注射用福美坦的稳定性考察

目的:考察注射用福美坦的稳定性。方法:根据《中国药典》2005年版要求,对注射用福美坦在市售包装条件下进行影响因素试验、加速试验和长期试验,考察各条件下药物含量、外观、pH值及有关物质等指标变化情况。结果:温度、湿度、光线及贮存时间等对注射用福美坦的质量指标影响不大,各项质量指标的检测结果均符合《中国药典》要求。结论:注射用福美坦在市售包装条件下的有效期内质量稳定、可靠。     

灭菌注射用水pH升高原因之初步探讨

目的查找造成灭菌注射用水pH升高的原因,寻求可能的解决方法。方法在灭菌注射用水生产过程中,分别在不同阶段取样,或以不同的工艺条件和不同生产厂家的安瓿来考察,并根据《中国药典》(2005年版)二部的规定对灭菌注射用水的pH值进行检测。结果高压灭菌时的高温使安瓿玻璃中的弱碱性成分分解释放到注射用水中是造成灭菌注射用水pH升高的主要原因。结论将安瓿经过注水后再煮沸的预处理方法能较好的解决灭菌注射用水的pH值升高问题。     

注射用水循环系统用水点水温控制及效能研究

目的在不影响注射用水循环系统水温的基础上,降低用水点注射用水的温度(50℃以下或常温),保证注射用水质量的同时,减少能源消耗。方法对注射用水输送系统及用水点进行改造,比较改造前后用水点水温变化、注射用水的质量(常规检查项目,特别是微生物和细菌内毒素)、相同时间用水时的能源消耗情况。结果改造后注射用水循环系统用水点水温能控制在50℃以下(可接近20℃);注射用水的质量符合规定;相同时间(2 h)用水时蒸汽减少0.5 MPa,1.5 h。结论对注射用水输送系统用水点的改造可行,降低用水点水温,保证注射用水的质量,保障生产工人的安全,同时节约能源和生产成本,值得在制药企业中推广。     

注射用水循环系统用水点水温控制及效能研究

目的 在不影响注射用水循环系统水温的基础上,降低用水点注射用水的温度(50℃以下或常温),保证注射用水质量的同时,减少能源消耗.方法 对注射用水输送系统及用水点进行改造,比较改造前后用水点水温变化、注射用水的质量(常规检查项目,特别是微生物和细菌内毒素)、相同时间用水时的能源消耗情况.结果 改造后注射用水循环系统用水点...     

注射用雷尼替丁稳定性的初步研究

考察药物制剂在温度、湿度、光线的影响下随时间变化的规律,为药品的生产、包装、贮存、运输条件提供科学依据,同时通过实验建立药品的有效期。稳定性实验包括影响因素实验、加速实验与长期实验。本部分研究按照《中国药典》2005版附录XIX C原料药与药物制荆稳定性试验指导原则以及药品研究技术指导原则。进行注射用雷尼替丁稳定性初步研究。对不同实验条件下的注射用雷尼替丁的外观性状、有关轻质、含量等各项目进行质量评价。     

ICP-MS法测定注射用水中16种金属元素的含量

目的：建立电感耦合等离子体质谱法（ICP-MS）测定注射用水中镁、铝、铬、铜、锌、砷、镉、锡、钡、铅、钙、钾、硒、银、钠、汞等16种元素含量的方法。方法：采用ICP-MS法碰撞池技术（CCT）,最大程度的减少多原子干扰,通过在线加入锂、钪、锗、铟、铱、铋内标液的方法校正由于基体效应和信号漂移对测量所造成的影响,样品直接酸化测定注射用水中的16种金属元素的含量。结果：ICP-MS技术测定16种金属元素的检测限范围为0.009-0.165 ng·ml^-1;标准曲线线性关系良好（r≥0.999 0）;回收率均在80%-120%范围之内（n=6）。结论：上述方法简便、快速、准确,可用于注射用水中16种金属元素含量的测定,并以此降低注射用水中存在毒性较大金属元素含量超标的潜在风险,为注射用水更严格的质量控制提供参考。     

