共查询到19条相似文献,搜索用时 643 毫秒
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目的运用近红外技术对具体的某"一厂一品一规"的药品建立近红外一致性检验模型。方法用近红外光谱仪采集样品光谱,通过OPUS软件建立一致性检验模型,并对图谱进行比对分析。结果建立的一致性检验模型可以很好地区分不同制药企业生产的注射用盐酸氨溴索。结论建立的一致性检验模型的方法能快速、准确地区分不同厂家生产的注射用盐酸氨溴索,对快速鉴定不同厂家生产的药品具有一定的参考价值。 相似文献
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李小峰 《临床合理用药杂志》2014,(35):80-80
目的应用近红外光谱法对利可君片进行一致性检验。方法将收集的12批江苏吉贝尔药业有限公司生产的利可君片扫描近红外光谱图和进行预处理,建立一致性检验方法。结果一致性检验模型可以显著区分与该厂家样本主成分相同的其他厂家样本。结论近红外光谱法快速简便,结果准确,适用于假劣药品的快速筛查。 相似文献
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目的 应用近红外光谱法对肠虫清(即中美天津史克制药有限公司生产的阿苯达唑片)进行一致性检验.方法 将收集的 10批肠虫清扫描近红外光谱图和进行预处理,建立一致性检验方法.结果 一致性检验模型可以显著区分与该厂家样本主成分相同的其他厂家样本.结论 本方法快速简便,结果准确,适用于假劣药品的快速筛查. 相似文献
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目的利用近红外光谱分析技术,建立本地企业知柏地黄丸的一致性和水分测定快速检测模型。方法以厂家成品留样和未干燥半成品自制样品作为研究样本,结合检验数据,通过采集样本光谱,综合考察各种光谱预处理方法对模型的影响,选择最佳条件分别建立模型。结果一致性模型对本企业和其它企业同品种有很好的识别能力,水分测定定量模型能对成品所含水分值作出预测。结论两类模型操作简便,分析快速,检测结果可靠,适用于药品检测车对特定厂家指定品种的快速筛查。 相似文献
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目的:建立佛山冯了性股份有限公司近红外一致性模型,快速鉴别其他厂家香砂六君丸.方法:采集香砂六君丸的近红外光谱,利用OPUS软件进行处理,建立佛山冯了性股份有限公司香砂六君丸的近红外光谱一致性检验模型,用不同厂家及功效相近样品的近红外光谱进行验证.结果:建立的近红外一致性模型可以快速、准确地判断不同厂家的真伪.结论:该方法是一种快速、简便、准确的分析技术,可用于药品快速检测. 相似文献
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目的 建立全覆盖抽样的普伐他汀钠片的近红外光谱法一致性检验模型,考察制剂工艺的差别和原料药晶型的差异,通过稳健、准确、代表性强的近红外光谱一致性模型实现普伐他汀钠片的快速检验和筛查。方法 对评价性抽验抽取的5个企业中的4个共65批样品建立普伐他汀钠片近红外一致性检验模型,并对4个厂家的原料药的近红外光谱图进行比较。结果 建立了4个厂家普伐他汀钠片剂的近红外一致性模型,预测成功率均为100%;4种原料药和1种无定型粉末的近红外光谱图显示不同晶型光谱图具有差异。结论 近红外光谱法能够用于快速鉴别质量工艺稳定的普伐他汀钠片产品,对制剂工艺进行考察,并能够区分不同晶型的原料药。 相似文献
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A NIR identification system consisting of two proposed models (Model I and Model II) has been developed for the analysis of 10 different products of macrolides tablets from different manufacturers. A total of 253 batches of the 10 products from 93 manufacturers in China were used for the system construction. First, a universal classification model (termed Model I) was constructed for 10 products using all the samples with the objective to distinguish the macrolides homologues which have the similar molecular structures. Secondly, 10 models (termed Model II) were developed separately for each product by using their samples. For each type of macrolides products, the two qualitative models are used in tandem as an identification system in mobile labs. Only when Model I and Model II both show acceptance results can an unknown sample be identified as “genuine”. Internal and external validation showed almost 100% correct identity. Our study has shown that the analytical accuracy can be greatly improved when using this identification system and it will be efficient for quickly prescreening the drug quality in the open market and distribution channels. 相似文献
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Universal quantitative models using NIR reflectance spectroscopy were developed for the analysis of API contents (active pharmaceutical ingredient) in roxithromycin and erythromycin ethylsuccinate tablets from different manufacturers in China. The two quantitative models were built from 78 batches of roxithromycin samples from 18 different manufacturers with the API content range from 19.5% to 73.9%, and 66 batches erythromycin ethylsuccinate tablets from 36 manufacturers with the API content range from 28.1% to 70.9%. Three different spectrometers were used for model construction in order to have robust and universal models. The root mean square errors of cross validation (RMSECV) and the root mean square errors