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A kind of HPLC fingerprint detection method of Kunling Pills

A high-performance liquid chromatography and fingerprint technology, which is applied in the field of high-performance liquid chromatography fingerprint detection of Kunling pills, can solve the problems such as the lack of research reports on the fingerprints of Kunling pills

Active Publication Date: 2018-08-21
TIANJIN TASLY PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The current standard of Kunling Pills is recorded in Volume 10 of the Drug Standards of the Ministry of Health of the People's Republic of China "Preparations of Traditional Chinese Medicine". The standard does not involve any qualitative and quantitative control items for the taste of the medicine. At present, there is no fingerprint research on Kunling Pills. According to reports, fingerprints can fully characterize the integrity and complexity of traditional Chinese medicine preparations, so the inventors studied the active ingredients of Kunling Pills

Method used

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  • A kind of HPLC fingerprint detection method of Kunling Pills
  • A kind of HPLC fingerprint detection method of Kunling Pills
  • A kind of HPLC fingerprint detection method of Kunling Pills

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0126] Embodiment 1, the fingerprint chromatogram determination of Kunling pill

[0127] Take the Kunling pill film-coated pill with batch number 20121102

[0128] Step 1, preparation of test solution

[0129] Take an appropriate amount of Kunling film-coated pills, grind them into fine powder, accurately weigh 0.5g into a 10ml volumetric flask, add an appropriate amount of 50% methanol, ultrasonically treat for 30min, cool to room temperature, set the volume to the mark, shake well, and pass through a micrometer of 0.45μm. Porous filter membrane, take the filtrate to obtain. Step 2, establishment of fingerprint

[0130] Using high performance liquid chromatography, the chromatographic conditions are as follows: the column stationary phase uses octadecylsilane bonded silica gel as the filler, Agilent ZORBAX (4.6*250mm, 5um); the mobile phase is gradient elution of acetonitrile-1% formic acid aqueous solution; The flow rate is 1.0ml / min; the column temperature is 30°C; the i...

Embodiment 2

[0134] Embodiment 2, the fingerprint chromatogram determination of Kunling pill

[0135] Take the Kunling pill film-coated pill with batch number 20121002

[0136] Step 1, preparation of test solution

[0137] Take an appropriate amount of Kunling film-coated pills, grind them into fine powder, accurately weigh 0.4g into a 10ml volumetric flask, add an appropriate amount of 40% methanol, ultrasonically treat for 25min, cool to room temperature, set the volume to the mark, shake well, and pass through a micrometer of 0.45μm. Porous filter membrane, take the filtrate to obtain. Determination of fingerprints,

[0138] Step 2, establishment of fingerprint

[0139] Using high performance liquid chromatography, the chromatographic conditions are as follows: the column stationary phase uses octadecylsilane bonded silica gel as the filler, Agilent ZORBAX (4.6*250mm, 5um); the mobile phase is gradient elution of acetonitrile-1% formic acid aqueous solution; The flow rate is 1.0ml / m...

Embodiment 3

[0143] Embodiment 3, the fingerprint chromatogram determination of Kunling pill

[0144] Take the Kunling Wan sugar-coated pill with batch number 20120901

[0145] Step 1, preparation of test solution

[0146] Take an appropriate amount of Kunling Wan sugar-coated pills, remove the sugar coating (direct beating method), grind into a fine powder, accurately weigh 0.6g into a 10ml volumetric flask, add an appropriate amount of 60% methanol, ultrasonicate for 35min, cool to room temperature, and set the volume to the mark , Shake well, pass through a 0.45μm microporous membrane, and take the subsequent filtrate.

[0147] Step 2, establishment of fingerprint

[0148] Using high performance liquid chromatography, the chromatographic conditions are as follows: the stationary phase of the chromatographic column is filled with octadecylsilane bonded silica gel, Agilent ZORBAX (4.6*250mm, 5μm); the mobile phase is gradient elution of acetonitrile-1% formic acid aqueous solution; The...

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Abstract

The invention provides a high-efficiency liquid-phase fingerprint detection method for Kunling Wan. The method comprises the following steps of establishment of a standard fingerprint spectrum of the Kunling Wan, determination of the fingerprint spectrum of the Kunling Wan to-be-determined, and comparison and determination of similarity. According to the invention, by trying a plurality of different elution conditions, the method finally determines the chromatographic condition for fingerprint spectrum analysis of the Kunling Wan, investigates contrast fingerprint spectrums of eight common peaks, and has the characteristics of simple process, fast speed, and good reappearance, the established standard fingerprint spectrum can satisfy relative requirements through methodology validation, applicability is strong, quality status of the product can be comprehensively reflected, and the method provides important basis for quality controlling and standard making.

Description

technical field [0001] The invention relates to a high-efficiency liquid phase fingerprint detection method for Kunling pills, belonging to the technical field of drug analysis. Background technique [0002] Kunling Pill is a compound preparation of traditional Chinese medicine. Its functions and indications are regulating menstruation and nourishing blood, removing blood stasis and promoting regeneration. It is used for irregular menstruation, more or less, abdominal pain during menstruation, cold uterus, prolonged infertility, habitual miscarriage, red and white vaginal discharge, metrorrhagia, prolonged illness, qi deficiency, kidney deficiency and low back pain. [0003] The prescription of Kunling Pills is as follows: [0004] 【prescription】 [0005] (1) Rhizoma Cyperus (made) 37g Licorice 7g Baiwei 14g Motherwort 14g Astragalus 14g Cockscomb 14g Ophiopogon japonicus 14g Schisandra 14g Rehmannia glutinosa 14g Safflower 14g Akebia 10g Atractylodes macrocephala (stir-fr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 阚红玉刘海涛耿晓梅孙玉侠曹凤兰徐立元杨建会李建杨雪梅张淑玉
Owner TIANJIN TASLY PHARMA CO LTD
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