Preparation method of compound bone peptide injection

A compound osteopeptide and injection technology, applied in the field of medicine, can solve the problems of low extraction efficiency of bone peptide content, long-term storage clarity decrease, long-term storage unresolved clarity, etc., to achieve the effect of enhancing the overall stability

Inactive Publication Date: 2021-04-13
NANJING XINBAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese patent CN1939343B discloses an osteopeptide sodium chloride solution injection and its preparation process. This process effectively controls the content of polymer impurities in the injection during long-term storage, but there is still the problem of low extraction efficiency of osteopeptide content.
[0005] Chinese patent CN108926703A discloses a preparation process of osteopeptide glucose injection, which solves the problem that the drug is easily contaminated, but still does not solve the problem of clarity in long-term storage
[0006] There are few companies in the country that have the approval number of compound bone peptide injection and produce and market it. The annual market demand is 100 million. The existing compound bone peptide injection has obvious clinical effect and moderate price, but there are problems such as long-term storage. The problem of the decrease of clarity, at the same time, it is necessary to further increase the content of active ingredients in bone peptide extract and scorpion extract

Method used

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  • Preparation method of compound bone peptide injection

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Effect test

Embodiment 1

[0034] Embodiment 1, the preparation of bone peptide extract

[0035] The preparation method of described bone peptide extract is:

[0036] 1) Grind pig limb bones, add 10 times the mass of water, and heat at 105°C and 1kg / cm 2 Extract 2 times under pressure conditions, 1 hour each time, combine the extracts extracted twice and filter;

[0037] 2) the filtrate is left to cool, add petroleum ether extraction of 1 / 5 of the filtrate quality, remove the upper layer of grease, concentrate to 1 / 7 of the original volume, add ethanol to the concentrated solution, so that the ethanol volume content in the filtrate is 65%, statically Set aside for 18h, filter, and distill the filtrate to 1 / 3 of the original volume;

[0038] 3) Use hydrochloric acid to adjust the pH of the filtrate obtained in step 2) to 5, remove the acid protein, filter, use sodium hydroxide to adjust the pH to 7 again, remove the alkali protein, filter with a 0.2 μm filter element, and then use an ultrafiltration me...

Embodiment 2

[0039] Embodiment 2, the preparation of bone peptide extract

[0040] The preparation method of described bone peptide extract is:

[0041] 1) Crush the bones of pig limbs, add 10 times the mass of water at 120°C and 2kg / cm 2 Under pressure conditions, extract 2 times, 2 hours each time, combine the extracts extracted twice and filter;

[0042] 2) The filtrate is allowed to stand for cooling, adding 1 / 5 of the quality of the filtrate to extract with petroleum ether, removing the upper layer of grease, concentrating to 1 / 6 of the original volume, adding ethanol to the concentrated solution so that the ethanol volume content in the filtrate is 75%, statically Set aside for 20h, filter, and distill the filtrate to 1 / 5 of the original volume;

[0043] 3) Use hydrochloric acid to adjust the pH of the filtrate obtained in step 2) to 3, remove the acid protein, filter, use sodium hydroxide acid to adjust the pH to 9 again, remove the alkali protein, filter with a 0.2 μm filter elem...

Embodiment 3

[0044] Embodiment 3, the preparation of bone peptide extract

[0045] The preparation method of described bone peptide extract is:

[0046] 1) Crush the bones of pig limbs, add 10 times the mass of water at 110°C and 2kg / cm 2 Under pressure conditions, extract 2 times, 2 hours each time, combine the extracts extracted twice and filter;

[0047] 2) The filtrate is allowed to stand for cooling, adding 1 / 5 of the quality of the filtrate to extract with petroleum ether, removing the upper layer of grease, concentrating to 1 / 6 of the original volume, adding ethanol to the concentrated solution so that the ethanol volume content in the filtrate is 75%, statically Set aside for 18h, filter, and distill the filtrate to 1 / 4 of the original volume;

[0048] 3) Use hydrochloric acid to adjust the pH of the filtrate obtained in step 2) to 4, remove the acid protein, filter, use sodium hydroxide to adjust the pH to 8 again, remove the alkali protein, filter with a 0.2 μm filter element, ...

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Abstract

The invention belongs to the technical field of medicines, and particularly relates to a preparation method of a compound bone peptide injection. The preparation method provided by the invention comprises the following steps: preparing a bone peptide extracting solution and a scorpion extracting solution, mixing the bone peptide extracting solution with the scorpion extracting solution, performing acid treatment, alkali treatment and activated carbon treatment on the mixed solution, performing filtering, adding an additive, and further performing treating. According to the invention, a production process is innovated, and acid protein and basic protein are treated in the step of preparing the bone peptide extracting solution. Acid treatment and neutral filtration are performed in the step of preparing the scorpion extracting solution, and finally, the additive is added, so that the prepared bone peptide extracting solution is high in medicine stability, the problem that the clarity is reduced after long-term storage is solved, polypeptide substances are larger than or equal to 30mg/ml, and total nitrogen is larger than or equal to 10mg/ml; and according to the scorpion extracting solution, polypeptide substances are larger than or equal to 0.5mg/ml, total nitrogen is larger than or equal to 0.25mg/ml, and the scorpion extracting solution is far superior to similar products.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of compound osteopeptide injection. Background technique [0002] Osteopeptide preparations are refined from fresh or frozen pig or fetal bovine limb bones through high-tech biotechnology extraction of bone active substances, which contain various bone growth factors and various inorganic elements, trace elements and Compound peptide active substances can regulate bone metabolism and have anti-inflammatory and analgesic effects. Clinically, it is mainly used for proliferative bone and joint diseases, rheumatism, rheumatoid arthritis, etc., and can promote fracture healing. Osteopeptide preparation products include Osteopeptide Injection, Osteopeptide Tablets, etc. The products have been on the market for many years and are well received by doctors and patients. [0003] The active ingredients of compound bone peptide injection are bone polypept...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/01A61K35/646A61K9/08A61K47/18A61K47/22A61P29/00A61P19/08A61P19/10
CPCA61K9/0019A61K9/08A61K35/646A61K38/012A61K47/183A61K47/22A61P19/08A61P19/10A61P29/00A61K2300/00
Inventor 于辉沈飞冯旌窦文轩潘爱梅
Owner NANJING XINBAI PHARMA
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