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JKM > Volume 35(1); 2014 > Article
Park and Lee: Introduction of evidence-based practical medicine through safety classification for herbal medicine(1)



Evidence-based medicine(EBM) advocates the use of up-to-date “best” scientific evidence from health care research as the basis for making medical decisions. EBM also has been applied to traditional Korean medicine(TKM), especially in the field of safety. Recently, the standard prescription for TKM by Korea Institute of Oriental Medicine was published based on toxic index from various toxicity tests. However, there are some limitations when the results from the study based on EBM are applied in clinics. To overcome these imitations, the term “evidence-based practical medicine” was developed and defined as clinically applicable results from the study based on EBM. And safety classification for TKM was suggested as an example of evidence-based practical medicine.


For safety classification for TKM, the data for LD50(50% lethal dose), which was transformed to theoretical LD1(1% lethal dose), was analyzed as one of tools for EMB study and divided by maximum dose used in clinics.

Results and Conclusions:

As a result, human equivalent dose(HED)-based MOS(margin of safety) for korean traditional medicine was calculated and used for safety classification with 5 categories. These categories would be helpful for oriental medicine clinicians to decide the increase and decrease of dosage according to various factors such as patient’s sensitivity, potential toxicity of herbal medicines, clinician’s experience for better cure. Thus, this safety classification provides some evidences enough that evidence-based practical medicine should be not the same with EBM and defined differently from EBM.

Table 1
Classification of Herbal-medicine based on HED-based MOS
등급 HED-based MOS 임상응용 특성
Class 1 < 1 효능용량과 치사용량이 겹치기 때문에 사용금지의 한약재 또는 기존 투여량의 1/10 –1/100 정도의 투여용량 감소가 필요한 한약재
Class 2 1–10 효능용량이 독성용량과 근접하여 소량의 투약으로 극도의 주의가 필요하며 장기 투약을 제한하는 한약재
Class 3 10–50 약물민감성을 가진 환자 및 노약자에게 독성을 유발할 가능성이 있는 한약재
Class 4 50–100 환자에 따라 임상용량의 3배 이하로 증가가 가능한 한약재
class 5 100–500 환자에 따라 임상용량의 5배 이하로 증가가 가능한 한약재
Class 6 > 500 식품과 같이 사용 가능
Table 2
Aristolochic acid containing herbal medicines
한약명 학명

방기 Radix Aristolochiae fangchi(광방기)
Radix Stephaniae tetrandrae(분방기)
Radix Aristolochiae heterophyllae(한중방기)
Radix Cocculi trilobi(목방기)
Fructus Aristolochia contort(마두령)*
Radix Aristolochia contort(청목향, 마두령근)*
Radix Aristolochia debilis(마령초)

목통 Caulis Aristolochiae manshuriensis(관목통)
Caulis Clematidis armandii(천목통)
Caulis Akebiae quinata(목통)

백모등 Herba Aristolochia mollissemae(백모등)
Herba Solani lyrati (백영)

세신 Asarum sieboldii Miq.(화세신)
Asarum heterotropoides(북세신)
Asarum sieboldi Var.(한성세신)

* 사용 금지된 한약재

Table 3
LD50 of Aristolochia debilis
한약재 동물 및 투여 LD50(g/kg)
마령초의 뿌리 마우스 경구 146.5
수치된 마령초 뿌리 마우스 경구 846.1
Table 4
HED-based MOS and safety classification of Aristolochia debilis
한약재 투여 LD50 (g/kg) ALD 전환인자 추정 ALD (g/kg) Km factor (animal/human) ALD의 theoretical HED (g/60kg) 임상투여최고 용량(g) HED-based MOS Class
Aristolochia debilis의뿌리 경구 146.5 2 293 3/37 1425 9 158 4
수치된 마령초 뿌리 경구 846.1 2 1692 3/37 8231 9 914 5
Table 5
HED-based MOS and safety classification of Aristolochia fangchi
부자 종류 동물 및 투여 LD50 (g/kg) ALD 전환인자 추정 ALD (g/kg) Km factor (animal/human) ALD의 theoretical HED (g/60kg) 임상투여최고용량(g) HED-based MOS Class
Aristolochia fangchi의전탕 마우스경구 7.76 2 15.52 3/37 75.5 9 8.3 2
Table 6
LD50 of Aristolochiaceae
여러 종류의 세신 추출형태 동물 및 투여 LD50(/kg)
화세신(Asarum sieboldii Miq.) 전탕 마우스 경구 100.8 g
분말 마우스 경구 7.5 g
휘발성오일 마우스 경구 3.13 ml
한성세신(Asarum sieboldii var. Seoulense Nakai) 전탕 마우스경구 48.7 g
분말 마우스 경구 31.2 g
휘발성오일 마우스 경구 1.92 ml
북세신(Asarum heterotropoides Fr. Schmidt var. mandshuricum kitag) 전탕 마우스 경구 240 g
분말 마우스 경구 4.8 g
휘발성오일 마우스 경구 2.53 ml
Table 7
HED-based MOS and safety classification of Aristolochiaceae
세신 종류 추출형태 LD50 (g/kg) ALD 전환인자 추정 ALD (g/kg) Km factor (animal/human) ALD의 theoretical HED (g/60kg) 임상투여최고용량(g) HED-based MOS Class
화세신 전탕 100.8 2 50.4 3/37 245 3 81 4
분말 7.5 2 3.75 3/37 18 1 18 3
휘발성오일 3.13 2 1.56 3/37 7.6 1 7.6 2
한성세신 전탕 48.7 2 24.35 3/37 118 3 39 3
분말 31.2 2 15.6 3/37 75 1 75 4
휘발성오일 1.92 2 0.96 3/37 4.7 1 4.7 2
북세신 전탕 240 2 120 3/37 584 3 194 5
분말 4.8 2 2.4 3/37 11.7 1 11.7 3
휘발성오일 2.53 2 1.27 3/37 3 1 3 2
Table 8
Summarized HED-based MOS and safety classification for Aristolochiaceae
세신 종류 추출형태 HED-based MOS Class
화세신 전탕 81 4
한성세신 전탕 39 3
북세신 전탕 194 5


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