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Tea saponin freeze-drying powder injection

A technology of tea saponin and freeze-dried powder injection, which is applied in the direction of freeze-dried transportation, powder transportation, medical preparations of non-active ingredients, etc. It can solve the problems of reducing free paclitaxel, increasing free paclitaxel, unevenness or shrinkage, etc. The composition is simple and effective, it is not easy to aggregate and agglomerate, and the effect of small toxic and side effects

Inactive Publication Date: 2020-08-25
泉州台商投资区忆品茶业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In view of the fact that the existing paclitaxel is extremely unstable in the solution state, it is easy to be inactivated by freeze-drying, free paclitaxel increases, and the surface of the freeze-dried preparation is uneven or shrunk after freeze-drying and during storage, the present invention discloses A tea saponin freeze-dried powder preparation and a preparation method thereof are disclosed. The tea saponin freeze-dried powder preparation prepared by the present invention is compared with the paclitaxel freeze-dried powder prepared by a common freeze-drying process, and the tea saponin paclitaxel freeze-dried The powder injection preparation improves drug stability and reduces free paclitaxel, and the surface of the tea saponin paclitaxel freeze-dried powder preparation will no longer appear uneven or shrinking after freeze-drying and during storage, and it also solves the problem of being in a solution state. Degradation and precipitation problems under

Method used

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  • Tea saponin freeze-drying powder injection
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  • Tea saponin freeze-drying powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Tea saponin freeze-dried powder preparation, preferred formula and mass volume percentage thereof are (ie g / 100ml):

[0053] Paclitaxel: 10%

[0054] Excipient Tea saponin: 1.5%

[0055] Solubilizer and stabilizer: 2.5%

[0056] pH regulator: 0.6%

[0057] The production technology of above-mentioned tea saponin freeze-dried powder preparation comprises the following steps:

[0058] (1) First prepare the solution, take the prescribed amount of solubilizer and stabilizer, add water for injection to make a solution, then weigh the prescribed amount of paclitaxel raw materials, fully stir and dissolve, and sterile filter with a 0.22 μm filter membrane to obtain a polypeptide solution ;

[0059] (2) The excipient tea saponin and PH regulator of prescription quantity are added into water for injection to form a solution, filtered through a 0.22 μm filter membrane to make sterile auxiliary material aqueous solution; the polypeptide solution and auxiliary material solution...

Embodiment 2

[0071] Paclitaxel freeze-dried powder preparation, the preferred formula and its mass volume percentage are (i.e. g / 100ml):

[0072] Paclitaxel: 12%

[0073] Solubilizer and stabilizer: 1.5%

[0074] pH regulator: 0.6%

[0075] The production technology of above-mentioned paclitaxel freeze-dried powder preparation comprises the following steps:

[0076] (1) First prepare the solution, take the prescribed amount of solubilizer and stabilizer, add water for injection to make a solution, then weigh the prescribed amount of paclitaxel raw materials, fully stir and dissolve, and sterile filter with a 0.22 μm filter membrane to obtain a polypeptide solution ;

[0077] (2) Weigh the PH regulator of prescription quantity and add water for injection to form a solution, filter through a 0.22 μm filter membrane to make sterile auxiliary material aqueous solution; mix the polypeptide solution and auxiliary material solution obtained in step (1); fill, mix the Put the solution into a c...

Embodiment 3

[0089] Paclitaxel freeze-dried powder preparation, the preferred formula and its mass volume percentage are (i.e. g / 100ml):

[0090] Paclitaxel: 12%

[0091] Excipient Tea saponin: 2%

[0092] pH regulator: 0.6%

[0093] The production technology of above-mentioned paclitaxel freeze-dried powder preparation comprises the following steps:

[0094] (1) First prepare the solution, weigh the paclitaxel raw material of the prescribed amount, add water for injection to make a solution, stir and dissolve, and filter aseptically with a 0.22 μm filter membrane to obtain a polypeptide solution;

[0095] (2) The excipient tea saponin and PH regulator of prescription quantity are added into water for injection to form a solution, filtered through a 0.22 μm filter membrane to make sterile auxiliary material aqueous solution; the polypeptide solution and auxiliary material solution obtained in the mixing step (1); Put the mixed solution into a clean and sterile vial, half stop it with a ...

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Abstract

The invention discloses a tea saponin freeze-drying powder injection and a preparation method thereof. Compared with a paclitaxtide freeze-drying powder prepared by a common freeze-drying technology,the tea saponin freeze-drying powder injection prepared by the preparation method disclosed by the invention improves medicine stability and reduces free taxol. In addition, after the paclitaxtide freeze-drying powder is added into tea saponin, phenomena, including unevenness or shrinking and the like, after the surface of the freeze-drying powder injection is subjected to freeze-drying and in a storage process can be avoided, and the problems of degradation and precipitation under a solution state can be solved.

Description

Technical field: [0001] The invention relates to the field of pharmaceutical manufacturing, in particular to the application of tea saponin in drug freeze-dried powder preparations, and more specifically to the application of tea saponin in paclitaxel freeze-dried powder preparations and a preparation method thereof. Background technique: [0002] Paclitaxel is formed through the combination of paclitaxel and polypeptide drug carrier. Compared with paclitaxel, the water solubility of paclitaxel is greatly improved, the clearance speed in the body is slow, and the aggregation degree in the tumor is strong, thereby reducing hair loss and vomiting. , allergic reactions and other side effects, there is no need for preventive use of anti-allergic drugs during clinical use. Chinese patent CN 1148227C discloses a therapeutic compound, paclitaxel, which is formed by chemically combining paclitaxel, aspartic acid and glutamic acid as a polypeptide drug carrier. And the currently dev...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/26A61K47/10A61K47/18A61K47/46A61K47/64A61K31/337A61P35/00
CPCA61K9/0019A61K9/19A61K31/337A61K47/10A61K47/183A61K47/26A61K47/46A61K47/64A61P35/00
Inventor 肖君清陈婉珍
Owner 泉州台商投资区忆品茶业有限公司
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