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Method of establishing fingerprint spectrum of infant diarrhea stopping drug preparation

A technology of pharmaceutical preparations and fingerprints, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of lack of objectivity and accuracy in quality inspection results, inability to guarantee the reflection of Erxieting Granules and Erxieting Granules, and achieve Improve effectiveness and safety, ensure stability and uniformity, and reproducible results

Active Publication Date: 2017-06-06
合肥华润神鹿药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] For this reason, the technical problem to be solved by the present invention is that the existing quality detection method of Erxieting Granules cannot comprehensively reflect the quality of Erxieting Granules as a whole, which may lead to the lack of objectivity and accuracy of the quality detection results, so that it cannot To ensure the safety and effectiveness of Erxieting Granules in clinical use, and then provide a method for establishing the fingerprint of Erxieting pharmaceutical preparations

Method used

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  • Method of establishing fingerprint spectrum of infant diarrhea stopping drug preparation
  • Method of establishing fingerprint spectrum of infant diarrhea stopping drug preparation
  • Method of establishing fingerprint spectrum of infant diarrhea stopping drug preparation

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0046] In this embodiment, the method for establishing the fingerprint of Erxieting Granules comprises the following steps:

[0047] (1) Take 1.0 g of Erxieting granule to be tested, accurately weigh it, accurately add 25 mL of ethanol aqueous solution with a volume fraction of 70%, weigh it, extract it by ultrasonic for 30 minutes, let it cool, filter, and take the filtrate as the test product solution;

[0048] (2) Accurately weigh the reference substance of liquiritin, add methanol to make a solution containing 0.00010g per 1mL, shake well, and use it as the reference substance A solution;

[0049] Accurately weigh the ammonium glycyrrhizinate reference substance, add methanol to make a solution containing 0.00020g per 1mL, shake well, and use it as the reference substance B solution;

[0050] (3) Chromatographic conditions: use octadecylsilane bonded silica gel as filler, Techmate C18-ST with 250mm×4.6mm and 5μm as chromatographic column, acetonitrile as mobile phase A, a...

Embodiment 2

[0054] In this embodiment, the method for establishing the fingerprint of Erxieting Granules comprises the following steps:

[0055] (1) Take 1.0 g of the Erxieting granule to be tested, accurately weigh it, accurately add 25 mL of methanol aqueous solution or ethanol aqueous solution with a volume fraction of 80%, weigh it, perform ultrasonic extraction for 30 minutes, let it cool, filter, and take the subsequent filtrate, As the test solution;

[0056] (2) Accurately weigh the reference substance of liquiritin, add methanol to make a solution containing 0.00005g per 1mL, shake well, and use it as the reference substance A solution;

[0057] Accurately weigh the ammonium glycyrrhizinate reference substance, add methanol to make a solution containing 0.00010g per 1mL, shake well, and use it as the reference substance B solution;

[0058] (3) Chromatographic conditions: use octadecylsilane bonded silica gel as filler, Techmate C18-ST with 250mm×4.6mm and 5μm as chromatographic...

Embodiment 3

[0062] In this embodiment, the method for establishing the fingerprint of Erxieting Granules comprises the following steps:

[0063] (1) Take 2.0 g of the Erxieting granule to be tested, accurately weigh it, accurately add 50 mL of methanol aqueous solution or ethanol aqueous solution with a volume fraction of 40%, weigh it, perform ultrasonic extraction for 20 minutes, let it cool, filter, and take the subsequent filtrate, As the test solution;

[0064] (2) Accurately weigh the reference substance of liquiritin, add methanol to make a solution containing 0.00015g per 1mL, shake well, and use it as the reference substance A solution;

[0065] Accurately weigh the ammonium glycyrrhizinate reference substance, add methanol to make a solution containing 0.00030g per 1mL, shake well, and use it as the reference substance B solution;

[0066] (3) Chromatographic conditions: use octadecylsilane bonded silica gel as filler, Techmate C18-ST with 250mm×4.6mm and 5μm as chromatographic...

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Abstract

The invention belongs to the field of drug analysis and particularly relates to a method of establishing a fingerprint spectrum of an infant diarrhea stopping drug preparation. According to the method, by taking the infant diarrhea stopping drug preparation as a detection object, the method of establishing the fingerprint spectrum of the infant diarrhea stopping drug preparation is established, common characteristic peaks including peak 1, peak 2 liquiritin, peak 3 ammonium glycyrrhizinate, peak 4, peak 5, peak 6, peak 7 and peak 8 are affirmed, the peak 2 liquiritin is selected as an internal reference peak in the fingerprint spectrum, and a relative retention time of each common characteristic peak is determined; and in addition, with combination of information of a plurality of chromatographic peaks in the fingerprint spectrum, the quality of the infant diarrhea stopping drug preparation can be comprehensively and rapidly detected, so that comprehensive quality detection and whole quality control of the infant diarrhea stopping drug preparation are facilitated, and improvement on the use safety and stability of the drug is facilitated. Simultaneously, the method of establishing the fingerprint spectrum of the infant diarrhea stopping drug preparation has the advantages of high precision, good repeatability, high stability and the like.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for establishing the fingerprint of Erxieting drug preparation. Background technique [0002] Erxieting Granules is a traditional Chinese medicine compound preparation made from three medicinal materials: madder vine, black plum and licorice. It has the functions of clearing away heat and dampness, strengthening the intestines and stopping diarrhea. Since it was approved for marketing in 1999, Erxieting Granules have been well received by clinicians and consumers due to its definite curative effect, stable quality and safe use; the clinical re-evaluation of Erxieting Granules in 2011 showed that its efficacy in treating acute diarrhea in children It is good and safe, and can be used as the first choice for children's diarrhea medicine. [0003] At present, the quality control of Erxieting Granules is carried out through the standard No. WS3-160(Z-16)-2002(Z) recorded in the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 秦海军张慧马雨涵楚庆霞吴艳芳于波
Owner 合肥华润神鹿药业有限公司
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