摘要
目的:考察医院制剂白色洗剂于不同贮存条件下进行加速实验和长期实验,制剂稳定性随贮存时间延长的变化情况,为该制剂的贮存方式、使用时间和生产工艺提供依据,通过实验进一步预测其贮存有效期。方法:根据《中国药典》2020年版第四部9001原料药物与制剂稳定性试验指导原则,对3批白色洗剂进行加速实验和长期实验研究,按照制剂质量标准对该制剂的性状、成分鉴别、苯酚含量、氧化锌含量及微生物限度进行检查,利用Minitab 21软件进行数据分析,考察白色洗剂的稳定性。结果:(1)加速实验结果表明,在温度(42±2)℃、相对湿度75%±5%条件下贮存6个月,白色洗剂的理化性质和主要成分含量符合质量标准,微生物限度符合规定;(2)长期实验结果表明,在温度(25±2)℃,相对湿度60%±10%条件下贮存36个月,白色洗剂的理化性质、微生物限度符合规定,氧化锌含量符合质量标准,苯酚含量从第18个月开始检测时低于限度值。结论:通过Minitab 21软件对加速实验、长期实验结果进行数据分析,白色洗剂常温(10~30℃)贮存,有效期可定为9个月。
Objective:To investigate the changes of stability of white lotion of hospital preparation with the extension of storage time in accelerated test and long-term test,to provide a basis for the storage mode,use time and production process of the preparation,and to further predict the storage period of validity through the test.Methods:According to the guiding principle of stability test of 9001 raw material drugs and preparations in the fourth edition of Chinese Pharmacopoeia in 2020,accelerated test and long-term test were carried out on three batches of white lotion.Based on the quality standard of the preparation,the properties,composition identification,phenol content,zinc oxide content and microbial limit of the preparation were examined.The data were analyzed by Minitab 21 software to investigate the stability of white lotion.Results:(1)Results of accelerated test showed that when the temperature was(42±2)℃and the relative humidity was 75%±5%for 6 months,the physical and chemical properties,and content of main components of white lotion met the quality standard,and the microbial limit met the regulations.(2)Long-term test results showed that the physical and chemical properties,and microbial limit were in line with the regulations and content of zinc oxide was in line with the quality standard under the condition of temperature(25±2)℃and relative humidity 60%±10%for 36 months.The content of phenol was lower than the limit from the 18 th month.Conclusion:According to the data analysis of accelerated test and long-term test by Minitab 21 software,the period of validity of white lotion can be set at 9 months when stored at room temperature(from 10 to 30℃).
作者
杨晓峰
李惠英
秦利芬
Yang Xiaofeng;Li Huiyin;Qin Lifen(Kunming Children’s Hospital,Kunming 650000,China)
出处
《儿科药学杂志》
CAS
2024年第7期5-8,共4页
Journal of Pediatric Pharmacy
关键词
长期试验
加速试验
稳定性
有效期
long-term test
accelerated test
stability
period of validity
