보고서 정보
주관연구기관 |
식품의약품안전평가원 |
연구책임자 |
박창원
|
참여연구자 |
김진호
,
이정표
,
김상섭
,
안재형
,
최용규
,
박은재
,
김달환
,
현성예
,
그외 다수
|
보고서유형 | 최종보고서 |
발행국가 | 대한민국 |
언어 |
한국어
|
발행년월 | 2014-12 |
과제시작연도 |
2014 |
주관부처 |
식품의약품안전평가원 |
과제관리전문기관 |
식품의약품안전평가원 National Institute of Food and Drug Safety Evaluation |
등록번호 |
TRKO201500007489 |
과제고유번호 |
1475008011 |
DB 구축일자 |
2015-06-27
|
키워드 |
의약외품,시험법,품질관리Quasi-drug ,Test method, Quality control
|
초록
▼
연구결과
필요성 및 목표
‘의약외품에 관한 기준 및 시험방법’에 수재된 시험법 개선 및 현대화의 필요성이 있어 시험법 개정(안)을 마련하고 신규 수재 필요 품목에 대한 규격(안) 마련 함
방 법 및 결 과
○ ‘의약외품에 관한 기준 및 시험방법’ 개선 연구
- 시험법 개선 필요 품목 및 시험항목 수요조사, 국내외 시험법 비교·검토 및 개정(안) 마련
○ 신규 수재 필요 품목에 규격(안) 마련
- 의약외품 관련 업계의 의견을 수렴하여 6-히드록시인돌 등 6 품목에 대한 신규 고시 수재(안) 마련<
연구결과
필요성 및 목표
‘의약외품에 관한 기준 및 시험방법’에 수재된 시험법 개선 및 현대화의 필요성이 있어 시험법 개정(안)을 마련하고 신규 수재 필요 품목에 대한 규격(안) 마련 함
방 법 및 결 과
○ ‘의약외품에 관한 기준 및 시험방법’ 개선 연구
- 시험법 개선 필요 품목 및 시험항목 수요조사, 국내외 시험법 비교·검토 및 개정(안) 마련
○ 신규 수재 필요 품목에 규격(안) 마련
- 의약외품 관련 업계의 의견을 수렴하여 6-히드록시인돌 등 6 품목에 대한 신규 고시 수재(안) 마련
기대성과
○ 국제적으로 경쟁력 있는 의약외품 품질관리 주도
○ 소비자가 안심하고 사용할 수 있는 의약외품 공급기반 조성
○ 의약외품 관련 업계 활성화 기반 조성
Abstract
▼
Korea Quasi-drug Codex(KQC), which is an official compendium of quasi-drugs including standards and test methods of raw materials and products of quasi-drugs, aims to improve not only efficiencies of review and approval of quasi-drugs but also quality control of them.
KQC includes total 743 items
Korea Quasi-drug Codex(KQC), which is an official compendium of quasi-drugs including standards and test methods of raw materials and products of quasi-drugs, aims to improve not only efficiencies of review and approval of quasi-drugs but also quality control of them.
KQC includes total 743 items of main ingredients and additives which are classified into Ga(28 items), Na(121 items, excluding domestic insecticides), Da(54 items, including domestic insecticides) and additives(540 items), according to ⌜Designation of the scopes of quasi-drugs'. ‘Ga’ consists of the health aids made of paper such as mask, dressing, sanitary pad, etc. ‘Da’ consists of pesticides for disinfection and germicides. And ‘Na’ consists of a variety of quasi-drug products including mouthwash, hair tonic, hair dye, contact lens care items, preparations for internal use or for oral hygiene, etc. Like this, raw materials and products included in ‘Na’ are very diverse, so in foreign countries these are classified as cosmetics or medical instruments.
KQC applies general test methods from the Korean Pharmacopoeia, Japanese standards of raw materials of quasi-drugs, and various test methods of overseas cosmetics and medical instruments, etc. Therefore, in order to revise existing test methods, foreign test methods need to be continuously monitored, however, even a study for an overall review of KQC has not been carried out so far.
Since KQC was completely revised in 2010, modifications or revisions of the items have not been made yet, whereas some studies with regard to KQC update or review of the test methods have been conducted since 2010. However, the majority of the studies were those on the health aids made of paper included in category ‘Ga’ and pesticides falling under category ‘Da’. Even though 540 items of additives and 10 items of category ‘Na’ were newly added in accordance with Notification of revision No. 2013-5(14 Feb. 2013), actually that could be made by being influenced by other Notifications.
Judging from the fact that there has not been any examination history on the items falling under category ‘Na’ and the evaluation department is currently preparing a plan for the advancement of an official compendium, it is desirable that category ‘Na’ generally be reviewed through this study.
Among 121 items falling under category ‘Na’, some items whose tests methods need to be clarified and terms need to be standardized in the Korea Pharmacopoeia have been reviewed and amended. Because the existing clause ‘Reagents, test solutions and standard solutions’ was poor in contents and thus other compendiums were needed for reference when test solutions are prepared, we arranged the reagents and test solutions used in KQC and tried to add them.