注射用头孢拉定在25℃时的稳定性研究

目的考察注射用头孢拉定在25℃时的稳定性,为其贮存条件的选择提供依据。方法选择3个厂家3个批号的注射用头孢拉定样品在25℃下贮存3个月,依据《中国药典》2010年版二部注射用头孢拉定项下规定,考察其性状、溶液澄清度和颜色、水分、pH值、有关物质和含量的变化情况。结果注射用头孢拉定在25℃下贮存3个月,性状、水分、pH值、有关物质和含量均符合《中国药典》2010年版的规定;其中,一个厂家一个批次的样品溶液颜色在放置2个月后,颜色超过规定的黄绿色8号标准比色液。结论不同厂家生产的注射用头孢拉定其稳定性不同,大部分厂家的药品可在25℃下贮存3个月。     

阿昔洛韦与盐酸左氧氟沙星配伍验证实验

目的：考察注射用阿昔洛韦与盐酸左氧氟沙星注射液的配伍稳定性,对有关论著中关于两药配伍的矛盾性结论进行验证。方法：模拟临床用药,在0℃及25℃条件下,于不同时间观察两药混合后的外观变化。结果：在不同温度下两药配伍后,不同质量浓度的配伍液随时间延长,溶液外观产生不同程度的结晶、沉淀等。结论：《400种中西药注射剂临床配伍应用检索手册》中关于注射用阿昔洛韦与盐酸左氧氟沙星注射液存在配伍禁忌的结论是可信的;《药品注射剂使用指南》（2007版）第6页中载两药可配伍,缺乏依据;《注射药临床应用速查手册》第155页载两药可配伍,同样缺乏依据。     

医院制剂白色洗剂稳定性的初步研究

目的:考察医院制剂白色洗剂于不同贮存条件下进行加速实验和长期实验,制剂稳定性随贮存时间延长的变化情况,为 该制剂的贮存方式、使用时间和生产工艺提供依据,通过实验进一步预测其贮存有效期。 方法:根据《中国药典》2020 年版第四 部 9001 原料药物与制剂稳定性试验指导原则,对 3 批白色洗剂进行加速实验和长期实验研究,按照制剂质量标准对该制剂的 性状、成分鉴别、苯酚含量、氧化锌含量及微生物限度进行检查,利用 Minitab 21 软件进行数据分析,考察白色洗剂的稳定性。 结果:(1)加速实验结果表明,在温度(42±2)℃ 、相对湿度 75%±5%条件下贮存 6 个月,白色洗剂的理化性质和主要成分含量符 合质量标准,微生物限度符合规定;(2)长期实验结果表明,在温度(25±2)℃ ,相对湿度 60%±10%条件下贮存 36 个月,白色洗 剂的理化性质、微生物限度符合规定,氧化锌含量符合质量标准,苯酚含量从第 18 个月开始检测时低于限度值。 结论:通过 Minitab 21 软件对加速实验、长期实验结果进行数据分析,白色洗剂常温(10~30 ℃ )贮存,有效期可定为 9 个月。     

盐酸吡柔比星在不同注射液中的稳定性考察

目的考察注射用盐酸吡柔比星在灭菌注射用水和5％葡萄糖注射液中的稳定性。方法分别用灭菌注射用水和5％葡萄糖注射液配成吡柔比星浓度为1mg／ml溶液,室温下,于光照及避光条件下放置,经0、1、2、4、6、8、10h考察溶液外观及含量变化。结果光照或避光条件下,10h内盐酸吡柔比星的灭菌注射用水或5％葡萄糖注射液溶液外观无明显变化,含量则存在不同程度的变化。结论注射用盐酸吡柔比星在灭菌注射用水或5％葡萄糖注射液中稳定性较差,应即配即用。     

Urokinase activity after freezing: implications for thrombolysis in intraventricular hemorrhage.

