基于省级监督抽检的小儿咳喘灵颗粒质量评价  

Quality Evaluation of XiaoEr KeChuanLing Granules Based on Provincial Supervision and Sampling Inspection

作　　者：刘小燕 夏巧红 王丽梅 倪琳 张义福[2] LIU Xiao-yan;XIA Qiao-hong;WANG Li-mei;NI Lin;ZHANG Yi-fu(Gansu Institute for Drug Control,Lanzhou 730030,China;Gansu University of Chinese Medicine,Lanzhou,Gansu 730000,China)

机构地区：[1]甘肃省药品检验研究院,甘肃兰州730070 [2]甘肃中医药大学,甘肃兰州730000

出　　处：《海峡药学》2024年第10期19-23,共5页Strait Pharmaceutical Journal

基　　金：国家药监局中药材及饮片质量控制重点实验室项目(2023GSMPA-KL07)。

摘　　要：目的对本省监督抽检品种小儿咳喘灵颗粒的质量进行评价,并对质量标准的修订提出建议。方法按现行标准对37批次样品进行检验分析,同时从药品有效性、真实性、质量一致性出发,开展了甘草、金银花薄层色谱鉴别、山银花掺伪金银花筛查、麻黄含量测定的探索性研究。结果按现行标准检验,37批次样品全部符合规定。探索性研究结果显示所有批次样品薄层色谱均检出甘草、金银花指标性成分甘草次酸、绿原酸;企业F的1批次样品中检出山银花特征成分灰毡毛忍冬皂苷乙;麻黄含量范围为(0.13~1.9)mg·g^(-1),有4批低于拟定限度0.35 mg·g^(-1)。结论小儿咳喘灵颗粒总体质量一般,生产工艺稳定性有待提高;现行质量标准过低,无法控制药品质量,亟待修订完善。OBJECTIVE To evaluate the quality of commercially available XiaoEr KeChuanLing granules based on provincial supervision and sampling inspection,and make suggestions for the revision of quality standards.METHODS 37 batches of samples were tested and analyzed according to the current standard.At the same time,from the perspective of the effectiveness,authenticity and quality consistency,the exploratory research on the TLC identification of licorice and honeysuckle,the screening of Lonicerae japonicae Flos.adulterated with Lonicerae similis Flos.and the determination of ephedra content were carried out.RESULTS According to the current standard test,37 batches of samples all meet the requirements.The results of exploratory research showed that glycyrrhetinic acid and chlorogenic acid,the index components of licorice and honeysuckle,were detected by TLC in all batches of samples.Macranthoidin B,the characteristic component of Lonicerae similis Flos,was detected in one batch of samples from enterprise F.The content range of ephedra sinica was 0.13-1.9 mg·g^(-1) of which 4 batches were below the proposed limit of 0.35 mg·g^(-1).CONCLUSION The overall quality of XiaoEr KeChuanLing granules is general,the stability of production process needs to be improved.The current quality standards are too low to control the quality of drugs and need to be revised and improved urgently.

关 键 词：小儿咳喘灵颗粒 质量评价 灰毡毛忍冬皂苷乙 麻黄 

分 类 号：R927[医药卫生—药学]