ó㳺í³÷íà îö³íêà ñó÷àñíèõ ìåòîä³â çíåøêîäæåííÿ â³äõîä³â ôàðìàöåâòè÷íî¿ ïðîìèñëîâîñò³ òà íåïðèäàòíèõ ìåäè÷íèõ ïðåïàðàò³â

Êëþ÷îâ³ ñëîâà: ï³ðîë³ç, ³ììîá³ë³çàö³ÿ, ³íêàïñóëÿö³ÿ, çíåøêîäæåííÿ ôàðìàöåâòè÷íèõ â³äõîä³â.

Àííîòàöèÿ

Êîâàëü Í.Ì. Ãèãèåíè÷åñêàÿ îöåíêà ñîâðåìåííûõ ìåòîäîâ îáåçâðåæèâàíèÿ îòõîäîâ ôàðìàöåâòè÷åñêîé ïðîìûøëåííîñòè è íåïðèãîäíûõ ìåäèöèíñêèõ ïðåïàðàòîâ. - Ðóêîïèñü. Äèññåðòàöèÿ íà ñîèñêàíèå íàó÷íîé ñòåïåíè êàíäèäàòà ìåäèöèíñêèõ íàóê ïî ñïåöèàëüíîñòè 14.02.01 - ãèãèåíà (ìåäèöèíñêèå íàóêè). - Èíñòèòóò ãèãèåíû è ìåäèöèíñêîé ýêîëîãèè øèìåíè À.Í. Ìàðçååâà ÀÌÍ Óêðàèíû, Êèåâ, 2005.

Íà îñíîâàíèè ðåçóëüòàòîâ ýêñïåðèìåíòàëüíûõ è íàòóðíûõ èññëåäîâàíèé âïåðâûå áûëè íàó÷íî îáîñíîâàíû ãèãèåíè÷åñêèå ïîäõîäû ê èñïîëüçîâàíèþ ñîâðåìåííûõ ìåòîäîâ îáåçâðåæèâàíèÿ îòõîäîâ ôàðìïðîèçâîäñòâà è íåêà÷åñòâåííûõ ëåêàðñòâ â çàâèñèìîñòè îò èõ õèìè÷åñêîãî ñîñòàâà, êëàññà îïàñíîñòè è ñòîéêîñòè â îêðóæàþùåé ñðåäå. Óñòàíîâëåíî, ÷òî ïðè ðåøåíèè âîïðîñà ïðèìåíåíèÿ àäåêâàòíîãî ìåòîäà îáåçâðåæèâàíèÿ, äàííûå îòõîäû òðåáóþò èíäèâèäóàëüíîãî ïîäõîäà.

Äîêàçàíî, ÷òî ñóùåñòâóþùàÿ íîðìàòèâíàÿ áàçà - Ïðèêàç ÌÇ Óêðàèíû îò 19.03.99 ã. ¹ 67/59 “Îá óòâåðæäåíèè Ïðàâèë ïðîâåäåíèÿ óòèëèçàöèè è óíè÷òîæåíèÿ íåêà÷åñòâåííûõ ëåêàðñòâåííûõ ñðåäñòâ, â ñîñòàâ êîòîðûõ âõîäÿò íàðêîòè÷åñêèå ñðåäñòâà, ïñèõîòðîïíûå âåùåñòâà è ïðåêóðñîðû” íå ãàðàíòèðóåò èõ áåçîïàñíîãî îáåçâðåæèâàíèÿ, òàê êàê íå ó÷èòûâàåò ñîâðåìåííûõ òåõíîëîãèé.  ñâÿçè ñ ýòèì íàìè áûëè àïðîáèðîâàíû ìåòîäû îáåçâðåæèâàíèÿ îòõîäîâ - ñðåäíåòåìïåðàòóðíûé ïèðîëèç, à òàêæå ìåòîä èììîáèëèçàöèè è èíêàïñóëÿöèè.

Ïîêàçàíî, ÷òî ïðè îáåçâðåæèâàíèè ñìåñè íåêà÷åñòâåííûõ ëåêàðñòâ âìåñòå ñ äðóãèìè îðãàíè÷åñêèìè ñîåäèíåíèÿìè íåâîçìîæíî ãàðàíòèðîâàòü ñîáëþäåíèå ðàñ÷åòíûõ ïàðàìåòðîâ âûáðîñîâ çàãðÿçíÿþùèõ âåùåñòâ. Ðåêîìåíäóåòñÿ èñïîëüçîâàòü ýòó òåõíîëîãèþ òîëüêî äëÿ ìåäïðåïàðàòîâ, ïîñêîëüêó ïðè ïèðîëèçå ñìåñåé òðåáóåòñÿ ââåäåíèå äîïîëíèòåëüíûõ ñòåïåíåé î÷èñòêè âûáðîñîâ.

