화학공학소재연구정보센터
홈 로그인 로그아웃 연락처 사이트맵
Polymer(Korea), Vol.44, No.2, 208-218, March, 2020
DOI10.7317/pk.2020.44.2.208  Export Citation
물오리나무 엑스의 폴리에틸렌글리콜 연고제 설계 및 가속 안정성 평가
Polyethylene Glycol-based Ointment Formulations of Alnus Sibirica Extract and Their Accelerated Stability Assessments
구윤태, 강태훈, 이계완1, 김도훈1, 박유화1, 김병덕, 이민원, 방효원2, 최영욱†
  • 중앙대학교 약학대학
  • 1주식회사 동국제약
  • 2중앙대학교 의과대학
Yoon Tae Goo, Tae Hoon Kang, Kye Wan Lee1, Do Hoon Kim1, Yu Hwa Park1, Byoung Deok Kim, Min Won Lee, Hyoweon Bang2, and Young Wook Choi†
  • College of Pharmacy, Chung-Ang University, 84 Heuksuk-ro, Dongjak-gu, Seoul 06974, Korea
  • 1Central Research Institute, Dongkook Pharm Co. Ltd, 145 Gwanggyo-ro, Yeongtong-gu, Suwon 16229, Korea
  • 2College of Medicine, Chung-Ang University, 84 Heuksuk-ro, Dongjak-gu, Seoul 06974, Korea
E-mail:
초록
천연물 유래 면역 조절제인 물오리나무 엑스는 불안정성으로 인해 연고제 개발에 제한적이었다. 본 연구에서는 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 °C. Furthermore, by applying a Q10 value of 2.17, the shelf life of P3 at 25 °C 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.
Keywords:Alnus sibirica extract;polyethylene glycol;ointments;stability;zinc stearate
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