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Faropenem sodium-containing granules and preparation method thereof

A technology of faropenem sodium and faropenem, which is applied in the field of pharmaceutical preparations, can solve the problems of increasing the safety of injections, large specifications of sustained-release tablets, and poor stability, and achieves the suppression of degradation products and polymers. The preparation process is simple Feasible and easy to operate

Inactive Publication Date: 2014-12-17
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Chinese patent CN 1236814C discloses a composition of faropenem sodium and glutathione. In this invention, glutathione is used as an antioxidant to improve the stability of faropenem sodium. The stability of glutathione is worse than that without glutathione
The application of above-mentioned antioxidant etc. has all increased the unsafety of injection
[0008] CN102133193A discloses a faropenem sodium powder injection, in which faropenem sodium raw material powder is used as the only component and directly packaged, but a filling machine is required for forced feeding, and the filling volume varies greatly
[0009] CN102920682A discloses a gastric floating sustained-release preparation of faropenem sodium and a preparation method thereof, wherein the waterproof airbag is made of a common gastric-soluble hard capsule shell and is made of a waterproof layer composed of stearic acid and ethyl cellulose, and the isolation coat layer is made of hydroxyl Composed of propyl methylcellulose, lactose and mannitol, the drug-containing layer is composed of faropenem sodium and hydroxypropyl cellulose-SL, and the slow-release coating layer is composed of ethyl cellulose N-100 and hydroxypropyl cellulose-SL. The preparation process is cumbersome and not suitable for industrial production
The sustained-release tablets prepared by this invention have larger specifications and need to be administered as a whole tablet, which is not suitable for patients with swallowing difficulties

Method used

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  • Faropenem sodium-containing granules and preparation method thereof
  • Faropenem sodium-containing granules and preparation method thereof
  • Faropenem sodium-containing granules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Prepare faropenem sodium granules according to the following prescription:

[0034]

[0035] Take the faropenem sodium raw material and crush it through a 100-mesh sieve, weigh anhydrous lactose equivalent to the faropenem sodium raw material and mix for 5 minutes, then add it to the multi-directional motion mixer, add the remaining anhydrous lactose, set the stirring speed to 3 speed, and cut Mix at low speed for 15 minutes, then add stevioside and mix for 5 minutes, put it into a dry granulator for dry granulation, set the extrusion pressure at 6kpa, crush it into granules by shaking, pass through 10 mesh and 80 mesh sieves respectively, and take Particles between 10 and 80 mesh are available.

Embodiment 2

[0037] Prepare faropenem sodium granules according to the following prescription:

[0038]

[0039] Take the raw material of faropenem sodium and crush it through a 100-mesh sieve, weigh the same amount of lactose monohydrate as the raw material of faropenem sodium and mix for 10 minutes, then add it to the multi-directional motion mixer, add the remaining lactose monohydrate, set the stirring speed to 3 speed, Shear gear at low speed, mix for 10 minutes, then add stevioside and mix for 5 minutes, put into dry granulator for dry granulation, set extrusion pressure at 6kpa, shake and crush into granules, pass through 10 mesh and 80 mesh sieve respectively , Take the particles between 10 and 80 meshes.

Embodiment 3

[0041] Prepare faropenem sodium granules according to the following prescription:

[0042]

[0043] Take the raw material of faropenem sodium and crush it through a 100-mesh sieve, weigh the same amount of lactose monohydrate as the raw material of faropenem sodium and mix for 10 minutes, then add it to the multi-directional motion mixer, add the remaining lactose monohydrate, set the stirring speed to 3 speed, Shear gear at low speed, mix for 20 minutes, then add stevioside and mix for 5 minutes, put into dry granulator for dry granulation, set extrusion pressure at 6kpa, shake and crush into granules, pass through 10 mesh and 80 mesh sieve respectively , Take the particles between 10 and 80 meshes.

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Abstract

The invention relates to faropenem sodium-containing granules, belonging to the technical field of pharmaceutic preparation. The faropenem sodium-containing granules comprise 10-20% of faropenem sodium, 78-89.5% of lactose and 0.5-2.0% of steviosin. The faropenem sodium-containing granules adopt dry granulation, and the technology is simple, feasible and beneficial to operation, so that the faropenem sodium-containing granules are suitable for industrial mass production; the product is stable in properties and good in mouth feel, thus being very suitable for children and elderly patients.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a granule containing faropenem sodium. Background technique [0002] The abuse of antibiotics has become one of the most important medical problems in the 21st century. Since the 1940s, penicillin was used clinically, which opened the precedent for the use of antibiotics. Penicillins belong to β-lactam antibiotics. With the extensive clinical use and abuse, the resistance of bacteria to antibiotics is increasing. The reason is that a variety of bacteria produce β-lactamase, which decomposes antibiotics, which makes penicillin The scope of application of antibiotics continues to decrease. Humans need to continuously develop new antibiotics to fight against various drug-resistant bacteria (even superbugs), and penem antibiotics are just a new type of β-lactam compounds discovered by people. Peptidases and various β-lactamases are stable and less resistant. ...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/431A61K47/26
Inventor 赵志全张丽萍冯中刘睿张瑜方克忠
Owner SHANDONG NEWTIME PHARMA
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