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Method for establishing HPLC (high performance liquid chromatography) fingerprint graphic for ointment for unblocking collaterals and relieving pain as well as standard fingerprint graphic thereof

A technology of fingerprints and determination methods, which is applied in the field of determination of fingerprints of traditional Chinese medicines, and achieves the effects of good reproducibility, good specificity, and good coincidence

Active Publication Date: 2012-10-24
河南羚锐制药股份有限公司北京药物研究院 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

How to carry out quality control macroscopical quality control method to Tongluo Qutong ointment preparation from the whole and from a more macroscopical point of view has not been reported at present

Method used

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  • Method for establishing HPLC (high performance liquid chromatography) fingerprint graphic for ointment for unblocking collaterals and relieving pain as well as standard fingerprint graphic thereof
  • Method for establishing HPLC (high performance liquid chromatography) fingerprint graphic for ointment for unblocking collaterals and relieving pain as well as standard fingerprint graphic thereof
  • Method for establishing HPLC (high performance liquid chromatography) fingerprint graphic for ointment for unblocking collaterals and relieving pain as well as standard fingerprint graphic thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] 1. Preparation of the test solution: Take an appropriate amount of sample, use 100% methanol solution, ethanol, and 75% ethanol solution as the extraction solvent, ultrasonically extract for 0.5h, and filter the solution with a 0.45um filter membrane. Take the continued filtrate as the test solution for subsequent use.

[0060] 2. HPLC analysis conditions

[0061] Kromasil 100-5C 18 Analytical column (4.6mm×250mm, 5um); mobile phase: A is 0.2% phosphoric acid aqueous solution, B phase is methanol, flow rate is 1.0ml / min; detection wavelength is 220-300nm; column temperature is 30°C, injection 15ul.

[0062] The gradient elution program is as follows:

[0063]

[0064] 3. Determination: Precisely draw the test solution and inject it into the liquid chromatograph, measure according to high performance liquid chromatography, obtain the corresponding atlas, and obtain the HPLC atlas under the corresponding chromatographic conditions.

Embodiment 2

[0066] 1. Preparation of the test solution: Take an appropriate amount of sample, use 75% methanol solution, methanol, ethanol, and 75% ethanol solution as extraction solvents, reflux extraction for 1 hour, and filter the solution with a 0.45um filter membrane. Take the continued filtrate as the test solution for subsequent use.

[0067] 2. HPLC analysis conditions

[0068] Kromasil 100-5C 18 Analytical column (4.6mm×250mm, 5um); mobile phase: A is water, B phase is acetonitrile, flow rate is 1.0ml / min; detection wavelength is 220-300nm; column temperature is 30°C, injection 20ul.

[0069] The gradient elution program is as follows:

[0070]

[0071] 3. Determination: Precisely draw the test solution and inject it into the liquid chromatograph, measure according to high performance liquid chromatography, obtain the corresponding atlas, and obtain the HPLC atlas under the corresponding chromatographic conditions.

Embodiment 3

[0073] 1. Preparation of the test solution: Take an appropriate amount of sample, use 75% methanol solution, methanol, ethanol, and 75% ethanol solution as extraction solvents, reflux extraction for 2 hours, and filter the solution with a 0.45um filter membrane. Take the continued filtrate as the test solution for subsequent use.

[0074] 2. HPLC analysis conditions

[0075] Shiseido MG C 18 (4.6mm×250mm, 5um); mobile phase: phase A is a mixed aqueous solution of 0.2% phosphoric acid and 0.4% triethylamine (v / v), phase B is acetonitrile, and the flow rate is 1.0ml / min; the detection wavelength is 220-300nm; Temperature 30 ℃, inject 20ul.

[0076] The gradient elution program is as follows:

[0077]

[0078] 3. Determination: Precisely draw the solution of the test product and inject it into the liquid chromatograph, measure according to the high performance liquid chromatography, and obtain the corresponding atlas.

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Abstract

The invention relates to a method for measuring the HPLC (high performance liquid chromatography) fingerprint graphic of an ointment for unblocking collaterals and relieving pain, and discloses a method for establishing the HPLC fingerprint graphic for the finished product of the ointment for unblocking collaterals and relieving pain based on numerous experiments as well as the standard HPLC fingerprint graphic thereof. The method comprises the following steps: a sample solution for the finished product of the ointment for unblocking collaterals and relieving pain is prepared, and is put in atriangular flask with a plug; a methanol solution of 75 percent is used for water bath backflow, the sample solution is then filtered by a filter membrane of 0.45 um, and the sample size of the filter membrane is 10 microliters; gradient elution is adopted, the mobile phase A adopts an aqueous phosphoric acid solution or aqueous glacial acetic acid solution of 0.1 percent, the mobile phase B adopts an acetonitrile solution, the velocity of flow is 1.0 millilitres per minute, the detection wavelengths are 250 nm and 280 nm, and the column temperature is 30 DEG C; and the fingerprint graphic for the ointment for unblocking collaterals and relieving pain is obtained by measuring the sample solution according to the HPLC method. The repeatability of the fingerprint graphics measured by the method is high, so that the method can be used for measuring the chemical constituents in the ointment for unblocking collaterals and relieving pain, and can also be used for controlling the quality of the measured ointment for unblocking collaterals and relieving pain.

Description

technical field [0001] The invention relates to a method for measuring the fingerprints of traditional Chinese medicines, in particular to a method for measuring the chemical components of the Tongluo Qutong Ointment finished product by using a high-performance liquid chromatography (HPLC) fingerprint method. Background technique [0002] Osteoarthropathy and osteoproliferative disease can occur at any age, and the incidence of osteoarthropathy and hyperosteoplastic disease increases with age, most of which are middle-aged and elderly people over 40 years old. The incidence rate is high, the course of disease is long, and it is easy to relapse after treatment. Every year, many patients die because they did not receive good treatment, which is very sad. There are many treatment methods at present, the most common ones are drug therapy, physical therapy, traction massage, surgical treatment, external application of traditional Chinese medicine and so on. Oral medication caus...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88
Inventor 申桂芬聂红梅王岩熊维政张军兵武惠斌
Owner 河南羚锐制药股份有限公司北京药物研究院