Roller die method for preparing freeze-dried preparation and product prepared with method

Abstract

The invention relates to a roller die method for preparing a freeze-dried preparation and a product prepared with the method. A soft ice mixture is prepared from a freeze-dried preparation stock solution, raw and auxiliary materials can be further mixed with the soft ice mixture, then, the mixture is quantified, set and cured with a relative rotation type roller die combined mold, a zero adhesion technology is adopted for demolding, and finally, the freeze-dried preparation which is in any shapes and mainly contains water, active components and a binder is obtained through freeze-drying and dehydration.

Description

technical field [0001] The present invention relates to a rolling mold method for preparing freeze-dried preparations and products obtained by the method, in particular to a soft ice mixture prepared by preparing the stock solution of the freeze-dried preparation, and further mixing raw and auxiliary materials into the soft ice mixture, Then use a relatively rotating rolling mold combination mold to quantify, shape, and solidify the mixture, use zero adhesion technology to demould, and finally freeze-dry and dehydrate to obtain any shape, mainly containing water, active ingredients and binders. Preparation method of freeze-dried preparation and products obtained according to the method. 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 p...

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 adhesion between the material and the mold is large, causing a large amount of material to adhere to the mold wall, making it difficult to demould, and increasing the production cost

[0007] (3) 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.

[0008] (4) Because of unidirectional filling, it is difficult to become a multi-layer structure, therefore, the preparation structure is single