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Method for preparing freeze-drying excipients of any shape by utilizing multiple molds and product made thereby

A freeze-dried excipient and arbitrary-shaped technology, which is applied in the field of freeze-dried excipients, can solve the problems of single preparation structure, inaccurate drug dosage, and difficulty in preparing freeze-dried excipients.

Inactive Publication Date: 2017-03-01
董玲
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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 refers to molding directly in a certain shape of packaging material
[0006] (2) Spherical, ellipsoidal, irregular spherical and other special shapes are rare. Because of the traditional preparation method, it is difficult to make special-shaped freeze-dried excipients
[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

Method used

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  • Method for preparing freeze-drying excipients of any shape by utilizing multiple molds and product made thereby
  • Method for preparing freeze-drying excipients of any shape by utilizing multiple molds and product made thereby
  • Method for preparing freeze-drying excipients of any shape by utilizing multiple molds and product made thereby

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] (a) Take a mold assembly consisting of 2 parts that can produce tablets without sharp edges, and pre-cool it to -40°C;

[0087] (b) adding bilberry extract: pullulan = 5:1, adding water to prepare a solution, centrifuging and degassing, to obtain a stock solution of freeze-dried excipient preparation;

[0088] (c) using a pipette pump to slowly inject the stock solution of the freeze-dried excipient preparation from the mold filling hole 13 into the mold for filling;

[0089] (d) After the stock solution of the freeze-dried excipient preparation is frozen and solidified, open the mold to take it out and place it on a tray;

[0090] (e) Freeze-drying the stock solution of the frozen lyophilized excipient in the tray, removing the solvent, and obtaining the lyophilized excipient;

[0091] (f) carry out internal packing, namely obtain cranberry solid instant drink.

Embodiment 2

[0093] (a) Take a rose-shaped mold assembly consisting of two parts that can produce tablets without sharp edges, and pre-cool it to -10°C;

[0094] (b) Stir rose extract: trehalose = 1:10 to form a solution, and vacuum degassing to obtain the stock solution of the freeze-dried excipient;

[0095] (c) Slowly inject the stock solution of the freeze-dried excipient preparation from the filling hole 13 of the mold into the mold for filling by using a filling pump;

[0096] (d) freezing the stock solution of the lyophilized excipient preparation in the mold until the stock solution is completely frozen into a solid;

[0097] (e) Open the mold, take out the freeze-dried excipient stock solution that has been completely frozen, and place it in the tray;

[0098] (f) freeze-drying, removing the solvent to obtain a freeze-dried excipient;

[0099] (g) Carry out inner packing, dissolve with water when using, form the skin care product of ready-to-use type.

Embodiment 3

[0101] (a) Take a mold combination composed of 3 parts, capable of producing tablets without sharp edges, and in the shape of a double-layer tablet, and pre-cool it to -0°C;

[0102] (b) Homogenizing fresh velvet antler: ginseng extract=2:1 to obtain component 1; homogenizing fresh velvet antler: ginseng extract=1:2 to obtain component 2;

[0103] (c) Prepare solutions 1 and 2 by adding water respectively, stir to form solutions, and vacuum degas to obtain lyophilized excipient stock solutions 1 and 2;

[0104] (d) Use a pipette to slowly inject the stock solution of the freeze-dried excipient preparation from the mold filling connection port 131 into the mold for filling; completely freeze;

[0105] (e) Take out the septum, and use a pipette to slowly inject the stock solution 2 of the freeze-dried excipient preparation from the mold filling connection port 131 into the mold for filling and freezing until the stock solution is completely frozen into a solid;

[0106] (f) Open ...

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Abstract

The invention relates to a method for preparing freeze-drying excipients of any shape by utilizing multiple molds and a product made thereby, in particular to a preparation method for obtaining freeze-drying excipients mostly containing active ingredients and binders by utilizing multiple molds and the product made thereby.

Description

technical field [0001] The invention relates to a method for preparing a freeze-dried excipient preparation of any shape by using multiple molds and the product obtained by the method, in particular to a preparation mainly containing active ingredients and binders of any shape by using multiple molds The preparation method of the freeze-dried excipient preparation and the product 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 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 preparation adopts a freeze-drying process, which can protect heat-se...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/00A61K9/20A61K8/02
Inventor 董玲
Owner 董玲
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