Preparation method of freeze-dried preparation and product prepared by same

Abstract

The invention relates to a preparation method of a freeze-dried preparation and a product prepared by the same, in particular to a preparation method of an arbitrarily-shaped active ingredient and / or binding agent-containing freeze-dried preparation obtained by coagulating and freezing an ingredient mixture into a soft ice mixture, putting in a certain mold, shaping, de-molding and finally freezing and drying, and a product prepared by the same.

Description

technical field [0001] The invention relates to a method for preparing a freeze-dried preparation and a product obtained by the method, in particular to a method of freezing each component into a soft ice mixture, filling it into a certain mold, demoulding after setting the shape, and finally obtaining the product through freeze-drying. A method for preparing freeze-dried preparations of any shape containing active ingredients and / or binders and products prepared by 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 poured into a molding mold and shaped by a freeze-drying process. The preparation prepared by the freeze-drying excipient technology is called a freeze-dried excipient preparation. [0003] Because this type of pre...

AI Technical Summary

Problems solved by technology

[0004] Most of the lyophilized excipients currently on the market have a single form and a single added component. The molding mold used is a mold in the traditional sense, that is, a common groove-shaped mold. This traditional lyophilized excipient and its preparation method There are 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) Because of unidirectional filling, it is difficult to become a multi-layer structure, therefore, the preparation structure is single

[0008] (4) The composition of the preparation is single. The reason is that the first step of the traditional preparation process is to prepare an aqueous solution, so some functional substances that are not easy to preserve under normal temperature and water conditions cannot be added, such as superoxide dismutase, lysozyme, volatile substances, etc.

The types of active ingredients in preparations are greatly restricted

[0009] (5) The amount of drug loading has a certain limit, because the solubility of many ingredients has a certain limit, and the active ingredient is formulated into an aqueous solution for lyophilization, and the amount of the active ingredient carried has an upper limit