药用辅料对小剂量片含量测定的干扰

醋酸地塞米松为甾体激素类药物,《中国药典》1995年版规定,原料为HPLC法测定含量,而片剂仍然沿用传统的紫外法测定。我们通过对本市两家制药厂生产的醋酸地塞米松片含量及含量均匀度有关数据进行了统计对比,发现其含量测定所得平均含量与含量均匀度测定所得平均含量有显著的差异(n=28,n=13,P<0.05),平均相差2.69％和6.97％,且据厂方反映,其测得的颗粒含量和片剂含量常高于投料理论值的5％～10％。这说明醋酸地塞米松片在生产过程中引入了某种干扰因素,从而使含量测定结果升高。     

高效液相色谱法测定药用辅料日落黄的含量

目的 建立高效液相色谱法测定药用辅料日落黄的含量.方法 采用安捷伦C18柱(4.6 mm×250 mm,5 μm),以甲醇-0.02 mol·L-1乙酸铵溶液(30∶70)为流动相,流速为1.0 mL· min-1,检测波长为236 nm,柱温为35℃.结果 日落黄线性范围为5.55～111.03 μg·mL-1,r=0.999 9,平均回收率为100.0％,RSD=0.23％.结论 改进后的方法简单、准确,能控制本品的质量.     

HPLC法测定药用辅料柠檬黄的含量

目的:建立HPLC法测定药用辅料柠檬黄的含量.方法:采用Agilent Zorbax SB-C18(250 mm×4.6 mm,5 μm)色谱柱,以甲醇-0.02 mol·L-1乙酸铵溶液(20:80)为流动相;流速为1.0 ml·min-1;检测波长为226 nm;柱温为35℃.结果:柠檬黄线性范围为0.050～1.000 μg(r=0.999 9),平均回收率为99.9%(RSD=0.9%,n=6).结论:该法简单、准确,可用于药用辅料柠檬黄的含量测定.     

药物制剂辅料β—环糊精的纯化及含量测定

分别用水、乙醇、丙酮等试剂处理β－环糊精（β－CD）产品,考察了提高β－CD纯度的方法,并用间接（褪色）分光光度法在552nm处测定了β－CD含量,结果发现,经纯化处理的β-CD纯度有不同程度的提高,其中以经水二次重结晶、再分别用乙醇和丙酮处理的β-CD纯度为最高,含量平均值为98．8%(n=4)。     

药用缓控释辅料海藻酸钠的研究概况

海藻酸钠又称藻酸钠、海草酸钠、褐藻胶（Sodium Alginate，AGS，Algin），分子式为（C6H7O6Na）n，是一种从褐藻类的海带或马尾藻中提取的聚阴离子多糖（海藻酸）的钠盐。自1883年由海带中发现AGS以来，直至1929年开始在美国应用于工业生产，1944年用于食品工业，1983年经美国食品与药品管理局（FDA）批准其可直接作为食品的成分，用于医药工业不过近30年的时间。本文着重对其相关性质及在缓控释制剂方面的应用情况综述如下。     

诺氟沙星胶囊以淀粉为辅料时含量测定的研究

诺氟沙星（Norfloxaxin）为化学合成的氟喹诺酮类抗菌药,由于能抑制DNA回旋酶、抗菌谱较广、口服吸收迅速、疗效确切、使用安全,近年来被广泛用于临床。诺氟沙星及其制剂已收载于中国药典95年版。诺氟沙星原料可因生产厂家、生产批号的不同在晶形、流动性、密度等物理性质上有很大差异,再加上吸湿性强,使胶囊制剂在重量差异、含量等方面波动较大,得不到有效控制。经处方筛选,对加有淀粉并制粒后的诺氟沙星进行含量测定研究,结果回收率高、变异系数小、重现性好,表明淀粉对诺氟沙星的含量测定无干扰,可以作为诺氟沙星制剂所用的辅…     

