A kind of assay method of sodium oleate content in dry emulsion for injection

A determination method and dry emulsion technology, which are applied in the field of determination of sodium oleate content in dry emulsion for injection, can solve problems such as difficulty in separation and detection, and achieve the effects of sensitive and low-cost determination methods

Active Publication Date: 2019-06-14
ZHEJIANG SUNDOC PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Sodium fatty acid in sodium oleate has a variety of compositions and similar carbon chain lengths, and sodium oleate is the main component. It is difficult to separate the content of sodium oleate in dry emulsion by using the existing detection methods for oleic acid and linoleic acid. Testing requirements

Method used

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  • A kind of assay method of sodium oleate content in dry emulsion for injection
  • A kind of assay method of sodium oleate content in dry emulsion for injection
  • A kind of assay method of sodium oleate content in dry emulsion for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1 The establishment process of this method

[0032] Experimental materials, instruments and chromatographic conditions

[0033] Sodium oleate supplementary material was purchased from Xi'an Libang Pharmaceutical Co., Ltd., and the oleic acid content in COA was 82.8% (gas chromatography), and the oleic acid reference substance was purchased from China Food and Drug Control Research Institute, and the content was 99.6%.

[0034] High performance liquid chromatography Waters e2695, the detector is UV detector; the chromatographic column is ZORBAX SB C8, 4.6mm*150mm, 5μm; column temperature: 40℃; detection wavelength is 210nm; injection volume: 60μl; flow rate: 1.0ml / min; mobile phase: 0.02M potassium dihydrogen phosphate buffer (pH=2.0)-acetonitrile gradient elution; MPA: 0.02M potassium dihydrogen phosphate buffer (pH=2.0), MPB: acetonitrile, MPA-MPB gradient elution Take off:

[0035] Elution condition:

[0036]

[0037] Experimental procedure

[0038]...

Embodiment 2

[0043] Experimental materials, instruments and chromatographic conditions

[0044] Alprostadil dry emulsion for injection, wherein the input amount of sodium oleate auxiliary material is 0.2mg / 250mg, sodium oleate auxiliary material is purchased from Xi'an Libang Pharmaceutical Co., Ltd., oleic acid reference substance is purchased from China Institute for Food and Drug Control, and the content is 99.6%.

[0045] Chromatographic condition is identical with embodiment 1

[0046] Experimental procedure

[0047] Take about 250mg of alprostadil dry emulsion powder for injection, accurately weigh it, put it in a volumetric flask, add 2.0ml of water, re-emulsion, add ethanol to make the volume to 5.0ml, shake for 2min, ultrasonic for 2.0min, and stand at room temperature After 30 minutes, an appropriate amount (2 mL) of the solution was centrifuged (15000 rpm, 15 minutes), and the supernatant was injected. Get an appropriate amount of oleic acid reference substance, dissolve and ...

Embodiment 3

[0050] Experimental materials, instruments and chromatographic conditions

[0051] Alprostadil blank dry emulsion for injection (without sodium oleate auxiliary material, other components are dosed according to the proportion of the formulation prescription), and the oleic acid reference substance was purchased from China National Institute for Food and Drug Control, with a content of 99.6%.

[0052] Chromatographic condition is identical with embodiment 1

[0053] Experimental procedure

[0054] Take about 250mg of the blank dry emulsion powder of alprostadil for injection, place it in a volumetric flask, add 2.0ml of water, re-emulsion, add ethanol to make the volume to 5.0ml, shake for 2min, ultrasonic for 2.0min, stand at room temperature Set aside for 30min, take an appropriate amount (2mL) of the solution and centrifuge (15000rpm, 15min), and take the supernatant to obtain the blank dry emulsion sample solution of alprostadil for injection.

[0055] Take an appropriate a...

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Abstract

The invention discloses a determination method of sodium oleate content in an injection use dry emulsion. The method comprises the steps that an HPLC method is adopted to separate oleic acid and other components, the oleic acid content is determined according to an external standard method, and based on the relation between the oleic acid and molecular weight of sodium oleate, the sodium oleate content in the dry emulsion is calculated. The determination method is sensitive, accurate, exclusive, efficient, convenient and low in cost.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for determining the content of sodium oleate in dry emulsion for injection. Background technique [0002] Sodium oleate is a commonly used excipient in dry emulsion for injection. It belongs to a mixture with complex and diverse ingredients. Its main component is sodium oleate. The values ​​are similar. [0003] The sodium oleate adjuvant standard recorded in "Chinese Pharmacopoeia" (2015 edition) and the method for detecting content in the import registration standard all adopt gas chromatography (area normalization method), and the sodium oleate adjuvant and the sodium oleate reference substance are both It should be pre-treated by methyl esterification, the operation steps are cumbersome, and the area normalization method is relatively rough in quantification. [0004] The sodium oleate excipient in the dry emulsion for injection is used as a pH adjuster, and the amount...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 王艳娟周华陈艳霞李深正
Owner ZHEJIANG SUNDOC PHARMA SCI & TECH CO LTD
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