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Sodium ibandronate injection composition

A technology of ibandronic acid sodium and ibandronic acid, applied in the field of ibandronic acid sodium injection composition and its preparation, can solve the problems of high content of related substances, low safety of excipients, high content of substances, etc., and achieve prescription Simplicity, high safety, low cost effect

Active Publication Date: 2015-09-23
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, listed products And the prescription of CN103239396 contains corrosive acetate; CN103961313 uses citrate to increase stability, but citric acid has anticoagulant activity, and is not suitable as an auxiliary material for injections; CN103385882 has adopted a serious safety hazard Sodium metabisulfite is used as antioxidant; CN103070824 adopts phosphate buffer system to replace acetate buffer solution, but the content of related substances is still relatively high
[0005] Therefore, the ibandronate sodium injection in the prior art all has problems such as low safety of excipients and high content of related substances.

Method used

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  • Sodium ibandronate injection composition
  • Sodium ibandronate injection composition
  • Sodium ibandronate injection composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1 ibandronate sodium injection of the present invention

[0041] prescription:

[0042] Sodium ibandronic acid (calculated as ibandronic acid) 1g,

[0043] Glucose 30g,

[0044] Add water for injection to 1L.

[0045] Preparation:

[0046] Dissolve sodium ibandronate and glucose in 80% water for injection, add 0.05% activated carbon for injection, stir and absorb for 30 minutes, filter for decarburization, fine filter with a 0.22 μm filter membrane, add water for injection to the full volume, and the pH should be 4.0- 6.0, if necessary, it can be adjusted with a pH regulator, aliquoted, 1-6ml / bottle, sterilized at 121°C for 15 minutes, ready to use.

Embodiment 2

[0047] Embodiment 2 ibandronate sodium injection of the present invention

[0048] prescription:

[0049] Sodium ibandronic acid (calculated as ibandronic acid) 1g,

[0050] Glucose 50g,

[0051] Add water for injection to 1L.

[0052] Preparation method: with embodiment 1.

Embodiment 3

[0053] Embodiment 3 ibandronate sodium injection of the present invention

[0054] prescription:

[0055] Sodium ibandronic acid (calculated as ibandronic acid) 1g,

[0056] Glucose 100g,

[0057] Add water for injection to 1L

[0058] Preparation method: with embodiment 1.

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PUM

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Abstract

The invention provides a sodium ibandronate injection composition. A sodium ibandronate injection comprises sodium ibandronate serving as an active ingredient, glucose serving as a stabilizer and water for injection. The sodium ibandronate injection has the characteristics of simple prescription, high stability, high safety, suitability for industrial production and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an ibandronate sodium injection composition and a preparation method thereof. Background technique [0002] Intravenous infusion is the main way of clinical treatment and emergency medication and nutrition supply, and drug infusion phlebitis is one of the common clinical drug-induced diseases. It is generally believed that phlebitis is one of the risk factors for venous thrombosis. The pH value of human blood is 7.35-7.45, and the pH range that the human body can tolerate infusion is 4-9. When the pH of the infusion is lower than 4 or higher than 9, it will cause pain and phlebitis, and the severity of phlebitis is directly related to the pH of the infusion. The lower the pH value, the more severe the phlebitis. Japan's Otsuka Pharmaceutical Co., Ltd. Kuwahara et al. used rabbits to conduct experiments, and the results showed that the infusion of pH values ​...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/663A61K47/26A61P9/10
Inventor 牛涛涛
Owner HEBEI RENHE YIKANG PHARMA
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