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A method for determining the dissolution rate of a pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride

A technology of phenylephrine hydrochloride and dextromethorphan hydrobromide, which is applied in the field of medicine to achieve the effect of saving detection cost, saving detection time, good accuracy and reproducibility

Active Publication Date: 2022-02-15
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 phenylephrine hydrochloride

Method used

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  • A method for determining the dissolution rate of a pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride
  • A method for determining the dissolution rate of a pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride
  • A method for determining the dissolution rate of a pharmaceutical preparation containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

experiment example

[0076] experimental method:

[0077] The dissolution rate determination method of the soft capsule containing paracetamol, dextromethorphan hydrobromide and phenylephrine hydrochloride, it comprises the steps:

[0078] (a) Place the dissolution medium in a water bath, preheat to 41°C, and vacuum filter and degas for 10 minutes;

[0079] (b) Add 900 mL of degassed dissolution medium into the dissolution vessel, and keep the temperature at 37°C;

[0080] (c) Put the soft capsule containing paracetamol, dextromethorphan hydrobromide and phenylephrine hydrochloride into the dissolution cup;

[0081] (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;

[0082] (e) adopt HPLC method to measure the content of acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride in stripping solution; Chromatographic conditions include:...

experiment example 1

[0098] 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 rate of soft capsules of phenol, dextromethorphan hydrobromide and phenylephrine hydrochloride, the results are as follows Figure 2-4 And shown in Table 1-4.

[0099] Table 1 Dissolution medium is the dissolution rate of purified water

[0100]

[0101]

[0102] Table 2 dissolution medium is the dissolution rate of 0.1N HCl solution

[0103]

[0104]

[0105] Table 3 dissolution medium is the dissolution rate of pH=4.5 acetate buffer solution

[0106]

[0107]

[0108] Table 4 dissolution medium is the dissolution rate of pH=6.8 phosphate buffer

[0109]

[0110]

[0111] As can be seen from the...

experiment example 2

[0113] 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 phenylephrine hydrochloride, the results are as follows Figure 5-7 And shown in Table 5-6.

[0114] Table 5 The dissolution rate at 50rpm / min

[0115]

[0116]

[0117]Table 6 The dissolution rate at 100rpm / min

[0118]

[0119] It can be seen from the above determination results that the dissolution effect of the soft capsule containing paracetamol, dextromethorphan hydrobromide and phenylephrine hydrochloride under the condition of 100rpm / min is better.

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Abstract

The invention discloses a method for measuring the dissolution rate of a pharmaceutical preparation containing paracetamol, dextromethorphan hydrobromide and phenylephrine hydrochloride. Add the pharmaceutical preparations of dextromethorphan and phenylephrine hydrochloride to the dissolution medium for dissolution treatment, sample and filter to obtain the dissolution liquid; (2) detect acetaminophen, dextromethorphan hydrobromide and deoxygen hydrochloride in the dissolution liquid The content of adrenaline; (3) determine 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 acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride, and provide technical support for drug research and development and quality control. The invention can simultaneously measure the dissolution results of three substances under the same condition, greatly saves detection time and 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 phenylephrine hydrochloride. 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), and decongestants (phenylephrine hydrochloride). [0003] The soft capsule containing acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride is a compound oral solid preparation made of gelatin. Its preparation method is as described in Chinese patent 201310360549.7. The current research on this product There is still room for improvement. In the prior art, t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 李海燕阮琼婷涂芳
Owner 安士制药(中山)有限公司