基于平喘生物效价的麻黄品质评价研究

目的研究37个不同产地麻黄平喘作用及其生物效价的差异。方法取豚鼠离体气管平滑肌建立平喘药效模型,按累积计量法于麦氏浴槽中加入不同质量浓度梯度(剂间距1:0.5)的麻黄水煎液,计算不同产地麻黄解痉率;按照《中国药典》2010年版二部附录XIV生物检定统计法项下"量反应平行线法"(2,2)法计算生物效价值;采用HPLC法测定麻黄药材中麻黄碱和伪麻黄碱的量;对不同产地麻黄生物效价值进行聚类分析。结果麻黄对磷酸组胺(His)引起的豚鼠离体气管平滑肌收缩有解痉作用,与麻黄对照药材相比,有20个产地的麻黄达显著水平(P0.05),麻黄解痉作用与给药质量浓度呈剂量依赖性,草麻黄与中麻黄种间解痉率无显著差异(P0.05);37个产地的麻黄药材与对照药材相比平喘效价值存在显著差异(P0.05、0.01),平喘效价值为22.35~489.04 U/g,可信限率(FL)13.15%~38.97%,效价相差近21.88倍,麻黄平喘生物效价与麻黄碱及伪麻黄碱总量之间相关不显著;采用聚类分析法能够将不同平喘生物效价值的麻黄区分开来,37份麻黄药材中有24份生物效价值高于对照药材,占麻黄样品总数的64.86%。结论平喘生物效价值可以定量评价不同产地麻黄的质量。

Antiasthma biological potency applied for Ephadra Herba quality evaluation

Objective To study the anti-asthma action and biological potency differences of Ephedra Herba from 37 different habitats. Methods Taking the isolated tracheal smooth muscle from guinea pig to establish antiasthma pharmacological model, the ephedra decoction at different concentration was added to the sink by cumulative metrology method, antispasmodic percentage and biological potency value of Ephedra Herba from different habitats were calculated and the cluster analysis for the biological potency value of Ephedra Herba from different habitats was conducted. Results Ephedra Herba had the antispasmodic acction to the isolated tracheal smooth muscle of guinea pig caused by histamine phosphate, and compared with the control medicine, Ephedra Herba from 20 habitats showed significant differences (P < 0.05), and the antispasmodic acction of Ephedra Herba was in a dose-dependent manner with administered concentration, when the concentration was raised and the antispasmodic percentage increased, and there were no significant difference in the antispasmodic percentage between Ephedra sinica and E. intermedia (P > 0.05); Compared with the control medicine, the antiasthma biological potency of Ephedra Herba from 37 different habitats existed significant or very significant differences (P < 0.05, 0.01), and the antiasthma biological potency value was 22.35-489.04 U/g, while FL% was 13.15%-38.97%, which revealed that the high potency level had a difference of 21.88 times from the low one. And the antiasthma biological potency of Ephedra Herba had lowly significant correlation differences with the total determination of ephedrine and D-pseudephedrine; The Ephedra Herba with different antiasthma biological potency could be identified by cluster analysis method, in which the biological potency from 24 ones in total of 37 Ephedra Herba was higher than that in the control medicine and accounted for 64.86% of the total samples. Conclusion The anti-asthmabiological potency value of Ephedra Herba could quantitatively evaluate the quality of Ephedra Herba from different habitats.