胞磷胆碱钠胶囊稳定性研究

文章主要考察了胞磷胆碱钠胶囊在贮存过程中药物稳定性,采用高效液相色谱法测定胞磷胆碱钠胶囊中胞磷胆碱的含量,通过光照试验、高温试验、高湿试验、长期试验、加速试验,考察样品稳定性。结果,本品连续三批经过影响因素试验和加速试验6个月和长期试验6个月的考察,其各项指标均在质量标准规定的范围内,得到胞磷胆碱钠胶囊的性质比较稳定。     

氯化钠注射液加速试验研究

氯化钠注射液为我厂常年生产的药品，我们通过加速试验观察该药品的化学或物理变化，探讨药物制剂的稳定性，为制订药品的有效期提供依据。我们按《中国药典》2005年版二部标准对该药品进行有关测定，结果如下。     

维生素C注射液加速试验研究

维生素C注射液为我厂常年生产的药品，我们通过加速试验观察该药品的化学或物理变化，探讨药物制剂的稳定性，为制订药品的有效期提供依据。我们按《中国药典》2005年版二部标准对该药品进行有关测定，结果如下。     

清开灵胶囊、清肺抑火片、莲花清瘟胶囊燃烧分析

选择清开灵胶囊、清肺抑火片、莲花清瘟胶囊作为研究对象,测定3种清热解毒药燃烧热、燃烧稳定性,建立3种清热解毒药的多指标综合评价体系,为热重分析方法研究食品药品燃烧稳定性评价与研究提供有力的科学依据.     

金莲花胶囊生产工艺研究

目的 探讨金莲花胶囊的制备工艺,确定生产工艺参数和最佳生产工艺路线,为金莲花胶囊的生产提供依据。方法 采用正交试验方法优化生产工艺,选择最佳工艺参数。结果 采用优化后的工艺生产,可提高金莲花胶囊的储存期稳定性,各项质量指标均合格。结论金莲花胶囊可采用优化的工艺生产。     

稳定性研究在药品质量控制中的应用

药品的稳定性是关系到临床用药安全的重要信息。通常条件下,随着储存时间的延长,化学药品会出现降解,直接导致有效成分的减少和有害物质的增加,对临床用药安全带来风险。了解并掌握药品的稳定性信息,不仅关系到临床用药,也关系到药品的研制、生产、销售各个环节。本文以原料药的稳定性实验为基础,采用风险评估和统计分析工具,评估原料药的成分变化,为确定产品质量稳定性和有效期,进行产品注册和质量控制提供指导。     

防暴弹药储存寿命研究综述

本文简述了防暴弹药储存寿命研究的背景,论述了国内外弹药贮存寿命试验所用的自然环境贮存试验和加速寿命试验方法的现状,并进行比较,得出优缺点,为今后防暴弹药储存寿命研究提供依据。     

稻曲病药剂防治试验

稻曲病是水稻生长后期发生的一种主要病害。近年来该病的发生及危害日趋严重，严重影响稻谷质量和产量。为了筛选出安全、高效的药剂，为指导大面积防治提供依据，本站2000年对安福、瘟曲净、稻后安等13种杀菌剂进行了药剂防治试验，并用瘟曲克星进行防治稻曲病适期试验。     

头孢拉定结晶工艺

考察了不同结晶体系对头孢拉定结晶过程的影响,通过正交试验优化了头孢拉定结晶工艺条件,即水量为头孢拉定质量的2倍,三乙胺和N,N-二甲基甲酰胺体积比为1.2,结晶初始温度30℃,结晶终了温度5℃。结果证明,在此条件下所得产品结晶收率可达92%左右。利用高效液相色谱、电子显微镜对产品进行检测证明产品纯度可达98%以上,粒度分布均匀,晶面完整;同时通过40 ℃储存条件下的化学稳定性试验表明产品稳定性符合药品质量要求。     

连花清瘟胶囊挥发性成分的吹扫捕集-气相色谱/质谱的指纹图谱研究

建立了连花清瘟胶囊挥发性成分的指纹图谱。采用吹扫捕集对挥发性成分进行自动萃取富集,吹扫时间11 min,吹扫温度40℃,脱附时间2 min,脱附温度190℃;采用气相色谱质谱(GC-MS)全扫描模式下进行检测,色谱柱DB-624 (60 m×0.32 mm, 1.4μm),进样口温度200℃,分流比为30∶1,柱流量1.5 mL/min,升温程序初始温度为38℃,保持1.8 min,以10℃/min升温至120℃,再以15℃/min升温至240℃,保持2 min,接口温度280℃,建立连花清瘟胶囊挥发性成分的指纹图谱。采用《中药色谱指纹图谱相似度评价系统软件(2004.0版)》对10批样品进行相似度评价,确定连花清瘟胶囊挥发性成分指纹图谱26个共有峰,通过参考文献以及NIST 11质谱谱库检索推测出全部色谱峰,10批次样品相似度均0.955。该法简便快速、准确,重现性好,可用于连花清瘟胶囊质量控制和评价。     

