Erdosteine composition and preparation method thereof

A composition and uniform mixing technology, applied in the field of medicine, can solve the problems of poor bioavailability of common dosage forms, microcrystalline cellulose is not suitable for disintegrating agents, and poor solubility of erdosteine, so as to improve the drug delivery effect, The effect of high drug dissolution efficiency and simple and easy preparation method

Active Publication Date: 2011-06-15
SHANDONG LUOXIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In addition, "Chinese Pharmaceutical Excipients" (Chemical Industry Press, 2006 edition, edited by Luo Mingsheng, etc.) discloses that sodium carboxymethyl starch is best when added externally, while microcrystalline cellulose is usually not suitable for use as a disintegrant
[0008] Erdosteine ​​dissolubility is relatively poor, and the bioavailability of making common dosage form is relatively poor, therefore, the present invention has carried out a large amount of experimental studies on the basis of above-mentioned disclosed literature, has proposed Erdosteine ​​dispersible tablet of the present invention and its preparation method

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  • Erdosteine composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0054] Erdosteine ​​150g

[0055] Lactose 50g

[0056] Microcrystalline Cellulose 50g

[0057] Low-substituted hydroxypropyl cellulose 30g

[0058] Acesulfame K 1g

[0059] Sodium carboxymethyl starch 20g

[0060] Magnesium stearate 0.3g

[0061] Made into 1000 pieces

[0062] Pass the prescribed amount of microcrystalline cellulose and low-substituted hydroxypropyl cellulose through an 80-mesh sieve, and pass through a 120-mesh sieve for lactose, acesulfame potassium, and sodium carboxymethyl starch. Mix erdosteine ​​and low-substituted hydroxypropyl cellulose evenly, pulverize them with a ball mill, pass through a 100-mesh sieve, add sodium carboxymethyl starch, dry-blend with a high-speed mixing granulator at a speed of 45 rpm, and mix for 10 minutes , after adding 20ml of absolute ethanol, perform wet mixing at a speed of 30 rpm, mix for 3 minutes, then wet mix and cut for 2 minutes, transfer the prepared wet granules into a boiling dryer, and dry at 65°C for 20 to 2...

Embodiment 2

[0064] Erdosteine ​​150g

[0065] Lactose 50g

[0066] Microcrystalline Cellulose 50g

[0067] Low-substituted hydroxypropyl cellulose 30g

[0068] Acesulfame K 1g

[0069] Sodium carboxymethyl starch 20g

[0070] Magnesium stearate 0.3g

[0071] Made into 1000 pieces

[0072] Pass the prescribed amount of microcrystalline cellulose and low-substituted hydroxypropyl cellulose through a 70-mesh sieve, and pass through a 100-mesh sieve for lactose, acesulfame potassium, and sodium carboxymethyl starch. Mix erdosteine ​​and low-substituted hydroxypropyl cellulose evenly, pulverize them with a ball mill, pass through a 100-mesh sieve, add sodium carboxymethyl starch, dry-mix with a high-speed mixing granulator at a speed of 35 rpm, and mix for 5 minutes , after adding 20ml of absolute ethanol, perform wet mixing at a speed of 30 rpm, mix for 3 minutes, then wet mix and cut for 2 minutes, transfer the prepared wet granules into a boiling dryer, and dry at 60°C for 15 to 20 mi...

Embodiment 3

[0074] Erdosteine ​​150g

[0075] Lactose 50g

[0076] Microcrystalline Cellulose 50g

[0077] Low-substituted hydroxypropyl cellulose 30g

[0078] Acesulfame K 1g

[0079] Sodium carboxymethyl starch 20g

[0080] Magnesium stearate 0.3g

[0081] Made into 1000 pieces

[0082] Pass the prescribed amount of microcrystalline cellulose and low-substituted hydroxypropyl cellulose through an 80-mesh sieve, and pass through a 100-mesh sieve for lactose, acesulfame potassium, and sodium carboxymethyl starch. Mix erdosteine ​​and low-substituted hydroxypropyl cellulose evenly, pulverize them with a ball mill, pass through a 100-mesh sieve, add sodium carboxymethyl starch, dry-blend with a high-speed mixing granulator at a speed of 45 rpm, and mix for 10 minutes , after adding 25ml of absolute ethanol, carry out wet mixing, the speed is 30 rpm, mixing for 2 minutes, then wet mixing and cutting for 2 minutes, the prepared wet granules are transferred to a boiling dryer, and the te...

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Abstract

The invention provides an Erdosteine composition which consists of the following components by weight portions: 130 to 170 portions of Erdosteine, 35 to 65 portions of lactose, 30 to 70 portions of microcrystalline cellulose, 20 to 40 portions of low substituted hydroxypropyl cellulose, 1 to 5 portions of acesulfame, 10 to 30 portions of sodium carboxymethyl starch and 0.1 to 0.5 portions of magnesium stearate; the invention also provides a preparation method of the Erdosteine composition, comprising the following steps of: preparing materials and pelleting; mixing the Erdosteine and the low substituted hydroxypropyl cellulose evenly, then grinding, adding the sodium carboxymethyl starch, adding absolute ethyl alcohol, wet-mixing, cutting, drying, granulation and tabletting; mixing granules and microcrystalline cellulose evenly, adding the lactose, the acesulfame and the magnesium stearate for pelleting, subpackaging and obtaining the Erdosteine composition. The Erdosteine compositionhas good dispersible uniformity and high drug dissolution efficiency.

Description

technical field [0001] The invention relates to the field of medicine, in particular to an erdosteine ​​composition and a preparation method thereof. Background technique [0002] Phlegm is the product of respiratory inflammation, which can irritate the respiratory mucosa, cause cough and asthma, and aggravate infection. When patients with acute and chronic bronchitis or chronic lung disease have respiratory failure, if the patient's sputum is too viscous or forms sputum plugs, it can block the airway and cause suffocation. Therefore, it is of great significance to use mucus sputum regulators to dissolve mucus sputum, make it thinner, lower its viscosity, accelerate the movement of mucous membranes and cilia in the respiratory tract, and improve the transport function. [0003] The currently marketed mucus regulators, such as bromhexine, sodium thioethanesulfonate, and carbocysteine, all have varying degrees of mucus regulation, but they have some pharmacological or clinica...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/381A61K47/38A61K47/36A61K9/20A61J3/10A61P11/12
Inventor 李明华陈雨宋良伟
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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