摘要
Abstract
Objective To promote the improvement of the quality of Chinese medicinal materials and decoction pieces.Methods Data on the spot-checks for Chinese medicinal materials and decoction pieces performed by the Shanghai Songjiang Institute for Food and Drug Control from 2013 to 2024 were collected,the overall quality was explored,and the reasons for unqualified quality were analyzed and summarized.Results A total of 413 varieties and 1 902 batches of Chinese medicinal materials and decoction pieces were sampled over the 12 years,of which 1 801 batches were qualified,with a qualified rate of 94.69%,the average qualified rate from 2013 to 2017 was 89.39%,and that from 2018 to 2024 was 97.98%;the overall qualified rate has shown a positive trend since 2018,with each year's qualified rate over 95.00%,and the highest was 99.53%in 2023.A total of 58 varieties were involved in 101 batches of unqualified samples.The varieties with the most unqualified batches were Pheretima(eight batches,involving total ash and acid insoluble ash items),followed by Platycladi Semen(five batches,involving aflatoxin item).The items involving more unqualified batches included characteristics(26 batches),moisture(25 batches),and content determination(21 batches).The unqualified samples were from manufacturing enterprises,pharmaceutical trading enterprises,public hospitals,and private hospitals,with unqualified rates of 2.43%(5/206),3.76%(19/505),2.67%(18/674),and 11.41%(59/517),respectively.Conclusion With the improvement of quality standards and the strengthening of supervision,the quality of Chinese medicinal materials and decoction pieces in the city has been improved.It is recommended to continuously improve quality standards,carry out source control,use small packaging rationally,strengthen professional training for practitioners,classify Chinese medicinal materials and decoction pieces by quality,and strengthen the scientificity of sampling inspection to further improve the quality of Chinese medicinal materials and decoction pieces,and better ensure the safety and effectiveness of public medication.关键词
中药材/饮片/质量控制/用药安全Key words
Chinese medicinal material/decoction piece/quality control/medication safety分类
药学
