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Quality detection method for fingerprint spectrum method of radix astragali saponin injection

A quality detection method and fingerprint technology, which are applied in the field of injection quality detection, can solve the problems of not involving the fingerprint of astragaloside injection, few studies, etc., and achieve the effects of good consistency, good reproducibility and easy operation.

Active Publication Date: 2006-10-11
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the current research does not involve the fingerprint of astragaloside injection, and there are few related studies

Method used

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  • Quality detection method for fingerprint spectrum method of radix astragali saponin injection
  • Quality detection method for fingerprint spectrum method of radix astragali saponin injection

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0015] Experimental Example 1 Determination of Common Peaks in Fingerprint of Astragaloside Injection

[0016] 1. Fingerprint

[0017] According to the relevant parameters given by 3 batches of test sample HPLC chromatograms, the main chromatographic peaks of astragaloside injection measured by the aforementioned preparation method all appeared within 60 minutes; Chromatographic peaks did not appear. 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.

[0018] 2. Calibration of common fingerprint peaks

[0019] According to the calculation results of the relevant data of the fingerprints of the test products, the average relative retention time (peak number) of each common peak is 0.800 (1), 0.850 (2), 0.873 (3), 0.908 (4), 1.000 (S) ), 1.031(5), as the basis for the common fingerprint peak calibration, the allowable relative deviation is ±10%.

[0020] 3. Relative rete...

experiment example 2

[0031] Experimental example 2 The common peaks of the fingerprint of astragaloside for injection are confirmed

[0032] 1. Fingerprint

[0033] According to the relevant parameters given by 3 batches of test sample HPLC chromatograms, the main chromatographic peaks of astragaloside for injection measured by the aforementioned preparation method all appeared within 60 minutes; Chromatographic peaks did not appear. 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 0.807 (1), 0.857 (2), 0.883 (3), 0.925 (4), 1.000 (S ), 1.023(5), as the basis for the common fingerprint peak calibration, the allowable relative deviation is ±10%.

[0036] 3....

experiment example 3

[0047] Experimental example 3 Astragaloside injection test product solution stability test

[0048] Get astragaloside injection need testing solution of the present invention as measuring object, measure according to aforementioned chromatographic conditions (4 ℃ preserve) respectively at 0 hour, 2 hours, 6 hours, 12 hours, 24 hours, record each common chromatographic peak retention time and Peak area. Taking the retention time of the reference substance astragaloside IV as a reference, the relative retention time of each common peak was calculated, and the results are shown in Tables 7-8.

[0049] Common peak number

[0050] Experiment time

[0051] Experimental result shows: the relative standard deviation of each common peak relative retention time is all less than 1%, very stable; The relative standard deviation of the peak area percentage of reference peak is 0.25%, and the result shows that need testing solution basically keeps stable in 24 hours.

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Abstract

The invention discloses a method for detecting the fingerprint drawing quality of astragalus root saponin injection. Said method uses octadecyl silane bonded silica gel as stuff; uses acetonitrile monohydrate as liquid, to process grad removing; the flow speed is 0.5-1.0mol / min, and the post temperature is 20-40Deg. C; getting some astragalus root saponin as comparison to be diluted with methanol as the comparison solution; concentrating some astragalus root saponin injection, using water saturated butanol as extraction solvent, using the water of saturated butanol to remove foreign matters; after the extracted matter of butanol solution is volatilized, adding methanol into the left matter to dilute, and using the methanol solution as the astragalus root saponin injection fingerprint test solution; using high-efficiency liquid spectrum to test the astragalus root saponin injection fingerprint test solution, while it has better similarity, that higher than 0.90.

Description

technical field [0001] The invention relates to a quality detection method of injection, in particular to a fingerprint quality detection method of astragaloside injection. 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 companies in our country have conducted fingerprint re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/26G01N30/06G01N30/86
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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