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Acetylcysteine effervescent tablet and preparation method and application thereof

A technology for acetylcysteine ​​and effervescent tablets, which is applied in the field of pharmaceutical preparations and can solve problems such as not being able to meet production conditions and increasing the difficulty of formulating

Active Publication Date: 2012-09-05
重庆健能医药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The excipients in this formula need to be pre-treated, and new equipment and operating procedures are required for spray drying or micronization, which increases the difficulty of the formula. The process adopts direct compression, which requires a special direct tablet machine. Chip machine can not meet the production conditions of the process

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] 1. Prescription:

[0027] Acetylcysteine ​​600g

[0028] Citric acid 1045g

[0029] Sodium bicarbonate 905g

[0030] Mannitol 235g

[0031] Absolute ethanol 300g

[0032] PVPK 30 30g

[0033] Glycerin 10g

[0034] Sodium chloride 24g

[0035] Sweet Orange Flavor 75g

[0036] Aspartame 30g

[0037] Macrogol 6000 45g

[0038] A total of 1000 pieces were made

[0039] 2. Process steps:

[0040] (1) Pretreatment of raw and auxiliary materials: Weigh the prescribed amount of acetylcysteine, citric acid, sodium bicarbonate, and mannitol, put them in a mixer for initial mixing for 3 minutes, and then put them in a universal grinder for powdering. Mesh sieve to get mixed powder I; take by weighing sodium chloride, sweet orange essence, aspartame, polyethylene glycol 6000 of prescription quantity, place in mixer and carry out primary mixing for 2 minutes, then put in universal pulverizer and make powder , passed through ...

Embodiment 2

[0063] 1. Prescription:

[0064] Acetylcysteine ​​600g

[0065] Citric acid 320g

[0066] Sodium bicarbonate 300g

[0067] Mannitol 1545g

[0068] Absolute ethanol 400g

[0069] PVPK 30 60g

[0070] Glycerin 15g

[0071] Sodium chloride 10g

[0072] Cherry essence 75g

[0073] Cyclamate 30g

[0074] Macrogol 6000 45g

[0075] A total of 1000 pieces were made

[0076] 2. Process steps:

[0077] (1) Pretreatment of raw and auxiliary materials: Weigh the prescribed amount of acetylcysteine, citric acid, sodium bicarbonate, and mannitol, put them in a mixer for initial mixing for 3 minutes, and then put them in a universal grinder for powdering. Mesh sieve to get mixed powder 1; take by weighing sodium chloride, cherry essence, cyclamate, polyethylene glycol 6000 of prescription quantity, place mixer and carry out primary mixing 2 minutes, then put powder in universal pulverizer, cross 80 Mesh sieve, dry under reduced pres...

Embodiment 3

[0090] 1. Prescription:

[0091] Acetylcysteine ​​600g

[0092] Citric acid 630g

[0093] Sodium bicarbonate 570g

[0094] Mannitol 950g

[0095] Absolute ethanol 350g

[0096] PVPK 30 55g

[0097] Glycerin 15g

[0098] Sodium chloride 10g

[0099] Raspberry essence 75g

[0100] Aspartame 40g

[0101] Sodium stearyl fumarate 55g

[0102] A total of 1000 pieces were made

[0103] 2. Process steps:

[0104] (1) Pretreatment of raw and auxiliary materials: Weigh the prescribed amount of acetylcysteine, citric acid, sodium bicarbonate, and mannitol, put them in a mixer for initial mixing for 3 minutes, and then put them in a universal grinder for powdering. Mesh sieve to get mixed powder I; take by weighing sodium chloride, raspberry essence, aspartame, sodium stearyl fumarate of prescription quantity, place in mixer and carry out primary mixing for 2 minutes, then put in universal pulverizer Powder, pass through 80-mesh sieve, ...

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Abstract

The invention discloses an acetylcysteine effervescent tablet, a preparation method and an application thereof; the effervescent tablet comprises the following pharmaceutical components by weight: 2-6 parts of acetylcysteine, 3.2-13 parts of organic acids, 3-9.5 parts of sodium bicarbonate, 1.5-13.5 parts of filling agents, 3-4 parts of anhydrous alcohol, 0.2-0.6 parts of PVPK30, 0.05-0.25 parts of glycerol, 0.05-0.35 parts of sodium chloride, 0.1-0.75 parts of essence, 0.1-0.4 parts of sweetening agents, and 0.15-0.8 parts of lubricants; the effervescent tablet has low hygroscopicity, and has no sticking and picking problem during tabletting in environment with humidity of less than 55%; and the effervescent tablet is applicable to the preparation of a preoperative adjuvant drug for digestive endoscope examinations and treatment or imaging examinations.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an effervescent tablet containing acetylcysteine, a preparation method, and the use of the effervescent tablet in the preparation of adjuvant medication for digestive endoscopy and treatment or imaging examination. application. Background technique [0002] Acetylcysteine ​​(Acetylcysteine, N-acetyl-3-mercapto-alanine) is the precursor of reduced glutathione (GSH), which is an oxygen free radical scavenger in vivo. The mechanism of its hepatoprotective effect is not very clear, and it may be related to maintaining or restoring glutathione levels. In addition, acetylcysteine ​​may also play a hepatoprotective role by improving hemodynamics and oxygen transport capacity and expanding microcirculation. [0003] Most of the beneficial effects of acetylcysteine ​​(NAC) stem from its ability to reduce the conversion of extracellular cystine to cysteine, as well as...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K49/18
Inventor 王国华李侠赵小萍刘萍罗磊
Owner 重庆健能医药开发有限公司
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