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Lyophilized preparation and preparation method thereof

A freeze-dried preparation and drying technology, applied in the field of freeze-dried preparations and their preparation, can solve the problems of single preparation shape, large adhesive force, single preparation components, etc., and achieve good preparation strength, fast disintegration speed, and good solubility. Effect

Inactive Publication Date: 2018-02-23
董玲
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AI Technical Summary

Problems solved by technology

[0005] 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:
[0006] (1) It must be shaped with the help of a molding die
[0007] (2) 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 spherical, Due to special shapes such as ellipsoid and irregular three-dimensional shape, it is difficult to make special-shaped freeze-dried excipients due to traditional preparation methods
[0008] (3) The structure of the preparation is single, because it is filled in one direction and it is difficult to become a multi-layer structure
[0009] (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
[0010] (5) 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
[0011] (6) 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

Method used

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  • Lyophilized preparation and preparation method thereof
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  • Lyophilized preparation and preparation method thereof

Examples

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preparation example Construction

[0060] The invention provides a preparation method of a freeze-dried preparation, comprising the following steps:

[0061] a) mixing and freezing the preparation raw materials to obtain a soft ice mixture, the preparation raw materials include active ingredients, a binder and water; the mass ratio of the active ingredients to the binder is 0-100:0-100, and they are The content is not 0 at the same time;

[0062] b) using a filling machine to release the soft ice mixture into the environment to solidify and form, and the filling machine is selected from a pipetting device, a plunger pump, a screw pump, a gear pump or a peristaltic pump to obtain a solidified product;

[0063] c) Freeze-drying the solidified product to obtain a freeze-dried preparation.

[0064] The freeze-dried preparation prepared by the preparation method provided by the invention has a controllable shape and a high drug loading amount. In addition, the freeze-dried preparation prepared by the method has go...

Embodiment 1

[0144] 35g of vitamin C, 10g of pullulan, 25g of mannitol, and 1 liter of water were prepared into a mixed solution to form Liquid 1;

[0145] Freeze liquid 1 at -11°C, and at the same time inflate to an expansion rate of 115% to form a soft ice mixture, which is component 2;

[0146] The surface of the oval-shaped concave die 51 and the flat die 52 combined mold at -150 ° C; Docking with the die 521 in turn to form a complete shape with a high degree of close contact; freeze component 2 to a certain amount to form component 6;

[0147] The quantitative component 6 and the flat mold 52 are freeze-dried together to form a freeze-dried oral VC health food, namely a freeze-dried preparation.

[0148] In this example, the strength, disintegration rate and solubility of the freeze-dried preparation were tested according to the test method described in the above technical solution, and the test results were: the preparation strength was good (friability <0.1%), the disintegration r...

Embodiment 2

[0150] 2 g of guar gum, 8 g of glycerin, 35 g of mannitol, and 1 liter of water were prepared into a mixed solution to form Liquid 1;

[0151] Freeze liquid 1 at -8°C, and at the same time inflate to an expansion rate of 135% to form a soft ice mixture, which is component 2;

[0152] Add vitamin C 55g in the form of dry powder to component 2, with uniform stirring, to form a soft ice mixture, which is component 4;

[0153] Combine the rolling die 51 with the spindle-shaped concave die on the surface and the flat die 52 to pre-cool at -86°C; fill the component 4 into the concave die 521, rotate the rolling die 51, and move the flat die 52 in parallel to make the concave die 511 Docking with the die 521 in turn to form a complete form with a high degree of close contact; freeze component 4 to a certain amount to form component 6;

[0154] Continue to reduce the temperature of quantitative component 6 to -145°C, and release from the mold;

[0155] The flat mold is turned over t...

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Abstract

The invention provides a lyophilized preparation and a preparation method thereof. The preparation method comprises the following steps: a) mixing preparation raw materials, and carrying out congelation, so that a soft ice mixture is obtained, wherein the preparation raw materials comprise active ingredients, a binding agent and water, the mass ratio of the active ingredients to the binding agentis (0-100):(0-100), and the contents of the active ingredients and the binding agent are not zero at the same time; b) releasing the soft ice mixture into an environment by adopting a filling machine,and carrying out consolidation forming, so that a condensate is obtained, wherein the filling machine is selected from a liquid moving device, a plunger pump, a screw pump, a gear pump or peristalticpump; and c) carrying out lyophilization on the condensate, so that the lyophilized preparation is obtained. The prepared lyophilized preparation is controllable in shape and relatively high in drugloading capacity; and the lyophilized preparation is good in strength, high in disintegration speed and good in solubility. Experimental results show that the drug loading capacity of the lyophilizedpreparation is 0.01-99.9%; friability of the preparation is less than 0.1%, disintegration time of the preparation in water is shorter than 15s, and complete dissolution time is shorter than 15s.

Description

[0001] This application is required to be submitted to the China Patent Office on August 11, 2016, the application number is 201610658872.6, the name of the invention is "a preparation method of a freeze-dried preparation", and the application was submitted to the China Patent Office on August 12, 2016, the application number is 2016106651950 , the priority of the Chinese patent application titled "A method for preparing freeze-dried preparations by a single-sided roll-molding method using a composite mold and products thereof", the entire contents of which are incorporated in this application by reference. technical field [0002] The present invention relates to the technical field of freeze-dried preparations, in particular to a freeze-dried preparation and a preparation method thereof. Background technique [0003] Freeze-drying excipient technology refers to adding matrix support and binder to flowable liquid, semi-solid or solid active ingredients, or the flowable liqui...

Claims

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Application Information

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IPC IPC(8): A61K9/19F26B5/06
CPCA61K9/19F26B5/06
Inventor 董玲
Owner 董玲
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