯度离心法及贴壁筛选法获得大鼠骨髓单个核细胞,以内皮细胞培养液培养,通过观察细胞形态、特异性细胞表面标志以及内皮祖细胞吞噬功能等进行鉴定;然后用MTT法检测药物对EPCs的半数抑制浓度（IC₅₀）,再用正交设计优选药物促进EPCs增殖的最佳剂量配伍。结果：细胞形态符合EPCs的生长特点,流式细胞术鉴定结果显示CD34和KDR双阳性率达到90%以上,细胞吞噬功能表明绝大多数的贴壁细胞都特异性地摄取了Dil-ac-LDL和FITC-UEA-1。丹皮酚、丹参酮ⅡA及rhG-CSF的IC₅₀值分别是0.223 9 mg·mL^-1,55.581 3 μg·mL^-1,56.701 2 μg·mL^-1;正交设计极差和方差分析,优化配伍组合剂量分别是6.996 9 μg·mL^-1,0.868 5 μg·mL^-1,14.175 0 ng·mL^-1。丹皮酚对EPCs的存活率有显著性影响（P<0.01）;其次是丹皮酚与丹参酮ⅡA交互作用和丹参酮ⅡA （P<0.05）;随着rhG-CSF剂量的增加,细胞存活率降低。结论：经鉴定培养的细胞绝大多数为EPCs。丹皮酚和丹参酮ⅡA可能协同rhG-CSF促进EPCs增殖,提高细胞存活率。丹皮酚是重要影响因素,减少了rhG-CSF的用量,发挥增效减毒的作用,可为其临床联合应用动员干细胞治疗脑缺血疾病提供实验依据。     

反相高效液相色谱法同时测定芪香胶囊中红景天苷、芍药苷及毛蕊异黄酮葡萄糖苷的含量

目的：建立高效液相色谱法同时测定芪香胶囊（黄芪、红景天、赤芍、红花）中红景天苷、芍药苷、毛蕊异黄酮葡萄糖苷3种活性成分的含量。方法：采用Phenomenex Luna色谱柱（250 mm×4.6 mm,5 μm）,以乙腈（A）和水（B）为流动相,梯度洗脱[0~11 min,A-B（10：90）,11~40 min,A-B（18：82）,40~45 min,A-B（10：90）],流速1.0 mL·min^-1,柱温为35℃,检测波长：230 nm。结果：红景天苷在55.07~192.8 μg·mL^-1、芍药苷在65.45~229.1 μg·mL^-1、毛蕊异黄酮葡萄糖苷在10.74~64.44 μg·mL^-1 范围内均呈良好线性关系;相关系数分别为0.999 8,0.999 7,0.999 8;红景天苷、芍药苷和毛蕊异黄酮葡萄糖苷的回收率分别为99.90%,100.88%,100.06%,样品溶液在24 h内稳定,含量分别为1.422 2,3.183 3,0.250 0 mg·g^-1。结论：该方法经验证,可为芪香胶囊多指标质量评价及控制提供科学依据。     

Stability of intravenous admixtures of doxorubicin and vincristine

The stability of doxorubicin and vincristine in admixtures containing both drugs in 0.9% sodium chloride injection, 0.45% sodium chloride and Ringer's acetate injection, and 0.45% sodium chloride and 2.5% dextrose injection was studied. Doxorubicin hydrochloride was added to 30-mL quantities of each base solution to achieve initial doxorubicin concentrations of 1.40 mg/mL and to 0.9% sodium chloride injection to achieve concentrations of 1.88 and 2.37 mg/mL. Vincristine sulfate was added to each doxorubicin admixture to achieve vincristine concentrations of 0.033 and 0.053 mg/mL. All admixtures were protected from light and stored in polysiloxan bags that are used with portable delivery devices. Admixtures were kept at temperatures of 25, 30, and 37 degrees C. Samples withdrawn immediately after preparation and at 1, 2, 4, 7, 10, and 14 days were analyzed by high-performance liquid chromatography for content of each drug. The stability of doxorubicin was dependent on temperature and composition of the base solution. Analysis of data from the samples containing 0.45% sodium chloride and Ringer's acetate injection showed that doxorubicin concentrations were less than 90% of the initial concentration by 12 hours at 37 degrees C, 35 hours at 30 degrees C, and 62 hours at 25 degrees C, and visual changes occurred in all of these admixtures over the course of the study. Vincristine degradation also was most rapid in 0.45% sodium chloride and Ringer's acetate admixtures. Data analysis showed that concentrations of vincristine were less than 90% of initial after eight days at 25 degrees C, five days at 30 degrees C, and three days at 37 degrees C.(ABSTRACT TRUNCATED AT 250 WORDS)     

