A method for determining the fingerprint of Shenzhiling preparation

A technology of fingerprints and Shenzhiling Oral Liquid, which is applied in the detection field of pharmaceutical preparations, can solve problems such as difficulty in judging the overall quality of preparations, and achieve the effects of good absorption value, high precision, stability and reproducibility

Active Publication Date: 2020-12-08
SHANDONG WOHUA PHARMACEUTICALS CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, its quality control technology mostly adopts the content determination method of one or a few components, such as the Chinese invention patent CN201510224392.4, which discloses a method for establishing the fingerprint of Shenzhiling oral liquid, which only detects cinnamic acid, peony glycoside, liquiritin, paeonifloride glycoside, ammonium glycyrrhizinate and other active ingredients were quantitatively analyzed, and only two raw medicinal materials of cassia twig and peony were involved. There is a lack of detection of medicinal materials such as licorice and poria cocos, which have an important impact on the efficacy of the drug, making it difficult to judge the overall quality of the preparation

Method used

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  • A method for determining the fingerprint of Shenzhiling preparation
  • A method for determining the fingerprint of Shenzhiling preparation
  • A method for determining the fingerprint of Shenzhiling preparation

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Experimental program
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Embodiment 1

[0055] Embodiment 1, assay method and methodology validation

[0056] Assay method of the present invention comprises the following steps:

[0057] (1) Prepare the test solution,

[0058] (2) Prepare the reference substance solution,

[0059] (3) Take the above solution and inject it into a high performance liquid chromatograph for measurement to obtain a chromatogram,

[0060] (4) Compare the chromatograms of the above solutions.

[0061] Among them, step (1) preparation of the test solution: take 15 batches of Shenzhiling Oral Liquid, accurately measure 1.0ml for each batch into a 10ml volumetric flask, add methanol to the volume, ultrasonically extract for 15min, return to room temperature, Extract with saturated n-butanol with water, pass the extract through a 0.45 μm microporous membrane, take the subsequent filtrate to recover n-butanol, transfer to a 10ml volumetric flask, add methanol to constant volume, and obtain the test solution.

[0062] In step (2), the prepa...

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Abstract

The invention relates to a method for detecting a pharmaceutical preparation, in particular to a method for constructing a fingerprint chromatogram of a traditional Chinese medicine preparation, namely, a radix codcnopsitis pilosulas, ramulus cinnamomi and poria cocos oral solution. High performance liquid chromatography is mainly adopted for detection, an acetonitrile-0.5% glacial acetic acid aqueous solution is taken as a mobile phase, A is acetonitrile, a 0.5% glacial acetic acid aqueous solution is taken as a mobile phase B, the detection wavelength is 203 nm, the column temperature is 30DEG C, the injection quantity is 10 mu l, and all the components are detected within 60 min.

Description

technical field [0001] The invention relates to a detection method of a medicinal preparation, in particular to a fingerprint determination method of a traditional Chinese medicine preparation Shenzhiling Oral Liquid. Background technique [0002] Alzheimer's Disease (AD) is a neurodegenerative disease that seriously endangers the health of the elderly in today's society. It is the most common type of senile dementia, accounting for 60% to 70% of dementia patients. my country is facing the challenge of population aging. At present, the number of patients with dementia in China has reached 10 million, ranking first in the world. my country has become the country with the largest number of dementias and the fastest growing rate in the world. Traditional Chinese medicine has its advantages in the treatment of Alzheimer's disease. For example, the traditional Chinese medicine Shenzhiling Oral Liquid, which is already on the market, its formula and process are described in Chines...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/062
Inventor 程世娟曾英姿周万辉王冬梅于洪亮赵磊刘春蕾高燕高阳
Owner SHANDONG WOHUA PHARMACEUTICALS CO LTD
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