CN100542602C - A kind of preparation method of injection of hydrolyzed peptide of liver - Google Patents
A kind of preparation method of injection of hydrolyzed peptide of liver Download PDFInfo
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- CN100542602C CN100542602C CNB2005101190945A CN200510119094A CN100542602C CN 100542602 C CN100542602 C CN 100542602C CN B2005101190945 A CNB2005101190945 A CN B2005101190945A CN 200510119094 A CN200510119094 A CN 200510119094A CN 100542602 C CN100542602 C CN 100542602C
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- hydrolyzed peptide
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Abstract
The present invention discloses a kind of preparation technology of liver hydrolytic peptide injection liquid, and behind the adding chitosan oligosaccharide, the impurity that adsorbable denatured protein, fat etc. are easily separated out forms precipitate, improves product purity in the production process; Cystine as protective agent can make the sterilising temp of medicine bring up to 121 ℃ 30 minutes, the residual rate of bacterial spore will reach 10-6, the bacterium of pharmaceutical preparation inspection result will not rely on the embedding production process.Pollute even bacterial spore appears in the embedding process, also can ensure the absolutesterility of preparation, reduced the economic loss of hanking, guaranteed drug safety to greatest extent because of contamination accident.Having overcome existing preparation technology mycete temperature can not be too high, the preparation disadvantage of " long bacterium " easily.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation for the treatment of hepatitis, liver cirrhosis disease, especially disclose a kind of preparation method of injection of hydrolyzed peptide of liver, belong to the biochemical pharmacy technical field.
Background technology:
Injection of hydrolyzed peptide of liver is to extract the aseptic aqueous solution that contains polypeptide class, nucleic acid class, amino acids material that makes through enzyme hydrolysis by the liver of healthy cattle, pig.Hydrolyzed peptide of liver can promote protein synthesis, reduces protein and decomposes, and promotes the propagation and the regeneration of normal liver cell, and the hepatocyte injury of tetrachloro-methane induction is had the better protect effect, reduces glutamate pyruvate transaminase, promotes pathological tissues to recover.Injection of hydrolyzed peptide of liver is used for the auxiliary smelting of diseases such as chronic hepatitis, liver cirrhosis and treats.
But; because injection of hydrolyzed peptide of liver is a kind of mixture preparation of biochemical substances; polypeptide class, nucleic acid class, amino acids material are at high temperature unstable to produce precipitation through regular meeting; therefore; preparation generally can not surpass 105 ℃ at the sterilising temp in final sterilization stage, can not reach the deactivation temperature of microbial spore.The fluctuation of injection of hydrolyzed peptide of liver preparation production process mid-early stage can import microbial spore, and spore can not be directed at preparation " long bacterium " under the situation of 105 ℃ of deactivations, influence drug quality.
Summary of the invention:
The present invention discloses a kind of preparation method of injection of hydrolyzed peptide of liver, and having overcome existing preparation technology mycete temperature can not be too high, the pharmaceutical preparation disadvantage of " long bacterium " easily.
Technical solution of the present invention is as follows:
With qualified cattle of quarantine or the liver of pig, remove connective tissue after, with after water for injection mixes, use high-speed tissue mashing machine's homogenate by the parts by weight of 0.80～0.82:1, be warming up to 50～51 ℃, usefulness Ca (OH)
2Transferring pH value is 7.0～7.5; press 4g/ and rise the adding pancreatin; 50～51 ℃ of hydrolysis 1～1.5 hour; add A.T.3942 enzyme 1g/ liter; continue hydrolysis 3～5 hours; the hydrolyzed solution phosphoric acid regulating ph value is 5.8～6.0; add 1g/ and rise active carbon; heated and boiled is incubated 30 minutes, and 3000rpm is centrifugal 30 minutes under the low temperature; getting supernatant adds 2g/ and rises chitosan oligosaccharide and form precipitate in room temperature; filter and remove precipitate, improve product purity, transferring pH value with NaOH then is 7.2; with 0.22 μ m microporous filter membrane filtration; 10,000 molecular weight ultrafilter membrane ultrafiltration get hydrolyzed peptide of liver solution, and behind the mensuration content of peptides, the cystine that adds the 0.1g/ liter is as protective agent; make the polypeptide class; the nucleic acid class; the more stable precipitation that do not produce under the amino acids material high temperature; add the dilution of a certain amount of water for injection, 121 ℃ of autoclavings after 30 minutes after the packing, through be up to the standards injection of hydrolyzed peptide of liver final drug preparation.
