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Cefprozil capsule and preparation method thereof

A technology of cefprozil and capsules, which is applied in the field of cefprozil capsules and its preparation, can solve the problems of large particles and difficult rapid disintegration, and achieve the effects of good fluidity, stable drug effect and guaranteed product quality

Active Publication Date: 2015-03-11
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The traditional technology for the preparation of cefprozil capsules is to add fillers to cefprozil and fill them after wet granulation and drying. The particles of wet granulation are generally larger and harder, and are not easy to disintegrate quickly

Method used

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  • Cefprozil capsule and preparation method thereof
  • Cefprozil capsule and preparation method thereof
  • Cefprozil capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] A cefprozil capsule comprises the following components in parts by weight:

[0045] Table 1. Embodiment a group of distribution ratio

[0046] components

Weight (parts)

cefprozil

125

Carboxymethyl Starch Sodium

8

[0047] A preparation method for cefprozil capsules, comprising the following steps (each component consumption is as described in Table 1):

[0048] 1) Sieving: Sieve cefprozil to control the particle size to 50μm≤d50≤120μm, 75μm≤d90≤200μm, and d100≤300μm;

[0049] 2) Mixing: add sodium starch glycolate and mix evenly;

[0050] 3) Intermediate detection;

[0051] 4) Filling: Cefprozil capsules are prepared.

Embodiment 2

[0053] A cefprozil capsule comprises the following components in parts by weight:

[0054] Table 2. Embodiment two groups distribution ratio

[0055] components

Weight (parts)

cefprozil

250

Carboxymethyl Starch Sodium

8

[0056] A preparation method of cefprozil capsules, comprising the following steps (each component consumption is as described in table 2):

[0057] 1) Sieving: Sieve cefprozil to control the particle size to 50μm≤d50≤120μm, 75μm≤d90≤200μm, and d100≤300μm;

[0058] 2) Mixing: add sodium starch glycolate and mix evenly;

[0059] 3) Intermediate detection;

[0060] 4) Filling: Cefprozil capsules are prepared.

Embodiment 3

[0062] A cefprozil capsule comprises the following components in parts by weight:

[0063] Table 3. Embodiment three groups distribution ratio

[0064] components

Weight (parts)

cefprozil

375

High expansion sodium carboxymethyl starch

8

[0065] A preparation method of cefprozil capsules, comprising the following steps (each component consumption is as described in table 3):

[0066] 1) Sieving: Sieve cefprozil to control the particle size to 50μm≤d50≤120μm, 75μm≤d90≤200μm, and d100≤300μm;

[0067] 2) Mixing: Add high-expansion sodium carboxymethyl starch and mix evenly;

[0068] 3) Intermediate detection;

[0069] 4) Filling: Cefprozil capsules are prepared.

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Abstract

The invention discloses a cefprozil capsule and a preparation method thereof. The cefprozil capsule adopts cefprozil as a main drug; after a provided disintegrating agent is added, and the particle size range is controlled as follows: d50 is more than or equal to 50 micrometers and less than or equal to 120 micrometers, d90 is more than or equal to 75 micrometers and less than or equal to 200 micrometers, and d100 is less than or equal to 300 micrometers. The prepared cefprozil capsule disclosed by the invention has good flowability and a dissolution effect and greatly saves the auxiliary materials. The preparation method disclosed by the invention has the advantages of simple process, easiness for quality control, energy conservation and consumption reduction and is easy to meet the requirement for mass production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a cefprozil capsule and a preparation method thereof. Background technique [0002] Cefprozil is a second-generation cephalosporin drug with broad-spectrum antibacterial activity. Its chemical name is (6R,7R)-7-[(R)-2-amino-2-(p-hydroxy-phenyl)acetamido]-8-oxo-3-propene-5-thia-1- Azabicyclo(4,2,0)oct-2-ene-2-carboxylic acid monohydrate, the English name is Cefprozil. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 18 h 19 N 3 o 5 S·H 2 o [0006] Molecular weight: 407.45 [0007] Cefprozil is slightly soluble in water (1g can be dissolved in 100~1000ml solvent), the solvent used for the dissolution test of cefprozil preparations stipulated in the 2010 edition of "Chinese Pharmacopoeia" is water 900ml, basket method 100 rpm, 45 minutes Sampling, after filtering, measure the dissolution rate, and the limit is 80% of the la...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/545A61K47/36A61P31/04
Inventor 罗炳锋李家炎曾环想王磊丁梅李娟
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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