Article(id=1322127449081622762, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1628697600000, acceptedDateStr=2021-08-12, onlineDate=1793149347801, onlineDateStr=2026-10-28, pubDate=1640793600000, pubDateStr=2021-12-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793149347801, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793149347801, creator=13701087609, updateTime=1793149347801, updator=13701087609, issue=Issue{id=1322127420036071763, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='24', pageStart='2225', pageEnd='2327', issueExtLink='null', onlineDate='null', pubDate='1640793600000', pubDateStr='2021-12-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793149340876, creator='13701087609', updateTime=1793149575427, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322128403881374295, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322128403881374296, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322127420036071763, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2315, endPage=2321, ext={EN=ArticleExt(id=1322127449236812011, articleId=1322127449081622762, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Methodology validation of the determination of aerodynamic particle size distribution by next generate impactor, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: The preferred method for measuring aerodynamic particle size distribution (APSD) is cascade impactor. The next generation impactor (NGI) is a relatively new instrument among cascade impactors (CI), which has been included in the pharmacopoeia of various countries, however, there are still many problems in the process of methodology validation due to the cumbersome and complex operation of the method. In this study, the established CI method was systematically validated to reduce the variability of method, which could be used for the quality control of inhalers.
Methods: The APSD of ambroxol hydrochloride inhalation solution was determined by NGI, the drug contents at different stages were determined by high performance liquid chromatography (HPLC) method, and aerodynamic statistical parameters were calculated by the CITDS software. The methodology investigation included the establishment of HPLC method, determination of NGI nebulization time, re-entrainment, robustness of flow velocity, inter-stage drug loss, instrument calibration and leakage test, recovery rate, influence of diluent, repeatability and intermediate precision, temperature and humidity, etc.
Results: The adopted HPLC method could be used for the assay of ambroxol hydrochloride; the nebulization time of APSD was determined to be 1 min; the inter-stage drug loss was not greater than 2% of the total nebulized drug amount; the instrument was calibrated and no leakage was detected. The total recoveries were over 95.0%. The source of diluent had no effect on APSD determination results. The established method had good repeatability and intermediate precision. In the laboratory environment (20 ℃~25 ℃) temperature had no effect on the experimental results. Humidity (30% and 50%) had certain influence on the measured results.
Conclusion: NGI was used to establish the method for the determination of APSD of ambroxol hydrochloride inhalation solution, and systematic validation was finished. It was proved that the precision and recovery of the method are good, and the method variability is small, which is suitable for the determination of APSD of ambroxol hydrochloride inhalation solution. This study provided a reference and basis for the establishment and verification of aerodynamic particle size distribution determination, and this method can be used for the quality control of inhaled preparations.
, authors=Xuan-tang LI, Cui-cui CHEN, Ning-yi WEI, Ying ZHOU, Bao-ming NING, authorsList=Xuan-tang LI, Cui-cui CHEN, Ning-yi WEI, Ying ZHOU, Bao-ming NING, authorCompany=null, correspAuthors=Bao-ming NING, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322127449480081644, articleId=1322127449081622762, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=新一代撞击器测定空气动力学粒径分布方法学验证, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的： 空气动力学粒径分布（aerodynamic particle size distribution，APSD）的首选测定方法是级联撞击器法（cascade impactor，CI），新一代撞击器（next generation impactor，NGI）是诸多CI中较新的仪器，已被收载在各国药典中，但由于方法的操作繁琐等问题，在方法学验证过程中仍存在诸多问题。本文对建立的CI测定方法进行系统验证，以减少CI方法的变异性，可用于吸入制剂的质量控制。
方法： 采用NGI对盐酸氨溴索吸入溶液的APSD进行测定，采用HPLC法测定各层级药物含量，采用CITDS软件计算空气动力学相关统计参数，方法学内容包括HPLC方法的建立、NGI雾化时间的确定、二次夹带现象考察、流速耐用性、器壁损失测定、仪器校验及泄漏测试、回收率、稀释液的影响、重复性和中间精密度、实验温湿度等。
结果： 采用的HPLC方法可用于盐酸氨溴索含量测定；APSD雾化时间确定为1 min；仪器的器壁损失不大于雾化总药量的2%；仪器进行校验，未检出泄露现象；总回收率均>95.0%；稀释液的来源对APSD的结果无影响；平行测定的重复性和中间精密度良好，在实验室环境中（20 ℃~25 ℃）温度对实验结果无影响；不同湿度条件下（30%和50%）测得结果有一定影响；该方法适用于盐酸氨溴索吸入溶液的APSD测定。
结论： 本文采用NGI仪器，建立盐酸氨溴索吸入溶液的APSD测定方法，并进行系统验证，证明该方法的精密度及回收率良好，变异性较小，为APSD测定方法的建立和验证提供参考和依据，可用于吸入制剂的质量控制。
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李选堂，男，本科，主要从事化学药品质量控制研究。E-mail：lixuantang@nifdc.org.cn。
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