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)
Description
Vynález sa týka preparátov imunoglobu-línov koncentrovaného typu IgG, IgA, IgM pre intramuskulárnu aplikáciu, kde ako stabilizátor a kryaprotektívna látka sa používa maltóza. Z literárnych údajov je známe, že maltóza sa doporučuje ako nosné médium imunoglobulínov. (Pirofsky B., Anderson J., Bar-dana 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 Admi-nistration DHHS Publication No. /FDA/ — 80 — 9005, 1979, str. 245.)
Pri príprave imunoglobulínov koncentrovaného typu IgG, IgA, IgM pre intramuskulárnu aplikáciu je veľmi dôležitý problém stability, rozpustnosti a zníženia percenta agregátov a fragmentov imunoglobulínov v koncovom prípravku. Prítomnosť maltózy v prípravkoch imunoglobulínov znižuje stupeň agregácie imunoglobulínových molekúl, čo má vplyv na bezpečnosť prípravku z hľadiska recipienta. (Good R. A.: Intravenous gamma globulin therapy. J. Clin. Immunol. 1982 Apr., Vol.: 2/2 Spupl/, str. 485,. Fernan-des 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 intrave nous immune globulin in 10 % maltose, Lan-cet 1980 Nov. 29, Vol.: 2/8205/, str. 1158 — 1159.) Maltóza ako uhľohydrát sa dobre uti-lizuje v organizme a je dobrým nosičom e-nergie (Gottinger E., Hagmuler K., Hellauer H.: The fate of intravenously admistreted su-gar as energy source. Wien. Klin. Wschr. 1981 Dec, 25, Vol: 93/24/, str. 755 —, 760).
Zvlášť u imunodeficientných pacientov, ktorým sa opakovane podávajú prípravky imunoglobulínov je dôležitá kvalita preparátu z hľadiska bezpečnosti recipienta. Maltóza použitá ako stabilizátor v značnej miere zvyšuje kvalitu imunoglobulínových prípravkov koncentrovaného typu.
Vynález sa týka prípravku 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.
Príklad prevedenia K 100 ml roztoku imunoglobulínov o obsahu IgG 0,3 g, IgA 0,25 g a IgM 0,05 g sa pridá 5 g maltózy. Roztok sa homogenizuje, sterilné filtruje a rozplňuje do 20 ml peni-ciliniek po 10 ml, tieto sa namrazujú a lyo-filizujú.
Takto pripravený prípravok je vhodný pre intramuskulárnu aplikáciu.
Claims (1)
- PREDMET VYNALEZU Prípravok obsahujúci imunoglobulíny IgG, IgA, IgM a stabilizátor vyznačujúci sa tým, že 1 liter vodného roztoku imunoglobulínov obsahuje 3,0 až 30,0 g IgG, 2,5 až 6,5 g IgA, 0,5 až 3,0 g IgM a 50,0 až 100,0 g maltózy.
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 (cs) |
-
1985
- 1985-06-13 CS CS854291A patent/CS254672B1/cs unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CS429185A1 (en) | 1987-06-11 |
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