A kind of determination method of dissolution rate of pharmaceutical preparation containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate

A technology of dextromethorphan hydrobromide and doxylamine succinate, applied in the field of medicine, achieves the effects of good accuracy and reproducibility, saving detection cost and saving detection time

Active Publication Date: 2022-08-09
安士制药(中山)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In the prior art, there is no method that can effectively simulate the dissolution behavior in vivo and determine the dissolution rate of soft capsules containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate

Method used

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  • A kind of determination method of dissolution rate of pharmaceutical preparation containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate
  • A kind of determination method of dissolution rate of pharmaceutical preparation containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate
  • A kind of determination method of dissolution rate of pharmaceutical preparation containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate

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Experimental program
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Effect test

experiment example

[0077] experimental method:

[0078] The dissolution assay method of the soft capsule containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate, it comprises the steps:

[0079] (a) The dissolution medium is placed in a water bath, preheated to 41°C, and degassed by vacuum filtration for 10 minutes;

[0080] (b) 900 mL of the degassed dissolution medium was added to the dissolution vessel, and the temperature was kept at 37°C;

[0081] (c) drop the soft capsule containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate into the dissolution vessel;

[0082] (d) running the dissolution apparatus, the rotation speed is set to 100rpm / min, at 45min, take 10mL of the dissolution solution, filter, and take the subsequent filtrate as the dissolution solution;

[0083] (e) adopt the HPLC method to measure the content of acetaminophen, dextromethorphan hydrobromide and doxylamine succinate in the leaching solution; chromatographic conditions in...

experiment example 1

[0100] In this experimental example, a variety of dissolution media were compared to determine the optimal dissolution media. Specifically, purified water, 0.1N HCl solution, acetate buffer with pH=4.5, and phosphate buffer with pH=6.8 were used as dissolution media, and different dissolution media were used to determine the content of acetaminophen according to the operation of the above experimental method. Dissolution of soft capsules of phenol, dextromethorphan hydrobromide, and doxylamine succinate, the results are as follows Figures 2 to 4 and Tables 1 to 4.

[0101] Table 1 Dissolution with purified water as the dissolution medium

[0102]

[0103]

[0104] Table 2 The dissolution rate of 0.1N HCl solution as the dissolution medium

[0105]

[0106]

[0107] Table 3 dissolution medium is pH=4.5 dissolution rate of acetate buffer

[0108]

[0109]

[0110] Table 4. The dissolution medium is the dissolution rate of pH=6.8 phosphate buffer

[0111] ...

experiment example 2

[0115] In this experimental example, different rotational speeds are compared to determine the optimal rotational speed. According to the operation of the above-mentioned experimental method, the dissolution rate of the soft capsules containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate was measured at different rotational speeds (50 rpm / min and 100 rpm / min), and the results are as follows Figures 5 to 7 and Tables 5-6.

[0116] Table 5 Dissolution at 50 rpm / min

[0117]

[0118]

[0119]Table 6 Dissolution at 100 rpm / min

[0120]

[0121] It can be seen from the above determination results that the soft capsules containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate have better dissolution effect under the condition of 100rpm / min.

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Abstract

The invention discloses a method for determining the dissolution rate of a pharmaceutical preparation containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate. The steps are as follows: (1) The pharmaceutical preparations of dextromethorphan and doxylamine succinate are added to the dissolution medium for dissolution treatment, sampling and filtration to obtain a dissolution liquid; (2) Detecting paracetamol, dextromethorphan hydrobromide and succinate in the dissolution liquid content of doxylamine acid; (3) determining the dissolution rate of the pharmaceutical preparation according to the detection result of step (2). The invention can effectively simulate the dissolution behavior in vivo in vitro, determine the dissolution rate of soft capsules containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate, and provide technical support for drug research and development and quality control . The invention can simultaneously measure the dissolution results of the three substances under the same condition, greatly saves the detection time and the detection cost, and has good accuracy and reproducibility.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for measuring the dissolution rate of a pharmaceutical preparation containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate. Background technique [0002] Cold as a common respiratory disease, its main symptoms are: headache, fever, cough, nasal congestion, runny nose, allergies and so on. Medications commonly used to treat these symptoms include: antipyretic analgesics (acetaminophen), antitussives (dextromethorphan hydrobromide), antihistamines (doxylamine succinate). [0003] The soft capsule containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate is a compound oral solid preparation made of gelatin, and its preparation method is as described in Chinese patent 201310359375.2. Research still needs to be improved. There is no method in the prior art that can effectively simulate the dissolution behavior in vivo and determi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/027G01N2030/062
Inventor 李海燕
Owner 安士制药(中山)有限公司
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