不同包装和贮藏条件下酸枣仁的质量比较

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8.64μg/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。

Quality Comparison of Ziziphi Spinosae Semen under Different Packaging and Storage Conditions

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 aluminumplastic 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 aluminumplastic composite bag in vacuum.