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Compound diphenoxylate tablet and preparation method thereof

A technology of phenoxylate tablets and diphenoxylate hydrochloride, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of poor dissolution rate and unsatisfactory uniformity of atropine, etc. problem, to achieve good uniformity and dissolution rate, good applicability, and cost reduction

Active Publication Date: 2018-11-30
HEBEI SAIKE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the dissolution rate of the existing compound diphenoxylate tablet is relatively poor, usually around 80%, and the uniformity of atropine is not ideal

Method used

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  • Compound diphenoxylate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] A compound diphenoxylate tablet, comprising 25g of diphenoxylate hydrochloride, 0.25g of atropine sulfate, 140g of cornstarch, 490g of powdered sugar, 40g of dextrin, 7g of sodium carboxymethyl starch and 8g of magnesium stearate.

[0032] The preparation method comprises the following steps:

[0033] (1) Crush powdered sugar and sieve other raw materials (80 mesh);

[0034] (2) Mix diphenoxylate hydrochloride, atropine sulfate, and corn starch in equal amounts; add 1 times the weight of water and stir evenly, then put it into the extruder, heat at 90°C for 1 second; heat at 60°C for 2 seconds, wherein the pressure is 1.2MPa; normal pressure extrusion, to obtain the pretreatment material;

[0035] (3) After pretreatment, it is crushed to 50 mesh, and then placed in a mixer;

[0036] (4) Prepare a mixed slurry of cornstarch and dextrin, 4.62g of cornstarch, 0.92g of dextrin, and 92.5g of water;

[0037] (5) Add the remaining cornstarch, powdered sugar and dextrin into...

Embodiment 2

[0042] A compound diphenoxylate tablet, comprising 25g of diphenoxylate hydrochloride, 0.25g of atropine sulfate, 150g of cornstarch, 500g of powdered sugar, 45g of dextrin, 40g of sodium carboxymethyl starch and 9g of magnesium stearate.

[0043] The preparation method comprises the following steps:

[0044] (1) Crush powdered sugar and sieve other raw materials (80 mesh);

[0045] (2) Mix diphenoxylate hydrochloride, atropine sulfate, and corn starch in equal amounts; add 3 times the weight of water and stir evenly, then put it into the extruder, heat at 110°C for 3 seconds; heat at 80°C for 5 seconds seconds, the pressure therebetween is 1.4MPa; extruded under normal pressure to obtain the pretreated material;

[0046] (3) After pretreatment, it is crushed to 100 mesh, and then placed in a mixer;

[0047] (4) Prepare a mixed slurry of cornstarch and dextrin, 6.36g of cornstarch, 2.73g of dextrin, and 90.9g of water;

[0048] (5) Add the remaining cornstarch, powdered sug...

Embodiment 3

[0053] A compound diphenoxylate tablet, comprising 25g of diphenoxylate hydrochloride, 0.25g of atropine sulfate, 145g of cornstarch, 495g of powdered sugar, 42g of dextrin, 25g of sodium carboxymethyl starch and 8.5g of magnesium stearate.

[0054] The preparation method comprises the following steps:

[0055] (1) Crush powdered sugar and sieve other raw materials (80 mesh);

[0056] (2) Mix diphenoxylate hydrochloride, atropine sulfate, and corn starch in equal amounts; add 2 times the weight of water and stir evenly, then put it into the extruder, heat at 100°C for 2 seconds; heat at 70°C for 3 seconds Seconds, wherein the pressure is 1.3MPa; extruded under normal pressure to obtain the pretreated material;

[0057] (3) After pretreatment, it is crushed to 80 mesh, and then placed in a mixer;

[0058] (4) Prepare a mixed slurry of cornstarch and dextrin, 5.3g of cornstarch, 1.77g of dextrin, and 88.4g of water;

[0059] (5) Add the remaining cornstarch, powdered sugar an...

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Abstract

The invention relates to a compound diphenoxylate tablet. The compound diphenoxylate tablet comprises components of, by weight, 25 parts of diphenoxylate hydrochloride, 0.25 part of atropine sulfate,140-150 parts of corn starch, 490-500 parts of powdered sugar, 40-45 parts of dextrin, 7-40 parts of sodium carboxymethyl starch and 8-9 parts of magnesium stearate. The invention further relates to apreparation method of the compound diphenoxylate tablet. The compound diphenoxylate tablet is excellent in dissolution rate, and drug uniformity in the tablet is good.

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. [0003] Diphenoxylate is a derivative of meperidine, an opiate substitute. The effect on the intestinal tract is similar to that of morphine. It directly acts on the smooth muscle of the intestinal mucosa. By inhibiting the intestinal mucosal receptors, eliminating the peristaltic reflex of the local mucosa and weakening the peristalsis, it can also increase the segmental contraction of the intestines, thereby prolonging the contact between the intestinal contents and the intestinal mucosa. Promotes the reabsorption of water in the intestines. Combined with the anticholinergic drug atropine, it synergistically strengthens the inhibitory effect ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/36A61K31/46A61K31/451A61P1/12A61P1/00
CPCA61K9/2059A61K9/2095A61K31/451A61K31/46A61P1/00A61P1/12A61K2300/00
Inventor 王朝晖李新联刘同梅刘九春杜蕊
Owner HEBEI SAIKE PHARMA
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