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Ophiopogon japonicus fingerprint, construction method thereof and ophiopogon japonicus quality detection method

A fingerprint and construction method technology, applied in the field of drug testing, can solve the problems of single quality evaluation method of Ophiopogon japonicus and indicate the overall quality of Ophiopogon japonicus and its preparations, and achieve stable retention time, no drift, and good reproducibility Effect

Active Publication Date: 2019-03-29
YAAN THREE NINE PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] The object of the present invention is to provide a fingerprint of Ophiopogon japonicus, its construction method and quality detection method of Ophiopogon japonicus, which aims to improve the quality evaluation method of Ophiopogon japonicus in the prior art, which is not enough to systematically and completely indicate The overall quality of its preparations

Method used

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  • Ophiopogon japonicus fingerprint, construction method thereof and ophiopogon japonicus quality detection method

Examples

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Effect test

Embodiment 1

[0077] This embodiment provides a fingerprint of Ophiopogon japonicus, which includes the following steps for construction:

[0078] Prepare the test solution: accurately weigh 2.0 g of Ophiopogon japonicus, dry and crush; place in a stoppered conical flask, add 15 times the volume of water, weigh, decoct for 2 hours, cool, add weight, and filter to obtain the test product Solution.

[0079] Prepare the reference solution: accurately weigh an appropriate amount of the uridine reference substance, and use a 5% methanol aqueous solution to prepare a solution containing 50 μg uridine per 1 ml.

[0080] High performance liquid chromatography

[0081] According to high performance liquid chromatography (2015 edition of "Chinese Pharmacopoeia" three general rules 0512) test.

[0082] Chromatographic conditions: chromatographic column is Wters Bridge (5μm, 4.6×250mm Column); mobile phase: A: acetonitrile; B: 0.058% trifluoroacetic acid; gradient elution; column temperature: 40°C; detection wa...

Embodiment 2

[0097] One of the differences between Example 2 and Example 1 is that the test solution used in Example 2 is different. In Example 2, the test solution is prepared by WS3-B-2865-98-2011 Shengmai injection Crafted.

[0098] Analyze the detection results of 11 batches of test product fingerprints with the similarity evaluation system of traditional Chinese medicine chromatographic fingerprints to generate control fingerprints; through the identification and identification of the characteristic peaks, 6 characteristic peaks of the HPLC fingerprint of the intermediate product of Ophiopogon japonicus are obtained , Fingerprints such as figure 2 As shown, with peak 2 uridine as the reference peak, the relative retention time of each characteristic peak is: peak 1: relative retention time is 0.859-0.868; relative peak area is 0.434-0.517; peak 2: relative retention time is 1; Relative peak area is 1; No. 3 peak: relative retention time is 1.235-1.242; relative peak area is 0.158-0.289;...

Embodiment 3

[0104] One of the differences between Example 3 and Example 1 is that the chromatographic conditions are different. The chromatographic conditions are: select the chromatographic column with octadecylsilane-bonded silica gel as the filler, use acetonitrile as the mobile phase A, and use 0.06vol% trifluoroacetic acid aqueous solution as the mobile phase B, respectively for the reference solution and the test solution Carry out gradient elution, and during the gradient elution process, the column temperature is controlled to 42° C., the flow rate is 0.61 mL / min; the detection wavelength is 278 nm.

[0105] The second difference between Example 3 and Example 1 is that the reference solution is different;

[0106] Reference solution: the solvent is 5 vol% methanol aqueous solution, the solute is uridine, and the uridine concentration is 51 μg / ml.

[0107] The third difference between Example 3 and Example 1 lies in the preparation of the test solution. In Example 3, the test solution wa...

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Abstract

The invention relates to the technical field of pharmaceutical quality detection, in particular to an ophiopogon japonicus fingerprint, a construction method thereof and an ophiopogon japonicus quality detection method. The construction method of the ophiopogon japonicus fingerprint mainly comprises a step of determining a reference solution and a test solution prepared from the ophiopogon japonicus with high performance liquid chromatography, wherein the chromatographic conditions are as follows: octadecyl silane bonded silica gel is utilized as a chromatography column of a filling agent; a mobile phase A is acetonitrile; a mobile phase B is a trifluoroacetic acid aqueous solution; and gradient elution is performed on the reference solution and the test solution respectively. The fingerprint provided in this embodiment can systematically and comprehensively reflect various chemical components in ophiopogon japonicus, the common peak has stable relative retention time, and the ophiopogon japonicus fingerprint has good stability. According to the ophiopogon japonicus fingerprint, the construction method thereof and the ophiopogon japonicus quality detection method, the analysis process of the ophiopogon japonicus and its preparations are simplified, the relevance of the ophiopogon japonicus is accurately evaluated, and the quality of the ophiopogon japonicus and preparations canbe controlled.

Description

Technical field [0001] The present invention relates to the technical field of drug detection, in particular to an Ophiopogon japonicus fingerprint atlas, a construction method thereof, and a Ophiopogon japonicus quality detection method. Background technique [0002] Ophiopogon japonicus (scientific name: Ophiopogon japonicus (Linn.f.) Ker-Gawl.) Liliaceae is a perennial evergreen plant. The small root of Ophiopogon japonicus is a traditional Chinese medicine, which has the effects of promoting body fluids and quenching thirst, moistening the lungs and relieving cough. At this stage, Ophiopogon japonicus in the "Chinese Pharmacopoeia" only has a single quality evaluation method, which is not enough to systematically and completely indicate the overall quality of Ophiopogon japonicus and its preparations. Summary of the invention [0003] The purpose of the present invention is to provide an Ophiopogon japonicus fingerprint map, its construction method and Ophiopogon japonicus qu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/86
CPCG01N30/8686
Inventor 韦婷干建伟胡敏史琳莉
Owner YAAN THREE NINE PHARMA
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