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Method for preparing bone peptide injection

An injection and osteopeptide technology, applied in the field of biopharmaceuticals, can solve the problems that the safety of clinical use cannot be guaranteed, and the preparation products are easy to cause allergic reactions, which are easy to cause allergic reactions, etc., so as to ensure clinical safety and reduce the incidence of allergic reactions. , to ensure a stable effect

Active Publication Date: 2012-05-23
武汉华龙生物制药有限公司
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Problems solved by technology

[0004] The above-mentioned process method has not been depyrogenated by activated carbon, which cannot guarantee the safety of clinical use; moreover, it has not been multi-stage ultrafiltration to remove macromolecular substances, so that the preparation product is easy to cause allergic reactions; secondly, no stabilizer is added in the injection preparation. Amino acids and small peptides in the solution are prone to polymerize into macromolecular substances and precipitate, resulting in unstable preparations and easy to cause allergic reactions

Method used

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  • Method for preparing bone peptide injection
  • Method for preparing bone peptide injection

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Experimental program
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Embodiment Construction

[0009] Take fresh pig (or fetal bovine) limb bones, peel off the fat attached to them, wash them three times with drinking water and purified water, and then crush them.

[0010] Add the broken pig (or fetal bovine) limb bone and its 4 times the weight of purified water into the reaction tank, keep it warm at 121° C. for 2 hours, and then cool to room temperature.

[0011] Filter the extract with gauze to discard the sediment, store the supernatant at 0-5°C for more than 12 hours, and remove the upper layer of fat.

[0012] The degreased extract was concentrated under reduced pressure and vacuum (temperature 70-80°C; vacuum degree -0.03~-0.08MPa) to 1 / 4 of the original volume.

[0013] Add the concentrated solution into -10~-20°C pre-cooled cold acetone in a volume ratio of 1:1, let it stand for 1-2 hours in a low temperature environment not higher than 5°C, then centrifuge quickly, discard the sediment and take the supernatant .

[0014] The supernatant is concentrated unde...

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Abstract

The invention discloses a method for preparing a bone peptide injection. Foreign protein is removed with cold acetone and acid-alkali deposition, and ultra-filtration for multiple stages is carried out through ultra-filtration films of 50, 10 and 5KD; therefore, the method not only can completely remove the foreign protein but also can effectively control high-molecular matter so that the high-molecular matter in the bone peptide injection is less than 2.1% which is greatly lower than state standard, thereby effectively ensuring the safety of preparation.

Description

technical field [0001] The invention belongs to the technical field of biopharmaceuticals, and in particular relates to a preparation method of osteopeptide injection. Background technique [0002] Osteotropic Injection, formerly known as: Guning Injection, is a sterile aqueous solution extracted from limb bones of healthy pigs or fetal cattle. Its main components are organic calcium, phosphorus, inorganic calcium, inorganic salts, trace elements, Amino acids, etc. This product can regulate bone metabolism, stimulate osteoblast proliferation, promote new bone formation, regulate calcium and phosphorus metabolism, increase bone calcium deposition, and prevent osteoporosis. [0003] At present, some preparation techniques related to osteopeptide have been disclosed, including hot-pressed extraction, acid-base precipitation to remove protein, centrifugal filtration, ultrafiltration, concentration and other processes. It usually includes the following methods: (1) crush the bo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K35/32A61K47/34A61K9/08A61P3/02A61P3/14A61P19/08A61K47/26
Inventor 吕家燕
Owner 武汉华龙生物制药有限公司
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