Medicinal composition containing paricalcitol and preparation method of medicinal composition

A technology of paricalcitol and its composition, which is applied in the field of injection containing paricalcitol and its preparation, can solve the problems of excessive impurities, time-consuming production, content reduction, etc., and achieve simple and rapid preparation and high-quality products High safety effect

Active Publication Date: 2017-01-04
CHENGDU GUOHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to overcome the problems of reduced content, time-consuming production and excessive impurities in the prior art of paricalcitol injection, the present invention provides the following technical solutions:

Method used

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  • Medicinal composition containing paricalcitol and preparation method of medicinal composition
  • Medicinal composition containing paricalcitol and preparation method of medicinal composition
  • Medicinal composition containing paricalcitol and preparation method of medicinal composition

Examples

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Comparison scheme
Effect test

Embodiment 1

[0077]

[0078] Mix 200ml of ethanol and 300ml of propylene glycol evenly, add 0.5% (w / v) activated carbon to absorb for 15 minutes, decarbonize, add the prescribed amount of paricalcitol, stir to dissolve completely, then add water for injection to the full amount, stir evenly, Fill in 1ml ampoules, seal, and sterilize at 121°C for 12 minutes.

Embodiment 2

[0080]

[0081] Mix 200ml of ethanol and 300ml of propylene glycol, add 0.5% (w / v) activated carbon to absorb for 60 minutes, decarbonize, add the prescribed amount of paricalcitol, stir to dissolve completely, then add water for injection to the full amount, stir evenly, Fill in 1ml ampoules, seal, and sterilize at 121°C for 12 minutes.

Embodiment 3

[0083] According to the prescription described in Example 1, mix 200ml of ethanol and 300ml of propylene glycol evenly, add 0.5% (w / v) activated carbon to absorb for 50 minutes, decarbonize, add the prescribed amount of paricalcitol, stir to dissolve completely, and then add Make up to the full amount of water for injection, stir evenly, fill in 2ml ampoules, seal, and sterilize at 121°C for 12min.

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Abstract

The invention relates to a medicinal composition containing paricalcitol. The medicinal composition is composed of paricalcitol, alcohol, propanediol and water for injection. A preparation method of the medicinal composition comprises the following steps: uniformly mixing alcohol and propanediol, adding with 0.5% (w/v) activated carbon, carrying out adsorption for 15-75 min, carrying out decarburization, adding with paricalcitol, carrying out stirring so that the dissolving is complete, adding with the water for injection, carrying out uniform stirring, carrying out filling, carrying out sealing, and carrying out sterilization for 12 min at 121 DEG C. The invention further relates to a method for reducing the degradation impurities of the medicinal composition containing paricalcitol, which comprises the step of encapsulating the composition in an ampoule bottle, wherein the residual oxygen quantity of gas in the ampoule bottle is controlled to be 0.32-2 ml. The product is simple and rapid in preparation, no precipitation of raw materials occurs, the long-time stirring for redissolving of the materials is not needed, meanwhile, the residual oxygen quantity of the gas in an injection container is controlled, so that the content of the degradation impurity PCL-9 is reduced to be 0.1% or below after illumination, and thus the safety of the product is good.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to an injection containing paricalcitol and a preparation method thereof. Background technique [0002] Paricalcitol, also known as 19-nor-1,25-(OH) 2 - Vitamin D 2 or 19-nor-1,25-dihydroxyvitamin D 2 , is a synthetic, selective, third-generation bioactive vitamin D 2 Analogue, for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage V chronic kidney disease. Although the structure of the drug is similar to that of calcitriol, compared with calcitriol, it can inhibit parathyroid hormone faster and longer, and has little effect on calcium, phosphorus and calcium-phosphorus product, so persistent Hypercalcemia, and the drug is also more effective than calcitriol in reducing aortic calcification and improving bone quality, and can reduce patient mortality, hospitalization frequency and length of hospitalization. [0003] Paricalcitol was researc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/10A61K31/592A61P5/20
Inventor 蒋代财陈洋郭礼新郭晖
Owner CHENGDU GUOHONG PHARMA
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