CN111234010A - Treatment method for reducing ACA in intravenous injection human immunoglobulin - Google Patents
Treatment method for reducing ACA in intravenous injection human immunoglobulin Download PDFInfo
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- CN111234010A CN111234010A CN202010065518.9A CN202010065518A CN111234010A CN 111234010 A CN111234010 A CN 111234010A CN 202010065518 A CN202010065518 A CN 202010065518A CN 111234010 A CN111234010 A CN 111234010A
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- human immunoglobulin
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- intravenous injection
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- 108060003951 Immunoglobulin Proteins 0.000 title claims abstract description 82
- 102000018358 immunoglobulin Human genes 0.000 title claims abstract description 82
- 238000010253 intravenous injection Methods 0.000 title claims abstract description 63
- 238000000034 method Methods 0.000 title claims abstract description 16
- 239000011265 semifinished product Substances 0.000 claims abstract description 56
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims abstract description 48
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 33
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims abstract description 19
- 230000003171 anti-complementary effect Effects 0.000 claims abstract description 14
- 230000000694 effects Effects 0.000 claims abstract description 10
- 238000003672 processing method Methods 0.000 claims abstract description 7
- 230000002391 anti-complement effect Effects 0.000 claims abstract description 6
- 108010008730 anticomplement Proteins 0.000 claims abstract description 6
- 239000011550 stock solution Substances 0.000 claims description 17
- 239000000243 solution Substances 0.000 claims description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 6
- 239000000706 filtrate Substances 0.000 claims description 6
- 238000002347 injection Methods 0.000 claims description 6
- 239000007924 injection Substances 0.000 claims description 6
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 6
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 6
- 229940068968 polysorbate 80 Drugs 0.000 claims description 6
- 229920000053 polysorbate 80 Polymers 0.000 claims description 6
- 239000002244 precipitate Substances 0.000 claims description 6
- 238000001556 precipitation Methods 0.000 claims description 6
- 238000003756 stirring Methods 0.000 claims description 6
- 238000000108 ultra-filtration Methods 0.000 claims description 6
- 239000003223 protective agent Substances 0.000 claims description 5
- 239000000047 product Substances 0.000 claims description 4
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 3
- 239000004471 Glycine Substances 0.000 claims description 3
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 3
- 238000004587 chromatography analysis Methods 0.000 claims description 3
- 238000000502 dialysis Methods 0.000 claims description 3
- 238000001914 filtration Methods 0.000 claims description 3
- 239000012452 mother liquor Substances 0.000 claims description 3
- 239000008215 water for injection Substances 0.000 claims description 3
- 238000005070 sampling Methods 0.000 claims 2
- 238000002360 preparation method Methods 0.000 abstract description 11
- 239000002253 acid Substances 0.000 abstract description 5
- 230000001105 regulatory effect Effects 0.000 abstract description 2
- 150000007513 acids Chemical class 0.000 description 3
- 238000003556 assay Methods 0.000 description 3
- 230000000295 complement effect Effects 0.000 description 3
- 238000010979 pH adjustment Methods 0.000 description 3
- 230000007812 deficiency Effects 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 208000023275 Autoimmune disease Diseases 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 208000027219 Deficiency disease Diseases 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
- 239000000427 antigen Substances 0.000 description 1
- 102000036639 antigens Human genes 0.000 description 1
- 108091007433 antigens Proteins 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000024203 complement activation Effects 0.000 description 1
- 230000003832 immune regulation Effects 0.000 description 1
- 244000052769 pathogen Species 0.000 description 1
- 210000002381 plasma Anatomy 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
Abstract
The invention discloses a processing method for reducing ACA in intravenous injection human immunoglobulin, which comprises the following steps: s1: preparing a semi-finished product of human immunoglobulin for intravenous injection; s2: respectively adding 0.5mol/L hydrochloric acid, 1.0mol/L acetic acid and 1.0mol/L citric acid into the semi-finished product of the intravenous injection human immunoglobulin to adjust the pH value of the semi-finished product to form a sample; s3: determining the anti-complement activity in the sample using the CH50 method; s4: the anticomplementary activity of the semi-finished product of the intravenous injection human immunoglobulin is obtained by analyzing experimental data. The method can better obtain the influence of different pH values regulated by acid on the anticomplementary activity of the semi-finished product of the human immunoglobulin to be infused, thereby ensuring the anticomplementary activity of the semi-finished product of the human immunoglobulin to be infused during preparation.
