背景:中国浙江不同规格延胡索(ZJCR)的质量控制方法相同,所以每种规格的质量都无法保证。明确不同规格ZJCR的质量控制方法和药效物质基础,为ZJCR的质量控制提供参考。
目的:建立不同规格ZJCR的质量控制方法,筛选不同规格ZJCR的药效物质基础。
方法:首先,根据现有的分级标准,药材分为规格,建立了不同规格的ZJCR的性能指标。用高效液相色谱法建立质量指标,网络药理学和文献检索。分析了不同规格的ZJCR的性状指标和质量指标之间的相关性,建立了最佳的质量控制方法。进一步结合不同规格的ZJCR的药效学指标,通过谱效分析筛选出不同规格的ZJCR的药效物质基础。分析性状指标与药效学指标的相关性,验证等级标准的合理性。
结果:ZJCR的三个规格为CR(直径≥1.1cm),CR(直径<1.1cm),和CR(没有尺寸区别)。直径,宽度,厚度,粒重,体积和50g粒数可作为ZJCR的性状指标。Protopine(CR1),盐酸巴马汀(CR2),盐酸小檗碱(CR3),脱氢视黄碱(CR4),延胡索乙素(CR5),四氢小檗碱(CR6),紫藤碱(CR7),确定了苯乙烯碱(CR8)和异欧前胡素(CR9)。组件总数,核心组件(CR5,CR6,CR7和CR8),醇溶提取物(ASE)可作为质量指标。三种规格的最佳质量控制方法分别为:直径越大、粒重越大,50克颗粒的数量越小;直径越大,体积越小,厚度,50克颗粒的宽度和数量;较大的颗粒重量和体积,50克谷物的数量越小。三种规格的主要镇痛成分分别为:CR1、CR2和核心成分;CR2、CR4;CR8、CR9。直径越大,50克颗粒的数量越少,ZJCR的镇痛效果越好,等级标准合理。
结论:本研究表明,不同规格的ZJCR的质量控制方法和药效物质基础不同,这可能是由性状差异和主要活性成分的贡献引起的。本研究构建了结合外部性状的评价模型,内部质量和整体功效,为ZJCR等级标准的合理性提供了理论支持。
BACKGROUND: The quality control methods of different specifications of Corydalis Rhizoma in Zhejiang
China (ZJ CR) are the same, so the quality of each specification couldnot be guaranteed. To clarify the quality control methods and pharmacodynamic material basis of ZJ CR with different specifications could provide reference for the quality control of ZJ CR.
OBJECTIVE: The purpose of this study was to establish a quality control method for ZJ CR with different specifications and to screen out the pharmacodynamic material basis of ZJ CR with different specifications.
METHODS: Firstly, according to the existing grading standards, the medicinal materials were divided into specifications, and the character indexes of ZJ CR with different specifications were established. The quality indexes were established by HPLC, network pharmacology and literature retrieval. The correlation between the trait indexes and quality indexes of ZJ CR with different specifications was analyzed, and the best quality control method was established. Further combined with the pharmacodynamic indexes of ZJ CR with different specifications, the pharmacodynamic material basis of ZJ CR with different specifications was screened out by spectrum-effect analysis. The correlation between trait indexes and pharmacodynamic indexes was analyzed to verify the rationality of grade standard.
RESULTS: The three specifications of ZJ CR were CR (Diameter ≥1.1 cm), CR (Diameter <1.1 cm), and CR (No size distinction). Diameter, width, thickness, grain weight, volume and 50 g grain number could be used as the trait indexes of ZJ CR. Protopine (CR1), palmatine hydrochloride (CR2), berberine hydrochloride (CR3), dehydrocorydaline (CR4), tetrahydropalmatine (CR5), tetrahydroberberine (CR6), corydaline (CR7), stylopine (CR8) and isoimperatorin (CR9) were identified. Total components, core components (CR5, CR6, CR7 and CR8), alcohol-soluble extracts (ASE) could be used as quality indexes. The best quality control methods of the three specifications respectively were: the larger the diameter and grain weight, the smaller the number of 50 g grains; The larger the diameter, the smaller the volume, thickness, width and number of 50 g particles; The larger the grain weight and volume, the smaller the number of 50 g grains. The main analgesic components of the three specifications respectively were: CR1, CR2 and core components; CR2, CR4; CR8, CR9. The larger the diameter and the less the number of 50 g grains, the better the analgesic effect of ZJ CR, and the grade standard was reasonable.
CONCLUSIONS: This study showed that the quality control methods and pharmacodynamic material basis of ZJ CR with different specifications were different, which may be caused by the differences in
traits and the contribution of main active ingredients. This study constructed an evaluation model combining external
traits, internal quality and overall efficacy, and provided theoretical support for the rationality of ZJ CR grade standard.