中国药事
中國藥事
중국약사
Chinese Pharmaceutical Affairs
2015年
8期
854-858
,共5页
陈惠玲%黄澜%段营辉%朱樵苏%李玲玲
陳惠玲%黃瀾%段營輝%硃樵囌%李玲玲
진혜령%황란%단영휘%주초소%리령령
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
藥品安全鑑測%藥品質量評價%藥品檢驗%探索性研究%HPLC特徵圖譜%人工甜味劑篩查%溶劑殘留檢測%近紅外光譜模型%拉曼光譜模型
약품안전감측%약품질량평개%약품검험%탐색성연구%HPLC특정도보%인공첨미제사사%용제잔류검측%근홍외광보모형%랍만광보모형
drug safety monitoring%drug quality evaluation%drug testing%exploratory study%HPLC characteristic spectrum%artiifcial sweetener screening%detection of residual solvents%near infrared spectroscopic model%Raman spectroscopic model
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；④HPLC法测定盐酸麻黄碱、吐根碱和吐根酚碱含量；⑤HPLC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；⑦GC 法测定成品及原料中的甲醇残留量；⑧HPLC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。
目的：通過對45箇生產企業的237批小兒化痰止咳顆粒（糖漿）的國傢評價性抽驗結果分析，評價小兒化痰止咳製劑質量狀況。方法：採用法定檢驗方法和探索性研究進行樣品檢測，統計分析小兒化痰止咳製劑質量狀況併進行評價。探索性研究：①吐根酊HPLC特徵圖譜研究；②製劑HPLC特徵圖譜研究；③桑白皮流浸膏薄層色譜研究；④HPLC法測定鹽痠痳黃堿、吐根堿和吐根酚堿含量；⑤HPLC法篩查可能的人工甜味劑和化學類祛痰鎮咳藥；⑥頂空GC 法測定糖漿劑中三氯甲烷殘留量；⑦GC 法測定成品及原料中的甲醇殘留量；⑧HPLC法測定鹽痠痳黃堿含量均勻度；⑨建立近紅外光譜模型、拉曼光譜模型。結果：法定檢驗結果顯示，226批小兒化痰止咳顆粒中8批不閤格，閤格率96.5%，11批糖漿劑均符閤規定；探索性研究結果錶明，全部糖漿劑和41.4%的顆粒劑存在質量問題。結論：小兒化痰止咳顆粒（糖漿）雖然法定檢驗閤格率很高，但通過探索性研究髮現部分樣品還存在一定的質量問題，質量標準亦有待提高。
목적：통과대45개생산기업적237비소인화담지해과립（당장）적국가평개성추험결과분석，평개소인화담지해제제질량상황。방법：채용법정검험방법화탐색성연구진행양품검측，통계분석소인화담지해제제질량상황병진행평개。탐색성연구：①토근정HPLC특정도보연구；②제제HPLC특정도보연구；③상백피류침고박층색보연구；④HPLC법측정염산마황감、토근감화토근분감함량；⑤HPLC법사사가능적인공첨미제화화학류거담진해약；⑥정공GC 법측정당장제중삼록갑완잔류량；⑦GC 법측정성품급원료중적갑순잔류량；⑧HPLC법측정염산마황감함량균균도；⑨건립근홍외광보모형、랍만광보모형。결과：법정검험결과현시，226비소인화담지해과립중8비불합격，합격솔96.5%，11비당장제균부합규정；탐색성연구결과표명，전부당장제화41.4%적과립제존재질량문제。결론：소인화담지해과립（당장）수연법정검험합격솔흔고，단통과탐색성연구발현부분양품환존재일정적질량문제，질량표준역유대제고。
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 qualiifed. 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.
