不同包装容器对复方碘口服溶液的稳定性观察

目的考察不同包装容器对复方碘口服溶液稳定性的影响。方法取复方碘口服溶液分别装于棕色玻璃瓶中(第一组)和棕色塑料瓶中(第二组)。两组均储藏于较暗处的储物架上,温度保持在20℃~25℃之间,相对湿度45%~65%之间。结果复方碘口服溶液用棕色塑料瓶包装含量下降,用棕色玻璃瓶包装碘的含量几乎无变化。结论复方碘口服液宜选用棕色玻璃瓶包装储藏。     

复方间苯二酚洗剂分装容器探讨

我院自制复方间苯二酚洗剂(复方雷锁辛洗剂)用聚乙烯塑料瓶分装,放置一定时间后出现药物含量降低和变红现象。本文报道不同容器分装该洗剂的稳定性。 1 材料 复方间苯二酚洗剂(自制);硫代硫酸钠标准溶液(常州市药检所提供);聚乙烯塑料瓶(金坛市后阳塑胶工艺厂);棕色玻璃瓶(丹阳市玻璃仪器厂)。     

塑料瓶宜贮存聚维酮碘溶液

目的　探讨塑料瓶贮存聚维酮碘溶液的可行性。方法　以塑料瓶为试验容器 ,玻璃瓶为参照容器 ,在不同时间测定存放其中的聚维酮碘溶液的pH值及有效碘含量 ,观察两种容器内溶液的测定值的变化情况 ,并与两容器贮存碘酊后的碘含量变化情况进行比较。结果　随着天数的延长 ,塑料瓶内聚维酮碘溶液的pH值及有效碘含量与玻璃瓶内聚维酮碘溶液的pH值及有效碘含量几呈等量缓慢下降 ;而对照品碘酊 ,随着天数的延长 ,玻璃瓶内含量不变 ,塑料瓶内呈不断下降趋势。结论　玻璃瓶可用于贮存碘酊及聚维酮碘溶液 ,而塑料瓶仅能作为贮存聚维酮碘溶液的容器。     

塑料瓶宜贮存聚维酮碘溶液

目的 探讨塑料瓶贮存聚维酮碘溶液的可行性。方法 以塑料瓶为试验容器，玻璃瓶为参照容器，在不同时间测定存放其中的聚维酮碘溶液的pH值及有效碘含量，观察两种容器内溶液的测定值的变化情况，并与两容器贮存碘酊后的碘含量变化情况进行比较。结果 随着天数的延长，塑料瓶内聚维酮碘溶液的pH值及有效碘含量与玻璃瓶内聚维酮碘溶液的pH值及有效碘含量几呈等量缓慢下降；而对照品碘酊，随着天数的延长，玻璃瓶内含量不变，塑料瓶内呈不断下降趋势。结论 玻璃瓶可用于贮存碘酊及聚维酮碘溶液，而塑料瓶仅能作为贮存聚维酮碘溶液的容器。     

含碘制剂包装材料选择

<正> 含碘制剂临床上应用较多的是碘酊、碘甘油和复方碘溶液。以上三种碘制剂的作用强弱与碘的含量有密切关系。笔者调查了以上三种碘制剂医疗单位的包装材料各有不同,大致有棕色玻璃磨口瓶、青霉素瓶、塑料瓶、塑料眼药瓶及玻璃眼药瓶等几种。为了探讨不同容器对各碘制中碘含量的影响,笔者作了碘制剂的稳定性试验,报告如下。1 实验方法与结果     

祛痰合剂两种贮存方法稳定性的探讨

目的 探讨我院配制的祛痰合剂(即铵远合剂)不同贮存方法的稳定性。方法 随机抽取3批祛痰合剂分别置于无色塑料瓶和无色玻璃瓶中,室温下贮存,每周监测其性状、氨含量的变化。结果 置于中性玻璃瓶中的祛痰合剂较于中性塑料瓶中放置的祛痰合剂稳定。结论 为本制剂的贮存条件提供新的参考资料。     

祛痰合剂两种贮存方法稳定性的探讨

目的探讨我院配制的祛痰合剂(即铵远合剂)不同贮存方法的稳定性.方法随机抽取3批祛痰合剂分别置于无色塑料瓶和无色玻璃瓶中,室温下贮存,每周监测其性状、氨含量的变化.结果置于中性玻璃瓶中的祛痰合剂较于中性塑料瓶中放置的祛痰合剂稳定.结论为本制剂的贮存条件提供新的参考资料.     

