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评估含药预混剂和含药农场饲料在加工和储存过程中稳定性的程序:硫氰酸红霉素

Procedure to evaluate the stability during processing and storage of a medicated premix and medicated farm feed: erythromycin thiocyanate.

作者信息

Bernabéu J A, Camacho M A, Gil-Alegre M E, Torres-Suárez A I

机构信息

Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, Complutense University of Madrid, 28040 Madrid, Spain.

出版信息

J Agric Food Chem. 2001 Aug;49(8):3709-12. doi: 10.1021/jf010169b.

DOI:10.1021/jf010169b
PMID:11513652
Abstract

In this paper, a stability study of a medicated premix and medicated farm feed containing erythromycin thiocyanate was planned. No drug degradation was detected during the medicated farm feed processing. In the medicated premix stability study, significant drug degradation was detected only at 40 degrees C and 75% relative humidity. Because after 2 years of storage at 25 degrees C and 60% relative humidity no degradation of erythromycin thiocyanate was detected, this period of time is proposed as the premix shelf life. In the medicated farm feed stability study, drug degradation was detected under accelerated conditions, but it was not detected under long-term storage conditions for 3 months. Therefore, the proposed shelf life of the medicated farm feed is 3 months, as this is time enough to be consumed. The planned stability study-storage conditions, testing frequency, and proposed data evaluation-allowed an easy and reliable evaluation of veterinary medicine stability.

摘要

本文计划对含有硫氰酸红霉素的药用预混剂和药用农场饲料进行稳定性研究。在药用农场饲料加工过程中未检测到药物降解。在药用预混剂稳定性研究中,仅在40摄氏度和75%相对湿度下检测到显著的药物降解。由于在25摄氏度和60%相对湿度下储存2年后未检测到硫氰酸红霉素降解,因此建议这段时间为预混剂保质期。在药用农场饲料稳定性研究中,在加速条件下检测到药物降解,但在3个月的长期储存条件下未检测到。因此,建议药用农场饲料的保质期为3个月,因为这段时间足够消耗。计划的稳定性研究——储存条件、测试频率和建议的数据评估——使得对兽药稳定性进行轻松可靠的评估成为可能。

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