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Radix astragali medicinal materials, intermediate body and method for testing fingerprint of formulation thereof as well as standard fingerprint

A detection method and fingerprint technology, applied in the field of drug quality control, can solve the problems of insufficient guarantee of the quality and efficacy of Huangqi granules

Active Publication Date: 2011-08-24
SICHUAN BAILI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is far from enough to ensure the quality and efficacy of the final product Huangqi Granules.

Method used

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  • Radix astragali medicinal materials, intermediate body and method for testing fingerprint of formulation thereof as well as standard fingerprint
  • Radix astragali medicinal materials, intermediate body and method for testing fingerprint of formulation thereof as well as standard fingerprint
  • Radix astragali medicinal materials, intermediate body and method for testing fingerprint of formulation thereof as well as standard fingerprint

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] This embodiment is the fingerprint spectrum detection method to 3 batches of Radix Astragali medicinal materials and the fingerprint spectrum obtained accordingly:

[0053] The detection method comprises the following main steps:

[0054] (1) Preparation of reference substance solution:

[0055] Weigh the reference substance of forbistin, put it in a volumetric flask, add methanol to dissolve and dilute to make a solution containing 0.1mg per 1ml, shake well to get the reference substance solution;

[0056] (2) Preparation of the test solution:

[0057] Weigh 2.0g of 3 batches of Radix Astragali (batches: 060530, 060827, and 070202) powder respectively, add 50ml of 80%, 90%, and 95% methanol, respectively, ultrasonically treat for 50min, 30min, and 20min, filter, and respectively Wash the filter residue, filter paper and funnel with an appropriate amount of methanol of the same concentration, merge the washing liquid into the filtrate, and evaporate it to dryness on a...

Embodiment 2

[0069] Present embodiment is to the fingerprint spectrum detection method of 3 batches of intermediates (Astragalus extractum) and the fingerprint spectrum obtained accordingly:

[0070] The detection method comprises the following main steps:

[0071] (1) Preparation of reference substance solution:

[0072] Weigh the reference substance of forbistin, put it in a volumetric flask, add methanol to dissolve and dilute to make a solution containing 0.1mg per 1ml, shake well to get the reference substance solution;

[0073] (2) Preparation of the test solution:

[0074] Weigh 5.0 g of 3 batches of astragalus intermediates (Astragalus extract; batches are: M070601, M070701, and M070702) respectively, put them in 25ml measuring bottles, add appropriate amounts of 80%, 90%, and 95% methanol respectively, and ultrasonically treat them for 20 minutes , 30min, and 40min, respectively add the same concentration of methanol to the scale, shake well, filter with a microporous membrane (...

Embodiment 3

[0084] This embodiment is the fingerprint detection method to 3 batches of preparations (Astragalus granules, sugar type) and the fingerprint spectrum obtained accordingly:

[0085] The detection method comprises the following main steps:

[0086] (1) Preparation of reference substance solution:

[0087] Weigh the reference substance of forbistin, put it in a volumetric flask, add methanol to dissolve and dilute to make a solution containing 0.1mg per 1ml, shake well to get the reference substance solution;

[0088] (2) Preparation of the test solution:

[0089] Take Radix Astragali preparation (Astragali granules, with glycoforms; batch numbers are: 070601, 070701, 070702), grind finely, weigh 3.0g, put it in a 50ml measuring bottle, add appropriate amount of 80%, 90%, 95% methanol respectively, Ultrasonic treatment for 20min, 30min, 50min, wash the filter residue, filter paper and funnel with an appropriate amount of methanol of the same concentration, put the washing liqu...

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Abstract

The invention discloses a fingerprint map detecting method of radix astragali drug, intermediate compound and a preparation thereof, the method is as follows: taking onocol as reference substance, obtaining each sample solution through the processes of extracting / dissolving, determining constant volume and the like, performing HPLC detection under the condition of the same chromatogram, performing gradient elution, recording a chromatogram map, and obtaining the product. In the method, the preliminary treatment method for each sample is simple, the reservation of the characteristic components is complete, the sample solution is stable; the precession is high, reproduction quality is good, and the solution has a certain specificity; the separation effect of each characteristic peak in theobtained fingerprint map is good, the fingerprint map of the radix astragali drug, intermediate compound and the preparation has better correlation; the method can be used for identifying the fake ofthe radix astragali drug, increases the controllability of the production process of the radix astragali preparation, and is in favour of ensuring the quality stability and the clinical healing efficacy of the radix astragali preparation. The invention also discloses a standard fingerprint map of radix astragali drug, intermediate compound and preparation thereof obtained by the fingerprint map detecting method.

Description

technical field [0001] The invention belongs to the technical field of medicine quality control, and particularly relates to a method for detecting fingerprints of astragalus medicinal materials, intermediates and preparations thereof, and obtains standard fingerprints thereof. Background technique [0002] Astragalus, also known as Astragalus membranaceus or Astragalus, is a leguminous, perennial herb. The main root is long, cylindrical, slightly woody, and the outer mass is khaki or brownish red. It likes drought and has strong adaptability. Distributed in Hebei, Shanxi, Shaanxi, Gansu, Qinghai, Liaoning, Jilin, Heilongjiang, Inner Mongolia and other places. [0003] The root of Astragalus membranaceus is well-known and commonly used in traditional Chinese medicine. Commercial Astragalus membranaceus is cylindrical, slightly twisted, and 20-60 cm long. It is better to have thick and long strips, less wrinkles, firm and soft texture, enough powder, and sweet taste. It m...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02A61K36/481A61P1/12A61P15/00A61P13/00A61P3/10A61P1/04A61P9/12A61P13/12A61K125/00
Inventor 曾大富陈颖
Owner SICHUAN BAILI PHARM CO LTD
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