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Atenolol frozen dry injecta and preparing method

A technology for freeze-dried preparations and injections, which is applied in the field of atenolol freeze-dried preparations for injection and its preparation, which can solve the problems of inconvenient transportation for water injections and low bioavailability of oral dosage forms, and achieve safe and effective clinical use and pharmaceutical preparations. Stable, good solubility effect

Inactive Publication Date: 2007-08-29
上海医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is to improve the low bioavailability of oral dosage forms and the inconvenient transportation of water injection, and design a new dosage form

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Formulation 1: Each bottle (bracket) of lyophilized preparation contains 2.5mg of atenolol

[0022] Atenolol 25mg

[0023] Mannitol 250mg

[0024] Dextran 40 200mg

[0025] 1mol / L HCl solution 5ml

[0026] 1mol / LNaOH solution appropriate amount

[0027] Add water for injection to 20ml

[0028]

[0029] Pack 10 bottles, 2ml each

[0030] Preparation method: add 1mol / L HCl solution to atenolol in the prescription, heat in a 30-70℃ water bath, stir to dissolve atenolol, add about 80% of the total amount of water for injection, and use 1mol / L NaOH solution Adjust the pH to 4.0-8.0, add the prescribed amount of mannitol and dextran 40, stir to dissolve all, add 30mg of activated carbon, and add water for injection to the full prescription, and stir for 15 minutes. Use a No. 3 vertical melting funnel to remove the activated carbon. The filtrate is finely filtered with a 0.22μm microporous membrane. After testing, the filtrate meets the requirem...

Embodiment 2

[0032] Formulation 2: Each bottle (tube) of freeze-dried preparation contains 5mg of Atenolol

[0033] Atenolol 50mg

[0034] Lactose 500mg

[0035] 50% lactic acid 10ml

[0036] 5%NaHCO 3 Solution amount

[0037] Add water for injection to 80ml

[0038]

[0039] Pack 10 bottles, 8ml each

[0040] Preparation method: add 50% lactic acid to atenolol in the prescription, heat and stir to dissolve atenolol completely, use 5% NaHCO 3 Adjust pH 4.0-8.0, add 60 mg of activated carbon, and add water for injection to the full amount of the prescription, and stir for 15 minutes. Other methods are the same as in Example 1.

Embodiment 3

[0042] Formula 3: Each bottle (bracket) of lyophilized preparation contains atenolol 7.5mg

[0043] Atenolol 75mg

[0044] Dextran 40 750mg

[0045] Citrate (anhydrous) 25mg

[0046] 5%NaHCO 3 Solution amount

[0047] Add water for injection to 80ml

[0048]

[0049] Pack 10 bottles, 8ml each

[0050] Preparation method: Take atenolol, dextran 40, citric acid in the prescription, add about 40ml of water for injection, heat and stir in a water bath at 80℃ to dissolve all, use 5% NaHCO 3 Adjust pH 4-8, add 80 mg of activated carbon, and add water for injection to the full amount of the prescription, and stir for 15 minutes. Other methods are the same as in Example 1.

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PUM

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Abstract

The present invention discloses an atenolol freeze-dried preparation for injection. Said atenolol freeze-dried preparation has good medicine stability, can be used fro clinical intravenous injection, and can be extensively used for early treatment of arrhythmia and acute myocardiac infarction. Besides, said invention also provides its preparation method.

Description

Technical field: [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a freeze-dried atenolol preparation for injection and a preparation method. Background technique: [0002] Atenolol is a selective β1 receptor blocker with no sympathomimetic activity and membrane stability developed by the British ICI company in 1976. In 1982, the US FDA approved it for the treatment of hypertension, angina pectoris, early acute myocardial infarction and arrhythmia. APIs, tablets and injections have been included in the British Pharmacopoeia and the United States Pharmacopoeia. Among them, the injection has been marketed in the United States, Britain, France, Canada, Switzerland and other countries, and has been included in the pharmacopoeia, and is clinically used for the early treatment of arrhythmia and acute myocardial infarction. The 2000 edition of the Chinese Pharmacopoeia contains atenolol raw materials and tablets, but there is no domest...

Claims

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Application Information

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IPC IPC(8): A61K31/165A61K9/19A61P9/12A61P9/10A61P9/06
Inventor 曾垂宇张晓航商鼎刘红
Owner 上海医药科技发展有限公司
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