次氯酸钠窦腔滴注液的制德及其稳定性

目择次氯酸钠窦腔滴注液的制备及其稳定性进行研究。方法：采用留样观察法。结果：2.5%次氯酸钠液,pH=13时,t0.9为170d,加入氮化硼作为稳定剂,t0.9为306d,0.0d25%次氯酸钠窦腔滴注液,pH=7.2,含氮化硼0.0075ug.ml^-1时有效期为18d。结论：次氯酸钠窦腔滴注液在碱性（pH=13)环境下稳定,加入氮化硼后稳定性显著增高。     

次氯酸钠窦腔滴注液的制备及其稳定性

目的:对次氯酸钠窦腔滴注液的制备及其稳定性进行研究。方法:采用留样观察法。结果:2.5%次氯酸钠液,pH＝13时,t0.9为170d,加入氮化硼作为稳定剂,t0.9为306d,0.025%次氯酸钠窦腔滴注液,pH＝7.2,含氮化硼0.0075μg·ml-1时有效期为18d。结论:次氯酸钠窦腔滴注液在碱性(pH=13)环境下稳定,加入氮化硼后稳定性显著增高。     

次氯酸钠等4种鼻窦腔局部抗菌药的鼻粘膜纤毛毒性研究

目的 :考察次氯酸钠、林可霉素、甲硝唑、庆大霉素等窦腔滴注液对鼻粘膜纤毛毒性。方法 :以在体蛙上腭粘膜为动物实验模型 ,连续点滴给药 (1 0 0mL/次 ,qd)。 结果 :0 .0 2 %～ 0 .0 3 %次氯酸钠溶液、0 .3 %林可霉素溶液、0 .5 %甲硝唑溶液未见明显毒性反应 ,浓度≥ 0 .0 35 %的次氯酸钠溶液和 2× 1 0 5U·L- 1 的庆大霉素溶液对蛙腭粘膜具有一定毒性 ,连续给药损伤加重。结论 :0 .0 2 %～ 0 .0 3 %次氯酸钠溶液、0 .3 %林可霉素溶液、0 .5 %甲硝唑溶液可作为鼻窦腔局部常规制剂应用     

pH对红霉素稳定性及抑菌作用的影响

目的:研究pH对红霉素葡萄糖滴注液稳定性及抑菌作用的影响.方法:采用高效液相色谱法、pH值测定法和测定最小抑菌浓度的方法考察pH对红霉素稳定性及抑菌作用的影响.结果:通过加入碳酸氢钠调节红霉素葡萄糖滴注液pH值后其稳定性明显提高,对部分菌株的抑菌活性增强.结论:加入碳酸氢钠有利于红霉素葡萄糖溶液的稳定性和抑菌活性;临床在使用葡萄糖溶液稀释乳糖酸红霉素时应严格按照药品说明书的要求加入规定量的碳酸氢钠.     

氧氟沙星漱口液的配制及稳定性试验

目的：配制氧氟沙星漱口液，并考察其稳定性。方法：通过参考有关资料，确定处方和制备方法，并采用紫外分光光度法测定氧氟沙星含量，进行稳定性研究。结果：初均速法考察稳定性，线性关系良好，预测其室温有效期为t0.9=310d，氧氟沙星平均回收率为99.46%，RSD=1.92%(n=5)。结论：该制剂稳定性良好，可作为临床辅助治疗药物。     

注射用加替沙星与美洛西林的配伍稳定性考察

目的:考察注射用加替沙星与美洛西林在0.9%氯化注射液和5%葡萄糖注射液中的配伍稳定性。方法:分别考察配伍液在室温(20±1)℃下放置8h内的外观、pH值变化,并用紫外双波长分光光度法测定其含量。结果:2药在0.9%氯化钠注射液中pH值和含量无显著变化,但在4h时配伍液出现极少量细微粉末状沉淀使溶液混浊;在5%葡萄糖注射液中加入美洛西林溶解后再加入加替沙星立即出现少量细微粉末状沉淀并使溶液混浊。结论:注射用加替沙星与美洛西林在0.9%氯化钠注射液中可以配伍使用,但宜在4h内滴注完毕;2药在5%葡萄糖注射液中不能配伍使用。     

刺五加注射液致过敏反应

患者男,78岁。因反复头痛、鼻塞3周,于2006年5月15日来我院就诊。查体:副鼻窦区压痛,脓涕,MRI检查诊断为左侧上颌窦炎及筛窦炎、腔隙性脑梗死。医嘱给予头孢曲松钠4g加入0.9%氯化钠溶液250ml静脉滴注,1次/d;灯盏花素注射液4mg加入0.9%氯化钠溶液250ml静脉滴注,1次/d。治疗10d患     

