Easily-disintegrated freeze-drying molding preparation having any form, and preparation method thereof

Abstract

The present invention relates to an easily-disintegrated freeze-drying molding preparation having any form, and a preparation method thereof, particularly to a freeze-drying molding preparation and a preparation method thereof, wherein water or a freeze-drying preparation raw liquid is completely stirred into ice sand during freezing, the remaining raw material and the remaining auxiliary material are further mixed into the ice sand, the obtained mixture is loaded into a certain mold, shaping is performed, freeze-drying is performed to obtain the easily-disintegrated freeze-drying molding preparation, and the obtained easily-disintegrated freeze-drying molding preparation has an any molding shape and mainly contains an active component, an adhesive and a disintegrating agent.

Description

technical field [0001] The present invention relates to an easily disintegrated freeze-dried preparation in any form and a preparation method thereof, in particular to a kind of smoothie made by fully stirring water or freeze-dried preparation stock solution during freezing, and further adding remaining raw and auxiliary materials Freeze-dried preparation product of arbitrary shape, mainly containing active ingredient, binder and disintegrating agent and its preparation method, which are prepared by mixing it into smoothie, filling it into a certain mold for shaping and freeze-drying. Background technique [0002] Freeze-drying excipient technology refers to adding a skeleton support agent and a binder to a flowable liquid, semi-solid or solid active ingredient, or the flowable liquid, semi-solid or solid itself contains a binder and a skeleton The support agent is then poured into a molding mold and shaped by a freeze-drying process. The preparation prepared by the freeze-d...

AI Technical Summary

Problems solved by technology

[0004] Most of the lyophilized excipients on the market are single in form, and the molds used are traditional moulds, i.e. common groove molds. This traditional lyophilized excipient and its preparation method have the following disadvantages:

[0005] (1) The shape of the preparation is single. The reason is that the shape of the mold is fixed, and it can only be demoulded without demoulding or from one direction. No demoulding means that it is molded directly in a certain shape of packaging material, so it is rare to be spherical, Due to special shapes such as ellipsoid and irregular sphere, it is difficult to make special-shaped freeze-dried excipients due to traditional preparation methods

[0006] (2) The prepared tablet has sharp-edged edges, and many tablets with sharp-edged edges obtained after demolding enter the same package together and are prone to abrasion between the sharp-angled edges, resulting in inaccurate drug dosage

[0007] (3) Because of unidirectional filling, it is difficult to become a multi-layer structure, therefore, the preparation structure is single

[0008] (4) The three-dimensional freeze-dried preparation with special form is affected by water disintegration, which affects product experience

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