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Quality detection method of traditional Chinese medicine callicarpa nudiflora preparation

A quality inspection method, the naked flower purple bead technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that cannot accurately and comprehensively reflect the internal quality of products, cannot guarantee clinical efficacy, and effectively control product quality, so as to achieve product quality. Uniform and stable and safe and effective, good stability and comprehensive control effect

Active Publication Date: 2014-03-05
JIANGXI POZIN PHARMA
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  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

However, the quality control of the nude flower purple pearl preparation currently mostly uses a single index component, and the quality control method established by it cannot accurately and comprehensively reflect the internal quality of the product, nor can it be used in the production process and effective control of product quality, let alone guarantee Its clinical efficacy

Method used

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  • Quality detection method of traditional Chinese medicine callicarpa nudiflora preparation
  • Quality detection method of traditional Chinese medicine callicarpa nudiflora preparation
  • Quality detection method of traditional Chinese medicine callicarpa nudiflora preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0034] Establishment of standard fingerprints of traditional Chinese medicine nudehuazizhu preparations (taking nudehuazizhu granules as an example).

[0035] (1) Experimental instruments and reagents.

[0036] Waters high performance liquid chromatography (Waters2695 separation unit, Waters2996 diode array detector, Empower chromatography workstation); chromatographic column: Elite C 18 (5μm, 250×4.6mm); KQ-250DB CNC ultrasonic cleaner, Kunshan Ultrasonic Instrument Co., Ltd.; AB104-N one-ten-thousandth balance, manufacturer: Mettler-Toledo; Millipore ultrapure water meter.

[0037] Acetonitrile (chromatographically pure): Chemical Branch of Shandong Yuwang Experimental Co., Ltd.; Phosphoric acid (excellent pure): Tianjin Fine Chemicals Development Co., Ltd.; Methanol (analytical pure): (Shanghai Zhenxing Chemical Factory No. 1).

[0038] Luteolin reference substance: National Institute for the Control of Pharmaceutical and Biological Products; Nudehuazizhu Granules: Jiangxi...

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Abstract

The invention discloses a quality detection method of a traditional Chinese medicine callicarpa nudiflora preparation, belonging to the technical field of medicine quality control. The quality detection method comprises the following steps of: (1) preparation of a comparison product solution, (2) preparation of a test product solution, (3) chromatographic condition, (4) making of a standard fingerprint spectrum which takes galuteolin as a reference peak, and (5) quality control of the fingerprint spectrum. Compared with the prior art, in the quality detection method disclosed by the invention, a high-performance liquid chromatography is adopted to establish the standard fingerprint spectrum; based on the active ingredient characteristics of callicarpa nudiflora, quantization parameters are obtained through the fingerprint spectrum; and the method is favorable in repeatability and stability and high in degree of precision, can more comprehensively control and reflect the quality of the preparation and can ensure the uniform stability, the safety and the effectiveness of the product quality.

Description

technical field [0001] The invention belongs to the technical field of medicine quality control, and in particular relates to a fingerprint detection method of a traditional Chinese medicine Zizhu nudehua preparation. Background technique [0002] Callicarpa nudiflorea Hook.et Am is the dry aerial part of Verbenaceae. Modern studies have shown that the active ingredients of the nude flower purple pearl have anti-inflammatory, detoxification, and hemostatic effects. At present, the related products on the market mainly include nudehuazizhu granules, nudihuazizhu capsules, nudihuazizhu mixture, nudihuazizhu dispersible tablets and nudehuazizhu suppositories, etc. [0003] As a Chinese patent medicine, the nude flower purple pearl preparation is the result of the joint action of various active ingredients. However, the quality control of the nude flower purple pearl preparation currently mostly uses a single index component, and the quality control method established by it ca...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
Inventor 肖军平郭锋吴永忠刘立鼎李旭尹文娟
Owner JIANGXI POZIN PHARMA
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