Cefdinir capsule and preparation method thereof

A cefdinir and capsule technology, applied in the field of pharmaceutical preparations and its preparation, can solve the problems of cumbersome process, easy hygroscopicity of cefdinir, and poor solubility of cefdinir

Inactive Publication Date: 2014-07-09
HARBIN PHARMA GRP CO LTD GENERAL PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The solubility of cefdinir is extremely poor, and the dissolution rate is the bottleneck detection item that limits cefdinir capsules, and cefdinir is extremely hygroscopic
Prior art mainly adopts dry granulation in order to prevent the hygroscopicity of cefdinir, adopts dry granulation as Chinese patent CN102058561A, has also adopted moisture-proof type film coat as coating agent for moisture-proof, although Chinese patent CN103263398A adopts wet granulation but process prescription 95% ethanol needs to be added as a dispersant, and the granules need to be sized at 65°C, and the heating of granules will also affect the product quality
Chinese patent CN102935075A uses different types of sieves for raw materials and auxiliary materials to sieve, and the process is relatively cumbersome

Method used

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  • Cefdinir capsule and preparation method thereof
  • Cefdinir capsule and preparation method thereof
  • Cefdinir capsule and preparation method thereof

Examples

Experimental program
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Effect test

example 1

[0043] Example 1: (the best formula obtained after screening)

[0044] Cefdinir 100 parts

[0045] Microcrystalline cellulose 80 parts

[0046] 6 parts of croscarmellose sodium

[0047] Sodium starch glycolate 7 parts

[0048] 6 parts of silicon dioxide

[0049] Sodium Lauryl Sulfate 6 parts

[0050] 5 parts crospovidone

[0051] 2 parts magnesium stearate

[0052] Process description:

[0053] Step 1, pulverize the former powder of cefdinir with a superfine pulverizer, adjust the frequency conversion of the air intake of the superfine pulverizer and the frequency conversion of the host speed to make it reach a dynamic balance, and collect the selected raw powder after the micropowder. Use MASTERSIZER2000 instrument to detect the particle size of cefdinir raw powder, make the particle size reach d(0.5) in the range of 10-25um.

[0054] Step 2, the cefdinir raw material is passed through an 80-mesh sieve for subsequent use. Other pharmaceutical excipients are sieved th...

example 2

[0060] Cefdinir 100 parts

[0061] Microcrystalline cellulose 50 parts

[0062] 13 parts of croscarmellose sodium

[0063] Carboxymethyl starch sodium 11 parts

[0064] 12 parts of silicon dioxide

[0065] Sodium Lauryl Sulfate 12 parts

[0066] 15 parts of crospovidone

[0067] 1 part magnesium stearate

[0068] Process description:

[0069] Step 1, pulverize the former powder of cefdinir with a superfine pulverizer, adjust the frequency conversion of the air intake of the superfine pulverizer and the frequency conversion of the host speed to make it reach a dynamic balance, and collect the selected raw powder after the micropowder. Use MASTERSIZER2000 instrument to detect the particle size of cefdinir raw powder, make the particle size reach d(0.5) in the range of 10-25um.

[0070] Step 2, the cefdinir raw material is passed through an 80-mesh sieve for subsequent use. Other pharmaceutical excipients are sieved through an 80 mesh sieve for later use.

[0071] Step 3, ...

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Abstract

The invention relates to cefdinir capsule preparation and a preparation method thereof. Particles of the cefdinir main drug are crushed, so that the patent medicine grain size d(0.5) is within a range of 10 mum m-25 mu m; proportion of each auxiliary material in the preparation is controlled, and wet-process pelletizing is adopted to obtain a cefdinir capsule preparation method which is simple and easy in process; the preparation is simple in preparation step, low in production cost and very suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to pharmaceutical preparations and preparation thereof, in particular to a cefdinir capsule preparation and a preparation method thereof. Background technique [0002] Cefdinir (cefdinir) is an oral third-generation cephalosporin with a broad antibacterial spectrum. Its antibacterial effect on Staphylococcus and Streptococcus is similar to that of cefpodoxime axetil, and its antibacterial activity on Enterobacteriaceae is lower than that of cefixime 2 -4 times. Currently, the formulations of cefdinir on the market include dispersible tablets, capsules, and granules. [0003] The structural formula of cefdinir is as follows: [0004] [0005] This product is used for Staphylococcus, Streptococcus, Pneumococcus, Peptostreptococcus, Propionibacterium, Neisseria gonorrhoeae, Moraxella catarrhalis, Escherichia coli, Klebsiella that are sensitive to cefdinir genus, Proteus mirabilis, Providencia, Haemophilus influenzae and other s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/546A61K47/38A61K47/32A61K47/36A61P31/04
Inventor 牟春福王硕冰石晓莹吕秀
Owner HARBIN PHARMA GRP CO LTD GENERAL PHARMA FACTORY
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