清热解毒颗粒剂不同制备工艺下量值传递规律研究  

Study on law of quality value transmitting of Qingrejiedu granules prepared by two different methods

作　　者：陈荣 钟水生 王亚琼 张超 陈卫 CHEN Rong;ZHONG Shui-shengg;WANG Ya-qiong;ZHANG Chao;CHEN Wei(Suzhou Institute for Drug Control,Suzhou 215104,China)

机构地区：[1]苏州市药品检验检测研究中心,苏州215104

出　　处：《药物分析杂志》2023年第9期1574-1585,共12页Chinese Journal of Pharmaceutical Analysis

基　　金：江苏省药品监督管理局科研计划课题(202128)。

摘　　要：目的:基于清热解毒颗粒剂指纹图谱和多组分含量测定,考察2种不同制备工艺下的量值传递情况。方法:建立清热解毒颗粒剂HPLC指纹图谱方法,标定30个共有峰,并对其中6个成分进行定量,通过比较2个厂家(湖南A厂和河南B厂)同一处方不同制法的样品、2种制法下的标准制剂及其中间体(制法Ⅰ和制法Ⅱ),以指纹图谱共有峰传递情况、多组分含量转移率计算、出膏率等为指标,分析清热解毒颗粒剂不同工艺造成的量值传递差异。结果:湖南A厂建立的对照指纹图谱明显峰信息更丰富、峰面积更高,多组分含量测定中主要体现在黄芩苷、栀子苷、4,5-二-O-咖啡酰奎宁酸、龙胆苦苷的含量差异。标准制剂中采取制法Ⅰ的样品哈巴俄苷、黄芩苷、栀子苷转移率明显高于制法Ⅱ,连翘酯苷A和龙胆苦苷转移率稍高,4,5-二-O-咖啡酰奎宁酸无显著差异。平均出膏率制法Ⅰ为17.9%,制法Ⅱ为11.3%。结论:阐明2种制法对不同药味的物质传递影响,为清热解毒颗粒剂采用不同工艺时的质量评价提供参考。Objective:To study the quality value transmitting of Qingrejiedu granules prepared by two different methods based on fingerprint and multi-component determination.Methods:The HPLC fingerprints were established and thirty chromatographic peaks were recognized as common peaks.Among them 6 components were qualified.To analyze the difference of quantity-value transfer caused by different processes of Qingrejiedu granules,the samples from two manufacturers(A from Hunan and B from Henan)were compared.Taking the common peaks transfer number,multi-component transfer rate and extraction ratio as indexes,the standard preparations and their intermediates(preparationⅠandⅡ)under the two methods were analyzed.Results:The fingerprint established by manufacturer A showed more information and higher peak area,and the differences of multi-component determination were mainly reflected in the contents of baicalin,geniposide,4,5-O-dicaffeoylquinic acid and gentiopicrin.The transfer rates of hapagoside,baicalin and gardeniside in standard preparations of preparationⅠwere significantly higher than those of preparationⅡ.The transfer rates of forsythoside A and gentiopicrin were slightly higher,but was not significantly different from 4,5-O-dicaffeoylquinic.The average extraction rates for preparationⅠand preparationⅡwere 17.9%and 11.3%,respectively.Conclusion:The effects of the two methods on the substance transfer of different herb are preliminary elucidated.The results of study lay a foundation for further research and quality evaluation of Qingrejiedu granules with different processes.

关 键 词：清热解毒颗粒剂 量值传递 指纹图谱 转移率 4 5-二-O-咖啡酰奎宁酸 黄芩苷 栀子苷 龙胆苦苷 

分 类 号：R917[医药卫生—药物分析学]