Freeze-drying preparation and preparation method thereof

A freeze-dried preparation and freeze-drying technology, which is applied in freeze-dried transportation, skin care preparations, pharmaceutical formulations, etc., can solve the problems of single preparation components, difficult demoulding, and difficult preparation of freeze-dried excipients

Inactive Publication Date: 2017-12-15
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 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, ...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0103] Mix 20g of vitamin C, 10g of propylene glycol, 15g of PVPK, and 1 liter of water to form a mixed solution to form liquid 1; freeze liquid 1 at -10°C and inflate to an expansion rate of 115% to form a soft ice mixture.

[0104] Using liquid nitrogen cooling method, the mold is pre-cooled to -85°C, and the soft ice mixture is filled into the drop-shaped mold for quantification; then the temperature is lowered again, so that the quantitative components and the mold are separated from the mold at -120°C; Freeze-dried to form a VC freeze-dried preparation.

Embodiment 2

[0106] 20g of European bilberry fruit extract, 15g of blueberry fruit extract, 20g of polydimethylsiloxane, and 500g of glycerin were prepared into a mixed solution, and the mixed solution was frozen at -15°C, inflated to 200%, and formed Soft ice mixture.

[0107] 18g of grape extract, 20g of sweet orange fruit extract, 9g of PVPK, 13g of pullulan, 13g of maltose, and 1 liter of water were prepared into a mixed solution; the mixed solution was frozen at -5°C and inflated to 150%. A soft ice mixture is formed.

[0108] Mix the above two soft ice mixtures evenly, put them into a cranberry fruit-shaped mold, and press them tightly with external force; use the liquid nitrogen circulation cooling method to make the quantitative components and the mold cool down to zero viscosity at -200°C The quantitative components are detached from the mould, and the components detached from the mold are freeze-dried to form an oral beverage preparation.

Embodiment 3

[0110] 16g of ibuprofen, 230g of propylene glycol, and 14g of PVPK were formulated into a mixed solution; the mixed solution was frozen at -9°C, and inflated to 185% to form a soft ice mixture.

[0111] Put the soft ice mixture into a capsule mold for quantification, and press it with external force until it is compact; use the liquid nitrogen circulation cooling method to make the quantitative components out of the mold at -170°C; freeze-dry the components out of the mold to form Freeze-dried medicines.

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PUM

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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...

Claims

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Application Information

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IPC IPC(8): A61K8/02A61K9/00A61K9/19A61Q19/00A23P30/10
CPCA61K8/0216A61K9/00A61K9/19A61K2800/10A61Q19/00
Inventor 董玲
Owner 董玲
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