CS254672B1 - Agent containing immunoglobulines and stabilizer - Google Patents
Agent containing immunoglobulines and stabilizer Download PDFInfo
- Publication number
- CS254672B1 CS254672B1 CS854291A CS429185A CS254672B1 CS 254672 B1 CS254672 B1 CS 254672B1 CS 854291 A CS854291 A CS 854291A CS 429185 A CS429185 A CS 429185A CS 254672 B1 CS254672 B1 CS 254672B1
- Authority
- CS
- Czechoslovakia
- Prior art keywords
- stabilizer
- maltose
- iga
- igm
- immunoglobulins
- Prior art date
Links
- 239000003381 stabilizer Substances 0.000 title claims abstract description 6
- 239000003795 chemical substances by application Substances 0.000 title description 2
- 108060003951 Immunoglobulin Proteins 0.000 claims abstract description 16
- 102000018358 immunoglobulin Human genes 0.000 claims abstract description 16
- 238000002360 preparation method Methods 0.000 claims abstract description 11
- 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 abstract description 10
- 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 abstract description 10
- 229940072221 immunoglobulins Drugs 0.000 claims abstract description 8
- 239000007864 aqueous solution Substances 0.000 claims description 2
- 238000007918 intramuscular administration Methods 0.000 abstract description 4
- 238000001990 intravenous administration Methods 0.000 description 4
- 108010074605 gamma-Globulins Proteins 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 229930182555 Penicillin Natural products 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 239000007795 chemical reaction product Substances 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 238000009177 immunoglobulin therapy Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 150000002960 penicillins Chemical class 0.000 description 1
- 238000013341 scale-up Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
Landscapes
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
Pripravok obsahujúci imunoglobulíny a stabilizátor obsahuje v 1 litru vodného roztoku imunoglobulínov 3,0 až 30,0 g IgG, 2,5 až 6,5 g IgA, 0,5 až 3,0 IgM a 50,0 až 100,Oj gramov maltózy. Pripravok je vhodný pro intramuskulárne podanie.The preparation containing the immunoglobulins and the stabilizer contains 3.0 to 30.0 g of IgG, 2.5 to 6.5 g of IgA, 0.5 to 3.0 IgM and 50.0 to 100, 0.1 g grams of maltose per liter of aqueous immunoglobulin solution. . The preparation is suitable for intramuscular administration.
Description
Vynález sa týká preparátov imunoglobulínov koncentrovaného typu IgG, IgA, IgM pre intramuskulárnu aplikáciu, kde ako stabilizátor a kryaprotektívna látka sa používá maltóza.The invention relates to immunoglobulin preparations of concentrated type IgG, IgA, IgM for intramuscular administration, wherein maltose is used as a stabilizer and a cryaprotective agent.
Z literárnych údajov je známe, že maltóza sa doporučuje ako nosné médium imunoglobulínov. (Pirofsky B., Anderson J., Bardana E.: Therapeutic and detrimental effect of Intravenous immunoglobulin therapy v: Immunoglobulins : Charasteristics and uses of intravenous preparations, vydali Alving B., Finlayson Y. S.: Food and Drug Administration DHHS Publication No. /FDA/ — 80 — 9005, 1979, str. 245.)It is known from the literature that maltose is recommended as a carrier medium for immunoglobulins. (Pirofsky, B., Anderson, J., Bardana, E .: Therapeutic and Detrimental Effect of Intravenous Immunoglobulin Therapy in: Immunoglobulins: Charasteristics and Uses of Intravenous Preparations, edited by Alving B., Finlayson YS: Food and Drug Administration DHHS Publication No. / FDA / - 80-9005, 1979, p. 245.)
