Freeze-drying preparation and preparation method thereof

Abstract

The invention relates to a freeze-drying preparation and a preparation method thereof. The freeze-drying preparation comprises an effective amount of an active component and a combined binder system comprising a low-temperature binder and a freeze-drying binder. The low-temperature binder is one or a combination of several of C1-C16 alcohol, grease, a surfactant, and high-molecular polymer, and the freeze-drying binder is artificial or natural high-molecular polymer, cellulose ethers, modified starch, hyaluronic acids, albumin, dextran, chitosan and different-molecular-weight products thereof, sodium alginate, PVP, PVA, polyethylene glycol, agar, polyamino acid, glycan or a combination thereof. A formula system comprising the component above matches a certain process, and a freeze-drying preparation product with any shape and a preparation method thereof are provided.

Description

technical field [0001] The invention relates to a freeze-dried preparation and a preparation method thereof, which comprises an effective dose of active ingredients and a combined binder system composed of a low-temperature binder and a freeze-dried binder. Among them, the low-temperature binder is one or more combinations of C1-C16 alcohols, oils, surfactants, and high molecular polymers; the freeze-drying binder is artificial or natural high molecular polymers, cellulose ethers, Modified starches, hyaluronic acids, albumin, dextran, chitosan and their products of different molecular weights, sodium alginate, PVP, PVA, polyethylene glycol, agar, polyamino acids, polysaccharides or their combinations; The formula system thus constituted is matched with a certain process to produce a freeze-dried product with any shape and a preparation method thereof. Background technique [0002] Freeze-drying excipient technology refers to adding a skeleton support agent and a binder to a...

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