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Method for determining dissolution rate of medicinal preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate

A technology of dextromethorphan hydrobromide and doxylamine succinate, which is applied in the field of medicine to achieve the effects of good accuracy and reproducibility, saving testing costs and saving testing time

Active Publication Date: 2019-09-27
安士制药(中山)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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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  • Method for determining dissolution rate of medicinal preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate
  • Method for determining dissolution rate of medicinal preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate
  • Method for determining dissolution rate of medicinal preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate

Examples

Experimental program
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Effect test

experiment example

[0077] experimental method:

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

[0079] (a) Place the dissolution medium in a water bath, preheat to 41°C, and vacuum filter and degas for 10 minutes;

[0080] (b) Add 900 mL of degassed dissolution medium into the dissolution vessel, and keep the temperature at 37°C;

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

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

[0083] (e) adopt HPLC method to measure the content of acetaminophen, dextromethorphan hydrobromide and doxylamine succinate in the eluate; Chromatographic conditions include:

[0084] Chromatographic c...

experiment example 1

[0100] In this experimental example, various dissolution media are compared to determine the optimal dissolution media. Specifically, purified water, 0.1N HCl solution, acetate buffer at pH=4.5, and phosphate buffer at pH=6.8 were used as dissolution media, and different dissolution media were used to determine the para-acetamido-containing The dissolution of soft capsules of phenol, dextromethorphan hydrobromide and doxylamine succinate, the results are as follows Figure 2-4 And shown in Table 1-4.

[0101] Table 1 Dissolution medium is the dissolution rate of purified water

[0102]

[0103]

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

[0105]

[0106]

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

[0108]

[0109]

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

[0111]

[0112]

[0113] It can be seen from the above measu...

experiment example 2

[0115] In this experimental example, different rotational speeds are compared to determine the optimal rotational speed. According to the operation of above-mentioned experimental method, different rotating speeds (50rpm / min and 100rpm / min) are used to measure the dissolution rate of the soft capsule containing paracetamol, dextromethorphan hydrobromide and doxylamine succinate, the results are as follows Figure 5-7 And shown in Table 5-6.

[0116] Table 5 The dissolution rate at 50rpm / min

[0117]

[0118]

[0119]Table 6 The dissolution rate at 100rpm / min

[0120]

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

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Abstract

The invention discloses a method for determining a dissolution rate of a medicinal preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate. The method comprises the following steps of: (1) adding medicinal preparation containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate into a dissolution medium for dissolution treatment, performing sampling and filtering to obtain dissolution liquid; (2) detecting the contents of acetaminophen, dextromethorphan hydrobromide and doxylamine succinate in the dissolution liquid; and (3) and determining the dissolution rate of the medicinal preparation according to the detection result of the step (2). The method can effectively simulate the dissolution behavior in vivo in vitro, can determine the dissolution rate of the soft capsule containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate, and provides technical support for the research and development and quality control of medicaments. The method can simultaneously determine 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] As a common respiratory disease, colds are mainly manifested in the following symptoms: headache, fever, cough, nasal congestion, runny nose, allergies, etc. Medications commonly used to treat these symptoms include: antipyretic pain relievers (acetaminophen), cough suppressants (dextromethorphan hydrobromide), antihistamines (doxylamine succinate). [0003] The soft capsule containing acetaminophen, 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. In the prior art, there is no method that can effectively simulate the disso...

Claims

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Application Information

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Patent Type & Authority Applications(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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