表柔比星、长春新碱和依托泊苷3种化疗药物混合配制的配伍稳定性考察

目的： 考察临床常用表柔比星、长春新碱和依托泊苷（EPOCH）方案中药物混合配制的配伍稳定性。方法： 选择临床常用3种药物剂量范围,混合配制低、中、高3种浓度注射液,考察不同浓度注射液室温放置24 h的配伍稳定性。结果： 经过24 h室温未避光条件放置后,各组混合配制溶液性状未发生肉眼可见改变,分别使用液相色谱和液质联用方法进行检测,含量均在90%以上。结论： EPOCH混合配制方案在室温未避光条件下放置24 h稳定,配伍稳定,但仍需注意配制环节的风险和质量控制。     

Compatibility of clindamycin phosphate with cefotaxime sodium or netilmicin sulfate in small-volume admixtures

The stability and compatibility of clindamycin phosphate plus either cefotaxime sodium or netilmicin sulfate in small-volume intravenous admixtures were studied. Admixtures containing each drug alone and two-drug admixtures of clindamycin phosphate plus cefotaxime sodium or netilmicin sulfate were prepared in 100 mL of 5% dextrose injection and 0.9% sodium chloride injection in both glass bottles and polyvinyl chloride (PVC) bags. Final concentrations of clindamycin, cefotaxime, and netilmicin were 9, 20, and 3 mg/mL, respectively. All solutions were prepared in duplicate and stored at room temperature (24 +/- 2 degrees C). Samples were visually inspected, tested for pH, and assayed for antibiotic concentration using stability-indicating assays at 0, 1, 4, 8, 16, and 24 hours for admixtures in glass bottles and at 0, 8, and 24 hours for admixtures in PVC bags. No substantial changes in color, clarity, pH, or drug concentration were observed in any of the solutions. Clindamycin phosphate is compatible with cefotaxime sodium or netilmicin sulfate in 5% dextrose and 0.9% sodium chloride injections in glass bottles or PVC bags for 24 hours.     

反相高效液相色谱法测定2型糖尿病人群血浆中盐酸二甲双胍浓度

目的：建立盐酸二甲双胍血药浓度测定的反相高效液相色谱法,并测定2型糖尿病人群血浆中盐酸二甲双胍药物浓度。方法：建立反相高效液相色谱法测定盐酸二甲双胍血药浓度,以阿替洛尔为内标,并考察方法学的专属性、线性、定量下限、精密度、准确度、回收率和稳定性。12名2型糖尿病患者连续服药3天以上,利用反相高效液相色谱法测定血浆中盐酸二甲双胍的稳态谷浓度和稳态峰浓度。结果：盐酸二甲双胍在血浆中浓度线性范围是0.2~5 μg·mL^-1,标准方程为Y=1.153X+0.036 6 （R²=0.999 9）,定量下限为0.2 μg·mL^-1。准确度（RE）在±5.58%以内,批内、批间精密度（RSD） ≤ 9.96%,提取回收率在65%~76.9%之间。治疗药物监测显示,12名2型糖尿病患者稳态谷浓度平均值为0.87 μg·mL^-1 （0.4~1.39 μg·mL^-1）,稳态峰浓度平均值为2.47 μg·mL^-1（0.7~3.41 μg·mL^-1）。结论：该法专属性强,灵敏度高,适用于2型糖尿病人群二甲双胍治疗药物监测。     

高效液相色谱-二极管阵列检测器同时测定清热祛浊胶囊中6种活性成分的含量

目的：建立高效液相色谱同时测定清热祛浊胶囊中绿原酸、栀子苷、芍药苷、盐酸小檗碱、连翘苷和丹皮酚含量的方法。方法：采用Agilent Eclipse XDB-C₁₈色谱柱,流动相为乙腈（A）和0.1%的磷酸水溶液（B）,梯度洗脱;流速：1.0 mL·min^-1;柱温：30℃;检测波长：绿原酸为327 nm,栀子苷、芍药苷和连翘苷为230 nm,盐酸小檗碱和丹皮酚为274 nm。结果：绿原酸、栀子苷、芍药苷、盐酸小檗碱、连翘苷和丹皮酚的线性范围分别为8.64~216 μg·mL^-1（r=0.999 8）,4.08~102 μg·mL^-1（r=0.999 8）,4.20~105 μg·mL^-1（r=0.999 9）,9.12~228 μg·mL^-1（r=0.999 8）,3.28~82.0 μg·mL^-1（r=0.999 9）和4.84~121 μg·mL^-1（r=0.999 8）,6种成分的平均加样回收率（n=6）分别为99.2%,99.1%,98.6%,98.6%,98.9%和99.3%,RSD分别为1.0%,1.1%,1.2%,1.0%,0.8%和0.9%。结论：本法结果准确,重现性好,回收率高,可用于清热祛浊胶囊的质量控制。     

