Method for detecting dissolution rates of glucosamine hydrochloride preparation in different media

A technology of glucosamine hydrochloride and detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as interference with glucosamine hydrochloride peak detection, and achieve the effects of fast detection time, low requirements, and good accuracy

Active Publication Date: 2021-08-31
NANJING HEALTHNICE MEDICAL TECH +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when this detection method uses pH4.5 sodium acetate solution and pH6.8 phosphate solution as the dissolution medium to meas

Method used

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  • Method for detecting dissolution rates of glucosamine hydrochloride preparation in different media
  • Method for detecting dissolution rates of glucosamine hydrochloride preparation in different media
  • Method for detecting dissolution rates of glucosamine hydrochloride preparation in different media

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] Embodiment 1: Determination of high performance liquid chromatography conditions

[0081] (1) Take glucosamine hydrochloride tablets, refer to the dissolution rate and release rate determination method (the second method of the Chinese Pharmacopoeia 2020 Edition Four General Rules 0931), use 900ml of pH4.5 sodium acetate solution as the solvent, and the rotation speed is 50 rpm, according to the law Operation, take the eluate at 45min, filter it through a 0.45μm filter membrane, and take the subsequent filtrate as the test solution; in addition, accurately weigh an appropriate amount of glucosamine hydrochloride reference substance dried to constant weight, add dissolution medium to dissolve and dilute to make each 1ml A solution containing 0.8 mg of glucosamine hydrochloride in the medium was shaken up as a reference solution; according to the formula of the auxiliary materials in the glucosamine hydrochloride tablets, each auxiliary material without the main component ...

Embodiment 2

[0100] Embodiment 2: the linearity of glucosamine hydrochloride in medium pH4.5 sodium acetate solution, pH6.8 phosphate solution and water

[0101] Accurately weigh 42 mg of glucosamine hydrochloride reference substance (3 parallel portions), add medium pH 4.5 sodium acetate solution, pH 6.8 phosphate solution, water to dissolve and dilute to 10ml, shake well to obtain medium pH 4.5 sodium acetate solution, pH 6.8 phosphate solution, linear stock solution in water. Precisely pipette 0.16ml, 0.4ml, 1ml, 1.6ml, 2ml, and 2.4ml of the linear stock solution of each medium in sequence, put them in different 10ml measuring bottles, add medium to dilute to the mark, and shake well; the pH of the medium is 4.5 Sodium acetate, pH 6.8 phosphate solution, linear solution in water.

[0102] Analysis and detection method The analysis method described in step (1) in Example 1 was used for chromatographic detection.

[0103] Precisely measure 10 μl of the above-mentioned linear solution of...

Embodiment 3

[0107] Embodiment 3: the recovery rate of glucosamine hydrochloride in medium pH4.5 sodium acetate solution, pH6.8 phosphate solution, water

[0108] Take an appropriate amount of glucosamine hydrochloride reference substance (6 parts in parallel), accurately weighed, add medium pH4.5 sodium acetate, pH6.8 phosphate solution, water to dissolve and dilute to make about 0.8mg of glucosamine hydrochloride in every 1ml solution, each medium in parallel in 2 parts.

[0109] Accurately weigh about 1042mg of glucosamine hydrochloride (3 parallel portions), add medium pH 4.5 sodium acetate, pH 6.8 phosphate solution, water to dissolve and dilute to 50ml, as the stock solution of each medium.

[0110]10% limit: Weigh an appropriate amount of auxiliary materials, put them in a 50ml measuring bottle, precisely pipette 0.2ml of the stock solution, add medium to dissolve and dilute to the mark, shake well, filter, and take the subsequent filtrate; each medium is paralleled in 3 copies.

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Abstract

The invention relates to a method for detecting the dissolution rates of a glucosamine hydrochloride preparation. Isocratic elution is carried out by taking a monopotassium phosphate buffer solution-acetonitrile containing a positive ion pair reagent (tetrabutylammonium hydroxide, tetrabutylammonium hydrogen sulfate or tetrabutylammonium bromide) as a mixed mobile phase, and the proportion of the mixed mobile phase is optimized; during chromatographic analysis, the retention time of the main peak of the glucosamine hydrochloride on a chromatographic column (such as a C8 column) is prolonged, the main peak is prevented from being interfered by a dissolution medium and an auxiliary material solution, the reproducibility is good, and the sensitivity is high. By adopting the dissolution rate detection method provided by the invention, the requirement on a chromatographic column is low in the chromatographic analysis process, an amino column is not needed, a pre-column derivatization reaction is not needed, the method can adapt to the accurate determination of the dissolution rates of the glucosamine hydrochloride preparation in different dissolution media, the interference of a blank solvent and auxiliary materials is eliminated, and the method has the advantages of simple operation, high sensitivity, low cost, good reproducibility, high accuracy and wide application range.

Description

technical field [0001] The invention belongs to the field of analysis and detection of pharmaceutical preparations, in particular to a method for detecting the dissolution rate of glucosamine hydrochloride preparations in different media. Background technique [0002] Glucosamine is a natural amino monosaccharide extracted from crustacean shells, and is an important structural component of glycosaminoglycans and hyaluronic acid. It is a very special drug, which belongs to both medicine and health care product. Because glucosamine belongs to biological extraction and has less side effects, it is directly sold as food or health care products abroad; also because it has a good therapeutic effect on osteoarthritis, it was first declared as a drug in Italy in the 1980s. In China, glucosamine is declared as an essential drug in the form of hydrochloride or sulfate. [0003] In the quality control of oral tablets of drugs, checking the dissolution rate of oral tablets is an essen...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8675G01N2030/047
Inventor 陈永红云邱王兰花薛亚军王华娟
Owner NANJING HEALTHNICE MEDICAL TECH
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