Method for measuring oxygen penetration of hollow capsule

A hollow-capsule, oxygen-permeable technology, applied in measuring devices, color/spectral property measurement, instruments, etc., can solve the problem of not being suitable for the detection of oxygen-permeability performance of hollow capsules, and achieve a flexible and simple method to ensure activity, quality, and method. Effect

Inactive Publication Date: 2018-12-18
JIANGSU LEFAN CAPSULE
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  • Application Information

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Problems solved by technology

[0003] Existing oxygen permeability test methods and devices are basically aimed at corneal repair materials, artificial corneas and other materials that contact the eyes. For example, patent application No. 201610408054.0 discloses an oxygen permeability test device and an oxygen permeability test method. The method adopts a relatively complicated test device, which is not suitable for the oxygen permeability test of hollow capsules.

Method used

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  • Method for measuring oxygen penetration of hollow capsule
  • Method for measuring oxygen penetration of hollow capsule
  • Method for measuring oxygen penetration of hollow capsule

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Embodiment 1

[0022] The mensuration of embodiment 1 hypromellose hollow capsule oxygen transmission rate

[0023] A method for measuring the oxygen transmission rate of hollow capsules, comprising the following steps:

[0024] Step 1, take a batch of hypromellose hollow capsules (batch number H217040N022), and randomly select 6 capsules;

[0025] Step 2: Accurately weigh six portions of 250 mg ascorbic acid, fill them into the hollow capsules taken out in step 1, place them in a drug stability test box at 40°C±2°C, 75%±5%, and take them out after 7 days;

[0026] Step 3, take out two samples, open the capsule, weigh 0.050±0.0003g of the contents (accurately weighed) in a suitable container, add an appropriate amount of 0.005mol / L sulfuric acid solution to dissolve, put it in a 100ml volumetric flask, and use Dilute 0.005mol / L sulfuric acid solution to the mark, shake well; accurately measure 1ml in a 100ml volumetric flask, dilute it to 100ml with 0.005mol / L sulfuric acid solution, as the...

Embodiment 2

[0034] The method validation of embodiment 2 gelatin hollow capsule oxygen transmission rate measurement

[0035] 1. Preparation of reference solution: Weigh 0.050±0.0003g of ascorbic acid (accurately weighed), put it in a suitable container, add an appropriate amount of 0.005mol / L sulfuric acid solution to dissolve it, put it in a 100ml volumetric flask, and add 0.005mol / L sulfuric acid Dilute the solution to the mark and shake well. Precisely measure 1ml into a 100ml volumetric flask, dilute to the mark with 0.005mol / L sulfuric acid solution, shake well, and you get it;

[0036] 2. Preparation of the test solution: Precisely weigh 250 mg of ascorbic acid, fill it into hollow capsules, put it in a 40°C ± 2°C, 75% ± 5% drug stability test box, and take it out after 7 days. Take the sample after 7 days of acceleration in the stability test box, open the capsule, accurately weigh the content of ascorbic acid 0.050±0.0003g, put it in a suitable container, add an appropriate amou...

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Abstract

The invention discloses a method for measuring oxygen penetration of a hollow capsule. The method comprises the following steps of precisely weighing ascorbic acid and filling into a to-be-measured hollow capsule; placing the filled sample in a drug stability test box, wherein the test conditions are 40 DEG C + / -2 DEG C, 75% + / -5% and 7 days for placement; determining the amount of the ascorbic acid by adopting an ultraviolet spectrophotometry or a high performance liquid chromatography method, and working out the oxygen permeation amount. Compared with the prior art, the method for measuringthe oxygen permeability of the hollow capsule is flexible and convenient and quick, a special device is not needed, and each hollow capsule can be tested, so that the oxygen permeation quantity of thehollow capsule is effectively ensured within a specified range, the quality of the hollow capsule is greatly guaranteed, and the activity of the medicine is effectively ensured.

Description

technical field [0001] The invention relates to analysis, measurement and control technology, in particular to a method for measuring the oxygen transmission rate of hollow capsules, which belongs to the technical field of medical capsules. Background technique [0002] Oxygen permeability is one of the important parameters of hollow capsules. Oxygen may cause some drugs to oxidize and deteriorate. Therefore, the oxygen permeability of hollow capsules directly affects the safety and stability of drugs. The hollow capsule with low oxygen permeability can protect the inner filling from oxidation, prolong the storage period and improve the stability of the drug. Therefore, it is particularly important to monitor the oxygen transmission rate of hollow capsules. [0003] Existing oxygen permeability test methods and devices are basically aimed at corneal repair materials, artificial corneas and other materials that contact the eyes. For example, patent application No. 2016104080...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/33G01N30/02
CPCG01N21/33G01N30/02
Inventor 陈思宇王飞潘恒
Owner JIANGSU LEFAN CAPSULE
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