Roasted Sunflower Kernel Paste (Tahini) Stability: Storage Conditions and Particle Size Influence

Sunflower tahini faces quality problems due to the tendency of oil to exudate, causing accelerated rancidity and low marketability. In this study, the colloidal and oxidative stability of different trimodal particle size distributions of sunflower tahini (cumulative volume percentages of small, middle and large class populations of 9.61–16.67, 43.03–55.03 and 47.36–28.3) was evaluated during storage at three different temperatures. Decreasing sample particle size decreased the sunflower tahini colloidal stability. The coarsest prototype, being the most stable tahini in terms of oil separation, was included in the oxidative stability storage test together with a commercial tahini. The peroxide values of the studied sunflower tahini samples increased significantly (p < 0.05) with storage time, irrespective of storage temperature, while the p‐anisidine values showed an irregular pattern. Considering 30‐meq O₂/kg as a PV limit, the commercial tahini showed good oxidative stability as it was under this when stored 3 months at 4 °C, 2 months at room temperature and 1 month at 40 °C. The coarsest tahini sample was under the limit when stored 2 months at 4 °C, 1 month at room temperature and 2 weeks at 40 °C. Particle size was shown to be an essential parameter for controlling sunflower tahini's overall stability.     

盐酸伊伐布雷定片的制备工艺及质量考察

制备盐酸伊伐布雷定片,并考察其质量。以溶出曲线、外观等为指标,用正交试验设计方法对处方工艺进行筛选与优化。制备盐酸伊伐布雷定片,与原研药进行质量对比,使其与原研药质量保持一致,以保证自研产品与原研药临床效果的一致性;通过加速试验和长期试验考察其稳定性。盐酸伊伐布雷定优选处方组成为：辅料微晶纤维素、一水乳糖、交联羧甲基纤维素钠、羟丙纤维素、二氧化硅和硬脂酸镁,流化床制粒。该处方工艺制备的产品符合标准,与原研药质量一致且质量稳定。本处方工艺可行,所得产品质量稳定,符合质量标准。     

3,4-二硝基呋咱基氧化呋咱炸药的安全贮存寿命预估研究

采用安定性试验标准物质黑索今验证了通过动态真空安定性试验(DVST)设备准确测定分解气体的压力来研究火炸药分解的可行性,并采用DVST装置,借鉴火药的热加速老化寿命评估方法研究了3,4-二硝基呋咱基氧化呋咱(DNTF)炸药的安全贮存寿命.结果显示,5.0g真空安定性标准物质黑索今100℃加热48h后的DVST放气量为0.292 mL,处于真空安定性试验的误差范围内((0.24±0.07)mL).热加速老化试验推测DNTF炸药在40℃下的安全贮存寿命为85a,25℃下安全贮存寿命为838a.     

护肝片改薄膜包衣生产工艺研究

为了解决糖衣片在临床使用中出现的问题,改变了包衣工艺,建立了护肝片薄膜包衣的最佳工艺条件并考察其稳定性。将护肝片的包衣工艺由糖衣改为薄膜衣,通过正交试验确定护肝片薄膜包衣的最佳包衣液浓度、喷量、喷雾风速温度,并用加速试验法和室温留样考察其稳定性。在包衣液浓度为13%、包衣液喷速为140 g/min、进风温度为75℃的条件下生产的薄膜衣片质量最佳,且按2010药典检验其稳定性合格。结果表明,此制备工艺稳定,可用于护肝薄膜衣片的工业生产。     

Preparation and thermal energy storage properties of poly(n‐butyl methacrylate)/fatty acids composites as form‐stable phase change materials

