CN1070380C - Application and prodn. method of HDL preparation - Google Patents
Application and prodn. method of HDL preparation Download PDFInfo
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- CN1070380C CN1070380C CN97119838A CN97119838A CN1070380C CN 1070380 C CN1070380 C CN 1070380C CN 97119838 A CN97119838 A CN 97119838A CN 97119838 A CN97119838 A CN 97119838A CN 1070380 C CN1070380 C CN 1070380C
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Abstract
The present invention relates to a purpose and a production method of HDL preparations, which belongs to the field of medicine. An HDL preparation is used for treating heart diseases and arteriosclerosis diseases and has the advantages of simple use and good effects. The production method comprises: ammonium sulfate or alcohol is used for separating proteins in human plasma for obtaining HDL; potassium oxalate is used in sections for removing dextran sulfolipid; after the operation of ultrafiltration for removing impurities, poison is inactivated; the operation of sterilization, filtration, subpackage and cryodesiccation is carried out. The present invention has the advantage that various components in the plasma are comprehensively used; the production method has the advantages of low investment, simple operation, etc.
Description
The invention belongs to field of medicaments, relate to a kind of production method of biochemical drug.
The purposes of HDL preparation of the present invention is prevention and treatment coronary heart disease, arteriosclerotic disease.At present, coronary heart disease shows as that cholesterol and neutral fat deposit to blood vessel in the blood, forms fatty speckle, makes blood vessel access narrow, even stops up, blood supply insufficiency and cause symptom such as angina pectoris.Now be broadly divided into lipid lowerers such as cholestyramine with prevention and curative, another kind of is Pimobendane, as nitrate esters, can only make remission, can not make the blood vessel that hardened pass commentaries on classics.
The purpose of this invention is to provide a kind of effect for reducing blood fat that promptly has, the fatty speckle on the blood vessel wall can be removed again, promote blood vessel to recover unimpeded, play the production method of the medicine HDL preparation for the treatment of both the principal and secondary aspects of a disease effect.
HDL preparation of the present invention is used for prevention and treatment coronary heart disease, the atherosclerosis such as blood vessel embolism that phlebitis and hyperlipemia cause.Detailed directions is that HDL preparation is made peace bottle or bottled lyophilizing powder, the inner protein quality is divided into two kinds in 30mg/ bottle and 60mg/ bottle, time spent adds the dissolving of 1ml sterile distilled water, intramuscular injection or intravenous drip, consumption and usage are decided according to the state of an illness by the doctor, generally can adopt intramuscular injection, one time one (peace) bottle, inferior on every Wendesdays, be a course of treatment all around, do not need to change dietary habit in the therapeutic process.Can proceed treatment in case of necessity.
The production method of HDL preparation is: with ammonium sulfate or ethanol lipoprotein in the human plasma and other albumen are separated, other albumen are used to make other blood products.Lipoprotein is partly removed low density lipoprotein, LDL with variable concentrations ammonium sulfate and dextran sulfate.The high density lipoprotein component of acquisition is removed dextran sulfate with potassium oxalate.Remaining potassium oxalate and other molecule are removed in ultrafiltration.The viral inactivation treatment application number is: 97119839.x.Aseptic filtration, packing, lyophilization.
The production technology of HDL preparation is:
(A) an amount of adding distil water equivalent dilution of blood plasma adds citron sodium 0.1-1%, and sodium chloride is 0.2-1.5%, stir evenly, add saturated ammonium sulfate solution and make the 30-80% saturation, stir evenly, placement makes its precipitation fully, filters with filter cloth, or centrifugal with the afterflow centrifuge, precipitation (once centrifugal) is used for different purpose, collect filtrate (or centrifuged supernatant), add ammonium sulfate and become 50%-95% saturated, precipitation back fully is centrifugal with filter cloth filtration or afterflow, clear liquid is used for different purpose, and collecting precipitation (secondary precipitation) is standby.
(B) blood plasma adds ethanol by Cohn third constellations method in right amount and reaches 15-50% concentration, and afterflow is centrifugal, and precipitation is used for different purpose, and supernatant appends ethanol and reaches 20-60%, the afterflow centrifugal collecting precipitation, and supernatant is used for different purpose, and precipitation (FIV) is standby.