Description
Technical Field
The invention relates to the technical field of biological engineering, in particular to a processing method for reducing ACA in intravenous injection human immunoglobulin.
Background
The active component of the intravenous injection human immunoglobulin is human immunoglobulin, and more than 1000 human blood plasma is used as a raw material to separate and prepare IgG immunoglobulin. The intravenous injection human immunoglobulin contains broad-spectrum IgG antibody resisting virus, bacteria or other pathogens, and in addition, idiotype and idiotype antibodies of the immunoglobulin can form a complex immune network, so the intravenous injection human immunoglobulin has the double treatment effects of immune substitution and immune regulation, and is mainly used for primary immunoglobulin deficiency, secondary immunoglobulin deficiency and autoimmune diseases clinically.
ACA is anticomplement activity, belongs to an important index in intravenous injection human immunoglobulin, is the ability of a polymer to activate complement under the condition of no antigen binding, the polymer enables complement to be consumed by activating complement, and the complement activation ability is activated
Therefore, the intravenous injection of human immunoglobulin is modulated by adopting different acids, and the relationship between the acids and the anti-complement activity is detected through experiments, so that the clinical significance is remarkable.
Disclosure of Invention
The invention aims to provide a processing method for reducing ACA in intravenous injection human immunoglobulin, which is simple to operate and low in cost and solves the problems in the background technology.
In order to achieve the purpose, the invention adopts the following technical scheme:
a treatment method for reducing ACA in human immunoglobulin for intravenous injection, comprising the steps of:
s1: preparing a semi-finished product of human immunoglobulin for intravenous injection;
s2: respectively adding 0.5mol/L hydrochloric acid, 1.0mol/L acetic acid and 1.0mol/L citric acid into the semi-finished product of the intravenous injection human immunoglobulin to adjust the pH value of the semi-finished product to form a sample;
s3: determining the anti-complement activity in the sample using the CH50 method;
s4: the anticomplementary activity of the semi-finished product of the intravenous injection human immunoglobulin is obtained by analyzing experimental data.
Further, the step S1 of preparing the semi-finished product of human immunoglobulin for intravenous injection includes the following steps:
a1: preparing a semi-finished stock solution of the human immunoglobulin for intravenous injection;
a2: and (3) respectively preparing 5% of the semi-finished product of the human immunoglobulin for intravenous injection and 10% of the semi-finished product of the human immunoglobulin for intravenous injection from the stock solution of the semi-finished product of the human immunoglobulin for intravenous injection.
Further, the step a1 of preparing the stock solution of the semi-finished product of human immunoglobulin for intravenous injection comprises the following steps:
m1: dissolving the secondary precipitate by using injection water with 7 times of precipitation amount and 2-8 ℃, and filtering to form secondary precipitate filtrate;
m2: adjusting the secondary precipitation filtrate with water for injection or mother liquor at 2-8 ℃ until the protein content is 10-13 g/L and the conductivity is less than or equal to 1.8 mS/cm;
m3: adjusting the pH value of the solution in the B2 to 5.60-6.00 by using 1.0mol/L acetic acid solution, and then carrying out chromatography;
m4: adjusting the pH value of the solution in the B3 to 3.50-3.60 by using 1.0mol/L acetic acid solution, and performing ultrafiltration;
m5: and (3) performing ultrafiltration dialysis by using injection water with the volume being 9 times that of the product and the temperature being 2-8 ℃ to form a semi-finished product stock solution of the human immunoglobulin for intravenous injection.
