Preparation method of lyophilized excipient preparation

Abstract

The invention discloses a preparation method of a freeze-dried excipient preparation. The preparation method of the lyophilized excipient preparation of the present invention is to use the liquid, solid or mixture that adds or contains the binder in the molding mold, and forms the predetermined shape of the molding mold in the process of freezing and freeze-drying. Take it out during the demoulding process and carry out inner packaging. Using this method to produce lyophilized excipients can increase the yield of lyophilized excipients several times, even dozens of times, and solve the problems of low productivity and high cost of traditional lyophilized excipients. The preparation is loose and porous, but has Sufficient hardness and toughness, not brittle, can be used in various packaging forms including bottled, boxed, and blister packaging.

Description

technical field [0001] The invention relates to a method for preparing a freeze-dried excipient, in particular to a method for preparing a freeze-dried excipient that is separated from a molding mold during packaging. Background technique [0002] Freeze-drying technology refers to adding a binder to a flowable liquid, semi-solid or solid, or the flowable liquid, semi-solid or solid itself contains a binder, and then pouring it into a molding mold , a technology that is shaped by a freeze-drying process, and a preparation prepared by a freeze-drying excipient technology is called a freeze-dried excipient preparation. [0003] Because this type of preparation undergoes a freeze-drying process, it can protect the heat-sensitive components from being destroyed, and at the same time produce a large number of micropores and channels through water sublimation, which can have a fast disintegration and dissolution speed, so it is widely used and can be applied to the oral cavity Di...

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Problems solved by technology

[0004] However, due to the traditional freeze-drying process of this type of preparation, a large number of pores are formed, so the strength of the preparation is not high, and it is easy to be brittle. After freeze-drying, it needs to be directly packaged in the molding mold and cannot be taken out. Limited by the sealing characteristics of the packaging machine and the design of the template, only less than 1 / 3 of its freezing and lyophilizing capacity can be used, as Dr. Das of Scherer Company summarized in his public treatise on Zydis "The Zydis Drug Delivery System" However, the production cost of traditional freeze-dried excipients remains high, which greatly limits its practical value

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