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Cefaclor composition particles and preparation method thereof

A technology of cefaclor and its composition, which is applied in the field of medicine, can solve problems such as poor dissolution rate, poor patient compliance, and unfavorable swallowing, and achieve the effects of enhancing antibacterial effect, improving drug dissolution rate, and avoiding drug agglomeration

Active Publication Date: 2012-07-04
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, most of the existing compound cefaclor preparations are tablets and capsules, which are not conducive to swallowing, and the dissolution rate is poor, resulting in poor compliance of patients.

Method used

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  • Cefaclor composition particles and preparation method thereof
  • Cefaclor composition particles and preparation method thereof
  • Cefaclor composition particles and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1: Cefaclor composition granule of the present invention

[0018]

[0019] Preparation method: Take 250g of cefaclor, 8g of bromhexine hydrochloride, 1490g of sucrose and 20g of acesulfame potassium and mix in a high-speed granulator for 10 minutes, then add 250g of sorbitol, mix for 3 minutes, release the granules, and granulate with a shaking granulator , the prepared wet granules are transferred to a boiling dryer and dried at 65°C for 25 to 30 minutes; the prepared dry granules and essence 2.5g are mixed, sized and sieved to obtain the product.

Embodiment 2

[0020] Embodiment 2: the antibacterial action of cefaclor composition granule of the present invention

[0021] Adopt agar dilution method to measure the minimum inhibitory concentration (MIC) of cefaclor composition of the present invention and existing cefaclor granule, the two adopt different concentration dilution ranges to different bacterial strains, inoculate with multi-point seeder, The number of bacteria contained in each point is about 104CFU. Incubate at 37°C for 24 hours, and the results are shown in Table 1.

[0022] Table 1 Antibacterial test results

[0023]

[0024] As can be seen from the results in Table 1, the cefaclor composition granules of the present invention have stronger antibacterial activity, inhibiting the minimum inhibitory concentration (MIC, μg / mL) of about 90% bacterial strains: Staphylococcus aureus 3.13, Streptococcus pneumoniae 0.39 , Streptococcus pyogenes 0.78, Escherichia coli, Klebsiella, Proteus mirabilis 3.13, Haemophilus influenz...

Embodiment 3

[0025] Example 3: Clinical research on the antibacterial effect of the cefaclor composition granules of the present invention

[0026] 2000 patients with respiratory tract infection, urinary tract infection and skin and soft tissue infection caused by sensitive bacteria were randomly divided into treatment group A, treatment group B and control group. Treatment group A gave existing compound cefaclor tablets on the basis of routine treatment, and treatment group B gave the cefaclor composition granules prepared in Example 1 of the present invention on the basis of routine treatment, 2 times a day, every day 300mg each time, the course of treatment was 10d, and the control group was given cephalexin. The bacterial clearance rate of each group was counted, and the results are shown in Table 2.

[0027] Table 2 Antibacterial effect clinical research

[0028] control group

Treatment group A

Treatment group B

Bacterial clearance

/

93.6％

...

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PUM

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Abstract

The invention relates to the technical field of medicine, and discloses cefaclor composition particles and a preparation method thereof. The cefaclor composition particles disclosed by the invention are prepared from the following raw materials in parts by weight: 250 parts of cefaclor, 8 parts of bromhexine hydrochloride, 1,490 parts of sucrose, 20 parts of acesulfame, 2.5 parts of essence and 250 parts of sorbitol. The cefaclor composition particles disclosed by the invention comprise sorbitol which can be taken as a medicament dispersing agent for enhancing the medicament solubility and can be used for enhancing the antibacterial action of cefaclor. As proved by a test, the cefaclor composition particles disclosed by the invention have enhanced antibacterial action and high stability and can be widely applied to treatment of bacterial infection diseases such as respiratory tract infection, bone and joint infection, pelvic infection, abdominal infection and the like.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a cefaclor composition granule and a preparation method thereof. Background technique [0002] Respiratory system infection is one of the most common infectious diseases clinically, such as acute and chronic respiratory infections, pneumonia, chronic obstructive pulmonary disease, and respiratory infections caused by colds. According to foreign statistics, the incidence of respiratory system infection accounts for more than 60% of the total incidence of various infectious diseases. In China, respiratory infection is the number one cause of death in rural areas, and it is also one of the four major killers in cities. Therefore, the treatment of respiratory system infection is a problem that is often faced clinically. [0003] When a respiratory tract infection occurs, due to the inflammation of the respiratory tract, a large amount of mucus is secreted by the trachea, bronchial...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/545A61K47/26A61P31/04A61P11/10A61P11/14A61K31/137
Inventor 李明杰杨丽娟王传凯
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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