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Test method of isotretinoin soft shell capsules

A test method, tretinoin technology, applied in the direction of testing pharmaceutical preparations, measuring devices, color/spectral characteristics measurement, etc., can solve the problem of dissolution testing, stability, anti-oxidation, and anti-corrosion. , There are no clear detection methods and measurement standards, etc., to achieve the effect of improving quality standards and great practical value

Inactive Publication Date: 2007-10-31
SHANGHAI SINE WANXIANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the test items recorded in the Pharmacopoeia only perform qualitative or quantitative tests on the active raw materials of the drug itself, and the pharmaceutical excipients used have no clear effect on drug stability (such as anti-oxidation, antiseptic, etc.) during the storage period. Therefore, there is no clear detection method and measurement standard for the effectiveness of the use of antioxidants and preservatives in this product
[0004] In addition, the Chinese Pharmacopoeia and the United States Pharmacopoeia currently record the quality standards of soft capsules, which do not include the dissolution test

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0030] Example 1 Dissolution test experimental steps:

[0031] Experimental equipment: Shimadzu UV spectrophotometer

[0032] Experimental reference substance: isotretinoin reference substance

[0033] Experimental samples: 6 capsules of isotretinoin capsules produced by our company

[0034] Experimental reagents: dichloromethane, n-hexane, NaOH, HCl, etc.

[0035] Method 1: Take 6 isotretinoin soft capsules, use the device under the disintegration time limit determination method, put 1 capsule in each cup; use 900ml 0.1NHCl as the medium; test temperature is 37.0℃±1℃; after 40 minutes, immediately Take 20ml of the eluate, filter it through a 0.45um membrane, and cool to room temperature. Accurately measure 5ml of the filtrate, dilute it with 0.1mol / L HCl to 25ml (10mg specification); accurately measure 5ml of the follow-up filtrate, dilute it with 0.1mol / L HCl to 50ml (20mg specification);

[0036] Control solution: Accurately weigh 10 mg of is...

example 2

[0041] Example 2 Antioxidant tert-butyl p-hydroxyanisole identification test test procedure:

[0042] Experimental instrument: Shimadzu gas chromatograph

[0043] Experimental reference substance: Antioxidant tert-butyl p-hydroxyanisole reference substance 40mg

[0044] Experimental samples: 20 capsules of isotretinoin capsules produced by our company

[0045] Experimental reagents: methanol, ethanol, n-hexane, etc.

[0046] Method 1: Preparation of the test sample: Take 20 samples, cut them open, take the contents into a glass container with a measuring tool, add 15ml of methanol, dissolve and centrifuge by ultrasonic, let it stand still, take the supernatant, and get it.

[0047] Chromatographic system: Chromatographic column type DB-1 (0.25mm*30m*0.25μm)

[0048] Temperature program: first stage: 100°C for 4 minutes

[0049] The second stage: 100℃~200℃ heating rate is 30℃ / s

[0050] The third stage: keep at 200°C for 5 mi...

example 3

[0069] Method is the same as example 2, and antioxidant is replaced by 2.6-di-tert-butyl p-cresol.

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PUM

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Abstract

This invention provides one different dimensional A acid capsule solvent degree and its anti-oxidant and antiseptic identification method, which improves the capsule quality standard helpful for monitor product initial period and effective storage period with large application value.

Description

Technical field: [0001] The invention belongs to the technical field of drug detection. It specifically relates to the dissolution rate of isotretinoin soft capsules and the identification test method of antioxidants and preservatives therein. Background technique: [0002] The currently implemented quality standards for Isotretinoin Soft Capsules are: the current edition of the Chinese Pharmacopoeia (Chinese Pharmacopoeia 2005 Edition, Part II P216), and the testing items are: traits, identification, content, content uniformity, disintegration, microbial limit control, etc.; The current version of the United States Pharmacopoeia, the testing items are: traits, identification, content, content uniformity, disintegration, related impurities, microbial limit control, etc. [0003] Because isotretinoin is an active raw material with extremely unstable properties, it is easily denatured when exposed to light, heat, and air. Therefore, through a special process and adding certa...

Claims

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Application Information

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IPC IPC(8): G01N33/15G01N21/31G01N30/02
Inventor 朱海芒
Owner SHANGHAI SINE WANXIANG PHARMA
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