0.025%碘伏溶液稳定性的研究

目的观察不同材质的容器对0.025%碘伏溶液降解规律的影响,考察不同比例碘化钾对其稳定性的作用。方法将含不同比例碘化钾的0.025%碘伏溶液放置在不同颜色、不同材质的溶器内,在规定时间点取样,然后使用容量测定法测定碘伏有效碘的含量。结果碘伏降解反应为一级反应。白色和棕色玻璃瓶以及白色和棕色PET塑料瓶对含不同比例的碘化钾的0.025%碘伏影响不变;第一次使用的PE塑料瓶和已染深棕色PE塑料桶对0.025%碘伏具有显著影响,不同比例的碘化钾对PE塑料桶内的0.025%碘伏溶液具有非线性影响。结论在常温下,不同颜色玻璃瓶和PET塑料溶器对碘伏溶液均具有较好的稳定性,其溶液降解速度常数不受碘化钾影响;使用次数较多的PE塑料容器对碘伏溶液具有一定的稳定性,碘化钾具有增加其溶液稳定性的作用。     

祛痰合剂两种贮存方法稳定性的探讨

目的 探讨我院配制的祛痰合剂(即铵远合剂)不同贮存方法的稳定性。方法 随机抽取3批祛痰合剂分别置于无色塑料瓶和无色玻璃瓶中，室温下贮存，每周监测其性状、氨含量的变化。结果置于中性玻璃瓶中的祛痰合剂较于中性塑料瓶中放置的祛痰合剂稳定。结论为本制剂的贮存条件提供新的参考资料。     

复方薄荷脑滴鼻液对不同药包材的选择

目的为复方薄荷脑滴鼻液选择合适的包材。方法采用低密度聚乙烯（LDPE）、聚酯（PET）和玻璃3种材料作为药液的包材,应用紫外分光光度法、微生物学方法,检测不同存放条件下（不同照度和温度）复方薄荷脑滴鼻液的品质变化情况。结果暗处和低温有利于复方薄荷脑滴鼻液的稳定。瓶内主药含量比较：PETI〉玻璃〉LDPE,4℃≥常温〉40℃。结论在阴凉处使用PET作为复方薄荷脑滴鼻液的容器能很好的保证其质量,效果优于LDPE,实用性强于玻璃。     

3种塑料外包装材料对复方西瓜霜滴眼液主要成分的影响

目的考察不同塑料外包装材料对复方西瓜霜滴眼液中主要成分含量的影响。方法采用常温留样和加速试验法（40℃±2℃）,用高效液相色谱法（测定瓜氨酸含量）和气相色谱法（测定天然冰片、乙醇的含量）,分别考察复方西瓜霜滴眼液在低密度聚乙烯（LDPE）、聚丙烯（PP）和聚酯（PET）3种塑料外包装材料中存放0、1、2、3、6个月后瓜氨酸、天然冰片和乙醇的含量。结果PET材料的药用滴眼剂瓶密封性最好,PP材料的次之,LDPE材料的密封性相对最差,不利于复方滴眼液的保存。结论复方西瓜霜滴眼液适合选择密封性相对较好的聚酯、聚丙烯材料作为外包装材料。     

复方鼻炎宁滴鼻剂的质量控制

目的建立复方鼻炎宁滴鼻剂的质量控制标准。方法采用高效液相色谱法测定制剂中甘草酸、木兰脂素含量。结果甘草酸质量浓度在83．136～415．68μg／mL范围内与峰面积呈良好线性关系（r=0．9991）,平均回收率为99．44％,RSD为0．61％（n=9）;木兰脂素质量浓度在1．68—33．6μg／mL范围内与峰面积呈良好的线性关系（r=0．9997）,平均回收率为100．95％,RSD为0．83％（n=9）。结论该分析方法简便、准确,可作为复方鼻炎宁滴鼻剂的质量控制方法。     

