盐酸多巴酚丁胺葡萄糖注射液制备工艺研究

目的：研究盐酸多巴酚丁胺葡萄糖注射液的制备工艺。方法：参考美国药典处方考察不同浓度的稳定剂、葡萄糖及盐酸多巴酚丁胺的吸附脱色，不同的灭菌条件及pH值。结果：制定了盐酸多巴酚丁胺葡萄糖注射液的处方与制备工艺。结论：制剂处方合理，工艺简便。     

盐酸多巴酚丁胺注射液处方及制备工艺研究

目的：研究盐酸多巴酚丁胺注射液处方及制备工艺。方法：以注射液的性状、PH、含量、有关物质为考察指标,通过加速试验,比较各处方的优劣,确定抗氧剂用量、金属络合剂用量、PH范围、活性炭用量和灭茵温度及时间。确定处方及制备工艺。结果：通过实验研究获得了优选的盐酸多巴酚丁胺注射液处方及制备工艺。结论：本品处方及工艺稳定、简便、易行。     

盐酸多巴酚丁胺注射液细胞毒性研究

目的：比较不同来源盐酸多巴酚丁胺注射液体外细胞毒性的差别,为遴选优质药品、保障用药安全提供科学依据.方法：将不同来源国产盐酸多巴酚丁胺注射液原液以及稀释液,与L929细胞接触培养,通过倒置相差显微镜观察其形态,采用MTT法量化细胞毒性,计算相对增值率和IC50值,进行细胞毒性评价.并将国产盐酸多巴酚丁胺注射液与进口制剂进行比较.结果：8个厂家生产的盐酸多巴酚丁胺注射液原液及进口产品的细胞毒性分级均为4级.不同企业生产的盐酸多巴酚丁胺注射液的IC50值差异较大.盐酸多巴酚丁胺注射液C和F的IC50值较小,说明这两个企业产品的细胞毒性较其他样品大.进口盐酸多巴酚丁胺注射液的IC50值为99.9 mg·L-1,较其他样品高,说明其细胞毒性较其他样品低.进口盐酸多巴酚丁胺注射液中仅添加亚硫酸氢钠一种辅料,国产盐酸多巴酚丁胺注射液中添加的辅料主要为依地酸二钠、亚硫酸氢钠、盐酸半胱氨酸等.按各辅料在国产盐酸多巴酚丁酸注射液中的浓度测其细胞毒性,依地酸二钠、盐酸半胱氨酸和亚硫酸氢钠的细胞毒性分级均为3级.将依地酸二钠的浓度稀释为0.03 mg·ml-时,其细胞毒性分级为1级,无细胞毒性.将盐酸半胱氨酸稀释到0.11 mg·ml-1时,其细胞毒性分级为1级,基本无细胞毒性.结论：不同厂家生产的盐酸多巴酚丁胺注射液由于生产条件不同、处方不同等原因,这些产品的细胞毒性存在较大的差别.与进口制剂比较,国产制剂中添加的辅料浓度较大,可适当降低其浓度,以减少药物制剂的细胞毒性,从而提高药品的安全性.     

法莫替丁葡萄糖注射液的制备工艺研究

目的:获得优化的法莫替丁葡萄糖注射液处方与制备工艺.方法:通过考察注射液的性状、颜色、pH以及主药、辅药的降解情况,获得处方的组成以及生产工艺.结果:通过试验研究,获得了优选的法莫替丁葡萄糖注射液的处方与制备工艺.结论:筛选得到的法莫替丁葡萄糖注射液处方合理,制备工艺可行,适合于工业化大生产.     

细菌内毒素检查法与家兔法同步检测盐酸多巴酚丁胺葡萄糖注射液热原的比较

目的考察细菌内毒素检查法与家兔法对盐酸多巴酚丁胺葡萄糖注射液进行热原检测结果的比较,以确定细菌内毒素检查法的可行性.方法用细菌内毒素检查法对供试品进行干扰实验,并以家兔法作对照,以明确供试品对鲎试验是否有干扰作用.结果供试品对鲎试验无干扰作用.结论用细菌内毒素检查法检测盐酸多巴酚丁胺葡萄糖注射液的热原是可行的.     

盐酸多巴酚丁胺葡萄糖注射液中盐酸多巴酚丁胺的HPLC测定

建立了HPLC法测定盐酸多巴酚丁胺葡萄糖注射液中盐酸多巴酚丁胺的含量.采用ODS柱,流动相为乙腈-磷酸盐缓冲溶液(((NH4)3PO4o3H2O)5.7g,加水1900ml,用磷酸调节pH值至2.4,补水至2000ml,摇匀)(梯度洗脱);检测波长284nm.盐酸多巴酚丁胺的线性范围为186～934 μg/ml,平均回收率为99.9%,RSD为0.11%.     