(C) get the secondary precipitation of (A) or FIV (B), add the suitable quantity of water dissolving, remaining ammonium sulfate (A) method or ethanol (B) method are removed in ultrafiltration or dialysis, collect ultrafiltration or dialyzed solution, adding dextran sulfate becomes 0.2-0.8% and the centrifugal son of divalent sun to become 0.2M, be stirred to moltenly entirely, place more than 16 hours centrifugal collecting precipitation, supernatant is used for different purpose, precipitation is with the dissolving of debita spissitudo oxalates, and is centrifugal or remove by filter the precipitation of generation, and oxalates is removed in supernatant ultrafiltration or dialysis, sterilize with bus moral method, aseptic filtration, the powder dosage form is made in packing, lyophilizing.
Good effect of the present invention is: can fully utilize various compositions in the blood plasma, can expand the scale of production arbitrarily, and easy and simple to handle, but application of advanced equipment such as low temperature afterflow centrifuge, ultrafilters etc. also can utilize filtration, and the lower equipment of investments such as dialysis all can obtain to meet the goods of medicinal standard.
Embodiments of the invention are as follows: the high-density protein purposes is that HDL preparation is peace bottle or bottled lyophilizing powder, the inner protein quality is divided into two kinds in 30mg/ bottle and 60mg/ bottle, time spent adds the dissolving of 1ml sterile distilled water, intramuscular injection or intravenous drip, consumption and usage are decided according to the state of an illness by the doctor, generally can adopt intramuscular injection, one time one (peace) bottle, inferior on every Wendesdays, be a course of treatment all around), rest 2-4 days, begin next course of treatment, totally three courses of treatment, do not need to change dietary habit in the therapeutic process.Can proceed treatment in case of necessity.
Production method of the present invention:
(I) ammonium sulfate method
Freeze human plasma, room temperature is dissolved the back filtered through gauze, collects blood plasma 40000ml, add sterile distilled water 40000ml and mix, add 0.4% sodium citrate again, 0.85% sodium chloride stirred 30 minutes, and then mix with the 80000ml saturated ammonium sulfate, stir, leave standstill after-filtration.
Get and reset and add ammonium sulfate 28160g, stir and to make it molten entirely, left standstill filter cake and add suitable quantity of water and make it whole dissolvings, dialysed 72 hours, dialysis solution adds D.S99g, calcium chloride 400g, make whole dissolvings, spend the night second day with 4000rpm, 4 ℃ centrifugal 20 minutes, collecting precipitation adds potassium oxalate 2000ml to all dissolvings, after spending the night again with the same centrifugal condition, centrifugal 20 minutes, collect supernatant, behind the ultrafiltration and concentration, inactivation of virus, aseptic filtration, packing lyophilizing.
(II) utilizes ethanol component IV (FIV) method
Human plasma adds ethanol in right amount and reaches 25% concentration, centrifugal combination I, II and the III section of removing, and supernatant partly appends ethanol and reaches 40% concentration, is settled out FIV.
Get FIV100g, add water 1000ml, stirring and dissolving, with 4000rpm, 4 ℃ centrifugal 20 minutes, get and reset and add D.S5.5g, calcium chloride 2.2g with above-mentioned centrifugal condition recentrifuge, gets precipitation and adds 10% potassium oxalate 300ml, to all dissolvings, the same centrifugal, behind the collection supernatant ultrafiltration and concentration, inactivation of virus, aseptic filtration, the packing lyophilizing.
Claims (1)
1, the production method of HDL preparation is characterized in that:
(1) an amount of adding distil water equivalent dilution of blood plasma adds citron sodium 0.1-1%, and sodium chloride is 0.2-1.5%, stir evenly, add saturated ammonium sulfate solution and become the 30-80% saturation, stir evenly, placement makes its precipitation fully, filters with filter cloth, or centrifugal with the afterflow centrifuge, precipitation (once centrifugal) is used for different purpose, collect filtrate (or centrifuged supernatant), add ammonium sulfate and become the 50%-95% saturation, precipitation back fully is centrifugal with filter cloth filtration or afterflow, clear liquid is used for different purpose, and collecting precipitation (secondary precipitation) is standby.
