Quality control method of artemisia argyi and indigofera tinctoria granules

Abstract

The invention discloses a quality control method of artemisia rupestris and indirubin granules, revises a thin-layer chromatography identification method of rupestonic acid, (R, S)-epigoitrin and indirubin, and revises a high performance liquid chromatography determination method of the content of rupestonic acid serving as a characteristic active ingredient of rupestonic acid, so that the productquality can be controlled more scientifically and effectively, and the curative effect is ensured. The characteristic active ingredients of the three medicinal materials in the medicine are identified by adopting thin-layer chromatography, the sample treatment method is simple and convenient, the separation degree is good, and spots are clear; the method for determining the content of the rupestonic acid in the medicine by the high performance liquid chromatography is simple and convenient to operate, strong in specificity, good in repeatability and high in accuracy. The quality control method of the artemisia argyi-radix isatidis granules is more comprehensive and perfect in detection items, more scientific and reasonable in quality control indexes, simpler and more convenient to operate, and capable of further improving the product quality level and ensuring the curative effect.

Description

technical field [0001] The invention belongs to the technical field of quality control of traditional Chinese medicine preparations for veterinary medicine, and particularly relates to a quality control method of Haobanqing granules. Background technique [0002] The prescription of Haobanqing Granules comes from the "Compound Yizhihao Granules" of the "Compendium of National Chinese Patent Medicine Standards Compilation of Internal Medicine Pulmonary System" of the State Drug Administration, and the standard number is WS-11137 (ZD-1137)-2002]. The prescription composition of this product is: Artemisia annua 240g, Banlangen 240g, Daqingye 240g; the preparation process is: the above three herbs are boiled twice with water for 2 hours each time, filtered, combined with the filtrate, the filtrate is concentrated into clear paste, added Equal volume of ethanol, let stand for 24 hours, pour out the supernatant, recover the ethanol and concentrate it into a thick paste, add an app...

AI Technical Summary

Problems solved by technology

[0004] The quality standard originally numbered WS-11137 (ZD-1137)-2002 carried out TLC identification on the components of Radix Isatidis and Folium Isatidis in the prescription - indigo and indirubin, but the spots in the chromatogram were not clear, even There is no spot at the corresponding position of the indigo identification chromatogram; the original quality standard also carried out thin-layer chromatography identification on Artemisia annua in the prescription, but the identification reference substance used in it was Artemisia annua control medicinal material, and the reference medicinal material was affected by the place of origin and harvest of the reference product. Influenced by time and other influences, the uniformity of batches cannot be guaranteed, and the extraction and processing procedures of the control medicinal materials are complicated, and the identification spectrum has a lot of interference, and the identification effect is poor; Identification, not conducive to its quality control

At present, there are also many documents disclosing the identification of Artemisia japonica in the prescription of Haobanqing Granules and the content determination method of artemisinic acid, the characteristic active ingredient of Artemisia japonica, but the extraction and purification degree of the test solution in the disclosed method is not deep enough, During the determination, there are many chromatographic impurity peaks, strong interference, poor resolution, and unstable peak time

Literature "Research on the Quality Standards of Artemisia Xinjiang" (Reyimuguli Abdullah et al., Medical Herald, Volume 30, No. 9, 2011) and "High Performance Liquid Chromatography for the Determination of Artemisinin in Artemisia Xinjiang Acid content" (Ma Cheng et al., Shizhen Guoyi Guoyao, Volume 19, No. 4, 2008) respectively disclosed the identification and content determination of Artemisia argentica in Artemisia arborescens, but the method is only applicable to the medicinal material Artemisia arborescens. Determination is not suitable for Chinese medicine preparations with complex components; the document "Research on the Quality Standards of Compound Yizhihao Granules" (Li Ge et al., Journal of Traditional Chinese Medicine, Vol. 21, No. 11, 2003) discloses the quality of Compound Yizhihao Granules. Control method, but its identification method is not significantly different from the original standard, only the content determination of the auxiliary drugs Folium Folium and Radix Radix in the prescription has been added, and the content determination of the main drug Artemisia argyi in the prescription has not been added; the literature "High Performance Liquid Chromatography "Content of Artemisinic Acid in Compound Yizhihao Capsules" (Zhang Xuefeng et al., Bingtuan Medicine, Volume 34, No. 4, 2012) discloses the high performance liquid chromatography method for the determination of artemisinic acid in Compound Yizhihao Capsules, but It is found that the temperature has a great influence on the determination, the retention time is extremely unstable, and the repeatability is poor

[0005] To sum up, the existing preparation quality control methods only establish a partial identification method for the medicinal materials in the prescription, and no identification method is established for the characteristic active ingredients of the main drug, especially there is no content determination method, the inspection items lack comprehensiveness, and the effect of the method is also poor not ideal

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