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Method for establishing fingerprint spectrum of liver-enhancing medicine

A method and a technology for establishing fingerprints, which are applied in the field of establishing high-performance liquid chromatography fingerprints

Active Publication Date: 2012-07-04
SHIJIAZHUANG DONGFANG PHARMA
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

Luo Chenqu et al established a method for the determination of gentiopicroside in Qianggan capsules by high performance liquid chromatography, and Chen Li et al used reversed-phase high performance liquid chromatography to determine the contents of tanshinone II A and glycyrrhizic acid in Qianggan capsules, but All are limited to the determination of one or two index components in the large compound prescription of Qianggan Capsules, but how to carry out macroscopic quality control methods for the quality of Qianggan Capsule preparations from a macroscopic point of view has not been reported

Method used

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  • Method for establishing fingerprint spectrum of liver-enhancing medicine
  • Method for establishing fingerprint spectrum of liver-enhancing medicine
  • Method for establishing fingerprint spectrum of liver-enhancing medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0096] Embodiment 1 adopts HPLC method to establish the fingerprint of Qianggan Capsule contents

[0097] Preparation of reference substance solution: Accurately weigh 2.54 mg of paeoniflorin reference substance, put it in a 25ml measuring bottle, add methanol to dissolve and dilute to the mark, shake well, and obtain paeoniflorin reference substance solution (0.1016mg / mL).

[0098] Preparation of the test solution: Weigh 1.0 g of the contents of Qianggan Capsules, add 100 ml of 70% methanol aqueous solution, ultrasonically extract for 1 h, let cool, centrifuge for about 10 min, take the supernatant and concentrate to about 10 ml, dissolve with 25 ml of water, Extract with saturated n-butanol 3 times with 30ml, 20ml, and 20ml each time, combine the 3 extracts, concentrate to dryness, dissolve in methanol and transfer to a 10ml volumetric flask, filter with a 0.45μm filter membrane, discard the initial The filtrate is obtained by taking the continued filtrate and set aside. ...

Embodiment 2

[0104] Methodology investigation of embodiment 2 fingerprint collection method

[0105] 1) Precision test

[0106] Using the same operation and conditions as in Example 1, the same test solution was accurately measured, and the sample was injected continuously for 5 times to investigate the consistency of the relative retention time and relative peak area of ​​the chromatographic peaks. Taking paeoniflorin as the reference peak, the relative retention time and relative peak area of ​​each chromatographic peak were calculated.

[0107] The results showed that the relative standard deviation RSD of the relative retention time of each chromatographic peak was lower than 0.5%, and the relative standard deviation RSD of the relative peak area of ​​each chromatographic peak was lower than 3.9%, which met the requirement of fingerprint.

[0108] 2) Stability inspection

[0109] Using the same operation and conditions as in Example 1, prepare the test solution, place it airtight a...

Embodiment 3

[0114] Example 3 Establishment of the Control Fingerprint of Qianggan Capsule Contents

[0115] According to the method described in Example 1, the contents of Qianggan Capsules in batches S1 to S38 were analyzed and determined to obtain fingerprints.

[0116] In the obtained fingerprint spectrum, there are 14 absorption peaks of chemical components in total, among which there are 8 absorption peaks with a single peak area exceeding 5%, and their characteristics are as follows:

[0117] For peak No. 2, the average retention time RT is 14.178min, the RSD is 0.41%, the peak area is 1743.0, and the RSD is 10.15%;

[0118] For peak No. 3, the average retention time RT is 15.812min, the RSD is 0.22%, the peak area is 2869.8, and the RSD is 21.26%;

[0119] For peak No. 6, the average retention time RT is 28.666min, the RSD is 0.07%, the peak area is 2779.5, and the RSD is 7.71%;

[0120] For peak No. 8, the average retention time RT is 32.911min, the RSD is 0.07%, the peak area...

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Abstract

The invention provides a method for establishing a fingerprint spectrum of a liver-enhancing medicine. The liver-enhancing medicine is composed of oriental wormwood, isatis root, angelica, white paeony root, red-rooted salvia root, Radix curcumae, Astragalus mongholicus, Codonopsis pilosula, rhizoma alismatis, sealwort, rehmannia, yam, hawthorn, large-leaved gentian, liquorice and medicated leaven. The establishing method comprises the step of detecting paeoniflorin in the liver-enhancing medicine by using a high efficiency liquid chromatography method, wherein conditions are as follows: a chromatographic column takes octadecylsilane chemically bonded silica as a filling material; mobile phases comprise a mobile phase A which is acetonitrile and a mobile phase B which is an acidic water solution, and the mobile phases are subjected to gradient elution; the flow velocity is 1.0mL / min; the column temperature is 30 DEG C; the detection wavelength is 210nm to 400nm; and the number of theoretical plates is calculated according to the paeoniflorin peak and should not be less than 6000. The obtained fingerprint spectrum is a chromatographic peak which mainly takes active ingredients of the large-leaved gentian, the white paeony root, the liquorice, the red-rooted salvia root, the oriental wormwood and the astragalus mongholicus in raw materials of the liver-enhancing medicine as main parts. According to the establishing method provided by the invention, the fingerprint spectrum capable of comprehensively representing the active ingredients of the liver-enhancing medicine can be effectively obtained and has the characteristics of high precision, stability and repeatability. The obtained fingerprint spectrum can be used for guaranteeing the stability and consistency of the product quality, so that the safety and effectiveness of a product are guaranteed.

Description

technical field [0001] The invention belongs to the field of drug analysis and detection, and relates to a method for establishing a fingerprint of a liver-enhancing drug, in particular to a method for establishing a high-performance liquid chromatography (HPLC) fingerprint of a liver-enhancing capsule. Background technique [0002] Compound Chinese medicine is the main form of TCM clinical medication, and it is the characteristic and essence of TCM. Traditional Chinese medicine is a complex system composed of multiple components and factors. The diversity and complexity of its chemical components are the material basis for its curative effect. Establish a modern quality control system in line with the characteristics of traditional Chinese medicine to overcome the problems of quality analysis and evaluation of traditional Chinese medicine. Improving the existing quality control methods of traditional Chinese medicine has become a subject of active research. [0003] The es...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 张铁军刘素香韦辉刘毅韩丰年何立新刘向
Owner SHIJIAZHUANG DONGFANG PHARMA
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