Ibandronate sodium containing injection

A technology of sodium ibandronate and injection, applied in the field of medicine, can solve the problems of irritation, respiratory system irritation, increase the potential cost of products, etc., and achieve the effect of eliminating irritation and good stability

Active Publication Date: 2014-07-16
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In 2003, the U.S. FDA approved Boniva, which is used once a day, to go on the market, but because pharmaceutical companies have developed a more convenient dosage, the drug has not been on the market.
[0006] Sodium ibandronate injection has imported and domestic drugs on the market at present, but without exception, acetate is used as the buffer system in the injection. As we all know, the components of acetate buffer, acetic acid and sodium acetate, have Corrosive, and glacial acetic acid is irritating to the respiratory system. Sodium acetate is also irritating because it can react with water in the air to form acetic acid. Both need to strengthen the operator's awareness of protection and strengthen protective measures, thus increasing the potential cost of the product

Method used

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  • Ibandronate sodium containing injection
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  • Ibandronate sodium containing injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Embodiment 1: Injection of the present invention

[0042]

[0043] Preparation Process:

[0044] 1) Take 90% of the prescribed amount of water for injection, add the prescribed amount of sodium chloride and disodium hydrogen phosphate dodecahydrate in sequence, and stir to dissolve without heating.

[0045] 2) Add the prescription amount of sodium ibandronate monohydrate to the solution obtained above, stir and dissolve without heating.

[0046] 3) Measure the pH value of the solution obtained above, and adjust the pH value of the solution to 3.5-4.5 with 0.1M hydrochloric acid or sodium hydroxide. Dilute to the total volume with water for injection and stir.

[0047] 4) Add 0.1% activated carbon for needles to the solution obtained above, and stir for 30 minutes.

[0048] 5) Filter the solution obtained above with a 5um titanium filter to remove activated carbon.

[0049] 6) Filter the above solution with a 0.2um plate filter to remove other insoluble particles ...

Embodiment 2

[0054] Embodiment 2: Injection of the present invention

[0055]

[0056] Preparation Process:

[0057] 1) Take 90% of the prescribed amount of water for injection, add the prescribed amount of sodium chloride and disodium hydrogen phosphate dodecahydrate in sequence, and stir to dissolve without heating.

[0058] 2) Add the prescription amount of sodium ibandronate monohydrate to the solution obtained above, stir and dissolve without heating.

[0059]3) Measure the pH value of the solution obtained above, and adjust the pH value of the solution to 3.54.5 with 0.1M hydrochloric acid or sodium hydroxide. Dilute to the total volume with water for injection and stir.

[0060] 4) Add 0.1% activated carbon for needles to the solution obtained above, and stir for 30 minutes.

[0061] 5) Filter the solution obtained above with a 5um titanium filter to remove activated carbon.

[0062] 6) Filter the above solution with a 0.2um plate filter to remove other insoluble particles sm...

Embodiment 3

[0067] Embodiment 3: Injection of the present invention

[0068]

[0069] Preparation Process:

[0070] 1) Take 90% of the prescribed amount of water for injection, add the prescribed amount of disodium hydrogen phosphate dodecahydrate in turn, stir to dissolve, without heating. 2) Add the prescription amount of sodium ibandronate monohydrate to the solution obtained above, stir and dissolve without heating.

[0071] 3) Measure the pH value of the solution obtained above, and adjust the pH value of the solution to 3.54.5 with 0.1M hydrochloric acid or sodium hydroxide. Dilute to the total volume with water for injection and stir.

[0072] 4) Add 0.1% activated carbon for needles to the solution obtained above, and stir for 30 minutes.

[0073] 5) Filter the solution obtained above with a 5um titanium filter to remove activated carbon.

[0074] 6) Filter the above solution with a 0.2um plate filter to remove other insoluble particles smaller than 5um and further increase...

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PUM

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Abstract

The invention relates to an ibandronate sodium containing injection. The injection is prepared by ibandronate sodium and pharmaceutically acceptable auxiliary materials; a pH value of the injection is controlled to be 3.5-4.5 by a phosphate buffer; activated carbon accounting for 0.1% of the total volume of the injection is used for removing a pyrogen; and adsorption of activated carbon to a main medicine is avoided while the pyrogen is removed. An accelerated stability test indicates that the impurity content of the injection is lower than that of the marketed injection, and the quality is stable and controllable.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an injection containing sodium ibandronic acid and a preparation method thereof. Background technique [0002] Ibandronate sodium (English name: ibandronate sodium) is a bisphosphonate compound of ibandronic acid, which can specifically act on bone tissue. The specific selective effect on bone is due to the effect of bisphosphonate on inorganic have a high degree of affinity. Its chemical name is [1-hydroxy-3-(N-methyl-N-pentylamino)propylene]-bisphosphonic acid monosodium salt-hydrate, namely sodium ibandronate monohydrate, and its structural formula As shown below: [0003] [0004] Ibandronate sodium is a third-generation bisphosphonate compound, which belongs to aminobisphosphonate. It was first registered in Germany and Austria under the trade name Bondronat in 1996 and used clinically. In 2003, the US FDA approved Boniva, which is used once a day, to go ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/663A61K47/02A61P35/04A61P19/08
Inventor 董凯李宝齐孙长海姚小青
Owner TIANJIN CHASE SUN PHARM CO LTD
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