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摘 要 目的:确定酸枣仁适合的贮藏条件、包装材料和包装方式,为保障酸枣仁质量提供参考。方法:选用同一批酸枣仁样品, 分别采取塑料编织袋包装、塑料袋包装、塑料袋真空包装、铝塑复合袋包装、铝塑复合袋真空包装和牛皮淋膜纸袋包装,贮藏在阴 凉库(温度≤20 ℃、相对湿度为45%~75%)和药品稳定性试验箱[温度为(40±2)℃、相对湿度为(75±5)%]中,以性状及水分、 黄曲霉毒素、酸枣仁皂苷A、斯皮诺素含量为考察指标,开展为期6个月的阴凉长期稳定性试验和加速稳定性试验研究。结果:6 个月阴凉长期稳定性试验结果显示,不同包装条件下酸枣仁样品的性状以及水分、黄曲霉毒素、酸枣仁皂苷A含量均符合2015年 版《中国药典》(一部)(后文简称“药典”)酸枣仁项下规定;斯皮诺素含量均不符合药典的规定(不低于0.080%),但其中铝塑复合 袋真空包装样品中斯皮诺素含量(0.079%)与药典要求接近。6个月加速稳定性试验结果显示,牛皮淋膜纸袋包装、塑料编织袋包 装样品发霉严重,塑料袋包装、塑料袋真空包装样品表面颜色变暗,铝塑复合袋包装样品颜色稍变暗,但铝塑复合袋真空包装样品 外观基本无变化;塑料编织袋包装、牛皮淋膜纸袋包装样品中水分含量超过了药典要求最高值(9.0%);仅在贮藏2个月时,编织塑 料袋包装样品被检出黄曲霉毒素B1含量为 8.64 μg/kg,超出药典规定;各包装样品中酸枣仁皂苷A含量虽有下降,但均满足药典 要求;仅塑料袋真空包装样品中斯皮诺素含量(0.084%)满足药典要求,其次属铝塑复合袋真空包装样品中含量(0.071%)相对较 高。结论:酸枣仁以铝塑复合袋真空包装后置于阴凉干燥处为宜。
ABSTRACT OBJECTIVE:To determine the suitable storage conditions,packaging materials and packaging methods of Ziziphi Spinosae Semen,and to provide reference for guaranteeing the quality. METHODS:The same batch of Ziziphi Spinosae Semen samples were packed in plastic woven bag,plastic bag,plastic bag in vacuum,aluminum-plastic composite bag,aluminum-plastic composite bag in vacuum and kraft coated paper bag. They were stored in a cool warehouse(temperature ≤20 ℃,relative humidity was 45%-75%) and drug stability test box [temperature was(40±2)℃,relative humidity was(75±5)%]. Five evaluation indexes were detected during 6-month of long-term cool stability test and accelerated stability test,including characters and the contents of moisture,aflatoxins,jujubosides A and spinosin. RESULTS:The results of 6-month long-term cool stability test showed that the character and the content of moisture,aflatoxins and jujubosides A of Ziziphi Spinosae Semen under different packaging conditions were in line with the requirements of 2015 edition of Chinese Pharmacopeia (part Ⅰ)(shorted for “pharmacopeia”). The content of spinosin didn’t meet the requirement of pharmacopeia(no less than 0.080%),but the content of spinosin(0.079%)of aluminum-plastic composite bag in vacuum was close to the requirements of pharmacopeia. The results of 6-month accelerated stability test showed that the sample packed in kraft coated paper bag and plastic woven bag were seriously moldy;the sample packed in plastic bag and plastic bag in vacuum were blackened;the color of the sample packed in aluminum-plastic composite bag was slightly darker;but the appearance of the sample packed in aluminum-plastic composite bag in vacuum was basically unchanged. Only when stored for 2-month,the content of aflatoxin B1 in the sample packed in plastic woven bag was 8.64 μg/kg,which exceeded the pharmacopoeia regulation. The moisture content of the sample packed in plastic woven bag and kraft coated paper bag exceeded the highest value (9.0%) required by the pharmacopoeia. Although the content of jujuboside A of samples in each package decreased,it meet the requirements of the pharmacopoeia. Only the content of spinosin (0.084%)of sample packed in plastic bag in vacuum meet the requirements of the pharmacopoeia,and the content of spinosin (0.071%)of sample packed in aluminum-plastic composite bag in vacuum was relatively high. CONCLUSIONS:Ziziphi Spinosae Semen should be stored in a cool and dry place after packed in aluminum-plastic composite bag in vacuum.
酸枣仁包装贮藏条件加速稳定性试验阴凉长期稳定性试验
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