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Freeze-dried preparation and preparation method and applications thereof

A freeze-dried preparation and freeze-drying technology, applied in biochemical equipment and methods, freeze-dried delivery, skin care preparations, etc., can solve the problems of limited drug loading, complex structure, disintegration and poor dissolution

Pending Publication Date: 2019-07-19
李和伟
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Triterpene saponins are a class of natural medicinal chemical components, which have the characteristics of complex structure, low content, and strong pharmacological activity. Many of these components are easily soluble in water and heat sensitive. Compared with steroidal saponins, three Acidic saponins in terpene saponins basically only exist in fresh materials due to their thermal instability characteristics. During the processing of products, acidic saponins will be converted into steroidal saponins, so it is difficult to preserve and is rarely used in actual products.
However, acidic saponins in triterpenoid saponins are subject to many restrictions in terms of processing technology and storage due to their thermal instability.
As a freeze-dried preparation containing saponin, due to its foaming characteristics, it often has the characteristics of very limited drug loading (generally 1-50mg / capsule, and the specification is 0.4-1ml / capsule), and the disintegration and dissolution become poor. (higher than 10s, even up to 1-3min), slow dissolution (15-60min) and other defects

Method used

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  • Freeze-dried preparation and preparation method and applications thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0135] A freeze-dried preparation, which is used as an oral preparation, the triterpene saponin in the freeze-dried preparation is malonyl ginsenoside Re, and its percentage content is 10%, the binder is pullulanase polysaccharide, and its The percentage content is 3%.

[0136] The freeze-dried preparation is prepared through the following steps:

[0137] a) After mixing water, malonyl ginsenoside Re and pullulanase polysaccharide to form a pre-preparation solution, constant volume and degassing;

[0138] b) Using a quantitative filling pump, inject the pre-dosing solution obtained in a) into a 1ml sheet-shaped molding mold for degassing;

[0139] c) freeze-drying the side product obtained in b), and removing the solvent to obtain an oral freeze-dried preparation.

[0140] The oral preparation has the function of lowering blood sugar, the disintegration time is within 3s, and the dissolution rate is 95% within 30s. In this example, malonyl ginsenoside Re was replaced with oth...

Embodiment 2

[0143] A freeze-dried preparation, which is used as an oral preparation, the triterpenoid saponins in the freeze-dried preparation are 10% malonyl ginsenoside Rg1 and 20% malonyl ginsenoside Rb1, the total is 30%, and the binder It is guar gum (0.5%) and butylene glycol (15%); the auxiliary material is a skeleton support agent (modified tapioca starch), and its percentage is 5%. The disintegration time of the oral preparation is within 3s, and the dissolution rate is 95% within 30s.

[0144] The freeze-dried preparation is prepared through the following steps:

[0145] a) Preparation of soft ice mixture: mix malonyl ginsenoside Rg1 and malonyl ginsenoside Rb1, guar gum and butylene glycol with water according to a set ratio to obtain a pre-preparation solution, and freeze the pre-preparation solution to obtain soft ice mix 1;

[0146] b) Use a spherical mold with a specification of 0.6ml to shape the shape, obtain the shaped mixture 2, and demould;

[0147] c) Freeze-drying...

Embodiment 3

[0151] A kind of freeze-dried preparation, this freeze-dried preparation is used as oral preparation, and triterpene saponin is platycodon saponin E30% in this freeze-dried preparation, and binding agent is modified starch (percentage content is 30%); Adjuvant is antioxidant ( Vitamin C, its percentage content is 7%), and active ingredient is ginseng polysaccharide (percentage content is 5%). The disintegration time of the oral preparation is within 3s, and the dissolution rate is 90% within 50s.

[0152] The freeze-dried preparation is prepared through the following steps:

[0153] a) Preparation of soft ice mixture: mixing platycodon saponin E, modified starch, vitamin C and water according to a set ratio to obtain a pre-preparation liquid, freezing the pre-preparation liquid to obtain a soft ice mixture;

[0154] b) using ginseng polysaccharide as dry powder;

[0155] e) mixing soft ice mixture and ice powder to obtain all soft ice mixtures;

[0156] f) use an ellipsoida...

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Abstract

The invention discloses a freeze-dried preparation and a preparation method and applications thereof. The mass percentage of triterpenoid saponin in the freeze-dried preparation is 0.004-95%, and themass percentage of a binder in the freeze-dried preparation is 0.01-99%. The freeze-dried preparation is prepared by freeze-drying a pre-blended solution containing the triterpenoid saponin and the binder. When the mass percentage of the triterpenoid saponin in the pre-blended solution is 0.001-50% and the mass percentage of the binder in the pre-blended solution is 0.01-50%, and the mass of the triterpenoid saponin increases along with the increase of the mass of the binder; and when the mass percentage of the triterpenoid saponin in the pre-blended solution is 50-95% and the mass percentageof the binder in the pre-blended solution is 0.01-20%, the mass of the triterpenoid saponin decreases with the increase of the mass of the binder. When used as an oral preparation, a solid beverage ora non-washing skin care product, the freeze-dried preparation has the advantage of quick disintegration.

Description

technical field [0001] The invention relates to the technical field of preparations, in particular to a freeze-dried preparation and its preparation method and application. Background technique [0002] The freeze-dried preparation is to dissolve the medicinal ingredients (raw materials) and auxiliary ingredients (excipients) in a solvent (such as water), prepare them to a certain concentration, and then freeze them at a low temperature in a sterile airtight environment. Ambient air pressure, the method of slowly raising the temperature of the product to sublimate the solvent (such as water) in the product, leaving a loose block or powder drug in solid form. [0003] Triterpene saponins are a class of natural medicinal chemical components, which have the characteristics of complex structure, low content, and strong pharmacological activity. Many of these components are easily soluble in water and heat sensitive. Compared with steroidal saponins, three Acidic saponins in ter...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/704A61K31/715A61K35/618A61K35/65A61K36/185A61K36/233A61K36/258A61K36/344A61K36/346A61K36/424A61K36/481A61K36/484A61K36/69A61K36/734A61K38/02A61K38/44A61K47/36A61K47/42A23L2/39A23L33/105A61K8/63A61K8/64A61K8/66A61K8/9789A61Q19/00A61K9/19A61K31/05A61K31/198
CPCA61K31/704A61K36/481A61K36/258A61K36/424A61K31/715A61K38/02A61K35/65A61K31/198A61K38/446A61K31/05A61K35/618A61K36/734A61K36/233A61K36/344A61K36/346A61K36/69A61K36/484A61K36/185A61K9/19A61K47/36A61K47/42C12Y115/01001A23L33/105A23L2/39A61K8/9789A61K8/64A61K8/66A61K8/63A61Q19/00A61K2800/10A61K2236/37A61K2236/55A61K2300/00A23L33/10A61Q19/02A61K8/731A61Q19/08A61K2800/84A61K8/602A61K8/987A61K9/0053A61K9/0095A61K31/375A61K35/32A61K35/616A61K2236/15A61K2236/331A61K2236/333
Inventor 李和伟
Owner 李和伟
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