The retention of urokinase activity after frozen storage was studied. Urokinase powder was reconstituted aseptically in sterile water for injection or preservative-free 0.9% sodium chloride injection to a final concentration of 5000 IU/mL. Samples were stored in 5-mL plastic syringes at -20 or -70 degrees C for up to six months. Samples containing urokinase 25,000 IU/mL were similarly prepared by using sodium chloride injection as the diluent and were stored frozen at the same temperatures for up to 93 days. Urokinase activity was measured with a chromogenic assay at each test interval. Samples were also cultured after thawing to evaluate their potential to support microbial growth. The activity of urokinase at either concentration did not change appreciably during the study period. The method of thawing-at room temperature or in a refrigerator-had no effect on urokinase activity. No microbial growth was observed. Urokinase 5000 IU/mL did not show any changes in activity when reconstituted with sterile water for injection or 0.9% sodium chloride injection and frozen for up to six months. Urokinase 25,000 IU/mL in sodium chloride injection was also stable after 93 days of frozen storage.     

Stability of galactose in aqueous solutions

The stability of 5%-30% w/v galactose in sterile water for injection and acetate and phosphate buffers was studied. The concentration of galactose was determined after each sample was diluted to a nominal concentration of 0.5% (w/v); for purposes of data analysis, the concentration as measured in the diluted sample was multiplied by a dilution factor to obtain the true concentration in the sample. The concentrations were determined from the regression line obtained by plotting the peak-height ratios (for various concentrations of galactose and the internal standard cellobiose) versus the galactose concentrations. Triplicate samples were quantitatively analyzed for galactose content by high-performance liquid chromatography. The stability of the samples was then studied in relation to buffer concentration; pH; storage at 25, 45, and 65 degrees C for six weeks, and autoclaving at 121 degrees C for 30 minutes. Galactose degradation increased in relation to its concentration, increasing temperature, and buffer concentration. Galactose solutions in water and phosphate incurred less than 5% degradation on autoclaving; however, the 30% solutions in acetate buffers lost up to 21% of initial content. Yellow discoloration of solutions was associated with autoclaving and prolonged exposure at 65 degrees C and appeared in some solutions that did not exceed the USP XXI limit of 5-hydroxymethylfurfural and related compounds in dextrose injection. The estimated room temperature shelf-life of galactose in sterile water for injection sterilized by 0.45-micron-porosity membrane filtration is four and one-half months. Solutions may also be sterilized by autoclaving at 121 degrees C for 30 minutes; galactose solutions containing pH buffers should not be sterilized by autoclaving.     

卵巢护养膏贮存期间的质量研究

目的研究卵巢护养膏贮存期间的质量变化。方法卵巢护养膏于常温(25℃)下贮存120 d,考察其微生物限度、相对密度;采用高效液相色谱法测定其有效成分淫羊藿苷的含量。结果贮存期间卵巢护养膏微生物限度符合要求,相对密度稳定,淫羊藿苷含量90 d内稳定,第120天略有下降。结论常温下,卵巢护养膏可贮存120 d。     

An investigation into water interactions with amorphous and milled salbutamol sulphate: the development of predictive models for uptake and recrystallization

An investigation into the effect of water uptake on the glass transition of spray dried and milled salbutamol sulphate has been performed, with a particular view to exploring how the water uptake, T(g) value and recrystallization behaviour correlate. Samples of milled and spray dried drug were stored under controlled humidity conditions and the T(g) measured as a function of time. The T(g) was measured using modulated temperature differential scanning calorimetry (MTDSC) while the water content was measured using thermogravimetric analysis (TGA). A correlation was found between time of storage, water content and T(g) in that the samples showed time dependent equilibration with the storage environment (either gaining or losing water depending on the RH). The relationship between water content and stability, based on the concept of T(g) lowering, was modelled using the semi-empirical approach of Royall et al. (1999) as well as a derivation of the Kwei equation which allowed the interaction between the water and substrate to be accounted for. A method for predicting stability based on two simple DSC runs is proposed. In addition, we discuss the observation of a double glass transition for the spray dried samples.     

