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Kangfuxin solution preparation fingerprint quality determination method and standard fingerprint

A technology of Kangfuxin liquid and fingerprints, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as difficult to effectively control the quality of Kangfuxin liquid preparations, chromatographic peak shapes and poor resolution, and achieve Kangfuxin liquid Accurate and objective quality control of preparations, rapid identification, and good separation

Inactive Publication Date: 2017-02-01
SICHUAN GOODDOCTOR PANXI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the quality evaluation of Kangfuxin liquid is mainly based on the content determination of one or more nucleoside components, amino acids and polysaccharides. Only a few reports have carried out the research on fingerprints of Kangfuxin liquid preparations. The peak shape and resolution are poor, making it difficult to effectively control the quality of Kangfuxin liquid preparations

Method used

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  • Kangfuxin solution preparation fingerprint quality determination method and standard fingerprint
  • Kangfuxin solution preparation fingerprint quality determination method and standard fingerprint
  • Kangfuxin solution preparation fingerprint quality determination method and standard fingerprint

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0020] (1) Instruments and reagents

[0021] TSQ Quantum Ultra liquid chromatography-tandem mass spectrometer; Hypersil Gold C18 column (4.6×150mm, 5μm).

[0022] Methanol is chromatographically pure, water is ultrapure water, and acetic acid is analytically pure.

[0023] 10 different batches of rehabilitation new liquid: batch number 140308, batch number 140309, batch number 140310, batch number 140311, batch number 140312, batch number 140313, batch number 140314, batch number 140315, batch number 140316, batch number 140317.

[0024] Trigonelline, uracil, hypoxanthine, adenosine, and inosine (all purchased from China Pharmaceutical and Biological Products Laboratory, batch numbers are A0654, PCS3048, PCS3055, PCS0217, PCS3058).

[0025] (2) Chromatographic conditions

[0026] a. Selection of detection wavelength

[0027] Since Kangfuxin Liquid is an alcohol extract of the medicinal insect Periplaneta americana, it contains a large amount of nucleoside substances, and existing studies ...

Embodiment 2

[0087] The quality measurement method of the fingerprint of Kangfuxinye preparation includes the following steps:

[0088] (A) Preparation of the test solution: take the Kangfuxin liquid preparation, pass through a 0.22μm microporous membrane, take the additional filtrate, and set aside;

[0089] (B) Preparation of reference solution: accurately weigh trigonelline, uracil, hypoxanthine, inosine, adenosine, and add water to make each 1mL containing trigonelline, uracil, hypoxanthine, inosine and Adenosine is a mixed control solution of 20μg, 30μg, 20μg, 40μg and 40μg, for use;

[0090] (C) Determination: Inject 20μL each of the test product and the reference solution into the high performance liquid chromatograph, use 0.08% acetic acid aqueous solution (A)-methanol (B) as the mobile phase, and use gradient elution to obtain the Kangfu Xinye preparation Fingerprint.

[0091] The measurement conditions of high performance liquid chromatograph are: filler is octadecylsilane bonded silica...

Embodiment 3

[0094] The quality measurement method of the fingerprint of Kangfuxinye preparation includes the following steps:

[0095] (A) Preparation of the test solution: take the Kangfuxin liquid preparation, pass through a 0.22μm microporous membrane, take the additional filtrate, and set aside;

[0096] (B) Preparation of reference solution: accurately weigh trigonelline, uracil, hypoxanthine, inosine, adenosine, and add water to make each 1mL containing trigonelline, uracil, hypoxanthine, inosine and Adenosine is a mixed control solution of 20μg, 30μg, 20μg, 40μg and 40μg, for use;

[0097] (C) Determination: Inject 20μL each of the test product and the reference solution into the high performance liquid chromatograph, use 1.0% acetic acid aqueous solution (A)-methanol (B) as the mobile phase, and use gradient elution to obtain the Kangfu Xinye preparation Fingerprint.

[0098] The measurement conditions of high performance liquid chromatograph are: filler is octadecylsilane bonded silica ...

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Abstract

The invention relates to a drug detection method and especially relates to a Kangfuxin solution preparation fingerprint quality determination method and a standard fingerprint. Through high performance liquid chromatography detection, a Kangfuxin solution fingerprint is obtained. The method comprises a, contrast solution preparation, b, sample solution preparation and c, fingerprint making. The method builds a Kangfuxin solution chemical fingerprint with good chromatographic peak resolution, repeatability and stability and can be used as a Kangfuxin solution preparation quality control method. The method provides scientific basis for scientific and effective evaluation and control of qualities of periplaneta americana medical raw materials and a Kangfuxin solution preparation.

Description

Technical field [0001] The invention relates to a method for measuring the quality of medicines, in particular to a method for measuring the quality of a fingerprint of Kangfuxin liquid preparation and a standard fingerprint. Background technique [0002] Kangfu Xinye is included in the nineteenth volume of Chinese patent medicines and WS3-B-3674-2000(Z) of the Pharmaceutical Standards of the Ministry of Health of the People’s Republic of China. Kangfuxin Liquid is a single preparation made from the extract of Periplaneta americana. It has various pharmacological activities such as anti-inflammatory, anti-peptic ulcer, anti-tumor, immune regulation, and anti-oxidation. Kangfuxin Liquid has a wide range of clinical applications. Oral administration can be used to treat diseases such as stomach pain and bleeding, gastric and duodenal ulcers, and external use can treat golden sores, trauma, ulcers, burns, scalds, etc. [0003] At present, the quality evaluation of Kangfuxin liquid is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/16
Inventor 刘越飞耿福能沈咏梅
Owner SICHUAN GOODDOCTOR PANXI PHARMA
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