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Sodium ibandronate injection composition and preparation method of sodium ibandronate injection composition

A technology of sodium ibandronate and composition is applied in the field of composition containing ibandronate sodium injection and its preparation, and can solve the problem of poor thermal stability and chemical stability and high toxicity of soda-lime-silicate glass ampoules and other problems, to achieve the effects of good thermal stability and chemical stability, stable quality and simple prescription

Active Publication Date: 2013-08-14
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, low molecular weight polyethylene glycol is more toxic, and there is a greater risk in adding polyethylene glycol to the injection, and the thermal stability and chemical stability of the soda lime silicate glass ampoule are relatively low. Poor glass ampoules

Method used

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  • Sodium ibandronate injection composition and preparation method of sodium ibandronate injection composition
  • Sodium ibandronate injection composition and preparation method of sodium ibandronate injection composition
  • Sodium ibandronate injection composition and preparation method of sodium ibandronate injection composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Example 1: (specification: 1ml:1mg)

[0060]

[0061] Add 950ml of water for injection, keep the temperature of the water for injection at 20°C to 30°C, weigh the prescribed amount of sodium acetate and add it, stir to dissolve and stir evenly; adjust the pH of the solution to 4.0 with glacial acetic acid; add 0.1% ( W / V) Medicinal charcoal, adsorb for 20 minutes, decarbonize; add the prescribed amount of ibandronate sodium, stir for 15 minutes to dissolve the main ingredient and stir evenly; add water to 1000ml, test the pH value of the solution, and use ice if necessary Adjust the pH value of the solution to 4.0 with acetic acid; use "0.45μm + 0.22μm" serial sterilizing filter for fine filtration; fill in low borosilicate glass ampoules and seal; sterilize with 121°C moist heat steam for 15 minutes, light inspection, Obtain ibandronate sodium injection.

Embodiment 2

[0062] Example 2: (specification: 2ml:2mg)

[0063]

[0064] Add 1900ml of water for injection, keep the temperature of the water for injection at 20°C to 30°C, weigh the prescribed amount of sodium acetate and add it, stir to dissolve and stir evenly; adjust the pH of the solution to 4.0 with glacial acetic acid; add 0.1% ( W / V) Medicinal charcoal, adsorb for 20 minutes, decarbonize; add the prescribed amount of ibandronate sodium, stir for 15 minutes to dissolve the main ingredient and stir evenly; add water to 2000ml, test the pH value of the solution, and use ice if necessary Adjust the pH value of the solution to 4.0 with acetic acid; use "0.45μm + 0.22μm" serial sterilizing filter for fine filtration; fill in low borosilicate glass ampoules and seal; sterilize with 121°C moist heat steam for 15 minutes, light inspection, Obtain ibandronate sodium injection.

Embodiment 3

[0065] Example 3: (specification: 6ml:6mg)

[0066]

[0067] Add 5700ml of water for injection, keep the temperature of the water for injection at 20°C to 30°C, weigh the prescribed amount of sodium acetate and add it, stir to dissolve and stir evenly; adjust the pH of the solution to 4.2 with glacial acetic acid; add 0.1% ( W / V) Medicinal charcoal, adsorb for 20 minutes, decarbonize; add the prescribed amount of ibandronate sodium, stir for 15 minutes to dissolve the main ingredient and stir evenly; add water to 6000ml, test the pH value of the solution, and use ice if necessary Adjust the pH value of the solution to 4.2 with acetic acid; use "0.45μm + 0.22μm" serial sterilizing filter for fine filtration; fill in low borosilicate glass ampoules and seal; sterilize with 121°C moist heat steam for 15 minutes, light inspection, Obtain ibandronate sodium injection.

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Abstract

The invention provides a sodium ibandronate injection composition. Every 1000 injections consist of the following components: 1.0684-6.4101g of sodium ibandronate, 1.66-9.96g of sodium acetate, suitable amount of glacial acetic acid, and 1000-6000ml of water for injection. The sodium ibandronate injection prepared by the invention has the advantages that the prescription is simple, auxiliary materials are all commonly used by the injection, and the safety is high. Simultaneously the sodium acetate content is low, irritation cannot be produced in intravenous administration, the prepared final product is stable in quality, and the indexes of related substances and contents are all superior to those in the prior art.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a composition containing sodium ibandronate injection and a preparation method thereof. Background technique [0002] Sodium ibandronate, the chemical name is [1-hydroxy-3-(N-methyl-N-pentylamino)propylene] bisphosphonic acid monosodium salt monohydrate, molecular formula C 9 h 22 NNaO 7 P 2 ·H 2 O, the molecular weight is 359.24, and the structural formula is: [0003] [0004] Sodium ibandronate is a bisphosphonate compound, suitable for hypercalcemia caused by tumors, prevention and treatment of bone-related events related to tumor bone metastasis, and prevention and treatment of osteoporosis in postmenopausal women. In the "Breast Cancer Clinical Practice Guidelines" (China Edition) promulgated by NCCN in 2008, it was recommended to use ibandronate sodium for the treatment of bone-related events after bone metastasis of breast cancer. Consensus has repeatedly recomm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/663A61P3/14A61P19/08A61P19/10
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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