复方小檗碱鞣酸蛋白胶囊的质量控制研究

目的：建立测定复方小檗碱鞣酸蛋白胶囊中4种成分含量及马来酸氯苯那敏与硝酸硫胺含量均匀度的方法。方法：采用均匀实验优选复方小檗碱鞣酸蛋白胶囊中4种成分含量测定提取方法,采用十八烷基硅烷键合硅胶为填充剂;以磷酸盐缓冲液[0.05 mol·L^-1磷酸二氢钾溶液和0.05 mol·L^-1庚烷磺酸钠溶液（1：1）,含0.2%三乙胺,并用磷酸调节至pH 3.0]-甲醇（43：57）为流动相;检测波长262 nm;进样量10 μL,测定复方小檗碱鞣酸蛋白胶囊中盐酸小檗碱、马来酸氯苯那敏、硝酸硫胺和乳酸依沙吖啶含量及马来酸氯苯那敏与硝酸硫胺含量均匀度。结果：硝酸硫胺在25.02~200.2 μg·mL^-1、马来酸氯苯那敏在6.555~78.66 μg·mL^-1、盐酸小檗碱在12.01~96.06 μg·mL^-1和乳酸依沙吖啶在2.491~24.91 μg·mL^-1范围内呈良好的线性关系。回收率分别为104.19%、98.41%、100.48%和98.72%,RSD（n=9）分别为0.56%、1.16%、1.72%和1.67%。结论：建立了简便、快速、准确测定复方小檗碱鞣酸蛋白胶囊中4种成分含量及马来酸氯苯那敏与硝酸硫胺含量均匀度的方法,为复方小檗碱鞣酸蛋白胶囊质量标准的完善提高提供依据。     

Compatibility of etoposide phosphate with selected drugs during simulated Y-site injection

OBJECTIVE: To evaluate the physical compatibility of etoposide phosphate with 101 selected secondary drugs, including antineoplastic chemotherapy agents, anti-infectives, and supportive care drugs, during simulated Y-site injection. DESIGN: Five-milliliter samples of etoposide 5 mg/mL as phosphate in 5% dextrose injection were mixed with 5 mL of the selected drugs diluted in 5% dextrose injection or, if necessary to avoid incompatibilities with the diluent, 0.9% sodium chloride injection. Samples were examined visually in normal fluorescent light with the unaided eye and using a Tyndall beam (high-intensity monodirectional light) to enhance the visibility of small particles and low-level haze. Turbidity of each sample was measured. In selected samples, electronic particle content assessment was performed. All of the samples were assessed initially and at one and four hours. RESULTS: Most of the secondary drugs were physically compatible with etoposide phosphate during the four-hour observation period. However, seven drug combinations had incompatibilities that included color change, increase in haze or turbidity, particulate formation, and gross precipitation. The drugs that were observed to be physically incompatible with etoposide phosphate were amphotericin B, cefepime hydrochloride, chlorpromazine hydrochloride, imipenem-cilastatin sodium, methylprednisolone sodium succinate, mitomycin, and prochlorperazine edisylate. CONCLUSION: Etoposide 5 mg/mL as phosphate in 5% dextrose injection is physically compatible for four hours at room temperature during simulated Y-site administration with 94 of the 101 drugs selected. Simultaneous Y-site administration of etoposide phosphate with the seven incompatible drugs should be avoided.     

