Method for establishing fingerprint spectrum of Jian Ganle preparation

A fingerprint and Jianganle technology, which is applied to establish the fingerprint of Jianganle preparations, detect and establish the quality or authenticity of Jianganle preparations, achieve high resolution, good peak shape, and improve the effect of separation

Active Publication Date: 2015-08-19
WUHAN KANGLE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] Therefore, the current method for establishing the fin

Method used

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  • Method for establishing fingerprint spectrum of Jian Ganle preparation
  • Method for establishing fingerprint spectrum of Jian Ganle preparation
  • Method for establishing fingerprint spectrum of Jian Ganle preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Embodiment 1: the investigation of chromatographic conditions

[0057] Preparation of the test solution: take an appropriate amount of Jianganle granules, grind and pulverize them, and use 50% ethanol to make a solution with a concentration of 10 mg / mL, and ultrasonicate the obtained solution for 10 minutes to obtain the test solution.

[0058] Preparation of the reference substance solution: Take an appropriate amount of the reference substance of paeoniflorin, weigh it accurately, add methanol to make a solution containing 60 μg of the reference substance of paeoniflorin per 1 ml, and obtain the solution.

[0059] Test method: inject 10 microliters of the solution to be tested into the high-performance liquid chromatograph, respectively use phosphoric acid-acetonitrile system (that is, phosphoric acid as mobile phase B and acetonitrile as mobile phase A), formic acid-acetonitrile system, phosphoric acid-methanol system, Water-acetonitrile system, water-methanol system...

Embodiment 2

[0073] Embodiment 2: the investigation of need testing solution preparation:

[0074] 1. Investigation of extraction solvent

[0075] Take an appropriate amount of Jianganle granule powder, add methanol, ethanol, 50% methanol, and 50% ethanol respectively to make a solution with a concentration of about 10 mg / mL, and ultrasonicate the obtained solution for 30 minutes, and after cooling, dilute to volume and filter. That is, different test solutions were obtained.

[0076] 10 microliters of the above-mentioned preparations were injected into the high-performance liquid chromatograph, and then detected according to the following chromatographic conditions:

[0077] Octadecylsilane bonded silica gel is used as filler, the elution conditions are as shown in Table 1, the flow rate is 1.0ml / min, the column temperature is 30°C, and the detection wavelength is 232nm; the number of theoretical plates calculated based on the peak of paeoniflorin should not be less than 2000; Waters Sy...

Embodiment 3

[0083] Example 3: Establishment of fingerprints of Jianganle preparations

[0084] 1. Chromatographic conditions and system suitability test

[0085] Octadecylsilane-bonded silica gel is used as filler; acetonitrile is used as mobile phase A, and 0.05% formic acid aqueous solution is used as mobile phase B. The gradient elution is shown in Table 1. The flow rate is 1.0ml / min, and the column temperature is 30°C. The detection wavelength is 232nm; the number of theoretical plates calculated based on the peak of paeoniflorin should not be less than 2000; Waters Symmetry C18 chromatographic column (4.6mm×250mm, 5μm).

[0086] 2. Preparation of the test solution:

[0087] Take an appropriate amount of Jianganle granule powder, add 50% ethanol to make a solution with a concentration of about 10 mg / ml, and ultrasonicate the obtained solution for 10 minutes, then let it cool down in turn, and constant volume to obtain the test solution.

[0088] 3. Preparation of reference solution:...

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Abstract

The invention provides a method for establishing a fingerprint spectrum of a Jian Ganle preparation, wherein, the method is a high performance liquid chromatography, which comprises the following steps: injecting 10 microliters of a tested object solution containing the Jian Ganle preparation, and detecting according to the following chromatogram condition: a filler is octadecylsilane chemically bonded silica, a mobile phase A is acetonitrile, a mobile phase B is 0.05% of formic acid aqueous solution (V/V), an elution method is gradient elution, the detection wavelength is 232 nano meters, and column temperature is 30 DEG C. An inventor found that the method can be used for rapidly and effectively obtaining the fingerprint spectrum of the Jian Ganle preparation, the quality information of the Jian Ganle preparation can be comprehensively reflected, and the method has good systematicness, characteristic feature and stability.

Description

technical field [0001] The present invention relates to the technical field of drug analysis, in particular, to a method for establishing a fingerprint of a Jianganle preparation and its application, more specifically, to a method for establishing a fingerprint of a Jianganle preparation, a method for detecting a Jianganle preparation and establishing a Jianganle preparation. The application of the method of the fingerprint of Ganle preparation in detecting and establishing the quality or authenticity of Jianganle preparation. Background technique [0002] Jianganle Granules comes from "Shaoyao Gancao Decoction" in Zhang Zhongjing's "Treatise on Febrile Diseases" in the Eastern Han Dynasty. It is composed of two traditional Chinese medicines, licorice and white peony. It is clinically used to improve the clinical symptoms of various types of hepatitis. Wuhan Kangle Pharmaceutical Co., Ltd Co., Ltd. exclusive production varieties. In 2012, the sales in Hubei Province alone e...

Claims

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Application Information

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IPC IPC(8): G01N30/88
Inventor 王学海江书银许勇曹儒宾李莉娥秦和平黄璐杨仲文刘世勇余通黄天赐杨成兵何水英尹海龙冯芸杨婷谢长于静肖强
Owner WUHAN KANGLE PHARMA
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