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Preparation method of polyinosinic acid-polycytidylic acid lyophilized powder injection

A technology of polycytidylic acid and polyinosinic acid, which is applied in the field of preparation of polyinosinic acid polycytidylic acid freeze-dried powder injection, can solve the toxic and side effects of oxidative degradation products, easy oxidative degradation, and short validity period To achieve the effect of increasing clinical pharmacological effects, prolonging the validity period, and reducing toxic and side effects

Inactive Publication Date: 2013-03-27
天津泽世德生物医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] According to the existing technical data and product instructions, polyinocytes are mainly made into injections, and the route of administration is intramuscular injection, which cannot be stored in frost below 0°C, has a short validity period (1 to 2 years), and is easy to oxidize and degrade. Its oxidative degradation products have relatively large toxic and side effects

Method used

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  • Preparation method of polyinosinic acid-polycytidylic acid lyophilized powder injection
  • Preparation method of polyinosinic acid-polycytidylic acid lyophilized powder injection

Examples

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Embodiment 1

[0026] A preparation method of polyinosinic acid polycytidylic acid freeze-dried powder injection, comprising the following steps:

[0027] (1) Take an appropriate amount of polycytidylic acid and polyinosinic acid, the compatibility ratio of polycytidylic acid and polyinosinic acid is 1:0.8, dissolve them in sterilized normal saline, keep warm at 35°C for half an hour, mix, slowly Stir for 0.5 hour to make polyinosinic acid and polycytidylic acid solution;

[0028] (2) Dissolve quantitative hydroxyethyl starch, sodium chloride, vitamin C, kanamycin sulfate, and sodium bisulfite in distilled water, adjust the pH value to 7.2-7.4, filter, sterilize, and cool to 5°C , dissolved in polyinosinic acid polycytidylic acid solution, so that the content of vitamin C is 0.1%, the content of sodium bisulfite is 0.02%, the content of kanamycin sulfate is 0.1%, and the content of sodium chloride is 0.5%. The content of hydroxyethyl starch is 5.0%;

[0029] (3) Filter with a 0.22 μm filte...

Embodiment 2

[0032] A preparation method of polyinosinic acid polycytidylic acid freeze-dried powder injection, comprising the following steps:

[0033] (1) Take an appropriate amount of polycytidylic acid and polyinosinic acid, the compatibility ratio of polycytidylic acid and polyinosinic acid is 1:1.2, dissolve them in sterilized normal saline, keep warm at 45°C for half an hour, mix, slowly Stir for 1.5 hours to make a polyinosinic acid polycytidylic acid solution;

[0034] (2) Dissolve quantitative hydroxyethyl starch, sodium chloride, vitamin C, kanamycin sulfate, and sodium bisulfite in double-distilled water, adjust the pH value to 7.2-7.4, filter, sterilize, and cool to 5 ℃, dissolved in polyinosinic acid polycytidylic acid solution, so that the content of vitamin C is 0.2%, the content of sodium bisulfite is 0.1%, the content of kanamycin sulfate is 0.15%, and the content of sodium chloride is 0.9%. , The content of hydroxyethyl starch is 10.0%.

[0035] (3) Filter with a 0.22 ...

Embodiment 3

[0038] A preparation method of polyinosinic acid polycytidylic acid freeze-dried powder injection, comprising the following steps:

[0039] (1) Take an appropriate amount of polycytidylic acid and polyinosinic acid, the compatibility ratio of polycytidylic acid and polyinosinic acid is 1:1.8, dissolve them in sterilized normal saline, keep warm at 55°C for half an hour, mix, slowly Stir for 1.0 hour, add kanamycin sulfate, make the content of kanamycin sulfate be 0.12%, make polyinosinic acid polycytidylic acid solution;

[0040] (2) Dissolve quantitative hydroxyethyl starch, sodium chloride, vitamin C, kanamycin sulfate, and sodium bisulfite in double-distilled water, adjust the pH value to 7.2-7.4, filter, sterilize, and cool to 5 ℃, dissolved in polyinosinic acid polycytidylic acid solution, so that the content of vitamin C is 0.35%, the content of sodium bisulfite is 0.8%, the content of kanamycin sulfate is 0.12%, and the content of sodium chloride is 0.8%. , The content...

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Abstract

The invention discloses a preparation method of a polyinosinic acid-polycytidylic acid lyophilized powder injection. The method comprises the preparation of a polyinosinic acid-polycytidylic acid solution and a preparation of a lyophilized powder injection thereof. According to the invention, proper amounts of polyinosinic acid and polycytidylic acid are respectively dissolved by using normal saline; the mixtures are mixed and stirred, such that the polyinosinic acid-polycytidylic acid solution is prepared; a lyophilization additive is added and well mixed; and filtering, sub-packaging, and lyophilization are carried out. The prepared injection is suitable for frost preservation under a temperature below 0 DEG C. Therefore, expiration date is postponed, oxidative degradation speed is reduced, toxic and side effect are reduced, and stability is improved.

Description

technical field [0001] The present invention relates to a preparation method of polyinosinic acid polycytidylic acid freeze-dried powder injection, in particular to polyinosinic acid polycytidylic acid, stabilizer, antioxidant, excipient, etc. The preparation method of the freeze-dried powder injection of composition. Background technique [0002] Polyinosinic acid Polycytidylic acid is also known as polyinosinic acid, polyinosine nucleotide, polycytosine nucleotide. It is one of the high-molecular polynucleotides (polynucleotides) substances. It is composed of polyinosinic acid and polycytidylic acid to form a double-stranded polynucleotide chain. It has characteristic color reduction and melting point, and is stable at -20°C. Whether it is freeze-dried powder or solution, sodium chloride is often contained in the product to achieve isotonicity while maintaining the solution state. First use biotechnology to synthesize polyinosinic acid and polycytidylic acid single chain...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/787A61K47/36A61P31/20A61P31/14A61P31/10A61P35/00A61P31/12
Inventor 沈丽丽张伟李婷
Owner 天津泽世德生物医药有限公司
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