Stability of cisplatin and etoposide in intravenous admixtures

The stability of various concentrations of etoposide and cisplatin in intravenous admixtures under various storage conditions was studied. Admixtures containing etoposide (200 and 400 micrograms/mL) with cisplatin (200 micrograms/mL) were prepared in 0.9% sodium chloride injection and in 5% dextrose and 0.45% sodium chloride injection. The admixtures were stored in either polyvinyl chloride bags or glass bottles. Mannitol and potassium chloride were added to selected admixtures. Half of the admixtures were protected from light, while the other half were exposed to fluorescent light. All admixtures were stored at room temperature. Samples were visually inspected and assayed for etoposide and cisplatin content by high-performance liquid chromatography within 15 minutes after admixture preparation and after 8, 24, and 48 hours of storage. Etoposide and cisplatin concentrations decreased less than 10% from the initial concentration after eight hours of storage. At 24 hours, the admixtures containing etoposide 400 micrograms/mL and cisplatin 200 micrograms/mL (with additives) in 0.9% sodium chloride injection precipitated. The decrease in etoposide concentrations during the first 24 hours in the rest of the admixtures was less than 10% of the initial concentration. The change in etoposide concentration was related to the type of i.v. solution and the presence of additives. After 24 hours, the change in cisplatin concentrations was less than 10% of the initial concentration, except in the admixtures that precipitated. For cisplatin, the presence of light was related to an increased loss of cisplatin concentration.(ABSTRACT TRUNCATED AT 250 WORDS)     

Compatibility of ciprofloxacin injection with selected drugs and solutions.

The compatibility of ciprofloxacin injection with selected antimicrobials and aminophylline was studied. Ciprofloxacin, amikacin sulfate, aminophylline, clindamycin phosphate, gentamicin sulfate, and tobramycin sulfate were mixed separately in minibags containing 0.9% sodium chloride injection or 5% dextrose injection; admixtures were stored for up to 48 hours at either 4 degrees C or 25 degrees C. Ciprofloxacin was also combined separately with each of the other drugs and solutions and stored under the same conditions. In addition, ciprofloxacin was combined with metronidazole in ready-to-use mini-bags of the latter drug and stored at 25 degrees C. Drug concentrations were measured by fluorescence polarization immunoassay or high-performance liquid chromatography. All admixtures were also examined visually. Stability was defined as retention of at least 90% of the original drug concentration with no visual evidence of incompatibility. With one exception, drugs in all single-drug admixtures were stable for 48 hours. The drug concentration eight hours after amikacin was mixed in 0.9% sodium chloride and refrigerated was 89% of the original concentration. When ciprofloxacin was combined with gentamicin, metronidazole, or tobramycin, all of the involved drugs were stable for 48 hours. Compatibility of ciprofloxacin-amikacin admixtures depended on the fluid and storage temperature; all such admixtures were stable for at least eight hours. A precipitate formed immediately whenever ciprofloxacin was mixed with clindamycin and within four hours after ciprofloxacin was mixed with aminophylline. Ciprofloxacin injection was compatible with gentamicin, metronidazole, and tobramycin and incompatible with aminophylline and clindamycin. The compatibility of ciprofloxacin-amikacin admixtures depended on the i.v. solution and storage temperature.     

Stability of amrinone and digoxin, procainamide hydrochloride, propranolol hydrochloride, sodium bicarbonate, potassium chloride, or verapamil hydrochloride in intravenous admixtures.

The stability of amrinone and digoxin, procainamide hydrochloride, propranolol hydrochloride, sodium bicarbonate, potassium chloride, or verapamil hydrochloride in intravenous admixtures was studied. Admixtures of amrinone and digoxin were studied at one concentration. Amrinone admixtures with propranolol hydrochloride, sodium bicarbonate, potassium chloride, and verapamil hydrochloride were studied at two concentrations. In general, 0.45% sodium chloride injection was used as the diluent; 5% dextrose injection was also used for the procainamide hydrochloride experiments. Duplicate solutions of each test admixture and single-drug control admixture were prepared and stored for four hours at 22-23 degrees C under fluorescent light. Samples were analyzed by visual inspection, tested for pH, and assayed by high-performance liquid chromatography. Admixtures containing amrinone 1.25 or 2.5 mg/mL (as the lactate salt) and sodium bicarbonate 37.5 mg/mL precipitated immediately or within 10 minutes. No changes in pH or visual appearance were noted for amrinone admixtures with procainamide hydrochloride, digoxin, propranolol hydrochloride, potassium chloride, and verapamil hydrochloride. Appreciable degradation of both amrinone and procainamide was observed after four hours when the two were mixed in 5% dextrose. No degradation of amrinone or procainamide was seen when the 5% dextrose was replaced by 0.45% sodium chloride. Amrinone and sodium bicarbonate were incompatible in intravenous admixtures. Amrinone was compatible with digoxin, propranolol hydrochloride, potassium chloride, and verapamil hydrochloride. Amrinone and procainamide were compatible in 0.45% sodium chloride injection but not in 5% dextrose injection.