Construction method and quality detection method of standard fingerprint and characteristic map of Shuoquan preparation

A standard fingerprint and feature map technology, which is applied in the construction method and quality inspection field of the standard fingerprint and feature map of Shuquan preparations, can solve the problems of not being able to better guarantee the clinical efficacy, unable to effectively control the production process and product quality, etc. , to achieve the effect of increasing quality coverage, improving detection sensitivity and detection quality, and simple pre-processing methods

Active Publication Date: 2016-01-20
HUNAN HANSEN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, there is no more comprehensive quality control method to reflect the quality status of existing Chinese medicinal materials, intermediates and finished products, nor can it effectively control the production process and product quality, and cannot better guarantee its clinical efficacy

Method used

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  • Construction method and quality detection method of standard fingerprint and characteristic map of Shuoquan preparation
  • Construction method and quality detection method of standard fingerprint and characteristic map of Shuoquan preparation
  • Construction method and quality detection method of standard fingerprint and characteristic map of Shuoquan preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Example 1 Establishment of the fingerprint of Shuquan preparation. (Take Shuquan Capsules as an example)

[0064] (1) Instruments and reagents

[0065] Agilent 1260 high performance liquid chromatography, quaternary pump (G-1311C, including online vacuum degassing machine), automatic sampler (G-1329B), intelligent column oven (G-1316A), DAD detector (G -1315B), ChemStationforLC3Dsystems chromatographic workstation (Agilent Technologies Co., Ltd., USA); SB-5200D ultrasonic cleaner (Ningbo Xinzhi Biotechnology Co., Ltd.); FAZ004B analytical balance (Shanghai Youke); BT125D electronic balance (Sartorius Scientific Instruments) (Beijing) Co., Ltd.).

[0066] (2) Selection of chromatographic conditions

[0067] ①Selection of mobile phase

[0068] Select acetonitrile-water, acetonitrile-0.1% phosphoric acid solution, acetonitrile-0.2% phosphoric acid solution, acetonitrile-0.1% formic acid solution, methanol-0.1% phosphoric acid solution, methanol-0.1% formic acid solutio...

Embodiment 2

[0115] Embodiment 2 The establishment of the fingerprint of the intermediate of Shuquan preparation

[0116] (1) Instruments and reagents

[0117] Agilent 1260 high performance liquid chromatography, quaternary pump (G-1311C, including online vacuum degassing machine), automatic sampler (G-1329B), intelligent column oven (G-1316A), DAD detector (G -1315B), ChemStationforLC3Dsystems chromatographic workstation (Agilent Technologies Co., Ltd.); Instrument (Beijing) Co., Ltd.).

[0118] (2) Chromatographic conditions

[0119] The chromatographic column is Agilent ZORBAXSB-C 18 (5 μ m, 4.6 * 250mm) reversed-phase chromatographic column; Column temperature is 30 ℃; Three wavelengths of 280, 260, 230nm are switched as detection wavelength; Mobile phase A is acetonitrile, mobile phase B is 0.1% phosphoric acid solution, and the total flow rate is 1.0ml / min; Analysis time 50 minutes; Gradient elution (Table 3):

[0120] Table 3 Gradient running table

[0121]

[0122] (3) Pre...

Embodiment 3

[0154] Example 3 Establishment of fingerprints of Shuquan preparations (taking Shuquan granules as an example).

[0155] (1) Instruments and reagents

[0156] Agilent 1260 high performance liquid chromatography, quaternary pump (G-1311C, including online vacuum degassing machine), automatic sampler (G-1329B), intelligent column oven (G-1316A), DAD detector (G -1315B), ChemStationforLC3Dsystems chromatographic workstation (Agilent Technologies Co., Ltd., USA); SB-5200D ultrasonic cleaner (Ningbo Xinzhi Biotechnology Co., Ltd.); FAZ004B analytical balance (Shanghai Youke); BT125D electronic balance (Sartorius Scientific Instruments) (Beijing) Co., Ltd.).

[0157] (2) Chromatographic conditions

[0158] The column is ThermoSyncronis-C 18 (5 μ m, 4.6 * 250mm) reversed-phase chromatographic column; Column temperature is 35 ℃; With 280, 260, 230nm three wavelengths are switched as detection wavelength; Mobile phase A is acetonitrile, and mobile phase B is 0.05% phosphoric acid so...

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Abstract

The invention discloses a construction method of a standard finger-print and a characteristic spectrum of a Suoquan preparation. The construction method comprises the following steps: preparing a reference solution; preparing a solution of a test article; and determining the correlations among medicinal raw materials and a finished product. By adopting a multi-wavelength switching technology to determine and by taking a retention time and a peak area of a chromatographic peak of a reference article as 1, the relative retention time and relative peak area of the test article are calculated, so that the HPLC standard finger-print of the Suoquan preparation is obtained. According to the HPLC standard finger-print of the Suoquan preparation prepared by the method, the finger-print assigned to Chinese yam has five common peaks; the finger-print assigned to alpinia oxyphylla has four common peaks; and finger-print assigned to lindera aggregata has nine common peaks. The method disclosed by the invention can be used for achieving the purpose of increasing the quality coverage by adopting the multi-wavelength detection method, and can be used for improving the detection sensitivity and the detection quality and comprehensively, objectively and scientifically evaluating the quality of the Suoquan preparation. Particularly, the method can be used as one of the indexes for true and false identification of the Suoquan preparation.

Description

technical field [0001] The invention belongs to the technical field of drug quality control, and in particular relates to a construction method and a quality detection method of a standard fingerprint and a characteristic map of a shrink spring preparation. Background technique [0002] Shuquan preparation is composed of three medicinal materials: yam, Yizhiren and black medicine. Based on the ancient famous prescription Shuquan Wan, it is refined by using modern advanced equipment and extraction technology. The prescription of Shuoquan preparation is the key prescription for the treatment of kidney deficiency and coldness and urinary disorders in the past dynasties. In the prescription, Yizhiren warms and nourishes the yang of the kidney, solidifies Qi and astringent essence as the main drug; yam nourishes the Qi of the spleen and kidney, and enhances the effect of Yizhiren, and is used as an auxiliary drug; Wuyao Shunqi relieves stagnation, clears the body's meridians, qi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/89
Inventor 刘令安杨华张妮瑜张飞飞王雄龙许志张建伟
Owner HUNAN HANSEN PHARMACEUTICAL CO LTD
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