Quality Standard of Clinopodii Herba(Clinopodium chinense)Formula Granules Based on Standard Decoction
Objective:To establish the quality standard of Clinopodii Herba(Clinopodium chinense)formula granules based on the standard decoction and provide data reference for the quality control of the dispensing granules.Methods:According to the Technical Requirements for Quality Control and Standard Formulation of Chinese Medicine Formula Granules,15 batches of Clinopodii Herba standard decoction were prepared.The extraction rate,rosmarinic acid(index component)content,and transfer rate were determined,and the high performance liquid chromatography(HPLC)fingerprints were established,evaluated for the similarity,and used for chemometrics.Three batches of Clinopodii Herba formula granules were prepared,and the rationality of the process and standard was evaluated in multiple dimensions based on the consistency of the extraction rate,rosmarinic acid content,and HPLC fingerprint compared with those of the standard decoction.Results:The 15 batches of standard decoction showed the extraction rates of 13.2%-21.1%,rosmarinic acid content of 7.3-16.0 mg·g-1,and the transfer rate of 20.2%-57.0%.Seven common peaks were identified in the HPLC fingerprints,among which peaks 2 and 5 were naringin and rosmarinic acid,respectively.The fingerprint similarity between different decoction batches was>0.8.The chemometric analysis showed that the chemical composition had differences between different batches of the standard decoction and the samples presented a clustering trend regarding the source regions.The three batches of formula granules showed the extraction rates of 18.3%,20.4%,and 19.2%,the rosmarinic acid content of 5.23,5.91,and 5.32 mg·g-1,and the transfer rates of 21.4%,24.0%,and 17.9%,respectively.Moreover,the fingerprint similarity between the formula granules and the standard decoction was>0.9.Conclusion:The three batches of Clinopodii Herba formula granules present consistent quality indexes with the standard decoction.The established quality standard of Clinopodii Herba based on the standard decoction is reasonable and feasible,which can provide data support for the preparation and quality control of Clinopodii Herba formula granules.
国家科技期刊平台
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