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Sodium ibandronate injection composition

A kind of ibandronate sodium, injection technology, applied in the field of medicine

Inactive Publication Date: 2013-11-13
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the detection wavelength of this detection method is longer, and accuracy is lower, can not accurately reflect the true content of free phosphate in the sodium iban phosphate composition, is unfavorable for the accurate measurement of product quality

Method used

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  • Sodium ibandronate injection composition
  • Sodium ibandronate injection composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Prescription: ibandronate sodium 6.75g

[0043] Sodium chloride 54g

[0044]Sodium metabisulfite 9.00g

[0045] Sodium acetate 4.8g

[0046] Acetic acid appropriate to pH 4

[0047] Add water for injection to 6000ml

[0048] Made 1000 pieces

[0049] Take the needle and add activated carbon to sodium hydroxide solution, raise the temperature to 50°C, stir for 1 hour, filter, wash the residue with dilute hydrochloric acid solution, and then rinse with water for injection 2-5 times until it becomes neutral, and dry it for later use.

[0050] Dissolve sodium chloride and sodium acetate in 95% of the prescribed amount of water for injection, stir to dissolve and adjust the pH to 4.0 with acetic acid; add the prescribed amount of sodium ibandronate, stir to dissolve, make up the water for injection to the full amount; 0.03% spare activated carbon, heat preservation and stirring for 15 minutes, primary filtration, fine filtration, cooling to room temperature, determinati...

Embodiment 2

[0057] Prescription: ibandronate sodium 6.75g

[0058] Sodium chloride 42g

[0059] Sodium metabisulfite 6.75g

[0060] Sodium acetate 4.8g

[0061] Acetic acid appropriate to pH 5

[0062] Add water for injection to 6000ml

[0063] Made 3000 pieces

[0064] Take the needle and add activated carbon to sodium hydroxide solution, raise the temperature to 50°C, stir for 1 hour, filter, wash the residue with dilute hydrochloric acid solution, and then rinse with water for injection 2-5 times until it becomes neutral, and dry it for later use.

[0065] Dissolve sodium chloride and sodium acetate in 90% of the prescribed amount of water for injection, stir to dissolve and adjust the pH to 5.0 with acetic acid; add the prescribed amount of sodium ibandronate, stir to dissolve, make up the water for injection to the full amount; 0.03% spare activated carbon, heat preservation and stirring for 15 minutes, primary filtration, fine filtration, cooling to room temperature, determinat...

Embodiment 3

[0072] Prescription: ibandronate sodium 6.75g

[0073] Sodium chloride 67.5g

[0074] Sodium metabisulfite 13.50g

[0075] Sodium acetate 4.8g

[0076] Acetic acid Appropriate to pH 6

[0077] Add water for injection to 6000ml

[0078] Made 6000 pieces

[0079] Take the needle and add activated carbon to sodium hydroxide solution, raise the temperature to 50°C, stir for 1 hour, filter, wash the residue with dilute hydrochloric acid solution, and then rinse with water for injection 2-5 times until it becomes neutral, and dry it for later use.

[0080] Dissolve sodium chloride and sodium acetate in 80% of the prescribed amount of water for injection, stir to dissolve and adjust the pH to 6.0 with acetic acid; add the prescribed amount of sodium ibandronate, stir to dissolve, make up the full amount of water for injection; 0.03% spare activated carbon, heat preservation and stirring for 15 minutes, primary filtration, fine filtration, cooling to room temperature, determinat...

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Abstract

The invention belongs to the technical field of medicines, especially relates to the field of pharmacy, and specifically relates to a sodium ibandronate injection composition. The composition consists of sodium ibandronate, an osmotic-pressure conditioning agent, an antioxidant, a pH conditioning agent and injection water, wherein the content of free phosphate is less than 0.2%. The sodium ibandronate injection composition not only is accord with a quality standard, but also is more stable, safer for patients, and more suitable for clinical application. Additionally, the invention also provides a detection method for an extremely low concentration phosphate; and the method is high in sensitivity, is capable of more accurately detecting the content of the free phosphate in the sodium ibandronate injection composition, and guaranteeing sensitivity and accuracy of quality detection on the sodium ibandronate injection composition.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to the field of pharmacy, and more specifically relates to a composition for sodium ibandronate injection. Background technique [0002] Sodium ibandronate, the chemical name is 1-hydroxy-3-(methyl-n-pentylamino)-propylidene-1,1-bisphosphonic acid, the structural formula is as follows, it is a bisphosphonate bone resorption inhibitor , the commonly used clinical dosage form is ibandronate sodium injection, which is used for the treatment of postmenopausal osteoporosis, bone pain caused by osteolytic bone metastasis of malignant tumors, and hypercalcemia caused by malignant tumors with or without bone metastasis blood disease. Sodium ibandronate mainly inhibits the dissolution and formation of hydroxyapatite by combining with hydroxyapatite in bone, thereby producing anti-bone resorption effect. [0003] . [0004] Generally, the synthesis of sodium ibandronate requires the use...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/663G01N21/33A61K47/12A61P19/10A61P29/00A61P19/08A61P3/14
Inventor 赵俊蔡继兰杨奇珍
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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