复方乳酸左氧氟沙星缓释滴鼻液的制备及稳定性研究

目的研究复方乳酸左氧氟沙星缓释滴鼻液的制备、质量控制方法及稳定性。方法以壳聚糖为缓释剂，拟订处方组成及制备工艺；用紫外分光光度法在293nm波长处测定乳酸左氧氟沙星的含量，用旋光法测定盐酸麻黄碱的含量；用初均速法考察制剂的稳定性。结果乳酸左氧氟沙星检测质量浓度在2～12μg／mL范围内与吸收度线性关系良好（r=0．9999，n=6），平均回收率为99．72％，RSD=0．42％（n=9）。结论该制剂组方合理，制备工艺简单，质量控制方法可靠，稳定性较好，室温贮存有效期为2．1年。     

Stability of nizatidine in commonly used intravenous fluids and containers

The stability of nizatidine in commonly used i.v. fluids stored in glass and plastic containers was studied. Stock solutions of nizatidine 0.75, 1.5, and 3.0 mg/mL in 15 i.v. fluids were prepared using nizatidine injection 25 mg/mL. Six 50-mL aliquots of each solution were transferred to separate glass infusion bottles and stored at room temperature or under refrigeration. Twenty-one 40-mL aliquots of additional stock solutions of nizatidine 0.75 and 3.0 mg/mL in 0.9% sodium chloride injection or 5% dextrose injection were transferred to polyvinyl chloride (PVC) bags and stored at room or refrigerated temperature; some of these solutions were frozen, thawed, and refrigerated before analysis. Samples of each admixture were analyzed after 0.5, 1, 2, 3, and 7 days of storage for nizatidine concentration using a stability-indicating high-performance liquid chromatographic assay and also for visible changes and pH. The concentration of nizatidine in each admixture remained within 92%-106% of actual initial storage concentration throughout the study period, with the exception of nizatidine 3.0 mg/mL in 8.5% amino acid injection. The stability of nizatidine in admixtures stored in polyvinyl chloride bags was similar to that of admixtures stored in glass bottles. In the i.v. fluids, concentrations, and containers studied, nizatidine admixtures are stable for at least 7 days at either room or refrigerated temperature and 30 days when stored frozen in polyvinyl chloride bags. Admixtures of nizatidine 3.0 mg/mL in 8.5% amino acid injection should not be stored at room temperature for longer than four days.     

Stability and sorption of FK 506 in 5% dextrose injection and 0.9% sodium chloride injection in glass, polyvinyl chloride, and polyolefin containers.

The effects of the diluent, the storage container, light, and infusion through various types of tubing on the stability and sorption of FK 506 were studied. Solutions of FK 506 in 0.9% sodium chloride injection or 5% dextrose injection were stored at room temperature (24 +/- 2 degrees C) in glass i.v. bottles, polyvinyl chloride (PVC) minibags, and polyolefin containers. FK 506 solution in 0.9% sodium chloride injection was stored in plastic syringes at room temperature and either exposed to normal room light or stored in the dark. FK 506 solution in 5% dextrose injection was placed in plastic syringes and infused through PVC anesthesia extension tubing, PVC i.v. administration set tubing, and fat emulsion tubing over a two-hour period. The infused samples and samples collected from the containers and syringes at intervals up to 48 hours were analyzed for FK 506 concentration by high-performance liquid chromatography. FK 506 concentrations remained greater than 90% of initial concentration for admixtures in 5% dextrose injection stored in glass bottles for 48 hours and for admixtures in 5% dextrose injection or 0.9% sodium chloride injection stored in polyolefin containers for 48 hours. No change in concentration was measured for admixtures in 0.9% sodium chloride injection stored in plastic syringes, and exposure to light did not affect the stability of FK 506 solution. No substantial change in concentration occurred in FK 506 solution in 5% dextrose injection infused through PVC anesthesia extension tubing, PVC i.v. administration set tubing, or fat emulsion tubing. FK 506 admixtures prepared with 5% dextrose injection or 0.9% sodium chloride injection should be stored in polyolefin containers. If polyolefin containers are not available, solutions should be prepared with 5% dextrose injection and stored in glass bottles.     

