Method for detecting phthalate plasticizer in inner packing material of medicine

A phthalic acid and detection method technology, which is applied in the field of detection of phthalate plasticizers in drug inner packaging materials, can solve the problems of inability to distinguish plasticizer types, activated carbon adsorption weight gain, poor controllability of results, etc. problems, to achieve the effect of short measurement period, avoiding equipment damage, and accurate and reliable results

Inactive Publication Date: 2016-02-03
YICHANG HEC CHANGJIANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] 2. Activated carbon adsorption increases weight after high temperature and high pressure volatilization; organic solvent extraction and evaporation to dryness to determine residue; both belong to gravimetric method, the biggest defect of this method is poor specificity, it is impossible to distinguish the type of plasticizer in the sample, and the operation cycle is long , resulting in poor controllability

Method used

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  • Method for detecting phthalate plasticizer in inner packing material of medicine
  • Method for detecting phthalate plasticizer in inner packing material of medicine
  • Method for detecting phthalate plasticizer in inner packing material of medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Determination of plasticizer residues in coating powder:

[0027] Weigh about 0.1g of the coating powder into a 100ml measuring bottle, add an appropriate amount of methanol, heat in a water bath at 80°C and shake continuously for 30 minutes, take it out and let it cool, then dilute to the mark, filter through a filter membrane, and take the subsequent filtrate as the test In addition, weigh about 50mg of DMP, DEP, and DBP in a 50ml measuring bottle, add methanol solvent and dilute to the mark, as the control solution 1; weigh about 50mg of DEHP in a 50ml measuring bottle, add methanol solvent and dilute to Scale, as the control solution 2.

[0028] The chromatographic conditions are as follows: DMP, DEP, DBP, and DEHP all use methanol-water system. Because the polarities of the four plasticizers are too different, two elution methods are used: the first three (DMP, DEP, DBP) Measured under one system, DEHP adopts a strong elution system.

[0029] The detection operat...

Embodiment 2

[0041] Determination of plasticizer residues in granule inner packaging, hard capsules or PVC hard tablets

[0042] Weigh about 5g of granule inner packaging, hard capsule, and PVC hard sheet, cut into pieces, wash with water, dry and place in a 250ml Erlenmeyer flask, add 100ml of methanol, seal, and place in an autoclave (121°C) for treatment 30min, take it out, and take the supernatant as the test solution; weigh about 50mg each of DMP, DEP, and DBP in a 50ml measuring bottle, add methanol solvent and dilute to the mark, as the control solution 1; weigh about 50mg of DEHP in In a 50ml measuring bottle, add methanol solvent and dilute to the mark as the control solution 2.

[0043] The chromatographic conditions are as follows: DMP, DEP, DBP, and DEHP all use methanol-water system. Because the polarities of the four plasticizers are too different, two elution methods are used: the first three (DMP, DEP, DBP) Measured under one system, DEHP adopts a strong elution system.

...

example 3

[0054] Example 3 is to ensure the scientificity and accuracy of the assay method in the actual application process, and comprehensively verify the DMP, DEP, DBP, DEHP residue assay methods in the laboratory, and the verification results are as follows:

[0055]

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Abstract

The invention provides a method for detecting a phthalate plasticizer in an inner packing material of medicine. The method comprises the following steps: weighing the inner packing material of medicine in a measuring flask, adding methanol for dilution, filtering with a filter membrane, and taking a subsequent filtrate as liquid for testing; respectively weighing dimethyl phthalate, diethyl phthalate and dibutyl phthalate in a measuring flask, adding a methanol solvent to a scale for dilution, and taking a solution as a contrast liquid 1; weighing dioctyl phthalate in a measuring flask, adding a methanol solvent to a scale for dilution, and taking a solution as a contrast liquid 2; injecting the liquid for testing, the contrast liquid 1 and the contrast liquid 2 in order for detection by a HPLC, and finishing the detection of the phthalate plasticizer in the inner packing material of medicine. The method can be used for distinguishing whether a plasticizer component is added into the common packing materials of medicines, and an accurate quantitative analysis is carried out, so that product quality which is influenced by migration of plasticizer components of medicine coating powder and packing materials to medicine is controlled.

Description

technical field [0001] The present invention relates to the inspection method of the phthalate ester plasticizer of medicine internal packing material, specifically the diethyl phthalate ( Phthalate plasticizers of DEP), dimethyl phthalate (DMP), dibutyl phthalate (DBP) or bis(2-ethylhexyl) phthalate (DEHP) The method of measuring the agent. technical background [0002] Plasticizer, also known as plasticizer (Taiwan Chinese, is the plasticizer in mainland Chinese). It is a polymer material additive widely used in industry. Adding this substance in plastic processing can make it more flexible, easy to process, and can be legally used for industrial purposes. Since May 2011, six phthalate plasticizers including DEHP, DINP, DNOP, DBP, DMP, and DEP have been detected in food in Taiwan, and DIDP has been detected in medicines. [0003] Almost all brands of cooking oil in plastic barrels contain two plasticizers, "dibutyl phthalate (DBP)" and "dioctyl phthalate (DOP)". [000...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 彭元丽李芳
Owner YICHANG HEC CHANGJIANG PHARMA CO LTD
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