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4个厂家83批复方桔梗麻黄碱糖浆（Ⅱ）的质量分析
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| 篇名： | 4个厂家83批复方桔梗麻黄碱糖浆（Ⅱ）的质量分析 |
| TITLE： | |
| 摘要： | 目的：通过对4个厂家83批复方桔梗麻黄碱糖浆（Ⅱ）的国家评价性抽验结果进行分析，评价其质量。方法：采用法定检验方法和探索性研究进行样品检测，统计分析并评价。探索性研究内容包括采用高效液相色谱法测定防腐剂苯甲酸等的含量和盐酸麻黄碱的含量，处方抑菌效力检查研究，溶液pH值测定；采用旋光光度法测定蔗糖的含量，氯化铵含量与微生物污染之间联系的研究，采用顶空气相色谱法同时测定薄荷脑和乙醇的含量，采用薄层色谱法对桔梗流浸膏进行鉴别研究。结果：法定检验结果显示，在83批样品中，80批合格，3批不合格，合格率为96.4％。不合格项目分别为装量、微生物限度及氯化铵含量、氯化铵含量。法定检验联合探索性研究结果表明，本品存在处方抑菌效力不符合规定、部分原辅料未按处方量投料、产品质量不均等情况。建议修订本品质量标准：增加桔梗薄层色谱鉴别、pH值测定、防腐剂含量测定、薄荷脑含量测定；将盐酸麻黄碱含量测定方法修订为高效液相色谱法等。结论：复方桔梗麻黄碱糖浆（Ⅱ）样品总体质量较差，部分厂家的生产工艺及质量控制存在较大缺陷，质量标准有待提高。 |
| ABSTRACT： | OBJECTIVE： To analyze the results of national evaluation inspection for 83 batches of Compound jiegeng mahuangjian syrup（Ⅱ）from 4 manufacturers， and to evaluate their quality. METHODS： Legal inspection method and exploratory research were adopted to test， analyze and evaluate sample statistically. The contents of exploratory research included HPLC method was used to determine the contents of preservative benzoic acid and ephedrine hydrochloride； antibacterial efficacy examination of formulation was studied； pH value of solution was determined； the content of sucrose was determined by polarimetry photometry； the relationship of the content of ammonium chloride with microbial contamination was studied； headspace GC method was used to determine the contents of menthol and ethanol； Platycodon grandiflorum extractum was identified and studied by TLC. RESULTS： Results of legal inspection showed that among 83 batches of sample， 80 batches were qualified and 3 batches were unqualified， with qualified rate of 96.4％. Unqualified items were loading capacity， microbial limit and content of ammonium chloride， content of ammonium chloride. The results of legal test combined with exploratory research showed that antibacterial efficacy of formulation of one manufacturer was not in accordance with the regulations； Some raw materials were not fed according to formulation, and the quality of products was not even. It is recommended to revise the quality standard：identificatied the Campanulaceae by TLC； determination the pH， preservative content， menthol content； revision ephedrine hydrochloride assay method to HPLC. CONCLUSIONS： The overall quality of Compound jiegeng mahuangjian syrup （Ⅱ） is not satisfactory； there is a big flaw in the production process and quality control of some manufacturers； quality standards needed to be improved. |
| 期刊： | 2018年第29卷第7期 |
| 作者： | 谭菊英，朱荣，孙煜，曾庆花，黄慧，杨娜，甘永琦，朱建萍，卢日刚 |
| AUTHORS： | TAN Juying，ZHU Rong，SUN Yu，ZENG Qinghua，HUANG Hui，YANG Na，GAN Yongqi，ZHU Jianping，LU Rigang |
| 关键字： | 复方桔梗麻黄碱糖浆（Ⅱ）；质量分析；评价性抽验；探索性研究 |
| KEYWORDS： | Compound jiegeng mahuangjian syrup （Ⅱ）； Quality analysis； Evaluation test； Exploratory research |
| 阅读数： | 329 次 |
| 本月下载数： | 10 次 |
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