Lyophilized powder injection of cepharantine hydrochloride and preparation method thereof

A technology of stephine hydrochloride and freeze-dried powder injection, which is applied in the field of stephine hydrochloride freeze-dried powder injection and its preparation, which can solve the problems of reduced drug clarity, inconvenient transportation and storage, and reduced storage content, and achieves the convenience of room temperature storage , extended validity period, and improved stability

Inactive Publication Date: 2006-12-13
GUANGZHOU JINAN BIOMEDICINE RES & DEV CENT +2
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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

Method used

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  • Lyophilized powder injection of cepharantine hydrochloride and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Take 1.1 grams of stephanine hydrochloride (pure) raw material for injection (purity 99%), add 1000 ml of water for injection (50 ° C), stir and dissolve, add 10 grams of mannitol, stir to dissolve, and filter through a 0.22 μm microporous membrane Sterilize, test that the content of stephanine hydrochloride (vegetable) reaches more than 99% of the marked amount, then pack in 2ml / bottle. Freeze-drying is carried out, and the freeze-drying conditions are a freeze-drying temperature of -20 to -35° C., a vacuum of 50 to 200 Pa, and a time of 24 hours. Then out of the box, sealing, leak detection, labeling. All are carried out in workshops meeting GMP requirements. Dosage: Intravenous infusion of 50mg / time, once a day. Usage: Shake and dissolve with 2ml of water for injection, add 250ml of normal saline or 5% glucose injection, and infuse intravenously.

Embodiment 2

[0018] Take 5 grams of stephine hydrochloride (pure) raw material for injection (purity 99%), add 900 ml of water for injection (60 ° C), stir to dissolve, add 100 grams of trehalose, stir to dissolve, add water to 2000 ml, and use 0.20 μm micro Sterilize by filtering through a pore filter membrane, measure the content of stephanine hydrochloride to reach more than 99% of the marked amount, then sub-package, 2ml / bottle, and freeze-dry. The freeze-drying condition is a freeze-drying temperature of -20 to -35°C, a vacuum of 50 to 200Pa, and a time of 32 hours. Then out of the box, sealing or capping, leak detection or capping, and labeling. All are carried out in workshops meeting GMP requirements. Dosage: Intravenous infusion of 50mg / time, once a day. Usage: Shake and dissolve with 2ml of water for injection, add to 250ml of 5% glucose injection, and inject intravenously.

Embodiment 3

[0020] Take 10 grams (purity 99%) of stephanine hydrochloride (purity) raw material for injection, add 3600ml of water for injection (55°C), stir to dissolve, add 400 grams of glucose, stir to dissolve, add water to 4000ml, and use 0.25μm micropore Sterilize by membrane filtration, measure the content of stephanine hydrochloride to reach 99% to 100% of the labeled amount, and carry out sub-packaging. Then freeze-dry for 36 hours at a temperature of -20 to -35°C and a vacuum of 50 to 200 Pa, take it out of the box, press the cap, crimp the cap, and stick a label. All are carried out in workshops meeting GMP requirements. Dosage: Intravenous infusion of 50mg / time, once a day. Usage: Shake and dissolve with 2ml of water for injection, add to 250ml of normal saline, and infuse intravenously.

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Abstract

The invention discloses a freeze dried stephanine hydrochloride injection for treating leukopenia caused by radiotheraphy and chemotherapy, which comprises the following medicaments (by weight ratio): stephanine hydrochloride 1-10 parts, freeze-drying excipient 10-400 parts. The invention also discloses the process for preparing the freeze dried injection. The freeze-drying excipient can be mannitol, glucose, trehalose, sucrose or lactose.

Description

technical field [0001] The invention relates to a medicine stephanine hydrochloride freeze-dried powder injection for treating leukopenia caused by radiotherapy and chemotherapy of tumor patients and a preparation method thereof. Background technique [0002] Cepharanthine (cepharanthine) is a bisbenzylisoquinoline alkaloid, which is extracted from Stephaniajaponiaca (Thunb 1) Miers. The function of Stephanine (Prime) is to promote the proliferation of bone marrow tissue, thereby increasing the number of white blood cells. It is mainly used clinically for leukopenia. In addition, some studies have found that stephanine can inhibit NF-к to reverse multi-drug resistance (muti-drug resistance, MDR) and promote apoptosis of drug-resistant cells. 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 ti...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4741A61P35/00
Inventor 王一飞王庆端杨崇仁王治平王东阳赵志鸿钱垂文杨柯
Owner GUANGZHOU JINAN BIOMEDICINE RES & DEV CENT
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