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A kind of stephanine hydrochloride freeze-dried powder, preparation method and application thereof

A technology of salicylic acid hydrochloride and freeze-dried powder, which is applied in freeze-dried delivery, powder delivery, pharmaceutical formulation and other directions, can solve the problems of large dosage, decreased storage content, low active pharmaceutical ingredients, etc., and achieves high bioavailability, high The effect of reducing the frequency of medication and reducing the amount of insoluble particles

Active Publication Date: 2017-11-21
广州少伯控股集团有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Water for injection has problems such as poor stability, significant drop in storage content above 30°C, and lower drug clarity. At the same time, it is inconvenient to transport and store due to the ampoule packaging.
However, the content of active ingredients in tablets and powders is relatively low, and the amount of medicine taken is relatively large.

Method used

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  • A kind of stephanine hydrochloride freeze-dried powder, preparation method and application thereof
  • A kind of stephanine hydrochloride freeze-dried powder, preparation method and application thereof
  • A kind of stephanine hydrochloride freeze-dried powder, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1: Lyophilized powder of stephenine hydrochloride

[0023] 1: In this example, the lyophilized powder of cephalanthine hydrochloride includes the following raw materials in weight: 13 g of cephalanthine hydrochloride, 20 g of trehalose, 26 g of lactose, and 100 g of sorbitol.

[0024] 2: The preparation method of the lyophilized powder of stephenine hydrochloride in this embodiment includes the following steps:

[0025] (1) Dissolve stephenine hydrochloride in water for injection at 70°C with 65% of the total solution and stir to dissolve;

[0026] (2) Add sorbitol, add trehalose and lactose after dissolution, and stir until completely dissolved;

[0027] (3) Add medicinal activated carbon, heat to 100°C for 20 minutes, filter, and add water for injection to the filtrate to the total amount of liquid preparation, the total amount of which is to add 6ml of water for injection per 1000 units of stephenine hydrochloride;

[0028] (4) Adjust the pH to 4;

[0029] (5) Filter wit...

Embodiment 2

[0031] Example 2: Lyophilized powder of stephenine hydrochloride

[0032] 1: In this example, the lyophilized powder of cephalothin hydrochloride includes the following materials: 10 g of cephalotine hydrochloride, 22 g of trehalose, 24 g of lactose, and 100 g of sorbitol.

[0033] 2: In this example, the preparation method of the lyophilized powder of stephenine hydrochloride is the same as that of example 1.

Embodiment 3

[0034] Example 3: Lyophilized powder of stephenine hydrochloride

[0035] 1: The lyophilized powder of cephaerine hydrochloride in this example includes the following raw materials in weight: 15 g of cephaerine hydrochloride, 18 g of trehalose, 28 lactose, and 100 g of sorbitol.

[0036] 2: In this example, the preparation method of the lyophilized powder of stephenine hydrochloride is the same as that of example 1.

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Abstract

The invention discloses a stephanine hydrochloride freeze-dried powder, which comprises stepherine hydrochloride and freeze-drying excipients, and the excipients include trehalose, lactose and sorbitol. The content of stephanine hydrochloride in the freeze-dried powder of the present invention reaches the selection of scalar components and proportions, so that the stability of the freeze-dried powder is good, the bioavailability is high, and the frequency and frequency of medication for patients are reduced. The clinical effect is good, and the validity period is prolonged compared with the prior art. The water content of the products obtained in the present invention is all lower than 3%. In addition, the freeze-dried powder prepared by the preferred technical solution of the present invention will not produce a large amount of fine powder and will not stick to the container wall. Regardless of whether water for injection, sodium chloride injection or glucose injection is used, the stephine hydrochloride freeze-dried powder of the present invention can be quickly dissolved, and the dissolution speed is fast and the insoluble particles are few.

Description

Technical field [0001] The invention relates to a freeze-dried powder of stephenine hydrochloride, a preparation method and application thereof, and belongs to the field of medical biology. Background technique [0002] Cepharanthine (cepharanthine) is a bisbenzyl isoquinoline alkaloid, extracted from Stephaniajaponiaca (Thunb 1) Miers. The role of stephenine (sugar) is to promote the proliferation of bone marrow tissue, thereby increasing white blood cells. Clinically, it is mainly used for leukopenia. In addition, studies have found that stephenine can inhibit NF-κ to reverse multi-drug resistance (muti-drug resistance, MDR) and promote drug-resistant cell apoptosis. Foreign studies have found that many of these alkaloids have strong anti-inflammatory, anti-viral, anti-hemolytic and anti-tumor effects, can stimulate the reticuloendothelial system, activate hematopoietic tissue, and promote bone marrow hyperplasia. At present, there are three dosage forms of stephenine medici...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/4741A61P7/00A61P35/00
Inventor 王一飞王治平董栋王巧利
Owner 广州少伯控股集团有限公司
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