差示分光光度法测定盐酸氯丙嗪糖浆含量

盐酸氯丙嗪糖浆[1]含有盐酸氯丙唤、维生素C等,直接用紫外法测定盐酸氯丙嗪含量,会受到维生素C等辅料的干扰,根据盐酸氯丙嗪经过氧乙酸氧化后的溶液和不经氧化的溶液于342．9nm处的A值,与盐酸氯丙嗪浓度成正比关系[2],用差示分光光度法消除了辅料干扰,取得了良好效果。l仪器与试药UV一24O型分光光度计（日立岛津）、盐酸氯丙嗓、维生素C、甘油、蔗糖（药用规格,其中盐酸氯丙唤为精制品）。1,l盐酸氯丙唤贮备液;精密称取IO5℃下干燥至慎重的盐酸氯丙唤适量,加盐酸液（0lmol／L）制成10mg／ml溶液I。］．2盐酸氯两唤溶液：取溶…     

测定利凡诺溶液含量的两种方法比较

本文通过紫外分光光度法与中和法测定利凡诺溶液含量的比较,结果表明紫外分光光度法优于中和法。     

我国药用辅料的现状及监管建议

目的促进药用辅料行业健康发展,确保药品安全。方法对目前国内药用辅料生产、使用、管理制度等情况进行总结,分析存在的问题,介绍国外药用辅料的管理经验,提出相关监管建议。结果与结论我国药用辅料行业发展仍相对落后,药用辅料生产、应用、监管等各方面均应予以加强。     

海藻酸钠在药物制剂中的研究进展

海藻酸钠是从海带或海藻中提取的天然多糖类化合物，作为缓释制剂辅料广泛应用于片剂、微九、微蠢、脂质体、纳米粒等缓释制剂中，现综述近年来海藻酸钠作为辅料的影响因素及在缓释制剂中的应用研究进展。     

荧光分光光度法测定褐藻酸钠中微量铅

目的建立一种快速测定褐藻酸钠中微量铅的方法。方法湿法消解样品,用荧光分光光度计测定。结果测定铅的检出限为2.71×10-2μg.mL-1,测定3种褐藻酸钠中铅的含量,相对标准差(RSD)分别为4.06%、1.57%、2.12%,平均回收率在88.32~100.8%之间。结论该法具有操作简便、准确、灵敏、重复性好等优点,可用于褐藻酸钠中铅含量的测定。     

EMA对药用辅料右旋糖酐新的安全性评价

欧洲药品局（EMA）于2018年11月发布了"人用药品辅料右旋糖酐的包装说明书资料"，该文件引用大量文献全面评价了右旋糖酐的安全性，特别指出含有右旋糖酐辅料的注射和吸入制剂的疫苗与药品，应在说明书中描述有关其过敏反应信息的新要求。介绍该文件的主要内容，期望对我国这类药品说明书的撰写和监管有所帮助。     

药用辅料四氟乙烷理化检测试验方法概述

目的分析概述药用辅料四氟乙烷(HFC-134a)理化检测中的试验方法,为建立复核用质量标准提供方法依据。方法对药用辅料四氟乙烷(HFC-134a)质量标准研究中理化检测的试验方法进行整理和分析,参考国家已有的工业标准、国外企业标准及中国药典的规定,概述质量标准制定中理化检测的试验方法。结果本文提供的四氟乙烷理化检测中的试验方法确信可行,能复核检测药用辅料四氟乙烷。结论采用药用辅料四氟乙烷理化检测中的试验方法,能有效检测该气体并确定产品质量。     

Spectrophotometric determination of oxytetracycline in pharmaceutical preparations using sodium molybdate as analytical reagent

A spectrophotometric method is proposed for the determination of oxytetracycline in pharmaceutical preparations. The method is based on the measurement of the absorbance of the molybdate—oxytetracycline complex at 404 nm (pH 5.50; μ = 0.1 M; 20°C). The composition of the complex (1:1) was determined by the application of the spectrophotometric methods of Job and Bent—French (pH 5.50; λ = 390 nm; μ = 0.1 M). The relative stability constant (K′ = 10^4.6) of the complex was obtained by the methods of Sommer and Nash (pH 5.50; λ = 390 nm; μ = 0.1 M; 20°C). The molar absorptivity of the complex was 9.5 × 10³ l mol⁻¹ cm⁻¹. Beer's law was obeyed over the concentration range 2.48–34.78 μg ml⁻¹. The relative standard deviation RSD (n = 10) was 0.27–0.39%. The method proposed can be applied to the assay of oxytetracycline in capsules. The detection limit of oxytetracycline is 2.5 μg ml⁻¹.     

