Journal of Korean Ophthalmic Optics Society (한국안광학회지)

The Korean Ophthalmic Optics Society (한국안광학회)
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Analysis of Evaluation Methods for the Efficacy of Protein Removal Agents for Soft Contact Lens

소프트콘택트렌즈 단백질제거제의 효능 평가법 분석

  • Byuna, Hyun Young (Dept. of Optometry, Seoul National University of Science & Technology) ;
  • Sung, Hyung Gyeong (Dept. of Optometry, Seoul National University of Science & Technology) ;
  • Won, Hye Lim (Dept. of Optometry, Seoul National University of Science & Technology) ;
  • Shim, Ji In (Dept. of Optometry, Seoul National University of Science & Technology) ;
  • Park, Mijung (Dept. of Optometry, Seoul National University of Science & Technology) ;
  • Kim, So Ra (Dept. of Optometry, Seoul National University of Science & Technology)
  • 변현영 (서울과학기술대학교 안경광학과) ;
  • 성형경 (서울과학기술대학교 안경광학과) ;
  • 원혜림 (서울과학기술대학교 안경광학과) ;
  • 심지인 (서울과학기술대학교 안경광학과) ;
  • 박미정 (서울과학기술대학교 안경광학과) ;
  • 김소라 (서울과학기술대학교 안경광학과)
  • Received : 2014.01.31
  • Accepted : 2014.03.15
  • Published : 2014.03.31
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Abstract

Purpose: The present study was conducted to establish the experimental condition for the proper evaluation of protein removal efficacy when developing protein removal agents. Its protein removal efficacy was further analyzed and compared with the result from protein removal efficacy against protein deposition on contact lens to suggest the evaluation method for efficacy of protein removal agents. Methods: Protein digestibility assay presented in the Korean pharmacopoeia was selected to establish the evaluation method for efficacy of papain, pancreatin, subtilisin A and protease itself as a ingredient and protein removal tablets or solution containing those enzymes and find a suitable test conditions. Furthermore, the cleaning efficacy of commercially available protein removal tablets and solution on balafilcon A lens deposited with protein artificially was measured and the correlation between two evaluation methods was further analyzed. Results: When pancreatin itself and the product containing pancreatin was evaluated by protein digestibility assay, both reached 28 IU/mg, the standard value of protein digestibility suggested by the Korean pharmacopoeia. In case of protease and subtilisin A tested with trichloroacetic acid B solution, both of them met the enzyme activity level proposed by the manufacturers when they were evaluated by protein digestibility assay however, papain and subtilisin A tested with trichloroacetic acid A solution were not reached the enzyme activity level. Among protein removal agents, three products except a product containing pancreatin did not meet the enzyme activity value specified by the manufacturer when they were evaluated by protein digestibility assay. However, actual protein removal efficacy of three products except a papain-containing product on the lens was greater than 90% protein removal. In the case of papain-containing protein removal product, its effect was not measured by protein digestibility assay however, its actual protein removal efficacy on the lens reached 73.72%. Conclusions: From the results, it was confirmed that the efficacy of protein removal agents for contact lens should be evaluated by different method according to the type of proteolytic enzyme contained. That is, the protein removal agents containing pancreatin, protease and subtilisin A can be evaluated by protein digestibility assay and protein removal efficiency evaluation and the products containing papain can be effectively evaluated by only the evaluation method for protein removal efficiency employing the lens.

목적: 본 연구에서는 콘택트렌즈 단백질제거제 개발 시 요구되는 단백질 제거효능의 적절한 평가를 위한 시험법을 확립하고 이를 실제 콘택트렌즈에 침착된 단백질의 제거효율을 측정한 결과와 비교, 분석하여 단백질제거제의 효능 평가법으로 제시하고자 하였다. 방법: 대한약전에 제시된 단백소화력 시험법을 이용하여 파파인, 판크레아틴, 섭틸리신 A 및 프로테아제와 각각의 효소가 포함된 단백질제거 정 또는 용액의 효능평가에 적절한 시험조건을 찾고자 하였다. 또한, balafilcon A 재질 렌즈에 인위적으로 침착시킨 단백질을 시판되고 있는 단백질제거 정 또는 용액으로 제거하여 세척효율을 확인하고 이들 방법의 상관관계를 분석하였다. 결과: 판크레아틴과 판크레아틴 함유 제품의 경우 단백소화력 시험법으로 평가하였을 때 둘 다 약전에서 제시하는 판크레아틴 단백소화력 기준값인 28 IU/mg를 충족하였다. 프로테아제와 삼염화아세트산 B 용액으로 실험한 섭틸리신 A의 경우는 단백소화력 시험법으로 평가하였을 때 제조사에서 제시한 효소활성 값을 충족하였으나, 파파인과 삼염화아세트산 A 용액으로 실험한 섭틸리신 A는 제조사에서 제시된 효소활성 값에 해당하는 단백소화력이 측정되지 않았다. 시판되는 단백질제거제의 경우 판크레아틴을 함유한 제품을 제외한 나머지 세 가지 제품은 단백소화력 시험법으로는 제조사에서 명시한 효소들의 단백질 효소활성 값을 확인할 수 없었다. 그러나 실제 렌즈에 침착된 단백질의 제거정도를 측정하였을 때에는 파파인을 함유한 제품을 제외한 3종의 단백질제거제는 모두 90%가 넘는 단백질 제거효율을 보였다. 파파인 함유 단백질제거제의 경우 단백소화력 시험법으로는 효능 측정이 불가능하였으나 실제 렌즈에 침착된 누액단백질 제거효율은 73.72%에 이르렀다. 결론: 본 연구결과로 콘택트렌즈 단백질제거제의 효능은 함유되어 있는 단백분해효소의 종류에 따라 시험법을 달리하여 평가되어야 함을 확인할 수 있었다. 즉, 판크레아틴, 프로테아제, 섭틸리신 A를 함유하는 단백질제거제는 단백소화력 시험법과 단백질제거효율 측정법으로 효능평가가 가능하고, 파파인을 함유하는 단백질제거제의 평가는 콘택트렌즈를 이용한 단백질제거효율 측정법만이 효율적임을 제안할 수 있다.

Keywords

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