注射用盐酸椒苯酮胺配伍稳定性研究

目的 考察注射用盐酸椒苯酮胺在不同制剂中的配伍稳定性.方法 采用高效液相色谱(HPLC)法测定注射用盐酸椒苯酮胺在10％葡萄糖注射液(pH=4.4)、5％葡萄糖注射液(pH=4.8)、5％葡萄糖氯化钠注射液(pH=3.9)和0.9％氯化钠注射液(pH=5.1)中的溶液澄清度、颜色、澄明度,并测定2,6,12,24h时含量变化.结果 本品在酸性液体中稳定,加入10％葡萄糖、5％葡萄糖或5％葡萄糖氯化钠注射液中,24 h内稳定性良好.结论 本品可加入葡萄糖注射液或5％葡萄糖氯化钠注射液中使用,不宜加入0.9％氯化钠注射液中使用.     

两种化疗方案治疗非小细胞肺癌的临床疗效观察

目的：观察并比较两种化疗方案治疗非小细胞肺癌（NSCLC）的临床疗效。方法：128例NSCLC患者随机分为DP组和GP组各64例,DP组：多西他赛75mg/m2,加入250ml5%的葡萄糖溶液,静脉滴注,d1,顺铂30mg/m2加入250ml0.9%氯化钠溶液,d1～3。GP组：吉西他滨1000mg/m2,加入0.9%氯化钠溶液250ml,静脉滴注,d1、d8,顺铂30mg/m2加入250ml0.9%氯化钠溶液,静脉滴注,d1～3。两组患者均以用药21d为1个周期,连续用药3个周期观察疗效。结果：DP组和GP组总有效率为分别46.9%和45.3%,差异无统计学意义（χ2=0.377,P〉0.05）,两组疾病控制率分别为93.8%和95.3%,差异无统计学意义（χ2=0.321,P〉0.05）。两组毒副反应以恶心呕吐、白细胞减少、中性粒细胞减少、血小板减少和血红蛋白降低为主,其中血小板减少Ⅲ～Ⅳ度发生率差异有统计学意义（χ2=3.263,P〈0.05）,其他指标比较差异无统计学意义（P〉0.05）。结论：DP方案和GP方案治疗NSCLC临床效果显著,且毒副反应类似,均可作为治疗NSCLC的有效药物。     

氧氟沙星漱口液的研制及稳定性考察

目的：配制氧氟沙星漱口液，并考察其稳定性。方法：通过参考有关资料确定处方、制备方法，并采用紫外分光光度法测定其氧氟沙星含量，采用初均速法考察其稳定性。结果：初均速法考察稳定性，线性关系良好，预测其室温有效期为t0.9=310d。氧氟沙星回收率为99．6％，RSD=2．0％（n=5）。结论：该制剂稳定性良好，可作为临床辅助治疗药物。     

硫酸肼的工業制法

一、緒言硫酸肼在第二次世界大战前,还只是試驗室中的一种試剂.近几年来成为一种很重要的工業原料.它能还原許多金属氧化物,如二氧化錳等.从它可以作成肼或水合肼,便可以还原許多的金屬离子、金屬氧化物而生成純金屬,所以在制造金屬接触剂的     

Intropin (dopamine hydrochloride) intravenous admixture compatibility. Part 1: stability with common intravenous fluids.

The stability of dopamine hydrochloride (Intropin) in several large-volume parenteral solutions was studied. Admixtures of dopamine were assayed by colorimetric and chromatographic procedures. Admixtures (800 mug dopamine per ml) in the following intravenous fluids in glass bottles at pH 6.85 or below were found to be chemically and physically stable for at least 48 hours at room temperature: dextrose 5%, dextrose 5% and sodium chloride 0.9%, 5% dextrose in 0.45% sodium chloride, dextrose 5% in lactated Ringer's solution, lactated Ringer's injection, 0.9% sodium chloride, 1/6 molar sodium lactate, and 20% mannitol. The admixture of dopamine in 5% dextrose was stable for a minimum of seven days at 5 C. A 5% dextrose-dopamine admixture in a polyvinylchloride bag was stable for at least 24 hours at room temperature. The admixture of dopamine in 5% sodium bicarbonate solution produced an unstable solution of pH 8.20. A chemical and physical change (development of a pink color) was observed in this admixture. It is recommended that dopamine not be added to 5% sodium bicarbonate solution or any alkaline intravenous solution.     

