摘要
目的 根据2020年版中国药典中花椒饮片的质量标准状况,对水分、总灰分、浸出物的检查项与含量测定项进行补充、修订和提高。方法 收集花椒饮片15批,按照2020年版中国药典四部通则0832水分测定法第四法甲苯法、通则2302灰分测定法、通则2201浸出物测定法与通则2204挥发油测定法甲法对花椒饮片的水分、灰分、浸出物、挥发油含量进行测定。结果15批花椒饮片的水分测定结果为(7.64±0.99)%,总灰分测定结果为(5.62±0.47)%,酸不溶性灰分测定结果为(0.23±0.13)%,浸出物测定结果为(32.87±1.98)%,挥发油含量测定结果为(2.59±0.46)%。结论 以水分、总灰分平均值上浮20%,浸出物、挥发油含量平均值下浮20%计,制订花椒饮片限度值为,水分不得过9.5%,总灰分不得过7.0%,不设定酸不溶性灰分限度,浸出物不得少于26.0%,挥发油含量不得少于2.0%(mL·g^(-1))。
OBJECTIVE To supplement,revise,and improve the inspection and content determination items for moisture,total ash,extract,and content determinationin Zanthoxylum slices according to the 2020 edition of the Chinese Pharmacopoeia.METHODSFifteenbatches of Zanthoxylum slices were collectedand analyzed using the toluene method for moisture determination,the 2302 ash content determination method,the 2201 extract determination method,and method A of 2204 volatile oil determination from the 2020 edition of the Chinese Pharmacopoeia.RESULTS The moisture content of 15 batches of Zanthoxylum sliceswas(7.64±0.99)%,total ash was(5.62±0.47)%,acid-insoluble ash was(0.23±0.13)%,extract content was(32.87±1.98)%,and volatile oil content was(2.59±0.46)%.CONCLUSION The limit value for Zanthoxylum set based on a 20%increase in the average moisture and total ash contentand a 20%decrease in the average leachate and volatile oil content:moisture should not exceed 9.5%,total ash should not exceed 7.0%,no limit for acid-insoluble ash is established,leachate should not be less than 26.0%,and volatile oil content should not be less than 2.0%(mL·g^(-1)).
作者
黎莉莉
杨洁丽
李依信
LI Lili;YANG Jieli;LI Yixin(Yunfu Institute for Food and Drug Control,Yunfu,Guangdong 527300,China)
出处
《今日药学》
CAS
2024年第8期578-582,共5页
Pharmacy Today
关键词
花椒
质量标准提高
水分
总灰分
浸出物
含量测定
Zanthoxylum
improve quality standards
moisture content
total ash content
extracts
content determination