This work is focused on the preparation, characterization, and determination of thermal energy storage properties of poly(n‐butyl methacrylate) (PnBMA)/fatty acid composites as form‐stable phase change material (PCM). In the composite materials, the fatty acids act as latent heat storage material whereas PnBMA serves as supporting material, which prevents the leakage of the melted fatty acids. The maximum encapsulation ratio for all fatty acids was found to be 40 wt%. The composites that do not allow PCM leakage in melted state were identified as form‐stable PCMs. The compatibility of fatty acids with PnBMA is investigated by optical microscopy (OM) and Fourier Transform Infrared (FT‐IR) spectroscopy. Thermal properties and thermal reliability of the form‐stable composite PCMs were determined using differential scanning calorimetry (DSC). DSC analysis revealed that the form‐stable composite PCMs had melting temperatures between 29.62°C and 53.73°C and latent heat values between 67.23 J/g and 87.34 J/g. Thermal stability of the composite PCMs was studied by thermal gravimetric (TG) analysis and the results indicated that the form‐stable PCMs had good thermal stability. In addition, thermal cycling test showed that the composite PCMs had good thermal reliability with respect to the changes in their thermal properties after accelerated 5,000 thermal cycling. On the basis of all results, it was also concluded that the prepared form‐stable composite PCMs had important potential for many thermal energy storage applications such as solar space heating of buildings by using wallboard, plasterboard or floors integrated with PCM. POLYM. COMPOS., 2012. © 2011 Society of Plastics Engineers     

奥拉西坦注射液处方工艺及研究

确定了奥拉西坦注射液的处方及制备工艺。选用适宜的络合剂,对处方进行筛选,并通过加速实验考察奥拉西坦注射液的稳定性。本品在加速条件下6个月的自制样品与0天的自制样品比较、与哈尔滨三联药业有限公司的奥拉西坦注射液比较,p H值、有关物质、含量均无明显变化。奥拉西坦注射液的处方和工艺可行,质量稳定。     

现行橡胶及其制品贮存期快速测定方法的可靠性研究

列举了大量橡胶及其制品的烘箱加速老化及室内自然老化的试验数据，表明根据橡胶及其制品的加速老化结果预测贮存期和使用寿命与实测结果是吻合的，贮存期快速测定方法是可靠的。同时列举了预测与实测结果偏差较大的几个实例，其主要原因是：相对湿度、物理松弛和溶胀等造成加速老化与自然老化的机理不同。其中相对湿度引起的偏差是无法避免的，因此基于热氧老化机理的贮存期快速测定方法还有一定缺陷。     

Inclusion complexes of eucalyptus essential oil with β-cyclodextrin: preparation,characterization and controlled release

In this study, eucalyptus essential oil (EEO) was encapsulated into β-cyclodextrin (β-CD) by saturated aqueous solution method. The success of EEO encapsulation was confirmed by laser light scatting, scanning electron microscopy, Fourier transform infrared spectroscopy, differential scanning calorimeter and thermogravimetric analysis. Releasing characteristics experiments were carried out at various temperatures, relative humidity (RH), storage time and high temperature stability test. Release kinetics of EEO from the inclusion complexes was investigated by zero-order kinetics, first-order kinetics and Avrami’s equation. The result showed that the release model of EEO from inclusion complexes fitted better for Avrami’s equation. Kinetics analysis based on the Avrami’s equation revealed that the release of EEO was accelerated with the increases of RH and temperature. For storage time treatment, the volatilization of EEO was significantly inhibited after encapsulation. High temperature stability test further revealed that EEO was protected after having been encapsulated into β-CD. For all treatments, the release parameter n was between 0.5 and 1.0, which presenting a diffusion-limited and first-order mode. These results indicated that encapsulation enhanced the stability and prolonged the acting time of EEO, and the release rate of EEO can also be passively controlled by the ambient temperature, humidity and storage time.     

Water-soluble sulfonated amino-formaldehyde resins. III. Effect of reaction conditions on stability

Several preparations of water-soluble sulfonated amino-formaldehyde resins were prepared under different reaction conditions. The stability of these solutions was studied after accelerated aging at 60°C for 2 weeks. Viscosity and pH changes were monitored with storage time. The results showed that our four-step reaction procedure more stable products than the three-step reaction procedure. The four steps of reaction are: hydroxymethylation, sulfonation, low-pH condensation, and high-pH rearrangement. The three-step process discussed in the literature combines hydroxymethylation and sulfonation as one step followed by low-pH condensation and high-pH rearrangement. It was found that the more stable products of the four-step process are affected slightly by the F/M molar ratio and the concentration of reactants in contrast with the three-step process in which these variables affect stability drastically. In general, the pH, temperature, and time of reaction of the fourth step are the main controlling factors for product stability. An attempt was made to explain the stability behavior of these solutions in terms of their molecular weight distribution curves.