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Compound diphenoxylate tablet and preparation method thereof

A technology for phenoxylate tablets and diphenoxylate hydrochloride is applied in the field of compound diphenoxylate tablets and their preparation, which can solve the problems of unsatisfactory content uniformity, low dissolution rate of compound diphenoxylate tablets, etc. Effects of dissolution and content uniformity

Active Publication Date: 2015-12-02
常州康普药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The present invention solves the technical problems of low dissolution rate and unsatisfactory content uniformity of existing compound diphenoxylate tablets

Method used

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  • Compound diphenoxylate tablet and preparation method thereof
  • Compound diphenoxylate tablet and preparation method thereof
  • Compound diphenoxylate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1 Compound Diphenoxylate Tablet Prescription

[0019] Table 1

[0020]

Embodiment 2

[0021] The preparation of embodiment 2 compound diphenoxylate tablets

[0022] 1. Crushing and sieving of raw and auxiliary materials: The crushing of raw and auxiliary materials is completed with the help of a universal high-speed pulverizer; the sieving is done with a vibrating sieve. The raw material diphenoxylate hydrochloride and auxiliary materials such as starch, magnesium stearate, and calcium hydrogen phosphate are required to be sieved through an 80-mesh sieve with a vortex oscillator; the lactose auxiliary material is required to be crushed with a universal high-speed pulverizer and then sieved through an 80-mesh sieve with a vortex oscillator;

[0023] 2. Weighing: first weigh the auxiliary material starch with the same weight as diphenoxylate hydrochloride and put it into the container for mixing and dilution, pass through a 80 mesh sieve, then weigh the starch with the same weight as the mixture, and pass through 80 mesh Sieve to obtain a well-mixed mixture;

[...

Embodiment 3

[0032] Embodiment 3 according to the item inspection of the compound diphenoxylate sheet prepared by the prescription of embodiment 1 and embodiment 2 method

[0033] Dissolution: Dissolution medium: acetic acid aqueous solution containing 0.2mol / L; using device 1, rotating speed 150rpm, time 45 minutes, detection method: mobile phase: acetonitrile: potassium dihydrogen phosphate (65:35), standard solution: the prepared concentration is Diphenoxylate hydrochloride standard solution of 250ug / ml, dilute to 500ml with dissolution medium, filter, chromatographic system; 210nm wavelength detector, L11 packed column (3.9mm*30mm), flow rate: 1.0ml / min, standard Inject the solution, record the chromatogram, the tailing factor shall not exceed 1.5, and the relative standard deviation shall not exceed 2.0%, inject the standard solution and the test product separately, the injection volume is 50ul, record the chromatogram, and the dissolution rate shall not be low within 45 minutes 75% o...

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Abstract

The invention relates to a preparation prescription and a technology of a compound diphenoxylate tablet. Every ten thousand compound diphenoxylate tablets comprise the following raw and auxiliary materials: 25g of diphenoxylate hydrochloride, 0.25g of atropine sulphate, 152-168g of starch, 522.5-577.5g of lactose, 47.5-52.5g of calcium hydrogen phosphate, 76g-84g 40 percent (ml / ml) of ethanol and 6.65-7.35g of magnesium stearate. The compound diphenoxylate tablet has better dissolution rate and content homogeneity.

Description

technical field [0001] The invention relates to a compound diphenoxylate tablet and a preparation method thereof. Background technique [0002] Each compound diphenoxylate tablet contains 2.5 mg of diphenoxylate hydrochloride and 25 μg of atropine sulfate, and is used for acute and chronic functional diarrhea and chronic enteritis. Diphenoxylate can directly act on intestinal smooth muscle, and weaken intestinal peristalsis by inhibiting intestinal mucosal receptors, eliminating local mucosal peristaltic reflexes, and at the same time increasing intestinal segmental contraction, delaying the passage of intestinal contents, and benefiting intestinal water Absorption, showing strong antidiarrheal effect, is a special drug for functional diarrhea. However, the existing compound diphenoxylate tablets have a large difference in dissolution rate, the ordinary tablet is less than 80%, and the A+1.8S is often relatively large. Due to the low content of the main drug atropine, the c...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/46
Inventor 王苏南汤金春
Owner 常州康普药业有限公司
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