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Romurtide injection and preparation method thereof

A technology for romotide and injection, which is applied in the field of romotide injection and its preparation, can solve the problems of long reconstitution time, inconvenient use, secondary pollution, etc., so as to solve the cost of packaging and transportation, and avoid secondary pollution. , the effect of improving work efficiency

Inactive Publication Date: 2013-02-06
BEIJING JIASHILIANBO PHARM SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, due to the special physical and chemical properties of romotide, it is almost insoluble in aqueous solution, and it is very easy to convert into a gel system after containing a very small amount of romotide in the aqueous solution. Therefore, the dosage form currently on the market in Japan is freeze-dried powder for injection. However, when the preparation is injected, special lysozyme must be used to dissolve it first. The dissolution process is very long, and the appearance of the obtained romotide injection is not completely clear, with a certain opalescence. So far, no individual or institution has solve the above problems
The clinical use of romotide injection freeze-dried powder that is currently on the market in Japan needs to be reconstituted with a special solvent. The long reconstitution time will bring inconvenience to the use, and it will have opalescence after dissolution and easily cause secondary pollution. Therefore, it is used in clinical practice. It is of great significance to make stable and clear romotide injection with acceptable and suitable lysozyme for injection

Method used

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  • Romurtide injection and preparation method thereof
  • Romurtide injection and preparation method thereof
  • Romurtide injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1: Preparation of Romotide Injection

[0026] Preparation formula:

[0027] Romotide 0.20g

[0028] Ethanol 100ml

[0029] Disodium hydrogen phosphate-sodium dihydrogen phosphate buffer to 1000ml

[0030] Made 1000 pieces

[0031] (1) Preparation of buffer solution: Weigh 8.31 g of anhydrous disodium hydrogen phosphate and 2.24 g of dihydrogen sodium phosphate, add water to 1000 ml, add 0.2% (g / v) activated carbon, stir well, and let stand for 15 minutes , filtered to remove charcoal, and the solution was set aside.

[0032] (2) Dissolve romotide in ethanol according to the prescription ratio, then add disodium hydrogen phosphate-sodium dihydrogen phosphate buffer, heat at 45°C, stir for 30 minutes, adjust the pH value to 6.5-8.0, and then use an ultrafilter In addition to pyrogens, the filtrate was sterilized by filtration with a 0.22 μm microporous membrane, and the content of romotide in the solution was determined to determine the exact filling volum...

Embodiment 2

[0033] Embodiment 2: Preparation of Romotide Injection

[0034] Preparation formula:

[0035] Romotide 0.20g

[0036] 1,2-propanediol 50ml

[0037] Ethanol 50ml

[0038] Disodium hydrogen phosphate-sodium dihydrogen phosphate buffer to 1000ml

[0039] Made 1000 pieces

[0040] (1) Preparation of buffer solution: Weigh 8.31 g of anhydrous disodium hydrogen phosphate and 1.95 g of potassium dihydrogen phosphate, add water to 1000 ml, add 0.2% (g / v) activated carbon, stir well, let stand for 15 minutes, filter After removing charcoal, the solution is set aside.

[0041] (2) Dissolve romotide in a mixed solvent of ethanol and 1,2-propylene glycol according to the prescription ratio, then add phosphate buffer, heat at 45°C, stir for 30 minutes, adjust the pH value to 6.5-8.0, and then use supernatant The filter was used to depyrogenate, the filtrate was sterilized by filtration with a 0.22 μm microporous membrane, the content of romotide in the solution was determined, the ex...

Embodiment 3

[0042] Embodiment 3: Preparation of Romotide Injection

[0043] Preparation formula:

[0044] Romotide 0.20g

[0045] Ethanol 200ml

[0046] Add acetic acid-sodium acetate buffer to 1000ml

[0047] Made 1000 pieces

[0048](1) Preparation of buffer solution: Weigh 6.8g of sodium acetate and an appropriate amount of acetic acid, add water to 1000ml, make the pH 6.5-8.0, add 0.2% (g / v) activated carbon, stir well, let stand for 15 minutes, filter After removing charcoal, the solution is set aside.

[0049] (2) Dissolve romotide in ethanol according to the prescription ratio, then add acetic acid-sodium acetate buffer solution, heat to 45°C, stir for 30 minutes, adjust the pH value to 6.5-8.0, and then use an ultrafilter to remove pyrogens, The filtrate was sterilized by filtration with a 0.22 μm microporous membrane, and the content of romotide in the solution was determined to determine the exact loading amount, and then packed, filled with nitrogen and sealed.

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Abstract

The invention provides a romurtide injection which comprises the effective dose of romurtide, solvent, pH regulator and buffer solution which function as active components. The preparation method of the romurtide injection comprises the following steps: the prescribed romurtide is put in a proper vessel, the prescribed solvent is added in the vessel for dissolution, the buffer solution is added until the total amount required is achieved, the mixture is processed by water bath and stirred for solution, the pyrogen is removed through an ultrafilter, the mixture is filtered by a microporous filter membrane and sterilized, and then the subpackaging and the top sealing are performed.

Description

field of invention [0001] The invention relates to a romotide injection for leukopenia caused by chemotherapy or radiotherapy and a preparation method thereof. technical background [0002] Malignant tumors have become one of the serious diseases that threaten human health and life. According to statistics, more than 10 million cancer patients are newly diagnosed in the world every year, with a total of 40 million patients and 7.1 million deaths. It ranks among the top three in the mortality rate with infection and cardiovascular and cerebrovascular diseases. Malignant tumors in my country have an average annual incidence of 2 million people and 1.6 million deaths, accounting for 18.63% of the national average annual total death toll, ranking first among various causes of death in urban areas. Antineoplastic drugs and immunomodulators ranked fifth in domestic hospital drug sales (accounting for 13.44%). Chemotherapy and radiotherapy are important means of anti-cancer treat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/08A61K9/08A61K47/02A61K47/10A61P7/00A61P37/04
Inventor 陈小平温守明丁浩
Owner BEIJING JIASHILIANBO PHARM SCI & TECH
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