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Propranolol·HCI-Solid Dispersion System을 함유하는 Poly Vinyl Alcohol hydrogel Hollow type 좌제로부터의 약물 방출

Propranolol·HCI-Solid Dispersion System을 함유하는 Poly Vinyl Alcohol hydrogel Hollow type 좌제로부터의 약물 방출
Other Titles
Drug Release from Poly Vinyl Alcohol hydrogel Hollow Type Suppository with Propranolol-HCl-Solid Dispersion System
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대학원 약학과
PropranololHCIDispersion System약물방출
이화여자대학교 대학원
좌제로부터의 약물방출제어를 목적으로 Poly Vinly Alcohol(PVA)을 기제로 사용한 통상형 좌제 및 중공좌제를 제조하였다. Model drug으로는 수용성 약물인 Propranolol-HCI(PPH)을 사용하였으며 약물의 용출속도 제어를 위하여 Ethyl Cellulose(EC)와 Methyl Cellulose(MC)를 carrier로 두 종류의 Solid Dispersion System(SDS)를 제조하고 각각을 중공좌제의 중공부에 봉입하여 PPH-SDS-PVA hydrogel중공좌제를 제조하였다. 강도 조절 및 약물 방출 속도 제어를 목적으로 기제로 사용한 PVA 1500 : PVA 2000을 0:1, 1:1, 1:2, 1:5로 하고 각각에 대해 동결-융해를 1회에서 4회 반복한 중공좌계를 제조한 후 PPH원말을 중공부에 봉입하였다. SDS로부터의 용출실험결과 PPH-MC-SDS는 4.5시간에서 전량이 용출된 반면 PPH-EC-SDS는 4.5시간에서의 누적용출량이 63%로 용출이 제어되었다. 기제의 강도실험결과 동결-융해를 반복하고 PVA 2000의 비율이 높을수록 강도가 증가하였다. 좌제로부터의 방출실험결좌 PPH-EC-SDS중공좌제는 약물방출이 지연되었으며 보존시간의 영향을 적게 받아 6시간 누적방출량이 제조직후는 16%, 12시간 보존 후는 17%였다. PPH-MC-SDS중공좌제는 방출은 지연되었으나 보존시간의 영향을 크게 받아 6시간 누적방출량이 제조직후는 20%, 12시간 보본 후는 50%였다. 그러나 동결-융해 반복 횟수 및 PVA 1500과 PVA 2000의 비율은 좌제로부터의 약물방출에 영향을 미치지 않았다. PPH원말중공좌제와 PPH-EC-SDS(PPH, EC=1 : 3)중공좌제의 토끼직장흡수결과 약물의 흡수가 지속적이었다.;In order to study the release control of drug from the suppository, the conventional type suppositories and the hollow type suppositories were prepared using PVA hydrogel as a base. Proprandolol-HCl(PPH, water soluble) was chosen as a model drug. For control of drug dissolution, two types of Solid Dispersion System(SDS) were prepared using Ethyl Cellulose(EC) and Methyl Cellulose(MC) as a carrier. Two types of hollow type suppositories were prepared. One was prepared with PPH-EC-SDS, PPH-MC-SDS in the cavity and the other was prepared with different number of freezing-thawing(from one to four times) of PVA 2000 solution and respectively different ratio of PVA 1500 : PVA 2000(0:1, 1:1, 1:2, 1:5) and PPH powder in it's cavity. For the comparative study, a conventional suppository and a hollow type suppository with PPH powder were prepared. In vitro dissolution test of SDS showed that the dissolved amounts of PPH-MC-SDS and PPH-EC-SDS for 4.5-hours were 100% and 63%, respectively. In the relative strength test of PVA hydrogel, PVA hydrogel became harder and more rigid when the number of cycles of freezing-thawing and the ratio of PVA 2000 is increasd. In vitro release test from the suppositories showed that release from the hollow type suppositories with PPH-EC-SDS, PPH-MC-SDS in the cavity was sustained. The hollow type suppository with PPH-EC-SDS in the cavity was not affected by storage time but with PPH-MC-SDS in the cavity was affected by storaged time. After a single rectal administration of the hollow type suppositories with PPH powder and PPH-EC-SDS(PPH:EC=1:3) to rabbits, absorption of drug was sustained.
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