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Method for detecting quality of blood fat recovery capsule

A quality inspection method, the technology of Xuezhikang Capsules, is applied in the direction of measuring devices, instruments, scientific instruments, etc., and can solve problems such as difficult to distinguish counterfeit products, endanger life safety, and content determination indicators cannot fully reflect and control the quality of preparations, etc., to improve Quality control standards, reproducible results

Active Publication Date: 2007-06-27
BEIJING WBL PEKING UNIV BIOTECH
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

With the increasing popularity of Xuezhikang Capsules, some counterfeit products have appeared on the market. These products seriously endanger people's lives and safety. However, the existing quality standards only use the determination of the content of a single ingredient lovastatin as an index, so it is difficult to distinguish counterfeit products.
In addition, a single content determination index cannot fully reflect and control the quality of preparations. In order to improve the quality standards of drugs, it is necessary to establish a quality detection method for drug fingerprints

Method used

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  • Method for detecting quality of blood fat recovery capsule
  • Method for detecting quality of blood fat recovery capsule
  • Method for detecting quality of blood fat recovery capsule

Examples

Experimental program
Comparison scheme
Effect test

experiment example

[0027] Experimental example Study on the quality detection method of Xuezhikang capsule fingerprint

[0028] 1. Preparation of the test solution

[0029] Xuezhikang capsule is the 75% ethanol extract of red yeast rice. Comparing the three extraction solvents of methanol, 75% ethanol and acetonitrile, the fingerprints of the three extracts are the same, but the color of the acetonitrile extract is much lighter. In the chromatogram, t R The dissolution of pigment components R The common fingerprint peaks > 10min are similar. In order to reduce column pollution and prolong column life, acetonitrile was used as the extraction solvent.

[0030] Compared with ultrasonic extraction and heating reflux extraction, the former method is simple and reproducible.

[0031] Comparing the chromatograms of ultrasonic extraction for 5min, 10min, and 20min, after 10min, the extraction rate of each substance in the fingerprint chromatogram did not change much, so the extraction time was determin...

Embodiment 1

[0055] Embodiment 1: Xuezhikang capsule quality detection method

[0056] Using fingerprint detection method:

[0057] Instrument used: Waters 600-996-717 high performance liquid chromatography (gradient lag time is 2.75min), Millennium 32 Chromatographic workstation; column: Apollo C 18 (4.6mm*250mm, 5μ) analytical column, TIANHE (P / N: TH0011, 5μ, C 18 ) guard column;

[0058] The method detects as follows:

[0059] Determine according to high performance liquid chromatography (Appendix VID of the Pharmacopoeia of the People's Republic of China), combined with fingerprint requirements;

[0060] Chromatographic conditions and system adaptability test, octadecylsilane bonded silica gel was used as filler; acetonitrile was used as mobile phase A, and 0.05% phosphoric acid was used as mobile phase B for gradient elution; detection wavelength was 256nm; column temperature was room temperature ;The flow rate is 1.0ml / min;

[0061] Preparation of the reference substance soluti...

Embodiment 2

[0065] Embodiment 2: Xuezhikang capsule quality detection method

[0066] Using fingerprint detection method:

[0067] Instrument used: Waters 600-996-717 high performance liquid chromatography (gradient lag time is 2.75min), Millennium 32 Chromatographic workstation; column: Apollo C 18 (4.6mm*250mm, 5μ) analytical column, TIANHE (P / N: TH0011, 5μ, C 18 ) guard column;

[0068] The method detects as follows:

[0069] Determine according to high performance liquid chromatography (Appendix VID of the Pharmacopoeia of the People's Republic of China), combined with fingerprint requirements;

[0070] Chromatographic conditions and system adaptability test, octadecylsilane bonded silica gel was used as filler; acetonitrile was used as mobile phase A, and 0.05% phosphoric acid was used as mobile phase B for gradient elution. The mobile phase gradient elution program was: 0 The volume ratio of mobile phase A increased linearly from 25% to 84% in ~45 minutes, and the volume ratio ...

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Abstract

The method includes following steps: using octadecylsilane chemically bonded silica as filler; using acetonitrile as mobile phase A, and 0.05% phosphoric acid as mobile phase B to carry out gradient elution; under condition of detection wavelength as 256nm, column temperature as room temperature, velocity of flow as 1.0ml / min, weighing up reference substance 1mg of rovastatin in 5ml volumetric flask, and adding constant volume of acetonitrile to scale so as to obtain solution of reference substance; taking content substance 0.3g of Xuezhikang capsule, adding acetonitrile 2ml, carrying out supersound extraction for 10-20min, using 0.45 micros microporous membrane to carry out filtering operation so as to obtain sample solution; mensuration according to high performance liquid chromatography; fingerprint of sample solution should possess good comparability to the referenced fingerprint, degree of similarity larger than 0.90. Features are: simple operation and good reproducibility.

Description

technical field [0001] The invention relates to a quality detection method of traditional Chinese medicine capsules, in particular to a fingerprint quality detection method of Xuezhikang capsules. Background technique [0002] Xuezhikang Capsules is a product with the functions of dehumidification and expectoration, promoting blood circulation and removing blood stasis, invigorating spleen and eliminating food, etc. It is also clinically used to treat hyperlipidemia and cardiovascular and cerebrovascular diseases caused by arteriosclerosis. With the increasing popularity of Xuezhikang Capsules, some counterfeit products have appeared on the market. These products seriously endanger people's lives and safety. However, the existing quality standards only use the content of a single ingredient, lovastatin, as an index, making it difficult to distinguish counterfeit products. In addition, a single content determination index cannot fully reflect and control the quality of prepa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34G01N30/86
Inventor 段震文马学敏郭树仁
Owner BEIJING WBL PEKING UNIV BIOTECH
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