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A kind of sodium ibandronate composition and preparation method thereof

A technology of sodium ibandronate and its composition, applied in the field of sodium ibandronate composition and its preparation

Active Publication Date: 2019-02-26
南京恒生制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In our experiments, we unexpectedly found that it has the effect of preventing the polymerization of ibandronic acid sodium, which has not been reported in the literature; moreover, there is no report about the addition of p-aminophenol in ibandronic acid preparations

Method used

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  • A kind of sodium ibandronate composition and preparation method thereof
  • A kind of sodium ibandronate composition and preparation method thereof
  • A kind of sodium ibandronate composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034]

[0035] step:

[0036] a) Add 1600mL of water for injection in the batching tank, sequentially add the prescribed amount of p-aminophenol, sodium ibandronate, acetic acid, sodium acetate, and stir to dissolve;

[0037] b) Dilute to a total volume of 2000ml with water for injection;

[0038] c) Add 0.1% activated carbon for needles to the solution obtained above, stir for 30 min, and adjust the osmotic pressure to 260-500 mOsmol / kg with potassium chloride;

[0039] d) filter and sterilize the above solution with a 0.2 μm microporous membrane, and measure the pH to be 3.6;

[0040] e) filling the above-mentioned solution with a glass ampoule according to the specifications to make 1000 liquid preparations;

[0041] f) Light inspection, check the appearance and visible foreign objects, vested.

Embodiment 2

[0043]

[0044]

[0045] step:

[0046] a) Add 1600mL of water for injection into the batching tank, add the prescribed amount of p-aminophenol and sodium ibandronate in sequence, and stir to dissolve;

[0047] b) Dilute to a total volume of 1800ml with water for injection;

[0048] c) Add 0.1% activated carbon for needles to the solution obtained above, stir for 30 minutes, adjust the pH to 3 with acetic acid, and adjust the osmotic pressure to 260-500 mOsmol / kg with sodium chloride;

[0049] d) filter and sterilize the above solution with a 0.2 μm microporous membrane;

[0050] e) Fill the above-mentioned solution with the vial according to the specification, and make 1000 liquid preparations;

[0051] f) Light inspection, check the appearance and visible foreign objects, vested.

Embodiment 3

[0053]

[0054] step:

[0055] a) Add 1600mL of water for injection into the batching tank, sequentially add the prescribed amount of p-aminophenol and ibandronate sodium, and stir to dissolve;

[0056] b) Dilute to a total volume of 2000ml with water for injection;

[0057] c) Add 0.1% activated carbon for needles to the solution obtained above, stir for 30 minutes, adjust the pH to 5 with sodium carbonate, and adjust the osmotic pressure to 260-500 mOsmol / kg with glucose;

[0058] d) filter and sterilize the above solution with a 0.2 μm microporous membrane;

[0059] e) filling the above-mentioned solution with a glass ampoule according to the specifications to make 1000 liquid preparations;

[0060] f) Light inspection, check the appearance and visible foreign objects, vested.

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PUM

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Abstract

The invention discloses a sodium ibandronate composition and a preparation method of the sodium ibandronate composition. The sodium ibandronate composition is prepared from the following components in parts by weight: 1-2 parts of p-aminophenol, and 100 parts of sodium ibandronate. The composition is stable in the long-term sample reserving process, thus the generation of iban-dimer is avoided, and the stability is good.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a sodium ibandronate composition and a preparation method thereof. Background technique [0002] Sodium ibandronate is a third-generation bisphosphonate drug, which is an analogue of endogenous pyrophosphate; it can strongly inhibit the activity of osteoclasts and bone resorption, with definite curative effect, long-lasting effect and relatively low side effects. Small, gradually become the drug of choice for the treatment of hypercalcemia complicated by malignant tumors and bone pain caused by osteolytic cancer metastasis. The structural formula of ibandronate sodium is as follows: [0003] [0004] Sodium ibandronic acid is unstable and has a tendency to polymerize as a solid or in dissolved water to form ibandronic acid dimers. Pharmacological experiments prove that ibandronic acid dimer is an allergen for the body. [0005] [0006] None of the currently...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/663A61K47/18A61K9/08A61P35/00A61P3/14A61P35/04A61P29/00A61P19/08
CPCA61K9/0019A61K9/08A61K31/663A61K47/18
Inventor 王卓异陈英睿顾泱泱
Owner 南京恒生制药有限公司
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