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Acetylcysteine tablet and preparation method thereof

A technology for acetylcysteine ​​and cysteine ​​tablets, which is applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. and reports, the appearance of the tablet is not smooth, the particle fluidity is not good, etc., to achieve the effect of smooth appearance, smooth appearance and good fluidity

Inactive Publication Date: 2021-05-28
广东赛康制药厂有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the tablets obtained in this way have poor particle fluidity, rough tablet appearance, and poor dissolution uniformity.
It can be seen that in the prior art, there are still many unresolved technical problems in the application and preparation process of acetylcysteine, and there are no related patents and reports on the preparation of acetylcysteine ​​tablets by powder direct compression.

Method used

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  • Acetylcysteine tablet and preparation method thereof
  • Acetylcysteine tablet and preparation method thereof
  • Acetylcysteine tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0025] Embodiment 1 A kind of acetylcysteine ​​sheet and preparation method thereof

[0026] The formula of table 1 acetylcysteine ​​tablet

[0027]

[0028] The preparation process of the acetylcysteine ​​tablets is dry granulation: according to the prescription quantity of 1000 tablets, the raw and auxiliary materials are weighed and sieved respectively. Then acetylcysteine ​​is mixed with copovidone, silicon dioxide (internal addition) and magnesium stearate (internal addition), and dry granulation is carried out, and the prepared granules are mixed with other auxiliary materials evenly, and compressed into tablets. Instantly.

Embodiment 2

[0029] Embodiment 2 A kind of acetylcysteine ​​sheet and preparation method thereof

[0030] The formula of table 2 acetylcysteine ​​sheet

[0031]

[0032] The preparation process of the acetylcysteine ​​tablets is dry granulation: according to the prescription quantity of 1000 tablets, the raw and auxiliary materials are weighed and sieved respectively. Mix acetylcysteine, polyvinyl alcohol, microcrystalline cellulose, sodium carboxymethyl starch, silicon dioxide (internal addition) and magnesium stearate (internal addition), and carry out dry granulation, and the obtained granules Mix evenly with the remaining other auxiliary materials, press into tablets, and get ready.

Embodiment 3

[0033] Embodiment 3 A kind of acetylcysteine ​​sheet and preparation method thereof

[0034] The formula of table 3 acetylcysteine ​​tablet

[0035]

[0036] The preparation process of the acetylcysteine ​​tablets is wet granulation: according to the prescription quantity of 1000 tablets, the raw and auxiliary materials are weighed and sieved respectively. Put acetylcysteine, microcrystalline cellulose and sodium carboxymethyl cellulose into a rapid wet granulator and mix evenly, spray purified water into granules, and dry in a fluidized bed, then mix the prepared granules with other excipients Mix well and press into tablets.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to an acetylcysteine tablet and a preparation method thereof. 1 unit of the acetylcysteine tablet provided by the invention comprises at least 65% by weight of acetylcysteine, 2%-30% by weight of an adhesive and other pharmaceutically acceptable auxiliary materials. According to the invention, acetylcysteine and one or more of adhesives such as copovidone, polyoxyethylene, polyvinyl alcohol, hydroxyethyl cellulose, ethyl cellulose and sodium carboxymethyl cellulose are creatively mixed with other pharmaceutically acceptable pharmaceutic adjuvants as required for dry-process, wet-process or fluidized bed granulation; or the acetylcysteine is directly mixed with the auxiliary materials to prepare the acetylcysteine tablet which is good in particle or powder flowability, smooth and clean in appearance, uniform in dissolution and good in stability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a high-proportion active ingredient acetylcysteine ​​and an adhesive for improving the moldability of the active ingredient. Background technique [0002] Acetylcysteine, also known as N-acetylcysteine ​​or N-acetyl-L-cysteine ​​or NAC, is primarily used as a mucolytic and in the management of acetaminophen poisoning. It is a derivative of cysteine, whose acetyl group is attached to the amino group of cysteine. NAC is essentially a prodrug that is converted to cysteine ​​(by the enzyme aminoacylase 1 in the gut) and absorbed in the gut into the bloodstream. Cysteine ​​is a key component of glutathione, so administration of acetylcysteine ​​replenishes glutathione stores. Acetylcysteine ​​also acts as a general antioxidant that can help alleviate the symptoms of a number of diseases exacerbated by reactive oxygen species (ROS). For example, acety...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/198A61K47/32A61K47/38A61P13/12A61P39/06A61P25/00A61P25/28A61P25/16A61P25/34A61P25/36
CPCA61K9/2027A61K9/2054A61K31/198A61P13/12A61P25/00A61P25/16A61P25/28A61P25/34A61P25/36A61P39/06
Inventor 罗向东王闪闪谢克扎提梁国焕肖光祥
Owner 广东赛康制药厂有限公司
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