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Cefetamet pivoxil hydrochloride capsule and preparation method thereof

A technology for preparing ceftamet pivoxil hydrochloride and capsules, which can be used in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve problems such as easy aggregation of ceftamet pivoxil hydrochloride, long process flow, and large amount of excipients , to achieve the effect of reducing agglomeration, low moisture, promoting dissolution and release

Inactive Publication Date: 2012-02-01
深圳国源国药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of this, the present invention provides a kind of ceftamet pivoxil hydrochloride capsules, which solves the technical problems in the prior art that ceftamet pivoxil hydrochloride is easy to agglomerate, the amount of auxiliary materials is large, the fluidity is poor and the process flow is long, etc.

Method used

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  • Cefetamet pivoxil hydrochloride capsule and preparation method thereof
  • Cefetamet pivoxil hydrochloride capsule and preparation method thereof
  • Cefetamet pivoxil hydrochloride capsule and preparation method thereof

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preparation example Construction

[0031] see figure 2 , figure 2 Show the embodiment of the present invention ceftazidime pivoxil hydrochloride capsule preparation method principle diagram, comprise the steps:

[0032] Step S01, drying process:

[0033] The components in the following weight percentages are dried separately:

[0034] Thinner 5~20%

[0035] Surfactant 0.1~4%

[0036] Disintegrant 2~10%;

[0037] Step S02, preparing the first mixture:

[0038] The components in the following weight percentages are mixed to obtain the first mixture:

[0039] Ceftazidime pivoxil hydrochloride 65~85%

[0040] Anti-adhesive agent 0.5-6%;

[0041] Step S03, preparing the second mixture:

[0042] mixing the first mixture, the dried diluent, surfactant and disintegrant, adding a lubricant with a weight percentage of 0.1 to 1%, and stirring to obtain a second mixture;

[0043] Step S04, preparing ceftazidime hydrochloride capsules:

[0044] The second mixture was filled into capsules to obtain ceftazidime h...

Embodiment 1

[0051] The ceftazidime hydrochloride capsule of the present embodiment one has the following components in weight percentage:

[0052]

[0053]

[0054] The preparation method of ceftazidime hydrochloride capsules of the present invention comprises the following steps:

[0055] (1), get cefetamet pivoxil hydrochloride 1212.18g, colloidal silicon dioxide N 20 62.3g, microcrystalline cellulose 272.18g, starch 50g, low-substituted hydroxypropyl cellulose 92.56g, crospovidone 71.2g, poloxamer 1.78g, magnesium stearate 17.8g;

[0056] (2), drying of auxiliary materials:

[0057] Dry the microcrystalline cellulose, starch, low-substituted hydroxypropyl cellulose, crospovidone and poloxamer in the above (1) at 105°C until the moisture content is 1%, and pass through a 80-mesh sieve respectively ;

[0058] (3), mixing:

[0059] Ceftazidime hydrochloride and colloidal silicon dioxide N in the above-mentioned (1) 20 Mix, cross 80 mesh sieves, obtain the first mixture;

[0060]...

Embodiment 2

[0064] The ceftazidime hydrochloride capsule of the present embodiment two has the following components in weight percentage:

[0065]

[0066]

[0067] The preparation method of ceftazidime hydrochloride capsules of the present invention comprises the following steps:

[0068] (1), get cefetamet pivoxil hydrochloride 1276.26g, colloidal silicon dioxide N 20 80.1g, microcrystalline cellulose 178g, pregelatinized starch 71.2g, crospovidone 129.94g, poloxamer 35.6g, talc 8.9g;

[0069] (2), drying of auxiliary materials:

[0070] Dry the microcrystalline cellulose, precrosslinked starch, crospovidone and poloxamer in the above (1) at 105° C. until the moisture content is 1%, and pass through 80-mesh sieve respectively;

[0071] (3), mixing:

[0072] Ceftazidime hydrochloride and colloidal silicon dioxide N in the above-mentioned (1) 20 Mix and pass through an 80-mesh sieve to obtain the first mixture;

[0073] (4), add microcrystalline cellulose, starch, low-substitut...

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Abstract

The invention is applicable to the technical field of pharmaceuticals, and provides a cefetamet pivoxil hydrochloride capsule and a preparation method thereof. The cefetamet pivoxil hydrochloride capsule comprises cefetamet pivoxil hydrochloride, a diluting agent, an antitack agent, a surface active agent, a lubricant and a disintegrating agent. In the cefetamet pivoxil hydrochloride capsule disclosed by the invention, the antitack agent, namely, colloidal silicon dioxide (N2O), is adopted to prevent the cefetamet pivoxil hydrochloride medicament from being agglomerated and caked so as to promote dissolution and release of the medicament; and by the use of the diluting agent, the further dispersion of the cefetamet pivoxil hydrochloride is realized, and the agglomeration phenomenon is reduced. The preparation method of the cefetamet pivoxil hydrochloride capsule is simple to operate, saves the processing step of material granulating, avoids the essential components from decomposing due to high temperature and high moisture, has low cost, and is beneficial to reducing the input of equipment funds; the preparation method is suitable for industrial production; and the product prepared by the method disclosed by the invention has the advantages of low water content, few impurities, desirable dissolution performance, and stable quality.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmacy, and in particular relates to a ceftamet pivoxil hydrochloride capsule and a preparation method thereof. Background technique [0002] Ceftazidime pivoxil hydrochloride is a semi-synthetic third-generation oral cephalosporin prodrug, which has antibacterial activity against both Gram-negative bacteria and positive bacteria. Escherichia coli, Klebsiella pneumoniae and Proteus all have good antibacterial effects. Stable to a variety of β-lactamases. Clinically, it is mainly used for pneumonia, acute bronchitis, pharyngitis, tonsillitis, urinary tract infection and infection in obstetrics and gynecology, surgery, otolaryngology and stomatology caused by sensitive bacteria. [0003] At present, adhesives are mostly used to make wet granules, then dry, and then granulate to improve the fluidity of the material and then fill the capsules. However, ceftazidime hydrochloride is unstable under ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/546A61K47/04A61K47/38A61K47/36A61P31/04
Inventor 张凯谢雁鸣王维东伍彪
Owner 深圳国源国药有限公司
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