Process for preparing cerebroprotein hydrolysate NaCl injection

Abstract

The invention discloses a method for preparing sodium chloride injection liquid of brain protein hydrolysate.The preparation includes the processes: weighing the sodium chloride of 90g and adding injection water of 3,000ml dissolve the sodium chloride; adding activated carbon, standing and filtering for removing the carbon; adding the injection water to 8,000ml to prepare sodium chloride solution; weighing stock solution of the brain protein hydrolysate of 1,000ml to ultrafilter by 8,000 dalton ultrafiltration membrane; adding the filtering liquid into the sodium chloride and adding the injection water to 10,000ml, stirring and mixing uniformly and inletting nitrogen into mixed liquid; respectively filtering through filteration membrane of 0.45Mum and 0.22Mum, filling, nitrogen-inletting, encapsulating and sterilizing the mixed liquid. The injection liquid provided by the invention can be directly used in clinic and is unnecessary to be diluted again, thus avoiding secondary pollution, improving the safety of the medicine and convenient for the clinical use; the operation is simplified due to one-time ultrafiltration in the production.

Description

1. Technical field [0001] The invention relates to a preparation method of medicine, in particular to a preparation method of cerebroprotein hydrolyzate sodium chloride injection. 2. Background technology [0002] At present, it is known that the main components of cerebroprotein hydrolyzate are a mixture of free amino acids and small molecule peptides with a molecular weight below 10,000, of which free amino acids account for 85%. Animal cerebroprotein hydrolyzate belongs to small molecule natural neuropeptides. Regulatory substances are being extensively studied. Cerebroprotein hydrolyzate drugs are widely used at home and abroad to treat functional diseases caused by brain tissue lesions. Clinically used for cerebrovascular disease and cerebral arteriosclerosis, sequelae of traumatic brain injury, sequelae of encephalomalacia or stroke, brain hypoplasia, dementia or senile dementia, neurasthenia with memory loss as the main manifestation, mild infant brain hypoplasia, et...

AI Technical Summary

Problems solved by technology

The shortcoming of this method is: (1) equipment investment is big, and production cycle is long, and production efficiency is low; Use chromatographic method to purify active ingredient, each process needs 30~48 hours, and production cycle is long; Quality requires Sephadex G-25 gel column chromatography in a cold storage workshop at 2-8°C, and Sephadex G-25 gel chromatography materials must be imported, which is expensive and produces 1 million tubes (10ml) of cerebroprotein hydrolyzate per year Injection calculation, the above-mentioned investment just reaches more than 2 million yuan; Using the steps of decompression concentration and centrifugation, the production efficiency is low, which is not conducive to the control of drug quality; (2) using a large amount of organic chemical solvents, the boiling point of acetone and ether Very low, it is a flammable, explosive, and toxic dangerous chemical. Ether is also used as an anesthetic. A large amount of acetone and ether is used to precipitate brain protein to make brain powder. This step is very dangerous and must be done in an explosion-proof workshop Production and operation are cumbersome, pollute the environment, and endanger the health of operators

[0005] Notification number is that the patent of CN1228082C discloses a kind of preparation method of cerebroprotein hydrolyzate preparation, and this method passes microporous membrane and ultrafiltration membrane ultrafiltration for many times, and its shortcoming is: (1) use ultrafiltration membrane to carry out ultrafiltration The concentration recovery rate is low. Although the process adopts ultrafiltration technology, it uses an ultrafiltration membrane with a cut-off molecular weight of 1000 for concentration, which causes the effective active ingredient brain polypeptide to be lost to varying degrees and greatly reduces the yield; (2) more The ultrafiltrate is obtained only after passing through the microporous membrane and the ultrafiltration membrane with a cut-off molecular weight of 70,000 and 10,000, and the operation is cumbersome.

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