稀苯扎溴铵溶液微生物限度检查方法的建立及方法学验证

目的建立稀苯扎溴铵溶液微生物限度检查方法并进行方法学验证,确保方法的有效性。方法按《中国药典》2010年版二部附录XI J方法验证试验的要求,对稀苯扎溴铵溶液进行微生物限度检查法的方法学验证。结果对本溶液的微生物限度检查可采用薄膜过滤法进行细菌、霉菌和酵母菌计数;可采用薄膜过滤法进行控制菌的检查。结论通过对溶液进行微生物限度方法学验证而建立的检查方法时,需先考虑消除其抑菌性后,再依法检查。     

Substance P Enhances Neuronal Area and Epithelial Cell Proliferation After Colon Denervation in Rats

We evaluated the neurotrophic effect of the neurokinin SP in the induced megacolon and the cell proliferation of the colonic epithelium after treatment. Colon segments of Wistar rats were chemically denervated by topical application of 2 mM benzalconium chloride and animals were daily injected intraperitoneally with SP (70 g/kg body wt) for 15 days. Control rats received either SP or were denervated and treated with saline. Neuronal profiles of the myenteric plexus were studied by immunohistochemistry to motor protein myosin V and cell proliferation by PCNA immunolabeling. Denervation induced a significant reduction in the number of neurons and an enlargement of the surviving perikarya (from 263.7 m² in the control-saline group to 468.9 m² in the denervated groups). The total area occupied by neurons was maintained in the denarvated SP group but was significantly smaller in the denervated-saline group. The proliferative index was significantly higher in the denervated groups, of which the SP-treated group showed the highest index. These results suggest that SP may have a neurotrophic effect for the neurons of the myenteric plexus chemically denervated and that this denervation stimulates cell proliferation, especially after SP administration.     

右旋糖酐70甘油滴眼液中苯扎氯铵含量测定方法研究

目的:建立高效液相色谱法测定右旋糖酐70甘油滴眼液中苯扎氯铵的含量。方法:以氰基硅烷键合硅胶为填充剂;以乙腈-0.03 mol.L-1磷酸二氢钠溶液(用1 mol.L-1氢氧化钠溶液调pH至7.0)(43∶57)为流动相;流速:2.0 mL.min-1;柱温:35℃;检测波长214 nm。苯扎氯铵C12、C14、C16之间的分离度应符合规定。结果:苯扎氯铵在1.28～3.00μg范围内与峰面积线性关系良好(r=0.9999,n=7);平均回收率(n=6)为100.9%,RSD=0.9%。结论:该法操作简便,快速、准确,灵敏度高,重复性好,可用于右旋糖酐70甘油滴眼液中苯扎氯铵含量测定。     

盐酸卡替洛尔滴眼液中抑菌剂最适浓度考察及抑菌效力评价

目的 探索盐酸卡替洛尔滴眼液中苯扎氯铵的最适添加浓度。方法 根据苯扎氯铵药敏试验结果,选择抑菌剂浓度5~70 μg·mL^-1的盐酸卡替洛尔滴眼液进行初步抑菌效力考察,筛选出适宜的抑菌剂添加量。分别于不同苯扎氯铵浓度的盐酸卡替洛尔滴眼液中加入一定浓度的金黄色葡萄球菌、大肠埃希氏菌、铜绿假单胞菌、白色念珠菌菌悬液和黑曲霉孢子悬液,进行挑战实验,测试上述微生物在不同时间点的存活情况。结果 苯扎氯铵40 μg·mL^-1对5种挑战微生物的生长有良好的抑制作用,且为最低有效剂量。结论 苯扎氯铵40 μg·mL^-1可作为盐酸卡替洛尔滴眼液中抑菌剂的最适添加浓度。     

建立电感耦合等离子体质谱分析法测定滴眼液中的苯扎溴铵

目的:建立了电感耦合等离子体质谱分析(ICP-MS)测定滴眼液中苯扎溴铵的含量:.方法:采用ICP-MS技术,检测苯扎溴铵中的溴元素,建立了滴眼液中苯扎溴铵的含量测定方法,并进行了完整的方法学验证.结果:苯扎溴铵在0.163 2～2.725μg· mL-1范围内线性关系良好(r=0.999 9),平均回收率为101.5...     

Quality of dorzolamide hydrochloride and timolol maleate containing eye drops distributed online

Patient safety risks associated with the online purchase of medications, especially in case of ophthalmic preparations, are significant. Our study aimed to carry out quality assessment of dorzolamide hydrochloride (DZA) and timolol maleate (TIM) eye drops preserved with benzalkonium chloride (BAC) via online test purchases.Three samples were purchased online, while control preparations were acquired through authorized national drug supply chain. Our method was based on the International Pharmaceutical Federation (FIP) Inspection Checklist and integrated the evaluation of packaging and labelling. Sterility was established according to the European Pharmacopoeia (Ph. Eur.), while qualitative and quantitative quality was assessed with high-performance liquid chromatographic (HPLC) analysis.Several signs of falsification were recognized upon visual inspection of the online samples. All the products were clear, colourless, slightly viscous solutions. They were free from visible contaminants. The samples were sterile as no evidence of microbial growth was found. A quick and inexpensive HPLC analysis, optimized by the authors showed that active ingredients and the preservative deviated significantly (p < 0,05) with more than 10% from the values stated on the labels for at least one component (DZA: 99.3–113.1%, TIM: 112.8–139.2%, BAC: 82.4–97.7%).Development of comprehensive and reliable quality assessment methods are vital to increase public safety of pharmaceutical products sold online. A complex approach, integrating visual inspection, labelling assessment, microbiological analysis coupled with qualitative and quantitative methods provide a most reliable method. Due to its limited feasibility and cost-effectiveness, raising public awareness and limiting illegal online sellers should be the primary approaches to protect patients from substandard and falsified medicinal products sold via the internet. Particularly important for health professionals to understand this market and its public health concern, and to raise patient awareness of the risks associated with uncontrolled online purchase of medication.