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Technology for preparing liquid drugs injection of liver cell growth promoting factor

A technology of hepatocyte growth hormone and water injection, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, digestive system, etc., can solve the problems of increasing aggregates, consuming energy, increasing interference factors, etc., and achieves reduction of external sources. Substance interference, ensuring safety and effectiveness, ensuring the effect of medication safety

Inactive Publication Date: 2007-02-07
沈阳斯佳科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the hepatocyte growth-stimulating hormones with molecular weights below 10,000 Daltons on the market are all powder injections. Because the freeze-drying process consumes energy, while increasing the production cost, the drastic temperature difference in the freeze-drying process makes the active factor space The conformation may change, resulting in the loss of activity; in addition, the powder injection formulations contain excipients to maintain the good frozen shape of the preparation and the stability of the activity during long-term storage, but the presence of excipients also increases the quality. Control possible interference factors, increase the possibility of polymer production, directly related to product quality and drug safety

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The preparation method of hepatocyte growth-promoting aqueous injection preparation, it comprises the following steps:

[0033] ①Pretreatment: cleaning and disinfection of containers, filters, agitators and pipelines required for liquid preparation.

[0034] ②Feeding and dosing: Take the qualified hepatocyte growth-promoting hormone solution, add sodium chloride and cold sterilized water for injection to dilute to obtain a dilution, and the polypeptide content in each 1000ml dilution is 9g, and each 1000ml dilution contains 9- - 15g sodium chloride stabilizer.

[0035] ③ Filtration: Filter with 0.45μm or 0.22μm microporous membrane.

[0036] ④ Filling and sealing: Aseptically pack the filtered medicinal solution in 2ml / bottle into clean, sterile, pyrogen-free ampoules, seal the seal, and the specification is 2ml: 20mg polypeptide, to obtain the hepatocyte growth-promoting hormone aqueous injection preparation.

[0037] The molecular weight of the hepatocyte growth-sti...

Embodiment 2

[0039] The hepatocyte growth-stimulating hormone solution is prepared by the following method:

[0040] ①Choose healthy, non-infected areas, qualified suckling pigs or non-lactating newborn cows that have passed the quarantine, take fresh livers, wash them with water for injection, and pack them in sterilized containers. 3 months use;

[0041] ②Tissue processing: Remove the outer membrane of the fresh or cryogenically frozen liver, wash it with water for injection, and cut it into pieces;

[0042] ③ Homogenate: Add sterile water for injection at a weight ratio of 1:1, repeat the homogenate in a colloid mill at a low temperature (4°C) for 2 minutes, check under a microscope that the cells are completely broken, and obtain a homogenate;

[0043] ④ Freezing and thawing: Repeated freezing and thawing of the homogenate for three times, adopting the quick freezing and slow thawing method, the freezing temperature is -20°C to -35°C, and the melting temperature is lower than 40°C;

...

Embodiment 3

[0055] The preparation method of hepatocyte growth-promoting aqueous injection preparation, it comprises the following steps:

[0056] ①Pretreatment: cleaning and disinfection of containers, filters, agitators and pipelines required for liquid preparation.

[0057] ②Feeding and dosing: take the qualified hepatocyte growth-promoting hormone solution, add sodium chloride and cold sterilized water for injection to dilute to obtain a dilution, and each 1000ml of dilution contains 10g of polypeptide, and each 1000ml of dilution contains 20g of chlorine Sodium chloride stabilizer.

[0058] ③ Filtration: Filter the diluted solution with a 0.45μm or 0.22μm microporous membrane.

[0059] ④ Filling and sealing: Aseptically pack the filtered medicinal solution in 2ml / bottle into clean, sterile, pyrogen-free ampoules, seal the seal, and the specification is 2ml: 20mg polypeptide, to obtain the hepatocyte growth-promoting hormone aqueous injection preparation.

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PUM

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Abstract

The invention discloses a preparing method of hepatocyte-accelerating bios liquid drugs injection agent with high stability, which comprises the following steps: adding nutria chloridum; injecting water to dilute with 9-11.5g peptide and 5-20g nutria chloridum stabilizer in each 1000ml diluted liquid; filtering; packing.

Description

technical field [0001] The present invention relates to a preparation process of medicinal water injection preparations, in particular to a kind of medicine extracted from suckling pig liver or non-lactating newborn bovine liver, which can treat or assist various severe viral hepatitis, such as acute, subacute, chronic The preparation process of hepatocyte growth-promoting hormone aqueous injection preparation with severe hepatitis effect and high stability. Background technique [0002] Hepatocyte growth-stimulating hormone is a mixture of multi-component small molecular peptides extracted from fresh suckling pig liver or non-lactating newborn bovine liver, with a molecular weight below 10,000Da. Its main pharmacological effect is to significantly stimulate the DNA synthesis of new liver cells, improve the phagocytic function of liver Kupffer cells, have a good protective effect on liver cell damage induced by carbon tetrachloride, and protect liver cells induced by D-galac...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K38/27A61K35/407A61P1/16
Inventor 王光李莉曲娜
Owner 沈阳斯佳科技发展有限公司
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