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Fingerprint detection method and quality control method of Yinchen Formula Granules

A technology of formula granules and fingerprints, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as untraceable reasons, uncontrollable product quality, poor product quality and uniformity, etc., to achieve uniform separation, Ensure the quality and stability, the effect of stable retention time

Active Publication Date: 2018-10-26
HARBIN ZHENBAO PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing capillary fingerprint detection methods mainly focus on detecting the product quality of capillary medicinal materials, and the capillary formula granules from different manufacturers and the product quality of each stage in the production process cannot be controlled, resulting in the final product quality. Poor quality and uniformity and cannot be traced

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] S1.1: Prepare the reference substance solution

[0083] Take an appropriate amount of chlorogenic acid reference substance, weigh it accurately, add 50% methanol to make a solution containing 0.2mg per 1mL, and obtain it.

[0084] S1.2: Prepare the test solution

[0085] Take multiple nodes of the test products (capillary chen decoction pieces, capillary standard decoction, capillary extract, capillary extract spray-dried powder, capillary formula granule 1 and capillary formula granule 2), and the multiple node test products Prepare a variety of node test product solutions respectively.

[0086] Among them, the capillary medicinal material was taken, processed according to the processing method under the item of capillary in the 2015 edition of the "Chinese Pharmacopoeia", the residual roots and impurities were removed, chopped, and the dust was sieved to obtain capillary slices.

[0087] Add 12 times the volume of purified water to Yinchen decoction pieces, soak in ...

Embodiment 2

[0124] The fingerprint detection method of the Capillaris formula granules provided in this example is basically the same as that in Example 1, the difference being that the chromatographic conditions in this example are different:

[0125] Chromatographic column: Agilent Zorbax eclipse XDB-C18 (4.6×250mm, 5μm)

[0126] Mobile phase A: Methanol; Mobile phase B: 1% glacial acetic acid in water

[0127] Detection wavelength: 330nm; flow rate 1.2ml / min, injection volume 10μL; column temperature 35℃

[0128] Gradient elution was carried out according to the gradient elution parameters in Table 3.

[0129] Table 4. Gradient elution parameters of embodiment 2

[0130]

Embodiment 3

[0132] The fingerprint detection method of the Capillaris formula granules provided in this example is basically the same as that in Example 1, the difference being that the chromatographic conditions in this example are different:

[0133] Chromatographic column: Agilent Zorbax eclipse XDB-C18 (4.6×250mm, 5μm)

[0134] Mobile phase A: Methanol; Mobile phase B: 1% glacial acetic acid in water

[0135] Detection wavelength: 327nm; flow rate 0.8ml / min, injection volume 10μL; column temperature 25℃

[0136] Gradient elution was carried out according to Table 4.

[0137] The gradient elution parameter of table 5 embodiment 3

[0138]

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Abstract

The invention relates to the field of quality inspection of capillary artemisia formula granules, and provides a fingerprint spectrum detection method of the capillary artemisia formula granules. The method includes the steps that chlorogenic acid is obtained for preparing a reference solution, capillary artemisia medicinal materials are obtained for preparing a multiple-node-sample solution, and high performance liquid chromatograph is conducted on the reference solution and the multiple-node-sample solution respectively, and the chromatographic conditions are as follows: an aqueous solution of methanol and acetic acid is used as a mobile phase, the reference solution and the multiple-node-sample solution are allowed to pass a chromatographic column respectively and subjected to gradient elution, the methanol volume is controlled in the gradient elution process, and the percentage, in the total amount of the le phase, of methanol volume is increased from 4-6% to 40-50% and then is reduced to 4-6%. The fingerprint spectrums of a product in all stages of the capillary artemisia formula granules can be established, and the quality of the capillary artemisia formula granules can be well controlled. Moreover, the invention provides a quality control method, including the capillary artemisia formula granule fingerprint spectrum detection method, of the capillary artemisia formula granules.

Description

technical field [0001] The invention relates to the field of quality detection of capillary formula granules, in particular to a fingerprint detection method and quality control method of capillary formula granules. Background technique [0002] Yinchen is the dry above-ground part of Artemisia chinensis or Artemisia chinensis, which has the functions of clearing damp heat and reducing jaundice, and is used for jaundice, oliguria, eczema and pruritus, and infectious jaundice hepatitis. At present, the liquid chromatographic quality control methods for capillary capillary and its preparations are mainly based on the content determination of one or several active ingredients. Fingerprint is a new quality control mode of traditional Chinese medicine based on modern analysis, and it is currently recognized internationally as the most ideal technology for quality control of traditional Chinese medicine. However, the existing capillary fingerprint detection methods mainly focus o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8809
Inventor 方同华许照芹项彦华王倩
Owner HARBIN ZHENBAO PHARMA
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