药厂制备的蛋白质酸银溶液稳定性研究

Valeriia Cherniakova, Nataliia Bevz, Oksana Strilets, Nataliia Harna, Olena Bevz, Olga Yevtifieieva
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引用次数: 0

摘要

今天,药店生产的药品越来越吸引消费者的注意,乌克兰的需求也在不断增长。制药生产面临许多问题,包括临时剂型的稳定性研究和最佳保质期的确定。1%和2%的水蛋白酸银溶液用于眼科、耳鼻喉科和肾科,在乌克兰的药房生产,既可以是临时生产,也可以作为储备。的目标。本工作的目的是建立1%和2%蛋白质酸银水溶液的质量支持方法,研究其化学稳定性,研究其微生物纯度以延长滴鼻液的保存时间。材料和方法。采用化学鉴定反应(对银和蛋白质)、硫氰酸滴定法定量测定和微生物纯度测定等方法,对1%和2%水蛋白质酸银溶液的化学稳定性进行了研究;结果。研究了该方法的验证特性(相关系数r = 0.9995、0.9996;系统误差分别为0.26%和0.03%,相对置信区间分别为0.88%和0.74%,证明了该方法的适用性。通过“微生物纯度”指标对药房制备的“1.0%蛋白质酸银溶液”和“2.0%蛋白质酸银溶液”进行了150天的生物稳定性研究。 结论。本文提出了临时剂型蛋白酸银的化学鉴定反应和定量测定方法,用于研究该药物的化学稳定性。化学稳定性和微生物纯度的研究结果使我们可以推荐药店将含有蛋白质酸银作为有效药物成分的滴鼻液的保质期延长150天
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The study of the stability of silver proteinate solutions prepared in pharmacies
Today, medicines made in pharmacies are increasingly attracting consumers' attention and are in growing demand in Ukraine. Pharmacy production faces a number of problems, including the study of the stability of extemporaneous dosage forms and the determination of an optimal shelf life. 1 % and 2 % water silver proteinate solutions used in ophthalmology, otolaryngology and nephrology are produced in Ukrainian pharmacies both extemporaneously and as a reserve. The aim. The aim of the work is to develop methods for quality support and study the chemical stability of 1 % and 2 % water solutions of silver proteinate, and to study the microbiological purity to extend the storage time of nasal drops. Materials and methods. A study of the chemical stability of 1 % and 2 % water silver proteinate solutions of pharmaceutical production is carried out using chemical identification reactions (to silver and protein), quantitative determination by thiocyanatometric titrimetric method and determination of microbiological purity. Results. The validation characteristics of the method for the quantitative thiocyanatometric determination of silver proteinate were studied (the correlation coefficient r = 0.9995 and 0.9996; the systematic error – 0.26 % and 0.03 %, the relative confidence interval – 0.88 % and 0.74 % for 1 % and 2 % solutions, respectively), as well as its suitability for this purpose was proven. “Silver proteinate solution, 1.0 %” and “Silver proteinate solution, 2.0 %” prepared in the pharmacy were studied for 150 days by the “Microbiological purity” indicator and were biologically stable. Conclusions. The chemical identification reactions and methods for the quantitative determination of silver proteinate in an extemporaneous dosage form used to study the chemical stability of the drug have been proposed. The study results of the chemical stability and microbiological purity allow us to recommend pharmacies to extend the shelf life of nasal drops containing silver proteinate as an active pharmaceutical ingredient for 150 days
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