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Content determination method of deoxycholic acid injection

A technology of deoxycholic acid and a determination method, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems such as few reports on the content determination method of deoxycholic acid injection, and achieve the advantages of good quality of medicine and high accuracy. , good quantitative ability

Pending Publication Date: 2022-03-04
NANJING MINOVA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The quality control of pharmaceutical preparations has always been an important and difficult point in the process of drug development. At present, there are few reports on the content determination method of deoxycholic acid injection.

Method used

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  • Content determination method of deoxycholic acid injection
  • Content determination method of deoxycholic acid injection
  • Content determination method of deoxycholic acid injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] The drug content assay method of the deoxycholic acid injection of the present invention of embodiment 1

[0090] 1. Instruments and analysis conditions

[0091] High performance liquid chromatography (Waters e2695), electrospray detector (model Corona Veo), chromatographic column is Agilent Pursuit C18, 3 μ m, 4.6 * 150mm, mobile phase A is 0.1% formic acid aqueous solution, and mobile phase B is 0.1% formic acid acetonitrile Solution, the elution condition is A phase: B phase = 35:65 isocratic elution, column temperature 35°C, flow rate 1.0ml / min, injection volume 25μl, electrospray detector parameters: T = 35°C, acquisition frequency 10HZ, filter=5.0s, injector temperature 5°C, running time 9 minutes.

[0092] 2. Preparation of solvent, standard solution and test solution

[0093] Solvent: the solvents described in the present invention are all 80% methanol solution, measure 800ml methanol and 200ml water respectively with a graduated cylinder, mix them with ultras...

Embodiment 2

[0116] Embodiment 2 The system suitability investigation test of assay method of the present invention

[0117] The purpose of this experiment is to confirm whether the content test method in Example 1 meets the requirements of system applicability. The acceptance criteria for the system applicability investigation experiment is: the RSD of the deoxycholic acid peak area of ​​6-pin standard solution 2 should be ≤ 3.0%, the RSD of the retention time should be ≤1.0%, and the deoxycholic acid peak tailing factor of the first injection of standard solution 2 should be ≤1.8.

[0118] 1. Instrument and analysis conditions: with embodiment 1.

[0119] 2. Solution preparation: prepare the standard solution and the test solution with reference to the method of Example 1.

[0120] 3. Experimental process:

[0121] Take 25 μl of the solvent, inject it into the high-performance liquid chromatograph, and record the chromatogram. The solvent should have no interference. Take 25 μl of sta...

Embodiment 3

[0125] The specificity investigation of embodiment 3 assay method of the present invention

[0126] The purpose of this experiment is to verify that the content determination method of the present invention can completely separate deoxycholic acid peaks from all known impurities and potential impurities, and that the content test is not interfered by impurity peaks, so as to prove that the content test method of the present invention has good specificity.

[0127] 1. Instrument and analysis condition are with embodiment 1.

[0128] 2. Solution preparation

[0129] Excipient blank solution: accurately measure 5.0ml of placebo, put it in a 50ml measuring bottle, add solvent to dilute to the mark, shake well, precisely measure 1.0ml of the above solution, put it in a 100ml measuring bottle, add solvent to dilute to the mark, shake well, Instantly.

[0130] Undamaged sample: Accurately measure 5.0ml of deoxycholic acid injection, put it in a 50ml measuring bottle, add solvent to...

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Abstract

The invention provides a method for determining the drug content of deoxycholic acid injection, which is simple, convenient, rapid and accurate to operate, and comprises the following steps: a) dissolving a deoxycholic acid standard substance in a solvent to prepare a deoxycholic acid standard substance solution with gradient concentration distribution of 8g / ml-12g / ml, the concentration of each standard substance solution being Xi; b) under normal pressure, determining the peak area Yi of each standard substance solution by adopting a high performance liquid chromatography analysis method; c) performing linear regression by applying a least square method, and establishing a mathematical relationship between the peak area and the concentration of the standard substance solution, namely Y = kX + b; d) under normal pressure, determining the peak area A of the deoxycholic acid test solution to be detected by adopting a high performance liquid chromatography method; and e) calculating the drug concentration and drug content of the to-be-detected deoxycholic acid injection according to the following formula by using the mathematical relationship in the step c).

Description

technical field [0001] The invention relates to the field of organic chemical analysis, in particular to a method for determining the content of deoxycholic acid injection. Background technique [0002] With the improvement of my country's per capita disposable income and consumption level, people's demand for medical cosmetology is also increasing. From a cosmetic point of view, fat deposition in parts of the body is aesthetically pleasing, especially on the face. For example, having a double chin or deep cheeks can make the face appear larger. In order to overcome this problem, exercise programs and diet control programs aimed at reducing fat have emerged in an endless stream, but the effect is limited. [0003] At present, the main means of effectively removing submental fat (double chin) include surgical treatment including liposuction, liposuction, and liposuction incision. However, surgical treatments are limited in that they take several weeks to heal, longer in so...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/88
CPCG01N30/02G01N30/06G01N30/88G01N2030/884G01N2030/027
Inventor 刘智慧周春燕卢月月
Owner NANJING MINOVA PHARM CO LTD
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