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Loperamide hydrochloride soft capsule and preparation method thereof

A technology of loperamide hydrochloride and soft capsules, applied in the field of loperamide hydrochloride soft capsules and preparation thereof, can solve the problems of affecting drug treatment compliance, difficulty in swallowing tablets and the like

Inactive Publication Date: 2018-04-17
HUAYI PHARMA ANHUI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] But this finished medicine preparation also has its certain shortcoming
For example, the common loperamide hydrochloride preparations on the market are mostly capsules or tablets, and in the field of pediatrics and geriatric medicine, about 50% of people have difficulty swallowing tablets and capsules, loperamide hydrochloride capsules or tablet dosage form interferes with compliance with drug therapy

Method used

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  • Loperamide hydrochloride soft capsule and preparation method thereof
  • Loperamide hydrochloride soft capsule and preparation method thereof

Examples

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Effect test

Embodiment 1

[0016] Take 2g of loperamide hydrochloride and add an appropriate amount of purified water, add 40g of polyethylene glycol-400, stir until dissolved, add 0.2g of sorbitol and stir until dissolved, add dilute hydrochloric acid to adjust the acidity to 4.5, add purified water to 100ml to fill liquid; the prepared filling hydraulic method is packed into rubber, compressed into 1000 soft capsules, and dried to obtain a kind of loperamide hydrochloride soft capsules.

Embodiment 2

[0018] Take 2g of loperamide hydrochloride and add an appropriate amount of purified water, add 50g of polyethylene glycol-400, stir until dissolved, add 0.4g of sorbitol and stir until dissolved, add dilute hydrochloric acid to adjust the acidity to 5.0, add purified water to 100ml to fill liquid; the prepared filling hydraulic method is packed into rubber, compressed into 1000 soft capsules, and dried to obtain a kind of loperamide hydrochloride soft capsules.

Embodiment 3

[0020] Take 2g parts by weight of loperamide hydrochloride and add an appropriate amount of purified water, add polyethylene glycol-400 according to 60g, stir until dissolved, add 0.6g sorbitol and stir until dissolved, add dilute hydrochloric acid to adjust the acidity to 5.5, add purified water to volume to 100ml filling solution; the prepared filling hydraulic method is packed into rubber, compressed into 1000 soft capsules, and dried to obtain a kind of loperamide hydrochloride soft capsules.

[0021] The rubber is selected from 0.8~1.2 parts by weight of gelatin, 0.3~1 glycerin, 0.3~1 sorbitol and 0.8~1.2 purified water to make conventional rubber; glycerin and sorbitol are mixed to make plasticizer, and the weight ratio of plasticizer and gelatin is (0.4 ~0.8):1.0; the weight ratio of gelatin to purified water is 1:1. Every loperamide hydrochloride soft capsule weighs 0.40g in the embodiment.

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Abstract

The present invention relates to the technical field of pharmaceutical preparations, in particular to a loperamide hydrochloride soft capsule and a preparation method thereof: a filling made of loperamide hydrochloride, polyethylene glycol-400, sorbitol, and citric acid according to a certain formula method Liquid, the compression method is filled with gelatin glycerin, sorbitol and purified water to make a conventional rubber cover, and the obtained loperamide hydrochloride soft capsules have a grain weight of 0.3~0.5g and an active ingredient content of 2mg / grain yellowish soft capsules. On the premise of not changing the stability of loperamide hydrochloride, the dosage form of loperamide hydrochloride is changed, which has the characteristics of convenient administration, fast release of active ingredients, rapid onset of effect and good compliance.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a loperamide hydrochloride soft capsule and a preparation method thereof. Background technique [0002] The chemical name of loperamide hydrochloride is N,N-dimethyl-α,α-diphenyl-4-(p-chlorophenyl)-4-hydroxyl-1-loperamide hydrochloride (from 2 , 2-diphenyl-4-bromobutyric acid as raw material, obtained after chlorination, amination, condensation, and salt formation), the chemical structure is similar to haloperidol and meperidine, but the therapeutic dose has no effect on the central nervous system effect. Loperamide hydrochloride is an opioid receptor agonist, and its mechanism of action is: by inhibiting the opioid receptors on the intestinal wall and blocking the release of acetylcholine and prostaglandins, it antagonizes the contraction of smooth muscle, thereby reducing intestinal peristalsis and secretion, and prolonging intestinal content. The retentio...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/451A61K47/10A61K47/42A61K47/12A61P1/12
CPCA61K31/451A61K9/4825A61K9/4858A61K9/4866
Inventor 操铖高煜
Owner HUAYI PHARMA ANHUI CO LTD
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