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目的:建立一种以化痰为主要效应的,既能关联浙贝母临床功效,又不增加质控难度的基于效应成分指数的浙贝母质量评价与控制新技术,使浙贝母品质评价与控制新技术更好地助力于浙贝母产业发展。方法:收集不同品种、不同产地的浙贝母药材,确定浙贝母药材中活性成分贝母素甲和贝母素乙含量的上下限,分析条件为Hypersil ODS-3色谱柱(4.6 mm×250 mm,5μm),流动相乙腈-水-二乙胺(70∶30∶0.03),流速0.8 m L·min~(-1);Alltech 2000-ELSD,漂移管温度85℃,载气流速2.2 L·min~(-1)。在确定的浓度范围内,配制不同浓度的贝母素甲、贝母素乙对照品溶液,采用小鼠气管酚红排痰实验法,以酚红浓度为化痰效应指标,将小鼠酚红排泌量与贝母素甲(X1),贝母素乙(X2)的质量浓度进行线性关系分析,拟合贝母素甲、贝母素乙与化痰效应指标之间的量-效关系方程f(Xi),构建浙贝母的化痰效应指数并验证。结果:浙贝母主要产区中贝母素甲的质量分数(以干燥品计)在0.046 5%~0.092 5%,贝母素乙的质量分数在0.017 5%~0.054 3%。给药溶液质量分数的范围为贝母素甲0.04%~0.10%,贝母素乙0.02%~0.06%。小鼠气管段酚红排痰实验结果表明,贝母素甲在0.09~0.23 g·L~(-1),贝母素乙在0.045~0.135 g·L~(-1)与小鼠气管酚红浓度有较好的线性关系(r甲=0.994 7,r乙=0.997 8)。根据拟合的量效方程构建的浙贝母化痰效应成分指数能很好地通过成分的量表征其祛痰的药效活性。结论:化痰效应成分指数的建立,不仅做到了量效关联,更实现了以量观效,对浙贝母品质评控、产业化发展及临床合理用药具有较好的指导意义和应用前景。
OBJECTIVE: To establish a new quality evaluation and control technology based on the effect component index (Fm) of Fritillaria cirrhosa, which can not only increase the clinical efficacy of Fritillaria cirrhosa, but also increase the quality control of Fritillaria cirrhosa. And control of new technologies to better help Fritillaria industry development. METHODS: The samples of Fritillaria cirrhosa from different varieties and different habitats were collected to determine the upper and lower limits of the active constituents Fritillaria and Fritillaria B in Fritillaria cirrhosa. The analytical conditions were Hypersil ODS-3 (4.6 mm × 250 mm, 5μm). The mobile phase consisted of acetonitrile-water-diethylamine (70:30:0.03) with a flow rate of 0.8 m L · min -1. Alltech 2000-ELSD with a drift tube temperature of 85 ° C and a carrier gas flow rate of 2.2 L · Min ~ (-1). In the determined concentration range, the preparation of different concentrations of peimine A, peimine B reference substance solution, the use of mouse tracheal phenol red sputum test method to phenol red concentration as the phlegm effect indicators, the mouse phenol red The relationship between the excretion and the mass concentrations of Fritillariae (X1) and Fritillaria (X2) was linearly analyzed, and the dose-response relationship between Fritillariae, Equation f (Xi), Constructed Fritillaria thrombolytic effect index and verified. Results: The mass fraction of Fritillaria nivalis in the main producing area of Fritillaria cirrhosa was 0.046 5% to 0.092 5%, and the mass fraction of peiminin B was 0.017 5% to 0.054 3%. The dosage range of the drug solution is 0.04% ~ 0.10% of peimine A and 0.02% ~ 0.06% of peiminilide B. The experimental results on the tracheal section of mice with phlegm excretion showed that the concentrations of Fritillariae from 0.09 to 0.23 g · L -1, Red concentration has a good linear relationship (r A = 0.994 7, r B = 0.997 8). According to the fitted dose-effect equation, the constituents of phlegm-dampness constituents of Fritillaria ussuriensis can well characterize its expectorant pharmacodynamic activity by the amount of components. Conclusion: The establishment of phlegm-phlegm effect component index not only achieves the relationship between quantity and effect, but also achieves the effect of quantity and effect. It has good guiding significance and application prospect for the quality control, industrialization development and clinical rational use of Fritillaria cirrhosa.