盐酸多巴酚丁胺葡萄糖注射液的HPLC测定

建立了盐酸驳巴酚丁胺葡萄糖注射液以及葡萄糖降解产物5-羟甲基糖醛含量的HPLC测定法。用DiamonsilC18色谱柱，以辛烷磺酸钠缓冲液（pH2.5）-乙腈-甲醇（58：28：14）为流动相，检测波长为278nm。盐酸多巴酚丁胺和5-羟甲基糖醛分别在50-200μg/ml和0.25-3.5μg/ml范围内线性关系良好。盐酸多巴酚丁胺的方法平均回收率为100.0％，RSD为1.0％。日内和日间精密度小于1.6％。     

高效液相色谱法测定盐酸多巴酚丁胺注射液中盐酸多巴酚丁胺的含量

目的建立测定盐酸多巴酚丁胺注射液中盐酸多巴酚丁胺的含量的HPLC方法。方法采用ODS柱,流动相为乙腈-磷酸盐缓冲溶液（取磷酸铵2.75g,加水950ml,用磷酸调节pH值至2.4,补水至1000ml,摇匀）（梯度洗脱）;检测波长282nm,流速1.0ml/min,柱温30℃。结果盐酸多巴酚丁胺的在浓度93.4～934μg/ml与峰面积呈良好的线性关系,平均回收率为99.9%,RSD为0.11%。结论所建立的方法简便易行,准确可靠,可用于盐酸多巴酚丁胺注射液中盐酸多巴酚丁胺的含量测定。     

盐酸多巴酚丁胺和注射用硝普钠在输液中的配伍实验

盐酸多巴酚丁胺为β肾上腺素受体激动药。临床上常与硝普钠联合使用治疗急性心肌梗塞及心排血量低的心衰取得满意效果。但是在注射用硝普钠使用说明书中注有“本品除用5％葡萄糖溶液稀释外,不可加其它药物”的说明。为了探讨盐酸多巴酚丁胺和注射用硝普钠混合配伍的可能性,方便临床用药,我对此进行了实验研究,现报告如下:     

以3-甲基苯并噻唑-2-一腙为显色剂的分光光度法测定盐酸多巴酚丁胺

盐酸多巴酚丁胺为一拟交感神经药,直接作用于肾上腺β受体,其作用平稳,对心脏有显著影响,盐酸多巴酚丁胺针剂广泛用于器质性心脏病的心力衰竭、     

盐酸丁咯地尔注射液的制备工艺研究

目的对盐酸丁咯地尔注射液处方及工艺进行初步研究,以期得到质量可靠的制剂。方法以澄明度、pH值、含量、有关物质为考察指标,通过加速试验,比较各处方的优劣,确定最佳处方、活性炭用量、灭菌时间及制备工艺;并采用HPLC法测定各处方中的含量及有关物质。结果优选出盐酸丁咯地尔注射液最佳制备工艺。结论本品处方及工艺稳定、简便、易行。     

盐酸溴己新3种注射剂型静脉滴注时药物含量的变化

目的比较盐酸溴己新注射液(水针,liquid injection)、注射用盐酸溴己新(粉针,solid injec-tion)和盐酸溴己新葡萄糖注射液(葡萄糖输液,glucose infusion)3种制剂在配制与注射过程中药物含量的变化。方法粉针、水针分别加至葡萄糖注射液中静脉滴注,与葡萄糖输液比较配制与注射过程中滴出液中盐酸溴己新含量的变化。结果粉针、水针与葡萄糖注射液混合振摇10 min与振摇1 min药物含量差异没有统计学意义;粉针、水针经输液器输注过程中,出现药物含量下降,在每分钟30滴的滴速下,粉针含量质量分数下降最高达9.2%,水针含量质量分数下降最高达19.8%,输液药物含量在输注过程中没有下降;粉针、水针在滴速为每分钟15滴时,药物含量下降多于每分钟30滴和60滴。药物滴完后,测定滴管内的药物残留量,发现输液器内有药物残留,比较不同厂家生产的8种输液器,其均有不同程度的药物残留,导致粉针、水针输注到患者体内的药量明显减少。结论冻干粉针、小水针在滴注过程中出现输液器对药物的吸附问题,注射速度越慢,药物进入患者体内的量越少,药物的含量质量分数最高损失可达标示量的20%。提示临床用药时注意!     