(2) blood plasma adds ethanol by Cohn third constellations method in right amount and reaches 15-50% concentration, and afterflow is centrifugal, and precipitation is used for different purpose, and supernatant appends ethanol and reaches 20-60%, the afterflow centrifugal collecting precipitation, and supernatant is used for different purpose, and precipitation (FIV) is standby.
(3) get the secondary precipitation of (1) or the FIV of (2), add the suitable quantity of water dissolving, remaining ammonium sulfate (1) method or ethanol (2) method are removed in ultrafiltration or dialysis, collect ultrafiltration or dialyzed solution, adding the dextran sulfuric acid ester becomes 0.2-0.8% and the centrifugal son of divalent sun to become 0.2M, be stirred to moltenly entirely, place more than 16 hours centrifugal collecting precipitation, supernatant is used for different purpose, precipitation is with the dissolving of debita spissitudo oxalates, and is centrifugal or remove by filter the precipitation of generation, and oxalates is removed in supernatant ultrafiltration or dialysis, sterilize with bus moral method, aseptic filtration, the powder dosage form is made in packing, lyophilizing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97119838A CN1070380C (en) | 1997-12-30 | 1997-12-30 | Application and prodn. method of HDL preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN97119838A CN1070380C (en) | 1997-12-30 | 1997-12-30 | Application and prodn. method of HDL preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1189378A CN1189378A (en) | 1998-08-05 |
| CN1070380C true CN1070380C (en) | 2001-09-05 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN97119838A Expired - Fee Related CN1070380C (en) | 1997-12-30 | 1997-12-30 | Application and prodn. method of HDL preparation |
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| Country | Link |
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| CN (1) | CN1070380C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1303413C (en) * | 2003-06-17 | 2007-03-07 | 余伟明 | Protein and virus quick-speed concentration method |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AUPN030794A0 (en) | 1994-12-22 | 1995-01-27 | Aruba International Pty Ltd | Discontinuous plasma or serum delipidation |
| EP2368565B1 (en) * | 2003-07-03 | 2015-06-24 | HDL Therapeutics, Inc. | Enrichment of pre-beta high density lipoproteins |
| EP3143041B1 (en) | 2014-05-15 | 2019-08-14 | Cleveland Heartlab, Inc. | Compositions and methods for purification and detection of hdl and apoa1 |
| CN106983856A (en) * | 2017-03-24 | 2017-07-28 | 杨宝田 | Human blood high density lipoprotein preparation manufacture method and application rich in aPoA |
| CN111868232B (en) | 2017-11-22 | 2024-05-28 | Hdl治疗公司 | System and method for priming a fluid circuit of a plasma processing system |
| CA3087207A1 (en) | 2017-12-28 | 2019-07-04 | Hdl Therapeutics, Inc. | Methods for preserving and administering pre-beta high density lipoprotein extracted from human plasma |
| CN110590937A (en) * | 2018-06-13 | 2019-12-20 | 杨宝田 | Preparation method and application of human apolipoprotein A1 product |
| CN110551207B (en) * | 2019-08-21 | 2023-05-05 | 广州蕊特生物科技有限公司 | Lipoprotein purification method |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DD273164A3 (en) * | 1985-02-06 | 1989-11-08 | Saechsisches Serumwerk | PROCESS FOR ENRICHING LIPOPROTEINS |
-
1997
- 1997-12-30 CN CN97119838A patent/CN1070380C/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DD273164A3 (en) * | 1985-02-06 | 1989-11-08 | Saechsisches Serumwerk | PROCESS FOR ENRICHING LIPOPROTEINS |
Non-Patent Citations (3)
| Title |
|---|
| 河北医学院学报 1992.1.1 宋光耀等，沉淀法和层析法经合分离纯化人血清HDL * |
| 河北医学院学报 1992.1.1 宋光耀等，沉淀法和层析法经合分离纯化人血清HDL;解放军医学杂志，17(2) 1992.1.1 张兴义等，高密度脂蛋白治疗冠心病初步观察 * |
| 解放军医学杂志，17(2) 1992.1.1 张兴义等，高密度脂蛋白治疗冠心病初步观察 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1303413C (en) * | 2003-06-17 | 2007-03-07 | 余伟明 | Protein and virus quick-speed concentration method |
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| Publication number | Publication date |
|---|---|
| CN1189378A (en) | 1998-08-05 |
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Granted publication date: 20010905 Termination date: 20121230 |