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Nizatidine freeze-dried powder injection and preparation method thereof

A nizatidine and freeze-drying technology, which is applied in the field of drugs and their preparations, can solve problems such as poor controllability, and achieve the effects of fast onset, high safety, and high bioavailability

Inactive Publication Date: 2009-06-10
湖南康鑫医药股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, only nizatidine tablets and capsules are available on the domestic market, which are imported varieties (150mg×6 capsules / box). At the same time, there are problems such as product quality stability, therapeutic effect and safety, and transportation is also considered. And storage and other factors, both tablets and capsules have disadvantages, poor controllability

Method used

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  • Nizatidine freeze-dried powder injection and preparation method thereof
  • Nizatidine freeze-dried powder injection and preparation method thereof
  • Nizatidine freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0234] Embodiment 1: Preparation of Nizatidine freeze-dried powder injection

[0235] Nizatidine 100g

[0236] Mannitol 100g

[0237] Aspartic Acid 20g

[0238] Edetate Disodium 0.8g

[0239] Water for injection 2000ml

[0240] A total of 1000 freeze-dried products were made

[0241] Preparation Process:

[0242] a. Preparation of liquid medicine

[0243] a1, take the prescribed amount of injection-grade nizatidine raw material (content not less than 98.0%), add water for injection to dissolve, then add the prescribed amount of mannitol, aspartic acid, disodium edetate, stir until all Dissolve, add water for injection to the specified volume, such as 2000ml.

[0244] a2. Or dissolve the specified amount of mannitol, aspartic acid, and edetate disodium in water, then add the injection grade nizatidine raw material, stir until completely dissolved, mix well, add water for injection to the specified volume, such as 2000ml .

[0245] b. Depyrogenation

[0246] Add activa...

Embodiment 2

[0258] Embodiment 2: Preparation of Nizatidine freeze-dried powder injection

[0259] Nizatidine 100g

[0260] Dextran 40 100g

[0261] L-Arginine 15g

[0262] Water for injection 2000ml

[0263] A total of 1000 freeze-dried products were made

[0264] The preparation method is the same as in Example 1 except that the auxiliary materials added are different.

Embodiment 3

[0265] Embodiment 3: Preparation of Nizatidine freeze-dried powder injection

[0266] Nizatidine 100g

[0267] Lactose 50g

[0268] L-Arginine 15g

[0269] Edetate Disodium 1g

[0270] Water for injection 2000ml

[0271] A total of 1000 freeze-dried products were made

[0272] The preparation method is the same as in Example 1 except that the auxiliary materials added are different.

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Abstract

The invention relates to a freeze-dry powder preparation for nizatidine injection and preparing method thereof. The freeze-dry powder is composed of active component nizatidine and pharmaceutically acceptable carrier component, the weight ratio of the nizatidine compound and the selected pharmaceutically acceptable carrier is 1-10:0-10, wherein, the pharmaceutically acceptable carrier is composed of at least one of excipient, latent solvent, antioxidant or water, the excipient is at least one of mannitol, sodium chloride, rheomacrodex, benzoic acid, glucide substance, cyclodextrin, soluble starch, cellulose substance, ascorbic acid, hydrolyzed gelatin, glycine or water, the latent solvent is at least one of aminoacids substance, alcohols substance, acidamides and carbamides derivatives or amines, the antioxidant is at least one of sodium bisulphate, ascorbic acid derivatives aminoacids or chelating agent. The freeze-dry powder preparation prepared by the invention has good stability, simple operating process and ontrollability.

Description

(1) Technical field [0001] The invention relates to the field of medicines and preparations thereof. Specifically, the invention relates to nizatidine, a medicine for treating peptic ulcer and recurrence after healing, and its freeze-dried powder injection, and a preparation method thereof. (2) Background technology [0002] Nizatidine (English name: Nizatidine, Axid, Nizax, Caemaxid) is a potent H 2 The receptor antagonist replaces the furan ring of ranitidine with a thiazole ring, and its basic chemical structure is similar to that of famotidine. Its molecular formula is C 12 h 21 N 5 o 2 S 2 , the molecular weight is 331.46. Chemical Structure: [0003] [0004] After cimetidine and ranitidine, nizatidine has higher curative effect and fewer adverse reactions, and is more competitive in peptic ulcer disease. [0005] At present, only nizatidine tablets and capsules are available on the domestic market, which are imported varieties (150mg×6 capsules / box). At the...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/426A61P1/04
Inventor 周利
Owner 湖南康鑫医药股份有限公司
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