A Study on the Management System of Herbal Medicine Used for Food and Drugs in Korean Market
- 주제(키워드) herbal medicine
- 발행기관 고려대학교 대학원
- 지도교수 김찬화
- 발행년도 2015
- 학위수여년월 2015. 2
- 학위구분 박사
- 학과 일반대학원 생명공학과
- 세부전공 생물법제학전공
- 원문페이지 163 p
- 실제URI http://www.dcollection.net/handler/korea/000000057556
- 본문언어 영어
- 제출원본 000045827252
초록/요약
In modern times, people want to live a healthy life and many health supplement products are being produced and sold claiming to do just that. Even amongst these products those derived from nature are of great interest and are getting the most attention from researchers. In Korea, medicinal herbs have been used to treat diseases and maintain health for a very long time. To this end, the Korean government has taken steps to implement politically enforceable policies to provide its citizens with medicinal herbs that have been shown to be safe and effective. Recently the use of medicinal herbs for HMFD (Herbal Medicine Used for Food and Drug) consumption purposes is on the rise. However compared to the medicinal herbs for medicinal purposes that are regulated by the KP (The Korean Pharmacopoeia), HMFD is regulated as a food, which means its quality management is relatively limited. In this research, the quality control analysis was carried out to measure heavy metals, sulfur dioxides, and aflatoxins in order to obtain safety standards for HMFD. To test the HMFDs for heavy metals, 518 products in 71 items (including Glycyrrhizae Radix, Rhizoma etc.) were tested. The contents of lead, cadmium and arsenic were analyzed with ICP-MS after using the microwave method to break down the organic compounds. Mercury levels were detected using a mercury analyzing device, and all heavy metal level detection methods were verified with a method validation. The products used for medicinal purposes in HMFD were divided into the two categories; 1) parts above ground and 2) parts underground. Lead (Pb) levels were relatively higher in the parts above ground, while cadmium (Cd) and arsenic (As) values (㎍/㎏) were relatively higher in the parts underground. Herba (0.628 ㎍/㎏) and caulis and cortex (0.628/0.623 ㎍/㎏), which are both parts above ground, showed especially high lead content levels. For the rhizoma part underground, high levels of Cd and As were detected at 0.192 ㎍/㎏ and 0.143 ㎍/㎏, respectively. The total heavy metal content levels were in the order of rhizoma 0.931 ㎍/㎏, caulis and cortex 0.866 ㎍/㎏, and herba 0.781 ㎍/㎏. There were no noticeable differences in heavy metal content levels between domestic (Korean) and imported HMFDs. Out of the harmful materials, the sulfur dioxide tests showed that out of total 532 test samples, 6.58% had sulfur dioxide levels that were higher than 10 ㎎/㎏. Imported HMFD had a fail rate of 8.05%, which is higher than the 2.87% fail rate of domestic HMFDs. In the sulfur dioxide test, Lycii Fructus showed particularly high residue levels of sulfur dioxide in both domestic and imported products, with a level above 4200 ㎎/㎏. This was determined to be caused by the high moisture content of Lycii Fructus, and also due to the methods used to intensify the product’s color, which uses extra sulfur dioxide. In the aflatoxin analysis, 191 product samples in 11 items were used. As a result, aflatoxin was detected in 41 samples from 10 items (21.5%). The detection frequency in the order was Cassiae semen (50.0%), Testudinis plastrum (43.8%), Batryticatus Bombyx (40.0%), Polygalae Radix (31.2%), Zizyphi Semen (23.5%), Dolichoris Semen, Myristicae Semen (20.0%), Nelumbinis Semen (15.8%), Glycyrrhizae Radix et Rhizoma (7.4%), and Hoveniae Semen Cum Fructus (4.3%). Out of aflatoxin, AFB1 (14.1%) was the most frequently detected, followed by AFB2, AFG1 and AFG2 in 18 cases (9.4%), 16 cases (8.4%), 05 cases (2.6%), respectively. In 41.4% of the samples, 2 or more aflatoxins were detected. In Cassiae Semen, Zizyphi Semen, and Polygalae Radix, all four types of aflatoxins, AFB1, AFB2, AFG1, and AFG2 were detected. In the case of Testudinis Plastrum, Cassiae Semen, Dolichoris Semen, Nelumbinis Semen, and Hoveniae Semen Cum Fructusi, the detected levels violated the KP aflatoxin safety standards. Due to the fragmented management of the safety standards for HMFD and medicinal herbs, this is an area of product safety regulation that needs to be covered by safety standards through more monitoring and research.
more목차
Table of Contents i
List of Tables i
List of Figures iv
Abstract vi
Ⅰ. Introduction 1
Ⅱ. Literature Review 11
2.1. Trend of Research 11
2.1.1. Trend of Overseas Research 11
2.1.2. Trend of Domestic Research 19
2.2. Quality Control of Herbal Medicines Used for Food and Drugs 21
2.2.1. Heavy Metals 21
2.2.2. Sulfur Dioxide (SO2) 25
2.2.3. Mycotoxin 28
2.2.4. Analytical Methods 31
2.2.5. Validation 32
III. Materials and Methods 33
3.1. Analysis of Toxic Metals 33
3.1.1. Materials 33
3.1.2. Analytical Method of Toxic Metals 40
3.2. Analysis of Sulfur Dioxide 51
3.2.1. Materials 51
3.2.2. Analytical Method of Sulfur Dioxide 53
3.2.3. Calculations 59
3.3. Analysis of Microbial Contaminations 60
3.3.1. Materials 60
3.3.2. Analytical Method of Microbial Contamination 66
IV. Results and Discussion 68
4.1. Toxic Metals 68
4.1.1. Validation of Analysis 68
4.1.2. Residual Heavy Metals 95
4.2. Sulfur Dioxide 101
4.3. Microbial contamination 111
4.3.1. Validation of Analysis 111
V. Conclusion 138
Ⅵ. References 141
Abstract in Korean 147
