Karakteristik Fisiko-Kimia Radiofarmaka 99m Tc-Human Serum Albumin (HSA)-Nanosfer (Nanny Kartini) ISSN 1411 – 3481 35 KARAKTERISTIK FISIKO-KIMIA RADIOFARMAKA 99m Tc-HUMAN SERUM ALBUMIN (HSA)-NANOSFER Nanny Kartini Oekar, Eva Maria Widyasari, Epy Isabela Pusat Teknologi Nuklir Bahan dan Radiometri – BATAN Jl. Tamansari 71, Bandung 40132 E-mail: kartini@batan-bdg.go.id ABSTRAK KARAKTERISTIK FISIKO-KIMIA RADIOFARMAKA 99m Tc-HUMAN SERUM ALBUMIN (HSA)-NANOSFER. Metode lymphoscintigraphy (limfosintigrafi) adalah metode diagnosis yang dilakukan dengan menyuntikkan sediaan radiofarmasi yang berbentuk nanokoloid dengan ukuran ideal 100-200 nm, bertanda radionuklida teknesium-99m ( 99m Tc) secara intradermal, subkutan atau peritumoral. Pergerakan radiofarmaka tersebut dideteksi dari luar tubuh dengan kamera gamma atau probe khusus untuk limfosintigrafi yang dilakukan secara paralel dengan pembedahan tumor/kanker terutama kanker payudara (breast cancer). Tahun 2006 dan 2007 telah berhasil diteliti pembuatan sediaan 99m Tc-HSA-nanosfer yang merupakan salah satu sediaan nanokoloid yang bersifat biodegredable dan bioavailable. Pada tahun 2008 dipelajari karakteristik fisiko-kimianya, meliputi: kemurnian radiokimia, pH sediaan, lipofilisitas, besarnya ikatan dengan protein plasma, muatan listrik, kestabilan pada penyimpanan pada suhu tertentu dan kestabilan plasmatiknya. Hasilnya menunjukkan bahwa radiofarmaka 99m Tc-HSA-nanosfer mempunyai kemurnian radiokimia 92,1± 2,6%, pH sediaan 6,5–7, angka lipofilisitasnya 0,127±0,03, ikatan dengan protein plasma 89,6 ± 1,2% dan mempunyai muatan listrik netral. Setelah 30 menit disimpan pada temperatur kamar kemurnian radiokimianya turun menjadi 71%, sedangkan apabila disimpan pada temperatur 4 o C (lemari es) sampai satu jam kemurnian radiokimianya masih > 90%. Kestabilan plasmatik yang ditentukan secara in-vitro menunjukkan bahwa kemurnian radiokimia turun secara drastis, dimulai dari 30 menit kemudian 1 jam, yaitu sebesar 61,8 % dan 55,9%, tetapi pada 2, 3 dan sampai 4 jam berikutnya angka ini tidak berubah signifikan yaitu 57,8%, 51,2%, 52% dan setelah 24 jam menjadi 8,2%. Kata kunci: limfosintigrafi, nanokoloid, karakteristik fisiko-kimia, HSA-nanosfer, stabilitas ABSTRACT PHYSICAL-CHEMISTRY CHARACTERISTIC OF 99m Tc-HUMAN SERUM ALBUMIN (HSA)-NANOSPHERES RADIOPHARMACEUTICAL. Lymphoscintigraphy is one of diagnostic method which is conducted by injecting a colloidal radiopharmaceutical labelled technetium-99m which have ideally size of 100-200 nm in diameters by intradermal, subcutanous or peritumoral route. The radiopharmaceutical movement in the lymphatic vessel can be detected from externalside using gamma camera or a special probe for lymphosintigraphy parallelly with surgery of tumor or cancer especially breast cancer. In the year of 2006 and 2007 have succeeded to be carried out designed and formulated of 99m Tc- HSA-nanospheres is representing one of the nanocolloid radiopharmaceutical which is having the biodegredable and bioavailable characters. In the year of 2008, the study was continued to study of phycical-chemistry characteristic of 99m Tc-HSA-nanospheres, including radiochemical purity, pH, lypophilicity, plasma protein binding, electricity charge, stability after storage at certain temperature and in the plasmatic media. The results shows that 99m Tc-HSA- nanospheres radiopharmaceutical have radiochemical purity of 92,1 ± 2,6%, pH = 6,5 - 7, its number of lypophilicity was 0,127 ± 0,03, plasma protein binding 89,6 ± 1,2% and neutral electricity charge. After 30 minutes, it was kept at room temperature, its radiochemical purity slow down became 71%, while if it was kept at temperature of 4 o C (refrigerator) after one hour the radiochemical purity still more than 90%. In vitro plasmatic stability indicated that radiochemical purity was go down drastically, started from 30 minutes later, then one hour that was 61,8 % and 55,9%, and at 2, 3 and until four hours storage this value did not change significantly that was 57,8%, 51,2%, 52% and after 24 hours became 8,2 %. Key words: lymphoscintigraphy, nanocolloid, physical-chemistry characteristics, HSA- nanospheres, stability