Aanlysis on Quality Attribute Transfer Law of Liquid-solid Preparation of Shengxuebao
10.13422/j.cnki.syfjx.20240861
- VernacularTitle:生血宝的液-固制剂质量属性传递规律分析
- Author:
Aijun CHEN
1
;
Siqi HUANG
2
;
Xiaoxuan LIU
2
;
Yu TANG
2
;
Fanghua ZHANG
3
;
Yumeng KONG
2
;
Wenlong LIU
2
;
Xili ZHANG
2
Author Information
1. Hunan Polytechnic of Environment and Biology，Hengyang 421005，China
2. School of Pharmacy，Hunan Provincial Key Laboratory of Drugability and Preparation Modification of Traditional Chinese Medicine，Hunan University of Chinese Medicine，Changsha 410208，China
3. Affiliated Hospital of Hunan Academy of Chinese Medicine，Changsha 410006，China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine;
quality control;
consistency evaluation;
reform of dosage form;
quality attribute transfer patterns;
Shengxuebao;
fingerprint
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(20):135-140
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTaking Shengxuebao as the model traditional Chinese medicine（TCM）， this study aims to explore the methodologies and transfer patterns in the composition changes of TCM compound preparations from liquid to solid dosage forms. MethodBased on the previously established ultra-high performance liquid chromatography（UPLC） qualitative and quantitative methods for Shengxuebao， the fingerprint profiles of three preparations of Shengxuebao（homemade decoction， commercially available granules and mixtures） were established， and nineteen components were quantitatively analyzed. The similarities of fingerprint profiles among these three preparations were assessed using the Similarity Evaluation System for Chromatographic Fingerprint of TCM（2012 edition） and the total quantum statistical moment similarity method， respectively. The molecular connectivity index （MCI） and the average molar MCI of the chemical components in the three preparations were calculated. Seventy-two MCI values across 0-8 orders， including 8 subclasses， were calculated. The average molar MCI of 0-3 orders was used to study the "imprint template" structural characteristics and transfer patterns of the medicinal component groups. ResultThe similarities of the fingerprint profile of the decoction with those of the control， granules， and mixtures were 0.971， 0.888 and 0.799， respectively， indicating that the chemical composition of the granules and mixtures differed from that of the decoction， and that the 19 components were able to basically respond to the overall situation of the component group of Shengxuebao decoction. The total mass fractions of the detectable major components in Shengxuebao decoction， granules and mixtures was measured to be 5.498 6， 2.282 0， 1.416 6 mg·g-1， respectively. The average molar MCI of 0-3 orders showed a gradual decrease across the three preparations， with the trend of decoction>granules>mixtures， indicating subtle changes in the overall structural characteristics of the chemical components in the samples of the three preparations. ConclusionAmong the three formulations of Shengxuebao， the traditional decoction contained the highest variety and quantity of components and carried the most substantial amount of component information， with a decreasing order observed in the granules and mixtures. This study further validates that traditional decoction is a reliable and fundamental dosage form， providing a reference for the modernization of TCM dosage forms and the quality consistency evaluation of compound preparations.
