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Stable thymalfasin preparation and preparation method thereof

A thymus method and preparation technology, which is applied in the field of medicine, can solve the problems of poor appearance of finished preparations, inconvenient clinical use, substandard quality, etc., and achieve the effects of avoiding adverse reactions, facilitating drug distribution, and increasing safety

Inactive Publication Date: 2012-12-12
苏州科耐尔医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present inventors have developed a novel type of drier called Throma® that helps prevent damage from excessive humidification when making certain types of medicine like tablets. By adding more glycerin into the mixture beforehand, the resulting medications are less likely to break down due to their own weightiness. Additionally, they use special techniques to control how quickly the material leaves through the container's opening while still maintain its shape integrity over several months without losing any remaining components. Overall these improvements make sure the final medical grade medicine works properly even if exposed to harsh environments where there might come out faster than usual.

Problems solved by technology

This patent describes different methods for producing lyophilized therapeutic compositions called THYLFISPIN®, which includes various chemical substances such as salts like tissue plasma extractives obtained from plants belonging to five genera - Xanthorrhaganiaceae family, Actinosynnema Blumei Follicularis, Lithiaton Bismuth Sulfapy Factor, Humula Antension Tape Agrossector, Bacillustochlium Calmette Yellow Aggregator Liquat Excipitation Compound made up of several technical means described below. These improvements aim towards improving purification efficiency, reducing costs associated with production processes, simplifying packaging procedures, controllability over time, ensuring consistence between multiple steps when administering them separately, maintaining stereoscopicity upon prolonged shelf life without losing its effectsiveness due to decomposition reactions caused by factors outside the body.

Method used

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  • Stable thymalfasin preparation and preparation method thereof
  • Stable thymalfasin preparation and preparation method thereof
  • Stable thymalfasin preparation and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0045] A kind of preparation method of stable thymus method new preparation, it comprises the steps:

[0046] (1) Add 0.1g of thymofasin and 10g of mannitol into about 800ml of water at 15°C to 25°C, stir to dissolve, measure the pH value, use a phosphate buffer solution with a pH of 7.4 (made of disodium hydrogen phosphate aqueous solution and phosphoric acid dihydrogen sodium aqueous solution) adjust the pH value to 6.8-7.2, make up the water volume to 1L, and control the solution temperature at 15°C-25°C during the whole process;

[0047] (2), add 0.5 g of medicinal activated carbon to the solution after step (1), adsorb at 15°C to 25°C for 15 minutes, decarbonize and filter, and then use a 0.22 μm microporous membrane to perform sterilizing filtration;

[0048] (3), the solution filtered through step (2) is sub-packed in 1000 cillin bottles, the loading capacity is 1ml, half stoppered, sampling is measured, and the content of thymus method is 0.1mg / ml, and the pH of the so...

Embodiment 2

[0052] A kind of preparation method of stable thymus method new preparation, it comprises the steps:

[0053] (1) Add 1.6g of thymofasin and 10g of mannitol into about 800ml of water at 15°C to 25°C, stir to dissolve, measure the pH value, use a phosphate buffer solution with a pH of 7.4 (made of disodium hydrogen phosphate aqueous solution and phosphoric acid dihydrogen sodium aqueous solution) adjust the pH to 6.8-7.2, add water to 1L, and control the solution temperature at 15°C-25°C during the whole process;

[0054] (2) Add 0.5 g of medicinal activated carbon, adsorb at 15°C to 25°C for 15 minutes, decarbonize and filter, and then use a 0.22 μm microporous membrane to perform sterilizing filtration;

[0055] (3), the solution filtered through step (2) is sub-packed in 1000 cillin bottles, the loading capacity is 1ml, half stoppered, sampling is measured, and the content of thymosin is 1.6mg / ml, and the pH of the solution is 6.94;

[0056] (4) Use a vacuum freeze dryer to...

Embodiment 3

[0059] A kind of preparation method of stable thymus method new preparation, it comprises the steps:

[0060] (1) Add 2g of thymosin and 20g of mannitol into about 800ml of water at 15°C to 25°C, stir and dissolve, measure the pH value, and use a phosphate buffer solution with a pH of 7.4 (made of disodium hydrogen phosphate aqueous solution and diphosphate Hydrogen-sodium aqueous solution) adjust the pH to 6.8-7.2, make up the water volume to 1L, and control the solution temperature at 15°C-25°C during the whole process;

[0061] (2) Add 0.5 g of medicinal activated carbon, adsorb at 15°C to 25°C for 15 minutes, decarbonize and filter, and then use a 0.22 μm microporous membrane to perform sterilizing filtration;

[0062] (3), the solution filtered through step (2) is sub-packed in 1000 cillin bottles, the loading capacity is 1ml, half stoppered, and sampling is determined, and the content of thymosin is 2mg / ml, and the pH is 6.95;

[0063] (4) Use a vacuum freeze dryer to p...

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Abstract

The invention relates to a stable thymalfasin preparation and a preparation method thereof. The thymalfasin preparation is freeze-dried powder prepared by performing vacuum freeze drying of the aqueous solution which contains thymalfasin and mannitol and has a pH value of 6.6-7.2, wherein the pH value of the aqueous solution is adjusted by the phosphate buffered solution; and the content of thymalfasin and mannitol in the aqueous solution is 0.1-10mg/ml and 10-100mg/ml respectively. Various performance of the thymalfasin preparation provided by the invention can meet the requirements of the thymalfasin quality standard issued by the State Food and Drug Administration; and compared with the existing thymalfasin powder injection, through the thymalfasin preparation provided by the invention, the components are much simpler, and the cost is obviously lowered. The preparation method provided by the invention has high operability, and is simple and convenient to operate and favorable for large-scale production.

Description

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Claims

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Application Information

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Owner 苏州科耐尔医药科技有限公司
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