Brain protein hydrolysate and production process of its freeze dried preparation

A technology of cerebroprotein hydrolyzate and production method, which is applied in the production field of cerebroprotein hydrolyzate freeze-dried preparations, can solve problems such as long production cycle, susceptibility to microbial contamination, difficult drug quality, etc., and achieve lower production environment requirements and less investment Production equipment, the effect of reducing microbial contamination

Inactive Publication Date: 2006-11-08
HAINAN JINXING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantages are: (1) The feed liquid passes through the microporous membrane with a pore size of 0.5-1um and the ultrafiltration membrane with a cut-off molecular weight of 70,000 and 10,000 for many times, and the obtained ultrafiltrate makes the operation more cumbersome and the production cycle is long. Susceptible to microbial contamination during production
(2) The recovery rate of ultrafiltration concentration using ultrafiltration membrane is low: the process adopts the ultrafiltration membrane with a cut-off molecular weight of 1000 to concentrate, because the effective active ingredient of cerebroprotein hydrolyzate is a small molecule polypeptide, it will be concentrated in the ultrafiltration concentration process. There are different degrees of permeation loss, and the yield is greatly reduced
Its disadvantages are: (1) long production cycle, large investment in equipment, and low production efficiency; trypsin hydrolysis for 30 hours at pH8. Hydrolysis with trypsin, the hydrolysis is not complete, and the solid-liquid separation is difficult, and the loss in the production process is large; the production efficiency is low when the vacuum concentration step is used, which is not conducive to the control of the quality of the drug
(2), use a large amount of organic chemical solvents, acetone and ether have extremely low boiling points, are flammable, explosive, poisonous dangerous chemicals, ether is also used as an anesthetic, use a large amount of acetone and ether to precipitate brain protein first It is produced into brain protein powder. This step is very dangerous and must be produced in an explosion-proof workshop. The operation is cumbersome, pollutes the environment, and endangers the health of production operators.

Method used

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  • Brain protein hydrolysate and production process of its freeze dried preparation
  • Brain protein hydrolysate and production process of its freeze dried preparation
  • Brain protein hydrolysate and production process of its freeze dried preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0029] Embodiment 1, the production of cerebroprotein hydrolyzate (stock solution) for injection

[0030] Take 100.0kg of fresh or frozen healthy pig brains that have passed the inspection, remove non-brain tissues such as connective tissue and bone fragments, wash them with water for injection, drain them, first grind them into pieces with a meat grinder, and adjust the scale to 200 The purpose is to grind the colloid finely, collect the homogenate, add 150.0 kg (1.5 times the weight) of water for injection and stir well. Warm the slurry to 42°C±2°C, adjust the pH to 1.5-1.7 with 4.5% hydrochloric acid, add 10g of pepsin per kg of slurry (1%), add 2.5kg of pepsin, and maintain the pH at 1.5-1.7. Hydrolyze at 42°C±2°C for 8 hours. Use 5M NaOH to adjust the pH of the pepsin hydrolyzed slurry to 7.1-7.3, add 10g of trypsin per kg of the slurry (1%), add 2.5kg of trypsin, stir well, and maintain the pH at 7.5-7.7, 42℃± Hydrolyze at 2°C for 4 hours, heat up to 100°C after enzyma...

Embodiment 2

[0032] Embodiment 2, the production method of cerebroprotein hydrolyzate freeze-dried agent for injection

[0033] (1) Preparation of raw and auxiliary materials

[0034] In a 10,000-class clean area, add the brain protein hydrolyzate stock solution and mannitol that have passed the full inspection into the liquid preparation tank according to the prescription amount, add water for injection to the mark, mix well, add activated carbon according to 0.2% of the liquid volume, and stir Decolorize for 20 minutes, coarsely filter with a 0.45um membrane, and then finely filter with a 0.22um membrane to measure its content, and send it to a 100-grade packing room for use.

[0035] The prescription is: cerebroprotein hydrolyzate stock solution, equivalent to about 30.0g of total nitrogen

[0036] Mannitol 240g

[0037] Add water for injection to 4000.0ml

[0038] Packed into 1000 bottles

[0039] In the prescription, cerebroprotein...

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Abstract

The present invention relates to a kind of brain protein hydrolysate and the production process of its freeze dried preparation. The brain protein hydrolysate for injection is prepared with pig brain and through the steps of homogenating in a colloid mill to collect slurry, hydrolyzing with pepsase and pancreatin to collect supernatant, filtering with filer paper to collect filtrate, separating and purifying the filtrate with hydroxyapetite column, regulating peptide map and collecting object, ultrafiltering with membrane of intercepting molecular weight 8 KD to collecting filtrate, nitrogen and amino acid analysis and adding amino acid in the required amount, and fine filtering with 0.22 micron filtering membrane. The brain protein hydrolysate for injection may be further freeze dried to obtain freeze dried brain protein hydrolysate preparation. The production process is environment friendly, high in yield and low in cost.

Description

technical field [0001] The invention relates to a production method of cerebroprotein hydrolyzate, and also relates to a production method of cerebroprotein hydrolyzate freeze-dried preparation, belonging to the field of pharmacy. Background technique [0002] Brain tissue is rich in protein. For a long time, people have been researching to hydrolyze the protein of animal brain tissue into amino acids and low-molecular-weight polypeptides, which can be used to treat dysfunction caused by insufficient compensation of cerebral blood vessels, stroke, brain memory impairment and traumatic brain injury. Dysfunction, sequelae of cerebral oscillations and other diseases. [0003] Cerebroprotein hydrolyzate is also called cerebrolysin in China. As early as the early 1990s, domestic scholars conducted research on its technology, quality, pharmacological efficacy and clinical application, and published a large number of articles. [0004] Chinese invention patent document CN01130523....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/01A61K9/19A61K35/30A61P25/00
Inventor 刘全胜夏中宁舒军林学良
Owner HAINAN JINXING PHARMA
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