Cefprozil suspension and preparation method thereof

A technology for cefprozil and dry suspension, which is applied in pharmaceutical formulations, medical preparations without active ingredients, medical preparations containing active ingredients, etc. and other problems, to achieve the effect of stable product quality, easy preparation process, low content of single impurities and total impurities

Active Publication Date: 2015-06-10
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention provides a kind of cefprozil dry suspension and preparation method thereof in order to solve the problems of many impurities, uneven main drug content and organic solvent residue in the prior art, the prepared product has low impurity content, high dissolution rate, Good stability, uniform dispersion of main ingredients, and simple process, no special equipment is required, and it can be adapted to large-scale industrial production

Method used

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  • Cefprozil suspension and preparation method thereof
  • Cefprozil suspension and preparation method thereof
  • Cefprozil suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 8-11

[0049] Embodiment 8-11 is all prepared according to the following steps:

[0050] (1) Pass the diluent, microcrystalline cellulose & sodium carboxymethyl cellulose through a 30-mesh sieve, and then pre-mix in a wet granulator for 3 minutes to obtain a pre-mixture;

[0051] (2) adding defoamer, cosolvent and wetting agent to the premixture in step 1, and carrying out wet granulation;

[0052] (3) Place the pellets obtained in step 2 in a boiling dryer through vacuum discharge, and dry at 55°C to 65°C; pass through a 20-mesh sieve for granulation, and mark it as material A;

[0053] (4) Cefprozil, suspending agent, corrective agent, essence, pigment and lubricant are mixed with material A in the manner of increasing in equal amounts, and after mixing evenly, subpackage to obtain cefprozil dry suspension.

Embodiment 8

[0054] Embodiment 8 (by preparing 1000 bag amounts)

[0055] prescription

[0056]

[0057]

Embodiment 9

[0058] Embodiment 9 (by preparing 1000 bag amounts)

[0059] prescription

[0060]

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PUM

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Abstract

The invention discloses cefprozil suspension. The cefprozil suspension is prepared through the following steps that 1, a diluent and microcrystalline cellulose & sodium carboxymethylcellulose are placed in a wet type granulator to be premixed; 2, cosolvent and wetting agents are added to conduct wet granulation; 3, whole grains are dried and marked as the material A; 4, cefprozil, suspending agents and wetting agents are mixed with the material A in an equivalent progressively-increasing mode, and the mixture is subpackaged after being evenly mixed, and the cefprozil suspension is obtained; the suspending agents are selected from one of xanthan gum or sodium carboxymethylcellulose or hydroxypropyl methyl cellulose; the weight proportion of the microcrystalline cellulose & sodium carboxymethylcellulose and suspending agents ranges from 2:1 to 8:1; the wetting agents are folic acid solutions with the concentration being 1 wt%. The cefprozil suspension is low in impurity content, high in dissolution rate, good in stability, even in main medicine spreading and simple in preparing process, no special equipment is needed, and the cefprozil suspension is capable of being suitable for industrialized mass production.

Description

technical field [0001] The invention relates to a dry suspension, in particular to a cefprozil dry suspension and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Dry suspension is a powder or granule made of poorly soluble drugs and suitable excipients. When in use, it can be dispersed into a suspension by shaking with water for oral administration by patients. Therefore, in the preparation process of the dry suspension, a suspending agent needs to be added to make the prepared dry suspension meet the quality requirements, that is, after adding water to form a suspension, the drug particles should be evenly dispersed and will not sink rapidly ; Even if it settles after standing still, it should not form a cake, and it should be quickly redispersed after shaking. Dry suspension not only has the characteristics of easy carrying and good stability of solid preparations, but also has the advantages of easy admin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K9/14A61K9/16A61K47/38A61P31/04
Inventor 刘海席柳世萍王朝卿张锁庆张文胜马亚微孙玉双刘树林郭慧娟王景欣贾玉捷刘雪飞李雪元门红乐郑宝莉张娴米建伟吴士军
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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