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Acetylcysteine composition granules and preparation method thereof

A technology of acetylcysteine ​​and composition, applied in the field of acetylcysteine ​​composition granules and preparation thereof, can solve the problems of high price of mannitol, unfavorable industrialized production, increase production cost and the like, achieve accurate dosage, Easy to control, low cost effect

Active Publication Date: 2013-06-12
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In addition, the above prescription uses mannitol as a filler, which has poor fluidity, and mannitol is expensive and expensive.
And the production process of the above-mentioned acetylcysteine ​​granules needs to be coated and then granulated. The process is more complicated, which increases the production cost and is not conducive to industrial production.

Method used

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  • Acetylcysteine composition granules and preparation method thereof
  • Acetylcysteine composition granules and preparation method thereof
  • Acetylcysteine composition granules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1: The effect of sucrose, mannitol, aspartame and steviol on the properties of drugs

[0030] Take acetylcysteine ​​and sucrose, mannitol, aspartame, and stevia in a ratio of 1:5 and mix them evenly. According to the test conditions of the influencing factors, observe for 10 days (while placing the main drug control) to examine the changes of related substances. The test results are shown in Table 1.

[0031] Table 1 Compatibility test results

[0032]

[0033] From the above results, it can be seen that after acetylcysteine ​​is mixed with sucrose, mannitol, aspartame, and steviol and examined under light conditions, the related substances increase slightly, but when used alone with acetylcysteine The results are consistent; after the investigation at a temperature of 60℃, the related substances have increased but the results are consistent with the investigation results of acetylcysteine ​​alone; it is unstable to humidity, and the related substances have increased ...

Embodiment 2

[0034] Example 2: Prescription screening test

[0035] Take acetylcysteine ​​and sucrose, mannitol, aspartame, steviol, 95% ethanol, respectively, and investigate the effect of acetylcysteine ​​with sucrose, mannitol, aspartame, steviol, and 95% ethanol. The influence of drug flow rate, appearance, particle size, solubility, related substances, dissolution, etc. The dosage of each prescription is shown in Table 2, and the results are shown in Table 3.

[0036] Table 2 Prescription Screening Test

[0037] Prescription number

[0038] Table 3 Screening results

[0039] investigation

[0040] Particle formability

[0041] It can be seen from the results in Table 3 that prescription 1 only used acetylcysteine ​​and mannitol to prepare granules, and the obtained granules were loose and not easy to shape, and other items were not tested. Recipe 2 replaced all the mannitol in Recipe 1 with sucrose powder. In the preparation process of the granules, the soft material is more suita...

Embodiment 3

[0042] Example 3: The acetylcysteine ​​composition granules of the present invention

[0043]

[0044] Preparation method: pulverize acetylcysteine ​​and sucrose through an 80 mesh sieve, then mix 100g of acetylcysteine, 880g of sucrose and 20g of steviol, add 70g of 95% ethanol to make soft material, pass After a 20-mesh sieve, the granules are prepared, and the obtained granules are dried at 40-50° C., passed through a 16-mesh sieve, granulated, and sprayed into 6 g of apple flavor.

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PUM

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Abstract

The invention belongs to the field of medicament preparations and discloses acetylcysteine composition granules and a preparation method thereof. The acetylcysteine composition granules disclosed by the invention comprise the active ingredients of acetylcysteine, sucrose, steviosin, 95% ethanol and apple essence, and have the advantages of safety, effectiveness, good flowability and stability, accurate dosage, convenience in administration, convenience in carrying, easiness in obtaining raw materials and low cost. The preparation method of the acetylcysteine composition granules disclosed by the invention has the advantages of simplicity in operation, easiness in control and labor-saving and time-saving properties, and is conductive to industrial mass production.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and particularly relates to an acetylcysteine ​​composition granule and a preparation method thereof. Background technique [0002] Acetylcysteine, the chemical name is N-acetyl-L-cysteine, and the molecular formula is C 5 H 9 NO 3 S, the molecular weight is 163.20, and the chemical structure is as follows: [0003] [0004] Acetylcysteine ​​was developed and marketed by the Italian Zamboanga Pharmaceutical Company. Its trade name is Fullux. It was first used in the 1960s and is a classic phlegm-reducing drug. Acetylcysteine ​​has an expectorant effect and is often used to rescue the liver toxicity caused by acetaminophen. In recent years, many literatures reported that NAC, as a sulfhydryl donor, is also an antioxidant. It can interfere with the generation of free radicals, scavenge the generated free radicals, and regulate the metabolic activity of cells. It is used in the clinical practice...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/198A61K47/26A61P11/10A61P39/06
Inventor 李明杰王林森王兴玉赵长生
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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