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Freeze-dried injection of Meglumine Glycididazole and preparation thereof

A technology of glycidazole meglumine and glycidazole meglumine is applied in the field of freeze-dried powder injection of glycidazole meglumine and its preparation, and can solve the problems of inconvenient storage, poor stability and the like , to achieve the effect of convenient transportation, ensuring stability and improvement, and avoiding adverse reactions

Inactive Publication Date: 2008-11-12
杨喜鸿
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The object of the present invention is to make it into a freeze-dried powder injection according to the properties of the glycididazole meglumine compound by using a freeze-drying process, and to provide a freeze-dried powder injection of glycididazole meglumine, which overcomes the problem of glycididazole meglumine. Due to the disadvantages of poor stability, inconvenient packaging, transportation, and storage of Amididazole Meglumine Injection, a stable, reliable, safe, effective, and easy-to-use Glycididazole Meglumine freeze-dried powder injection is provided for clinical use, and its Preparation

Method used

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  • Freeze-dried injection of Meglumine Glycididazole and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Glycindiazole Meglumine 310g

[0065] Lactose 50g

[0066] Mannitol 40g

[0067] Sodium dihydrogen phosphate amount

[0068] Add water for injection to 2800ml

[0069] Take the prescription amount of meglumine, lactose, and mannitol and add 2500ml of water for injection to dissolve, add 1M sodium dihydrogen phosphate aqueous solution to adjust the pH to 7.8, add water for injection to 2800ml, and filter to sterilize with a microporous membrane. Carry out aseptic filling into 1000 vials under the condition of grade 100. After checking the content, add rubber stoppers, leave holes, and send the glass vials into a sterilized freeze-drying box for freeze-drying. Pre-freeze for 5 hours. Drop to -35, the first sublimation takes 8 hours, and the temperature rises to -5°C; the second sublimation takes 7 hours, the temperature rises to 25°C, take out the vacuum cap or nitrogen-filled cap, and label the aluminum cap. The finished product, each bottle of lyophilized powder for...

Embodiment 2

[0071] Glycindiazole Meglumine 150g

[0072] Sodium chloride 10g

[0073] Glucose 40g

[0074] Edetate Calcium Sodium 0.15g

[0075] Hydrochloric acid (0.1M) appropriate amount

[0076] Add water for injection to 2000ml

[0077] Take the prescription amount of meglumine glycididazole acid, sodium chloride, glucose, add 2800ml of water for injection to dissolve, then add calcium and sodium edetate to dissolve, adjust the pH to 8-9 with 0.1M hydrochloric acid, add water for injection to 2000ml, and use Stir 0.3% (w / v) needles with activated carbon, stir at 45°C for 30 minutes, decarbonize with a sterilized 0.6 μm filter membrane, filter and sterilize with a 0.22 μm filter membrane, measure and adjust the pH to 8-9, The filtrate is filled in 1000 vials, sent to a freeze dryer for freeze-drying, capped or filled with nitrogen, then capped and taken out, and then labeled. The freeze-drying curve is as follows:

[0078] process

[0079] Each bottle of the above-prep...

Embodiment 3

[0081] Glycindiazole Meglumine 600g

[0082] Sorbitol 100g

[0083] Sodium sulfite 12g

[0084] Phosphoric acid (solution) appropriate amount

[0085] Add water for injection to 4000ml

[0086] The preparation method is the same as in Example 1 except that the auxiliary materials are added.

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Abstract

The invention relates to a freeze-dried powder injection for meglumine glycididazole, which contains the meglumine glycididazole, a pharmaceutical carrier and a pH value regulator. According to the property of the meglumine glycididazole compound, a freeze drying process is adopted to prepare the meglumine glycididazole compound into the freeze-dried powder injection, thereby providing the clinical application with the meglumine glycididazole freeze-dried powder injection with reliable stability, safety, effectiveness, and convenient use. And a method for preparing the meglumine glycididazole freeze-dried powder injection is provided.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a freeze-dried powder injection of glycididazole meglumine and a preparation method thereof. Background technique [0002] Glycindiazole acid meglumine is the meglumine salt compound of glycididazole acid. It is a new type of radiochemotherapy sensitizer, which can enhance the killing effect of radiation and radiochemotherapy drugs on hypoxic cells of tumors. There is less damage to aerobic normal tissues, while the tolerance of hypoxic cells to radiation and chemotherapy drugs is three times stronger than that of aerobic cells in tumor tissues, and they have obvious resistance to radiation and radiotherapy and chemotherapy drugs, so , in conventional radiotherapy and chemotherapy doses, hypoxic cells cannot be effectively killed, and become a "shelter" for tumor metastasis and survival. The root cause of recurrence, and glycidazole acid meglumine has a def...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/417A61K47/10A61K47/26A61K47/40A61P43/00
Inventor 杨喜鸿
Owner 杨喜鸿
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