Pri príprave imunoglobulínov koncentrovaného typu IgG, IgA, IgM pre intramuskulárnu aplikáciu je velmi dóležitý problém stability, rozpustnosti a zníženia percenta agregátov a fragmentov imunoglobulínov v koncovom přípravku. Přítomnost maltózy v prípravkoch imunoglobulínov znižuje stupeň agregácie imunoglobulínových molekúl, čo má vplyv na bezpečnost přípravku z htadiska recipienta. [Good R. A.: Intravenous gamma globulin therapy. J. Clin. Immunol. 1982 Apr., Vol.: 2/2 Spupl/, str. 485,. Fernandes P. M., Lundblad J. L.: Preparation of a stabile intravenous gammaglobulin: process desing and scale up., Vox. Sang. 1980 Aug., Vol. 39/2/, str. 101 — 112, Ochs H D., ot al.: Safety and pacient acceptability of intrave72 nous immune globulin in 10 % maltose, Lancet 1980 Nov. 29, Vol.: 2/8205/, str. 1158 — 1159.) Maltóza ako uhlohydrát sa dobré utilizuje v organizme a je dobrým nosičom energie (Gottinger E., Hagmuler K., Hellauer H.: The fate of Intravenously admistreted sugar as energy source. Wien. Kliň. Wschr. 1981 Dec, 25, Vol: 93/24/, str. 755 —, 760).In preparing immunoglobulins of the concentrated type IgG, IgA, IgM for intramuscular administration, the problem of stability, solubility, and a decrease in the percentage of aggregates and fragments of immunoglobulins in the end product is very important. The presence of maltose in immunoglobulin preparations reduces the degree of aggregation of the immunoglobulin molecules, which affects the safety of the preparation from the point of view of the recipient. [Good R. A .: Intravenous gamma globulin therapy. J. Clin. Immunol. 1982 Apr., Vol .: 2/2 Spupl /, p. 485 ,. Fernandes P.M., Lundblad JL .: Preparation of Stabile Intravenous Gammaglobulin: Process Desing and Scale Up., Vox. Sang. 1980 Aug., Vol. 39 (2), p. 101 - 112, Ochs H D., ot al .: Safety and patient acceptability of intrave72 nous immune globulin in 10% maltose, Lancet 1980 Nov. 29, Vol .: 2/8205 /, p. Maltose as a carbohydrate is well utilized in the body and is a good energy carrier (Gottinger E., Hagmuler K., Hellauer H .: The Fate of Intravenously Admitted Sugar as an Energy Source. Wien. Klíň. Wschr. 1981 Dec, 25, Vol: 93/24, pp. 755-760).
Zvlášť u imunodeficientných pacientov, ktorým sa opakované podávajú přípravky imunoglobulínov je důležitá kvalita preparátu z hladiska bezpečnosti recipienta. Maltóza použitá ako stabilizátor v značnej miere zvyšuje kvalitu imunoglobulínových prípravkov koncentrovaného typu.Especially in immunodeficient patients receiving multiple immunoglobulin preparations, the quality of the preparation is important for the safety of the recipient. The maltose used as a stabilizer greatly improves the quality of the concentrated type immunoglobulin preparations.
Vynález sa týká přípravku obsahujúceho imunoglobulíny IgG, IgA, IgM a stabilizátor, ktorý je složený z 1 litra vodného roztoku imunoglobulínov o koncentrácii 3,0 až 30,0 gramov IgG, 2,5 až 6,5 g IgA, 0,5 až 3,0 g IgM a 50,0 až 100 g maltózy.The invention relates to a composition comprising IgG, IgA, IgM and a stabilizer comprising 1 liter of an aqueous solution of immunoglobulins at a concentration of 3.0 to 30.0 grams of IgG, 2.5 to 6.5 g of IgA, 0.5 to 3 1.0 g IgM and 50.0 to 100 g maltose.
Příklad prevedeniaExecution example
K 100 ml roztoku imunoglobulínov o obsahu IgG 0,3 g, IgA 0,25 g a IgM 0,05 g sa přidá 5 g maltózy. Roztok sa homogenizuje, sterilně filtruje a rozplňuje do 20 ml peniciliniek po 10 ml, tieto sa namrazujú a lyofilizujú.To 100 ml of an immunoglobulin solution with an IgG content of 0.3 g, an IgA of 0.25 g and an IgM of 0.05 g is added 5 g of maltose. The solution is homogenized, sterile filtered and filled into 20 ml of 10 ml penicillins, which are frozen and freeze-dried.
Takto připravený prípravok je vhodný pre intramuskulárnu aplikáciu.The composition thus prepared is suitable for intramuscular administration.
Claims (1)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CS854291A CS254672B1 (en) | 1985-06-13 | 1985-06-13 | Agent containing immunoglobulines and stabilizer |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CS854291A CS254672B1 (en) | 1985-06-13 | 1985-06-13 | Agent containing immunoglobulines and stabilizer |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CS429185A1 CS429185A1 (en) | 1987-06-11 |
| CS254672B1 true CS254672B1 (en) | 1988-01-15 |
Family
ID=5385293
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CS854291A CS254672B1 (en) | 1985-06-13 | 1985-06-13 | Agent containing immunoglobulines and stabilizer |
Country Status (1)
| Country | Link |
|---|---|
| CS (1) | CS254672B1 (en) |
-
1985
- 1985-06-13 CS CS854291A patent/CS254672B1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CS429185A1 (en) | 1987-06-11 |
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