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Drug-release controlled dry suspension containing medical resin compound and preparation method thereof

A dry suspension and compound technology, applied in the field of pharmaceutical preparations, can solve the problems of single dosage form and increased workload of skeleton-type sustained-release preparations, and achieve the effects of fast drug release, low equipment requirements, and simple preparation process

Inactive Publication Date: 2018-05-15
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dosage form of the matrix type sustained and controlled release preparation is relatively single, most of which are tablets, which are not suitable for children and patients with dysphagia; the film-controlled type requires additional coating equipment, and additional consideration needs to be given to the composition and stability of the coating material, which greatly increases the Workload; osmotic pump type is mainly used for tablets and capsules, also not suitable for children and patients with dysphagia

Method used

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  • Drug-release controlled dry suspension containing medical resin compound and preparation method thereof
  • Drug-release controlled dry suspension containing medical resin compound and preparation method thereof
  • Drug-release controlled dry suspension containing medical resin compound and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: preparation of drug-ion exchange resin complex

[0029] The preparation process of the drug-ion exchange resin complex is as follows: dissolve a certain amount of drug in 1000mL of the corresponding solvent, then add a certain amount of ion exchange resin, react at the corresponding temperature for a certain period of time, filter, and wash the product with deionized water , and dry to obtain the drug-ion exchange resin complex. See Table 1 for the dosage and conditions for the preparation of the corresponding compounds of each label.

[0030] Table 1 Conditions for the preparation of drug-ion exchange resin complexes

[0031]

Embodiment 2

[0032] Embodiment 2: Modification of drug-ion exchange resin complex

[0033] The modification process of the drug-ion exchange resin compound is as follows: the modification material is dissolved in water or swelled in water to obtain a modification material solution, and then the drug-ion exchange resin compound of each number in Example 1 is added to the modification material solution and stirred, filtered , washing the product, and drying to obtain the modified drug-ion exchange resin complex. The complex modification conditions corresponding to each label are shown in Table 2.

[0034] Table 2 Modification conditions of drug-ion exchange resin complexes

[0035]

Embodiment 3

[0036] Example 3: Drug loading before and after modification of the drug-ion exchange resin complex

[0037] The drug-loading capacity of each drug-ion exchange resin complex before and after modification was measured by dissociation method, and the measured results are shown in Table 3 below.

[0038] Table 3 Drug loading of drug-ion exchange resin complexes before and after modification

[0039]

[0040]

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Abstract

The invention provides an oral dry suspension composition capable of realizing controllable drug-release speed through modification combination design and a preparation method thereof. The oral dry suspension composition comprises a pharmaceutically acceptable excipient and a modified medicine-ion exchange resin compound. The medicine-ion exchange resin compound comprises a compound formed by combining a pharmaceutically acceptable active medicine and pharmaceutically acceptable ion exchange resin, and a polymer system which can be dissolved in water for modifying the compound. The invention provides a medical resin compound preparation and modification method as well as a preparation method of a dry suspension containing the compound; better taste masking effect is realized, the drug release speed is controllable according to different treatment requirements, and the dry suspension has the characteristics of small particles and no gritty mouthfeel, and is especially suitable for a children preparation.

Description

technical field [0001] The invention relates to a taste-masking dry suspension of a drug-ion exchange resin complex, which can provide controllable drug release characteristics in the gastrointestinal tract through modification and combination design, and belongs to the field of pharmaceutical preparations. Background technique [0002] For children's medicine, taste masking is a major technical point. Capsule and tablet coating are not suitable for children due to the limitation of patients' swallowing ability, while the preparation technology of granule coating, microcapsule, solid dispersion and clathrate requires Higher, complex production process. As a new type of material, ion exchange resin can form a drug-ion exchange resin complex through ion exchange, and replace the drug under certain ion concentration conditions to achieve drug release. Ion exchange resin is a polymer compound insoluble in acid, alkali and organic reagents, with good chemical stability and ion e...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K47/32A61K47/58A61K47/61
CPCA61K9/146
Inventor 姚静唐林芳颜蕾
Owner CHINA PHARM UNIV
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