Method for Establishing Fingerprint of Bailemian Capsules

A technology of fingerprint spectrum and establishment method, which is applied to the establishment method of Bailemian Capsule fingerprint and the field of fingerprint spectrum, can solve the problem that the quality detection method of Bailemian Capsule cannot comprehensively reflect the quality of Bailemian Capsule as a whole.

Active Publication Date: 2020-08-14
YANGTZE RIVER PHARMA GRP JIA NGSU LONGFENGTANG TRADITIONAL CHINESE MEDICINE CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to solve the problem that the existing quality detection method of Bailemian capsules cannot fully reflect the quality of Bailemian capsules as a whole, and to provide a method for establishing the fingerprint of Bailemian capsules, which can ensure the quality of Bailemian capsules. The quality stability, consistency and controllability of Bailemian Capsules, thus ensuring the safety and effectiveness of Bailemian Capsules

Method used

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  • Method for Establishing Fingerprint of Bailemian Capsules
  • Method for Establishing Fingerprint of Bailemian Capsules
  • Method for Establishing Fingerprint of Bailemian Capsules

Examples

Experimental program
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Effect test

Embodiment 100

[0074] The method for establishing the fingerprint of Bailemian Capsules in this embodiment comprises the following steps:

[0075] (1) Preparation of the test solution: take 1.0 g of the contents of Bailemian Capsules, weigh them accurately, put them in a stoppered Erlenmeyer flask, add 25 mL of methanol aqueous solution with a volume fraction of 70%, weigh them, and heat to reflux for 30 minutes , let it cool, use a volume fraction of 70% methanol aqueous solution to make up the lost weight, shake well, pass through a 0.45 μm microporous membrane, and take the subsequent filtrate as the test solution;

[0076] (2) Preparation of reference solution: accurately weigh quercitrin reference substance, 2,3,5,4′-tetrahydroxystilbene-2-O-D glucoside reference substance, schisandrol A reference substance, dandelion Phenolic acid B reference substance, emodin reference substance, add volume fraction of 70% methanol aqueous solution to make each 1mL containing 65μg quercitrin, 45μg 2,3...

Embodiment 2

[0081] The method for establishing the fingerprint of Bailemian Capsules in this embodiment comprises the following steps:

[0082] (1) Preparation of the test solution: take 1.0 g of the contents of Bailemian Capsules, weigh them accurately, put them in a stoppered Erlenmeyer flask, add 25 mL of methanol aqueous solution with a volume fraction of 70%, weigh them, and heat to reflux for 60 minutes , let it cool, use a volume fraction of 70% methanol aqueous solution to make up the lost weight, shake well, pass through a 0.45 μm microporous membrane, and take the subsequent filtrate as the test solution;

[0083] (2) Preparation of reference solution: accurately weigh quercetin reference substance, 2,3,5,4′-tetrahydroxystilbene-2-O-D glucoside reference substance, schisandra alcohol A reference substance, salvianol Acid B reference substance, emodin reference substance, add volume fraction of 70% methanol aqueous solution to make each 1mL containing 65μg quercitrin and 45μg 2,3...

Embodiment 3

[0088] (1) Preparation of the test solution: take 1.0 g of the contents of Bailemian Capsules, accurately weigh it, put it in a stoppered Erlenmeyer flask, add 25 mL of methanol precisely, weigh it, heat to reflux for 90 minutes, let it cool, and use methanol Make up for the lost weight, shake well, pass through a 0.45 μm microporous membrane, and take the subsequent filtrate as the test solution;

[0089] (2) Preparation of reference solution: accurately weigh quercetin reference substance, 2,3,5,4′-tetrahydroxystilbene-2-O-D glucoside reference substance, schisandra alcohol A reference substance, salvianol Acid B reference substance and emodin reference substance were prepared by adding methanol, each containing 65 μg quercitrin, 45 μg 2,3,5,4′-tetrahydroxystilbene-2-O-D glucoside, 48 μg schisandrin A, 72 μg salvianolic acid B, 4 μg emodin reference substance solution;

[0090] (3) Determination of HPLC chromatographic conditions: the chromatographic column uses octadecylsi...

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Abstract

The invention relates to the field of pharmaceutical analysis and in particular relates to a method for establishing a fingerprint spectrum of Bailemian capsules and the fingerprint spectrum thereof.The method comprises the following steps: with a content solution of Bailemian capsules as a test solution, and a solution dissolving quercitrin, 2,3,5,4'-tetrahydro-xystilbene-2-O-D glucoside, schizandrin, danshinolic acid and rheum emodin as a reference solution, determining to obtain a liquid chromatogram of each of the test solution and the reference solution by virtue of an HPLC instrument; analyzing the liquid chromatogram in a traditional Chinese medicine chromatographic fingerprint spectrum similarity evaluation system, so as to obtain the fingerprint spectrum of Bailemian capsules byvirtue of multipoint correction and data matching. Totally 24 common peaks are calibrated, five common characteristic peaks are identified, the ninth quercitrin peak is selected as a reference peak inthe fingerprint spectrum, and relative retention time of each common peak is determined. The quality information of Bailemian capsules can be comprehensively reflected by the fingerprint spectrum, and uniform and stable product quality is ensured.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for establishing the fingerprint of Bailemian capsules and the fingerprint thereof. Background technique [0002] The current insomnia treatment drugs mainly include western medicine and traditional Chinese medicine. Western medicine mainly includes benzodiazepines and non-benzodiazepines. Chinese patent medicines have attracted much attention because of their synergistic and detoxifying effects. Bailemian Capsules are improved by Professor Gao Pengxiang, an old Chinese medicine doctor, combined with 50 years of clinical experience and classic prescriptions. It is the only drug approved by the State Food and Drug Administration for insomnia of liver depression and yin deficiency. [0003] Bailemian Capsules are composed of Lily, Acanthopanax (raw), Radix Polygonum, Albizia Julibrissin, Mother of Pearl, Gypsum, Jujube Seed, Poria, Polygala, Scrophulariaceae, Rehmannia (raw),...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 赵静陈炜伟谭琴姚仲青宋敏朱建华李鹏
Owner YANGTZE RIVER PHARMA GRP JIA NGSU LONGFENGTANG TRADITIONAL CHINESE MEDICINE CO LTD
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