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A preparation method of hydro-acupuncture of liver cell growth promoting factors

A technology of hepatocyte growth hormone and water injection, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, and digestive systems, etc., can solve problems such as increasing production costs, increasing interference factors, and increasing aggregates, and achieves the possibility of reducing or exempting The effect of ensuring the safety of medication and quality control

Inactive Publication Date: 2009-03-04
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

[0034] The preparation method of the hepatocyte growth-promoting water injection preparation includes the following steps:

[0035] ①Pretreatment: cleaning and disinfection of containers, filters, stirrers and pipelines required for liquid preparation.

[0036] ②Dosing and liquid preparation: take a qualified hepatocyte growth factor solution, dilute with sodium chloride and cold sterilized water for injection to obtain a diluent. Each 1000ml diluent contains 9g of polypeptide, and each 1000ml diluent contains 9- -15g sodium chloride stabilizer.

[0037] ③Filtration: filter with 0.45μm or 0.22μm microporous membrane.

[0038] ④ Potting: The filtered liquid is aseptically divided into a clean, sterile, pyrogen-free ampoule according to 2ml / bottle, and sealed. The specification is 2ml: 20mg polypeptide to obtain the hepatocyte growth-promoting water injection preparation.

[0039] The molecular weight of the hepatocyte growth-promoting factor is below 10,000 Daltons.

Embodiment 2

[0041] The hepatocyte growth-promoting hormone solution is prepared by the following method:

[0042] ①Select suckling pigs or newborn cows that have passed quarantine inspection from healthy, non-infectious areas, take fresh livers, wash with water for injection and pack them into sterile containers, use them directly or freeze them at -20℃ for no more than 3 months use;

[0043] ②Tissue processing: remove the outer membrane of fresh or low-temperature frozen liver, wash it with water for injection, and cut or chop it;

[0044] ③ Homogenization: Add sterile water for injection at a weight ratio of 1:1, homogenize repeatedly in a colloid mill at low temperature (4°C) for 2 minutes, check the cells under a microscope to be completely broken, and obtain a homogenate;

[0045] ④Freezing and thawing: The homogenate is repeatedly frozen and thawed three times, using quick freezing and slow thawing, the freezing temperature is -20℃~-35℃, and the melting temperature is lower than 40℃;

...

Embodiment 3

[0057] The preparation method of the hepatocyte growth-promoting water injection preparation includes the following steps:

[0058] ①Pretreatment: cleaning and disinfection of containers, filters, stirrers and pipelines required for liquid preparation.

[0059] ②Dosing and liquid preparation: take a qualified hepatocyte growth factor solution, dilute with sodium chloride and cold sterilized water for injection to obtain a diluent. Each 1000ml diluent contains 10g of polypeptide, and each 1000ml diluent contains 20g of chlorine. Sodium stabilizer.

[0060] ③Filtration: filter the diluted solution with 0.45μm or 0.22μm microporous membrane.

[0061] ④ Potting: The filtered liquid is aseptically divided into a clean, sterile, pyrogen-free ampoule according to 2ml / bottle, and sealed. The specification is 2ml: 20mg polypeptide to obtain the hepatocyte growth-promoting water injection preparation.

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

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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