Method for detecting vitamin D content in vitamin D drop

A vitamin and drops technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of cumbersome, low inspection efficiency, and no literature and patent reports on the rapid detection of vitamin D drops have been found, and achieves high analysis efficiency. Sensitive, accurate, qualitative, stable and reproducible results

Active Publication Date: 2016-03-02
SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, the detection methods of vitamin D drops recorded in the United States Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia and Chinese Pharmacopoeia are quite cumb

Method used

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  • Method for detecting vitamin D content in vitamin D drop
  • Method for detecting vitamin D content in vitamin D drop
  • Method for detecting vitamin D content in vitamin D drop

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1, vitamin D in vitamin D drops 3 Assay

[0027] The instrument uses Agilent1200 high performance liquid chromatography; METTLERXP205 electronic balance.

[0028] The material is the vitamin D drops produced by the soft capsule workshop of our company.

[0029] Vitamin D 3 The reference substance was purchased from China National Institute for the Control of Pharmaceutical and Biological Products, the batch number is 100061-201208;

[0030] n-Hexane is chromatographically pure;

[0031] Other reagents are analytically pure.

[0032] 1. Preparation of the test solution

[0033] Precisely measure about 720mg (containing 20μg vitamin D 3 ) vitamin D drops content, put in 20mL brown volumetric flask, add normal hexane to dissolve, constant volume, shake up and promptly need testing solution.

[0034] A total of two test products were set; wherein, the sample size of test product 1 was 719.5 mg; the sample size of test product 2 was 720.3 mg;

[0035] Seco...

Embodiment 2

[0063] Embodiment 2, linearity test

[0064] 1. Prepare a series of different concentrations of vitamin D 3 Reference solution

[0065] Precise Measures of Vitamin D 3 Put 0.6, 0.8, 1.0, 1.2, 1.4 μL of the reference solution (20μg / ml) into 20ml brown measuring bottles respectively, add n-hexane to dilute to the mark and shake well to get vitamin D 3 Reference substance solution.

[0066] 2. Vitamin D 3 The reference substance solution is detected by HPLC, and the detection conditions are as follows:

[0067] The stationary phase of the chromatographic column used is silica gel, and the particle size of the silica gel is 3-10 μm; the column height is 100 mm, and the inner diameter is 4.6 mm;

[0068] The injection volume is 100 μL;

[0069] The mobile phase is a mixed solution composed of n-hexane and Virahol with a volume ratio of 995:5;

[0070] The flow rate is 1.5mL / min;

[0071] The column temperature is 30°C;

[0072] The detection wavelength is 265nm;

[0073] ...

experiment example 3

[0080] Experimental example 3, specificity test

[0081] 1. Preparation of the test solution

[0082] With embodiment 1;

[0083] Second, the preparation of vitamin D 3 Reference solution

[0084] Accurately weigh 10mg vitamin D 3 For the reference substance, put it in a 100mL brown volumetric flask, add n-hexane to dissolve, constant volume, and shake well to get vitamin D 3 The stock solution of the reference substance, and then accurately measure 1mL of the stock solution into a 100mL brown volumetric flask, add n-hexane to dilute to the volume, and shake well to obtain vitamin D 3 Reference substance solution.

[0085] 3. Vitamin D in the test solution and the negative control solution 3 Determination of content

[0086] For the above test solution, vitamin D 3 The reference substance solution and the negative control solution were subjected to chromatographic analysis, and the chromatogram was shown in Figure 4 , 3 , 5, indicating that the negative control solu...

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Abstract

The present invention discloses a method for detecting the vitamin D content in a vitamin D drop. According to the present invention, through a large number of optimizations, the optimal mobile phase composition, the optimal flow rate, the optimal detection wavelength, the optimal chromatography column and other analysis conditions are obtained, and the multiple experiment results show that the method has characteristics of good stability, good repeatability, high analysis efficiency and good separation, and can sensitively and accurately perform qualitative and quantitative detection on the vitamin D3, such that the quality of the vitamin D drop can be objectively, completely and accurately evaluated, and the important significance can be provided for the vitamin D drop quality control and the clinical treatment effect ensuring.

Description

technical field [0001] The method belongs to the technical field of drug analysis and relates to a method for detecting vitamin D content in vitamin D drops. Background technique [0002] Vitamin D drops are a medicine for the prevention and treatment of rickets in children. After a lot of evidence-based medical research and basic research, it has been found that vitamin D drops have a certain curative effect on the treatment of cancer, hypertension, diabetes, tuberculosis, and abnormal immune function. At present, the detection methods of vitamin D drops recorded in the United States Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia and Chinese Pharmacopoeia are quite cumbersome and the detection efficiency is low. After domestic and foreign literature and patent searches, no literature and patent reports on the rapid detection of vitamin D drops content have been found. Contents of the invention [0003] The purpose of the present invention is to provide a m...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 陶元景胡醒解春文王凤英
Owner SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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