The good effect of this patent is: after adding chitosan oligosaccharide in the production process, the impurity that adsorbable denatured protein, fat etc. are easily separated out forms precipitate, improves product purity; Cystine as protective agent can make the sterilising temp of medicine bring up to 121 ℃ 30 minutes, the residual rate of bacterial spore will reach 10-6, the bacterium of pharmaceutical preparation inspection result will not rely on the embedding production process.Pollute even bacterial spore appears in the embedding process, also can ensure the absolutesterility of preparation, reduced the economic loss of hanking, guaranteed drug safety to greatest extent because of contamination accident.
The specific embodiment:
By following examples the present invention is described for example further, and do not limit the present invention in any way, under the prerequisite that does not deviate from technical solution of the present invention, any change or change that those of ordinary skills that the present invention did are realized easily all will fall within the claim scope of the present invention.
Embodiment 1
With the qualified cattle liver of quarantine, remove connective tissue after, the ratio of weight and number of press 0.80:1 is with after water for injection mixes, high-speed tissue mashing machine's homogenate is warming up to 51 ℃, usefulness Ca (OH)
2Transferring pH value is 7.2, presses 4g/ and rises the adding pancreatin, 50～51 ℃ of hydrolysis 1 hour, adds A.T.3942 enzyme 1g/ liter, continue hydrolysis 4 hours, the hydrolyzed solution phosphoric acid regulating ph value is 5.8～6.0, adds 1g/ and rises active carbon, heated and boiled is incubated 30 minutes, and 3000rpm is centrifugal 30 minutes under the low temperature.Getting supernatant adds 2g/ and rises chitosan oligosaccharide and form precipitate in room temperature; filter and remove precipitate; transferring pH value with NaOH then is 7.2; with 0.22 μ m microporous filter membrane filtration; 10,000 molecular weight ultrafilter membrane ultrafiltration get hydrolyzed peptide of liver solution; after measuring content of peptides; the cystine that adds the 0.1g/ liter is as protective agent; add the dilution of a certain amount of (calculating) water for injection by the content of peptides that records; 121 ℃ of autoclavings are after 30 minutes after the packing, through be up to the standards injection of hydrolyzed peptide of liver final drug preparation.
Embodiment 2
With the qualified pig liver of quarantine, remove connective tissue after, the ratio of weight and number of press 0.82:1 is with after water for injection mixes, tissue mashing machine's homogenate is warming up to 51 ℃, usefulness Ca (OH)
2Transferring pH value is 7.0, presses 4g/ and rises the adding pancreatin, 50～51 ℃ of hydrolysis 1 hour, adds the A.T.3942 enzyme, continue hydrolysis 5 hours, the hydrolyzed solution phosphoric acid regulating ph value is 5.8～6.0, adds 1g/ and rises active carbon, heated and boiled is incubated 30 minutes, and 3000rpm is centrifugal 30 minutes under the low temperature.Getting supernatant adds 2g/ and rises chitosan oligosaccharide and form precipitate in room temperature; filter and remove precipitate; transferring pH value with NaOH is 7.2; with 0.22 μ m microporous filter membrane filtration, 10,000 molecular weight ultrafilter membrane ultrafiltration get hydrolyzed peptide of liver solution, behind the mensuration content of peptides; add the protective agent cystine that 0.1g/ rises; add the dilution of a certain amount of water for injection, 121 ℃ of autoclavings after 30 minutes after the packing, through be up to the standards injection of hydrolyzed peptide of liver final drug preparation.
