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 (preparation Ⅰ and Ⅱ) 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 preparation Ⅰ were significantly higher than those of preparation Ⅱ. 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 preparation Ⅰ and preparation Ⅱ were 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.
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