In order to clarify test methods of 121 items, we clearly specified test methods in the official compendium. In the case of an ambiguous description on testing processes, we prepared a notification of revision(plan) to help better understand. After preparing notifications of revisions(plans) of 121 items and the clause ‘Reagents, test solutions and standard solutions’, we consulted and reviewed with Cosmetics Evaluation Division(Evaluation Department) and are making the final plan for the notifications of revisions.
In addition, through experiments, we investigated the items whose test methods need to improve and asked for opinions from not only academic-industrial collaborative research groups but also researchers from city or provincial Public Health & Environment Research Institutes. Then we chose 6 items(absorbency test method for menstrual tampons, etc) that need to be studied for the improvement of test methods.
The results of absorbency test for menstrual tampons(The reason for selection, A gradient of a glass cylinder that is used to fix a tampon during the test was not specified.) showed that one item among the six items was inconsistent with the criteria of absorbency of menstrual tampon by the variations of gradients. If the gradient of a glass cylinder is a factor that affects judgment of conformity or nonconformity, it has to be clearly specified in its test method. Plus, additional test devices such as a holder for syngyna test, etc should be installed.
And the verification tests for Compound Nicotinamide, Dexpanthenol and Biotin Solution were carried out according to the guidelines on validation for analysis of pharmaceutical, etc. products. The results showed that the test method using ultraviolet-visible spectrophotometry was consistent with the criteria of linearity, accuracy, preciseness and repeatability and thus it could be used for the test.
In the tests for Compound Dibasic Calcium Phosphate, Precipitated Calcium Carbonate and Aminocaproic Acid Paste, as a result of the test for quantitative method of Aminocaproic Acid Paste, preconditioning processes have been simplified so that convenience will be raised. Plus, validation tests for the improvement of preconditioning processes and analytical conditions were carried out and the results showed all the items i.e. system conformance, linearity, accuracy(recovery) and preciseness between the laboratories(testers and analysis equipments) satisfied all the criteria.
In the verification tests of Phthalthrin(cis:trans 20:80), the solvent alternative test was conducted. Using a study on the development of the green test methods in the official compendium, we selected methanol as a solvent alternative. It was repeatedly measured 10 times according to the infrared spectrum method and the results showed a consistent absorption pattern.
In the verification test of Henna leaf powder and the test for the quantity of the clinical specimen in the quantitative method, it was proved that the increase of the quantity of the specimen did not affect the test method. Plus, according to the guidelines of validation, additional validation was completed. A test for specifying iodine concentration that is used for titration in the quantitative method of Thioglycolic acid 80% was carried out and as a result, it was proved to be 0.1 mol/L.
Lastly, we inquired about industry opinions on the items that need to be included in KQC through quasi-drug academic-industrial collaborative research groups. Quasi-drugs related industries insisted that 6 ingredients of haircolorants i.e. 6-hydroxyindole, hydroxybenzomorpholine, hydroxypropylbis-HCL, 2-amino-3-hydroxypyridine, 1-hydroxyethyl-4,5-diamino pyrazole sulfate, and indigofera tinctoria should be included. Thus, we prepared a new standard plan for the six ingredients of haircolorants and consulted with Cosmetics Evaluation Division(Evaluation Department), so that the final plan of revision is now preparing.
Based on the results of this study, we will complete the final plan of KQC revision and discuss with the evaluation department so that the notification of revision will be made in 2015. This will increase work efficiencies relating to quasi-drug approval and review, improve national competitiveness in the quasi-drug industry and contribute to raising consumer relief and satisfaction.
목차 Contents
- 표지 ... 1
- 자체연구개발과제 최종보고서 ... 2
- 국문 요약문 ... 3
- 영문요약서 ... 6
- 목 차 ... 10
- 연구개발과제 연구결과 ... 11
- 제1장 연구개발과제의 개요 ... 11
- 제1절 연구개발과제의 목표 ... 11
- 제2절 연구개발과제의 필요성 ... 11
- 제2장 연구개발과제의 국내·외 연구개발 현황 ... 11
- 제3장 연구개발과제의 연구수행 내용 및 결과 ... 14
- 제1절 「의약외품에 관한 기준 및 시험방법」 수재 품목 개정(안) 마련 ... 14
- 제2절 「의약외품에 관한 기준 및 시험방법」 시험법 개선을 위한 검증 연구 ... 102
- 제3절 「의약외품에 관한 기준 및 시험방법」 신규 수재 품목 규겨(안) 마련 ... 153
- 제4장 연구개발과제의 연구결과 고찰 및 결론 ... 157
- 제5장 연구개발과제의 목표달성도 및 관련분야에의 기여도 ... 160
- 제6장 연구개발과제의 연구개발 결과 활용계획 ... 161
- 제1절 활용성과 ... 161
- 제2절 활용계획 ... 161
- 제7장 참고문헌 ... 162
- 제8장 첨부서류 ... 163
- 끝페이지 ... 463
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