不同溶剂与奥美拉唑钠配伍稳定性考察

目的:研究注射用奥美拉唑钠在7种溶剂中的配伍稳定性。方法:将40 mg奥美拉唑加入0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液、果糖、5%碳酸氢钠溶液、10%葡萄糖酸钙溶液、25%硫酸镁溶液中,用高效液相色谱法测定配伍后的奥美拉唑钠的含量,并测定其pH值及观察液体变化,观察温度对0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液中奥美拉唑钠颜色的影响。结果:注射用奥美拉唑钠与7种溶剂配伍后,其中0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液在1 h内未出现颜色的变化,但放置3 h后5%葡萄糖注射液、10%葡萄糖注射液的液体由无色变为淡黄色,而果糖、10%葡萄糖酸钙及25%硫酸镁溶液30 min后即出现了颜色的变化以及沉淀。在37℃下,5%葡萄糖注射液、10%葡萄糖注射液在1 h内就出现了颜色变化。结论:奥美拉唑钠可以与0.9%氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液配伍,其中以0.9%氯化钠注射液最佳,但与5%葡萄糖注射液、10%葡萄糖注射液配伍要注意温度以低于25℃为宜,放置时间不宜超过2 h,而果糖、10%葡萄糖酸钙溶液、25%硫酸镁溶液与奥美拉唑钠配伍禁忌。     

注射用甲泼尼龙琥珀酸钠与5%转化糖注射液配伍稳定性考察

目的:考察注射用甲泼尼龙琥珀酸钠与5%转化糖注射液的配伍稳定性。方法:于室温不避光条件下,将注射用甲泼尼龙琥珀酸钠40 mg加入5%转化糖注射液250 ml中,3 h内观察配伍液外观及测定pH值变化,并采用高效液相色谱法测定甲泼尼龙琥珀酸钠的含量。结果:配伍液的外观澄清,pH值及甲泼尼龙琥珀酸钠的含量均无明显变化。结论:注射用甲泼尼龙琥珀酸钠40 mg与5%转化糖注射液250 ml配伍在3 h内稳定。     

Radiolabeling of a cyclic RGD (cyclo Arg‐Gly‐Asp‐d‐Tyr‐Lys) peptide using sodium hypochlorite as an oxidizing agent

A simple and rapid nonradioactive iodide labeling/radiolabeling method for peptides, using an inexpensive oxidizing agent such as sodium hypochlorite and a cyclic peptide, cRGDyK (cyclo Arg‐Gly‐Asp‐d‐Tyr‐Lys), was developed in this work. Labeling reaction was optimized by conducting experiments under variable ratios of the reagents, the reaction times, and the pH. The study demonstrated that radiolabeling of the cyclic peptide was fast and pH independent. Monoiodinated and di‐iodinated cRGDyK were formed under all conditions and varied with the ratio of the reagents and the reaction time. Total percent of the iodinated cRGDyK (monoiodinated and di‐iodinated cRGDyK) varied between 44 and 100 depending on the reaction conditions. Excess cyclic peptide over equal molar ratio of sodium iodide and sodium hypochlorite yielded in predominant amounts of monoiodinated cRGDyK, ie, >60% under 2:1:1 ratio and ~88% under 5:1:1 ratio of cRGDyK:sodium iodide:sodium hypochlorite.     

氨苄西林钠在不同pH值5%葡萄糖注射液中稳定性研究

目的探讨氨苄西林钠在不同pH值5%葡萄糖注射液中的稳定性。方法分别用pH值为3.2、4.2、5.4、6.0、6.5的5%葡萄糖注射液作为溶媒制备1%氨苄西林钠溶液,温度20℃,用高效液相色谱法法分别测定氨苄西林钠的浓度在0、0.5、1、2、4、6 h变化情况,计算降解速率。结果在pH 3.2~6.5的5%葡萄糖注射液中,氨苄西林钠的分解基本符合零级动力学方程,其速率随着pH值增大而减小,其稳定性随着pH值增大逐步增强。结论 5%葡萄糖注射液的pH值对氨苄西林钠的稳定性影响较大,静脉滴注使用氨苄西林钠可以选择pH值相对较大(在合格范围)的5%葡萄糖注射液,以减少氨苄西林钠的降解,确保疗效,降低药品不良反应的发生率。     

