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Determination method for fingerprint spectrum of Linaoxin Pian as well as standard fingerprint spectrum of Linaoxin Pian

A technology of Naoxin Tablet and its detection method, which is applied in the determination of HPLC fingerprints of Linaoxin Tablets and the field of fingerprints of Linaoxin Tablet preparations, can solve problems such as difficult to effectively control the overall quality, and cannot guarantee the safety and effectiveness of medication

Active Publication Date: 2019-01-18
WUXI JIYU SHANHE PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] It has been found that it is difficult to effectively control the overall quality through the determination of the above components, and the safety and effectiveness of the drug cannot be guaranteed.

Method used

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  • Determination method for fingerprint spectrum of Linaoxin Pian as well as standard fingerprint spectrum of Linaoxin Pian
  • Determination method for fingerprint spectrum of Linaoxin Pian as well as standard fingerprint spectrum of Linaoxin Pian
  • Determination method for fingerprint spectrum of Linaoxin Pian as well as standard fingerprint spectrum of Linaoxin Pian

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0100] Step (1) The preparation method of the test solution is: take Linaoxin tablets, remove the coating, grind finely, weigh 1g, put in a stoppered Erlenmeyer flask, add 20ml of 50% methanol precisely, seal it tightly, and weigh it , sonicated for 30 minutes, allowed to cool, and then weighed, supplemented with the extraction solvent to make up the lost weight, filtered with a 0.45 μm microporous membrane, and the filtrate was the test solution.

[0101] Step (2) The concentration of the reference substance solution preparation is respectively: the concentration of the Danshensu reference substance is 55.8 μg / ml, the concentration of the protocatechualdehyde reference substance is 52.6 μg / ml, the concentration of the puerarin reference substance is 55.3 μg / ml, and the concentration of the peony reference substance is 55.8 μg / ml. The concentration of the glucoside reference substance was 27.6 μg / ml, the concentration of the polyglutinin reference substance was 25.5 μg / ml, the ...

Embodiment 2

[0108] For the fingerprint determination of batch 171202 of Linaoxin Tablets, the specific steps are as follows:

[0109] Step (1) The preparation method of the test solution is: take Linaoxin Tablet 171202, remove the coating, grind finely, weigh 1g, put it in a stoppered Erlenmeyer flask, add 20ml of double-distilled water precisely, seal it, and weigh it. Weight, sonicate for 30 minutes, let cool, weigh again, make up the lost weight with extraction solvent, filter with 0.45 μm microporous membrane, and the subsequent filtrate is the test solution.

[0110] Step (2) The concentration of the reference substance solution preparation is respectively: the concentration of the Danshensu reference substance is 55.8 μg / ml, the concentration of the protocatechualdehyde reference substance is 52.6 μg / ml, the concentration of the puerarin reference substance is 55.3 μg / ml, and the concentration of the peony reference substance is 55.8 μg / ml. The concentration of the glucoside referen...

Embodiment 3

[0118] For the fingerprint determination of batch 180303 of Linaoxin Tablets, the specific steps are as follows:

[0119] Step (1) The preparation method of the test solution is: take Linaoxin Tablet 180303, remove the coating, grind finely, weigh 1g, put it in a stoppered Erlenmeyer flask, add 20ml of double-distilled water precisely, seal it, and weigh it. Weight, sonicate for 30 minutes, let cool, weigh again, make up the lost weight with extraction solvent, filter with 0.45 μm microporous membrane, and the subsequent filtrate is the test solution.

[0120] Step (2) The concentration of the reference substance solution preparation is respectively: the concentration of the Danshensu reference substance is 55.8 μg / ml, the concentration of the protocatechualdehyde reference substance is 52.6 μg / ml, the concentration of the puerarin reference substance is 55.3 μg / ml; The concentration of the glucoside reference substance was 27.6 μg / ml; the concentration of the Polygonum glycos...

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Abstract

The invention discloses a determination method for an HPLC fingerprint spectrum of a Linaoxin Pian as well as a standard fingerprint spectrum of the Linaoxin Pian. The determination method comprises the following steps: (1) preparing reference solution, namely respectively preparing sodium tanshinol, protocatechualdehyde, puerarin, paeoniflorin, liquiritin, polygonum multiflorum glycoside and salvianolic acid B reference solution; (2) preparing test solution, namely taking the Linaoxin Pian, extracting, and filtering extract with a micropore filter membrane, so that the test solution is obtained; and (3) performing the determination method, namely performing determination by adopting high performance liquid chromatography, wherein chromatographic conditions comprise that a chromatographiccolumn takes octadecyl silane bonded silica gel as filler, gradient elution is adopted, a mobile phase A is 0.01-3% phosphoric acid aqueous solution, a mobile phase B is acetonitrile, flow rate is 0.3-1.5ml / min, column temperature is 20-45 DEG C, and detection wavelength is 230nm.

Description

technical field [0001] The invention relates to a method for analyzing fingerprints of traditional Chinese medicines, in particular to a method for determining HPLC fingerprints of Linaoxin Tablets, and the obtained fingerprints of Linaoxin Tablet preparations. technical background [0002] Cardiovascular and cerebrovascular diseases are common diseases that seriously endanger human health in recent years. Due to the improvement of human quality of life, cardiovascular and cerebrovascular diseases are on the rise. In the treatment of cardiovascular and cerebrovascular diseases, although the single-target effect of traditional Chinese medicine is weaker than that of Western medicine, the advantages of multi-channel, multi-target, dynamic overall treatment, and less toxic and side effects are far superior to Western medicine, especially the comprehensive treatment of Chinese patent medicines with definite curative effects. The effect is better than western medicine. [0003]...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/86
CPCG01N30/8686G01N30/88G01N2030/8809
Inventor 朱音李璐於江华毛菊红过晓磊戴亚妮
Owner WUXI JIYU SHANHE PHARM CO LTD
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