Ïðè îáåçâðåæèâàíèè îòäåëüíûõ íåêà÷åñòâåííûõ ëåêàðñòâ áûëî óñòàíîâëåíî, ÷òî ôàêòè÷åñêèå âûáðîñû çàãðÿçíÿþùèõ âåùåñòâ â àòìîñôåðó è âîçäóõ ðàáî÷åé çîíû, èõ ñîäåðæàíèå â àòìîñôåðíîì âîçäóõå íà ãðàíèöå ñàíèòàðíî-çàùèòíîé çîíû è æèëîé çàñòðîéêè íå ïðåâûøàëè íîðìàòèâíûõ çíà÷åíèé. Âêëàä ïðîöåññà ïèðîëèçà â ñóììàðíîå çàãðÿçíåíèå âîçäóõà ñîñòàâèë 15-28% îò ïðåäåëüíî äîïóñòèìîãî, ÷òî ñâèäåòåëüñòâóåò î äîñòàòî÷íî âûñîêîé ýôôåêòèâíîñòè äàííîé òåõíîëîãèè.

Âûÿâëåíî, ÷òî ïðè íàëè÷èè ôàêòè÷åñêèõ âûáðîñîâ îñíîâíûõ çàãðÿçíèòåëåé íà óðîâíå ïðåäåëüíî äîïóñòèìûõ âî âðåìÿ ïèðîëèçà íåêà÷åñòâåííûõ ëåêàðñòâ, èõ ñîäåðæàíèå â àòìîñôåðíîì âîçäóõå íà ãðàíèöå ÑÇÇ è æèëîé òåððèòîðèè áûëî çíà÷èòåëüíî íèæå ÏÄÊ è ñîîòâåòñòâåííî ñîñòàâëÿëî (â ñðåäíåì) äëÿ: ôîðìàëüäåãèäà (0,2 ÏÄÊ), àììèàêà (0,06 ÏÄÊ), àíãèäðèäà ñåðíîãî (0,04 ÏÄÊ); ôåíîë, òîëóîë, áåíçîë - íå áûëè âûÿâëåíû. Íà ãðàíèöå ÑÇÇ ëèìèòèðóþùèìè ïîêàçàòåëÿìè çàãðÿçíåíèÿ àòìîñôåðíîãî âîçäóõà áûëè ôîðìàëüäåãèä è õëîðèä âîäîðîäà, ïî êîòîðûì ðåêîìåíäóåòñÿ êîíòðîëèðîâàòü ïðîöåññ ïèðîëèçà íåêà÷åñòâåííûõ ëåêàðñòâ.

Óñòàíîâëåíî, ÷òî òåõíîëîãèÿ ïèðîëèçíîãî îáåçâðåæèâàíèÿ ìåäïðåïàðàòîâ íå îêàçûâàåò ñóùåñòâåííîãî âëèÿíèÿ íà çàãðÿçíåíèå àòìîñôåðíîãî âîçäóõà íà ãðàíèöå ÑÇÇ (50 ì) áåíç(à)ïèðåíîì: äî ïèðîëèçà åãî óðîâåíü ñîñòàâëÿë (4,06±0,07)íã/ì3, âî âðåìÿ ïèðîëèçà - (4,20±0,08) íã/ì3.

 ýêñïåðèìåíòàëüíûõ óñëîâèÿõ ïîêàçàíî, ÷òî ñ ïîâûøåíèåì òåìïåðàòóðû îò 550 äî 650 °Ñ óâåëè÷èâàëñÿ âûõîä ãàçîîáðàçíûõ ïðîäóêòîâ ïèðîëèçà àíàëüãèíà (r=0,45, p<0,1) è ïàðàöåòàìîëà (r=0,89, p<0,05), à îáðàçîâàíèå êîíäåíñèðîâàííûõ ñîåäèíåíèé (ñìîëû è óãëåðîäà) ïîíèæàëîñü (r=-0,46, p<0,1) è (r=-0,89, p<0,04) ñîîòâåòñòâåííî. Ñ óìåíüøåíèåì ñîîòíîøåíèÿ îáúåìà ðåòîðòû ê ìàññå óíè÷òîæàåìûõ îòõîäîâ îòìå÷àëèñü îáðàòíûå ïðîöåññû. Óñòàíîâëåíî, ÷òî òåìïåðàòóðà 650 °Ñ è âûøå - íàèáîëåå îïòèìàëüíàÿ äëÿ ïèðîëèçà ìåäïðåïàðàòîâ. Ðåçóëüòàòû ýêñïåðèìåíòà ïîäòâåðæäàþò íåîáõîäèìîñòü âêëþ÷åíèÿ ñèñòåìû äîæèãàíèÿ ïèðîëèçíûõ ãàçîâ â òåõíîëîãè÷åñêóþ ñõåìó ïðîìûøëåííûõ óñòàíîâîê.

