물오리나무 엑스의 폴리에틸렌글리콜 연고제 설계 및 가속 안정성 평가open accessPolyethylene Glycol-based Ointment Formulations of Alnus Sibirica Extract and Their Accelerated Stability Assessments
- Authors
- Goo, Yoon Tae; Kang, Tae Hoon; Lee, Kye Wan; Kim, Do Hoon; Park, Yu Hwa; Kim, Byoung Deok; Lee, Min Won; Bang, Hyoweon; Choi, Young Wook
- Issue Date
- Mar-2020
- Publisher
- 한국고분자학회
- Keywords
- sibirica extract; polyethylene glycol; ointments; stability; zinc stearate.
- Citation
- POLYMER(KOREA), v.44, no.2, pp 208 - 218
- Pages
- 11
- Journal Title
- POLYMER(KOREA)
- Volume
- 44
- Number
- 2
- Start Page
- 208
- End Page
- 218
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/38968
- DOI
- 10.7317/pk.2020.44.2.208
- ISSN
- 0379-153X
2234-8077
- Abstract
- 천연물 유래 면역 조절제인 물오리나무 엑스는 불안정성으로 인해 연고제 개발에 제한적이었다. 본 연구에서 는 폴리에틸렌글리콜을 기반으로 한 안정화된 물오리나무 엑스 연고를 개발하였다. 허쉘-버클리 모델에 대입하였을 때 유동 거동 지수는 0.41~0.97로 계산되었으며, 전단박화 유동을 확인하였다. 사람을 대상으로 한 관능 평가에서 폴리에틸렌글리콜 연고가 습윤성 및 수세성 측면에서 백색바셀린 연고보다 높은 점수를 나타내었다. 물오리나무 엑스의 온도의존성 분해반응은 1차 속도식을 따랐으며, 40°C 가속 안정성 시험에서 폴리에틸렌글리콜 연고(P3)의 유효기간이 527일로 가장 길었다. 또한 계산된 2.17의 Q10 값을 이용하였을 때, P3의 유효기간은 25°C에서 4년을 초과하는 것으로 추정되었다. 따라서 우수한 안정성을 갖는 제품 개발에 P3 제제가 적절한 후보군이라 할 수 있다.
Ointment formulation development of Alnus sibirica extract (ASEx), a natural immunomodulator, has been limited because of instability problem. In this study, stabilized ASEx-containing ointments were developed using polyethylene glycol (PEG) base. By the Herschel–Bulkley model, the flow behavior indices were calculated as 0.41~0.97, indicating a shear-thinning flow. The PEG ointments were superior to other comparative formulation, white petrolatumbased ointment, in terms of moistness and removal capacity in a simplified sensory assessment by human volunteers.
ASEx degradation followed first-order kinetics with temperature dependence. From accelerated stability assessments, a selective formulation (P3) was found to have longest shelf life of 527 days at 40 oC. Furthermore, by applying a Q10 value of 2.17, the shelf life of P3 at 25 oC was estimated to exceed four years. Thus, we conclude that the P3 formulation may be an appropriate candidate for development of a commercial product with good long-term stability.
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