Further, the preparation of the 5% intravenous injection human immunoglobulin semi-finished product is to adopt the stock solution of the intravenous injection human immunoglobulin semi-finished product to add two protective agents of maltose and polysorbate-80 for preparation, adjust the protein content to 53g/L, and sample after stirring for 30 minutes.
Further, the preparation of the 10% intravenous injection human immunoglobulin semi-finished product is to adopt the stock solution of the intravenous injection human immunoglobulin semi-finished product to add two protective agents of glycine and polysorbate-80 for preparation, adjust the protein content to 105g/L, and sample after stirring for 30 minutes.
Further, the pH of the semi-finished product of 5% human immunoglobulin was adjusted to 4.1, 4.2, 4.3 and 4.4 with 0.5mol/L hydrochloric acid, 1.0mol/L acetic acid and 1.0mol/L citric acid, respectively.
Further, the pH of 10% of the semi-finished human immunoglobulin to be injected intravenously was adjusted to 4.4, 4.6, 4.8 and 5.0 with 0.5mol/L hydrochloric acid, 1.0mol/L acetic acid and 1.0mol/L citric acid, respectively.
The invention has the beneficial effects that:
the method can better obtain the influence of different pH values regulated by acid on the anticomplementary activity of the semi-finished product of the human immunoglobulin to be infused, thereby ensuring the anticomplementary activity of the semi-finished product of the human immunoglobulin to be infused during preparation.
Detailed Description
The invention will be further illustrated with reference to specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. The experimental methods in the following examples, which are not specified under specific conditions, are generally performed under conventional conditions. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In addition, any methods and materials similar or equivalent to those described herein can be used in the methods of the present invention. The preferred embodiments and materials described herein are intended to be exemplary only.
The first embodiment is as follows:
a treatment method for reducing ACA in human immunoglobulin for intravenous injection, comprising the steps of:
s1: preparing a semi-finished product of human immunoglobulin for intravenous injection;
s2: respectively adding 0.5mol/L hydrochloric acid, 1.0mol/L acetic acid and 1.0mol/L citric acid into the semi-finished product of the intravenous injection human immunoglobulin to adjust the pH value of the semi-finished product to form a sample;
s3: determining the anti-complement activity in the sample using the CH50 method;
s4: the anticomplementary activity of the semi-finished product of the intravenous injection human immunoglobulin is obtained by analyzing experimental data.
Further, the step S1 of preparing the semi-finished product of human immunoglobulin for intravenous injection includes the following steps:
a1: preparing a semi-finished stock solution of the human immunoglobulin for intravenous injection;
a2: and (3) respectively preparing 5% of the semi-finished product of the human immunoglobulin for intravenous injection and 10% of the semi-finished product of the human immunoglobulin for intravenous injection from the stock solution of the semi-finished product of the human immunoglobulin for intravenous injection.
Specifically, the preparation of the semi-finished product stock solution of the human immunoglobulin for intravenous injection in the step a1 includes the following steps:
m1: dissolving the secondary precipitate by using injection water with 7 times of precipitation amount and 2-8 ℃, and filtering to form secondary precipitate filtrate;
m2: adjusting the secondary precipitation filtrate with water for injection or mother liquor at 2-8 ℃ until the protein content is 10-13 g/L and the conductivity is less than or equal to 1.8 mS/cm;
m3: adjusting the pH value of the solution in the B2 to 5.60-6.00 by using 1.0mol/L acetic acid solution, and then carrying out chromatography;
m4: adjusting the pH value of the solution in the B3 to 3.50-3.60 by using 1.0mol/L acetic acid solution, and performing ultrafiltration;
m5: and (3) performing ultrafiltration dialysis by using injection water with the volume being 9 times that of the product and the temperature being 2-8 ℃ to form a semi-finished product stock solution of the human immunoglobulin for intravenous injection.
Specifically, the preparation of the 5% intravenous injection human immunoglobulin semi-finished product is to adopt the stock solution of the intravenous injection human immunoglobulin semi-finished product to add two protective agents of maltose and polysorbate-80 for preparation, adjust the protein content to 53g/L, stir for 30 minutes and then sample.
