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Cefcapene pivoxil hydrochloride granule and preparation method thereof

A technology for cefcapine hydrochloride and cefcapine hydrochloride, which is applied in the directions of anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc. problems such as low rate, to achieve the effect of simple formula and process, high yield of finished product and good stability

Active Publication Date: 2020-04-10
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the cefcapene hydrochloride tablets prepared according to the composition of the above auxiliary materials still have disintegration difficulties, resulting in unqualified dissolution rate
[0007] At present, the preparation of cefcapene pivoxil granules is to directly prepare drug-containing pellets with a centrifugal coating granulator after mixing the raw materials and auxiliary materials. However, the yield of the finished product is low because of the dust flying during the granulation and the loss is relatively large. , how to overcome the above problems is the focus of research in recent years

Method used

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  • Cefcapene pivoxil hydrochloride granule and preparation method thereof
  • Cefcapene pivoxil hydrochloride granule and preparation method thereof
  • Cefcapene pivoxil hydrochloride granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0024] Experimental Example 1: Screening and investigation of fillers, disintegrants, binders, and sweeteners in the prescription, the main inspection items: preparation formability, appearance, hardness, etc. of the drug-containing pellets, the formulation screening is shown in the table 1.

[0025] Inspection items: preparation formability, appearance, particle size, solubility, taste, etc. of drug-containing pellets.

[0026] Examination method: Refer to Appendix ⅠN of the second volume of "Chinese Pharmacopoeia" 2010 edition.

[0027] Preparation formability, appearance: visual inspection; particle size, solubility: refer to "Chinese Pharmacopoeia" 2010 edition, appendix I N; taste: tasting. The experimental results of each prescription are shown in Table 2.

[0028] Table 1 Prescription Screening

[0029]

[0030] Note 1: Cefcarpine pivoxil hydrochloride is produced by Zhejiang Huafang Pharmaceutical Co., Ltd. 17 h 19 N 5 o 6 S 2 100g is equivalent to 140g raw ...

experiment example 2

[0049] Experimental example 2: Influencing factors Test method: Take this product, remove the outer packaging, put it in a suitable open container, and conduct the following tests:

[0050] (1) High temperature test Take this product, put it in a suitable clean container, store it at 60°C for 10 days, take samples on the 5th and 10th day, and test according to the stability investigation items of this product. The results are shown in Table 3.

[0051] (2) High humidity test Take this product, put it in a closed container with constant humidity, and place it at 25°C for 10 days under the conditions of relative humidity 90% ± 5% and 75% ± 5%, respectively, on the 5th and 10th day Sampling was carried out according to the stability investigation project of this product, and the measurement results are shown in Table 3.

[0052] (3) Illumination test Take this product, put it in a light box device equipped with a fluorescent lamp, and place it under the condition of an illuminati...

experiment example 3

[0056] Experimental example 3: Accelerated test In accordance with the relevant provisions of the Chinese Pharmacopoeia 2010 edition of the drug stability test guidelines, the accelerated test of this product is packaged in the market, under the conditions of a temperature of 40°C ± 2°C and a relative humidity of 75% ± 5%. carried out for 6 months. Samples were taken at the end of the first month, second month, third month, and sixth month of the test period, and tested according to the stability inspection items of this product. The results are shown in Table 4.

[0057] Table 4 Accelerated test results (40°C±2°C, RH75%±5%)

[0058]

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Abstract

The invention relates to the technical field of medicine, in particular to a cefcapene pivoxil hydrochloride granule and a preparation method thereof. The cefcapene pivoxil hydrochloride granule comprises cefcapene pivoxil hydrochloride, microcrystalline cellulose, mannitol, croscarmellose sodium, hydroxypropyl methylcellulose, talcum powder and steviosin. The obtained cefcapene pivoxil hydrochloride granule is good in stability, rapid in disintegration, good in taste and good in curative effect, and has an obvious anti-inflammatory effect which is remarkably higher than inflammatory effect inthe prior art.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a cefcapene hydrochloride granule and a preparation method thereof. Background technique [0002] Cefcapene pivoxil hydrochloride (cefcapene pivoxil hydrochloride), its chemical name is (6R, 7R)-7-[(Z)-2-(2-aminothiazol-4-yl)-2-pentenylamino]-3 -[(aminocarbonyl)oxy]methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (2,2-dimethyl Oxypropoxymethyl) ester hydrochloride monohydrate, its structural formula is as follows: [0003] [0004] Cefcapene pivoxil hydrochloride was developed by Shionogi Co., Ltd. of Japan. It has two specifications of 75mg and 100mg tablets, and 100mg granules. It is used to treat epidermal infections, deep skin infections, chronic pyoderma, and trauma caused by sensitive bacteria. Secondary infection of wounds such as burns and surgical trauma, mastitis, perianal abscess, pharyngitis, laryngitis, tonsillitis (including peritons...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K31/546A61K47/38A61P31/04A61P29/00
CPCA61K9/5042A61K9/5047A61K31/546A61P31/04A61P29/00
Inventor 陈雨李文婷相光西徐桂超
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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