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[大青叶与板蓝根药材及制剂的质量控制研究]

[Study of quality control on herbal drugs and preparations of daqingye and banlangen].

作者信息

Li L, Qiao C Z, Li X L, Dong T Y

机构信息

School of Pharmacy, Second Military Medical University, Shanghai.

出版信息

Yao Xue Xue Bao. 1993;28(3):229-33.

PMID:8368085
Abstract

This paper first suggests that 2,4 (1H,3H) quinazolinedione (QZL) may be used as a quality control standard for the Chinese herbal drugs Daqingye (Folium Strobilanthis et Polygoni) and Banlangen (Radix Strobilanthis) as well as its preparations. QZL was found for the first time from the above mentioned two Chinese herbal drugs which has a representative property. Its content is stable. This made it possible to solve the difficulty of quality control for the preparations "antipyretic and common cold granules" and "Banlangan granules" and provide a reliable assay method to evaluate the quality of the herbal preparations. By changing the wavelength and using gradient elution in HPLC, 3 constituents can be determined through one injection by the present method, thus the time of determination may be shortened and the efficiency of assay increased. The method showed good linearity (r = 0.99998, n = 4) in the range of 0.2-3.2 micrograms/ml of QZL, the average recovery was above 95% with RSD < 1.5% (n = 3). HPLC condition: Column: LiChrosorb RP 18; elution gradient: methanol from 35% to 90% in water solution; determination wavelength: 226 nm and 288 nm.

摘要

本文首次提出2,4(1H,3H)喹唑啉二酮(QZL)可作为中药大青叶(南板蓝叶)、板蓝根及其制剂的质量控制标准。QZL首次从上述两种具有代表性的中药中发现,其含量稳定。这使得解决“解热感冒冲剂”和“板蓝根冲剂”制剂的质量控制难题成为可能,并为评价中药制剂质量提供了可靠的测定方法。通过改变波长并在高效液相色谱中采用梯度洗脱,本法一次进样可测定3种成分,从而缩短了测定时间,提高了检测效率。该方法在0.2 - 3.2微克/毫升的QZL范围内线性良好(r = 0.99998,n = 4),平均回收率在95%以上,相对标准偏差<1.5%(n = 3)。高效液相色谱条件:色谱柱:LiChrosorb RP 18;洗脱梯度:甲醇在水溶液中的比例从35%至90%;测定波长:226纳米和288纳米。

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