Äîêàçàíà ýôôåêòèâíîñòü ìåòîäà èììîáèëèçàöèè è èíêàïñóëÿöèè ïðè èñïîëüçîâàíèè ïîðòëàíä öåìåíòà, äîáàâîê ñîðáåíòîâ è õëîðíîé èçâåñòè äëÿ îñîáî îïàñíûõ âåùåñòâ 1-2 êëàññà îïàñíîñòè. Óñòàíîâëåíî, ÷òî ìåòîä èíêàïñóëÿöèè íàèáîëåå ïðèåìëåìûé äëÿ èõ îáåçâðåæèâàíèÿ.

 ýêñïåðèìåíòå âûÿâëåíî âëèÿíèå êîëè÷åñòâà èììîáèëèçóåìîãî îòõîäà íà ýôôåêòèâíîñòü ìåòîäà: íàèëó÷øèé ðåçóëüòàò íàáëþäàëñÿ ïðè èñïîëüçîâàíèè 5% îòõîäà è äîáàâîê (% îò îáùåé ìàññû êîìïîíåíòîâ) äëÿ: òåòðàöèêëèíîâ - ñìåñè õëîðíîé èçâåñòè (2,0%) è àêòèâèðîâàííîãî óãëÿ (0,7-1,0%); ôòîðõèíîëîíîâ - áåíòîíèòà (1,5%) èëè òîëüêî öåìåíòà; ìàêðîëèäîâ - àêòèâèðîâàííîãî óãëÿ (0,7-1,0%) èëè òîëüêî öåìåíòà. Ýòè äîáàâêè ñíèæàþò ìèãðàöèþ îïàñíûõ èíãðåäèåíòîâ òåòðàöèêëèíîâ íà 94,4%; ôòîðõèíîëîíîâ - íà 94,7-95,2%; ìàêðîëèäîâ - íà 98,0%. Ýôôåêòèâíîñòü èììîáèëèçàöèè íåêîòîðûõ êëàññîâ àíòèáèîòèêîâ áûëà ïîäòâåðæäåíà ìèêðîáèîëîãè÷åñêèì ìåòîäîì.

Óñòàíîâëåíî, ÷òî èñïîëüçîâàíèå õëîðíîé èçâåñòè è äîáàâîê óâåëè÷èâàåò ïðî÷íîñòü öåìåíòíûõ áëîêîâ â 1,1 è 1,5 ðàçà (ð<0,05) ñîîòâåòñòâåííî. Ïîêàçàíî, ÷òî óâåëè÷åíèå êîëè÷åñòâà îòõîäà, êîòîðûé èììîáèëèçóåòñÿ, ñóùåñòâåííî óìåíüøàåò (ð<0,05) ïðî÷íîñòü íà ñæàòèå öåìåíòíîãî áëîêà.

Íàøè èññëåäîâàíèÿ ïîçâîëèëè íàó÷íî îáîñíîâàòü è ðàçðàáîòàòü Èíñòðóêöèþ ïî óíè÷òîæåíèþ íåêà÷åñòâåííûõ ñðåäñòâ â ëàáîðàòîðèÿõ ïî êîíòðîëþ êà÷åñòâà ëåêàðñòâåííûõ ñðåäñòâ, óòâåðæäåííóþ â óñòàíîâëåííîì ïîðÿäêå ÌÇ Óêðàèíû, è Ïðàâèëà ïðîâåäåíèÿ óòèëèçàöèè è óíè÷òîæåíèÿ íåêà÷åñòâåííûõ ëåêàðñòâåííûõ ñðåäñòâ (Ïðèêàç ÌÇ Óêðàèíû îò 08.07.2004 ã. ¹ 349).

Êëþ÷åâûå ñëîâà: ïèðîëèç, èììîáèëèçàöèÿ, èíêàïñóëÿöèÿ, îáåçâðåæèâàíèå ôàðìàöåâòè÷åñêèõ îòõîäîâ.

Annotation

Koval N.M. Hygienic assessment of modern methods for the liquidation the waste of pharmaceutical industry and unqualified medical preparations. - Manuscript. Thesis for the Degree of a Candidate of Medical Science on the speciality 14.02.01 - hygiene (medical sciences). - A.N. Marzeyev Institute for Hygiene and Medical Ecology of the Academy of Medical Sciences of Ukraine, Kiev, 2005.

Fulfilment of sanitary-and-hygienic assessment of modern methods for the liquidation of the waste of pharmaceutical industry and unqualified medical preparations and scientific substantiation of the hygienic approaches to their use is a basis of the dissertation. First of the ground of the experimental and field research of the technologies of middle temperature pyrolis a scientific foundation for sale liquidation of mentioned waste was elaborated. Efficiency of the use of the methods and incapsulation for the liquidation of especially dangerous unqualified medical preparations and waste of pharmaceutical industry was studied in the experimental conditions. Instruction on the liquidation of the unqualified medical preparations in the laboratories for the analysis of the quality of medical preparations confirmed in the established order and Rules for the utilization and liquidation of unqualified medical preparations confirmed by the Order of the Ministry of Public Health of Ukraine, 08.07.2004 ¹ 349 were elaborated.

Key words: pyrolis, immobilization, incapsulation, liquidation the pharmaceutical waste.

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