Flucloxacillin sodium taste-masking granules and preparation method thereof

A technology of flucloxacillin sodium and taste-masking granules, which is applied in the field of flucloxacillin sodium taste-masking granules and its preparation, can solve the problems of high physical and chemical properties and stability requirements, incomplete absorption, and poor drug stability, etc., and achieve The product has good stability, high dosage, and the effect of improving stability

Active Publication Date: 2016-08-03
ZHEJIANG JUTAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] These methods of the prior art all have certain defects for the taste-masking of strong peculiar smell, high dosage, and water-soluble drugs, such as in method (1), the flavoring agent cannot completely cover the bitter taste; methods (2) and (3) Among them, due to the use of water-insoluble materials, it is easy to cause drug release, incomplete absorption, gritty feeling when taking it, and high production costs; methods (4) and (5) have relatively high requirements on the physical and chemical properties and stability of the drug itself, and may change The physical and chemical properties of the drug, causing the drug stability to deteriorate

Method used

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  • Flucloxacillin sodium taste-masking granules and preparation method thereof

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Effect test

Embodiment 1

[0029] Weigh 25g of hypromellose-E5 and dissolve it in 100g of water to form a 20% solution, add 12.5g of flucloxacillin sodium into the above solution under stirring conditions, and vigorously stir to form a uniform system. Then add to the 60g adjuvant mixture (mass percentage is as follows: lactose 93.4%, crospovidone 4%, cyclamate 0.5%, aspartame 1%, monosodium glutamate 0.1%, citric acid 1% by spraying) ), fluidized bed granulation and drying to obtain taste-masked granules. Each dose is 1g, containing 125mg of flucloxacillin sodium.

Embodiment 2

[0031] Weigh 5g of hypromellose-E15 and dissolve it in 45g of 10% ethanol solution to form a solution with a concentration of 10%. Add 12.5g of flucloxacillin sodium to the above solution under stirring, and stir vigorously to form a nearly pasty solution. Add it into 70g of auxiliary material mixture that has been mixed uniformly, granulate and dry to obtain taste-masking granules. Each dose is 1g, containing 125mg of flucloxacillin sodium.

Embodiment 3

[0033] Weigh 30g of hypromellose-E5 and dissolve in 70g of 85% ethanol solution to form a 30% solution, add 12.5g of flucloxacillin sodium into the above solution under stirring, and vigorously stir to form a solution. Spray it into 60 g of adjuvant mixture that has been uniformly mixed, granulate in a fluidized bed, and dry to obtain taste-masking granules. Each dose is 1g, containing 125mg of flucloxacillin sodium.

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Abstract

The invention discloses flucloxacillin sodium taste-masking granules and a preparation method thereof, particularly relates to a taste masking method for preparing granules from water-soluble medicines (such as flucloxacillin sodium) with strong bitterness and large taking dosage, belongs to the technical field of medicines, and aims to realize masking of the bitterness of the medicines, keep or improve the water solubility and the stability of the medicines to improve the drug compliance of a clinical patient. The flucloxacillin sodium taste-masking granules comprise a master medicine and slave medicinal materials, and are prepared by dissolving or highly dispersing the master medicine into a carrier solution, and then preparing the medicines into granules by a conventional granulation mode, wherein the ratio of a carrier to the master medicines is 25-200 percent; the carrier is a molecular material with high film-forming property and high water solubility. A carrier solution medium is water or an ethanol solution with certain condition; the master medicine is a medicine which is represented by flucloxacillin sodium and is strong in bitterness, high in clinical dosage and high in water solubility.

Description

technical field [0001] The invention relates to flucloxacillin sodium taste-masking granules and a preparation method thereof, belonging to the technical field of medicines. Background technique [0002] Flucloxacillin sodium, a semi-synthetic penicillin antibiotic, is mainly used for severe infection and sepsis of penicillin-resistant Staphylococcus aureus. However, it is also a drug with strong bitter taste, high dosage and water solubility, which is used clinically During the process, the patient's compliance was poor due to the strong bitter taste. Therefore solve the taste problem of flucloxacillin sodium medicine, be the difficult problem of scientific and technical personnel always. [0003] For general bitter medicines, the prior art mainly performs taste masking through the following methods: [0004] (1) Mix bitter medicine with flavoring agent, hydrophobic polymer or waxy lipid auxiliary materials, etc., and granulate by dry method, wet method or melting method;...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/431A61K47/38A61K47/32A61P31/04
CPCA61K9/1635A61K9/1652A61K31/431
Inventor 易建勇祝方猛赵能选何燕华
Owner ZHEJIANG JUTAI PHARMA
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