复方水杨酸酊在分装及贮藏中的含量变化考察

目的:分析复方水杨酸酊在分装及贮藏过程中的含量变化,确定较佳分装及贮藏方法。方法:采用容量分析法,测定并比较制剂在分装前、后,用不同容器(塑料瓶、玻璃瓶)包装放置90d及分别在室温、室温避光、冷处避光3种不同贮藏条件下放置90d后总酸量(水杨酸、苯甲酸)及碘的含量变化。结果:与分装前比较,分装后总酸量略有升高,碘含量略有降低;在90d贮藏过程中,总酸量变化不大;但随着放置时间延长,用2种容器包装的制剂碘的含量从约95%下降至约31%;碘在3种贮藏条件下含量从约98%分别降至约60%、60%、81%。结论:本制剂制备后应尽快分装,并在冷处避光条件下放置是较佳贮藏方法。     

复方薄荷脑滴鼻液的质量控制

目的 建立复方薄荷脑滴鼻液的质量标准.方法 采用差示分光光度法对樟脑进行定性分析,分别采用旋光度测定法、紫外-可见分光光度法测定其中薄荷脑、樟脑的含量.结果 薄荷脑、樟脑检测浓度的线性范围分别为1.0～10.0 g/L(r =0.9994,n=5),1.0～5.0 g/L(r=0.999 8,n=5);平均回收率分别为99.92％(RSD=1.25％,n=9),99.38％(RSD=1.56％,n=9).结论 所用方法简便、准确、专属性强,可用于复方薄荷脑滴鼻液的质量控制.     

Effect of container on the physicochemical stability of propofol injectable emulsion after being diluted with 0.9% NaCl for intravenous infusion

Effects of glass and plastic containers on the physicochemical properties of propofol injectable emulsion consisting of medium-chain triglycerides (MCTs) and long-chain triglycerides (LCTs) after being diluted with 0.9% NaCl were evaluated. Propofol MCT/LCT reconstituted with normal saline to 2.0 mg/mL, 2.5 mg/mL, 3.0 mg/mL, 4.0 mg/mL, and 5.0 mg/mL were packaged into glass (type II soda-lime-silica), polyvinyl chloride (PVC) soft bag, and non-PVC soft bag (Cryovac^® polyolefin soft bag container), and then stored at ambient temperature/humidity (25 ± 2 °C/50 ± 5% RH) for 3 days to test its stability. We found that the pH and osmolarity of propofol injectable emulsions were consistent among different formulations. All formulations packaged in glass and plastic containers were stable for 6 hours; the globule size distribution of these emulsions met the requirements described in Chapter 729 of the United States Pharmacopeia. However, propofol formulations of higher concentrations (3.0 mg/mL, 4.0 mg/mL, and 5.0 mg/mL) stored in plastic containers were found to have abnormal globule size distribution profiles compared with those stored in glass containers after 24 hours. We therefore recommend that the propofol MCT/LCT emulsions should be packaged into glass containers and used within 6 hours after reconstitution with diluents.     

Sorption of various drugs in polyvinyl chloride, glass, and polyethylene-lined infusion containers

The sorption of chloroquine sulfate, diazepam, isosorbide dinitrate, lorazepam, midazolam, nitroglycerin, promethazine hydrochloride, thiopental sodium, and warfarin sodium to three types of containers was studied. Appropriate amounts of the drugs were added to 500 mL of 0.9% sodium chloride injection in polyvinyl chloride (PVC) bags, glass bottles, and Clear-Flex bags composed of a laminate of polyethylene, nylon, and polypropylene. The containers were stored in the dark at room temperature for 24 hours. Samples were taken at various intervals and assayed for drug concentration by high-performance liquid chromatography. There were no appreciable changes in pH after 24 hours, and all the admixtures remained clear and colorless. The potency of chloroquine sulfate, lorazepam, midazolam, promethazine hydrochloride, and thiopental sodium remained unchanged in glass, PVC, and Clear-Flex containers. Diazepam, isosorbide dinitrate, nitroglycerin, and warfarin sodium did not show any sorption to glass bottles and Clear-Flex bags. In PVC bags, however, up to 55% of diazepam, 23% of isosorbide dinitrate, 51% of nitroglycerin, and 24% of warfarin sodium was lost during the 24-hour study period. Diazepam, isosorbide dinitrate, nitroglycerin, and warfarin sodium in 0.9% sodium chloride injection showed a loss of potency when stored in PVC containers for 24 hours at room temperature, but none of the drugs studied lost potency when stored in glass bottles and Clear-Flex bags.