光谱分析在药物质量控制中的应用

发布时间：2018-05-12 23:45

本文选题：盐酸小檗碱 + 维生素B2　；参考：《新疆医科大学》2017年硕士论文

【摘要】：目的:建立采用可调激光-光纤传感快速检测维生素B2和盐酸小檗碱片含量的方法及建立用荧光分光光度法测定瑞舒伐他汀钙,且用正交试验优化及提升其含量测定的质控方法,为其质量控制的研究尊定基础。方法:采用可调激光光源(激发波长分别为520 nm和620 nm)光纤传感技术分别快速检测药品中盐酸小檗碱和维生素B2的含量。将实验数据汇总录入Excel数据库中,并对不同厂家的盐酸小檗碱和维生素B2的激光强度等指标进行统计描述分析。运用SPSS22.0软件,对计量资料的两组比较使用t检验,两组以上的资料使用方差分析,画散点图,绘制标准曲线,做线性回归。瑞舒伐他汀钙在激发波长为ex:250 nm,发射波长em:516 nm的条件下测定其荧光强度,用三因素三水平的正交试验优化条件,后用线性回归方程找出荧光强度与浓度的回归方程。结果:盐酸小檗碱片剂85-120 mg,国内市场上卖的维生素B2片1-20 mg,国外的维生素B2 85-120 mg范围内有较强的特征波峰,质量与光的强度之间呈良好的线性关系及呈负相关,相关系数R小檗碱=0.999 9、R维生素B2=0.999 7(国内),R维生素B2=0.999 8(国外);荧光强度与瑞舒伐他汀钙浓度在3.17-39.72 mg/L范围内具有良好的线性关系,检出限为:0.38 mg/L,以荧光强度为指标,考察pH值,甲醇浓度和时间等3个因素,选定最佳条件,将正交试验数据进行统计分析,差异有统计学意义(P0.05)。按最佳条件进行3次重复实验,结果显示用荧光分光光度法测定瑞舒伐他汀钙含量特异性好,灵敏度高,检测线低。结论:本方法经过方法学验证,可用于盐酸小檗碱及维生素B2的质量控制。选用荧光分光光度计检测瑞舒伐他汀钙,结果采用紫外-分光光度法进行验证,结果令人满意。
[Abstract]:Objective: to establish a rapid method for the determination of vitamin B2 and berberine hydrochloride tablets by tunable laser-fiber sensing and to establish a fluorescence spectrophotometric method for the determination of rosuvastatin calcium. The orthogonal test was used to optimize and improve the quality control method for the determination of its content. Methods: the content of berberine hydrochloride and vitamin B _ 2 in medicine was determined rapidly by the optical fiber sensing technique with adjustable laser light source (excitation wavelength 520 nm and 620 nm). The experimental data were collected into the Excel database and the laser intensity of berberine hydrochloride and vitamin B2 from different manufacturers were described and analyzed statistically. Using SPSS22.0 software, t test is used to compare two groups of measurement data, and more than two groups of data use ANOVA, draw scatter plot, draw standard curve, and make linear regression. The fluorescence intensity of rosuvastatin calcium was determined at excitation wavelength of ex:250 nm and emission wavelength of em:516 nm. Three factors and three levels of orthogonal test were used to optimize the conditions. The regression equation of fluorescence intensity and concentration was obtained by linear regression equation. Results: berberine hydrochloride tablets 85-120 mg, vitamin B2 tablets sold in domestic market 1-20 mg, vitamin B 285-120 mg abroad have a strong characteristic wave peak. There is a good linear relationship and negative correlation between quality and light intensity. The correlation coefficient R berberine (R berberine) 0.999 9 ~ R Vitamin B _ 2N _ (0.999 ~ 7). The fluorescence intensity has a good linear relationship with the concentration of recuvastatin calcium in the range of 3.17-39.72 mg/L, the detection limit is 0.38 mg / L, the fluorescence intensity is taken as the index, and the pH value is investigated. Three factors, methanol concentration and time, were selected and the data of orthogonal test were statistically analyzed. The difference was statistically significant (P 0.05). The results showed that the determination of rosuvastatin calcium by fluorescence spectrophotometry had good specificity, high sensitivity and low detection line. Conclusion: the method can be used for the quality control of berberine hydrochloride and vitamin B2. A fluorescence spectrophotometer was used for the determination of rosuvastatin calcium. The results were verified by UV-spectrophotometry and the results were satisfactory.
【学位授予单位】：新疆医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：O657.3;R927

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