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Hydrochlorothiazide orally disintegrating tablets and preparation method thereof

A technology for hydrochlorothiazide and orally disintegrating tablets, applied in the field of oral disintegrating tablets and their preparation, can solve the problems of poor tablet compliance, poor fluidity, low bulk density of hydrochlorothiazide raw materials, etc. Effect

Inactive Publication Date: 2014-06-04
QINGDAO BAICAOHUI INST OF CHINESE HERBAL MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The commonly used preparation methods for orally disintegrating tablets are direct compression method and granulation compression method. Disintegrating tablets leave insoluble material after disintegrating in the mouth
In addition, the raw material of hydrochlorothiazide has small bulk density, poor fluidity, and strong electrostatic force between drug particles, which requires a large amount of excipients with strong fluidity to dilute, and patients have poor compliance with large-volume tablets. The technical difficulty in preparing hydrochlorothiazide orally disintegrating tablets is to improve the fluidity of the main drug and reduce the amount of excipients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0019] Hydrochlorothiazide 10% microcrystalline cellulose 45% Lactose for direct compression 34.2% Low Substituted Hydroxypropyl Methyl Cellulose 10% aspartame 0.2% Magnesium stearate 0.5%

[0020] Preparation: Weigh the prescription amount of hydrochlorothiazide and mix it with 20% microcrystalline cellulose, add an appropriate amount of anhydrous ethanol to wet, and fully mix the main drug and the fluid auxiliary materials in a wet state. The above-mentioned wet material was fully dried in a blast drying oven at 50°C, and passed through an 80-mesh sieve for use. Each auxiliary material was pre-dried and passed through an 80-mesh sieve for use. Weigh the remaining excipients according to the prescribed amount, and mix the hydrochlorothiazide to be processed with other excipients evenly. Measure the content of the intermediate, add magnesium stearate, mix evenly, and press into tablets.

[0021] Take a dimple punching tablet with ...

preparation example 2

[0023] Hydrochlorothiazide 20% microcrystalline cellulose 35% Mannitol 29.9% pregelatinized starch 12％ Croscarmellose sodium 12% 3.0% polyvinylpyrrolidone K30 ethanol solution Moderate aspartame 0.1% Magnesium stearate 0.5%

[0024] Preparation: All ingredients are pre-passed through an 80-mesh sieve for later use. Weigh the ingredients according to the prescribed amount, and mix the hydrochlorothiazide and other excipients evenly. Add an appropriate amount of 3.0% polyvinylpyrrolidone K30 ethanol solution to make softener, granulate with a 20-mesh sieve, dry in a 40-degree blast drying oven, and granulate with an 18-mesh sieve. Measure the content of the intermediate, add magnesium stearate and mix evenly, then press into tablets.

[0025] Take a dimple punching tablet with a diameter of 6mm, the tablet weight is about 100mg, and the tablet hardness is controlled at 2-4kg / cm 2 , according to the Disintegration Time L...

preparation example 3

[0028] Hydrochlorothiazide 15% microcrystalline cellulose 48% sucrose 24.0% Cross-linked polyvinylpyrrolidone 10% sodium bicarbonate 2.3% Citric acid 2.5% aspartame 0.2% talcum powder 0.5%

[0029] Preparation: Weigh the prescription amount of hydrochlorothiazide and mix it with 48% microcrystalline cellulose, add an appropriate amount of anhydrous ethanol to moisten, and fully mix the main drug and fluid auxiliary materials in a moist state. The above-mentioned wet material was fully dried in a blast drying oven at 50°C, and passed through an 80-mesh sieve for use.

[0030] Each auxiliary material was pre-dried and passed through an 80-mesh sieve for use. Weigh the remaining excipients according to the prescribed amount, and mix the hydrochlorothiazide to be processed with other excipients evenly. Measure the content of the intermediate, add magnesium stearate, mix evenly, and press into tablets.

[0031] Take a dimpl...

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Abstract

The invention provides hydrochlorothiazide orally disintegrating tablets and a preparation method thereof. A patient does not need to drink water for taking the orally disintegrating tablets, thereby reducing the burden on the patient; moreover, by adopting a tabletting pretreatment process on the orally disintegrating tablets, the problems that a large quantity of accessories insoluble in water are adopted and insoluble substances are left after the disintegration are successfully solved.

Description

[0001] Summary [0002] The invention provides a hydrochlorothiazide orally disintegrating tablet and a preparation method thereof. The orally disintegrating tablet does not require drinking water, which reduces the burden on patients, and the orally disintegrating tablet adopts the pretreatment method before tableting to successfully solve the problems of large amount of excipients, insoluble in water, and insoluble substances left after disintegration. technical field [0003] The invention relates to an orally disintegrating tablet that can be used for diuresis and a preparation method thereof, in particular to a hydrochlorothiazide orally disintegrating tablet and a preparation method thereof. Background technique [0004] Hydrochlorothiazide, the chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide. As a diuretic and antihypertensive drug, hydrochlorothiazide is mainly applicable to cardiogenic edema, hepatic edema and nephrotic ede...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/549A61P7/10A61P9/12
Inventor 张伟福
Owner QINGDAO BAICAOHUI INST OF CHINESE HERBAL MEDICINE
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