Identification of pharmaceutical excipients using NIR spectroscopy and SIMCA

Soft independent modelling of class analogy (SIMCA) is applied to identify near-infrared (NIR) spectra of ten excipients used in the pharmaceutical industry. For each class at least 15 excipient samples were collected for the data base, considering different batches and occasionally various suppliers. Therefore the data of the classes are not always homogeneous. The performance of the original SIMCA method, which is usually described in the literature and also applied by the users, carried out at two confidence levels, 95 and 99%, on original data, SNV (standard normal variate transformation) and second derivative pre-processed data, is discussed. Reasons for the rejection rates are given. No objects were assigned to a wrong class using SIMCA.     

复方醋酸钠注射液中醋酸钠含量测定方法的探讨

本文报道采用改良中和法代替离子交换法，测定复方醋酸钠注射液中醋酸钠的含量。本法系利用醋酸钠在乙醇、甘油混合液中用盐酸液滴定，有明显突跃的终点，结果准确、可靠，重现性、回收率均好，平均回收率为９９．９９％，相对标准差为０．１６％。     

海藻酸钠复合水凝胶的制备及其细菌检测应用研究

目的 制备海藻酸钠-金纳米颗粒复合水凝胶并研究其检测细菌的性能,为可视化细菌检测创伤敷料的开发奠定基础。方法 以海藻酸钠为原料,掺杂显色底物氯酚红β-D-吡喃半乳糖苷及半乳糖苷酶修饰的金纳米颗粒,通过钙离子引发的海藻酸钠交联制备复合水凝胶,研究其对细菌的检测性能。结果 当金纳米颗粒尺寸为5 nm,浓度为100 nmol/L时,水相中传感器对大肠杆菌和金黄色葡萄球菌的检测限可达100 CFU/mL;复合凝胶对金黄色葡萄球菌的检测限可达1 000 CFU/mL。结论 海藻酸钠-金纳米颗粒复合水凝胶具有生物相容性好、细菌检测灵敏度高的优点,有望作为伤口敷料用于检测伤口愈合过程中的细菌感染。     

海藻糖作为药用辅料的安全性评价

目的 评价海藻糖作为药用辅料使用的总体安全性。方法 以SD大鼠为试验对象,测定急性经口毒性;以健康白色家兔为试验对象,测定皮肤、眼刺激性;以豚鼠为试验对象,测定皮肤变态反应（致敏）性;以SD大鼠为试验对象,采用肌肉注射的方法进行90d给药试验,测定长期毒性。结果 在本试验条件下,海藻糖对SD大鼠急性经口毒性为实际无毒,对家兔皮肤、眼睛无刺激性,对豚鼠皮肤的致敏强度为弱致敏物,SD大鼠连续90d肌肉注射给药试验未观察到海藻糖明显的毒性反应,其无毒作用剂量＞200 mg/kg。结论 海藻糖作为药用辅料,安全性良好。     

Effects of pharmaceutical excipients on membrane permeability in rat small intestine

Pharmaceutical excipients should not disturb the effects of drug therapy. In recent years, however, it has been reported that excipients induce some changes to the tight junction (TJ) and P-glycoprotein (P-gp), which can affect drug disposition. In this study, we examined the effects of 20 common pharmaceutical excipients from different classes on mucosal membrane and the differences of such effects among regions of the small intestine. We used the in vitro sac method in rat jejunum and ileum to study the effects of excipients on the membrane permeation of 5(6)-carboxyfluorescein (5-CF). 5-CF was used as a model of water-soluble compounds. In some dosage conditions of methyl-β-cyclodextrin, the membrane permeability of 5-CF was significantly increased in the jejunum, but such change was not observed in the ileum. Similarly, in the cases of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose and croscarmellose sodium, the membrane permeability of 5-CF was significantly increased in the jejunum, but no change was observed in the ileum. On the other hand, in both the jejunum and the ileum, the membrane permeation of 5-CF was decreased with 0.02% (w/v) hydroxypropyl cellulose, but significantly increased with it at 0.20% (w/v). It was shown that excipients affected the membrane permeability of water-soluble compounds via the paracellular route, and these effects on absorption differed among regions of the small intestine. Moreover, in the case of 20 excipients, not only an increase in membrane permeability but also a decrease was observed. Therefore, it was suggested that a more effective formulation could be designed by changing the combination of excipients.