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Quality detection method of liver protection tablets

A quality inspection method and technology of Hugan Tablets, which are applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of single-component content determination, single-fingerprint, and difficulty in controlling the quality of single-flavor medicinal materials by fingerprints.

Active Publication Date: 2020-12-01
HEILONGJIANG KUIHUA PHARMA
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  • Claims
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Problems solved by technology

Liver-protecting tablets have been used clinically for many years and have been accepted by the majority of patients. There are many types of liver-protecting tablets on the market, but the quality of the products varies
This is mainly due to the fact that the quality testing method is not comprehensive enough for the quality control of Hugan Tablets. At present, there are many researches on the testing methods of Hugan Tablets, which are basically a single fingerprint study or single-component content determination or multi-component content determination.
[0003]Among them, a single fingerprint can evaluate the quality of medicines as a whole, but it is difficult to control the quality of single medicinal materials, and the determination of component content can control the main components well, but it is difficult Control quality other than medicinal materials
In addition, the detection cycle of existing methods is generally long, and it is not realistic to use two quality detection methods at the same time, and it is difficult to apply them to actual production

Method used

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  • Quality detection method of liver protection tablets
  • Quality detection method of liver protection tablets
  • Quality detection method of liver protection tablets

Examples

Experimental program
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Embodiment 1

[0040] This embodiment provides a quality detection method for Hugan Tablets, that is, to detect the fingerprints and multi-component content of Hugan Tablets. The specific steps for the fingerprint determination of Hugan Tablets are as follows:

[0041] Instruments: Waters e2695 (PDA detector); Thermo U3000 (PDA detector); Agilent 1260 (VWD detector); Thermo U3000-QE high-resolution mass spectrometer; electronic balance (1 / 100,000), XSE105DU, Mettler -Toledo; electronic balance (1 / 10,000), MS204TS / 02, Mettler-Toledo; ultrasonic instrument, P120H, ElmaSchmidbauer GmbH, Germany; ultrapure water preparation instrument, Elix Advantage 15, Merck Millipore.

[0042]Material: liver protection tablet (batch number: 201705024, 201903092, 201903034, 201902044, 201902037, 201902021, 201902020, 201812170, 201812052, 201710026, 201707026), lack of five flavors Bile powder negative preparation, Heilongjiang Sunflower Pharmaceutical Co., Ltd.

[0043] Reference substances: Schizandrin A, p...

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Abstract

The invention discloses a quality detection method of liver protection tablets, and relates to the technical field of pharmacy. According to the quality detection method of the liver protection tablets, the content of eight components of chlorogenic acid, vitexin, glycine hyodeoxycholic acid, saikoside b2, schizandrin, saikoside b1, schizandrin A and schizandrin B in a to-be-detected sample prepared from the liver protection tablets is detected by adopting liquid chromatography. The method comprises the following steps: carrying out gradient elution by using a mobile phase A and a mobile phaseB, determining a detection spectrum and calculating the content of the eight components; and controlling the composition of the mobile phase A and the mobile phase B to make each component can form the detection spectrogram, so that the content of the eight components are effectively detected. The method has the characteristics of high efficiency, systematicness, characteristics, stability and the like.

Description

technical field [0001] The invention relates to the technical field of pharmacy, and in particular to a quality detection method for liver-protecting tablets. Background technique [0002] Hugan Tablets are made of Bupleurum, Yinchen, Banlangen, Schisandra, Pig Gall Powder and Mung Bean Powder as the main raw materials. cirrhosis of the liver. Liver-protecting tablets have been used clinically for many years and have been accepted by patients. There are many types of liver-protecting tablets on the market, but the quality of the products varies. This is mainly due to the fact that the quality testing methods are not comprehensive enough for the quality control of Hugan Tablets. At present, there are many studies on the testing methods of Hugan Tablets, which are basically a single fingerprint study or single-component content determination or multi-component content determination. [0003] Among them, a single fingerprint can evaluate the quality of medicines as a whole, b...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8686G01N2030/047
Inventor 关彦斌
Owner HEILONGJIANG KUIHUA PHARMA
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