of prediction (RMSEP) of the model for roxithromycin tablets were 1.84% and 1.45%, respectively. The values of RMSECV and RMSEP of the model for erythromycin ethylsuccinate tablets were 2.31% and 2.16%, respectively. Based on the ICH guidelines and characteristics of NIR spectroscopy, the quantitative models were then evaluated in terms of specificity, linearity, accuracy, precision, robustness and model transferability. Our study has shown that it is feasible to build a universal quantitative model for quick analysis of pharmaceutical products from different manufacturers. Therefore, the NIR method could be used as an effective method for quick, non-destructive inspection of medicines in the distribution channels or open market. 相似文献
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目的运用近红外(near-infrared,NIR)漫反射光谱法快速鉴别及区分不同厂家的磷霉素钙片,鉴别假劣药品,保障人民用药安全有效。方法通过收集A厂家生产的18个批次的样本以及其他厂家生产的多批样本,扫描其近红外光谱,运用布鲁克公司的OPUS软件,建立A厂家生产的磷霉素钙片的一致性检验模型,并对模型进行优化以及用其他厂家的样本来验证所建最优模型。结果建立的模型可以显著快速鉴别和区分不同厂家的磷霉素钙片。结论所建立的方法快速、简便、有效,可应用于药品的快速检验。 相似文献
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目的:利用近红外光谱建立快速测定盐酸吡格列酮片含量的方法。方法:用HPLC法测定100批盐酸吡格列酮片样品含量并采集各样品的近红外光谱数据,从中随机抽取80批样品组成校正集,另20批样品组成测试集,采用偏最小二乘法(PLS)建立定量模型,并预测测试集样品的盐酸吡格列酮含量。结果:所建立定量模型的交叉验证测定系数r^2为0.9903,交叉验证均方差(RMSPCV)为0.394;测试集样品的测定系数r^2为0.9875,预测均方差(RMSEP)为0.259,平均预测偏差0.18%。结论:本法操作简便、快速、环保,可用于盐酸吡格列酮片的快速定量分析。 相似文献
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盐酸环丙沙星片近红外定量分析模型的建立 总被引:1,自引:0,他引:1
目的 利用近红外光谱法,建立盐酸环丙沙星片含量快速测定方法.方法 采集盐酸环丙沙星片的近红外(NIR)光谱,建立近红外定量模型.结果 盐酸环丙沙星片定量模型经内部交叉验证建立预测模型,浓度范围为54.51%~77.72%(mg/mg ),决定系数(R2) 为97.49%,内部交叉验证预测均方根误差( RMSECV)为0.74.外部验证,决定系数(R2)为97.2%,外部验证预测均方根误差( RMSEP) 为0.813.结论 该方法快速、简便、无损,结果准确,适用于药品的现场快检. 相似文献
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目的:利用光纤溶出度过程分析方法,监测盐酸维拉帕米片的溶出度,反映不同厂家及同一厂家不同批号盐酸维拉帕米片间的质量差异.方法:采用《中国药典》盐酸维拉帕米片溶出度检测方法中的条件,利用光纤传感溶出度实时过程分析方法考察4个不同厂家及同一厂家5个不同批号盐酸维拉帕米片的溶出度.结果:过程溶出曲线反映每一药片溶出过程全部信息.4个不同厂家盐酸维拉帕米片的溶出度均符合《中国药典》2010年版规定,但溶出速度和曲线存在差异.结论:光纤溶出度过程分析原位实时反映了药物体外溶出特性,并真实地反映了同一药物的药片存在明显的差异.对考察体内外相关性、评价药品品质和评价生物等效性提供了有效途径. 相似文献
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Yuksel N Baykara M Shirinzade H Suzen S 《International journal of pharmaceutics》2011,415(1-2):102-109
The influx of medicines from different sources into healthcare systems of developing countries presents a challenge to monitor their origin and quality. The absence of a repository of reference samples or spectra prevents the analysis of tablets by direct comparison. A set of paracetamol tablets purchased in Malaysian pharmacies were compared to a similar set of sample purchased in the UK using near-infrared spectroscopy (NIRS). Additional samples of products containing ibuprofen or paracetamol in combination with other actives were added to the study as negative controls. NIR spectra of the samples were acquired and compared by using multivariate modeling and classification algorithms (PCA/SIMCA) and stored in a spectral database. All analysed paracetamol samples contained the purported active ingredient with only 1 out of 20 batches excluded from the 95% confidence interval, while the negative controls were clearly classified as outliers of the set. Although the substandard products were not detected in the purchased sample set, our results indicated variability in the quality of the Malaysian tablets. A database of spectra was created and search methods were evaluated for correct identification of tablets. The approach presented here can be further developed as a method for identifying substandard pharmaceutical products. 相似文献