注射用头孢吡肟在急诊应用中的处方点评

目的探讨急诊处方的点评程序和方法,建立急诊抗菌药物使用合理性评估程序。方法利用医院信息系统采集某医院2009年3月至2009年8月期间注射用头孢吡肟急诊处方信息和病历信息,并对2009年8月开具的注射用头孢吡肟处方进行逐一分析,分析该药品的消耗趋势,并对用药指征、用药方案、用药手续等逐一进行点评。结果该院急诊注射用头孢吡肟应用以治疗复杂性腹腔内感染和皮肤及软组织感染为主,分别占64.69%和13.95%;用法用量的合理率为91.80%;联合用药合理率为87.83%;使用申请程序规范率仅有20.18%。提示应当对注射用头孢吡肟分级管理规定的落实情况、与其他药物的联合应用进行重点干预。结论急诊抗菌药物处方点评程序的建立克服了处方分析的局限性,充分考虑了病种病情的复杂程度,可以比较客观地评估临床药物使用的合理性。     

Stability and compatibility of tirofiban hydrochloride during simulated Y-site administration with other drugs.

The stability and compatibility of tirofiban hydrochloride injection during simulated Y-site administration with various other drugs were studied. Tirofiban hydrochloride, dobutamine, epinephrine hydrochloride, furosemide, midazolam hydrochloride, and propranolol hydrochloride injections were each prepared from their respective concentrates in both 0.9% sodium chloride injection and 5% dextrose injection at both the minimum and maximum concentrations normally administered. The high-concentration solutions of midazolam hydrochloride and furosemide were used as is. Morphine sulfate was diluted in 5% dextrose injection only. Nitroglycerin premixed infusions, atropine sulfate injection, and diazepam injection were used as is. Tirofiban hydrochloride solutions were combined 1:1 with each of the secondary drug solutions in separate glass containers. Samples were stored for four hours at room temperature under ambient fluorescent light and were assayed for drug content and degradation by high-performance liquid chromatography and for pH, appearance, and turbidity. All mixtures except those containing diazepam remained clear and colorless, with no visual or turbidimetric indication of physical instability. Mixing of tirofiban hydrochloride and diazepam solutions resulted in immediate precipitation. all remaining mixtures remained clear. There was no significant loss of any of the drugs tested, no increase in known degradation products, and no appearance of unknown drug-related peaks. The pH of all test solutions remained constant. Tirofiban hydrochloride injection 0.05 mg/mL was stable for at least four hours when combined 1:1 in glass containers with atropine sulfate, dobutamine, epinephrine hydrochloride, furosemide, midazolam hydrochloride, morphine sulfate, nitroglycerin, and propranolol hydrochloride at the concentrations studied. Tirofiban hydrochloride was incompatible with diazepam.     

盐酸消旋山莨菪碱注射液处方的优化研究

目的 优化盐酸消旋山莨菪碱注射液工艺处方,提高产品稳定性。方法 盐酸消旋山莨菪碱注射液工艺处方改为预先配制盐酸溶液,再将消旋山莨菪碱缓缓加入盐酸溶液中,成盐时pH值控制在5.0～5.2。结果 工艺处方更改后,可降低产品的有关物质,提高稳定性。结论 经处方优化后,盐酸消旋山莨菪碱注射液可在室温条件下稳定储存。     

门冬氨酸洛美沙星注射液的制备工艺研究

目的：获得优化的门冬氨酸洛美沙星注射液的处方与制备工艺。方法：通过考察注射液的性状、颜色、pH以及主药的降解情况,获得处方的组成以及生产工艺。结果：通过实验研究,获得了优选的门冬氨酸洛美沙星注射液的处方与制备工艺。结论：筛选得到的门冬氨酸洛美沙星注射液处方合理,制备工艺可行,适合于工业化大生产。     

Stability of dobutamine hydrochloride and verapamil hydrochloride in 0.9% sodium chloride and 5% dextrose injections

The stability of dobutamine hydrochloride (250 micrograms/ml) and verapamil hydrochloride (160 micrograms/ml) alone and in combination in 0.9% sodium chloride injection or 5% dextrose injection was studied. Solutions were stored both in plastic i.v. bags and in amber-colored glass bottles at 24 degrees C and 5 degrees C for up to seven days. Before storage and at various times during storage, solutions were assayed at least in triplicate by high-performance liquid chromatography, pH was recorded, and visual appearance was noted. All solutions tested under all conditions retained at least 90% potency for seven days. In plastic i.v. bags, dobutamine either alone or in combination with verapamil in both diluents turned a light-pink color in 24 hours at 24 degrees C. The intensity of the pink color increased with time in 0.9% sodium chloride injection; in 5% dextrose injection, solutions, became clear in 48 hours. The pH of solutions prepared in plastic i.v. bags in 5% dextrose injection decreased from 4.0 to 3.1 during the seven-day period at 24 degrees C; results for solutions in amber bottles were similar. At 5 degrees C, the pH and clarity of all solutions in bags and bottles remained stable for seven days. At the concentrations tested, dobutamine hydrochloride combined with verapamil hydrochloride is stable in 0.9% sodium chloride injection and 5% dextrose injection for 48 hours at 24 degrees C and for seven days at 5 degrees C.