Embodiment 3
With the qualified cattle liver of quarantine, remove connective tissue after, the parts by weight of press 0.81:1 are used high-speed tissue mashing machine's homogenate with after water for injection mixes, and are warming up to 50～51 ℃, usefulness Ca (OH)
2Transferring pH value is 7.0～7.5, presses 4g/ and rises the adding pancreatin, 50～51 ℃ of hydrolysis 1.5 hours, adds the A.T.3942 enzyme by the 1g/ liter, continue hydrolysis 4 hours, the hydrolyzed solution phosphoric acid regulating ph value is 6.0, adds 1g/ and rises active carbon, heated and boiled is incubated 30 minutes, and 3000rpm is centrifugal 30 minutes under the low temperature.Getting supernatant adds 2g/ and rises chitosan oligosaccharide and form precipitate in room temperature; filter and remove precipitate; improve product purity; transferring pH value with NaOH then is 7.2; with 0.22 μ m microporous filter membrane filtration; 10,000 molecular weight ultrafilter membrane ultrafiltration get hydrolyzed peptide of liver solution; after measuring content of peptides; the cystine that adds the 0.1g/ liter is as protective agent; make the polypeptide class; the nucleic acid class; the more stable precipitation that do not produce under the amino acids material high temperature; add the dilution of a certain amount of water for injection, 121 ℃ of autoclavings after 30 minutes after the packing, through be up to the standards injection of hydrolyzed peptide of liver final drug preparation.
Claims (1)
1, a kind of preparation method of injection of hydrolyzed peptide of liver may further comprise the steps:
With qualified cattle of quarantine or the liver of pig, remove connective tissue after, with after water for injection mixes, use high-speed tissue mashing machine's homogenate by the parts by weight of 0.80～0.82:1, be warming up to 50～51 ℃, usefulness Ca (OH)
2Transferring pH value is 7.0～7.5; press 4g/ and rise the adding pancreatin; 50～51 ℃ of hydrolysis 1～1.5 hour; add A.T.3942 enzyme 1g/ liter; continue hydrolysis 3～5 hours; the hydrolyzed solution phosphoric acid regulating ph value is 5.8～6.0; add 1g/ and rise active carbon; heated and boiled is incubated 30 minutes, and 3000rpm is centrifugal 30 minutes under the low temperature; getting supernatant adds 2g/ and rises chitosan oligosaccharide and form precipitate in room temperature; filter and remove precipitate, improve product purity, transferring pH value with NaOH then is 7.2; with 0.22 μ m microporous filter membrane filtration; 10,000 molecular weight ultrafilter membrane ultrafiltration get hydrolyzed peptide of liver solution, and behind the mensuration content of peptides, the cystine that adds the 0.1g/ liter is as protective agent; make the polypeptide class; the nucleic acid class; the more stable precipitation that do not produce under the amino acids material high temperature; add the water for injection dilution, 121 ℃ of autoclavings after 30 minutes after the packing, through be up to the standards injection of hydrolyzed peptide of liver final drug preparation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101190945A CN100542602C (en) | 2005-12-21 | 2005-12-21 | A kind of preparation method of injection of hydrolyzed peptide of liver |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101190945A CN100542602C (en) | 2005-12-21 | 2005-12-21 | A kind of preparation method of injection of hydrolyzed peptide of liver |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1824287A CN1824287A (en) | 2006-08-30 |
| CN100542602C true CN100542602C (en) | 2009-09-23 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2005101190945A Expired - Fee Related CN100542602C (en) | 2005-12-21 | 2005-12-21 | A kind of preparation method of injection of hydrolyzed peptide of liver |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102228676B (en) * | 2011-07-07 | 2013-01-30 | 白求恩医科大学制药厂 | Heparolysate injection pharmaceutical composition |
| WO2015022927A1 (en) * | 2013-08-12 | 2015-02-19 | ゼリア新薬工業株式会社 | Amp-activated protein kinase activator |
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2005
- 2005-12-21 CN CNB2005101190945A patent/CN100542602C/en not_active Expired - Fee Related
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| Title |
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| 1235026 1999.11.17 |
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| CN1824287A (en) | 2006-08-30 |
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Granted publication date: 20090923 Termination date: 20161221 |
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| CF01 | Termination of patent right due to non-payment of annual fee |