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Freeze-drying manufactured product of cytidine triphosphate disodium and arginine and preparation method thereof

A technology of disodium cytidine triphosphate and freeze-dried products, which is applied to medical preparations with no active ingredients, medical preparations containing active ingredients, freeze-dried transportation, etc. It can solve the problems that the stability needs to be further improved, and achieve good safety effect

Inactive Publication Date: 2012-01-04
广东彼迪药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The pH of the resulting product of the invention is acidic, and the stability needs to be further improved

Method used

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  • Freeze-drying manufactured product of cytidine triphosphate disodium and arginine and preparation method thereof
  • Freeze-drying manufactured product of cytidine triphosphate disodium and arginine and preparation method thereof
  • Freeze-drying manufactured product of cytidine triphosphate disodium and arginine and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: Get 10.0 g of arginine and 5.0 g of mannitol, dissolve them in water for injection, add an appropriate amount of activated carbon, absorb, filter and decarbonize, add 10.0 g of cytidine triphosphate disodium (purified), stir to dissolve, add Water for injection to 500ml, the measured pH value is 9.0, filtered with a 0.22 μm microporous membrane, subpackaged in vials according to the aseptic method, freeze-dried in a freeze dryer, plugged and capped, and 462 bottles of samples were obtained. Each bottle contains 20mg of cytidine triphosphate disodium.

Embodiment 2

[0031] Comparative Example 2: Get 5.0 g of glycine and 2.5 g of mannitol, dissolve them in water for injection, add an appropriate amount of activated carbon, absorb, filter and decarbonize, add 5.0 g of cytidine triphosphate disodium (purified), stir to dissolve, and hydrogenate Sodium oxide solution was used to adjust and measure the pH value to 7.0, add water for injection to 250ml, filter with 0.22μm microporous membrane, pack into vials according to the aseptic method, freeze-dry in a freeze dryer, press the stopper, roll the cap, 202 bottles of qualified samples were obtained, and each bottle contained 20 mg of disodium cytidine triphosphate.

Embodiment 3

[0032] Comparative Example 3: Get 10.0 g of arginine hydrochloride and 5.0 g of mannitol, dissolve them with water for injection, add an appropriate amount of activated carbon, absorb, filter and decarbonize, add 10.0 g of cytidine triphosphate disodium (purified), stir and dissolve , add water for injection to 500ml, add sodium hydroxide solution to adjust the measured pH value to 6.0, filter with a 0.22 μm microporous membrane, pack in vials according to the aseptic method, freeze-dry in a freeze dryer, press stopper, Roll the cap to obtain 454 bottles of qualified samples, each containing 20 mg of cytidine triphosphate disodium.

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PUM

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Abstract

The invention provides a freeze-drying manufactured product of cytidine triphosphate disodium and arginine, which comprises cytidine triphosphate disodium used as an active component and arginine used as a stabilizing agent, wherein the weight ratio of the cytidine triphosphate disodium and the arginine is 1:0.4-3.2. The pH of a water solution of the freeze-drying manufactured product is 7.0-11.0. The freeze-drying manufactured product provided by the invention minimizes the degradation of the cytidine triphosphate disodium, thereby ensuring the effectiveness and the safety of a medicine. A freeze-drying product or injection with stable quality can be prepared according to the formula and the control parameter of the invention and can be used for producing the injection or can be directlyused in clinic. In addition, the invention also provides a method for producing the freeze-drying manufactured product.

Description

technical field [0001] The invention relates to a stable form of cytidine triphosphate disodium, in particular to a freeze-dried product of cytidine triphosphate disodium with arginine as a stabilizer. The invention also relates to a preparation method of cytidine triphosphate disodium freeze-dried product. Background technique [0002] Cytidine triphosphate disodium is a nucleotide derivative and a coenzyme drug, which has the pharmacological effects of participating in and regulating substance metabolism, nourishing nerves and anti-vascular sclerosis, so it is widely used. However, cytidine triphosphate disodium is thermally unstable, and its raw materials are required to be stored in a cold place, and the preparation is required to be stored in a cool place. After investigation, the chemical stability of the currently commercially available products cannot be guaranteed under the specified cool storage conditions. The reason for the instability of disodium cytidine trip...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/36A61K9/19A61P25/00A61K47/10A61K31/7068A61K47/18A61P3/00A61P9/10A61K47/26
Inventor 杨松明蒋林波陈杰
Owner 广东彼迪药业有限公司