Absorption of sodium pentobarbital by three types of activated charcoal

The in vitro adsorption of sodium pentobarbital by activated charcoal (USP), Darco G-60 and SuperChar was studied. Various solutions of sodium pentobarbital, ranging in concentration from 2.5 to 10 mg/ml (pH = 9), were prepared in distilled water. Radiolabeled (14C) sodium pentobarbital was added to serve as a concentration marker. Two millimeters of each solution was added to from 5 to 350 mg of each charcoal in a test tube. The resulting charcoal-drug slurries were mixed thoroughly and incubated at 37 C for 10 min. Analysis of supernatant allowed calculation of percentage of drug bound. Plots of percentage of drug bound vs log quantity of charcoal necessary to bind 50% of the drug (B-50) were constructed. B-50 was lowest for SuperChar (indicating highest binding capacity), followed by USP and Darco G-60 activated charcoals. In a second series of experiments, drug adsorption was determined at various pH's, or when sodium pentobarbital was dissolved in various volumes of distilled water. Adsorption of the drug from solutions buffered at pH 8.1, 9, 9.7, 11 and 12 did not differ from adsorption in aqueous solution. Adsorption of sodium pentobarbital by 50 or 100 mg of each charcoal did not change when 5 mg of the drug was dissolved in 1, 2, 4, 6, 8 or 10 ml of water. The results suggest that sodium pentobarbital is most readily adsorbed by SuperChar under all conditions studied, followed by USP and Darco G-60 activated charcoals. Changes in pH, or in the initial mixture volume, did not influence the degree of drug adsorption to activated charcoal.     

Dose-response studies with chemical irritants in the albino rabbit eye as a basis for selecting optimum testing conditions for predicting hazard to the human eye

Twenty-one chemicals, solutions, and mixtures with different degrees of recognized irritant potential to the human eye were tested in albino rabbit eyes at dose volumes of 0.003, 0.01, 0.03, and 0.1 ml. Materials were administered directly to the central corneal surface. Irritation that developed was followed up to 21 days and graded by the Draize scale. Maximum irritation scores and median number of days for eyes to return to normal were compared with available data on human experience as a basis for selecting the dose volume that would best predict human response. Using irritation categories of negligible = clearing within 24 hr, moderate = clearing within 7 days, substantial = clearing within 21 days, and severe or corrosive = persisting beyond 21 days, a dose volume of 0.01 ml most often gave results that were consistent with information on effects of human exposures. This dose of hexane, triethanolamine, 0.1% benzalkonium chloride, 0.5% sodium hydroxide, 5% hydrochloric acid, and 20% sodium chloride caused negligible irritations. Granular sodium chloride, 10% sulfuric acid, 5% sodium hypochlorite, isopropyl alcohol, cocount soap powder and 10% solution, a powdered laundry soap, two phosphate laundry detergents, sodium carbonate-sodium sulfate mixtures, 3% acetic acid, 1% silver nitrate, and 10 and 40% sodium lauryl sulfate gave moderate irritation. Sodium lauryl sulfate, 29%, in another experiment was substantially irritating, and 10% acetic acid, 10% sodium hydroxide, formaldehyde, and calcium hydroxide were severely irritating or corrosive. Corneal application of 0.01 ml of material is proposed as a more realistic test of eye hazard than is the Draize test.     

泮托拉唑钠冻干注射剂的研制

目的 :制备泮托拉唑钠冻干针剂。方法 :结合制剂的色泽、外观、pH值、澄明度及与输液间配伍变化 ,单因素筛选支架剂的种类 ,采用高效液相色谱法测定主药的含量及有关物质。结果 :选用甘露醇作为支架剂 ,依地酸二钠作为金属螯合剂 ,以NaOH调节 pH值于9 5～11 5之间 ,泮托拉唑钠检测浓度在12 0～60 0μg/ml范围内线性关系良好 (r=0 9998) ,平均回收率为100.26 % ,RSD=1 14 % (n=9) ,标示量为98.6 %。结论 :制备工艺合理 ,质量控制方法简便、易行 ,制备的冻干针剂能满足制剂学及临床需要。     

Stability of ganciclovir sodium (DHPG sodium) in 5% dextrose or 0.9% sodium chloride injections

The stability of 9-[(1,3-dihydroxy-2-propoxymethyl]) guanine sodium (ganciclovir sodium, also known as DHPG sodium) in two infusion solutions was studied. Lyophilized ganciclovir sodium 500 mg was reconstituted with sterile water 10 mL to give a theoretical concentration of 50 mg/mL. After reconstitution, 6-mL aliquots of the solution were added to 100 mL of 0.9% sodium chloride injection or 5% dextrose injection in polyvinyl chloride i.v. bags. One sample was withdrawn from each of 10 bags of each solution and analyzed by high-performance liquid chromatography (HPLC). Thirty bags of each solution were then stored under each of the following conditions: at room temperature under laboratory light, at room temperature in the dark, and under refrigeration for up to five days. Single potency assays were performed by HPLC on each of three bags of solution at three and five days after initial dilution of the solutions. The solutions were visually inspected, and the pH of the solutions was measured. All solutions of ganciclovir were stable for at least five days under all storage conditions; mean ganciclovir concentrations did not drop below 98% of initial theoretical values throughout the storage period. No important changes in the pH of the solutions occurred during the study period. Under the conditions of this study, ganciclovir sodium is stable for up to five days when prepared in 5% dextrose injection or 0.9% sodium chloride injection.