小儿化痰止咳颗粒(糖浆)质量评价分析  

Quality Evaluation on Xiaoer Huatan Zhike Granules and Syrup

作　　者：陈惠玲[1] 黄澜[1] 段营辉[1] 朱樵苏 李玲玲[1] 

机构地区：[1]厦门市药品检验所,厦门361012

出　　处：《中国药事》2015年第8期854-858,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:通过对45个生产企业的237批小儿化痰止咳颗粒(糖浆)的国家评价性抽验结果分析,评价小儿化痰止咳制剂质量状况。方法:采用法定检验方法和探索性研究进行样品检测,统计分析小儿化痰止咳制剂质量状况并进行评价。探索性研究:1吐根酊HPLC特征图谱研究;2制剂HPLC特征图谱研究;3桑白皮流浸膏薄层色谱研究;4 HPLC法测定盐酸麻黄碱、吐根碱和吐根酚碱含量;5 HPLC法筛查可能的人工甜味剂和化学类祛痰镇咳药;6顶空GC法测定糖浆剂中三氯甲烷残留量;7 GC法测定成品及原料中的甲醇残留量;8 HPLC法测定盐酸麻黄碱含量均匀度;9建立近红外光谱模型、拉曼光谱模型。结果:法定检验结果显示,226批小儿化痰止咳颗粒中8批不合格,合格率96.5%,11批糖浆剂均符合规定;探索性研究结果表明,全部糖浆剂和41.4%的颗粒剂存在质量问题。结论:小儿化痰止咳颗粒(糖浆)虽然法定检验合格率很高,但通过探索性研究发现部分样品还存在一定的质量问题,质量标准亦有待提高。Objective： To evaluate the quality status of Xiaoer Huatan Zhike preparations through analysis of the results of the national evaluative sampling inspection on 237 batches of Xiaoer Huatan Zhike preparations from 45 manufacturers. Methods： Statutory testing methods combined with the exploratory study were used to examine samples, and the quality status of Xiaoer Huatan Zhike preparations was evaluated by statistical analysis of the results. The exploratory study was focused on the aspects as follows： the characteristic chromatograms of ipecac tinctura and Xiaoer Huatan Zhike preparations, the thin layer chromatography of Cortex Mori fluid extracts, the content of ephedrine hydrochloride, emetine and cephaeline by HLC, screening of the potential artificial sweetener and the chemical expectorant cough medicine, detection of the residues of methanol in products and raw materials by GC, detection of the content uniformity of ephedrine hydrochloride by HPLC, as well as establishment of near infrared spectroscopic model and Raman spectroscopic model. Results： The statutory test showed eight out of the 226 batches of Xiaoer Huatan Zhike Granules were unqualified and the pass rate was 96.5%. All of 11 batches of Xiaoer Huatan Zhike Syrup were qualified. However, the exploratory study showed that quality problems existed in all of Xiaoer Huatan Zhike Syrup and 41.1% of Xiaoer Huatan Zhike Granules. Conclusion： Although the pass rate of the statutory inspection was high for Xiaoer Huatan Zhike Granules （Syrup）, the exploratory study found that some samples still had some quality problems, indicating that quality standards needed to be improved.

关 键 词：药品安全监测 药品质量评价 药品检验 探索性研究 HPLC特征图谱 人工甜味剂筛查 溶剂残留检测 近红外光谱模型 拉曼光谱模型 

分 类 号：R917[医药卫生—药物分析学]