Specifically, the preparation of the 10% intravenous injection human immunoglobulin semi-finished product is to adopt the stock solution of the intravenous injection human immunoglobulin semi-finished product to add two protective agents of glycine and polysorbate-80 for preparation, adjust the protein content to 105g/L, stir for 30 minutes and then sample.
Specifically, the pH of a semi-finished product of 5% human immunoglobulin which is injected with 0.5mol/L hydrochloric acid, 1.0mol/L acetic acid and 1.0mol/L citric acid is adjusted to be 4.1, 4.2, 4.3 and 4.4 respectively.
Specifically, the pH of 10% of the semi-finished human immunoglobulin after intravenous injection is adjusted to 4.4, 4.6, 4.8 and 5.0 by using 0.5mol/L hydrochloric acid, 1.0mol/L acetic acid and 1.0mol/L citric acid respectively.
The effect of pH adjustment with different acids on the anticomplementary activity of 5% of the semi-finished human immunoglobulin for intravenous injection was determined by CH50 method according to 3410 "anticomplementary activity assay" in pharmacopoeia of China (four parts of 2015).
Table 1: results of the assay of the anticomplementary activity of 5% intravenous human immunoglobulin semi-finished products:
TABLE 1
As can be seen from Table 1, pH adjustment to 4.3 using 0.5mol/L HCl had the least effect on the anticomplementary activity of 5% of the human immunoglobulin semifinished product for intravenous injection, and ACA was-21%.
Table 2: results of the assay of the anticomplementary activity of 10% intravenous human immunoglobulin semi-finished products:
TABLE 2
As can be seen from Table 2, pH adjustment to 4.6 with 1.0mol/L citric acid had the least effect on anticomplementary activity of 10% of the human immunoglobulin semifinished product for intravenous injection, and ACA was-10%.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.
Claims (7)
1. A process for reducing ACA in human immunoglobulin for intravenous injection comprising the steps of:
s1: preparing a semi-finished product of human immunoglobulin for intravenous injection;
s2: respectively adding 0.5mol/L hydrochloric acid, 1.0mol/L acetic acid and 1.0mol/L citric acid into the semi-finished product of the intravenous injection human immunoglobulin to adjust the pH value of the semi-finished product to form a sample;
s3: determining the anti-complement activity in the sample using the CH50 method;
s4: the anticomplementary activity of the semi-finished product of the intravenous injection human immunoglobulin is obtained by analyzing experimental data.
2. The processing method for reducing ACA in human immunoglobulin according to claim 1, wherein the step S1 of formulating the semi-finished product of human immunoglobulin comprises the steps of:
a1: preparing a semi-finished stock solution of the human immunoglobulin for intravenous injection;
a2: and (3) respectively preparing 5% of the semi-finished product of the human immunoglobulin for intravenous injection and 10% of the semi-finished product of the human immunoglobulin for intravenous injection from the stock solution of the semi-finished product of the human immunoglobulin for intravenous injection.
3. The processing method for reducing ACA in human immunoglobulin according to claim 2, wherein said preparing a semi-finished solution of human immunoglobulin in step a1 comprises the following steps:
m1: dissolving the secondary precipitate by using injection water with 7 times of precipitation amount and 2-8 ℃, and filtering to form secondary precipitate filtrate;
m2: adjusting the secondary precipitation filtrate with water for injection or mother liquor at 2-8 ℃ until the protein content is 10-13 g/L and the conductivity is less than or equal to 1.8 mS/cm;
m3: adjusting the pH value of the solution in the B2 to 5.60-6.00 by using 1.0mol/L acetic acid solution, and then carrying out chromatography;
m4: adjusting the pH value of the solution in the B3 to 3.50-3.60 by using 1.0mol/L acetic acid solution, and performing ultrafiltration;
m5: and (3) performing ultrafiltration dialysis by using injection water with the volume being 9 times that of the product and the temperature being 2-8 ℃ to form a semi-finished product stock solution of the human immunoglobulin for intravenous injection.