盐酸氯丙嗪注射液的稳定性预测

目的:预测盐酸氯丙嗪注射液稳定性,为临床提供贮存期依据。方法:采用紫外分光光度法测定其含量,用经典恒温法预测其有效期。结果:本品稳定性与温度有关,符合Arrhenius公式,但对日光不稳定。结论:本品不稳定,应制定有效期,并注意在避光条件下贮存。     

红花黄色素氯化钠注射液稳定性研究

目的研究红花黄色素注射液的化学稳定性,为储存提供依据.方法采用经典恒温加速法,分别在60,70,80,90,100℃下,恒温加热不同时间,用高效液相色谱测定红花黄色素注射液及氯化钠注射液各样品含量.结果红花黄色素氯化钠注射液相关系数为0.9988,说明lgk与1/T线形关系良好,符合一级动力学公式.结论红花黄色素氯化钠注射液热解反应活化能为105.43kJ·mol-1,t0.925℃有效期约311.5天.     

活性炭影响甲硝唑注射液含量的考察

目的:探求甲硝唑注射液配制过程中适宜的条件及活性炭用量。方法:考察活性炭不同用量以及不同配制温度、放置时间、pH值对甲硝唑注射液含量的影响,并作统计分析。结果:甲硝唑含量下降程度与活性炭加入量呈正相关(P<0.01);放置时间越长,下降幅度越大;而温度与pH值对含量影响则较小。结论:甲硝唑注射液配制温度、放置时间、pH值、活性炭用量以分别控制在40℃～80℃、10min～15min、4.5～7.0、0.02%～0.05%为宜,超出此控制范围应适当调整甲硝唑的用量。     

注射用奥美拉唑钠与奥硝唑配伍稳定性的考察

目的:考察在避光条件下,温度分别为4、253、7℃的环境中6 h内注射用奥美拉唑钠与奥硝唑的配伍稳定性。方法:采用HPLC法测定配伍液在不同温度条件下放置6 h内不同时间点含量的变化,并观察其外观及测定pH值。结果:注射用奥美拉唑钠与奥硝唑配伍液在4、25、37℃的环境中6 h内,色泽和含量都有明显变化。结论:注射用奥美拉唑钠与奥硝唑不能配伍使用。     

The control of biofilm formation by hydrodynamics of purified water in industrial distribution system

Systems for storage and distribution of purified water at ambient temperature are highly susceptible to microbial contamination. The water flow, microbial content and chemical quality of the purified water in an industrial water system have been simulated in a biofilm annular reactor (BAR) to study the impact of different hydrodynamic conditions on biofilm development. Our results reveal the potential of stagnant purified water at total organic compounds (TOC) below 50ppb to develop biofilm that allows detachment of planktonic bacteria and colonization of new surfaces within 24h. However, under constant water flow over 7 days, the growth of initial biofilm was 40 times less, fewer bacteria were detached, and new surfaces were colonized to a lesser extent. Heterotrophic plate counts (HPCs) in biofilm were highly positively correlated with numbers of detached planktonic bacteria in effluent water. The study shows that the hydrodynamic conditions and level of planktonic HPC in water are critical for the development of biofilm at very low TOC. The results in the BAR agreed well with those from regular industrial microbial monitoring of purified water. To conclude, the BAR successfully simulates biofilm growth and can be used to establish an effective biofilm control strategy. However, the microbial quality of purified water in industrial system is a constant challenge; any increase of HPC in effluent water is a sign to take steps against excessive microbial growth.     

注射用氯诺昔康在不同输液容器中的稳定性考察

目的：考察注射用氯诺昔康与0.9%氯化钠注射液在聚丙烯塑料瓶与一次性使用电子镇痛泵储液盒中的稳定性。方法：采用高效液相色谱法,以Hypersil-C18色谱柱,甲醇-0.05 mol.L-1磷酸二氢钾（50∶50）为流动相,测定氯诺昔康不同配伍液室温下不同时间的含量变化,并观察和检测配伍液的外观及pH值变化。结果：注射用氯诺昔康与0.9%氯化钠注射液在聚丙烯塑料瓶与一次性使用电子镇痛泵储液盒中含量、外观与pH值均无明显变化。结论：注射用氯诺昔康与0.9%氯化钠注射液在聚丙烯塑料瓶中8 h稳定,在一次性使用电子镇痛泵储液盒中72 h内稳定。