A method of preparing a freeze-drying excipient by using rolling dies and a product thereof

A freeze-dried excipient and roll-molding technology, which is applied in the field of freeze-dried excipient preparations, can solve the problems of single shape, single form, and difficult multi-layer structure of the preparation

Active Publication Date: 2017-04-05
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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  • A method of preparing a freeze-drying excipient by using rolling dies and a product thereof
  • A method of preparing a freeze-drying excipient by using rolling dies and a product thereof
  • A method of preparing a freeze-drying excipient by using rolling dies and a product thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] A. Use a relatively rotating rolling mold combination, including rolling mold (1), rolling mold (2), filling head (3), and material tray (4); among them, rolling mold (1) and rolling mold (2) The surface has a concave mold (11) and a concave mold (12) of a certain shape, the shape of which is hemispherical, and when the concave mold (11) and the concave mold (12) are docked, a complete spherical shape can be formed with a gap of 1 mm;

[0075] B. The rolling mold (1) and the rolling mold (2) are precooled by injecting liquid nitrogen (7) into the hollow pipe (6) therein, and the temperature of the rolling film after precooling is -20°C;

[0076] C, bilberry extract: pullulan=5:1, add water to prepare a solution, centrifuge and degas to obtain the stock solution of freeze-dried excipient preparation;

[0077] D, the roller molds (1) and (2) are rotated, when the concave mold (11) on its surface and the lower edge of the concave mold (12) are engaged, the freeze-dried exc...

Embodiment 2

[0082] A. Use a relatively rotating rolling mold combination, including rolling mold (1), rolling mold (2), filling head (3), and material tray (4); among them, rolling mold (1) and rolling mold (2) The surface has a concave mold (11) and a concave mold (12) of a certain shape, each of which is capsule-shaped, and when the concave mold (11) and the concave mold (12) are docked, a complete capsule shape can be formed, with a gap of 0.5 mm;

[0083] B, precooling the rolling mold (1) and the rolling mold (2), the precooling temperature is 0°C;

[0084] C. Mix GTCC: vitamin D: lecithin = 5:1:1 fully, vacuum degassed to prepare component 1; hydrolyzed gelatin: pullulan = 1:1, add water to fully stir, centrifuge and degas to prepare component two;

[0085] D. The roller molds (1) and (2) are rotated, and when the concave mold (11) on the surface and the lower edge of the concave mold (12) are joined, component one and component two are filled into the concave mold (11) in sequence...

Embodiment 3

[0090] A. Use a relatively rotating rolling mold combination, including rolling mold (1), rolling mold (2), filling head (3), and material tray (4); among them, rolling mold (1) and rolling mold (2) The surface has a concave mold (11) and a concave mold (12) of a certain shape, and its overall shape is mango-shaped, and the respective shapes of the concave mold (11) and the concave mold (12) are asymmetrical, and a complete mango shape can be formed when they are docked. Gap 0.3mm;

[0091] B, precooling the rolling mold (1) and the rolling mold (2), the precooling temperature is -10°C;

[0092] C. Concentrated mango juice: trehalose = 3: 1, add water to prepare a solution, centrifuge and degas to obtain the stock solution of freeze-dried excipient preparation;

[0093] D, the roller molds (1) and (2) are rotated, when the concave mold (11) on its surface and the lower edge of the concave mold (12) are engaged, the freeze-dried excipient preparation stock solution (5) is fill...

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Abstract

The invention relates to a method of preparing a freeze-drying excipient of any shape by using rolling dies and a product prepared by the method, particularly a method of preparing a freeze-drying excipient of any shape and mainly comprising an active component and an adhesive by using rolling dies and a product prepared by the method. The problem that freeze-drying excipients have a single form is overcome. Dies can be designed according to needs to prepare the freeze-drying excipient into various required shapes, and therefore the freeze-drying excipient can have various forms and structures (double-layer sheets and multi-layer sheets), and continuous production can be achieved. The production efficiency is increased and the cost is effectively reduced.

Description

technical field [0001] The invention relates to a method for preparing a freeze-dried excipient preparation of any shape by using a rolling die and a product obtained by the method, in particular to a preparation mainly containing active ingredients and binders of an arbitrary shape by using a rolling die 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 he...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K8/73A61K8/67A61K8/02A61K9/19A61Q19/00A23L2/395A23L33/00A23G3/50A23G3/48
CPCA23G3/48A23G3/50A23L2/395A61K8/0216A61K8/676A61K8/732A61K9/19A61Q19/00A23V2002/00A61K2800/84A61K2800/10A23V2250/2106A23V2250/5076A23V2250/1842A23V2250/18A23V2250/71A23V2250/636A23V2250/5432A23V2300/10A23V2300/20A61K8/67A61K8/73A61J3/06A61K8/02A23L33/00A23G3/0268A23G3/0289A23P30/10A23L33/105A61K8/9728A23G3/0278A23L3/44A61K8/11A61K8/361A61K8/553A61K8/602A61K8/65A61K8/735A61K8/8182A61K36/07A61K36/258A61K47/36A61K2800/805
Inventor 董玲
Owner 董玲
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