4. The processing method for reducing ACA in human immunoglobulin for intravenous injection according to claim 3, wherein the 5% semi-finished product of human immunoglobulin for intravenous injection is prepared by adding maltose and polysorbate-80 as two protective agents into the stock solution of semi-finished product of human immunoglobulin for intravenous injection, adjusting the protein content to 53g/L, stirring for 30 minutes, and then sampling.
5. The processing method for reducing ACA in human immunoglobulin for intravenous injection according to claim 3, wherein the 10% semi-finished product of human immunoglobulin for intravenous injection is prepared by adding glycine and polysorbate-80 into the stock solution of semi-finished product of human immunoglobulin for intravenous injection, adjusting the protein content to 105g/L, stirring for 30 minutes, and then sampling.
6. The method of claim 4, wherein the pH of the semi-finished product of human immunoglobulin to be treated for intravenous injection is adjusted to 4.1, 4.2, 4.3 and 4.4 with 0.5mol/L HCl, 1.0mol/L acetic acid and 1.0mol/L citric acid, respectively.
7. The method of claim 6, wherein the pH of 10% of the immunoglobulin half-finished product is adjusted to 4.4, 4.6, 4.8 and 5.0 with 0.5mol/L HCl, 1.0mol/L acetic acid and 1.0mol/L citric acid.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202010065518.9A CN111234010A (en) | 2020-01-20 | 2020-01-20 | Treatment method for reducing ACA in intravenous injection human immunoglobulin |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202010065518.9A CN111234010A (en) | 2020-01-20 | 2020-01-20 | Treatment method for reducing ACA in intravenous injection human immunoglobulin |
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|---|---|---|---|---|
| US20090018314A1 (en) * | 1997-02-20 | 2009-01-15 | Biogen Idec Inc. | Gamma-1 and gamma-3 anti-human cd23 monoclonal antibodies and use thereof as therapeutics |
| CN104004089A (en) * | 2014-04-12 | 2014-08-27 | 浙江海康生物制品有限责任公司 | Producing method of human immunoglobulin for intravenous injection |
| CN104479011A (en) * | 2015-01-05 | 2015-04-01 | 深圳市卫光生物制品股份有限公司 | Method for preparing intravenous immunoglobulin |
| CN105601736A (en) * | 2016-01-28 | 2016-05-25 | 哈尔滨派斯菲科生物制药股份有限公司 | Respiratory syncytial virus resistance human immune globulin and preparation method thereof |
| CN108101981A (en) * | 2018-01-15 | 2018-06-01 | 四川远大蜀阳药业股份有限公司 | A kind of production technology of intravenous immunoglobulin |
| CN108623677A (en) * | 2018-06-06 | 2018-10-09 | 华兰生物工程重庆有限公司 | A kind of method of purification of intravenous human immunoglobulin(HIg) |
-
2020
- 2020-01-20 CN CN202010065518.9A patent/CN111234010A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20090018314A1 (en) * | 1997-02-20 | 2009-01-15 | Biogen Idec Inc. | Gamma-1 and gamma-3 anti-human cd23 monoclonal antibodies and use thereof as therapeutics |
| CN104004089A (en) * | 2014-04-12 | 2014-08-27 | 浙江海康生物制品有限责任公司 | Producing method of human immunoglobulin for intravenous injection |
| CN104479011A (en) * | 2015-01-05 | 2015-04-01 | 深圳市卫光生物制品股份有限公司 | Method for preparing intravenous immunoglobulin |
| CN105601736A (en) * | 2016-01-28 | 2016-05-25 | 哈尔滨派斯菲科生物制药股份有限公司 | Respiratory syncytial virus resistance human immune globulin and preparation method thereof |
| CN108101981A (en) * | 2018-01-15 | 2018-06-01 | 四川远大蜀阳药业股份有限公司 | A kind of production technology of intravenous immunoglobulin |
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Non-Patent Citations (1)
| Title |
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| 王宗刚等: ""静注人免疫球蛋白抗补体活性测定影响因素的探讨"", 《中国医药生物技术》 * |
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Application publication date: 20200605 |