Method for detecting medicine material astragalus quality

A quality detection method and technology for medicinal materials, which are applied in the field of fingerprint quality detection of astragalus medicinal materials and their extracts, can solve the problems of less research on fingerprints and the like, and achieve the effect of stable quality

Inactive Publication Date: 2006-11-08
SICHUAN KELUN PHARMA CO LTD
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Problems solved by technology

However, there are few studies on the fingerpri

Method used

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  • Method for detecting medicine material astragalus quality
  • Method for detecting medicine material astragalus quality

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0015] Experimental example 1 Determination of the common peaks of the fingerprint of Radix Astragali

[0016] 1. Fingerprint

[0017] According to the relevant parameters given by 10 batches of test sample HPLC chromatograms, the main chromatographic peaks of Astragalus medicinal material measured by the aforementioned preparation method all appeared within 60 minutes; the 2-hour test sample solution chromatogram showed that it did not appear after 60 minutes Chromatographic peaks. Comparing the chromatograms of each batch of samples, it was found that there were 7 peaks common to each batch, and thus a standard fingerprint was established.

[0018] 2. Calibration of common fingerprint peaks

[0019] According to the calculation results of relevant data of 10 batches of test product fingerprints, the common peak average relative retention time (peak number) is 0.387 (1), 0.802 (2), 0.852 (3), 0.875 (4), 0.909 (5) , 1.000(S), 1.030(6), as the basis for common fingerprint pe...

experiment example 2

[0031] Experimental example 2 Determination of the common peaks of astragaloside fingerprint

[0032] 1. Fingerprint

[0033] According to the relevant parameters given by 3 batches of test sample HPLC chromatograms, the main chromatographic peaks of astragaloside measured by the aforementioned preparation method all appeared within 60 minutes; the chromatogram of need test solution in 2 hours showed that it did not appear after 60 minutes Chromatographic peaks. Comparing the chromatographic peaks of each batch of samples, it was found that 6 peaks were common to each batch, thus establishing a standard fingerprint.

[0034] 2. Calibration of common fingerprint peaks

[0035] According to the calculation result of relevant data of 3 batches of test product fingerprints, each common peak average relative retention time (peak number) is successively 0.797 (1), 0.847 (2), 0.870 (3), 0.905 (4), 1.000 (S ), 1.029(5), as the basis for the common fingerprint peak calibration, the ...

experiment example 3

[0047] Experimental Example 3 Astragalus test product solution stability test

[0048] Get the Astragalus membranaceus test solution of the present invention as the measurement object, measure according to the aforementioned chromatographic conditions on the day of preparation, the next day, and the fourth day (preserved at 4°C), record the retention time and peak area of ​​each common chromatographic peak, and use the reference substance Astragalus membranaceus The retention time of glycoside is used as a reference, and the ratio of the relative retention time of each common peak is converted, and the results are shown in Tables 1-2. The results show that the relative standard deviation of the relative retention time of each common peak is less than 2%, which is very stable; the relative standard deviation of the peak area percentage of the reference peak is less than 2%. The above results show that the test solution is stable within 4 days. See Tables 7 and 8.

[0049] ...

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Abstract

The present invention discloses the fingerprint method for detecting the quality of astragalus medicine material and its extract. The fingerprint method includes: adopting octodecyl silane bonded silicon gel as filler, acetoitrile-water as flow phase for gradient elution and astragalin A dissolved in methanol as contrast; taking detected astragalus sample through crushing astragalus root, methanol extracting and other steps; detecting the astragalus sample in high efficiency liquid phase chromatographic process to obtain the fingerprint of the detected astragalus sample; and comparing the fingerprint of the detected astragalus sample and the standard fingerprint for similarity degree over 0.90.

Description

technical field [0001] The invention relates to a quality detection method of Chinese medicinal materials, in particular to a fingerprint quality detection method of astragalus medicinal materials and extracts thereof. Background technique [0002] Traditional Chinese medicine fingerprint refers to the chromatogram or spectrum of a kind of characteristic components shared by a kind of Chinese medicinal materials or Chinese patent medicines. Fingerprint technology is a key means to evaluate the quality of traditional Chinese medicine, which is conducive to the modernization of traditional Chinese medicine. Japan, the United States, Germany, France and other countries have successively started to use fingerprints to control the quality of natural medicines, which can effectively control the quality of medicines and ensure the safety and effectiveness of medicines, which has become an international consensus. Today, under the advocacy of the state, some pharmaceutical companie...

Claims

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Application Information

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IPC IPC(8): A61K36/481G01N30/02G01N33/15
Inventor 程志鹏梁隆胡思玉张德奎余启波
Owner SICHUAN KELUN PHARMA CO LTD
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