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Medicinal solid composition containing cephalosporin antibiotics and preparation method thereof

A composition and medicine technology, applied in the field of pharmaceutical solid compositions containing cephalosporin antibiotics and the preparation thereof, can solve the problems of clinical use limitation, not overcoming the bitter taste of ceftazidime hydrochloride products and the like

Active Publication Date: 2012-10-17
ZHEJIANG ZHENYUAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] At present, there is no ceftazime pivoxil hydrochloride product that overcomes the bitter taste, which greatly limits its clinical use
If the bitterness problem is not solved, the product can only be withdrawn from the market early

Method used

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  • Medicinal solid composition containing cephalosporin antibiotics and preparation method thereof
  • Medicinal solid composition containing cephalosporin antibiotics and preparation method thereof
  • Medicinal solid composition containing cephalosporin antibiotics and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0105] Preferred preparation method of ceftazidime pivoxil hydrochloride dry suspension

[0106] Another aspect of the present invention provides a taste-masking preparation method of ceftazidime pivoxil hydrochloride dry suspension, mainly using fluidized bed coating technology, specific steps:

[0107] 1. Preparation of coating solution:

[0108] Mix magnesium stearate, talcum powder and a small amount of water, then disperse the talc powder and magnesium stearate at high speed and stir evenly, then add triethyl citrate, stir evenly, pass through 80 mesh, and finally add quaternary aminoformazine quaternary aminomethacrylic acid copolymer type A aqueous dispersion solution, stirred for 0.5 to 1 hour, and passed through an 80-mesh sieve to obtain a quaternary aminomethacrylic acid copolymer type A aqueous dispersion solution as a coating solution.

[0109] 2. Preparation of 30-120 mesh drug granules or pellets:

[0110] 2.1. Ceftazidime hydrochloride was pulverized, sieved ...

Embodiment 1

[0132] Prescription of pharmaceutical composition: input amount 10000 bags

[0133] prescription composition

Dosage

Quantity per bag

active pharmaceutical ingredient

2500g

0.25g

Microcrystalline Cellulose (MCC)

2500g

0.25g

Quaternary Amino Methacrylate Copolymer Type A (RLPO)

2550g

0.255g

Absolute ethanol

Appropriate amount

Appropriate amount

water

Appropriate amount

Appropriate amount

[0134] Preparation:

[0135] Pharmaceutical active ingredient + microcrystalline cellulose + part of RLP0 → mix well, use PLP0 ethanol solution to make soft material or extrude and spheronize, pass through 20-150 mesh, get 20-150 mesh granules or 20-150 mesh pellets, and carry out drying treatment That's it.

[0136] Evaluation of experimental results:

[0137] project

Embodiment 2

[0139] Taste-masking agent selection

[0140] In this example, the following multiple resins were used for comparison:

[0141]

[0142] 1. Experimental comparison of RL30D resin

[0143] 1.1. Prescription: input amount 100 bags

[0144]

[0145] Formula 1, the coating solution is prepared as follows according to the prescription quantity:

[0146] prescription

Dry material calculation (g)

Actual weighing (g)

RL30D

15

50g concentration is 30% RL30D aqueous solution

TEC (Triethyl Citrate)

3

3

Talc powder

3.5

3.5

Magnesium stearate

3.5

3.5

water

65

Total (g)

25

125

[0147] 125g of coating solution with 20% solid content

[0148] Formula 2, the coating solution is prepared as follows according to the prescription quantity:

[0149]

[0150] 125g of coating solution with 20% solid content

[0151] Formula 3, the coating liquid is prepared as ...

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Abstract

The invention relates to medicinal solid composition containing cephalosporin antibiotics which mainly comprises medicinal active components, quaternary amine methacrylic ester copolymer as taste-masking agent and adsorbent, and optimally comprises one or more selected from anti-sticking agent, plasticizing agent, hydrophobic agent, aromatizer, sweetener and other components; and the solid composition can be granular or micro-pill and can be coated by coating substance containing the taste-masking agent, the plasticizing agent, the hydrophobic agent, the anti-sticking agent, and the like. Theinvention further provides the preparation method of the medicinal solid composition. The medicinal granules of the medicinal solid composition have the advantages of no bitter taste when being orally taken and no influence on the release of the medicines.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a medicine solid composition containing cephalosporin antibiotics and a preparation method thereof. The pharmaceutical composition of the present invention can be formulated into a dry suspension, and has the advantages of no bitter taste and unaffected drug release when taken orally. Background technique [0002] Ceftazidime pivoxil hydrochloride is a third-generation broad-spectrum cephalosporin antibiotic. After oral administration, it is rapidly hydrolyzed in the body to cefetamet with antibacterial activity to play a bactericidal effect. Ceftazidime hydrochloride is effective against Streptococcus (except Streptococcus faecalis), pneumonia Gram-positive bacteria such as cocci, as well as Escherichia coli, Klebsiella, influenza bacillus, gonorrhea Neisseria has strong antibacterial activity, especially against Serratia, indole-positive Proteus, Enterobacter, and Citrobacter, whic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K9/16A61K31/545A61K31/546A61K47/32A61K47/38A61P31/04
Inventor 宋逸婷林政阮霞琴俞建生林谊张育贺燕娜沈斌彬韩海岭
Owner ZHEJIANG ZHENYUAN PHARMA CO LTD